nct_id
string | updated_at
timestamp[us] | brief_title
string | official_title
string | acronym
string | study_type
string | overall_status
string | study_first_submit_date
timestamp[ms] | start_date
timestamp[ms] | primary_completion_date
timestamp[ms] | completion_date
timestamp[ms] | phases
sequence | enrollment_count
float64 | minimum_age
float64 | maximum_age
float64 | sex
string | healthy_volunteers
bool | brief_summary
string | detailed_description
string | eligibility_criteria
string | lead_sponsor_name
string | lead_sponsor_class
string | org_study_id_info
dict | why_stopped
string | expanded_access_info
dict | last_update_submit_qc_date
timestamp[ms] | last_update_post_date_struct
dict | study_first_post_date_struct
dict | std_ages
sequence | study_population
string | sampling_method
string | oversight_has_dmc
bool | design_info
dict | conditions
sequence | keywords
string | interventions
null | locations
list | collaborators
list | arm_groups
null | outcomes
dict | overall_officials
list | study_references
string | misc_info_module
string | condition_browse_module
dict | intervention_browse_module
dict | mesh_terms
dict |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT00391833 | null | Effect of Panax Ginseng on the Cognitive Performance in Alzheimer's Disease | null | None | INTERVENTIONAL | COMPLETED | 2006-10-22T00:00:00 | null | null | null | [
"PHASE1",
"PHASE2"
] | null | 40 | 83 | FEMALE | null | We investigate the clinical efficacy of Panax ginseng in Alzheimer's disease (AD). | Alzheimer's disease (AD) is characterized by a progressive decline of memory and intellectual abilities, interfering activity in daily living, the overall quality of life, and ultimately leads to death. Although pharmacologic treatments are currently approved for treating mild- to moderate AD using acetylcholinesterase inhibitors (ACEI) or memantine, the NMDA antagonist, for the advanced stage of AD, the therapeutic efficacies need to be further improved.
For millennia, ginseng or its components have been used to treat medical conditions, and the pharmacologic effects have been demonstrated in cardiovascular, endocrine and immune system (Attele et al., 1999). In means of memory and learning, a number of studies suggested that ginseng can attenuate learning deficits of damaged or ageing brains in rodent models (Kennedy et al., 2003; Zhao and McDaniel, 1998; Nitta et al., 1995). In studies with human healthy participants, correspondently, both acute and chronic dosage of ginseng increased the cognitive performance (Kennedy et al., 2001; Kennedy et al., 2003; D'Angelo et al., 1986; Sorensen and Sonne, 1996).
In this study, we we will investigate the contribution of ginseng treatment in increasing the cognitive improvement of AD patients. In addition, we will test various bio-markers and hematopoietic progenitor cell count in those included patients using their blood samples. Patients with AD as well as memory decline will be included | Inclusion Criteria:
* Alzheimer's disease
Exclusion Criteria:
* other neurologic disease | Seoul National University Hospital | OTHER | {
"id": "ginseng-AD",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2006-10-22T00:00:00 | {
"date": "2006-10-24",
"type": "ESTIMATED"
} | {
"date": "2006-10-24",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
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"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Alzheimer's Disease",
"Memory Decline"
] | ["Alzheimer's disease, Ginseng, CD34"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Cognitive performances monitored by MMSE and Alzheimer's disease assessment scales.",
"timeFrame": null
},
{
"description": null,
"measure": "Biomarkers including hematopoietic progenitor cell count.",
"timeFrame": null
}
],
"secondary": null
} | [
{
"affiliation": "Department of Neurology, Seoul National University Hospital",
"name": "Manho Kim, MD, PhD",
"role": "STUDY_CHAIR"
}
] | [{"pmid": "18580589", "type": "DERIVED", "citation": "Lee ST, Chu K, Sim JY, Heo JH, Kim M. Panax ginseng enhances cognitive performance in Alzheimer disease. Alzheimer Dis Assoc Disord. 2008 Jul-Sep;22(3):222-6. doi: 10.1097/WAD.0b013e31816c92e6."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D003704",
"term": "Dementia"
},
{
"id": "D001927",
"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D024801",
"term": "Tauopathies"
},
{
"id": "D019636",
"term": "Neurodegenerative Diseases"
},
{
"id": "D019965",
"term": "Neurocognitive Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
}
],
"browseBranches": [
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"abbrev": "BC10",
"name": "Nervous System Diseases"
},
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"name": "Behaviors and Mental Disorders"
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"name": "All Conditions"
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"name": "Rare Diseases"
}
],
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"id": "M3885",
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"relevance": "HIGH"
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"id": "M6904",
"name": "Dementia",
"relevance": "LOW"
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"id": "T2192",
"name": "Familial Alzheimer Disease",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D000544",
"term": "Alzheimer Disease"
}
]
} | {
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"name": "Herbal and Botanical"
},
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],
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"asFound": "Technical",
"id": "T168",
"name": "Ginseng",
"relevance": "HIGH"
}
],
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} | {
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{
"id": "D000544",
"term": "Alzheimer Disease"
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],
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} |
NCT04378933 | null | Glasses for Adolescent Delayed Sleep-Wake Phase Disorder | Glasses for Adolescent Delayed Sleep-Wake Phase Disorder (GLAD) | None | INTERVENTIONAL | COMPLETED | 2020-05-05T00:00:00 | null | 2022-06-03T00:00:00 | 2022-06-03T00:00:00 | [
"NA"
] | 34 | 14 | 17 | ALL | true | The purpose of this study is to determine if evening amber glasses combined with stable wake times will show an increase in total sleep time (TST) and an advance in sleep onset times (shift earlier) compared to the control group. | We propose a 3-week field study that examines the efficacy, acceptance, and compliance of using evening amber glasses to block evening light combined with a stable wake time in adolescents (14-17 years) with DSWPD (International Classification of Sleep Disorders \[ICSD-3\] criteria).3 After 1 week of baseline measurements, subjects will be instructed to wear glasses (which allow 14% entry of ambient light exposure) starting 7 h before individually calculated midsleep time measured during the preceding week. This corresponds to the time when adolescents are most sensitive to phase delaying light according to Co-I Crowley's recently published phase response curve (PRC) to light in adolescents (Figure 1).22 This "amber glasses + stable wake time" group will be compared to a control group: adolescent DSWPD patients who will wear clear-lensed glasses (which allow 100% of ambient light to reach the eyes, otherwise identical in appearance) in the evening at the same times as the alternate group, but without scheduled wake times. Outcome measures will include TST and sleep onset time derived from wrist actigraphy, daytime subjective sleepiness, salivary DLMO, and assessments of acceptance and compliance. | Inclusion Criteria
* Regular school attendance in the setting of a fixed start time.
* Adherence to ICSD-3 DSWPD diagnostic criteria.
* Average spontaneous weekend wake time ≥1 hour than school day wake time.
* Initiation of school-night sleep at 12 a.m. or later, ≥50% of the time, during a 14-day period (items 3-4 to be determined by sleep logs and actigraphy). As there are no discrete clock times associated with the ICSD-3 DSWPD description, this cutoff is based on data obtained from the 2006 Sleep in America Poll and experiences gleaned from prior recruitment.
Exclusion Criteria
* A positive urine drug abuse screen will disqualify the individual from further participation.
* Subjects will be withdrawn from the study if the sleep log and wrist monitor activity does not correspond with the sleep schedule identified with the pre-study sleep log.
* Alcohol and nicotine use will also be screened to qualify for the study. We will also screen for alcohol immediately before each DLMO assessment because alcohol acutely suppresses melatonin.
* Patients receiving medications that might contribute to sleep disturbances and/or affect treatment responses will be considered ineligible (e.g., hypnotics, antidepressants, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs), beta blockers).
* All subjects will be asked to refrain from caffeine use on the days of phase assessments, and to cease ingestion at least 6 hours prior to nightly bedtime.
* The Ishihara Color Blindness Test will be done and patients who are color blind/deficient will be disqualified from participating in the study. | Mayo Clinic | OTHER | {
"id": "18-003036",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-05-05T00:00:00 | {
"date": "2023-05-06",
"type": "ACTUAL"
} | {
"date": "2020-05-07",
"type": "ACTUAL"
} | [
"CHILD"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Delayed Sleep-Wake Phase Disorder"
] | null | null | [
{
"city": "Chicago",
"country": "United States",
"facility": "Rush University Medical Center",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois"
},
{
"city": "Rochester",
"country": "United States",
"facility": "Mayo Clinic in Rochester",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change in School Night Sleep Onset Time",
"timeFrame": "baseline, week 3"
},
{
"description": null,
"measure": "Change in Non-school Night Sleep Onset Time",
"timeFrame": "baseline, week 3"
},
{
"description": null,
"measure": "Change in Dim Light Melatonin Onset (DLMO)",
"timeFrame": "baseline, week 3"
},
{
"description": null,
"measure": "Change in Dim Light Melatonin Onset (DLMO) Phase Shift",
"timeFrame": "baseline, week 2"
}
],
"secondary": null
} | [
{
"affiliation": "Mayo Clinic",
"name": "R. Robert Auger, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D021081",
"term": "Chronobiology Disorders"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D020920",
"term": "Dyssomnias"
},
{
"id": "D012893",
"term": "Sleep Wake Disorders"
},
{
"id": "D009784",
"term": "Occupational Diseases"
},
{
"id": "D001523",
"term": "Mental Disorders"
}
],
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"abbrev": "BC10",
"name": "Nervous System Diseases"
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"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
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"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC24",
"name": "Occupational Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
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"id": "M22242",
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"relevance": "LOW"
},
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"id": "M22007",
"name": "Sleep Disorders, Circadian Rhythm",
"relevance": "HIGH"
},
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},
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},
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"relevance": "LOW"
},
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"relevance": "LOW"
},
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"relevance": "LOW"
},
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D020178",
"term": "Sleep Disorders, Circadian Rhythm"
}
]
} | {
"ancestors": [
{
"id": "D000697",
"term": "Central Nervous System Stimulants"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D013566",
"term": "Sympathomimetics"
},
{
"id": "D001337",
"term": "Autonomic Agents"
},
{
"id": "D018373",
"term": "Peripheral Nervous System Agents"
},
{
"id": "D015259",
"term": "Dopamine Agents"
},
{
"id": "D018377",
"term": "Neurotransmitter Agents"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D018663",
"term": "Adrenergic Agents"
},
{
"id": "D018759",
"term": "Adrenergic Uptake Inhibitors"
},
{
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"term": "Neurotransmitter Uptake Inhibitors"
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{
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"term": "Membrane Transport Modulators"
},
{
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"term": "Dopamine Uptake Inhibitors"
}
],
"browseBranches": [
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"name": "Central Nervous System Stimulants"
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"name": "All Drugs and Chemicals"
},
{
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"name": "Cardiotonic Agents"
}
],
"browseLeaves": [
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"asFound": "Obtained",
"id": "M11674",
"name": "Methamphetamine",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4029",
"name": "Central Nervous System Stimulants",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M16345",
"name": "Sympathomimetics",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7473",
"name": "Dopamine",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17962",
"name": "Dopamine Agents",
"relevance": "LOW"
},
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"id": "M20504",
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"asFound": null,
"id": "M20746",
"name": "Adrenergic Agents",
"relevance": "LOW"
},
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"id": "M20832",
"name": "Dopamine Uptake Inhibitors",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D008694",
"term": "Methamphetamine"
}
]
} | {
"conditions": [
{
"id": "D020178",
"term": "Sleep Disorders, Circadian Rhythm"
}
],
"interventions": [
{
"id": "D008694",
"term": "Methamphetamine"
}
]
} |
NCT02324933 | null | Post-Operative Pain Control in Opioid Tolerant Patients: Fentanyl Challenge Protocol Versus Standard of Care | Post-Operative Pain Control in Opioid Tolerant Patients: Fentanyl Challenge Protocol Versus Standard of Care | None | INTERVENTIONAL | WITHDRAWN | 2014-12-19T00:00:00 | null | null | null | [
"PHASE4"
] | 0 | 18 | null | ALL | false | This study will evaluate the value of dosing pain medications based upon a patient's pre-operative tolerance to pain medications. Study participants will be assigned to one of two groups, a treatment group and a control group. The treatment group will be given pain medications after surgery based upon their measured response to pain medications prior to surgery. The control group will be given pain medications based upon the normal dosing routine as is currently practiced. Both groups will be closely monitored for side effects and have their pain scores recorded for the first 48 hours following surgery. | This study will focus on patients who are opioid-tolerant pre-operatively, a patient population which typically has both higher pain scores and more complications related to analgesics than opioid naïve patients. Currently, there is no standardized system for determining an adequate pain control regimen for a patient post-operatively. At this institution, pain medications are dosed per physician preference. The most widely-discussed method for calculating tolerance to opioids relies on converting a patient's daily opioid consumption to a morphine equivalent dose and basing a pain regimen upon that number. This method does not account for variability of response to different medications or dosing forms however. It would be advantageous to have a method of dosing opioid pain medications in this population that is both safe and effective. | Inclusion Criteria:
1. Age \> 18
2. Anticipated need for PCA dosing post-operatively
3. Will undergo major general, plastic, vascular, thoracic or spine surgery
4. Have taken opioid medications orally or transdermally daily for the past 30 days
Exclusion Criteria:
1. Patients assessed to have a difficult airway
2. Known sensitivity or allergy to fentanyl | Bassett Healthcare | OTHER | {
"id": "1064",
"link": null,
"type": null
} | insufficient population, unable to recruit | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-12-19T00:00:00 | {
"date": "2015-11-01",
"type": "ESTIMATED"
} | {
"date": "2014-12-24",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
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"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Pain, Postoperative"
] | null | null | [
{
"city": "Cooperstown",
"country": "United States",
"facility": "Bassett Healthcare Network",
"geoPoint": {
"lat": 42.70048,
"lon": -74.92426
},
"state": "New York"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Pain Score",
"timeFrame": "48 hours post-operatively"
}
],
"secondary": [
{
"description": null,
"measure": "Pain Score",
"timeFrame": "24 hours post-operatively"
},
{
"description": null,
"measure": "Events requiring intervention for respiratory depression",
"timeFrame": "48 hours post-operatively"
},
{
"description": null,
"measure": "Number of dose adjustments required",
"timeFrame": "48 hours post-operatively"
}
]
} | [
{
"affiliation": "Bassett Healthcare",
"name": "jose Monzon, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "16037150", "type": "BACKGROUND", "citation": "Davis JJ, Swenson JD, Hall RH, Dillon JD, Johnson KB, Egan TD, Pace NL, Niu SY. Preoperative \"fentanyl challenge\" as a tool to estimate postoperative opioid dosing in chronic opioid-consuming patients. Anesth Analg. 2005 Aug;101(2):389-395. doi: 10.1213/01.ANE.0000156563.25878.19."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D011183",
"term": "Postoperative Complications"
},
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D010146",
"term": "Pain"
},
{
"id": "D009461",
"term": "Neurologic Manifestations"
}
],
"browseBranches": [
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
}
],
"browseLeaves": [
{
"asFound": "Pain, Postoperative",
"id": "M13069",
"name": "Pain, Postoperative",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M13066",
"name": "Pain",
"relevance": "LOW"
},
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"relevance": "LOW"
},
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D010149",
"term": "Pain, Postoperative"
}
]
} | {
"ancestors": [
{
"id": "D000701",
"term": "Analgesics, Opioid"
},
{
"id": "D009294",
"term": "Narcotics"
},
{
"id": "D002492",
"term": "Central Nervous System Depressants"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D000700",
"term": "Analgesics"
},
{
"id": "D018689",
"term": "Sensory System Agents"
},
{
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"term": "Peripheral Nervous System Agents"
},
{
"id": "D000759",
"term": "Adjuvants, Anesthesia"
},
{
"id": "D018686",
"term": "Anesthetics, Intravenous"
},
{
"id": "D018681",
"term": "Anesthetics, General"
},
{
"id": "D000777",
"term": "Anesthetics"
}
],
"browseBranches": [
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"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
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"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "AdjAn",
"name": "Adjuvants, Anesthesia"
},
{
"abbrev": "PsychDr",
"name": "Psychotropic Drugs"
},
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"name": "Analgesics"
}
],
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M11845",
"name": "Midazolam",
"relevance": "LOW"
},
{
"asFound": "Collection",
"id": "M8418",
"name": "Fentanyl",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4033",
"name": "Analgesics, Opioid",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4032",
"name": "Analgesics",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12245",
"name": "Narcotics",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4089",
"name": "Adjuvants, Anesthesia",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20766",
"name": "Anesthetics, Intravenous",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20761",
"name": "Anesthetics, General",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D005283",
"term": "Fentanyl"
}
]
} | {
"conditions": [
{
"id": "D010149",
"term": "Pain, Postoperative"
}
],
"interventions": [
{
"id": "D005283",
"term": "Fentanyl"
}
]
} |
NCT01461733 | null | Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit | Atrial Fibrillation WITHOUT Hemodynamic Stability | AFIB | INTERVENTIONAL | COMPLETED | 2010-08-19T00:00:00 | null | null | null | [
"PHASE4"
] | 25 | 18 | null | ALL | false | Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence that resolves as the patient recovers from their underlying condition. However, patients who develop AF can present with a very rapid heart rate that in some cases can put stress on the heart which can lead to life threatening heart attacks, low blood pressure or breathing problems. Not all patients with AF will have unstable heart function but those who have rapid heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate but no unstable heart function are two fold. Patients can be treated by controlling the heart rate and/or by attempting to convert the AF to a normal heart rhythm. The heart rate can be controlled by medication and the AF can be converted by either electrical cardioversion (an electric shock that jump-starts the heart) or medication. Currently it is unknown if the goal of treatment should be to simply control the heart rate and wait for the patient to spontaneously convert to a normal heart rhythm or convert the AF with medication for patients who only have the rapid heart rate.
The objective of this project is to conduct a pilot study to determine if it would be feasible to conduct a larger definitive trial that would answer the following question: Should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart rhythm in patients with AF who have a rapid heart rate without unstable heart function. | see above | Inclusion Criteria:
* new onset afib
Exclusion Criteria:
* hemodynamically unstable | Ottawa Hospital Research Institute | OTHER | {
"id": "NA5936 Heart and Stroke",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2011-10-27T00:00:00 | {
"date": "2014-09-15",
"type": "ESTIMATED"
} | {
"date": "2011-10-28",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Atrial Fibrillation"
] | ["atrial fibrillation", "amiodarone"] | null | null | [
{
"class": "OTHER",
"name": "Heart and Stroke Foundation of Ontario"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Conversion From Atrial Fibrillation to Sinus Rhythm",
"timeFrame": "From randomization to conversion or ICU discharge up to 100 months."
}
],
"secondary": null
} | [
{
"affiliation": "Ottawa Hospital Research Institute",
"name": "Salmaan Kanji, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D001145",
"term": "Arrhythmias, Cardiac"
},
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
"browseBranches": [
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Atrial Fibrillation",
"id": "M4586",
"name": "Atrial Fibrillation",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4453",
"name": "Arrhythmias, Cardiac",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9419",
"name": "Heart Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001281",
"term": "Atrial Fibrillation"
}
]
} | {
"ancestors": [
{
"id": "D000889",
"term": "Anti-Arrhythmia Agents"
},
{
"id": "D014665",
"term": "Vasodilator Agents"
},
{
"id": "D026902",
"term": "Potassium Channel Blockers"
},
{
"id": "D049990",
"term": "Membrane Transport Modulators"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D026941",
"term": "Sodium Channel Blockers"
},
{
"id": "D065609",
"term": "Cytochrome P-450 CYP1A2 Inhibitors"
},
{
"id": "D065607",
"term": "Cytochrome P-450 Enzyme Inhibitors"
},
{
"id": "D004791",
"term": "Enzyme Inhibitors"
},
{
"id": "D065688",
"term": "Cytochrome P-450 CYP2C9 Inhibitors"
},
{
"id": "D065690",
"term": "Cytochrome P-450 CYP2D6 Inhibitors"
},
{
"id": "D065692",
"term": "Cytochrome P-450 CYP3A Inhibitors"
}
],
"browseBranches": [
{
"abbrev": "AnArAg",
"name": "Anti-Arrhythmia Agents"
},
{
"abbrev": "ChanBlk",
"name": "Channel Blockers"
},
{
"abbrev": "VaDiAg",
"name": "Vasodilator Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
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{
"asFound": "ERAS",
"id": "M3976",
"name": "Amiodarone",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4213",
"name": "Anti-Arrhythmia Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17412",
"name": "Vasodilator Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23171",
"name": "Potassium Channel Blockers",
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},
{
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"name": "Sodium Channel Blockers",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M30025",
"name": "Diuretics, Potassium Sparing",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M30537",
"name": "Cytochrome P-450 Enzyme Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M30564",
"name": "Cytochrome P-450 CYP3A Inhibitors",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000638",
"term": "Amiodarone"
}
]
} | {
"conditions": [
{
"id": "D001281",
"term": "Atrial Fibrillation"
}
],
"interventions": [
{
"id": "D000638",
"term": "Amiodarone"
}
]
} |
NCT05654233 | null | The Study of Reducing Adverse Effects After Radiofrequency Ablation Combined With Sclerotherapy | The Study of Reducing Adverse Effects After Radiofrequency Ablation Combined With Sclerotherapy | None | INTERVENTIONAL | UNKNOWN | 2022-11-22T00:00:00 | null | 2023-08-01T00:00:00 | 2023-09-01T00:00:00 | [
"NA"
] | 120 | 18 | 80 | ALL | false | The purpose of this study is to evaluate whether adding sulodexide to the patients with varicose veins who received radiofrequency ablation combined with sclerotherapy can reduce or improve the impact of adverse events。 | Chronic venous insufficiency（CVI）of the lower extremities is a commonly clinically syndrome。 It can manifest as telangiectasias (or spider veins), reticular veins, varicose veins（VVS）, edema, pigmentation and/or eczema, liposomal sclerosis, white atrophy, and venous ulcers。 Patients often seek treatment for varicose veins because of cosmetic problems, pain, swelling, itching, ulcers, and other symptoms。 With the development of society, more and more patients require to choose local anesthesia, minimally invasive, and rapid recovery surgery. Radiofrequency ablation(RFA) combined with sclerotherapy is a treatment with a broad clinically applicable spectrum for varicose veins, ranging from the Great saphenous vein （GSV）trunk to telangiectases (or spider veins).US guidelines for treating varicose veins and chronic venous disease of the lower extremities recommend endovascular thermal ablation (including RFA) as safe and effective for treating saphenous venous insufficiency. Foam sclerotherapy is to close the diseased vein by mixing sclerosants with air in a particular proportion and injecting it into the venous blood vessels so that the vein generates artificial thrombus and fibrosis. Because of its simple, economical, and minimally invasive characteristics, it is widely used in clinical practice.
Pigmentation, fibrous induration, and pain are the most common complications after RFA combined with sclerotherapy. Hyperpigmentation is a brownish discoloration of the skin due to extravasation of red blood cells and hemosiderin deposition。 Fibrous induration and pain are mainly caused by thrombosis, inflammation, and vascular fibrosis。 Sulodexide is an orally vasoactive drug consisting of 80% heparin sulfate + 20% corn sulfate， with antithrombotic, fibrinolytic, anti-inflammatory, endothelial protective, and vascular regulating properties. This agent is used in venous ulcers, prevents recurrent venous thromboembolism, and has a low incidence of bleeding complications.
Clinical observation in our department found that adding sulodexide can reduce or improve the impact of adverse events after RFA combined with sclerotherapy。
The purpose of this study is to evaluate whether adding sulodexide to the patients with varicose veins who received RFA combined with sclerotherapy accelerates the dissipation of pigmentation and fibrosis。 | Inclusion Criteria:
* Age \>18 years and \<80 years, and able to understand the requirements of the study and provide informed consent and accept the exams and follow-up.
* C2 - C5 varicose veins / CVI Symptomatic primary GSV, SSV, or AASV incompetence, with reflux \>0.5 seconds on color duplex, eligible for patients undergoing radiofrequency ablation plus sclerotherapy
* BMI\<35
* The skin color is within the normal range, and no obvious skin color unevenness or skin diseases affect the observed indicators.
Exclusion Criteria:
* Acute superficial or deep vein thrombosis
* History of asthma and stroke
* There are skin diseases, scars, infections, and other conditions in the surgical area that affect the observation indicators
* Pregnancy
* Serious damage to liver and kidney function
* Severe obesity (BMI\>35) and severe edema of the lower extremities
* Others are not eligible for intravenous radiofrequency ablation combined with sclerotherapy | Chengdu University of Traditional Chinese Medicine | OTHER | {
"id": "ChengduUTCMvs4",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-12-07T00:00:00 | {
"date": "2023-01-03",
"type": "ACTUAL"
} | {
"date": "2022-12-16",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A total of 120 patients with varicose veins who received radiofrequency ablation combined with sclerotherapy were randomly divided into two groups。 Each group included 60 people, one group added sulodexide based on the conventional treatment process, and the other group was a control group. The recovery of adverse reactions after surgery in both groups was observed.",
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]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Vascular Diseases, Peripheral",
"Venous Insufficiency of Leg",
"Varicose Veins of Lower Limb"
] | ["Radiofrequency ablation combined with sclerotherapy", "varicose veins", "Sulodexide"] | null | [
{
"city": "Chengdu",
"country": "China",
"facility": "Hospital of Chengdu University of Traditional Chinese Medicine",
"geoPoint": {
"lat": 30.66667,
"lon": 104.06667
},
"state": "Sichuan"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Changes in pigmentation area and color depth over the three months after surgery.",
"timeFrame": "three months"
},
{
"description": null,
"measure": "Changes in the incidence and hardness (Shore hardness) of fibrous induration in the three months after surgery.",
"timeFrame": "three months"
},
{
"description": null,
"measure": "Changes in the area of congestion in the three months after surgery.",
"timeFrame": "three months"
}
],
"secondary": [
{
"description": null,
"measure": "Changes in pain scores on a visual analogue scale over the three months postoperatively postoperative",
"timeFrame": "three months"
},
{
"description": null,
"measure": "Incidence of bleeding complications",
"timeFrame": "three months"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D050197",
"term": "Atherosclerosis"
},
{
"id": "D001161",
"term": "Arteriosclerosis"
},
{
"id": "D001157",
"term": "Arterial Occlusive Diseases"
}
],
"browseBranches": [
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
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"id": "M17400",
"name": "Vascular Diseases",
"relevance": "HIGH"
},
{
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"id": "M17396",
"name": "Varicose Veins",
"relevance": "HIGH"
},
{
"asFound": "Venous Insufficiency",
"id": "M17435",
"name": "Venous Insufficiency",
"relevance": "HIGH"
},
{
"asFound": "Vascular Disease, Peripheral",
"id": "M29213",
"name": "Peripheral Arterial Disease",
"relevance": "HIGH"
},
{
"asFound": "Vascular Disease, Peripheral",
"id": "M18894",
"name": "Peripheral Vascular Diseases",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M26188",
"name": "Atherosclerosis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4469",
"name": "Arteriosclerosis",
"relevance": "LOW"
},
{
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"id": "M4465",
"name": "Arterial Occlusive Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D014689",
"term": "Venous Insufficiency"
},
{
"id": "D014648",
"term": "Varicose Veins"
},
{
"id": "D016491",
"term": "Peripheral Vascular Diseases"
},
{
"id": "D058729",
"term": "Peripheral Arterial Disease"
}
]
} | {
"ancestors": [
{
"id": "D000925",
"term": "Anticoagulants"
},
{
"id": "D000960",
"term": "Hypolipidemic Agents"
},
{
"id": "D000963",
"term": "Antimetabolites"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D057847",
"term": "Lipid Regulating Agents"
},
{
"id": "D005343",
"term": "Fibrinolytic Agents"
},
{
"id": "D050299",
"term": "Fibrin Modulating Agents"
},
{
"id": "D007004",
"term": "Hypoglycemic Agents"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
}
],
"browseBranches": [
{
"abbrev": "Hypo",
"name": "Hypoglycemic Agents"
},
{
"abbrev": "FiAg",
"name": "Fibrinolytic Agents"
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{
"abbrev": "AnCoag",
"name": "Anticoagulants"
},
{
"abbrev": "Lipd",
"name": "Lipid Regulating Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Ot",
"name": "Other Dietary Supplements"
}
],
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"id": "M261787",
"name": "Glucuronyl glucosamine glycan sulfate",
"relevance": "HIGH"
},
{
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"id": "M4244",
"name": "Anticoagulants",
"relevance": "LOW"
},
{
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"id": "M4278",
"name": "Hypolipidemic Agents",
"relevance": "LOW"
},
{
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"id": "M4281",
"name": "Antimetabolites",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M28883",
"name": "Lipid Regulating Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8473",
"name": "Fibrinolytic Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10054",
"name": "Hypoglycemic Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T395",
"name": "Glucosamine",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "C007858",
"term": "Glucuronyl glucosamine glycan sulfate"
}
]
} | {
"conditions": [
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D014689",
"term": "Venous Insufficiency"
},
{
"id": "D014648",
"term": "Varicose Veins"
},
{
"id": "D016491",
"term": "Peripheral Vascular Diseases"
},
{
"id": "D058729",
"term": "Peripheral Arterial Disease"
}
],
"interventions": [
{
"id": "C007858",
"term": "Glucuronyl glucosamine glycan sulfate"
}
]
} |
NCT02374333 | null | Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy | Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 Attached to TCRζ and 4-1BB Signaling Domains in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy | None | INTERVENTIONAL | COMPLETED | 2015-02-23T00:00:00 | null | 2021-09-02T00:00:00 | 2021-09-02T00:00:00 | [
"PHASE1"
] | 81 | 1 | 24 | ALL | false | This is a pilot study to evaluate humanized CD19 redirected autologous T cells (or huCART19 cells) in patients with relapsed or refractory CD19+ leukemia and lymphoma that was previously treated with cell therapy. This study is targeting pediatric patients aged 1-24 years with CD19+ B cell malignancies with no available curative treatment options (such as autologous or allogeneic stem cell transplantation) who have a limited prognosis with currently available therapies and were previously treated with a B cell directed engineered cell therapy product. | null | Inclusion Criteria:
Male and female subjects with documented CD19+ B cell malignancies and no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \<2 year survival) with currently available therapies will be enrolled:
1. Eligible diseases: CD19+ leukemia or lymphoma. In general, these will be patients with:
1. ALL without curative options for therapy, including those not eligible for allogeneic SCT. Patient may be in any complete response, or patient may have active disease but responding or stable after most recent therapy.The intent is not to enroll patients with no degree of disease control or rapidly increasing disease burden between enrollment and cell infusion.
2. Diffuse large cell lymphoma or other high-grade NHL, previously identified as CD19+ including residual disease after primary therapy and not eligible for autologous SCT; relapsed after prior autologous SCT; beyond 1st CR with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT.
2. Patients previously treated with B cell directed engineered cell therapy are eligible if they meet one of the following criteria:
1. partial response or no response to prior cell therapy
2. relapsed after prior cell therapy
3. demonstrated B cell recovery suggesting loss of engineered cells.
3. Documented CD19 expression (after previous B cell directed cell therapy, if applicable)
4. Age 1 to 24 years
5. Expected survival \> 12 weeks
6. Creatinine \< 2.5 mg/dl and less than 2.5x normal for age
7. Bilirubin \<2.0 mg/dl
8. Adequate pulmonary function defined as \< Grade 3 hypoxia
9. Adequate cardiac function defined as LVSF ≥ 28% confirmed by ECHO
10. Adequate performance status (Lansky or Karnofsky score ≥50)
11. Patients with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) will be eligible if they meet all other inclusion criteria and
1. Have no active GVHD and require no immunosuppression
2. Are more than 4 months from transplant (6 months at infusion)
12. Patients with CNS3 disease will be eligible if CNS disease is responsive to therapy
13. For those patients who require leukapheresis for T cell collection (i.e. no previously collected product exists), adequate venous access for apheresis or eligible for appropriate catheter placement, and no other contraindications for leukapheresis.
14. Voluntary informed consent is given.
Exclusion Criteria:
1. Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
2. Uncontrolled active infection.
3. Active hepatitis B or hepatitis C infection.
4. Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.
5. Presence of grade 2-4 acute or extensive chronic GVHD.
6. Under treatment for GVHD.
7. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity
8. Any uncontrolled active medical disorder that would preclude participation as outlined.
9. HIV infection | University of Pennsylvania | OTHER | {
"id": "13BT022, 819851",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-02-26T00:00:00 | {
"date": "2021-09-23",
"type": "ACTUAL"
} | {
"date": "2015-02-27",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Acute Lymphocytic Leukemia",
"Diffuse Large Cell Lymphoma"
] | null | null | [
{
"city": "Philadelphia",
"country": "United States",
"facility": "Children's Hospital of Philadelphia",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment.",
"timeFrame": "Study treatment until Week 24"
}
],
"secondary": null
} | [
{
"affiliation": "University of Pennsylvania",
"name": "Carl June, MD",
"role": "STUDY_CHAIR"
}
] | [{"pmid": "36351239", "type": "DERIVED", "citation": "Newman H, Li Y, Liu H, Myers RM, Tam V, DiNofia A, Wray L, Rheingold SR, Callahan C, White C, Baniewicz D, Winestone LE, Kadauke S, Diorio C, June CH, Getz KD, Aplenc R, Teachey DT, Maude SL, Grupp SA, Bona K, Leahy AB. Impact of poverty and neighborhood opportunity on outcomes for children treated with CD19-directed CAR T-cell therapy. Blood. 2023 Feb 9;141(6):609-619. doi: 10.1182/blood.2022017866."}, {"pmid": "34515338", "type": "DERIVED", "citation": "Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2."}, {"pmid": "34156874", "type": "DERIVED", "citation": "Myers RM, Li Y, Barz Leahy A, Barrett DM, Teachey DT, Callahan C, Fasano CC, Rheingold SR, DiNofia A, Wray L, Aplenc R, Baniewicz D, Liu H, Shaw PA, Pequignot E, Getz KD, Brogdon JL, Fesnak AD, Siegel DL, Davis MM, Bartoszek C, Lacey SF, Hexner EO, Chew A, Wertheim GB, Levine BL, June CH, Grupp SA, Maude SL. Humanized CD19-Targeted Chimeric Antigen Receptor (CAR) T Cells in CAR-Naive and CAR-Exposed Children and Young Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia. J Clin Oncol. 2021 Sep 20;39(27):3044-3055. doi: 10.1200/JCO.20.03458. Epub 2021 Jun 22."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D008232",
"term": "Lymphoproliferative Disorders"
},
{
"id": "D008206",
"term": "Lymphatic Diseases"
},
{
"id": "D007160",
"term": "Immunoproliferative Disorders"
},
{
"id": "D007154",
"term": "Immune System Diseases"
},
{
"id": "D006402",
"term": "Hematologic Diseases"
},
{
"id": "D007945",
"term": "Leukemia, Lymphoid"
},
{
"id": "D016393",
"term": "Lymphoma, B-Cell"
},
{
"id": "D008228",
"term": "Lymphoma, Non-Hodgkin"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC15",
"name": "Blood and Lymph Conditions"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC20",
"name": "Immune System Diseases"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
"asFound": "Leukemia",
"id": "M10945",
"name": "Leukemia",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M10951",
"name": "Leukemia, Lymphoid",
"relevance": "LOW"
},
{
"asFound": "Lymphoma",
"id": "M11220",
"name": "Lymphoma",
"relevance": "HIGH"
},
{
"asFound": "Acute Lymphocytic Leukemia",
"id": "M27585",
"name": "Precursor Cell Lymphoblastic Leukemia-Lymphoma",
"relevance": "HIGH"
},
{
"asFound": "Diffuse large cell lymphoma",
"id": "M18831",
"name": "Lymphoma, Large B-Cell, Diffuse",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M12315",
"name": "Neoplasms by Histologic Type",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11225",
"name": "Lymphoproliferative Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11203",
"name": "Lymphatic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10206",
"name": "Immunoproliferative Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10200",
"name": "Immune System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9490",
"name": "Hematologic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M18828",
"name": "Lymphoma, B-Cell",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11222",
"name": "Lymphoma, Non-Hodgkin",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T170",
"name": "Acute Graft Versus Host Disease",
"relevance": "LOW"
},
{
"asFound": "Lymphoma",
"id": "T3543",
"name": "Lymphosarcoma",
"relevance": "HIGH"
},
{
"asFound": "Acute Lymphocytic Leukemia",
"id": "T175",
"name": "Acute Lymphoblastic Leukemia",
"relevance": "HIGH"
},
{
"asFound": "Acute Lymphocytic Leukemia",
"id": "T3533",
"name": "Lymphoblastic Lymphoma",
"relevance": "HIGH"
},
{
"asFound": "Diffuse large cell lymphoma",
"id": "T1866",
"name": "Diffuse Large B-Cell Lymphoma",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "T640",
"name": "B-cell Lymphoma",
"relevance": "LOW"
}
],
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{
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"term": "Lymphoma"
},
{
"id": "D007938",
"term": "Leukemia"
},
{
"id": "D016403",
"term": "Lymphoma, Large B-Cell, Diffuse"
},
{
"id": "D054198",
"term": "Precursor Cell Lymphoblastic Leukemia-Lymphoma"
}
]
} | null | {
"conditions": [
{
"id": "D008223",
"term": "Lymphoma"
},
{
"id": "D007938",
"term": "Leukemia"
},
{
"id": "D016403",
"term": "Lymphoma, Large B-Cell, Diffuse"
},
{
"id": "D054198",
"term": "Precursor Cell Lymphoblastic Leukemia-Lymphoma"
}
],
"interventions": null
} |
NCT03471533 | null | Efficacy of a Natural Ingredient on Blood Pressure | Clinical Trial and Randomized Efficacy of a Natural Ingredient on the Arterial Tension of Normother Subjects or With Arterial Hypertension Grade i Without Pharmacological Treatment | FISTA | INTERVENTIONAL | COMPLETED | 2018-02-27T00:00:00 | null | 2019-02-28T00:00:00 | 2019-03-30T00:00:00 | [
"NA"
] | 80 | 18 | 65 | ALL | true | Randomized controlled trial with two parallel branches (experimental product and placebo), double blind and unicentric with which it is intended to evaluate the efficacy of the product under investigation against placebo on blood pressure of normotensive subjects or with hypertension grade I without Pharmacotherapy. The subjects that meet the selection criteria will make a total of five visits to the research laboratory and perform the tests that were pre-established in the protocol. Later, a statistical analysis will be carried out with the variables measured in the study to obtain results. | null | Inclusion Criteria:
* Subjects of both sexes between 18-65 years old.
* Systolic blood pressure between 120 and 159 mmHg or diastolic blood pressure between 80 and 100 mm Hg. taken in basal conditions.
* Volunteers able to understand the clinical study and willing to comply with the procedures and requirements of the study
Exclusion Criteria:
* In pharmacological treatment of arterial hypertension.
* Subjects with acute diseases.
* Volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathological conditions or malignant tumor disease that can modify the blood pressure of subjects.
* Subjected to major surgery in the last 3 months.
* Subjects who stopped smoking in the last 6 months or who intend to quit during the study.
* Subjects with allergies or eating disorders.
* Participation in another study that includes blood extractions or dietary intervention.
* Pregnant woman.
* Subjects whose condition does not make them eligible for the study, according to the researcher. | Universidad Católica San Antonio de Murcia | OTHER | {
"id": "UCAM-CFE-0001",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-03-19T00:00:00 | {
"date": "2019-10-04",
"type": "ACTUAL"
} | {
"date": "2018-03-20",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized, controlled clinical trial, with two parallel branches, (experimental product and placebo), double blind and unicentric.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Hypertension"
] | null | null | [
{
"city": "Murcia",
"country": "Spain",
"facility": "Catholic University of Murcia",
"geoPoint": {
"lat": 37.98704,
"lon": -1.13004
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Assessing a change of blood pressure five times",
"timeFrame": "Blood pressure measurements will be taken with a Holter on five separate occasions and for 24 hours each day. The measurements will be made at baseline and at 14, 28, 56 and 84 days of consumption of the product."
}
],
"secondary": [
{
"description": null,
"measure": "body composition",
"timeFrame": "Two densitometries will be performed. One at the beginning of the test, in basal conditions and another at the end of the test after 84 days of taking the product.e beginning and at the end"
},
{
"description": null,
"measure": "body composition",
"timeFrame": "A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days."
},
{
"description": null,
"measure": "blood samples",
"timeFrame": "Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use."
},
{
"description": null,
"measure": "Subjective sensation of product consumption",
"timeFrame": "Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study."
},
{
"description": null,
"measure": "physical activity",
"timeFrame": "An accelerometer will be placed twice on the subjects. The first time at baseline and the second after taking 84 days of consumption of the product under study."
},
{
"description": null,
"measure": "Control of dietary intake",
"timeFrame": "A nutritional registry will be carried out. The nutritional intake of for days in two periods will be collected. One record at the beginning and another at the end, that is, six days."
},
{
"description": null,
"measure": "quality of life questionnaire",
"timeFrame": "The cuestionnaire will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use. The subjects have to answer 26 items on a scale of one to five, being one never and 5 always."
},
{
"description": null,
"measure": "Gastrointestinal well-being evaluation",
"timeFrame": "The questionnaire will be completed five times (GIQLI). It will be completed at baseline (without consumption of the product), at 14, 28, 56 and 84 days of consumption of the experimental product."
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Hypertension",
"id": "M10024",
"name": "Hypertension",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M17400",
"name": "Vascular Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D006973",
"term": "Hypertension"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "HB",
"name": "Herbal and Botanical"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "T184",
"name": "Hibiscus",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D006973",
"term": "Hypertension"
}
],
"interventions": []
} |
NCT06523933 | null | Distribution of Bacteria in OME After Radiotherapy For NPC. | Distribution of Bacteria in Otitis Media With Effusion After Radiotherapy For Nasopharyngeal Carcinoma. | None | OBSERVATIONAL | ACTIVE_NOT_RECRUITING | 2024-07-10T00:00:00 | null | 2024-11-12T00:00:00 | 2025-05-12T00:00:00 | null | 234 | 15 | 70 | ALL | false | To observe the prognostic difference of tympanocentesis in different kinds of otitis media effusion. | This study is a prospective, observational clinical study to observe the difference in prognosis of tympanocentesis in different kinds of otitis media effusion (OME), especially OME after radiotherapy for nasopharyngeal carcinoma (NPC). A total of 234 patients diagnosed with OME who are given the treatment of tympanocentesis only, including outpatient and inpatient patients, were included in the study. The middle ear effusion collected during the tympanocentesis is sent for bacterial culture. The positive rate of the effusion and the recurrence rate within 24 weeks will be compared in order to figure out whether bacterial infection is an important influencing factor for some kinds of OME in addition to eustachian tube dysfunction, which is acknowledged. | Inclusion Criteria:
* patients clinical diagnosis of OME or OME after radiotherapy for NPC (Diagnostic criteria: fluid visible in the middle ear and a type B tympanogram).
* patients volunteered to participate in the study and signed the informed consent
Exclusion Criteria:
* NPC recurrence or other malignant tumor after radiotherapy.
* clear diagnosis of Eustachian ostium atresia or nasal obstruction diseases, such as severe deviated nasal septum, choanal atresia, osteoradionecrosis of skull base after radiotherapy, etc.
* pregnant and lactating women.
* patients with severe underlying diseases or with severe liver and kidney dysfunction.
* patients who could not cooperate (including poor hearing and radiation encephalopathy)
* patients with other middle ear diseases, such as middle ear cholesteatoma, osteoradionecrosis of temporal bone after radiotherapy, etc.
* severe deglutition disorders
* cleft palate | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER | {
"id": "SYSKY-2023-448-01",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-07-23T00:00:00 | {
"date": "2024-07-26",
"type": "ACTUAL"
} | {
"date": "2024-07-26",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | Patients diagnosed with OME and OME after radiotherapy for NPC, who are given the treatment of tympanostomy only, including outpatient and inpatient patients, were included in the study. | NON_PROBABILITY_SAMPLE | null | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Otitis Media Effusion",
"Nasopharyngeal Carcinoma"
] | ["Otitis Media Effusion", "Nasopharyngeal Carcinoma", "Bacteria"] | null | [
{
"city": "Guangzhou",
"country": "China",
"facility": "Sun Yat-sen Memorial Hospital, Sun Yat-sen University",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Positive Bacterial Culture Rate in Middle Ear Effusion",
"timeFrame": "Up to 24 weeks"
}
],
"secondary": [
{
"description": null,
"measure": "Changes in Air Pressure (Tympanogram)",
"timeFrame": "Collected at 6, 12, 24 Weeks after Tympanocentesis"
},
{
"description": null,
"measure": "Eustachian Tube Dysfunction Questionnaire (ETDQ-7)",
"timeFrame": "Collected at 6, 12, 24 Weeks after Tympanocentesis"
}
]
} | [
{
"affiliation": "Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",
"name": "Hao Xiong",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009375",
"term": "Neoplasms, Glandular and Epithelial"
},
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D009303",
"term": "Nasopharyngeal Neoplasms"
},
{
"id": "D010610",
"term": "Pharyngeal Neoplasms"
},
{
"id": "D010039",
"term": "Otorhinolaryngologic Neoplasms"
},
{
"id": "D006258",
"term": "Head and Neck Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009302",
"term": "Nasopharyngeal Diseases"
},
{
"id": "D010608",
"term": "Pharyngeal Diseases"
},
{
"id": "D009057",
"term": "Stomatognathic Diseases"
},
{
"id": "D010038",
"term": "Otorhinolaryngologic Diseases"
},
{
"id": "D004427",
"term": "Ear Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC09",
"name": "Ear, Nose, and Throat Diseases"
},
{
"abbrev": "BC07",
"name": "Mouth and Tooth Diseases"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
"asFound": "Carcinoma",
"id": "M5534",
"name": "Carcinoma",
"relevance": "HIGH"
},
{
"asFound": "Otitis",
"id": "M12954",
"name": "Otitis",
"relevance": "HIGH"
},
{
"asFound": "Nasopharyngeal Carcinoma",
"id": "M1730",
"name": "Nasopharyngeal Carcinoma",
"relevance": "HIGH"
},
{
"asFound": "Otitis Media",
"id": "M12956",
"name": "Otitis Media",
"relevance": "HIGH"
},
{
"asFound": "Otitis Media Effusion",
"id": "M12957",
"name": "Otitis Media with Effusion",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M12320",
"name": "Neoplasms, Glandular and Epithelial",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12315",
"name": "Neoplasms by Histologic Type",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12254",
"name": "Nasopharyngeal Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M13517",
"name": "Pharyngeal Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12962",
"name": "Otorhinolaryngologic Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9348",
"name": "Head and Neck Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12253",
"name": "Nasopharyngeal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M13515",
"name": "Pharyngeal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12017",
"name": "Stomatognathic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12961",
"name": "Otorhinolaryngologic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7601",
"name": "Ear Diseases",
"relevance": "LOW"
},
{
"asFound": "Nasopharyngeal Carcinoma",
"id": "T4047",
"name": "Nasopharyngeal Carcinoma",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D002277",
"term": "Carcinoma"
},
{
"id": "D000077274",
"term": "Nasopharyngeal Carcinoma"
},
{
"id": "D010031",
"term": "Otitis"
},
{
"id": "D010033",
"term": "Otitis Media"
},
{
"id": "D010034",
"term": "Otitis Media with Effusion"
}
]
} | null | {
"conditions": [
{
"id": "D002277",
"term": "Carcinoma"
},
{
"id": "D000077274",
"term": "Nasopharyngeal Carcinoma"
},
{
"id": "D010031",
"term": "Otitis"
},
{
"id": "D010033",
"term": "Otitis Media"
},
{
"id": "D010034",
"term": "Otitis Media with Effusion"
}
],
"interventions": null
} |
NCT06019533 | null | A Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles | A Multicentre, Single Arm Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles | None | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2023-08-25T00:00:00 | null | 2025-04-30T00:00:00 | 2026-04-30T00:00:00 | [
"PHASE3"
] | 750 | 15 | 45 | FEMALE | true | Multicentre, single arm phase III trial to assess the pearl index of LVDS. The trial lasts 13 cycles.The assessments include (but are not limited to) recording demographic data, pregnancy tests, gynaecological examinations, laboratory tests and a quality of life questionnaire. Adolescents will undergo DXA scans to measure bone mineral density (at selected sites only). The women will be provided with an e-diary app for their smartphone, to record IP use and vaginal bleeding. | null | Inclusion Criteria:
* At Visit 1a, subjects must meet ALL of the following criteria:
1. Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women.
2. Women who either
1. have never used hormonal contraceptives before consent/assent (naïve users), or
2. have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent and a full menstrual cycle during the drug-free period (previous users) or
3. directly switch from another hormonal contraceptive (switchers).
3. Only for subjects who were not pregnant and did not use hormonal contraception during the last 6 months before consent/assent:
Regular cycles (i.e. cycle length between 24 and 35 days) during the last 6 months.
Exclusion Criteria:
1. Pregnancy or wish of pregnancy.
2. Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary.
3. History of infertility.
4. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a.
5. Unexplained amenorrhoea.
6. Abnormal finding on pelvic, breast or ultrasound examination that in the investigator's opinion contraindicates participation in the trial. | Insud Pharma | INDUSTRY | {
"id": "LR-301",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-08-30T00:00:00 | {
"date": "2025-02-21",
"type": "ACTUAL"
} | {
"date": "2023-08-31",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Contraception"
] | null | null | [
{
"city": "Móstoles",
"country": "Spain",
"facility": "LR-301/",
"geoPoint": {
"lat": 40.32234,
"lon": -3.86496
},
"state": "Madrid"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Pearl Index",
"timeFrame": "1 year"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | null | {
"ancestors": null,
"browseBranches": [
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"abbrev": "Repr",
"name": "Reproductive Control Agents"
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{
"abbrev": "All",
"name": "All Drugs and Chemicals"
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],
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"asFound": null,
"id": "M6494",
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],
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} | {
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NCT01555333 | null | An Open Label Extension Study in Subjects With Fragile X Syndrome | An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subject With Fragile X Syndrome | 209FX303 | INTERVENTIONAL | TERMINATED | 2012-03-01T00:00:00 | null | null | null | [
"PHASE3"
] | 357 | 5 | 50 | ALL | false | This study will enroll subjects who have completed Protocols 209FX301, 209FX302, or are currently participating in Protocol 2202 into a long-term study in which all subjects will receive active drug (arbaclofen). | Three studies sponsored by Seaside Therapeutics, Inc., are currently evaluating the efficacy of STX209 for management of typical problem behaviors in subjects with FXS. These are Study 209FX301, "A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Adolescents and Adults with Fragile X Syndrome;" Study 209FX302, "A Randomized, Double-Blind, Placebo-Controlled, Fixed- Dose Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Children with Fragile X Syndrome;" and Study 22002, "An Open-Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects with Fragile X Syndrome." This study will enroll subjects who have completed Protocols 209FX301, 209FX302, or are currently participating in Protocol 22002 into a long-term, open-label study. The open-label extension protocol will provide data on the long-term safety and tolerability of STX209 among subjects with FXS who receive treatment under conditions reflective of their typical medical care rather than in their previously completed study. | Inclusion Criteria:
1. Successfully completed all scheduled visits of the previous protocol ( 22002, 209FX301, or 209FX302).
2. A parent,LAR, or caregiver must be willing and able to accompany the subject to all study visits, participate in phone calls, complete study assessments, administer study medication, and report the subject's condition and medication use to site staff members.
3. Prior to the conduct of any study-specific procedures, the subject must provide written informed consent to participate in the study ( if developmentally appropriate) or verbal assent and the parent/caregiver/LAR must provide written informed consent. If the caregiver attending the clinic visits is not the parents, caregiver, or LAR, written consent must also be obtained for the caregiver's participation in the study.
4. Current treatment with no more than 3 psychoactive medications, including anti-epileptics, unless the Medical Monitor is consulted.
5. Subjects with a history of seizure disorder must have been seizure free for 6 months and be taking anti-epileptics, or seizure free for 3 years if not receiving anti-epileptic treatment. If currently receiving treatment with anti-epileptics, serum concentration levels must be tested and be in therapeutic range.
6. Negative pregnancy test for females of childbearing potential or be using a medically acceptable form of birth control.
Exclusion Criteria
1. Subjects with any condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. This includes, but is not limited to impairment of renal function, evidence or history of malignancy or any significant hematological, endocrine, cardiovascular, respiratory, hepatic, or gastrointestinal disease.
2. Subjects who are currently engaged in illicit drug or alcohol abuse.
3. Subjects who had a serious adverse event (SAE) while taking STX209 during their previous protocol (22002,209FX301,309FX302)that the Investigator considered related to STX209, unless approval from the Medical Monitor is obtained.
4. The occurrence or continuation of any AE or condition during Studies 22002, 209FX301, or 209FX302 that, in the opinion of the Investigator, should exclude this subject from participating in the open-label extension.
5. Subjects taking another investigational drug, other than STX209, currently or within 30 days of Visit 1. Subject must not take any investigational drugs during this study.
6. Subjects who, in the Investigator's opinion, might not be suitable for the study.
7. Subjects treated with vigabatrin, tiagabine, or riluzole currently or within 2 weeks of Visit 1.
8. Subjects treated with racemic baclofen currently or within 1 week of Visit 1. | Seaside Therapeutics, Inc. | INDUSTRY | {
"id": "209FX303",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-03-13T00:00:00 | {
"date": "2013-07-31",
"type": "ESTIMATED"
} | {
"date": "2012-03-15",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Fragile X Syndrome"
] | null | null | [
{
"city": "Phoenix",
"country": "United States",
"facility": "Seaside Therapeutics Site #16",
"geoPoint": {
"lat": 33.44838,
"lon": -112.07404
},
"state": "Arizona"
},
{
"city": "Long Beach",
"country": "United States",
"facility": "Seaside Therapeutics Site #07",
"geoPoint": {
"lat": 33.76696,
"lon": -118.18923
},
"state": "California"
},
{
"city": "Sacramento",
"country": "United States",
"facility": "Seaside Therapeutics Site #10",
"geoPoint": {
"lat": 38.58157,
"lon": -121.4944
},
"state": "California"
},
{
"city": "Aurora",
"country": "United States",
"facility": "Seaside Therapeutics Site #17",
"geoPoint": {
"lat": 39.72943,
"lon": -104.83192
},
"state": "Colorado"
},
{
"city": "Miami",
"country": "United States",
"facility": "Seaside Therapeutics Site #01",
"geoPoint": {
"lat": 25.77427,
"lon": -80.19366
},
"state": "Florida"
},
{
"city": "Orange City",
"country": "United States",
"facility": "Seaside Therapeutics Site #14",
"geoPoint": {
"lat": 28.94888,
"lon": -81.29867
},
"state": "Florida"
},
{
"city": "Decatur",
"country": "United States",
"facility": "Seaside Therapeutics Site #20",
"geoPoint": {
"lat": 33.77483,
"lon": -84.29631
},
"state": "Georgia"
},
{
"city": "Chicago",
"country": "United States",
"facility": "Seaside Therapeutics Site #02",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois"
},
{
"city": "Kansas City",
"country": "United States",
"facility": "Seaside Therapeutics Site #23",
"geoPoint": {
"lat": 39.11417,
"lon": -94.62746
},
"state": "Kansas"
},
{
"city": "Baltimore",
"country": "United States",
"facility": "Seaside Therapeutics Site #12",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland"
},
{
"city": "Worcester",
"country": "United States",
"facility": "Seaside Therapeutics Site #08",
"geoPoint": {
"lat": 42.26259,
"lon": -71.80229
},
"state": "Massachusetts"
},
{
"city": "Columbia",
"country": "United States",
"facility": "Seaside Therapeutics Site #03",
"geoPoint": {
"lat": 38.95171,
"lon": -92.33407
},
"state": "Missouri"
},
{
"city": "New York",
"country": "United States",
"facility": "Seaside Therapeutics Site #22",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York"
},
{
"city": "Staten Island",
"country": "United States",
"facility": "Seaside Therapeutics Site #04",
"geoPoint": {
"lat": 40.56233,
"lon": -74.13986
},
"state": "New York"
},
{
"city": "Chapel Hill",
"country": "United States",
"facility": "Seaside Therapeutics Site #24",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina"
},
{
"city": "Durham",
"country": "United States",
"facility": "Seaside Therapeutics Site #21",
"geoPoint": {
"lat": 35.99403,
"lon": -78.89862
},
"state": "North Carolina"
},
{
"city": "Akron",
"country": "United States",
"facility": "Seaside Therapeutics Site #05",
"geoPoint": {
"lat": 41.08144,
"lon": -81.51901
},
"state": "Ohio"
},
{
"city": "Oklahoma City",
"country": "United States",
"facility": "Seaside Therapeutics Site #15",
"geoPoint": {
"lat": 35.46756,
"lon": -97.51643
},
"state": "Oklahoma"
},
{
"city": "Media",
"country": "United States",
"facility": "Seaside Therapeutics Site #11",
"geoPoint": {
"lat": 39.91678,
"lon": -75.38769
},
"state": "Pennsylvania"
},
{
"city": "Nashville",
"country": "United States",
"facility": "Seaside Therapeutics Site #19",
"geoPoint": {
"lat": 36.16589,
"lon": -86.78444
},
"state": "Tennessee"
},
{
"city": "Houston",
"country": "United States",
"facility": "Seaside Therapeutics Site #25",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas"
},
{
"city": "San Antonio",
"country": "United States",
"facility": "Seaside Therapeutics Site #18",
"geoPoint": {
"lat": 29.42412,
"lon": -98.49363
},
"state": "Texas"
},
{
"city": "Seattle",
"country": "United States",
"facility": "Seaside Therapeutics Site #13",
"geoPoint": {
"lat": 47.60621,
"lon": -122.33207
},
"state": "Washington"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Safety Measures",
"timeFrame": "100 weeks"
}
],
"secondary": [
{
"description": null,
"measure": "Efficacy",
"timeFrame": "100 Weeks"
}
]
} | [
{
"affiliation": "Seaside Therapeutics, Inc.",
"name": "Paul Wang, M.D.",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D004194",
"term": "Disease"
},
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D038901",
"term": "Mental Retardation, X-Linked"
},
{
"id": "D008607",
"term": "Intellectual Disability"
},
{
"id": "D019954",
"term": "Neurobehavioral Manifestations"
},
{
"id": "D009461",
"term": "Neurologic Manifestations"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D025064",
"term": "Sex Chromosome Disorders"
},
{
"id": "D025063",
"term": "Chromosome Disorders"
},
{
"id": "D000013",
"term": "Congenital Abnormalities"
},
{
"id": "D030342",
"term": "Genetic Diseases, Inborn"
},
{
"id": "D040181",
"term": "Genetic Diseases, X-Linked"
},
{
"id": "D020271",
"term": "Heredodegenerative Disorders, Nervous System"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BC16",
"name": "Diseases and Abnormalities at or Before Birth"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
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],
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"name": "Syndrome",
"relevance": "HIGH"
},
{
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"id": "M8721",
"name": "Fragile X Syndrome",
"relevance": "HIGH"
},
{
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"id": "M11589",
"name": "Intellectual Disability",
"relevance": "LOW"
},
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M21826",
"name": "Neurobehavioral Manifestations",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12404",
"name": "Neurologic Manifestations",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23023",
"name": "Chromosome Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23024",
"name": "Sex Chromosome Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12",
"name": "Congenital Abnormalities",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23686",
"name": "Genetic Diseases, Inborn",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M24877",
"name": "Genetic Diseases, X-Linked",
"relevance": "LOW"
},
{
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"id": "M22092",
"name": "Heredodegenerative Disorders, Nervous System",
"relevance": "LOW"
},
{
"asFound": "Fragile X Syndrome",
"id": "T2370",
"name": "Fragile X Syndrome",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D005600",
"term": "Fragile X Syndrome"
},
{
"id": "D013577",
"term": "Syndrome"
}
]
} | null | {
"conditions": [
{
"id": "D005600",
"term": "Fragile X Syndrome"
},
{
"id": "D013577",
"term": "Syndrome"
}
],
"interventions": null
} |
NCT02565433 | null | Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases (PRAMECE-1302) | Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases | PRAMECE-1302 | INTERVENTIONAL | TERMINATED | 2015-05-19T00:00:00 | null | null | null | [
"NA"
] | 52 | 18 | null | ALL | false | The aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases. | The patients who meet the selection criteria and who have accepted to participate at the study will answer different questionnaires of the study before radiosurgery and at 3, 6, 9 and 12 months after the treatment of brain metastases. Baseline examinations will be done before receiving the treatment during the hospitalisation for the Gamma Knife treatment, and then they will be repeated at the evaluation visits which are classically done every 3 months. MRI's will also be performed every 3 months. In this way, no additional travel or MRI will be carried out as part of the study. | Inclusion Criteria:
* Patient with newly diagnosed brain metastases
* Patient with cancer regardless of the type of primary cancer, with anatomopathological proof
* At least, one measurable lesion ≥ 10 mm on the MRI T1 gadolinium sequences
* Number of brain metastases lower or equal to 5
* Indication of radiosurgery treatment
* Age ≥ 18 years old
* ECOG-PS 0-2
* Expected survival \> 3 months
* Ability to complete self-administered questionnaires. If the patient has a motor disability (hemibody deficit) that does not allow to complete himself the questionnaires, these will be read by a CRA of the Neurosurgery department who will outline the questions without making any comment.
* A non-opposition form must have been completed by the patient
Exclusion Criteria:
* Previous cancer (\< 5 years) except of carcinoma of cervix uteri, basal cell or squamous cell skin carcinoma adequately treated
* Previous brain radiotherapy
* Neurological pathology with cognitive disorders existing before the study
* Having a contraindication for MRI
* Associated leptomeningeal disease
* Patients having another severe or uncontrolled pathology which could compromise the participation at the study (such as infection, cardiovascular, digestive, renal or pulmonary disease)
* Pregnant or breastfeeding woman. The women must not breastfeed for at least 6 months
* Impossibility to submit to the medical examinations of the study due to geographic, social or mental reasons | Centre Oscar Lambret | OTHER | {
"id": "PRAMECE-1302",
"link": null,
"type": null
} | lack of recruitment | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-09-29T00:00:00 | {
"date": "2018-10-22",
"type": "ACTUAL"
} | {
"date": "2015-10-01",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
} | [
"Neoplasm Metastases"
] | ["brain metastases", "Gamma Knife", "Radiosurgery", "Quality of Life"] | null | [
{
"city": "Lille",
"country": "France",
"facility": "CHRU de Lille - Hôpital Salengro",
"geoPoint": {
"lat": 50.63297,
"lon": 3.05858
},
"state": null
}
] | [
{
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Besancon"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Impact at 6 months of the radiosurgery based on the evaluation of 4 criteria of the QLQ C30 questionnaire",
"timeFrame": "6 months"
}
],
"secondary": [
{
"description": null,
"measure": "Comparison of the scores obtained on the scales, questionnaires and Performance status at baseline and every 3 months (until 12 months) after Gamma Knife treatment",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Comparison of the scores obtained on the scales and questionnaires according to the type of primary cancer at baseline and every 3 months (until 12 months) after Gamma Knife treatment",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Comparison of the scores obtained on different scales according to the type of associated treatments at baseline and every 3 months (until 12 months) after Gamma Knife treatment",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Correlation between the scores obtained on the different scales at the baseline and the progression-free survival / overall survival",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Correlation between the scores obtained on the scales QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition), ESAS (quality of life) at baseline and those obtained at 3, 6, 9, 12 months",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Correlation between the scores obtained on the scales during the study and the clinical neurological response at baseline and every 3 monts until 12 months after Gamma Knife treatment",
"timeFrame": "1 year"
}
]
} | [
{
"affiliation": "Centre Oscar Lambret",
"name": "Emilie Le Rhun, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "CHRU de Besançon",
"name": "Franck Bonnetain, MD",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D009385",
"term": "Neoplastic Processes"
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{
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"term": "Neoplasms"
},
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"term": "Pathologic Processes"
},
{
"id": "D016543",
"term": "Central Nervous System Neoplasms"
},
{
"id": "D009423",
"term": "Nervous System Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D001927",
"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC23",
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},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
}
],
"browseLeaves": [
{
"asFound": "Metastases",
"id": "M12307",
"name": "Neoplasm Metastasis",
"relevance": "HIGH"
},
{
"asFound": "Brain Metastases",
"id": "M5209",
"name": "Brain Neoplasms",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M12330",
"name": "Neoplastic Processes",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M18937",
"name": "Central Nervous System Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
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"relevance": "LOW"
},
{
"asFound": null,
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"name": "Brain Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5742",
"name": "Central Nervous System Diseases",
"relevance": "LOW"
},
{
"asFound": "Quality of Life",
"id": "T6034",
"name": "Quality of Life",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D009362",
"term": "Neoplasm Metastasis"
},
{
"id": "D001932",
"term": "Brain Neoplasms"
}
]
} | null | {
"conditions": [
{
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"term": "Neoplasm Metastasis"
},
{
"id": "D001932",
"term": "Brain Neoplasms"
}
],
"interventions": null
} |
NCT06612333 | null | Evaluation of the French Version of the PEERS Social Skills Training Program for Adolescents With Rare Neurodevelopmental Disorders | Evaluation of the French Version of the PEERS Social Skills Training Program for Adolescents With Rare Neurodevelopmental Disorders / PEERS-MRND | PEERS-MRND | OBSERVATIONAL | RECRUITING | 2024-04-26T00:00:00 | null | 2026-08-31T00:00:00 | 2026-08-31T00:00:00 | null | 80 | 12 | 30 | ALL | false | Adolescents and young adults with rare neurodevelopmental disorders are at risk of developing psychiatric pathologies during the transition to adulthood. Loneliness and lack of social relationships can lead to anxiety and depression in adolescents and young adults with rare neurodevelopmental disorders. Anxiety and depression are major risk factors for the transition to psychiatric symptoms in adulthood. The improvement of social skills and the positive evolution of social relationships in adolescents and young adults with rare neurodevelopmental disorders can lead to a reduction in the risk factors for anxiety and depression. It therefore seems essential to evaluate the evolution of social skills in this population of young adults under the care of the social skills program, PEERS, in France to assess the overall benefit of the program, particularly in this population of young people with rare neurodevelopmental disorders. | null | Inclusion criteria:
* Aged between 12 and 30 years, included at the start of the social skills program.
* Patients with rare neurodevelopmental diseases
* Patients benefiting from the social skills program
* Appropriate level of verbal elaboration
* Patient with a family member or a friend also participating in the social skills program
Non-inclusion criteria :
* Opposition of the patient or, if a minor, of his/her parents to participation in the study
* Patient not psychiatrically stabilized: acute symptoms of anxiety, depression, psychotic disorders.
* Severe intellectual disability | Imagine Institute | OTHER | {
"id": "HJ-23-PEERS-MRND",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-09-24T00:00:00 | {
"date": "2024-09-25",
"type": "ACTUAL"
} | {
"date": "2024-09-25",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT"
] | The study will focus on data from 40 patients with rare neurodevelopmental disorders and their 40 relatives/friends. | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
} | [
"Neurodevelopmental Disorders",
"Rare Diseases"
] | null | null | [
{
"city": "Paris",
"country": "France",
"facility": "Necker - Enfants Malades Hospital",
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NCT00859833 | null | Effects of Body Mass Index on the Hyperemic Response to Regadenoson | Effects of Body Mass Index on the Hyperemic Response to Regadenoson | None | INTERVENTIONAL | COMPLETED | 2009-03-10T00:00:00 | null | null | null | [
"NA"
] | 30 | 18 | 88 | ALL | true | We will test the hypothesis that a single dose of Regadenoson will produce equivalent degrees of coronary hyperemia in patients of widely different body size. This will be a prospective, open-label, comparative trial using MRI to measure myocardial perfusion reserve (ratio of myocardial blood flow with vasodilator to myocardial blood flow at rest) during sequential administration of the coronary vasodilators adenosine and regadenoson. Non-invasive MRI measurements of resting myocardial blood flow, and sequential measurements of blood flow during adenosine infusion (weight adjusted dosing) and then blood flow during regadenoson infusion (single, fixed dose. Blood flow measurements will be obtained sequentially and in the same sequence in each subject during a two hour MRI exam. 32 subjects will be recruited for this study. The first 2 will be for testing of the protocol. Inclusion criteria: 2 subjects for initial protocol evaluation, then 30 subjects with body mass index (BMI) between 18 and 40. Exclusions are pregnancy, renal dysfunction and claustrophobia. | Introduction: Regadenoson (Lexiscan) is currently recommended for use as a targeted vasodilator in myocardial perfusion studies and is available as a single, fixed dose for all patients. Here we propose to compare the hyperemic response measured with MRI in subjects with a wide range of BMI 18-40.
MRI is an ideal test to compare the effects of regadenoson in patients with different body mass indices (BMIs). No radiation is used and multiple perfusion tests can be performed in close temporal sequence. Importantly, a number of researchers have shown the ability to obtain quantitative stress and rest myocardial blood flow values in the heart with MR imaging. This allows the calculation of myocardial perfusion reserve (MPR). Flow reserve measurements also can be done with dynamic PET, but not with SPECT. PET has the disadvantage of radiation exposure.
Regadenoson may be a more desirable agent for use with MRI than is adenosine. Adenosine requires the use of 2 intravenous lines, and the use of either a specialized, expensive, MRI-compatible infusion pump to deliver the drug, or long lengths of tubing to run to a pump outside the scanner room. Neither solution is ideal. Regadenoson does not require any such pumps or the starting of a second i.v.. The work here would accomplish 2 goals: 1) to demonstrate the feasibility of performing quantitative MRI perfusion measurements with regadenoson, and 2) to test whether a single dose of regadenoson produces maximal coronary hyperemia across a wide range of body sizes.
Study Design: This will be a prospective, open-label, study. The design is single group, one arm, 2 interventions in which we will compare MPR measured sequentially during adenosine and regadenoson using MRI. Non-invasive MRI measurements of resting flow, flow at adenosine stress, and flow at regadenoson stress will be obtained sequentially in each subject during a single two hour MRI exam. Each drug will be given in the same order to all subjects.
32 subjects will be recruited for this study. The first two subjects will be imaged only with resting perfusion, in order to determine optimal acquisition parameters for the study, and will not be used in the analysis. The main outcome measure is MPR with each agent. | Inclusion Criteria:
* BMI 20-40 kg/m\^2
* age 18-88
Exclusion Criteria:
* critically ill patients, patients on ventilators, patients with hypotension, asthmatics, and other patients whose medical care or safety may be compromised from undergoing an MRI examination will be excluded.
* Patients with claustrophobia will also be excluded.
* Also, anyone with contraindications to MRI (pacemaker, ICD, metal implants), pregnant subjects, minors, and prisoners will be excluded from this study.
* If subjects are over 60 or have any suspicion of abnormal kidney function, a blood test to determine GFR will be performed prior to imaging.
* Subjects with GFR \< 30 will be excluded from the study. | University of Utah | OTHER | {
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"Endothelial Dysfunction",
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"class": "INDUSTRY",
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"affiliation": "University of Utah",
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NCT01830933 | null | Breast Cancer Risk Reduction: A Patient Doctor Intervention | Breast Cancer Risk Reduction: A Patient Doctor Intervention | BreastCARE | INTERVENTIONAL | COMPLETED | 2013-04-10T00:00:00 | null | null | null | [
"NA"
] | 1,235 | 40 | 74 | ALL | false | The proposed research combines the scientific advances in breast cancer research with health information technology (IT) to design a personalized intervention that assesses breast cancer risk for women, disseminates important breast health information, and facilitates discussion of breast cancer risk reduction practices. Our goal is to implement a tablet-PC (personal computer) based breast cancer risk education (BreastCare) intervention in the primary care setting that estimates a woman's individual risk for breast cancer and provides her and her physician with personalized breast cancer risk information and recommendations for action. | null | Inclusion Criteria:
1. Patient component:
* Women who visit the General Internal Medicine (GIM) practices at SFGH and UCSF during the study period
* Between the ages of 40 and 74
* Self-identify as Asian American, Spanish- and English-speaking Latinas, African American, or White
* Have no history of breast cancer are eligible to participate.
2. Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF
Exclusion Criteria:
1. Patient component: Women whose physicians object to their participation in the study
2. Physician component: No exclusion criteria for physicians | University of California, San Francisco | OTHER | {
"id": "150B-0158",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2013-04-10T00:00:00 | {
"date": "2014-08-19",
"type": "ESTIMATED"
} | {
"date": "2013-04-12",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
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} | [
"Breast Cancer"
] | ["Breast cancer concern, breast cancer risk perception, breast cancer risk"] | null | [
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"country": "United States",
"facility": "San Francisco General Hospital (SFGH)",
"geoPoint": {
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"facility": "University of California, San Francisco Mt. Zion campus",
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"class": "OTHER",
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},
{
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"name": "California Breast Cancer Research Program"
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},
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"measure": "Percentage of Participants With Correct Perception of Risk",
"timeFrame": "baseline, one week post-initial visit (approximately one week)"
},
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"description": null,
"measure": "Percentage of Participants Who Had a Discussion of Breast Cancer Risk",
"timeFrame": "one week post-initial visit (approximately one week)"
},
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"description": null,
"measure": "Percentage of Participants Who Reported Discussion of Mammography Screening",
"timeFrame": "up to 14 months"
}
],
"secondary": null
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"affiliation": "University of California, San Francisco",
"name": "Celia P Kaplan, DrPH, MA",
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NCT02921633 | null | Childhood Influenza Immunisation in General Practice Invitation Trial | Can Uptake of Childhood Influenza Immunisation in GP Practices be Increased Through Behavioural-insight Informed Changes to the Invitation Process? | None | INTERVENTIONAL | COMPLETED | 2016-09-27T00:00:00 | null | null | null | [
"NA"
] | 21,786 | 2 | 3 | ALL | true | This study will investigate whether behaviourally informed changes to the invitation process can improve uptake of childhood influenza vaccine by two and three year olds at primary care. | Previous research has shown that small changes to routine invitations/reminders to attend local health services informed by behavioural science can be used to increase a desired behaviour (e.g. uptake of health checks, reducing missed appointments).
This trial will determine whether an invitation letter, informed by behavioural insights and sent through a central system (Child Health Information System, CHIS), can increase uptake of childhood flu vaccine in primary care.
The trial will take place within the existing national childhood immunisation programme in the participating area in England. Randomisation will be clustered at the primary care practice level. Outcome data will be anonymised, routinely collected, individual-level influenza vaccine uptake data extracted from CHIS. For CHIS data validation purposes, practice-level vaccine uptake data reported through an alternative, routine system will be collected. Data will be collected on additional invitations/communications that primary care practices (in both the intervention and control arms) send to their patients. Cost data for the centralised letter will also be obtained.
The analysis will investigate the main effect of the intervention on uptake of the flu vaccination for all eligible children included in the trial. The model will include primary care practice and Clinical Commissioning Group effects to account for clustering. Secondary analysis will investigate the impact of such individual factors as age, immunisation history and socioeconomic status and practice-level factors (e.g. direct communication from practices) on uptake of the flu vaccination. | Inclusion Criteria:
* 2 years or 3 year olds at 31st August 2016
* Registered with a primary care practice in the participating area | Public Health England | OTHER_GOV | {
"id": "2016_FluInvGP",
"link": null,
"type": null
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} | 2016-09-29T00:00:00 | {
"date": "2019-08-29",
"type": "ACTUAL"
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NCT00437333 | null | Metformin Suspension and Insulin Sensitivity | Insulin Sensitivity After Metformin Suspension in Normal-Weight Women With Polycystic Ovary Syndrome | None | INTERVENTIONAL | COMPLETED | 2007-02-20T00:00:00 | null | null | null | [
"PHASE4"
] | 30 | 20 | 30 | FEMALE | false | Metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory patients with polycystic ovary syndrome (PCOS). To date, the metabolic effects of the long-term metformin administration are know but no data are available on the effects after its suspension.
The purpose of this study is to evaluate the effects of metformin suspension on insulin sensitivity in PCOS patients. | Thirty young normal-weight anovulatory PCOS women will be enrolled. The diagnosis of PCOS will be based on the presence of clinical \[Ferriman-Gallwey score ≥ 8\] or biochemical hyperandrogenism (serum testosterone levels (\>2 SD above our reference mean values) and chronic anovulation \[serum luteal progesterone (P) below 2 ng/mL)\].
Patients will be randomly allocated into two groups (metformin and placebo group) using a computer-software. Fifteen PCOS patients will be treated with metformin at a dosage of 1700 mg daily (one tablet of 850 mg twice daily; metformin group), whereas other 15 PCOS will be treated with placebo tables (one tablet twice daily; placebo group). The duration of the treatment will be 12 months. Patients will be instructed to follow their usual diet and physical activity, and to use barrier contraception throughout the study. The length and the frequency of the menstrual cycles, and the adverse experiences (AEs) will be reported on a daily diary.
Each subject will undergo follow-up visits under (at six and 12 months from treatment starting) and after treatment (at six and 12 months from treatment withdrawal). At each follow-up visit, in all subjects the same operator will perform clinical, hormonal, metabolic, and insulin sensitivity assessments by euglycemic hyperinsulinemic clamp. | Inclusion Criteria:
* Polycystic ovary syndrome (using NIH criteria).
Exclusion Criteria:
* Age \<20 or \>30 years;
* BMI higher than 25 and lower than 18;
* Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses;
* Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia;
* Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs;
* Intention to start a diet or a specific program of physical activity. | University Magna Graecia | OTHER | {
"id": "MM-187-2004",
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"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2007-02-20T00:00:00 | {
"date": "2007-02-21",
"type": "ESTIMATED"
} | {
"date": "2007-02-21",
"type": "ESTIMATED"
} | [
"ADULT"
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} | [
"Polycystic Ovary Syndrome"
] | ["Insulin sensitivity", "Insulin-sensitizing drug", "Metformin", "PCOS", "Treatment"] | null | [
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NCT02137733 | null | The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J) | The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J) | None | INTERVENTIONAL | UNKNOWN | 2014-05-01T00:00:00 | null | null | null | [
"NA"
] | 220 | 20 | 85 | ALL | false | The purpose of this study is to investigate the non-inferiority of bisoprolol to carvedilol by evaluating tolerability (The probability that administered maintenance dose reaches the maximum will be determined as an indicator) as a primary endpoint when bisoprolol or carvedilol is administered for 48 weeks to Japanese chronic heart failure patients. In addition, the safety and efficacy of bisoprolol will be investigated. | null | Inclusion Criteria:
As a result of diagnosis and tests before registration, a patient who is considered by an investigator to meet all requirements and to have ability to consent can be enrolled.
1. Primary disease: In principle, ischemic heart disease or dilated cardiomyopathy.
2. Heart failure patients with 40% or less of left ventricular ejection fraction (LVEF) .
3. Patients in NYHA functional classification Class II, III, or IV (including a medical history).
4. Basic treatment: In principle, patients undergoing treatment with an ACE inhibitor (or angiotensin receptor blocker (ARB)), a diuretic, a digitalis preparation, etc.
5. Patients who had not undergone treatment with a beta-blocker (except eye drops) within 8 weeks before the registration date.
6. Age: Patients aged 20 to less than 85 on the day of obtaining written informed consent.
7. Hospitalized/outpatient: Either hospitalized or outpatient status.
8. Gender: Male or Female
Exclusion Criteria:
Patients who meet any of the following exclusion criteria at the time of registration will be excluded:
1. Patients who are considered not to be candidates for administration of bisoprolol or carvedilol.
2. Patients who have developed acute myocardial infarction within 8 weeks before the registration day.
3. Patients who have history of stroke or serious cerebrovascular accident within 1 year before the registration day.
4. Patients with poor prognosis and life-threatening disease, such as malignant tumor, or such medical history within 5 years before the registration day.
5. Patients who are scheduled to undergo coronary revascularization (Coronary artery bypass grafting; CABG, Percutaneous coronary intervention; PCI) during the study period.
6. Patients who are pregnant, lactating, may become pregnant, or want to become pregnant during the study.
7. Patients from whom written informed consent cannot be obtained.
8. Patients who are judged by an investigator to be inappropriate for this study for any other reason. | Mebix Inc | INDUSTRY | {
"id": "Ji 012-0386",
"link": null,
"type": null
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"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-05-10T00:00:00 | {
"date": "2014-05-14",
"type": "ESTIMATED"
} | {
"date": "2014-05-14",
"type": "ESTIMATED"
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"interventionModel": "PARALLEL",
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"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
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NCT00868933 | null | Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease | Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease - A Randomized Controlled Trial | None | INTERVENTIONAL | COMPLETED | 2009-03-24T00:00:00 | null | null | null | [
"NA"
] | 159 | 18 | 70 | ALL | false | Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in affluent countries. It may progress to cirrhosis and liver cancer. At present, there is no approved drug for NAFLD. Although healthy diet and exercise is often recommended, there is little supportive evidence. Therefore, the investigators plan to conduct a randomized controlled trial comparing a low glycemic index dietary intervention program and simple lifestyle advice in NAFLD patients. The primary endpoint is resolution of NAFLD. Non-invasive tests will be used to assess the study subjects. Proton-magnetic resonance spectroscopy is used to quantify hepatic triglyceride content, and transient elastography is used to quantify liver fibrosis. | null | Inclusion Criteria:
* Age 18 to 70 years
* Fatty liver by proton-magnetic resonance spectroscopy, defined as hepatic triglyceride content 5% or above
* Serum alanine aminotransferase (ALT) above 30 U/L in men and 19 U/L in women
* Informed written consent obtained
Exclusion Criteria:
* Positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-nuclear antibody titer above 1/160
* Alcohol consumption above 30 g per week in men or 20 g per week in women
* Alanine aminotransferase (ALT) above 10 times the upper limit of normal
* Liver decompensation, as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 10e9/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices
* Evidence of hepatocellular carcinoma
* Terminal illness or cancer, unless in complete remission for more than 5 years | Chinese University of Hong Kong | OTHER | {
"id": "NAFLD-Diet",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-03-24T00:00:00 | {
"date": "2014-02-24",
"type": "ESTIMATED"
} | {
"date": "2009-03-25",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": null,
"timePerspective": null
} | [
"Nonalcoholic Fatty Liver Disease"
] | null | null | [
{
"city": "Hong Kong SAR",
"country": "China",
"facility": "Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital",
"geoPoint": null,
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Resolution of NAFLD by proton-magnetic resonance spectroscopy",
"timeFrame": "Month 12"
}
],
"secondary": [
{
"description": null,
"measure": "Partial resolution of NAFLD",
"timeFrame": "Month 12"
},
{
"description": null,
"measure": "Visceral fat measurement",
"timeFrame": "Month 12"
},
{
"description": null,
"measure": "Liver fibrosis by transient elastography",
"timeFrame": "Month 12"
},
{
"description": null,
"measure": "Metabolic endpoints",
"timeFrame": "Month 12"
}
]
} | null | [{"pmid": "16447287", "type": "BACKGROUND", "citation": "Farrell GC, Larter CZ. Nonalcoholic fatty liver disease: from steatosis to cirrhosis. Hepatology. 2006 Feb;43(2 Suppl 1):S99-S112. doi: 10.1002/hep.20973."}, {"pmid": "15225170", "type": "BACKGROUND", "citation": "Wong VW, Chan HL, Hui AY, Chan KF, Liew CT, Chan FK, Sung JJ. Clinical and histological features of non-alcoholic fatty liver disease in Hong Kong Chinese. Aliment Pharmacol Ther. 2004 Jul 1;20(1):45-9. doi: 10.1111/j.1365-2036.2004.02012.x."}, {"pmid": "18616651", "type": "BACKGROUND", "citation": "Wong VW, Wong GL, Chim AM, Tse AM, Tsang SW, Hui AY, Choi PC, Chan AW, So WY, Chan FK, Sung JJ, Chan HL. Validation of the NAFLD fibrosis score in a Chinese population with low prevalence of advanced fibrosis. Am J Gastroenterol. 2008 Jul;103(7):1682-8. doi: 10.1111/j.1572-0241.2008.01933.x. Epub 2008 Jul 4."}, {"pmid": "15709991", "type": "BACKGROUND", "citation": "Hui AY, Wong VW, Chan HL, Liew CT, Chan JL, Chan FK, Sung JJ. Histological progression of non-alcoholic fatty liver disease in Chinese patients. Aliment Pharmacol Ther. 2005 Feb 15;21(4):407-13. doi: 10.1111/j.1365-2036.2005.02334.x."}, {"pmid": "10051466", "type": "BACKGROUND", "citation": "Caldwell SH, Oelsner DH, Iezzoni JC, Hespenheide EE, Battle EH, Driscoll CJ. Cryptogenic cirrhosis: clinical characterization and risk factors for underlying disease. Hepatology. 1999 Mar;29(3):664-9. doi: 10.1002/hep.510290347."}, {"pmid": "16904946", "type": "BACKGROUND", "citation": "Wong VW, Hui AY, Tsang SW, Chan JL, Tse AM, Chan KF, So WY, Cheng AY, Ng WF, Wong GL, Sung JJ, Chan HL. Metabolic and adipokine profile of Chinese patients with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2006 Sep;4(9):1154-61. doi: 10.1016/j.cgh.2006.06.011. Epub 2006 Aug 14."}, {"pmid": "17519430", "type": "BACKGROUND", "citation": "Targher G, Bertolini L, Rodella S, Tessari R, Zenari L, Lippi G, Arcaro G. Nonalcoholic fatty liver disease is independently associated with an increased incidence of cardiovascular events in type 2 diabetic patients. Diabetes Care. 2007 Aug;30(8):2119-21. doi: 10.2337/dc07-0349. Epub 2007 May 22. No abstract available."}, {"pmid": "17014580", "type": "BACKGROUND", "citation": "Wong VW, Hui AY, Tsang SW, Chan JL, Wong GL, Chan AW, So WY, Cheng AY, Tong PC, Chan FK, Sung JJ, Chan HL. Prevalence of undiagnosed diabetes and postchallenge hyperglycaemia in Chinese patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2006 Oct 15;24(8):1215-22. doi: 10.1111/j.1365-2036.2006.03112.x."}, {"pmid": "17135584", "type": "BACKGROUND", "citation": "Belfort R, Harrison SA, Brown K, Darland C, Finch J, Hardies J, Balas B, Gastaldelli A, Tio F, Pulcini J, Berria R, Ma JZ, Dwivedi S, Havranek R, Fincke C, DeFronzo R, Bannayan GA, Schenker S, Cusi K. A placebo-controlled trial of pioglitazone in subjects with nonalcoholic steatohepatitis. N Engl J Med. 2006 Nov 30;355(22):2297-307. doi: 10.1056/NEJMoa060326."}, {"pmid": "17517853", "type": "BACKGROUND", "citation": "Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007 Jun 14;356(24):2457-71. doi: 10.1056/NEJMoa072761. Epub 2007 May 21."}, {"pmid": "17565632", "type": "BACKGROUND", "citation": "Chan HL, de Silva HJ, Leung NW, Lim SG, Farrell GC; Asia-Pacific Working Party on NAFLD. How should we manage patients with non-alcoholic fatty liver disease in 2007? J Gastroenterol Hepatol. 2007 Jun;22(6):801-8. doi: 10.1111/j.1440-1746.2007.04977.x."}, {"pmid": "17376032", "type": "BACKGROUND", "citation": "Chan HL, Wong VW. Can dietetic intervention for obesity ever succeed in real life? J Gastroenterol Hepatol. 2007 Apr;22(4):459-60. doi: 10.1111/j.1440-1746.2007.04931.x. No abstract available."}, {"pmid": "17368136", "type": "BACKGROUND", "citation": "Ludwig DS. Clinical update: the low-glycaemic-index diet. Lancet. 2007 Mar 17;369(9565):890-2. doi: 10.1016/S0140-6736(07)60427-9. No abstract available."}, {"pmid": "18070255", "type": "BACKGROUND", "citation": "Woo J, Sea MM, Tong P, Ko GT, Lee Z, Chan J, Chow FC. Effectiveness of a lifestyle modification programme in weight maintenance in obese subjects after cessation of treatment with Orlistat. J Eval Clin Pract. 2007 Dec;13(6):853-9. doi: 10.1111/j.1365-2753.2006.00758.x."}, {"pmid": "25040896", "type": "DERIVED", "citation": "Shen J, Wong GL, Chan HL, Chan RS, Chan HY, Chu WC, Cheung BH, Yeung DK, Li LS, Sea MM, Woo J, Wong VW. PNPLA3 gene polymorphism and response to lifestyle modification in patients with nonalcoholic fatty liver disease. J Gastroenterol Hepatol. 2015 Jan;30(1):139-46. doi: 10.1111/jgh.12656."}, {"pmid": "23623998", "type": "DERIVED", "citation": "Wong VW, Chan RS, Wong GL, Cheung BH, Chu WC, Yeung DK, Chim AM, Lai JW, Li LS, Sea MM, Chan FK, Sung JJ, Woo J, Chan HL. Community-based lifestyle modification programme for non-alcoholic fatty liver disease: a randomized controlled trial. J Hepatol. 2013 Sep;59(3):536-42. doi: 10.1016/j.jhep.2013.04.013. Epub 2013 Apr 23."}] | {"versionHolder": "2025-06-18"} | {
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NCT00597233 | null | Human Insulin NPH and Insulin Aspart in Type 1 Diabetes | Comparative Evaluation of Human NPH Insulin + Insulin Aspart and Human NPH Insulin + Human Soluble Insulin in Type 1 Diabetes Mellitus | None | INTERVENTIONAL | COMPLETED | 2008-01-09T00:00:00 | null | null | null | [
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* Treatment with insulin NPH
* Body Mass Index (BMI) below 30 kg/m2
Exclusion Criteria:
* Total daily insulin dose greater than 1.40 IU/kg
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NCT05842733 | null | A Novel, Potent and Non-addictive Analgesic of Combinations for Knee Replacement Moderate to Severe Pain Management | A Novel, Potent and Non-addictive Analgesic of Combinations for Knee Replacement Moderate to Severe Pain Management | None | INTERVENTIONAL | ENROLLING_BY_INVITATION | 2023-04-12T00:00:00 | null | 2024-12-31T00:00:00 | 2024-12-31T00:00:00 | [
"PHASE2"
] | 36 | 20 | null | ALL | false | To assess the safety, efficacy, and pharmacokinetics of oral SafeTynadol, Naldebain and Naldebain combine with SafeTynadol in the treatment of moderate to severe pain following knee replacement. | Randomized, double-blind, parallel-group, 3-arm, oral Placebo A 650 mg + Naldebain 37.5 mg (0.5 mL oil solution) + Tween 20 and PEG 400 (1 capsule), oral SafeTynadol 650 mg + Placebo B (0.5 mL oil solution) + Tween 20 and PEG 400 (1 capsule), oral Naldebain 37.5 mg (0.5 mL oil solution) + SafeTynadol 650 mg + Tween 20 and PEG 400 (1 capsule), multiple doses for 3 days. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose.
The complete evaluable 36 subjects (12 subjects in each group) will be analysis in this study. The experiment is divided into three groups of 12 people each. All subjects will be evaluated pharmacokinetics by drawing blood single point at 70.75 ± 2 hours after the first dose..
The population for this study in patients scheduled for knee replacement.
Each group of 12 subjects are administered group 1-3 from day 1-4 after surgery. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose. Mode of administration of oral Naldebain 37.5 mg (0.5 mL oil solution) or Placebo B (0.5 mL oil solution) is withdrawing 0.5 mL of Naldebain 37.5 mg (0.5 mL oil solution) or Placebo B (0.5 mL oil solution) from the vial by a syringe, then is injected into the empty capsule and dispense within 10 minutes prior to dosing.
Screening (Days -30 to -1) (All Study Subjects)
The nature of the study as well as the potential risks and benefits associated with study participation will be fully explained to all potential subjects. The following will then be obtained:
1. Informed consent.
2. Demographic information, including height and weight.
3. Vital signs (temperature, respiratory rate, blood pressure and heart rate).
4. Medical history, including medication use.
5. Complete physical examination including 12-lead ECG.
6. Laboratory testing (blood 50 ± 5 mL) to include the following:
1. CBC with differential, platelets, White blood cell count (WBC), Red blood cell count (RBC), Hemoglobin, Hematocrit, Mean cell volume (MCV), Mean cell hemoglobin (MCH), Mean cell hemoglobin concentration (MCHC), Platelet count, Differential white cell count.
2. Blood chemistry screen (Glucose, AST, ALT, BUN, creatinine, K, Na, Antibody screening, ABO Grouping \& RH Type, Activated partial thromboplastin time, Prothrombin time).
3. Galactose single-point (GSP) test.
4. Urine pregnancy test (female only) (not applicable to female who has stopped menstruating for at least five years).
7. CHEST PA VIEW
Study Day -1
Subjects will be required to check into the clinical site before surgery (Day -1). The following procedures will be performed:
1. Physical examination.\*
2. Vital signs.\*
3. Urine pregnancy test (female only) (not applicable to female who has stopped menstruating for at least five years).\*
4. Review of concomitant medications.\*
5. Blood (8 ± 3 mL) will be obtained to assess SDE, nalbuphine, AAP and metabolites (AAP-Sul, AAP-Glc, AAP-Cys, AAP-Nac and APAP-protein adducts) concentrations.
* If the screening test items are performed in Day -1, the repeat test items only need to be tested once.
Study Day 1-4
All subjects will be given regional anesthesia and be preferentially randomized into one of group 1-3. The study drug will be administered 1-4 days after surgery. First dose of study medication is given 2 ± 2 hours after surgery. Total trial drug will be giving eight times. Each group of 12 subjects are administered group 1-3 from day 1-4 after surgery.
Group 1: Oral Placebo A 650 mg + Naldebain 37.5 mg (0.5 mL oil solution) + Tween 20 and PEG 400 (1 capsule), multiple doses for 3 days. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose.
Group 2: Oral SafeTynadol 650 mg + Placebo B (0.5 mL oil solution) +Tween 20 and PEG 400 (1 capsule), multiple doses for 3 days. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 25, 58 ± 2 and 70 ± 2 hours after the first dose.
Group 3: Oral Naldebain 37.5 mg (0.5 mL oil solution) + SafeTynadol 650 mg + Tween 20 and PEG 400 (1 capsule), multiple doses for 3 days. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose.
After surgery, the following evaluations will be performed.
1. Pain assessment: All subjects will assess their average pain intensity using a VAS pain scale. The VAS pain scale assessment will start at 0 ± 0.5, 2 ± 0.5, 4 ± 0.5, 6 ± 2, 10 ± 25, 14 ± 2, 22 ± 2, 28 ± 2, 34 ± 2, 46 ± 2, 52 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose.
2. Blood draw (5 ± 3 mL) for assessment of liver chemistry tests (ALT and AST) at 1 ± 0.5 hours after the first oral administration. If significant hepatotoxicity occurs (ALT or AST level more than 5 folds of ULN (upper limit of normal); or ALT or AST level more than 3 folds of ULN with signs of hepatitis, such as jaundice; or ALT or AST \> 1000IU), subject needs to withdraw.
3. VAS score assessed for three times in 5-minut e intervals before giving rescue medication. The VAS score is greater than 7 at least two times. VAS score assessed before giving rescue medication as VAS score for the remaining assessments.
4. When the subject takes the study medication or rescue medication, and request further rescue medication. VAS score assessed for three times in 5-minute intervals before giving rescue medication. The VAS score has to greater than 7 at least two times. Rescue medication will be given in the order of (1) to (2). The interval between rescue medications should be at least 1 hour.
5. If the subject requests rescue medicine, the group 1-3 will receive sequence of rescue medications follow the (1) IV Parecoxib 40 mg Q12H and (2) IV morphine 4 mg Q4H PRN.The above method of administration shall be carried out according to the procedure of administration in the hospital ward.
6. Recorded the first time to IV Parecoxib 40 mg and IV morphine 4 mg, and then the amount and frequency of the medications' use within 72 hours will be recorded.
7. Blood draw (8 ± 3 mL) for assessment of SDE, nalbuphine, acetaminophen and metabolites (AAP-Sul, AAP-Glc, AAP-Cys, AAP-Nac and APAP-protein adducts) concentrations before giving the first time's rescue medicationor termination or withdrawals.
8. Vital signs (temperature, respiratory rate, blood pressure and heart rate) will be checked at 0 ± 0.5, 2 ± 0.5, 4 ± 0.5, 6 ± 2, 10 ± 2, 14 ± 2, 22 ± 2, 28 ± 2, 34 ± 25, 46 ± 2, 52 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose.
9. The evaluation of adverse events will continue until the end of the trial 120 hours after the first dose.
10. Review of concomitant medications.
11. Using Brief Pain Inventory short form (BPIsf) to assess pain intensity and pain interference at 22 ± 2, 46 ± 2 and 70 ± 2 hours after the first dose.
On Day 4, following evaluations will be performed:
1. Review of adverse events.
2. Review of concomitant medications.
3. Blood draw (8 ± 3 mL) for assessment of SDE, nalbuphine, acetaminophen and metabolites (AAP-Sul, AAP-Glc, AAP-Cys, AAP-Nac and APAP-protein adducts) concentrations at 70.75 ± 2 hours after the first dose in all subjects and Blood draw (20 ± 3 mL) for CBC with differential, platelets and blood chemistry screen (Not include Antibody screening and ABO Grouping \& RH Type determination). The blood collection time is carried out according to the routine blood drawing procedure in the hospital ward.
4. Physical examination, including vital signs and 12-lead ECG.
5. Patient satisfaction.
6. Galactose single-point (GSP) test.
Follow-up visit:
24 and 48 hours after the subject took the last medication then researchers conduct telephone interviews to track the overall condition of the subject. | Inclusion Criteria:
* Male or female ≧ 20 years of age at Screening.
* Knee replacement patients.
* American Society of Anesthesiology Physical Class 1 and 2.
* Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.
Exclusion Criteria:
* Body weight less than 50 kg.
* Subject is pregnant or breastfeeding. Women of childbearing potential have a positive urine pregnancy test at baseline.
* Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
* History of hypersensitivity or allergy to amide-type local anesthetics, opioid, acetaminophen, or any ingredient of the medications administered in this study.
* Subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 %.
* Administration of an investigational drug within 5 elimination half-lives of such investigational drug prior to study drug administration.
* The investigator judged that any psychiatric disorder or psychological condition that may interfere with study assessments or compliance.
* History of abuse illicit medications, prescription medicines or alcohol within the past 2 years. History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120 mL wine or 14 cans of 350 mL beer).
* Current painful physical condition other than knee pain.
* The investigator judged that the sensory nerve examination results were abnormal before the knee replacement in this trial. | Sinew Pharma Inc. | INDUSTRY | {
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"primaryPurpose": "TREATMENT",
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} | [
"Pain, Postoperative"
] | ["SafeTynadol", "Naldebain"] | null | [
{
"city": "Taipei City",
"country": "Taiwan",
"facility": "Taipei Veterans General Hospital",
"geoPoint": {
"lat": 25.04776,
"lon": 121.53185
},
"state": "Beitou District"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Area under the curve (AUC) of visual analogue scale",
"timeFrame": "0 hour - 70 hours after first dose"
}
],
"secondary": [
{
"description": null,
"measure": "The first time using any one kind of rescue medication",
"timeFrame": "Day 1 - Day 4"
},
{
"description": null,
"measure": "Consumption of rescued parecoxib",
"timeFrame": "Day 1 - Day 4"
},
{
"description": null,
"measure": "Brief Pain Inventory short form (BPIsf)",
"timeFrame": "Day 2 - Day 4"
},
{
"description": null,
"measure": "The evaluation of adverse events",
"timeFrame": "Day 1 - Day 6"
},
{
"description": null,
"measure": "Patient satisfaction",
"timeFrame": "Day 4"
},
{
"description": null,
"measure": "Assessment of ALT and AST",
"timeFrame": "Day 4"
}
]
} | [
{
"affiliation": "Taipei Veterans General Hospital, Taiwan",
"name": "Cheng-Fong Mr Chen, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D011183",
"term": "Postoperative Complications"
},
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
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"term": "Pain"
},
{
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}
],
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"abbrev": "BC23",
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],
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}
],
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{
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]
} | {
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"abbrev": "PhSol",
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},
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}
],
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],
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} | {
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} |
NCT05747833 | null | The Effect of Toy IV Catheter on Children's Pain, Fear and Emotional Indicators | Randomized Controlled Trial: The Effect of Preparation for Procedure With Toy IV Catheter Before Peripheral Cannula Administration on Children's Pain, Fear, and Emotional Indicators | None | INTERVENTIONAL | COMPLETED | 2022-12-26T00:00:00 | null | 2022-05-15T00:00:00 | 2022-12-30T00:00:00 | [
"NA"
] | 80 | 6 | 10 | ALL | true | Aim: Research was conducted to determine the effect of preparation for the procedure with a toy IV catheter before IV catheterization in children aged 6-10 years, on children's pain, fear and emotional indicators.
Methods: It is a randomized controlled intervention study. The study was completed with 80 children. There are two groups in the study. Before the IV catheterization, the children in the intervention group were treated with the toy IV catheter developed by the researchers on the knitted doll, and then the procedure was provided to them. Conversely, no intervention was applied to the control group other than the normal procedure of the hospital. Stratified block randomization method was used to assign children to groups. In the study; "Personal Data Collection Form", "Wong-Baker Faces Pain Scale (WBFPS)", "Child Fear Scale (CFS)" and "Child Emotional Manifestation Scale (CEMS)" were used to collect data. | Children may be sick during their normal development and may have to come to the hospital. For children, the hospital environment, especially emergency rooms, conveys uncertainty. The reason for this uncertainty; the presence of health team members that children do not know, equipment they have not seen before, and interventions. The child's sense of uncertainty and the thought that his own control is in danger may cause him to become stressed and afraid of the hospital. As a matter of fact, studies on children's hospital experience indicate that they experience negative emotions such as stress, anger, restlessness, and tension. It is known that the most common negative emotion and experience children experience in the hospital environment is anxiety due to pain and fear.
Children can experience pain in all healthcare settings. Almost all diagnostic and therapeutic applications cause pain. It is also known that children experience more fear in the hospital environment than adults. Among the biggest fears children experience in the hospital environment are; Losing body functions, having surgery can be counted as painful invasive procedures performed for diagnosis and treatment. Especially made using a needle such as an injector; Procedures such as vaccination, bloodletting, and IV catheterization may cause pain and fear in children.
More than 80% of children admitted to hospitals are administered IV catheters. Almost all children are adversely affected by this process. In reducing these negative emotions experienced, it is very important to prepare children for the procedure. Control of pain and fear; requires cooperation between physicians, nurses and other health professionals. Especially nurses have important duties in this regard, as they have the opportunity to observe the patient closely and for a longer period of time. The American Association of Pain Management Nursing (ASPMN) also reports that nurses are responsible for controlling pain using pharmacological and non-pharmacological methods before, during and after painful intervention. For this purpose, therapeutic play can be used.
Therapeutic play is a type of play used to reduce the child's fear and stress towards the hospital, to alleviate the feeling of uncertainty, to evaluate misunderstandings about the hospital environment and the interventions applied in the hospital, to teach clinical procedures and to reduce pain in painful procedures. Ensuring that the child touches the tools and equipment to be used in the treatment during the game played in the hospital allows him to recognize them and perceive them as less threatening. At the same time, it improves the feeling of trust towards the health professional. Particularly, when preparation for play-based treatment is combined with treatment, the child can better tolerate painful procedures by developing positive coping methods. As a matter of fact, in the experimental study of Uluışık (2019) with 60 children aged 5-6 years, it was seen that the information provided with the play dough consisting of a dentist set reduced dental fear. In a randomized controlled study conducted by Miller et al. (2016) with 98 children aged 3-12, using an electronic device called Ditto (Diversionary Therapy Technologies, Brisbane, Australia) that provides procedural preparation and distraction during the vascular access procedure, significantly reduced stress. In another study conducted by Tunç Tuna and Açikgoz (2015) on 60 children aged 9-12, it was found that pre-procedural information on preparation for the peripheral venous cannula application in children and performing the procedure by showing it on the toy reduced the child's pain and anxiety. In the study conducted by Tunç Tuna and Açikgöz, real IV catheters were used in preparation for the procedure before the peripheral cannula application of the children. However, giving such tools and equipment to the hands of especially small children and having them applied can be dangerous and harmful for them. Instead, alternative methods should be developed.For example, the process can be explained through pictures and/or the toys/models of the tools to be used in the process can be given to children and practice can be made. In the literature review, no study could be found on the preparation of the child for the procedure with realistic toys before the IV catheterization procedure. | Inclusion Criteria:
* Your child;
* Age between 6-10,
* To receive IV treatment upon the request of a physician,
* Being conscious and able to communicate verbally,
* Understanding and speaking Turkish,
* Having a mother and / or father with him,
* After the information, the child and his parents agree to participate in the study in writing and verbally,
* Pediatric Emergency Clinic has been accepted to the Green Area,
* Not using analgesic and / or sedative drugs in the last 8 hours.
Exclusion Criteria:
* Your child;
* Being younger than 6 and over 10 years old,
* Having pain,
* Having a high fever (body temperature of 38 ° C and above) Applying to the hospital with a complaint that requires urgent intervention such as convulsion or trauma,
* Having applied to the hospital by ambulance,
* Admitted to the Yellow or Red Area of the Pediatric Emergency Clinic after triage,
* Having had an IV catheter before,
* Having mental disability,
* Having a chronic and / or fatal disease, Having a diagnosis made by psychiatry,
* Communication problems with his family and / or himself (not speaking Turkish, agitation, etc.) | Eskisehir Osmangazi University | OTHER | {
"id": "10346826",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-02-17T00:00:00 | {
"date": "2023-02-28",
"type": "ACTUAL"
} | {
"date": "2023-02-28",
"type": "ACTUAL"
} | [
"CHILD"
] | null | null | false | {
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"interventionModel": "CROSSOVER",
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"maskingDescription": null,
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]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Intravenous Catheterization"
] | ["Toy", "Therapeutic play", "Preparation", "Pain", "Fear"] | null | [
{
"city": "Eskişehir",
"country": "Turkey",
"facility": "Hazal",
"geoPoint": {
"lat": 39.77667,
"lon": 30.52056
},
"state": "Odunpazarı"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Personal data collection form",
"timeFrame": "1.5 month"
},
{
"description": null,
"measure": "Wong-Baker faces pain scale",
"timeFrame": "1.5 month"
},
{
"description": null,
"measure": "Child Fear Scale",
"timeFrame": "1.5 month"
},
{
"description": null,
"measure": "Child Emotional Manifestation Scale",
"timeFrame": "1.5 month"
}
],
"secondary": null
} | [
{
"affiliation": "Eskişehir Osmangazi University",
"name": "Hazal USLU",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
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"id": "M13066",
"name": "Pain",
"relevance": "LOW"
}
],
"meshes": null
} | null | {
"conditions": [],
"interventions": null
} |
NCT06660433 | null | Respiratory Outbreak Mitigation in Long-Term Care Using Point-of-Care Testing | ImProving Respiratory Outbreak Mitigation Through Point-of-care Testing in Long Term Care (PROMPT-LTC): a Cluster Randomized Trial | PROMPT-LTC | INTERVENTIONAL | RECRUITING | 2024-10-24T00:00:00 | null | 2025-04-30T00:00:00 | 2025-08-31T00:00:00 | [
"NA"
] | 24 | null | null | ALL | false | Outbreaks of seasonal respiratory viruses can spread rapidly in long-term care homes. Timely results for diagnostic tests remains a challenge for respiratory viruses due to the logistics of using a reference laboratory with delays leading to missed opportunities to implement virus-specific control measures to interrupt transmission resulting in larger outbreaks. Use of a point-of-care testing platform is a potential solution that provides faster results, but it is uncertain whether this translates into benefits for long-term care residents. This trial aims to assess whether rapid test results for respiratory pathogens (Influenza, COVID-19 and Respiratory Syncytial Virus) can impact the number and size of respiratory virus outbreaks in long-term care homes. | null | Inclusion Criteria:
- Long-term care facility engaged with an Ontario Health Team overseen by Sunnybrook Health Science Centre, Michael Garron Hospital or Humber River Health
Exclusion Criteria:
* No signed statement of agreement for study participation
* Pre-existing use of a point-of-care testing platform | Michael Garron Hospital | OTHER | {
"id": "CK-19-2024",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-10-24T00:00:00 | {
"date": "2024-11-27",
"type": "ACTUAL"
} | {
"date": "2024-10-28",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Cluster Randomized Trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
} | [
"Outbreaks"
] | ["respiratory virus outbreaks", "outbreak mitigation", "long-term care home"] | null | [
{
"city": "Toronto",
"country": "Canada",
"facility": "Michael Garron Hospital",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario"
},
{
"city": "Toronto",
"country": "Canada",
"facility": "Sunnybrook Health Sciences Centre",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario"
}
] | [
{
"class": "OTHER",
"name": "Sunnybrook Health Sciences Centre"
},
{
"class": "UNKNOWN",
"name": "Humber River Health"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Number of long-term care residents infected with COVID-19, Influenza, or RSV",
"timeFrame": "7 months"
}
],
"secondary": [
{
"description": null,
"measure": "The number of outbreaks of Influenza, COVID-19 or RSV",
"timeFrame": "7 months"
},
{
"description": null,
"measure": "The number of long-term care residents infected during an outbreak of Influenza, COVID-19 or RSV",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Frequency of hospital transfers for long-term care residents infected with Influenza, COVID-19 or RSV",
"timeFrame": "14 days"
},
{
"description": null,
"measure": "Number of deaths in long-term care residents infected with Influenza, COVID-19 or RSV",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Duration of outbreaks in of Influenza, COVID-19 or RSV in long-term care facilities",
"timeFrame": "60 days"
},
{
"description": null,
"measure": "Secondary attack rate of high-risk exposures to each long-term care resident with Influenza, COVID-19 or RSV infection",
"timeFrame": "28 days"
}
]
} | null | [{"pmid": "38659123", "type": "BACKGROUND", "citation": "Tan C, Chan CK, Ofner M, O'Brien J, Thomas NR, Callahan J, Pascual B, Palmer SJ, Serapion V, Fabro H, Kozak RA, Candon H, Chan AK, Powis JE, Leis JA. Implementation of point-of-care molecular testing for respiratory viruses in congregate living settings. Infect Control Hosp Epidemiol. 2024 Apr 25;45(9):1-5. doi: 10.1017/ice.2024.72. Online ahead of print."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "BC01",
"name": "Infections"
},
{
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"name": "All Conditions"
}
],
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"id": "M17522",
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} |
NCT02682433 | null | 3D Sonohysterography vs Hysteroscopy: Study for the Evaluation of Intrauterine Abnormalities | 3D Sonohysterography vs Hysteroscopy: Study for the Evaluation of Intrauterine Abnormalities | None | INTERVENTIONAL | UNKNOWN | 2016-01-12T00:00:00 | null | null | null | [
"PHASE3"
] | 250 | 20 | 70 | FEMALE | false | Uterine cavity diseases can cause mild to severe symptoms, and may indicate the functional problems of the female reproductive system. Many articles examine the efficacy of diagnostic hysteroscopy compared to sonohysterography in the diagnosis of uterine cavity diseases. Most of the articles are from the last decade, but the subject has been laid aside in the recent years. Antonio Simone Lagana and his group have found that there is 100% correlation in uterine cavity structure between diagnostic hysteroscopy and sonohysterography, and only 78% correlation when it comes to intrauterine fibroids and polyps. Walid El-Sherbiny, MD and his group have found that there is a significant advantage to three-dimensional sonohysterography over two-dimensional in the diagnosis of uterine cavity diseases. No significant difference was observed, and 97% correlation was found, comparing three-dimensional sonar and hysteroscopy. Work rationale is that there is a reason to reconsider the status of the diagnostic hysteroscopy to sonohysterography due to evolving technologies, and an improvement in resolution and three dimensional technologies. | Uterine cavity diseases can cause mild to severe symptoms, and may indicate the functional problems of the female reproductive system. Many articles examine the efficacy of diagnostic hysteroscopy compared to sonohysterography in the diagnosis of uterine cavity diseases. Most of the articles are from the last decade, but the subject has been laid aside in the recent years. Antonio Simone Lagana and his group have found that there is 100% correlation in uterine cavity structure between diagnostic hysteroscopy and sonohysterography, and only 78% correlation when it comes to intrauterine fibroids and polyps. Walid El-Sherbiny, MD and his group have found that there is a significant advantage to three-dimensional sonohysterography over two-dimensional in the diagnosis of uterine cavity diseases. No significant difference was observed, and 97% correlation was found, comparing three-dimensional sonar and hysteroscopy. Work rationale is that there is a reason to reconsider the status of the diagnostic hysteroscopy to sonohysterography due to evolving technologies, and an improvement in resolution and three dimensional technologies.
Purpose of the study:
Comparison of the sensitivity, specificity, and the amount of information between diagnostic hysteroscopy and sonohysterography (Two and three-dimensional, in abdominal and vaginal access).
The comparison will be will be made immediately after the completion of diagnostic hysteroscopy test, while using liquid drizzled earlier during the hysteroscopy, in order to simulate sonohysterography which is considered less intrusive and is made As part of standard treatment. | Inclusion Criteria:
* Women aged 20 to 70 who were referred by a physician to perform diagnostic hysteroscopy.
Exclusion Criteria:
* refusal to sign a consent form | Tel-Aviv Sourasky Medical Center | OTHER_GOV | {
"id": "522-15",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-02-10T00:00:00 | {
"date": "2016-04-08",
"type": "ESTIMATED"
} | {
"date": "2016-02-15",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
} | [
"Uterine Diseases"
] | null | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "The difference between US and hysteroscopy for the diagnosis and assessment of uterine cavity.",
"timeFrame": "1 hour"
},
{
"description": null,
"measure": "The difference between US and hysteroscopy for the diagnosis and assessment of polyps",
"timeFrame": "1 hour"
}
],
"secondary": null
} | [
{
"affiliation": "Tel Aviv Medical Center",
"name": "Gad Malinger, professor",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D005831",
"term": "Genital Diseases, Female"
},
{
"id": "D052776",
"term": "Female Urogenital Diseases"
},
{
"id": "D005261",
"term": "Female Urogenital Diseases and Pregnancy Complications"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D000091662",
"term": "Genital Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC16",
"name": "Diseases and Abnormalities at or Before Birth"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
}
],
"browseLeaves": [
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"asFound": null,
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},
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}
],
"meshes": [
{
"id": "D014591",
"term": "Uterine Diseases"
}
]
} | null | {
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{
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"term": "Uterine Diseases"
}
],
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} |
NCT02870933 | null | Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery | The Effect of Transepicardial Augmentation on Transseptal Autologous CD 133+ Bone Marrow Cell Implantation to Myocardial Perfusion in Patient Following Coronary Artery Bypass Grafting | None | INTERVENTIONAL | COMPLETED | 2016-08-07T00:00:00 | null | null | null | [
"PHASE4"
] | 30 | 40 | 70 | ALL | false | Heart Failure has several etiologies and one of them is coronary artery disease. Coronary artery bypass grafting (CABG) is one of revascularizations method which has been used for decades in coronary artery disease theraphy. However, data about coronary artery bypass grafting shows that post-CABG patients still have low ejection fraction. For the last decade, there have been a lot of studies about the using of stem cells to increase heart contractility and reverse the heart remodelling process. In this study, we use CD 133+ bone marrow stem cells which has been proved to have higher angiogenesis potential. The stem cells is given during CABG by injection transepicardial and transseptal. The purpose of this study is to determine whether transpicardial and transseptal injection of CD 133+ bone marrow stem cells can improve myocardial perfusion in patient with low ejection fraction following CABG surgery. | Study sample : patient with low ejection fraction indicated for CABG surgery in NCCHK who fulfill inclusion and exclusion criteria
Sampling method : first we use consecutive method to find subject with male sex and age 40-70. After that, we use simple random sampling to allocate each subject to each group.
Total samples is 13 for each group. To anticipated drop out rate 10%, total sample is 15 for each group.
Intervention and measurement :
Control group will only receive CABG surgery. Study group will receive CBAG surgery and stem cell implantation. Stem cell aspiration will be performed 1 day before CABG procedure. Before aspiration, patients will be given local anesthetic and light sedation. Stem cell will be collected from posterior iliac crest. Total aspirate 190 cc. Stem cell CD133+ will be separated using CliniMACS® Magnetic Separation Device after labelled with Magnetic microbeads - anti CD133 labelling.
Myocardial perfusion reserve index will be measure using MRI. MPRI value will be obtained globally and segmentally in each 16 ventricle segments VEGF plasma level will be measured using sandwich Enzyme-linked Immunosorbent Assay method.
Ejection fraction, left ventricle dimension, and scar size will be measured using MRI.
Quality of life will be measured using Minnesota Living With Heart Failure Questionnaire.
Statistical analysis is done using IBM SPSS Statistics version 21.0 (SPSS inc, Chicago, IL, USA). Numerical data will be presented in either mean/standard deviation or median/min-max depend on distribution of data. Hypothesis test for numeric variable is done using paired/non-paired T test or Mann-Whitney/Wilcoxon depend on normality of data. Normality test is done using Shapiro-Wilk test. Hypothesis test for category varible is done using chi-square or fischer test. | Inclusion Criteria:
* patients with coronary artery disease 3 vessels disease indicated for CABG
* LVEF \< 35% which has been confirmed by MRI
* Patients with akinetic or hypokineic segment, and left ventricle myocardial hypoperfusion confirmed in MRI
* has signed informed consent
Exclusion Criteria:
Emergency CABG Ungraftable coronary artery Acute myocardial Infarct (\<14 days) Valve disease which need surgery repair Contraindicated for MRI High degree ventricular arrhytmia Coagulation disorder HIV positive patient, Hepatitis B + patients, HCV + patients AST/ALT \> 1,5 upper normal value Creatinine \> 2 g/dl. Malignancy
Drop out criteria :
Aortic cross clamp \>120 minutes and CABG total time \>180 | National Cardiovascular Center Harapan Kita Hospital Indonesia | OTHER | {
"id": "LB.02.01/VII/086/KEP.007.EV",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2016-08-12T00:00:00 | {
"date": "2020-04-02",
"type": "ACTUAL"
} | {
"date": "2016-08-17",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
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} | [
"Coronary Artery Disease"
] | ["CD 133+", "Transepicardial with Transseptal Implantation", "CABG"] | null | [
{
"city": "Jakarta",
"country": "Indonesia",
"facility": "National Cardiovascular Center Harapan Kita",
"geoPoint": {
"lat": -6.21462,
"lon": 106.84513
},
"state": "DKI Jakarta"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Myocardial Defect Perfusion",
"timeFrame": "Baseline, 6 months"
},
{
"description": null,
"measure": "Left Ventricular Ejection Fraction",
"timeFrame": "Baseline, 6 months"
}
],
"secondary": [
{
"description": null,
"measure": "Six Minutes Walking Test",
"timeFrame": "Baseline, 6 months"
},
{
"description": null,
"measure": "Wall Motion Score Index",
"timeFrame": "Baseline, 6 months"
},
{
"description": null,
"measure": "Myocardial Scar Size",
"timeFrame": "Baseline, 6 months"
},
{
"description": null,
"measure": "Vascular Endothelial Growth Factor",
"timeFrame": "Baseline, 6 months"
},
{
"description": null,
"measure": "Left Ventricle End Systolic Volume",
"timeFrame": "Baseline, 6 months"
},
{
"description": null,
"measure": "Minnesota Living With Heart Failure Questionnaire",
"timeFrame": "Baseline, 6 months"
},
{
"description": null,
"measure": "Left Ventricle End Diastolic Volume",
"timeFrame": "Baseline, 6 months"
}
]
} | [
{
"affiliation": "National Cardiovascular Center Harapan Kita",
"name": "Tri Wisesa Soetisna, MD, MHA",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D003327",
"term": "Coronary Disease"
},
{
"id": "D017202",
"term": "Myocardial Ischemia"
},
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D001161",
"term": "Arteriosclerosis"
},
{
"id": "D001157",
"term": "Arterial Occlusive Diseases"
},
{
"id": "D014652",
"term": "Vascular Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
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"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
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"id": "M19506",
"name": "Myocardial Ischemia",
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},
{
"asFound": "Coronary Artery Disease",
"id": "M6546",
"name": "Coronary Artery Disease",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M6549",
"name": "Coronary Disease",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10543",
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},
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"asFound": null,
"id": "M9419",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M4469",
"name": "Arteriosclerosis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4465",
"name": "Arterial Occlusive Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17400",
"name": "Vascular Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D003324",
"term": "Coronary Artery Disease"
}
]
} | null | {
"conditions": [
{
"id": "D003324",
"term": "Coronary Artery Disease"
}
],
"interventions": null
} |
NCT04540133 | null | Dexamethasone Solution and Dexamethasone in Mucolox™ | Dexamethasone Solution and Dexamethasone in Mucolox™ for the Treatment of Oral Inflammatory Ulcerative Diseases | None | INTERVENTIONAL | COMPLETED | 2020-08-28T00:00:00 | null | 2023-01-06T00:00:00 | 2023-01-06T00:00:00 | [
"PHASE2"
] | 29 | 18 | null | ALL | true | Topical steroid therapy is considered the first line of treatment for Oral Inflammatory Ulcerative Diseases with current treatment regimens requiring multiple application or rinses daily. Using Mucolox™ as a vehicle to deliver topical dexamethasone to the oral mucosa has the potential to effectively prolong contact time between the medication. The primary objective of this study is to determine the clinical efficacy and tolerability of compound dexamethasone at 0.5 mg/5 mL in Mucolox™ for the treatment of Oral Inflammatory Ulcerative Diseases as measured by a reduction in oral symptoms between patients treated with compounded dexamethasone 0.5mg/5ml solution in Mucolox™ (group A) and patients treated with topical commercial dexamethasone 0.5mg/5ml solution only (group B). and mucosa, leading to improved clinical outcomes due to the need for less frequent application. | null | Inclusion Criteria:
* Age 18 years and older.
* Patients with symptomatic biopsy proven Oral Inflammatory Ulcerative Diseases (worst VAS sensitivity score ≥ 7 over the last week).
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients already on topical or systemic steroids.
* Inability to comply with study instructions.
* Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
* VAS sensitivity score \< 7.
* Pregnant women. A urine pregnancy test will be performed for women of child bearing potential.
* Allergy to fluconazole. | University of California, San Francisco | OTHER | {
"id": "20-32068",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-08-31T00:00:00 | {
"date": "2023-12-15",
"type": "ACTUAL"
} | {
"date": "2020-09-07",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Oral Lichen Planus",
"Mucous Membrane Pemphigoid",
"Pemphigus Vulgaris",
"Chronic Graft-versus-host-disease"
] | null | null | [
{
"city": "San Francisco",
"country": "United States",
"facility": "Sol Silverman Oral Medicine Clinic - UCSF",
"geoPoint": {
"lat": 37.77493,
"lon": -122.41942
},
"state": "California"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Mean Change From Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks",
"timeFrame": "4 weeks"
}
],
"secondary": [
{
"description": null,
"measure": "Mean Change From Baseline in Reticulation/Keratosis, Erythema, and Ulceration (REU) Scores at 4 Weeks",
"timeFrame": "4 weeks"
}
]
} | [
{
"affiliation": "University of California, San Francisco",
"name": "Alessandro Villa, DDS, PhD, MPH",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D007154",
"term": "Immune System Diseases"
},
{
"id": "D017512",
"term": "Lichenoid Eruptions"
},
{
"id": "D017444",
"term": "Skin Diseases, Papulosquamous"
},
{
"id": "D012871",
"term": "Skin Diseases"
},
{
"id": "D000092124",
"term": "Organizing Pneumonia"
},
{
"id": "D001989",
"term": "Bronchiolitis Obliterans"
},
{
"id": "D001988",
"term": "Bronchiolitis"
},
{
"id": "D001991",
"term": "Bronchitis"
},
{
"id": "D001982",
"term": "Bronchial Diseases"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
},
{
"id": "D008173",
"term": "Lung Diseases, Obstructive"
},
{
"id": "D008171",
"term": "Lung Diseases"
},
{
"id": "D009059",
"term": "Mouth Diseases"
},
{
"id": "D009057",
"term": "Stomatognathic Diseases"
},
{
"id": "D012872",
"term": "Skin Diseases, Vesiculobullous"
},
{
"id": "D001327",
"term": "Autoimmune Diseases"
},
{
"id": "D003229",
"term": "Conjunctival Diseases"
},
{
"id": "D005128",
"term": "Eye Diseases"
}
],
"browseBranches": [
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"abbrev": "BC20",
"name": "Immune System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "BC07",
"name": "Mouth and Tooth Diseases"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "BC11",
"name": "Eye Diseases"
},
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "BC01",
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},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
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},
{
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"id": "M17206",
"name": "Ulcer",
"relevance": "LOW"
},
{
"asFound": "Oral Lichen Planus",
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},
{
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},
{
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},
{
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},
{
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"id": "M16355",
"name": "Syndrome",
"relevance": "LOW"
},
{
"asFound": "Chronic Graft Versus Host Disease",
"id": "M2893",
"name": "Bronchiolitis Obliterans Syndrome",
"relevance": "HIGH"
},
{
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M5265",
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},
{
"asFound": null,
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M8219",
"name": "Exanthema",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M19775",
"name": "Lichenoid Eruptions",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15674",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M19713",
"name": "Skin Diseases, Papulosquamous",
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},
{
"asFound": null,
"id": "M13904",
"name": "Pneumonia",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2894",
"name": "Organizing Pneumonia",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5267",
"name": "Bronchitis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5258",
"name": "Bronchial Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14977",
"name": "Respiratory Tract Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11168",
"name": "Lung Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11170",
"name": "Lung Diseases, Obstructive",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12019",
"name": "Mouth Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12017",
"name": "Stomatognathic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15675",
"name": "Skin Diseases, Vesiculobullous",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4629",
"name": "Autoimmune Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6453",
"name": "Conjunctival Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8271",
"name": "Eye Diseases",
"relevance": "LOW"
},
{
"asFound": "Graft Versus Host Disease",
"id": "T2832",
"name": "Homologous Wasting Disease",
"relevance": "HIGH"
},
{
"asFound": "Chronic Graft Versus Host Disease",
"id": "T1303",
"name": "Chronic Graft Versus Host Disease",
"relevance": "HIGH"
},
{
"asFound": "Pemphigus",
"id": "T4478",
"name": "Pemphigus",
"relevance": "HIGH"
},
{
"asFound": "Pemphigus Vulgaris",
"id": "T4481",
"name": "Pemphigus Vulgaris",
"relevance": "HIGH"
},
{
"asFound": "Mucous Membrane Pemphigoid",
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"name": "Mucous Membrane Pemphigoid",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "T891",
"name": "Bullous Pemphigoid",
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},
{
"asFound": null,
"id": "T871",
"name": "Bronchiolitis Obliterans",
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},
{
"asFound": null,
"id": "T872",
"name": "Bronchiolitis Obliterans Organizing Pneumonia",
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}
],
"meshes": [
{
"id": "D017676",
"term": "Lichen Planus, Oral"
},
{
"id": "D000092122",
"term": "Bronchiolitis Obliterans Syndrome"
},
{
"id": "D010390",
"term": "Pemphigoid, Benign Mucous Membrane"
},
{
"id": "D008010",
"term": "Lichen Planus"
},
{
"id": "D010392",
"term": "Pemphigus"
},
{
"id": "D010391",
"term": "Pemphigoid, Bullous"
},
{
"id": "D006086",
"term": "Graft vs Host Disease"
}
]
} | {
"ancestors": [
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"term": "Anti-Inflammatory Agents"
},
{
"id": "D000932",
"term": "Antiemetics"
},
{
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"term": "Autonomic Agents"
},
{
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"term": "Peripheral Nervous System Agents"
},
{
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"term": "Physiological Effects of Drugs"
},
{
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"term": "Gastrointestinal Agents"
},
{
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"term": "Glucocorticoids"
},
{
"id": "D006728",
"term": "Hormones"
},
{
"id": "D006730",
"term": "Hormones, Hormone Substitutes, and Hormone Antagonists"
},
{
"id": "D018931",
"term": "Antineoplastic Agents, Hormonal"
},
{
"id": "D000970",
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},
{
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"term": "Protease Inhibitors"
},
{
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},
{
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"term": "Molecular Mechanisms of Pharmacological Action"
}
],
"browseBranches": [
{
"abbrev": "Infl",
"name": "Anti-Inflammatory Agents"
},
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
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},
{
"abbrev": "Gast",
"name": "Gastrointestinal Agents"
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{
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"name": "All Drugs and Chemicals"
},
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"name": "Pharmaceutical Solutions"
},
{
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],
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"relevance": "HIGH"
},
{
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},
{
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"id": "M235549",
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"relevance": "HIGH"
},
{
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},
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"relevance": "LOW"
},
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"relevance": "LOW"
},
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},
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"relevance": "LOW"
},
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"relevance": "LOW"
},
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"relevance": "LOW"
},
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"relevance": "LOW"
}
],
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"term": "Dexamethasone"
},
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{
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"term": "Pharmaceutical Solutions"
},
{
"id": "C101468",
"term": "BB 1101"
}
]
} | {
"conditions": [
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},
{
"id": "D000092122",
"term": "Bronchiolitis Obliterans Syndrome"
},
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],
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{
"id": "D019999",
"term": "Pharmaceutical Solutions"
},
{
"id": "C101468",
"term": "BB 1101"
}
]
} |
NCT03055533 | null | Headsprout Reading Program in Children With Autism Spectrum Disorder and Reading Delay | A Feasibility Study of Headsprout Reading Program in Children With Autism Spectrum Disorder and Reading Delay | None | INTERVENTIONAL | COMPLETED | 2017-02-14T00:00:00 | null | 2022-03-03T00:00:00 | 2022-06-24T00:00:00 | [
"NA"
] | 16 | 7 | 18 | ALL | false | Headsprout is a commercially available computer-based reading program that teaches children fundamental reading skills, including phonics, fluency, and comprehension. The Headsprout reading intervention has been shown to be effective with children with various levels of reading skills, but it has not been rigorously tested in children with autism spectrum disorder (ASD). The purpose of this study is to evaluate the effectiveness of Headsprout in a pilot sample of 18 children with ASD and reading delays to serve as a foundation for a larger, future randomized clinical trial (RCT).
Eighteen participants will be included in the study and randomly assigned to one of two groups; the first group will immediately receive treatment with the Headsprout reading program and the second treatment group will receive treatment after 12 weeks. Treatment sessions will occur for one to two hours, two to four days a week, for twelve weeks. The participants who do not receive treatment immediately will be asked to complete reading assessments periodically throughout their wait time. Participation may occur in clinic or via telehealth. | A large number of children with autism spectrum disorder (ASD) experience reading delays, yet few empirically supported reading interventions exist for this population. Reading delay can interfere with academic progress, impede vocational opportunities, hinder self-expression, and limit capacity for independent living. Accessing empirically supported interventions for reading skills can be difficult, with parents of children with ASD facing long waiting lists at specialty clinics, reflecting the simple fact that demand is greater than the supply of trained providers. There is a pressing need for access to affordable interventions that do not depend on specialty clinics.
As a commercially available, computer-based program, Headsprout may be a good fit for children with ASD. Headsprout has shown effectiveness in children with reading delay uncomplicated by ASD, but has not been rigorously studied in children with ASD. This study will investigate the effects of the Headsprout reading program on improving reading skills of children with autism. Eighteen children will be recruited and the researchers will evaluate their current language use by: 1) asking their parents to rate their child's language, 2) completing an echoic skill assessment. Current reading skills will be determined by administering a reading assessment that evaluates their reading accuracy and fluency.
Participants will be randomly assigned to one of two groups; the first group will immediately receive treatment with the Headsprout reading program and the second treatment group will receive treatment after 12 weeks. Participation may be in clinic or via telehealth. During the intervention, children will meet with a trained therapist, several times per week for approximately twelve weeks. The therapist will instruct them to complete various reading activities on the computer. These reading activities may include tasks such as receptively identifying letter names and letter sounds presented on the computer or practicing saying sounds out loud and blending combinations of sounds together.
The participants who do not receive treatment immediately will be asked to complete reading assessments periodically throughout their wait time. At the end of 12 weeks these participants will be able to start the Headsprout reading program. | Inclusion Criteria:
* Age 7.0 to 18.9
* Confirmed clinical diagnosis of autism spectrum disorder (ASD)
* Minimum score of 40 on the Early Echoic Skills Assessment (EESA), which assesses language skills
* Minimum score of 20 on the Expressive Vocabulary Test (EVT), which assesses language skills
* Display deficits in reading, testing at least one grade levels below current grade level on the Dynamic Indicators of Basic Early Literacy Skills (DIBELS)
* English is primary language
Exclusion Criteria:
* Currently receiving an individualized intervention for reading
* Significant problem behavior | University of Nebraska | OTHER | {
"id": "0275-18-EP",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-02-14T00:00:00 | {
"date": "2023-09-29",
"type": "ACTUAL"
} | {
"date": "2017-02-16",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Autism Spectrum Disorder"
] | ["Behavioral", "Social", "Headsprout reading program"] | null | [
{
"city": "Omaha",
"country": "United States",
"facility": "University of Nebraska Medical Center",
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NCT00576433 | null | A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor. | An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor | None | INTERVENTIONAL | COMPLETED | 2007-12-18T00:00:00 | null | null | null | [
"PHASE4"
] | 60 | 18 | 80 | ALL | false | This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals. | null | Inclusion Criteria:
* adult patients, 18-80 years of age;
* moderate to severe active rheumatoid arthritis;
* inadequate response to previous or current treatment with 1 anti-TNF agent;
* receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for \>=4 weeks.
Exclusion Criteria:
* previous treatment with MabThera;
* use of an anti-TNF alpha agent within 8 weeks of study start;
* concurrent treatment with any DMARD other than methotrexate;
* active infection, or history of serious recurrent or chronic infection. | Hoffmann-La Roche | INDUSTRY | {
"id": "ML21271",
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NCT05799833 | null | Low QRS Voltages in Young Healthy Individuals and Athletes | The Prevalence and Significance of Low QRS Voltages in Young Healthy Individuals and Athletes | None | OBSERVATIONAL | RECRUITING | 2023-03-23T00:00:00 | null | 2025-05-01T00:00:00 | 2025-11-01T00:00:00 | null | 240 | 17 | 35 | ALL | true | There is some limited evidence that reduced size of electrical complexes/traces of the heart on the electrocardiogram (ECG) may be associated with scarring in the heart muscle, which may predispose to serious life-threatening electrical abnormalities and sudden cardiac death (SCD). There is no current guidance on how young individuals and athletes with reduced ECG traces should be managed. Therefore, correct interpretation of this ECG finding is crucial for identifying athletes with disease and at risk of SCD. Some athletes experience SCD despite normal standard cardiac tests. The investigators, therefore, propose to study young healthy individuals and young athletes using cardiovascular MRI, cardiopulmonary exercise testing, 24 hour ECG monitoring and genetic analysis to determine the significance of reduced ECG traces and possibly revise current international sports recommendations. | There is emerging evidence that low QRS voltages \<0.5mV in the limb leads may be associated with left ventricular myocardial fibrosis and a predisposition to serious ventricular arrhythmias and sudden cardiac death (SCD). Sudden death in young individuals is highlighted most commonly when an athlete is affected. A proportion of decedents are diagnosed with idiopathic myocardial fibrosis at autopsy. Recent studies have revealed myocardial fibrosis in athletes with low QRS complexes, who have survived a sudden cardiac arrest. Low QRS voltages do not feature in the electrical anomalies that warrant further investigation according to the international recommendations for electrocardiographic (ECG) interpretation in athletes, hence there is no information on the precise significance or outcome data in athletes with small QRS voltages. The investigators postulate that further evaluation of athletes with low QRS voltages using CMR and gene analysis will help determine the prevalence and significance of these ECG changes potentially identifying young vulnerable individuals at risk of SCD. There are currently 2 studies which have assessed small QRS complexes in athletes. These studies revealed 1.1-4% of Italian athletes had small QRS complexes. One study performed ultrasound of the heart showing that athletes in general had larger hearts compared to sedentary counterparts but no evidence of structural disease. The second study did not perform CMR in all athletes with small QRS complexes and only conducted CMR in 5 athletes with small QRS complexes and electrical issues and demonstrated scar in 2 athletes. The scientific basis of these studies does not prove the precise significance of small QRS complexes on the ECG in this population to elucidate the sensitivity and specificity of disease identification. It is possible that young individuals with serious cardiac abnormalities may be identified if the significance of small QRS complexes is elucidated. The prevalence of small QRS complexes in the general population is 0.3-2% but there is paucity of data on prevalence and significance on small QRS complexes in young non-athletic individuals aged 17-35 years old. This study will allow the investigators to identify the prevalence and significance of small QRS complexes in athletes and non-athletes aged 17-35 years old potentially identifying young vulnerable individuals at risk of sudden cardiac death. These results should enable informed clinical decisions (at national and international level) following pre-participation screening evaluation and help ultimately to identify young individuals and athletes who are genuinely deemed to be at risk of sudden cardiac death (SCD) whilst providing appropriate reassurance to those with normal QRS voltages. This study will also potentially aid the investigators in updating the current recommendations on ECG interpretation in athletes which will influence future international ECG recommendations in athletes.This would be a cross-sectional observational study involving 240 participants aged 17-35 years old. This will involve 4 groups; 60 athletes with low QRS voltage and 60 age and sex matched control group of athletes with normal QRS voltage, 60 non-athletes with low QRS voltage and 60 age and sex matched controls with normal QRS voltage. | Inclusion Criteria:
* No cardiovascular symptoms
* Body mass index \<30.
Exclusion Criteria:
* Individuals with cardiac symptoms;
* Past medical history of cardiac disease, previous myocarditis or lung disease;
* Individuals with pacemakers or defibrillators
* Family history of SCD \<40 years old or cardiomyopathy
* Pregnant women
* Advanced kidney and/or liver disease
* Known thyroid disease,
* T-wave inversion or other training unrelated ECG changes
* Known significant valvular heart disease or intra-cardiac shunt on echocardiography. | Imperial College London | OTHER | {
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* 60 athletes with low QRS voltage and 60 age and sex matched control group of athletes with normal QRS voltage
* 60 non-athletes with low QRS voltage and 60 age and sex matched controls with normal QRS voltage | NON_PROBABILITY_SAMPLE | false | {
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} | [
"Sudden Cardiac Death",
"Sudden Cardiac Arrest",
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"Arrhythmogenic Right Ventricular Cardiomyopathy",
"Arrhythmogenic Left Ventricular Cardiomyopathy",
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] | ["Low QRS Voltage", "Low QRS amplitude", "Sudden Cardiac Death", "Cardiac magnetic resonance", "Myocardial fibrosis", "Premature Ventricular complexes", "Dilated Cardiomyopathy", "Arrythmogenic right ventricular cardiomyopathy", "Arrhythmogenic Left Ventricular Cardiomyopathy", "Late Gadolinium Enhancement", "Implantable cardioverter defibrillator", "Cardiopulmonary exercise testing", "Athletes", "Genetic inheritance", "Non sustained ventricular tachycardia", "Pre participation screening", "Sports screening"] | null | [
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"facility": "Royal Brompton Hospital",
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"name": "St George's, University of London"
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"measure": "The proportion of individuals with low QRS complexes and myocardial fibrosis with rare protein altering variant in a cardiomyopathy gene.",
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"timeFrame": "36 months"
}
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"id": "M6845",
"name": "Death",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M8485",
"name": "Fibrosis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9411",
"name": "Heart Arrest",
"relevance": "LOW"
},
{
"asFound": "Cardiac Arrhythmias",
"id": "M4453",
"name": "Arrhythmias, Cardiac",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M16384",
"name": "Tachycardia",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M19488",
"name": "Tachycardia, Ventricular",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20921",
"name": "Ventricular Premature Complexes",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M25869",
"name": "Premature Birth",
"relevance": "LOW"
},
{
"asFound": "Cardiomyopathy",
"id": "M12154",
"name": "Cardiomyopathies",
"relevance": "HIGH"
},
{
"asFound": "Sudden Cardiac Death",
"id": "M19118",
"name": "Death, Sudden, Cardiac",
"relevance": "HIGH"
},
{
"asFound": "Dilated Cardiomyopathy",
"id": "M5567",
"name": "Cardiomyopathy, Dilated",
"relevance": "HIGH"
},
{
"asFound": "Arrhythmogenic Right Ventricular Cardiomyopathy",
"id": "M21507",
"name": "Arrhythmogenic Right Ventricular Dysplasia",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M6847",
"name": "Death, Sudden",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9419",
"name": "Heart Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9420",
"name": "Cardiomegaly",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2392",
"name": "Laminopathies",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23686",
"name": "Genetic Diseases, Inborn",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9418",
"name": "Heart Defects, Congenital",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12",
"name": "Congenital Abnormalities",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20503",
"name": "Cardiovascular Abnormalities",
"relevance": "LOW"
},
{
"asFound": "Dilated Cardiomyopathy",
"id": "T1876",
"name": "Dilated Cardiomyopathy",
"relevance": "HIGH"
},
{
"asFound": "Arrhythmogenic Right Ventricular Cardiomyopathy",
"id": "T483",
"name": "Arrhythmogenic Right Ventricular Cardiomyopathy",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D009202",
"term": "Cardiomyopathies"
},
{
"id": "D001145",
"term": "Arrhythmias, Cardiac"
},
{
"id": "D002311",
"term": "Cardiomyopathy, Dilated"
},
{
"id": "D016757",
"term": "Death, Sudden, Cardiac"
},
{
"id": "D019571",
"term": "Arrhythmogenic Right Ventricular Dysplasia"
},
{
"id": "D003643",
"term": "Death"
}
]
} | null | {
"conditions": [
{
"id": "D009202",
"term": "Cardiomyopathies"
},
{
"id": "D001145",
"term": "Arrhythmias, Cardiac"
},
{
"id": "D002311",
"term": "Cardiomyopathy, Dilated"
},
{
"id": "D016757",
"term": "Death, Sudden, Cardiac"
},
{
"id": "D019571",
"term": "Arrhythmogenic Right Ventricular Dysplasia"
},
{
"id": "D003643",
"term": "Death"
}
],
"interventions": null
} |
NCT00898833 | null | Plasma and Urine Samples From Patients With Hormone-Refractory Prostate Cancer Enrolled on Clinical Trials CALGB-9480 or CALGB-9583 | Laboratory Studies in Hormone Refractory Prostate Cancer - A Companion Study to CALGB 9480 and 9583 | None | OBSERVATIONAL | TERMINATED | 2009-05-09T00:00:00 | null | null | null | null | 868 | 18 | null | MALE | false | RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This laboratory study is measuring plasma and urine biomarkers in patients with advanced prostate cancer that did not respond to hormone therapy. | OBJECTIVES:
Primary
* Correlate plasma and urine vascular endothelial growth factor (VEGF) levels with survival duration in patients with advanced hormone-refractory adenocarcinoma of the prostate previously enrolled on CALGB-9480.
* Determine whether plasma chromogranin A (CgA) and plasma interleukin-6 (IL-6) levels predict survival duration in these patients.
* Determine whether plasma human Kallikrein 2 (hK2) levels are prognostic for overall survival of these patients.
Secondary
* Determine the prognostic significance of plasma and urine VEGF levels, plasma CgA levels, plasma IL-6 levels, and plasma hK2 levels in relation to overall survival of these patients.
* Correlate plasma VEGF levels with urine VEGF levels in these patients.
* Correlate plasma CgA levels with previously measured serum prostate-specific antigen (PSA) and plasma VEGF levels in these patients.
* Correlate plasma hK2 levels with PSA changes after treatment with suramin to determine if hK2 may have predictive value, independent or additive to measures of disease response in these patients.
* Correlate plasma hK2 levels with PSA levels in these patients.
OUTLINE: Plasma from patients is collected for measurement of the following biomarkers: vascular endothelial growth factor (VEGF), chromogranin A, interleukin-6, and human Kallikrein 2. Urine is collected for VEGF measurement. | * Registration to CALGB 9480 or 9583
* Samples collected and shipped appropriately
* Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required | Alliance for Clinical Trials in Oncology | OTHER | {
"id": "CALGB-150201",
"link": null,
"type": null
} | The proposed work could not be completed. | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-05-09T00:00:00 | {
"date": "2017-08-08",
"type": "ACTUAL"
} | {
"date": "2009-05-12",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients with hormone refractory prostate cancer enrolled on CALGB-9480 or 9583 | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
} | [
"Prostate Cancer"
] | ["recurrent prostate cancer", "stage III prostate cancer", "stage IV prostate cancer", "adenocarcinoma of the prostate"] | null | [
{
"city": "Buffalo",
"country": "United States",
"facility": "Roswell Park Cancer Institute",
"geoPoint": {
"lat": 42.88645,
"lon": -78.87837
},
"state": "New York"
}
] | [
{
"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Confirmation of plasma VEGF levels inversely correlate with survival time",
"timeFrame": "Up to 3 years"
},
{
"description": null,
"measure": "Confirmation of urine VEGF levels inversely correlate with survival time",
"timeFrame": "Up to 3 years"
},
{
"description": null,
"measure": "CgA levels in predicting survival time",
"timeFrame": "Up to 3 years"
}
],
"secondary": null
} | [
{
"affiliation": "Dana-Farber Cancer Institute",
"name": "Mary Ellen Taplin, MD",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D005834",
"term": "Genital Neoplasms, Male"
},
{
"id": "D014565",
"term": "Urogenital Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D005832",
"term": "Genital Diseases, Male"
},
{
"id": "D000091662",
"term": "Genital Diseases"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D011469",
"term": "Prostatic Diseases"
},
{
"id": "D052801",
"term": "Male Urogenital Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
{
"asFound": "Prostate Cancer",
"id": "M14335",
"name": "Prostatic Neoplasms",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M14850",
"name": "Recurrence",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M3585",
"name": "Adenocarcinoma",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8946",
"name": "Genital Neoplasms, Male",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17315",
"name": "Urogenital Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2876",
"name": "Genital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8944",
"name": "Genital Diseases, Male",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2875",
"name": "Urogenital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14333",
"name": "Prostatic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M27095",
"name": "Male Urogenital Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D011471",
"term": "Prostatic Neoplasms"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M9789",
"name": "Hormones",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D011471",
"term": "Prostatic Neoplasms"
}
],
"interventions": []
} |
NCT06456333 | null | Exploring Paraspinal Electromyographic Features in Adolescent Idiopathic Scoliosis Patients | Paravertebral Electromyographic Characteristics of Adolescent Idiopathic Scoliosis Patients Explored on the Basis of High-density Surface Electromyography | None | OBSERVATIONAL | COMPLETED | 2024-06-07T00:00:00 | null | 2023-12-31T00:00:00 | 2024-05-31T00:00:00 | null | 70 | 10 | 18 | ALL | true | Adolescent Idiopathic Scoliosis (AIS) is a complex three-dimensional spinal deformity with onset in adolescents between the ages of 10 and 18 years, characterized by coronal curvature, sagittal imbalance and horizontal rotation of the spine. The incidence of AIS is 1-4% globally, with more females than males, and it is a common, frequent and difficult-to-treat disease that seriously jeopardizes the physical and mental health of adolescents.
Previous studies have found significant changes in the morphologic structure and physiologic characteristics of the paraspinal muscles in patients with AIS, including muscle fiber distribution, muscle contraction and relaxation capacity, the convex side of the AIS curve exhibits a higher level of electromyographic activity, and asymmetric changes in the paraspinal muscles are highly correlated with progression of scoliosis. The current single-electrode sEMG technique extracts limited muscle activity signals and is susceptible to interference from random noise. Compared with the single-electrode sEMG technique, HD-sEMG can provide rich spatiotemporal information on paraspinal muscle activity, so it is necessary to use a wide and closely spaced electrode array for signal acquisition to obtain more accurate and detailed characteristics of paraspinal muscle activity.
In summary, this study used high-density surface electromyography to collect muscle parameters of the paraspinal muscles on the concave and convex sides of AIS patients and compared them with those of healthy people to comprehensively summarize the characteristics of their paraspinal muscles, so as to provide scientific basis for the subsequent development of precise treatment plans and improvement of clinical efficacy. | Paravertebral muscle EMG signals were acquired from AIS patients and healthy controls under the BST test paradigm.
Acquisition site: paravertebral muscle at the L1-L3 level, with the electrode sheet placed 1.5 cm adjacent to the spinous process.
（Biering-Sorensen test,BST）：The subject was lying prone on the bed, with the upper half of the body poking out of the bed, the anterior superior iliac spine located at the edge of the bed, both lower limbs partially immobilized on the bed with straps, both hands crossed in front of the chest grasping the contralateral shoulder and tightly pressed against the chest wall, and the torso was suspended in the air and parallel to the floor, and the patient stopped the test when he/she maintained this position for 90s.
Observation indicators:
1, the average change (mean) characteristics of each channel signal, including the 32 channels of the root mean square value （RMS）, mean power frequncy（MPF）, fractal dimension（FD）,Slope sign change(SSC), a total of 4 types of indicators-reflecting the strength and fatigue of muscle contractions.. | Inclusion Criteria:
* Patients with a diagnosis of AIS
* Any gender, age 10-18 years old
* Signed informed consent and able to cooperate with follow-up
* Ability to cooperate with electromyography examination and evaluation, and to perform measurements of relevant indexes.
Exclusion Criteria:
* Subjects with spine-related diseases such as Marfan's syndrome
* Subjects with previous spine-related diseases such as ankylosing spondylitis, spinal neurofibroma, spinal tuberculosis, spinal trauma, etc
* Subjects with comorbid serious medical diseases and patients with psychiatric disorders
* Subjects with ECOG scores of \>2, which may have an effect on the results of the study | The First Affiliated Hospital of Zhejiang Chinese Medical University | OTHER | {
"id": "2023-K-286-01",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-06-07T00:00:00 | {
"date": "2024-07-03",
"type": "ACTUAL"
} | {
"date": "2024-06-13",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT"
] | AIS patients and healthy control populations | NON_PROBABILITY_SAMPLE | null | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
} | [
"Scoliosis; Adolescence",
"Electromyography"
] | ["Adolescent idiopathic scoliosis", "high-density surface electromyography", "Cross-sectional study"] | null | [
{
"city": "Hangzhou",
"country": "China",
"facility": "The First Affiliated Hospital of Zhejiang Chinese Medical University",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "root mean square value （RMS）",
"timeFrame": "Day 1"
},
{
"description": null,
"measure": "mean power frequncy（MPF）",
"timeFrame": "Day 1"
},
{
"description": null,
"measure": "fractal dimension（FD）",
"timeFrame": "Day 1"
},
{
"description": null,
"measure": "Slope sign change(SSC)",
"timeFrame": "Day 1"
}
],
"secondary": null
} | [
{
"affiliation": "The First Affiliated Hospital of Zhejiang Chinese Medical University",
"name": "Honggen Du, doctor",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D013121",
"term": "Spinal Curvatures"
},
{
"id": "D013122",
"term": "Spinal Diseases"
},
{
"id": "D001847",
"term": "Bone Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
"asFound": "Scoliosis",
"id": "M15417",
"name": "Scoliosis",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M15918",
"name": "Spinal Curvatures",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15919",
"name": "Spinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5126",
"name": "Bone Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12097",
"name": "Musculoskeletal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T4202",
"name": "Oculocerebral Syndrome With Hypopigmentation",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D012600",
"term": "Scoliosis"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "HB",
"name": "Herbal and Botanical"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "T256",
"name": "Poke",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D012600",
"term": "Scoliosis"
}
],
"interventions": []
} |
NCT04988633 | null | "CAP" Fetge Gras. Lifestyle Modification Program in Catalonia. | "CAP" Fetge Gras. Lifestyle Modification Program of Nurse Management Through a Mobile Application for Patients With MFLD. | None | INTERVENTIONAL | COMPLETED | 2021-07-22T00:00:00 | null | 2022-06-30T00:00:00 | 2022-07-31T00:00:00 | [
"NA"
] | 90 | 18 | 70 | ALL | false | The main purpose of this study is to investigate whether an online lifestyle modification program for people with Metabolic Associated Fatty Liver Disease (MAFLD) through a mobile application produces a significant reduction in liver steatosis and is associated with a higher rate of weight loss compared to standard recommendations currently indicated in Primary Care. | Chronic liver disease are very common and potentially severe. For the most part, they are diagnosed in an advanced stage, which prevents the introduction of curative treatments.
MAFLD is currently the most common cause of chronic liver disease affecting approximately 25% of the world's population. MAFLD is characterized by an excessive accumulation of liver fat associated with insulin resistance (IR) which is defined by the presence of steatosis in\> 5% of hepatocytes according to histological analysis.
Currently, the only effective strategy for treating MAFLD is weight loss. Several studies show that a 3-5% weight loss manages to reduce hepatic steatosis and associated metabolic parameters. Despite this, a reduction of at least 7-10% is required to improve fibrosis. Guidelines from the European Association for the Study of Liver Diseases (EASL) and the American Association for the Study of Liver Diseases (AASLD) recommend following an energy-restricted diet adjusted to the Mediterranean diet, excluding MAFLD-promoting components (processed products and high in added fructose), and perform physical activity in order to achieve this goal. However, it is a difficult goal to achieve and maintain over time. Epidemiological evidence recommends implementing structured lifestyle modification programs with the goal of losing weight.
In people with MFGNA, participation in structured lifestyle programs may be compromised by work and time constraints. An application-based online intervention may be more appropriate for young people, people of working age, and those living far from primary care. EHealth technology is a possible resource for promoting behavior change but is a little-studied field in lifestyles modification of people with MAFLD. Given the lack of information regarding lifestyle modification programs in people with MAFLD as the main therapeutic intervention in Primary Care (PC), we consider to analyze the effectiveness of an online program based on the Mediterranean diet with calorie restriction, associated with specific goals of weight loss and physical activity, which allows to reduce hepatic steatosis of individuals with MAFLD.
This study, along with studies of early detection of chronic liver disease through liver elastography "LiverScreen", aims to be the beginning of the approach to chronic liver disease in Primary Care. The aim of this study is to evaluate a strategy for treating MAFLD. | Inclusion Criteria:
* Age ≥ 18 years old
* Fibroscan® with a CAP ≥ 300 dB/m and liver stiffness \<8 Kpa.
Exclusion Criteria:
* Serious chronic disease (heart, respiratory, cancer, etc.).
* Chronic liver disease.
* Chronic kidney disease (FGR \<60ml/min).
* Weight loss\> 5% during the last three months.
* AUDIT- C\> 8
* Impossibility to follow the recommended diet (for religious reasons, swallowing problems, etc.) or inability to perform physical activity.
* Inability to follow the scheduled visits to the intervention (institutionalized individuals, lack of autonomy, inability to walk, lack of a stable home, travel plans, etc.).
* Have been included in another weight loss advice program (\>5 kg) during the 6 months prior to the selection visit (basal visit).
* History of having followed a low calorie diet (\<900Kcal/day) for the last 6 months.
* History of surgical procedures to lose weight or intend to undergo bariatric surgery in the next 12 months.
* Hemoglobin A1c ≥ 9%.
* History of resection of the small or large intestine.
* History of inflammatory bowel disease.
* BMI\> 40 or obesity of known endocrine origin (with the exception of treated hypothyroidism).
* Current treatment with systemic corticosteroids.
* Current use of medication for weight loss.
* Current treatment with steatogenic drugs.
* People participating in a clinical trial with drugs.
* Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
* Refusal to give informed consent. | Hospital Clinic of Barcelona | OTHER | {
"id": "CFG",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-07-26T00:00:00 | {
"date": "2024-01-23",
"type": "ACTUAL"
} | {
"date": "2021-08-03",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Phase III, single-centre, randomized clinical trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Non-Alcoholic Fatty Liver Disease",
"Liver Diseases",
"Lifestyle, Healthy"
] | null | null | [
{
"city": "Barcelona",
"country": "Spain",
"facility": "Núria Fabrellas",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null
}
] | [
{
"class": "OTHER",
"name": "University of Barcelona"
},
{
"class": "OTHER",
"name": "Institut d'Investigacions Biomèdiques August Pi i Sunyer"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Rate of reduction in hepatic steatosis in people with MAFLD.",
"timeFrame": "Month 12"
}
],
"secondary": [
{
"description": null,
"measure": "Liver steatosis improvement rate according to CAP value (dB/m)",
"timeFrame": "Month 6 and 12"
},
{
"description": null,
"measure": "Changes from baseline in weight (kg) at month 6 and month 12.",
"timeFrame": "Month 6 and 12"
},
{
"description": null,
"measure": "Changes from baseline in abdominal circumference (cm) and anthropometric variables at month 6 and 12.",
"timeFrame": "Month 6 and 12"
},
{
"description": null,
"measure": "Adherence to healthy lifestyle with",
"timeFrame": "Month 6 and 12"
},
{
"description": null,
"measure": "Changes from baseline in cardiovascular risk through REGICOR at month 6 and 12.",
"timeFrame": "Month 6 and 12"
},
{
"description": null,
"measure": "Changes from baseline in lipid profile (TG, total COL, HDL, LDL), glycemia and HbA1c at month 6 and month 12.",
"timeFrame": "Month 6 and 12"
},
{
"description": null,
"measure": "Changes from baseline in liver stiffness values for Fibroscan®, FIB-4 and NAFLD-score and on steatosis scores FLI, HSI, ION at month 6 and 12.",
"timeFrame": "Month 6 and 12"
},
{
"description": null,
"measure": "Changes from baseline in steatosis scores FLI, HSI, ION at month 6 and 12.",
"timeFrame": "Month 6 and 12"
},
{
"description": null,
"measure": "Changes from baseline in quality of life of individuals at month 6 and 12 and throughout the study throught EuroqoL questionnarie.",
"timeFrame": "Month 6 and 12"
},
{
"description": null,
"measure": "Satisfaction of individuals in the participation of the study throught adHoc questionnaire",
"timeFrame": "D0, month 6, month 12"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D004066",
"term": "Digestive System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC06",
"name": "Digestive System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
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},
{
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"id": "M8375",
"name": "Fatty Liver",
"relevance": "HIGH"
},
{
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{
"asFound": null,
"id": "M8883",
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{
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},
{
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]
} | null | {
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},
{
"id": "D005234",
"term": "Fatty Liver"
},
{
"id": "D065626",
"term": "Non-alcoholic Fatty Liver Disease"
}
],
"interventions": null
} |
NCT00573833 | null | Internal Radiation Therapy in Treating Patients With Prostate Cancer | A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer | None | INTERVENTIONAL | COMPLETED | 2007-12-13T00:00:00 | null | null | null | [
"NA"
] | 23 | 18 | 120 | MALE | false | RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.
PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer. | OBJECTIVES:
Primary
* To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of external-beam radiotherapy) as definitive treatment for patients with intermediate-risk prostate cancer.
* To assess acceptable toxicity, defined as treatment related toxicity (urinary and rectal), no worse than that seen by patients treated with conventional therapy (grade 3 urinary toxicity \< 10% and grade 3 rectal toxicity \< 10%).
Secondary
* To achieve adequate dosimetric coverage of the prostate comparable to current standards.
* To assess the effect of treatment on sexual function.
OUTLINE: Patients undergo 4 high-dose rate brachytherapy treatments over 2 days.
Patients complete bladder, bowel, sexual function, and quality of life questionnaires, including the International Index of Erectile Function (IIEF) questionnaire, the International Prostate Symptom Score Index (IPSS), and the MSKCC Prostate Quality of Life questionnaire at baseline and then at every follow-up visit.
After completion of study treatment, patients are followed every 3 months for 1 year. | DISEASE CHARACTERISTICS:
Inclusion criteria:
* Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria:
* PSA 10-20 ng/mL
* Gleason score ≥ 7
* Stage ≥ T2b AND \< T3
* Less than 20% risk of seminal vesicle involvement or lymph node involved based upon the Kattan nomogram (pre-treatment risk with IMRT)
* Prostate size \< 60 cc by MRI or CT imaging
* International Prostate Symptom Score Index ≤ 15
Exclusion criteria:
* Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by MRI (endorectal coil) and DRE (digital rectal examination)
* Suspected extracapsular disease will not be considered an exclusion criteria
* PSA \> 20 ng/mL
* Presence of distant metastases
PATIENT CHARACTERISTICS:
* WBC ≥ 3,500/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin ≥ 10 g/dL
* Creatinine ≤ 1.5 mg/dL
* Liver function tests ≤ 1.5 times normal
* INR ≤ 2.5
* Able to complete quality of life questionnaires
* Able to give informed consent
* No active perineal infections
* No history of urethral stricture
* No prior history of pelvic malignancy
* No prior history of lymphoma disease, ulcerative colitis, or anal fissures
* No contraindications to general anesthesia
* No pacemaker
PRIOR CONCURRENT THERAPY:
* No prior transurethral resection of the prostate
* No prior pelvic radiotherapy
* No prior treatment for prostate cancer except for hormone therapy | Memorial Sloan Kettering Cancer Center | OTHER | {
"id": "07-120",
"link": null,
"type": null
} | Unknown | {
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"nctId": null,
"statusForNctId": null
} | 2007-12-13T00:00:00 | {
"date": "2017-10-20",
"type": "ACTUAL"
} | {
"date": "2007-12-14",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
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"interventionModel": "SINGLE_GROUP",
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} | [
"Prostate Cancer"
] | ["adenocarcinoma of the prostate", "stage IIB prostate cancer", "stage IIA prostate cancer"] | null | [
{
"city": "New York",
"country": "United States",
"facility": "Memorial Sloan-Kettering Cancer Center",
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"lat": 40.71427,
"lon": -74.00597
},
"state": "New York"
}
] | [
{
"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
] | null | {
"other": [
{
"description": null,
"measure": "Number of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint",
"timeFrame": "week 12 reported"
},
{
"description": null,
"measure": "Median International Prostate Symptom Total Score",
"timeFrame": "week 12 reported"
}
],
"primary": [
{
"description": null,
"measure": "Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity",
"timeFrame": "At scheduled 3 month intervals for one year"
},
{
"description": null,
"measure": "Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity",
"timeFrame": "Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)"
}
],
"secondary": null
} | [
{
"affiliation": "Memorial Sloan Kettering Cancer Center",
"name": "Josh Yamada, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Memorial Sloan Kettering Cancer Center",
"name": "Michael J. Zelefsky, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Memorial Sloan Kettering Cancer Center",
"name": "Sherri M. Donat, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Memorial Sloan Kettering Cancer Center",
"name": "Marco Zaider, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D005834",
"term": "Genital Neoplasms, Male"
},
{
"id": "D014565",
"term": "Urogenital Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D005832",
"term": "Genital Diseases, Male"
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{
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"term": "Genital Diseases"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D011469",
"term": "Prostatic Diseases"
},
{
"id": "D052801",
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],
"browseBranches": [
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"abbrev": "BC04",
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],
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"relevance": "LOW"
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"asFound": null,
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],
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NCT05365633 | null | Empowering LGBTQ+ Tobacco Cessation Pilot | Empowering Sexual and/or Gender Minority Tobacco Cessation: A Pilot Study | None | INTERVENTIONAL | COMPLETED | 2022-04-12T00:00:00 | null | 2023-09-01T00:00:00 | 2024-01-11T00:00:00 | [
"NA"
] | 20 | 18 | null | ALL | true | Sexual and/or gender minority (SGM) people have disproportionately high rates of tobacco use - the number one cause of preventable death. Reasons for this include using tobacco to cope with social minority stressors, pro-tobacco use norms in SGM social spaces and networks, and targeted tobacco industry marketing. Empowerment Theory explains how positive behavior change, like quitting smoking, can be promoted through skills development with greater participation in the public affairs of one's community. An empowerment approach may enhance tobacco cessation treatment for SGM people and other stigmatized groups because it links individual well-being with the larger social and political context. This pilot study will assess the acceptability, feasibility, and preliminary impact of empowerment-enhanced tobacco smoking cessation assistance for SGM adults. We will enroll N=20 SGM adults in Oklahoma who smoke and are willing to quit. Participants will receive standard tobacco cessation assistance through the Stephenson Cancer Center Tobacco Treatment Research Program (TTRP). Concurrently, they will also engage in 'empowerment activities', meaning SGM organizing and community-building activities, like conducting follow-up phone calls to name change clinic participants. This will be guided by an Oklahoman SGM-serving community partner. Participants will complete 8 surveys during the intervention period and 12 weeks post-quit-date, a 60-minute, in-depth exit interview, and biochemically-verified smoking status before the intervention and 12 weeks post-quit-date. This pilot study will establish collaborative relationships between the PI's team and local SGM-serving organizations, and will produce preliminary findings to support future R01-level funding to conduct a fully-powered randomized control trial of a multi-level empowerment-enhanced SGM tobacco cessation intervention. | Aim 1: Assess the feasibility and acceptability of empowerment-enhanced tobacco cessation assistance for sexual and/or gender minority (SGM) adults. Use baseline and exit surveys and in-depth interviews to assess retention, empowerment activity participation (e.g., number, duration, intensity, roles), and participants' perceptions of the intervention.
Aim 2: Compare individual empowerment and cessation predictors pre- and post-intervention. Hypothesis: Post intervention, participants will have (i) increased adaptive coping strategies, social support, and smoking abstinence self-efficacy; and (ii) decreased internalized SGM stigma.
Aim 3: Assess tobacco cessation outcomes post-intervention. Hypothesis: The proportion of participants with biochemically-verified smoking abstinence at 12 weeks post-quit-date will be equal to or greater than the general Stephenson Cancer Center Tobacco Treatment research Program (TTRP) intervention (i.e., 18% biochemically-verified abstinence at 12 weeks1); medication and counseling adherence will be moderate/optimal for \>50% of treatment weeks.
Study overview. This study will assess the feasibility and acceptability of empowerment-enhanced tobacco cessation assistance for SGM adults. A single-arm pilot design will be used given funding, time, and sampling pool limits. Participants (N=20) will receive standard TTRP tobacco cessation assistance and concurrently participate in SGM empowerment activities. Outcomes will be assessed quantitatively and qualitatively. Primary outcome variables will be retention, perceptions of the intervention, adaptive coping strategies, biochemically-verified smoking abstinence at 12 weeks post-quit-date, and treatment adherence.
Recruitment. Participants will be enrolled over a 4-month period and recruit through the TTRP, which serves an average of 30 SGM individuals per year without SGM-targeted recruitment. This will be supplement by recruiting via local SGM-serving organizations, SGM targeted social media ads (e.g., Facebook), and snowball recruitment.
Intervention. Participants will receive standard TTRP tobacco cessation assistance either remotely or in-person: 6 weekly counseling sessions and 12 weeks of combination NRT (nicotine patches + nicotine gum or lozenges). During the 6 weeks of counseling, participants will also engage in at least 4 'empowerment activities' (i.e., SGM social change mobilization and community-building activities48) for a total of at least 8 hours. Activities will be tailored to each participant's comfort level and skills. Examples are compiling publicly-available school board information to make it easier for community members to participate in their school districts and follow-up phone calls to Freedom OK's name correction clinic participants.
Participants will complete the following assessments: (i) 8 surveys (baseline, exit, quit-day, 1-4 and 12 weeks post-quit-date); (ii) biochemically-verified smoking status at baseline and 12 weeks post-quit-date via expired carbon monoxide monitors; and (iii) a 60-minute in-depth interview over Zoom video chat within weeks 6-8 post-quit-date. Participants will be incentivized a total of $200 for the baseline survey ($25), 6 subsequent surveys ($70), 2 expired carbon monoxide tests ($20), exit survey ($25), and 60-minute interview ($60). Freedom Oklahoma staff will participate in interviews and reflect on the intervention and Freedom OK's role in it. Freedom Oklahoma will adopt a tobacco-free policy and provide feedback on the cultural competence of TTRP materials.
Partnerships. TTRP will provide the standard tobacco cessation assistance. Freedom Oklahoma will design the empowerment activities. Freedom Oklahoma is a community-based organization in Oklahoma City that has worked to secure lived equality and legal protection for SGM Oklahomans for over 15 years. PI McQuoid and Freedom OK have held more than 4 project planning meetings over the past year.
Measurement of Feasibility and Acceptability (Aim 1). Exit surveys administered via REDCap will be used to assess retention and self-reported empowerment activity participation (i.e., total hours, types of events/activities, roles played).73 This will be cross-referenced with research project records of empowerment activity participation. Perceptions of the intervention will be qualitatively assessed by interviewing participants over Zoom video chat at 12 weeks post-quit-date. PI McQuoid, a qualitative methods expert, will train a team to conduct semi-structured, in-depth interviews lasting approximately 60 minutes. Rich content will be elicited regarding experiences of empowerment activity participation and tobacco cessation as an SGM person in Oklahoma. Interview guide domains will include: (i) best intervention aspects (e.g. highlights, peak experiences); (ii) biggest challenges or negative experiences; (iii) empowerment activity experiences; (iv) interactions of empowerment activity participation with tobacco cessation experiences; (v) outcomes and personal growth (vi) suggestions for intervention improvements. Interviews will be audio-recorded and professionally transcribed verbatim.
Qualitative Analysis: Dedoose qualitative data analysis software will be used to conduct an inductive-deductive thematic transcript analysis with a priori themes derived from ET and SGM tobacco cessation literature.33-35 An iterative codebook development process will be used involving weekly team discussions, independent coding, and member checking of findings74 to enhance rigor and trustworthiness.75,76 Freedom Oklahoma staff will also be interviewed about their perceptions of the intervention and their organization's role in it.
Measurement of Individual Empowerment and Cessation Predictors (Aim 2). Individual empowerment and cessation predictors pre- and post-intervention will be compared with baseline and exit surveys. Predictors of smoking cessation51-54,77,78 and individual empowerment outcome measures will be compared, adapted from a youth empowerment tobacco control model42,73 and SGM social change mobilization participation research.48 These will include: (i) adaptive coping strategies (Cognitive Emotion Regulation Questionnaire79), (ii) (v) social support (Relational Health Indices80), (iii) abstinence self-efficacy (Confidence Inventory81), and (iv) internalized SGM stigma (Internalized Transphobia and Pride82 and Internalized Homophobia items83).
Measurement of Tobacco Cessation Outcomes (Aim 3). Benchmarks will be used to assess participants' tobacco cessation outcomes. Tobacco abstinence will be measured via self-report and biochemically-verified via expired carbon monoxide at baseline and 12 weeks post-quit-date. Treatment adherence will be assessed with the 4-item Medication Adherence Questionnaire (MAQ)84 and counseling session attendance tracking.
Sample Size/Analysis Plan. Primary outcome variables will be: retention, perceptions of the intervention, adaptive coping strategies, biochemical verification of tobacco abstinence at 12 weeks post-quit-date, and treatment adherence. Retention will be evaluated by calculating the proportion of participants who complete the final study visit at 12-weeks post-quit, with the goal of retaining \>80% of participants. Perceptions of the intervention will be qualitatively evaluated (as described above). A two-sided paired samples t-test will be used to examine the mean differences in adaptive coping strategies pre- and post-intervention (α=0.05). Assuming 20% attrition and a standard deviation of differences of 4.085, n=20 participants will provide 80% power to detect a mean difference of 2.6 in adaptive coping strategies. Tobacco cessation outcomes will be considered successful if the proportion of participants with biochemically-verified smoking abstinence (expired carbon monoxide) at 12 weeks post-quite-date is equal to or greater than the general TTRP sample (i.e., 18% at 12 weeks1). Treatment adherence will be considered successful with all participants having \>50% of treatment weeks with an MAQ score indicating moderate/high adherence and counseling session attendance.
Expected outcomes: Empowerment-enhanced tobacco cessation assistance will be acceptable and feasible (Aim 1), will increase within-subject empowerment and improve cessation predictors (Aim 2), and will meet benchmarks for tobacco cessation outcomes (Aim 3). | Inclusion Criteria:
* At least 18 years old
* Self-identify as sexual and/or gender minority
* Reside in the State of Oklahoma
* Report past 30 day use of combustible tobacco
* Willing to quit using combustible tobacco within the next 2 weeks
* English-speaking
* Willing to refrain from smoking any substance, such as cannabis, within 48 hours of expired carbon monoxide collection
* Willing to complete all intervention components and data collection activities
Exclusion Criteria:
* Have contraindications for nicotine replacement therapy (NRT) | University of Oklahoma | OTHER | {
"id": "14472",
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"type": null
} | Unknown | {
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"nctId": null,
"statusForNctId": null
} | 2022-05-03T00:00:00 | {
"date": "2025-05-15",
"type": "ACTUAL"
} | {
"date": "2022-05-09",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
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} | [
"Smoking Cessation"
] | ["sexual and gender minorities", "LGBT", "empowerment", "tobacco use", "smoking cessation"] | null | [
{
"city": "Oklahoma City",
"country": "United States",
"facility": "Health Promotion Research Center",
"geoPoint": {
"lat": 35.46756,
"lon": -97.51643
},
"state": "Oklahoma"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Retention",
"timeFrame": "12-weeks post-quit"
},
{
"description": null,
"measure": "Number of Participants Endorsing That They Would Recommend This Intervention to Another LGBTQ2S+ Identified Person Who Wants to Quit Smoking",
"timeFrame": "12 weeks post-quit-date"
},
{
"description": null,
"measure": "Number of Community Partner Staff Who Perceived Their Organization's Partnership on the Intervention as Beneficial",
"timeFrame": "within 1 month of data collection completion"
},
{
"description": null,
"measure": "Number of Participants Having Had ≥ 2 Weeks With Moderate to High Adherence to the Nicotine Patch Assessed With the 4-item Medication Adherence Questionnaire (MAQ)",
"timeFrame": "12 weeks post-quit-date"
},
{
"description": null,
"measure": "Number of Participants Attending at Least 4 Smoking Cessation Counseling Sessions",
"timeFrame": "12 weeks post-quit-date"
},
{
"description": null,
"measure": "Number of Participants Attending at Least 4 Volunteer Sessions",
"timeFrame": "12 weeks post-quit-date"
}
],
"secondary": [
{
"description": null,
"measure": "Number of Participants Self-reporting 7-day Point Prevalence Abstinence at Week 12",
"timeFrame": "12 weeks post-quit-date"
},
{
"description": null,
"measure": "Number of Participants for Whom Self-reported Smoking Abstinence is Biochemically-verified",
"timeFrame": "12 weeks post-quit-date"
},
{
"description": null,
"measure": "Number of Participants Who Reported an Increase in Adaptive Coping From Baseline to Exit",
"timeFrame": "baseline and 12 weeks post-quit-date"
}
]
} | [
{
"affiliation": "University of Oklahoma",
"name": "Julia McQuoid, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | {
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"abbrev": "All",
"name": "All Drugs and Chemicals"
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"name": "Nicotine",
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NCT02646033 | null | Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position | Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position | None | OBSERVATIONAL | COMPLETED | 2016-01-04T00:00:00 | null | null | null | null | 100 | 40 | 60 | ALL | false | This study analyse the rise in Intraocular Pressure while patient is in surgery in head low position. | Patient undergoing robotic surgeries requires steep trendelenburg position (upto 60 degrees) along with pneumoperitoneum. These both can cause a significant rise in intraocular pressure. Significant rise of pressure for prolonged period can cause post operative visual disturbances, which can be of medicolegal importance. Thus studying the quantitative rise and thus trend of intraocular pressure is first step in managing ophthalmic changes during robotic surgeries. | Inclusion Criteria:
* American Society of Anaesthesiologists (ASA) status 1-3
* without any ophthalmic complains or interventions
Exclusion Criteria:
* lasix given during preoperative or intraoperative period
* cardiac patients who are on medications for stents or post Coronary Artery Bypass Graft (CABG)
* pre-existing glaucoma, eye surgeries, cataract or retinal vascular diseases, corneal diseases which may affect IOP measurement were excluded | Rajiv Gandhi Cancer Institute & Research Center, India | OTHER | {
"id": "RajivGCIRC",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-01-04T00:00:00 | {
"date": "2020-03-17",
"type": "ACTUAL"
} | {
"date": "2016-01-05",
"type": "ESTIMATED"
} | [
"ADULT"
] | Patients undergoing robotic surgeries in steep trendelenburg position | NON_PROBABILITY_SAMPLE | false | {
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"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Intraocular Pressure"
] | ["Intraocular Pressure, Trendelenburg position"] | null | [
{
"city": "New Delhi",
"country": "India",
"facility": "Rajiv Gandhi Cancer Institute & Research Centre",
"geoPoint": {
"lat": 28.63576,
"lon": 77.22445
},
"state": "Delhi"
}
] | null | null | {
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"description": null,
"measure": "Intraocular pressure",
"timeFrame": "7-8 months"
}
],
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} | [
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"affiliation": "Rajiv Gandhi Cancer Institute & Research Centre",
"name": "Nitesh Goel, MBBS,DA, DNB",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT03696433 | null | Visualizing Vascular Mechanisms of Salt Sensitivity | Visualizing Vascular Mechanisms of Salt Sensitivity | None | INTERVENTIONAL | COMPLETED | 2018-09-25T00:00:00 | null | 2022-11-04T00:00:00 | 2022-11-04T00:00:00 | [
"NA"
] | 19 | 18 | 55 | ALL | true | This study aims to assess the salt sensitive blood pressure response to dietary salt load compared with radiological markers of salt handling. | Hypertension is a major cause of heart disease, heart failure, and stroke. Hypertension, or high blood pressure, affects people differently and is related to the body's ability to maintain healthy circulation of salt. Some individuals may be affected by salt sensitive blood pressure (SSBP), when their blood pressure changes in response to dietary salt load. SSBP is a prevalent, independent risk factor for developing cardiovascular disease that preferentially affects black individuals. Current methods to assess SSBP require dietary salt loading over the course of days to weeks, and measurement of blood pressure following high salt diet and low salt diet. Such lengthy protocols are not feasible in a clinical setting to evaluate this risk factor for cardiovascular disease, and more importantly, these procedures provide incomplete information about mechanisms of salt sensitivity.
Our knowledge regarding salt handling in the body is limited. While renal dysfunction is partly responsible for SSBP, recent research points to the role of lymphatic vascular clearance in regulating tissue salt storage and blood pressure control. To better understand these mechanisms in vivo, we have recently developed a noninvasive magnetic resonance (MR) lymphangiography method sensitive to lymphatic vasculature, and applied standardized MR protocols for measuring tissue sodium and fat storage in adults with impaired lymphatic clearance. We found evidence of lymph stasis and tissue salt deposition that correlated with local subcutaneous fat volume. Here, we will test whether similar lymphatic pathways are impaired in persons with SSBP, leading to tissue salt and fat storage, in comparison to the involvement of renal dysfunction in SSBP tissue profiles.
The aims of this study are to improve our understanding of vascular mechanisms of human salt storage, and to provide standardized radiologic biomarkers sensitive to the SSBP phenotype. This study will test the primary hypothesis that the SSBP response is correlated with baseline tissue sodium storage, and elevated in persons with salt sensitivity. Secondary hypotheses will address whether the SSBP response is related to fat storage, lymphatic vascular function, renal vascular function, and impaired target organ responses to salt loading, including decreased urinary sodium excretion, and less suppression of plasma renin and serum aldosterone. | Inclusion Criteria:
* Identification as black race
* Age between 18 and 55 years
* Body mass index between 25 and \<35 kg/m2
* Normotensive or pre-hypertensive
* Willing to adhere to study diets
* Able to provide informed consent and communicate with study personnel
Exclusion Criteria:
* Prevalent cardiovascular disease or use of medications for cardiovascular disease
* Current or prior history of hypertension or use of blood pressure lowering medications
* Current or prior history of diabetes mellitus or use of anti-diabetic medications
* Prevalent renal disease (eGFR \< 60 ml/min/1.73m2), abnormal serum sodium or potassium
* Current or prior smoker
* Current pregnancy, or use of hormone replacement therapy or oral contraceptive
* Current steroid use
* Contraindications to MRI
* Active infection or open wounds on the top of the feet or hands | Vanderbilt University Medical Center | OTHER | {
"id": "181610",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-10-03T00:00:00 | {
"date": "2025-01-15",
"type": "ACTUAL"
} | {
"date": "2018-10-04",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | false | {
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} | [
"Obesity",
"Cardiovascular Risk Factor",
"Salt; Excess"
] | ["salt sensitive, blood pressure, obesity, magnetic resonance imaging"] | null | [
{
"city": "Nashville",
"country": "United States",
"facility": "Vanderbilt University Medical Center",
"geoPoint": {
"lat": 36.16589,
"lon": -86.78444
},
"state": "Tennessee"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Mean Arterial Blood Pressure Following High-salt Diet and Low-salt Diet",
"timeFrame": "Following completion of all dietary supplements and washout, in no less than 21 days."
}
],
"secondary": null
} | [
{
"affiliation": "Department of Radiology, Vanderbilt University Medical Center",
"name": "Rachelle Crescenzi, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "29280322", "type": "BACKGROUND", "citation": "Crescenzi R, Marton A, Donahue PMC, Mahany HB, Lants SK, Wang P, Beckman JA, Donahue MJ, Titze J. Tissue Sodium Content is Elevated in the Skin and Subcutaneous Adipose Tissue in Women with Lipedema. Obesity (Silver Spring). 2018 Feb;26(2):310-317. doi: 10.1002/oby.22090. Epub 2017 Dec 27."}, {"pmid": "28245075", "type": "BACKGROUND", "citation": "Crescenzi R, Donahue PMC, Hartley KG, Desai AA, Scott AO, Braxton V, Mahany H, Lants SK, Donahue MJ. Lymphedema evaluation using noninvasive 3T MR lymphangiography. J Magn Reson Imaging. 2017 Nov;46(5):1349-1360. doi: 10.1002/jmri.25670. Epub 2017 Feb 28."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D050177",
"term": "Overweight"
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"term": "Overnutrition"
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"term": "Nutrition Disorders"
},
{
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"term": "Body Weight"
}
],
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],
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"term": "Obesity"
}
]
} | null | {
"conditions": [
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"id": "D009765",
"term": "Obesity"
}
],
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} |
NCT01346033 | null | Evaluation of SCOUT DS in Subjects With Type 2 Diabetes | An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 Diabetes | TCOYD | OBSERVATIONAL | COMPLETED | 2011-04-28T00:00:00 | null | null | null | null | 270 | 18 | null | ALL | false | The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes. | Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the SCOUT DS diabetes screening algorithm. | Inclusion Criteria:
1. Age greater than or equal to 18 years
2. Self-reported diagnosis of type 2 diabetes
Exclusion Criteria:
* Not diagnosed with type 2 diabetes
* Diagnosed with type 1 diabetes
* Known to be pregnant (Self Reported)
* Receiving dialysis or having known renal compromise
* Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
* Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity) | VeraLight, Inc. | INDUSTRY | {
"id": "VL-2714",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2011-04-29T00:00:00 | {
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"type": "ESTIMATED"
} | {
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"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Attendees of the Taking Control of Your Diabetes Health Fair, San Diego CA Convention Center | NON_PROBABILITY_SAMPLE | false | {
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"city": "San Diego",
"country": "United States",
"facility": "San Diego Convention Center",
"geoPoint": {
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"lon": -117.15726
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"state": "California"
}
] | null | null | {
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"description": null,
"measure": "Validation of SCOUT DS algorithm for detecting known type 2 diabetes",
"timeFrame": "1 day"
}
],
"secondary": null
} | [
{
"affiliation": "Accelovance San Diego",
"name": "Martin L Kabongo, MD,PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D044882",
"term": "Glucose Metabolism Disorders"
},
{
"id": "D008659",
"term": "Metabolic Diseases"
},
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"term": "Endocrine System Diseases"
}
],
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"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
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"name": "All Conditions"
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],
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"relevance": "HIGH"
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"name": "Glucose Metabolism Disorders",
"relevance": "LOW"
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"asFound": null,
"id": "M7862",
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D003920",
"term": "Diabetes Mellitus"
},
{
"id": "D003924",
"term": "Diabetes Mellitus, Type 2"
}
]
} | null | {
"conditions": [
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"id": "D003920",
"term": "Diabetes Mellitus"
},
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"id": "D003924",
"term": "Diabetes Mellitus, Type 2"
}
],
"interventions": null
} |
NCT06794333 | null | Single Center Comparative Trial of Trans-Perineal Laser Ablation Vs Water Vapor Ablation | Comparative Efficacy of Trans-Perineal Laser Ablation Vs Water Vapor Ablation for Benign Prostatic Hyperplasia: a Single Center Randomized Controlled Trial | None | INTERVENTIONAL | COMPLETED | 2024-10-16T00:00:00 | null | 2024-07-05T00:00:00 | 2024-10-15T00:00:00 | [
"NA"
] | 80 | 50 | null | MALE | false | The primary aim of this clinical trial is to determine whether one of the two methods under investigation, TPLA or WVA, is superior in the treatment of BPH. Additionally, as a secondary objective, the study seeks to evaluate the potential superiority of one method over the other concerning the sexual parameters of treated participants, assessed using the International Index of Erectile Function 5 (IIEF5) and the Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EJ).
The researchers will compare the two methods under investigation (TPLA and WVA) to assess the potential superiority of one over the other.
Participants will:
* be randomized 1:1 between the two techniques and will undergo treatment at time 0;
* undergo follow-up including uroflowmetry and assessment of the International Prostate Symptoms Score (IPSS), IIEF5, and MSHQ-EJ questionnaires at 3, 6, and 12 months. | Therapeutic options for the treatment of benign prostatic hyperplasia (BPH) encompass a wide range of both pharmacological and surgical approaches. BPH is an age-related condition that increasingly affects relatively younger individuals, starting from the age of 50.
Pharmacological therapy primarily involves medications that can alleviate symptoms but do not cure or lead to a regression of the prostate gland enlargement over time.
Surgical therapy aims to reduce the degree of obstruction, and in most cases, it can result in significant alterations in sexual function, such as inducing retrograde ejaculation or causing erectile dysfunction. These side effects are more common with the use of classical treatment methods, whose clinical value is widely recognized and confirmed by clinical evidence reported in international guidelines (EAU Guidelines, 2021 edition).
The classical surgical treatment methods include the removal of the adenoma (benign hyperplastic part of the prostate gland) through open surgery, transurethral resection (TURP), laser ablation with en bloc removal (holmium and thulium lasers), or direct cavitation (green light laser). These classical methods typically require hospital admission with a stay of three days or more, depending on the extent of postoperative bleeding and the risk of post-surgical obstructive complications (bladder clots).
On the other hand, some minimally invasive and innovative methods can reduce the symptoms caused by the disease while preserving the patient's sexual function. These techniques also allow for treatment without hospitalization or, at most, in a outpatients setting, utilizing local anesthesia or sedation and presenting a low risk of bleeding or other complications. Specifically, the minimally invasive technologies aim for thermal ablation of the hyperplastic tissue without cavitation. This approach results in longer healing times and clinical improvement, as they are dependent on cellular apoptosis, tissue necrosis, and spontaneous gland remodeling, which occur in the months following treatment, thus not producing immediate visible or effective results.
These methods include Rezum (WVA), I-Tind, and SoracteLite trans-perineal laser ablation (TPLA). All of these minimally invasive methods have been extensively validated by clinical studies and scientific evidence.
SoracteLite-TPLA increases the temperature of the treated tissue through the absorption of laser radiation delivered to the targeted tissue by very thin optical fibers inserted perineally. Exposure to high temperatures causes coagulative necrosis of the tissues. In contrast, WVA involves the transurethral injection of water vapor through a radiofrequency needle. The local temperature increase generated by radiofrequency and water vapor leads to progressive tissue necrosis, reducing the size of the prostate adenoma and significantly improving urinary flow.
It is also logical that the use of minimally invasive methods allows for treating a larger number of patients with a lower risk of complications, although with an apparently reduced effectiveness in deobstruction compared to classical methods. The economic and social advantages are further highlighted by the faster resolution of waiting lists and greater psychological acceptance by the patient, due to the preservation of certain sexual functions and the reduced personal burden associated with the complex system of hospitalization/anesthesia/surgery/outcomes.
The primary objective is to evaluate the efficacy of TPLA vs WVA treatment at 3, 6, and 12 months in patients with BPH in terms of improvement in uroflowmetry parameters and symptoms. Specifically, the uroflowmetry parameters analyzed include maximum flow (Qmax), average flow (Qmed), and post-void residual (PVR). For symptom assessment, the IPSS questionnaire will be used.
The secondary objective includes evaluating the impact of these methods on the sexual health of treated participants through the IIEF5 and MSHQ-EJ questionnaires, which will be administered at 3, 6, and 12 months.
All participants will therefore undergo follow-up at 3, 6, and 12 months, during which they will undergo uroflowmetry with recording of Qmax, Qmed, and PVR parameters, as well as administration of the IPSS, IIEF5, and MSHQ-EJ questionnaires. This is a single-center randomized clinical trial in which participants are randomized 1:1 into the two treatment arms by the researchers. | Inclusion Criteria:
* PSA levels under 4 ng/ml (if PSA is over 4 ng/ml, a multiparametric prostate magnetic resonance will be performed; if a lesion with a PIRADS score over 2 is detected, a prostate biopsy will be conducted);
* Post void residual (PVR) over 50 ml;
* Maximum flow (Qmax) under 15 ml/s;
* IPSS score over 7;
* The possibility of undergoing transrectal ultrasound to assess the size of the prostate and prostate adenoma;
* Negative urinary culture.
Exclusion Criteria:
* Diabetes;
* Overactive or Underachieve bladder;
* Contraindications for performing MRI or prostate biopsy in cases where PSA is over 4 ng/ml;
* Intolerance to transrectal ultrasound;
* Intolerance or allergy to local anesthetics. | University of Pisa | OTHER | {
"id": "SPIT_2",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2025-01-20T00:00:00 | {
"date": "2025-01-27",
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"date": "2025-01-27",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
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} | [
"Benign Prostatic Hyperplasia"
] | ["Benign Prostatic Hyperplasia", "MISTs", "LUTS", "Rezum Vapor Therapy", "Transperineal Laser Ablation"] | null | [
{
"city": "Pisa",
"country": "Italy",
"facility": "University of Pisa",
"geoPoint": {
"lat": 43.70853,
"lon": 10.4036
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Improvement of Urodynamics parameters after 3 and 12 Months of Follow up",
"timeFrame": "up to 12 months"
},
{
"description": null,
"measure": "Improvement in post voided residual",
"timeFrame": "up to 12 months"
},
{
"description": null,
"measure": "Improvement in International Prostate Symptoms Score",
"timeFrame": "up to 12 months"
}
],
"secondary": [
{
"description": null,
"measure": "Postoperative complications",
"timeFrame": "up to 3 months"
},
{
"description": null,
"measure": "Prostate Specific Antigen (PSA) value",
"timeFrame": "up to 12 months"
},
{
"description": null,
"measure": "sexual outcomes",
"timeFrame": "up to 12 months"
},
{
"description": null,
"measure": "sexual outcomes",
"timeFrame": "up to 12 months"
}
]
} | [
{
"affiliation": "University of Pisa",
"name": "Alessandro Zucchi, Professor",
"role": "STUDY_CHAIR"
}
] | [{"pmid": "35528781", "type": "BACKGROUND", "citation": "van Riel LAMJG, van Kollenburg RAA, Vis AN, van Leeuwen PJ, de Reijke TM, de Bruin DM, Oddens JR. Safety and Feasibility of Soractelite Transperineal Focal Laser Ablation for Prostate Cancer and Short-term Quality of Life Analysis from a Multicenter Pilot Study. Eur Urol Open Sci. 2022 Apr 2;39:48-54. doi: 10.1016/j.euros.2022.02.012. eCollection 2022 May."}, {"pmid": "29122620", "type": "BACKGROUND", "citation": "McVary KT, Roehrborn CG. Three-Year Outcomes of the Prospective, Randomized Controlled Rezum System Study: Convective Radiofrequency Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Urology. 2018 Jan;111:1-9. doi: 10.1016/j.urology.2017.10.023. Epub 2017 Nov 6."}, {"pmid": "28474112", "type": "BACKGROUND", "citation": "Patelli G, Ranieri A, Paganelli A, Mauri G, Pacella CM. Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1440-1446. doi: 10.1007/s00270-017-1662-9. Epub 2017 May 4."}, {"pmid": "31827239", "type": "BACKGROUND", "citation": "Pacella CM, Patelli G, Iapicca G, Manenti G, Perretta T, Ryan CP, Esposito R, Mauri G. Transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a feasibility study. Results at 6 and 12 months from a retrospective multi-centric study. Prostate Cancer Prostatic Dis. 2020 Jun;23(2):356-363. doi: 10.1038/s41391-019-0196-4. Epub 2019 Dec 11."}] | {"versionHolder": "2025-06-18"} | {
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],
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{
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} | {
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"browseBranches": [
{
"abbrev": "PhSol",
"name": "Pharmaceutical Solutions"
},
{
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"name": "All Drugs and Chemicals"
},
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
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"name": "Anti-Arrhythmia Agents"
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{
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{
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"relevance": "LOW"
}
],
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} | {
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"term": "Prostatic Hyperplasia"
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],
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} |
NCT06341933 | null | Risk Factors for AKI in Patients Undergoing VATS for Pulmonary Resection | Risk Factors for Acute Kidney Injury in Patients Undergoing Video-Assisted Thoracoscopic Surgery for Pulmonary Resection: A Prospective Observational Study | None | OBSERVATIONAL | RECRUITING | 2024-03-26T00:00:00 | null | 2025-07-15T00:00:00 | 2025-12-15T00:00:00 | null | 100 | 18 | 65 | ALL | false | This study aims to investigate the potential factors contributing to the development of Acute Kidney Injury (AKI) in patients undergoing pulmonary resection with Video Assisted Thoracoscopic Surgery (VATS) for lung malignancy. The study will focus on demographic data, laboratory parameters, perioperative fluid management, and haemodynamics.
The research will be conducted at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital. The study will involve patients who have given informed consent and will undergo VATS with standard anaesthesia monitoring. Anaesthesia management will follow our routine protocol in our clinic.
Patients will be divided into two groups based on whether they have a more than 25% decrease in estimated glomerular filtration rate (t-GFH) and/or a 1.5-fold increase in serum creatinine and/or a 6-hour urine volume of less than 0.5 ml/kg/h. The patients will be divided into two groups based on this definition, and the risk factors between these groups will be analysed.
The preoperative routine blood values, demographic data (age, gender, height, weight, and BMI), ASA physical status, smoking and alcohol habits, comorbidities, and regular medication use will be recorded. Intraoperative urine output and haemodynamic parameters will also be monitored. Routine blood gas analysis, blood urea nitrogen (BUN), glomerular filtration rate (GFR), albumin, haemoglobin, sodium, potassium, chlorine, and magnesium will be measured and recorded, along with urine output and t-GFH. Patients will be evaluated in the hospital on the day the surgeon calls for a postoperative check-up and on the 30th postoperative day to see if there are any complications. | null | Inclusion Criteria:
* Over 18 years of age, under 65 years of age,
* American Society of Anesthesiologists (ASA) physical status 1-3,
* Data of patients who will undergo wedge resection, segmentectomy or lobectomy with elective VATS due to lung malignancy will be examined prospectively.
Exclusion Criteria:
* Patients with a body mass index (BMI) less than 18.5kg/m2 or greater than 35 kg/m2,
* Those with impaired renal function (the upper limit of the creatinine reference range is more than 50%; 1.3 mg/dL for men and 1.1 mg/dL for women),
* A radiological examination was performed using radiocontrast material in the preoperative period,
* Clinically and radiologically diagnosed with congestive heart failure and treatment has been started,
* Having a history of pulmonary edema,
* Those who have used steroids and non-steroidal anti-inflammatory drugs for a long time (exceeding 30 days),
* Intubated to intensive care unit,
* In need of massive peroperative blood transfusion,
* Patients with deficiencies in the parameters examined will be excluded from the study. | Atatürk Chest Diseases and Chest Surgery Training and Research Hospital | OTHER | {
"id": "2024-BÇEK/41",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-03-26T00:00:00 | {
"date": "2025-01-30",
"type": "ACTUAL"
} | {
"date": "2024-04-02",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Based on the given parameters of a 1/3 patient ratio, two-sided (two-tailed) type I error of 0.05, power of 95%, effect size of 0.86, and group distribution ratio of 3, it was determined that the group with acute kidney injury should include 24 patients and the group without acute kidney injury should include 72 patients. Our study was designed to include an average of 100 patients. | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Acute Kidney Injury",
"Surgery",
"Lung Cancer"
] | ["Acute Kidney Injury", "Lung Cancer", "Video Assisted Thoracoscopic Surgery"] | null | [
{
"city": "Ankara",
"country": "Turkey",
"facility": "Ankara Atatürk Sanatorium Training and Research Hospital",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": "Keçiören"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Glomerular Filtration Rate",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Serum Creatinine",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Amount of Urine",
"timeFrame": "1 day"
}
],
"secondary": null
} | [
{
"affiliation": "Ankara Ataturk Sanatorium Training and Research Hospital",
"name": "Ali ALAGÖZ, professor",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D051437",
"term": "Renal Insufficiency"
},
{
"id": "D007674",
"term": "Kidney Diseases"
},
{
"id": "D014570",
"term": "Urologic Diseases"
},
{
"id": "D052776",
"term": "Female Urogenital Diseases"
},
{
"id": "D005261",
"term": "Female Urogenital Diseases and Pregnancy Complications"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
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NCT00930033 | null | Clinical Trial to Assess the Importance of Nephrectomy | Randomized Phase III Trial Evaluating the Importance of Nephrectomy in Patients Presenting With Metastatic Renal Cell Carcinoma Treated With Sunitinib | CARMENA | INTERVENTIONAL | COMPLETED | 2009-06-29T00:00:00 | null | 2018-10-22T00:00:00 | 2018-10-22T00:00:00 | [
"PHASE3"
] | 452 | 18 | null | ALL | false | The study compare the standard treatment with nephrectomy + sunitinib to treatment with sunitinib alone without nephrectomy. This study will be the first trial on this competitive context | The 2 previous studies on the impact of nephrectomy (EORTC, SWOG) in metastatic renal cell carcinoma have justified recommendation to initial nephrectomy for patients presenting with metastatic renal cell carcinoma. But these studies were performed at the time of immunotherapy.
The objective is Evaluation of the importance of nephrectomy in patients with metastatic renal cell carcinoma treated with sunitinib (AA) Arm A : Nephrectomy followed by Sunitinib Arm B : Sunitinib alone Sunitinib will be administrated orally daily for 4 weeks followed by a 2 week rest( schedule 4/2), 6 weeks are considered as a cycle The starting dose will be 50 mg daily with provision for dose reduction based on tolerability Patient will be treated until disease progression or unacceptable toxicity occurrence or withdraw. | Inclusion Criteria:
* age ≥ 18 years
* ECOG Performance Status 0 - 1
* Biopsy (primary tumour or metastases) confirming the diagnosis of clear cell carcinoma
* Documented metastatic disease
* Absence of prior systemic treatment for kidney cancer including AA
* Tumour amenable to nephrectomy (partial or total) in the opinion of the patient's urologist. Patients presenting with an inferior vena cava thrombosis can be included.
* Patients for which the indication of Sunitinib is considered according to the recommendations rules given by national health authorities of participating countries. The prescription of Sunitinib in the circumstances of the study is considered as a standard treatment.
* Platelets \> or = 100 x 109/L, haemoglobin \>or = 9 g/dl, neutrophils \>or = 1.5 x 109/L;
* Bilirubin \< or = 2 mg/dL, aspartate transaminase (ASAT) and alanine transaminase (ALAT)\< or = 2.5 times the upper normal limit (UNL) or \< or = 5 times UNL for patients with liver metastases
* Patients of child bearing age should use contraceptive methods
* Patient able to follow the procedures outlined in the protocol as far as the planning of visits and examinations are concerned.
* Life expectancy ≥ 3 months
* Written informed consent
* Patient without brain metastases or with radiotherapy or surgery treated brain metastases without progression into 6 weeks and non treated by corticoid
* Patient non treated by anticoagulants excepted HBPM
Exclusion Criteria:
* Prior systemic treatment for kidney cancer (including Anti Angiogenic)
* Bilateral kidney cancer
* Pregnant or breast feeding women
* Acute coronary syndrome or episode of myocardial infarction or severe or unstable angina within the last 6 months as well as severe diabetes with severe peripheral arteriopathy or deep phlebitis not treated with low molecular weight heparin or arterial thrombosis within the last 3 months
* Patients being treated with antivitamin K with curative intent (please note that patients being treated with low molecular weight heparin can be included)
* Medical, general or psychiatric difficulties which, in the opinion of the Investigator, would make it inappropriate for trial entry
* Symptomatic or untreated brain metastases (patients with brain metastases that have been treated by radiotherapy or surgery and have stable disease within 6 weeks, and are not requiring treatment with corticosteroids can be included)
* Previous history of gastric disease or malabsorption, syndrome compromising the absorption of Sunitinib
* Experimental treatment within the 28 days preceding inclusion
* Other cancer within the previous 5 years (except for insitu skin carcinoma and treated localised prostate cancer with undetectable PSA)
* Patient has received treatment with IV biphosphonate | Assistance Publique - Hôpitaux de Paris | OTHER | {
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"city": "Paris",
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"class": "INDUSTRY",
"name": "Pfizer"
}
] | null | {
"other": null,
"primary": [
{
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"measure": "The primary endpoint is overall survival.",
"timeFrame": "starting at 4 months"
}
],
"secondary": [
{
"description": null,
"measure": "Objective Response (complete or partial) is evaluated according to RECIST 1.1 criteria",
"timeFrame": "Starting at 4 months"
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{
"description": null,
"measure": "Clinical benefit (complete response, partial or stable for at least 12 weeks).",
"timeFrame": "Starting at 4 months"
},
{
"description": null,
"measure": "Progression-Free Survival",
"timeFrame": "Starting at 4 months"
},
{
"description": null,
"measure": "Non-compliance to Sunitinib treatment is evaluated in arm A (nephrectomy + sunitinib) as the percentage of patients not starting sunitinib treatment within 6 weeks after nephrectomy",
"timeFrame": "Starting at 4 months"
},
{
"description": null,
"measure": "Non-compliance to sunitinib treatment is evaluated in arm B (sunitinib alone) as the percentage of patients needing nephrectomy",
"timeFrame": "Starting at 4 months"
},
{
"description": null,
"measure": "Post operative morbidity is evaluated as the percentage of deaths within 30 days following nephrectomy",
"timeFrame": "Starting at 4 months"
}
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} | [
{
"affiliation": "Assistance Publique - Hôpitaux de Paris",
"name": "Arnaud Mejean, MD PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "29860937", "type": "DERIVED", "citation": "Mejean A, Ravaud A, Thezenas S, Colas S, Beauval JB, Bensalah K, Geoffrois L, Thiery-Vuillemin A, Cormier L, Lang H, Guy L, Gravis G, Rolland F, Linassier C, Lechevallier E, Beisland C, Aitchison M, Oudard S, Patard JJ, Theodore C, Chevreau C, Laguerre B, Hubert J, Gross-Goupil M, Bernhard JC, Albiges L, Timsit MO, Lebret T, Escudier B. Sunitinib Alone or after Nephrectomy in Metastatic Renal-Cell Carcinoma. N Engl J Med. 2018 Aug 2;379(5):417-427. doi: 10.1056/NEJMoa1803675. Epub 2018 Jun 3."}, {"pmid": "24338498", "type": "DERIVED", "citation": "Leon L, Garcia-Figueiras R, Suarez C, Arjonilla A, Puente J, Vargas B, Mendez Vidal MJ, Sebastia C. Recommendations for the clinical and radiological evaluation of response to treatment in metastatic renal cell cancer. Target Oncol. 2014 Mar;9(1):9-24. doi: 10.1007/s11523-013-0304-7. Epub 2013 Dec 12."}] | {"versionHolder": "2025-06-18"} | {
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NCT01390233 | null | Comparison of Pre-Induction Cervical Ripening | Comparison of Pre-Induction Cervical Ripening Using Prepidil Gel Administered Through a Urinary Balloon Catheter. | None | INTERVENTIONAL | COMPLETED | 2011-02-11T00:00:00 | null | null | null | [
"NA"
] | 102 | 18 | null | FEMALE | false | This study is designed to assess the effectiveness of a combination method of induction of labor using a urinary balloon catheter and prostaglandin gel.
The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed induction in the United States is rising. This has led to a renewed effort to examine the effectiveness of the varied methods of induction.
The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto Health Richland for a scheduled induction of labor will be offered enrollment in the trial. Patients who enroll in the study will be randomized into one of 3 study arms: urinary balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and prostaglandin gel. Randomization will be per sealed envelope from the locked nurse medication storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland. The investigator will be given the next sequentially numbered study randomization envelope by the patient's nurse. The randomization assignment will be unblinded to the patient and her physicians. If the patient is not in active labor 6 hours after initiation of the intervention, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician. | Title: Comparison of pre-induction cervical ripening using Prepidil gel administered through a urinary balloon catheter
Precis- This study is designed to assess the effectiveness of a combination method of induction of labor using a urinary balloon catheter and prostaglandin gel.
Background
Induction of labor is a common intervention during pregnancy1. The frequency of hospital admissions for induction of labor is increasing in the United States. Indications for induction of labor include maternal disease, fetal complications and social/geographical issues. Obstetricians may also choose elective induction, to facilitate delivery at term for the physician or patient who does not have a medical indication for delivery.
The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed induction in the United States is rising2. This has led to a renewed effort to examine the effectiveness of the varied methods of induction3-5.
The vaginal delivery rate for induction of labor can be predicted by assessing the patient's cervical examination prior to induction. The Bishop Score uses the cervical examination components to predict the vaginal delivery rate for a particular patient. A low or poor Bishop score predicts a low success rate for vaginal delivery.
There are 3 common methods used to induce labor. The first are physiological methods such as breaking the patient's water or causing contractions by nipple stimulation. Breaking the patient's water requires a high (favorable) Bishop Score and cannot be safely performed with a low (poor) Bishop score. This method has a higher success rate in patients who have had a prior vaginal delivery. Nipple stimulation has been associated with an increased risk of tachysystole (too frequent contractions) and non-reassuring fetal heart rate patterns. It is not considered an acceptable method of induction in the United States.
Physical methods include pre-induction cervical ripening with laminaria or urinary balloon catheter6. Both of these methods are designed to force the cervix to open mechanically. Laminaria are small sticks of dehydrated seaweed which are placed in the cervical canal. As the sticks hydrate, the cervical canal dilates. Balloon urinary catheters are inserted into the cervical canal. The balloon is inflated in the lower uterine segment. A weight is placed on the catheter to apply traction which forces the fluid-filled balloon to dilate the cervical canal. Urinary balloon catheters have been used alone7,8, with saline infusion9-11 or with prostaglandin infusion12-16.
Pharmacological methods include ergot alkaloids, prostaglandin E and F series and oxytocin. Ergot alkaloids cause forceful uterine contractions and have been used to treat postpartum hemorrhage. Ergot alkaloids may cause severe hypertension during induction of labor and are not used in the United States. Prostaglandin E and F series cause increased uterine muscle tone (tonic contractions). They are used for pre-induction cervical ripening. The different prostaglandins have varying complications which may include nausea, vomiting, diarrhea and fever. Use of misoprostol for pre-induction cervical ripening has been associated with an increased risk of uterine rupture both in normal patients and in patients who have had previous cesarean sections17. The method of drug delivery for prostaglandin medications has varied. It can be administered as an oral tablet, a vaginal suppository, a vaginal gel, or by infusion into the lower uterine segment via a urinary balloon catheter. It is unclear, based on evidence-based medicine, whether any particular method of delivery is superior to another. The Food and Drug Administration of the United States (FDA) has approved the use of Prepidil gel (prostaglandin E2) for pre-induction cervical ripening18,19. Prepidil gel is administered as a gel into the vaginal fornix using a syringe. Oxytocin is a pituitary hormone which can be used to augment spontaneous labor or to induce labor. It results in both increased uterine tone (tonic contractions) and increased contraction frequency (clonic contractions). It is considered the most physiologic method of pre-induction cervical ripening. Oxytocin is administered by intravenous infusion.
Methods of induction can be used individually or in combination. The most common combination method for induction of labor is the use of prostaglandin for pre-induction cervical ripening followed by oxytocin.
Objectives-
The current study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel for induction of labor in term pregnant patients. The primary outcome to be studied is vaginal delivery rate for urinary balloon catheter alone, prostaglandin gel alone and a combination of urinary balloon catheter and prostaglandin gel. Secondary outcomes to be studied include the safety of the method, composite maternal morbidity and composite neonatal morbidity.
The null hypothesis is that there is no difference in the vaginal delivery rate between the three study protocols.
Study Design and Methods-
Pregnant women presenting to the Palmetto Health Richland for a scheduled induction of labor will be offered enrollment in the trial.
Eligible patients will undergo an interview with the investigator. Enrollment pre-requisites and exclusions will be reviewed with the patient. The patient will also be provided with written information regarding the safety of prepidil as an pre-induction cervical ripening agent and the safety of urinary balloon catheters as a pre-induction cervical ripening agent. The investigator will review general information on the trial and an informed consent. Patients who decline enrollment in the trial will have the method of pre-induction cervical ripening chosen by their physician.
Inclusion Criteria:
1. Single, live fetus
2. Cephalic (head-first) presentation
3. Reassuring fetal health assessment
4. Gestational age between 26 and 42 weeks
5. Maternal age 18 and above
6. Bishop score less than 5
Exclusion Criteria:
1. Multiple Gestation (twins, triplets, quadruplets)
2. Fetal demise
3. Fetal malpresentation
4. Estimated fetal weight less than 500 grams or more than 4000 grams
5. Placenta previa
6. Non-reassuring fetal health assessment
7. Maternal asthma
8. Latex allergy
9. Spontaneous labor
10. Other contraindication to vaginal delivery
Patients who enroll in the study will be randomized into 3 study arms: urinary balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and prostaglandin gel. Randomization will be made by choosing a sealed envelope from the locked nurse medication storage area (Pyxis) located on Labor and Delivery at Palmetto Health Richland. Randomization will be 1:1:1 with randomization envelopes prepared by statisticians at the University of South Carolina Arnold School of Public Health. The investigator will be given the next sequentially numbered study envelope by the patient's nurse. The randomization included will be unblinded to the patient and her physicians.
URINARY BALLLOON CATHETER ONLY ARM
The patient will be placed in the lithotomy position, either in the bed or in stirrups. A baseline digital exam of the cervix will be performed by the physician and a Bishop score recorded. A urinary balloon catheter will be placed through the cervix into the lower uterine segment, either digitally or with the aid of a speculum. Once the catheter is properly positioned, the bulb will be inflated with 40ml of normal saline. The urinary balloon catheter will then be secured to the patient's thigh using tape. The catheter will then be placed under traction by attaching it to a liter bag of saline.
The catheter will be deflated and removed after 6 hours, with the time of removal recorded in the medical record. If the catheter is spontaneously expelled from the uterus, the time of expulsion will be noted by the nurse. Six (6) hours after insertion of the catheter, the physician will perform a digital cervical exam and a Bishop score recorded.
If the patient is not in active labor at the time of catheter removal or expulsion, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician. Artificial rupture of membranes may also be carried out at the physician's discretion.
PREPIDIL ONLY ARM
The patient will be placed in the lithotomy position, either in the bed or in stirrups. A baseline digital exam of the cervix will be performed by the physician and a Bishop score recorded in the medical record.
Prepidil gel will be inserted into the vaginal fornix according to the manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of the gel. Six (6) hours after insertion of the gel, the physician will perform a digital cervical exam and a Bishop score recorded.
If the patient is not in active labor 6 hours after the administration of Prepidil gel, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician. Artificial rupture of membranes may also be carried out at the physician's discretion.
COMBINED URINARY BALLOON CATHETER AND PREPIDIL GEL ARM
The patient will be placed in the lithotomy position, either in the bed or in stirrups. A baseline digital exam of the cervix will be performed by the physician and a Bishop score recorded. A urinary balloon catheter will be placed through the cervix into the lower uterine segment, either digitally or with the aid of a speculum. Once the catheter is properly positioned, the bulb will be inflated with 40ml of normal saline. The urinary balloon catheter will then be secured to the patient's thigh using tape. The catheter will then be placed under traction by attaching it to a liter bag of saline.
Prepidil gel will be inserted through the urinary balloon catheter into the lower uterine segment, in a dose equivalent to the manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and prepidil gel (even if the catheter is spontaneously expelled prior to that time). Six (6) hours after insertion of the catheter and gel, the physician will perform a digital cervical exam and a Bishop score recorded.
The catheter will be deflated and removed after 6 hours, with the time of removal noted by the nurse. If the catheter is spontaneously expelled from the uterus, the time of expulsion will be noted by the nurse. If the patient is not in active labor 6 hours after insertion of prepidil gel, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician. Artificial rupture of membranes may also be carried out at the physician's discretion. | Inclusion Criteria:
1. Single, live fetus
2. Cephalic (head-first) presentation
3. Reassuring fetal health assessment
4. Gestational age between 26 and 42 weeks
5. Maternal age 18 and above
6. Bishop score less than 5
Exclusion Criteria:
1. Multiple Gestation (twins, triplets, quadruplets)
2. Fetal demise
3. Fetal malpresentation
4. Estimated fetal weight less than 500 grams or more than 4000 grams
5. Placenta previa
6. Non-reassuring fetal health assessment
7. Maternal asthma
8. Latex allergy
9. Spontaneous labor
10. Other contraindication to vaginal delivery | University of South Carolina | OTHER | {
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"Failed Labour"
] | ["Labor, obstetric", "Labor, induced"] | null | [
{
"city": "Columbia",
"country": "United States",
"facility": "Palmetto Health Richland Hospital",
"geoPoint": {
"lat": 34.00071,
"lon": -81.03481
},
"state": "South Carolina"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Vaginal Delivery",
"timeFrame": "Gestational age 26-42 weeks"
}
],
"secondary": null
} | [
{
"affiliation": "University of South Carolina",
"name": "Paul C Browne, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "20334736", "type": "BACKGROUND", "citation": "Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8."}, {"pmid": "11209625", "type": "BACKGROUND", "citation": "Greybush M, Singleton C, Atlas RO, Balducci J, Rust OA. Preinduction cervical ripening techniques compared. J Reprod Med. 2001 Jan;46(1):11-7."}, {"pmid": "12830603", "type": "BACKGROUND", "citation": "Matonhodze BB, Hofmeyr GJ, Levin J. Labour induction at term--a randomised trial comparing Foley catheter plus titrated oral misoprostol solution, titrated oral misoprostol solution alone, and dinoprostone. S Afr Med J. 2003 May;93(5):375-9."}, {"pmid": "19821301", "type": "BACKGROUND", "citation": "Kelly AJ, Malik S, Smith L, Kavanagh J, Thomas J. Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD003101. doi: 10.1002/14651858.CD003101.pub2."}, {"pmid": "19623003", "type": "BACKGROUND", "citation": "ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available."}, {"pmid": "18674661", "type": "BACKGROUND", "citation": "Heinemann J, Gillen G, Sanchez-Ramos L, Kaunitz AM. Do mechanical methods of cervical ripening increase infectious morbidity? A systematic review. Am J Obstet Gynecol. 2008 Aug;199(2):177-87; discussion 187-8. doi: 10.1016/j.ajog.2008.05.005."}, {"pmid": "7705527", "type": "BACKGROUND", "citation": "James C, Peedicayil A, Seshadri L. Use of the Foley catheter as a cervical ripening agent prior to induction of labor. Int J Gynaecol Obstet. 1994 Dec;47(3):229-32. doi: 10.1016/0020-7292(94)90566-5."}, {"pmid": "17316649", "type": "BACKGROUND", "citation": "Cromi A, Ghezzi F, Tomera S, Uccella S, Lischetti B, Bolis PF. Cervical ripening with the Foley catheter. Int J Gynaecol Obstet. 2007 May;97(2):105-9. doi: 10.1016/j.ijgo.2006.10.014. Epub 2007 Feb 20."}, {"pmid": "5082574", "type": "BACKGROUND", "citation": "Saunders JR. Foley-catheter induction of labour. Br Med J. 1972 Oct 28;4(5834):237. doi: 10.1136/bmj.4.5834.237-a. No abstract available."}, {"pmid": "9492717", "type": "BACKGROUND", "citation": "Hemlin J, Moller B. Extraamniotic saline infusion is promising in preparing the cervix for induction of labor. Acta Obstet Gynecol Scand. 1998 Jan;77(1):45-9."}, {"pmid": "16449106", "type": "BACKGROUND", "citation": "Karjane NW, Brock EL, Walsh SW. Induction of labor using a foley balloon, with and without extra-amniotic saline infusion. Obstet Gynecol. 2006 Feb;107(2 Pt 1):234-9. doi: 10.1097/01.AOG.0000198629.44186.c8."}, {"pmid": "4464977", "type": "BACKGROUND", "citation": "Wagman H, Usherwood M. Intrauterine death treated with intrauterine extra-amniotic prostaglandin E2. Br J Clin Pract. 1974 Sep;28(9):318."}, {"pmid": "299460", "type": "BACKGROUND", "citation": "Luengo J, Keirse MJ, Bennebroek Gravenhorst J. Extraamniotic prostaglandin F2 alpha for intrauterine death and fetal abnormality. Eur J Obstet Gynecol Reprod Biol. 1977;7(5):325-9. doi: 10.1016/0028-2243(77)90017-x."}, {"pmid": "6594722", "type": "BACKGROUND", "citation": "Fuchs AR, Goeschen K, Rasmussen AB, Rehnstrom JV. Cervical ripening and plasma prostaglandin levels. Comparison of endocervical and extra-amniotic PGE2. Prostaglandins. 1984 Aug;28(2):217-27. doi: 10.1016/0090-6980(84)90058-3."}, {"pmid": "9849711", "type": "BACKGROUND", "citation": "Liu HS, Chang YK, Chu TY, Yu MH, Chen WH. Extra-amniotic balloon with PGE2 versus extra-ovular Foley catheter with PGF2alpha in mid-trimester pregnancy termination. Int J Gynaecol Obstet. 1998 Oct;63(1):51-4. doi: 10.1016/s0020-7292(98)00114-3."}, {"pmid": "11239640", "type": "BACKGROUND", "citation": "Sherman DJ, Frenkel E, Pansky M, Caspi E, Bukovsky I, Langer R. Balloon cervical ripening with extra-amniotic infusion of saline or prostaglandin E2: a double-blind, randomized controlled study. Obstet Gynecol. 2001 Mar;97(3):375-80. doi: 10.1016/s0029-7844(00)01168-6."}, {"pmid": "16880321", "type": "BACKGROUND", "citation": "American College of Obstetricians and Gynecologists Committee on Obstetric Practice. ACOG Committee Opinion No. 342: induction of labor for vaginal birth after cesarean delivery. Obstet Gynecol. 2006 Aug;108(2):465-8. doi: 10.1097/00006250-200608000-00045."}, {"pmid": "12738178", "type": "BACKGROUND", "citation": "ACOG Committee Opinion. American College of Obstetrician and Gynecologist. ACOG Committee Opinion. Number 283, May 2003. New U.S. Food and Drug Administration labeling on Cytotec (misoprostol) use and pregnancy. Obstet Gynecol. 2003 May;101(5 Pt 1):1049-50. doi: 10.1016/s0029-7844(03)00396-x."}, {"pmid": "3524549", "type": "BACKGROUND", "citation": "Thomas IL, Chenoweth JN, Tronc GN, Johnson IR. Preparation for induction of labour of the unfavourable cervix with Foley catheter compared with vaginal prostaglandin. Aust N Z J Obstet Gynaecol. 1986 Feb;26(1):30-5. doi: 10.1111/j.1479-828x.1986.tb01524.x."}, {"pmid": "7856707", "type": "BACKGROUND", "citation": "St Onge RD, Connors GT. Preinduction cervical ripening: a comparison of intracervical prostaglandin E2 gel versus the Foley catheter. Am J Obstet Gynecol. 1995 Feb;172(2 Pt 1):687-90. doi: 10.1016/0002-9378(95)90594-4."}, {"pmid": "7774736", "type": "BACKGROUND", "citation": "Orhue AA. Induction of labour at term in primigravidae with low Bishop's score: a comparison of three methods. Eur J Obstet Gynecol Reprod Biol. 1995 Feb;58(2):119-25. doi: 10.1016/0028-2243(94)01963-0."}, {"pmid": "11451546", "type": "BACKGROUND", "citation": "Ghezzi F, Massimo F, Raio L, Di Naro E, Balestreri D, Bolis P. Extra-amniotic Foley catheter and prostaglandin E(2) gel for cervical ripening at term gestation. Eur J Obstet Gynecol Reprod Biol. 2001 Aug;97(2):183-7. doi: 10.1016/s0301-2115(00)00544-3."}, {"pmid": "11275035", "type": "BACKGROUND", "citation": "Sciscione AC, Nguyen L, Manley J, Pollock M, Maas B, Colmorgen G. A randomized comparison of transcervical Foley catheter to intravaginal misoprostol for preinduction cervical ripening. Obstet Gynecol. 2001 Apr;97(4):603-7. doi: 10.1016/s0029-7844(00)01186-8."}, {"pmid": "14586350", "type": "BACKGROUND", "citation": "Chung JH, Huang WH, Rumney PJ, Garite TJ, Nageotte MP. A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction. Am J Obstet Gynecol. 2003 Oct;189(4):1031-5. doi: 10.1067/s0002-9378(03)00842-1."}, {"pmid": "12676389", "type": "BACKGROUND", "citation": "Niromanesh S, Mosavi-Jarrahi A, Samkhaniani F. Intracervical Foley catheter balloon vs. prostaglandin in preinduction cervical ripening. Int J Gynaecol Obstet. 2003 Apr;81(1):23-7. doi: 10.1016/s0020-7292(02)00392-2."}, {"pmid": "16335645", "type": "BACKGROUND", "citation": "Al-Taani MI. Comparison of prostaglandin E2 tablets or Foley catheter for labour induction in grand multiparas. East Mediterr Health J. 2004 Jul-Sep;10(4-5):547-53."}, {"pmid": "15919393", "type": "BACKGROUND", "citation": "Afolabi BB, Oyeneyin OL, Ogedengbe OK. Intravaginal misoprostol versus Foley catheter for cervical ripening and induction of labor. Int J Gynaecol Obstet. 2005 Jun;89(3):263-7. doi: 10.1016/j.ijgo.2005.02.010. Epub 2005 Apr 2."}, {"pmid": "15762966", "type": "BACKGROUND", "citation": "Dalui R, Suri V, Ray P, Gupta I. Comparison of extraamniotic Foley catheter and intracervical prostaglandin E gel for preinduction cervical ripening. Acta Obstet Gynecol Scand. 2005 Apr;84(4):362-7. doi: 10.1111/j.0001-6349.2005.00662.x."}, {"pmid": "16234141", "type": "BACKGROUND", "citation": "Owolabi AT, Kuti O, Ogunlola IO. Randomised trial of intravaginal misoprostol and intracervical Foley catheter for cervical ripening and induction of labour. J Obstet Gynaecol. 2005 Aug;25(6):565-8. doi: 10.1080/01443610500231450."}, {"pmid": "16325816", "type": "BACKGROUND", "citation": "Adeniji AO, Olayemi O, Odukogbe AA. Intravaginal misoprostol versus transcervical Foley catheter in pre-induction cervical ripening. Int J Gynaecol Obstet. 2006 Feb;92(2):130-2. doi: 10.1016/j.ijgo.2005.10.010. Epub 2005 Dec 2. No abstract available."}, {"pmid": "16624192", "type": "BACKGROUND", "citation": "Saleem S. Efficacy of dinoprostone, intracervical foleys and misoprostol in labor induction. J Coll Physicians Surg Pak. 2006 Apr;16(4):276-9."}] | {"versionHolder": "2025-06-18"} | null | {
"ancestors": [
{
"id": "D010120",
"term": "Oxytocics"
},
{
"id": "D012102",
"term": "Reproductive Control Agents"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
}
],
"browseBranches": [
{
"abbrev": "Repr",
"name": "Reproductive Control Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M13041",
"name": "Oxytocin",
"relevance": "LOW"
},
{
"asFound": "Casualty",
"id": "M17936",
"name": "Dinoprostone",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D015232",
"term": "Dinoprostone"
}
]
} | {
"conditions": null,
"interventions": [
{
"id": "D015232",
"term": "Dinoprostone"
}
]
} |
NCT04011033 | null | Study of Adoptive Transfer of iNKT Cells Combined With TAE/TACE to Treat Unresectable HCC | Study of Adoptive Transfer of Invariant Natural Killer T Cells Combined With TAE/TACE to Treat Unresectable Hepatocellular Carcinoma (HCC): Phase II Clinical Trial | None | INTERVENTIONAL | COMPLETED | 2019-07-03T00:00:00 | null | 2020-03-01T00:00:00 | 2023-10-01T00:00:00 | [
"PHASE2"
] | 60 | 18 | 80 | ALL | false | Hepatocellular carcinoma (HCC) is a common disease with high mortality. More than 80% patients receive a diagnosis when their tumors are too advanced for curative approaches and have a dismal prognosis. invariant Natural Killer T (iNKT) cell exhibit antitumor activity against malignant tumors through producing high levels of cytokines. iNKT cells are abundant in the liver, but their function is defective in liver cancer. After expansion and restored function in vitro, iNKT cells can home to liver, then they play key antitumor function. We have finished a phase I study of adoptive transfer of autologous iNKT cells for treating patients with unresectable HCC. Safety and feasibility of iNKT infusion was proved. The purpose of this study was to verify the effectiveness of iNKT cell infusion in patients with unresectable HCC who had previously failed transcatheter arterial embolization (TAE) / transcatheter arterial chemoembolization (TACE). | Patients with unresectable HCC will be enrolled and divided into two groups. Patients in trial group will be treated with combination of TAE/TACE and adoptive transfer of autologus iNKT cells. TAE/TACE will be performed at 0th and 4th week. iNKT cells will be infused at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy. Patients in control group will be treated with TAE/TACE at 0th and 4th week. Overall survival (OS) time, progression-free survival (PFS) time, objective response rate(ORR), disease control rate(DCR) will be monitored.
According to JSH guidelines, TAE/TACE failure is defined as an insufficient response after ≧2 consecutive TAE/TACE procedures that is evident on response evaluation computed tomography or magnetic resonance imaging after 1-3 months, these patients do not respond sufficiently to TAE/TACE. | Inclusion Criteria:
* Age 18-80 years.
* Patients with hepatocellular carcinoma (BCLC, stageB/C) proved by histopathology or proved by CT or MRI imaging system, relapsed after previous therapy and no effective therapies known at this time.
* Life expectancy of ≥ 12 weeks.
* WBC\>3.0×10\^9/L, LYMPH\> 0.8×10\^9/L, Hb\>85g/L, PLT\>50×10\^9/L, Cre\<1.5×the upper limit of normal value.
* iNKT\>10 cell/mL in peripheral blood mononuclear cell (PBMC).
* Able to understand and sign the informed consent.
Exclusion Criteria:
* Any uncontrolled systematic disease: hypertension, heart disease, and et al.;
* Portal vein tumor thrombus, central nervous system tumor metastasis, or combined with other tumors;
* Receiving radiochemotherapy, local therapy, or targeting drugs within 4 weeks prior to this treatment;
* Unstable immune systematic diseases or infectious diseases;
* Combined with AIDS or syphilis;
* Patients with history of stem cell or organ transplantation;
* Patients with allergic history to related drugs and immunotherapy;
* Patients with complications associated with liver diseases: moderate or severe pleural effusion, pericardial effusion, ascites, or gastrointestinal hemorrhage;
* Pregnant or lactating subjects;
* Unsuitable subjects considered by clinicians. | Beijing YouAn Hospital | OTHER | {
"id": "Beijing Youan Ethics [2018]016",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-07-05T00:00:00 | {
"date": "2024-10-08",
"type": "ACTUAL"
} | {
"date": "2019-07-08",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Hepatocellular Carcinoma"
] | null | null | [
{
"city": "Beijing",
"country": "China",
"facility": "Beijing Youan Hospital,Capital Medical University",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing"
}
] | [
{
"class": "OTHER",
"name": "Beijing Shijitan Hospital, Capital Medical University"
},
{
"class": "OTHER",
"name": "Beijing Ditan Hospital"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Progression-Free Survival(PFS)",
"timeFrame": "From date of enrollment to disease progression according to mRECIST, or death from any cause, whichever occurred first，approximately 2 years."
}
],
"secondary": [
{
"description": null,
"measure": "Overall Survival(OS)",
"timeFrame": "From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months."
},
{
"description": null,
"measure": "Objective Response Rate(ORR)",
"timeFrame": "Evaluation was performed at the 12th week after the start of the treatment."
},
{
"description": null,
"measure": "Disease Control Rate (DCR)",
"timeFrame": "Evaluation was performed at the 12th week after the start of the treatment."
},
{
"description": null,
"measure": "Adverse Events(AEs)",
"timeFrame": "The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total."
},
{
"description": null,
"measure": "Time to Quality of Life (QoL) Deterioration",
"timeFrame": "Data will be collected at baseline and every 4 weeks until disease progression, then every 8 weeks for up to 60 weeks."
}
]
} | [
{
"affiliation": "Beijing YouAn Hospital",
"name": "Jun Lu, Director",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009375",
"term": "Neoplasms, Glandular and Epithelial"
},
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D000230",
"term": "Adenocarcinoma"
},
{
"id": "D008113",
"term": "Liver Neoplasms"
},
{
"id": "D004067",
"term": "Digestive System Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D004066",
"term": "Digestive System Diseases"
},
{
"id": "D008107",
"term": "Liver Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC06",
"name": "Digestive System Diseases"
}
],
"browseLeaves": [
{
"asFound": "Carcinoma",
"id": "M5534",
"name": "Carcinoma",
"relevance": "HIGH"
},
{
"asFound": "Hepatocellular Carcinoma",
"id": "M9613",
"name": "Carcinoma, Hepatocellular",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M12320",
"name": "Neoplasms, Glandular and Epithelial",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12315",
"name": "Neoplasms by Histologic Type",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M3585",
"name": "Adenocarcinoma",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11113",
"name": "Liver Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8886",
"name": "Gastrointestinal Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7256",
"name": "Digestive System Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8883",
"name": "Gastrointestinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7255",
"name": "Digestive System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11107",
"name": "Liver Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D002277",
"term": "Carcinoma"
},
{
"id": "D006528",
"term": "Carcinoma, Hepatocellular"
}
]
} | {
"ancestors": [
{
"id": "D000970",
"term": "Antineoplastic Agents"
},
{
"id": "D018712",
"term": "Analgesics, Non-Narcotic"
},
{
"id": "D000700",
"term": "Analgesics"
},
{
"id": "D018689",
"term": "Sensory System Agents"
},
{
"id": "D018373",
"term": "Peripheral Nervous System Agents"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
}
],
"browseBranches": [
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "Analg",
"name": "Analgesics"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "Specified",
"id": "M10411",
"name": "Interleukin-2",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M5982",
"name": "Chlorotrianisene",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4032",
"name": "Analgesics",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20786",
"name": "Analgesics, Non-Narcotic",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007376",
"term": "Interleukin-2"
}
]
} | {
"conditions": [
{
"id": "D002277",
"term": "Carcinoma"
},
{
"id": "D006528",
"term": "Carcinoma, Hepatocellular"
}
],
"interventions": [
{
"id": "D007376",
"term": "Interleukin-2"
}
]
} |
NCT00818233 | null | Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry. | Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry. | None | OBSERVATIONAL | WITHDRAWN | 2008-11-18T00:00:00 | null | null | null | null | 0 | 18 | null | ALL | true | The aim of the protocol is to document intra-observer and inter-observer variability with dynamic contour tonometry, and will also test the theory that pulse amplitude, as measured by dynamic contour tonometry, is correlated with the difference in systolic and diastolic blood pressures. | null | Inclusion Criteria:
* Normal, healthy eyes
* Minimal to moderate refractive error
* Willingness to participate in the study
Exclusion Criteria:
* Diagnosis of any type of glaucoma
* Any prior ocular surgery
* Any prior ocular trauma
* Any known anterior segment pathology | Yale University | OTHER | {
"id": "0601001047",
"link": null,
"type": null
} | Difficulty recruiting patients. PI left research facility. | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-01-06T00:00:00 | {
"date": "2016-05-13",
"type": "ESTIMATED"
} | {
"date": "2009-01-07",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Healthy, competent adults with normal, healthy eyes. | NON_PROBABILITY_SAMPLE | true | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Intraocular Pressure"
] | ["dynamic contour tonometry", "variability", "pulse amplitude", "Ocular pulse amplitude"] | null | [
{
"city": "New Haven",
"country": "United States",
"facility": "Yale Eye Center",
"geoPoint": {
"lat": 41.30815,
"lon": -72.92816
},
"state": "Connecticut"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "The variability of intraocular pressure measurements using dynamic contour tonometry",
"timeFrame": "Same day"
}
],
"secondary": [
{
"description": null,
"measure": "Observe how pulse amplitude, as measured by dynamic contour tonometry, correlates with the difference in systolic and diastolic blood pressures",
"timeFrame": "Same day"
}
]
} | [
{
"affiliation": "Yale University",
"name": "Hylton R Mayer, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT06800833 | null | Effects of Mango or Low-Fat Cookie Consumption on Gut Health, and Its Relationship With Mental, Sexual and Skin Health | Effects of Mango or Low-Fat Cookie Consumption on Gut Health, and Its Relationship With Mental, Sexual and Skin Health | None | INTERVENTIONAL | RECRUITING | 2025-01-24T00:00:00 | null | 2027-12-31T00:00:00 | 2027-12-31T00:00:00 | [
"NA"
] | 60 | 18 | 50 | ALL | true | The objective of the proposed research is to determine the effects of fresh mango consumption on gut microbiome, and its relationship with skin health, sexual and mental health in relatively healthy adults. | null | Inclusion Criteria:
* Generally healthy subjects
* BMI 20-40 kg/m2
Exclusion Criteria:
* Smoker
* Pregnant woman
* Required antibiotics use
* Required dietary supplement use
* Required medication of metabolic disorders, mental health and sexual health
* Allergy to mango or wheat | San Diego State University | OTHER | {
"id": "IRB-25-0010",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2025-01-24T00:00:00 | {
"date": "2025-01-30",
"type": "ACTUAL"
} | {
"date": "2025-01-30",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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NCT05103033 | null | Systems Analysis and Improvement Approach to Optimize the Task-shared Mental Health Treatment Cascade (SAIA-MH) | Systems Analysis and Improvement Approach to Optimize the Task-shared Mental Health Treatment Cascade (SAIA-MH): A Cluster Randomized Trial | SAIA-MH | INTERVENTIONAL | RECRUITING | 2021-10-20T00:00:00 | null | 2024-10-14T00:00:00 | 2026-02-28T00:00:00 | [
"NA"
] | 155 | null | null | ALL | false | The purpose of this study is to test the effectiveness of a multicomponent implementation strategy entitled the Systems Analysis and Improvement Approach for mental health (SAIA-M) using a cluster randomized trial at the health facility level. SAIA-MH focuses on improving the mental health treatment cascade in primary outpatient mental healthcare. The mental health treatment cascade is a model that outlines the sequential, linked treatment steps that people with mental illness must navigate, from initial diagnosis to symptom/function improvement.
This study will also assess the potential mechanisms by which the SAIA-MH implementation strategy works, or does not work, along with the cost and effectiveness of scaling-up SAIA-MH in Mozambique. | Due to a shortage of 1.2 million mental health (MH) workers across low- and middle-income countries (LMICs), academic and policy leaders have advocated scaling-up task-sharing to lower-level providers to close the mental health care gap, which exceeds 90% in many LMICs. While task-sharing may increase access to care, limited attention has been paid to quality of care provided by lower-level providers. Task-shared outpatient management of mental health in Mozambique has shown low rates of retention in care (40%), medication adherence (\<15%), and proportion of patients achieving function improvement (\<5%). Similarly high rates of loss-to-follow-up, poor adherence, and poor patient outcomes have been reported across other LMICs. To our knowledge, there are no evidence-based implementation strategies targeting optimization of the MH treatment cascade in low-resource settings. This is an urgent need for the field of MH care delivery globally.
The MH treatment cascade is a model that outlines the sequential, linked treatment steps that people with mental illness must navigate, from initial diagnosis to symptom/function improvement. Quality problems in one step of a treatment cascade can have non-linear and compounding impacts across the larger complex care system. Implementation strategies focused on only one step in a cascade can potentially contribute to unintended system bottlenecks and quality of care issues. By contrast, the "Systems Analysis and Improvement Approach (SAIA)" is a multicomponent implementation strategy focused on optimizing an entire treatment cascade. SAIA blends facilitation, enhanced local clinical consultation, and the creation of facility-level learning collaboratives with systems-engineering tools in a 5-step approach specifically developed for task-shared providers, which include: (1) cascade analysis to visualize treatment cascade drop-offs and prioritize areas for system improvements; (2) process mapping to identify modifiable facility-level bottlenecks; (3) identification and implementation of modifications to improve system performance; (4) assessment of modification effects on the cascade; and (5) repeated analysis and improvement cycles. A previous cluster RCT established effectiveness of SAIA for HIV treatment cascade improvement (R01HD075057; PI: Sherr). However, no effectiveness data exist on SAIA applied to other complex treatment cascades - such as task-shared MH care. Preliminary data suggest that applying SAIA to MH treatment cascade optimization (SAIA-MH; R21MH113691; PI: Wagenaar) is feasible, acceptable, and can result in clinically-significant treatment cascade improvements; Five months of SAIA-MH implementation resulted in a 1.5-fold increase in medication adherence (aOR: 1.5; CI: 1.2, 1.9) and a 3.7-fold increase in function improvement (aOR: 3.7; CI: 2.5, 5.4). These data suggest that SAIA-MH is a promising strategy for task-shared MH systems improvement globally. Our specific aims are to:
Primary Aim 1: Test the effectiveness of the SAIA-MH strategy using a pragmatic cluster RCT design and assess determinants of implementation success. The investigators will implement SAIA-MH using a 3-year parallel cluster RCT across 8 intervention and 8 attentional control facilities and evaluate effects on mental health function improvement (primary) and retention / medication adherence (secondary). Two years of study implementation will be followed by a 1-year maintenance phase to examine routine fidelity and sustainability. The Consolidated Framework for Implementation Research (CFIR) will be used to assess determinants of implementation success.
Secondary Aim 1: Test causal pathway models to analyze mechanisms of action for effects (or non-effects) of the SAIA-MH implementation strategy. Using 3-years of monthly data on strategy-mechanism linkages, moderators, preconditions, and outcomes for the full 8 intervention and 8 attentional control facilities, the investigators will examine causal pathway effect estimates using longitudinal structural equation modeling. Qualitative CFIR data from Primary Aim 1 will contextualize quantitative path analyses.
Specific Aim 2: Estimate the cost and cost-effectiveness of scaling-up SAIA-MH in Mozambique. The investigators will conduct micro-costing and time-and-motion observation of the SAIA-MH RCT to estimate costs of implementing the intervention. The investigators will construct a Markov model parameterized with cost and outcome data from the SAIA-MH RCT to project budget impact and cost-effectiveness for SAIA-MH scale-up to provincial and national levels. | Inclusion Criteria for Primary and Secondary Outcomes:
1. Patient diagnosed with a mental health condition in outpatient primary care, prescribed a medication, and given a follow-up date.
Exclusion Criteria for Primary and Secondary Outcomes:
1. Patient enrolled in treatment outside of targeted mental health systems analysis and improvement approach (SAIA-MH) facilities.
2. Patients not prescribed a medication.
3. Patients not given a follow-up date.
Inclusion Criteria for Qualitative Interviews:
1. Mental health workers currently working and collaborating on the treatment of outpatient mental health patients in target clinics in Sofala or Manica provinces, Mozambique.
2. Mental health workers must be employed by Ministry of Health.
3. Mental health managers or directors currently supervising mental health workers who are leading treatment of outpatient mental health patients in target clinics in Sofala or Manica provinces, Mozambique. Must be employed by the Ministry of Health.
Exclusion Criteria for Qualitative Interviews:
1. Health worker not involved in outpatient mental healthcare delivery. Health worker not employed by the Ministry of Health. | University of Washington | OTHER | {
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"measure": "Patient Medication Adherence",
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"affiliation": "University of Washington",
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NCT05545033 | null | Use of Virtual Reality in Pain Management in Hospitalized Patients | Evaluating the Feasibility and Acceptability of the Use of Virtual Reality in Pain Management in Hospitalized Patients | None | INTERVENTIONAL | COMPLETED | 2022-09-11T00:00:00 | null | 2022-03-16T00:00:00 | 2022-03-16T00:00:00 | [
"NA"
] | 50 | 21 | 99 | ALL | false | Acute and chronic non-cancer pain is a common healthcare problem locally and globally, leading to many inpatient admissions for poorly controlled pain. The World Health Organisation has declared that access to adequate pain control is a fundamental human right. Yet in our current practice, both acute and chronic non-cancer pain remain poorly controlled.
There is passive over-reliance on pharmacological agents and interventional procedures in the management of pain. The opioid epidemic with issues of dependence, misuse, and overdose is especially concerning. Therefore, there is a pertinent clinical need to find sustainable non-pharmacological adjuncts in the complex management of pain.
Virtual reality (VR) involves the use of technology to create a three-dimensional multisensory artificial environment replacing real-world sensory inputs. Initially created solely for entertainment purposes, VR applications have since expanded and made its way into healthcare. In Pain Medicine, the application of VR has been promising. There is currently no VR study done in our local population who suffer from pain issues. In our study, we aim to test the feasibility of applying the use of VR in patients admitted inpatient due to pain issues. We believe that VR can be used as an adjunctive tool improve pain management and patient satisfaction. | Patients who agree to participate in the study will undergo the following procedures:
1. Provide written informed consent,
2. Provide baseline demographic information,
3. Provide baseline pain and anxiety ratings,
4. Undergo 5 to 15 minutes VR exposure,
5. Take 3 to 5 minutes break,
6. Undergo 5 to 15 minutes VR exposure,
7. Provide post-intervention pain and anxiety ratings,
8. Complete validated questionnaires.
The Oculus Go Head-Mounted Devices (HMD) will be put in place on the patients as follows:
1. Patient places sanitary hairnet on head,
2. Patient places disposable face liners secured by rubber bands over their ears,
3. Study coordinator places pre-sanitized Oculus Go HMD over patient's disposable face mask and adjusts straps for comfort.
Trial Product:
This study will be using immersive VR technology for intervention and management of acute and chronic pain. It will deploy the latest commercially available all-in-one HMDs as an adjunct to pain management in an inpatient hospital setting.
The VR hardware configuration and all content is currently being developed by technology partner Vue Networks, a leader in the development of VR content for implementation in education and training for the Social Sciences sector and in health and mental wellness for community and institutional usage, such as for the elderly and demented in hospitals and in nursing homes. Content experts consulted include certified MBCT practitioners as well as VR content researchers in Singapore and Germany.
VR Hardware: This study will utilize the Oculus Go all-in-one HMD set designed by Facebook Reality Labs. This is the first wireless HMD created that is able to display 4K images in a 3-degrees of Freedom environment.
VR Software: In immersive VR, high resolution (minimum 4K) 360-degree video and 3D computer graphics and paired with suitable ambience sounds and audio cues to fully immerse the user in the selected environment.
The proposed VR experiences include the following:
1. Gardens by the Bay - Limit-Oriented Therapy (Cognitive Restructuring)
2. Animated Nature Environment - Enhance-Oriented Therapy (Mindfulness Meditation)
3. Animated Beach Environment - Active-Oriented Therapy (Behavioural Activation)
4. Underwater Fish \& Mammals - Integrated Treatment (Multimodal Treatment)
Content will be a mixture of life-action and animation, as well as foreign and local | Inclusion Criteria:
1. Hospitalised patients with complain of pain issues (at least one of the following),
* Acute pain
* Acute exacerbations of chronic pain
* Chronic non-cancer pain
* Post-procedural pain (limited to those who undergo procedures with \< 2 hours in duration)
2. Age equal or more than ≥ 21 years,
3. No visual or hearing impairment,
4. English literacy.
Exclusion Criteria:
1. Cancer-related pain,
2. Comorbidities affecting usage of VR e.g. motion sickness, stroke, seizure, dementia, transmissible diseases, severe facial eczema,
3. Undergoing litigation. | Changi General Hospital | OTHER | {
"id": "VIRTUAL01",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-09-14T00:00:00 | {
"date": "2022-09-19",
"type": "ACTUAL"
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"date": "2022-09-19",
"type": "ACTUAL"
} | [
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] | ["virtual reality", "pain management", "inpatients"] | null | [
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"country": "Singapore",
"facility": "Changi General Hospital",
"geoPoint": {
"lat": 1.28967,
"lon": 103.85007
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"state": null
}
] | null | null | {
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"measure": "Patient acceptability and tolerability",
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],
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"description": null,
"measure": "Clinical efficacy of virtual reality",
"timeFrame": "pre- and post-intervention (up to 1hr)"
}
]
} | [
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"affiliation": "Changi General Hospital",
"name": "Lydia Li",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "27349654", "type": "BACKGROUND", "citation": "Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801."}, {"pmid": "27997539", "type": "BACKGROUND", "citation": "Jones T, Moore T, Choo J. The Impact of Virtual Reality on Chronic Pain. PLoS One. 2016 Dec 20;11(12):e0167523. doi: 10.1371/journal.pone.0167523. eCollection 2016."}] | {"versionHolder": "2025-06-18"} | {
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NCT04056533 | null | Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy | Anti-CMV Pilot Clinical Trial: Prophylaxis of Cytomegalovirus Infection in Haploidentical Transplatation of Hematopoietic Progenitors With Adoptive Cell Inmunotherapy | INMUNOCELL | INTERVENTIONAL | RECRUITING | 2019-08-13T00:00:00 | null | 2026-03-01T00:00:00 | 2026-12-01T00:00:00 | [
"PHASE2"
] | 15 | 18 | 80 | ALL | false | Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Recently, strategies based on immunotherapy adoptive cells (IAC) with anti-CMV Cytolitic T Lymphocytes (CMV-CTLs) has been incorporated to prevent or treat CMV after HSCT. The aim to study donor derived CMV-CTLs after haploidentical HSCT (HAPLO) as prophylaxis for CMV infection in transplant patients. CMV-CTLs will be administer at day 21 (+-7 days) post-HAPLO. CMV DNA levels with quantitative PCR will be weekly monitored. | In HAPLO, CMV infection and disease are more frequent than in other type of HSCT, this is related to delayed immune reconstitution after transplant increasing post-transplant infectious complications. Approximately 60% of patients reactivated CMV infection after HAPLO and 15%, developed CMV disease afecting organs and causing the death of the patient in 8% of CMV disease cases.
If patient and donor are eligible, it will take 1x10\^9 cells from donor leukapheresis. Donor cells will be selected and procesed by CliniMACs PRODIGY and after 12h it will obtain 7mL of CMV-CTLs. It will use 6mL of CMV-CTLs to infused a dose of 1x10\^5 cells/kg in our patient. The donor derived CMV-CTL cells will be transfused into the patients' intravenous line. The patients will receive the dose of CMV-CTL cells when they are sero-positive for CMV-DNA 21 (+- 7 days) days after transplant.
The CMV-DNA levels will be monitored weekly for at least 100 days after the transplant. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then the patient will receive treatment with anti-CMV comercial drugs. | Inclusion Criteria:
* Adult patients who received an alogeneic stem cell transplantation from haploidentical donors (HAPLO).
* Any source of stem cells (peripheral blood or bone marrow).
* CMV-seropositive donors.
* Negative pregnancy test in women.
* Signed writen informed consent.
* DONORS:
1. HLA haploidentical and CMV-seropositve donors.
2. Donor must be checked and suitable.
3. Signed writen informed consent.
4. Donor without active infection evidence at leukapheresis.
Exclusion Criteria:
* Patients without haploidentical CMV-seropositive donors.
* Patients who are not suitable for follow up visits.
CMV-CTLs Infusion Criteria:
* Hematopoiesis recovery at least partial (neutrophil counts \>0.5x10\^9/L in at least 3 consecutive samples post-transplant).
CMV-CTLs NON-Infusion Criteria:
* Patients receiving corticosteroid (dose of 0.5mg/kg/day of prednisone or equivalent) at infusion.
* ECOG \> or = 3.
* Organic toxicities grade \> or = 3.
* Patients who received ATG, donor lymphocytes or alemtuzuamb, 28 days pre-infusion.
* Patients with uncontroled infection defined by fevers and/or inestability and/or infection not resolved.
* Persistent fevers 3 days before infusion.
* Acute Graft Versus Host Disease (GVHD) grade II-IV.
* Relapse or progression after transplant and before infusion day.
* CMV reactivation/infection after transplant and before infusion day.
Patients who don´t fill infusion criteria, after day 28 post-HAPLO, will be considered screening failures and will be out of the study. | Instituto de Investigación Marqués de Valdecilla | OTHER | {
"id": "INMUNOCELL",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-08-13T00:00:00 | {
"date": "2024-08-28",
"type": "ACTUAL"
} | {
"date": "2019-08-14",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
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} | [
"CMV"
] | ["Citomegalovirus", "Haploidentical", "Hematopoietic Stem Cell Transplantation"] | null | [
{
"city": "Santander",
"country": "Spain",
"facility": "Hospital Marques de Valdecilla",
"geoPoint": {
"lat": 43.46472,
"lon": -3.80444
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"state": null
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] | null | null | {
"other": [
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"description": null,
"measure": "1-year incidence of CMV-CTLs adverse events",
"timeFrame": "From date of CMV-CTLs infusion to 1 year after transplant"
},
{
"description": null,
"measure": "CMV-CTLs persistence",
"timeFrame": "From date of CMV-CTLs infusion to 2 months after infusion"
},
{
"description": null,
"measure": "Immune reconstitution post-HAPLO",
"timeFrame": "From date of transplant to day 180 post-transplant"
}
],
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{
"description": null,
"measure": "100-days incidence of CMV infection",
"timeFrame": "From date of CMV-CTLs infusion to 100 days after transplant"
}
],
"secondary": [
{
"description": null,
"measure": "1-year incidence of CMV specific antiviral drug use",
"timeFrame": "From date of CMV-CTLs infusion to 1 year after transplant"
},
{
"description": null,
"measure": "1-year incidence of CMV disease",
"timeFrame": "From date of CMV-CTLs infusion to 1 year after transplant"
}
]
} | [
{
"affiliation": "Instituto de Investigación Marqués de Valdecilla",
"name": "Galo Peralta Fernandez, MD",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Infections"
},
{
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"term": "DNA Virus Infections"
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}
],
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},
{
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"name": "All Conditions"
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},
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}
],
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}
]
} | {
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NCT02972333 | null | Open Label, Prospective Study to Investigate Efficacy and Safety of AZD9291 in BM From NSCLC Patients With EGFR T790M | Open Label, Multi-center, Prospective Study to Investigate the Efficacy and Safety of AZD9291 in Brain Metastases From Patients With EGFR T790M Positive NSCLC Who Have Received Prior Therapy With an EGFR-TKI | None | INTERVENTIONAL | UNKNOWN | 2016-11-16T00:00:00 | null | null | null | [
"PHASE3"
] | 150 | 18 | null | ALL | false | The study aims to investigate the efficacy and safety of AZD9291 in brain metastases from patients with EGFR T790M positive NSCLC who have received prior therapy with an EGFR-TKI. | Patients with confirmed EGFR T790M positive NSCLC who have received prior therapy with an EGFR-TKI and concurrent with brain metastasis will be enrolled into the study. All eligible patients will have access to AZD9291 regimen through the ASTRIS study as long as they continue to show clinical benefit. | Inclusion Criteria:
1. Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures
2. Metastatic (stage IV) EGFRm NSCLC, not amenable to curative surgery or radiotherapy, with confirmation of the presence of the T790M mutation.
3. For patients with LM: Confirmed diagnosis of LM by positive CSF cytology. Diagnosis by MRI only is not eligible for study entry. At least one site of CNS leptomeningeal disease that can be assessed by magnetic resonance imaging (MRI) and which is suitable for repeat assessments. Measurable CNS or extracranial disease is not required.
4. For patients with measurable BM but without LM: At least one measurable intracranial lesion that, if previously irradiated, has progressed or not responded to radiation therapy, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter by magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements. Measurable extracranial disease is not required.
5. Prior therapy with an EGFR-TKI. Patients may have also received additional lines of treatment.
6. World Health Organization (WHO) performance status 0-2 with no deterioration over the previous 2 weeks and a minimum life expectancy of 3 months.
7. Adequate bone marrow reserve and organ function as demonstrated by complete blood count, biochemistry in blood and urine at baseline.
8. ECG recording at baseline showing absence of any cardiac abnormality as per exclusion criterion #10.
9. Female patients of childbearing potential must be using adequate contraceptive measures (see Restrictions, Section 3.5), must not be breast feeding, and must have a negative pregnancy test prior to start of dosing. Otherwise, they must have evidence of nonchild bearing potential as defined below:
1. Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
2. Women less than 50 years would be consider post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
3. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
10. Male patients must be willing to use barrier contraception, i.e., condoms.
Exclusion Criteria:
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
1. Previous (within 6 months) or current treatment with AZD9291
2. Patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of AZD9291) any treatment known to be potent inhibitors or inducers of cytochrome P450 (CYP) 3A4 (Appendix B)
3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, active infection\* including hepatitis B, hepatitis C and human immunodeficiency virus, or significantly impaired bone marrow reserve or organ function, including hepatic and renal impairment, which in the investigator's opinion would significantly alter the risk/benefit balance.
\* active infection will include any patients receiving intravenous treatment for any infection and patients with hepatitis B or C surface antigen (+) - Patients receiving oral antiviral suppressive therapy for hepatitis B or C will be permitted to enrol in the study.
4. Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids to manage CNS symptoms within the 2 weeks prior to start AZD9291 administration.
5. Prior whole brain radiation therapy.
6. Known intracranial hemorrhage which is unrelated to tumor.
7. For patients with LM and/or BM, CNS complications that require urgent neurosurgical intervention (e.g. resection or shunt placement).
8. For patients with LM, inability to undergo collection of CSF.
9. Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
10. Any of the following cardiac criteria:
1. Mean resting corrected QT interval (QTcF) \> 470 ms using Fredericia's formula :
2. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block)
3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
11. Any unresolved toxicity from prior therapy CTCAE \> grade 3 at the time of starting treatment
12. History of hypersensitivity to excipients of AZD9291 or to drugs with a similar chemical structure or class to AZD9291
13. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
* Absolute neutrophil count \< 1.5 x 10\^9/L
* Platelet count \< 100 x 10\^9/L
* Haemoglobin \< 90 g/L
* Alanine aminotransferase \> 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or \> 5 times ULN in the presence of liver metastases
* Aspartate aminotransferase \> 2.5 times ULN if no demonstrable liver metastases or \> 5 times ULN in the presence of liver metastases
* Total bilirubin \> 1.5 times ULN. Total bilirubin \>3 times the ULN in patients with documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or in the presence of liver metastases
* Creatinine \>1.5 times ULN concurrent with creatinine clearance \< 50 mL/min (measured or calculated by Cockcroft and Gault equation). Confirmation of creatinine clearance is only required when creatinine is \>1.5 times ULN.
* If bone metastases are present and liver function is otherwise considered adequate by the investigator then elevated ALP will not exclude the patient. | Shandong Cancer Hospital and Institute | OTHER | {
"id": "APOLLO",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-11-20T00:00:00 | {
"date": "2016-11-23",
"type": "ESTIMATED"
} | {
"date": "2016-11-23",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
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} | [
"EGFR-TKI Resistant Mutation",
"Nonsmall Cell Lung Cancer",
"AZD9291",
"Brain Metastases"
] | null | null | null | [
{
"class": "INDUSTRY",
"name": "AstraZeneca"
}
] | null | {
"other": [
{
"description": null,
"measure": "T790M mutation positive rate",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "Concordance of T790M status between CSF and plasma",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "Change of imputed ctDNA concentration before and after treatment",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "Proportion of each genetic mutation",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "Change from baseline in glucose and protein levels",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "Change from baseline in tumor cell count",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "AZD9291 concentration level in CSF/plasma",
"timeFrame": "2 years"
}
],
"primary": [
{
"description": null,
"measure": "PFSo (overall progression free survival)",
"timeFrame": "2 years"
}
],
"secondary": [
{
"description": null,
"measure": "PFSe (extracranial progression-free survival)",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "PFSi (intracranial progression-free survival)",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "ORRo (overall objective response rate)",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "ORRe (extracranial objective response rate)",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "ORRi (intracranial objective response rate)",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "DCRo (overall disease control rate)",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "DCRe (extracranial disease control rate)",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "DCRi (intracranial disease control rate)",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "DoRo (overall duration of response)",
"timeFrame": "3 years"
},
{
"description": null,
"measure": "DoRe (extracranial duration of response)",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "DoRi (intracranial duration of response)",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "OS(overall survival)",
"timeFrame": "3 years"
},
{
"description": null,
"measure": "Adverse events/Serious adverse events",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "QoL",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "Cognitive function",
"timeFrame": "2 years"
}
]
} | [
{
"affiliation": "Shandong Cancer Hospital and Institute",
"name": "Jinming Yu, MD.PhD.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "32817079", "type": "DERIVED", "citation": "Xing L, Pan Y, Shi Y, Shu Y, Feng J, Li W, Cao L, Wang L, Gu W, Song Y, Xing P, Liu Y, Gao W, Cui J, Hu N, Li R, Bao H, Shao Y, Yu J. Biomarkers of Osimertinib Response in Patients with Refractory, EGFR-T790M-positive Non-Small Cell Lung Cancer and Central Nervous System Metastases: The APOLLO Study. Clin Cancer Res. 2020 Dec 1;26(23):6168-6175. doi: 10.1158/1078-0432.CCR-20-2081. Epub 2020 Aug 17."}] | {"versionHolder": "2025-06-18"} | {
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]
} | {
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],
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} |
NCT04115033 | null | Randomized Controlled Trial of CES for Fibromyalgia | Randomized Double-Blind Placebo-Controlled Trial: fMRI Assessment of Cranial Electrical Stimulation for Fibromyalgia in Veterans | None | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2019-10-02T00:00:00 | null | 2025-09-30T00:00:00 | 2025-10-31T00:00:00 | [
"NA"
] | 50 | 20 | 60 | ALL | false | Given recent increasing opioid-related deaths and evidence showing against the use of opioids for non-malignant chronic pain, there is growing need for non-narcotic pain management. Fibromyalgia is a difficult to treat chronic pain condition that is often treated with opioids despite existing evidence. The prevalence of fibromyalgia is increased among Veterans returning from the gulf war and is already a significant burden in senior Veterans who may have suffered with chronic pain for decades already. Many treatment options for fibromyalgia carry intolerable side effects. CES (Cranial Electrical Stimulation) is a FDA-approved, non-pharmacologic therapy that is currently utilized within the military and VA system, but sufficient evidence regarding its outcomes and neural mechanisms have not been adequately investigated. An understanding of its neural underpinnings and analgesic effects could lead to 1) improvements in pain management and quality of life, 2) cost-savings and 3) development of new techniques to address pain. | RESEARCH PLAN: In the setting of the opioid epidemic, it is crucial to develop non-pharmacologic treatments for pain and biomarkers to accurately assess pain treatment outcomes. In the present investigation, the investigators assess a novel non-pharmacologic approach to chronic pain treatment in patients suffering from fibromyalgia (a notoriously difficult to treat pain syndrome), utilizing neuroimaging as a biomarker. Resting state functional connectivity MRI (rs-fcMRI), a specific neuroimaging technique, has emerged as a reliable research tool to objectively assess, understand, and predict clinical pain in syndromes such as fibromyalgia. Preliminary results reveal a trend towards improved pain and function with a FDA-approved, non-pharmacologic therapy - auricular Cranial Electrical Stimulation (CES) - over standard therapy control, correlating to altered network connectivity on rs-fcMRI. CES-related improvements continued through 12 weeks following the completion of treatment and correlated to changes in cross-network connectivity, which differed between groups. OBJECTIVE: The proposed CDA-2, a randomized, sham-controlled trial of auricular CES, evaluates 1) the clinical utility of CES for fibromyalgia as compared to sham placebo control, 2) short- and long-term CES-related neural changes visualized on rs-fcMRI and 3) the ability of rs-fcMRI to predict CES treatment response. HYPOTHESIS: True CES results in non-placebo-related short- and long-term pain and functional improvements that can be correlated with altered connectivity and predicted by baseline rs-fcMRI. METHODS: Fifty total subjects (male and female Veterans, age 20-60 years old) will be randomized to either sham (n=25) or true (n=25) auricular CES. Neuroimaging data, self-reported pain, and function will be assessed at baseline and at 1 and 12 weeks post-treatment to evaluate neural correlates of CES-related treatment. Subjects who meet study criteria will receive baseline assessments including rs-fcMRI, Defense and Veterans Pain Rating Scale (DVPRS) measures, PROMIS measures, arm curl, 30-s chair stand, handgrip strength tests, and baseline analgesic consumption. Subjects will be block-randomized, stratified based on gender, to either true or sham CES (series of 4, weekly) treatments and assessed for rs-fcMRI and functional changes at 1 and 12 weeks post-treatment. This study addresses the critical need to identify and understand neural correlates of pain and non-opioid pain management. | Inclusion Criteria:
* Subjects must be male and female Veterans age 20-60 with a diagnosis of fibromyalgia as diagnosed by a clinician, by chart review, and by the most recent American College of Rheumatology 2010 criteria for the diagnosis of fibromyalgia.
* Subjects must self-report consistent, daily pain (greater than 5 on the VAS) \>90 days.
* Subjects must have intact skin free of infection at the site of electrode placement.
* Subjects must be willing to participate and understand the consent.
* Subjects must be right-handed in order to provide consistency in brain structure and function.
Exclusion Criteria:
* Subjects must not be currently pregnant, since effects of fMRI and electrical current on the developing fetus are not well-known.
* Subjects must not have an implanted electrical device such as a vagal stimulator, pacemaker, or spinal pain pump, which are not compatible with MRI.
* Subjects must not have a history of seizures or neurologic condition that may alter the structure of the brain.
* Subjects must not have a history of drug abuse or severe, uncontrolled psychiatric illness such as schizophrenia or major depressive disorder with suicidal ideation.
* Subjects must not have psoriasis vulgaris or other skin conditions that may increase the risk of infection at the implantation site.
* Subjects must not have severe anxiety, claustrophobia, or other conditions that may prevent their ability to lie at rest in an MRI scanner. This will be determined after discussion with the patient regarding their own perceived ability to lie at rest in an MRI scanner without the use of additional sedating medications.
* Subjects must not introduce new medications or treatments for fibromyalgia symptoms during the course of the study to prevent confounding results. | VA Office of Research and Development | FED | {
"id": "B3227-W",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-10-02T00:00:00 | {
"date": "2024-11-18",
"type": "ACTUAL"
} | {
"date": "2019-10-03",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Cranial electrical stimulation (CES) using a FDA-approved device that uses earclip electrodes to deliver current through the earlobe. The stimulator is meant to stimulate branches of the cranial nerves via the external ear.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Double-blind, sham placebo-controlled",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Fibromyalgia"
] | ["Pain", "Fibromyalgia", "Magnetic Resonance Imaging", "Cranial Electrical Stimulation", "Myofascial Pain Syndromes", "Veterans"] | null | [
{
"city": "Decatur",
"country": "United States",
"facility": "Atlanta VA Medical and Rehab Center, Decatur, GA",
"geoPoint": {
"lat": 33.77483,
"lon": -84.29631
},
"state": "Georgia"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Clinical Pain Change",
"timeFrame": "baseline, 1 week following treatment, and 12 weeks following treatment completion"
}
],
"secondary": [
{
"description": null,
"measure": "rs-fcMRI Connectivity Change",
"timeFrame": "baseline, 1 week, and 12 weeks following treatment completion"
},
{
"description": null,
"measure": "Sit-to-stand",
"timeFrame": "baseline, 1 week, and 12 weeks following treatment"
},
{
"description": null,
"measure": "PROMIS Change",
"timeFrame": "baseline, 1 week, and 12 weeks following treatment"
},
{
"description": null,
"measure": "Bicep-curl",
"timeFrame": "baseline, 1 week, and 12 weeks following treatment"
},
{
"description": null,
"measure": "Handgrip strength",
"timeFrame": "baseline, 1 week, and 12 weeks following treatment"
}
]
} | [
{
"affiliation": "Atlanta VA Medical and Rehab Center, Decatur, GA",
"name": "Anna Woodbury, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009135",
"term": "Muscular Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
},
{
"id": "D012216",
"term": "Rheumatic Diseases"
},
{
"id": "D009468",
"term": "Neuromuscular Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
}
],
"browseBranches": [
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
}
],
"browseLeaves": [
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"asFound": null,
"id": "M16355",
"name": "Syndrome",
"relevance": "LOW"
},
{
"asFound": "Fibromyalgia",
"id": "M8486",
"name": "Fibromyalgia",
"relevance": "HIGH"
},
{
"asFound": "Fibromyalgia",
"id": "M12161",
"name": "Myofascial Pain Syndromes",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M13066",
"name": "Pain",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12092",
"name": "Muscular Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12097",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M15045",
"name": "Rheumatic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6323",
"name": "Collagen Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12411",
"name": "Neuromuscular Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D005356",
"term": "Fibromyalgia"
},
{
"id": "D009209",
"term": "Myofascial Pain Syndromes"
}
]
} | {
"ancestors": null,
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"abbrev": "Antipy",
"name": "Antipyretics"
},
{
"abbrev": "Analg",
"name": "Analgesics"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
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"asFound": null,
"id": "M2340",
"name": "Acetaminophen",
"relevance": "LOW"
}
],
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} | {
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"term": "Fibromyalgia"
},
{
"id": "D009209",
"term": "Myofascial Pain Syndromes"
}
],
"interventions": []
} |
NCT05746533 | null | An Evaluation of Hip Preservation Outcomes | A Comparison of Total Hip Arthroplasty and Hip Preservation Outcomes | None | OBSERVATIONAL | RECRUITING | 2023-02-16T00:00:00 | null | null | null | null | 10,000 | 12 | null | ALL | false | The purpose of this study is to assess outcomes of hip preservation surgeries including open and arthroscopic treatment of femoroacetabular impingement (FAI). | The purpose of this study is to assess outcomes of hip preservation surgeries including open and arthroscopic treatment of femoroacetabular impingement (FAI). Data will be prospectively and retrospectively collected on about 10,000 patients undergoing hip preservation at Yale-New Haven Hospital. Patients who are candidates for surgical intervention of the hip are potential participants.
The primary objective of this study is to determine whether hip arthroscopy reduces or improves post-operative outcome measures compared to pre-operative measures (including patient reported outcomes \[PROs\], revision surgery, conversion to total hip arthroplasty, and return to sport) in patients with FAI and labral tears.
The secondary objective of this study is to be able to better gauge (by assessments of patient satisfaction and psychometric thresholds of success) the progress made by recent advancements in arthroscopic hip preservation procedures with longitudinal follow-up.
The focus of this clinical trial will be the data collected prospectively. | Inclusion Criteria:
* Candidates for surgical intervention of the hip
* Participant and/or guardian has given informed consent and assent as applicable.
Exclusion Criteria:
* Documented history of pre-existing hip conditions (SCFE, LCPD, acetabular fractures)
* Has language or cognitive barriers preventing understanding of study and consent and assent documents
* Prior revision surgeries
* Patients from the trauma/emergency department
* Individuals with Unusable x-rays | Yale University | OTHER | {
"id": "2000032269",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-02-16T00:00:00 | {
"date": "2025-04-29",
"type": "ACTUAL"
} | {
"date": "2023-02-27",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | Patients age 12 years and older who are candidates for surgical intervention of the hip. | NON_PROBABILITY_SAMPLE | true | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Hip Arthroscopy",
"Femoroacetabular Impingement"
] | null | null | [
{
"city": "New Haven",
"country": "United States",
"facility": "Yale New Haven Health",
"geoPoint": {
"lat": 41.30815,
"lon": -72.92816
},
"state": "Connecticut"
}
] | [
{
"class": "INDUSTRY",
"name": "Arthrex, Inc."
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change in Hip Outcome Score (iHOT-12)",
"timeFrame": "Baseline, 3 months post-operatively, 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively"
},
{
"description": null,
"measure": "Change in Hip Outcome Score (HOS)",
"timeFrame": "Baseline, 3 months post-operatively, 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively"
},
{
"description": null,
"measure": "Change in PROMIS questionnaire Score",
"timeFrame": "Baseline, 3 months post-operatively, 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively"
},
{
"description": null,
"measure": "Change in Sports Survey Score",
"timeFrame": "Baseline, 3 months post-operatively, 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively"
},
{
"description": null,
"measure": "Change in Pain Score using a visual analog scale (VAS)",
"timeFrame": "Baseline, 3 months post-operatively, 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively"
},
{
"description": null,
"measure": "Change in PROMIS Pain Interference",
"timeFrame": "Baseline, 3 months post-operatively, 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively"
},
{
"description": null,
"measure": "Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10",
"timeFrame": "Baseline, 3 months post-operatively, 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively"
}
],
"secondary": [
{
"description": null,
"measure": "Change in Patients Satisfaction Post Surgery",
"timeFrame": "3 months, 6 months, 1 year, 2 year, 5 year and 10 year"
},
{
"description": null,
"measure": "Psychometric thresholds of success will be assessed using anchor questions",
"timeFrame": "up to 10 years"
}
]
} | [
{
"affiliation": "Yale University",
"name": "Andrew Jimenez, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D007592",
"term": "Joint Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
"browseBranches": [
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
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"asFound": "Femoroacetabular Impingement",
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},
{
"asFound": null,
"id": "M10621",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M12097",
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D057925",
"term": "Femoracetabular Impingement"
}
]
} | null | {
"conditions": [
{
"id": "D057925",
"term": "Femoracetabular Impingement"
}
],
"interventions": null
} |
NCT02214433 | null | A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers | A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Debio 1450 in Healthy Subjects | None | INTERVENTIONAL | COMPLETED | 2014-08-08T00:00:00 | null | null | null | [
"PHASE1"
] | 70 | 18 | 55 | ALL | true | Debio 1450-103 is a trial to study the pharmacokinetics (PK) of an experimental drug called Debio 1450 in healthy adult volunteers. Originally, Part A was registered separately (in NCT02214355). The registrations have been revised so all parts of this single trial (Parts A-C) are now included in this single registration (NCT02214433).
The primary purpose of each part is provided below:
* 10 volunteers participate in PART A to assess the PK of a single oral dose of Debio 1450 (tablet formulation) under varying gastric conditions
* 40 volunteers participate in PART B to assess the safety, tolerability and PK of multiple ascending doses of Debio 1450, administered sequentially IV and orally, once or twice daily.
* An additional 10 volunteers participate in PART C which is designed to assess the absolute bioavailability of various formulations of Debio 1450 under varying gastric conditions
The dose administered during Part A is based on the safety, tolerability and PK data from study Debio 1450-102 \[NCT02162199\], a single ascending dose (SAD) study, in which single oral doses up to 800 mg/day are being investigated. Doses are adjusted during Parts B and C based on the available safety and PK data from preceding cohorts. | null | Inclusion Criteria:
* Meets protocol-specified criteria for qualification and/or contraception
* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Exclusion Criteria:
* Has a history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
1. the safety or well-being of the participant or study staff
2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
3. the analysis of results | Debiopharm International SA | INDUSTRY | {
"id": "Debio 1450-103",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-08-08T00:00:00 | {
"date": "2015-02-25",
"type": "ESTIMATED"
} | {
"date": "2014-08-12",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
} | [
"Bacterial Infections"
] | ["Antibiotic", "Antibiotic Resistant Bacterial Infection"] | null | [
{
"city": "Baltimore",
"country": "United States",
"facility": "Early Phase Clinical Unit",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Number of participants with clinically significant change from baseline in safety parameters",
"timeFrame": "within 10 days post-dose"
},
{
"description": null,
"measure": "Maximum observed plasma concentration (Cmax) of Debio 1450 (prodrug) and Debio 1452 (active moiety)",
"timeFrame": "within 60 hours post-dose, depending on the assessment schedule for the cohort"
},
{
"description": null,
"measure": "Time of maximum observed plasma concentration (tmax) of Debio 1450 and Debio 1452",
"timeFrame": "within 60 hours post-dose, depending on the assessment schedule for the cohort"
},
{
"description": null,
"measure": "Area under the plasma concentration-time curve (AUC) of Debio 1450 and Debio 1452",
"timeFrame": "within 60 hours post-dose, depending on the assessment schedule for the cohort"
},
{
"description": null,
"measure": "Percentage of AUC(0-o) that is due to extrapolation beyond the last quantifiable concentration measurement (%AUCex) of Debio 1450 and Debio 1452",
"timeFrame": "within 60 hours post-dose, depending on the assessment schedule for the cohort"
},
{
"description": null,
"measure": "Elimination half-life (t1/2) of Debio 1450 and Debio 1452",
"timeFrame": "within 60 hours post-dose, depending on the assessment schedule for the cohort"
},
{
"description": null,
"measure": "Terminal elimination rate constant (Az) of Debio 1450 and Debio 1452",
"timeFrame": "within 60 hours post-dose, depending on the assessment schedule for the cohort"
},
{
"description": null,
"measure": "Mean residence time (MRT) of Debio 1450 and Debio 1452",
"timeFrame": "within 60 hours post-dose, depending on the assessment schedule for the cohort"
},
{
"description": null,
"measure": "Apparent clearance following oral administration (CL/F) of Debio 1450 and Debio 1452",
"timeFrame": "within 60 hours post-dose, depending on the assessment schedule for the cohort"
},
{
"description": null,
"measure": "Apparent volume of distribution of Debio 1450 and Debio 1452 during terminal phase (Vz/F)",
"timeFrame": "within 60 hours post-dose, depending on the assessment schedule for the cohort"
},
{
"description": null,
"measure": "Cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae)",
"timeFrame": "within 60 hours post-dose, depending on the assessment schedule for the cohort"
},
{
"description": null,
"measure": "Percentage of cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae%)",
"timeFrame": "within 60 hours post-dose, depending on the assessment schedule for the cohort"
},
{
"description": null,
"measure": "Renal clearance following oral administration",
"timeFrame": "within 60 hours post-dose, depending on the assessment schedule for the cohort"
}
],
"secondary": null
} | [
{
"affiliation": "Debiopharm International SA",
"name": "Frederick Wittke, MD",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D001423",
"term": "Bacterial Infections and Mycoses"
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],
"browseBranches": [
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"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
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},
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"asFound": null,
"id": "M6368",
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"relevance": "LOW"
},
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"name": "Bacterial Infections",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M12136",
"name": "Mycoses",
"relevance": "LOW"
},
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"asFound": null,
"id": "M4721",
"name": "Bacterial Infections and Mycoses",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001424",
"term": "Bacterial Infections"
}
]
} | {
"ancestors": [
{
"id": "D000897",
"term": "Anti-Ulcer Agents"
},
{
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"term": "Gastrointestinal Agents"
},
{
"id": "D054328",
"term": "Proton Pump Inhibitors"
},
{
"id": "D004791",
"term": "Enzyme Inhibitors"
},
{
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"term": "Molecular Mechanisms of Pharmacological Action"
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],
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"abbrev": "PhSol",
"name": "Pharmaceutical Solutions"
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"name": "All Drugs and Chemicals"
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"abbrev": "Gast",
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],
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"relevance": "LOW"
},
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"relevance": "LOW"
},
{
"asFound": "Parenting",
"id": "M1783",
"name": "Pantoprazole",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4188",
"name": "Antacids",
"relevance": "LOW"
},
{
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"relevance": "LOW"
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"relevance": "LOW"
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"relevance": "LOW"
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],
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"term": "Pantoprazole"
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{
"id": "D019999",
"term": "Pharmaceutical Solutions"
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]
} | {
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{
"id": "D001424",
"term": "Bacterial Infections"
}
],
"interventions": [
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"id": "D000077402",
"term": "Pantoprazole"
},
{
"id": "D019999",
"term": "Pharmaceutical Solutions"
}
]
} |
NCT01027533 | null | Visual Performance of New Apodized Diffractive Multifocal IOL With Addition of Plus Three | null | None | OBSERVATIONAL | COMPLETED | 2009-12-07T00:00:00 | null | null | null | null | 32 | 40 | null | ALL | true | The purpose of the study is to determine whether implantation of a multifocal IOL with a modified addition at lens plane(Restor +3) results in better intermediate visual acuity with similar performance at distance and near compared to other multifocal IOL with similar design but with higher addition at lens plane. Patient's contrast sensitivity of vision and best reading distance following Restor +3 implantation were also assessed.
Study hypothesis: the implantation of an intraocular lens (IOL) with a modified addition at lens plane (restor +3, Alcon Laboratories,Inc) results in better intermediate visual acuity with similar distance and near visual acuity after cataract surgery. | Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters) will be eligible for inclusion in the study. Exclusion criteria will be any ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination), or incomplete follow-up.
Patients will be examined before surgery and at 1, 7, 30, 90 days and 3and 6 months after surgery. | Inclusion Criteria:
* •Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters)
Exclusion Criteria:
* Ocular diseases, such as corneal opacities or irregularity, dry eye amblyopia, anisometropia, glaucoma, retinal abnormalities
* Surgical complications
* Intraocular lens (IOL) tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination)
* Incomplete follow-up. | University of Sao Paulo | OTHER | {
"id": "MRS.1703",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-12-07T00:00:00 | {
"date": "2010-07-02",
"type": "ESTIMATED"
} | {
"date": "2009-12-08",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | The sutdy population will be patients implanted bilaterally with the selected multifocal IOL | PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": null,
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"To Study the Influence of an Multifocal Intraocular Lens With Different Addition on Intermediate Visual Acuity"
] | ["multifocal intraocular lens", "visual acuity", "presbiopia"] | null | [
{
"city": "São Paulo",
"country": "Brazil",
"facility": "University of São Paulo",
"geoPoint": {
"lat": -23.5475,
"lon": -46.63611
},
"state": "SP"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "distance,intermediate and near visual acuity",
"timeFrame": "1, 3 and 6 months"
}
],
"secondary": [
{
"description": null,
"measure": "reading speed and contrast sensitivity",
"timeFrame": "6 months"
}
]
} | [
{
"affiliation": "University of Sao Paulo",
"name": "Marcony Santhiago, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "19631128", "type": "BACKGROUND", "citation": "Gupta N, Wolffsohn JS, Naroo SA. Comparison of near visual acuity and reading metrics in presbyopia correction. J Cataract Refract Surg. 2009 Aug;35(8):1401-9. doi: 10.1016/j.jcrs.2009.03.026."}, {"pmid": "19545814", "type": "BACKGROUND", "citation": "Biber JM, Sandoval HP, Trivedi RH, de Castro LE, French JW, Solomon KD. Comparison of the incidence and visual significance of posterior capsule opacification between multifocal spherical, monofocal spherical, and monofocal aspheric intraocular lenses. J Cataract Refract Surg. 2009 Jul;35(7):1234-8. doi: 10.1016/j.jcrs.2009.03.013."}, {"pmid": "19393889", "type": "BACKGROUND", "citation": "Alfonso JF, Fernandez-Vega L, Amhaz H, Montes-Mico R, Valcarcel B, Ferrer-Blasco T. Visual function after implantation of an aspheric bifocal intraocular lens. J Cataract Refract Surg. 2009 May;35(5):885-92. doi: 10.1016/j.jcrs.2009.01.014."}, {"pmid": "19152978", "type": "BACKGROUND", "citation": "Hayashi K, Yoshida M, Hayashi H. All-distance visual acuity and contrast visual acuity in eyes with a refractive multifocal intraocular lens with minimal added power. Ophthalmology. 2009 Mar;116(3):401-8. doi: 10.1016/j.ophtha.2008.09.052. Epub 2009 Jan 18."}] | {"versionHolder": "2025-06-18"} | null | null | null |
NCT06370533 | null | Healthy Gestational Weight Gain Programme | The Effects of Mobile Health Based Lifestyle Intervention on Gestational Weight Gain in Pregnant Women With Overweight and Obesity: A Randomized Controlled Trial | None | INTERVENTIONAL | RECRUITING | 2024-03-31T00:00:00 | null | 2025-03-31T00:00:00 | 2026-03-31T00:00:00 | [
"NA"
] | 200 | 18 | 40 | FEMALE | false | This study aims to evaluate the efficacy of a multi-component lifestyle interventions during pregnancy on promoting appropriate gestational weight gain, preventing GDM, and improving pregnancy, delivery, and neonatal outcomes among overweight or obese pregnant women. The intervention strategies are developed based on the transtheoretical model and mobile health (via WeChat Public Account in smartphone), and will be conducted online and offline. This study will recruit and follow-up 200 overweight or obese singleton pregnant women (pre-pregnancy 24kg/m2≤BMI≤40 kg/m2) during the first trimester of pregnancy from Weifang Maternal and Child Health Hospital, Shandong Province, China, and Tongzhou Maternal and Child Health-care Institution, Beijing, China, with 100 pregnancy women in each institution. The 200 overweight or obese pregnant women will be randomly allocated at a 1:1 ratio to either the intervention or control group, stratified by the categorical variables of age, BMI and parity. Participants in the control group will be provided usual prenatal care. The lifestyle intervention will last for approximately 6 months (from 10-14 weeks to 32-36 weeks of gestation). Follow-up timepoints included 8-14 weeks of gestation, 24-28 weeks of gestation, 32-36 weeks of gestation. The interventions are composed of health education related to gestational weight gain and healthy lifestyles, diet modification, active physical activity, regular individual in-person and telephone sessions, diet behavior monitoring, physical activity monitoring, and weight monitoring with Huawei Wristband and WeChat Public Account. The hypothesis is that lifestyle interventions based on the transtheoretical model and mobile health will result in more appropriate gestational weight gain and lower risk of adverse pregnancy outcomes compared with usual care. | Overweight and obesity is a major public health problem among women in reproductive age. Excessive gestational weight gain (EGWG) among this group is becoming a worldwide epidemic over recent decades. EGWG is associated with adverse outcomes including increased risk of developing gestational diabetes mellitus (GDM), cesarean section, hypertensive disorders of pregnancy (HDP), elevated infant birth weight and adiposity, and increased risk of metabolic syndrome and childhood obesity in offspring. Therefore, interventions are needed to help overweight and obese pregnant women to control GWG.
Lifestyle intervention has been proved effective on weight management during pregnancy. However, the effects of interventions on controlling overweight and obese women's GWG are inconsistent. Traditional face-to-face counseling are less cost effective. Effective intervention models based on Mobile health that can be scaled up are scarce. Thus, this randomized controlled trial aims to identify: firstly, whether the mobile health lifestyle interventions will be effective on improving gestational weight gain and preventing GDM among overweight or obese pregnant women; secondly, whether the intervention will be beneficial for improving pregnancy outcomes, delivery outcomes, neonatal outcomes, metabolic indicators, body composition indicators, etc. among overweight or obese pregnant women.
The interventions are composed of health education (online and offline health education on recommended gestational weight gain, prenatal dietary guidance and physical activity recommendation), diet behavior modification (8 core dietary goal setting and monitoring weekly), active physical activity (150 min per week of moderate-to vigorous-intensity physical activity including aerobic exercise (brisk walking) and resistance exercise; goal of 6000 steps/day), regular face to face or telephone sessions, lifestyle (diet and physical activity behavior) and weight monitoring via Huawei Wristband or WeChat Public Account. Tailoring of the intervention will be guided by the transtheoretical model. A total of 200 overweight or obese singleton pregnant women of 8-14 weeks of gestation will be recruited and they will be randomly allocated at a 1:1 ratio to either the intervention or control group, stratified by the categorical variables of age, BMI and parity. Participants in the control group will be provided usual prenatal care.
Women in both study arms will attend three research appointments at 8-14 weeks (baseline),24-28 weeks (midterm) and 32-36 weeks (terminal) of gestation for data collection via questionnaires, physical measurements, and clinical laboratory examination. Information on demography, socioeconomic status, medical and family history, obstetric history, current pregnancy information, smoking, consumption of alcohol, attitude and knowledge about GWG, diet and exercise habits, sleep situation, quality of life, mental health (depression, anxiety), social support, self-efficacy, etc. will be collected with questionnaires and interviews by research stuff. Physical measurements including weight, height, blood pressure, and body composition using bioelectrical impedance (BIA) will be obtained using standardized methods. Laboratory tests performed in conjunction with antenatal visits include a 75 g 2-hour oral glucose tolerance test (OGTT). Data on mode of delivery, gestational age at birth, birth weight, Apgar scores, perinatal complications, etc. will be obtained from patient records. In addition, blood and urine samples will be drawn at three appointments and a sample of cord blood will be collected at birth. Maternal postpartum weight (42 days,6 months,1 year after delivery) will be obtained through routine physical examination or telephone follow-up. Offspring physical growth indicators, such as height, weight, head circumference, etc., will be collected from routine physical examination in 42 days, 6 months and 12 months of age. | Inclusion Criteria:
1. At 8-14 weeks of gestation
2. Overweight or obese (pre-pregnancy 40 kg/m2≥BMI≥24 kg/m2) based on BMI recommendations of the Group of China Obesity Task Force of the Chinese Ministry of Health accounting for interracial differences (overweight BMI 24-28 kg/m2 and obese BMI≥28kg/m2)
3. 18-40 years of age
4. Singleton pregnant
5. Skilled at using smartphones and WeChat during pregnancy
6. Attend regular antenatal care and plan delivery at W.F. Maternal and Child Health Hospital or Tongzhou Maternal and Child Health-care Institution of Beijing
7. No contraindications to physical activity according to Physical Activity Readiness Questionnaire (PAR-Q)
8. Willing to be randomized and cooperate with research and regular follow-up visits and sign informed consent.
Exclusion Criteria:
1. Pre-pregnancy hypertension, severe cardiovascular and cerebrovascular diseases, respiratory disease, hepatic and renal disease, malignant tumors, systemic lupus erythematosus, thyroid disease, severe anemia, and other chronic consumptive diseases.
2. Cervical insufficiency (historical painless cervical dilation leading to recurrent second-trimester births in the absence of other causes; dilated cervix on manual or speculum examination, etc.), multiple pregnancy, or continuous vaginal bleeding, etc.
3. Diabetes before pregnancy
4. Special dietary needs (e.g. , vegetarianism)
5. Severe psychiatric disorders (serious mental health disorders including depression, anxiety, bipolar disorders, etc.)
6. Cognitive impairment, visual impairment or hearing impairment
7. History of bariatric surgery or surgical history involving important organs within 3 months
8. Participated in other clinical trials within 6 months | Peking University | OTHER | {
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"measure": "Change of body fat percentage (%)",
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"measure": "Change of Quality of life (12-Item Short Form Survey, SF-12)",
"timeFrame": "From baseline (8-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)"
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"measure": "Incidence of depression",
"timeFrame": "From baseline (8-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)"
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"measure": "Incidence of anxiety",
"timeFrame": "From baseline (8-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)"
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"description": null,
"measure": "The Change of Self-efficacy score (General Self-Efficacy Scale, GSES)",
"timeFrame": "From baseline (8-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)"
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"description": null,
"measure": "The stage of change related to gestational weight control behavior",
"timeFrame": "From baseline (8-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)"
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"description": null,
"measure": "Rate of Postpartum weight retention",
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"timeFrame": "From 20 weeks of gestation to delivery"
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NCT00498433 | null | Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension | Part 1: An Open Label Pilot Study to Determine Interstitial and Tissue Concentrations of Aliskiren and Effects on the Renin- Angiotensin System (RAS) in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity. Part 2: A Randomized, Double Blind, 12-weeks Parallel Group Study to Compare Effects of Aliskiren 300 mg and Amlodipine 5 mg on the RAS and Lipid/Carbohydrate Metabolism in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity | None | INTERVENTIONAL | TERMINATED | 2007-07-08T00:00:00 | null | null | null | [
"PHASE2"
] | 46 | 18 | 65 | ALL | false | Part 1 determined: aliskiren, amlodipine and angiotensin II concentrations in interstitial fluid of fat and skeletal muscle; aliskiren and angiotensin II concentrations, and renin activity and concentration in fat and skeletal muscle tissues (biopsies); aliskiren, amlodipine and angiotensin II concentrations, and renin activity and concentration in plasma.
Part 2 investigated the potential for aliskiren to modulate renin-angiotensin-aldosterone system (RAAS) activity, and lipid/carbohydrate metabolism in adipose and skeletal muscle tissue in obese patients with hypertension in comparison to amlodipine. | null | Inclusion criteria:
PART 1:
* Male and female patients 20 to 65 years of age with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)
* For patients with a history of treated hypertension, mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) had to be ≥ 120/80 mmHg and ≤ 160/100 mm Hg. For patients with newly diagnosed, untreated hypertension msSBP/msDBP had to be ≥ 135/85 mmHg and ≤ 160/100 mm Hg
* Pulse rate 40 - 90 bpm
PART 2:
* Male and female patients 18 to 65 years of age , with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)
* Systolic and diastolic blood pressure and pulse rate were assessed after the patient had rested for at least five (5) minutes. Vital signs had to be within the following ranges:
1. Patients with history of treated hypertension: msSBP/msDBP ≥ 135/85 mmHg and \< 160/100 mmHg at baseline
2. Patients with newly diagnosed, untreated hypertension: msSBP/msDBP ≥ 135/85 mmHg and \< 160/100 mmHg at screening and baseline.
Exclusion criteria:
PART 1
* Hypertension Grade 2 (msSBP ≥ 160 mmHg) or Grade 3 (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg) WHO classification
* Current treatment with three or more antihypertensive drugs.
PART 2
* Hypertension Grade 2 (msSBP ≥ 160 and/or msDBP ≥ 100 mmHg).
* Current treatment with three or more antihypertensive drugs.
Other protocol-defined inclusion/exclusion criteria applied | Novartis | INDUSTRY | {
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"description": null,
"measure": "Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period",
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"description": null,
"measure": "Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period",
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"description": null,
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"description": null,
"measure": "Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period",
"timeFrame": "Day 42"
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"description": null,
"measure": "Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period",
"timeFrame": "Day 98"
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"description": null,
"measure": "Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period",
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},
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"description": null,
"measure": "Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period",
"timeFrame": "Day 98"
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"description": null,
"measure": "Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period",
"timeFrame": "Day 42"
},
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"description": null,
"measure": "Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period",
"timeFrame": "Day 98"
},
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"description": null,
"measure": "Part 1: Renin Activity From Plasma During Aliskiren Treatment Period",
"timeFrame": "Day 42"
},
{
"description": null,
"measure": "Part 1: Renin Activity From Plasma During Amlodipine Treatment Period",
"timeFrame": "Day 98"
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"description": null,
"measure": "Part 2: Change From Baseline in Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Double Blind Treatment Period",
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"measure": "Part 2: Change From Baseline in Plasma Angiotensin II Levels During Double Blind Treatment Period",
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"description": null,
"measure": "Part 2: Plasma Renin Activity (PRA) Concentration During Double Blind Treatment Period",
"timeFrame": "Day 98"
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{
"description": null,
"measure": "Part 2: Plasma Renin Concentration (PRC) Levels During Double Blind Treatment Period",
"timeFrame": "Day 98"
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"description": null,
"measure": "Part 2: Microdialysis Metabolic Analytes in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)",
"timeFrame": "Day 14 and Day 98"
},
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"description": null,
"measure": "Part 2: Change From Baseline in Official Blood Pressure",
"timeFrame": "Placebo Baseline (Day 14), Active Treatment (Day 98)"
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"description": null,
"measure": "Part 2: Renin Activity and Concentration of Aliskiren and Amlodipine in Fat and Skeletal Muscle Interstitial Fluid",
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},
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"description": null,
"measure": "Part 2: Change From Baseline in Peripheral Insulin Sensitivity in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)",
"timeFrame": "Placebo Baseline (Day 14), Active Treatment (Day 98)"
},
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"description": null,
"measure": "Part 2: Change From Baseline in Mitochondrial Mass in Subcutaneous Fat and Skeletal Muscle (Tissue Biopsies)",
"timeFrame": "Placebo Baseline (Day 14), Active Treatment (Day 98)"
},
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"description": null,
"measure": "Part 2: Number of Participants With Reported Any Adverse Events, Serious Adverse Events and Death",
"timeFrame": "98 days"
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"term": "Membrane Transport Modulators"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
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{
"id": "D000077264",
"term": "Calcium-Regulating Hormones and Agents"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D014665",
"term": "Vasodilator Agents"
},
{
"id": "D000092502",
"term": "Renin Inhibitors"
},
{
"id": "D011480",
"term": "Protease Inhibitors"
},
{
"id": "D004791",
"term": "Enzyme Inhibitors"
}
],
"browseBranches": [
{
"abbrev": "AnAg",
"name": "Antihypertensive Agents"
},
{
"abbrev": "ChanBlk",
"name": "Channel Blockers"
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{
"abbrev": "VaDiAg",
"name": "Vasodilator Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "BDCA",
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{
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],
"browseLeaves": [
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"asFound": "Oxycodone",
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"name": "Aliskiren",
"relevance": "HIGH"
},
{
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},
{
"asFound": null,
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"name": "Calcium",
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{
"asFound": null,
"id": "M5384",
"name": "Calcium Channel Blockers",
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},
{
"asFound": null,
"id": "M5398",
"name": "Calcium, Dietary",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9789",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M17412",
"name": "Vasodilator Agents",
"relevance": "LOW"
},
{
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"id": "M2932",
"name": "Renin Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M19609",
"name": "HIV Protease Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14343",
"name": "Protease Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
}
],
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{
"id": "D017311",
"term": "Amlodipine"
},
{
"id": "C446481",
"term": "Aliskiren"
}
]
} | {
"conditions": [
{
"id": "D006973",
"term": "Hypertension"
},
{
"id": "D009765",
"term": "Obesity"
},
{
"id": "D056128",
"term": "Obesity, Abdominal"
}
],
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{
"id": "D017311",
"term": "Amlodipine"
},
{
"id": "C446481",
"term": "Aliskiren"
}
]
} |
NCT03539133 | null | Systemic Organ Communication in STEMI | Systemic Organ Communication in STEMI | SYSTEMI | OBSERVATIONAL | UNKNOWN | 2018-05-03T00:00:00 | null | null | null | null | 1,000 | 18 | null | ALL | false | Despite progress in pre-hospital care, ambulance logistics, pharmacotherapy and PPCI techniques, ST-segment elevation myocardial infarction (STEMI) continues to confer a substantial burden of morbidity and mortality.
Within the STEMI population, there is a spectrum of higher and lower risk patients. The aim of this cohort study is to collect prospectively and systematically clinical research data from STEMI patients. This cohort study is an open-end observational study to identify master switches in myocardial ischemia. | null | Inclusion Criteria:
* Patients suffering from STEMI
Exclusion Criteria:
* \< 18 years | Heinrich-Heine University, Duesseldorf | OTHER | {
"id": "17-018",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-05-25T00:00:00 | {
"date": "2022-05-05",
"type": "ACTUAL"
} | {
"date": "2018-05-29",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients suffering from STEMI | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
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"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"ST-segment Elevation Myocardial Infarction (STEMI)"
] | ["STEMI", "infarction", "coronary artery disease", "comorbidities", "diabetes", "anemia"] | null | [
{
"city": "Duesseldorf",
"country": "Germany",
"facility": "Division of Cardiology, Pulmonary Disease and Vascular Medicine",
"geoPoint": {
"lat": 51.22172,
"lon": 6.77616
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "MACCE (cardiovascular death, non-fatal stroke or myocardial infarction)",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Rehospitalization due to heart failure",
"timeFrame": "12 months"
}
],
"secondary": [
{
"description": null,
"measure": "Patency rate",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "left ventricular enddiastolic volume index (LVEDVi)",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Ejection fraction (%)",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "stroke volume",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Restenosis rate",
"timeFrame": "6 months"
}
]
} | [
{
"affiliation": "Division of Cardiology, Pulmonary Disease and Vascular Medicine",
"name": "Christian Jung, MD, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Division of Cardiology, Pulmonary Disease and Vascular Medicine",
"name": "Malte Kelm, MD",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D007511",
"term": "Ischemia"
},
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D009336",
"term": "Necrosis"
},
{
"id": "D017202",
"term": "Myocardial Ischemia"
},
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D014652",
"term": "Vascular Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
},
{
"abbrev": "BC19",
"name": "Gland and Hormone Related Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "BC15",
"name": "Blood and Lymph Conditions"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M7115",
"name": "Diabetes Mellitus",
"relevance": "LOW"
},
{
"asFound": "Myocardial Infarction",
"id": "M12155",
"name": "Myocardial Infarction",
"relevance": "HIGH"
},
{
"asFound": "Infarction",
"id": "M10282",
"name": "Infarction",
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},
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{
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"relevance": "LOW"
},
{
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},
{
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{
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},
{
"asFound": null,
"id": "M9419",
"name": "Heart Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17400",
"name": "Vascular Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D009203",
"term": "Myocardial Infarction"
},
{
"id": "D000072657",
"term": "ST Elevation Myocardial Infarction"
},
{
"id": "D007238",
"term": "Infarction"
}
]
} | null | {
"conditions": [
{
"id": "D009203",
"term": "Myocardial Infarction"
},
{
"id": "D000072657",
"term": "ST Elevation Myocardial Infarction"
},
{
"id": "D007238",
"term": "Infarction"
}
],
"interventions": null
} |
NCT04746833 | null | Development/Testing of SUMMIT: a Tool to Help Patients Manage Pain While Tapering Opioids | Development and Pilot Testing of LIMIT: a Multicomponent Tool to Support Opioid Tapering | None | INTERVENTIONAL | COMPLETED | 2021-02-04T00:00:00 | null | 2023-03-23T00:00:00 | 2023-11-30T00:00:00 | [
"PHASE2",
"PHASE3"
] | 44 | 18 | null | ALL | true | There are nearly one million veterans being treated with long-term opioid therapy (LTOT) for chronic pain. Numerous short and long-term harms associated with LTOT and mounting evidence suggest they have modest or no benefit. Yet, currently available resources to support veterans to taper are inadequate. Primary care, where most LTOT in VHA is prescribed, is overburdened and straining to meet the challenge of caring for patients with chronic pain. A scalable, relatively inexpensive tapering intervention to support primary care and/or to extend the reach of resource-intensive specialty clinics would be of great benefit to veterans who are not deriving sufficient benefit from LTOT. As such, the goal of this study is to develop and test an interactive, theory-informed, multi-component mobile website to enable veterans to safely taper opioids while managing their pain. | The investigators will conduct a 9-month, randomized, two-arm, parallel, open-label, feasibility trial of the multicomponent mobile website called SUMMIT. Eligible participants will be randomized to SUMMIT versus a pain monitoring app. Outcome measures will be collected over 9 months.
To ensure rigor and successful future implementation, the investigators will: 1) develop an evidence based program with features proven to maximize engagement and retention; 2) ensure that the program includes mechanisms to address the diverse obstacles veterans report when consider opioid tapering (e.g. fear of pain flares and abandonment by the system); 3) employ a User Centered Design - with meaningful input from veterans and primary care providers throughout the development and testing phases; and 4) adhere to recently published guidelines for mobile health interventions. | Inclusion Criteria:
Inclusion criteria for Veterans will be primary care patients who are dispensed 84 consecutive days of a stable dose of opioids (reflecting three consecutive 28-day prescriptions) through primary care and who report stable levels of pain intensity over the past month.
Exclusion Criteria:
Exclusion criteria will be Veterans on liquid methadone or buprenorphine for opioid use disorder (OUD) and those who have transitioned to buprenorphine (transdermal or sublingual) for chronic pain, have hearing or visual impairments (not corrected with hearing aids or glasses), psychiatric conditions, cognitive impairments, or participating in a concurrent pain or opioid-related research study. | VA Office of Research and Development | FED | {
"id": "IIR 17-228",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-02-04T00:00:00 | {
"date": "2023-12-07",
"type": "ACTUAL"
} | {
"date": "2021-02-10",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "We will conduct a 9-month, randomized, two-arm, parallel, open-label, feasibility trial. Eligible participants will be randomized to LIMIT versus a pain monitoring app. Outcome measures will be collected over 9 months.\n\nTo ensure rigor and successful future implementation, we will: 1) develop an evidence based program with features proven to maximize engagement and retention; 2) ensure that the program includes mechanisms to address the diverse obstacles veterans report when consider opioid tapering (e.g. fear of pain flares and abandonment by the system); 3) employ a User Centered Design - with meaningful input from veterans and primary care providers throughout the development and testing phases; and 4) adhere to recently published guidelines for mobile health interventions.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Chronic Pain"
] | ["m-health"] | null | [
{
"city": "West Haven",
"country": "United States",
"facility": "VA Connecticut Healthcare System West Haven Campus, West Haven, CT",
"geoPoint": {
"lat": 41.27065,
"lon": -72.94705
},
"state": "Connecticut"
},
{
"city": "Leeds",
"country": "United States",
"facility": "VA Central Western Massachusetts Healthcare System, Leeds, MA",
"geoPoint": {
"lat": 42.35148,
"lon": -72.69954
},
"state": "Massachusetts"
},
{
"city": "Philadelphia",
"country": "United States",
"facility": "Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania"
},
{
"city": "Salt Lake City",
"country": "United States",
"facility": "VA Salt Lake City Health Care System, Salt Lake City, UT",
"geoPoint": {
"lat": 40.76078,
"lon": -111.89105
},
"state": "Utah"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "opioid dose",
"timeFrame": "9-months"
}
],
"secondary": null
} | [
{
"affiliation": "VA Connecticut Healthcare System West Haven Campus, West Haven, CT",
"name": "William C Becker, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "32221855", "type": "RESULT", "citation": "Becker WC. \"Clues\" That Patients May Be Willing to Consider Opioid Reductions. J Gen Intern Med. 2020 Jun;35(6):1629-1630. doi: 10.1007/s11606-020-05712-6. No abstract available."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D010146",
"term": "Pain"
},
{
"id": "D009461",
"term": "Neurologic Manifestations"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
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"name": "Chronic Pain",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M13066",
"name": "Pain",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12404",
"name": "Neurologic Manifestations",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T1303",
"name": "Chronic Graft Versus Host Disease",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D059350",
"term": "Chronic Pain"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "Analg",
"name": "Analgesics"
},
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M4033",
"name": "Analgesics, Opioid",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D059350",
"term": "Chronic Pain"
}
],
"interventions": []
} |
NCT02739633 | null | Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas | Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas | None | INTERVENTIONAL | UNKNOWN | 2016-03-21T00:00:00 | null | null | null | [
"PHASE2"
] | 47 | 20 | null | ALL | false | Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas. | The aim of the this phase II study is to assess the efficacy and safety of a combination treatment of Genexol®-PM plus gemcitabine in patients with recurrent and metastatic adenocarcinoma of the pancreas. | Inclusion Criteria:
1. Patient has definitive histologically or cytologically confirmed recurrent and metastatic adenocarcinoma of the pancreas. The definitive diagnosis of recurrent and metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.
2. Initial diagnosis of recurrent and metastatic disease must have occurred ≤6 weeks prior to randomization in the study.
3. Patient has one or more lesions measurable by CT scan or MRI (if patient is allergic to CT contrast media).
4. Male or non-pregnant and non-lactating female, and ≥ 20 years of age.
5. Patient must meet the following blood counts at Baseline (obtained ≤14 days prior to randomization):
* Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L
* Platelet count ≥ 100,000/mm3 (100 × 10\^9/L)
* Hemoglobin (Hgb) ≥ 9 g/dL.
6. Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior to randomization):
* AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤ 5 × ULN is allowed.
* Total bilirubin ≤ULN
7. Patient has a Karnofsky performance status (KPS) ≥ 70. Two observers will be required to assess KPS. If discrepant, the one with the lowest assessment will be considered true.
8. Patient has voluntarily agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
Exclusion Criteria:
1. History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
2. Patients have uncontrolled bacterial, viral, or fungal infections
3. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C.
4. Patients have a history of allergy or hypersensitivity to any of Paclitaxel, Gemcitabine, or Cremophor EL.
5. Patients with high cardiovascular risk, including recent coronary stenting or myocardial infarction in the past 6 months.
6. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease). | Samyang Biopharmaceuticals Corporation | INDUSTRY | {
"id": "Genexol-PM PC",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-04-14T00:00:00 | {
"date": "2018-04-18",
"type": "ACTUAL"
} | {
"date": "2016-04-15",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Recurrent Adenocarcinoma of the Pancreas",
"Metastatic Adenocarcinoma of the Pancreas"
] | ["Chemotherapy", "Gemcitabine", "Recurrent and metastatic adenocarcinoma of the pancreas", "Genexol-PM", "Paclitaxel"] | null | [
{
"city": "Seoul",
"country": "Korea, Republic of",
"facility": "Samyang Biopharmaceuticals",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Objective response rate (ORR) as assessed by RECIST.",
"timeFrame": "8 weeks"
}
],
"secondary": [
{
"description": null,
"measure": "Progression free survival (PFS)",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "Overall survival (OS)",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "Disease control rate (DCR)",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "Number of participants with adverse events",
"timeFrame": "Baseline up to Day 21 after the last dose of study treatment"
}
]
} | [
{
"affiliation": "Ajou University Medical Center",
"name": "Hyun Woo Lee, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D020969",
"term": "Disease Attributes"
},
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D002277",
"term": "Carcinoma"
},
{
"id": "D009375",
"term": "Neoplasms, Glandular and Epithelial"
},
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
"id": "D009369",
"term": "Neoplasms"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC04",
"name": "Neoplasms"
}
],
"browseLeaves": [
{
"asFound": "Recurrent",
"id": "M14850",
"name": "Recurrence",
"relevance": "HIGH"
},
{
"asFound": "Adenocarcinoma",
"id": "M3585",
"name": "Adenocarcinoma",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M22700",
"name": "Disease Attributes",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5534",
"name": "Carcinoma",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12320",
"name": "Neoplasms, Glandular and Epithelial",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12315",
"name": "Neoplasms by Histologic Type",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000230",
"term": "Adenocarcinoma"
},
{
"id": "D012008",
"term": "Recurrence"
}
]
} | {
"ancestors": [
{
"id": "D000972",
"term": "Antineoplastic Agents, Phytogenic"
},
{
"id": "D000970",
"term": "Antineoplastic Agents"
},
{
"id": "D050257",
"term": "Tubulin Modulators"
},
{
"id": "D050256",
"term": "Antimitotic Agents"
},
{
"id": "D050258",
"term": "Mitosis Modulators"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D000964",
"term": "Antimetabolites, Antineoplastic"
},
{
"id": "D000963",
"term": "Antimetabolites"
}
],
"browseBranches": [
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Gast",
"name": "Gastrointestinal Agents"
}
],
"browseLeaves": [
{
"asFound": "Without",
"id": "M2985",
"name": "Gemcitabine",
"relevance": "HIGH"
},
{
"asFound": "Surgery",
"id": "M19537",
"name": "Paclitaxel",
"relevance": "HIGH"
},
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}
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]
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NCT02903433 | null | Effects of Avocado Intake on the Nutritional Status of Families | Effects of Avocado Intake on the Nutritional Status of Families | None | INTERVENTIONAL | COMPLETED | 2016-09-02T00:00:00 | null | 2019-01-08T00:00:00 | 2019-01-08T00:00:00 | [
"NA"
] | 72 | 5 | null | ALL | true | Avocados are an excellent source of fiber, potassium, magnesium, and poly- and mono-unsaturated fats. They can be a nutrient dense component of healthful dietary patterns and have the potential to improve the cardiovascular disease (CVD) risk profiles of families in the United States (US). The proposed research plan will focus on the contribution of avocado intake to the reduction in CVD risk of US families, by examining the effects of avocado intake on the overall nutritional status of families. Of particular interest is establishing these effects in ethnic populations such as Hispanics/Latinos. On average, Hispanic/Latinos are at increased risk for metabolic diseases that predispose to CVD. This 6-month cluster randomized trial in Hispanic/Latino Americans aims to accurately determine the impact of avocados on the overall dietary pattern of their families. Future research will extend the results of the current trial to a larger sample of ethnically diverse families in order to evaluate whether sustained changes occur in nutritional, cardiovascular and metabolic health status. | Specific Aim 1: To determine how avocados are incorporated into the family's dietary pattern and impact selected measures of nutritional status:
1. To determine if avocado intake substitutes for, or adds to, other sources of calories in the family diet.
2. To determine if avocado intake helps reduce between-meal snacking of family members.
3. To determine if avocados help families meet US Dietary Guidelines for recommended intake of: poly- and monounsaturated fats; vegetables; fiber; selected nutrients (vitamins C, D and E, Folate, Calcium, Magnesium, potassium, iron); lutein and other carotenoids.
Specific aim 2: To determine if increased avocado intake affects cardio-metabolic risk factors to include lipids, glucose, insulin, and HbA1c. | Inclusion Criteria:
1. Be part of a family that consists of at least 3 individuals, but no more than 8, who reside in the same home
2. Self-identify as Latino or Hispanic
3. Be older than 5 years of age
Exclusion Criteria:
1. Families with members who have clinically severe chronic diseases requiring specific diets (e.g. stage IV congestive heart failure, chronic kidney disease requiring dialysis)
2. Those allergic to avocados
3. Those with LATEX allergy
4. Families who are already high consumers of avocados (i.e. more than 1 avocado per adult and more than ½ avocado per child per day);
5. Those who are unwilling to eat avocados.
6. Family members with nursing or pregnant females or females planning to become pregnant
7. Family members under the age of 5 years will not be counted toward the number of family members who will be expected to participate in the intervention (i.e., adhere to healthy diet tips or consume avocados)
8. Families intending to move, or which include family members intending to move, within the next 6 months | University of California, San Diego | OTHER | {
"id": "160584",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-09-12T00:00:00 | {
"date": "2020-04-07",
"type": "ACTUAL"
} | {
"date": "2016-09-16",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
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},
"observationalModel": null,
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} | [
"Cardiovascular Disease"
] | ["Avocado", "Cardiovascular disease"] | null | [
{
"city": "Chula Vista",
"country": "United States",
"facility": "South Bay Latino Research Center",
"geoPoint": {
"lat": 32.64005,
"lon": -117.0842
},
"state": "California"
}
] | [
{
"class": "OTHER",
"name": "San Diego State University"
},
{
"class": "OTHER",
"name": "San Ysidro Health Center"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change in family energy consumption at 3 and 6 months",
"timeFrame": "3 months and 6 months"
},
{
"description": null,
"measure": "Change in distribution of macro and micronutrient intake at 6 months",
"timeFrame": "3 months and 6 months"
}
],
"secondary": [
{
"description": null,
"measure": "Change in cardio-metabolic risk factors by serum lipids at 6 months",
"timeFrame": "3 months and 6 months"
},
{
"description": null,
"measure": "Change in cardio-metabolic risk factors by insulin at 6 months",
"timeFrame": "3 months and 6 months"
},
{
"description": null,
"measure": "Change in cardio-metabolic risk factors by glucose at 6 months",
"timeFrame": "3 months and 6 months"
},
{
"description": null,
"measure": "Change in cardio-metabolic risk factors by computation of homeostasis model assessment at 6 months",
"timeFrame": "3 months and 6 months"
},
{
"description": null,
"measure": "Change in nutritional status by red blood cell fatty acid composition at 6 months",
"timeFrame": "3 months and 6 months"
},
{
"description": null,
"measure": "Change in nutritional status by red blood cell magnesium at 6 months",
"timeFrame": "3 months and 6 months"
},
{
"description": null,
"measure": "Change in nutritional status by serum total and fractionated carotenoids at 6 months",
"timeFrame": "3 months and 6 months"
}
]
} | [
{
"affiliation": "University of California, San Diego",
"name": "Matthew A Allison, MD, MPH",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"meshes": [
{
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"term": "Cardiovascular Diseases"
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]
} | null | {
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{
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"term": "Cardiovascular Diseases"
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],
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NCT05617833 | null | Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage | Safety of Combined Therapy With Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage (SCEMPI) | SCEMPI | INTERVENTIONAL | RECRUITING | 2022-11-08T00:00:00 | null | 2027-09-30T00:00:00 | 2027-09-30T00:00:00 | [
"PHASE1"
] | 60 | 12 | 2 | ALL | false | Very preterm infants are prone to numerous medical complications with lifelong impact. Amongst the most serious are significant intraventricular hemorrhage (sIVH) and the subsequent progression to posthemorrhagic hydrocephalus (PHH). Currently, the only treatment for PHH is surgery, most commonly with shunts that are prone to malfunction across the lifespan. Preclinical data show that melatonin (MLT) and erythropoietin (EPO), when administered in a sustained dosing regimen, can prevent the hallmarks of progression from early postnatal sIVH to subsequent PHH. The investigators will perform a Phase I, single institution, randomized, double-blind trial for very preterm infants with sIVH to define a safe combination dose of MLT and EPO. A maximum of 60 very preterm neonates with sIVH will be enrolled, treated through 33w6/7d, and followed to 37w6/7d. Neonates will be randomized 3:1 between MLT+EPO and placebo, with all receiving standard of care. The primary endpoint is a composite serious adverse event (SAE)/dose limiting toxicity (DLT). The investigators hypothesize that the MLT+EPO SAE/DLT rate will not be higher than the placebo rate. Secondary outcomes will be rate of co-morbidities of preterm birth. Exploratory data, collected to guide design of future clinical trials for efficacy, will include serial neuro-imaging metrics acquired from clinical images, serial neonatal neurodevelopmental examinations, serum and urine MLT and EPO levels, and liquid biomarkers. Successful implementation of this initial safety trial will provide essential data to guide the next stage of clinical trials to test if sustained MLT+EPO treatment can reduce the need for surgical intervention, and avoid the lifelong burden of shunted hydrocephalus. | null | Inclusion Criteria:
1. Neonatal intensive care unit (NICU) inpatients born at \>22 and \<32 weeks gestation (born after 22w-6/7 and before or on 31-6/7 week GA)
2. sIVH within the first 21 days from birth, defined as at least unilateral grade II on head ultrasound (HUS) performed within 18 days of enrollment
3. Approval of the primary neonatologist
4. Appropriate caregiver to provide informed consent
5. Is not known to meet or suspected of meeting any of the exclusion criteria (below).
Exclusion Criteria:
1. Participation in another pharmacological intervention trial that involves multiple doses of a medication that may interact with EPO+MLT. Examples of exemptions would include single dose administration for pharmacokinetic studies of an antibiotic, a single or few doses of a new surfactant, or a single intervention to reduce pain.
2. Is on jet ventilator or has not been off jet ventilator for at least 72 hours
3. Has been diagnosed with or is suspected of having a congenital anomaly or genetic disorder associated with brain malformation or life expectancy \<40 weeks post menstrual age (PMA). These include but are not limited to TORCH infections associated with radiographic evidence of substantial brain injury, trisomy 13, coarctation of the aorta, and severe liver failure. TORCH infections not associated with radiographic evidence of brain malformation or treatment for presumed TORCH infection are not exclusionary.
4. Is within 3 days of starting treatment for a severe clinical condition which is potentially associated with a life expectancy \<3 days. These include but are not limited to disseminated intravascular coagulation (DIC)/severe hematologic crisis, severe sepsis, Hypoxic-ischemic encephalopathy (HIE), severe brain injury
5. Other clinical conditions including:
Hydrops fetalis Hypertension for age requiring sustained medication Polycythemia (hematocrit \>65%)
6. No caregiver to provide consent
The clinical condition of potential candidates will be monitored throughout the eligibility period to ensure the participant's continued candidacy for participating in the trial. | Johns Hopkins University | OTHER | {
"id": "IRB00301237",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-11-08T00:00:00 | {
"date": "2025-05-07",
"type": "ACTUAL"
} | {
"date": "2022-11-16",
"type": "ACTUAL"
} | [
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} | [
"Intraventricular Hemorrhage of Prematurity"
] | ["SCEMPI", "Erythropoietin", "Melatonin", "preterm infants", "Intraventricular Hemorrhage"] | null | [
{
"city": "Baltimore",
"country": "United States",
"facility": "Johns Hopkins Hospital",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
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"state": "Maryland"
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] | [
{
"class": "NIH",
"name": "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Rate of SAE/DLT including death",
"timeFrame": "4 weeks after the conclusion of treatment, up to 38 weeks gestational age"
}
],
"secondary": [
{
"description": null,
"measure": "Efficacy of EPO plus MLT as assessed by rate of preterm birth related co-morbidities",
"timeFrame": "4 weeks after the conclusion of treatment, up to 38 weeks gestational age"
}
]
} | [
{
"affiliation": "Johns Hopkins University",
"name": "Shenandoah Robinson, MD",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D020300",
"term": "Intracranial Hemorrhages"
},
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"id": "D002561",
"term": "Cerebrovascular Disorders"
},
{
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"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
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"term": "Vascular Diseases"
},
{
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}
],
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"abbrev": "BC23",
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"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
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"name": "Nervous System Diseases"
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"abbrev": "BC14",
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],
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"id": "M5792",
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},
{
"asFound": null,
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},
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},
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},
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"id": "M17400",
"name": "Vascular Diseases",
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}
],
"meshes": [
{
"id": "D002543",
"term": "Cerebral Hemorrhage"
},
{
"id": "D006470",
"term": "Hemorrhage"
}
]
} | {
"ancestors": null,
"browseBranches": [
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"abbrev": "Hemat",
"name": "Hematinics"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
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{
"abbrev": "Ot",
"name": "Other Dietary Supplements"
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],
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} | {
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NCT00776633 | null | Triple Therapy in Patients on Oral Anticoagulation After Drug Eluting Stent Implantation | Intracoronary Stenting and Antithrombotic Regimen: Testing of a Six-week Versus a Six-month Clopidogrel Treatment Regimen in Patients With Concomitant Aspirin and Oral Anticoagulant Therapy Following Drug-eluting Stenting | ISAR-TRIPLE | INTERVENTIONAL | UNKNOWN | 2008-10-20T00:00:00 | null | null | null | [
"PHASE4"
] | 614 | 18 | null | ALL | false | The investigators hypothesize that reducing the duration of clopidogrel therapy from 6 months to 6 weeks after DES implantation is associated with improved clinical outcomes in patients on ASA and an oral anticoagulant. | The introduction of drug-eluting stents (DES) was associated not only with a widening of the indication for percutaneous coronary intervention (PCI) but also with longer antithrombotic therapy duration. Dual antiplatelet therapy with ASA and a thienopyridine is very efficient in preventing adverse events after coronary stenting but it is inferior to oral anticoagulation (OAC) to reduce the risk of stroke in patients with atrial fibrillation. OAC is also superior to antiplatelet therapy in patients with mechanical heart valves and the therapy of choice for the treatment of deep vein thrombosis and pulmonary embolism. OAC is also administered for left ventricular thrombi and low ejection fraction. There is an increasing number of patients undergoing coronary stenting who are in need of life-long anticoagulation therapy and would therefore require a triple therapy consisting of aspirin, clopidogrel and oral anticoagulation. As oral anticoagulation and antithrombotic therapy impair primary and secondary hemostasis there are concerns that adding warfarin to dual antiplatelet therapy might cause increased bleeding rates. Several studies have retrospectively assessed efficacy and safety in patients receiving a triple therapy with various results: major bleeding rates varied from 3,1%-14,9% with total bleeding rates up to 27,5%. Prospective randomized data on this topic are not available. Therefore the aim of this study is to compare a 6 week versus a 6 month triple therapy after DES implantation. | Key Inclusion Criteria:
1. Patients with an indication for oral anticoagulation and a DES implantation.
2. Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.
Key Exclusion Criteria:
1. Age ≤18 years
2. Previous stent thrombosis
3. DES in left main | Deutsches Herzzentrum Muenchen | OTHER | {
"id": "GE IDE No. A01508",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
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"statusForNctId": null
} | 2008-10-20T00:00:00 | {
"date": "2016-08-30",
"type": "ESTIMATED"
} | {
"date": "2008-10-21",
"type": "ESTIMATED"
} | [
"ADULT",
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} | [
"Coronary Artery Disease",
"Atrial Fibrillation"
] | ["aspirin", "clopidogrel", "oral anticoagulation", "warfarin", "drug eluting stent", "phenprocoumon"] | null | [
{
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"country": "Denmark",
"facility": "Aarhus University Hospital",
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"lon": 10.21076
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"state": null
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] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding.",
"timeFrame": "9 months"
}
],
"secondary": [
{
"description": null,
"measure": "Ischemic complications (composite of cardiac death, myocardial infarction, stent thrombosis or ischemic stroke)",
"timeFrame": "9 months"
},
{
"description": null,
"measure": "Bleeding complications (Major bleeding)",
"timeFrame": "9 months"
}
]
} | [
{
"affiliation": "Deutsches Herzzentum München",
"name": "Adnan Kastrati, MD",
"role": "STUDY_CHAIR"
},
{
"affiliation": "Deutsches Herzzentrum Muenchen",
"name": "Stefanie Schulz, MD",
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] | [{"pmid": "18608125", "type": "BACKGROUND", "citation": "Rubboli A, Halperin JL, Airaksinen KE, Buerke M, Eeckhout E, Freedman SB, Gershlick AH, Schlitt A, Tse HF, Verheugt FW, Lip GY. Antithrombotic therapy in patients treated with oral anticoagulation undergoing coronary artery stenting. An expert consensus document with focus on atrial fibrillation. Ann Med. 2008;40(6):428-36. doi: 10.1080/07853890802089786."}, {"pmid": "8598866", "type": "BACKGROUND", "citation": "Schomig A, Neumann FJ, Kastrati A, Schuhlen H, Blasini R, Hadamitzky M, Walter H, Zitzmann-Roth EM, Richardt G, Alt E, Schmitt C, Ulm K. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. N Engl J Med. 1996 Apr 25;334(17):1084-9. doi: 10.1056/NEJM199604253341702."}, {"pmid": "25908066", "type": "DERIVED", "citation": "Fiedler KA, Maeng M, Mehilli J, Schulz-Schupke S, Byrne RA, Sibbing D, Hoppmann P, Schneider S, Fusaro M, Ott I, Kristensen SD, Ibrahim T, Massberg S, Schunkert H, Laugwitz KL, Kastrati A, Sarafoff N. Duration of Triple Therapy in Patients Requiring Oral Anticoagulation After Drug-Eluting Stent Implantation: The ISAR-TRIPLE Trial. J Am Coll Cardiol. 2015 Apr 28;65(16):1619-1629. doi: 10.1016/j.jacc.2015.02.050."}, {"pmid": "24655693", "type": "DERIVED", "citation": "Fiedler KA, Byrne RA, Schulz S, Sibbing D, Mehilli J, Ibrahim T, Maeng M, Laugwitz KL, Kastrati A, Sarafoff N. Rationale and design of The Intracoronary Stenting and Antithrombotic Regimen-Testing of a six-week versus a six-month clopidogrel treatment Regimen In Patients with concomitant aspirin and oraL anticoagulant therapy following drug-Eluting stenting (ISAR-TRIPLE) study. Am Heart J. 2014 Apr;167(4):459-465.e1. doi: 10.1016/j.ahj.2014.01.005. Epub 2014 Jan 14."}] | {"versionHolder": "2025-06-18"} | {
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NCT05581433 | null | Vapocoolant Spray Application During Intraarticular Knee Injection | Vapocoolant Spray Application During Intraarticular Knee Injection: Myth or Reality? A Prospective Randomized Controlled Trial | None | INTERVENTIONAL | UNKNOWN | 2022-10-11T00:00:00 | null | 2022-10-20T00:00:00 | 2023-01-30T00:00:00 | [
"NA"
] | 150 | 18 | 85 | ALL | false | The goal of this observational study is to learn about the effects of vapocoolant spray applied during intraarticular knee injections on pain and anxiety compared to injections without any agent application in patients with knee osteoarthritis.
The main questions it aims to answer are: • Contrary to popular belief, does coolant spray application really reduce pain? • Does it have an advantage over patients with placebo or no spray at all? After intraarticular knee hyaluronic acid application, patients will be asked to indicate injection-related pain and anxiety levels on a 100mm visual analog scale. Researchers will compare the patient groups who were applied coolant spray, placebo spray and injection without any spray. | Patients who underwent intra-knee hyaluronic acid injection due to knee degenerative diseases (osteoarthritis), meniscus and cartilage problems between October 2022 and December 2022 will be prospectively included in the study. Demographic characteristics of the patients (age, gender, body mass index), degree of knee degeneration, and past surgical procedures will be recorded.
Before intra-articular injection can be given, one group will be sprayed with a vapocoolant, and one group will receive a placebo spray, while another group will receive no analgesic treatment while injection. Which patient will be evaluated in which group will be decided by randomization on the website www.random.org.
1 minute after the injection, the patients will be asked to indicate their pain level (1) and anxiety level (2) while inserting the needle on the 100mm Visual Analogue Scale (VAS). The same survey will be repeated after 10 minutes, and whether they are satisfied with the whole process will be measured with the same scale and the results will be recorded. The results will be compared between the groups, and the demographic characteristics of the patients, the level and types of disease, and the effects of vapocoolant spray application will be evaluated. | Inclusion Criteria:
* The patients with osteoarthritis of the knee undergoing a normal HA injection scheduled between October 2022 and December 2022.
Exclusion Criteria:
* Prior history of injection of the knee joint
* Inability to understand the Visual Analog Scale,
* History of cold intolerance
* Use of pain medications or topical anesthetics within the previous 24 hours
* Abnormal sensation or signs of infection over the injection site. | Istanbul Rumeli University | OTHER | {
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"facility": "Private Silivri Anadolu Hospital",
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"affiliation": "Istanbul Rumeli University",
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NCT04571333 | null | Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults. | Feasibility Study: A Totally Implantable Cochlear Implant (Mi2000) for Electrical Stimulation of the Auditory Pathway of Adults With Severe to Profound Sensorineural Hearing Loss | TICI | INTERVENTIONAL | COMPLETED | 2020-09-09T00:00:00 | null | 2021-07-01T00:00:00 | 2021-12-31T00:00:00 | [
"NA"
] | 6 | 18 | null | ALL | false | This clinical investigation aims to collect data on the use of the Mi2000 system, a totally implantable cochlear implant system, for the first time in human subjects. | Cochlear implants (CI) provide a large majority of recipients with a significant degree of speech understanding. However, CI systems rely on external parts, namely Behind-the-Ear (BTE) audio processors with coils or single-unit processors to function. This can have several disadvantages: for instance, the hardware is exposed to external trauma and to the effects of head movement and gravity. The device is also put at risk by humid, dusty, or dirty conditions as well as by physical activities that lead to water exposure such as swimming or sports in general (e.g. perspiration).
In addition, some patients are concerned with the cosmetic appearance of the external parts which are visible (more so than modern behind-the-ear hearing aids), something that may not be desirable to many potential candidates.
This clinical investigation aims to collect data on the use of the Mi2000 system, a totally implantable cochlear implant system, for the first time in human subjects. | Inclusion Criteria:
* Minimum age of eighteen (18) years at time of enrolment
* Bilateral sensorineural hearing loss with no or limited benefit from a hearing aid (\>70 dB HL PTA4)
* Post-lingual onset of deafness
* No or limited benefit from hearing aids for less than 10 years.
* A maximum score of 50% on a monosyllables test in the language of the test centre in the ear to be implanted
* General health condition, psychological and emotional condition deemed compatible with the treatment and tests performed in this study and realistic expectations, as deemed appropriate by the implanting surgeon/implant board
* Fluency in the test language with excellent proficiency, as appropriate to perform speech testing
* Evidence of up-to-date vaccinations against meningitis, as per recommendations by the applicable national body
* Signed and dated informed consent before the start of any study-specific procedure
Exclusion Criteria:
* Lack of compliance with any inclusion criterion
* Previously having received an implant on the location chosen for placing the cochlear implant
* Having received a hearing implant from another manufacturer than MED-EL on the contralateral ear
* Pre-existing condition known to necessitate MRI scans after implantation of the Mi2000
* Women being pregnant or nursing
* Women of child-bearing age not reporting to use effective contraception
* Contraindication to surgery in the middle and inner ear
* Contraindication to general anaesthesia
* Cochlear malformations, ossification or other obliteration of the cochlea, history of meningitis preventing placement of the electrode array, as confirmed by medical examination
* Acute cholesteatoma
* Acute external or middle ear infections
* Perforated tympanic membrane
* Known intolerance to any of the materials used for the implant or accessories
* Non-functional auditory nerve and/or upper auditory pathway including a history of vestibular schwannoma
* Factors preventing appropriate placement of the stimulator housing and the microphone, including fixation with screws, in the bone of the skull
* Unstable Meniere's disease, Auditory Neuropathy, Epilepsy not responding to treatment
* Unrealistic expectations of the subject
* Permanent inability and/or unwillingness to participation in post-operative care and rehabilitation
* Known intellectual disability and/or psychological diseases
* Participation in other pharmacological clinical trials within four weeks prior to enrolment | MED-EL Elektromedizinische Geräte GesmbH | INDUSTRY | {
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"date": "2020-10-01",
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"Cochlear Implants"
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"city": "Liège",
"country": "Belgium",
"facility": "Centre Hospitalier Universitaire de Liège, Department ORL",
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"country": "Germany",
"facility": "Klinikum der Universität München, Campus Großhadern",
"geoPoint": {
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"lon": 11.57549
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"state": "Bayern"
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"other": null,
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"description": null,
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"description": null,
"measure": "Speech perception in quiet",
"timeFrame": "up to 52 weeks"
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"description": null,
"measure": "Speech perception in noise",
"timeFrame": "up to 52 weeks"
},
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"description": null,
"measure": "Audiograms",
"timeFrame": "up to 52 weeks"
},
{
"description": null,
"measure": "Impedance Field Telemetry",
"timeFrame": "up to 52 weeks"
},
{
"description": null,
"measure": "Auditory Nerve Response Telemetry (ART)",
"timeFrame": "up to 52 weeks"
},
{
"description": null,
"measure": "Hardware and device parameters stored in the internal memory",
"timeFrame": "up to 52 weeks"
},
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"description": null,
"measure": "Questionnaire on usability of the device",
"timeFrame": "up to 52 weeks"
},
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"description": null,
"measure": "Health Utilities Index 2/3 (HUI2/3)",
"timeFrame": "up to 52 weeks"
},
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"description": null,
"measure": "Speech, Spatial and Qualities of Hearing (12 item version) (SSQ12)",
"timeFrame": "up to 52 weeks"
},
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"description": null,
"measure": "Nijmegen Cochlear Implant Questionnaire (NCIQ)",
"timeFrame": "up to 52 weeks"
},
{
"description": null,
"measure": "Sound quality ratings",
"timeFrame": "up to 52 weeks"
}
]
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NCT05901233 | null | Speech-Language Treatment with Remotely Supervised Transcranial Direct Current Stimulation in Primary Progressive Aphasia | Telerehabilitation with Remotely-Supervised TDCS in Progressive Aphasia | None | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2023-05-08T00:00:00 | null | 2025-06-30T00:00:00 | 2025-06-30T00:00:00 | [
"NA"
] | 10 | null | null | ALL | true | Primary progressive aphasia (PPA) is a disorder characterized by gradual decline in speech-language ability caused by underlying neurodegenerative disease. PPA is a devastating condition that can affect adults as young as their 50's, depriving them of the ability to communicate and function in society. Along with Alzheimer's Disease and other Alzheimer's Disease Related Dementias (AD/ADRD), PPA is now identified earlier and with greater precision. Increasingly, patients and families seek options for behavioral and neuromodulatory treatments to address PPA's devastating effects on communication, prolong speech-language skills, and maximize quality of life. Studies have documented the robust benefits of speech-language telerehabilitation methods for persons with PPA, with in-home treatment resulting in immediate and long-term benefits. This investigation aims to further enhance the potency of these treatment approaches by pairing them with tailored neuromodulatory intervention that targets critical brain networks supporting treatment in each clinical subtype of PPA. The study will evaluate the feasibility and preliminary benefit of home-based transcranial direct current stimulation (tDCS) combined with evidence-based speech-language telerehabilitation methods. tDCS will be delivered to patients in their own homes and site of stimulation will be tailored for each clinical subtype of PPA. This project has the potential to enhance clinical management and rehabilitation for individuals with PPA by establishing the benefit of behavioral and neuromodulatory treatment that is neurobiologically-motivated and accessible for patients and families. | null | Because PPA is a rare disease, the study aims to recruit all eligible participants with PPA who are referred to the Aphasia Research and Treatment Lab at the University of Texas (UT) Austin, the UT/Dell Medical School Department of Neurology, and the University of California at San Francisco (UCSF) Memory and Aging Center, as well as individuals with PPA from other clinical and research sites. The study will aim to include males, females, and transgender or non-binary individuals. Great efforts will be made to recruit participants from minority populations, subject to the limitation that participants need to be fluent speakers of English.
Inclusion Criteria:
* Meets diagnostic criteria for PPA
* Meets diagnostic criteria for a specific variant of PPA
* Score of 20 or higher on the Mini-Mental State Examination
* Adequate hearing and vision (with hearing or vision aids, if needed)
* Has a study partner that can co-enroll in the study and attend pre-treatment training as well as continue to be present for weekly teleconference meetings
* Able and willing to undergo MRI brain scan
* Access to high speed internet
Exclusion Criteria:
* Speech and language deficits better accounted for by another neurological disorder
* Does not meet diagnostic criteria for a specific variant of PPA
* Score of less than 20 on the Mini-Mental State Examination
* Does not have a study partner who can co-enroll in the study
* Contraindications for tDCS or MRI scan (History of seizures, head injury, craniotomy, skull surgery or fracture; History of severe or frequent migraines; Metallic implant in head or any metal in head; Pacemaker or cardioverter-defibrillator or any other stimulator; Chronic skin problems; Pregnancy)
* History of stroke, epilepsy, or significant brain injury | University of Texas at Austin | OTHER | {
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"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-06-02T00:00:00 | {
"date": "2024-10-18",
"type": "ACTUAL"
} | {
"date": "2023-06-13",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Participants undergo 4 weeks of video-implemented script training (VISTA) or Lexical Retrieval Training (LRT) with either sham or tDCS, a 2-month washout phase, and then another 4 weeks of LRT or VISTA with the other condition (sham or tDCS). Order will be randomized.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "The order of administration for active and sham stimulation phases will be masked for the participant, study partner, study clinician, and primary investigator.",
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
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},
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} | [
"Primary Progressive Aphasia"
] | ["Speech-Language Pathology", "Primary Progressive Aphasia", "Fronto-Temporal Dementia", "Alzheimer's Disease", "Neurodegenerative Disease", "Logopenic", "Semantic", "Nonfluent", "Logopenic Variant Primary Progressive Aphasia", "Semantic Variant Primary Progressive Aphasia", "Nonfluent Variant Primary Progressive Aphasia", "Semantic Dementia", "Speech Entrainment", "Script Training", "Teletherapy", "Transcranial Direct Current Stimulation", "Remotely-Supervised Transcranial Direct Current Stimulation", "Lexical Retrieval", "Noninvasive Brain Stimulation", "Telehealth"] | null | [
{
"city": "San Francisco",
"country": "United States",
"facility": "Memory and Aging Center, University of California, San Francisco",
"geoPoint": {
"lat": 37.77493,
"lon": -122.41942
},
"state": "California"
},
{
"city": "Austin",
"country": "United States",
"facility": "University of Texas",
"geoPoint": {
"lat": 30.26715,
"lon": -97.74306
},
"state": "Texas"
}
] | [
{
"class": "OTHER",
"name": "University of California, San Francisco"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "RS-LRT arm: Change in spoken naming",
"timeFrame": "change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)"
},
{
"description": null,
"measure": "RS-VISTA arm: Change in script production accuracy",
"timeFrame": "change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)"
}
],
"secondary": [
{
"description": null,
"measure": "Change on Communication Confidence Rating Scale for Aphasia",
"timeFrame": "change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)"
},
{
"description": null,
"measure": "Change on Aphasia Impact Questionnaire",
"timeFrame": "change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)"
},
{
"description": null,
"measure": "Client Satisfaction Questionnaire",
"timeFrame": "four months after treatment onset"
},
{
"description": null,
"measure": "Remotely-supervised Transcranial Direct Current Stimulation (RS-tDCS) Survey",
"timeFrame": "four months after onset of treatment"
},
{
"description": null,
"measure": "Care Partner Survey",
"timeFrame": "four months after onset of treatment"
}
]
} | [
{
"affiliation": "University of Texas at Austin",
"name": "Maya Henry, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "29718131", "type": "BACKGROUND", "citation": "Henry ML, Hubbard HI, Grasso SM, Mandelli ML, Wilson SM, Sathishkumar MT, Fridriksson J, Daigle W, Boxer AL, Miller BL, Gorno-Tempini ML. Retraining speech production and fluency in non-fluent/agrammatic primary progressive aphasia. Brain. 2018 Jun 1;141(6):1799-1814. doi: 10.1093/brain/awy101."}, {"pmid": "31390290", "type": "BACKGROUND", "citation": "Henry ML, Hubbard HI, Grasso SM, Dial HR, Beeson PM, Miller BL, Gorno-Tempini ML. Treatment for Word Retrieval in Semantic and Logopenic Variants of Primary Progressive Aphasia: Immediate and Long-Term Outcomes. J Speech Lang Hear Res. 2019 Aug 15;62(8):2723-2749. doi: 10.1044/2018_JSLHR-L-18-0144. Epub 2019 Aug 7."}, {"pmid": "30880927", "type": "BACKGROUND", "citation": "Dial HR, Hinshelwood HA, Grasso SM, Hubbard HI, Gorno-Tempini ML, Henry ML. Investigating the utility of teletherapy in individuals with primary progressive aphasia. Clin Interv Aging. 2019 Feb 25;14:453-471. doi: 10.2147/CIA.S178878. eCollection 2019."}] | {"versionHolder": "2025-06-18"} | {
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{
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{
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{
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{
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{
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{
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{
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{
"id": "D057177",
"term": "TDP-43 Proteinopathies"
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{
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"term": "Neurodegenerative Diseases"
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"term": "Proteostasis Deficiencies"
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},
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],
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{
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"term": "Pick Disease of the Brain"
},
{
"id": "D057180",
"term": "Frontotemporal Dementia"
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]
} | null | {
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"term": "Aphasia"
},
{
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"term": "Aphasia, Primary Progressive"
},
{
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"term": "Pick Disease of the Brain"
},
{
"id": "D057180",
"term": "Frontotemporal Dementia"
}
],
"interventions": null
} |
NCT06460233 | null | Blood Pressure Changes After Bariatric Surgery | Dynamics of Blood Pressure Changes After Bariatric Surgery, Assessed With 24-h Blood Pressure Monitoring | None | OBSERVATIONAL | RECRUITING | 2024-05-24T00:00:00 | null | 2025-06-15T00:00:00 | 2026-06-15T00:00:00 | null | 60 | 18 | 70 | ALL | false | The aim of the study is to assess changes in blood pressure, cardiac function and selected laboratory measurements after bariatric surgery and to find most important factors associated with blood pressure reduction after weight loss.
Description of the study
Patients: consecutive patients with class III obesity (BMI ≥ 40kg/m2) or class II obesity (BMI 35-40kg/m2) with comorbidities, admitted for sleeve gastrectomy
Methods: bedside and 24-hour blood pressure measurement, cardiac ultrasound and laboratory tests performed before surgery and at 1 week, 4 weeks, 6 months and 12 months after bariatric surgery | Pathogenesis of blood pressure reduction associated with weight loss is not established. We hypothesize that monitoring of blood pressure changes after weight loss, with concomitant evaluation of cardiac output and selected biochemical parameters related to blood pressure regulation may help in the understanding of weight loss-associated decrease in blood pressure.
The study protocol include measurement of blood pressure (bedside and 24h blood pressure monitoring), assessment of the cardiac function and biochemistry 1-2 days before laparoscopic sleeve gastrectomy and at the time of routine surgical follow-up visits after surgery ie. one week, one month, six and twelve months. Blood pressure measurements will be performed using automatic oscillometric monitors (OnTrak , Spacelabs,USA). Cardiac evaluation will include an echocardiographic assessment of the systolic and diastolic left ventricular function as well as cardiac output measurement using Doppler method. Biochemistry measures, in addition to routine blood tests needed for surgical follow-up, will include fasting insulin, high sensivity C-reactive protein, cystatin C, and NT-proBNP. | Inclusion Criteria:
* BMI ≥40kg/m2 or ≥35 kg/m2 with comorbidities
Exclusion Criteria:
* Lack of informed consent
* Expected lack of compliance
* Psychiatric illness
* Previous bariatric surgery
* Severe gastroesophageal reflux disease
* Active neoplastic disease
* Pregnancy
* Chronic atrial fibrillation or other persistent arrhythmia | Medical University of Warsaw | OTHER | {
"id": "KB/173/2020",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-06-10T00:00:00 | {
"date": "2024-06-14",
"type": "ACTUAL"
} | {
"date": "2024-06-14",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | The study includes all consecutive patients with class III obesity or class II obesity with comorbidities, admitted for bariatric surgery (sleeve gastrectomy) to the Departement of General, Transplant and Liver Surgery, Medical University of Warsaw | NON_PROBABILITY_SAMPLE | null | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Blood Pressure",
"Obesity",
"Bariatric Surgery",
"Hypertension"
] | ["Hypertension", "Obesity", "Bariatric surgery"] | null | [
{
"city": "Warsaw",
"country": "Poland",
"facility": "Central Warsaw Medical University Teaching Hospital",
"geoPoint": {
"lat": 52.22977,
"lon": 21.01178
},
"state": "Mazowieckie"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change from baseline in the 24-hour blood pressure at one week after bariatric surgery (sleeve gastrectomy)",
"timeFrame": "1-2 days before and 7 to 10 days after surgery"
}
],
"secondary": [
{
"description": null,
"measure": "Change from baseline in the 24-hour blood pressure at one month after bariatric surgery (sleeve gastrectomy)",
"timeFrame": "1-2 days before and 28 to 31 days after surgery"
},
{
"description": null,
"measure": "Change from baseline in the 24-hour blood pressure at six months after bariatric surgery (sleeve gastrectomy)",
"timeFrame": "1-2 days before and 5 to 7 months after surgery"
},
{
"description": null,
"measure": "Change from baseline in the 24-hour blood pressure at one year after bariatric surgery (sleeve gastrectomy)",
"timeFrame": "1-2 days before and 11 to 13 months after surgery"
},
{
"description": null,
"measure": "Change from baseline in bedside blood pressure at one week after bariatric surgery",
"timeFrame": "1-2 days before and 7 to 10 days after surgery"
},
{
"description": null,
"measure": "Change from baseline in bedside blood pressure at one month after bariatric surgery",
"timeFrame": "1-2 days before and 28 to 31 days after surgery"
},
{
"description": null,
"measure": "Change from baseline in bedside blood pressure at six months after bariatric surgery",
"timeFrame": "1-2 days before and 5 to 7 months after surgery"
},
{
"description": null,
"measure": "Change from baseline in bedside blood pressure at one year after bariatric surgery",
"timeFrame": "1-2 days before and 11 to 13 months after surgery"
},
{
"description": null,
"measure": "Change from baseline in cardiac output at one week after bariatric surgery",
"timeFrame": "1-2 days before and 7 to 10 days after surgery"
},
{
"description": null,
"measure": "Change from baseline in cardiac output at one month after bariatric surgery",
"timeFrame": "1-2 days before and 28 to 31 days after surgery"
},
{
"description": null,
"measure": "Change from baseline in cardiac output at six months after bariatric surgery",
"timeFrame": "1-2 days before and 5 to 7 months after surgery"
},
{
"description": null,
"measure": "Change from baseline in cardiac output at one year after bariatric surgery",
"timeFrame": "1-2 days before and 11 to 13 months after surgery"
},
{
"description": null,
"measure": "Change from baseline in the left ventricular systolic function at one week after bariatric surgery",
"timeFrame": "1-2 days before and 7 to 10 days after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in the left ventricular systolic function at one month after bariatric surgery",
"timeFrame": "1-2 days before and 28 to 31 days after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in the left ventricular systolic function at six months after bariatric surgery",
"timeFrame": "1-2 days before and 5 to 7 months after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in the left ventricular systolic function at one year after bariatric surgery",
"timeFrame": "1-2 days before and 11 to 13 months after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in the left ventricular diastolic function at one week after bariatric surgery",
"timeFrame": "1-2 days before and 7 to 10 days after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in the left ventricular diastolic function at one month after bariatric surgery",
"timeFrame": "1-2 days before and 28 to 31 days after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in the left ventricular diastolic function at six months after bariatric surgery",
"timeFrame": "1-2 days before and 5 to 7 months after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in the left ventricular diastolic function at one year after bariatric surgery",
"timeFrame": "1-2 days before and 11 to 13 months after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum fasting insulin level at one week after bariatric surgery",
"timeFrame": "1-2 days before and 7 to 10 days after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum fasting insulin level at one month after bariatric surgery",
"timeFrame": "1-2 days before and 28 to 31 days after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum fasting insulin level at six months after bariatric surgery",
"timeFrame": "1-2 days before and 5 to 7 months after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum fasting insulin level at one year after bariatric surgery",
"timeFrame": "1-2 days before and 11 to 13 months after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum high- sensivity C-Reactive Protein level at one week after bariatric surgery",
"timeFrame": "1-2 days before and 7 to 10 days after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum high- sensivity C-Reactive Protein level at one month after bariatric surgery",
"timeFrame": "1-2 days before and 28 to 31 days after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum high- sensivity C-Reactive Protein level at six months after bariatric surgery",
"timeFrame": "1-2 days before and 5 to 7 months after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum high- sensivity C-Reactive Protein level at one year after bariatric surgery",
"timeFrame": "1-2 days before and 11 to 13 months after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum Cystatin C level at one week after bariatric surgery",
"timeFrame": "1-2 days before and 7 to 10 days after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum Cystatin C level at one month after bariatric surgery",
"timeFrame": "1-2 days before and 28 to 31 days after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum Cystatin C level at six months after bariatric surgery",
"timeFrame": "1-2 days before and 5 to 7 months after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum Cystatin C level at one year after bariatric surgery",
"timeFrame": "1-2 days before and 11 to 13 months after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum NT-proBNP level at one week after bariatric surgery",
"timeFrame": "1-2 days before and 7 to 10 days after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum NT-proBNP level at one month after bariatric surgery",
"timeFrame": "1-2 days before and 28 to 31 days after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum NT-proBNP level at six months after bariatric surgery",
"timeFrame": "1-2 days before and 5 to 7 months after bariatric surgery"
},
{
"description": null,
"measure": "Change from baseline in serum NT-proBNP level at one year after bariatric surgery",
"timeFrame": "1-2 days before and 11 to 13 months after bariatric surgery"
}
]
} | [
{
"affiliation": "Medical University of Warsaw",
"name": "Grzegorz Styczynski, MD, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M12701",
"name": "Obesity",
"relevance": "LOW"
},
{
"asFound": "Hypertension",
"id": "M10024",
"name": "Hypertension",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M17400",
"name": "Vascular Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D006973",
"term": "Hypertension"
}
]
} | null | {
"conditions": [
{
"id": "D006973",
"term": "Hypertension"
}
],
"interventions": null
} |
NCT03147833 | null | Protein Before Night Sleep to Improve Recovery and Performance in Runners | Ingestion of Protein Before Each Night Sleep to Improve Recovery and Performance in Runners | None | INTERVENTIONAL | COMPLETED | 2017-05-08T00:00:00 | null | 2017-10-09T00:00:00 | 2017-10-09T00:00:00 | [
"NA"
] | 32 | 18 | 50 | MALE | true | 32 runners will be randomized into two groups. The duration of the intervention is one week including a strenuous endurance training program. Group 1 receive a protein beverage before each night sleep and Group 2 receive an isocaloric carbohydrate beverage. Performance test before and after the intervention and blood sampling before and during the intervention to check for markers for muscle damage. | null | Inclusion Criteria: VO2max \>55 ml O2/kg/min -
Exclusion Criteria:women, smokers
- | University of Aarhus | OTHER | {
"id": "1107229216",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-05-08T00:00:00 | {
"date": "2018-06-11",
"type": "ACTUAL"
} | {
"date": "2017-05-10",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Healthy"
] | null | null | [
{
"city": "Aarhus",
"country": "Denmark",
"facility": "Aarhus University, Department for Public Health, Section for Sport Science",
"geoPoint": {
"lat": 56.15674,
"lon": 10.21076
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Performance",
"timeFrame": "8 days"
}
],
"secondary": [
{
"description": null,
"measure": "Muscle damage",
"timeFrame": "8 days"
}
]
} | [
{
"affiliation": "University of Aarhus",
"name": "Mette Hansen, PhD",
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NCT00430833 | null | CHANCE - Candesartan in Hypertrophic Cardiomyopathy | Candesartan Use in Hypertrophic and Non-Obstructive Cardiomyopathy Estate (The CHANCE): a Double-Blind, Placebo-Controlled, Randomized, Multicenter Study | None | INTERVENTIONAL | UNKNOWN | 2007-01-31T00:00:00 | null | null | null | [
"PHASE2"
] | null | 18 | null | ALL | null | The primary hypothesis of the study is that treatment with AT1-R antagonist in patients with nonobstructive form of HCM will be first save, second will cause regression of myocardial hypertrophy. | Patients will be randomly assigned in 1:1 ratio either to candesartan (target dose 32 mg once daily) or matching placebo. The initial dose of the study drug will be 8 mg once daily. Study drug dose will be then doubled as tolerated every 2 weeks while aiming for a target dose of 32 mg once daily. Monitoring of blood pressure, serum creatinine, serum potassium and pressure gradient in LV outflow tract will be performed during dose increase. Patients will be observed clinically at 3, 6, and 12 months after the maintenance dose was reached. Exercise tolerance will be assessed by bicycle ergometry, presence of malignant arrhythmias by Holter monitoring, extent of LV hypertrophy by 2-dimensional echocardiography, and LV outflow tract pressure gradient by Doppler echocardiography at baseline and 12-month follow-up. | Inclusion Criteria:
* HCM defined on the basis of echocardiographic criteria showing a nondilated, hypertrophied left ventricle (any wall thickness \> 15 mm) in the absence of known causes of LV hypertrophy hypertension or valvular disease
Exclusion Criteria:
* Hypertrophic obstructive cardiomyopathy defined as presence of resting gradient in left ventricular outflow tract ³30 mmHg or in righ ventricular outflow tract ³15 mmHg at Doppler echocardiography;
* Atrial fibrillation;
* Treatment with ACE inhibitors or AT1-R antagonists any time in the past;
* Contraindications to AT1-R antagonists;
* Coronary artery disease, renal failure, hepatic disorders or serious intercurrent illness limiting survival; and
* Poor echocardiographic image quality. | Charles University, Czech Republic | OTHER | {
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NCT06585033 | null | Placebo Effect In Spinal Cord Electrical Stimulation for Pain | Spinal Cord Stimulation for the Treatment of Therapy-Resistant Neuropathic Pain After Lumbar Spinal Surgery - A Randomized, Double-Blind, Sham-Controlled, Cross-over Study | PISCES | INTERVENTIONAL | RECRUITING | 2024-09-02T00:00:00 | null | 2026-08-31T00:00:00 | 2026-08-31T00:00:00 | [
"NA"
] | 50 | 18 | 70 | ALL | false | Objective: To evaluate if spinal cord stimulation (SCS) performs better than placebo (no stimulation) in the long term to reduce persistent neuropathic leg pain refractory to medication and other conservative treatments in patients who have undergone lumbar spinal surgery.
Study design: Multicenter, double blind, randomized, sham-controlled trial.
After a positive SCS test trial, participants (18-70 years) will be implanted with a non-rechargeable SCS system providing active, subthreshold stimulation and followed for 12 months in a blinded cross-over design. The primary outcome measure is the difference in change in leg pain intensity scores using the Numeric Rating Scale (NRS) between a 3-month period with optimized subthreshold stimulation, and a 3-month period with no stimulation, as compared to baseline. Quality of life, physical functioning, sleep quality, return to work, and reduction in medication use will also be investigated.
Background: Up to 20% of patients who have undergone lumbar spinal surgery experience persistent back/leg pain leading to long-term reduction in functionality and quality of life. SCS is an established and safe, minimally invasive treatment for these patients when no further surgery is indicated and conservative therapies have been found to be ineffective. Placebo-controlled studies, comparing active and sham stimulation, were lacking until recently as traditional SCS relied on the patient feeling the stimulation (paresthesia). Technological progress with development of paresthesia-free stimulation forms now allows for the execution of placebo-controlled studies. A recent trial showing no significant difference in long-term effectiveness between active SCS and sham suffers from significant methodological shortcomings. This necessitates further sham-controlled studies to determine the effectiveness of SCS. | 1. INTRODUCTION AND RATIONALE
SCS is an established and safe, minimally invasive treatment for patients with therapy-resistant chronic neuropathic pain. The treatment is based on the development of the gate-control theory presented in the mid-1960s as a way to dampen pain impulses at the spinal cord level. SCS treatment involves the insertion of electrode(s) in the epidural space, delivering weak electrical stimulation to the dorsal columns of the spinal cord to block pain impulses traveling to the brain. In patients experiencing sufficient pain relief (usually pain reduction over 50%) during a test trial period, an implantable pulse generator (IPG) is placed under the skin and connected to the electrode(s). Patients with chronic neuropathic pain may experience pain relief with SCS when other more invasive, surgical, and conservative treatments have been attempted and appeared to be ineffective.
The most common condition treated with SCS is enduring neuropathic back and/or leg pain after lumbar spinal surgeries, such as lumbar discectomy. Up to 20% of patients who have undergone lumbar spinal surgery for degenerative conditions exhibit new or persistent low back/leg pain, leading to impaired functionality and reduced quality of life. This condition is entitled persistent spinal pain syndrome type 2 (PSPS2, formerly known as failed back surgery syndrome). Randomized controlled trials (RCTs) with SCS have shown long-term pain reduction of up to 70-80% in this patient group. In these studies, the effectiveness of SCS is based on either comparing different forms of stimulation or comparing SCS with reoperations and medication treatments. However, placebo/sham-controlled studies, comparing active stimulation with inactive stimulation, were lacking until recently since traditional SCS relied on the patient feeling the stimulation (paresthesia), making it impossible to conduct blinded studies where the patient does not know if the stimulation is on or off. This has constituted a major disadvantage in terms of the strength of the scientific evidence for the effect of SCS treatment, as it is known that the placebo effect is significant in surgical treatments.
New SCS treatments for pain in which the patient does no longer experience paresthesia have been developed in recent years, which allows the execution of sham-controlled studies. A recently published study showed no significant difference between SCS and sham stimulation in long-term pain relief and improving physical functioning in patients with PSPS2, raising doubts about the effectiveness and use of the treatment, which is costly due to high material costs. However, this single study has significant methodological shortcomings. This necessitates further sham-controlled studies to ascertain whether SCS is an adequate treatment for chronic pain. The aim of the current study is to compare the long-term effect of paresthesia-free SCS with a sham treatment (no stimulation) in reducing neuropathic pain in patients with PSPS2. It is hypothesized that SCS treatment will be superior compared to treatment with sham stimulation.
2. OBJECTIVES
Primary Objective: To compare active subthreshold SCS with sham stimulation in reducing neuropathic leg pain.
Secondary Objective(s): To compare subthreshold SCS with sham stimulation on:
1. quality of life
2. physical functioning
3. sleep quality
4. medication use
5. return to work
3. STUDY DESIGN
This is an international, multicenter, double-blind, randomized, sham-controlled study. Patients evaluated as candidates for SCS will after a positive test trial be implanted with the non-rechargeable Boston Alpha Prime system (Boston Sci, Marlborough, MA, USA) providing active subthreshold stimulation forms that the patient does not feel (i.e., paresthesia-free) and are proven to be effective in reducing chronic neuropathic pain. According to standard clinical practice, research participants are implanted with electrode(s) during an initial surgery, which are inserted into the epidural space posterior to the spinal cord dorsal columns, with the aim of obtaining the best possible coverage of the painful area. Subsequently, patients undergo a trial phase of 2 weeks with an external IPG to determine if treatment with a subthreshold stimulation provides adequate pain relief (over 50% pain reduction). If no adequate pain relief is experienced during the trial phase, the electrode(s) are removed and the patient is excluded from further study participation. In patients responding with adequate pain relief, a permanent IPG is placed under the skin and connected to the electrode(s). Patients will then be randomized into either the active subthreshold stimulation or sham stimulation group. After randomization, patients will undergo a four-week period where stimulation settings will be optimized and patients can recover from their surgery.
After the optimization period, patients will receive either subthreshold or sham stimulation in accordance with the randomization. The subthreshold stimulation form that will be used will be based on patient response in terms of optimal pain reduction during the 2-week trial and the 4-week optimization period. Patients can use any of the subthreshold stimulation forms or combinations that are available within the Alpha Prime system. After 3 months, patients will switch to the other stimulation group according to a crossover design, where they will receive the other stimulation form until the 6-month follow-up. Subsequently, patients will receive the stimulation form they found most effective for an additional 6 months until the end of the study. Both the physician who implanted the system and the patient will be unaware of the stimulation type received (a double-blind design) during the entire study period. Patients will be aware they will receive two different stimulation forms, while being unaware of the fact that one of the stimulation forms is sham stimulation. Activation/deactivation and programming of the stimulation will be performed by a research nurse, who is the only person in the study aware of which group the patient belongs to. Subjects enrolled will be asked to complete several questionnaires prior to their procedure and at routine follow up visits at 3, 6 and 12 months. After study termination at the 12-month follow-up, blinding will be lifted and patients can receive any stimulation form available within the Boston Alpha Prime system. | Inclusion Criteria:
* History consistent with PSPS2 of at least 6 months after the last spinal surgery. The patient experienced no effect of conservative treatments and has been assessed as not eligible for further spinal surgery.
* Patients between 18-70 years of age.
* Average perceived pain intensity in one or both legs of 5 or more and average perceived pain intensity in the back of less than 3 measured with the validated 11-box NRS (0 no pain, 10 worst imaginable pain)
* The patient should have been informed verbally and in writing about the study and should have provided informed written consent to participate.
* Adequate pain relief effect (50% or more) after a two week trial with active test stimulation.
Exclusion Criteria:
* Subject is unable to understand or operate the SCS device.
* Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system.
* Ongoing coagulation disorder.
* Ongoing abuse of alcohol, drugs, or prescription opioids.
* Active debilitating psychiatric illness.
* Active malignancy.
* Condition with increased general infection sensitivity, such as known immunodeficiency.
* Expected lifespan \&amp;lt;1 year.
* Ongoing local infection or other skin disease where the IPG is planned to be placed.
* Pregnancy. | Sahlgrenska University Hospital | OTHER | {
"id": "PISCES study",
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Textbook of Neuromodulation: Principles, Methods and Clinical Applications. New York: Springer; 2015:35-52."}, {"pmid": "37436342", "type": "BACKGROUND", "citation": "Zheng Y, Liu CW, Hui Chan DX, Kai Ong DW, Xin Ker JR, Ng WH, Wan KR. Neurostimulation for Chronic Pain: A Systematic Review of High-Quality Randomized Controlled Trials With Long-Term Follow-Up. Neuromodulation. 2023 Oct;26(7):1276-1294. doi: 10.1016/j.neurom.2023.05.003. Epub 2023 Jul 10."}, {"pmid": "5320816", "type": "BACKGROUND", "citation": "Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available."}, {"pmid": "28505029", "type": "BACKGROUND", "citation": "Amirdelfan K, Webster L, Poree L, Sukul V, McRoberts P. Treatment Options for Failed Back Surgery Syndrome Patients With Refractory Chronic Pain: An Evidence Based Approach. Spine (Phila Pa 1976). 2017 Jul 15;42 Suppl 14:S41-S52. doi: 10.1097/BRS.0000000000002217."}, {"pmid": "30911339", "type": "BACKGROUND", "citation": "Rigoard P, Gatzinsky K, Deneuville JP, Duyvendak W, Naiditch N, Van Buyten JP, Eldabe S. Optimizing the Management and Outcomes of Failed Back Surgery Syndrome: A Consensus Statement on Definition and Outlines for Patient Assessment. Pain Res Manag. 2019 Feb 18;2019:3126464. doi: 10.1155/2019/3126464. eCollection 2019."}, {"pmid": "31360272", "type": "BACKGROUND", "citation": "Gatzinsky K, Eldabe S, Deneuville JP, Duyvendak W, Naiditch N, Van Buyten JP, Rigoard P. Optimizing the Management and Outcomes of Failed Back Surgery Syndrome: A Proposal of a Standardized Multidisciplinary Team Care Pathway. Pain Res Manag. 2019 Jul 8;2019:8184592. doi: 10.1155/2019/8184592. eCollection 2019."}, {"pmid": "25694267", "type": "BACKGROUND", "citation": "Parker SL, Mendenhall SK, Godil SS, Sivasubramanian P, Cahill K, Ziewacz J, McGirt MJ. Incidence of Low Back Pain After Lumbar Discectomy for Herniated Disc and Its Effect on Patient-reported Outcomes. Clin Orthop Relat Res. 2015 Jun;473(6):1988-99. doi: 10.1007/s11999-015-4193-1."}, {"pmid": "28893756", "type": "BACKGROUND", "citation": "Weir S, Samnaliev M, Kuo TC, Ni Choitir C, Tierney TS, Cumming D, Bruce J, Manca A, Taylor RS, Eldabe S. The incidence and healthcare costs of persistent postoperative pain following lumbar spine surgery in the UK: a cohort study using the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES). BMJ Open. 2017 Sep 11;7(9):e017585. doi: 10.1136/bmjopen-2017-017585."}, {"pmid": "26218762", "type": "BACKGROUND", "citation": "Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, Amirdelfan K, Morgan DM, Brown LL, Yearwood TL, Bundschu R, Burton AW, Yang T, Benyamin R, Burgher AH. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015 Oct;123(4):851-60. doi: 10.1097/ALN.0000000000000774."}, {"pmid": "28108641", "type": "BACKGROUND", "citation": "Veizi E, Hayek SM, North J, Brent Chafin T, Yearwood TL, Raso L, Frey R, Cairns K, Berg A, Brendel J, Haider N, McCarty M, Vucetic H, Sherman A, Chen L, Mekel-Bobrov N. Spinal Cord Stimulation (SCS) with Anatomically Guided (3D) Neural Targeting Shows Superior Chronic Axial Low Back Pain Relief Compared to Traditional SCS-LUMINA Study. Pain Med. 2017 Aug 1;18(8):1534-1548. doi: 10.1093/pm/pnw286."}, {"pmid": "28961366", "type": "BACKGROUND", "citation": "Deer T, Slavin KV, Amirdelfan K, North RB, Burton AW, Yearwood TL, Tavel E, Staats P, Falowski S, Pope J, Justiz R, Fabi AY, Taghva A, Paicius R, Houden T, Wilson D. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018 Jan;21(1):56-66. doi: 10.1111/ner.12698. Epub 2017 Sep 29."}, {"pmid": "31870766", "type": "BACKGROUND", "citation": "Mekhail N, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Pope JE, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, Carlson J, Kim CK, Yang MI, Stauss T, Poree L; Evoke Study Group. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. Lancet Neurol. 2020 Feb;19(2):123-134. doi: 10.1016/S1474-4422(19)30414-4. Epub 2019 Dec 20."}, {"pmid": "15617591", "type": "BACKGROUND", "citation": "North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98-106; discussion 106-7. doi: 10.1227/01.neu.0000144839.65524.e0."}, {"pmid": "17845835", "type": "BACKGROUND", "citation": "Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007 Nov;132(1-2):179-88. doi: 10.1016/j.pain.2007.07.028. Epub 2007 Sep 12."}, {"pmid": "37642628", "type": "BACKGROUND", "citation": "Deer T, Gilligan C, Falowski S, Desai M, Pilitsis J, Jameson J, Moeschler S, Heros R, Tavel E, Christopher A, Patterson D, Wahezi S, Weisbein J, Antony A, Funk R, Ibrahim M, Lim C, Wilson D, Fishell M, Scarfo K, Dickerson D, Braun E, Buchanan P, Levy RM, Miller N, Duncan J, Xu J, Candido K, Kreiner S, Fahey ME, Yue J. Treatment of Refractory Low Back Pain Using Passive Recharge Burst in Patients Without Options for Corrective Surgery: Findings and Results From the DISTINCT Study, a Prospective Randomized Multicenter Controlled Trial. Neuromodulation. 2023 Oct;26(7):1387-1399. doi: 10.1016/j.neurom.2023.07.009. Epub 2023 Aug 28."}, {"pmid": "31448203", "type": "BACKGROUND", "citation": "Dettori JR, Norvell DC, Chapman JR. The Art of Surgery: The Strange World of the Placebo Response. Global Spine J. 2019 Sep;9(6):680-683. doi: 10.1177/2192568219861972. Epub 2019 Jul 17. No abstract available."}, {"pmid": "35895060", "type": "BACKGROUND", "citation": "Karjalainen T, Heikkinen J, Busija L, Jokihaara J, Lewin AM, Naylor JM, Harris L, Harris IA, Buchbinder R, Adie S. Use of Placebo and Nonoperative Control Groups in Surgical Trials: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Jul 1;5(7):e2223903. doi: 10.1001/jamanetworkopen.2022.23903."}, {"pmid": "31453983", "type": "BACKGROUND", "citation": "Duarte RV, Nevitt S, McNicol E, Taylor RS, Buchser E, North RB, Eldabe S. Systematic review and meta-analysis of placebo/sham controlled randomised trials of spinal cord stimulation for neuropathic pain. Pain. 2020 Jan;161(1):24-35. doi: 10.1097/j.pain.0000000000001689."}, {"pmid": "36255427", "type": "BACKGROUND", "citation": "Hara S, Andresen H, Solheim O, Carlsen SM, Sundstrom T, Lonne G, Lonne VV, Taraldsen K, Tronvik EA, Oie LR, Gulati AM, Sagberg LM, Jakola AS, Solberg TK, Nygaard OP, Salvesen OO, Gulati S. Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery: A Randomized Clinical Trial. JAMA. 2022 Oct 18;328(15):1506-1514. doi: 10.1001/jama.2022.18231."}, {"pmid": "36917057", "type": "BACKGROUND", "citation": "Thomson S, Kallewaard JW, Gatzinsky K. Spinal Cord Burst Stimulation vs Placebo Stimulation for Patients With Chronic Radicular Pain After Lumbar Spine Surgery. JAMA. 2023 Mar 14;329(10):847. doi: 10.1001/jama.2022.24742. No abstract available."}, {"pmid": "36526546", "type": "BACKGROUND", "citation": "Taylor RS, Eldabe S. Placebo (Sham) Controlled Trials of Spinal Cord Stimulation. Neuromodulation. 2023 Feb;26(2):474-475. doi: 10.1016/j.neurom.2022.11.013. Epub 2022 Dec 15. No abstract available."}, {"pmid": "35041592", "type": "BACKGROUND", "citation": "Paz-Solis J, Thomson S, Jain R, Chen L, Huertas I, Doan Q. Exploration of High- and Low-Frequency Options for Subperception Spinal Cord Stimulation Using Neural Dosing Parameter Relationships: The HALO Study. Neuromodulation. 2022 Jan;25(1):94-102. doi: 10.1111/ner.13390."}, {"pmid": "29220121", "type": "BACKGROUND", "citation": "Thomson SJ, Tavakkolizadeh M, Love-Jones S, Patel NK, Gu JW, Bains A, Doan Q, Moffitt M. Effects of Rate on Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized Controlled Trial. Neuromodulation. 2018 Jan;21(1):67-76. doi: 10.1111/ner.12746. Epub 2017 Dec 8."}, {"pmid": "33656411", "type": "BACKGROUND", "citation": "Metzger CS, Hammond MB, Paz-Solis JF, Newton WJ, Thomson SJ, Pei Y, Jain R, Moffitt M, Annecchino L, Doan Q. A novel fast-acting sub-perception spinal cord stimulation therapy enables rapid onset of analgesia in patients with chronic pain. Expert Rev Med Devices. 2021 Mar;18(3):299-306. doi: 10.1080/17434440.2021.1890580. Epub 2021 Mar 3."}] | {"versionHolder": "2025-06-18"} | {
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NCT00195533 | null | Study Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients | Monotherapy With Piperacillin-tazobactam Versus Combination Therapy With Piperacillin-tazobactam Plus Glycopeptide as an Initial Empiric Therapy for Fever in Neutropenic Patients. An Observational Prospective Study. | None | OBSERVATIONAL | COMPLETED | 2005-09-13T00:00:00 | null | null | null | null | 801 | 18 | null | ALL | false | The aim of this study is to compare the efficacy and tolerance of piperacillin-tazobactam versus piperacillin-tazobactam plus glycopeptide as initial empiric antibiotic treatment for fever in neutropenic patients. Study of consecutive cohorts(2). First the patients will be included in the monotherapy branch until completing the predicted number of cases. When this happens, the Coordinating Center will communicate it to the participant centers and from then the patients will be included in the combined therapy. | null | Inclusion Criteria:
* Patients with hematological malignancy or those who had undergone stem cell transplantation for neoplastic disease.
* Fever (\>38ºC)
* Neutropenia (absolute neutrophil count \< 500 or \< 1000 anticipated to fall below 500 cells within 24-48 hours).
Exclusion Criteria:
* Known allergy to any of the antibiotics used in this trial
* A high probability of death within 48 hours | Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY | {
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NCT00846833 | null | Haploidentical NK Cell Infusion in Malignant Melanoma | Phase I/II Study of Haploidentical Natural Killer Cell Infusion in Patients With Refractory or Relapsed Malignant Melanoma | None | INTERVENTIONAL | COMPLETED | 2009-02-17T00:00:00 | null | null | null | [
"PHASE1",
"PHASE2"
] | 12 | 18 | 75 | ALL | false | We hypothesized that haploidentical NK cells kill tumor cells more efficiently than autologous NK cells, based on the missing-self hypothesis. Therefore, we performed this study to investigate the role of haploidentical NK cell therapy in patients with refractory or relapsed malignant melanoma. | Human NK cells recognize and kill transformed cells in a MHC-unrestricted fashion, suggesting the role of cancer immunotherapy. However, autologous NK cells showed the lack of significant clinical effects, because they are inhibited by self MHC class I molecules, based on the missing-self hypothesis. Contrarily, haploidentical NK cells with KIR-ligand incompatibility can mediate graft-versus-leukemia effect and protect patients with acute myelogenous leukemia (AML) from graft-versus-host disease. In addition, adoptive transfer of haploidentical NK cells following high-intensity conditioning induced complete remission (26%) in poor-prognosis AML patients. Thus, this study was designed to investigate the role of adoptive NK cell therapy in patients with refractory or relapsed malignant melanoma using CD3+ depleting CliniMACS® system. | Inclusion Criteria:
* Histologically confirmed metastatic or relapsed malignant melanoma
* Patients who received prior chemotherapy or immunotherapy
* Patients who have at least one haploidentical donor willing to donate
* ECOG performance status 0 or 1
* 18 - 75 years
* At least one measurable disease according to the RECIST criteria
* Patients with 45% or more left ventricular ejection fraction
* Patients with 50% or more predicted DLCO
* Adequate bone marrow function: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L; and hemoglobin ≥ 9 g/dL
* Adequate liver function: total bilirubin ≤ 1.0 x upper limit of the normal range (ULN); AST/ALT ≤ 2.5 x ULN; and alkaline phosphatase ≤ 2.5 x ULN
* Adequate renal function: serum creatinine ≤ 1.0 x ULN or creatinine clearance ≥ 60 mL/min/1.73m2
* At least 3 months of expected survival
* Patients who signed informed consent
Exclusion Criteria:
* Patients who received other chemotherapeutic agents within 30 days prior to study enrollment
* Patients who received adoptive cell therapy including hematopoietic stem cell transplantation
* Patients infected with HIV, HBV, or HCV
* Hypersensitivity to cyclophosphamide or interleukin-2
* Patients who received organ transplantation
* Patients who had arrhythmia or ischemic heart disease
* Pregnant or lactating women
* Patients with uncontrolled infection who did not respond to appropriate antimicrobial agents | Seoul National University Hospital | OTHER | {
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}
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"description": null,
"measure": "To assess NK cell infusion-related toxicity",
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},
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"description": null,
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},
{
"description": null,
"measure": "To determine immune reconstitution after NK cell infusion",
"timeFrame": "2 years"
}
]
} | [
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NCT05872633 | null | Online Self-management in Hand Osteoarthritis | An Online Self-management Intervention for Patients With Hand Osteoarthritis - a Randomized Controlled Trial | None | INTERVENTIONAL | COMPLETED | 2023-03-30T00:00:00 | null | 2021-05-19T00:00:00 | 2021-05-19T00:00:00 | [
"NA"
] | 70 | 18 | null | ALL | false | NB. This study has been previously registered with the National Trial Registry (NTR6266) that has been cancelled. The registered trial has been automatically transferred to a new "Landelijk Trial Register", which does not contain all correct information on the current study and where no corrections can be made. Hence, the current study has been registered again with ClinicalTrials.gov.
The goal of this clinical trial is to study the effectiveness of an online self-management intervention in adult patients with hand osteoarthritis and to explore the possibilities to implement the intervention in clinical practice after the study period. An RCT will be performed, in which 70 participants will be randomized to either care-as-usual (hand osteoarthritis care path, including consultation with the rheumatologist and a 1,5-hour consultation with a clinical nurse or occupational therapist, n=35) or care-as-usual plus the online self-management intervention (n=35). The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention. As secondary outcomes, a number of other psychological and physical outcome measures will be assessed (e.g., health-related quality of life, well-being, pain impact on daily life, pain cognitions). Also, cost-effectiveness of the intervention will be measured, by assessing productivity loss and health care use of participants (using iPCQ and iMCQ). | Rationale: Hand osteoarthritis has a high clinical burden, as reflected by considerable pain, decreased strength and mobility, physical disability, and an often-decreased health-related quality of life. Self-management factors related to physical and psychosocial adjustment, such as patients' perceptions about their disease and coping, play an important role in heath-related quality of life and functional ability in patients with chronic diseases, such as osteoarthritis. Improving capacities of patients in managing a chronic condition is increasingly recognized as important in the treatment of (somatic) conditions and is becoming more common in clinical practice and research. In this study, the effect of an online self-management intervention focusing on coping skills related to chronic pain in comparison to care-as-usual is studied.
Objective: To study the effectiveness of the online self-management intervention in patients with hand osteoarthritis and to explore the possibilities to implement the intervention in clinical practice after the study period.
Study design: An RCT will be performed, in which 70 participants will be randomized to either care-as-usual (hand osteoarthritis care path, including consultation with the rheumatologist and a 1,5-hour consultation with a clinical nurse or occupational therapist, n=35) or care-as-usual plus the online self-management intervention (n=35). Baseline, post-intervention, 6-week, and three-month follow-up questionnaires will be used to measure primary and secondary outcomes. To assess implementation possibilities of the online intervention, structured qualitative interviews among patients and health professionals will examine to what extent the intervention suits the needs and skills of patients and to what extent the intervention fits within the current care process.
Study population: All patients ≥18 years with hand osteoarthritis who are referred to the hand osteoarthritis care path at the rheumatology clinic at Leiden University Medical Center with on-going pain complaints during at least three months will be invited to participate in the study. Patients need to be fluent in Dutch, need to be able to give informed consent, and have internet access. Severe psychiatric co-morbidity, on-going psychological treatment elsewhere, difficulties with (written) communication, a lack of internet literacy, and having secondary osteoarthritis are exclusion criteria.
Intervention: The intervention is based on cognitive-behavioral methods. It starts off with a face-to-face introduction consultation. Subsequently, the tailored self- management intervention will be offered via an online program. The intervention consists of six modules containing pain education, practical assignments, relaxation training, and registrations. The first and last modules are an introductory and closure module; in between are four modules aimed at learning how to cope with the consequences of a chronic condition in daily life. The modules focus on (1) activity, (2) mood, (3) thoughts, and (4) the social environment. At least once a week, participants receive feedback on the assignments and motivational support from a psychologist, by means of text messages in a secured mail box in the online program. After finishing the online program, patients will be approached by their treating psychologist for two booster sessions via telephone. In these booster sessions it will be evaluated how the patient further attained his/her pre-set goals for the intervention. Strategies to strengthen the achieved results will be discussed. The booster sessions will take place 1 month and 2,5 months after finishing the online program.
Main study parameters/endpoints: The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention. As secondary outcomes, a number of other psychological and physical outcome measures will be assessed (e.g., health-related quality of life, well-being, pain impact on daily life, pain cognitions). Also, cost-effectiveness of the intervention will be measured, by assessing productivity loss and health care use of participants (using iPCQ and iMCQ).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In the control group the usual standard of care is provided. In the intervention group patients will be offered an internet-based self-management intervention, which potentially improves their pain coping and other psychological and physical outcomes. No risk is involved with participation in this study. The only burden for participants is investment of time. | Inclusion Criteria:
* Diagnosed with hand osteoarthritis, following American College of Rheumatology (ARC) criteria (Altman et al., 1990)
* Referred to the hand osteoarthritis care path
* Complaints from hand osteoarthritis including pain, with a minimal duration of 3 months
* Minimum age of 18 years
* Fluent in Dutch language
* Able to give informed consent
* Own a computer with internet access
Exclusion Criteria:
* Difficulties with (written) communication (e.g., due to analphabetism) and lack of internet literacy
* Severe psychiatric comorbidities that interfere with the study protocol
* On-going psychological treatment elsewhere
* Patients with secondary osteoarthritis due to diseases, such as 1) inflammatory rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, etc., 2) bone diseases, such as M. Paget, osteochondritis, 3) metabolic diseases associated with joint disease, such as hemochromatosis, acromegaly, 4) severe crystal arthropathies, such as tophaceous polyarticular gout. | Leiden University Medical Center | OTHER | {
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"measure": "Economic evaluation: Five-Level Version of the EQ-5D (EQ-5D-5L)",
"timeFrame": "Baseline, immediately after the intervention, at 3 months follow-up."
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"description": null,
"measure": "Economic evaluation: iMTA Medical Consumption Questionnaire (iMCQ)",
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"measure": "Change in illness cognitions",
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"description": null,
"measure": "Change in illness perceptions",
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"measure": "Change in pain",
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"description": null,
"measure": "Change in pain and disability",
"timeFrame": "Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up."
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"description": null,
"measure": "Change in pain interference in daily functioning and pain severity, and as exploratory measures support, life control, and affective distress",
"timeFrame": "Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up."
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"measure": "Change in health-related quality of life",
"timeFrame": "Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up."
},
{
"description": null,
"measure": "Change in health-related quality of life",
"timeFrame": "Baseline, immediately after the intervention, at 3 months follow-up."
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"affiliation": "Leiden University",
"name": "Andrea Evers, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
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NCT03907033 | null | Liposomal Bupivacaine in Vaginal Hysterectomy | Preemptive Local Analgesia With Liposomal Bupivacaine in Vaginal Hysterectomy: A Randomized Controlled Study | None | INTERVENTIONAL | TERMINATED | 2019-04-05T00:00:00 | null | 2021-07-23T00:00:00 | 2021-07-23T00:00:00 | [
"PHASE4"
] | 28 | 18 | 85 | FEMALE | false | The aim of this study is to compare the effects of preemptive analgesia using liposomal bupivacaine mixed with bupivacaine HCl, versus bupivacaine HCl alone for uterosacral ligament injection in patients undergoing vaginal hysterectomy. We hypothesize that the group receiving a combination of liposomal bupivacaine and bupivacaine HCl will report superior postoperative pain management. Enhancement in pain control should confer a decrease in opioid and other analgesic medication requirements, which may contribute to decreased nausea, vomiting, and higher overall patient satisfaction with pain control. | Prior to surgery, patients are assigned by chance (like a coin toss) to receive either the bupivacaine HCl injection at the time of surgery or bupivacaine HCl plus liposomal bupivacaine. Patients and the Principal Investigator cannot choose the study group. Patients will have a 50% chance of being assigned to either group; however, regardless of which group they are assigned to, the medical record will show that they received liposomal bupivacaine. The injections will be given in the vaginal area when the patient is under anesthesia.
After surgery, patients will be asked to record their pain, medication use, pain scores and symptoms in a diary for each 12 hour interval up to 72 hours. Someone will also call twice a day during the 72 hours after surgery to ask about pain level and pain medication use.
Patients will also receive a phone call 7-10 days after the surgery to ask about their recovery and pain level. | INCLUSION CRITERIA
1. Women 18-85 who will be having an outpatient vaginal hysterectomy with or without concurrent prolapse repair surgery at Mayo Clinic Hospital in Arizona
EXCLUSION CRITERIA
1. Known history of hepatic (liver) disease as evidenced by an AST or ALT that is greater than normal values
2. Known history of renal (kidney) disease as evidenced by a serum creatinine that is greater than normal values
3. Known history of prolonged QT (QTc greater than 500 m/s)
4. Opiate tolerance as noted by daily use of greater than 20 mg morphine daily oral equivalents per day for a minimum of 1 month prior to surgery
5. Allergy or contraindication to amide local anesthetics, celecoxib, ketorolac, NSAIDs, acetaminophen, gabapentin, sulfa drugs, or ondansetron
6. Allergy to both oxycodone and hydromorphone
7. Patients with acute gastrointestinal bleed that has occurred less than 6 months prior to study enrollment
8. Adults lacking the ability to consent | Mayo Clinic | OTHER | {
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"link": null,
"type": null
} | Insufficient funding to continue with study activities | {
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} | 2019-04-05T00:00:00 | {
"date": "2021-10-15",
"type": "ACTUAL"
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"date": "2019-04-08",
"type": "ACTUAL"
} | [
"ADULT",
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{
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"country": "United States",
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],
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},
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"description": null,
"measure": "VAS Pain Score at 24, 48, and 72 Hours Post-surgery Completion",
"timeFrame": "24, 48, and 72 hours post-surgery completion"
},
{
"description": null,
"measure": "Nausea at 24, 48, and 72 Hours Post-surgery Completion",
"timeFrame": "24, 48, and 72 hours post-surgery"
},
{
"description": null,
"measure": "Emesis at 24, 48, and 72 Hours Post-surgery Completion",
"timeFrame": "24, 48, and 72 hours post-surgery"
},
{
"description": null,
"measure": "Urinary Retention",
"timeFrame": "At voiding trial prior to discharge from hospital, approximately 72 hours"
},
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"description": null,
"measure": "Patient Satisfaction With Pain Management at 72 Hours and 7-10 Days Post Surgery",
"timeFrame": "72 hours and 7-10 days post surgery"
}
]
} | [
{
"affiliation": "Mayo Clinic",
"name": "Jeffrey L Cornella",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "18830553", "type": "BACKGROUND", "citation": "Long JB, Eiland RJ, Hentz JG, Mergens PA, Magtibay PM, Kho RM, Magrina JF, Cornella JL. Randomized trial of preemptive local analgesia in vaginal surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):5-10. doi: 10.1007/s00192-008-0716-6. Epub 2008 Oct 2."}, {"pmid": "26204387", "type": "BACKGROUND", "citation": "Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283."}, {"pmid": "22570563", "type": "BACKGROUND", "citation": "Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1."}, {"pmid": "26056753", "type": "BACKGROUND", "citation": "Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6."}, {"pmid": "28802777", "type": "BACKGROUND", "citation": "Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25."}, {"pmid": "23969801", "type": "BACKGROUND", "citation": "Kalogera E, Bakkum-Gamez JN, Jankowski CJ, Trabuco E, Lovely JK, Dhanorker S, Grubbs PL, Weaver AL, Haas LR, Borah BJ, Bursiek AA, Walsh MT, Cliby WA, Dowdy SC. Enhanced recovery in gynecologic surgery. Obstet Gynecol. 2013 Aug;122(2 Pt 1):319-328. doi: 10.1097/AOG.0b013e31829aa780."}] | {"versionHolder": "2025-06-18"} | null | {
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NCT03485833 | null | End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness | End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness in Mechanically Ventilated Cardiac Surgical Patients | EEOFR | INTERVENTIONAL | UNKNOWN | 2018-03-24T00:00:00 | null | 2020-12-31T00:00:00 | 2020-12-31T00:00:00 | [
"NA"
] | 60 | 18 | 85 | ALL | false | The purpose of the study is to verify the efficacy of using end-expiratory and end-inspiratory occlusion tests as an index of fluid responsiveness in mechanically ventilated patients with cardiac surgery. | Patients with hypotension after anesthetic induction for cardiac surgery, who requires fluid resuscitation based on clinical judgement by the anesthesiologists are enrolled in this study. Patients are monitored by transesophageal echocardiography and FloTrac/Vigileo. Hemodynamic variables (heart rate, systolic blood pressure, diastolic blood pressure, mean artery pressure, central venous pressure, stroke volume variation, cardiac index, velocity time integral of the aorta etc) are measured at baseline, after end-expiratory occlusion (EEO) test, after end-inspiratory occlusion (EIO) test, after passive legs raising test, and after fluid challenge respectively. Responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution. | Inclusion Criteria:
* cardiac surgical patients
* hypotension after induction of anesthesia
* required volume expansion by clinical judgement of the anesthesiologist
Exclusion Criteria:
* younger than 18 years
* severe valve regurgitation or systolic dysfunction of the right ventricle
* contraindication of the transesophageal echocardiography examination
* cardiac arrhythmia
* left ventricular ejection fraction less than 30% before surgery | Shanghai Zhongshan Hospital | OTHER | {
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NCT05551533 | null | Mobile App Intervention for Informal Dementia Caregivers | Design and Pilot-test of an Innovative Mobile-based Intervention to Promote Mental Health of Informal Dementia Caregivers Through User-Centered Design | None | INTERVENTIONAL | RECRUITING | 2022-09-16T00:00:00 | null | null | null | [
"NA"
] | 60 | 21 | null | ALL | true | Informal caregivers of persons with dementia (PWD) usually experience elevated levels of caregiving burden and potential depression. This project aims to develop and pilot-test a mobile app intervention for informal caregivers of PWD in Singapore. The project will have three phases in total including 1) phase 1 - to develop the app prototype and collect feedback from caregivers via focused group discussions. 2) a pilot RCT with 60 participants in total - 30 will be required to use the app for one month while another 30 will be on a waiting list for one month. and 3) in-depth interviews to seek users' feedback on the app for its future improvements. We hypothesize that the mobile app designed through a user-centered process would lead to high acceptance and high user engagement among local dementia caregivers. The 1-month intervention using the app developed subsequently would lower the reported depressive symptoms among local dementia caregiver. It will also improve their knowledge of dementia, caregiving efficacy, positive coping strategy, perceived positive aspects of caregiver and social support, and their mental well-being; and reduce their caregiving burden, and level of anxiety, compared to the control group. | The prevalence of dementia was found to be 10% among residents aged 60 years and above in Singapore according to the Well-being of the Singapore Elderly study, equivalent to 51,934 older adults. As the population is aging in Singapore, and the fact that the incidence of dementia doubles with every 6.3-year increase in age after 60 years old, this number is going to grow as well, together with an increasing number of their informal caregivers. Informal caregivers of persons with dementia (PWD) usually experience elevated levels of caregiving burden from supporting the daily functioning of the PWD as well as issues such as work-family-caregiving conflicts and social isolation. These stressors can lead to potential depression among informal caregivers. The aggregate prevalence of depression was reported to be 34% according to a previous meta-analysis. Due to their heavy involvement in daily caregiving, caregivers usually have difficulties in attending face-to-face interventions. For instance, the average weekly hours spent on caregiving were reported to be 55 hours in our recent study among local informal caregivers. And this situation might be even worse in the current COVID-19 outbreak. To better support them now and in the future, an alternative could be to rely on a mobile-based intervention, as the penetration rate of smartphones among local residents is quite high (aged 15-49: \>95%, aged 50-59: 88%, and aged 60 and above: 56%). Several studies have strengthened the evidence that these methods are feasible and acceptable among dementia caregivers. And preliminary evidence also suggested that such interventions were viable and potentially effective in promoting the mental health status among informal dementia caregivers.
This study aims to address the following gaps - Firstly, there is a lack of user-centered design in app development as well as rigorously designed studies based on a clear theoretical framework for dementia caregivers. Secondly, none of the existing evidence-based mobile apps for supporting dementia caregivers is Singapore-based. Lastly, a mobile-based intervention developed with culturally relevant knowledge, support, and resources is needed for local dementia caregivers, especially seeing the current Covid-19 outbreak and the new normal in the future.
Primary Objective The current study aims to design and develop a mobile-based multi-component intervention (i.e. an app) to promote mental health among informal caregivers of individuals with dementia in Singapore, and pilot-test the effectiveness of the app among a convenience sample of local informal dementia caregivers.
Secondary Objective(s) Secondary objectives include 1) seeking users' feedback and identifying areas for future improvements; 2) exploring the potential for future bigger trials; 3) providing a development framework for future similar programs. | Inclusion Criteria:
1. aged 21 or above;
2. Singapore citizen or permanent resident;
3. primary caregiver who is currently taking care of a PWD;
4. scores 4 and above using the 4-item screening version Zarit Burden Interview;
5. has sufficient skills in using mobile apps;
6. able to read, write, and speak in English
Exclusion Criteria:
1. Caregivers who are pregnant
2. caregivers with vision and hearing problems | Institute of Mental Health, Singapore | OTHER | {
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"name": "National Healthcare Group, Singapore"
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"measure": "Baseline depressive symptom",
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},
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"measure": "Post-intervention depressive symptom",
"timeFrame": "within 2 weeks after the intervention"
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"measure": "Baseline knowledge of dementia",
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"measure": "Post intervention knowledge of dementia",
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"measure": "Post intervention coping strategy",
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"measure": "Baseline positive aspects of caregiving",
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"measure": "Post intervention positive aspects of caregiving",
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"measure": "Post intervention caregiver burden",
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"measure": "Baseline anxiety level",
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},
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"measure": "Post intervention anxiety level",
"timeFrame": "within 2 weeks after the intervention"
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"measure": "Baseline mental well-being",
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"measure": "Post intervention mental well-being",
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"name": "Qi Yuan, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "11574710", "type": "BACKGROUND", "citation": "Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652."}, {"pmid": "29977440", "type": "BACKGROUND", "citation": "Brown EL, Ruggiano N, Page TF, Roberts L, Hristidis V, Whiteman KL, Castro J. CareHeroes Web and Android Apps for Dementia Caregivers: A Feasibility Study. Res Gerontol Nurs. 2016 Jul-Aug;9(4):193-203. doi: 10.3928/19404921-20160229-02. Epub 2016 Mar 4."}, {"pmid": "25945597", "type": "BACKGROUND", "citation": "Callan JA, Siegle GJ, Abebe K, Black B, Martire L, Schulz R, Reynolds C 3rd, Hall MH. Feasibility of a pocket-PC based cognitive control intervention in dementia spousal caregivers. Aging Ment Health. 2016;20(6):575-82. doi: 10.1080/13607863.2015.1031635. Epub 2015 May 6."}, {"pmid": null, "type": "BACKGROUND", "citation": "Fogg, B. J. (2009). A behavior model for persuasive design. Paper presented at the Proceedings of the 4th international Conference on Persuasive Technology."}, {"pmid": "31790857", "type": "BACKGROUND", "citation": "Lorca-Cabrera J, Grau C, Marti-Arques R, Raigal-Aran L, Falco-Pegueroles A, Albacar-Rioboo N. Effectiveness of health web-based and mobile app-based interventions designed to improve informal caregiver's well-being and quality of life: A systematic review. Int J Med Inform. 2020 Feb;134:104003. doi: 10.1016/j.ijmedinf.2019.104003. Epub 2019 Nov 23."}, {"pmid": "23039777", "type": "BACKGROUND", "citation": "McCurdie T, Taneva S, Casselman M, Yeung M, McDaniel C, Ho W, Cafazzo J. mHealth consumer apps: the case for user-centered design. Biomed Instrum Technol. 2012 Fall;Suppl:49-56. doi: 10.2345/0899-8205-46.s2.49. No abstract available."}, {"pmid": "29631492", "type": "BACKGROUND", "citation": "Rathnayake S, Moyle W, Jones C, Calleja P. mHealth applications as an educational and supportive resource for family carers of people with dementia: An integrative review. Dementia (London). 2019 Oct-Nov;18(7-8):3091-3112. doi: 10.1177/1471301218768903. Epub 2018 Apr 9. No abstract available."}, {"pmid": null, "type": "BACKGROUND", "citation": "Reyes, A. K., Camargo, J. E., & D\u00edaz, G. M. (2015). Design of a mobile application to support non-pharmacological therapies for people with Alzheimer disease. Paper presented at the International Conference on Smart Health."}, {"pmid": "26593303", "type": "BACKGROUND", "citation": "Sallim AB, Sayampanathan AA, Cuttilan A, Ho R. Prevalence of Mental Health Disorders Among Caregivers of Patients With Alzheimer Disease. J Am Med Dir Assoc. 2015 Dec;16(12):1034-41. doi: 10.1016/j.jamda.2015.09.007."}, {"pmid": "31518275", "type": "BACKGROUND", "citation": "Sikder AT, Yang FC, Schafer R, Dowling GA, Traeger L, Jain FA. Mentalizing Imagery Therapy Mobile App to Enhance the Mood of Family Dementia Caregivers: Feasibility and Limited Efficacy Testing. JMIR Aging. 2019 Mar 21;2(1):e12850. doi: 10.2196/12850."}, {"pmid": "25672767", "type": "BACKGROUND", "citation": "Subramaniam M, Chong SA, Vaingankar JA, Abdin E, Chua BY, Chua HC, Eng GK, Heng D, Hia SB, Huang W, Jeyagurunathana A, Kua J, Lee SP, Mahendran R, Magadi H, Malladi S, McCrone P, Pang S, Picco L, Sagayadevan V, Sambasivam R, Seng KH, Seow E, Shafie S, Shahwan S, Tan LL, Yap M, Zhang Y, Ng LL, Prince M. Prevalence of Dementia in People Aged 60 Years and Above: Results from the WiSE Study. J Alzheimers Dis. 2015;45(4):1127-38. doi: 10.3233/JAD-142769."}, {"pmid": "32592582", "type": "BACKGROUND", "citation": "Yuan Q, Wang P, Tan TH, Devi F, Poremski D, Magadi H, Goveas R, Ng LL, Chong SA, Subramaniam M. Coping Patterns Among Primary Informal Dementia Caregivers in Singapore and Its Impact on Caregivers-Implications of a Latent Class Analysis. Gerontologist. 2021 Jul 13;61(5):680-692. doi: 10.1093/geront/gnaa080."}] | {"versionHolder": "2025-06-18"} | {
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NCT02313233 | null | Research on Benefit of Umooze as Add- on Therapy in Benign Prostatic Hyperplasia | Research on Benefit of Umooze as Add-on Therapy in Benign Prostatic Hyperplasia | None | INTERVENTIONAL | COMPLETED | 2014-12-05T00:00:00 | null | null | null | [
"NA"
] | 41 | 40 | null | MALE | false | To evaluate the improvement in symptoms of Benign Prostatic Hyperplasia (BPH) according to the Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of Umooze twice daily administration for 56 days in patients with BPH. | The study product, Umooze, contain Astragalus radix extracts and Soy extracts as the combination of 960:40 in one 500 mg tablet. Umooze is sold in the market as food. The objective of this study is to evaluate the benefit of Umooze as add- on therapy in BPH, by evaluation the improvement in symptoms of BPH assessed according to the International Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of Umooze in patients with BPH. The IPSS is a validated 7-item urinary symptom severity scale.
A randomized, two-regimen, placebo-controlled, parallel- design is used in this study in which each subject will receive Umooze or placebo. The add- on study product will be administered twice daily for 56 days. Benefit will be evaluated at baseline and subsequently on the study day 28, 42, and 56, such as IPSS index, QoL index, Qmax, PVR, prostate volume and Prostate-specific antigen(PSA). | Inclusion Criteria:
* Males aged \>=40 years old
* Screened by inquiry and diagnosed as BPH based on the result of a digital rectal examination (DRE) or transrectal ultrasonography (TRUS)
* Prostate volume \>= 20 cm3
* Has complained of voiding symptoms related to BPH
* Has an IPSS \>= 13 or an UFR measure of Qmax \<= 15 ml/sec together with a voided volume \>= 150 ml.
* Serum PSA \< 6.5 ng/ml
* Has been treated with medication for BPH
* Informed consent form signed.
Exclusion Criteria:
* Sensitivity to study product
* Had received prostatic surgery for BPH during the past 24 weeks
* Hard nodule found by DRE
* Ongoing neurogenic bladder, urinary tract infection, bladder stone, urethral stricture, bladder cancer, prostate cancer, severe liver dysfunction, severe renal dysfunction or severe cardiovascular disease.
* Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co- investigator.
* Participation of any clinical investigation during the last 30 days.
* Individuals are judged by the investigators or co- investigator to be undesirable as subjects. | Golden Biotechnology Corporation | INDUSTRY | {
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"id": "D005832",
"term": "Genital Diseases, Male"
},
{
"id": "D000091662",
"term": "Genital Diseases"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D052801",
"term": "Male Urogenital Diseases"
}
],
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"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
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}
],
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},
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"id": "M10016",
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},
{
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},
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},
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}
],
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"term": "Prostatic Hyperplasia"
},
{
"id": "D006965",
"term": "Hyperplasia"
}
]
} | {
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},
{
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}
],
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"id": "T63",
"name": "Astragalus",
"relevance": "LOW"
}
],
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} | {
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"term": "Prostatic Hyperplasia"
},
{
"id": "D006965",
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}
],
"interventions": []
} |
NCT01053533 | null | A Pragmatic Randomized Controlled Trial of Chinese Herbal Medicine for Severe Pandemic H1N1 Influenza | null | 200907001-2A | INTERVENTIONAL | UNKNOWN | 2010-01-19T00:00:00 | null | null | null | [
"NA"
] | 1,100 | 6 | null | ALL | false | The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe pandemic H1N1 influenza. | null | Inclusion Criteria:
* Clinical diagnosis of severe pandemic H1N1 influenza patients and pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza
* Rapid Diagnostic Tests:positive
* Age≥6 years
* Influenza symptoms occurred less than 48 hours and body temperature≥37.5℃ for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza
Exclusion Criteria:
* Suffering from mental illness
* Attending other clinical studies on influenza
* Critical pandemic H1N1 influenza patients | Beijing Ditan Hospital | OTHER | {
"id": "20100118",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2010-01-20T00:00:00 | {
"date": "2010-06-08",
"type": "ESTIMATED"
} | {
"date": "2010-01-21",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Influenza A Virus, H1N1 Subtype"
] | ["Chinese herbal medicines", "pandemic H1N1 influenza", "effectiveness", "safety"] | null | [
{
"city": "Beijing",
"country": "China",
"facility": "Mao Yu",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing"
}
] | [
{
"class": "OTHER",
"name": "Beijing University of Chinese Medicine"
},
{
"class": "OTHER_GOV",
"name": "State Administration of Traditional Chinese Medicine of the People's Republic of China"
},
{
"class": "OTHER",
"name": "China Academy of Chinese Medical Sciences"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "incidence of complication",
"timeFrame": "10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients."
},
{
"description": null,
"measure": "mortality of pandemic H1N1 influenza and all-cause mortality(only for severe pandemic H1N1 influenza patients)",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "proportion of deteriorating into severe H1N1 influenza (only for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza)",
"timeFrame": "10 days"
}
],
"secondary": [
{
"description": null,
"measure": "time to allaying a fever",
"timeFrame": "10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients"
},
{
"description": null,
"measure": "time to symptom relief",
"timeFrame": "10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients"
},
{
"description": null,
"measure": "time and proportion of H1N1 virus turning to negative",
"timeFrame": "10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients"
},
{
"description": null,
"measure": "direct medical cost",
"timeFrame": "10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients"
},
{
"description": null,
"measure": "safety outcome(adverse effects)",
"timeFrame": "10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients"
},
{
"description": null,
"measure": "days in hospital",
"timeFrame": "10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients"
},
{
"description": null,
"measure": "dose and usage of hormones(only for severe pandemic H1N1 influenza patients)",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Inflammation of lung tissue(only for severe pandemic H1N1 influenza patients)",
"timeFrame": "28 days"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012141",
"term": "Respiratory Tract Infections"
},
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D009976",
"term": "Orthomyxoviridae Infections"
},
{
"id": "D012327",
"term": "RNA Virus Infections"
},
{
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"term": "Virus Diseases"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
}
],
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"name": "Infections"
},
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"name": "All Conditions"
},
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],
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},
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}
],
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}
]
} | null | {
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"term": "Influenza, Human"
}
],
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} |
NCT06009133 | null | Surgical Approach for Acute External Thrombosed Hemorrhoidal Disease | Surgical Excision Versus Medical Treatment in Acute External Thrombosed Hemorrhoidal Disease | None | OBSERVATIONAL | COMPLETED | 2023-08-17T00:00:00 | null | 2022-12-31T00:00:00 | 2023-03-14T00:00:00 | null | 132 | 18 | 70 | ALL | false | Acute external thrombosed hemorrhoidal disease (AETHH) is one of the emergent complications of hemorrhoidal disease that results in pain and loss of work force. Although surgical excision is recommended in the treatment of AETHH in the guidelines of the American Society of Colorectal Surgeons (ASCRS) and the European Society of Coloproctology (ESCP), the level of evidence is low and it is emphasized that additional studies are needed. Therefore, the investigators aimed to compare the efficacy of surgical excision with medical treatment in the treatment of AETHH. | Hemorrhoids are normal anatomical structures and are divided into internal and external according to the dentate line. External hemorrhoids distal to the dentate line, unlike internal hemorrhoids, are covered with squamous epithelium (anoderm), have somatic innervation, and are highly sensitive to pain.
While internal hemorrhoidal disease causes symptoms such as painless bleeding, mucosal prolapse, soiling, and itching, external hemorrhoids do not cause clinical findings unless thrombosed. Acute constipation or excessive straining are held responsible for acute external thrombosed hemorrhoidal disease (AETHD). It appears as a painful, firm, purple-colored mass in the anoderm, and the main symptom is anal pain. The severity of pain increases in the first 24-48 hours after the formation of the thrombosed pack and reaches its peak. The pain is quite severe in the first 72-96 hours. Afterwards, with the resorption of the thrombosis, the severity of the pain decreases and the disease heals, leaving a skin tag behind.
AETHD can be treated with surgical excision or conservative approaches. Conservative treatment includes a warm water sitz bath, analgesics, anti-inflammatory drugs. Also, phlebotonic drugs can be added. In the ASCRS and ESCP guidelines, early surgical excision is recommended for patients with acute external thrombosed hemorrhoidal disease in the first 72-96 hours (low quality evidence 2C). Guidelines highlight the lack of controlled studies of AETHD treatment .
In this study, the investigators aimed to compare early surgical excision with conservative treatment in terms of pain control and recurrence in the treatment of AETHD. | Inclusion Criteria:
* Patients between the ages of 18-70 who present with isolated external thrombosed hemorrhoids
* Patients with the onset of the complaint before 96 hours
Exclusion Criteria:
Patients under the age of 18 and patients over the age of 70
* Mentally retarded patients
* Pregnant patients
* Patients with concomitant proctological disorders (anal fissure, anal fistula, anal abscess, etc.)
Those with a history of proctology surgery
* Patients with grade 3-4 internal hemorrhoids
* Patients using anticoagulant drugs
* Patients whose complaint has passed 96 hours after onset | Konya Meram State Hospital | OTHER | {
"id": "Konya HH Group",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-08-18T00:00:00 | {
"date": "2023-08-28",
"type": "ACTUAL"
} | {
"date": "2023-08-24",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | The population of the study consisted of patients who applied to the general surgery outpatient clinic due to acute external thrombosed hemorrhoids disease. Patients who fully met the inclusion criteria and did not meet the exclusion criteria constituted the sample group. | PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
} | [
"Hemorrhoids External Thrombosed"
] | null | null | [
{
"city": "Konya",
"country": "Turkey",
"facility": "Konya Training and Research Hospital",
"geoPoint": {
"lat": 37.87135,
"lon": 32.48464
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Pain score with visual analog scale",
"timeFrame": "12 hours"
}
],
"secondary": [
{
"description": null,
"measure": "Time to return to daily activities",
"timeFrame": "15 days"
},
{
"description": null,
"measure": "Recurrence",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Satisfaction survey",
"timeFrame": "6 months"
}
]
} | [
{
"affiliation": "Konya City Hospital",
"name": "Hasan Yaldız, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"id": "D012002",
"term": "Rectal Diseases"
},
{
"id": "D007410",
"term": "Intestinal Diseases"
},
{
"id": "D005767",
"term": "Gastrointestinal Diseases"
},
{
"id": "D004066",
"term": "Digestive System Diseases"
},
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
}
],
"browseBranches": [
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"abbrev": "BC06",
"name": "Digestive System Diseases"
},
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
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"abbrev": "All",
"name": "All Conditions"
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{
"abbrev": "Rare",
"name": "Rare Diseases"
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],
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"relevance": "LOW"
},
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"asFound": null,
"id": "M10444",
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"relevance": "LOW"
},
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"id": "M8883",
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"relevance": "LOW"
},
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"id": "M7255",
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"relevance": "LOW"
},
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"relevance": "LOW"
},
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"asFound": null,
"id": "T170",
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D006484",
"term": "Hemorrhoids"
}
]
} | {
"ancestors": null,
"browseBranches": [
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"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Infl",
"name": "Anti-Inflammatory Agents"
},
{
"abbrev": "ARhu",
"name": "Antirheumatic Agents"
},
{
"abbrev": "Gast",
"name": "Gastrointestinal Agents"
}
],
"browseLeaves": [
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"id": "M4107",
"name": "Anesthetics",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4217",
"name": "Anti-Inflammatory Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4218",
"name": "Anti-Inflammatory Agents, Non-Steroidal",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M27664",
"name": "Laxatives",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5651",
"name": "Cathartics",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D006484",
"term": "Hemorrhoids"
}
],
"interventions": []
} |
NCT03073733 | null | Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells in Adults With Retinitis Pigmentosa | A Prospective, Multicenter, Randomized, Study of the Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa (RP) | None | INTERVENTIONAL | COMPLETED | 2017-03-02T00:00:00 | null | 2020-11-13T00:00:00 | 2020-11-13T00:00:00 | [
"PHASE2"
] | 84 | 18 | null | ALL | false | This study evaluates the changes in visual function at 12 months following a single injection of human retinal progenitor cells compared to sham treated controls in a cohort of adult subjects with RP. | There is no effective treatment for RP; once photoreceptors are lost, they do not regenerate. The rate of deterioration of vision varies from person to person, with most people with RP legally blind by age 40. Preclinical studies demonstrated that transplantation of retinal progenitor cells into the eye can result in both photoreceptor replacement and significant slowing of host photoreceptor loss. Thus, the primary goal of this therapy is to preserve, and potentially improve, vision by intervening in the disease at a time when dystrophic host photoreceptors can be protected and reactivated. Based on the demonstration of acceptable safety and tolerability in a phase 1/2a study, this phase 2b study is designed as a controlled comparison of the changes in visual function and functional vision in subjects who receive a single jCell injection in comparison to a comparable sham-treated control group of subjects with RP. | Inclusion Criteria:
Clinical diagnosis of RP confirmed by ERG and willing to consent to mutation typing, if not already done Best corrected visual acuity (BCVA) 20/80 or worse and no worse than 20/800 Adequate organ function and negative infectious disease screen Female of childbearing potential must have negative pregnancy test and be willing to use medically accepted methods of contraception throughout the study
Exclusion Criteria:
Eye disease other than RP that impairs visual function Pseudo-RP, cancer-associated retinopathies History of malignancy or other end-stage organ disease, or any chronic disease requiring continuous treatment with system steroids, anticoagulants or immunosuppressive agents Known allergy to penicillin or streptomycin Treatment with corticosteroids or any investigational or neuroprotectant therapy within 90 days of enrollment Cataract surgery within 3 months prior to enrollment | jCyte, Inc | INDUSTRY | {
"id": "JC-02",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-03-02T00:00:00 | {
"date": "2024-06-18",
"type": "ACTUAL"
} | {
"date": "2017-03-08",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Subjects, their family members and clinical staff performing key efficacy assessments will be masked to the randomization assignment of subjects. Due to the nature of some safety assessments and the sham treatment, not all personnel can be masked.",
"whoMasked": [
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Retinitis Pigmentosa"
] | null | null | [
{
"city": "Irvine",
"country": "United States",
"facility": "Gavin Herbert Eye Inst, Univ Cal Irvine",
"geoPoint": {
"lat": 33.66946,
"lon": -117.82311
},
"state": "California"
},
{
"city": "Los Angeles",
"country": "United States",
"facility": "Retina-Vitreous Associates Medical Group",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California"
},
{
"city": "Boston",
"country": "United States",
"facility": "Ophthalmic Consultants of Boston",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts"
}
] | [
{
"class": "OTHER",
"name": "California Institute for Regenerative Medicine (CIRM)"
}
] | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Best Corrected Visual Acuity (BCVA)",
"timeFrame": "12 months"
}
],
"secondary": [
{
"description": null,
"measure": "Contrast Sensitivity (CS) at 1.0 CPD",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Kinetic Visual Field (KVF)",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Low Luminance Mobility Test (LLMT)",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Low Vision Functional Questionnaire (Visual Ability)",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Safety of Intravitreal Injection of Retinal Progenitor Cells (RPC)",
"timeFrame": "12 months"
}
]
} | [
{
"affiliation": "UCI",
"name": "Mitul Mehta, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "RVA",
"name": "David Liao, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "OCB",
"name": "Anthony Joseph, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D012164",
"term": "Retinal Diseases"
},
{
"id": "D005128",
"term": "Eye Diseases"
},
{
"id": "D015785",
"term": "Eye Diseases, Hereditary"
},
{
"id": "D058499",
"term": "Retinal Dystrophies"
},
{
"id": "D012162",
"term": "Retinal Degeneration"
},
{
"id": "D030342",
"term": "Genetic Diseases, Inborn"
}
],
"browseBranches": [
{
"abbrev": "BC11",
"name": "Eye Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC16",
"name": "Diseases and Abnormalities at or Before Birth"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
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"id": "M15008",
"name": "Retinitis",
"relevance": "HIGH"
},
{
"asFound": "Retinitis Pigmentosa",
"id": "M15009",
"name": "Retinitis Pigmentosa",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M14999",
"name": "Retinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8271",
"name": "Eye Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M18339",
"name": "Eye Diseases, Hereditary",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M29107",
"name": "Retinal Dystrophies",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14997",
"name": "Retinal Degeneration",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23686",
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"relevance": "LOW"
},
{
"asFound": "Retinitis Pigmentosa",
"id": "T4945",
"name": "Retinitis Pigmentosa",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D012173",
"term": "Retinitis"
},
{
"id": "D012174",
"term": "Retinitis Pigmentosa"
}
]
} | {
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"abbrev": "CNSDep",
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{
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],
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"name": "Anesthetics",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D012173",
"term": "Retinitis"
},
{
"id": "D012174",
"term": "Retinitis Pigmentosa"
}
],
"interventions": []
} |
NCT05975333 | null | Writing Intervention With Adolescents and Young Adults With Cancer | ChronCan (Chronicling Cancer): Piloting a Novel Writing Intervention With Adolescents and Young Adults With Cancer | None | INTERVENTIONAL | RECRUITING | 2023-07-27T00:00:00 | null | 2024-05-17T00:00:00 | null | [
"NA"
] | 26 | 15 | 25 | ALL | false | Young people with cancer have difficult experiences and writing exercises may help improve their well-being. However, very few studies have examined how a creative writing activity might be useful for young people with cancer. In this pilot study, researchers at St. Jude Children's Research Hospital hope to explore whether teenagers and young adults with cancer want to participate in a writing exercise and whether they find it to be valuable.
Primary Objective
To assess the feasibility and acceptability of a writing-based narrative medicine intervention for adolescent and young adult patients with cancer. | Participants will be given the opportunity to write about their experiences with cancer, with support and guidance from an expert writer. Participants will meet briefly with the expert at the start of the exercise (15-30 minutes), and they can choose to meet 1-3 additional times with the expert over the next 2 months to receive further support if they wish.
After completing the writing exercise, participants will do an informal interview to share their thoughts about whether the experience of writing felt helpful or not. The post-intervention interview will occur at around 2 months after enrollment, +/- 1 month. Patients may participate in a second informal semi-structured interview 6 to 12 months after completing the first interview. Additionally, bereaved parents may participate in an informal interview on study. | Inclusion Criteria:
* Aged 15-25
* Currently receiving cancer-directed therapy
* Active patient at St. Jude Children's Research Hospital
* Parent of a ChronCan participant who has passed away
Exclusion Criteria:
* Does not meet the inclusion criteria
* If the parents have not responded or not interviewed till December 31, 2025. | St. Jude Children's Research Hospital | OTHER | {
"id": "ChronCan",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-07-27T00:00:00 | {
"date": "2025-03-07",
"type": "ACTUAL"
} | {
"date": "2023-08-03",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
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"maskingDescription": null,
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},
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"primaryPurpose": "OTHER",
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} | [
"Cancer Patients",
"Communication Research"
] | ["Adolescents", "Young Adults", "Writing Intervention", "Interview"] | null | [
{
"city": "Memphis",
"country": "United States",
"facility": "St. Jude Children's Research Hospital",
"geoPoint": {
"lat": 35.14953,
"lon": -90.04898
},
"state": "Tennessee"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Number of touchpoints that participants have with the narrative medicine expert/guide",
"timeFrame": "During the narrative exercise, up to 2 months after enrollment"
},
{
"description": null,
"measure": "Number of participants who complete the writing exercise",
"timeFrame": "During the narrative exercise, up to 2 months after enrollment"
},
{
"description": null,
"measure": "Intervention acceptability",
"timeFrame": "Post-intervention interview will occur after the narrative exercise is completed at around 2 months after enrollment, +/- 1 month"
}
],
"secondary": null
} | [
{
"affiliation": "St. Jude Children's Research Hospital",
"name": "Trisha K. Paul, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT06965933 | null | Perioperative Use of Erector Spinae Plane Block (ESPB) and Intravenous Lidocaine Infusion in Anesthetic Management of Spinal Surgery in Children | Perioperative Use of Erector Spinae Plane Block (ESPB) and Intravenous Lidocaine Infusion in Anesthetic Management of Spinal Surgery in Children | None | INTERVENTIONAL | NOT_YET_RECRUITING | 2025-04-04T00:00:00 | null | null | null | [
"PHASE4"
] | 68 | 3 | 17 | ALL | false | Testing the hypothesis that in children undergoing spinal surgery, ESP-block will increase the time to emergency anesthesia in the postoperative period compared with intravenous lidocaine infusion. | Interventions for congenital or acquired spinal anomalies are usually voluminous and traumatic, which causes a high level of pain stimulation during the perioperative period. Thus, the problem of pain in spinal surgery is extremely important and is one of the main components of successful treatment.
Combined anesthesia using regional techniques (local anesthesia is added to general anesthesia) can be a significant alternative to performing traditional combined anesthesia with high doses of opioids (narcotic painkillers with undesirable side effects). It allows you to follow the principles of multimodal analgesia, with the possibility of rapid recovery of the patient in the postoperative period.
The use of ESPB (spinal straightening plane blockade) in vertebrology has currently been studied only in adult patients. ESPB is effective and safe for postoperative pain relief after lumbar spine surgery. ESPB can reduce the consumption of opioids (narcotic painkillers) after surgery, increase patient satisfaction, and shorten the length of hospitalization.
Currently, the use of the local anesthetic lidocaine as a medicinal agent for intravenous infusion in children, as an alternative to narcotic anesthesia, is also being actively discussed.
A large number of studies indicate the effectiveness of intravenous lidocaine infusion for perioperative anesthesia in adult patients. In pediatric practice, this technique is not widely used due to the lack of evidence base for efficacy and safety.
Intravenous infusion of lidocaine consistently improves analgesic parameters in the adult and pediatric populations in the first 24 hours, while an effective decrease in the consumption of narcotic painkillers is noted by 48 hours.
Intravenous lidocaine has demonstrated antineuropathic, antihyperalgesic and anti-inflammatory effects and is a new method. Numerous studies in adults have demonstrated the beneficial effects of intravenous lidocaine, including improved pain relief with reduced postoperative use of narcotic painkillers, earlier activation, and shorter length of stay in the intensive care unit. To date, the dose ranges studied in the pediatric population have not been associated with serious side effects, and current evidence suggests that intravenous lidocaine administration will be well tolerated. | Inclusion Criteria:
* 1. Elective surgery on the thoracic and lumbosacral spine. 2. Signed informed consent to participate in the study; 3. Age 3-17 years.
Exclusion Criteria:
1. Contraindications to the use of local anesthetics;
2. Operations on the cervical spine;
3. Contraindications to performing ESPB;
4. The patient's refusal to participate in the study. | Saint Petersburg State University, Russia | OTHER | {
"id": "SaintPetersburgSU",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2025-05-02T00:00:00 | {
"date": "2025-05-14",
"type": "ACTUAL"
} | {
"date": "2025-05-11",
"type": "ACTUAL"
} | [
"CHILD"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
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"PARTICIPANT",
"OUTCOMES_ASSESSOR"
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
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} | [
"Regional Anesthesia",
"Lidocaine Infusion"
] | ["ESPB", "Erector Spinae Plane Block", "Lidocaine", "Regional Anesthesia", "Lidocaine infusion", "Spinal Surgery"] | null | [
{
"city": "Saint Petersburg",
"country": "Russian Federation",
"facility": "SaintPetersburgSU",
"geoPoint": {
"lat": 59.93863,
"lon": 30.31413
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Time before emergency pain relief (opioid).",
"timeFrame": "24 hours postoperatively"
}
],
"secondary": [
{
"description": null,
"measure": "the need for opioids in the postoperative period within 24 hours",
"timeFrame": "24 hours"
},
{
"description": null,
"measure": "pain level assessment using pain scales (Wong-Baker Faces Pain Rating Scale)",
"timeFrame": "24 hours postoperatively"
},
{
"description": null,
"measure": "assessment of intraoperative analgesia quality (pulse)",
"timeFrame": "during surgery"
},
{
"description": null,
"measure": "assessment of intraoperative analgesia quality (BP)",
"timeFrame": "during surgery"
},
{
"description": null,
"measure": "Complications associated with intravenous lidocaine infusion (general toxic effects on the cardiovascular and central nervous systems)",
"timeFrame": "24 hours"
},
{
"description": null,
"measure": "Complications associated with spinal straightening plane block (ESPB)",
"timeFrame": "24 hours"
}
]
} | [
{
"affiliation": "Saint Petersburg State University, Russia",
"name": "Maxim Sergeevich Monastirniy",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | {
"ancestors": [
{
"id": "D000779",
"term": "Anesthetics, Local"
},
{
"id": "D000777",
"term": "Anesthetics"
},
{
"id": "D002492",
"term": "Central Nervous System Depressants"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D018689",
"term": "Sensory System Agents"
},
{
"id": "D018373",
"term": "Peripheral Nervous System Agents"
},
{
"id": "D000889",
"term": "Anti-Arrhythmia Agents"
},
{
"id": "D061567",
"term": "Voltage-Gated Sodium Channel Blockers"
},
{
"id": "D026941",
"term": "Sodium Channel Blockers"
},
{
"id": "D049990",
"term": "Membrane Transport Modulators"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
}
],
"browseBranches": [
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"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "AnArAg",
"name": "Anti-Arrhythmia Agents"
},
{
"abbrev": "ChanBlk",
"name": "Channel Blockers"
}
],
"browseLeaves": [
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"id": "M4107",
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"relevance": "LOW"
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"id": "M1700",
"name": "Ropivacaine",
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"id": "M4109",
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]
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"term": "Lidocaine"
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]
} |
NCT04839133 | null | Robotic-assisted Exercise Training in Heart Failure | Feasibility of Robotic Assisted Exercise Training in Patients With Advanced Heart Failure or Advanced Pulmonary Diseases | None | INTERVENTIONAL | COMPLETED | 2021-03-29T00:00:00 | null | 2021-07-30T00:00:00 | 2021-07-31T00:00:00 | [
"NA"
] | 30 | 18 | null | ALL | false | Background:
Regular physical activity is an evidence-based adjuvant therapy of chronic heart failure or chronic lung diseases. Structured exercise training is safe, increases exercise capacity and quality of life, relieves symptoms and reduces hospitalization rates. Even a trend towards reduction of mortality has been identified. However, dyspnea and fatigue, typical symptoms of heart or lung failure, force patients to physical inactivity which fatally aggravates deconditioning and exercise intolerance, leading to an increased risk of hospitalization and a loss of independence and quality of life. To break through this vicious circle physical activity must be restored, since exercise intolerance can be successfully improved by physical training.
Purpose:
This study will address the challenging task of remobilizing patients with advanced chronic lung or heart failure in a functional New York Heart Association class III-IV by using an externally physically-supported exosuit movement therapy. This soft, wearable robot (fig. 1) assists mobilization according to individual needs by activating neuromuscular feedback systems, promoting physical activity and preventing early physical exhaustion. The investigators hypotheses that an exosuit-supported training increases exercise capacity and quality of life in a greater degree than non-supported training.
Methods:
The study will consist of two parts investigating i) the feasibility, tolerance and safety (n= 30) and ii) the efficacy of an exosuit device-supported training (n=30). In i) patients will perform a walking test and a set of everyday life skills or participate in a standardized rehabilitation sports program. In ii) patients will be randomized in a 2:1 ratio for an exosuit-supported or non-supported exercise training protocol, training 3 units per week for 8 weeks. Assessment of outcome will be performed by various functional, mobility and endurance tests, questionnaires and clinical parameters. Furthermore, the transfer of regained motor and balance skills to everyday life will be analyzed. | null | Inclusion Criteria:
* \>17 years old
* written informed consent
* chronic end-stage systolic heart failure without ventricular assist device, LVEF ≤ 45% OR chronic advanced pulmonary diseases
* clinically stable for at least 6 weeks
* ability to mobilize into standing and walking of at least 10 meters with or without rollator
* ability to get up from a chair without rotating the upper body \>45° sagittally
Exclusion Criteria:
* addictions or other illnesses that impact the ability to understand the nature, scope and consequences of the trial
* lack of knowledge of German to fully understand study information
* pregnancy, pre-menopausal women
* contraindications of cardiopulmonary exercising
* BMI \> 35 kg/m², waist size \> 135 cm.
* Height \<150 cm, \>195 cm
* Weight\<45 kg, \>110 kg
* Functional Reach Test \<15,24 cm
* Flexion contracture in the knee/hip joint \>10°
* Chronic colonization or active infection with multi-resistant pathogens | German Heart Institute | OTHER | {
"id": "MyoSuit Feasibility Trial",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-04-06T00:00:00 | {
"date": "2021-11-24",
"type": "ACTUAL"
} | {
"date": "2021-04-09",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Heart Failure, Systolic",
"Pulmonary Disease"
] | ["Exercise training", "Robotic training", "Exosuit training"] | null | [
{
"city": "Berlin",
"country": "Germany",
"facility": "German Heart Center",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null
},
{
"city": "Berlin",
"country": "Germany",
"facility": "German Heart Institute",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null
}
] | [
{
"class": "OTHER",
"name": "ETH Zurich"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Incidence of Treatment-Emergent Falls - Safety of the MyoSuit",
"timeFrame": "1 hour"
},
{
"description": null,
"measure": "Incidence of Treatment-Emergent Adverse Events - Safety of the MyoSuit",
"timeFrame": "1 hour"
},
{
"description": null,
"measure": "Exercise can be performed when wearing a MyoSuit - Feasibility and Tolerability of walking test, activities of daily life, rehabilitation exercise group.",
"timeFrame": "1 hour"
},
{
"description": null,
"measure": "Necessity of assistance in exercising when wearing a MyoSuit - Feasibility and Tolerability",
"timeFrame": "1 hour"
},
{
"description": null,
"measure": "MyoSuit assistance leads to changes in walking distance in patients with advanced heart or pulmonary failure assessed by 6-minute walking test.",
"timeFrame": "30 minutes"
}
],
"secondary": null
} | null | [{"pmid": "35320878", "type": "DERIVED", "citation": "Just IA, Fries D, Loewe S, Falk V, Cesarovic N, Edelmann F, Feuerstein A, Haufe FL, Xiloyannis M, Riener R, Schoenrath F. Movement therapy in advanced heart failure assisted by a lightweight wearable robot: a feasibility pilot study. ESC Heart Fail. 2022 Jun;9(3):1643-1650. doi: 10.1002/ehf2.13903. Epub 2022 Mar 23."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
}
],
"browseBranches": [
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"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
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"abbrev": "All",
"name": "All Conditions"
},
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
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"id": "M9421",
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},
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"asFound": null,
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"name": "Systolic Murmurs",
"relevance": "LOW"
},
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"asFound": "Heart Failure, Systolic",
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],
"meshes": [
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},
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},
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"term": "Heart Failure, Systolic"
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]
} | null | {
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],
"interventions": null
} |
NCT05149833 | null | European Study of Opioid Induced Constipation | An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid Induced Constipation (OIC) in European Patients With Cancer Pain | E-StOIC | OBSERVATIONAL | COMPLETED | 2021-10-05T00:00:00 | null | 2024-07-31T00:00:00 | 2024-07-31T00:00:00 | null | 1,200 | 18 | null | ALL | false | Constipation is common (40-90%) in advanced cancer patients , and has a significant negative impact on quality of life. The aetiology of constipation is often multifactorial in advanced cancer patients. However, it is well recognised that opioid analgesics are a common cause of constipation in this group. The prevalence of opioid-induced constipation (OIC) is stated to be 40-70%, although a recent large study reported an even higher figure.
OIC has been reported to exceed pain in terms of distress caused, and studies have found that some patients choose to reduce or discontinue opioid medication in order to attempt to better control constipation. Moreover, OIC is associated with a variety of physical (gastrointestinal, systemic), psychological and social problems. | This European study follows on from a United Kingdom study, and aims to confirm findings of the previous study in a larger, more heterogeneous sample: it also aims to explore additional strategies to manage OIC. Moreover, the study aims to identify differences in perception of normal bowel habit / constipation, and differences in OIC management in the different European countries. Previous studies suggest that there are cultural differences in people's beliefs about constipation / normal bowel function. The aim of the project is to investigate OIC in a real world / heterogenous group of European patients with cancer. | Inclusion Criteria:
* Age 18 years or over
* Diagnosis of cancer
* Diagnosis of cancer pain or cancer treatment-related pain
* Taking regular opioids for at least one week (i.e. opioid for mild to moderate pain / "weak" opioid; or opioid for moderate to severe pain / "strong" opioid)
Exclusion Criteria:
* Unable to provide consent
* Unable to complete questionnaire | University of Dublin, Trinity College | OTHER | {
"id": "PM2021/65",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-11-24T00:00:00 | {
"date": "2025-04-03",
"type": "ACTUAL"
} | {
"date": "2021-12-08",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Participants may be inpatients, or outpatients at the study sites. Participants must meet all of the inclusion criteria for the study, and none of the exclusion criteria for the study. Participants must have a diagnosis of cancer and be on regular opioids for at least one week for cancer/ cancer treatment related pain. | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
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"maskingInfo": null,
"observationalModel": "COHORT",
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} | [
"Opioid-Induced Constipation"
] | null | null | [
{
"city": "Dublin",
"country": "Ireland",
"facility": "Norah Fagan",
"geoPoint": {
"lat": 53.33306,
"lon": -6.24889
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Prevalence of opioid induced constipation (OIC)",
"timeFrame": "5 minutes"
}
],
"secondary": [
{
"description": null,
"measure": "Impact of OIC on quality of life",
"timeFrame": "5 minutes"
},
{
"description": null,
"measure": "Efficacy of treatment for OIC",
"timeFrame": "3 minutes"
},
{
"description": null,
"measure": "Adherence with treatment for OIC No scale - yes / no options",
"timeFrame": "5 minutes"
},
{
"description": null,
"measure": "Use of non-prescribed treatments for OIC",
"timeFrame": "5 minutes"
}
]
} | [
{
"affiliation": "University of Dublin, Trinity College",
"name": "Andrew Davies, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "10474699", "type": "BACKGROUND", "citation": "Fallon MT, Hanks GW. Morphine, constipation and performance status in advanced cancer patients. Palliat Med. 1999 Mar;13(2):159-60. doi: 10.1191/026921699677653615. No abstract available."}, {"pmid": "15781174", "type": "BACKGROUND", "citation": "Goodman M, Low J, Wilkinson S. Constipation management in palliative care: a survey of practices in the United kingdom. J Pain Symptom Manage. 2005 Mar;29(3):238-44. doi: 10.1016/j.jpainsymman.2004.06.013."}, {"pmid": "19564094", "type": "BACKGROUND", "citation": "van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Quality of life and non-pain symptoms in patients with cancer. J Pain Symptom Manage. 2009 Aug;38(2):216-33. doi: 10.1016/j.jpainsymman.2008.08.014. Epub 2009 Jun 28."}, {"pmid": "11331334", "type": "BACKGROUND", "citation": "Cherny N, Ripamonti C, Pereira J, Davis C, Fallon M, McQuay H, Mercadante S, Pasternak G, Ventafridda V; Expert Working Group of the European Association of Palliative Care Network. Strategies to manage the adverse effects of oral morphine: an evidence-based report. J Clin Oncol. 2001 May 1;19(9):2542-54. doi: 10.1200/JCO.2001.19.9.2542."}, {"pmid": "32701649", "type": "BACKGROUND", "citation": "Davies A, Leach C, Butler C, Gregory A, Henshaw S, Minton O, Shorthose K, Batsari KM. Opioid-induced constipation in patients with cancer: a \"real-world,\" multicentre, observational study of diagnostic criteria and clinical features. Pain. 2021 Jan;162(1):309-318. doi: 10.1097/j.pain.0000000000002024."}, {"pmid": "12229965", "type": "BACKGROUND", "citation": "Walter S, Hallbook O, Gotthard R, Bergmark M, Sjodahl R. A population-based study on bowel habits in a Swedish community: prevalence of faecal incontinence and constipation. Scand J Gastroenterol. 2002 Aug;37(8):911-6. doi: 10.1080/003655202760230865."}, {"pmid": "24935009", "type": "BACKGROUND", "citation": "Lee TH, Choi SC, Park MI, Park KS, Shin JE, Kim SE, Jung KW, Koo HS, Kim WJ, Cho YK, Kim YS, Lee JS. Constipation misperception is associated with gender, marital status, treatment utilization and constipation symptoms experienced. J Neurogastroenterol Motil. 2014 Jul 31;20(3):379-87. doi: 10.5056/jnm14011."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"id": "D012817",
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},
{
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},
{
"id": "D019966",
"term": "Substance-Related Disorders"
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{
"id": "D064419",
"term": "Chemically-Induced Disorders"
},
{
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],
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{
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],
"browseLeaves": [
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},
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},
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NCT01682733 | null | Endoscopic Gastric Reduction for Weight Management | Endoscopic Gastric Reduction for Weight Management: A Pilot Feasibility Study | None | INTERVENTIONAL | COMPLETED | 2012-08-27T00:00:00 | null | null | null | [
"PHASE1"
] | 10 | 18 | 50 | ALL | false | The proposed study is a prospective, pilot study to assess the feasibility of a novel endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for the primary treatment of obesity. The investigators aim to recruit ten subjects with a body mass index between 30-40 for this study. Vertical sutures will be performed using the endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum toxin(approximately 30 units) will be injected around the sutures insertion sites in half of the subjects randomly to slow down muscular grinding of the stomach to see if it improves durability of the procedure. | null | Inclusion Criteria:
* Body Mass Index (BMI) between 30 and 40
* Age \>18 and ≤50
* Stable weight for 3 months (within 5% of BMI)
* Normal basic labs (CBC, chemistry profile, creatinine)
* Negative pregnancy test for females \>18 or ≤ 50
Exclusion Criteria:
* Diabetes
* Unstable coronary artery disease
* Heart failure
* Cardiac arrhythmia
* Cardiac valvular disease
* Obstructive of interstitial lung disease
* Females of child-bearing age \>18 or ≤ 50 who are pregnant or lactating
* Mallampati score of 4
* ASA 3 or above
* Previous gastric surgery
* Ulcer disease
* Gastroparesis,
* \> 5 cm Hiatal hernia
* Congenital anomalies of the GI tract
* Currently on or prescribed a medication known to affect weight within 3 months of study entry. | Mayo Clinic | OTHER | {
"id": "12-003195",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-09-07T00:00:00 | {
"date": "2015-04-07",
"type": "ESTIMATED"
} | {
"date": "2012-09-11",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
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"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Obesity"
] | ["Obesity", "Weight loss", "Gastric reduction (volume)", "BMI 30-40"] | null | [
{
"city": "Rochester",
"country": "United States",
"facility": "Mayo Foundation",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
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"state": "Minnesota"
}
] | null | null | {
"other": null,
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"description": null,
"measure": "Change from baseline Bariatric Quality of Life (BQL) Questionaire",
"timeFrame": "baseline to 3 months"
}
],
"secondary": [
{
"description": null,
"measure": "Change from baseline Three factor Eating Questionnaire (TFEQ-R21)",
"timeFrame": "baseline to 3 months"
}
]
} | [
{
"affiliation": "Mayo Clinic",
"name": "Barham K AbuDayyeh, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "26748219", "type": "DERIVED", "citation": "Abu Dayyeh BK, Acosta A, Camilleri M, Mundi MS, Rajan E, Topazian MD, Gostout CJ. Endoscopic Sleeve Gastroplasty Alters Gastric Physiology and Induces Loss of Body Weight in Obese Individuals. Clin Gastroenterol Hepatol. 2017 Jan;15(1):37-43.e1. doi: 10.1016/j.cgh.2015.12.030. Epub 2015 Dec 31."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D050177",
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"term": "Overnutrition"
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"term": "Nutrition Disorders"
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"term": "Body Weight"
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"abbrev": "BC18",
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"term": "Acetylcholine Release Inhibitors"
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"term": "Membrane Transport Modulators"
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"term": "Molecular Mechanisms of Pharmacological Action"
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"id": "D018678",
"term": "Cholinergic Agents"
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"term": "Neurotransmitter Agents"
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"relevance": "LOW"
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"id": "M20504",
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"relevance": "LOW"
}
],
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{
"id": "D001905",
"term": "Botulinum Toxins"
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],
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"id": "D001905",
"term": "Botulinum Toxins"
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]
} |
NCT04865133 | null | Efficacy and Safety of COVID-19 Vaccine in Cancer Patients | Efficacy and Safety of COVID-19 Vaccine in Cancer Patients | None | OBSERVATIONAL | COMPLETED | 2021-04-22T00:00:00 | null | 2022-09-08T00:00:00 | 2022-09-08T00:00:00 | null | 89 | 18 | null | ALL | true | This study gathers information about how a cancer patient responds to COVID-19 vaccine during cancer treatment compared to healthy individuals. The information gained may help determine how effective currently available COVID-19 vaccines are in cancer patients receiving chemotherapy and learn more regarding how long an immune response will last compared to healthy individuals. | PRIMARY OBJECTIVES:
I. To determine the antibody response to COVID-19 vaccine after vaccination. II. To assess the adverse events of COVID-19 vaccines in cancer patients. III. To determine the incidence and severity of COVID-19 infection after the vaccination.
OUTLINE:
Patients undergo blood sample collection at baseline (prior to first COVID-19 vaccination), prior to second vaccination, 1, 6, and 12 months after the last vaccination. Patients receiving a booster vaccine will undergo blood collection prior to and 1-3 months after vaccination. Patients who receive the types of COVID-19 vaccines that do not require the second injection skip blood sample collection at this time point. This study will collect information regarding the type of COVID-19 vaccine received, date of vaccine injection, and any side effects associated with the COVID-19 vaccine that trial participant encountered. This study will also review the medical record for outcomes and information related to the blood testing. | Inclusion Criteria:
* Willing to receive COVID-19 vaccination as per standard of care or has already received one or both COVID-19 vaccine injections as long as it has not been longer than three months since their second injection (or the only injection if they receive the types of COVID019 vaccines that do not require the second injection)
* Willing and able to provide research blood samples
* Capable of providing valid informed consent
* For cancer patient cohort:
* Male or female age \>= 18 years
* Histologically confirmed solid malignancy on or will be starting on systemic cytotoxic chemotherapy
* For healthy individual cohort:
* Male or female age \>= 18 years
* No history of active malignancy =\< 3 years
* EXCEPTIONS: Adequately treated non-melanotic skin cancer (adequate wound healing is required prior to study entry) or carcinoma-in-situ of the cervix
* NOTE: If there is a history of prior solid tumor malignancy, it must have been treated curatively with no evidence of recurrence =\< 3 years
* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Willing and able to provide research blood samples
* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Capable of providing valid informed consent
* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Male or female age \>= 18 years
* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Previous history of COVID-19 infection with positive SARS-CoV-2 ribonucleic acid (RNA) by polymerase chain reaction (PCR) or anti-SARS-CoV-2 nucleocapsid antibody
Exclusion Criteria:
* Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on immunosuppressive therapy other than chemotherapy in the judgment of the investigator | Mayo Clinic | OTHER | {
"id": "21-001818",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-04-27T00:00:00 | {
"date": "2024-12-10",
"type": "ACTUAL"
} | {
"date": "2021-04-29",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients diagnosed with cancer on or will be starting on systemic cytotoxic chemotherapy for their cancer and healthy individuals who will receive COVID-19 vaccine | NON_PROBABILITY_SAMPLE | false | {
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"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "OTHER"
} | [
"COVID-19 Infection",
"Malignant Solid Neoplasm"
] | null | null | [
{
"city": "Jacksonville",
"country": "United States",
"facility": "Mayo Clinic in Florida",
"geoPoint": {
"lat": 30.33218,
"lon": -81.65565
},
"state": "Florida"
}
] | null | null | {
"other": [
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"description": null,
"measure": "Incidence and severity of COVID-19 infection after the vaccination in cancer patients and health individuals",
"timeFrame": "Up to 12 months"
}
],
"primary": [
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"description": null,
"measure": "Antibody response to COVID-19 vaccine after vaccination in cancer patients and health individuals",
"timeFrame": "Up to 12 months"
}
],
"secondary": [
{
"description": null,
"measure": "Adverse events of COVID-19 vaccines in cancer patients and health individuals",
"timeFrame": "Up to 12 months"
},
{
"description": null,
"measure": "T cell response to COVID-19 vaccine after vaccination in cancer patients and health individuals",
"timeFrame": "Up to 12 months"
}
]
} | [
{
"affiliation": "Mayo Clinic",
"name": "Saranya Chumsri, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D011024",
"term": "Pneumonia, Viral"
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"id": "D011014",
"term": "Pneumonia"
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"id": "D012141",
"term": "Respiratory Tract Infections"
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"id": "D007239",
"term": "Infections"
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"id": "D014777",
"term": "Virus Diseases"
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"id": "D018352",
"term": "Coronavirus Infections"
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"id": "D003333",
"term": "Coronaviridae Infections"
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"term": "Nidovirales Infections"
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"term": "RNA Virus Infections"
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"term": "Lung Diseases"
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"term": "Respiratory Tract Diseases"
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],
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"abbrev": "BC01",
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"name": "All Conditions"
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NCT02925533 | null | Ph 1B B-701 in Combination With Pembrolizumab in Metastatic Transitional Cell Carcinoma of the Urothelial Tract | A Phase 1B Study of B-701 in Combination With Pembrolizumab in Relapsed or Refractory Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract | None | INTERVENTIONAL | TERMINATED | 2016-10-04T00:00:00 | null | null | null | [
"PHASE1"
] | 1 | 18 | 18 | ALL | false | This research study is studying a combination of two experimental drugs as a possible treatment for Bladder Cancer that recurred after treatment with standard therapy, or Bladder Cancer that got worse while on treatment with standard therapy.
The following interventions will be involved in this study:
* B-701
* Pembrolizumab | This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved B-701 as a treatment for any disease.
The FDA has not approved Pembrolizumab for Bladder Cancer but it has been approved for other uses.
This is the first time that B-701 in combination with Pembrolizumab will be given to humans.
In this research study, Investigators are...
* Testing the effectiveness and safety of the combination of two experimental drugs (B-701 and Pembrolizumab);
* Learning about the good and/or bad effects the drugs have on participants and their cancer;
* Administering B-701 and Pembrolizumab, which are antibodies (proteins that bind to other molecules), because...
* B-701 binds to a protein receptor called FGFR3 (fibroblast growth factor receptor 3). FGFR3 has been found to be present (expressed) or changed (mutated) on the surface of in many types of cancer cells. Targeting FGFR3 may inhibit cancer growth.
* Pembrolizumab binds to a protein cell surface receptor called PD-1, which is found on certain types of lymphocytes and which are also involved in many types of cancer;
* Treating participants with Pembrolizumab, which is approved by the FDA for the treatment of Metastatic Melanoma, a Cancer of the skin;
* Collecting blood and tissue samples and other related medical information to learn more about the development of cancer and predictors of response;
* And hoping to learn how the combination of study drugs work in the treatment of cancer to help develop new treatments. | Inclusion Criteria:
* Participants must have Stage IV, locally advanced or metastatic (T4b, any N; or any T, N2-3) urothelial bladder cancer or transitional cell carcinoma (TCC) arising in another location of the urinary tract, including urethra, ureter, and renal pelvis. The diagnosis must be histologically or cytologically confirmed. Mixed histologies are permitted as long as TCC is the major component (i.e. \> 50% of the pathologic specimen). Pure or predominant squamous cell carcinomas or adenocarcinomas are not permitted.
* Relapsed after or refractory to one or two prior lines of chemotherapy for advanced or metastatic/recurrent disease (at least one cycle each) which have not included a PD-L1 or FGFR inhibitor. At least one regimen should have included a platinum agent unless contraindicated for the subject. Prior neoadjuvant or adjuvant chemotherapy (without a PD-L1 or FGFR inhibitor) is permitted and will not be counted as first-line chemotherapy, as long as the subject has not progressed within 12 months of the last dose. However, a regimen of neoadjuvant or adjuvant chemotherapy will be counted as first-line chemotherapy if the patient progressed within 12 months of the last dose.
* Age ≥ 18 years
* Eastern cooperative oncology group (ECOG) performance status ≤ 1 (Karnofsky ≥ 60%)
* Participants must have normal organ and marrow function as defined below:
* leukocytes ≥ 3000/mcL
* absolute neutrophil count ≥ 1500/mcL
* platelets ≥ 75,000/mcL
* hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
* total bilirubin within normal institutional limits
* EXCEPTION: Subjects with known Gilbert's disease: total bilirubin ≤ 3 × institutional upper limit of normal (ULN)
* aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT)/Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 × institutional ULN
* EXCEPTION: Subjects with documented liver metastases: AST and/or ALT ≤ 5 × institutional ULN
* creatinine within normal institutional limits OR
* creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (derived by the Cockcroft-Gault formula \[Cockcroft 1976\])
* albumin ≥ 2.5 mg/dL
* prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 × institutional ULN
* Note: Screening labs should be performed within 10 days of treatment initiation.
* Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (such conditions should be discussed with the subject before study entry)
* The effects of B-701 on the developing human fetus are unknown. For this reason and because PD-1 inhibitors such as pembrolizumab may potentially cause fetal harm, women of child-bearing potential (defined as those who have not been surgically sterilized or have not been free from menses for \> 1 year) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration.
* Female of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medications. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Female of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study and through 4 months after the last dose of study medication.
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Participants who have had chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
* Participants who are receiving, or have received, any other investigational drugs or devices within the 2 weeks prior to the first dose of study medications.
* Participants who received major surgery must be recovered adequately from the toxicity and/or complications from the interventions prior to starting therapy.
* Participants with a diagnosis of immunodeficiency or who are receiving systemic steroid therapy (\>5 mg prednisone or its equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
* Participants who have a primary central nervous system (CNS) malignancy, or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Individuals with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:
* Evaluable or measurable disease outside the CNS
* Radiographic demonstration of stability upon the completion of CNS directed therapy and no evidence of interim progression (for at least 4 weeks prior to the first dose of study drug) between the completion of CNS-directed therapy and the screening radiographic procedure
* The screening CNS radiographic procedure is ≥ 8 weeks since completion of radiotherapy and ≥ 4 weeks since the discontinuation of corticosteroids and anticonvulsants Note: These exceptions do not include carcinomatous meningitis which is excluded regardless of clinical stability.
* Participants with a history of allergic reactions attributed to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
* Participants with active autoimmune disease that has required systemic treatment (\>5 mg of prednisone or its equivalent) in the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Participants with known evidence of active, non-infectious pneumonitis.
* Participants with an active infection requiring systemic therapy.
* Participants who have received a live vaccine within 30 days of planned start of study therapy.
Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
* Participants who have had a prior anti-cancer monoclonal antibody (mAb) within 2 weeks prior to Cycle 1 Day 1 or who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 2 weeks earlier.
* Participants unwilling or unable to discontinue use of prohibited therapies, including any cytotoxic chemotherapy, radiotherapy, immunotherapy or biologic agent (approved or investigational) for the treatment of TCC are ineligible.
* Participants with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Participants who have undergone a major surgical procedure or trauma within 4 weeks prior to Cycle 1, Day 1. All wounds must be fully healed on Cycle 1, Day 1
* Participants with a history of other malignancy which could affect compliance with the protocol or interpretation of results. Individuals with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are allowed. Participants with a malignancy that has been treated with curative intent will also be allowed if the malignancy has been in remission without treatment for ≥ 2 years prior to Cycle 1, Day 1.
* Pregnant women are excluded from this study because the risks with B-701 are unknown and pembrolizumab is a PD-1 inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with B-701 and pembrolizumab, breastfeeding should be discontinued. Women of child-bearing potential must agree to use adequate birth control throughout the study duration.
* Hepatitis B, hepatitis C, and HIV serology-positive (or known history of HIV seropositive status) participants are ineligible because these underlying diseases will confound interpretation of important safety assessments, e.g. liver function tests, increased potential for reactivation or exacerbation of viral infections. Such individuals may be taking or require other drugs, and may be at higher risk of opportunistic infections and adverse effects. Hepatitis B, hepatitis C, and HIV serology-positive individuals were excluded from the pivotal pembrolizumab clinical trial in melanoma, so safety of this drug in this setting is unknown.
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at screening or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1
* Has a known history of active TB (Bacillus Tuberculosis)
* Participants who weigh \> 110 kg will be ineligible due to study drug limitations | Dana-Farber Cancer Institute | OTHER | {
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"date": "2016-10-06",
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"Bladder Cancer"
] | ["Bladder Cancer", "Urothelial Cancer"] | null | [
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"name": "Merck Sharp & Dohme LLC"
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{
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"name": "Rainier Therapeutics"
}
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"measure": "Preliminarily Evaluate The Safety Of B-701 In Combination With Pembrolizumab For The Treatment Of TCC",
"timeFrame": "2 years"
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"description": null,
"measure": "To Assess The Efficacy Of B-701 In Combination With Pembrolizumab For The Treatment Of TCC",
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"affiliation": "Dana-Farber Cancer Institute",
"name": "Mark Pomerantz, MD",
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NCT04133233 | null | Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder | Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder | DEPIL-2 | INTERVENTIONAL | COMPLETED | 2019-09-17T00:00:00 | null | 2022-05-20T00:00:00 | 2022-07-20T00:00:00 | [
"PHASE2"
] | 15 | 18 | 65 | ALL | false | The purpose of this study will be to demonstrate improvement of the T regulatory cells (Treg) response, under add on low-dose Interleukin 2 (ld-IL2) in patients with bipolar disorders experiencing a depressive relapse | A hypothesis still under study concerning the pathophysiological mechanisms of bipolar disorder concerns an immunological disorder that could possibly be involved in this disease and during a depressive episode. In particular, that the multiplication of a certain category of white blood cells called "regulators" that block the toxic effect of more aggressive white blood cells could improve these disorders.
The aim of this research is therefore to check the effectiveness and safety of injections of Interleukin 2 (IL-2) to induce this multiplication of regulatory white blood cells.
IL-2 is a natural protein released by white blood cells that is used for the proper functioning of the immune defence system. The favourable effects of injecting small doses of IL-2 are known and assessed in other diseases, including autoimmune diseases.
The secondary objective of this study is to assess the effect of these injections on patient's mood, which could be improved by this treatment. | Inclusion Criteria:
* A depressive episode according to DSM-V criteria in the course of a bipolar disorder
* MADRS score \> 17
* Already on a mood stabilizer and/or antidepressant
* Patient with a normal or controlled thyroid function
* Male or female both using effective methods of contraception during treatment if sexually active.
Exclusion Criteria:
* - Contraindication to IL-101 therapy:
* Hypersensitivity to active substance or excipient;
* Active infection requiring antibiotics therapy;
* Organ failure (e.g., liver, kidney, lung and heart);
* Immunosuppressed patient
* Hepatotoxic, nephrotoxic, myelotoxic or cardiotoxic drugs
* Other chronic diseases
* Signs of active infection requiring treatment
* Previous history of organ transplantation
* Leukocytes \< 4000 / mm3, platelets \< 100 000 / mm3, Hemoglobin \< 10.0 g/dL or 6.2 mmol/L, red cell blood \< 3.5 T/L.
* Anti-TPO or anti-TG or anti-TRACKS positive at inclusion.
* Use of anti-inflammatory medication on a regular basis for a chronic inflammatory/autoimmune Disorder (NSAD, immunosuppressant IV-Ig based treatment);
* Ongoing fever \< 38
* uncontrolled diabetes type I or II;
* Existing cancer or history of cancer in the last 5 years (except skin epidermoid cancer or in-situ cervix cancer);
* Existing or planned pregnancy or lactation;
* Person under legal protection (1121-8 of CSP, Public Health Code
* Pregnant and parturient and Breast feeding women (1121-5 of CSP)
* legally detained person (1121-6 of CSP)
* hospitalisation without consent
* under the age of majority (1121-7of CSP)
* Immediate risk for suicidal behaviour (MADRS-item 10 \>2 or columbia \> 2 for suicide idea);
* Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS), Parkinson's or Alzheimer's disease, or any other serious condition likely to interfere with the conduct of the trial;
* Participation to an interventional study concomitantly or within 30 days prior to this study, except in the cohorts studies aiming at the analysis of immuno-inflammatory biomarkers and/or brain imaging studies.
* Patients thought to be unreliable or incapable of complying with the requirements of the protocol;
* Patient is relative of, or staff directly reporting to the investigator;
* Patient is employee of the sponsor. | Assistance Publique - Hôpitaux de Paris | OTHER | {
"id": "D20180617",
"link": null,
"type": null
} | Unknown | {
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"nctId": null,
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} | 2019-10-18T00:00:00 | {
"date": "2023-08-08",
"type": "ACTUAL"
} | {
"date": "2019-10-21",
"type": "ACTUAL"
} | [
"ADULT",
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"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized, double-blind, placebo-controlled (2 active: 1 placebo), multicentre, 6-week, proof-of concept trial of add on low dose IL-2 therapy in patients with a depressive episode in the course of a bipolar disorder, hospitalized or not. The study will be an add-on study, with no wash-out period.",
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"Bipolar Depression"
] | ["Low dose of IL-2", "Treg response"] | null | [
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"facility": "Pr Marion Leboyer",
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"class": "INDUSTRY",
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"measure": "change of Treg response",
"timeFrame": "baseline to Day 5"
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"measure": "Treg response, under ld-IL2 in relation with symptomatic assessment of mood improvements",
"timeFrame": "from baseline to week 6"
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"description": null,
"measure": "changes in immune homeostasis under ld-IL2 in relation with symptomatic assessment of mood improvements",
"timeFrame": "between Day 5 and Day 60"
},
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"description": null,
"measure": "Assess the incidence of ld-IL2(safety and tolerability) in patients with a depressive episode in the course of a bipolar disorder",
"timeFrame": "baseline to Day 60"
}
]
} | [
{
"affiliation": "Assistance Publique - Hôpitaux de Paris",
"name": "Marion Leboyer, Pr",
"role": "STUDY_CHAIR"
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NCT05723133 | null | Visual Feedback on Brushing Technique and Habits on Patient Oral Hygiene | A Randomized Controlled Trial Comparing Manual Versus Powered Toothbrushes With Visual Feedback | None | INTERVENTIONAL | RECRUITING | 2023-01-30T00:00:00 | null | 2024-07-30T00:00:00 | 2024-07-30T00:00:00 | [
"NA"
] | 150 | 21 | null | ALL | false | The goal of this clinical trial is to learn about the influence of providing visual feedback on brushing technique and habits on oral health of patients undergoing periodontal treatment.
The main question\[s\] it aims to answer are:
* Is patients' oral health improved by providing visual feedback on their brushing technique using the smartphone brushing app?
* Is there behavioural change of patients based on this daily visual feedback? Participants will receive oral hygiene instructions after initial periodontal treatment and will be randomized in group 1, 2 or 3. Participants will be asked to
* fulfill a brushing diary with the time of brushing every day.
* come back for a check-up appointment every 3 weeks during the study to evaluate oral hygiene.
Researchers will compare manual toothbrush, electric toothbrush without daily personal feedback and electric toothbrush with daily personal feedback to see if visual feedback provide improved oral health | Periodontitis is gum disease with jawbone deterioration. Diagnosis is based on clinical examination: plaque score, pocket measurement (measuring the pockets or gum pockets around the teeth with a probe), gingival bleeding index (= bleeding after probing) and radiographic examination. Smoking, genetic factors, and systemic diseases such as diabetes, for example, are known risk factors for this condition. Treatment consists of a deep cleaning, where the tooth roots are freed of plaque and tartar under local anaesthesia, complemented by the necessary oral hygiene instructions. It is important that patients follow these oral hygiene instructions carefully at home and perform them daily, as the aim is to achieve optimal oral hygiene. Good oral hygiene is fundamental in the treatment of periodontitis (Arweiler et al, 2018).
Despite many patients undergoing the proposed professional treatment (deep cleaning), they are often insufficiently able to remove the dental plaque present on a daily basis. To optimise brushing efficiency, both behavioural change and improved brushing technique should be obtained at the patient level.
The primary aim of this randomised clinical trial is to improve patients' oral health by providing visual feedback on their brushing technique using the smartphone brushing app. The secondary aim of the study is to investigate possible behavioural changes of patients based on this daily visual feedback.
Patients requiring periodontal treatment will be recruited at the Department of Periodontology \& Oral Implantology at Ghent University Hospital. Patients will be assigned to three groups by randomisation. In group 1, patients will receive oral hygiene instructions and a new manual toothbrush. In group 2, patients receive the same oral hygiene instructions and a basic electric toothbrush without daily personal feedback using the brushing application. In group 3, patients receive the same oral hygiene instructions and an electric toothbrush with daily personal feedback using the brushing app (Oral-B app). No raw study data will be transferred to Oral B. The only data that will be available to Oral-B is the data that will be included in the publication of this study (A1 article). The use of the app does not require registration of personal data. Brushing time, tooth surface cleaning and brushing pressure will be recorded. Patients will only complete the brushing time in the brushing diary.
Oral hygiene will be evaluated at the start and every 3 weeks during the study through a check-up appointment. Only the first (after 3 weeks) and the last check-up appointment (after 12 weeks) are standard protocol, the remaining appointments (after 6 and 9 weeks) are study-specific. Oral hygiene will be assessed by: plaque score, gingival bleeding index, brushing frequency and brushing duration. The full study will take 12 weeks. Pocket depth will be measured according to usual protocols, namely at intake and at the last check-up (after 12 weeks). The patient's brushing technique and frequency will be recorded through a brushing diary completed by the patient. Where necessary, oral hygiene can be adjusted during each sitting. The check-up after 3 weeks and 12 weeks with measurement of plaque scores, gingival bleeding index and pocket depth are part of the standard protocol for treating periodontitis and are therefore not study-specific. Monitoring after 6 and 9 weeks are study-specific. The primary goal will be evaluated by comparing plaque scores and gingival bleeding index at intake with those at the final check. The secondary goal will be evaluated by brushing frequency and brushing duration throughout the study course. All data collected will be pseudonymised.
Overview:
* Consultation 1 - at start:
o Standard treatment: Evaluation of oral hygiene Determination of clinical score: plaque score, gingival bleeding index Determination of pocket depth
o Study-specific treatment (duration: 10 minutes): Clinical photographs
* Consultation 2 - after 3 weeks:
o Standard treatment: Evaluation of oral hygiene and brushing frequency. Determination of clinical score: plaque score, gingival bleeding index
o Study-specific treatment (duration: 10 minutes): Clinical photographs
* Consultation 3 - after 6 weeks:
o Study-specific treatment (duration: 30 minutes ): Evaluation of oral hygiene + clinical photographs Determination of clinical score: plaque score, gingival bleeding index
* Consultation 4 - after 9 weeks:
o Study-specific treatment (duration: 30 minutes ): Evaluation of oral hygiene + clinical photographs Determination of clinical score: plaque score, gingival bleeding index
* Consultation 5 - after 12 weeks:
o Standard treatment: Evaluation of oral hygiene and brushing frequency. Determination of clinical score: plaque score, gingival bleeding index Determination of pocket depth
o Study-specific treatment (duration: 10 minutes): Clinical photographs
* Completion of the brushing diary by the patient:
* Brushing time, cleaning of tooth surfaces, brushing pressure, brushing technique, frequency and motivation
* 2x a day, 2 min per brushing | Inclusion Criteria:
* Patients in need of periodontal treatment
* Willing to keep a brushing diary
* Possess a smartphone so that they are able to install and handle the application on their phone
Exclusion Criteria:
* Smoking
* Systemic disease
* Pregnancy | University Ghent | OTHER | {
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"date": "2024-01-09",
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"date": "2023-02-10",
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"ADULT",
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"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized clinical trial with 3 treatment arms (control group: manual toothbrush; test group 1: electric toothbrush without digital visual feedback; test group 2: electric toothbrush with visual feedback). Every patient received the same initial treatment and oral hygiene instructions. Sealed envelops will determine in which group the patient will participate.",
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} | [
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"Oral Hygiene",
"Dental Plaque"
] | ["Dental plaque", "Toothbrush", "Oscillating-rotating", "Manual", "Electric", "Dental Plaque Index", "Electrical Equipment and Supplies"] | null | [
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"country": "Belgium",
"facility": "BV Paro Glibert",
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"lon": 3.88223
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"timeFrame": "12 weeks"
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"timeFrame": "12 weeks"
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"timeFrame": "12 weeks"
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} | [
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"affiliation": "University Ghent",
"name": "Véronique Christiaens, Prof. Dr.",
"role": "PRINCIPAL_INVESTIGATOR"
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] | [{"pmid": "32243576", "type": "RESULT", "citation": "Adam R, Ram Goyal C, Qaqish J, Grender J. Evaluation of an oscillating-rotating toothbrush with micro-vibrations versus a sonic toothbrush for the reduction of plaque and gingivitis: results from a randomized controlled trial. Int Dent J. 2020 Apr;70 Suppl 1(Suppl 1):S16-S21. doi: 10.1111/idj.12569."}, {"pmid": "23448083", "type": "RESULT", "citation": "Nathoo S, Mankodi S, Mateo LR, Chaknis P, Panagakos F. A clinical study comparing the supragingival plaque and gingivitis efficacy of a specially engineered sonic powered toothbrush with unique sensing and control technologies to a commercially available manual flat-trim toothbrush. J Clin Dent. 2012;23 Spec No A:A11-6."}, {"pmid": "32243573", "type": "RESULT", "citation": "Grender J, Ram Goyal C, Qaqish J, Adam R. An 8-week randomized controlled trial comparing the effect of a novel oscillating-rotating toothbrush versus a manual toothbrush on plaque and gingivitis. Int Dent J. 2020 Apr;70 Suppl 1(Suppl 1):S7-S15. doi: 10.1111/idj.12571."}] | {"versionHolder": "2025-06-18"} | {
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},
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}
],
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]
} | null | {
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],
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} |
NCT00408954 | null | Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms | A Multi Center Randomized Cross Over Double Blind Third Party Open Placebo Controlled Pilot Study to Assess the Urodynamic Effects of Modified Release UK-369,003 in Men With Lower Urinary Tract Symptoms. | None | INTERVENTIONAL | COMPLETED | 2006-12-06T00:00:00 | null | null | null | [
"PHASE2"
] | 27 | 40 | null | MALE | false | This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms. | null | Inclusion Criteria:
* Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13.
* Clinical diagnosis of BPH
* Qmax 5 to 15 ml/sec with a voided volume of ≥150 ml
* Urodynamically defined bladder outlet obstruction
Exclusion Criteria:
* prostate cancer
* Post-void residual urine volume \>200 ml
* Documented UTI
* History of relevant urological surgery | Pfizer | INDUSTRY | {
"id": "A3711045",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2006-12-07T00:00:00 | {
"date": "2010-11-23",
"type": "ESTIMATED"
} | {
"date": "2006-12-08",
"type": "ESTIMATED"
} | [
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"OLDER_ADULT"
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Prostatic Hyperplasia"
] | null | null | [
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"city": "Brno",
"country": "Czech Republic",
"facility": "Pfizer Investigational Site",
"geoPoint": {
"lat": 49.19522,
"lon": 16.60796
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},
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"country": "Slovakia",
"facility": "Pfizer Investigational Site",
"geoPoint": {
"lat": 48.89452,
"lon": 18.04436
},
"state": null
}
] | null | null | {
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"description": null,
"measure": "There is no specific primary endpoint for this study as it is not powered for that. It is mainly to generate hypotheses on the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.",
"timeFrame": "Duration of study"
}
],
"secondary": [
{
"description": null,
"measure": "Maximum flow rate (Qmax)",
"timeFrame": "Duration of study"
},
{
"description": null,
"measure": "Cystometric capacity",
"timeFrame": "Duration of study"
},
{
"description": null,
"measure": "Post void residual volume (PVR)",
"timeFrame": "Duration of study"
},
{
"description": null,
"measure": "Average flow rate (Qave)",
"timeFrame": "Duration of study"
},
{
"description": null,
"measure": "Volume at first unstable contraction",
"timeFrame": "Duration of study"
},
{
"description": null,
"measure": "Average detrusor pressure during micturition",
"timeFrame": "Duration of study"
},
{
"description": null,
"measure": "Detrusor pressure at maximum flow rate (PdetQmax)",
"timeFrame": "Duration of study"
},
{
"description": null,
"measure": "Bladder outlet obstruction index (BOOI)",
"timeFrame": "Duration of study"
},
{
"description": null,
"measure": "Bladder contractility index (BCI)",
"timeFrame": "Duration of study"
},
{
"description": null,
"measure": "Bladder voiding efficiency (BE)",
"timeFrame": "Duration of study"
},
{
"description": null,
"measure": "Frequency of unstable contractions",
"timeFrame": "Duration of study"
},
{
"description": null,
"measure": "International Prostate Symptom Score (IPSS)",
"timeFrame": "Duration of study"
},
{
"description": null,
"measure": "Mean amplitude of unstable contractions",
"timeFrame": "Duration of study"
},
{
"description": null,
"measure": "Patient Reported Treatment Impact (PRTI)",
"timeFrame": "Duration of study"
}
]
} | [
{
"affiliation": "Pfizer",
"name": "Pfizer CT.gov Call Center",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"id": "D010335",
"term": "Pathologic Processes"
},
{
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"term": "Genital Diseases, Male"
},
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},
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"term": "Urogenital Diseases"
},
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"term": "Male Urogenital Diseases"
},
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"term": "Urological Manifestations"
}
],
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"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
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"name": "All Conditions"
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"name": "Rare Diseases"
}
],
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},
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"id": "M10016",
"name": "Hyperplasia",
"relevance": "HIGH"
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},
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"term": "Lower Urinary Tract Symptoms"
}
]
} | null | {
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"term": "Prostatic Hyperplasia"
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],
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NCT05049954 | null | Weight Loss for a Healthier You Programme | The Effect of a Healthy Ketogenic Diet Versus Calorie-restricted Low Fat Diet on Weight Loss and Metabolic Outcomes for Obesity: A Randomised Controlled Trial | None | INTERVENTIONAL | UNKNOWN | 2021-09-09T00:00:00 | null | 2022-12-31T00:00:00 | 2023-06-01T00:00:00 | [
"NA"
] | 70 | 21 | 65 | ALL | true | In view of the research gap in the safety of traditional ketogenic diet, there is a need for a healthy alternative to the ketogenic diet that reduces the individual's propensity to adverse diet choices. Healthy guidelines to be adopted include a diet low in saturated fat, trans fat, and sugar, along with adequate fibre. Potentially with these guidelines in effect, the associated risks for CVD would be reduced. Therefore, this study will investigate the effect of a calorie-restricted healthy ketogenic diet versus a calorie-restricted low fat diet on weight loss and metabolic outcomes among individuals with obesity. | The ketogenic diet has recently gained popularity as an effective dietary plan for weight management. Some of the cited benefits include a reduction in appetite and hunger, as well as improvements in fat oxidation leading to weight loss. Remarkably, some studies have also demonstrated increases in high-density lipoprotein (HDL) cholesterol and decreases in triglyceride levels, which point to a reduction in cardiovascular disease (CVD) risk.
In spite of these, there are still widespread concerns regarding the potentially high proportion of total and saturated fats derived from ketogenic diets owing to the high-fat and moderate-protein nature. These are associated with elevated low-density lipoprotein (LDL) cholesterol levels which may offset the purportedly lower CVD risk, especially in obese individuals. Furthermore, few randomised controlled trials (RCTs) have placed emphasis on the reduction of saturated fat, leading to confounding effects on the safety of the traditional ketogenic diet. To address the research gap, our study aims to assess the effect of a calorie-restricted healthy ketogenic diet, as compared to a calorie-restricted low fat diet on weight loss and metabolic outcomes among Asian individuals with obesity.
In this randomized controlled trial, participants will be randomly assigned to either the healthy ketogenic diet (HKD) or low fat calorie-restricted diet (LFD) using computer-generated random sequencing. Both the HKD and LFD groups will attend group workshops conducted by dietitians at weeks 1, 3, 5, 7, and thereafter at 6-week intervals over the course of a 6-month period.
The participants will be recommended to achieve their incremental daily step count goal from 3,000, 7,000 to 10,000 to promote increased physical activity, as per their tolerance. All participants are to provide for their own meals and follow a calorie-restricted diet with emphasis on the consumption of healthy fats and the reduction of saturated and trans fats in both diets.
Participants in the HKD group will be advised to follow a calorie-restricted healthy ketogenic diet (n=35), with a maximum of 50g net carbohydrate intake daily. Those in the control group will be instructed to follow a calorie-restricted low fat diet (LFD) (n=35). Calorie prescriptions for both diets were calculated based on the Schofield equation, adjusted with a deficit of 500 kcal daily to promote weight loss. Participants will also be recommended to use the Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake, steps count and to aid in their adherence to the diet and physical activity recommendations. | Inclusion Criteria:
* Body mass index (BMI) between 27.5 to 40 kg/m2
* Aged 21 to 65 years
Exclusion Criteria:
* Individuals with type 1 diabetes or type 2 diabetes on insulin
* heart failure
* active cancer or in remission for less than 5 years
* advanced kidney disease
* hypothyroidism
* pregnancy
* depression
* untreated anemia, known thalassaemia, or other blood disorders. | National University Hospital, Singapore | OTHER | {
"id": "2021/00833",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-09-09T00:00:00 | {
"date": "2022-09-23",
"type": "ACTUAL"
} | {
"date": "2021-09-20",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "In this randomized controlled trial, participants in the HKD group will be advised to follow a calorie-restricted healthy ketogenic diet (n=35), with a maximum of 50g net carbohydrate intake daily. Those in the control group will be instructed to follow a calorie-restricted low fat diet (LFD) (n=35).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "It is not feasible to apply blinding to the study design due to the nature of the intervention.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Ketogenic Dieting",
"Weight Loss",
"Obesity",
"Metabolic Syndrome"
] | ["Low carbohydrates", "mHealth", "Randomized controlled trial"] | null | [
{
"city": "Singapore",
"country": "Singapore",
"facility": "National University Hospital",
"geoPoint": {
"lat": 1.28967,
"lon": 103.85007
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Body weight",
"timeFrame": "6 months"
}
],
"secondary": [
{
"description": null,
"measure": "Body weight",
"timeFrame": "3 months and 1 year"
},
{
"description": null,
"measure": "Blood pressure",
"timeFrame": "3 months, 6 months, 1 year"
},
{
"description": null,
"measure": "Hemoglobin A1c",
"timeFrame": "3 months, 6 months, 1 year"
},
{
"description": null,
"measure": "Fasting blood glucose",
"timeFrame": "3 months, 6 months, 1 year"
},
{
"description": null,
"measure": "Total cholesterol",
"timeFrame": "3 months, 6 months, 1 year"
},
{
"description": null,
"measure": "Low-density lipoprotein cholesterol",
"timeFrame": "3 months, 6 months, 1 year"
},
{
"description": null,
"measure": "High-density lipoprotein cholesterol",
"timeFrame": "3 months, 6 months, 1 year"
},
{
"description": null,
"measure": "Triglycerides",
"timeFrame": "3 months, 6 months, 1 year"
},
{
"description": null,
"measure": "Alanine transaminase",
"timeFrame": "3 months, 6 months, 1 year"
},
{
"description": null,
"measure": "Aspartate transaminase",
"timeFrame": "3 months, 6 months, 1 year"
},
{
"description": null,
"measure": "Plasma 3-hydroxybutyrate (3-OHB)",
"timeFrame": "3 months, 6 months, 1 year"
},
{
"description": null,
"measure": "Dietary intake",
"timeFrame": "3 months, 6 months, 1 year"
},
{
"description": null,
"measure": "Physical activity",
"timeFrame": "3 months, 6 months, 1 year"
}
]
} | [
{
"affiliation": "National University Hospital, Singapore",
"name": "Su Lin Lim, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D050177",
"term": "Overweight"
},
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"id": "D044343",
"term": "Overnutrition"
},
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"term": "Nutrition Disorders"
},
{
"id": "D001836",
"term": "Body Weight Changes"
},
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"term": "Insulin Resistance"
},
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"id": "D006946",
"term": "Hyperinsulinism"
},
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"id": "D044882",
"term": "Glucose Metabolism Disorders"
},
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"term": "Metabolic Diseases"
}
],
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},
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},
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},
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},
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},
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"asFound": null,
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"relevance": "LOW"
},
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"asFound": null,
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"name": "Hyperinsulinism",
"relevance": "LOW"
},
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"asFound": null,
"id": "M11639",
"name": "Metabolic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M25403",
"name": "Glucose Metabolism Disorders",
"relevance": "LOW"
}
],
"meshes": [
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"id": "D009765",
"term": "Obesity"
},
{
"id": "D024821",
"term": "Metabolic Syndrome"
},
{
"id": "D001835",
"term": "Body Weight"
},
{
"id": "D015431",
"term": "Weight Loss"
}
]
} | null | {
"conditions": [
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"id": "D009765",
"term": "Obesity"
},
{
"id": "D024821",
"term": "Metabolic Syndrome"
},
{
"id": "D001835",
"term": "Body Weight"
},
{
"id": "D015431",
"term": "Weight Loss"
}
],
"interventions": null
} |
NCT02342054 | null | Single Fraction Real-time High-Dose-Rate Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer | Prospective Phase II Trial of Single Fraction Real-time High-Dose-Rate (19-HDR) Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer | SINFRA_PROST | INTERVENTIONAL | UNKNOWN | 2015-01-12T00:00:00 | null | null | null | [
"PHASE2"
] | 49 | 18 | null | MALE | false | High-dose rate brachytherapy (HDR-BT) is an advanced technology theorized to be more advantageous than LDR-BT and External Beam Radiotherapy (EBRT), to the patient himself, and in terms of resource allocation. Studies of HDR-BT monotherapy have encouraging results in terms of biochemical control, patient survival and toxicity, but there are still certain limitations that preclude recommending HDR-BT monotherapy outside the setting of a clinical trial.
The primary endpoint of this study is to evaluate the safety, tolerance and impact on quality of life (QoL) of the BT-HDR 19Gy administered in single fraction in patients with low and intermediate risk prostate cancer. Secondary endpoint is to measure the efficacy, in terms of cancer control and satisfaction of the patients undergoing the experimental treatment.
Forty nine patients will be recruited for the experimental procedure Quality of Life, tolerance, gastrointestinal and genitourinary toxicity will be assessed using standardized procedures and scales. Patient satisfaction with the procedure will be appraised using five-category predetermined Likert scale questions.
Two different types of intermediate analyses will be performed: with 15 and 30 recruited patients.
The experimental treatment tested in this study is very innovative. Since prostate cancer is the most frequent cancer in men in Spain, this trial results are very likely to have a major impact on the standard therapy for prostate cancer in our National Health Service, allowing for a higher number of Hospitals within our country and other countries starting protocols of HDR BT 19Gy in single fraction. | Treatment:
The patient´s treatment will consist of MRI-TRUS fusion single HDR brachytherapy fraction (1 fraction of 1900 cGray).
Brachytherapy performed under general anesthesia as an outpatient procedure
TRUS-MRI fusion:
T2 axial volumetric sequence (VISTA) is imported directly from the picture archiving and communication systems (PACS). Then MR images are reconstructed and segmented. Target volumes (prostate gland, dominant intraprostatic lesions (DILs) Organs at risk (OARs) urethra and rectum are delineated.
A transrectal sagittal volumetric ultrasound image is immediately acquired every 2 degrees, a rapid reconstruction algorithm converts the series of 2D images into a 3D volume, which is then displayed in axial, sagittal and coronal views and transferred to the module of fusion with the MRI.
The MRI images and the real-time sonography examination are displayed on a split-screen with the possibility of overlaying the images live in one image. A graphical user interface is used for rigid manual registration of the ultrasound and MRI volumes. This interface allows for displacements in the three dimensions and rotations, until both images are correctly superimposed.
Then the contoured structures are transferred to the US dataset, and these contours are slightly modified until a perfect matching with the US images is achieved.
Dose prescription:
Ultrasound images with the catheters in place will be exported to Oncentra Prostate. The prostate, Foley catheter and anterior rectal wall will be contoured. Catheters will be reconstructed on the planning system. Anatomy based inverse planning will be used for dwell time optimization.
The homogeneity parameters used for optimization aim are:
-For prostate V100 \> 95%, V150 \<35%, V200 \< 6%, where Vn is the fractional volume of the organ that receives n% of the prescribed dose.
The dose constraints for the organ at risk will be:
* Urethral dmax \< 110% and
* Rectal 1cc \< 60% of prescribed dose.
Endpoints
Feasibility of higher doses administration, toxicity and efficacy will be measured | Inclusion Criteria:
* Men older than 18 years old
* Histologically confirmed diagnosis of adenocarcinoma of the prostate
* Clinical stage T1c/T2a disease
* Low and Intermediate risk disease defined as either Gleason 6 or Gleason 7 and PSA \< 20 ng/ml.
* Prostate volume \< 60 cc as determined by ultrasound, CT or MRI
* Life expectancy of more than 10 years
* Willing to give informed consent to participate in this clinical trial
* Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire
* Eastern Cooperative Oncology Group (ECOG) of 0 - 2.
* Give competent informed consent to participate in this trial.
Exclusion Criteria:
* Documented nodal or distant metastases
* Previous pelvic radiotherapy
* Previous trans-urethral resection of prostate, previous prostatectomy or HIFU
* Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors is permitted
* Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>19
* Contra-indication to radical prostate radiotherapy
* Significant medical co-morbidity rendering patient unsuitable for general anaesthetic | Hospital de Cruces | OTHER | {
"id": "SINFRA_PROST",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-01-16T00:00:00 | {
"date": "2015-01-19",
"type": "ESTIMATED"
} | {
"date": "2015-01-19",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Prostate Cancer"
] | ["Cancer", "Prostate Cancer", "Brachytherapy", "Dose escalation", "High Dose Rate", "MRI-TRUS fusion", "Detection of DILs by MRI", "SINGLE FRACTION"] | null | [
{
"city": "Barakaldo",
"country": "Spain",
"facility": "Hospital Universitario Cruces",
"geoPoint": {
"lat": 43.29639,
"lon": -2.98813
},
"state": "Bizkaia"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Safety measured by i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Quality of Life measured by alidated instruments including International Prostate Symptom Score and the urinary, bowel and sexual domains of EPIC",
"timeFrame": "12 months"
}
],
"secondary": [
{
"description": null,
"measure": "Acute toxicity measured by urinary retention rate, International Prostate Symptom Score over time, rectal toxicity and genitourinary toxicity",
"timeFrame": "24 months"
},
{
"description": null,
"measure": "Efficacy, measured by PSA",
"timeFrame": "24 months"
},
{
"description": null,
"measure": "Patient satisfaction measured with Likert scale question",
"timeFrame": "24 months"
}
]
} | [
{
"affiliation": "Hospital Universitario Cruces/Biocruces",
"name": "Alfonso Gomez-Iturriaga, MD, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "29153462", "type": "DERIVED", "citation": "Gomez-Iturriaga A, Casquero F, Pijoan JI, Minguez P, Espinosa JM, Irasarri A, Bueso A, Cacicedo J, Buchser D, Bilbao P. Health-related-quality-of-life and toxicity after single fraction 19 Gy high-dose-rate prostate brachytherapy: Phase II trial. Radiother Oncol. 2018 Feb;126(2):278-282. doi: 10.1016/j.radonc.2017.10.039. Epub 2017 Nov 15."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D005834",
"term": "Genital Neoplasms, Male"
},
{
"id": "D014565",
"term": "Urogenital Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D005832",
"term": "Genital Diseases, Male"
},
{
"id": "D000091662",
"term": "Genital Diseases"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D011469",
"term": "Prostatic Diseases"
},
{
"id": "D052801",
"term": "Male Urogenital Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Prostate Cancer",
"id": "M14335",
"name": "Prostatic Neoplasms",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M8946",
"name": "Genital Neoplasms, Male",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17315",
"name": "Urogenital Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2876",
"name": "Genital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8944",
"name": "Genital Diseases, Male",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2875",
"name": "Urogenital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14333",
"name": "Prostatic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M27095",
"name": "Male Urogenital Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D011471",
"term": "Prostatic Neoplasms"
}
]
} | null | {
"conditions": [
{
"id": "D011471",
"term": "Prostatic Neoplasms"
}
],
"interventions": null
} |
NCT01532154 | null | Fampridine Pregnancy Exposure Registry | Fampridine Pregnancy Exposure Registry | None | OBSERVATIONAL | TERMINATED | 2011-12-15T00:00:00 | null | null | null | null | 1 | null | null | FEMALE | false | This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged-release fampridine since the first day of their last menstrual period prior to conception or at any time during pregnancy. | There are no mandatory physician visits. The registry will collect pregnancy outcome data from the participants health care provider during the prenatal follow up (6-7 months gestation), pregnancy outcome (4 weeks after estimated delivery date) and finally the pediatric follow up (at 4 weeks and 12 weeks post birth). | Key Inclusion Criteria:
* Documentation that the patient was exposed to prolonged-release fampridine since the first day of her last menstrual period (LMP) prior to conception or at any time during pregnancy. (If exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure.)
* The outcome of the pregnancy must not be known at the time of report.
Key Exclusion Criteria:
* None
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. | Biogen | INDUSTRY | {
"id": "218MS402",
"link": null,
"type": null
} | Due to low enrollment, registration closed in agreement with the Regulatory Agency | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-02-13T00:00:00 | {
"date": "2016-10-18",
"type": "ESTIMATED"
} | {
"date": "2012-02-14",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | The study population will be pregnant female participants with multiple sclerosis who have been exposed to prolonged release fampridine since the first day of the last menstrual period or at any time during pregnancy. This information will be from ongoing fampridine clinical studies or the post-marketing setting. The outcome of the pregnancy must not be known at the time of report. | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Multiple Sclerosis",
"Pregnancy"
] | null | null | [
{
"city": "Paris",
"country": "France",
"facility": "Hopital Pitie Salpetriere",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Spontaneous abortions",
"timeFrame": "< 22 weeks of gestation"
},
{
"description": null,
"measure": "Elective or therapeutic terminations",
"timeFrame": "Up to 9 months of pregnancy"
},
{
"description": null,
"measure": "Ectopic pregnancy",
"timeFrame": "Up to 9 months of pregnancy"
},
{
"description": null,
"measure": "Fetal death including still births",
"timeFrame": ">22 weeks of gestation or weighing 500 grams"
},
{
"description": null,
"measure": "Live born infants",
"timeFrame": "During delivery time ( at expected average 9 months of pregnancy)"
},
{
"description": null,
"measure": "Premature births",
"timeFrame": "Delivered before 37 Weeks of gestation"
},
{
"description": null,
"measure": "Maternal death",
"timeFrame": "During pregnancy, labor or delivery"
},
{
"description": null,
"measure": "Neonatal death",
"timeFrame": "Prior to 28 days of life"
},
{
"description": null,
"measure": "Birth Defects",
"timeFrame": "Delivery time (expected 9 months of pregnancy)"
}
],
"secondary": null
} | [
{
"affiliation": "Biogen",
"name": "Medical Director",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D020278",
"term": "Demyelinating Autoimmune Diseases, CNS"
},
{
"id": "D020274",
"term": "Autoimmune Diseases of the Nervous System"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D003711",
"term": "Demyelinating Diseases"
},
{
"id": "D001327",
"term": "Autoimmune Diseases"
},
{
"id": "D007154",
"term": "Immune System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BC20",
"name": "Immune System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
{
"asFound": "Multiple Sclerosis",
"id": "M12060",
"name": "Multiple Sclerosis",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M15415",
"name": "Sclerosis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4629",
"name": "Autoimmune Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22098",
"name": "Demyelinating Autoimmune Diseases, CNS",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22094",
"name": "Autoimmune Diseases of the Nervous System",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6909",
"name": "Demyelinating Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10200",
"name": "Immune System Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D009103",
"term": "Multiple Sclerosis"
}
]
} | {
"ancestors": [
{
"id": "D026902",
"term": "Potassium Channel Blockers"
},
{
"id": "D049990",
"term": "Membrane Transport Modulators"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
}
],
"browseBranches": [
{
"abbrev": "ChanBlk",
"name": "Channel Blockers"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "Cardiogenic Shock",
"id": "M18321",
"name": "4-Aminopyridine",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M23171",
"name": "Potassium Channel Blockers",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D015761",
"term": "4-Aminopyridine"
}
]
} | {
"conditions": [
{
"id": "D009103",
"term": "Multiple Sclerosis"
}
],
"interventions": [
{
"id": "D015761",
"term": "4-Aminopyridine"
}
]
} |
NCT00394654 | null | A Study to Evaluate the Efficacy of MEDI-528 on Late Asthmatic Response With Atopic Asthma | A Phase 2A, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy of MEDI-528, a Humanized Anti-Interleukin-9 Monoclonal Antibody, on Late Asthmatic Response Induced By Allergen Inhalation In Adults With Atopic Asthma | None | INTERVENTIONAL | COMPLETED | 2006-10-31T00:00:00 | null | null | null | [
"PHASE2"
] | 30 | 18 | 65 | ALL | false | This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma. | This study (MI-CP138) is a Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma. Approximately three investigative sites in Canada will participate in this study, with up to 40 evaluable patients randomized in a 1:1 ratio to receive MEDI-528 (9.0 mg/kg) or placebo as a single IV infusion. | Inclusion Criteria:
* Male or female adults, age 18 through 65 years of age at the time of screening;
* Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
* Previously documented diagnosis of asthma of \> 1 year duration, based on episodic symptoms of airflow obstruction, at least partial reversibility of airflow obstruction, with alternative diagnoses (e.g., chronic obstructive pulmonary disease) ruled out;
* AHR in the methacholine challenge test with a PC20 (provoking concentration of methacholine to cause a 20% fall in FEV1) ≤ 16 mg/mL (Crapo, 2000);
* Have dual response of EAR, defined as a decrease in FEV1 ≥ 20% at 0 to 3 hours after inhalation, and LAR, defined as a decrease in FEV1 ≥ 15% 3 to 7 hours after inhalation, to inhaled allergen;
* Asthma symptoms are adequately controlled on short-acting β2 agonists (e.g., albuterol) alone;
* Have had no significant changes in regular asthma medications and no acute asthma exacerbations requiring corticosteroid rescue, hospitalization, or emergency department visits for at least 4 weeks prior to screening and up through the time of the first dose of study drug on Study Day 0.
* Sexually active women, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 21 days prior to the first dose of study drug on Study Day 0, and must agree to continue using such precautions through Study Day 126. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active men, unless surgically sterile, must likewise use an effective method of birth control (condom) and must agree to continue using such precautions through Study Day 126;
* Able to complete the follow-up period through Study Day 126, as required by the protocol.
* Willing to forego other forms of experimental treatment and study procedures during the study; and
* Able to provide spirometric readings that meet American Thoracic Society (ATS) standards (ATS, 1995).
Exclusion Criteria:
* Receipt of MEDI-528 in any previous clinical study;
* History of allergy or adverse reactions to any component of the MEDI-528 formulation;
* Lung disease other than allergic asthma (e.g. chronic bronchitis);
* Current use of any systemic or inhaled immunosuppressive drugs, including systemic and inhaled corticosteroids (topical corticosteroids are permitted), long-acting β2 agonists, leukotriene antagonists, cromolyn sodium, nedocromil sodium, theophylline or any inhaled or systemic medication for asthma other than short-acting β2 agonists, for at least 4 weeks prior to study drug administration on Study Day 0.
* Current use of any β-adrenergic antagonist (e.g. propranolol).
* Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period.
* Acute illnesses or evidence of clinically significant active infection, such as fever ³ 38.0°C (100.5°F) at screening and through the time of the study drug administration on Study Day 0;
* Current allergy-vaccination therapy (i.e., desensitization immunotherapy) with less than 3 months of stable maintenance doses prior to the baseline allergen inhalation challenge;
* Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to the first dose of study drug through Study Day 150;
* Receipt of any therapy with a leukocyte-depleting agent unless recovery in white cell count has been documented before screening;
* Pregnancy (sexually active females must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
* Is a nursing mother at the time of study enrollment;
* Evidence of infection with hepatitis B or C virus, or HIV-1 or HIV-2, or active infection with hepatitis A;
* History of significant systemic disease (e.g., cancer; infection; coronary artery disease or other cardiovascular disease; or hematological, renal, hepatic, endocrinologic, neurologic, rheumatologic, or gastrointestinal disease);
* History of cancer other than nonmelanoma skin cancer or cervical carcinoma-in-situ that have been treated successfully with curative therapy;
* History of primary immunodeficiency;
* History of pancreatitis;
* History of use of tobacco products within 2 years of baseline or history of smoking \>= 10 pack-years;
* Elective surgery planned from the time of screening through Study Day 126;
* Clinically significant abnormalities (other than asthma) upon physical examination prior to study drug administration on Study Day 0;
* Clinically significant abnormality, as determined by the investigator, on 12-lead ECG or chest radiograph at the time of screening;
* At the time of screening, any of the following abnormalities: aspartate transaminase (AST), alanine transaminase (ALT), or amylase \> 1.5 × above the upper limits of normal (ULN); or serum creatinine \> 1.3 × ULN; or any other abnormal laboratory values in the screening panel that, in the opinion of the principal investigator (PI), are judged to be clinically significant; or
* Evidence of any systemic disease or respiratory disease (other than asthma), any finding upon physical examination or history of any disease that, in the opinion of the PI or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study. | MedImmune LLC | INDUSTRY | {
"id": "MI-CP138",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2006-10-31T00:00:00 | {
"date": "2013-12-11",
"type": "ESTIMATED"
} | {
"date": "2006-11-01",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Asthma"
] | null | null | [
{
"city": "Hamilton",
"country": "Canada",
"facility": "McMaster University",
"geoPoint": {
"lat": 43.25011,
"lon": -79.84963
},
"state": "Ontario"
},
{
"city": "Saskatoon",
"country": "Canada",
"facility": "University of Saskatchewan",
"geoPoint": {
"lat": 52.13238,
"lon": -106.66892
},
"state": "Saskatchewan"
},
{
"city": "Quebec",
"country": "Canada",
"facility": "Hopital Laval",
"geoPoint": {
"lat": 46.81228,
"lon": -71.21454
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7",
"timeFrame": "Day 7"
},
{
"description": null,
"measure": "Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28",
"timeFrame": "Day 28"
},
{
"description": null,
"measure": "Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56",
"timeFrame": "Day 56"
},
{
"description": null,
"measure": "Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7",
"timeFrame": "Day 7"
},
{
"description": null,
"measure": "Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28",
"timeFrame": "Day 28"
},
{
"description": null,
"measure": "Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56",
"timeFrame": "Day 56"
}
],
"secondary": [
{
"description": null,
"measure": "Incidence of Adverse Events",
"timeFrame": "Days 0 - 126"
},
{
"description": null,
"measure": "Incidence of Serious Adverse Events",
"timeFrame": "Days 0 - 126"
},
{
"description": null,
"measure": "Incidence of Anti-drug Antibodies (ADA) to MEDI-528",
"timeFrame": "Days 0, 27, 55, 84, and 126"
},
{
"description": null,
"measure": "Time to Observed Maximum Serum Concentration (Tmax)",
"timeFrame": "Days 0, 6, 7, 27, 55, 84, and 126"
},
{
"description": null,
"measure": "Time to Observed Maximum Sputum Concentration (Tmax)",
"timeFrame": "Days -21 to -7, 7, 28, and 56"
},
{
"description": null,
"measure": "Time to Observed Maximum Nasal Lavage Concentration (Tmax)",
"timeFrame": "Days -6 to -1, 8, 29, and 57"
},
{
"description": null,
"measure": "Observed Maximum Serum Concentration (Cmax)",
"timeFrame": "Days 0, 6, 7, 27, 55, 84, and 126"
},
{
"description": null,
"measure": "Observed Maximum Sputum Concentration (Cmax)",
"timeFrame": "Days -21 to -7, 7, 28, and 56"
},
{
"description": null,
"measure": "Observed Maximum Nasal Lavage Concentration (Cmax)",
"timeFrame": "Days -6 to -1, 8, 29, and 57"
},
{
"description": null,
"measure": "Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]",
"timeFrame": "Days 0, 6, 7, 27, 55, 84, and 126"
},
{
"description": null,
"measure": "Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]",
"timeFrame": "Days -21 to -7, 7, 28, and 56"
},
{
"description": null,
"measure": "Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]",
"timeFrame": "Days -6 to -1, 8, 29, and 57"
},
{
"description": null,
"measure": "Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]",
"timeFrame": "Days 0, 6, 7, 27, 55, 84, and 126"
},
{
"description": null,
"measure": "Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]",
"timeFrame": "Days -21 to -7, 7, 28, and 56"
},
{
"description": null,
"measure": "Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]",
"timeFrame": "Days -6 to -1, 8, 29, and 57"
},
{
"description": null,
"measure": "Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]",
"timeFrame": "Days 0, 6, 7, 27, 55, 84, and 126"
},
{
"description": null,
"measure": "Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]",
"timeFrame": "Days -21 to -7, 7, 28, and 56"
},
{
"description": null,
"measure": "Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]",
"timeFrame": "Days -6 to -1, 8, 29, and 57"
},
{
"description": null,
"measure": "Terminal Phase Half-Life (T1/2)",
"timeFrame": "Days 0, 6, 7, 27, 55, 84, and 126"
},
{
"description": null,
"measure": "Terminal Phase Half-Life (T1/2)",
"timeFrame": "Days -21 to -7, 7, 28, and 56"
},
{
"description": null,
"measure": "Terminal Phase Half-Life (T1/2)",
"timeFrame": "Days -6 to -1, 8, 29, and 57"
},
{
"description": null,
"measure": "Total Body Clearance (CL)",
"timeFrame": "Days 0, 6, 7, 27, 55, 84, and 126"
},
{
"description": null,
"measure": "Terminal Phase Volume of Distribution (Vz)",
"timeFrame": "Days 0, 6, 7, 27, 55, 84, and 126"
}
]
} | [
{
"affiliation": "MedImmune LLC",
"name": "Nestor Molfino, M.D.",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D001982",
"term": "Bronchial Diseases"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
},
{
"id": "D008173",
"term": "Lung Diseases, Obstructive"
},
{
"id": "D008171",
"term": "Lung Diseases"
},
{
"id": "D012130",
"term": "Respiratory Hypersensitivity"
},
{
"id": "D006969",
"term": "Hypersensitivity, Immediate"
},
{
"id": "D006967",
"term": "Hypersensitivity"
},
{
"id": "D007154",
"term": "Immune System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "BC20",
"name": "Immune System Diseases"
},
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"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
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"id": "M4556",
"name": "Asthma",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M27137",
"name": "Respiratory Aspiration",
"relevance": "LOW"
},
{
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"id": "M5258",
"name": "Bronchial Diseases",
"relevance": "LOW"
},
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"relevance": "LOW"
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},
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},
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"id": "M10020",
"name": "Hypersensitivity, Immediate",
"relevance": "LOW"
},
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"id": "M10200",
"name": "Immune System Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001249",
"term": "Asthma"
}
]
} | {
"ancestors": null,
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"abbrev": "All",
"name": "All Drugs and Chemicals"
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],
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"asFound": null,
"id": "M10184",
"name": "Immunoglobulins",
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"name": "Antibodies, Monoclonal",
"relevance": "LOW"
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],
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} | {
"conditions": [
{
"id": "D001249",
"term": "Asthma"
}
],
"interventions": []
} |
NCT03606954 | null | Potency of Topical Corticosteroids in Combination Preparations | Evaluation of Topical Corticosteroids Potency in Combination Preparations in Healthy Volunteers | None | INTERVENTIONAL | UNKNOWN | 2018-07-21T00:00:00 | null | null | null | [
"PHASE4"
] | 20 | 18 | 65 | ALL | true | Several combination topical drugs are available on the market. The potency of corticosteroids depends on a particular molecular structure and the skin penetration properties. Besides molecular structure, a penetration of a corticosteroid molecule correlates with physical properties of the vehicle which depend on physical properties of the vehicle constituents.
Vasoconstriction assay is considered as the gold standard for testing potency of topical corticosteroids. | Primary outcome: Change in Vasoconstriction index following application of topical corticosteroids that are incorporated with or without an antibiotic and/or antifungal drugs in healthy volunteers. | Inclusion Criteria:
* No prior history of internal diseases that required vaccine-suppressing treatments
* Absence of an active skin disease.
Exclusion Criteria:
* Treatment with topical corticosteroids in the 4 weeks prior to the study
* Immune-suppressive treatment in the 4 weeks prior to the study
* Pregnancy or breast feeding | Ben-Gurion University of the Negev | OTHER | {
"id": "0316-17-SOR",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-07-29T00:00:00 | {
"date": "2018-07-31",
"type": "ACTUAL"
} | {
"date": "2018-07-31",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "double-blind controlled comparative study",
"whoMasked": [
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"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
} | [
"Skin Toxicity"
] | null | null | null | [
{
"class": "OTHER",
"name": "Soroka University Medical Center"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Vasoconstriction Index (VI) measured by Skin Color Reflectometry",
"timeFrame": "24 hours"
}
],
"secondary": null
} | [
{
"affiliation": "Soroka University Medical Center & Ben Gurion University",
"name": "Raed Khoury, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT02520154 | null | Pembrolizumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | Matched Paired Pharmacodynamics and Feasibility Study of Pembrolizumab in Combination With Chemotherapy in Frontline Ovarian Cancer | None | INTERVENTIONAL | COMPLETED | 2015-08-07T00:00:00 | null | 2025-05-22T00:00:00 | 2025-05-22T00:00:00 | [
"PHASE2"
] | 31 | 18 | null | FEMALE | false | This phase II trial studies how well pembrolizumab works when given in combination with carboplatin and paclitaxel in treating patients with stage III-IV ovarian, primary peritoneal, or fallopian tube cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab in combination with carboplatin and paclitaxel may be a better treatment for ovarian, primary peritoneal, or fallopian tube cancer. | PRIMARY OBJECTIVES:
I. To evaluate progression-free survival of paclitaxel/carboplatin and pembrolizumab in patients with advanced stage, metastatic ovarian cancer undergoing neoadjuvant chemotherapy (NACT).
SECONDARY OBJECTIVES:
I. To describe the feasibility of combination therapy with pembrolizumab in this population.
II. To evaluate the safety of combination and maintenance pembrolizumab. III. To report overall survival.
EXPLORATORY OBJECTIVES:
I. To describe the sequential effects of chemotherapy on immune response and PD-1 expression and receptor occupancy.
II. To evaluate circulating lymphoid populations (subsets). III. To determine tissue PD-L1 expression and T-cell infiltration.
OUTLINE:
NACT: Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
ADJUVANT THERAPY: Beginning 3-6 weeks after surgery, paclitaxel IV over 1 hour on days 1, 8, and 15, patients receive carboplatin IV over 1 hour on day 1, and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 20 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks. | Inclusion Criteria:
* Signed, written informed consent
* Histology showing high-grade epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer
* No more than 4 prior cycles of chemotherapy for primary advanced (stage III or IV) epithelial ovarian, primary peritoneal, or fallopian tube cancer
* No prior treatment involving irradiation, hormonal therapy, immunotherapy, investigational therapy, and/or other concurrent agents or therapies for ovarian cancer
* A disposition to neoadjuvant chemotherapy with planned interval tumor reductive surgery after 4 complete cycles of treatment
* Planned dose-dense chemotherapy with combination carboplatin and paclitaxel given intravenously
* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Measurable disease is defined at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each "target" lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or \>= 10 mm when measured by spiral CT
* Patients with non-measurable but evaluable solid tumors may be deemed eligible contingent upon principal investigator (PI) review
* Peripheral neuropathy grade 0 or 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
* Tissue from an archival tissue sample or fresh tissue obtained from a core or excisional biopsy of a tumor lesion
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
* Absolute neutrophil count (ANC) \>= 1,500 /mcL
* Platelets \>= 100,000/mcL
* Hemoglobin (Hgb) \>= 9 g/dL or \>= 5.6 mmol/L
* Creatinine clearance \>= 60 mL/min for subject with creatinine levels \> 1.5 x institutional upper limit of normal (ULN)
* Total bilirubin =\< 1.5 x ULN OR direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 ULN
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN OR =\< 5 x ULN for subjects with liver metastases
* International normalized ratio (INR)/prothrombin time (PT) =\< 1.5 x ULN (unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time \[PTT\] is within therapeutic range of intended use of anticoagulants)
* PTT =\< 1.5 x ULN (unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants)
* Women of child-bearing potential (intact uterus) should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Pre-treatment fresh frozen tissue available for research purposes; this tissue can be collected from preoperative laparoscopy, other diagnostic biopsy, or a research-specific biopsy
* Signed informed consent on protocol LAB02-188
Exclusion Criteria:
* Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
* Histology showing mucinous or low grade epithelial ovarian carcinoma
* History of another primary malignancy except for:
* Malignancy treated with curative intent and with no known active disease \>= 5 years before the first dose of study drug and or low potential risk for recurrence
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ
* Concomitant stage 1A/B, grade 1-2 endometrioid endometrial cancer as allowable contemporary tumor
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study treatment
* Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
* Patients with ovarian cancer not medically fit for diagnostic laparoscopy prior to initiation of therapy
* Patients with any evidence of severe or uncontrolled systemic disease (e.g. severe hepatic impairment, interstitial lung disease \[bilateral, diffuse, parenchymal lung disease\], uncontrolled chronic renal disease \[glomerulonephritis, nephritic syndrome, Fanconi syndrome or renal tubular acidosis\]), or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension blood pressure \>= 140/90, active bleeding diatheses or active infection
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
* Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to a previously administered agent; Note: subjects with =\< grade 2 neuropathy are an exception to this criterion and may qualify for the study; Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
* No active autoimmune disease that has required systemic treatment in past two years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment
* Has evidence of interstitial lung disease or active, non-infectious pneumonitis
* Has an active infection requiring systemic therapy
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment
* Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
* Has known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected)
* Has received a live vaccine within 30 days prior to the first dose of study treatment
* Patients with tuberculosis
* Patients with known hypersensitivity to pembrolizumab or any of its excipients
* Patients receiving concurrent additional biologic therapy
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel not responsive to traditional desensitization procedures
* Patient that is not able to understand or to comply with the study instructions and requirements or has a history of non-compliance to the medical regimen | M.D. Anderson Cancer Center | OTHER | {
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"date": "2025-06-08",
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"date": "2015-08-11",
"type": "ESTIMATED"
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"Stage III Fallopian Tube Cancer AJCC v7",
"Stage III Ovarian Cancer AJCC v6 and v7",
"Stage III Primary Peritoneal Cancer AJCC v7",
"Stage IIIA Fallopian Tube Cancer AJCC v7",
"Stage IIIA Ovarian Cancer AJCC v6 and v7",
"Stage IIIA Primary Peritoneal Cancer AJCC v7",
"Stage IIIB Fallopian Tube Cancer AJCC v7",
"Stage IIIB Ovarian Cancer AJCC v6 and v7",
"Stage IIIB Primary Peritoneal Cancer AJCC v7",
"Stage IIIC Fallopian Tube Cancer AJCC v7",
"Stage IIIC Ovarian Cancer AJCC v6 and v7",
"Stage IIIC Primary Peritoneal Cancer AJCC v7",
"Stage IV Fallopian Tube Cancer AJCC v6 and v7",
"Stage IV Ovarian Cancer AJCC v6 and v7",
"Stage IV Primary Peritoneal Cancer AJCC v7"
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"city": "Houston",
"country": "United States",
"facility": "M D Anderson Cancer Center",
"geoPoint": {
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"lon": -95.36327
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"geoPoint": {
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"facility": "MD Anderson League City",
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"geoPoint": {
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"other": null,
"primary": [
{
"description": null,
"measure": "To Evaluate Progression-free Survival of Paclitaxel/Carboplatin and Pembrolizumab in Patients With Advanced Stage, Metastatic Ovarian Cancer Undergoing NACT",
"timeFrame": "Up to 3 years"
}
],
"secondary": [
{
"description": null,
"measure": "To Describe the Feasibility of Combination Therapy and Maintenance Pembrolizumab in This Population",
"timeFrame": "Up to 3 years"
},
{
"description": null,
"measure": "To Evaluate the Safety of Combination and Maintenance Pembrolizumab",
"timeFrame": "up to 3 years"
}
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} | [
{
"affiliation": "M.D. Anderson Cancer Center",
"name": "Amir Jazaeri, MD",
"role": "PRINCIPAL_INVESTIGATOR"
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] | [{"pmid": "39151421", "type": "RESULT", "citation": "How JA, Dang M, Lee S, Fellman B, Westin SN, Sood AK, Fleming ND, Shafer A, Yuan Y, Liu J, Zhao L, Celestino J, Hajek R, Morgan MB, Parra ER, Laberiano Fernandez CD, Arrechedera CA, Solis Soto LM, Schmeler KM, Nick A, Lu KH, Coleman R, Wang L, Jazaeri AA. Pembrolizumab plus chemotherapy in frontline treatment of advanced ovarian cancer: Clinical and translational results from a phase 2 trial. Med. 2025 Jan 10;6(1):100494. doi: 10.1016/j.medj.2024.07.022. Epub 2024 Aug 15."}] | {"versionHolder": "2025-06-18"} | {
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{
"id": "D004701",
"term": "Endocrine Gland Neoplasms"
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{
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{
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{
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"term": "Digestive System Diseases"
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{
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{
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{
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"term": "Fallopian Tube Neoplasms"
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{
"id": "D010534",
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]
} | {
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},
{
"id": "D000074322",
"term": "Antineoplastic Agents, Immunological"
},
{
"id": "D000082082",
"term": "Immune Checkpoint Inhibitors"
}
],
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"abbrev": "ANeo",
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"term": "Albumin-Bound Paclitaxel"
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]
} | {
"conditions": [
{
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"term": "Ovarian Neoplasms"
},
{
"id": "D000077216",
"term": "Carcinoma, Ovarian Epithelial"
},
{
"id": "D005185",
"term": "Fallopian Tube Neoplasms"
},
{
"id": "D010534",
"term": "Peritoneal Neoplasms"
}
],
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"term": "Pembrolizumab"
},
{
"id": "D000068196",
"term": "Albumin-Bound Paclitaxel"
}
]
} |
NCT06780254 | null | A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of Single- and Multiple-Ascending Doses of MH-001 in Healthy Volunteers | A Two-Part Randomized Double-Blinded Placebo-Controlled, Phase 1 Study of Single and Multiple Ascending Doses of MH-001 in Healthy Participants | None | INTERVENTIONAL | RECRUITING | 2025-01-07T00:00:00 | null | 2025-03-21T00:00:00 | 2025-06-30T00:00:00 | [
"PHASE1"
] | 64 | 18 | 65 | ALL | true | First-in-Human study to demonstrate the safety and tolerability of single- and multiple-ascending doses of MH-001 in Healthy Volunteers (HVs) | null | Inclusion Criteria:
* Male or non-childbearing potential Female, non smoker, with a Body Mass Index (BMI) between 18.5 and 32.0 kilogram per meter square (kg/m2) and red blood cells greater or equal (≥) to 120 grams per liter (g/L) for women and ≥135 g/L for men
* In good health, determined by no clinically significant findings of skin, dental, neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease
Exclusion Criteria:
* Have a history or presence of clinically significant medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, chronic or relevant acute infections, relevant immunodeficiency, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality that, in the judgment of the Investigator, indicates a medical problem that would preclude study participation.
* History of skin disorders including clinically significant active skin disease.
* History/signs and symptoms of current or recurrent teeth and gums disease
* Clinically significant abnormal laboratory test results or positive hepatitis panel and/or positive human immunodeficiency virus test. | Vespina Lifesciences Inc. | INDUSTRY | {
"id": "MH001-01",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2025-01-14T00:00:00 | {
"date": "2025-01-28",
"type": "ACTUAL"
} | {
"date": "2025-01-17",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "SAD: Single Ascending Dose, 5 cohorts of different dosages versus placebo MAD: Multiple Ascending Dose, 3 cohorts of different dosages versus placebo",
"maskingInfo": {
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},
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"timePerspective": null
} | [
"Healthy"
] | ["Healthy Volunteers", "First In Human", "Safety", "Tolerability", "Pharmacokinetics", "Pharmacodynamics"] | null | [
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"city": "Quebec",
"country": "Canada",
"facility": "Syneos Health clinic",
"geoPoint": {
"lat": 46.81228,
"lon": -71.21454
},
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}
] | [
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"class": "OTHER",
"name": "Syneos Health"
},
{
"class": "INDUSTRY",
"name": "PrimeVigilance Ltd., UK"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Percentage of participants with treatment-emergent adverse events (TEAEs)",
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}
],
"secondary": [
{
"description": null,
"measure": "Area under the concentration-time curve (AUC) of the analyte in plasma over time",
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},
{
"description": null,
"measure": "Peak Plasma Concentration (Cmax) of the analyte in plasma",
"timeFrame": "SAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 15; MAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 56"
},
{
"description": null,
"measure": "Time to reach Peak Concentration (Tmax) of the analyte in plasma",
"timeFrame": "SAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 15; MAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 56"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT00610454 | null | Safety and Tolerability of Levetiracetam Intravenous 15 Minute Infusion in Subjects Suffering From Partial Onset Seizures | Trial Evaluating the Safety and Tolerability of Levetiracetam Intravenous 15-minute Infusion, Administered in b.i.d. Regimen as an Adjunctive Antiepileptic Treatment in Subjects From 16 to 65 Years Suffering From Partial Onset Seizures | None | INTERVENTIONAL | COMPLETED | 2008-01-18T00:00:00 | null | null | null | [
"PHASE2"
] | 25 | 16 | 65 | ALL | false | Subjects receiving LEV as adjunctive therapy to 1 or 2 other AEDs for partial onset seizures and subjects who are temporarily unable to take oral LEV, may require alternative routes of administration. The purpose of this trial was to evaluate the safety and tolerability of 1000 to 3000 mg/day LEV administered as a 15-min IV infusion b.i.d. after switching from the same oral dose. | null | Inclusion Criteria:
* Adult
* in- or out-subjects suffering from partial onset seizures according to the ILAE classification of Epileptic Seizures;
* intake of levetiracetam as an adjunctive antiepileptic oral treatment in addition to one or two antiepileptic drugs (AED).
Exclusion Criteria:
* Had problems of venous accessibility;
* showed safety issues related to the administration of one of the concomitant AEDs requiring medical intervention;
* clinically significant ECG/lab abnormalities;
* administered vigabatrine;
* administered felbamate for less than 18 months;
* had contraindication to any component of the study medication treatment as IV formulation or known allergic reaction to or intolerance of pyrrolidone derivatives. | UCB Pharma | INDUSTRY | {
"id": "N01166",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-01-27T00:00:00 | {
"date": "2013-12-06",
"type": "ESTIMATED"
} | {
"date": "2008-02-08",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Epilepsy"
] | ["Levetiracetam", "Keppra"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "safety and tolerability of levetiracetam after switching from oral formulation to 15-minute IV infusion during repeated dosing (4 days b.i.d.)",
"timeFrame": "Adverse events after each infusion"
}
],
"secondary": null
} | [
{
"affiliation": "+1 877 822 9493 (UCB)",
"name": "UCB Clinical Trial Call Center",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "17326794", "type": "BACKGROUND", "citation": "Baulac M, Brodie MJ, Elger CE, Krakow K, Stockis A, Meyvisch P, Falter U. Levetiracetam intravenous infusion as an alternative to oral dosing in patients with partial-onset seizures. Epilepsia. 2007 Mar;48(3):589-92. doi: 10.1111/j.1528-1167.2006.00959.x. Epub 2007 Feb 22."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D009461",
"term": "Neurologic Manifestations"
}
],
"browseBranches": [
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"abbrev": "BC10",
"name": "Nervous System Diseases"
},
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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"abbrev": "All",
"name": "All Conditions"
}
],
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"id": "M15452",
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"relevance": "HIGH"
},
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"id": "M7983",
"name": "Epilepsy",
"relevance": "LOW"
},
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"id": "M12404",
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D012640",
"term": "Seizures"
}
]
} | {
"ancestors": [
{
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"term": "Anticonvulsants"
},
{
"id": "D018697",
"term": "Nootropic Agents"
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],
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"abbrev": "AntiConv",
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"relevance": "LOW"
}
],
"meshes": [
{
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"term": "Levetiracetam"
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],
"interventions": [
{
"id": "D000077287",
"term": "Levetiracetam"
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]
} |
NCT02847754 | null | Differentiated Resistance Training of the Paravertebral Muscles in Patients With Unstable Spinal Bone Metastasis Under Concomitant Radiotherapy | Differentiated Resistance Training of the Paravertebral Muscles in Patients With Unstable Spinal Bone Metastasis Under Concomitant Radiotherapy | DISPO-2 | INTERVENTIONAL | UNKNOWN | 2016-07-12T00:00:00 | null | null | null | [
"PHASE2"
] | 60 | 18 | 80 | ALL | false | Standard indications for palliative radiation of bony metastases include pain, spinal cord compression, and impending pathologic fractures.
Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid complications. Tailored training of the paravertebral musculature may support Radiation therapy and improve above named factors. DISPO-2 was designed to investigate the impact of tailored physical exercise in patients with unstable vertebral metastases as compared to manual therapy (massage etc.). The trial includes patients with painful unstable bony metastases, patients with spinal cord compression or impending pathological fractures are excluded. The investigations are carried out in a prospective randomized controlled phase-II parallel group design. | Standard indications for palliative radiation of bony metastases include pain, spinal cord compression, and impending pathologic fractures. Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid complications. Tailored training of the paravertebral musculature may support radiation therapy and improve above named factors. DISPO-2 was designed to investigate the impact of tailored physical exercise in patients with unstable vertebral metastases as compared to manual therapy (progressive muscle relaxation). The trial includes patients with painful bony metastases, patients with spinal cord compression or impending pathological fractures are excluded. The investigations are carried out in a prospective randomized controlled phase-II parallel group design.
Patients are randomized to one of the following groups: patients in arm A carry out daily physical training consisting of four different isometric exercises under the guidance and supervision of a physiotherapist. Training starts day one (first radiotherapy session), 10 daily units of 30 min each are scheduled during radiotherapy. Patients are expected to continue training until 12 weeks post completion of radiotherapy at home. Patients in arm B (control group) receive 10 daily sessions of 15 min progressive muscle relaxation starting from day one of radiotherapy. Follow-up of the patients is scheduled at 12 weeks post completion of radiotherapy incl. CT of the spine and physical examination. | Inclusion Criteria:
* solitary or multiple vertebral metastases
* thoracic spine
* lumbar spine
* sacrum
* indication for palliative radiation therapy
* age: 18 - 80 years
* Karnofsky index \> 70%
* bisphosphonate therapy initiated
Exclusion Criteria:
* bony metastases of cervical spine or pelvis
* impending fracture
* other serious illnesses or medical conditions: therapy-refractory unstable heart disease, congestive heart failure NYHA °III and °IV; coagulopathies
* Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators
* Legal incapacity or limited legal capacity
* Positive serum/ urine beta-HCG/ pregnancy | Heidelberg University | OTHER | {
"id": "DISPO 2",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-07-25T00:00:00 | {
"date": "2016-07-28",
"type": "ESTIMATED"
} | {
"date": "2016-07-28",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Vertebral Bony Metastases"
] | ["bony metastases", "physical exercise"] | null | [
{
"city": "Heidelberg",
"country": "Germany",
"facility": "Dept of Radiation Oncology, University of Heidelberg, Germany",
"geoPoint": {
"lat": 49.40768,
"lon": 8.69079
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "feasibility of isometric exercise in unstable vertebral bony metastases",
"timeFrame": "12 weeks post completion of radiotherapy"
}
],
"secondary": [
{
"description": null,
"measure": "progression-free survival (PFS)",
"timeFrame": "2 years post completion of radiotherapy"
},
{
"description": null,
"measure": "fracture-free survival (FFS)",
"timeFrame": "2 years post completion of radiotherapy"
},
{
"description": null,
"measure": "bone density",
"timeFrame": "12 weeks post completion radiotherapy"
},
{
"description": null,
"measure": "pain reduction",
"timeFrame": "Immediately after completion of radiotherapy, 12 and 24 weeks post completion of radiotherapy"
},
{
"description": null,
"measure": "Quality of life",
"timeFrame": "12 and 24 weeks post completion of therapy"
},
{
"description": null,
"measure": "Fatigue",
"timeFrame": "12 and 24 weeks post completion of therapy"
}
]
} | null | [{"pmid": "15405683", "type": "RESULT", "citation": "ABRAMS HL, SPIRO R, GOLDSTEIN N. Metastases in carcinoma; analysis of 1000 autopsied cases. Cancer. 1950 Jan;3(1):74-85. doi: 10.1002/1097-0142(1950)3:13.0.co;2-7. No abstract available."}, {"pmid": "8433390", "type": "RESULT", "citation": "Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365."}, {"pmid": "10836297", "type": "RESULT", "citation": "Bubendorf L, Schopfer A, Wagner U, Sauter G, Moch H, Willi N, Gasser TC, Mihatsch MJ. Metastatic patterns of prostate cancer: an autopsy study of 1,589 patients. Hum Pathol. 2000 May;31(5):578-83. doi: 10.1053/hp.2000.6698."}, {"pmid": "20531162", "type": "RESULT", "citation": "Cheville AL, Girardi J, Clark MM, Rummans TA, Pittelkow T, Brown P, Hanson J, Atherton P, Johnson ME, Sloan JA, Gamble G. Therapeutic exercise during outpatient radiation therapy for advanced cancer: Feasibility and impact on physical well-being. Am J Phys Med Rehabil. 2010 Aug;89(8):611-9. doi: 10.1097/PHM.0b013e3181d3e782."}, {"pmid": "3819423", "type": "RESULT", "citation": "Harrington KD. Impending pathologic fractures from metastatic malignancy: evaluation and management. Instr Course Lect. 1986;35:357-81."}, {"pmid": "21523349", "type": "RESULT", "citation": "Murnane A, Geary B, Milne D. The exercise programming preferences and activity levels of cancer patients undergoing radiotherapy treatment. Support Care Cancer. 2012 May;20(5):957-62. doi: 10.1007/s00520-011-1167-z. Epub 2011 Apr 27."}, {"pmid": "17453366", "type": "RESULT", "citation": "Nikander R, Sievanen H, Ojala K, Oivanen T, Kellokumpu-Lehtinen PL, Saarto T. Effect of a vigorous aerobic regimen on physical performance in breast cancer patients - a randomized controlled pilot trial. Acta Oncol. 2007;46(2):181-6. doi: 10.1080/02841860600833145."}, {"pmid": "21271338", "type": "RESULT", "citation": "Pilge H, Holzapfel BM, Prodinger PM, Hadjamu M, Gollwitzer H, Rechl H. [Diagnostics and therapy of spinal metastases]. Orthopade. 2011 Feb;40(2):185-93; quiz 194-5. doi: 10.1007/s00132-010-1738-6. German."}, {"pmid": "21430531", "type": "RESULT", "citation": "Roe JW, Ashforth KM. Prophylactic swallowing exercises for patients receiving radiotherapy for head and neck cancer. Curr Opin Otolaryngol Head Neck Surg. 2011 Jun;19(3):144-9. doi: 10.1097/MOO.0b013e3283457616."}, {"pmid": "16968322", "type": "RESULT", "citation": "Stevinson C, Fox KR. Feasibility of an exercise rehabilitation programme for cancer patients. Eur J Cancer Care (Engl). 2006 Sep;15(4):386-96. doi: 10.1111/j.1365-2354.2006.00677.x."}, {"pmid": "1515244", "type": "RESULT", "citation": "Verger E, Salamero M, Conill C. Can Karnofsky performance status be transformed to the Eastern Cooperative Oncology Group scoring scale and vice versa? Eur J Cancer. 1992;28A(8-9):1328-30. doi: 10.1016/0959-8049(92)90510-9."}, {"pmid": "10582706", "type": "RESULT", "citation": "Zhong H, De Marzo AM, Laughner E, Lim M, Hilton DA, Zagzag D, Buechler P, Isaacs WB, Semenza GL, Simons JW. Overexpression of hypoxia-inducible factor 1alpha in common human cancers and their metastases. Cancer Res. 1999 Nov 15;59(22):5830-5."}, {"pmid": "28359283", "type": "DERIVED", "citation": "Welte SE, Wiskemann J, Scharhag-Rosenberger F, Forster R, Bostel T, Bruckner T, Schlampp I, Meyerhof E, Sprave T, Nicolay NH, Debus J, Rief H. Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial. Trials. 2017 Mar 31;18(1):155. doi: 10.1186/s13063-017-1903-x."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009385",
"term": "Neoplastic Processes"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
"browseBranches": [
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"abbrev": "BC04",
"name": "Neoplasms"
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"abbrev": "BC23",
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"abbrev": "All",
"name": "All Conditions"
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],
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D009362",
"term": "Neoplasm Metastasis"
}
]
} | null | {
"conditions": [
{
"id": "D009362",
"term": "Neoplasm Metastasis"
}
],
"interventions": null
} |
NCT00445133 | null | Study on Magnetic Field Therapy to Improve Quality of Sleep and Reduction of Chronic Spine Pain | A Double-Blind, Randomized, Placebo-Controlled Study on Magnetic Field Therapy to Improve Quality of Sleep and Reduction of Chronic Spine Pain (Sleep/Mag) | SLEEP/MAG | INTERVENTIONAL | UNKNOWN | 2007-03-06T00:00:00 | null | null | null | [
"PHASE4"
] | 80 | 18 | 85 | ALL | false | HYPTHOTHESIS:
The researchers hypothesize that application of active magnetic therapy vs. sham utilized while individuals sleep can reduce neuropathic pain in the spine and improve the quality of sleep. The null hypothesis is that treatment of subjects with spine pain with exposure to permanent/static magnetic fields has no measurable effect on neuropathic pain scores or quality of sleep scores. | DESIGN:
This is a double-blind, randomized, placebo-controlled study which will consist of two treatment groups. Treated subjects will receive a permanent/static magnetic sleeping pad with a nominal strength of less than 1000 Gauss. Control subjects will receive physically identical sleeping pad with a nominal surface field strength of 0 Gauss (placebo). The magnets will be contained in a standard mattress pad and subjects will sleep on the pad. The primary outcome measures will be quality of sleep as well as the daily VAS scores. These are subjective. There will be objective assessment by the quantification of autonomic nervous system (ANS) strengths of the parasympathetic and sympathetic effects from this non-invasive digital study using spectral analysis. Individuals will be evaluated at onset of study and at end of study to look at specifics of range of motion, spasm, radiculitis, etc. Scores will be kept on a monthly basis as well as repeat of ANS testing each month. At the end of the study, individuals will return all forms, be reevaluated by Dr. Weintraub and also will be asked questions regarding PGIC for bias, etc. Additionally heart rate and systolic and diastolic BP readings at rest and with challenge of standing will be recorded at baseline and each visit to determine if there is an anti-hypertensive effect from sleeping on magnetic device. A reduction of 3 mm Hg improves stroke and cardiac risk by a minimum of 4%. No new anti-hypertensive medications will be allowed. | Inclusion Criteria:
* Female or male subjects age 18-80.
* Capable of understanding and complying with study protocols.
* Chronic cervical, thoracic or lumbar pain for at least six months.
* Sleep difficulties and/or insomnia
Exclusion Criteria:
* Unable to understand informed consent (mental retardation, psychosis, communicative impairment).
* Cardiac pacemaker or other mechanical internal devices.
* Tumor in the spine/history of malignancy.
* Pregnancy.
* Prior spine surgery | Weintraub, Michael I., MD, FACP, FAAN | INDIV | {
"id": "00781440",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2007-03-07T00:00:00 | {
"date": "2007-09-27",
"type": "ESTIMATED"
} | {
"date": "2007-03-08",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
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},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Back Pain",
"Neck Pain",
"Sleep Initiation and Maintenance Disorders"
] | ["Neck Pain/Lumbar pain/Magnets/sleep deficiency/ insomnia/"] | null | [
{
"city": "Briarcliff Manor",
"country": "United States",
"facility": "Dr. Michael I . Weintraub",
"geoPoint": {
"lat": 41.14565,
"lon": -73.82375
},
"state": "New York"
}
] | null | null | {
"other": null,
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"description": null,
"measure": "VAS Pain scores/Pittsburgh Sleep scores/Insomnia sleep scores/SF 15 pain descriptor scores/PGIC/",
"timeFrame": null
}
],
"secondary": [
{
"description": null,
"measure": "Autonomic Nerve Functions",
"timeFrame": null
}
]
} | [
{
"affiliation": "Phelps Memorial Hospital",
"name": "Michael I. Weintraub, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D010146",
"term": "Pain"
},
{
"id": "D009461",
"term": "Neurologic Manifestations"
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"term": "Sleep Disorders, Intrinsic"
},
{
"id": "D020920",
"term": "Dyssomnias"
},
{
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"term": "Sleep Wake Disorders"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
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],
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"id": "M4815",
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"relevance": "LOW"
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"id": "M14473",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "T1303",
"name": "Chronic Graft Versus Host Disease",
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],
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"id": "D007319",
"term": "Sleep Initiation and Maintenance Disorders"
},
{
"id": "D019547",
"term": "Neck Pain"
}
]
} | null | {
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"term": "Sleep Initiation and Maintenance Disorders"
},
{
"id": "D019547",
"term": "Neck Pain"
}
],
"interventions": null
} |
NCT06676033 | null | Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome | Correlative Study of Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome | None | INTERVENTIONAL | RECRUITING | 2024-11-05T00:00:00 | null | 2027-07-01T00:00:00 | 2027-07-01T00:00:00 | [
"PHASE1"
] | 30 | 18 | 100 | ALL | false | This correlative study aims to understand the pharmacodynamic effects and clonal dynamics in response to epcoritamab by obtaining and analyzing lymph node, bone marrow, and blood samples from subjects enrolled in GCT3013-03 trial sponsored by Genmab at NIH. Samples will be collected before and at multiple time points during treatment with epcoritamab. National Heart, Lung, and Blood Institute (NHLBI) investigators are experienced in testing samples treated with bsAb2,3 including epcoritamab in an ongoing pre-clinical collaboration with Genmab. Addressing the objectives of this correlative study will advance the science and clinical application of epcoritamab specifically as well as T-cell engaging bsAb in general as an emerging class of immunotherapy for cancer.
The study is enrolling by invitation only. | Study Description:
Subjects enrolled in GCT3013-03, a phase 1b/2 study of epcoritamab in R/R CLL and RS, at the National Institutes of Health (NIH) Clinical Center (CC) will be invited to simultaneously participate in this companion correlative study. Subjects will undergo percutaneous lymph node coreneedle biopsies, bone marrow biopsies, lymphapheresis, and blood draws for pharmacodynamic evaluation of tumor and immune cells in affected tissue sites and blood before and during treatment with epcoritamab.
Objectives:
Primary Objective:
-Assess the pharmacodynamic effects of epcoritamab in the tumor microenvironment.
Secondary Objectives:
* Assess the pharmacodynamic effects of epcoritamab in blood
* Investigate clonal dynamics during treatment with epcoritamab
Exploratory Objective:
-Evaluate pharmacodynamic and predictive biomarkers
Endpoints:
Primary Endpoint:
-Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow
Secondary Endpoints:
* Immunophenotype and transcriptome of T cells and tumor cells in peripheral blood
* DNA sequencing of tumor cells
Exploratory Endpoints:
-Tests include, but are not limited to single cell multiomics, bulk lymph node transcriptome cytokine analysis | * INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Must be undergoing screening for GCT3013-03
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Ability of subject to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
None | National Institutes of Health Clinical Center (CC) | NIH | {
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"date": "2025-06-18",
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"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
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} | [
"Leukemia, Chronic Lymphocytic",
"Richter Syndrome"
] | ["Epcoritamab, Pharmacodynamic, Tumor Microenvironment, Clonal Dynamics, Biomarker"] | null | [
{
"city": "Bethesda",
"country": "United States",
"facility": "National Institutes of Health Clinical Center",
"geoPoint": {
"lat": 38.98067,
"lon": -77.10026
},
"state": "Maryland"
}
] | null | null | {
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"primary": [
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"description": null,
"measure": "Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow",
"timeFrame": "25 days (Cycle 1 Day 25)"
}
],
"secondary": [
{
"description": null,
"measure": "Immunophenotype and transcriptome of T cells and tumor cells in peripheral blood",
"timeFrame": "167 Days (Cycle 7 Day 1)"
},
{
"description": null,
"measure": "DNA sequencing of tumor cells",
"timeFrame": "167 Days (Cycle 7 Day 1)"
}
]
} | [
{
"affiliation": "National Heart, Lung, and Blood Institute (NHLBI)",
"name": "Clare C Sun, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D004194",
"term": "Disease"
},
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D006402",
"term": "Hematologic Diseases"
},
{
"id": "D008232",
"term": "Lymphoproliferative Disorders"
},
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"term": "Lymphatic Diseases"
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"id": "D007160",
"term": "Immunoproliferative Disorders"
},
{
"id": "D007154",
"term": "Immune System Diseases"
},
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"id": "D015448",
"term": "Leukemia, B-Cell"
},
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"term": "Chronic Disease"
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"term": "Disease Attributes"
}
],
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"name": "Symptoms and General Pathology"
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"name": "All Conditions"
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"name": "Neoplasms"
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"abbrev": "BC15",
"name": "Blood and Lymph Conditions"
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"name": "Immune System Diseases"
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"name": "Rare Diseases"
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],
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"id": "M10945",
"name": "Leukemia",
"relevance": "HIGH"
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"name": "Leukemia, Lymphoid",
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"term": "Leukemia, Lymphocytic, Chronic, B-Cell"
},
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]
} | null | {
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},
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],
"interventions": null
} |
NCT04960033 | null | Evaluating Fracture Risk Assessment Tools (FRAX) From Different Regions in Central South Chinese Postmenopausal Women | Central South University | None | OBSERVATIONAL | COMPLETED | 2021-07-02T00:00:00 | null | 2017-09-30T00:00:00 | 2017-09-30T00:00:00 | null | 264 | 50 | null | FEMALE | true | We evaluated fracture risk assessment tools (FRAXs) from different regions in Chinese postmenopausal women. | This cross-sectional study recruited 264 postmenopausal women aged ≥50 years in September 2017. Basic information, general condition, history of illness, family history, and clinical risk factors were evaluated via a questionnaire. All subjects underwent a bone mineral density examination of the femur and lumbar spine and thoracolumbar spinal X-ray. The 10-year major osteoporotic fracture (MOF) and hip fracture (HF) risks were calculated using FRAXs from mainland China, Hong Kong, Taiwan, and Asia-America. All data were analyzed using SPSS 17.0. Sensitivity, specificity, and likelihood ratio were used to compare the effectiveness of each FRAX. | Inclusion Criteria:
* Postmenopausal women aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017. Menopause was defined as the absence of menstrual cycles for at least one year. All subjects were noninstitutionalized and in good health.
Exclusion Criteria:
* The criteria for exclusion were morphological abnormalities or skeletal distortions that prohibited either clinical measurements or morphometric assessments of skeletal radiographs. | Central South University | OTHER | {
"id": "Sheng zhifeng",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-07-02T00:00:00 | {
"date": "2021-07-13",
"type": "ACTUAL"
} | {
"date": "2021-07-13",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Postmenopausal women aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017. | PROBABILITY_SAMPLE | true | {
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"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
} | [
"Osteoporosis Fracture"
] | ["FRAX", "osteoporosis", "Chinese population"] | null | [
{
"city": "Changsha",
"country": "China",
"facility": "The 2nd Xiangya Hospital, Central South University",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
},
"state": "Hunan"
}
] | null | null | {
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"primary": [
{
"description": null,
"measure": "Osteoporosis fracture",
"timeFrame": "2017years"
}
],
"secondary": null
} | null | [{"pmid": "24146412", "type": "BACKGROUND", "citation": "Zhang Z, Ou Y, Sheng Z, Liao E. How to decide intervention thresholds based on FRAX in central south Chinese postmenopausal women. Endocrine. 2014 Mar;45(2):195-7. doi: 10.1007/s12020-013-0076-y. Epub 2013 Oct 22."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D050723",
"term": "Fractures, Bone"
},
{
"id": "D014947",
"term": "Wounds and Injuries"
},
{
"id": "D001851",
"term": "Bone Diseases, Metabolic"
},
{
"id": "D001847",
"term": "Bone Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
},
{
"id": "D008659",
"term": "Metabolic Diseases"
}
],
"browseBranches": [
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"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
},
{
"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC26",
"name": "Wounds and Injuries"
}
],
"browseLeaves": [
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"asFound": "Osteoporosis",
"id": "M12947",
"name": "Osteoporosis",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M26370",
"name": "Fractures, Bone",
"relevance": "LOW"
},
{
"asFound": "Osteoporosis Fracture",
"id": "M29260",
"name": "Osteoporotic Fractures",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M17685",
"name": "Wounds and Injuries",
"relevance": "LOW"
},
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"asFound": null,
"id": "M5130",
"name": "Bone Diseases, Metabolic",
"relevance": "LOW"
},
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"name": "Bone Diseases",
"relevance": "LOW"
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M11639",
"name": "Metabolic Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D010024",
"term": "Osteoporosis"
},
{
"id": "D058866",
"term": "Osteoporotic Fractures"
}
]
} | null | {
"conditions": [
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"term": "Osteoporosis"
},
{
"id": "D058866",
"term": "Osteoporotic Fractures"
}
],
"interventions": null
} |
NCT04854733 | null | Motor and Cognitive Dual Task Performance in Sports | Dual Task Performance of Soccer Referees: Cognitive Task or Motor Task | None | OBSERVATIONAL | COMPLETED | 2021-04-18T00:00:00 | null | 2021-05-31T00:00:00 | 2021-06-23T00:00:00 | null | 102 | 18 | 30 | MALE | true | In this study, it is aimed to examine the dual-task performance of soccer referees. For this purpose, it will be investigated whether the motor or cognitive performance of the referees changes when dual-task is assigned and also whether there are differences in dual-task performance between the referees and athletes with similar training program. | In this study, the motor and cognitive dual-task performances of referees will be evaluated. It also will be investigated whether the referees prioritize one of the performances, motor or cognitive, during the dual-task and whether their role in the competition makes a difference compared to athletes. For this purpose, appropriate motor and cognitive tasks were determined by considering the roles of the referees during the competition.
After completing the Demographic Information Form respectively; Edgren Side Step Agility Test as motor performance assessment, Multiple Object Tracking (MOT) as cognitive performance assessment, and finally Dual-Task evaluation using MOT and Edgren Side Step Agility Test will be applied simultaneously. Dual-task costs will be calculated as a percentage of single-task for both motor and cognitive tasks. | Inclusion Criteria:
* To be a soccer referee who trains for a total of 5 hours two days a week, takes part in a maximum of two competitions a week and has been actively affiliated with the National Football Federation for at least 1 year,
* Being an athlete with similar to soccer referees in terms of sociodemographic and physical characteristics and training program,
* Being between aged 18-30 years.
Exclusion Criteria:
* Not attending weekly trainings regularly,
* Having had a surgical operation in the last year,
* Having a history of trauma in the last 6 months,
* Not being able to communicate,
* Having uncorrected visual deficit and hearing problem. | Marmara University | OTHER | {
"id": "24.04.2019/59",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-04-21T00:00:00 | {
"date": "2021-07-12",
"type": "ACTUAL"
} | {
"date": "2021-04-22",
"type": "ACTUAL"
} | [
"ADULT"
] | Soccer referees affiliated with the National Football Federation and athletes with similar to soccer referees in terms of sociodemographic and physical characteristics and training program. | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
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"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
} | [
"Task Performance"
] | ["Dual-Task Performance", "Task- specific Performance", "Sports", "Agility", "Multiple Object Tracking", "Referee"] | null | [
{
"city": "Istanbul",
"country": "Turkey",
"facility": "Marmara University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Maltepe"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Multiple Object Tracking (MOT)",
"timeFrame": "20 minutes"
},
{
"description": null,
"measure": "Edgren Side Step Test",
"timeFrame": "20 minutes"
},
{
"description": null,
"measure": "Dual Task Assessment",
"timeFrame": "20 minutes"
}
],
"secondary": null
} | [
{
"affiliation": "Marmara University Faculty of Health Sciences",
"name": "Semra Oğuz, Phd",
"role": "STUDY_DIRECTOR"
},
{
"affiliation": "Marmara University Faculty of Health Sciences",
"name": "Nilufer Keskin Dilbay, MSc",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Marmara University Faculty of Health Sciences",
"name": "Hilal B Can, MSc",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT06357533 | null | Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations | A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10) | TROPION-Lung10 | INTERVENTIONAL | RECRUITING | 2024-04-05T00:00:00 | null | 2028-04-24T00:00:00 | 2030-05-24T00:00:00 | [
"PHASE3"
] | 675 | 18 | null | ALL | false | The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations. | This is a Phase III, randomized, open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig monotherapy versus Pembrolizumab monotherapy for the first-line treatment of participants with locally-advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations. | Inclusion Criteria:
* Histologically or cytologically documented non-squamous NSCLC.
* Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation.
* Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies.
* Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.
* Known tumour PD-L1 expression status defined as TC ≥ 50%
* At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline
* ECOG performance status of 0 or 1
* Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention
Exclusion Criteria:
* Prior systemic therapy for advanced/metastatic NSCLC.
* Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
* History of another primary malignancy within 3 years
* Active or prior documented autoimmune or inflammatory disorders (with exceptions)
* Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
* Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
* History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
* Has significant pulmonary function compromise, as determined by the investigator
* Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.
* History of leptomeningeal carcinomatosis
* Known clinically significant corneal disease
* Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled
* History of active primary immunodeficiency | AstraZeneca | INDUSTRY | {
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] | [
{
"class": "INDUSTRY",
"name": "Daiichi Sankyo"
}
] | null | {
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{
"description": null,
"measure": "Safety of Dato-DXd in combination with rilvegostomig and rilvegostomig monotherapy as compared with pembrolizumab.",
"timeFrame": "Approximately 6 years"
}
],
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"measure": "Progression-Free Survival (PFS) in TROP2 biomarker positive participants.",
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},
{
"description": null,
"measure": "Overall Survival (OS) in TROP2 biomarker positive participants.",
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}
],
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{
"description": null,
"measure": "Progression-Free Survival (PFS) in the FAS population.",
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},
{
"description": null,
"measure": "Overall Survival (OS) in the FAS population.",
"timeFrame": "Approximately 6 years"
},
{
"description": null,
"measure": "Assessment of Objective Response Rate (ORR) by BICR in TROP2 biomarker positive and FAS populations",
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},
{
"description": null,
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},
{
"description": null,
"measure": "Participant-reported lung cancer symptoms of NSCLC and participant-reported GHS/QOL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab.",
"timeFrame": "Approximately 6 years"
},
{
"description": null,
"measure": "Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab.",
"timeFrame": "Approximately 6 years"
},
{
"description": null,
"measure": "Pharmacokinetics (PK)",
"timeFrame": "Approximately 6 years"
},
{
"description": null,
"measure": "Immunogenicity",
"timeFrame": "Approximately 6 years"
},
{
"description": null,
"measure": "Second Progression-Free Survival (PFS2).",
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}
]
} | [
{
"affiliation": "Emory University, Atlanta, Georgia, United States of America.",
"name": "Suresh S. Ramalingam, MD",
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}
] | null | {"versionHolder": "2025-06-18"} | {
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{
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{
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],
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} | {
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],
"interventions": [
{
"id": "C582435",
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]
} |
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