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NCT02961179 | Dairy Products, Diabetes and Genetics | https://clinicaltrials.gov/study/NCT02961179 | PRODIGE | COMPLETED | This study will investigate the in-depth the benefits of dairy consumption on glucose metabolism in patients at risk of type 2 diabetes using novel genomics methodology.To do so, 33 individuals at risk of type 2 diabetes will be randomly subjected to an intervention study including a 6-week intensive dairy product consumption period and a 6-week dietary counselling period. | NO | Insulin Sensitivity|Type2 Diabetes | BEHAVIORAL: Increased dairy product|BEHAVIORAL: Dietary counselling | Change from baseline to 6 weeks in insulin sensitivity between high dairy and dietary counselling phases, 2h-oral glucose tolerance test (OGTT), Change from 0 to 6 weeks | Change from baseline to 6 weeks in fasting glucose between high dairy and dietary counselling phases, Change from 0 to 6 weeks|Change from baseline to 6 weeks in 2 h plasma glucose post OGTT between high dairy and dietary counselling phases, Change from 0 to 6 weeks|Change from baseline to 6 weeks in insulin secretion (Insulinogenic index ) between high dairy and dietary counselling phases, Insulinogenic index, Change from 0 to 6 weeks|Change from baseline to 6 weeks in insulin secretion (area under the curve of C-peptide) between high dairy and dietary counselling phases, Area under the curve of C-peptide, Change from 0 to 6 weeks|Change from baseline to 6 weeks in b-cell function (disposition index) between high dairy and dietary counselling phases, Change from 0 to 6 weeks|Change from baseline to 6 weeks in glucagon-like peptide-1 secretion between high dairy and dietary counselling phases, Change from 0 to 6 weeks|Change from baseline to 6 weeks in fat mass between high dairy and dietary counselling phases, Dual-energy X-ray absorptiometry, Change from 0 to 6 weeks|Change from baseline to 6 weeks in blood pressure between high dairy and dietary counselling phases, Change from 0 to 6 weeks|Change from baseline to 6 weeks in aortic stiffness (pulse wave velocity) between high dairy and dietary counselling phases, Change from 0 to 6 weeks|Change from baseline to 6 weeks in lipid profile (total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) between high dairy and dietary counselling phases, Change from 0 to 6 weeks|Change from baseline to 6 weeks in inflammatory profile (C-reactive protein, Tumor necrosis factor-alpha, Interleukin-6) between high dairy and dietary counselling phases, Change from 0 to 6 weeks|Change from baseline to 6 weeks in oxidative stress profile (F2-isoprostane profiles) between high dairy and dietary counselling phases, Change from 0 to 6 weeks|Change from baseline to 6 weeks in fatty acid profile between high dairy and dietary counselling phases, Change from 0 to 6 weeks|Change from baseline to 6 weeks in serum 25(OH) vitamin D between high dairy and dietary counselling phases, Change from 0 to 6 weeks|Change from baseline to 6 weeks in gene expression profiles between high dairy and dietary counselling phases, Change from 0 to 6 weeks|Change from baseline to 6 weeks in metabolomics profiles between high dairy and dietary counselling phases, Change from 0 to 6 weeks | null | CHU de Quebec-Universite Laval | Canadian Institutes of Health Research (CIHR) | ALL | ADULT, OLDER_ADULT | null | 33 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION | 2017-3228 | 2017-01 | 2018-07-13 | 2018-07-13 | 2016-11-10 | null | 2019-03-01 | Research Center CHU de Quebec-Université Laval, Quebec, G1V 4G2, Canada | null | {
"Increased dairy product": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Dietary counselling": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT04287179 | SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes | https://clinicaltrials.gov/study/NCT04287179 | SUSTAIN SWITCH | WITHDRAWN | This study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide. The study will also evaluate the use of a new pen-injector for semaglutide used to inject medicine under the skin, at a new dose of 2 mg. People taking part in the study will take this medicine together with their current diabetes tablets other than semaglutide. Participants will either get a start dose of 0.25 mg semaglutide or 0.50 mg semaglutide, and the dose will be gradually increased to 2.0 mg semaglutide - which treatment is decided by chance. Participants will inject semaglutide under the skin once a week, any time of the day. When the dose reaches 2.0 mg semaglutide, participants will inject the medicine with a new type of pen-injector. The study will last for about 24 weeks. Participants will have 9 visits and 1 phone call with the study doctor. At 9 visits participants will have blood taken and at 2 visits they will have eye examination done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Women who are able to get pregnant will be checked 10 times for pregnancy via urine tests. | NO | Diabetes Mellitus, Type 2 | DRUG: Semaglutide | Change in glycosylated haemoglobin (HbA1c), Percent-point, From baseline (week 0) to week 12 | Change in fasting plasma glucose, mmol/L, From baseline (week 0) to week 12|Change in body weight, Kg, From baseline (week 0) to week 12|Number of treatment emergent adverse events (TEAEs), Count, From baseline (week 0) to week 12|Number of treatment emergent gastrointestinal adverse events, Count, From baseline (week 0) to week 12|Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes, Count, From baseline (week 0) to week 12|Change in pulse rate, Beats per minute (bpm), From baseline (week 0) to week 12|Number of treatment emergent adverse events (TEAEs), Count, From week 12 to week 17 | null | Novo Nordisk A/S | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 0 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | NN9535-4650|U1111-1242-5426|2019-004234-42 | 2020-03-09 | 2020-11-16 | 2021-01-25 | 2020-02-27 | null | 2022-02-03 | Novo Nordisk Investigational Site, Buena Park, California, 90620, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, San Jose, California, 95148, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Waterbury, Connecticut, 06708, United States|Novo Nordisk Investigational Site, Honolulu, Hawaii, 96814, United States|Novo Nordisk Investigational Site, Idaho Falls, Idaho, 83404-7596, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46260, United States|Novo Nordisk Investigational Site, Troy, Michigan, 48098, United States|Novo Nordisk Investigational Site, Albany, New York, 12206, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-9302, United States|Novo Nordisk Investigational Site, Round Rock, Texas, 78681, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77478, United States|Novo Nordisk Investigational Site, Graz, 8036, Austria|Novo Nordisk Investigational Site, Stockerau, 2000, Austria|Novo Nordisk Investigational Site, Wien, 1090, Austria|Novo Nordisk Investigational Site, Wien, 1130, Austria|Novo Nordisk Investigational Site, Jyväskylä, 40100, Finland|Novo Nordisk Investigational Site, Kuopio, 70100, Finland|Novo Nordisk Investigational Site, Lahti, 15100, Finland|Novo Nordisk Investigational Site, Raisio, 21200, Finland|Novo Nordisk Investigational Site, Seinäjoki, 60220, Finland|Novo Nordisk Investigational Site, Göteborg, 413 45, Sweden|Novo Nordisk Investigational Site, Malmö, 205 02, Sweden | null | {
"Semaglutide": [
{
"intervention_type": "DRUG",
"description": "Semaglutide",
"name": "Semaglutide",
"synonyms": [
"Wegovy",
"Semaglutide",
"Reybelsus",
"S\u00e9maglutide",
"Ozempic",
"Rybelsus"
],
"medline_plus_id": "a618008",
"generic_names": [
"Semaglutide"
],
"drugbank_id": "DB13928",
"wikipedia_url": "https://en.wikipedia.org/wiki/Semaglutide"
}
]
} |
NCT00501579 | Study of Difluprednate in the Treatment of Uveitis | https://clinicaltrials.gov/study/NCT00501579 | null | COMPLETED | The purpose of this study is to determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitis. | NO | Uveitis | DRUG: Difluprednate|DRUG: Prednisolone Acetate | null | null | null | Sirion Therapeutics, Inc. | null | ALL | CHILD, ADULT, OLDER_ADULT | PHASE3 | null | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: | ST-601A-001 | null | null | null | 2007-07-16 | null | 2008-08-29 | John-Kenyon American Eye Institute, New Albany, Indiana, 47150, United States | null | {
"Difluprednate": [
{
"intervention_type": "DRUG",
"description": "Difluprednate",
"name": "Difluprednate",
"synonyms": [
"Durezol",
"Difluoroprednisolone butyrate acetate",
"DFBA",
"Difluprednate"
],
"medline_plus_id": "a609025",
"generic_names": [
"Difluprednate"
],
"drugbank_id": "DB06781"
}
],
"Prednisolone acetate": [
{
"intervention_type": "DRUG",
"description": "Prednisolone Acetate",
"name": "Prednisolone acetate",
"synonyms": [
"Prednisolone acetate"
],
"drugbank_id": "DB15566",
"generic_names": [
"Prednisolone acetate"
]
}
]
} |
NCT05229679 | HPV-based Screening Among Women 23-29 Years of Age | https://clinicaltrials.gov/study/NCT05229679 | null | RECRUITING | The aim of the trial is to determine whether organized screening with primary HPV analysis provide higher cancer protection in the age group 23-29 years compared to primary cytology. | NO | Human Papilloma Virus|Cervical Intraepithelial Neoplasia|Cervical Cancer | DIAGNOSTIC_TEST: HPV testing | Incidence of cervical cancer, Cervical cancer incidence in the intervention group compared to a historical control group., Measured once during 1 year, year 1.|Incidence of cervical cancer, Cervical cancer incidence in the intervention group compared to a historical control group., Measured once during 1 year, year 2.|Incidence of cervical cancer, Cervical cancer incidence in the intervention group compared to a historical control group., Measured once during 1 year, year 3.|Incidence of cervical cancer, Cervical cancer incidence in the intervention group compared to a historical control group., Measured once during 1 year, year 4.|Incidence of cervical cancer, Cervical cancer incidence in the intervention group compared to a historical control group., Measured once during 1 year, year 5.|Incidence of cervical cancer, Cervical cancer incidence in the intervention group compared to a historical control group., Measured once during 1 year, year 6.|Incidence of cervical cancer, Cervical cancer incidence in the intervention group compared to a historical control group., Measured once during 1 year, year 7.|Incidence of cervical cancer, Cervical cancer incidence in the intervention group compared to a historical control group., Measured once during 1 year, year 8.|Incidence of cervical cancer, Cervical cancer incidence in the intervention group compared to a historical control group., Measured once during 1 year, year 9.|Incidence of cervical cancer, Cervical cancer incidence in the intervention group compared to a historical control group., Measured once during 1 year, year 10. | Cost-effectiveness of the new screening method, Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data., Measured once during 1 year, year 1.|Cost-effectiveness of the new screening method, Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data., Measured once during 1 year, year 2.|Cost-effectiveness of the new screening method, Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data., Measured once during 1 year, year 3.|Cost-effectiveness of the new screening method, Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data., Measured once during 1 year, year 4.|Cost-effectiveness of the new screening method, Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data., Measured once during 1 year, year 5.|Cost-effectiveness of the new screening method, Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data., Measured once during 1 year, year 6.|Cost-effectiveness of the new screening method, Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data., Measured once during 1 year, year 7.|Cost-effectiveness of the new screening method, Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data., Measured once during 1 year, year 8.|Cost-effectiveness of the new screening method, Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data., Measured once during 1 year, year 9.|Cost-effectiveness of the new screening method, Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data., Measured once during 1 year, year 10. | null | Karolinska Institutet | null | FEMALE | ADULT | null | 180,000 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | 2020-00053 | 2020-11-16 | 2038-12-31 | 2038-12-31 | 2022-02-08 | null | 2023-10-06 | Region of Skåne, Lund, Skåne, 221 00, Sweden|Region Stockholm, Stockholm, 102 39, Sweden | null | {
"Human Papillomavirus (HPV) Vaccine (Cervarix)": [
{
"intervention_type": "DIAGNOSTIC_TEST",
"description": "HPV testing",
"name": "Human Papillomavirus (HPV) Vaccine (Cervarix)",
"synonyms": [
"Human Papillomavirus (HPV) Vaccine (Cervarix)",
"Cervarix",
"HPV",
"Gardasil-9",
"Human Papillomavirus (HPV) Vaccine",
"HPV",
"Human Papillomavirus (HPV) Vaccine "
],
"medline_plus_id": "a610014",
"generic_names": [
"Human Papillomavirus (HPV) Vaccine (Cervarix)",
"Human Papillomavirus (HPV) Vaccine "
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Cervarix"
}
]
} |
NCT06291779 | Diagnosis of Pancreatic Cancer by Purine Metabolite (Hypoxanthine, Xanthine) in Urine | https://clinicaltrials.gov/study/NCT06291779 | null | RECRUITING | * This study aim to develope a diagnostic method of pancreatic cancer by using a reagent for analyzing purine metabolite (Hypoxanthine, Xanthine) in urine.
* It is safe and cost effective compare to radiologic or blood test. It can be used for initial screening test for healty population. | NO | Pancreas Cancer|Diagnosis | DEVICE: Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio | Urine, mean concentration of purine metabolites in urine, 1 day | null | null | Ho-Seong Han | Seoul National University Bundang Hospital | ALL | ADULT, OLDER_ADULT | null | 120 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | SNUBH-GS- HBP5|E-2211-792-350 (local IRB) | 2022-11-30 | 2024-02-26 | 2024-05-31 | 2024-03-04 | null | 2024-03-04 | Ho-Seong Han, Seongnam, Gyeonggi-do, Korea, Republic of | null | {
"Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT01867879 | Study to Evaluate the Cardiac Safety of TAS-102 in Patients With Advanced Solid Tumors | https://clinicaltrials.gov/study/NCT01867879 | null | COMPLETED | The purpose of this study is to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors. | NO | Advanced Solid Tumors (Excluding Breast Cancer) | DRUG: TAS-102|DRUG: Placebo | QTc interval, Predose (Day -2) to post-dose changes and absolute values in QTc interval after placebo (Day -1, Cycle 1), after a single dose of TAS-102 (Day 1, Cycle 1), and after multiple doses (Day 12, Cycle 1), Days -2, -1, 1, and 12 of Cycle 1 | Quantitative and Qualitative ECG parameters, Predose (Day -2) to postdose changes and absolute values in quantitative Holter ECG parameters (heart rate, RR, PR and QRS intervals) after placebo (Day -1, Cycle 1), after a single dose of TAS-102 (Day 1, Cycle 1), and after multiple doses (Day 12, Cycle 1). In addition, qualitative assessments of Holter ECG recordings will be performed., Days -2, -1, 1, and 12 of Cycle 1|Relationship between TAS-102 pharmacokinetics and its effect on cardiac repolarization, Pharmacokinetic samples are taken on Days 1 and 12 of Cycle 1. The relationship between plasma concentrations of TAS-102 and the change from baseline in QTc adjusted by placebo will be quantified using a linear mixed effect model approach., Days 1 and 12 of Cycle 1|Safety monitoring including adverse events, vital signs, and laboratory assessments, Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used., Through 30 days following last administration of study medication or until initiation of new anticancer treatment|Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST), Every 8 weeks through Cycle 6 (ie, through 24 weeks). Thereafter, assessments will be performed at least every 12 weeks according to site standard of care, until at least one of the treatment discontinuation criteria is met. | null | Taiho Oncology, Inc. | null | ALL | ADULT, OLDER_ADULT | PHASE1 | 44 | INDUSTRY | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT | TPU-TAS-102-103|2013-000650-21 | 2013-06 | 2014-08 | 2015-04 | 2013-06-04 | null | 2015-11-09 | Sarah Cannon Research Institute, Nashville, Tennessee, 37203, United States | null | {
"TAS-102": [
{
"intervention_type": "DRUG",
"description": "TAS-102",
"name": "TAS-102",
"synonyms": [
"",
"TAS-102"
],
"drugbank_id": "DB08937",
"generic_names": [
"TAS-102"
]
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT03505879 | Next Generation Sequencing Detection of Lyme Disease | https://clinicaltrials.gov/study/NCT03505879 | null | COMPLETED | Next Generation Sequencing is capable of sequencing millions of small strands of DNA from a single blood sample, potentially improving its sensitivity compared to PCR testing, which only detects predetermined larger strands of DNA. We will test the ability of NGS to detect Borrelia burgdorferi DNA in the blood of pediatric patients with Lyme disease. We will conduct an observational study of NGS testing on pediatric patients at all stages of Lyme disease. Study involvement will require a single study visit for clinical data collection and blood draw. We will enroll patients at all phases of suspected Lyme disease, collect clinically relevant information, and test for Lyme disease using Next Generation Sequencing and standard Lyme serologic testing. If the patient has multiple erythema migrans, Lyme meningitis, facial nerve palsy, arthritis, or carditis, a B. burgdorferi serum PCR will also be sent. Enrollment and Next Generation Sequencing blood draw will occur before or up to 24 hours after the first dose of antibiotics is administered. We will also study the impact of antibiotics on NGS testing by running the test 6-24 hours after antibiotics are started among a small subset of patients with a multiple erythema migrans rash. Collected data will be analyzed with basic descriptive statistics. | NO | Lyme Disease|Pediatric Infectious Disease|Erythema Migrans|Lyme Arthritis|Lyme Carditis|Lyme Disease Meningitis | null | Ability of Next Generation Sequencing to detect Borrelia burgdorferi DNA in blood, To determine if Next Generation Sequencing (NGS) is able to detect Borrelia burgdorferi DNA in the blood of pediatric patients with Lyme disease, including those with erythema migrans (single or multiple), Lyme meningitis, Lyme carditis, Lyme disease facial palsy, and Lyme arthritis, 1 year|NGS detection of Borrelia burgdorferi DNA following antibiotics, To determine if Next Generation Sequencing (NGS) is able to detect Borrelia burgdorferi DNA in the blood of pediatric patients with a multiple erythema migrans rash shortly after the first dose of antibiotics., 1 year | null | null | Stony Brook University | Karius, Inc. | ALL | CHILD | null | 15 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 1205731-1 | 2018-07-24 | 2020-05-31 | 2020-05-31 | 2018-04-23 | null | 2022-02-25 | Clinical Research Center, Setauket, New York, 11733-9219, United States | null | {} |
NCT02632279 | Tryptophan Depletion in PD Patients Treated With STN DBS | https://clinicaltrials.gov/study/NCT02632279 | null | TERMINATED | The purpose of this study is to assess the effect of tryptophan depletion on mood and behavior in Parkinsons disease (PD) patients treated with deep brain stimulation (DBS) of the subthalamic nucleus (STN). By doing this, the investigators hope to be able to identify risk factors for and mechanisms underlying psychiatric side effects of STN DBS. The study will be an intervention study with a placebo controlled, randomized cross-over design. | NO | Parkinsons Disease | DIETARY_SUPPLEMENT: Tryptophan (TRP) depletion|DIETARY_SUPPLEMENT: Placebo|DEVICE: Stimulator ON|DEVICE: Stimulator OFF | Mood, as assessed through the Profile of Mood States, There will be 6 measurements spread over 2 testing days with a wash-out period of min. 1 weak. baseline measure, 3.5 hours after intake of the amino acid mixture, and 5.5 hours after intake of the amino acid mixture | Motor scores, as assessed through the MDS-UPDRS, There will be 6 measurements spread over 2 testing days with a wash-out period of min. 1 weak. baseline measure, 3.5 hours after intake of the amino-acid mixture, and 5.5 hours after intake of the amino-acid mixture|Impulsivity, as assessed through a reaction time task, There will be 6 measurements spread over 2 testing days with a wash-out period of min. 1 weak. baseline measure, 3.5 hours after intake of the amino-acid mixture, and 5.5 hours after intake of the amino-acid mixture|Emotional Responsiveness, as assessed through the emotional responsiveness task, There will be 4 measurements spread over 2 testing days with a wash-out period of min. 1 weak. baseline measure, 3.5 hours after intake of the amino-acid mixture | null | Maastricht University Medical Center | Netherlands Brain Foundation | ALL | CHILD, ADULT, OLDER_ADULT | null | 7 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | Tryptophan depletion in PD | 2015-11 | 2017-11 | 2017-11-15 | 2015-12-16 | null | 2018-08-22 | Maastricht University Medical Center, Maastricht, Limburg, Netherlands | null | {
"Tryptophan": [
{
"intervention_type": "DIETARY_SUPPLEMENT",
"description": "Tryptophan (TRP) depletion",
"name": "Tryptophan",
"synonyms": [
"PMS Tryptophan",
"Optimax",
"Tryptophan Metabolism Alterations",
"Trofan",
"ratio Tryptophan",
"Tryptophan",
"PMS-Tryptophan",
"Triptofano",
"Tryptan",
"Levotryptophan",
"Lyphan",
"Ardeydorm",
"L Tryptophan ratiopharm",
"L-(\u2212)-tryptophan",
"Naturruhe",
"L Tryptophan",
"Ardeytropin",
"ratio-Tryptophan",
"Tryptacin",
"L-Tryptophan-ratiopharm",
"L-Tryptophan"
],
"mesh_id": "D018687",
"generic_names": [
"Tryptophan"
],
"drugbank_id": "DB00150"
}
],
"Placebo": [
{
"intervention_type": "DIETARY_SUPPLEMENT"
}
],
"Stimulator ON": [
{
"intervention_type": "DEVICE"
}
],
"Stimulator OFF": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT04029779 | Evaluation of Immediately Placed Dental Implants With Local Application of Injectable PRF in Periodontally Compromised Sites | https://clinicaltrials.gov/study/NCT04029779 | PRF | COMPLETED | The present study is a human, prospective, parallel, randomised controlled clinical trial conducted to explore the efficacy of injectable PRF around dental implants. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010. | NO | Bone Density|Bone Loss, Alveolar | BIOLOGICAL: I-PRF | Crestal bone level, Measured using CBCT scan both on mesial and distal sides .The coronal surface of the implant will be taken as reference line from where two perpendicular lines are dropped on both mesial and distal aspect of implants to first bone to implant contact., 6 months|Bone density, measured using CBCT scan using Hounsfield units at mid point of the implant both on mesial and distal side with coronal portion of implant as reference line., 6 months | Angular bleeding index, A periodontal probe passed along the buccal margin at 60 degrees angulation in gingival sulcus. The resultant bleeding is recorded as present (+) or absent (-)., 6 months|Peri-implant Probing pocket depth, measured mesially and distally using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)., 6 months|Pink esthetic score, Digital photographs will be used for evaluation of the pink esthetic score(PES). Charts containing the seven variables will be designed. These include: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue colour and texture. Each variable will be recorded with a 2-1-0 score, where 2 is the best and 0 is the poorest score., 6 months | null | Krishnadevaraya College of Dental Sciences & Hospital | null | ALL | ADULT | PHASE2 | 10 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 02_D012_81520 | 2017-11-11 | 2019-11-30 | 2019-11-30 | 2019-07-23 | null | 2019-12-12 | Krishnadevaraya college of dental sciences, Bangalore, Karnataka, 562157, India | null | {
"I-PRF": [
{
"intervention_type": "BIOLOGICAL"
}
]
} |
NCT00790179 | Continuous Lumbar Plexus Block for Postoperative Pain Control After Total Hip Arthroplasty | https://clinicaltrials.gov/study/NCT00790179 | null | COMPLETED | Continuous lumbar plexus and femoral blocks have been demonstrated to provide effective postoperative analgesia of the lower extremity following total joint arthroplasty. The purpose of this study was to compare these two techniques when used with intravenous patient-controlled analgesia and the use of patient-controlled analgesia alone for postoperative pain management following unilateral total hip arthroplasty. | NO | Postoperative Pain | PROCEDURE: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA | VAS pain scores, at 24 and 48 hours | hydromorphone consumption,patient satisfaction,distance ambulated, opioid-related side effects, at 24 and 48 hours | null | Northwell Health | null | ALL | ADULT, OLDER_ADULT | null | 225 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT | 1989md | 2003-01 | 2007-01 | 2007-03 | 2008-11-13 | null | 2008-11-13 | null | null | {
"Ropivacaine": [
{
"intervention_type": "PROCEDURE",
"description": "continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA",
"name": "Ropivacaine",
"synonyms": [
"Ropivacaina",
"1-Propyl-2',6'-pipecoloxylidide",
"(S)-(\u2212)-1-propyl-2',6'-pipecoloxylidide",
"Naropeine",
"Ropivacaine Hydrochloride",
"L-N-n-propylpipecolic acid-2,6-xylidide",
"AL-381",
"Ropivacaine",
"Ropivacainum",
"Naropin",
"1 Propyl 2',6' pipecoloxylidide",
"Ropivacaine Monohydrochloride",
"LEA 103",
"Ropivacaine Monohydrochloride, (S)-isomer",
"LEA103",
"AL381",
"LEA-103",
"(S)-ropivacaine",
"AL 381"
],
"mesh_id": "D000779",
"generic_names": [
"Ropivacaine"
],
"drugbank_id": "DB00296"
}
],
"Pidolic acid": [
{
"intervention_type": "PROCEDURE",
"description": "continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA",
"name": "Pidolic acid",
"synonyms": [
"L-pyrrolidone carboxylic acid",
"(S)-(\u2212)-2-pyrrolidone-5-carboxylic acid",
"5-oxo-2-pyrrolidinecarboxylic acid",
"Pidolic acid",
"L-pyroglutamic acid",
"5-L-oxoproline",
"(S)-pyroglutamic acid",
"5-Pyrrolidone-2-carboxylic acid",
"Pyroglutamic acid",
"5-oxo-L-proline",
"PCA",
"L-5-Pyrrolidone-2-carboxylic acid",
"Glutimic acid",
"(\u2212)-2-pyrrolidone-5-carboxylic acid"
],
"drugbank_id": "DB03088",
"generic_names": [
"Pidolic acid"
]
}
]
} |
NCT05585879 | Demonstrating Effective Salvage of Inadequate Colonoscopies | https://clinicaltrials.gov/study/NCT05585879 | null | TERMINATED | The aim of this study is to demonstrate that the use of the Pure-Vu EVS System can salvage inadequately prepared optical colonoscopies (OCs) to adequate OCs. | NO | Colorectal Screening | DEVICE: Pure-Vu EVS | Rate of incomplete colonoscopies, Rate of incomplete colonoscopies due to inadequate preparation salvaged to adequate colonoscopies with the use of the Pure-Vu EVS System.
Inadequate OCs defined as such if any of the following are met:
* BBPS < 6 (Adequacy is defined as BBPS of 2 or greater in each segment)
* Inability to identify > 5mm polyps The estimated rate of salvaged preparations will be calculated and presented with exact one-sided 95% confidence interval: Number of preps inadequate with SOC and adequate after Pure-VU EVS System / Number of preps inadequate with SOC.
The lower bound will be compared to a 35% performance goal., Day 0 (Procedure Day) | Assessment of Screening, The following secondary endpoint will be assessed:
Number of polyps and adenomas: type, location, size, pathology and morphology, Day 0 (Procedure Day)|Assessment of Screening, Boston Bowel Prep Score (BBPS) before and after Pure-Vu EVS use. Throughout the procedure, the study endoscopist will be requested to document the pre-cleansing BBPS and post- cleansing BBPS for each colon segment., Day 0 (Procedure Day)|Procedural Outcome, Sedation type The type of sedation will not be dictated by the study but will be documented., Day 0 (Procedure Day)|Procedural Outcome, Cecum Intubation Rate, Day 0 (Procedure Day)|Assessment screening, Polyp Miss Rate (PMR), Day 0 (Procedure Day)|Assessment screening, Adenoma Detection Rate (ADR), Day 0 (Procedure Day)|Assessment screening, Adenoma Miss Rate (AMR), Day 0 (Procedure Day)|Assessment screening, Adenoma Per Colonoscopy (APC), Day 0 (Procedure Day)|Assessment screening, Adenomas Per Positive Patient (APP), Day 0 (Procedure Day)|Assessment screening, Sessile Serrated Adenoma Detection Rate, Day 0 (Procedure Day)|Assessment Screening, Polyp Detection Rate (PDR), Day 0 (Procedure Day)|Procedural Outcomes, Procedure Time: Time to cecum and withdrawal time, Day 0 (Procedure Day)|Procedural Outcomes, Intraprocedural tools The type of Intraprocedural tools will not be dictated by the study but will be documented., Day 0 (Procedure Day) | User Satisfaction, Clinician Satisfaction Questionnaire: Each clinician will complete a questionnaire for each completed Pure-Vu EVS procedure., Day 0(Procedure Day)|Comparison Rates, Comparison of SAE rates between Pure-Vu subjects and the published serious complication rate of standard colonoscopy procedures (2.8%), Day 0 (Procedure Day) - 1-14 day follow up|Economic Impact, Economic Impact: Impact will be calculated by utilizing both data generated as part of the study and data published on the costs associated with outpatient colonoscopies and subsequent findings., Through study completion, an average of 1 year. | Motus GI Medical Technologies Ltd | null | ALL | ADULT, OLDER_ADULT | null | 16 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER | CL00052 | 2022-11-03 | 2024-04-26 | 2024-04-26 | 2022-10-19 | null | 2024-05-13 | NYU, New York, New York, 02241, United States | Study Protocol, https://cdn.clinicaltrials.gov/large-docs/79/NCT05585879/Prot_001.pdf | {
"Pure-Vu EVS": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT03131479 | Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function. | https://clinicaltrials.gov/study/NCT03131479 | null | COMPLETED | The purpose of this trial was to evaluate whether the study drug, LIK066, causes glucose excretion in urine in patients with varying degrees of decreased kidney function and in subjects with normal kidney function. Blood samples were collected to measure the concentrations of LIK066 and to study the pharmacokinetics of LIK066. Pharmacokinetics is meant to study how LIK066 is absorbed, distributed and eliminated, in other words what the body does to the drug. The results of this study may be used to help determine whether LIK066 can be used to treat people with reduced kidney function and the proper dosing regimen. | YES | Renal Impairment | DRUG: LIK066 | Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7, Urine was collected over 24 h to measure Urinary Glucose Excretion (UGE) at baseline (Day -1), following a single dose (Day 1) and at the end of the 7-day treatment (Day 7) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function., Baseline , Day 7|Maximum Observed Plasma Concentration (Cmax) for LIK066, Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.
Cmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done., Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Time to Reach the Maximum Plasma Concentration (Tmax) for LIK066, Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.
Tmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done., Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for LIK066, Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.
AUCtau was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done., Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for LIK066 on Day 7, Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.
AUClast was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUClast is similar to AUCtau on Day 1 since the Tlast for Day 1 = 24hrs (tau = 24hrs); therefore AUClast is not reported for Day1, it is however reported for Day 7 since the Tlast is different from 24 hours. Only descriptive analysis done., Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for LIK066 on Day 1, Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.
AUCinf was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUCinf is a single dose parameter and therefore is presented on Day 1 only, after the first dose of LIK066. Only descriptive analysis done., Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Terminal Elimination Half-life (T1/2) for LIK066 on Day 7, Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.
T1/2 was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. T1/2 is only reported at Day 7 only, since there was sampling out to ~5 half-lives after the Day 7 dose of LIK066. Only descriptive analysis done., Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Apparent Systemic (or Total Body) Clearance From Plasma Following Extravascular Administration (CL/F) for LIK066 on Day 1, Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.
CL/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Since Day 7 represented steady state of LIK066 in the study, the appropriately calculated steady-state clearance parameter computed was CLss/F and was presented. Only descriptive analysis done., Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) for LIK066 on Day 1, Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.
Vz/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done., Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Renal Clearance From Plasma (CLr) for LIK066, Urine PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.
CLr was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done., Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) | null | null | Novartis Pharmaceuticals | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 53 | INDUSTRY | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT | CLIK066B2202|2016-004770-18 | 2017-04-28 | 2018-01-16 | 2018-01-16 | 2017-04-27 | 2019-02-06 | 2021-01-05 | Novartis Investigative Site, Orlando, Florida, 32809, United States | Study Protocol, https://cdn.clinicaltrials.gov/large-docs/79/NCT03131479/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/79/NCT03131479/SAP_001.pdf | {
"LIK066": [
{
"intervention_type": "DRUG"
}
]
} |
NCT06012279 | Clinical Outcomes of Dapagliflozin in Acute Heart Failure With Reduced Ejection Fraction (CODA-HFrEF) | https://clinicaltrials.gov/study/NCT06012279 | null | COMPLETED | The goal of this clinical trial is to evaluate the short-term clinical outcomes of starting Dapagliflozin on the same day of hospital admission in patients with acute decompensated heart failure (ADHF) with reduced ejection fraction.
The main questions it aims to answer are:
* Does early initiation of Dapagliflozin improve the length of hospital stay and in-hospital mortality in patients with ADHF?
* Does early initiation of Dapagliflozin enhance the diuretic response, weight reduction and pro-BNP reduction in the acute stage of HF?
* Does early initiation of Dapagliflozin adversely affect the hemodynamic stability and kidney functions in the acute stage of HF?
Participants will be randomized with the ratio of 1:1 within 24 hours of admission to receive Dapagliflozin 10 mg/day versus standard of care. Follow up will continue for 2 months after hospital discharge.
Researchers will compare the in-hospital and 60-day clinical outcomes in the Dapagliflozin group versus the standard treatment group. | NO | Acute Heart Failure | DRUG: Dapagliflozin 10mg Tab | All-cause mortality during hospitalization., Death from any cause during the period of hospital stay., From the date of admission until the date of discharge, average of 7 days|Length of hospital stay, The number of days from hospital admission to discharge., From the date of admission until the date of discharge, average of 7 days|Diuretic response during the hospital phase., Defined as adjusted urine output and weight change per 40 mg of IV Furosemide or equivalent dose, First 4 days of hospital admission|Change in NT-proBNP at day 4 (or at discharge if earlier)., The percentage change between baseline NT-proBNP on admission and NT-proBNP at day 4., First 4 days of hospital admission | Composite endpoint of cardiovascular death, re-admission for HF, or urgent clinic visit for decompensation at 2 months after hospital discharge., Decompensation is defined as worsening symptoms +/- signs of HF requiring intensification of diuretic dose., 60 days after hospital discharge|Change in serum NT-proBNP after 2 months., The percentage change between baseline NT-proBNP and 2 months after discharge., 60 days after hospital discharge|Worsening renal functions, Defined as > 50% worsening of baseline eGFR, or absolute drop below 30 ml/min/1.73 m2., During hospital stay and up to 60 days after hospital discharge|Composite endpoint of urogenital infections, hypoglycemic events, hypotension events or diabetic ketoacidosis., Reporting any side effects that could be due to Dapagliflozin after discharge, During hospital stay and up to 60 days after hospital discharge | null | Cairo University | Aswan Heart Centre | ALL | ADULT, OLDER_ADULT | PHASE4 | 117 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | MD-343-2021 | 2023-08-01 | 2024-02-01 | 2024-02-26 | 2023-08-25 | null | 2024-02-28 | Aswan Heart Centre, Aswan, Egypt|Kasr Al-Ainy Medical School, Cairo, 11562, Egypt | null | {
"Dapagliflozin": [
{
"intervention_type": "DRUG",
"description": "Dapagliflozin 10mg Tab",
"name": "Dapagliflozin",
"synonyms": [
"(2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol",
"Edistride",
"Dapagliflozina",
"Forxiga",
"Dapagliflozin",
"Farxiga"
],
"medline_plus_id": "a614015",
"generic_names": [
"Dapagliflozin"
],
"nhs_url": "https://www.nhs.uk/medicines/dapagliflozin",
"drugbank_id": "DB06292",
"wikipedia_url": "https://en.wikipedia.org/wiki/Dapagliflozin"
}
]
} |
NCT04406779 | The Frequency of Thyroid Diseases in Women With Breast Cancer | https://clinicaltrials.gov/study/NCT04406779 | null | COMPLETED | Breast cancer and thyroid disorders are important health challenges commonly encountered in women. The relationship between both conditions still remains unknown. In this study, the frequency of thyroid diseases was investigated in breast cancer patients | NO | Breast Cancer|Thyroid Diseases | DEVICE: thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies | to investigate the frequency of thyroid diseases in breast cancer patients., 1 year | null | null | Uşak University | null | FEMALE | ADULT, OLDER_ADULT | null | 160 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | UsakU-Cevdet1 | 2016-03-01 | 2017-03-31 | 2017-03-31 | 2020-05-28 | null | 2020-05-28 | null | null | {
"thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT01506479 | Study in Parkinsons Disease of Exercise | https://clinicaltrials.gov/study/NCT01506479 | SPARX | COMPLETED | The purpose of this study is to learn more about the effects of exercise on patients who have been recently diagnosed with Parkinsons disease (PD). The investigators are going to test two levels of exercise (moderate to vigorous) against no exercise. The investigators think that exercise may reduce the symptoms the of PD, and the investigators hope to learn what level of exercise will offer the most benefit. | YES | Parkinson Disease | BEHAVIORAL: Moderate Exercise|BEHAVIORAL: Vigorous Exercise|BEHAVIORAL: No Intervention | Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise, To test whether individuals with de novo Parkinsons disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol., 9 to 26 weeks | 6 Month Change in Unified Parkinsons Disease Rating Scale (UPDRS) Motor Score, Participants were assessed at baseline and at 6 months on their UPDRS. If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. The change in the UPDRS motor score at 6 months was used as the measure for the futility component of the trial. The change at 6 months was measured as the 6 month value minus the baseline score. A positive change represents worsening of motor symptoms; 0 represents no change; negative values represent improvement. The minimum score on the UPDRS motor is 0 and the maximum is 108 at baseline and 6 months with higher scores representing worse motor symptoms., Baseline and 6 months | Number of Days of Exercise Per Week, The number of days the participant exercised per week, 9 to 26 weeks | University of Colorado, Denver | University of Illinois at Chicago|University of Pittsburgh|Rush University Medical Center|National Institute of Neurological Disorders and Stroke (NINDS)|Northwestern University | ALL | ADULT, OLDER_ADULT | null | 128 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 11-1237|R01NS074343 | 2012-05 | 2016-11 | 2016-11 | 2012-01-10 | 2017-10-13 | 2017-10-13 | University of Colorado Denver, Aurora, Colorado, 80045, United States|University of Illinois, Chicago, Chicago, Illinois, 60612, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States | null | {
"Moderate Exercise": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Vigorous Exercise": [
{
"intervention_type": "BEHAVIORAL"
}
],
"No Intervention": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT02777879 | Lung Microbiome and Inflammation in Early COPD | https://clinicaltrials.gov/study/NCT02777879 | null | RECRUITING | This is a cross sectional case controlled study to assess lung microbiome and inflammation in smokers with and without Chronic Obstructive Pulmonary Disease (COPD). Investigators will look at active bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches an assess relationships among microbiome, metagenome, metabolome and host immune responses in COPD and controls. Investigators believe COPD cases will have higher prevalence of pneumotype supraglottic predominant taxa (SPT) than matched controls. | NO | Chronic Obstuctive Pulmonary Disease | PROCEDURE: Bronchoscopy | Site specific microbiome (supraglotic area) constituents using background subtraction and source tracking approaches via a multivariable conditional logistic regression model. following broncho-alveolar lavage, BAL, 4 Hours | Bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches, Bioinformatic methods such as Procrustes will be used to integrate the analysis of the generated multi-omic datasets through this study to attain a more accurately defined COPD phenotype. By elucidating the interplay between bacterial composition, microbiome functional repertoire, metabolism, and immunological status in the human lung, we will obtain further insights for hypothesis generation into the pathophysiological mechanisms underlying COPD., 4 Hours | null | NYU Langone Health | null | ALL | ADULT, OLDER_ADULT | null | 230 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 14-01546 | 2014-05 | 2026-08 | 2026-08 | 2016-05-19 | null | 2024-04-30 | New York University School of Medicine, New York, New York, 10016, United States | null | {
"Bronchoscopy": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT03059979 | The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc ) | https://clinicaltrials.gov/study/NCT03059979 | null | UNKNOWN | This is a 12 week double-blind randomized placebo controlled trial in which 30 patients with very early SSc, fulfilling the Very Early Diagnosis Of Systemic Sclerosis (VEDOSS) criteria (9) will be randomized in a 2:1 fashion to receive intravenous methylprednisolone or placebo. Three-day treatment courses are given at week 0, week 4 and week 8. The final assessment is at week 12, and patients will be followed up to one year after baseline | NO | Systemic Sclerosis|Raynaud Phenomena | DRUG: Methylprednisolone|OTHER: sodium chloride | the change in capillary density from baseline, presence of enlarged and giant capillaries, hemorrhages, loss of capillaries, disorganization of the micro vascular array, and capillary ramifications., 12 weeks | change in selected biomarkers: the interferon signature in peripheral blood from baseline, Plasma biomarkers consist soluble inflammatory mediators platelet factor 4, interleukin-1β, interleukin-6, tumor necrosis factor-α, endothelin-1, intercellular adhesion molecule-1 and vascular endothelial growth factor, 1 year|change in nail fold capillary changes other than capillary density and giant capillaries from baseline, changes in nail fold capillary pattern (early, active, late, normal, 1 year|change in modified Rodnan skin score (mRSS) from baseline, 1 year|presence of puffy fingers from baseline, 1 year|presence of synovitis from baseline, 1 year|presence of tendon friction rubs from baseline, 1 year|fulfilling EULAR/ACR ( American College of Rheumatology )classification from baseline criteria for SSc from baseline, 1 year|pulmonary function tests from baseline, 1 year|presence of interstitial lung disease from baseline, 1 year|suspicion of pulmonary hypertension from baseline, 1 year|Change in physical function from baseline, 1 year|general health score from baseline, 1 year|Change in 36-Item Short Form Survey (SF-36) total score from baseline, 1 year|Change in Scleroderma Health Assessment Questionnaire (SHAQ)total score from baseline, 1 year|Change in EQ-5D is a standardised instrument for use as a measure of health outcome. (EQ5D) total score from baseline, 1 year|Change in gastrointestinal tract ( GIT ) total score from baseline, 1 year | null | Radboud University Medical Center | null | ALL | ADULT, OLDER_ADULT | EARLY_PHASE1 | 30 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT | HHaE | 2017-01 | 2021-07-01 | 2021-07-01 | 2017-02-23 | null | 2019-11-29 | Radboudumc, Rheumatology department, Nijmegen, Gelderland, 6500 HB, Netherlands | null | {
"Methylprednisolone": [
{
"intervention_type": "DRUG",
"description": "Methylprednisolone",
"name": "Methylprednisolone",
"synonyms": [
"Urbason",
"Solu-Medrol",
"A-Methapred",
"Methylprednisolonum",
"Metipred",
"6\u03b1-methyl-11\u03b2,17\u03b1,21-triol-1,4-pregnadiene-3,20-dione",
"Methylprednisolon",
"Metilprednisolona",
"Methylprednisolone",
"Depo-Medrol (as acetate)",
"1-dehydro-6\u03b1-methylhydrocortisone",
"delta(1)-6alpha-Methylhydrocortisone",
"(6\u03b1,11\u03b2)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione",
"Solu-Medrol (as succinate)",
"6-Methylprednisolone",
"6 Methylprednisolone",
"Medrol"
],
"medline_plus_id": "a601157",
"generic_names": [
"Methylprednisolone"
],
"mesh_id": "D018696",
"drugbank_id": "DB00959",
"wikipedia_url": "https://en.wikipedia.org/wiki/Methylprednisolone"
}
],
"Sodium chloride": [
{
"intervention_type": "OTHER",
"description": "sodium chloride",
"name": "Sodium chloride",
"synonyms": [
"Cloruro s\u00f3dico",
"Sodium chloride",
"Natrum muriaticum",
"Natriumchlorid"
],
"drugbank_id": "DB09153",
"generic_names": [
"Sodium chloride"
]
}
]
} |
NCT00020579 | MS-275 in Treating Patients With Advanced Solid Tumors or Lymphoma | https://clinicaltrials.gov/study/NCT00020579 | null | COMPLETED | RATIONALE: MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I trial is studying the side effects and best dose of MS-275 in treating patients with advanced solid tumors or lymphoma. | NO | Cancer | DRUG: entinostat | Dose-limiting toxicities and maximum tolerated dose|Pharmacology and pharmacokinetics | Acetylation of histones in peripheral blood|Tumor response by CT scan every 12 weeks | null | National Institutes of Health Clinical Center (CC) | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | PHASE1 | 75 | NIH | INTERVENTIONAL | Allocation: |Intervention Model: |Masking: NONE|Primary Purpose: TREATMENT | 010124|01-C-0124|NCI-2792|CDR0000068615 | 2001-03 | 2008-04 | 2008-10 | 2003-01-27 | null | 2012-03-15 | National Naval Medical Center, Bethesda, Maryland, 20889-5000, United States|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, 20892-1182, United States|NCI - Center for Cancer Research, Bethesda, Maryland, 20892, United States | null | {
"Entinostat": [
{
"intervention_type": "DRUG",
"description": "entinostat",
"name": "Entinostat",
"synonyms": [
"Entinostat",
"Entinostatum",
"N-(2-aminophenyl)-4-(N-(pyridin-3-ylmethoxycarbonyl)aminomethyl)benzamide",
"N-[[4-[(2-aminoanilino)-oxomethyl]phenyl]methyl]carbamic acid 3-pyridinylmethyl ester"
],
"drugbank_id": "DB11841",
"generic_names": [
"Entinostat"
]
}
]
} |
NCT00348179 | Vascular Function in Adolescent, Diabetic Children | https://clinicaltrials.gov/study/NCT00348179 | null | COMPLETED | The objectives of this investigator initiated study are to:
1. Determine if and when vascular abnormalities occur during early adolescence
2. Determine if poor diabetic control is related to vascular abnormalities.
The development of vascular plaques and vascular contractility will be assessed through the use of the SyphmgnoCor equipment. | NO | Type 1 Diabetes | PROCEDURE: Measurement of vascular function per SphymgnoCor equipment | Vascular abnormalities as measured by the SyphmgnoCor equipment, End of study | null | null | Childrens Mercy Hospital Kansas City | null | ALL | CHILD | null | 85 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | 04 04-036E | 2004-04 | 2007-04 | 2007-04 | 2006-07-04 | null | 2008-01-24 | Childrens Mercy Hospital, Kansas City, Missouri, 64108, United States | null | {
"Measurement of vascular function per SphymgnoCor equipment": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT03478579 | Non-technical Skills of Emergency Physicians in a Virtual Emergency Department | https://clinicaltrials.gov/study/NCT03478579 | 3D-QUAMU | COMPLETED | The investigators will study nontechnical skills of emergency physicians in a virtual standardized emergency room and their impact on quality of care. | NO | Emergencies | OTHER: observational | Nontechnical skills, The nontechnical skills will be assessed by the Anaesthetists Non-Technical Skills (ANTS) system., 3 hours | Quality of care will be measured by a composite criteria (process and result), Quality of care will be measured by a composite criterion associating a process indicator and a result indicator :
* The process indicator is the average time to medical care of patients
* The result indicator corresponds to the relevance of the choice of the orientation of each patient by the emergency doctor at the end of medical care, 3 hours|ED length of stay, The quality of care will be assessed by ED length of stay : ED length of stay will be measured from triage completion to disposition decision, 3 hours|The authenticity of the virtual emergency medicine service, Evaluation of the consistency : perceived internal consistency in the proposed rules and situations will be assessed using a 4-item questionnaire by answering yes or no, 3 hours|The authenticity of the virtual emergency medicine service, Evaluation of the realism (the assumed resemblance with a real life reference) will be evaluated through a questionnaire containing 3 areas of comparison between the virtual and real environment (layout of the premises, duration of the actions, staff / patient ratio) with as answer possible for each comparison: Realistic or not realistic., 3 hours|The authenticity of the virtual emergency medicine service, Evaluation of the relevance (necessary to allow users to take ownership of the problems posed by the designers) will be assessed through direct observation with a yes / no evaluation of the acceptance to use the virtual environment, to test the environment, to make choices during the scenario and to control the environment., 3 hours | null | University Hospital, Toulouse | null | ALL | ADULT, OLDER_ADULT | null | 30 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | RC 31/16/8763 | 2018-06-01 | 2019-09-01 | 2020-12-01 | 2018-03-27 | null | 2022-02-03 | CHU Toulouse, Toulouse, 31059, France | null | {
"observational": [
{
"intervention_type": "OTHER"
}
]
} |
NCT03045679 | One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass | https://clinicaltrials.gov/study/NCT03045679 | MGBvsRYGB | TERMINATED | The aim of this prospective randomized controlled trial is to compare the two procedures One-anastomosis gastric Bypass/Mini-gastric Bypass (OAGB/MGB) and Roux-en Y gastric bypass (RYGB) in relation to intraoperative and postoperative complications (classification of Clavien-Dindo), mortality, metabolic impact (remission of type 2 diabetes mellitus, hypertonus, gastro-esophageal reflux disease, sleep apnea, dyslipidemia, quality of life, operation time, postoperative excess weight loss, malnutrition and re-do/revisonal surgery. | NO | Obesity | OTHER: RYGB|OTHER: OAGB/MGB | complications, complications classified next to Clavien-Dindo, up to 2 years after surgery | mortality, death up to 2 years after surgery, up to 2 years after surgery|remission of type 2 diabetes mellitus, HbA1c < 6.5% without medication, up to 2 years after surgery|remission of hypertonus, blood pressure < 140/90 mmHg without medication, up to 2 years after surgery|gastro-esophageal reflux disease, GERD-HRGL Heartburn Scale, up to 2 years after surgery|remission of sleep apnea, presence/absence of CPAP, up to 2 years after surgery|remission of hypertrigliceridemia, triglyceride < 200mg/dl without medication, up to 2 years after surgery|remission of hypercholesterinemia, cholesterin < 155 mg/dl without medication, up to 2 years after surgery|quality of life questionnaire, changing in quality of life measured by questionnaire, up to 2 years after surgery|weight loss, postoperative excess weight loss in %, up to 2 years after surgery|operation time, operation time during surgery in minutes, operation time during surgery in minutes|malnutrition 1, postoperative malnutrition: protein < 64 g/l, up to 2 years after surgery|malnutrition 2, postoperative malnutrition: albumin < 35 g/l, up to 2 years after surgery|malnutrition 3, postoperative malnutrition: ferritin (< 30 µg/l), up to 2 years after surgery|malnutrition 4, postoperative malnutrition: vitamin E < 12 µmol/l, up to 2 years after surgery|malnutrition 5, postoperative malnutrition: vitamin K < 90 ng/l, up to 2 years after surgery|malnutrition 6, postoperative malnutrition: vitamin 25-OH- Vitamin D3 < 50 nmol/l, up to 2 years after surgery|malnutrition 7, postoperative malnutrition: vitamin A < 1.05 µmol/l, up to 2 years after surgery|malnutrition 8, postoperative malnutrition: vitamin B12 < 145 pmol/l, up to 2 years after surgery|revisional surgery, revisional surgery during follow up, up to 2 years after surgery | null | Sana Klinikum Offenbach | null | ALL | ADULT, OLDER_ADULT | null | 100 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT | FF 74/2016 | 2018-01-01 | 2020-12-01 | 2020-12-01 | 2017-02-07 | null | 2023-01-17 | Sana Klinikum Offenbach, Offenbach, Hessen, 63069, Germany | null | {
"RYGB": [
{
"intervention_type": "OTHER"
}
],
"OAGB/MGB": [
{
"intervention_type": "OTHER"
}
]
} |
NCT01018979 | Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients | https://clinicaltrials.gov/study/NCT01018979 | null | COMPLETED | A phase II study to evaluate the safety, pharmacokinetics, and hematopoietic stem cell mobilization of TG-0054 in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease. | YES | Multiple Myeloma|Non-Hodgkin Lymphoma|Hodgkin Disease | DRUG: TG-0054 (2.24 mg/kg)|DRUG: TG-0054 (3.14 mg/kg) | Number of Patients Who Achieved Mobilization Success of Hematopoietic Stem Cells in Patients With Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD)., Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success., 1 week | Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD., Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method., 36 hrs after infusion|Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood., Baseline, 3 hours and 6 hours after infusion|Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD., Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method., 36 hrs after infusion|Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD., Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method., 36 hrs after infusion|Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD., Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method., 36 hrs after infusion|The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Time t of TG-0054 in 12 Consented Patients With MM, NHL or HD., Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method., 36 hrs after infusion|The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Infinity of TG-0054 in 12 Consented Patients With MM, NHL or HD., Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method., 36 hrs after infusion|Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD., Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method., 36 hrs after infusion|Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD., Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method., 36 hrs after infusion|Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD., Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method., 36 hrs after infusion|Circulating CD34+ Cell Counts in Peripheral Blood., Baseline, 3 hours and 6 hours after infusion | null | GPCR Therapeutics, Inc. | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 19 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | TG-0054-02 | 2010-02 | 2011-10 | 2011-10 | 2009-11-25 | 2015-01-15 | 2021-05-11 | Chang-Gung Memorial Hospital Chiayi, Chiayi, Taiwan|Buddist Tzu Chi General Hospital, Hualien, Taiwan|Kaohsiung Medical University Hospital, Kaohsiung, Taiwan|Chang-Gung Memorial Hospital Linkou, Linkou, Taiwan|National Taiwan University Hospital, Taipei, Taiwan|Taipei Veterans General Hospital, Taipei, Taiwan | null | {
"TG-0054 (2.24 mg/kg)": [
{
"intervention_type": "DRUG"
}
],
"TG-0054 (3.14 mg/kg)": [
{
"intervention_type": "DRUG"
}
]
} |
NCT02738879 | Randomized Sitagliptin Withdrawal Study (MK-0431-845) | https://clinicaltrials.gov/study/NCT02738879 | null | COMPLETED | This is a trial of continuing sitagliptin versus withdrawing sitagliptin in participants with Type 2 diabetes mellitus (T2DM) and inadequate glycemic control who initiate and titrate insulin glargine (LANTUS®) based on a treat-to-target algorithm to achieve fasting glucose levels of 72-100 mg/dL (4-5.6 mmol/L). A primary hypothesis of this trial is that after 30 weeks, continuing sitagliptin results in a greater reduction of hemoglobin A1C (A1C) relative to withdrawing sitagliptin. | YES | Type 2 Diabetes Mellitus | DRUG: Sitagliptin|DRUG: Placebo to sitagliptin|DRUG: Metformin|DRUG: Metformin XR|DRUG: Insulin glargine | Change From Baseline in A1C at Week 30, A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 30 A1C minus the Week 0 A1C., Baseline and Week 30|Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L), Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant., Up to 30 weeks|Percentage of Participants Who Discontinued Study Drug Due to an AE, An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to 30 weeks|Percentage of Participants Who Experienced One or More Adverse Events (AEs), An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to 32 weeks | Percentage of Participants With Events of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L), Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The incidence (number of participants with ≥1 event divided by number of participants) of documented symptomatic hypoglycemia was determined., Up to 30 weeks|Change From Baseline in Total Daily Insulin Dose (Units) at Week 30, Change from baseline reflects the Week 30 total daily insulin dose minus the Week 0 total daily insulin dose. The Week 0 total daily insulin dose was 0, by definition, because insulin was not administered at baseline., Baseline and Week 30|Event Rate of Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L), Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant., Up to 30 weeks|Event Rate of Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L), Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant., Up to 30 weeks|Percentage of Participants With Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L), Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L)., Up to 30 weeks|Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol) at Week 30, A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100., Week 30|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30, Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at Week 0)., Baseline and Week 30|Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L), Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant., Up to 30 weeks|Percentage of Participants With Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L), Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L)., Up to 30 weeks|Percentage of Participants With Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L), Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L)., Up to 30 weeks|Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol at Week 30 and No Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) up to Week 30, A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100., Week 30 | null | Merck Sharp & Dohme LLC | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 746 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | 0431-845|2015-004990-34|MK-0431-845 | 2016-05-09 | 2018-01-22 | 2018-01-30 | 2016-04-14 | 2019-02-25 | 2019-02-25 | null | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/79/NCT02738879/Prot_SAP_000.pdf | {
"Sitagliptin": [
{
"intervention_type": "DRUG",
"description": "Sitagliptin",
"name": "Sitagliptin",
"synonyms": [
"Sitagliptin",
"Sitagliptina",
"Sitagliptinum",
"Sitagliptine",
"Januvia"
],
"medline_plus_id": "a606023",
"generic_names": [
"Sitagliptin"
],
"nhs_url": "https://www.nhs.uk/medicines/sitagliptin",
"drugbank_id": "DB01261"
},
{
"intervention_type": "DRUG",
"description": "Placebo to sitagliptin",
"name": "Sitagliptin",
"synonyms": [
"Sitagliptin",
"Sitagliptina",
"Sitagliptinum",
"Sitagliptine",
"Januvia"
],
"medline_plus_id": "a606023",
"generic_names": [
"Sitagliptin"
],
"nhs_url": "https://www.nhs.uk/medicines/sitagliptin",
"drugbank_id": "DB01261"
}
],
"Metformin": [
{
"intervention_type": "DRUG",
"description": "Metformin",
"name": "Metformin",
"synonyms": [
"Dimethylbiguanidine",
"Dimethylguanylguanidine",
"Fortamet",
"Metabet",
"Metformin HCl",
"Hydrochloride, Metformin",
"Metformin",
"Metformin Hydrochloride",
"Diagemet",
"Metformina",
"Glumetza",
"Trijardy",
"Metforminum",
"Glucient",
"Glucophage",
"Axpinet",
"Dimethylbiguanid",
"Metformine",
"1,1-Dimethylbiguanide",
"HCl, Metformin"
],
"medline_plus_id": "a696005",
"generic_names": [
"Metformin"
],
"nhs_url": "https://www.nhs.uk/medicines/metformin",
"mesh_id": "D007004",
"drugbank_id": "DB00331",
"wikipedia_url": "https://en.wikipedia.org/wiki/Metformin"
},
{
"intervention_type": "DRUG",
"description": "Metformin XR",
"name": "Metformin",
"synonyms": [
"Dimethylbiguanidine",
"Dimethylguanylguanidine",
"Fortamet",
"Metabet",
"Metformin HCl",
"Hydrochloride, Metformin",
"Metformin",
"Metformin Hydrochloride",
"Diagemet",
"Metformina",
"Glumetza",
"Trijardy",
"Metforminum",
"Glucient",
"Glucophage",
"Axpinet",
"Dimethylbiguanid",
"Metformine",
"1,1-Dimethylbiguanide",
"HCl, Metformin"
],
"medline_plus_id": "a696005",
"generic_names": [
"Metformin"
],
"nhs_url": "https://www.nhs.uk/medicines/metformin",
"mesh_id": "D007004",
"drugbank_id": "DB00331",
"wikipedia_url": "https://en.wikipedia.org/wiki/Metformin"
}
],
"Insulin glargine": [
{
"intervention_type": "DRUG",
"description": "Insulin glargine",
"name": "Insulin glargine",
"synonyms": [
"insulin glargine-yfgn",
"Insulina glargina",
"Insulin glargine",
"Abasaglar",
"Lantus",
"Insulin glargine recombinant",
"Insulin glargine (rDNA origin)",
"Toujeo",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Fiasp",
"Humulin I",
"Humulin S",
"Insulatard",
"Trurapi",
"Tresiba",
"Abasaglar",
"Lantus",
"Apidra",
"Admelog",
"NovoRapid",
"Semglee",
"Toujeo",
"insulin",
"Levemir",
"Humalog",
"Actrapid",
"Lyumjev",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Fiasp",
"Humulin I",
"Humulin S",
"Insulatard",
"Trurapi",
"Tresiba",
"Abasaglar",
"Lantus",
"Apidra",
"Admelog",
"NovoRapid",
"Semglee",
"Toujeo",
"insulin",
"Levemir",
"Humalog",
"Actrapid",
"Lyumjev",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Fiasp",
"Humulin I",
"Humulin S",
"Insulatard",
"Trurapi",
"Tresiba",
"Abasaglar",
"Lantus",
"Apidra",
"Admelog",
"NovoRapid",
"Semglee",
"Toujeo",
"insulin",
"Levemir",
"Humalog",
"Actrapid",
"Lyumjev",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Fiasp",
"Humulin I",
"Humulin S",
"Insulatard",
"Trurapi",
"Tresiba",
"Abasaglar",
"Lantus",
"Apidra",
"Admelog",
"NovoRapid",
"Semglee",
"Toujeo",
"insulin",
"Levemir",
"Humalog",
"Actrapid",
"Lyumjev",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Fiasp",
"Humulin I",
"Humulin S",
"Insulatard",
"Trurapi",
"Tresiba",
"Abasaglar",
"Lantus",
"Apidra",
"Admelog",
"NovoRapid",
"Semglee",
"Toujeo",
"insulin",
"Levemir",
"Humalog",
"Actrapid",
"Lyumjev",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Fiasp",
"Humulin I",
"Humulin S",
"Insulatard",
"Trurapi",
"Tresiba",
"Abasaglar",
"Lantus",
"Apidra",
"Admelog",
"NovoRapid",
"Semglee",
"Toujeo",
"insulin",
"Levemir",
"Humalog",
"Actrapid",
"Lyumjev",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar"
],
"drugbank_id": "DB00047",
"generic_names": [
"Insulin glargine",
"Insulin Glargine (rDNA origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Glargine (rDNA origin)"
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Insulin%20glargine",
"nhs_url": "https://www.nhs.uk/medicines/insulin/intermediate-acting-insulin"
}
]
} |
NCT02430779 | Irreversible Electroporation(IRE) For Unresectable Renal Pelvic and Ureteral Neoplasms | https://clinicaltrials.gov/study/NCT02430779 | IRE | COMPLETED | The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Renal Pelvic and Ureteral Neoplasms. | NO | Renal Pelvic and Ureteral Neoplasms | PROCEDURE: rreversible electroporation (IRE)|DEVICE: NanoKnife | Number of participants with Adverse events, 6 month | Percentage of lesions that show no sign of recurrence 12 months after IRE, 12 months|Voltage (A minimum and maximum range of voltage for safe and effective IRE), A minimum and maximum range of voltage for safe and effective IRE will be, 3 months|Progress free disease (PFS), 12 months|Overall survival (OS), Patients will be followed for 36 months after IRE for OS analyzed., 36 months | null | Fuda Cancer Hospital, Guangzhou | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 30 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT | pelvis ureter Neoplasms-IRE-01 | 2015-01-01 | 2020-12-01 | 2021-01-01 | 2015-04-30 | null | 2021-09-05 | Biological treatment center in Fuda cancer hospital, Guangzhou, Guangdong, 510000, China | null | {
"rreversible electroporation (IRE)": [
{
"intervention_type": "PROCEDURE"
}
],
"NanoKnife": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT05084079 | Different Initial Insulin Dose Regimens on Time to Achieve Glycemic Targets and Treatment Safety in SIIT | https://clinicaltrials.gov/study/NCT05084079 | null | UNKNOWN | To compare the effects of different initial insulin dose regimens during the short-term insulin intensive treatment on time to glycemic goal, hypoglycemia prevalence, glycemic variability and other safety problems in newly diagnosed type 2 diabetes mellitus(T2DM) patients, in order to investigate the rational of formula based initiation regimen. | NO | Diabetes Mellitus|Diabetes Mellitus, Type 2|Glucose Metabolism Disorders|Metabolic Disease|Endocrine System Diseases | DRUG: CSII with formula-based initial insulin regimen|DRUG: CSII with weight-based initial insulin regimen | The time to glycemic goal, After CSII begin, the time(days) to reach glycemic goal of each patients. The glycemic goal defined as at least six out of eight-point fingertip blood glucose meet the standard that fasting blood glucose(FBG) or non-postprandial blood glucose is between 4.4-6.0 mmol/L and 2h postprandial blood glucose(PBG) is between 4.4-8.0 mmol/L., 1 year | Incidence of hypoglycemia, Differences in incidence of hypoglycemia among treatment arms at the end of study., 1 year|Change of blood glucose fluctuations, Differences in blood glucose fluctuations among treatment arms at the end of study., 1 year|Change of β cell function, Differences in β-cell indicators among treatment arms at the end of study., 1 year|Change of insulin sensitivity, Differences in insulin sensitivity indicators among treatment arms at the end of study., 1 year|Change of insulin dosage, Differences in insulin dosage among treatment arms at the end of study., 1 year | null | Sun Yat-sen University | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 56 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 2021526 | 2021-11 | 2022-10 | 2022-10 | 2021-10-19 | null | 2021-10-19 | endocrinology department of the first affiliated hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510080, China | null | {
"insulin": [
{
"intervention_type": "DRUG",
"description": "CSII with formula-based initial insulin regimen",
"name": "insulin",
"synonyms": [
"Insulin",
"Insulin A Chain",
"Actrapid",
"Chain, Insulin B",
"Regular insulin",
"Insulin, Sodium",
"Insulin, Regular",
"Novolin R",
"Iletin",
"Novolin",
"Soluble Insulin",
"Regular Insulin",
"Humulin R",
"Insulin B Chain",
"Sodium Insulin",
"Insulin, Soluble",
"Humulin R U-500",
"Novolin 70/30",
"Novolin R",
"Humulin R",
"Humulin 70/30",
"Human Insulin",
"Humulin R U-500",
"Novolin 70/30",
"Novolin R",
"Humulin R",
"Humulin 70/30",
"Human Insulin",
"Humulin R U-500",
"Novolin 70/30",
"Novolin R",
"Humulin R",
"Humulin 70/30",
"Human Insulin",
"Humulin R U-500",
"Novolin 70/30",
"Novolin R",
"Humulin R",
"Humulin 70/30",
"Human Insulin",
"Fiasp",
"Humulin I",
"Humulin S",
"Insulatard",
"Trurapi",
"Tresiba",
"Abasaglar",
"Lantus",
"Apidra",
"Admelog",
"NovoRapid",
"Semglee",
"Toujeo",
"insulin",
"Levemir",
"Humalog",
"Actrapid",
"Lyumjev",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Fiasp",
"Humulin I",
"Humulin S",
"Insulatard",
"Trurapi",
"Tresiba",
"Abasaglar",
"Lantus",
"Apidra",
"Admelog",
"NovoRapid",
"Semglee",
"Toujeo",
"insulin",
"Levemir",
"Humalog",
"Actrapid",
"Lyumjev",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Fiasp",
"Humulin I",
"Humulin S",
"Insulatard",
"Trurapi",
"Tresiba",
"Abasaglar",
"Lantus",
"Apidra",
"Admelog",
"NovoRapid",
"Semglee",
"Toujeo",
"insulin",
"Levemir",
"Humalog",
"Actrapid",
"Lyumjev",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Humulin",
"Novolin",
"Insulin (medication)",
"Insuman",
"Humulin",
"Novolin",
"Insulin (medication)",
"Insuman",
"Insulin human",
"Insulin human regular (rDNA)",
"Insulin recombinant human",
"human insulin (rDNA)",
"High molecular weight insulin human",
"Insulin recombinant purified human",
"Insulina regular",
"Insulin (human)",
"Insulin Human Regular",
"Neutral insulin",
"Regular Insulin, human",
"Human insulin",
"Insulin human, rDNA origin",
"Insulin, human",
"Insulin regular",
"Insulin human [rDNA origin]",
"Soluble insulin",
"Humulin R U-500",
"Novolin 70/30",
"Novolin R",
"Humulin R",
"Humulin 70/30",
"Human Insulin"
],
"nhs_url": "https://www.nhs.uk/medicines/insulin/insulin-for-gestational-diabetes",
"generic_names": [
"Insulin",
"Human Insulin",
"Human Insulin",
"Human Insulin",
"Human Insulin",
"Insulin Degludec (rDNA Origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Glargine (rDNA origin)",
"Insulin human",
"Human Insulin"
],
"mesh_id": "D007004",
"wikipedia_url": "https://en.wikipedia.org/wiki/Regular%20insulin"
},
{
"intervention_type": "DRUG",
"description": "CSII with weight-based initial insulin regimen",
"name": "insulin",
"synonyms": [
"Insulin",
"Insulin A Chain",
"Actrapid",
"Chain, Insulin B",
"Regular insulin",
"Insulin, Sodium",
"Insulin, Regular",
"Novolin R",
"Iletin",
"Novolin",
"Soluble Insulin",
"Regular Insulin",
"Humulin R",
"Insulin B Chain",
"Sodium Insulin",
"Insulin, Soluble",
"Humulin R U-500",
"Novolin 70/30",
"Novolin R",
"Humulin R",
"Humulin 70/30",
"Human Insulin",
"Humulin R U-500",
"Novolin 70/30",
"Novolin R",
"Humulin R",
"Humulin 70/30",
"Human Insulin",
"Humulin R U-500",
"Novolin 70/30",
"Novolin R",
"Humulin R",
"Humulin 70/30",
"Human Insulin",
"Humulin R U-500",
"Novolin 70/30",
"Novolin R",
"Humulin R",
"Humulin 70/30",
"Human Insulin",
"Fiasp",
"Humulin I",
"Humulin S",
"Insulatard",
"Trurapi",
"Tresiba",
"Abasaglar",
"Lantus",
"Apidra",
"Admelog",
"NovoRapid",
"Semglee",
"Toujeo",
"insulin",
"Levemir",
"Humalog",
"Actrapid",
"Lyumjev",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Fiasp",
"Humulin I",
"Humulin S",
"Insulatard",
"Trurapi",
"Tresiba",
"Abasaglar",
"Lantus",
"Apidra",
"Admelog",
"NovoRapid",
"Semglee",
"Toujeo",
"insulin",
"Levemir",
"Humalog",
"Actrapid",
"Lyumjev",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Fiasp",
"Humulin I",
"Humulin S",
"Insulatard",
"Trurapi",
"Tresiba",
"Abasaglar",
"Lantus",
"Apidra",
"Admelog",
"NovoRapid",
"Semglee",
"Toujeo",
"insulin",
"Levemir",
"Humalog",
"Actrapid",
"Lyumjev",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Tresiba",
"Insulin Degludec (rDNA Origin)",
"Xultophy",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Soliqua",
"Insulin Glargine (rDNA origin)",
"Semglee",
"Basaglar",
"Humulin",
"Novolin",
"Insulin (medication)",
"Insuman",
"Humulin",
"Novolin",
"Insulin (medication)",
"Insuman",
"Insulin human",
"Insulin human regular (rDNA)",
"Insulin recombinant human",
"human insulin (rDNA)",
"High molecular weight insulin human",
"Insulin recombinant purified human",
"Insulina regular",
"Insulin (human)",
"Insulin Human Regular",
"Neutral insulin",
"Regular Insulin, human",
"Human insulin",
"Insulin human, rDNA origin",
"Insulin, human",
"Insulin regular",
"Insulin human [rDNA origin]",
"Soluble insulin",
"Humulin R U-500",
"Novolin 70/30",
"Novolin R",
"Humulin R",
"Humulin 70/30",
"Human Insulin"
],
"nhs_url": "https://www.nhs.uk/medicines/insulin/insulin-for-gestational-diabetes",
"generic_names": [
"Insulin",
"Human Insulin",
"Human Insulin",
"Human Insulin",
"Human Insulin",
"Insulin Degludec (rDNA Origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Degludec (rDNA Origin)",
"Insulin Glargine (rDNA origin)",
"Insulin Glargine (rDNA origin)",
"Insulin human",
"Human Insulin"
],
"mesh_id": "D007004",
"wikipedia_url": "https://en.wikipedia.org/wiki/Regular%20insulin"
}
]
} |
NCT01462279 | Effect of Thiamine on Oxygen Utilization (VO2) in Critical Illness | https://clinicaltrials.gov/study/NCT01462279 | VO2 | COMPLETED | The objective of this study is to determine the effect of thiamine therapy on oxygen consumption in critically-ill patients. The investigators will evaluate this by measuring VO2 before and after thiamine administration in patients admitted to the ICU and requiring mechanical ventilation. | YES | Acute Respiratory Failure | DRUG: Thiamine | Improvement in VO2, VO2 measurements are taken at baseline and VO2 is continuously monitored over 9 hours. Thiamine is administered three hours after baseline measurements are taken., Baseline to 9 Hours | Improvement in Hemodynamics, Hemodynamics were collected in all patients but we did not evaluate change in hemodynamics over the 9 hour protocol of the study. Due to the single-arm nature and small size of the study, and with no comparison arm, we did not think we had the statistical power to evaluate for a change in hemodynamics so this was not a planned outcome and was entered in error., Baseline to Nine Hours | null | Beth Israel Deaconess Medical Center | American Medical Association | ALL | ADULT, OLDER_ADULT | null | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 2010P000312 | 2011-09 | 2012-10 | 2012-10 | 2011-10-31 | 2016-11-30 | 2018-01-16 | Beth Israel Deaconess Medical Center (BIDMC), Boston, Massachusetts, 02115, United States | null | {
"Thiamine": [
{
"intervention_type": "DRUG"
}
]
} |
NCT03447379 | Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent | https://clinicaltrials.gov/study/NCT03447379 | null | ACTIVE_NOT_RECRUITING | To compare the clinical outcomes of P2Y12 antagonist monotherapy with aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with bioabsorbable polymer Everolimus-eluting stents (Synergy®) | NO | Coronary Artery Disease | DRUG: P2Y12 antagonist monotherapy|DRUG: Aspirin plus P2Y12 antagonist | Major adverse cardiovascular clinical events (MACCE), cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization, between 3 and 12 month after the procedure|Major bleeding, The Bleeding Academic Research Consortium (BARC) type 3 or 5, between 3 and 12 month after the procedure | null | null | Gangnam Severance Hospital | null | ALL | ADULT, OLDER_ADULT | null | 1,452 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 3-2017-0230 | 2017-12-15 | 2022-08-17 | 2022-10-31 | 2018-02-27 | null | 2022-09-15 | Gangnam Severance Hospital, Seoul, Souel, Korea, Republic of | null | {
"P2Y12 antagonist monotherapy": [
{
"intervention_type": "DRUG"
}
],
"Aspirin": [
{
"intervention_type": "DRUG",
"description": "Aspirin plus P2Y12 antagonist",
"name": "Aspirin",
"synonyms": [
"Valomag",
"Endosprin",
"Acetysal",
"Acetylsalicylic acid",
"Azetylsalizyls\u00e4ure",
"Magnecyl",
"Acetylsalicylic Acid",
"2-(Acetyloxy)benzoic Acid",
"Aloxiprimum",
"Polopirin",
"Bonjela",
"Acetylsalicylate",
"Dispril",
"Ecotrin",
"Acylpyrin",
"Acid, Acetylsalicylic",
"Anadin",
"Zorprin",
"Polopiryna",
"Solupsan",
"Colfarit",
"Solprin",
"Micristin",
"Easprin",
"Aspirin",
"Boots Haemorrhoid",
"2-(Diethylamino)-2',6'-acetoxylidide",
"2-2EtN-2MePhAcN",
"\u03b1-diethylamino-2,6-dimethylacetanilide",
"Xylocaine",
"Lidocaine Monohydrochloride, Monohydrate",
"Lidocaine Carbonate",
"Xyloneural",
"2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide",
"Ztlido",
"EMLA",
"Lidocaina",
"Lidocaine",
"2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide",
"Covonia",
"Xylopract",
"Nulbia",
"Lidoca\u00edna",
"Octocaine",
"Lidocainum",
"LMX4",
"Bonjela",
"Lidocaine Hydrochloride",
"Dalcaine",
"Lidocaine Sulfate (1:1)",
"Anbesol",
"Perinal",
"Anusol",
"Lidocaine Monohydrochloride",
"Germaloids",
"Iglu",
"Xylesthesin",
"Lidocaine Monoacetate",
"Lignocaine",
"Calgel",
"Lidocaine Carbonate (2:1)",
"Denela",
"Lidocaine Hydrocarbonate",
"alpha-diethylamino-2,6-dimethylacetanilide",
"Xylocitin",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Xylocaine",
"Lidocaine Viscous",
"Xylocaine",
"Lidocaine Viscous",
"Senstend",
"Emla",
"Fortacin",
"Lidocaine/prilocaine",
"Boots Haemorrhoid",
"2-(Diethylamino)-2',6'-acetoxylidide",
"2-2EtN-2MePhAcN",
"\u03b1-diethylamino-2,6-dimethylacetanilide",
"Xylocaine",
"Lidocaine Monohydrochloride, Monohydrate",
"Lidocaine Carbonate",
"Xyloneural",
"2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide",
"Ztlido",
"EMLA",
"Lidocaina",
"Lidocaine",
"2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide",
"Covonia",
"Xylopract",
"Nulbia",
"Lidoca\u00edna",
"Octocaine",
"Lidocainum",
"LMX4",
"Bonjela",
"Lidocaine Hydrochloride",
"Dalcaine",
"Lidocaine Sulfate (1:1)",
"Anbesol",
"Perinal",
"Anusol",
"Lidocaine Monohydrochloride",
"Germaloids",
"Iglu",
"Xylesthesin",
"Lidocaine Monoacetate",
"Lignocaine",
"Calgel",
"Lidocaine Carbonate (2:1)",
"Denela",
"Lidocaine Hydrocarbonate",
"alpha-diethylamino-2,6-dimethylacetanilide",
"Xylocitin",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Xylocaine",
"Lidocaine Viscous",
"Xylocaine",
"Lidocaine Viscous",
"Senstend",
"Emla",
"Fortacin",
"Lidocaine/prilocaine"
],
"medline_plus_id": "a621021",
"generic_names": [
"Acetylsalicylic acid",
"Aspirin",
"Lidocaine",
"Lidocaine Patch",
"Lidocaine Patch",
"Lidocaine Viscous",
"Lidocaine Viscous",
"Lidocaine",
"Lidocaine Patch",
"Lidocaine Patch",
"Lidocaine Viscous",
"Lidocaine Viscous"
],
"nhs_url": "https://www.nhs.uk/medicines/aspirin-for-pain-relief",
"mesh_id": "D058633",
"drugbank_id": "DB00945",
"wikipedia_url": "https://en.wikipedia.org/wiki/Aspirin"
}
]
} |
NCT04782479 | Hand Position for Stylet Removal During Tracheal Intubation | https://clinicaltrials.gov/study/NCT04782479 | null | COMPLETED | Investigators compared the tube movement between two situations; the one was that the practitioners hand holding the tracheal tube was placed in the air, and the other was that the hand was placed on the manikins cheek, while two residents took the roles of the practitioner and the assistant in tracheal intubation with a stylet for a manikin. | NO | Manikin | PROCEDURE: hand position | tube movement distance, tube movement distance in the process of pulling out the stylet by the assistant, procedure (at the time when the assistant pulling back the stylet) | null | null | Seoul National University Hospital | SMG-SNU Boramae Medical Center | ALL | CHILD, ADULT, OLDER_ADULT | null | 33 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 30-2018-18 | 2020-05-11 | 2021-02-16 | 2021-02-16 | 2021-03-04 | null | 2023-09-13 | Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, 07061, Korea, Republic of | null | {
"hand position": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT05787379 | Care for Veterans Post-COVID-19 | https://clinicaltrials.gov/study/NCT05787379 | null | NOT_YET_RECRUITING | The evidence-based Concordant Care approach involves engaging in processes that: 1) validate the patients experience, 2) develop a shared understanding of the condition, and 3) create a patient-centered, whole health-oriented action plan to manage the condition. This is consistent with published expert opinion that Concordant Care underlies patients (and clinicians) positive experiences of care for poorly understood conditions. Despite strong evidence supporting this care approach, there are no interventions to train clinicians on practices to provide Concordant Care for Veterans with poorly understood conditions such as Long-COVID. Part 1 of the study will optimize and test if a Concordant Care training improves VA clinicians engagement in recommended practices to provide Concordant Care (i.e., validate, shared understanding, action plan) for Veterans with Long-COVID. This study will adapt and refine Concordant Care training for Long-COVID. Part 2 of this study will determine if Concordant Care training increases clinicians engagement in recommended practices to provide Concordant Care and will explore the effectiveness of Concordant Care on care outcomes including satisfaction, adherence to care, & disability for Veterans with Long-COVID. Veterans treated by clinicians receiving Concordant Care training will report their clinician more frequently engaged in recommended conversations (i.e., ask about Long-COVID, validate experience with Long-COVID, create a shared understanding and action plan), and Veterans will perceive greater shared understanding of Long-COVID with their clinicians than Veterans treated by clinicians in the control arm. | NO | Post-Acute COVID-19 Syndrome | BEHAVIORAL: Concordant Care Training|BEHAVIORAL: Education Packet Training | Concordant Care Practice Change, Concordant Care practices will be measured with the 11-item measure that asks the patient if the clinician talked with them about multiple dimensions of their understanding of the health condition (i.e., cause, consequence, treatment). Participants answer yes or no to each question. Scores range from 0 to 11 with a higher score = more Concordant Care practices., Baseline and 3-months|Concordance of Illness Perceptions Questionnaire Change, Shared Understanding will be captured with the concordance of illness perceptions questionnaire, a 6-item validated measure of shared understanding of the 5 components of illness perception between patients and clinicians. Veterans respond on a 5-point Likert scale. Scores range from 6 to 30 with higher scores = greater concordant understanding., Baseline and 3-months | Patient Satisfaction Questionnaire (PSQ-III), The 18-item PSQ measures patient satisfaction in health care services and has been used specifically to assess patient satisfaction of VA healthcare services. Response options are 1-5 with 1=strongly agree and 5=strongly disagree. Scores range from 18 to 90 with higher scores = greater satisfaction with medical care., Baseline and 3-months|Medical Outcomes Survey Adherence Scale, The Medical Outcomes Survey Adherence 5-item scale captures Veterans adherence to primary care clinicians recommendations. Scores range from 6 to 30 with greater scores = better adherence., Baseline and 3-months|Veterans Rand (VR-12), Veterans Rand 12-item Health Survey (VR-12). The VR-12 is a well-validated quality of life measure that assesses multiple domains of physical and mental health functioning. Scores range from 0 to 100 with higher scores = less disability., Baseline and 3-months | null | VA Office of Research and Development | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 348 | FED | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH | SDR 23-001 | 2024-10-01 | 2027-09-30 | 2027-09-30 | 2023-03-28 | null | 2023-10-06 | East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ, East Orange, New Jersey, 07018, United States | null | {
"Concordant Care Training": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Education Packet Training": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT02641379 | A Study of Peginterferon Alfa-2a (Pegasys) When Administered in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) | https://clinicaltrials.gov/study/NCT02641379 | null | COMPLETED | This study will compare the efficacy and safety of 2 different treatment durations of peginterferon alfa-2a (Pegasys) plus ribavirin in patients with CHC. The anticipated time on study treatment is 1-2 years, and the target sample size is greater than (>) 500 individuals. | YES | Hepatitis C, Chronic | DRUG: Peginterferon alfa-2a|DRUG: Ribavirin | Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1), Relapse rate (RR) was defined as the percentage of participants with non-detectable HCV RNA (< 100 copies/ml) at the end of treatment and detectable HCV RNA at the end of follow-up. End of treatment was defined as Week 48 for Group A and Week 72 for Group B, respectively. The end of follow-up was defined as Week 72 for Group A and Week 96 for Group B, respectively. Relapse rate for treatment Groups A and B, stratified for genotype (Genotype I and Genotype IV) and Week 4 response (< 600 units/milliliter [U/ml] and >= 600 U/ml) is presented., Up to Week 96|Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2), The Sustained Virological Response (SVR) was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 72 of Groups A1 and E, and at Week 96 of Group B1). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 72 for Groups A1 and E, and Week 96 for Group B1. The SVR for treatment Groups A1 + B1 and E, stratified for genotype (Genotype I and Genotype IV) is presented., Up to Week 96 | Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1), End of treatment response (ETR) rate was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV negative at Week 24 of Group D, Week 48 of Group A and at Week 72 of Groups B and C). Participants without a HCV RNA results at this time point were considered as non-responders. End of the treatment period was defined as Week 48 for Group A, Week 72 for Groups B and C, and Week 24 for Group D., Up to Week 72|Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1), The SVR was defined as the percentage of participants in each group with a non-detectable HCV RNA result at 24 weeks post-completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D, at Week 72 of Group A, and at Week 96 of Groups B and C). Participants without a HCV RNA PCR at this time point were considered as non-responders in this calculation. The end of follow-up was defined as Week 72 for Group A, Week 96 for Groups B and C, and Week 48 for Group D., Up to Week 96|Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1), The Short Form-36 (SF-36) is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual and Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores are presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A and B) and at Week 96 (for Group B). Lower score indicate worsening., Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96|Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1), The Fatigue Severity Scale (FSS) is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A and B) and at Week 96 (for Group B)., Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96|Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1), Liver fibrosis stage was scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline is presented., Baseline (Day 1)|Number of Participants With Adverse Events and Serious Adverse Events (Part 1), An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect., Up to Week 96|Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2), Virological relapse rate was defined as percentage of participants with non-detectable HCV RNA (< 15 IU/ml) at the EoT and detectable HCV RNA (≥ 15 IU/ml) at the end of FU. The end of treatment was defined as Week 48 in Group A1 and Week 72 in Group B1 and the end of follow-up was defined as Week 72 in Group A1 and Week 96 in Group B1., Up to Week 96|Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2), ETR virological response rate at the end of treatment period was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV RNA quantitative PCR result < 15 IU/ml at Week 24 for Group D, at Week 48 for Group A1, at Week 72 for Groups B1 and C). Participants without a HCV RNA PCR (missing values) at this time point were considered as non-responders in this calculation. The end of treatment period was defined as Week 48 for Group A1, Week 72 for Groups B1 and C1, and Week 24 for Group D., Up to Week 72|Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2), The SVR was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D and at Week 96 of Group C). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 96 for Group C and Week 48 for Group D., Up to Week 96|Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2), The SF-36 is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores were presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C). Lower score indicate worsening., Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96|Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2), The FSS is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C)., Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96|Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2), Liver fibrosis stage was based upon biopsy and scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline (Day 1) is presented., Baseline (Day 1)|Number of Participants With Adverse Events and Serious Adverse Events (Part 2), An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect., Up to Week 96 | null | Hoffmann-La Roche | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 737 | INDUSTRY | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | ML17131 | 2003-05 | 2013-11 | 2013-11 | 2015-12-29 | 2016-08-04 | 2016-08-04 | Feldkirch, 6800, Austria|Gratwein, 8112, Austria|Graz, 8020, Austria|Graz, 8036, Austria|Innsbruck, 6020, Austria|Krems, 3500, Austria|Linz, 4010, Austria|Linz, 4020, Austria|Oberndorf, 5110, Austria|Oberpullendorf, 7350, Austria|Ried-innkreis, 4910, Austria|Salzburg, 5020, Austria|Villach, 9500, Austria|Wels, 4600, Austria|Wiener Neustadt, 2700, Austria|Wien, 1030, Austria|Wien, 1090, Austria|Wien, 1100, Austria|Wien, 1130, Austria|Wien, 1140, Austria|Wien, 1160, Austria | null | {
"Peginterferon alfa-2a": [
{
"intervention_type": "DRUG",
"description": "Peginterferon alfa-2a",
"name": "Peginterferon alfa-2a",
"synonyms": [
"Peginterferon alfa-2a",
"PEG-IFN alfa-2A",
"Pegasys",
"Pegylated Interfeaon alfa-2A",
"Pegylated interferon alpha-2a",
"Pegylated-interferon alfa 2a",
"Pegylated interferon alfa-2a",
"PEG-Interferon alfa-2A",
"Pegasys",
"Peginterferon Alfa-2a",
"Pegasys",
"Peginterferon Alfa-2a",
"Pegasys",
"Peginterferon Alfa-2a"
],
"drugbank_id": "DB00008",
"generic_names": [
"Peginterferon alfa-2a",
"Peginterferon Alfa-2a",
"Peginterferon Alfa-2a",
"Peginterferon Alfa-2a"
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Peginterferon%20alfa-2a"
}
],
"Ribavirin": [
{
"intervention_type": "DRUG",
"description": "Ribavirin",
"name": "Ribavirin",
"synonyms": [
"Copegus",
"Ribamide",
"Ribovirin",
"Ribavirinum",
"Virazole",
"Vilona",
"Tribavirin",
"Virazide",
"tribavirin",
"Viramide",
"Ribamidil",
"RBV",
"1-beta-D-Ribofuranosyl-1,2,4-triazole-3-carboxamide",
"Ribavirin",
"ICN-1229",
"Ribamidyl",
"Ribavirine",
"Rebetol",
"Ribavirina",
"ICN1229",
"ICN 1229",
"Ribasphere",
"1-beta-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide"
],
"medline_plus_id": "a605018",
"generic_names": [
"Ribavirin"
],
"mesh_id": "D000998",
"drugbank_id": "DB00811"
}
]
} |
NCT01125579 | Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness | https://clinicaltrials.gov/study/NCT01125579 | null | COMPLETED | Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12.
Each patient is treated with NPB. No placebo group is established. Course and severity of symptoms is documented by a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS). A standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physicians discretion. The planned treatment and observation period is 2 - 4 weeks. | NO | Nervousness|Restlessness|Depression (Agitated)|Affective Disorders | null | Change in Parent Child Behaviour Checklist (CBCL/4-18), Parent Child Behaviour Checklist (CBCL/4-18), standardized questionnaire, after 2 + 4 weeks´ treatment | Tolerability of NEURAPAS balance, kind, frequency, duration, outcome of ADR, after 2 + 4 weeks|Change of 13 common symptoms of nervous restlessness, Questionnaire on 13 common symptoms of nervous restlessness in children, after 2 + 4 weeks|Change of the impact of the child´s complaints on daily family life (VAS), Visual Analogue Scale (VAS)to assess the impact of the child´s complaints on daily family life, after 2 + 4 weeks | null | Pascoe Pharmazeutische Praeparate GmbH | null | ALL | CHILD | null | 115 | INDUSTRY | OBSERVATIONAL | Observational Model: |Time Perspective: p | 162A07NPB | 2008-03 | 2008-11 | 2008-11 | 2010-05-18 | null | 2021-09-21 | multiple German Paediatric Practices, Giessen, Hessen, 35394, Germany | null | {} |
NCT04467879 | A Pivotal Study To Evaluate The Effectiveness of Isometric Handgrip Therapy In Prehypertensive And Hypertensive Patients | https://clinicaltrials.gov/study/NCT04467879 | null | TERMINATED | This is a double-blind, sham-controlled clinical trial assessing the effectiveness of personalized isometric handgrip device therapy. Approximately 230 patients who present with a Systolic Blood Pressure reading of ≤ 149mmHg and who have not taken any antihypertensive medication for more than 30 days will be enrolled. | NO | Hypertension, Systolic | DEVICE: Zona Plus Device|DEVICE: Control Device | Change from Baseline in Systolic Blood Pressure to Day 70 ± 2 Days, Comparative assessment in the change from Baseline in seated cuff Systolic Blood Pressure after ten(10) weeks of treatment between patients treated with the Zona Plus nominal device ( stronger grip ) and patients treated with the Placebo control device ( weaker grip ). A reduction in Systolic Blood ≥ 5 Preassure after 10 weeks of treatment is considered to be a better outcome., Change from Baseline to Day 70 ±2 Days | Change from Baseline in Diastolic Blood Pressure to Day 70 ± 2 Days, Comparative assessment of the change from Baseline in seated cuff Diastolic Blood Pressure after 10 weeks of treatment between patients treated with the Zona Plus nominal device ( stronger grip ) and patients treated with the Placebo control device ( weaker grip )., Change from Baseline to Day 70 ±2 Days|Percentage change from Baseline in Systolic Blood Pressure reduction at Day 70 ± 2 Days, Comparative assessment in the percentage of patients who achieve a clinically significant Systolic Blood Pressure reduction (defined as ≥ 5 mmHg) at Day 70 ± 2 Days., Change from Baseline to Day 70 ± 2 Days|Percentage change from Baseline in Diastolic Blood Pressure reduction at Day 70 ± 2 Days, Comparative assessment in the percentage of patients who achieve a clinically significant Diastolic Blood Pressure reduction (defined as ≥3 mmHg) at Day 70 ± 2 Days., Change from Baseline to Day 70 ± 2 Days|Percentage change from Baseline in Systolic Blood Pressure reduction at Day 160 ± 4 Days, Comparative assessment in change from Baseline in the seated cuff Systolic Blood Pressure after 6 months Day 160 ± 4 of treatment between patients treated with the Zona Plus nominal device and patients treated with the Placebo control device., Change from Baseline to Day 160 ± 4 Days|Percentage change in Diastolic Blood Pressure reduction at Day 160 ± 4 Days, Comparative assessment in change from Baseline in the seated cuff Diastolic Blood Pressure after 6 months Day 160 ± 4 Days of treatment between patients treated with the Zona Plus nominal device and patients treated with the Placebo control device., Change from Baseline to Day 160 ± 4 Days|Percentage change from Baseline in Systolic Blood Pressure reduction at Day 160 ± 4 Days, Comparative assessment in the percentage of patients who achieve a clinically significant Systolic Blood Pressure reduction (defined as ≥ 5 mmHg) at Day 160 ± 4 Days, Change from Baseline to Day 160 ± 4 Days|Percentage change in Diastolic Blood Pressure reduction at Day 160 ± 4 Days, Comparative assessment in the percentage of patients who achieve a clinically significant Diastolic Blood Pressure reduction defined as ≥3 mmHg at Day 160 ± 4 Days, Change from Baseline to Day 160 ± 4 Days|Comparison of Heart Rate between Zona Plus nominal device and Placebo controlled device, The Heart Rate (HR) will be recorded and compared between the Zona Plus nominal device and the Placebo control device treatment groups., Change from Baseline to Day 160 ± 4 Days | null | Zona Health, Inc | Research & Development Concierge Company | ALL | ADULT, OLDER_ADULT | null | 146 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | 1 | 2020-06-01 | 2022-09-13 | 2022-09-14 | 2020-07-13 | null | 2022-09-22 | Saint Louis Heart & Vascular, P.C., Saint Louis, Missouri, 63044, United States|Carolinas Research Center LLC, Charlotte, North Carolina, 28215, United States|Goldsboro Medical Center, Goldsboro, North Carolina, 27534, United States|Sante Clinical Research, Kerrville, Texas, 78028, United States|Sun Research Institute, San Antonio, Texas, 78215, United States | null | {
"Zona Plus Device": [
{
"intervention_type": "DEVICE"
}
],
"Control Device": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT05813379 | Mesenchymal Stem Cells Derived Exosomes in Skin Rejuvenation | https://clinicaltrials.gov/study/NCT05813379 | null | RECRUITING | Aging is a natural and complex process. The effect of environmental factors, genetics on the body eventually leads to damage in different ways. Exosomes are present in almost all body fluids, such as synovial fluid and blood. Exosomes and microvesicles are very efficient mediators of cell-to-cell communication by transferring their specific cargo to recipient cells; for example, exosomes are involved in the delivery of genetic materials, causing epigenetic modifications in the target cells .The applications of MSC-derived exosomes have more effect in cutaneous regeneration by collagen stimulation.The basic biology of exosomes indicates that MSC-exosomes may contain MSC-specific components to exert specific effects on recipient cells, which are somewhat equivalent to the regenerative effects of MSCs. This study aims to slow down the aging process of the skin by using exosome. | NO | Anti Aging | COMBINATION_PRODUCT: exosime injection | Proportion of re-epithelialization, In order to evaluate the treatment effect, to evaluate wrinkles and collagen before the treatment, take a photo/CT of the face, 1 month|Proportion of re-epithelialization, In order to evaluate the treatment effect, to evaluate wrinkles and collagen before the treatment, take a photo/CT of the face, 3 months | null | null | Isfahan University of Medical Sciences | null | FEMALE | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | Islamic Azad University | 2022-02-01 | 2023-07-29 | 2023-08-30 | 2023-04-14 | null | 2023-04-14 | Isfahan University of Medical Sciences, Isfahan, 81745319, Iran, Islamic Republic of | null | {
"exosime injection": [
{
"intervention_type": "COMBINATION_PRODUCT"
}
]
} |
NCT01561079 | Fetal and Infant Effects of Maternal Buprenorphine Treatment | https://clinicaltrials.gov/study/NCT01561079 | null | COMPLETED | This research will track the longitudinal neurobehavioral development of the buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine the safety of this medication for use during gestation, the relationship between maternal physiologic changes due to buprenorphine administration and newborn functioning, and to determine potential fetal neurobehavioral markers that may predict Neonatal Abstinence Syndrome expression and infant neurobehavioral outcome. Comparisons to results from a similar project in methadone-exposed pregnancies will be made. This proposal seeks to advance the way the investigators inform the treatment of the opioid dependent woman during pregnancy and her infant after birth. | YES | Neonatal Abstinence Syndrome | DRUG: Buprenorphine | Fetal Heart Rate, Fetal heart rate in beats per minute at time of trough and peak maternal buprenorphine levels, 24, 28, 32 and 36 weeks of gestation|Fetal Heart Rate Variability, Fetal heart rate variability at 24, 28, 32 and 36 weeks of gestation at times of trough and peak maternal buprenorphine levels, 24, 28, 32 and 36 weeks of gestation|Accelerations of Fetal Heart Rate, Number of accelerations of fetal heart rate exhibited during the 60 minute recordings, 24, 28, 32 36 weeks of gestation|Fetal Movement, Fetal movement (number x duration of fetal movements) during the 60 minute recordings at times of trough and peak maternal buprenorphine levels, 24, 28, 32, 36 weeks of gestation|Fetal Movement - Fetal Heart Rate Coupling, The integration between fetal movements and heart rate (FM-FHR coupling) was quantified as the proportion of time individual movements were associated with a change in FHR, using previously developed criteria. FM-FHR coupling reflects coactivation of the sympathetic and parasympathetic components of the autonomic nervous system., 24, 28, 32, 36 weeks of gestation | null | null | Johns Hopkins University | null | FEMALE | ADULT | PHASE2|PHASE3 | 127 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | 51600 | 2012-02 | 2016-06 | 2016-06 | 2012-03-22 | 2017-08-28 | 2017-09-26 | Center for Addiction and Pregnancy, Baltimore, Maryland, 21224, United States|Johns Hopkins Bayview Medical Center, Baltimore, Maryland, 21224, United States | null | {
"Buprenorphine": [
{
"intervention_type": "DRUG",
"description": "Buprenorphine",
"name": "Buprenorphine",
"synonyms": [
"Prefin",
"Subutex",
"Buprenorfina",
"Buprenorphine Hydrochloride",
"RX-6029-M",
"Espranor",
"17-cyclopropylmethyl-4,5\u03b1-epoxy-7\u03b1-((S)-1-hydroxy-1,2,2-trimethylpropyl)-6-methoxy-6,14-endo-ethanomorphinan-3-ol",
"Buprenorphine",
"6029-M",
"21-cyclopropyl-7\u03b1-[(S)-1-hydroxy-1,2,2-trimethylpropyl]-6,14-endo-ethano-6,7,8,14-tetrahydrooripavine",
"2-(N-cyclopropylmethyl-4,5\u03b1-epoxy-3-hydroxy-6-methoxy-6,14-endo-ethanomorphinan-6\u03b1-yl)-3,3-dimethyl-2-butanol",
"Suboxone",
"Butec",
"Temg\u00e9sic",
"RX6029M",
"(\u2212)-buprenorphine",
"Buprenex",
"Buprex",
"RX 6029 M",
"2-[3-cyclopropylmethyl-11-hydroxy-15-methoxy-(14R)-13-oxa-3-azahexacyclo[13.2.2.12,8.01,6.06,14.07,12]icosa-7,9,11-trien-16-yl]-3,3-dimethyl-2-butanol",
"Hydrochloride, Buprenorphine",
"Temgesic",
"Buprenophine",
"Sublocade",
"6029M",
"Buprenorphinum",
"6029 M",
"Buvidal",
"Sixmo",
"Subutex",
"Buprenorphine Sublingual and Buccal (opioid dependence)",
"Subutex",
"Buprenorphine Sublingual and Buccal (opioid dependence)",
"Buprenorphine/naloxone",
"Suboxone",
"Zubsolv",
"Bunavail",
"Buprenorphine/naloxone",
"Suboxone",
"Zubsolv",
"Bunavail"
],
"medline_plus_id": "a618015",
"generic_names": [
"Buprenorphine",
"Buprenorphine Sublingual and Buccal (opioid dependence)",
"Buprenorphine Sublingual and Buccal (opioid dependence)"
],
"nhs_url": "https://www.nhs.uk/medicines/buprenorphine-for-pain",
"mesh_id": "D009294",
"drugbank_id": "DB00921",
"wikipedia_url": "https://en.wikipedia.org/wiki/Buprenorphine"
}
]
} |
NCT00380679 | Offering Influenza and Pneumococcal Vaccine to Patients Being Evaluated in the Emergency Department | https://clinicaltrials.gov/study/NCT00380679 | null | UNKNOWN | According to the Advisory Committee on Immunization Practices (ACIP), all people aged 50 years or older and persons aged less than 50 years who have medical conditions that put them at increased risk for serious influenza disease should receive an annual influenza vaccination. However, since the mid-1990s, vaccination rates and racial disparities have mostly remained static, and there has been limited progress towards the Healthy People 2010 objectives for influenza vaccination coverage.
The purpose of this study is to determine what proportion of previously unvaccinated persons in target groups for whom influenza and pneumococcal vaccine are recommended will accept and receive influenza and/or pneumococcal vaccine in an urban emergency department (ED), and to estimate the potential impact of ED vaccination on population-based vaccination coverage. The intervention will utilize a combination of assessment survey, vaccine information and pre-printed vaccine order sheets.
The target population for influenza vaccinations includes all patients aged 18 years and older for whom influenza vaccine is recommended by the ACIP. This includes all persons aged 50 years and older and persons aged 18 to 49 years who are in one of the following groups: 1) health care workers, 2) pregnant women, 3) residents of long-term care facilities, 4) household contacts and out-of-home caregivers of children aged 0 to 23 months, or 5) persons with underlying chronic medical conditions which increase their risk of influenza-related complications. The target population for pneumococcal vaccination includes all patients aged 65 years or older who have not previously been vaccinated against pneumococcus or have not received the vaccine within 5 years (and were less than 65 years at the time of vaccination). | NO | High Risk for Serious Influenza|High Risk for Pneumonia | BIOLOGICAL: Influenza vaccination|BIOLOGICAL: Pneumococcal polysaccharide vaccination | Acceptance of vaccinations|Receipt of vaccination | Reasons vaccines were refused|Reasons vaccines were not administered | null | Louisiana State University Health Sciences Center in New Orleans | Centers for Disease Control and Prevention | ALL | ADULT, OLDER_ADULT | PHASE2 | null | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | 5800 | 2005-12 | null | 2006-03 | 2006-09-26 | null | 2006-09-26 | Baton Rouge General Medical Center, Baton Rouge, Louisiana, 70806, United States|Our Lady of the Lake Regional Medical Center, Baton Rouge, Louisiana, 70808, United States | null | {
"Influenza vaccination": [
{
"intervention_type": "BIOLOGICAL"
}
],
"Pneumococcal polysaccharide vaccination": [
{
"intervention_type": "BIOLOGICAL"
}
]
} |
NCT05126979 | The Objectives of This Study Are Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years | https://clinicaltrials.gov/study/NCT05126979 | null | COMPLETED | Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years | NO | Influenza | BIOLOGICAL: Inactivated Split Influenza Vaccine|BIOLOGICAL: Placebo | Severity of reported local reactions and their relationship with the vaccination, days 1-7|Severity of reported system reactions and their relationship with the vaccination - during 7 days after the vaccination (the day of vaccination and 6 subsequent days), days 1-7|Severity of local reactions reported by participants of the study and their relationship with the vaccination, days 8-20|Severity of system reactions reported by participants of the study and their relationship with the vaccination, days 8-20|The measurement physical data at each visit of the trial site by the volunteer, days 1-20 | The immunogenicity assessment of the vaccine was carried out by the seroconversion factor, Measurements will be taken at screening, then up to 21 days post-vaccination|The immunogenicity assessment of the vaccine was carried out by Geometric mean titer, Measurements will be taken at screening, then up to 21 days post-vaccination|The immunogenicity assessment of the vaccine was carried out by seroprotection levels, Measurements will be taken at screening, then up to 21 days post-vaccination|The immunogenicity assessment of the vaccine was carried out by seroconversion, Measurements will be taken at screening, then up to 21 days post-vaccination | null | St. Petersburg Research Institute of Vaccines and Sera | null | ALL | ADULT | PHASE1 | 45 | OTHER_GOV | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION | FMV-VGIR-1-001/15 | 2016-03-09 | 2016-04-25 | 2016-05-13 | 2021-11-19 | null | 2022-01-06 | Perm State Medical University named after academician E.A. Wagner, Perm, Russian Federation | null | {
"Influenza vaccine": [
{
"intervention_type": "BIOLOGICAL",
"description": "Inactivated Split Influenza Vaccine",
"name": "Influenza vaccine",
"synonyms": [
"Afluria",
"Influenza vaccine",
"Fluarix",
"Fluzone",
"Afluria",
"Influenza Vaccine, Inactivated or Recombinant",
"Flucelvax",
"Fluarix",
"Fluzone",
"Flu Vaccine",
"Afluria",
"Influenza Vaccine, Inactivated or Recombinant",
"Flucelvax",
"Fluarix",
"Fluzone",
"Flu Vaccine",
"Afluria",
"Influenza Vaccine, Inactivated or Recombinant",
"Flucelvax",
"Fluarix",
"Fluzone",
"Flu Vaccine",
"Afluria",
"Influenza Vaccine, Inactivated or Recombinant",
"Flucelvax",
"Fluarix",
"Fluzone",
"Flu Vaccine",
"Afluria",
"Influenza Vaccine, Inactivated or Recombinant",
"Flucelvax",
"Fluarix",
"Fluzone",
"Flu Vaccine",
"Afluria",
"Influenza Vaccine, Inactivated or Recombinant",
"Flucelvax",
"Fluarix",
"Fluzone",
"Flu Vaccine"
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Influenza%20vaccine",
"generic_names": [
"Influenza Vaccine, Inactivated or Recombinant",
"Influenza Vaccine, Inactivated or Recombinant",
"Influenza Vaccine, Inactivated or Recombinant",
"Influenza Vaccine, Inactivated or Recombinant",
"Influenza Vaccine, Inactivated or Recombinant",
"Influenza Vaccine, Inactivated or Recombinant"
]
}
],
"Placebo": [
{
"intervention_type": "BIOLOGICAL"
}
]
} |
NCT00935779 | Ultra Structure Of Peritoneum At Electronic Microscopy In Control Subjects And Patients With Gastric Cancer | https://clinicaltrials.gov/study/NCT00935779 | null | COMPLETED | Peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma. Involved mechanisms are poorly understood though experimentally it has been demonstrated that neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of damaged peritoneum. Objectives: to study ultra-structure of peritoneal surface by electronic microscopy in control subjects and in patients with early or locally advanced gastric cancer looking for spontaneous changes in peritoneal surface not related with surgical injury. | NO | Stomach Neoplasm | null | null | null | null | University of Chile | null | ALL | ADULT, OLDER_ADULT | null | 18 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | OAIC 043/02 | 2002-10 | 2004-07 | 2004-12 | 2009-07-09 | null | 2009-07-09 | Department of Surgery, Clinical Hospital, University of Chile, Santiago, Region Metropolitana, Chile | null | {} |
NCT05025579 | What is the Effect of Aerobic Exercise on Depression in Geriatric Individuals Diagnosed With Depression? | https://clinicaltrials.gov/study/NCT05025579 | null | COMPLETED | This study was planned to examine the effect of aerobic exercises on depression in geriatric individuals with a diagnosis of depression. | NO | Aerobic Exercise|Depression|Geriatric|Chronic Illness | OTHER: Aerobic Exercise | geriatric depression, Change from Clinically useful depression outcome scale score at beginning and 6th. weeks, before and after treatment (24 sessions, beginning and 6th. weeks) | Life Quality, Change from World Health Organization Quality of Life Questionnaire (EUROHIS-QOL) score at beginning and 6th. weeks, before and after treatment (24 sessions, beginning and 6th. weeks) | null | Ankara Yildirim Beyazıt University | null | ALL | OLDER_ADULT | null | 30 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 03/15/2019-74 | 2019-04-01 | 2019-06-30 | 2019-07-30 | 2021-08-27 | null | 2021-08-27 | Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department, Ankara, 06760, Turkey|Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department, Ankara, Turkey | null | {
"Aerobic Exercise": [
{
"intervention_type": "OTHER"
}
]
} |
NCT03903679 | Is Endotracheal Tube Use Mandatory in Patients Undergoing Nasal Septum Surgery? | https://clinicaltrials.gov/study/NCT03903679 | LMA | COMPLETED | The efficacy of supraglottic airway device use in many surgeries has been shown. Due to concerns such as tracheal blood leakage and vocal cord contamination in nasal septum surgery, there are doubts about the use of laryngeal mask airway among anesthesiologists.
The primary purpose of this study is; the aim of this study was to evaluate the tracheal blood leak with a flexible fiberoptic endoscope in patients who underwent nasal septum surgery and continued airway patency via laryngeal mask airway or endotracheal tube. Secondly, oropharyngeal leak pressure, hemodynamic response, airway reflexes (laryngospasm, bronchospasm, cough, desaturation), postoperative nausea, vomiting, sore throat, hoarseness and difficulty in swallowing will be evaluated. | NO | Airway Aspiration|Airway Complication of Anesthesia | DEVICE: Laryngeal mask airway|DEVICE: Endotracheal tube | Presence of blood in trachea, Presence of blood in trachea will be evaluated on a scale and it is defined as the level of presence of blood on glottis-trachea and distal trachea. (1 = no, 2 = mild, 3 = moderate, 4 = severe)., From the time 2minutes after the septal surgery to the time of extubation | Sore-throat, Sore-throat is defined as constant pain felt independently of swallowing. The evaluation was made with 0 ile10 numerical pain rating scale. According to numerical pain rating scale, sore throat score was evaluated as; 0-1 none, 2-4 between mild, 5-7 intermediate and 8-10 severe N, From the time 10 minutes after awakening from anesthesia to the time 24 hours postoperatively|Oropharyngeal leak pressure, Oropharyngeal leak pressures were measured while the head was in neutral position. The flowmeter oxygen current was set at 3 L/min and the expiratory valve was closed. When an investigator who did not know which type of airway device was placed, another researcher looked at the current pressure value from the aneroid manometer and confirmed that the pressure remained constant (pressure gauge stability test). This value was recorded as the value of Oropharyngeal leakage pressure. To prevent lung exposure to barotrauma, the expiratory valve was opened when the peak inspiratory pressure reached 40 pressure, and the test was terminated., From the time 2 minutes after anesthesia induction to the correction of inserted device 5 minutes after anesthesia induction | null | Inonu University | null | ALL | ADULT, OLDER_ADULT | null | 80 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC | erolkaraaslan2 | 2019-04-05 | 2019-06-01 | 2019-06-08 | 2019-04-04 | null | 2019-06-25 | Inonu University Medical Faculty, Malatya, 44090, Turkey | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/79/NCT03903679/Prot_SAP_000.pdf | {
"Laryngeal mask airway": [
{
"intervention_type": "DEVICE"
}
],
"Endotracheal tube": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT00171379 | Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium After Equimolar Conversion From Mycophenolate Mofetil (MMF) in Patients With Renal Transplant | https://clinicaltrials.gov/study/NCT00171379 | null | COMPLETED | The aim of the study is to evaluate the safety and efficacy of equimolar conversion from MMF to enteric-coated mycophenolate sodium, in renal transplant patients receiving cyclosporine. | NO | Prevention of Acute Rejection After Kidney Transplantation | DRUG: Enteric-Coated Mycophenolate Sodium | Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula | Incidence of biopsy proven acute rejection|Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms)|Quality of life related to GI symptoms (GIQLI scale)|Full blood count|Gastrointestinal Adverse Events (check-list) | null | Novartis | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 162 | INDUSTRY | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | CERL080AIT01 | 2004-03 | 2005-06 | 2005-06 | 2005-09-15 | null | 2011-02-02 | null | null | {
"Mycophenolate": [
{
"intervention_type": "DRUG",
"description": "Enteric-Coated Mycophenolate Sodium",
"name": "Mycophenolate",
"synonyms": [
"Myfortic",
"Mycophenolic acid",
"Acidum mycophenolicum",
"Acido micofenolico",
"CellCept",
"Mycophenolate",
"Micofenolico acido",
"(e)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic acid",
"Mycophenols\u00e4ure",
"Acide mycophenolique"
],
"medline_plus_id": "a601081",
"generic_names": [
"Mycophenolic acid",
"Mycophenolate"
],
"drugbank_id": "DB01024",
"wikipedia_url": "https://en.wikipedia.org/wiki/Mycophenolic%20acid"
}
]
} |
NCT02584179 | Biparametric MRI for Detection of Significant Prostate Cancer | https://clinicaltrials.gov/study/NCT02584179 | BIDOC | COMPLETED | Our aim is to develop a new diagnostic approach to improve the diagnosis of men suspicious of having significant prostate cancer (sPCa). The current diagnostic technique (standard transrectal ultrasound-guided biopsies [TRUS-bx]) rely on multiple prostate biopsy cores (10-12 samples) and if negative repeated biopsy sessions. This increases both patient complications (severe infections, bleeding and anxiety) and the diagnosis of insignificant cancer causing overtreatment. Still, significant cancers are missed. In addition, worldwide antibiotic-resistant bacteria increase, while effective antibiotics are declining. Thus, a noninvasive diagnostic tool to improve selection of men with clinically suspicion of PCa who need a biopsy from those who can avoid one is strongly needed. Previous studies in our department show that MRI in a selected patient cohort with prior negative TRUS-bx can improve the detection rate of clinically significant PCa and allows for a more accurate assessment of cancer stage and aggressiveness. However, the value of an MRI used as a first-line tool in the diagnostic examination of men in suspicion of PCa is uncertain. Furthermore, a full scale MRI prostate examination recommended by the European Society of Urogenital Radiology includes intravenous contrast-media and multiple sequences. This is both time-consuming and cost full, which reduces its feasibility for more widespread clinical implementation. We believe that a simpler, faster biparametric MRI (bpMRI) using less scan sequences and circumvents intravenous contrast-media and anti-peristaltic drugs would decrease image acquisition time, reduce costs and is sufficient to preserve diagnostic accuracy for sPCa detection in biopsy-naive men. Consequently, we will include biopsy-naive men in a protocol-based research project. The objective is to assess the diagnostic accuracy of bpMRI to rule out sPCa and whether a bpMRI can be used as a diagnostic non-invasive screening tool to 1) improve the diagnosis of sPCa 2) assess cancer aggressiveness 3) increase precision of biopsies and 4) reduce the number of biopsy sessions and cores. We evaluate the clinical significance of the detected cancers and whether bpMRI could be used as a triage test to improve the diagnosis of sPCa and aid in the determination of which men could safely avoid unnecessary biopsies.
This new diagnostic approach has the potential to significantly reduce patient hazards and complications. We aim to reach 1000 included men. We believe that bpMRI used in the clinical decision-making has the potential to change the future management of PCa. However, we still miss the scientific evidence to substantiate its preliminary promising results before this technique can be widely used to benefit all men. This large research project is to the best of our knowledge powered to include the largest patient sample size published within this field. | NO | Prostate Cancer | DEVICE: Biparametric MRI before biopsy | Diagnostic accuracy of a bp-MRI in detection and ruling out significant PCa in biopsy-naive men, All included men undergo bp-MRI at inclusion followed by diagnostic standard TRUS biopsies (current diagnostic standard). Men with any suspicious lesions on bpMRI undergo additional bpMRI-guided biopsies (bpMRI-bx) using bpMRI-TRUS image fusion based software. BpMRI suspicion scores and biopsy results ( detection of any PCa and sPCa) from standard TRUS-bx and bpMRI-bx are compared using combined biopsy results as standard reference.
Sensitivity and negative predictive value of bpMRI to detect and rule out sPCa will be determined, 24 months | null | null | Herlev Hospital | null | MALE | ADULT, OLDER_ADULT | null | 1,063 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | Herlev-MR-Prost-BP | 2015-12 | 2017-06 | 2018-12-01 | 2015-10-22 | null | 2019-08-13 | Herlev Hospital, Herlev, 2730, Denmark | null | {
"Biparametric MRI before biopsy": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT06464679 | An Exploratory Clinical Study of CD19 CAR NK Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases | https://clinicaltrials.gov/study/NCT06464679 | null | NOT_YET_RECRUITING | A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19 CAR NK cells in patients with autoimmune diseases. 36-72 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study was to evaluate the safety and feasibility of CD19 CAR-NK cells for the treatment of patients with autoimmune diseases. The secondary objective is to evaluate the efficacy of CD19 CAR-NK cells in patients with autoimmune diseases. | NO | Autoimmune Diseases | DRUG: CD19 CAR NK cells | Incidence of Dose-Limiting Toxicity (DLT), To characterize the safety of CD19 CAR NK Cells (KN5501) for Relapsed/Refractory autoimmune diseases, up to 48 weeks after infusion|Incidence of Treatment Emergent Adverse Events (TEAEs), To characterize the safety of CD19 CAR NK Cells (KN5501) for Relapsed/Refractory autoimmune diseases, up to 48 weeks after infusion | The overall response rate (ORR), To characterize the efficacy of CD19 CAR NK Cell (KN5501) for Relapsed/Refractory autoimmune diseases, Time Frame: 1, 3, 6, 12 and 12 months after infusion|Disease control rate (DCR), To characterize the efficacy of CD19 CAR NK Cell (KN5501) for Relapsed/Refractory autoimmune diseases, Time Frame: 1, 3, 6, 12 and 12 months after infusion | null | Changhai Hospital | Rui Therapeutics | ALL | ADULT, OLDER_ADULT | PHASE1 | 72 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | CHEC2024-181 | 2024-06-30 | 2025-06-30 | 2026-06-30 | 2024-06-18 | null | 2024-06-18 | null | null | {
"Natural Killer Cell": [
{
"intervention_type": "DRUG",
"description": "CD19 CAR NK cells",
"name": "Natural Killer Cell",
"synonyms": [
"NK Cells",
"Natural Killer Cell"
],
"drugbank_id": "DB15721",
"generic_names": [
"Natural Killer Cell"
]
}
]
} |
NCT02114879 | Enhanced Medical Rehabilitation in Older Adults | https://clinicaltrials.gov/study/NCT02114879 | EMR | COMPLETED | The purpose of this study is to provide evidence that Enhanced Medical Rehabilitation is an effective treatment for older adults after disabling medical events. | YES | Disabling Medical Events|Disabled|Depression | BEHAVIORAL: Enhanced Medical Rehabilitation|BEHAVIORAL: Standard of Care Rehabilitation | Change in Barthel Index Score, Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function., Baseline and Discharge, an average of 24 days. | Gait Speed (Determined by 4 or 10 Meter Walk Test), Meters walked per second., Discharge, an average of 24 days after baseline.|Distance Ambulated in 6-Minute Walk Test, Feet walked during 6 minute interval., Discharge, an average of 24 days after baseline.|Self-reported Barthel Index, Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function. Conducted as a self-report at timepoints where patient was not in an institutional setting., 30, 60, and 90 Days Post Admission to the SNF|Discharge Disposition, Number of participants discharged from skilled nursing facility to home, Discharge, an average of 24 days after baseline.|Rehospitalizations, Assesses whether the participant was readmitted to the hospital., Days 30, 60, and 90 post admission to a SNF as well as at Discharge | null | Washington University School of Medicine | National Institutes of Health (NIH)|National Institute of Mental Health (NIMH) | ALL | OLDER_ADULT | null | 229 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | R01 MH099011A1|5R01MH099011-02 | 2014-07-29 | 2018-07-13 | 2018-07-13 | 2014-04-15 | 2020-07-07 | 2020-07-07 | Barnes-Jewish Extended Care, Saint Louis, Missouri, 63105, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|Alexian Brothers Sherbrooke Village, Saint Louis, Missouri, 63125, United States | Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/79/NCT02114879/SAP_000.pdf|Study Protocol, https://cdn.clinicaltrials.gov/large-docs/79/NCT02114879/Prot_001.pdf | {
"Enhanced Medical Rehabilitation": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Standard of Care Rehabilitation": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT05147779 | Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Peyronies Disease, ED, and Interstitial Cystitis | https://clinicaltrials.gov/study/NCT05147779 | null | RECRUITING | This trial will study the safety and efficacy of intravenous and intracavernosal or interstitial delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Peyronies disease, erectile dysfunction , and Interstitial Cystitis | NO | Erectile Dysfunction|Peyronies Disease|Interstitial Cystitis | BIOLOGICAL: AlloRx | Safety (adverse events), Clinical monitoring of possible adverse events or complications, Four year follow-up | null | null | The Foundation for Orthopaedics and Regenerative Medicine | null | ALL | CHILD, ADULT, OLDER_ADULT | PHASE1 | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | ATG-1-MSC-015 | 2021-09-12 | 2025-12 | 2025-12 | 2021-12-07 | null | 2022-10-27 | Medical Surgical Associates Center, St. Johns, Antigua and Barbuda | null | {
"AlloRx": [
{
"intervention_type": "BIOLOGICAL"
}
]
} |
NCT01730079 | Near Infrared Spectroscopy in Children With Autism and ADHD | https://clinicaltrials.gov/study/NCT01730079 | null | TERMINATED | Background:
- Near-infrared spectroscopy (NIRS) is a functional imaging technique that can be uses light to study brain function while allowing for movement. To look at blood flow in the brain, NIRS uses a low-power light source with detectors that see how the light changes as it passes through brain tissue. Brain blood flow can indicate which parts of the brain are active during different tasks. Researchers want to study children with attention deficit hyperactivity disorder (ADHD) and autism spectrum disorders (ASD) and will use NIRS to compare the blood flow in the brain of children with ADHD and ASD with that of typically developing children.
Objectives:
* To see how well NIRS can detect changes in brain blood flow during tests of thinking and memory in children.
* To compare blood flow in the brains of typically developing children and those with ADHD or ASD.
Eligibility:
- Children between 4 and 8 years of age with ASD, ADHD, or children with no psychiatric diagnoses.
Design:
* Participants will be screened for eligibility. Those who are taking stimulant medication for ADHD or ASD will need to stop taking it for 3 days before the study visit.
* After participating in a screening assessment, all participants will have one study visit. At this visit, they will have be asked to complete two tasks during a NIRS scan. For both tasks, they will react to images on a computer screen. This visit will last about 2 hours.
* This is a testing study only. No blood or other samples will be needed for this study. | NO | Attention Deficit Disorder With Hyperactivity|Attention Deficit Disorder|Attention Deficit Hyperactivity Disorder|Autism|Autism Spectrum Disorders | null | Graded changes in blood flow and oxygen, measured with NIRS, in response to different functional tasks. | Differential activity according to region of the frontal cortext and task elements. | null | National Institute of Mental Health (NIMH) | null | ALL | CHILD | null | 42 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 130007|13-M-0007 | 2012-10-23 | 2017-04-11 | 2017-04-11 | 2012-11-21 | null | 2019-10-18 | National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States | null | {} |
NCT03902379 | Web-Based Coping and Communication Skills Intervention in Improving Psychological Adaptation in Patients With Gynecological Cancer | https://clinicaltrials.gov/study/NCT03902379 | null | WITHDRAWN | This pilot clinical trial studies how well web-based coping and communication skills intervention works in improving psychological adaptation in patients with gynecological cancer. Web-based intervention, such as coping and communication skills intervention, may help doctors to get a better understanding of ways to help gynecological cancer patients cope with their cancer experience. | NO | Endometrial Carcinoma|Stage 0 Fallopian Tube Cancer AJCC v7|Stage I Fallopian Tube Cancer AJCC v6 and v7|Stage I Ovarian Cancer AJCC v6 and v7|Stage IA Fallopian Tube Cancer AJCC v6 and v7|Stage IA Ovarian Cancer AJCC v6 and v7|Stage IB Fallopian Tube Cancer AJCC v6 and v7|Stage IB Ovarian Cancer AJCC v6 and v7|Stage IC Fallopian Tube Cancer AJCC v6 and v7|Stage IC Ovarian Cancer AJCC v6 and v7|Stage II Cervical Cancer AJCC v7|Stage II Fallopian Tube Cancer AJCC v6 and v7|Stage II Ovarian Cancer AJCC v6 and v7|Stage II Uterine Corpus Cancer AJCC v7|Stage IIA Cervical Cancer AJCC v7|Stage IIA Fallopian Tube Cancer AJCC v6 and v7|Stage IIA Ovarian Cancer AJCC V6 and v7|Stage IIA1 Cervical Cancer AJCC v7|Stage IIA2 Cervical Cancer AJCC v7|Stage IIB Cervical Cancer AJCC v6 and v7|Stage IIB Fallopian Tube Cancer AJCC v6 and v7|Stage IIB Ovarian Cancer AJCC v6 and v7|Stage IIC Fallopian Tube Cancer AJCC v6 and v7|Stage IIC Ovarian Cancer AJCC v6 and v7|Stage III Cervical Cancer AJCC v6 and v7|Stage III Fallopian Tube Cancer AJCC v7|Stage III Ovarian Cancer AJCC v6 and v7|Stage III Primary Peritoneal Cancer AJCC v7|Stage III Uterine Corpus Cancer AJCC v7|Stage IIIA Cervical Cancer AJCC v6 and v7|Stage IIIA Fallopian Tube Cancer AJCC v7|Stage IIIA Ovarian Cancer AJCC v6 and v7|Stage IIIA Primary Peritoneal Cancer AJCC v7|Stage IIIA Uterine Corpus Cancer AJCC v7|Stage IIIB Cervical Cancer AJCC v6 and v7|Stage IIIB Fallopian Tube Cancer AJCC v7|Stage IIIB Ovarian Cancer AJCC v6 and v7|Stage IIIB Primary Peritoneal Cancer AJCC v7|Stage IIIB Uterine Corpus 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 IIIC Uterine Corpus Cancer AJCC v7|Stage IIIC1 Uterine Corpus Cancer AJCC v7|Stage IIIC2 Uterine Corpus Cancer AJCC v7|Stage IV Cervical Cancer AJCC v6 and 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|Stage IV Uterine Corpus Cancer AJCC v7|Stage IVA Cervical Cancer AJCC v6 and v7|Stage IVA Uterine Corpus Cancer AJCC v7|Stage IVB Cervical Cancer AJCC v6 and v7|Stage IVB Uterine Corpus Cancer AJCC v7|Uterine Carcinosarcoma|Uterine Corpus Sarcoma | OTHER: Internet-Based Intervention|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration|OTHER: Survey Administration | Examine feasibility of an online CCI as defined by participants evaluation of the online intervention, Will define feasibility/acceptability as participants evaluation of the online intervention using both qualitative and quantitative methods. Will summarize participant?s feedback by their overall impressions, the ease of use, how much the web intervention kept their attention, how much they liked the program, feedback about how the program looked, suggestions on how to improve the look, their satisfaction with the program and why, how useful they found the program and why, how easy the information was to understand and why, to what degree they think it would make them more confident in coping with cancer, what the most and least helpful components of the program were, what aspects if any were confusing, evaluation of places where navigation were unclear, and anything they would like to add to the program., Up to 2 months | Changes in psychological adaptation- Beck Depression Inventory (BDI), Pre-post changes in the(BDI) scales will be examined. BDI has 21 items and scores range 0-63, Baseline up to 2 months|Changes in psychological adaptation-Mental Health Inventory (MHI), Pre-post changes in the (MHI) scales will be examined t-tests. 38-item MHI measure used, Baseline up to 2 months|Changes in psychological coping, Pre-post changes in the Impact of Event Scale (IES) scales will be examined using t-tests., Baseline up to 2 months|Examine acceptability of an online CCI, Will define acceptability as participants evaluation of the online intervention using both qualitative and quantitative methods. Will summarize participant?s feedback by their overall impressions, the ease of use, how much the web intervention kept their attention, how much they liked the program, feedback about how the program looked, suggestions on how to improve the look, their satisfaction with the program and why, how useful they found the program and why, how easy the information was to understand and why, to what degree they think it would make them more confident in coping with cancer, what the most and least helpful components of the program were, what aspects if any were confusing, evaluation of places where navigation were unclear, and anything they would like to add to the program., Up to 2 months | null | Rutgers, The State University of New Jersey | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | null | 0 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | Pro20160000637|NCI-2017-02300|Pro20160000637|131602|P30CA072720 | 2016-07-27 | 2020-05-31 | 2020-05-31 | 2019-04-04 | null | 2021-04-19 | Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, 08903, United States | null | {
"Internet-Based Intervention": [
{
"intervention_type": "OTHER"
}
],
"Quality-of-Life Assessment": [
{
"intervention_type": "OTHER"
}
],
"Questionnaire Administration": [
{
"intervention_type": "OTHER"
}
],
"Survey Administration": [
{
"intervention_type": "OTHER"
}
]
} |
NCT00826579 | Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer | https://clinicaltrials.gov/study/NCT00826579 | null | COMPLETED | The study is a feasibility and validation study of the sentinel lymph node (SLN) procedure in all stages of colon cancer. If the SLN can be reliably identified, it could be submitted to a more accurate histopathological examination (multiple sections, special staining). The detection of micrometastases in the SLN (occult stage III, upstaging) is possible. Patients with micrometastases should be considered at higher risk.
Additionally, a search for occult metastatic tumor cells in the bone marrow is performed. | NO | Colonic Neoplasms | PROCEDURE: Sentinel lymph node procedure|PROCEDURE: Bone marrow aspiration | To assess the extent of upstaging due to the SLN procedure for colon cancer., 1 month | To evaluate the accuracy of the SLN procedure for colon cancer. To identify factors influencing the success of the procedure. To correlate SLN results with the presence of colon cancer cell in bone marrow aspirates. To assess OS and DFS., 1 month, 3 and 5 years after surgery | null | University Hospital, Basel, Switzerland | null | ALL | CHILD, ADULT, OLDER_ADULT | PHASE1|PHASE2 | 192 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | Rhein4031 | 2000-05 | 2009-01 | 2009-01 | 2009-01-22 | null | 2015-03-12 | Carsten T. Viehl, MD, Basel, 4031, Switzerland|Urban Laffer, MD, Biel, 2501, Switzerland|Markus Zuber, MD, Olten, 4600, Switzerland | null | {
"Sentinel lymph node procedure": [
{
"intervention_type": "PROCEDURE"
}
],
"Bone marrow aspiration": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT00453479 | A Dose Ascending, Study To Examine The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of GSK233705B. | https://clinicaltrials.gov/study/NCT00453479 | null | COMPLETED | GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for the treatment of chronic obstructive pulmonary disease. This is a randomised, double-blind, placebo-controlled, dose ascending, parallel group study to examine the safety, tolerability, pharmacokinetics and pharmacodynamics of twice daily inhaled doses of GSK233705B for 7 days, in COPD subjects. | YES | Pulmonary Disease, Chronic Obstructive | DRUG: GSK233705B | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE), An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition., Up to follow-up (approximately 45 days)|Summary of Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Blood pressure was measured subsequent to 12 lead electrocardiogram (ECG). Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on Baseline (triplicate), 15, 30 minutes, 1.5, 4, 8 and 24 hours on Day 1 and 7., Up to Day 7 (24 hours post-dose)|Summary of Mean Heart Rate, Heart rate was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on Baseline (triplicate), 15, 30 minutes, 1.5, 4, 8 and 24 hours on Day 1 and 7., Up to Day 7 (24 hour post dose)|Maximum Value of SBP and DBP (0-4 Hour) for the Morning Dose, Blood pressure was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean., Up to Day 7 (0-4 hour)|Maximum Value of Heart Rate (0-4 Hour) for the Morning Dose, Heart rate was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean., Up to Day 7 (0-4 hour)|Weighted Mean of SBP and DBP (0-4 Hour) for the Morning Dose, Blood pressure was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean., Up to Day 7 (0-4 hour)|Weighted Mean of Heart Rate (0-4 Hour) for the Morning Dose, Heart rate was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean., Up to Day 7 (0-4 hour)|Number of Participants With Abnormal 12-lead ECG Findings, Single measurements were taken at all time points. The pre-dose values were classed as Baseline. Data for number of participants with normal, abnormal not clinically significant and abnormal clinically significant is presented. It was assessed on Baseline (triplicate), 15, 30 minutes, 1.5, 4, 8 and 24 hours on Day 1 and 7., Up to Day 7 (24 hour post dose)|Maximum Value (0-4 Hour) for the Morning Dose of ECG Parameters Corrected According to Fredericias Formula (QTcF) and Corrected According to Bazetts Formula (QTc B), Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean., Up to Day 7 (0-4 hour)|Weighted Mean (0-4 h) for the Morning Dose of ECG Parameters QTcF and QTc B, Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean., Up to Day 7 (0-4 hour)|Summary of Mean Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC), It was assessed on 1, 2, 4, 9, 12 and 24 hours on Days 1 and 7. Also on Day 7, it was measured on 0 hour (Baseline). At all time points 3 measurements were taken and formal statistical analysis was carried out on the derived maximum readings. Data for adjusted mean is presented as least square mean., Up to Day 7 (24-hour post dose)|Number of Participants Who Used Rescue Medication, Inhaled salbutamol was used as a rescue medication. Participants were required to keep a diary of their rescue medication (total number of salbutamol doses taken) over the entire 7-day treatment period. Diaries were reviewed by the Investigator when participants were admitted to the unit on Days 1, 2, 7 and 8., Up to Day 7|Number of Participants With Abnormalities in Chemistry Data of Clinical Concern, Clinical chemistry parameters included urea, potassium, aspartate aminotransferase (AST), total bilirubin, creatinine, creatine kinase, chloride, alanine aminotransferase (ALT), uric acid, glucose, gamma glutamyltransferase (GGT), albumin, sodium, phosphorus inorganic, calcium, alkaline phosphatase (ALP) and total protein. It was assessed on Day 1 (pre-dose, 24 hours) and Day 7 (pre-dose, 24 hours). Data for parameters with above and below the potential clinical concern (PCI) is provided., Up to Day 7|Number of Participants With Abnormalities in Hematology Data of Clinical Concern, Hematology parameters included platelet count, red blood cell (RBC) count, mean corpuscular volume (MCV), total neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Day 1 (pre-dose, 24 hours) and Day 7 (pre-dose, 24 hours). Data for parameters with above and below the PCI is provided., Up to Day 7|Summary of Microscopy Data for Participants With Abnormal Urinalysis Dipstick Results, Urinalysis parameters included protein, blood, ketones, glucose, bilirubin, urobilinogen, leukocyte esterase, specific gravity, nitrites and pH. Sediment microscopy was performed only on urine samples showing an abnormality on the dipstick. Microscopy was performed for: WBC, RBC, hyaline casts, granular casts and cellular casts. It was assessed on Day 1 (pre-dose, 24 hours) and Day 7 (pre-dose, 24 hours)., Up to Day 7 (pre dose)|Summary of Mean (0-24 Hour) and Maximum (0-24 Hour) Heart Rate Measured Using 24 Hour Using Holter ECG Data, Holter monitors were switched on immediately prior to dosing (up to 15mins pre-dose) so as to capture Holter ECG data from the 24 hour period following dosing. It was assessed on Day 1 and 7., Up to Day 7 | Plasma Concentrations of GSK233705, Blood samples were collected at indicated time points. 12 hour pharmacokinetic (PK) sampling was before evening dose., Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|Urine Concentrations of GSK233705, Urine GSK233705 pharmacokinetic excretion rate-time data is presented. Urine samples were collected throughout study and consolidated data is presented as 0-12 hours and 12-24 hours. 12 hour pharmacokinetic sampling was before evening dose., Day 1 and 7 throughout 24 hours|Derived Plasma PK Parameters-area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC0-tau), Blood samples were collected at indicated time points. 12 hour PK sampling was before evening dose. Data presented for morning samples., Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|Derived Plasma PK Parameters-area Under Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t), Blood samples were collected at indicated time points. 12 hour PK sampling was before evening dose. Data presented for morning sample as adjusted geometric mean., Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|Derived PK Plasma Parameters-area Under Concentration-maximum Observed Plasma Concentration (Cmax), Blood samples were collected at indicated time points. 12 hour PK sampling was before evening dose. Data presented for morning and evening samples as adjusted geometric mean., Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|Derived PK Plasma Parameters-area Under Concentration-time of Maximum Observed Plasma Concentration (T-max), Half-life (T-half) and Last Time Point Where the Concentration is Above the Limit of Quantification (T-last), Blood samples were collected at indicated time points. 12 hour PK sampling was before evening dose. Data presented for morning and evening samples., Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|Derived Urine Pharmacokinetic (PK) Parameters-area Under the Plasma Concentration-amount of Drug Excreted Unchanged in Urine (Ae), Urine GSK233705 pharmacokinetic excretion rate-time data is presented. Urine samples were collected throughout study and consolidated data presented as AM dose and PM dose. 12 hour pharmacokinetic sampling was before evening dose., Day 1 and 7 throughout 24 hours|Derived Urine PK Parameters-area Under Concentration-fraction of Dose Excreted Unchanged in Urine (Fe), Urine GSK233705 pharmacokinetic excretion rate-time data is presented. Urine samples were collected throughout study and consolidated data presented as 0-12 hours and 12-24 hours. 12 hour pharmacokinetic sampling was before evening dose., Day 1 and 7 throughout 24 hours|Derived Urine PK Parameters-area Under Concentration-renal Clearance (Clr), Urine GSK233705 pharmacokinetic excretion rate-time data is presented. Urine samples were collected throughout study. 12 hour pharmacokinetic sampling was before evening dose., Day 1 and 7 throughout 24 hours | null | GlaxoSmithKline | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 23 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: |Primary Purpose: DIAGNOSTIC | AC2108378 | 2007-03-28 | 2007-10-11 | 2007-10-11 | 2007-03-29 | 2018-02-08 | 2018-03-12 | GSK Investigational Site, Eindhoven, 5623 EJ, Netherlands|GSK Investigational Site, Harderwijk, 3844 DG, Netherlands|GSK Investigational Site, Utrecht, 3584 CJ, Netherlands|GSK Investigational Site, Zuidlaren, 9471 GP, Netherlands | null | {
"GSK233705B": [
{
"intervention_type": "DRUG"
}
]
} |
NCT00261079 | Fexofenadine in Pruritic Skin Disease | https://clinicaltrials.gov/study/NCT00261079 | null | COMPLETED | Primary objective:
* To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease
Secondary objective:
* To evaluate patients satisfaction of Allegra treatment | NO | Pruritus | DRUG: Fexofenadine | The change of physicians assessment on pruritic score before and after 7-day treatment. | Patient visual analogue scale change and Overall satisfaction. | null | Handok Inc. | null | ALL | CHILD, ADULT, OLDER_ADULT | PHASE4 | 435 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | M016455_4125 | 2005-04 | null | 2006-10 | 2005-12-02 | null | 2007-11-07 | Handok, Seoul, Korea, Republic of | null | {
"Fexofenadine": [
{
"intervention_type": "DRUG",
"description": "Fexofenadine",
"name": "Fexofenadine",
"synonyms": [
"Almerg",
"Terfenadine-COOH",
"Fexofenadina",
"Allegra",
"Terfenadine carboxylate",
"Terfenadine acid metabolite",
"Fexofenadine",
"Treathay",
"4-(1-Hydroxy-4-(4-(hydroxydiphenylmethyl)-1-piperidinyl)butyl)-alpha,alpha-dimethylbenzeneacetic acid",
"Carboxyterfenadine",
"Telfast"
],
"medline_plus_id": "a697035",
"generic_names": [
"Fexofenadine"
],
"nhs_url": "https://www.nhs.uk/medicines/fexofenadine",
"drugbank_id": "DB00950",
"wikipedia_url": "https://en.wikipedia.org/wiki/Fexofenadine"
}
]
} |
NCT00849979 | Validating M.D. Anderson Symptom Inventory (MDASI-GI) in GI Cancer Patients Under Chemotherapy | https://clinicaltrials.gov/study/NCT00849979 | null | COMPLETED | The goal of this study is to learn more about the symptoms that may occur in patients with GI cancer. The types of GI cancer being studied are cancers of the stomach, liver, pancreas, colon, and rectum. Researchers want to test a newly-designed questionnaire called the M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) questionnaire. | NO | Gastrointestinal Cancer | BEHAVIORAL: Questionnaire|OTHER: Interview | Validation of M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) Questionnaire (Response), 2 Years | null | null | M.D. Anderson Cancer Center | null | ALL | ADULT, OLDER_ADULT | null | 184 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING | 2007-0228 | 2008-07 | 2010-01 | 2010-01 | 2009-02-24 | null | 2012-07-30 | UT MD Anderson Cancer Center, Houston, Texas, 77030, United States | null | {
"Questionnaire": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Interview": [
{
"intervention_type": "OTHER"
}
]
} |
NCT06332079 | Holmium-166 TARE in Liver Limited Unresectable Colorectal Cancer Patients | https://clinicaltrials.gov/study/NCT06332079 | HAITI | RECRUITING | The aim of this study is to assess the efficacy of 166Ho-TARE followed by maintenance therapy with fluoropyrimidine and anti-EGFR or bevacizumab in liver-limited unresectable colorectal cancer patients, in terms of progression free rate 9- and 8-months for cohort A and B, respectively. | NO | Colorectal Cancer Metastatic | PROCEDURE: 166Holmium TARE|DRUG: Cetuximab|DRUG: Panitumumab|DRUG: 5-Fluorouracil|DRUG: Bevacizumab|DRUG: Capecitabine | Progression-free survival (PFS) Rate, PFS is defined as the time from study enrolment to the first documentation of objective disease progression or death due to any cause, whichever occurs first. PFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of progressive disease for patients who are alive, on study and progression free at the time of the analysis., 36 months | Overall Toxicity rate, Overall Toxicity rate is defined as the percentage of patients, relative to the total of enrolled subjects, who receive 166Ho-TARE and at least one cycle of chemotherapy, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0) during the study treatment., 36 months|Grade 3/ Grade 4 Toxicity rate, Grade 3/ Grade 4 Toxicity rate is defined as the percentage of patients, relative to the total of enrolled subjects, who receive 166Ho-TARE and at least one cycle of chemotherapy, experiencing a specific adverse event of severity grade 3/ grade 4, according to National Cancer Institute Common Toxicity Criteria (version 5.0) during the study treatment., 36 months|Post-treatment Disease Control Rate (DCR), Post-treatment DCR, is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR), partial (PR) response or stable disease (SD), according to RECIST 1.1 criteria, during the study treatment. The determination of clinical response will be based on investigator reported measurements. Tumor re-assessment with CT scan will be repeated every 8- weeks., 36 months|Progression free survival, Progression free survival (PFS), is defined as the time from study enrolment to the first documentation of objective disease progression or death due to any cause, whichever occurs first. PFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of progressive disease for patients who are alive, on study and progression free at the time of the analysis., 36 months|Overall Survival, Overall Survival (OS), is defined as the time from enrolment to death from any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive., 36 months|Dose-response relationships, Dose-response relationships are defined as the relationships between the tumor-absorbed doses calculated on post-treatment SPECT-CT (dependent variables) and the following independent variables: tumor response (SD, PR, CR according to RECIST CRITERIA v 1.1), progression free survival rate, and Overall Survival., 36 months|Quality of Life (QoL) assessed using the EORTC QLQ-CR29 questionnaire, The EORTC QLQ-CR29 is a patient-reported outcome measure to evaluate health-related quality of life among colorectal cancer patients in research and clinical practice.
QoL assessed using the EORTC QLQ-CR29 questionnaire will be evaluate at specific time-points (baseline, tumor reassessment and disease progression) and will be assessed through descriptive summary statistics., 36 months|Quality of Life (QoL) assessed using the EORTC QLQ-CR30 questionnaire, The EORTC QLQ-CR30 is 30-item instrument designed to measure quality of life in all cancer patients.
QoL assessed using the EORTC QLQ-CR30 questionnaire will be evaluate at specific time-points (baseline, tumor reassessment and disease progression) and will be assessed through descriptive summary statistics., 36 months|Quality of Life (QoL) assessed using the EuroQol EQ-5D questionnaire, The EuroQol EQ-5D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
QoL assessed using the EuroQol EQ-5D questionnaire will be evaluate at specific time-points (baseline, tumor reassessment and disease progression) and will be assessed through descriptive summary statistics., 36 months | null | Gruppo Oncologico del Nord-Ovest | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 46 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | HAITI 2023-505356-22-00 | 2024-03-13 | 2026-11 | 2027-02 | 2024-03-27 | null | 2024-03-27 | Azienda Ospedaliero Universitaria Pisana, Pisa, 56126, Italy | null | {
"166Holmium TARE": [
{
"intervention_type": "PROCEDURE"
}
],
"Cetuximab": [
{
"intervention_type": "DRUG",
"description": "Cetuximab",
"name": "Cetuximab",
"synonyms": [
"Erbitux",
"C\u00e9tuximab",
"Cetuximab",
"IMC-C225",
"Cetuximabum",
"IMC C225",
"C225",
"MAb C225"
],
"medline_plus_id": "a607041",
"generic_names": [
"Cetuximab"
],
"mesh_id": "D000074322",
"drugbank_id": "DB00002",
"wikipedia_url": "https://en.wikipedia.org/wiki/Cetuximab"
}
],
"Panitumumab": [
{
"intervention_type": "DRUG",
"description": "Panitumumab",
"name": "Panitumumab",
"synonyms": [
"ABX-EGF MAb",
"ABX EGF Monoclonal Antibody",
"Panitumumab",
"Human Panitumumab Antibody",
"Vectibix",
"Monoclonal Antibody, ABX-EGF",
"ABX-EGF",
"Panitumumab Antibody, Human",
"ABX-EGF Monoclonal Antibody"
],
"medline_plus_id": "a607066",
"generic_names": [
"Panitumumab"
],
"mesh_id": "D000074322",
"drugbank_id": "DB01269",
"wikipedia_url": "https://en.wikipedia.org/wiki/Panitumumab"
}
],
"Fluorouracil": [
{
"intervention_type": "DRUG",
"description": "5-Fluorouracil",
"name": "Fluorouracil",
"synonyms": [
"5-Fluoracil",
"Fluoro Uracil",
"Ribofluor",
"5-Fluoropyrimidine-2,4-dione",
"Efudix",
"Fluorouracile Dakota",
"5-FU",
"Neofluor",
"Dakota, Fluorouracile",
"Fluoroplex",
"Fluoro-Uracile ICN",
"Fluorouracilo Ferrer Far",
"5-Fluorouracil-Biosyn",
"5-FU Lederle",
"Onkofluor",
"5 Fluorouracil Biosyn",
"Fluorouracil",
"Haemato-FU",
"Fluorouracilum",
"5-FU Medac",
"5 HU Hexal",
"5-Fluracil",
"Carac",
"Fluoruracil",
"5 FU Medac",
"Fluouracil",
"5 Fluorouracil",
"5 FU Lederle",
"Fluorouracil Monopotassium Salt",
"Fluorouracilo",
"5-Fluorouracil",
"Fluorouracil Potassium Salt",
"Haemato FU",
"5-HU Hexal",
"Fluorouracil-GRY",
"Adrucil",
"Flurodex",
"Fluorouracil GRY",
"Efudex",
"Fluorouracil Monosodium Salt",
"Fluorouracil Mononitrate",
"5FU",
"Fluoro Uracile ICN",
"Fluracedyl"
],
"medline_plus_id": "a605010",
"generic_names": [
"Fluorouracil"
],
"mesh_id": "D007166",
"drugbank_id": "DB00544"
}
],
"Bevacizumab": [
{
"intervention_type": "DRUG",
"description": "Bevacizumab",
"name": "Bevacizumab",
"synonyms": [
"Bevacizumab",
"Bevacizumab awwb",
"bevacizumab-awwb",
"rhuMAb-VEGF",
"Zirabev",
"Avastin",
"Anti-VEGF monoclonal antibody",
"Bevacizumab-awwb",
"Mvasi",
"Anti-VEGF Humanized Monoclonal Antibody"
],
"medline_plus_id": "a607001",
"generic_names": [
"Bevacizumab"
],
"mesh_id": "D000074322",
"drugbank_id": "DB00112",
"wikipedia_url": "https://en.wikipedia.org/wiki/Bevacizumab"
}
],
"Capecitabine": [
{
"intervention_type": "DRUG",
"description": "Capecitabine",
"name": "Capecitabine",
"synonyms": [
"Capecitabinum",
"Xeloda",
"(1-(5-Deoxy-beta-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinyl)-carbamic acid pentyl ester",
"pentyl 1-(5-deoxy-\u03b2-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinecarbamate",
"Cap\u00e9citabine",
"Capecitabina",
"N(4)-pentyloxycarbonyl-5'-deoxy-5-fluorocytidine",
"Capecitabine",
"Pentyl [1-(5-deoxy-\u03b2-D-ribofuranosyl)-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]carbamate",
"Capecitabin"
],
"medline_plus_id": "a699003",
"generic_names": [
"Capecitabine"
],
"mesh_id": "D000964",
"drugbank_id": "DB01101"
}
]
} |
NCT01954979 | Abatacept to Treat Steroid Refractory Chronic Graft Versus Host Disease (cGVHD) | https://clinicaltrials.gov/study/NCT01954979 | null | COMPLETED | The participant is invited to take part in this study because they have chronic Graft versus Host Disease (cGVHD) that is not responding to standard treatment with steroids. This research study is a way of gaining new knowledge about the treatment of patients with cGVHD. This research study is evaluating a drug called abatacept.
Abatacept is a drug that alters and suppresses the immune system. Abatacept is approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe active rheumatoid arthritis in adults and of severe juvenile idiopathic arthritis (JIA) in patients who have failed prior therapy with disease-modifying anti-rheumatic drugs (DMARDs). These are autoimmune conditions, ie caused by an overactive immune system that attacks normal tissues and organs. It is currently being tested in a variety of other autoimmune conditions. In this case it is considered experimental.
cGVHD is caused by the donor cells attacking various organs of the recipient. The investigators try to minimize this immune attack by using corticosteroids such as prednisone. In severe cases prednisone is not sufficient and other immunosuppressive medications are used in addition in order to more efficiently control cGVHD and to limit the dose and consequently the multiple side-effects of corticosteroids. This study is being done to determine if the use of abatacept is safe in patients with cGVHD and if it can facilitate a better control of cGVHD.
During this study the participants will be evaluated for side effects from the treatment with abatacept, and for response of the cGVHD to the treatment. There will be two groups of participants in the study. The first group will be treated at a relatively low dose of abatacept. If this is found to be safe then the second group will be treated at a higher dose. Three to four tablespoons of blood will be drawn at every 2 week visit in order to determine your blood counts, kidney and liver function. Some of the blood will be used in a research lab in order to study measures of your immune system and how they might be affected by the treatment. | NO | Chronic Graft Versus Host Disease | DRUG: Abatacept | Determination of the Maximum Tolerated Dose (among two dose levels) and toxicity profile of a 141 day/6 dose course of abatacept in patients with steroid refractory cGVHD., Determination of the Maximum Tolerated Dose (among two dose levels) and toxicity profile of a 141 day/6 dose course of abatacept in patients with steroid refractory cGVHD., 2 Years | Determination of the efficacy (in terms of cGVHD symptoms, score and steroid dose) of a 141 day/6 dose course of abatacept in patients with steroid refractory cGVHD, Determination of the efficacy (in terms of cGVHD symptoms, score and steroid dose) of a 141 day/6 dose course of abatacept in patients with steroid refractory cGVHD, 2 Years|Examination of the immunologic effects associated with the administration of abatacept in patients with steroid refractory cGVHD., Examination of the immunologic effects associated with the administration of abatacept in patients with steroid refractory cGVHD., 2 Years | null | Beth Israel Deaconess Medical Center | Bristol-Myers Squibb|Dana-Farber Cancer Institute | ALL | ADULT, OLDER_ADULT | PHASE1 | 56 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 13-358 | 2014-03-27 | 2023-06-01 | 2024-01-16 | 2013-10-07 | null | 2024-01-18 | Dana-Farber Cancer Institute, Boston, Massachusetts, 02115, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States | null | {
"Abatacept": [
{
"intervention_type": "DRUG",
"description": "Abatacept",
"name": "Abatacept",
"synonyms": [
"BMS-188667",
"CTLA4-Ig Immunoconjugate",
"CTLA4 Ig Immunoconjugate",
"BMS-224818",
"CTLA4-Ig",
"BMS 188667",
"BMS188667",
"Immunoconjugate, CTLA4-Ig",
"Cytotoxic T Lymphocyte-Associated Antigen 4-Immunoglobulin",
"Belatacept",
"Abatacept recombinant",
"BMS 224818",
"Abatacept",
"CTLA-4-Ig",
"BMS224818",
"LEA29Y",
"CTLA4-Fc",
"Nulojix",
"Cytotoxic T Lymphocyte Associated Antigen 4 Immunoglobulin",
"Orencia"
],
"medline_plus_id": "a606016",
"generic_names": [
"Abatacept"
],
"mesh_id": "D000082082",
"drugbank_id": "DB01281"
}
]
} |
NCT01429779 | The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme | https://clinicaltrials.gov/study/NCT01429779 | null | UNKNOWN | The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal passage through the preoperative use of Movicol.
Hypothesis The use of Movicol® during one week prior to partial liver resection combined with the Enhanced Recovery After Surgery (ERAS®) programme accelerates functional recovery by promoting early return of gastro-intestinal function, defined as the passage of stools and early oral intake. | NO | Liver Diseases | DRUG: Movicol | Recovery of gastro-intestinal function, Recovery of gastro-intestinal function defined as time to first intake of solid food continued for more than 24 hours, 20 days | Recovery of gastro-intestinal function, Recovery of gastro-intestinal function defined as time to continuous oral intake of clear liquids for more than 24 hours, 20 days|Functional recovery, Functional recovery (measured by the following functional recovery criteria)
* Adequate pain control on oral analgesics only
* Eating and drinking properly without the need of IV fluids
* Independently mobile or mobile at preoperative level
* Standard laboratory tests and liver function returning to normal level, 20 days|Hospital length of stay, 20 days | null | Maastricht University Medical Center | Norgine | ALL | ADULT, OLDER_ADULT | PHASE4 | 80 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE | 11-1-039 | 2012-07 | 2014-10 | null | 2011-09-07 | null | 2014-04-11 | Universitatsklinikum Aachen, Aachen, 52074, Germany|Maastricht University Hospital, Maastricht, Limburg, 6202 AZ, Netherlands | null | {
"Macrogol": [
{
"intervention_type": "DRUG",
"description": "Movicol",
"name": "Macrogol",
"synonyms": [
"Macrogol",
"Macrogol 4000",
"Molaxole",
"CosmoCol",
"Laxido",
"Movicol"
],
"nhs_url": "https://www.nhs.uk/medicines/macrogol",
"generic_names": [
"Polyethylene glycol"
],
"drugbank_id": "DB09287"
}
]
} |
NCT03119779 | Effect of Pulpotomy Using TheraCal Versus MTA on Survival Rate of Cariously-Exposed Vital Permanent Molars | https://clinicaltrials.gov/study/NCT03119779 | null | COMPLETED | Objective:
To assess which is the most efficient pulpotomy medicament on tooth survival in patients with a cariously-exposed vital young permanent molar regarding: absence of postoperative pain, sinus or swelling, internal/ external root resorption, periapical radiolucency), root maturation and decrease chair side time of treated patient.
Trial design Randomized Clinical Trial (RCT), double-blinded with parallel group and allocation ratio (1:1), equivalence framework. | NO | Caries, Dental | DRUG: MTA-Anglus|DRUG: TheraCal | Survival rate, absence of any complication or complementary treatment (absence of spontaneous pain or swelling), 12 months | periapical radiolucency, presence or absence of periapical radiolucency radiographically, 12 months|internal/ external root resorption, presence or absence of internal/ external root resorption radiographically, 12 months|Root maturation, Root maturation assessment radiographically, 12 months | Time lapse till final restoration performed, measured using stop watch to assess which material needs less chair side time to be finished., from 5 till 20 minutes | Cairo University | null | ALL | CHILD | null | 22 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | CEBD-CU-2014-09-15 | 2015-09 | 2017-04-30 | 2017-04-30 | 2017-04-19 | null | 2017-07-25 | null | null | {
"MTA-Anglus": [
{
"intervention_type": "DRUG"
}
],
"TheraCal": [
{
"intervention_type": "DRUG"
}
]
} |
NCT05485779 | SAD, MAD and Food Effect Evaluation of Safety, Tolerability, and PK of AQ280 in Healthy Subjects | https://clinicaltrials.gov/study/NCT05485779 | null | COMPLETED | The principal aim of this study is to obtain safety and tolerability data when AQ280 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies in patients. | NO | Eosinophilic Esophagitis (EoE) | DRUG: AQ280|DRUG: Placebo | Part A (SAD): Number of treatment emergent adverse events (TEAEs) per subject, Part A (SAD): Screening up to Day 8(±2)|Part A (SAD): Number of subjects with clinically significant abnormalities in vital signs, Vital signs: systolic and diastolic blood pressure, pulse rate, and oral body temperature, Part A (SAD): Screening up to Day 3|Part A (SAD): Number of subjects with abnormal ECG, QTcF interval of >450 msec for males and >470 msec for females, or change from baseline of >30 msec, Part A (SAD): Screening up to Day 3|Part A (SAD): Number of subjects with clinically significant changes in laboratory evaluations, Part A (SAD): Screening up to Day 3|Part A (Food Effect): Number of treatment emergent adverse events (TEAEs) per subject, Part A (Food Effect): Screening up to Day 18(±2)|Part A (Food Effect): Number of subjects with clinically significant abnormalities in vital signs, Vital signs: systolic and diastolic blood pressure, pulse rate, and oral body temperature, Part A (Food Effect): Screening up to Day 13|Part A (Food Effect): Number of subjects with abnormal ECG, QTcF interval of >450 msec for males and >470 msec for females, or change from baseline of >30 msec, Part A (Food Effect): Screening up to Day 13|Part A (Food Effect): Number of subjects with clinically significant changes in laboratory evaluations, Part A (Food Effect): Screening up to Day 13|Part B (MAD): Number of treatment emergent adverse events (TEAEs) per subject, Part B (MAD): Screening up to Day 14(±3)|Part B (MAD): Number of subjects with clinically significant abnormalities in vital signs, Vital signs: systolic and diastolic blood pressure, pulse rate, and oral body temperature, Part B (MAD): Screening up to Day 14(±3)|Part B (MAD): Number of subjects with abnormal ECG, QTcF interval of >450 msec for males and >470 msec for females, or change from baseline of >30 msec, Part B (MAD): Screening up to Day 14(±3)|Part B (MAD): Number of subjects with clinically significant changes in laboratory evaluations, Part B (MAD): Screening up to Day 14(±3) | Part A (SAD) - Primary PK parameters derived from plasma concentration-time profile of AQ280: area under the concentration time curve from time 0 extrapolated to infinity, Area under the concentration time curve over a dosing interval (AUCτ) may be included as a primary PK parameter if AUC 0-infinity cannot be calculated, Days 1, 2 and 3|Part A (SAD) - Primary PK parameter derived from plasma concentration-time profile of AQ280: maximum observed concentration (Cmax), Days 1, 2 and 3|Part A (SAD) - Primary PK parameter derived from plasma concentration-time profile of the AQ280 main metabolite, AQ282: area under the concentration time curve from time 0 extrapolated to infinity, Area under the concentration time curve over a dosing interval (AUCτ) may be included as a primary PK parameter if AUC 0-infinity cannot be calculated, Days 1, 2 and 3|Part A (SAD) - Primary PK parameter derived from plasma concentration-time profile of the AQ280 main metabolite, AQ282: maximum observed concentration (Cmax), Days 1, 2 and 3|Part A (SAD) - Difference in Primary PK parameters derived from plasma concentration-time profile of AQ280: area under the concentration time curve from time 0 extrapolated to infinity in fasted state and in fed state, Area under the concentration time curve over a dosing interval (AUCτ) may be included as a primary PK parameter if AUC 0-infinity cannot be calculated, Days 1, 2 and 3|Part A (SAD) - Difference in Primary PK parameters derived from plasma concentration-time profile of AQ280: maximum observed concentration (Cmax) in fasted state and in fed state, Area under the concentration time curve over a dosing interval (AUCτ) may be included as a primary PK parameter if AUC 0-infinity cannot be calculated, Days 1, 2 and 3|Part B (MAD) - Primary PK parameters derived from plasma concentration-time profile of AQ280: accumulation ratio (AR), Day 1 and Day 7|Part B (MAD) - Primary PK parameters derived from plasma concentration-time profile of AQ280: area under the concentration time curve over a dosing interval (AUCτ), Day 1 and Day 7|Part B (MAD) - Primary PK parameters derived from plasma concentration-time profile of AQ280: maximum observed concentration (Cmax), Day 1 and Day 7|Part B (MAD) - Primary PK parameter derived from plasma concentration-time profile of the AQ280 main metabolite, AQ282: area under the concentration time curve over a dosing interval (AUCτ), Day 1 and Day 7|Part B (MAD) - Primary PK parameter derived from plasma concentration-time profile of the AQ280 main metabolite, AQ282: maximum observed concentration (Cmax), Day 1 and Day 7 | null | AQILION AB | null | ALL | ADULT, OLDER_ADULT | PHASE1 | 64 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | ARIA-1 | 2022-07-20 | 2023-07-10 | 2023-07-10 | 2022-08-03 | null | 2023-08-07 | Fortrea Clinical Research Unit Ltd., Leeds, LS2 9LH, United Kingdom | null | {
"AQ280": [
{
"intervention_type": "DRUG"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT04482179 | Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Alzheimer Disease | https://clinicaltrials.gov/study/NCT04482179 | null | ACTIVE_NOT_RECRUITING | Impaired verbal communication is a cardinal symptom of Alzheimer Disease (AD) and the source of enormous distress and disability. Effective therapies for this deficit are lacking. In light of the emerging literature demonstrating that Transcranial Magnetic Stimulation (TMS) improves general cognition in subjects with Alzheimer Disease (AD), the investigators propose to study the effectiveness of TMS as a therapy for impaired verbal communication. The hypothesis to be tested is that TMS combined with Constraint Induced Language Therapy (CILT) improves verbal communication more than sham TMS and CILT. A second aim is to use state-of-the-art neuroimaging to understand the mechanisms underlying any beneficial effect of the treatment. | NO | Alzheimer Disease | DEVICE: Active TMS|BEHAVIORAL: CILT|DEVICE: Sham TMS | Change in WAB-AQ, Overall change in Western Aphasia Battery - Aphasia Quotient (WAB-AQ) between the first baseline visit and the 6-month follow-up visit. WAB-AQ is measured on a scale from 0 to 100, with higher scores meaning greater language ability, 6-months post-treatment | Change in PNT, Change in naming accuracy on the Philadelphia Naming Test (PNT) between the first baseline visit and the 6-month follow-up visit. PNT naming accuracy is measured as a percentage from 0% to 100% with higher percentages meaning better naming ability., 6-months post-treatment | null | University of Pennsylvania | National Institutes of Health (NIH)|National Institute on Deafness and Other Communication Disorders (NIDCD) | ALL | ADULT, OLDER_ADULT | PHASE1 | 30 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 831532|R01DC016800-01A1 | 2020-02-19 | 2024-08-31 | 2024-08-31 | 2020-07-22 | null | 2024-02-01 | University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States | null | {
"Active TMS": [
{
"intervention_type": "DEVICE"
}
],
"CILT": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Sham TMS": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT06229379 | The Effects of a Large Language Model on Clinical Questioning Skills | https://clinicaltrials.gov/study/NCT06229379 | null | RECRUITING | The researchers have used the ophthalmology textbook, clinical guideline consensus, the Internet conversation data and knowledge base of Zhongshan Ophthalmology Center in the early stage, combined with artificial feedback reinforcement learning and other techniques to fine-tune and train the LLM, and developed Digital Twin Patient , a localized large language model that has the ability to answer ophthalmology-related medical questions, and also constructed a combination of automated model evaluation and manual evaluation by medical experts. The evaluation system combining automated model evaluation and manual evaluation by medical experts was constructed at the same time.
This project intends to integrate Digital Twin Patient into undergraduate ophthalmology apprenticeship, simulate the consultation process of real patients through the online interaction between students and Digital Twin Patient , explore the effect of Digital Twin Patient consultation teaching, provide emerging technology tools for guiding medical students to actively learn a variety of ophthalmology cases, cultivate clinical thinking, and provide the possibility of creating a new mode of intelligent teaching. | NO | Cataract|Glaucoma|Diabetic Retinopathy|Keratitis|Conjunctivitis | DEVICE: Digital twin patient |BEHAVIORAL: Interaction with real patients | Students scores in the medical history acquisition exam, Weekly during this study (up to 10 months) | null | null | Sun Yat-sen University | null | ALL | ADULT | null | 84 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER | 2023KYPJ283 | 2023-09-01 | 2024-02 | 2024-06 | 2024-01-29 | null | 2024-01-29 | Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity, Guangzhou, Guangdong, 510060, China | null | {
"Digital twin patient": [
{
"intervention_type": "DEVICE"
}
],
"Interaction with real patients": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT05797779 | Molecular Characterization of Induced Neuronal Cells in Parkinsons Disease | https://clinicaltrials.gov/study/NCT05797779 | null | RECRUITING | To describe the molecular, electrophysiological and morphological expression profile of dopaminergic neurons derived from fibroblasts of patients with Parkinsons disease. | NO | Parkinson Disease | PROCEDURE: Skin biopsy | Neurophysiological characterization of dopaminergic neurons derived from patients with Parkinsons disease., To evaluate the firing frequency in the dopaminergic neurons derived from fibroblasts of patients with Parkinsons disease., Baseline|Biochemical characterization of dopaminergic neurons derived from patients with Parkinsons disease., To determine the amount of dopamine released from differentiated neurons derived from fibroblasts of patients with Parkinsons disease., Baseline|α-synuclein misfolding in dopaminergic neurons derived from patients with Parkinsons disease., To document the presence of abnormal accumulation of misfolded alpha-synuclein in the dopaminergic neurons derived from fibroblasts of patients with Parkinsons disease., Baseline | null | null | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | null | ALL | ADULT, OLDER_ADULT | null | 45 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER | 3482 | 2021-03-25 | 2024-06-01 | 2025-03-25 | 2023-04-04 | null | 2023-04-04 | Flavia Torlizzi, Roma, 00168, Italy | null | {
"Skin biopsy": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT06189079 | Arterial Embolization for the Treatment of Bone Metastases: Prospective Observational Study | https://clinicaltrials.gov/study/NCT06189079 | EMBONEMET | RECRUITING | To date, arterial embolization constitutes one of the most popular methods in minimally invasive treatment of bone metastases, allowing good results in terms of pain reduction, local control of disease and reduction of peri-operative bleeding, with low invasiveness. | NO | Bone Metastases | null | Reduction of pain (VAS score), Clinical assessment regarding pain by Visual Analogue Scale (VAS) score (0-100 mm), in which 0 represents no pain, and 100 represents maximum pain imaginable., 1 year|Improvement in quality of life (EORTC QLQ - BM22), Clinical assessment regarding quality of life by EORTC QLQ - BM22 questionnaire. The questionnaire consists of several scales, covering different aspects related to palliation. The maximum and minimum scores for each scale of the questionnaire can range from 0 to 100. The interpretation of scores depends on the specific scale in the questionnaire, and a higher value may indicate either greater negative impact (e.g., more symptoms or more suffering) or greater positive impact (e.g., better quality of life or less symptomatology). The overall assessment requires a detailed analysis of individual scores and related scales., 1 year|Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire), Clinical assessment regarding quality of life by EORTC QLQ-C15-PAL questionnaire. The questionnaire consists of several scales, covering different aspects related to palliation. The maximum and minimum scores for each scale of the questionnaire can range from 0 to 100. The interpretation of scores depends on the specific scale in the questionnaire, and a higher value may indicate either greater negative impact (e.g., more symptoms or more suffering) or greater positive impact (e.g., better quality of life or less symptomatology). The overall assessment requires a detailed analysis of individual scores and related scales., 1 year | Volume reduction in cm, Reduction of the lesion evaluated with CT scans, measuring the diameter of the lesion in cm., 1 year | null | Istituto Ortopedico Rizzoli | null | ALL | ADULT, OLDER_ADULT | null | 60 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | CE AVEC: 313/2023/Oss/IOR | 2023-05-10 | 2025-05-10 | 2026-05-10 | 2024-01-03 | null | 2024-01-03 | Istituto Ortopedico Rizzoli, Bologna, Emilia Romagna, 40136, Italy | null | {} |
NCT04257279 | Prospective Robotic Global Research Study (PROGRESS) | https://clinicaltrials.gov/study/NCT04257279 | PROGRESS | UNKNOWN | The purpose of this study is to prospectively review outcomes of patients who have surgery with the ExcelsiusGPS™ robotics system in order to analyze screw placement accuracy. Patient demographics, intraoperative data and radiographic imaging to determine screw placement accuracy will be collected and reviewed. This information will be compared in a separate study to retrospectively collected data from sites who have done a similar number of cases without the robot. | NO | Lumbar Disc Disease | PROCEDURE: ExcelsiusGPS™ | Numeric Rating Scale, Pain rating scale, Baseline|Numeric Rating Scale, Pain rating scale, 2 weeks|Numeric Rating Scale, Pain rating scale, 3 months|Numeric Rating Scale, Pain rating scale, 6 months|Numeric Rating Scale, Pain rating scale, 12 months|Numeric Rating Scale, Pain rating scale, 24 months|Oswestry Disability Index, Index derived from the Oswestry Low Back Pain Questionnaire, Baseline|Oswestry Disability Index, Index derived from the Oswestry Low Back Pain Questionnaire, 2 weeks|Oswestry Disability Index, Index derived from the Oswestry Low Back Pain Questionnaire, 3 months|Oswestry Disability Index, Index derived from the Oswestry Low Back Pain Questionnaire, 6 months|Oswestry Disability Index, Index derived from the Oswestry Low Back Pain Questionnaire, 12 months|Oswestry Disability Index, Index derived from the Oswestry Low Back Pain Questionnaire, 24 months|SF-12, 12-Item short form health survey, Baseline|SF-12, 12-Item short form health survey, 2 weeks|SF-12, 12-Item short form health survey, 3 months|SF-12, 12-Item short form health survey, 6 months|SF-12, 12-Item short form health survey, 12 months|SF-12, 12-Item short form health survey, 24 months|Screw Placement Accuracy, Gertzbein Robbins Scale for screw accuracy, 2 weeks|Complications, Adverse Event, through study completion, 2 years | null | null | Globus Medical Inc | null | ALL | ADULT, OLDER_ADULT | null | 200 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | RGC18-002 | 2019-12-18 | 2021-12 | 2021-12 | 2020-02-06 | null | 2021-10-19 | Southeastern Spine Institute, Mount Pleasant, South Carolina, 29464, United States | null | {
"ExcelsiusGPS\u2122": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT06138379 | Video-supported Training in Line With the Health Belief Model | https://clinicaltrials.gov/study/NCT06138379 | null | NOT_YET_RECRUITING | Summary The only treatment method for those with incurable, irreversible, progressive, acute or chronic liver disease is liver transplantation. Compliance with the disease and immunosuppressive treatment has an important place in the success of transplants. This study was planned to examine the effect of video-supported education given to liver transplant patients in line with the Health Belief Model on adaptation to chronic disease and medication use.
The research will be conducted as a randomized controlled experimental study. The population of the research will consist of adult patients who received liver transplantation at İnönü University Turgut Özal Medical Center. The sample will consist of 90 patients determined by power analysis. Patients will be divided into three groups: control (n=30), 1st experiment (n=30) and 2nd experiment (n=30). Data will be collected between August 2023 and December 2023 using the Patient Information Form, Chronic Disease Adaptation Scale, Immunosuppressive Drug Use Compliance Scale and Rational Drug Use Scale. Video-supported training will be provided to patients in the experimental group to increase compliance with the disease and immunosuppressive treatment and to ensure rational drug use. Patients in the 1st experimental group will receive video-supported training in line with the Health Belief Model for one month, and patients in the 2nd experimental group will receive video-supported standard training for one month. This video training will be given to the experimental group patients outside the routine nursing care of the clinic. The video-supported training is planned to last 20-30 minutes. Nursing care in the routine practice of the clinic will be applied to the control group. Evaluation of data; It will be done with number, percentage, mean, standard deviation, chi-square, paired t test, t test analysis in independent groups, ANOVA and ANCOVA.
As a result, it is predicted that video-supported education will increase compliance with chronic disease and medication use and reduce post-transplant symptoms and discomfort caused by these symptoms. | NO | Education | OTHER: Experimental: 1st Experimental Group|OTHER: Experimental: 2nd Experimental Group | Patient Introduction Form, It is a form prepared by the researcher and examines the sociodemographic and medical characteristics of liver transplant patients. This form includes 11 questions to determine the patients age, gender, marital status, education level, employment status, income level, how long they have had liver disease, additional diseases, the presence of people assisting in the care, how long ago the transplant was performed, and the donor type., 6 months|Chronic Illness Adjustment Scale, It was developed by Derya Atik and Hilal Karatepe in 2016. The scale consists of 25 items. It consists of three subscales: Physical Adaptation (11 items), Social Adaptation (7 items), and Psychological Adaptation (7 items). Subdimensions of the scale; 1. Physical Harmony; Items 1, 9, 10, 13, 14, 15, 16, 18, 22, 23, 24 (minimum 11, maximum 55 points), 2. Social Cohesion; 2nd, 3rd, 5th, 7th, 17th, 19th, 25th items (minimum 7, maximum 35 points), 3. Psychological Adjustment; Items 4, 6, 8, 11, 12, 20, 21 measure (minimum 7, maximum 35 points). Scoring: 1st, 2nd, 3rd, 4th, 7th, 8th, 9th, 10th, 11th, 13th, 14th, 15th, 16th, 18th, 21st, 22nd, The 23rd items are normal (in the form of 1,2,3,4,5), the 5th, 6th, 12th, 17th, 19th, 20th, 24th, 25th items are reverse (5,4,3,2). It is scored as .1). The total score that can be obtained from the scale is 125. Higher scores from the subscales and/or the entire scale mean that patients adaptation levels to the disease increase., 6 months|Compliance with Immunosuppressive Medication Use Scale, In the scale developed by Özdemir, the compliance with medication use of patients who have had solid organ transplants and are taking immunosuppressive drugs is evaluated. In order for the scale to be applied, patients must complete at least two months after transplantation. The scale consists of 11 items in total. Scoring is done with a 5-point and 2-point Likert type rating. The scale includes positive and negative expressions. Positive statements are 4 and 6, and negative statements are 1, 2, 3, 5, 7, 8, 9, 10 and 11. Positive statements are scored from 1 to 5, while negative statements are scored from 5 to 1. For positive items, 1 point is given for a yes answer and 5 points are given for a no answer. The lowest score of the scale is 11 and the highest score is 55. As the score from the scale increases, compliance with medication use increases, and as the score decreases, compliance with medication use decreases. Cronbachs alpha value was calculated as 0.611 by Özdemir., 6 months|Rational Drug Use Scale, It consists of 21 items and a single dimension. Items are scored on a 5-point Likert-type scale according to the situations in which they realize the statements (1-Never, 2-Rarely, 3-Occasionally, 4-Often and 5-Always). Only the 17th item in the scale is reverse scored. After the reverse-scored item is translated, the sum of all scale items gives the total scale score . The total score of AİKÖ varies between 21 and 105. As the total score obtained from ADAS increases, rational drug use increases. When evaluating the total score received from AİKÖ; If the total score is between 21 and 52, it is scored as low, between 53 and 67, as medium, and between 68 and 105, it is scored as high., 6 months | null | null | Inonu University | null | ALL | ADULT, OLDER_ADULT | null | 90 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SCREENING | 2023/4674 | 2023-12-01 | 2024-06-01 | 2024-10-01 | 2023-11-18 | null | 2023-11-18 | Turgut Ozal Medical Center, Malatya, 44000, Turkey | null | {
"Experimental: 1st Experimental Group": [
{
"intervention_type": "OTHER"
}
],
"Experimental: 2nd Experimental Group": [
{
"intervention_type": "OTHER"
}
]
} |
NCT03270579 | A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]JNJ-64511070 | https://clinicaltrials.gov/study/NCT03270579 | null | COMPLETED | The main purpose of the study is to measure the whole-body distribution and radiation dosimetry of [18F]JNJ-64511070 in healthy male participants by positron emission tomography (PET) (Part A); and to measure the uptake, binding, distribution, and washout of [18F]JNJ-64511070 in the brain of healthy male participants by PET and to model tissue specific kinetics of [18F]JNJ-64511070 with the appropriate arterial input function (IF) (Part B). | NO | Healthy | DRUG: [18F]JNJ-64511070 | Part A: Effective Radiation Dose Following Injection of [18F]JNJ-64511070, The tissue radioactivity will be measured per organ for up to 5 hours after injection of up to 185 megaBecquerel (MBq) of [18F]JNJ-64511070 and corrected for attenuation by computed tomography (CT) transmission scans using positron emission tomography (PET) /CT. These measurements will be used to estimate effective radiation dose per organ and total body., Up to 5 hours on Day 1|Part B: Total and Regional Brain Compartmental Kinetics for Volume of Distribution of [18F]JNJ-64511070 in Brain, The Distribution of [18F]JNJ-64511070 in brain will be measured by PET/CT scans obtained from the time of injection for up to 120 minutes along with measurement of the tracer input function with arterial samples for intact tracer and metabolites to establish the total and regional compartmental kinetics and volume of distribution (V[t]) of [18F]JNJ-64511070., Day 1 | Number of Participants With Adverse Events as a Measure of Safety and Tolerability, An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product., Approximately Up to 4 weeks | null | Janssen Research & Development, LLC | null | MALE | ADULT | PHASE1 | 8 | INDUSTRY | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE | CR108379|2017-002262-47|64140284EDI1002 | 2017-09-12 | 2018-02-06 | 2018-02-06 | 2017-09-01 | null | 2019-04-19 | UZ Leuven Gasthuisberg, Leuven, 3000, Belgium | null | {
"[18F]JNJ-64511070": [
{
"intervention_type": "DRUG"
}
]
} |
NCT04181879 | Appropriate Polypharmacy in Older People in Primary Care | https://clinicaltrials.gov/study/NCT04181879 | PolyPrime | UNKNOWN | In the past, prescribing many medicines (polypharmacy) was seen in a negative light. However, because people are living longer and have several medical conditions at the same time, views on polypharmacy have changed. The challenge is to have the correct balance between enough medicines and too many medicines. Members of the research team have developed a new approach to achieving this balance. This approach has been tested in two general practices in Northern Ireland (NI). The approach (intervention package) currently consists of two parts: (1) a video showing how general practitioners (GPs) can prescribe appropriate polypharmacy for older patients, and (2) an appointment system for patients to visit a GP to have their medicines reviewed. As the intervention package was developed and tested in NI, further testing needs to be carried out in NI and the six border counties of the Republic of Ireland (ROI; Cavan, Donegal, Leitrim, Louth, Monaghan, and Sligo). This will be done in three stages or phases. In phase 1, which is now complete, 13 GPs were interviewed across 12 practices in the six border counties in the ROI; shown the video, asked about this new approach and asked if any changes are needed before doing more testing. In the next two phases (Phase 2 & 3) a small study will be carried out involving 12 practices: six practices in NI and six practices in the six border counties in the ROI and approximately 10 patients per practice. GP practices will either receive the intervention package and conduct medication reviews with recruited patients (intervention group) or continue to treat recruited patients as usual (control group). Interviews with up to 10 GPs and six members of practice staff (i.e. those involved in implementing the intervention within each practice) respectively in the six intervention group practices will also be conducted at the end of the intervention. Patients from the six intervention group practices will be asked to complete a feedback questionnaire after the delivery of the intervention (i.e. after completion of their final follow-up questionnaires). | NO | Polypharmacy | BEHAVIORAL: Intervention | The number of patients contacted and recruited, Through study completion, an average of 1 year|The number of GP practices contacted and recruited, Through study completion, an average of 1 year|The retention rate of patients, The number of patients retained over the study period, Through study completion, an average of 1 year|The retention rate of GP practices, The number of GP practices retained over the study period, Through study completion, an average of 1 year|Medication appropriateness, Assessed using STOPP/START criteria, Baseline|Medication appropriateness, Assessed using STOPP/START criteria, Six months post-initial medication review in the intervention arm and the equivalent time points in the control arm|Medication appropriateness, Assessed using STOPP/START criteria, Nine months post-initial medication review in the intervention arm and the equivalent time points in the control arm | The number of video view counts per GP participant for the online video, The number of times the GPs watched the online video; taken from the hosting website, Through study completion, an average of 1 year|The numbers of appointments scheduled, Collected on study-specific data collection forms, Through study completion, an average of 1 year|The number of medication review appointments attended (first and second reviews), Collected on study-specific data collection forms, Through study completion, an average of 1 year|The length of the medication reviews, The length of the medication reviews will be based on audio-recordings of a selection of patient medication reviews, Through study completion, an average of 1 year|The number of scheduled weekly meetings within each practice at which explicit plans were made to recall patients for medication reviews, Recorded on GP practice staff data collection form, Through study completion, an average of 1 year|The number of prompts made by reception staff, The number of prompts made by reception staff will be recorded on a GP practice staff data collection form, Through study completion, an average of 1 year|The resource use and associated costs of the intervention, Baseline, six months post-initial medication review in the intervention arm and the equivalent time points in the control arm and nine months post-initial medication review in the intervention arm and the equivalent time points in the control arm|Participant health and social care service use, As reported in GP notes and compared with self-reported health service use, Baseline, six months post-initial medication review in the intervention arm and the equivalent time points in the control arm and 12 months post--initial medication review in the intervention arm and the equivalent time points in the control arm|Health-related quality of life, Measured using the EQ-5D-5L, Baseline, six months post-initial medication review in the intervention arm and the equivalent time points in the control arm and nine months post-initial medication review in the intervention arm and the equivalent time points in the control arm|Medication-Related Burden Quality of Life, Measured using the Medication-Related Burden Quality of Life (MRB-QoL) tool, Baseline, six months post-initial medication review in the intervention arm and the equivalent time points in the control arm and nine months post-initial medication review in the intervention arm and the equivalent time points in the control arm|Estimates of effect size between groups, cluster size and intraclass correlation coefficients (ICCs), Through study completion, an average of 1 year | null | Queens University, Belfast | University of Dublin, Trinity College|Royal College of Surgeons, Ireland|National University of Ireland, Galway, Ireland|Belfast Health and Social Care Trust | ALL | OLDER_ADULT | null | 68 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH | B19/20 | 2019-09-01 | 2021-10-21 | 2021-12 | 2019-12-02 | null | 2021-12-02 | Trinity College Dublin, Dublin, D02PN40, Ireland|Queens University Belfast, Belfast, Antrim, BT9 7BL, United Kingdom | null | {
"Intervention": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT06082479 | The Effect of Intra Oral Cryotherapy in Patients With Symptomatic Apical Periodontitis | https://clinicaltrials.gov/study/NCT06082479 | null | COMPLETED | The participants were divided into two groups: Group I (cryotherapy) (n =10) after the completion of the mechanical preparation intra oral cryotherapy was applied. Group II (control) (n =10) received standard root canal treatment without the application of any type of cryotherapy. | NO | Post Operative Pain|Inflammation | PROCEDURE: intraoral cryotherapy,ice gel | Level of post operative pain using 10 cm visual analoge scale (VAS), On a10-cm Visual Analogue Scale (VAS) questionnaire, each patient reported their level of pain as follows: There is no pain at 0, 1-3, mild, 4-6, moderate, 7-9, severe, and 10, the worst pain., after 6hours, 24hours, 48hours, 72hours h, and 7days after the visit | Level of inflammatory mediator substance P in apical fluid, Apical fluid samples were obtained using paper points size 25 passing 2 mm beyond the apex.where they were soaked by the periapical interstitial fluid for 1 minute .Four mm from the tip of each paper point was cut and dropped into 1.5-mL Eppendorf tubes (Swanscombe, UK) with 1 mL (pH 7.4) phosphate buffered saline, then stored at -80°C. Levels of substance p were measured using the ELISAtest., base line: immediately after procedure.the second is 30 minutes later in both groups. | null | Ain Shams University | null | ALL | ADULT, OLDER_ADULT | null | 20 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 304 | 2022-09-01 | 2023-02-01 | 2023-02-01 | 2023-10-13 | null | 2024-01-30 | Ain Shams University, Cairo, Egypt | null | {
"intraoral cryotherapy,ice gel": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT02116179 | DVD-based HIV/HCV Prevention Intervention for Drug-Involved Latino Criminal Justice Clients | https://clinicaltrials.gov/study/NCT02116179 | null | COMPLETED | The purpose of the study are the following: 1) Pilot test and conduct baseline and 3 month follow up assessments to evaluate the preliminary efficacy of the DVD-based HIV/HCV intervention by randomly assigning 210 Latino corrections-involved, outpatient abuse treatment clients to either the experimental intervention or to a wait list control group; and 2) to evaluate both participant and interventionist acceptability of this novel DVD-based intervention.
They study hypothesis are the following:
1. participants in the intervention condition will report greater reductions in sexual risk behaviors (e.g., unprotected sexual contact) from baseline to 3 month follow-up compared to the control group;
2. participants will report greater reductions in drug risk behaviors (e.g., sharing injection equipment, drug use during sex) from baseline to 3 month follow-up compared to the control group;
3. participants who report more HIV prevention information, motivation, and behavioral skills will report fewer sexual risk behaviors. | NO | Human Immunodeficiency Virus|Acquired Immunodeficiency Syndrome|Hepatitis C | BEHAVIORAL: DVD Intervention | Sexual risk behaviors, 90 days | Drug Use Behaviors, 90 days | null | University of Delaware | National Institute on Drug Abuse (NIDA) | ALL | ADULT | null | 201 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 5R34DA031063|5R34DA031063 | 2014-07 | 2016-05 | 2016-05 | 2014-04-16 | null | 2016-10-21 | University of Delaware Center for Drug and Alcohol Studies, Coral Gables, Florida, 33143, United States | null | {
"DVD Intervention": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT02759679 | Canine-Assisted Profiling of Lung Cancer From Human Breath | https://clinicaltrials.gov/study/NCT02759679 | null | TERMINATED | The study aims to optimize and define a reproducible and non-invasive method for canine assisted lung cancer detection, using human breath samples from patients and controls for training and testing purposes. | NO | Lung Cancer | OTHER: Human breath samples | Sensitivity and specificity for lung cancer, of canines sniffing breath samples, Patients and Controls deliver breath samples to be presented for dogs in a Remote facility. Outcomes will be reported for individual dogs and combinations of dogs., 2 years | null | null | Haukeland University Hospital | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 650 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC | REK_2013/2053 | 2016-05 | 2019-12 | 2019-12 | 2016-05-03 | null | 2024-03-01 | Haukeland University Hospital, Bergen, Norway | null | {
"Human breath samples": [
{
"intervention_type": "OTHER"
}
]
} |
NCT01991379 | MEK162 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST) | https://clinicaltrials.gov/study/NCT01991379 | null | ACTIVE_NOT_RECRUITING | The purpose of this study is to evaluate the effects, good and/or bad, of MEK162 and imatinib on the patient and on Gastrointestinal Stromal Tumor (GIST).
Funding Source - FDA OOPD, Array/Pfizer | NO | Gastrointestinal Stromal Tumor (GIST) | DRUG: MEK162|DRUG: Imatinib Mesylate (Gleevec®; STI571; NSC #716051)|OTHER: Blood draws|PROCEDURE: biopsy | maximum tolerated dose (MTD) (phase 1b portion), The first three patients will be enrolled at Dose Level 1. If dose level 1 is not found to be tolerable, then the next cohort will be enrolled at dose level -1. If dose level -1 is not found to be tolerable, then the study may be terminated based on discussions with the sponsor and the combination may be deemed intolerable. If 0/3 patients or 1/6 patients experience a DLT on dose level 2, this will be the RP2D., 1 year|Best Response Rate (phase II portion), Response Rate (CR+PR, RECIST 1.1). Response rate (RECIST 1.1) will be determined as the proportion of evaluable patients who have complete response or partial response defined by the RECIST 1.1., 2 years | Response Rate (RR) (phase 1b portion), defined by RECIST 1.1 criteria and by CHOI criteria RR will be estimated as the proportion of patients who have complete response or partial response for each criterion., 1 year|Progression Free Survival (PFS), PFS will be calculated using Kaplan-Meier estimate among all patients enrolled. Patients who have not experienced the event of interest by the end of the study will be censored at the time of the last follow-up., 1 year|RR by CHOI criteria (phase II portion), It will be determined as the proportion of patients who have complete response or partial response defined by the CHOI criteria with a two-sided 95% CI provided., 1 year|RR by EORTC criteria, It will be determined as the proportion of patients who have complete response or partial response defined by the EORTC criteria with a two-sided 95% CI provided., 1 year | null | Memorial Sloan Kettering Cancer Center | null | ALL | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 75 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 13-162 | 2013-11 | 2024-11 | 2024-11 | 2013-11-25 | null | 2023-12-04 | Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States | null | {
"MEK162": [
{
"intervention_type": "DRUG"
}
],
"Imatinib": [
{
"intervention_type": "DRUG",
"description": "Imatinib Mesylate (Gleevec\u00ae; STI571; NSC #716051)",
"name": "Imatinib",
"synonyms": [
"Imatinib",
"Glivec",
"Gleevec",
"Imatinibum",
"\u03b1-(4-methyl-1-piperazinyl)-3'-((4-(3-pyridyl)-2-pyrimidinyl)amino)-p-toluidide"
],
"medline_plus_id": "a606018",
"generic_names": [
"Imatinib"
],
"drugbank_id": "DB00619",
"wikipedia_url": "https://en.wikipedia.org/wiki/Imatinib"
}
],
"Blood draws": [
{
"intervention_type": "OTHER"
}
],
"biopsy": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT02031679 | Efficacy and Safety of Chemoattractant Receptor-homologous Molecule Expressed on T Helper Type 2 (CRTh2) Antagonist AZD1981 in Chronic Idiopathic Urticaria (CIU) Antihistamines | https://clinicaltrials.gov/study/NCT02031679 | null | COMPLETED | The investigators are recruiting for a chronic hives study. This research is being done to test whether an investigational drug called AstraZeneca drug (AZD)1981 may be helpful for treating people with Chronic Idiopathic Urticaria who continue to have symptoms despite taking antihistamines. The word investigational means that AZD1981 is not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of AZD1981 in this study.
People with chronic hives lasting for at least 6 months and without a known cause may join. The study involves 6 visits over 8 weeks. Approximately 48 participants expected to take part in this study at the Johns Hopkins Asthma and Allergy Clinic. All participants will be treated with the study medication and/or placebo for 8 weeks.
The results of this trial may have a benefit others with Chronic Idiopathic Urticaria who dont respond well to antihistamines by generating experience and data to support the design of a larger, multicenter trial investigating the efficacy of AZD1981 in treating antihistamine refractory CIU. | YES | Chronic Idiopathic Urticaria | DRUG: AZD1981|DRUG: Placebo | The Change in Diary-based Clinical Symptoms as Measured by the Urticaria Activity Score 7 (UAS7), The UAS score, which is the sum of pruritus and hives, will be used to calculate the UAS7. UAS is a validated measure of Chronic Spontaneous Urticaria (CSU) disease activity which scores the intensity of pruritus (0-3, with 0 = no itch and 3 is severe itch) and number of hives (0-3 0 means no hives and 3 means greater than 50 hives) with a maximum value of 6 for a given day. The UAS7 is the sum of the daily average UAS scores (average of a.m. and p.m.) for 7 days with a minimum score of 0 and a maximum value of 42. The UAS7 is a sum of the daily average (average of a.m. and p.m.) for 7 days. The baseline score was established during the second placebo therapy week and compared to the final week of the 4 week active treatment period., 7 Days | The Number of Participants With Adverse Events, The safety of AZD1981 will be assessed using the following outcome measures: incidence and severity of treatment-emergent adverse events and serious adverse events, clinical laboratory measures, and vital signs. In particular we will measure CBCs with differential at baseline and week 4 and liver function tests every 2 weeks based on past trial experience of dose-related toxicity., 8 weeks|The Ability of AZD1981 to Inhibit Prostaglandin D2 (PGD2)-Induced Eosinophil Shape, The measure of Eosinophil shape change was assessed by cell scatter characteristics using a flow cytometer. Cellular scatter was established with buffer and then several doses of PGD2 stimulation., Baseline, End of treatment, end of washout | null | Johns Hopkins University | AstraZeneca | ALL | ADULT, OLDER_ADULT | PHASE2 | 38 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | NA_00089252 | 2014-01 | 2016-01 | 2016-01 | 2014-01-09 | 2017-07-12 | 2017-07-12 | Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, 21224-6821, United States | null | {
"AZD1981": [
{
"intervention_type": "DRUG"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT05258279 | Lenvatinib in Combination With Carboplatin Pemetrexed and Pembrolizumab for NSCLC With EGFR Mutations | https://clinicaltrials.gov/study/NCT05258279 | null | ACTIVE_NOT_RECRUITING | The purpose of this study is to assess the safety and efficacy of pemetrexed + carboplatin + pembrolizumab (MK-3475) with lenvatinib (MK-7902/E7080) in patients with advanced nonsquamous non-small cell lung cancer harboring EGFR mutations. | NO | Non-squamous Non-small-cell Lung Cancer|EGFR Activating Mutation | DRUG: Pembrolizumab|DRUG: Lenvatinib|DRUG: Carboplatin|DRUG: Pemetrexed | Objective Response Rate (ORR) as Assessed by BICR according to RECIST 1.1, ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1., Up to approximately 18 months | Objective Response Rate (ORR) as Assessed by investigators according to RECIST 1.1., ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1., Up to approximately 18 months|Progression-free Survival (PFS) as Assessed by investigators according to RECIST 1.1, PFS is defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1., Up to approximately 30 months|Overall Survival (OS), OS is defined as the time from randomization to the time of death from any cause. OS will be presented., Up to approximately 30 months|Duration of Response (DOR) as Assessed by investigators according to RECIST 1.1., For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until PD or death from any cause, whichever occurs first. Per RECIST 1.1., Up to approximately 30 months|Number of Participants with One or More Adverse Events, An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention., Up to approximately 30 months|Disease Control Rate (DCR) as Assessed by investigators according to RECIST 1.1., ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD) per RECIST 1.1., Up to approximately 18 months | null | Juntendo University | Merck Sharp & Dohme LLC | ALL | ADULT, OLDER_ADULT | PHASE2 | 30 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | NEJ052 | 2022-07-01 | 2023-10 | 2024-10 | 2022-02-28 | null | 2023-10-04 | Juntendo Urayasu Hospital, Urayasu, Chiba, 279-0021, Japan|St. Marianna University Hospital, Kawasaki, Kanagawa, 216-8511, Japan|Kanagawa Cardiovascular and Respiratory Center, Yokohama, Kanagawa, 236-0051, Japan|Kanagawa Cancer Center, Yokohama, Kanagawa, 241-8515, Japan|Saitama Medical University International Medical Center, Hidaka, Saitama, 350-1298, Japan|Saitama Cancer Center, Ina, Saitama, 362-0806, Japan|Shizuoka Cancer Center, Nagaizumi-cho, Shizuoka, 411-8777, Japan|Juntendo University Hospital, Bunkyo-ku, Tokyo, 113-8431, Japan|Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyo-ku, Tokyo, 113-8677, Japan|Chiba University Hospital, Chiba, 26-8677, Japan | null | {
"Pembrolizumab": [
{
"intervention_type": "DRUG",
"description": "Pembrolizumab",
"name": "Pembrolizumab",
"synonyms": [
"Keytruda",
"Lambrolizumab",
"Pembrolizumab"
],
"medline_plus_id": "a614048",
"generic_names": [
"Pembrolizumab"
],
"drugbank_id": "DB09037",
"wikipedia_url": "https://en.wikipedia.org/wiki/Pembrolizumab"
}
],
"Lenvatinib": [
{
"intervention_type": "DRUG",
"description": "Lenvatinib",
"name": "Lenvatinib",
"synonyms": [
"4-{3-chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy}-7-methoxyquinoline-6-carboxamide",
"Lenvatinib",
"Lenvima"
],
"medline_plus_id": "a615015",
"generic_names": [
"Lenvatinib"
],
"drugbank_id": "DB09078"
}
],
"Carboplatin": [
{
"intervention_type": "DRUG",
"description": "Carboplatin",
"name": "Carboplatin",
"synonyms": [
"Carboplatino",
"Carboplatin",
"cis-diammine(1,1-cyclobutanedicarboxylato)platinum",
"cis-diammine(1,1-cyclobutanedicarboxylato)platinum(II)",
"Paraplatin",
"Carboplatine",
"cis-(1,1-cyclobutanedicarboxylato)diammineplatinum(II)",
"CBDCA"
],
"medline_plus_id": "a695017",
"generic_names": [
"Carboplatin"
],
"drugbank_id": "DB00958"
}
],
"Pemetrexed": [
{
"intervention_type": "DRUG",
"description": "Pemetrexed",
"name": "Pemetrexed",
"synonyms": [
"LY-231,514",
"Pemetrexed",
"LY 231514",
"LY231514",
"LY-231514",
"Alimta",
"231,514, LY",
"Disodium, Pemetrexed",
"LY 231,514",
"MTA",
"Pemetrexed Disodium",
"231514, LY",
"N-(4-(2-(2-amino-3,4-dihydro-4-oxo-7H-pyrrolo(2,3-d)pyrimdin-5-yl)ethyl)benzoyl)glutamic acid",
"5-Methylthioadenosine",
"5'-Deoxy-5'-(methylthio)adenosine",
"S-Methyl-5'-thioadenosine",
"Methylthioadenosine",
"5'-S-methyl-5'-thioadenosine",
"Thiomethyladenosine",
"9-(5-S-methyl-5-thio-\u03b2-D-ribofuranosyl)-9H-purin-6-amine",
"MTA",
"5'-Methylthioadenosine"
],
"medline_plus_id": "a607043",
"generic_names": [
"Pemetrexed",
"5'-S-methyl-5'-thioadenosine"
],
"mesh_id": "D019384",
"drugbank_id": "DB00642"
}
]
} |
NCT04947579 | A Study of CC-99677 in Participants With Active Ankylosing Spondylitis | https://clinicaltrials.gov/study/NCT04947579 | AS SpA axSpA | TERMINATED | This study is designed to learn about response to CC-99677 treatment by measuring signs and symptoms of Ankylosing Spondylitis (AS), objective measures of disease activity, quality of life assessments, pharmacokinetics, safety, and tolerability over a 12-week double-blind period. | YES | Spondylitis, Ankylosing | DRUG: CC-99677|OTHER: Placebo | Percentage of Participants Who Achieve ASAS 20 at Week 12, Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 20% and ≥ 1 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining domain on a scale of 0 to 10. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are:
* Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale [NRS]);
* Total Back Pain NRS;
* Function (the Bath Ankylosing Spondylitis Functional Index [BASFI] score NRS);
* Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] NRS Questions #5 and #6 for morning stiffness)., Week 12 | Percentage of Participants Who Achieve ASAS 40 at Week 12, Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 40% and ≥ 2 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening at all from baseline in the remaining domain. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are:
* Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale [NRS]);
* Total Back Pain NRS;
* Function (the Bath Ankylosing Spondylitis Functional Index [BASFI] score NRS);
* Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] NRS Questions #5 and #6 for morning stiffness)., Week 12|Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12, ASDAS-CRP is a score of disease activity that combines patient reported assessments of back pain (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] question 2), duration of morning stiffness (BASDAI question 6), peripheral joint pain and/or swelling (BASDAI question 3), general wellbeing, and CRP in a weighted manner. The cut-off values for disease activity states and improvement scores are defined as follows: <1.3 inactive disease, ≥1.3 and <2.1 low disease activity, ≥2.1 and ≤3.5 high disease activity and 3.5 very high disease activity. The minimum clinically important difference (MCID) are defined as: change of at least 1.1 unit for clinically important improvement and change of at least 2.0 units for major improvement. Baseline is the last non-missing value on or before the date of the first dose of investigational product. ASDAS-CRP Formula: 0.12xBack Pain+0.06xDuration of Morning Stiffness+0.11xPatient Global+0.07xPeripheral Pain/Swelling+0.58xln(CRP+1), Baseline and Week 12|Change From Baseline in BASDAI at Week 12, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses five major symptoms of AS during the last week: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater is considered to be indicative of active AS disease. Baseline is the last non-missing value on or before the date of the first dose of investigational product., Baseline and Week 12|Change From Baseline in BASFI at Week 12, Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a self administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses degree of mobility and functional ability during the last week. The questionnaire consists of eight questions regarding function in AS and the two last questions reflecting ability to cope with everyday life. The left-hand box of 0 represents easy, and the right-hand box represents impossible. The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced functional ability. Baseline is the last non-missing value on or before the date of the first dose of investigational product., Baseline and Week 12|Change From Baseline in the SPARCC SI Joint Score at Week 12, Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the sacroiliac joints. The SPARCC assesses 16 sites for enthesitis using a score of 0 for no activity or 1 for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. Baseline is the last non-missing value on or before the date of the first dose of investigational product., Baseline and Week 12|Change From Baseline in the SPARCC Spine Score at Week 12, Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the total spine. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease.
Baseline is the last non-missing value on or before the date of the first dose of investigational product., Baseline and Week 12|Percent Change From Baseline in hsCRP at Week 12, Percent change from baseline in high-sensitivity C-reactive protein (hsCRP). Baseline is the last non-missing value on or before the date of the first dose of investigational product., Baseline and Week 12 | null | Celgene | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 167 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | CC-99677-AS-001|U1111-1265-3951|2019-004108-37 | 2021-08-25 | 2023-02-21 | 2023-02-21 | 2021-07-01 | 2024-05-01 | 2024-05-01 | Local Institution - 024, Flagstaff, Arizona, 86001, United States|Local Institution - 021, Gilbert, Arizona, 58297, United States|Local Institution - 022, Phoenix, Arizona, 95037, United States|Local Institution - 025, Tucson, Arizona, 85704, United States|Local Institution - 017, Tustin, California, 92780, United States|Local Institution - 026, Saint Clair Shores, Michigan, 48081, United States|Local Institution - 028, Cleveland, Ohio, 44106, United States|Local Institution - 004, Dayton, Ohio, 45417, United States|Local Institution - 009, Portland, Oregon, 97239, United States|Local Institution - 003, Duncansville, Pennsylvania, 16635, United States|Local Institution - 005, Jackson, Tennessee, 38305, United States|Local Institution - 002, Memphis, Tennessee, 38119, United States|Local Institution - 029, Austin, Texas, 78731, United States|Local Institution - 006, Colleyville, Texas, 76034, United States|Local Institution - 019, Fort Worth, Texas, 76107, United States|Local Institution - 008, Houston, Texas, 77099, United States|Local Institution - 154, Shanghai, Shanghai, 200040, China|Local Institution - 151, Guangzhou, 510630, China|Local Institution - 152, Hangzhou, 310014, China|Local Institution - 153, Huangpu District, 200000, China|Local Institution - 150, Wuhan, 430030, China|Local Institution - 205, Brno, 61141, Czechia|Local Institution - 206, Ostrava, 702 00, Czechia|Local Institution - 207, Ostrava, 702 00, Czechia|Local Institution - 201, Pardubice, 530 02, Czechia|Local Institution - 211, Praha 11, 148 00, Czechia|Local Institution - 202, Praha 3, 13000, Czechia|Local Institution - 203, Praha 4, 140 00, Czechia|Local Institution - 204, Uherské Hradište, 686 01, Czechia|Local Institution - 900, Herne, 44649, Germany|Local Institution - 311, Bialystok, 15-077, Poland|Local Institution - 315, Bialystok, 15-351, Poland|Local Institution - 305, Bydgoszcz, 85-065, Poland|Local Institution - 302, Bydgoszcz, 85-168, Poland|Local Institution - 301, Elblag, 82-300, Poland|Local Institution - 307, Katowice, 40-282, Poland|Local Institution - 300, Krakow, 30-002, Poland|Local Institution - 308, Krakow, 30-363, Poland|Local Institution - 310, Nowa Sol, 67-100, Poland|Local Institution - 313, Onyksowa 10, 20-582, Poland|Local Institution - 312, Sochaczew, 96-500, Poland|Local Institution - 306, Torun, 87-100, Poland|Local Institution - 303, Warsaw, 02-691, Poland|Local Institution - 309, Wroclaw, 52-416, Poland|Local Institution - 400, Brasov, 500283, Romania|Local Institution - 404, Bucuresti, 011025, Romania|Local Institution - 402, Bucuresti, 011172, Romania|Local Institution - 403, Bucuresti, 011172, Romania|Local Institution - 604, A Coruña, 15006, Spain|Local Institution - 607, Barcelona, 08035, Spain|Local Institution - 606, Cordoba, 14001, Spain|Local Institution - 605, Merida, 06800, Spain|Local Institution - 601, Sabadell, 8208, Spain|Local Institution - 602, Santiago De Compostela, 15706, Spain|Local Institution - 603, Sevilla, 41013, Spain|Local Institution - 702, Adapazari, 54100, Turkey|Local Institution - 707, Altındağ/Ankara, 06230, Turkey|Local Institution - 700, Ankara, 06100, Turkey|Local Institution - 701, Edirne, 22030, Turkey|Local Institution - 705, Istanbul, 34098, Turkey|Local Institution - 706, Izmir, 35100, Turkey|Local Institution - 704, Karabaglar, 35360, Turkey|Local Institution - 703, Trabzon, 61080, Turkey | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/79/NCT04947579/Prot_SAP_000.pdf | {
"CC-99677": [
{
"intervention_type": "DRUG"
}
],
"Placebo": [
{
"intervention_type": "OTHER"
}
]
} |
NCT05719779 | Tolerance and Benefits of Mandibular Advanced Device for Snoring and Sleep Apnea in Oropharyngeal Cancer. | https://clinicaltrials.gov/study/NCT05719779 | Ronco-Onco | RECRUITING | Evaluation of the Tolerance and Benefits of Mandibular Advanced Device (MAD) for Snoring and Sleep Apnea in Patients with Oropharyngeal Cancer (OPC): Mixed Design Study. | NO | Oral Cancer|Pharynx Cancer|Sleep Apnea|Snoring|Oral Squamous Cell Carcinoma | DEVICE: Ronco-Onco and MAD | Index apnea-hypopnea, respiratory cessation index (number of event per hour of sleep, 1 to max of 100, rare value), From sleep onset to wake time (6-8 hrs) in morning of night 1 for baseline vs difference of 2 or 3 according to ramdom allocation|Snoring, Total snoring time (minute per sleep duration of a given participant, average as mean or median) and event frequency (number of event per hour of sleep) - values expected from 0 to 100 for each outcome, From sleep onset to wake time (6-8 hrs) in morning of night 1 for baseline vs difference of 2 or 3 according to ramdom allocation | Sleep quality, Duration (estimated by participant in number of hour) and self perception of quality (0-10 visual analog scale), Done in morning from 6-8 sleep period, assessed in morning of each of 3 nights | null | Centre hospitalier de lUniversité de Montréal (CHUM) | null | ALL | ADULT, OLDER_ADULT | null | 35 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | 22.204 | 2023-02-03 | 2025-06-30 | 2025-06-30 | 2023-02-09 | null | 2023-05-11 | CHUM, Montréal, Quebec, H3X 3E4, Canada | null | {
"Ronco-Onco and MAD": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT04305379 | Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy | https://clinicaltrials.gov/study/NCT04305379 | BLANKET | TERMINATED | The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only. | NO | Prostate Cancer|Urinary Incontinence|Surgery | PROCEDURE: Augmented Bladder Neck Reconstruction|PROCEDURE: Standard Bladder Neck Reconstruction | EPIC Urinary Incontinence subscale score, Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence)., 1 Month | EPIC Urinary Incontinence subscale score, Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence)., 2 Weeks|EPIC Urinary Incontinence subscale score, Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence)., 3 Months|EPIC Urinary Incontinence subscale score, Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence)., 6 Months|EPIC Urinary Incontinence subscale score, Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence)., 12 Months | null | Johns Hopkins University | null | MALE | ADULT, OLDER_ADULT | null | 31 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | IRB00208651 | 2020-01-16 | 2021-03-01 | 2021-03-01 | 2020-03-12 | null | 2021-03-17 | Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States | null | {
"Augmented Bladder Neck Reconstruction": [
{
"intervention_type": "PROCEDURE"
}
],
"Standard Bladder Neck Reconstruction": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT00212979 | Measuring Kidney Function in Kidney Transplantation | https://clinicaltrials.gov/study/NCT00212979 | null | COMPLETED | Kidney transplantation is the preferred treatment for permanent kidney failure. Following transplantation, the kidney function must be followed closely to detect problems so that investigations and appropriate treatment can be started early. Currently, function is monitored with the use of serum creatinine. In clinical trials involving kidney transplant recipients, markers of kidney function, such as serum creatinine, are increasingly being used as outcomes to evaluate new treatments. However, serum creatinine is not very accurate or sensitive at detecting change in kidney transplant function. Newer methods of evaluating kidney function, such as the Modification of Diet in Renal Disease (MDRD) equation and cystatin C, are known to be accurate markers of function in patients with non-transplant kidney disease. This study will compare the MDRD estimate and cystatin C estimate of kidney function with an accepted method (radioisotope clearance study) of measuring true kidney function in 250 renal transplant patients. Each patient will have 2 measurements made at least 3 months apart to determine the accuracy and responsiveness to change over time for the MDRD equation and cystatin C. If the results demonstrate that these new methods are accurate then clinical care and research studies involving transplant patients will be greatly enhanced. Patients and physicians would have a simple test that could detect problems earlier and more precisely monitor response to treatment leading to improved outcomes for renal transplant recipients. | NO | Renal Transplant | OTHER: non intervention study | null | null | null | Ottawa Hospital Research Institute | The Physicians Services Incorporated Foundation | ALL | ADULT, OLDER_ADULT | null | 250 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | PSI Grant R03-59|REB Protocol #2003435-01H | 2004-04 | 2006-10 | 2006-10 | 2005-09-21 | null | 2016-03-31 | The Ottawa Hospital, Ottawa, Ontario, K1H 7W9, Canada | null | {
"non intervention study": [
{
"intervention_type": "OTHER"
}
]
} |
NCT05305079 | NA-AION Risk Factors: New Perspectives | https://clinicaltrials.gov/study/NCT05305079 | NARROW | UNKNOWN | The purpose of the study is to use new diagnostic methods (OCT and OCT-A) to shed light on risk factors for the development of NA-AION. The risk factors we are focusing on are comorbidities along with anatomical and vascular characteristics of the optic nerve. | NO | Non-arteritic Ischemic Optic Neuropathy|Optic Disk Drusen | null | Anatomical characteristics on OCT, Presence of ODD. Diameter of the scleral canal, disc area and rim on each quadrant of the optic disc, thickness of the peripapillary choroid, presence of peripapillary hyperreflective ovoid mass-like structures, and prelaminar hyperreflective lines., At enrollment|Anatomical characteristics on OCT, Presence of ODD. Diameter of the scleral canal, disc area and rim on each quadrant of the optic disc, thickness of the peripapillary choroid, presence of peripapillary hyperreflective ovoid mass-like structures, and prelaminar hyperreflective lines., 3-months follow-up visit|Vascular characteristics on OCT-A, Transient versus persistent findings of ischemia, segmental location and extent of reduced vessel density. If ODD is present the vessel density will be compared to ODD location and volume., 3-months follow-up visit | ODD characteristics, If ODD is present the volume and location of the ODD (superficial vs. deep) is measured using 3D-segmentation, At 3-months follow-up visit|Best corrected visual acuity, Assessed on Snellen or ETDRS chart, At enrollment|Best corrected visual acuity, Assessed on Snellen or ETDRS chart, 3-months follow-up visit|Visual field test, Autoperimetry: SITA fast or standard 24-2, At enrollment|Visual field test, Autoperimetry: SITA fast or standard 24-2, 3-months follow-up visit|Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score, Score on questionnaire: National Eye Institute Visual Function Questionnaire 25 and 10-item Neuro-Ophthalmic Supplement
A vision-targeted composite score of the NEI-VFQ-25 together with the 10-item NO supplement score is calculated. The scale is 0-100 where a high score represents better functioning., At enrollment|Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score, Score on questionnaire: National Eye Institute Visual Function Questionnaire 25 and 10-item Neuro-Ophthalmic Supplement.
A vision-targeted composite score of the NEI-VFQ-25 together with the 10-item NO supplement score is calculated. The scale is 0-100 where a high score represents better functioning., 3-months follow-up visit|Prevalence of comorbidities, ischemic heart disease, stroke (ischemic or hemorrhagic), arterial hypertension, diabetes mellitus, end stage renal disease, smoking (now or previous), dyslipidemia, obstructive sleep apnea/continuous positive airway pressure (CPAP) use, phosphodiesterase-5 inhibitor use or ocular surgery., At enrollment | Eye refraction in diopters, Spherical and cylindrical refraction. Measurements in diopters., At enrollment|Color vision test score as fraction, Assessed on Ishihara or Hardy-Rand-Rittler plates. Measured as the fraction of how many correct plates out how many plates are used in the assessment in total. A score of 0 means no plates were read correctly and 1 means all plates were read correctly., At enrollment|Color vision test score as fraction, Assessed on Ishihara or Hardy-Rand-Rittler plates. Measured as the fraction of how many correct plates out how many plates are used in the assessment in total. A score of 0 means no plates were read correctly and 1 means all plates were read correctly., 3-months follow-up visit|Eye biometry: Axial length, axial length of the eye in mm, At enrollment|Eye biometry: Keratometry, The curvature of the cornea in diopters, At enrollment | Rigshospitalet, Denmark | Velux Fonden|Fight for Sight|Synoptik-Fonden|University of Copenhagen|Hamilton Health Sciences Corporation|Aarhus University Hospital|Aalborg University Hospital|Zealand University Hospital|Odense University Hospital|Farabi Eye Hospital|Wellington Hospital|University of Colorado, Denver|University of Utah|Lawson Health Research Institute|University of Sydney|Stanford University|Moorfields Eye Hospital NHS Foundation Trust|Kings College Hospital NHS Trust|University of Calgary|Massachusetts Eye and Ear Infirmary|University of California, San Francisco|Stony Brook University|Sheba Medical Center|University Hospital, Bordeaux | ALL | CHILD, ADULT, OLDER_ADULT | null | 650 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | H-20073063 | 2021-08-01 | 2023-05-31 | 2023-08-31 | 2022-03-31 | null | 2022-03-31 | Stanford Medicine, Palo Alto, California, 94305, United States|UCSF Medical Center, San Francisco, California, 94143, United States|University og Colorado, Boulder, Colorado, 80309, United States|Massachusetts Eye and Ear, Boston, Massachusetts, 02114, United States|John A. Moran Eye Center, Salt Lake City, Utah, 84132, United States|Sydney Eye Hospital, Sydney, Australia|University of Calgary, Calgary, Canada|Research St. Josephs, Hamilton, Canada|Lawson Health Research Institute, London, Canada|Aalborg University Hospital, Aalborg, Denmark|Aarhus University Hospital, Aarhus, Denmark|Odense University Hospital, Odense, Denmark|Zealand University Hospital, Roskilde, Denmark|Bordeaux University Hospital, Bordeaux, France|Farabi Eye Hospital, Teheran, Iran, Islamic Republic of|Sheba Medical Center, Tel Aviv, Israel|Capital and Coast DHB, Wellington, New Zealand|University of Cambridge, Cambridge, United Kingdom|Kings College Hospital, London, United Kingdom|Moorfields Eye Hospital, London, United Kingdom | null | {} |
NCT04408079 | A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets | https://clinicaltrials.gov/study/NCT04408079 | null | UNKNOWN | This is a study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3558 tablets in Chinese adult patients with advanced solid tumors .The study is divided into phase Ia and phase Ib. Phase Ia: dose escalation period, to evaluate the safety and tolerability of TQB3558 tablets, determine MTD; Phase Ib: effectiveness exploration period, to expand the safe and effective dose group, recommend appropriate dosage and method for subsequent clinical research. | NO | Advanced Solid Tumors | DRUG: TQB3558 | Maximum tolerated dose (MTD), MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT., Baseline up to 28 days|Adverse events (AE) and serious adverse events (SAE), The occurrence of all adverse events (AE) and serious adverse events (SAE)., Baseline up to 28 days|Overall response rate (ORR), Percentage of participants achieving complete response (CR) and partial response (PR)., up to 96 weeks | Tmax, To characterize the pharmacokinetics of TQB3558 by assessment of time to reach maximum plasma concentration., 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.|Cmax, Cmax is the maximum plasma concentration of TQB3558 or metabolite(s)., 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.|AUC0-t, To characterize the pharmacokinetics of TQB3558 by assessment of area under the plasma concentration time curve from zero to infinity., 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.|CL/f, CL/f is total clearance rate for TQB3558., 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.|Disease control rate（DCR）, Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD)., up to 96 weeks|Progression-free survival (PFS), PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause., up to 96 weeks|Duration of Response (DOR), DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment., up to 96 weeks | null | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | null | ALL | ADULT, OLDER_ADULT | PHASE1 | 70 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | TQB3558-Ⅰ-01 | 2020-06-25 | 2022-07-31 | 2022-10-31 | 2020-05-29 | null | 2020-07-08 | Shanghai Sixth Peoples Hospital, Shanghai, Shanghai, 200233, China | null | {
"TQB3558": [
{
"intervention_type": "DRUG"
}
]
} |
NCT06081179 | Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans | https://clinicaltrials.gov/study/NCT06081179 | null | RECRUITING | The study looks into whether administering psychedelic substances that stimulate the serotonin system influences pro-social behavior when compared to administering substances that stimulate the dopamine system in healthy individuals. | NO | Healthy | DRUG: Psilocybin|DRUG: 3,4 Methylenedioxymethamphetamine|DRUG: Methylphenidate | Multifaceted Empathy Test, The Multifaceted Empathy Test is a task assessing the cognitive and emotional aspects of empathy. Participants process 40 photos of people in emotionally charged situations. Each aspect of empathy (implicit and explicit emotional empathy, and cognitive empathy) is tested with 20 positive valence stimuli and 20 negative valence stimuli, yielding a total of 120 trials., t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration|Moral Inference Task, The Moral Inference task is an approach to evaluate the computational basis of moral inference and its temporal dynamics. Participants observe and predict the decisions of two agents who repeatedly choose on administering painful electric shocks to another person in a different room in return for money, and rate them every third trial for their moral character. At the end of the game there is a short trust game. Participants can win actual money in this game (up to 1 CHF)., t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration|Zurich Prosocial Game, The Zurich Prosocial Game is a computer-based pro-social game which allows for assessment of prosocial behavior, considering the influence of helping cost, distress cues in helping behavior, and reciprocity on pro-social behavior through different trial types. Participants can win actual money in this game (up to 6.50 CHF)., t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration|Social Gaze Task, The Social Gaze Task is a paradigm in which participants gaze is used to control the gaze of a tropomorphic virtual figure. The aim is to capture the reciprocal and interactive nature of joint attention. Participants gaze behavior is recorded using an eye-tracking device. The outcome measures we will use are pupil size, valence, and arousal ratings., t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration|Moral Expansion Task, In the Moral Expansion Task, the influence of social distance is elicited by having participants indicate countries with different social distances and decide how much money out of CHF 100 they would like to donate to the Red Cross in each country. One participants choice is then randomly selected, and the donation is implemented while the chosen participant receives the remaining amount., t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration|Social Network Questionnaire, The Social Network Questionnaire is used to assess the size of a persons social network and the emotional support and strain experienced from that network. Participants provide the initials of personal contacts from various domains with whom they have had contact with in the past 4 weeks. 28 items are rated on a 6-point scale, asking how much emotional support and emotional burden they have felt from their social contacts. The total score for those items ranges from 28 to 168., t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration|Pro-social Voting Behavior, The Pro-social Voting Behavior is used to evaluate pro-social voting behavior as a real-world measure of social behavior. The scale consists of 11 items. Each item is rated on a 4-point scale. The total score ranges from 11 to 44. Not all items are accounted equally to capture pro-social voting behavior, as some are reversed., t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration|Oxford Utilitarianism Scale, The Oxford Utilitarianism Scale measures two dimensions of utilitarian tendencies. The scale consists of 9 items. Each item is rated on a 7-point scale. The total score ranges from 9 to 63., t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration|Compassion Scale, The Compassion Scale measures an individuals level of compassion towards others. The scale consists of 16 items. Each item is rated on a 5-point scale. The total score ranges from 16 to 80., t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration|Inclusion of others in the self, The Inclusion of others in the self is designed to assess the perceived relationship between an individuals self and other people/all living things. It consists of two items. Each item is rated as circles corresponding to a numerical score, ranging from 1 to 8. The total score ranges from 2 to 16., t0 - 10 days (+/- 7 days), t0, and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration | 5-Dimensional Altered States of Consciousness Rating Scale, The 5-Dimensional Altered States of Consciousness Rating Scale measures subjective experiences of altered states of consciousness. It contains 94 items, which are formulated as a visual analog scale, assessing different dimensions of altered states of consciousness., t0 (the day of substance administration)|5-Dimensional Altered States of Consciousness Rating Scale short, The 5-Dimensional Altered States of Consciousness Rating Scale short is a shorter version of the 5-Dimensional Altered States of Consciousness Rating Scale for measuring subjective experiences of altered states of consciousness. The scale consists of 15 items chosen from the full version, which are formulated as a visual analog scale., t0 (the day of substance administration)|Mystical Experience Questionnaire, The Mystical Experience Questionnaire is used to assess mystical experiences. The scale consists of 30 items. Each item is rated on a 6-point scale (from 0 to 5). The total score ranges from 0 to 150., t0 (the day of substance administration)|Persisting Effects Questionnaire, The Persisting Effects Questionnaire is used to assess changes in attitudes, moods, behavior, and spiritual experience. The scale consists of 144 items. 140 items are rated on a 6-point scale (from 0 to 5). The last four items use different scaling. The total score ranges from 4 to 724., t0 + 4 weeks (+/- 3 days) and t0 + 16 weeks (+/- 7 days); t0 being the day of substance administration|Epistemic and personal transformation (pre and post versions), The Epistemic and personal transformation is used to capture the intensity and qualities of epistemic and personal transformation and participants expectations and desires thereof. Both pre and post versions include open questions and 4 items that are rated on a visual analog scale from 0 to 100. The total score ranges from 0 to 400 for pre and post versions each. The post version additionally captures the substance intake assumption of the participants., t0 (the day of substance administration)|Symptom Checklist 90-R, The Symptom Checklist 90-R is used to assess a broad range of psychological problems and symptoms of psychopathology within the past seven days. It consists of 90 items. Each item is rated on a 5-point scale (from 0 to 4). The total score ranges from 0 to 360., t0 - 10 days (+/- 7 days) and t0 + 16 weeks (+/- 7 days); t0 being the day of substance administration|The Positive and Negative Affect Schedule, The Positive and Negative Affect Schedule is used to assess both positive and negative affect. It consists of two 10-item scales, one measuring positive affect and one measuring negative affect. Each item is rated on a 5-point scale (from 0 to 4). The total scores range from 0 to 80., t0 - 10 days (+/- 7 days), t0, t0 + 4 weeks (+/- 3 days), and t0 + 16 weeks (+/- 7 days); t0 being the day of substance administration|FEELINGS, The FEELINGS scales consist of a series of six short questionnaires to assess regulation, self-esteem, satisfaction with life, life orientation, and meaning in life. Emotional Regulation Questionnaire uses a 7-point scale with a total score range from 7 to 70 (10 items). Satisfaction with Life Scale uses a 7-point scale with a total score range from 5 to 35 (5 items). Rosenberg Self-Esteem Scale uses a 4-point scale with a total score range from 10 to 40 (10 items). Life Orientation Test-Revised uses a 5-point scale with a total score range from 10 to 50 (10 items). Lebenssinn-Fragebogen uses a 7-point scale with a total score range from 10 to 70 (10 items). HSF uses a 5-point scale with a total score range from 6 to 30 (6 items)., t0 - 10 days (+/- 7 days) and t0 + 16 weeks (+/- 7 days); t0 being the day of substance administration|Ego Consciousness Change of Perspective Questionnaire (1 & 2), Ego Consciousness Change of Perspective Questionnaire is used to measure the two dimensions Consciousness and Ego. Questions for the acute effects of substance intake (27 items) and questions for the longer-lasting effects (6 items) are included. Each item is rated on a visual analog scale from 0 to 100. The total score ranges from 0 to 3300., t0 and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration | null | University of Zurich | null | ALL | ADULT | PHASE1 | 120 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE | 2A-SC-1 | 2023-10-24 | 2025-04 | 2025-06 | 2023-10-13 | null | 2023-12-07 | Psychiatrische Universitätsklinik Zürich, Zürich, 8032, Switzerland | null | {
"Psilocybin": [
{
"intervention_type": "DRUG",
"description": "Psilocybin",
"name": "Psilocybin",
"synonyms": [
"1H-Indol-4-ol, 3-(2-(Dimethylamino)ethyl)-, Dihydrogen Phosphate (ester)",
"Psilocybin",
"Psilocybinum",
"Psilocybine",
"Psilocibin",
"Psilocibina"
],
"mesh_id": "D006213",
"generic_names": [
"Psilocybin"
],
"drugbank_id": "DB11664"
}
],
"Midomafetamine": [
{
"intervention_type": "DRUG",
"description": "3,4 Methylenedioxymethamphetamine",
"name": "Midomafetamine",
"synonyms": [
"Methylenedioxymethamphetamine"
],
"drugbank_id": "DB01454",
"generic_names": [
"Midomafetamine"
]
}
],
"Methylphenidate": [
{
"intervention_type": "DRUG",
"description": "Methylphenidate",
"name": "Methylphenidate",
"synonyms": [
"methyl \u03b1-phenyl-\u03b1-2-piperidinylacetate",
"Metadate",
"Hydrochloride, Methylphenidate",
"methyl phenyl(piperidin-2-yl)acetate",
"Jornay PM",
"Phenidylate",
"Concerta",
"Delmosart",
"Methylphenidate",
"Ritalin",
"Ritaline",
"Adhansia XR",
"methyl \u03b1-phenyl-\u03b1-(2-piperidyl)acetate",
"Methylin",
"\u03b1-phenyl-2-piperidineacetic acid methyl ester",
"Daytrana",
"Methylphenidatum",
"Methyl phenidylacetate",
"Equasym",
"Methylphenidate Hydrochloride",
"Ritalin-SR",
"Tsentedrin",
"Metilfenidato",
"Ritalin SR",
"Quillivant",
"Medikinet",
"Methylphenidylacetate hydrochloride",
"MPH",
"Methylphenidan",
"Centedrin",
"Methylphenidylacetate hydrochloride",
"Methylphenidate Patch",
"Daytrana",
"Methylphenidylacetate hydrochloride",
"Methylphenidate Patch",
"Daytrana",
"Methylphenidylacetate hydrochloride",
"Methylphenidate Patch",
"Daytrana",
"Methylphenidylacetate hydrochloride",
"Methylphenidate Patch",
"Daytrana"
],
"medline_plus_id": "a682188",
"generic_names": [
"Methylphenidate",
"Methylphenidate Patch",
"Methylphenidate Patch",
"Methylphenidate Patch",
"Methylphenidate Patch"
],
"nhs_url": "https://www.nhs.uk/medicines/methylphenidate-children",
"mesh_id": "D018765",
"drugbank_id": "DB00422"
}
]
} |
NCT01541579 | Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohns Disease | https://clinicaltrials.gov/study/NCT01541579 | ADMIRE-CD | COMPLETED | The current multicentre phase III study is proposed to confirm in an add-on therapy design compared to a placebo-control group, the efficacy of adipose-derived stem cells (eASCs) from healthy donors for the treatment of complex anal fistulas in patients with Crohns disease over a 24-week period and an extended follow-up period up to 104 weeks. | NO | Crohns Disease | OTHER: Cx601|OTHER: Saline solution | Combine remission of perianal fistulising Crohns, Combined Remission of perianal fistulising Crohns disease defined as the clinical assessment of closure of all treated external openings (EO) that were draining at baseline despite gentle finger compression at week 24, and absence of collections > 2 cm of the treated perianal fistulas confirmed by centrally blinded MRI assessment by week 24., 24 weeks | Efficacy Assessment by week 24, * Clinical Remission (CR) defined as closure of all treated EO that were draining at baseline despite gentle finger compression, as clinically assessed
* Response defined as closure of at least 50% of all treated EO that were draining at baseline, as clinically assessed
* Time to Clinical Remission (time from treatment start to 1st visit with closure of all treated EO as described above)
* Time to Response (time from treatment start to 1st visit with closure of at least 50% of all treated EO as described above)
* Relapse defined, in patients with CR at previous visit, as reopening of any of the treated EO with active drainage, or the development of a perianal collection > 2 cm of the treated perianal fistulas confirmed by centrally blinded MRI
* Time to Relapse in patients with CR (time from CR to 1st visit with reopening of any of the treated EO as described above)
* Severity of the perianal CD, assessed with the PDAI
* QoL assessed by IBDQ
* CDAI score
* Van Assche, 24 weeks|Efficacy Assessment by week 52, * Combined Remission of perianal fistulising Crohns disease at week 52 (as defined for week 24)
* Clinical Remission defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed at week 52
* Response defined as closure of at least 50% of all treated external openings that were draining at baseline, as clinically assessed at week 52
* Time to Combined Remission by week 52 (as defined for week 24)
* Time to Clinical Remission by week 52 (as defined for week 24)
* Time to Response by week 52 (as defined for week 24)
* Relapse by week 52 in patients with Combined Remission at week 24 (as defined for week 24)
* Time to Relapse by week 52 in patients with Combined Remission at week 24 (as defined for week 24)
* Severity of the perianal Crohns disease up to week 52 assessed PDAI
* QoL up to week 52 by the IBDQ
* CDAI score up to week 52
* Van Assche score up to week 52, 52 weeks|Efficacy Assessment by week 104, * Clinical Remission of perianal fistulising Crohns disease defined as the clinical assessment of closure of all treated external openings that were draining at baseline despite gentle finger compression at week 104
* Relapse by week 104 in patients with Combined Remission at week 52, defined as reopening of any of the treated external openings with active drainage as clinically assessed
* Time to Relapse by week 104 in patients with Combined Remission at week 52 (defined as time from Combined Remission to first visit with reopening of any of the treated external openings with active drainage as clinically assessed)
* Severity of the perianal Crohns disease, assessed with the Perianal Disease Activity Index (PDAI) up to week 104
* Quality of Life (QoL) assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) up to week 104
* CDAI score up to week 104, 104 Weeks|Safety analysis throughout the study:, * Adverse events including: Treatment emergent Adverse Events (TEAEs), TEAEs related to study treatment, Treatment emergent Serious Adverse Events (TESAEs), TESAEs related to study treatment, TEAEs leading to study withdrawal, adverse events related to surgical procedure(s) to provide study treatment, deaths Only SAEs will be reported during the 2nd follow-up period between week 52 and week 104.
* Physical examination
* Vital signs
* Laboratory tests (biochemistry, haematology, urinalysis), week 24, 52 and 104 | null | Tigenix S.A.U. | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 278 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | Cx601-0302 | 2012-07 | 2015-07 | 2016-11 | 2012-03-01 | null | 2019-11-29 | Univ.-Klinik Innsbruck, Innsbruck, 6020, Austria|Krankenhaus, St. Veit/Glan, 9300, Austria|Medizinische Universität, Wien, 1090, Austria|Hospital Oost-Limburg, Genk, 3600, Belgium|Gent University Hospital, Gent, 9000, Belgium|Leuven University Hospital, Leuven, 3000, Belgium|Hospital Hartziekenhuis, Roeselare, 8800, Belgium|CHU dAmiens, Amiens, 80054, France|CHU de Bordeaux, Bordeaux, 3300, France|CHU de Caen, Caen, 14033, France|Hôpital Beaujon, Clichy, France|CHRU de Lille, Lille, 59037, France|CHU de Marseille, Marseille, 13915, France|CHU de Nice, Nice, 06202, France|Hôpital Saint-Louis, Paris, France|Charite, Berlin, 13353, Germany|Krakenhaus Walfriede, Berlin, 14163, Germany|Klinikum Braunscheweig, Braunschweig, 38126, Germany|Klinikum Frankfurt, Frankfurt/Main, 60431, Germany|Evangelisches Krankenhaus Kalk, Köln, 51103, Germany|Klinikum Lüneburg, Lüneburg, 21339, Germany|Rambam MC, Haifa, 31096, Israel|Sharee Zedek MC, Jerusalem, 91031, Israel|Rabin MC, Petah Tikva, 49100, Israel|Tel Aviv Sourasky MC, Tel Aviv, 64239, Israel|Sheba MC, Tel Hashomer, 52621, Israel|Azienda Ospedaliero-Universitaria di Bologna Policlinico SantOrsola Malpighi, Bologna, Italy|Azienda Ospedaliero-Universitaria Careggi, Firenze, 50134, Italy|Instituto Clinico Humanitas IRCCS, Milano, 20089, Italy|Seconda Università degli Studi di Napoli, Napoli, Italy|Azienda Ospedaliera di Padova, Padova, 35128, Italy|Azienda Ospedaliera San Camillo-Forlanini, Rome, 00149, Italy|Università Cattolica del Sacro Cuore, Rome, 00168, Italy|AMC, Amsterdam, Netherlands|VUMC, Amsterdam, Netherlands|Catharina Ziekenhuis, Eindhoven, 5623, Netherlands|UMCU, Utrecht, Netherlands|Hospital de Manises, Manises, Valencia, 46940, Spain|Hospital Clinic de Barcelona, Barcelona, Spain|Hospital Universitario Reina Sofia, Cordoba, Spain|Hospital Juan Ramon Jimenez, Huelva, Spain|Hospital Ramón y Cajal, Madrid, 28034, Spain|Fundacion Jimenez Diaz, Madrid, 28040, Spain|Hospital 12 de Octubre, Madrid, Spain|Hospital Clinico San Carlos, Madrid, Spain|Hospital La Princesa, Madrid, Spain|Hospital Universitario La Paz, Madrid, Spain|Son Espases, Palma de Mallorca, 07010, Spain|Hospital de Montecelo, Pontevedra, Spain|Hospital Virgen del Rocio, Seville, Spain|Hospital de Sagunto, Valencia, Spain|Hospital Universitario La Fe, Valencia, Spain | null | {
"Cx601": [
{
"intervention_type": "OTHER"
}
],
"Saline solution": [
{
"intervention_type": "OTHER"
}
]
} |
NCT06017479 | Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention | https://clinicaltrials.gov/study/NCT06017479 | null | COMPLETED | The goal of this clinical trial is to compare the use of single dose fosfomycin and single dose levofloxacin as pre-urodynamic antibiotic prophylaxis for urinary tract infection prevention post-urodynamic in patients with lower urinary tract symptoms. The main question[s] it aims to answer are:
* What is the difference between the effectiveness of administering a single dose of fosfomycin and levofloxacin prior to the procedure in terms of the incidence rate of urinary tract infection (UTI) post-urodynamic examination?
* What is the incidence rate of UTI in the administration of single-dose fosfomycin and levofloxacin prior to the procedure on the incidence rate of UTI post-urodynamic examination? Participants fulfilling the inclusion criteria will be taken their history and vital signs and consume either fosfomycin or levofloxacin based on the randomisation prior to urodynamic procedure. Afterwards, participants will undergo urine analysis 4 days post urodynamic to evaluate if theres any urinary tract infection. If there is any bacteria present, the sample will be cultured to identify bacteria found in the urine. | NO | Urological System Complication of Procedure|Urinary Tract Infections | DRUG: Fosfomycin 3000 MG|DRUG: Levofloxacin 500mg | Number of Participant With Urinary Tract Infection, Urinary tract infection is defined based on the result of urinalysis in which one of the following condition present : leukocytes > 5 / high power field, bacteria positive, nitrite positive, and/or positive leukocyte esterase, 4 days post-urodynamic procedure | null | null | Indonesia University | null | ALL | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 126 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | 22-11-1343 | 2022-12-30 | 2024-03-25 | 2024-03-25 | 2023-08-30 | null | 2024-04-18 | Cipto Mangunkusumo Hospital, Jakarta Pusat, DKI Jakarta, 10430, Indonesia | null | {
"Fosfomycin": [
{
"intervention_type": "DRUG",
"description": "Fosfomycin 3000 MG",
"name": "Fosfomycin",
"synonyms": [
"Fosfocina",
"cis-(1R,2S)-epoxypropylphosphonic acid",
"L-cis-1,2-epoxypropylphosphonic acid",
"Phosphomycin",
"Fosfomycinum",
"Monuril",
"Monurol",
"1R-cis-(1,2-epoxypropyl)phosphonic acid",
"Phosphonomycin",
"(2R-cis)-(3-Methyloxiranyl)phosphonic acid",
"Fosfomycin",
"Fosfomycin Tromethamine",
"(-)-(1R,2S)-(1,2-Epoxypropyl)phosphonic acid",
"Fosfomycine",
"FCM",
"Fosfomicina",
"(1R,2S)-epoxypropylphosphonic acid",
"Phosphonemycin",
"Tromethamine, Fosfomycin",
"Fosfomycin Trometamol Salt"
],
"medline_plus_id": "a697008",
"generic_names": [
"Fosfomycin"
],
"mesh_id": "D000900",
"drugbank_id": "DB00828"
}
],
"Levofloxacin": [
{
"intervention_type": "DRUG",
"description": "Levofloxacin 500mg",
"name": "Levofloxacin",
"synonyms": [
"(3S)-(-)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid",
"Ofloxacin, (S)-Isomer",
"Tavanic",
"Ofloxacin S-(-)-form",
"L-Ofloxacin",
"Iquix",
"Levofloxacine",
"Levobact",
"(-)-Ofloxacin",
"Levofloxacin Anhydrous",
"Leflox",
"Quixin",
"(S)-Ofloxacin",
"(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid",
"Levofloxacino",
"Levofloxacin",
"Levofloxacin anhydrous",
"Levaquin",
"(S)-(-)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzooxazine-6-carboxylic acid",
"Levofloxacinum",
"Anhydrous, Levofloxacin"
],
"medline_plus_id": "a601154",
"generic_names": [
"Levofloxacin"
],
"mesh_id": "D065609",
"drugbank_id": "DB01137",
"wikipedia_url": "https://en.wikipedia.org/wiki/Levofloxacin"
}
]
} |
NCT00363779 | Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia | https://clinicaltrials.gov/study/NCT00363779 | null | TERMINATED | Background:
* Large granular lymphocyte (LGL) leukemia is a low-grade non-Hodgkins lymphoma.
* LGL is associated with low numbers of white blood cells (leading to recurring infections), red blood cells (causing anemia) and platelets (causing abnormal bleeding).
* Cyclosporine (CSA) is an immunosuppressive drug that improves low blood cell counts in about 50 percent of patients with LGL leukemia.
Objectives:
* To identify what factors determine why cyclosporine works in some patients and not in others.
* To identify what causes low blood counts in LGL leukemia.
Eligibility: Patients 18 years of age and older with LGL leukemia.
Design:
* Patients have a medical history, physical examination blood tests, bone marrow biopsy and x-ray studies, including chest x-rays and computed tomography (CT) scans of the chest, abdomen and pelvis. Patients with an easily accessible enlarged lymph node have a node biopsy (removal of a small piece of tissue for microscopic examination).
* Patients take cyclosporine twice a day by mouth. Blood samples are taken at least weekly to adjust the cyclosporine dosing to maintain therapeutic serum levels.
* Patients undergo apheresis (collection of white blood cells) at a number of different time points in the study (maximum 6 times) to look at the differences in the leukemia cells before and during treatment with cyclosporine. For apheresis, blood is withdrawn through a needle in an arm vein and directed through a catheter (plastic tube) into a machine that separates it into its components. The white cells are extracted and the rest of the blood is returned through the same needle or through a second needle in the other arm. | YES | Large Granular Lymphocytic Leukemia|LGL Leukemia | DRUG: Cyclosporine|GENETIC: Gene expression analysis|GENETIC: Microarray analysis|OTHER: Laboratory biomarker analysis | Changes in Gene Expression Patterns, The goal was to examine which genes had a 2-fold gene expression between pre-treatment (baseline) and post treatment (12 weeks). Genes significant at the 0.001 level will be considered as differentially expressed due to treatment., Baseline and 12 weeks | Number of Participants With Adverse Events, Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module., 3 months | null | National Cancer Institute (NCI) | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 5 | NIH | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 060177|06-C-0177 | 2006-06 | 2010-11 | 2010-11 | 2006-08-15 | 2012-07-06 | 2015-07-21 | National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States | null | {
"Cyclosporine": [
{
"intervention_type": "DRUG",
"description": "Cyclosporine",
"name": "Cyclosporine",
"synonyms": [
"Cyclosporine",
"CsA-Neoral",
"Ciclosporine",
"CyA NOF",
"Ciclosporina",
"Sandimmune",
"Ciclosporin",
"Cequa",
"OL 27 400",
"CsA Neoral",
"CsANeoral",
"OL 27-400",
"Cyclosporin",
"Cyclosporin A",
"Gengraf",
"Sandimmun",
"OL 27400",
"CsA",
"CyA-NOF",
"Ciclosporinum",
"Restasis",
"Cyclosporine A",
"Sandimmun Neoral",
"CyA",
"Neoral"
],
"medline_plus_id": "a604009",
"generic_names": [
"Cyclosporine"
],
"mesh_id": "D065095",
"drugbank_id": "DB00091",
"wikipedia_url": "https://en.wikipedia.org/wiki/Ciclosporin"
}
],
"Gene expression analysis": [
{
"intervention_type": "GENETIC"
}
],
"Microarray analysis": [
{
"intervention_type": "GENETIC"
}
],
"Laboratory biomarker analysis": [
{
"intervention_type": "OTHER"
}
]
} |
NCT05731479 | Radiofrequency Diathermy and Therapeutic Exercise Protocol in Women With Abdominal Diastasis | https://clinicaltrials.gov/study/NCT05731479 | null | RECRUITING | Diastasis recti abdominis (DRA) is defined as the presence of divergence between the rectus abdominis muscles along the linea alba. DRA is associated with decreased abdominal strength and degraded health and physical functioning, which results in poorer body perception and satisfaction and negatively affects the quality of life in its multiple spheres (social, sexual and personal). Regarding the different treatment techniques for DRA, different treatments have been described, such as bandages, electrotherapy or therapeutic exercise, the latter being the most scientifically supported option to approach DRA conservatively. Exercise has shown positive effects on DRA severity, abdominal muscle thickness, abdominal strength and endurance, and quality of life in women with DRA.
Another treatment that has shown promising effects in various pathologies is radiofrequency diathermy using the Capacitive-Resistive Electrical Transfer system. The capacitive mode acts on soft tissues containing electrolytes such as muscles and vascular and lymphatic tissues. On the other hand, the resistive mode acts on tissues of higher density and fat and fiber content, such as bones, ligaments and tendons. It has been documented that this type of therapy acts favoring the vascularization of tissues, decreasing inflammation and favoring the processes of cellular repair and analgesia. Its beneficial effect on low back pain and various pelvic floor disorders has been studied. However, at present, there are no studies evaluating the effectiveness of this type of intervention in people with abdominal diastasis.
In view of the above, the objective of our study is to evaluate the effectiveness of a protocol based on therapeutic exercise preceded by a radiofrequency diathermy program on anthropometric parameters, anatomo-physiological parameters, functional parameters, and parameters related to psychological aspects in women with postpartum abdominal diastasis. | NO | Abdominal Diastasis | OTHER: Diathermy + exercise group|OTHER: Diathermy placebo + exercise group | Rectus abdominis distance, The distance between rectus abdominis in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer., Baseline|Rectus abdominis distance, The distance between rectus abdominis in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer., Immediately after the intervention|Rectus abdominis thickness, The rectus abdominis thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer., Baseline|Rectus abdominis thickness, The rectus abdominis thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer., Immediately after the intervention | Body composition, Body composition by means of Bioimpedance (Tanita DC-430MA, Tanita Corporation of America, Inc., Arlington Heights, IL, USA)., Baseline|Body composition, Body composition by means of Bioimpedance (Tanita DC-430MA, Tanita Corporation of America, Inc., Arlington Heights, IL, USA)., Immediately after the intervention|Strength of the abdominal flexor musculature, Strength of the abdominal flexor musculature by means of a dynamometer (Lafayette, Indiana, USA), Baseline|Strength of the abdominal flexor musculature, Strength of the abdominal flexor musculature by means of a dynamometer (Lafayette, Indiana, USA), Immediately after the intervention|Kinesiophobia, Kinesiophobia with the Tampa Scale of Kinesiophobia-11 questionnaire: It maintains items 1, 2, 3, 5, 6, 7, 10, 11, 13, 15, and 17 from the original 17-point scale, and its score ranges from 11-44, where the lowest 11 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia, Baseline|Kinesiophobia, Kinesiophobia with the Tampa Scale of Kinesiophobia-11 questionnaire: It maintains items 1, 2, 3, 5, 6, 7, 10, 11, 13, 15, and 17 from the original 17-point scale, and its score ranges from 11-44, where the lowest 11 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia, Immediately after the intervention|Body image, Body image using the Multidimensional Body Self Relations Questionnaire: It consists of 69 items each rated on a 5-point scale from 1 to 5 (strongly disagree-strongly agree). The higher the score, the greater the satisfaction with ones own body image, so the total score of the instrument requires reversing the score of the items that indicate dissatisfaction, Baseline|Body image, Body image using the Multidimensional Body Self Relations Questionnaire: It consists of 69 items each rated on a 5-point scale from 1 to 5 (strongly disagree-strongly agree). The higher the score, the greater the satisfaction with ones own body image, so the total score of the instrument requires reversing the score of the items that indicate dissatisfaction, Immediately after the intervention|Perception of change after the intervention, Perception of change after the intervention with the Patient Perception of Change after Treatment questionnaire. consisting of a verbal scale, with 7 points very much improved , much improved , minimally improved , no change , minimally worse , much worse , very much worse ., Baseline|Perception of change after the intervention, Perception of change after the intervention with the Patient Perception of Change after Treatment questionnaire. consisting of a verbal scale, with 7 points very much improved , much improved , minimally improved , no change , minimally worse , much worse , very much worse ., Immediately after the intervention|Linea alba thickness, Linea alba thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer., Baseline|Linea alba thickness, Linea alba thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer., Immediately after the intervention|Linea alba distortion index, Linea alba distortion index in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer., Baseline|Linea alba distortion index, Linea alba distortion index in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer., Immediately after the intervention|Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule, Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule, with a battery of validated maneuvers: gluteal bridge, gluteal bridge with unipodal support, lateral planks and horizontal plank.
The measurement unit is the second (s) for all maneuvers, and the time for each manoeuvre shall be averaged., Baseline|Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule, Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule, with a battery of validated maneuvers: gluteal bridge, gluteal bridge with unipodal support, lateral planks and horizontal plank.
The measurement unit is the second (s) for all maneuvers, and the time for each manoeuvre shall be averaged., Immediately after the intervention|Abdominal circumference, Abdominal circumference will be assessed by means of tape measure in centimetres (cm). Two measurements shall be taken and averaged., Baseline|Abdominal circumference, Abdominal circumference will be assessed by means of tape measure in centimetres (cm). Two measurements shall be taken and averaged., Immediately after the intervention|Abdominal fold, Abdominal fold will be assessed by means of a plicometer in milimetres (mm). Two measurements shall be taken and averaged., Baseline|Abdominal fold, Abdominal fold will be assessed by means of a plicometer in milimetres (mm). Two measurements shall be taken and averaged., Immediately after the intervention | null | University of Valencia | null | FEMALE | ADULT | null | 34 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 2524988 | 2023-01-16 | 2025-06 | 2026-06 | 2023-02-16 | null | 2023-03-17 | Faculty of Physiotherapy. University of Valencia, Valencia, 46002, Spain | null | {
"Diathermy + exercise group": [
{
"intervention_type": "OTHER"
}
],
"Diathermy placebo + exercise group": [
{
"intervention_type": "OTHER"
}
]
} |
NCT05156879 | Aspirin for the Management of Endometriosis-associated Pelvic Pain | https://clinicaltrials.gov/study/NCT05156879 | null | RECRUITING | Endometriosis-associated pelvic pain (EAPP) is common in endometriosis and pain control is an important goal of long-term management. Non-steroidal anti-inflammatory drugs and oral contraception are the two first line therapies for endometriosis. High quality study about aspirin for the EAPP is absent. In this study, the investigators hypothesis that aspirin is effective in controlling EAPP. A randomized, open, and controlled study will be implemented. participants with EAPP with visual Analogue Scale(VAS）>30 mm will be included and low dose aspirin（75mg/day） be prescribed. Yasmin(Drospirenone ethinyl estradiol tablet) will be used as positive control. The primary efficacy end points is the reduction of the pain score of EAPP at 24th week assessed with VAS score. Pelvic examination, sonography and blood test will be to performed to evaluate the lesion and coagulation function. The adverse event and medication compliance will be investigated. The aim of this study is to explore the efficacy and safety of low dose aspirin therapy in management of EAPP. This study will provide new options for the long-term management of endometriosis, which will help reduce the medical cost of endometriosis. | NO | Pelvic Pain | DRUG: Aspirin|DRUG: Drospirenone ethinyl estradiol | visual Analogue Scale, a scale with 0-100 mm values, higher scores mean a worse outcome, baseline , 12 weeks after treatment , and 24 weeks of treatment | Tenderness, Tenderness during pelvic examination from 1 to 4,higher scores mean a worse outcome, baseline , 12 weeks of treatment , and 24 weeks of treatment|size of endometrioid lesions, endometrioid lesions detected by sonorgraphy, baseline , 12 weeks of treatment , and 24 weeks of treatment|C reactive protein, a biomarker of inflammation, baseline , 12 weeks of treatment , and 24 weeks of treatment|carbohydrate antigen 125, a biomarker of endometriosis, baseline , 12 weeks of treatment , and 24 weeks of treatment|platelets counts, associated with inflammation and wound healing, baseline , 12 weeks of treatment , and 24 weeks of treatment | null | Womens Hospital School Of Medicine Zhejiang University | null | FEMALE | ADULT | PHASE4 | 220 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | IRB-20210267-R | 2021-12-23 | 2024-12 | 2025-06 | 2021-12-14 | null | 2022-01-24 | Womens Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, 321006, China | null | {
"Aspirin": [
{
"intervention_type": "DRUG",
"description": "Aspirin",
"name": "Aspirin",
"synonyms": [
"Valomag",
"Endosprin",
"Acetysal",
"Acetylsalicylic acid",
"Azetylsalizyls\u00e4ure",
"Magnecyl",
"Acetylsalicylic Acid",
"2-(Acetyloxy)benzoic Acid",
"Aloxiprimum",
"Polopirin",
"Bonjela",
"Acetylsalicylate",
"Dispril",
"Ecotrin",
"Acylpyrin",
"Acid, Acetylsalicylic",
"Anadin",
"Zorprin",
"Polopiryna",
"Solupsan",
"Colfarit",
"Solprin",
"Micristin",
"Easprin",
"Aspirin",
"Boots Haemorrhoid",
"2-(Diethylamino)-2',6'-acetoxylidide",
"2-2EtN-2MePhAcN",
"\u03b1-diethylamino-2,6-dimethylacetanilide",
"Xylocaine",
"Lidocaine Monohydrochloride, Monohydrate",
"Lidocaine Carbonate",
"Xyloneural",
"2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide",
"Ztlido",
"EMLA",
"Lidocaina",
"Lidocaine",
"2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide",
"Covonia",
"Xylopract",
"Nulbia",
"Lidoca\u00edna",
"Octocaine",
"Lidocainum",
"LMX4",
"Bonjela",
"Lidocaine Hydrochloride",
"Dalcaine",
"Lidocaine Sulfate (1:1)",
"Anbesol",
"Perinal",
"Anusol",
"Lidocaine Monohydrochloride",
"Germaloids",
"Iglu",
"Xylesthesin",
"Lidocaine Monoacetate",
"Lignocaine",
"Calgel",
"Lidocaine Carbonate (2:1)",
"Denela",
"Lidocaine Hydrocarbonate",
"alpha-diethylamino-2,6-dimethylacetanilide",
"Xylocitin",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Xylocaine",
"Lidocaine Viscous",
"Xylocaine",
"Lidocaine Viscous",
"Senstend",
"Emla",
"Fortacin",
"Lidocaine/prilocaine",
"Boots Haemorrhoid",
"2-(Diethylamino)-2',6'-acetoxylidide",
"2-2EtN-2MePhAcN",
"\u03b1-diethylamino-2,6-dimethylacetanilide",
"Xylocaine",
"Lidocaine Monohydrochloride, Monohydrate",
"Lidocaine Carbonate",
"Xyloneural",
"2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide",
"Ztlido",
"EMLA",
"Lidocaina",
"Lidocaine",
"2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide",
"Covonia",
"Xylopract",
"Nulbia",
"Lidoca\u00edna",
"Octocaine",
"Lidocainum",
"LMX4",
"Bonjela",
"Lidocaine Hydrochloride",
"Dalcaine",
"Lidocaine Sulfate (1:1)",
"Anbesol",
"Perinal",
"Anusol",
"Lidocaine Monohydrochloride",
"Germaloids",
"Iglu",
"Xylesthesin",
"Lidocaine Monoacetate",
"Lignocaine",
"Calgel",
"Lidocaine Carbonate (2:1)",
"Denela",
"Lidocaine Hydrocarbonate",
"alpha-diethylamino-2,6-dimethylacetanilide",
"Xylocitin",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Xylocaine",
"Lidocaine Viscous",
"Xylocaine",
"Lidocaine Viscous",
"Senstend",
"Emla",
"Fortacin",
"Lidocaine/prilocaine"
],
"medline_plus_id": "a621021",
"generic_names": [
"Acetylsalicylic acid",
"Aspirin",
"Lidocaine",
"Lidocaine Patch",
"Lidocaine Patch",
"Lidocaine Viscous",
"Lidocaine Viscous",
"Lidocaine",
"Lidocaine Patch",
"Lidocaine Patch",
"Lidocaine Viscous",
"Lidocaine Viscous"
],
"nhs_url": "https://www.nhs.uk/medicines/aspirin-for-pain-relief",
"mesh_id": "D058633",
"drugbank_id": "DB00945",
"wikipedia_url": "https://en.wikipedia.org/wiki/Aspirin"
}
],
"Ethinylestradiol": [
{
"intervention_type": "DRUG",
"description": "Drospirenone ethinyl estradiol",
"name": "Ethinylestradiol",
"synonyms": [
"Ethinylestradiolum",
"Ethinyl estradiol",
"17-ethinyl-3,17-oestradiol",
"17alpha-Ethinyl estradiol",
"Ethinyloestradiol",
"17-ethinyl-3,17-estradiol",
"17-ethinylestradiol",
"Ethinylestradiol",
"Ethynyl estradiol",
"Etinilestradiol",
"17\u03b1-ethynylestradiol"
],
"drugbank_id": "DB00977",
"generic_names": [
"Ethinylestradiol"
]
}
],
"Drospirenone": [
{
"intervention_type": "DRUG",
"description": "Drospirenone ethinyl estradiol",
"name": "Drospirenone",
"synonyms": [
"6\u03b2,7\u03b2;15\u03b2,16\u03b2-Dimethylene-3-oxo-17\u03b1-pregn-4-ene-21,17-carbolactone",
"DRSP",
"Drospirenone",
"Yaz",
"Drospirenonum",
"Drospirenona",
"''Alone'': Slynd<br />''With estradiol'': Angeliq<br />''With [[ethinylestradiol'': Yasmin",
"1,2-Dihydrospirorenone",
"Yasminelle",
"Drospir\u00e9none",
"Dehydrospirorenone"
],
"drugbank_id": "DB01395",
"generic_names": [
"Drospirenone"
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Drospirenone"
}
]
} |
NCT02965079 | Registry on the EXperience of Extracorporeal CO2 Removal in Intensive Care Units | https://clinicaltrials.gov/study/NCT02965079 | REXECOR | UNKNOWN | Investigators will aim to conduct an observational study in order to assess very thoroughly all patients implanted by Extracorporeal carbon dioxide removal (ECCO2R) in 10 critical care units of Paris and its surburb (APHP, Assistance Publique des hôpitaux de Paris).
Secondary objectives will be:
1. to assess efficacy and safety of ECCO2R,
2. to compare the data issue from the registry to others studies assessing the same population and to other centers and
3. to compare the different ECCOR devices in terms of efficacy and adverse events. | NO | Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease|Patients With Acute Respiratory Distress Syndrome | DEVICE: ECCO2R | Incidence of ECCO2R use, Number of ECCO2R implantation monthly by center, Recorded monthly up to 100 weeks (24 months) | ICU mortality, Recorded From date of ICU admission until the date of death or ICU discharge, assessed up to 100 weeks|Duration of mechanical ventilation, Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks|ICU duration, Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks|Ventilation modalities at discharge, Recorded from the initiation of ventilation until ventilation removal,assessed up to 100 weeks|hemorragic and thrombotic complications, Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks|hemolysis, Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks | null | Rexecor | null | ALL | ADULT, OLDER_ADULT | null | 200 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | APHP | 2016-01 | 2022-01 | 2022-06 | 2016-11-16 | null | 2020-10-14 | Assistance Publique - Hopitaux de Paris, Paris, 75015, France | null | {
"ECCO2R": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT04734379 | Rho Kinase (ROCK) Inhibitor in Tauopathies - 1 | https://clinicaltrials.gov/study/NCT04734379 | ROCKIT-1 | UNKNOWN | A Phase 2a Open-Label Preliminary Safety, Tolerability, and Biomarker Study of Oral Fasudil in Patients with the 4-Repeat Tauopathies of Progressive Supranuclear Palsy-Richardson Syndrome or Corticobasal Syndrome | NO | Progressive Supranuclear Palsy|Corticobasal Syndrome | DRUG: Fasudil | Adverse events, Incidence of adverse events [AEs] and serious adverse events [SAEs] as assessed by clinically significant abnormal physical examination findings; changes in vital signs; 12-lead electrocardiogram [ECG]; magnetic resonance imaging [MRI]; and hematology, blood chemistry, liver function, and urine tests., 48 weeks | Phosphorylated tau, Number of participants with changes in concentrations of cerebrospinal fluid (CSF) and plasma phosphorylated tau, 48 weeks|Biomarkers of neurodegeneration, Number of participants with changes in biomarkers of neurodegeneration, including neurofilament light chain (NfL), and total tau fragment levels., 48 weeks|Imaging biomarkers of neurodegeneration, Number of participants with changes in imaging biomarkers of neurodegeneration, including changes in brain volume (whole brain, ventricles, hippocampus, frontal operculum, pre-central gyri, midbrain, pons and superior cerebellar peduncle) and white matter tract integrity (aslant tract, superior longitudinal fasciculus, and superior cerebellar peduncle) as determined by T1-weighted volumetric magnetic resonance imaging (MRI), diffusion tensor imaging (DTI), 48 weeks | null | Woolsey Pharmaceuticals | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 15 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | WP-0512-002 | 2021-01-22 | 2022-11-30 | 2023-11-30 | 2021-02-02 | null | 2022-06-03 | University of California Weill Institute for Neurosciences, San Francisco, California, 94158, United States | null | {
"Fasudil": [
{
"intervention_type": "DRUG",
"description": "Fasudil",
"name": "Fasudil",
"synonyms": [
"Fasudil"
],
"drugbank_id": "DB08162",
"generic_names": [
"Fasudil"
]
}
]
} |
NCT03735979 | Multi-arm Optimization of Stroke Thrombolysis | https://clinicaltrials.gov/study/NCT03735979 | MOST | ACTIVE_NOT_RECRUITING | The primary efficacy objective of the MOST trial is to determine if argatroban (100µg/kg bolus followed by 3µg/kg per minute for 12 hours) or eptifibatide (135µg/kg bolus followed by 0.75µg/kg/min infusion for two hours) results in improved 90-day modified Rankin scores (mRS) as compared with placebo in acute ischemic stroke (AIS) patients treated with standard of care thrombolysis (0.9mg/kg IV rt-PA or 0.25mg/kg IV tenecteplase or TNK) within three hours of symptom onset. Patients may also receive endovascular thrombectomy (ET) per usual care. Time of onset is defined as the last time the patient was last known to be well. | NO | Acute Ischemic Stroke | DRUG: Argatroban|DRUG: Eptifibatide|DRUG: Placebo | 90-day modified Rankin scores (mRS), 90 days after randomization | proportion of participants with NIHSS less than or equal to 2 at 24 hours, 2 at 24 hours after randomization|change from baseline to 24-hour NIHSS, 24 hours after randomization|proportion of participants with 90-day mRS 0-1 (or return to their historical mRS), 90 days after randomization|proportion of participants with 90-day mRS 0-2 (or return to their historical mRS), 90 days after randomization|90-day ordinal analysis of the mRS, 90 days after randomization|90-day EQ-5D, 90 days after randomization|proportion of participants who have thrombectomy, baseline | null | Washington University School of Medicine | National Institute of Neurological Disorders and Stroke (NINDS) | ALL | ADULT, OLDER_ADULT | PHASE3 | 514 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 2018-1464|1U01NS100699-01A1 | 2019-10-15 | 2023-12-01 | 2025-04 | 2018-11-08 | null | 2024-03-15 | University of Alabama Hospital, Birmingham, Alabama, 35233, United States|St. Jude Medical Center, Fullerton, California, 92835, United States|UCSD Health La Jolla, La Jolla, California, 92037, United States|Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, 90027, United States|Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States|UC Irvine Medical Center, Orange, California, 92868, United States|UCSD Medical Center - Hillcrest Hospital, San Diego, California, 92103, United States|San Francisco General Hospital, San Francisco, California, 94110, United States|UCSF Medical Center, San Francisco, California, 94143, United States|Santa Barbara Cottage Hospital, Santa Barbara, California, 93105, United States|Yale New Haven Hospital, New Haven, Connecticut, 06510, United States|Baptist Medical Center Jacksonville, Jacksonville, Florida, 32207, United States|Mayo Clinic Hospital, Jacksonville, Florida, 32224, United States|Jackson Memorial Hospital, Miami, Florida, 33136, United States|Sarasota Memorial Hospital, Sarasota, Florida, 34239, United States|Tampa General Hospital, Tampa, Florida, 33606, United States|Grady Memorial Hospital, Atlanta, Georgia, 30303, United States|University of Chicago Medical Center, Chicago, Illinois, 60637, United States|Loyola University Medical Center, Maywood, Illinois, 60153, United States|Javon Bea Hospital - Riverside, Rockford, Illinois, 61114, United States|Central DuPage Hospital, Winfield, Illinois, 60190, United States|University of Kansas Hospital, Kansas City, Kansas, 66160, United States|University of Kentucky Hospital, Lexington, Kentucky, 40536, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|UMASS Memorial Medical Center, Worcester, Massachusetts, 01655, United States|University of Michigan University Hospital, Ann Arbor, Michigan, 48109, United States|Henry Ford Hospital, Detroit, Michigan, 48202, United States|McLaren Flint, Flint, Michigan, 48532, United States|Trinity Health Saint Marys, Grand Rapids, Michigan, 49503, United States|Fairview Southdale Hospital, Edina, Minnesota, 55425, United States|University of Minnesota Medical Center Hospital, Minneapolis, Minnesota, 55455, United States|Regions Hospital, Saint Paul, Minnesota, 55101, United States|Saint Lukes Hospital, Kansas City, Missouri, 64111, United States|St. Louis University Hospital, Saint Louis, Missouri, 63108, United States|Barnes Jewish Hospital, Saint Louis, Missouri, 63110, United States|University of New Mexico Hospital, Albuquerque, New Mexico, 87106, United States|North Shore University Hospital, Manhasset, New York, 11030, United States|Mount Sinai Beth Israel, New York, New York, 10003, United States|SUNY Upstate University Hospital, Syracuse, New York, 13210, United States|Forsyth Medical Center, Winston-Salem, North Carolina, 27103, United States|Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, 27103, United States|Cleveland Clinic Akron General, Akron, Ohio, 44307, United States|Mercy Health West Hospital, Cincinnati, Ohio, 45211, United States|University of Cincinnati Medical Center, Cincinnati, Ohio, 45219, United States|The Jewish Hospital, Cincinnati, Ohio, 45236, United States|OSU Wexner Medical Center, Columbus, Ohio, 43210, United States|St. John Medical Center, Tulsa, Oklahoma, 74104, United States|Abington Memorial Hospital, Abington, Pennsylvania, 19001, United States|Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Temple University Hospital, Philadelphia, Pennsylvania, 19140, United States|UPMC Presbyterian Hospital, Pittsburgh, Pennsylvania, 15213, United States|UPMC Mercy Hospital, Pittsburgh, Pennsylvania, 15219, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, 29605, United States|Vanderbilt University Hospital, Nashville, Tennessee, 37232, United States|Houston Methodist Hospital, Houston, Texas, 77030, United States|Memorial Hermann-Texas Medical Center, Houston, Texas, 77030, United States|South Texas Health System McAllen, McAllen, Texas, 78503, United States|University of Utah Healthcare, Salt Lake City, Utah, 84132, United States|UVA Medical Center, Charlottesville, Virginia, 22908, United States | null | {
"Argatroban": [
{
"intervention_type": "DRUG",
"description": "Argatroban",
"name": "Argatroban",
"synonyms": [
"",
"Argatroban anhydrous",
"Argatroban"
],
"drugbank_id": "DB00278",
"generic_names": [
"Argatroban"
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Argatroban"
}
],
"Eptifibatide": [
{
"intervention_type": "DRUG",
"description": "Eptifibatide",
"name": "Eptifibatide",
"synonyms": [
"Epifibatide",
"Eptifibatide",
"Epifibratide",
"Eptifibatida",
"Integrilin",
"7H-Pyrrolo(2,1-g)(1,2,5,8,11,14,17,20)dithiahexaazacyclotricosine-17-acetic acid, 3-(aminocarbonyl)-11-(4-((aminoiminomethyl)amino)butyl)docosahydro-20-(1H-indol-3-ylmethyl)-1,9,12,15,18,21-hexaoxo-, (3R,11S,17S,20S,25aS)-",
"Integrelin",
"Intrifiban"
],
"mesh_id": "D010975",
"generic_names": [
"Eptifibatide"
],
"drugbank_id": "DB00063"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT04566679 | Butyrate in Children With IBS: Double Blind Placebo Controlled Randomized Clinical Trial | https://clinicaltrials.gov/study/NCT04566679 | BUZIR | UNKNOWN | We will perform a randomized, double-blind, placebo-controlled trial to establish whether calcium butyrate relieves symptoms in children with irritable bowel syndrome (IBS). The direct effects of butyrate on inflammation and GI symptoms will be studied in children with IBS. The design used to study the effects of calcium butyrate will be a double blind randomized placebo-controlled parallel design. | NO | Irritable Bowel Syndrome (IBS)|Children, Only | DIETARY_SUPPLEMENT: Dibuzin|DIETARY_SUPPLEMENT: placebo | butyrate on GI symptoms, To assess the severity of pain, a combination of the self-reported visual analog scale (VAS) and the Faces Pain Scale (FPS) will be used. The 0- to 10-mm VAS scale (0, no pain; 10, worst possible pain) include a horizontal color gradient (green to red) plus a rating., daily for 14 weeks|butyrate on GI symptoms, Gastrointestinal Symptom Rating Scale (GSRS), every two weeks for 14 weeks | butyrate on inflammation, fecal calprotectin and lactoferrin, 14 weeks | null | University of Bari | null | ALL | CHILD | null | 50 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | BUZIR2020 | 2021-04-21 | 2023-01-01 | 2023-01-01 | 2020-09-28 | null | 2021-04-23 | Pediatric Department B Trambusti Ospedale Giovanni XXIII Via Amendola 270, Bari, Ba, 70126, Italy|Clinica Pediatrica, Bari, Puglia, 70125, Italy | null | {
"Dibuzin": [
{
"intervention_type": "DIETARY_SUPPLEMENT"
}
],
"placebo": [
{
"intervention_type": "DIETARY_SUPPLEMENT"
}
]
} |
NCT02233179 | The Association Between Unprotected Standing, Walking and Wound Healing in Diabetes | https://clinicaltrials.gov/study/NCT02233179 | null | COMPLETED | The aim of the study was to explore the association between activities of daily living ( measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an exploratory study, there was no study hypothesis. | NO | Diabetic Foot | DEVICE: Removable cast walker|DEVICE: Irremovable cast walker | Wound size, Wound size was measured every week for 12 weeks, 12 weeks|Daily Physical Activities, Recorded using a body-worn sensor and measured every 4 weeks for 2 days., 12 weeks | null | null | University of Arizona | Qatar National Research Foundation, Qatar | ALL | ADULT, OLDER_ADULT | null | 49 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 900000701 | 2009-06 | 2011-08 | 2012-11 | 2014-09-08 | null | 2014-09-08 | University Medical Center, Tucson, Arizona, 85724, United States | null | {
"Removable cast walker": [
{
"intervention_type": "DEVICE"
}
],
"Irremovable cast walker": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT06442579 | The Influence of Cortical Lateralization on Selective Motor Control of the Arm Swing During Independent Walking After Stroke. | https://clinicaltrials.gov/study/NCT06442579 | null | RECRUITING | The upper limbs play an essential role for safe and efficient walking in healthy persons and persons post-stroke. Nevertheless, in current post-stroke gait rehabilitation (research) the upper limbs are barely targeted. To address this gap, my project aims to investigate the selective motor control of the upper limbs during walking and the contribution of the cortical activity to the arm swing in independent walkers after stroke.
To gain insight in the direct effects of stroke on the arm swing, the primary motor control of the arm swing will be evaluated by determining muscle synergies (i.e group of muscles working together as a task-specific functional unit). Additionally, the cortical activity (EEG-analysis) during walking of persons post-stroke will be compared to healthy controls and the relationship between stroke-induced changes in cortical activity and arm swing deviations will be assessed. Furthermore, I will evaluate whether improvements in cortical activity relate to improvements in primary motor control of the arm swing.
This innovative project will be the first to investigate the direct coupling between the cortex and the muscle synergies in persons post-stroke during independent walking to investigate the arm swing. These fundamental insights in the primary motor control of the arm swing and the contribution of the cortical activity will allow to develop targeted interventions aiming to improve arm swing and as such optimize post-stroke gait rehabilitation.
Research questions:
1. How can muscle synergies explain arm swing alterations in independent walkers after stroke?
2. How do stroke-induced changes in cortical activity relate to arm swing deviations in persons after stroke?
3. Are changes in primary motor control of the upper limb during walking related to normalization of brain activity in independent walkers after stroke? | NO | Stroke, Ischemic|Healthy | OTHER: Walking on a treadmill | Number of muscle synergies, The number of muscle synergies needed to account for 90% variance in muscle activity measured by surface EMG during walking in stroke survivors compared to healthy controls. Following muscles will be examined:
* tibialis anterior,
* gastrocnemius lateralis
* soleus
* vastus medialis
* vastus lateralis
* rectus femoris
* biceps femoris
* gluteus medius
* erector spinae
* latissimus dorsi
* anterior deltoid
* posterior deltoid
* biceps brachii
* triceps brachii, Single point of assessment at inclusion|Number of muscle synergies, The number of muscle synergies needed to account for 90% variance in muscle activity measured by surface EMG during walking in stroke survivors after a follow-up period of three months. Following muscles will be examined:
* tibialis anterior,
* gastrocnemius lateralis
* soleus
* vastus medialis
* vastus lateralis
* rectus femoris
* biceps femoris
* gluteus medius
* erector spinae
* latissimus dorsi
* anterior deltoid
* posterior deltoid
* biceps brachii
* triceps brachii, Single point of assessment 3 months after inclusion (only for stroke survivors)|Weight of muscle synergies, The number or distribution of muscle weightings within a synergy during walking in stroke survivors compared to healthy controls.
The distribution of muscle activation averages over one gait cycle measured by surface EMG of following muscles:
* tibialis anterior,
* gastrocnemius lateralis
* soleus
* vastus medialis
* vastus lateralis
* rectus femoris
* biceps femoris
* gluteus medius
* erector spinae
* latissimus dorsi
* anterior deltoid
* posterior deltoid
* biceps brachii
* triceps brachii, Single point of assessment at inclusion|Weight of muscle synergies, The number or distribution of muscle weightings within a synergy during walking in stroke survivors after a follow-up period of three months.
The distribution of muscle activation averages over one gait cycle measured by surface EMG of following muscles:
* tibialis anterior,
* gastrocnemius lateralis
* soleus
* vastus medialis
* vastus lateralis
* rectus femoris
* biceps femoris
* gluteus medius
* erector spinae
* latissimus dorsi
* anterior deltoid
* posterior deltoid
* biceps brachii
* triceps brachii, Single point of assessment 3 months after inclusion (only for stroke survivors)|Brain symmetry index (BSI), The amount of cortical lateralization during walking in stroke survivors compared to healthy controls. The score ranges from -1 to +1 with BSI = 0 reprenting perfect symmetry. Positive values represent higher power in the right hemishere compared to the left hemisphere, vice versa for negative values. For left side lesions, BSI was multiplied by -1., Single point of assessment at inclusion|Brain symmetry index (BSI), The amount of cortical lateralization during walking in stroke survivors after a follow-up period of three months. The score ranges from -1 to +1 with BSI = 0 reprenting perfect symmetry. Positive values represent higher power in the right hemishere compared to the left hemisphere, vice versa for negative values. For left side lesions, BSI was multiplied by -1., Single point of assessment 3 months after inclusion (only for stroke survivors) | Upper limb kinematics, Movements of the upper limb during walking measured by 3D kinematics and expressed as angles (°), Single point of assessment at inclusion|Upper limb kinematics, Movements of the upper limb during walking measured by 3D kinematics and expressed as angles (°), Single point of assessment 3 months after inclusion (only for stroke survivors)|Cortico-synergy coherence, The amount of coherence (i.e. phase locking) between the muscle synergies and cortical activity during walking in stroke survivors compared to healthy controls. Higher values (0-1) indicate a better linear association., Single point of assessment at inclusion|Cortico-synergy coherence, The amount of coherence (i.e phase locking) between the muscle synergies and cortical activity during walking in stroke survivors after a follow-up period of three months. Higher values (0-1) indicate a better linear association., Single point of assessment 3 months after inclusion (only for stroke survivors) | National Institutes of Health Stroke Scale (NIHSS), Quantifies the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The highest score is 42., Single point of assessment at inclusion (only for stroke survivors)|National Institutes of Health Stroke Scale (NIHSS), Quantifies the general impairment caused by a stroke after a follow-up period of three months. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The highest score is 42., Single point of assessment 3 months after inclusion (only for stroke survivors)|Fugl-Meyer assesment - Upper limbs, Assesses specifc motor impairments of the upper limbs of stroke survivors. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively., Single point of assessment at inclusion (only for stroke survivors)|Fugl-Meyer assesment - Upper limbs, Assesses specifc motor impairments of the upper limbs of stroke survivors after a follow-up period of three months. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively., Single point of assessment 3 months after inclusion (only for stroke survivors)|Tardieu scale, Quantifies spasticity by assessing the muscles response (0-5) to different stretch velocities (V1, V2 or V3) and by determining the spasticity angle (R1 or R2)., Single point of assessment at inclusion (only for stroke survivors)|Tardieu scale, Quantifies spasticity by assessing the muscles response (0-5) to different stretch velocities (V1, V2 or V3) and by determining the spasticity angle (R1 or R2)., Single point of assessment 3 months after inclusion (only for stroke survivors)|10 Meter Walking Test, Examins the walking capacity of a stroke survivor by measuring how long it takes to walk a distance of 10 meters (in seconds)., Single point of assessment at inclusion (only for stroke survivors)|10 Meter Walking Test, Examins the walking capacity of a stroke survivor by measuring how long it takes to walk a distance of 10 meters (in seconds)., Single point of assessment 3 months after inclusion (only for stroke survivors)|Fugl-Meyer assesment - Lower limbs, Assesses specifc motor impairments of the lower limbs of stroke survivors. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively., Single point of assessment at inclusion (only for stroke survivors)|Fugl-Meyer assesment - Lower limbs, Assesses specifc motor impairments of the lower limbs of stroke survivors after a follow-up period of three months. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively., Single point of assessment 3 months after inclusion (only for stroke survivors) | University Hospital, Ghent | University Ghent|VU University of Amsterdam|Vrije Universiteit Brussel | ALL | ADULT, OLDER_ADULT | null | 84 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | ONZ-2024-0089|11PEU24N | 2024-06-15 | 2026-06-30 | 2026-09-30 | 2024-06-04 | null | 2024-06-20 | Ghent University Hospital, Ghent, Oost-Vlaanderen, Belgium | null | {
"Walking on a treadmill": [
{
"intervention_type": "OTHER"
}
]
} |
NCT05550779 | What Makes People Better at Retrieving Proper Names? | https://clinicaltrials.gov/study/NCT05550779 | null | COMPLETED | This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce names of pictured people. Participants will perform a brief mental exercise, then see 83 celebrity photographs to produce the names of. Participants will also complete other surveys and measures. Collected data will give researchers a better understanding of how different variables relate to proper name production. | NO | Healthy Aging | BEHAVIORAL: Mental Exercise | Name retrieval performance, Percent of trials with correct responses and percent of trials that are name retrieval failures will be measured on a task created for this purpose. Specifically, participants will try to provide names that fit photographs, indicating when a name gets stuck on the tip of their tongue , During the 60-75 minute experimental session | null | null | University of Colorado, Colorado Springs | null | ALL | ADULT, OLDER_ADULT | null | 102 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE | 2023-023 | 2022-10-01 | 2023-03-23 | 2023-03-30 | 2022-09-22 | null | 2023-04-04 | UCCS, Colorado Springs, Colorado, 80918, United States | null | {
"Mental Exercise": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT01930279 | Effect of Partial Sleep Deprivation on Immunological System in Peripheral Blood | https://clinicaltrials.gov/study/NCT01930279 | null | UNKNOWN | Sleep deprivation was found to affect many organs including the immune system and predisposing for various health consequences including diabetes hypertension infections and increase in neoplastic diseases.
Subjects will be evaluated for immune parameters in peripheral blood test following a regular nigh sleep and compared with a test performed following a night shift in which they slept less than 3 hours.
Each participant will serve as its own control. | NO | Sleep Deprivation | OTHER: Blood withdrawal | surface markers of T cell as assessed by FACS, 6 months|serum cytokine levels, 6 months|immune parameters to be assessed by western including STAT proteins, 6 months | null | null | Hadassah Medical Organization | null | ALL | ADULT | null | 50 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | LDB001 | 2013-09 | 2014-09 | 2014-09 | 2013-08-28 | null | 2013-08-28 | Hadassah Medical Organization, Jerusalem, 91120, Israel | null | {
"Blood withdrawal": [
{
"intervention_type": "OTHER"
}
]
} |
NCT01698879 | Prospective Study of Mylotarg and G-CSF in Acute Myeloid Leukemia Treatment | https://clinicaltrials.gov/study/NCT01698879 | null | COMPLETED | Acute myeloid leukemia (AML) is a neoplasm of immature hematopoietic cells (blasts) with altered ripening capacity. Due to excessive proliferation, the blasts displace normal hematopoietic cells and bone marrow failure appears. Leukemic cells also infiltrate extramedullary tissues.
Following the standard chemotherapy treatment, the CR rate achieved is around 65-75% for all patients and 15% lower when considering only patients over 65 years. Modifications to the standard regimen consist of replacing the DNR for a cytotoxic one, modifying the dose of ara-C or adding a third drug.
Gemtuzumab ozogamicin (Mylotarg ®) is an immunoconjugate between anti-CD33 antibody and a cytotoxic antitumor antibiotic, calicheamicin. Mylotarg ® antibody specifically binds to CD33, a sialic acid-dependent adhesion protein expressed in over 90% of LMA10. Mylotarg ® selectively transports the cytotoxic agent calicheamicin into leukemic cells and hematopoietic progenitors differentiated from the myelomonocytic line, while respecting the pluripotent hematopoietic stem cells. Calicheamicin is released only after the fixation of the antibody anti-CD33 and its internalization by the cell, after which binds to and damages the DNA.
Mylotarg ® is approved in the U.S. for the treatment of CD33 positive AML in first relapse, for patients older than 60 years non-candidates for other intensive treatment modalities.
Since the efficacy of Mylotarg ® is equivalent and its toxicity profile less than the conventional therapy, it is logical to conduct a phase II trial exploring the role of Mylotarg ® in the early stages of treatment of AML.
Previous experience with gemtuzumab ozogamicin in relapsed patients led to its use combined with induction chemotherapy. The aim was to improve the CR rate reached with the latter and reduce relapse after achieving greater leukemic cytoreduction.
Recent data from the HOVON group support that the administration of G-CSF before and during induction chemotherapy decreases the incidence of relapse in patients with AML, particularly those considered to have intermediate risk.
Everything mentioned above justifies to investigate the combination of GO combined with chemotherapy with IDR and ara-C in standard 3x7 scheme and analyze the effect of sensitization with G-CSF in patients with AML de novo. If the treatment proposed here is effective and presents an acceptable toxicity it should be investigated. | YES | Novo Acute Myeloid Leukemia | DRUG: Mylotarg | Complete Remission of the Disease, Rate of patients that have obtained complete remission. Complete remission is defined as, bone marrow normocellular or slightly hypocellular with proportion of blasts <5%, including the erythroid cell count (and including promonocytes in case of M5), no Auer rods, no extramedullary leukemia, neutrophils and platelets rising. The persistence of minimal residual disease in immunophenotypic study will not invalidate the standard cytogenetic complete remission., 28 days after chemotherapy | Secondary Toxicity to Mylotarg(R), Hematological toxicity, hepatic and gastrointestinal toxicity, fever and infections, pulmonary complications, duration of hospitalization, Baseline, weekly during treatment and at month 3 and month 6 after first induction.|Mortality at Induction, all deaths occurring after the first administration of MylotargTM until the time of transplantation with no leukemic relapse has occurred, and all deaths in the 6 first months after administration of the second dose of MylotargTM with no leukemic relapse occurred., Weekly during treatment, at third month and at 6 months after last administration of Mylotarg|Capacity to Obtain Hematopoietic Progenitor Cells (HPC) for Autotransplantation - DATA NOT COLLECTED, Rate of patients with capacity to obtain hematopoietic progenitor cells (HPC) for autotransplantation. This analysis has not been performed, because data were not available in sites., One month before transplant, expected at 9 months after end of treatment.|Relapse After 6 Months, Rate of patients that have relapse after 6 months of obtained complete remission., 6 months from complete remission|Survival After 6 Months, rate of patients alive within 6 months of obtained complete remission, 6 months after complete remission | null | Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 46 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | ICOG-07|2007-006295-11 | 2009-10 | 2016-09-14 | 2016-09-26 | 2012-10-03 | 2021-01-27 | 2021-01-27 | Hospital Germans Trias i Pujol, Badalona, Barcelona, 08916, Spain|Hospital de la Santa Creu i Sant Pau, Barcelona, 08025, Spain|Hospital Clinic Barcelona, Barcelona, 08036, Spain|Hospital Clinico Universitario de Salamanca, Salamanca, 37007, Spain|Hospital Universitario Virgen del Rocio, Sevilla, 41013, Spain|Hospital Clínico Universitario de Valencia, Valencia, 496010, Spain | null | {
"Gemtuzumab ozogamicin": [
{
"intervention_type": "DRUG",
"description": "Mylotarg",
"name": "Gemtuzumab ozogamicin",
"synonyms": [
"Gemtuzumab ozogamicin",
"Mylotarg",
"Gemtuzumab Ozogamicin",
"Mylotarg",
"Gemtuzumab Ozogamicin",
"Mylotarg",
"Gemtuzumab Ozogamicin",
"Mylotarg"
],
"drugbank_id": "DB00056",
"generic_names": [
"Gemtuzumab ozogamicin",
"Gemtuzumab Ozogamicin",
"Gemtuzumab Ozogamicin",
"Gemtuzumab Ozogamicin"
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Gemtuzumab%20ozogamicin"
}
]
} |
NCT02885779 | Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study. | https://clinicaltrials.gov/study/NCT02885779 | ANTATROC | COMPLETED | The advantages of the celioscopy mini--trocar and monotrocar technical are recognized.
There is however no forward-looking or retrospective study comparing the microcomputed-celioscopy (use of microphone) - trocar of 3mm of diameter in access celioscopic pluri--trocar) in the celioscopy monotrocar ( a single intra-umbilical section) in gynecological surgery.
The objective of this preliminary study is to compare both surgical care in terms of morbidity died operating, in adnexa surgeries. | NO | Gynecologic Surgical Procedures for Adnexa Surgery in Ovarian Disease | null | Immediate post operative pains, consumption of analgesic for pains in immediate operating comment, Up to 1 month|Court term post operative pains, consumption of analgesic for pains, Up to 2 month|Medium term post operative pains, consumption of analgesic for pains, Up to 3 month | Complications per operating, Blood loss, During surgery|Complications per operating, Addition of trocar, During surgery|Complications post operating, Duration of hospitalization, Up to 1 month | null | Institut Paoli-Calmettes | null | FEMALE | ADULT, OLDER_ADULT | null | 16 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | ANTATROC-IPC 2015-011 | 2015-05 | 2015-09 | 2015-09 | 2016-09-01 | null | 2016-09-01 | Institut Paoli-Calmettes, Marseille, Bouches-du-Rhône, 13273, France | null | {} |
NCT03865979 | AI ENRICH - AI Detection of ICH | https://clinicaltrials.gov/study/NCT03865979 | null | UNKNOWN | To evaluate the performance of the Viz RECRUIT software in subjects identified as symptomatic of a stroke event as determined by standard of care imaging assessments and interpretation. | NO | Intracerebral Hemorrhage | DEVICE: Viz RECRUIT | Performance, Rate of concordance of Viz RECRUIT software identification of ICH via Head CT images and standard of care radiologist identification of ICH., Enrollment | null | null | Viz.ai, Inc. | Nico Corporation | ALL | ADULT, OLDER_ADULT | null | 5,000 | INDUSTRY | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH | VIZ-ICH-01 | 2020-01-23 | 2022-12 | 2022-12 | 2019-03-07 | null | 2022-04-27 | UAMS Medical Center, Little Rock, Arkansas, 72205, United States|Northshore University Health System, Evanston, Illinois, 60201, United States|Cooper University Hospital, Camden, New Jersey, 08103, United States|Montefiore Medical Center, Bronx, New York, 10467, United States|SUNY Buffalo, Buffalo, New York, 14203, United States|Geisinger Medical Center, Danville, Pennsylvania, 17822, United States | null | {
"Viz RECRUIT": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT05154279 | The Effect of Intramyometrial Injection of Terlipressin Versus Intramyometrial Injection of Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations | https://clinicaltrials.gov/study/NCT05154279 | null | RECRUITING | Our study aims to evaluate the efficacy of intramyometrial injection of Terlipressin versus intramyometrial injection of Carbetocin on hemoglobin level in women undergoing abdominal myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time and to describe the injection sequelae for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements. | NO | Laparoscopic Myomectomy | DRUG: Terlipressin | effect of intramyometrial terlipressin vs carbitocin vs saline on decreasing blood loss in laparoscopic myomectomy, 1- To evaluate the efficacy of intramyometrial injection of Terlipressin versus intramyometrial injection of Carbetocin in decreasing blood loss in women undergoing laparoscopic myomectomy, 12 hours | effect of intramyometrial terlipressin vs carbitocin vs saline on decrease hemoglobin level in laparoscopic myomectomy, To evaluate the efficacy of intramyometrial injection of Terlipressin versus intramyometrial injection of Carbetocin on hemoglobin level in women undergoing laparoscopic myomectomy, 24 hours|effect of intramyometrial terlipressin vs carbitocin vs saline on operative time, 2. To evaluate the efficacy of intramyometrial injection of Terlipressin versus intramyometrial injection of Carbetocin on operative time in women undergoing laparoscopic myomectomy, 12 hours | null | Wael Elbanna Clinic | null | FEMALE | CHILD, ADULT | null | 99 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | Elbanna_005 | 2022-02-27 | 2024-12-30 | 2026-03-30 | 2021-12-13 | null | 2024-06-25 | National Research center, Cairo, Egypt|Wael El Banna Clinic, Maadi, Egypt | null | {
"Terlipressin": [
{
"intervention_type": "DRUG",
"description": "Terlipressin",
"name": "Terlipressin",
"synonyms": [
"Triglycyl Lysine Vasopressin",
"tri-Gly-8-Lys- Vasopressin",
"Glipressin",
"Vasopressin, tri-Gly-8-Lys-",
"Gly Gly Gly 8 Lys vasopressin",
"Terlipressin",
"Terlipresina",
"Terlipressina",
"Terlipressine",
"N-(alpha)-glycyl-glycyl-glycyl-8-lysine vasopressin",
"Glycylpressin",
"Triglycyl-(8-lysine)vasopressin",
"Gly-Gly-Gly-8-Lys-vasopressin",
"Triglycylvasopressin",
"Terlypressin",
"Glypressin",
"TGLVP",
"Terlipressinum",
"Remestyp"
],
"mesh_id": "D014662",
"generic_names": [
"Terlipressin"
],
"drugbank_id": "DB02638"
}
]
} |
NCT01408979 | Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia | https://clinicaltrials.gov/study/NCT01408979 | MgSO4 | COMPLETED | Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal duration of this treatment after delivery is still to be established. The hypothesis is that in stable patients a shorter course of treatment is possible without prejudice to the mother. | NO | Severe Preeclampsia | DRUG: Magnesium sulfate 12 hours|DRUG: Magnesium sulfate 24 hours | Need to continue therapy for another 12 hours., Defined as the need to continue therapy for another 12 hours, this will occur when after the first 12 hours of magnesium sulfate therapy the patient has severe hypertension, unsatisfactory diureses or has signs or symptoms of iminent eclampsia., 24 hours | Satisfaction, Patients satisfaction with the duration of therapy, 24 hours | null | Instituto Materno Infantil Prof. Fernando Figueira | null | FEMALE | CHILD, ADULT | PHASE4 | 120 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | MgSO4 | 2011-08 | 2011-12 | 2012-02 | 2011-08-03 | null | 2012-08-22 | IMIP, Recife, Pernambuco, 50.000, Brazil | null | {
"Sulfate ion": [
{
"intervention_type": "DRUG",
"description": "Magnesium sulfate 12 hours",
"name": "Sulfate ion",
"synonyms": [
"Sulfate dianion",
"Sulfate(2-)",
"Sulfate",
"Sulfate ion",
"Sulfuric acid ion(2-)"
],
"drugbank_id": "DB14546",
"generic_names": [
"Sulfate ion"
]
},
{
"intervention_type": "DRUG",
"description": "Magnesium sulfate 24 hours",
"name": "Sulfate ion",
"synonyms": [
"Sulfate dianion",
"Sulfate(2-)",
"Sulfate",
"Sulfate ion",
"Sulfuric acid ion(2-)"
],
"drugbank_id": "DB14546",
"generic_names": [
"Sulfate ion"
]
}
]
} |
NCT00567879 | A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer (MBC) Whose Disease Has Progressed on or After Trastuzumab | https://clinicaltrials.gov/study/NCT00567879 | null | TERMINATED | The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer | YES | Breast Cancer | DRUG: Panobinostat|DRUG: Trastuzumab | Number of Participants With Dose Limiting Toxicities (DLTs), Safety data was reviewed to determine the DLTs. DLTs comprised adverse events (AEs) or abnormal laboratory values that occurred at any time and were assessed as clinically relevant and meeting any of the following criteria: considered to be related to the study treatment and unrelated to disease, disease progression, inter-current illness, or concomitant medications. Toxicities were assessed using the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE), version 3.0. Disease related symptoms were not considered a DLT., day 21 | Number of Participants With Best Overall Response, Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST). Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm., day 21 | null | Novartis Pharmaceuticals | null | FEMALE | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 56 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | CLBH589C2204|2007-002449-19 | 2008-04 | 2011-05 | 2011-05 | 2007-12-05 | 2016-05-09 | 2016-05-09 | University of California at Los Angeles, Los Angeles, California, 90095, United States|University of Colorado Dept. of Univ. of Colorado, Aurora, Colorado, 80045, United States|Norwalk Hospital Dept of Norwalk Hospital (2), Norwalk, Connecticut, 06856, United States|VA Maryland Health Care Dept.of GreenbaumCancerCent(3), Baltimore, Maryland, 21201, United States|The Center for Cancer Care and Research, St. Louis, Missouri, 63141, United States|Ohio State Comprehensive Cancer Center/James Cancer Hospital SC, Columbus, Ohio, 43210, United States|University of Pittsburgh Cancer Institute Dept of Magee Womens Hospital, Pittsburgh, Pennsylvania, 15232, United States|Novartis Investigative Site, Kelowna, British Columbia, V1Y 5L3, Canada|Novartis Investigative Site, Toronto, Ontario, M5G 2M9, Canada|Novartis Investigative Site, Montreal, Quebec, H3T 1E2, Canada|Novartis Investigative Site, Dijon Cedex, 21034, France|Novartis Investigative Site, Paris, 75231, France|Novartis Investigative Site, Saint-Herblain Cédex, 44805, France|Novartis Investigative Site, Heidelberg, 69115, Germany|Novartis Investigative Site, Meldola, FC, 47014, Italy|Novartis Investigative Site, Genova, GE, 16132, Italy|Novartis Investigative Site, Modena, MO, 41100, Italy|Novartis Investigative Site, Birmingham, B15 2TH, United Kingdom|Novartis Investigative Site, London, W12 0HS, United Kingdom|Novartis Investigative Site, Manchester, M20 4BX, United Kingdom | null | {
"Panobinostat": [
{
"intervention_type": "DRUG",
"description": "Panobinostat",
"name": "Panobinostat",
"synonyms": [
"LBH 589",
"LBH589",
"2-PROPENAMIDE, N-HYDROXY-3-(4-(((2-(2-METHYL-1H-INDOL-3-YL)ETHYL)AMINO)METHYL)PHENYL)-, (2E)-",
"Panobinostatum",
"NVP-LBH589",
"hydroxypropyl-B-cyclodextrin-panobinostat complex",
"Farydak",
"Panobinostat",
"(2E)-N-hydroxy-3-[4-({[2-(2-methyl-1H-indol-3-yl)ethyl]amino}methyl)phenyl]acrylamide",
"NVP LBH589"
],
"medline_plus_id": "a615020",
"generic_names": [
"Panobinostat"
],
"mesh_id": "D056572",
"drugbank_id": "DB06603"
}
],
"Trastuzumab": [
{
"intervention_type": "DRUG",
"description": "Trastuzumab",
"name": "Trastuzumab",
"synonyms": [
"Trastuzumab qyyp",
"trastuzumab-pkrb",
"- OtherHerzuma",
"Trastuzumab-qyyp",
"Trastuzumab beta",
"RHUMAB HER2",
"Trastuzumab",
"trastuzumab-dttb",
"Herzuma",
"trastuzumab-anns",
"Herceptin",
"Ontruzant",
"beta, Trastuzumab",
"trastuzumab-qyyp",
"Kanjinti",
"Zercepac",
"Trazimera",
"Ogivri",
"trastuzumab-dkst"
],
"medline_plus_id": "a699019",
"generic_names": [
"Trastuzumab"
],
"nhs_url": "https://www.nhs.uk/medicines/trastuzumab-herceptin",
"mesh_id": "D000074322",
"drugbank_id": "DB00072",
"wikipedia_url": "https://en.wikipedia.org/wiki/Trastuzumab"
}
]
} |
NCT04660279 | Dynamic FDG PET/CT: Optimization and Validation of Data Acquisition | https://clinicaltrials.gov/study/NCT04660279 | VALIDATE | COMPLETED | Quantification of the metabolic rate of glucose from Dynamic Whole-Body PET examinations requires measurements of the time course of the radioactivity concentrations in arterial blood by blood sampling, and in the tissue of interest by dynamic PET. Invasive arterial blood sampling cannot be part of a standard examination, and therefore the blood samples need to be replaced by activity concentrations derived from the PET images, usually from small volumes in the descending aorta or left ventricle.
Newly developed scanner software (Siemens) allows automated CT-based identification of blood pool regions and extraction of an image-derived blood input function from the corresponding PET data.
However, this automated method needs validation, as it could be prone to systematic errors caused by limited spatial resolution, patient movement, and image reconstruction. We will use invasively measured arterial blood samples as a reference for validation of methods to extract non-invasive PET image-derived input functions and quantify any systematic errors that could propagate to the resulting parametric images. | NO | Positron-Emission Tomography | DIAGNOSTIC_TEST: Dynamic Whole-Body parametric PET/CT | Validation of current parametric reconstruction protocol, We will perform a correlation of the image derived input function and the input function obtained from blood sampling. This will allow us to confirm that the information obtained by the equipment is accurate enough and can be trusted., through study completion, an average of 1 year|Time reduction of current parametric reconstruction protocol, After we have validated the image derived input function we will use the data we sampled to construct a normal population input function that can be applied to the current protocol. This way we will be able to skip the acquisition on the camera of the input function and be able to only scan the patients at a later period, therefor shortening the acquisition protocol to something more manageable in daily clinic., through study completion, an average of 1 year | null | null | Aarhus University Hospital | null | ALL | ADULT, OLDER_ADULT | null | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | AarhusUH | 2020-01-01 | 2021-12-31 | 2021-12-31 | 2020-12-09 | null | 2022-02-22 | Aarhus University Hospital, Aarhus, Denmark | null | {
"Dynamic Whole-Body parametric PET/CT": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
]
} |
NCT00766779 | HCT Versus CT in Elderly AML | https://clinicaltrials.gov/study/NCT00766779 | null | TERMINATED | A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission. | NO | Acute Myeloid Leukemia | PROCEDURE: hematopoietic cell transplantation|DRUG: Non-Transplant treatment approach for consolidation | To evaluate Leukaemia Free Survival (LFS) after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy, 5 years | To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT, 5 Years | null | European Society for Blood and Marrow Transplantation | Acute Leukemia French Association|Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias|European Organisation for Research and Treatment of Cancer - EORTC|French Innovative Leukemia Organisation|HOVON - Dutch Haemato-Oncology Association|East German Study Group of Hematology and Oncology (OSHO)|Swiss Group for Clinical Cancer Research | ALL | ADULT, OLDER_ADULT | PHASE3 | 126 | NETWORK | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 2007-003514-34|EBMT-ALWP01/2008 | 2010-01 | 2020-12 | 2020-12 | 2008-10-06 | null | 2021-10-14 | The Alfred Hospital, Melbourne Victoria, Australia|Hanusch Krankenhaus der Wiener Gebietskrankenkasse, Wien, Austria|Medizinische Universität Wien, Wien, Austria|ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen, Antwerpen, Belgium|UZ Gasthuisberg Leuven, Leuven, Belgium|Centre Hospitalier Sud Amiens, Amiens cedex 1, France|Hopital Femme Enfant Hématologie, Caen Cedex 9, France|Hôpital dinstruction des armées Percy, Clamart, France|Centre hospitalier et universitaire (CHU) d´ Estaing, Clermont-Ferrand, France|Centre hospitalier et universitaire (CHU) de Limoges, Limoges cedex, France|Institut Paoli-Calmettes, Marseille cedex 9, France|CHU de Nantes, Hôtel Dieu, Nantes cedex 01, France|Centre Antoine Lacassagne, Nice cedex 2, France|Centre hospitalier et universitaire (CHU) de Nice, Nice, France|Hopital Saint Antoine, Paris 12ème, France|CHU du Haut Lévêque, Pessac, France|Centre Hospitalier (CH) Saint Quentin, Saint Quentin cedex, France|University Aachen, Aachen, Germany|II. Medizinische Klinik, Hämatologie/Internistische Onkologie, Augsburg, Germany|Charité - Campus Benjamin Franklin, Berlin, Germany|Klinikum Chemnitz gGmbH, Chemnitz, Germany|Universitaetsklinikum Dresden, Dresden, Germany|Klinik für Innere Medizin C, Greifswald, Germany|University of Heidelberg, Heidelberg, Germany|Friedrich-Schiller-Universität Jena, Jena, Germany|University Hospital, Leipzig, 04103, Germany|Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität, Magdeburg, Germany|University of Münster, Münster, Germany|Klinikum Ernst von Bergmann gGmbH, Potsdam, Germany|University Regensburg, Regensburg, Germany|Universität Rostock, Rostock, Germany|Robert-Bosch-Krankenhaus, Stuttgart, Germany|Universität Tübingen, Tübingen, Germany|Allogeneic Stem Cell Transplant Cente, Würzburg, Germany|Academisch Ziekenhuis bij de Universiteit Amsterdam, Amsterdam, Netherlands|VU University Medical Center Amsterdam, Amsterdam, Netherlands|University Medical Centre Groningen, Groningen, Netherlands|University Hospital Maastricht, Maastricht, Netherlands|Erasmus MC-Daniel den Hoed Cancer Centre, Rotterdam, 3008, Netherlands|University Medical Centre Utrecht, Utrecht, Netherlands|Isala klinieken, Zwolle, Netherlands|Kantonsspital Aarau, Aarau, Switzerland|University Hospital, Basel, 4031, Switzerland|Inselspital Bern, Bern, Switzerland|Hopitaux Universitaires de Geneve, Geneve, 1211, Switzerland|CHUV Lausanne, Lausanne, Switzerland|Kantonsspital Luzern, Luzern 16, Switzerland|University Hospital Zürich, Zürich, Switzerland | null | {
"hematopoietic cell transplantation": [
{
"intervention_type": "PROCEDURE"
}
],
"Non-Transplant treatment approach for consolidation": [
{
"intervention_type": "DRUG"
}
]
} |
NCT00987779 | Bioequivalence Study Of Gabapentin Between Tablet And Liquid Formulation And The Food Effect Study Of Liquid Formulation | https://clinicaltrials.gov/study/NCT00987779 | null | COMPLETED | Primary objective for this study is to demonstrate bioequivalence between Japanese commercial tablet and Japanese commercial image liquid formulation. Secondary objective for this study is to estimate the food effect for Japanese commercial image liquid formulation. | NO | Healthy | DRUG: Gabapentin|DRUG: Gabapentin | Pharmacokinetic (PK) Endpoints - Primary: plasma Cmax and AUCt of gabapentin. - Secondary: plasma AUCinf, AUClast, Tmax, kel, MRT and t1/2 of gabapentin, dosing to 3 days | Safety Endpoints - Adverse events and safety laboratory data, dosing to 3 days | null | Pfizers Upjohn has merged with Mylan to form Viatris Inc. | null | ALL | ADULT | PHASE1 | 26 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT | A9451168 | 2009-10 | 2009-10 | 2009-10 | 2009-10-01 | null | 2021-02-02 | Pfizer Investigational Site, Singapore, 188770, Singapore | null | {
"Gabapentin": [
{
"intervention_type": "DRUG",
"description": "Gabapentin",
"name": "Gabapentin",
"synonyms": [
"Gabapentina",
"Gabapentin",
"Gabapentinum",
"Gabapentino",
"Gabapentine",
"Gralise",
"Neurontin",
"1-(Aminomethyl)cyclohexaneacetic acid"
],
"medline_plus_id": "a694007",
"generic_names": [
"Gabapentin"
],
"nhs_url": "https://www.nhs.uk/medicines/gabapentin",
"drugbank_id": "DB00996",
"wikipedia_url": "https://en.wikipedia.org/wiki/Gabapentin"
},
{
"intervention_type": "DRUG",
"description": "Gabapentin",
"name": "Gabapentin",
"synonyms": [
"Gabapentina",
"Gabapentin",
"Gabapentinum",
"Gabapentino",
"Gabapentine",
"Gralise",
"Neurontin",
"1-(Aminomethyl)cyclohexaneacetic acid"
],
"medline_plus_id": "a694007",
"generic_names": [
"Gabapentin"
],
"nhs_url": "https://www.nhs.uk/medicines/gabapentin",
"drugbank_id": "DB00996",
"wikipedia_url": "https://en.wikipedia.org/wiki/Gabapentin"
}
]
} |
NCT01632579 | A Single Dose Study of LY3023703 in Healthy Participants | https://clinicaltrials.gov/study/NCT01632579 | null | COMPLETED | This is a phase I study of LY3023703 in healthy participants. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Participants will remain in the study for approximately 3 months. This study is for research purposes only and is not intended to treat any medical condition. | YES | Healthy Volunteers | DRUG: LY3023703|DRUG: Placebo|DRUG: Celecoxib | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AE, AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible study drug relatedness, is located in the Reported Adverse Events module., Baseline up to Day 7 post-dose | Pharmacokinetics: Maximum Concentration (Cmax) of LY3023703, Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 8 and 12 hours, post-dose|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3023703, Area under the concentration time curve from the time of dosing to the time of the last observation., Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 8 and 12 hours, post-dose|Pharmacodynamics: Percent Change From Baseline of ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation, Percent change from baseline of PGE synthesis=(postdose PGE synthesis-baseline PGE synthesis)/baseline PGE synthesis*100, where the unit of measure for PGE synthesis is nanograms per milliliter (ng/ml)., Baseline, 0.5 hours (h), 1 h, 2 h, 8 h, 24 h, and 144 h post-dose|Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM), Urinary excretion of PGEM, after correcting for urinary creatinine. PGEM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of PGEM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100., Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, 6 to 12 h, and 12 to 24 hours post-dose|Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostacyclin Metabolite (PGIM), Urinary excretion of PGIM, after correcting for urinary creatinine. PGIM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of PGIM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100., Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, and 6 to 12 h post-dose|Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Thromboxane A Metabolite (TXAM), Urinary excretion of TXAM, after correcting for urinary creatinine. TXAM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of TXAM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100., Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, and 6 to 12 h post-dose | null | Eli Lilly and Company | null | ALL | ADULT | PHASE1 | 30 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE | 14707|I6H-MC-MCBA | 2012-06 | 2012-09 | 2012-09 | 2012-07-03 | 2018-08-06 | 2018-08-06 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Evansville, Indiana, United States | null | {
"LY3023703": [
{
"intervention_type": "DRUG"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
],
"Celecoxib": [
{
"intervention_type": "DRUG",
"description": "Celecoxib",
"name": "Celecoxib",
"synonyms": [
"SC-58635",
"p-(5-p-Tolyl-3-(trifluoromethyl)pyrazol-1-yl)benzenesulfonamide",
"Celecoxib",
"SC 58635",
"Onsenal",
"SC58635",
"Elyxyb",
"Celecoxibum",
"Celebrex",
"4-(5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide",
"C\u00e9l\u00e9coxib"
],
"medline_plus_id": "a699022",
"generic_names": [
"Celecoxib"
],
"mesh_id": "D052246",
"drugbank_id": "DB00482",
"wikipedia_url": "https://en.wikipedia.org/wiki/Celecoxib"
}
]
} |
NCT06263179 | Feasibility of Aerobic Exercise for Recovery From Work-related Concussion | https://clinicaltrials.gov/study/NCT06263179 | null | NOT_YET_RECRUITING | There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion. | NO | Concussion, Brain | BEHAVIORAL: Target Heartrate Aerobic Exercise | Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting the number and duration of exercise sessions completed., Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting exercise sessions completed., Up to 6 weeks | Change in post-concussive symptom burden as measured by the Post-Concussion Symptom Scale, The Post-Concussion Symptom Scale (PCSS) is a validated 22-item self-report symptom questionnaire. Scores range from 0-132 with greater scores indicating increased symptom burden., Baseline, week 1, week 2, week 3, week 4, week 5, week 6|Change in Patient Health Questionnaire-9 (PHQ-9), The Patient Health Questionnaire-9 (PHQ-9) is used for rating the severity of depression among participants. Scores range from 0-27. Higher scores indicate increased severity of depression., Baseline, up to week 6|Change in Generalized Anxiety Disorder-7 (GAD-7), The Generalized Anxiety Disorder-7 (GAD-7) is used to measure the severity of anxiety among participants. Scores range from 0-21. Higher scores indicate increased severity of anxiety., Baseline, up to week 6|Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5), The Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5) is used to measure probable PTSD among participants. Scores range from 0-5. Higher scores indicate increased probability of PTSD., Baseline|Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10), The Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10) is used to measure general healthcare-related quality of life, including global physical health and global mental health. Both global physical health and global mental health have raw scores ranging from 4-20. Higher scores reflect higher participant ratings for global physical and mental health. This measure will be used to assess change in global physical and mental health between the initial and final visits., Baseline, up to week 6|Work Climate Questionnaire - 6-Item Version, The Work Climate Questionnaire - 6-Item Version is used for assessing participants perceptions regarding the degree of autonomy supportiveness of their work managers or employers. Scores range of 6-42. Higher scores indicate a greater degree of perceived autonomy supportiveness., Baseline|Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS), The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS) is used to assess participant satisfaction or frustration with the psychological needs for autonomy, competence, and relatedness. The scale involves 6 subscales, including autonomy satisfaction, autonomy frustration, relatedness satisfaction, relatedness frustration, competence satisfaction, and competence frustration. Each subscale has scores ranging from 4-20. Higher scores indicate higher participant perceptions of the psychological need satisfaction or frustration reflected in the subscale. This measure will be used to assess change in psychological needs satisfaction and psychological needs frustration between the initial and final visits., Baseline, up to week 6|Time to return to work measured in days, Time to return to work as measured by difference between date of injury and date the participant is medically cleared to return to work, Up to week 6 | Rate of adverse Events as assessed by questioning the participant, At each weekly follow-up meeting participants will be asked about any adverse events including injuries or other negative events., Up to week 6 | State University of New York at Buffalo | National Center for Advancing Translational Sciences (NCATS) | ALL | ADULT | null | 40 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | STUDY00007706|UL1TR001412 | 2024-06-21 | 2024-10-14 | 2024-12-30 | 2024-02-16 | null | 2024-06-10 | null | Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/79/NCT06263179/ICF_000.pdf | {
"Target Heartrate Aerobic Exercise": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
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