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NCT03858595
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Optimizing Gestational Weight Gain, Birth Weight and Other Perinatal Outcomes Among Pregnant Women at Risk of Hypertension in Pregnancy by Regular Monitoring of Weight Gain and Blood Pressure: A Pilot Randomized Controlled Trial
Brief Summary: Background:
1. Burden: Hypertensive disorders of pregnancy, including preeclampsia, complicate up to 10% of pregnancies worldwide, constituting one of the greatest causes of fetal growth restriction, preterm birth, low birth weight, perinatal mortality, and maternal morbidity and mortality. In Bangladesh, 24% of all maternal deaths are directly attributed to hypertensive causes. Conventional antenatal care practice often delays in or misses diagnosing hypertension in pregnancy, which makes the women vulnerable to its adverse consequences.
2. Knowledge gap: Although there are randomised controlled trials (RCT) of efforts directed at preventing development of hypertension in pregnancy or reducing its complications, there have been no published RCTs of the intervention focusing on regular monitoring of weight gain and blood pressure among pregnant women who are at risk of developing hypertension in pregnancy or its complications to ensure early diagnosis, and thereby optimizing the perinatal outcomes through prompt referral and management.
3. Relevance: To undertake an RCT of intervention to optimize adverse consequences in hypertension in pregnancy raises important practical concerns including: commitment of the enrolled women, the need to make a decision regarding participation due to longer duration of intervention and adherence to protocol. Investigators aim to perform this study to address whether an RCT of the intervention in individual patients is an appropriate trial design, and is feasible.
Objectives:
1. To evaluate the accuracy of Salu Health Gauge device in measuring blood pressure.
2. To test the design, feasibility, acceptability and fidelity of a future definitive randomized controlled trial focusing on regular monitoring of weight gain and continuous self-monitoring of blood pressure among pregnant women who are at risk of developing hypertension in pregnancy.
Methods:
The study will be completed in two steps: 1) the validation of Salu Health Gauge and 2) the pilot trial. The study will be conducted in Matlab, Bangladesh. Salu Health Gauge device will be validated according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP revision 2010) in general adult population (including men and non-pregnant women) as well as in specific groups such as adolescents and pregnant women. The pilot trial is designed as a prospective, two-arm, parallel, and open-label randomized controlled external pilot trial. Eligible participants (pregnant women at risk of developing hypertension in pregnancy) will be individually randomized 1:1 to the intervention arm who will use a wearable device (Salu Health Gauge) from 20 weeks of gestation up to termination of pregnancy alongside conventional antenatal and postnatal care or the control arm who will receive conventional antenatal and postnatal care only. In Matlab, a woman is diagnosed as pregnant by HDSS field staff by 12-16 weeks of gestation and is enlisted. The investigators will obtain this list from HDSS and conduct baseline interviews to identify pregnant women at risk of developing hypertension in pregnancy.
Outcome measures/variables:
1. Feasibility outcomes: Recruitment rate, Retention rate, compliance, Acceptability etc.
2. Clinical outcomes: gestational weight gain, birth weight, adverse consequence of hypertension in pregnancy (episodes or occurrence and when), blood pressure profile of high-risk pregnancies, prevalence of specific risk factors for hypertension in pregnancy
3. Serious adverse events
|
{
"A": "Arm Label: Mercury; Type: NO_INTERVENTION; Interventions: Device: Automated blood pressure recording device Omron HEM 705CP | Intervention Type: DEVICE; Name: Automated blood pressure recording device Omron HEM 705CP; Assigned to Arm(s): Mercury",
"B": "Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: remote monitoring group; Type: EXPERIMENTAL; Interventions: Device: remote monitoring | Intervention Type: DEVICE; Name: remote monitoring; Assigned to Arm(s): remote monitoring group",
"C": "Arm Label: AH Telemonitoring; Type: EXPERIMENTAL; Interventions: Device: Self measurement of blood pressure | Intervention Type: DEVICE; Name: Self measurement of blood pressure; Assigned to Arm(s): AH Telemonitoring",
"D": "Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Device: Self monitoring of blood pressure using Health Gauge Device and monthly monitoring of weight gain | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Self monitoring of blood pressure using Health Gauge Device and monthly monitoring of weight gain; Assigned to Arm(s): Intervention"
}
|
D
|
[
"NCT00809666",
"NCT03509272",
"NCT03648645",
"NCT03858595"
] | 27,100 |
val
|
NCT03858790
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Spinal Cord Stimulation System in the Treatment of Chronic Pain
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of spinal cord stimulation (SCS) using the PINS spinal cord stimulator device for chronic and intractable pain.
|
{
"A": "Arm Label: Burst spinal cord stimulation (SCS); Type: EXPERIMENTAL; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Arm Label: sham spinal cord stimulation (SCS); Type: SHAM_COMPARATOR; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Intervention Type: PROCEDURE; Name: Burst Spinal Cord Stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS) | Intervention Type: PROCEDURE; Name: Sham spinal cord stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS)",
"B": "Arm Label: Experimental; Type: EXPERIMENTAL; Interventions: Device: PINS Spinal Cord Stimulator | Arm Label: Control; Type: SHAM_COMPARATOR; Interventions: Device: PINS Spinal Cord Stimulator | Intervention Type: DEVICE; Name: PINS Spinal Cord Stimulator; Assigned to Arm(s): Control, Experimental",
"C": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Arm Label: Pregabalin 300 mg/day; Type: EXPERIMENTAL; Interventions: Drug: pregabalin | Arm Label: Pregabalin 600 mg/day; Type: EXPERIMENTAL; Interventions: Drug: pregabalin | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: pregabalin; Assigned to Arm(s): Pregabalin 300 mg/day | Intervention Type: DRUG; Name: pregabalin; Assigned to Arm(s): Pregabalin 600 mg/day",
"D": "Arm Label: EES on; Type: EXPERIMENTAL; Interventions: Device: EES on | Arm Label: EES off; Type: PLACEBO_COMPARATOR; Interventions: Device: EES off | Intervention Type: DEVICE; Name: EES on; Assigned to Arm(s): EES on | Intervention Type: DEVICE; Name: EES off; Assigned to Arm(s): EES off"
}
|
B
|
[
"NCT04039633",
"NCT03858790",
"NCT00553475",
"NCT04894734"
] | 27,101 |
val
|
NCT03858790
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Spinal Cord Stimulation System in the Treatment of Chronic Pain
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of spinal cord stimulation (SCS) using the PINS spinal cord stimulator device for chronic and intractable pain.
|
{
"A": "Arm Label: Experimental; Type: EXPERIMENTAL; Interventions: Device: PINS Spinal Cord Stimulator | Arm Label: Control; Type: SHAM_COMPARATOR; Interventions: Device: PINS Spinal Cord Stimulator | Intervention Type: DEVICE; Name: PINS Spinal Cord Stimulator; Assigned to Arm(s): Control, Experimental",
"B": "Arm Label: Sham; Type: SHAM_COMPARATOR; Interventions: Device: Sham | Arm Label: 1200 Hz; Type: EXPERIMENTAL; Interventions: Device: 1200 Hz | Arm Label: 3030 Hz; Type: EXPERIMENTAL; Interventions: Device: 3030 Hz | Arm Label: 5882 Hz; Type: EXPERIMENTAL; Interventions: Device: 5882 Hz | Intervention Type: DEVICE; Name: Sham; Assigned to Arm(s): Sham | Intervention Type: DEVICE; Name: 1200 Hz; Assigned to Arm(s): 1200 Hz | Intervention Type: DEVICE; Name: 3030 Hz; Assigned to Arm(s): 3030 Hz | Intervention Type: DEVICE; Name: 5882 Hz; Assigned to Arm(s): 5882 Hz",
"C": "Intervention Type: DEVICE; Name: Spinal Cord Stimulation; Assigned to Arm(s): N/A",
"D": "Arm Label: Sequence 1; Type: OTHER; Interventions: Device: High frequency spinal cord stimulation | Arm Label: Sequence 2; Type: OTHER; Interventions: Device: High frequency spinal cord stimulation | Intervention Type: DEVICE; Name: High frequency spinal cord stimulation; Assigned to Arm(s): Sequence 1, Sequence 2"
}
|
A
|
[
"NCT03858790",
"NCT01750229",
"NCT00200122",
"NCT01400282"
] | 27,102 |
val
|
NCT03858790
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Spinal Cord Stimulation System in the Treatment of Chronic Pain
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of spinal cord stimulation (SCS) using the PINS spinal cord stimulator device for chronic and intractable pain.
|
{
"A": "Intervention Type: DEVICE; Name: Medtronic Manufactured Spinal Cord Stimulators; Assigned to Arm(s): N/A",
"B": "Arm Label: Burst spinal cord stimulation (SCS); Type: EXPERIMENTAL; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Arm Label: sham spinal cord stimulation (SCS); Type: SHAM_COMPARATOR; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Intervention Type: PROCEDURE; Name: Burst Spinal Cord Stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS) | Intervention Type: PROCEDURE; Name: Sham spinal cord stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS)",
"C": "Arm Label: Monocolumn spinal cord stimulation; Type: ACTIVE_COMPARATOR; Interventions: Device: comparison of spinal cord stimulation | Arm Label: Multicolumn spinal cord stimulation; Type: EXPERIMENTAL; Interventions: Device: comparison of spinal cord stimulation | Intervention Type: DEVICE; Name: comparison of spinal cord stimulation; Assigned to Arm(s): Monocolumn spinal cord stimulation, Multicolumn spinal cord stimulation",
"D": "Arm Label: Experimental; Type: EXPERIMENTAL; Interventions: Device: PINS Spinal Cord Stimulator | Arm Label: Control; Type: SHAM_COMPARATOR; Interventions: Device: PINS Spinal Cord Stimulator | Intervention Type: DEVICE; Name: PINS Spinal Cord Stimulator; Assigned to Arm(s): Control, Experimental"
}
|
D
|
[
"NCT00351208",
"NCT04039633",
"NCT01628237",
"NCT03858790"
] | 27,103 |
val
|
NCT03860116
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Development and Evaluation of a Smart Phone App-based Case Management Model Among ART-naive HIV-infected MSM： A Randomized Controlled Trial
Brief Summary: This is a randomized controlled trial about an app-based case management intervention. The intervention is a comprehensive case management approach consisting of the following aspects: articles delivery, online communication with case managers, supportive service information and hospital visits reminders. The aim of this study is to evaluate the efficacy of the intervention among HIV-positive men who have sex with men compared to standard-of-care service.
|
{
"A": "Arm Label: Arm 1 (\"group\" sessions); Type: EXPERIMENTAL; Interventions: Behavioral: Group sessions | Arm Label: Arm 2 (\"group+home\" sessions); Type: EXPERIMENTAL; Interventions: Behavioral: Group+Home sessions | Arm Label: Arm 3; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Arm B (Booster villages); Type: EXPERIMENTAL; Interventions: Behavioral: Group sessions, Behavioral: Group+Home sessions, Behavioral: Booster sessions | Arm Label: Arm A (Non-booster villages); Type: OTHER; Interventions: Behavioral: Group sessions, Behavioral: Group+Home sessions | Arm Label: Arm X: Fathers invited; Type: EXPERIMENTAL; Interventions: Behavioral: Group sessions, Behavioral: Group+Home sessions, Behavioral: Fathers invited | Arm Label: Arm Y: Fathers not invited; Type: OTHER; Interventions: Behavioral: Group sessions, Behavioral: Group+Home sessions | Intervention Type: BEHAVIORAL; Name: Group sessions; Assigned to Arm(s): Arm 1 (\"group\" sessions), Arm A (Non-booster villages), Arm B (Booster villages), Arm X: Fathers invited, Arm Y: Fathers not invited | Intervention Type: BEHAVIORAL; Name: Group+Home sessions; Assigned to Arm(s): Arm 2 (\"group+home\" sessions), Arm A (Non-booster villages), Arm B (Booster villages), Arm X: Fathers invited, Arm Y: Fathers not invited | Intervention Type: BEHAVIORAL; Name: Booster sessions; Assigned to Arm(s): Arm B (Booster villages) | Intervention Type: BEHAVIORAL; Name: Fathers invited; Assigned to Arm(s): Arm X: Fathers invited",
"B": "Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: APP-based case management service, Behavioral: Standard-of-care followup service | Arm Label: control group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard-of-care followup service | Intervention Type: BEHAVIORAL; Name: APP-based case management service; Assigned to Arm(s): Intervention group | Intervention Type: BEHAVIORAL; Name: Standard-of-care followup service; Assigned to Arm(s): Intervention group, control group",
"C": "Arm Label: Collaborative Stepped Care; Type: EXPERIMENTAL; Interventions: Other: Collaborative Stepped Care Intervention | Arm Label: Enhanced Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Enhanced Usual Care | Intervention Type: OTHER; Name: Collaborative Stepped Care Intervention; Assigned to Arm(s): Collaborative Stepped Care | Intervention Type: OTHER; Name: Enhanced Usual Care; Assigned to Arm(s): Enhanced Usual Care",
"D": "Arm Label: REACH-VN; Type: EXPERIMENTAL; Interventions: Behavioral: REACH-VIETNAM | Arm Label: Enhanced control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: REACH-VIETNAM; Assigned to Arm(s): REACH-VN"
}
|
B
|
[
"NCT03548558",
"NCT03860116",
"NCT00446407",
"NCT03587974"
] | 27,104 |
val
|
NCT03862612
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of Serratus Anterior Plane (SAP) Block Versus Erector Spinae Plane (ESP) Block for Quality of Recovery After Video Assisted Thoracic Surgery : A Randomised Control Trial
Brief Summary: During VATS (Video assisted thoracic surgery) small incisions are made in the patient's chest through which a camera and instruments are inserted to allow a lung operation to be performed. Often patients experience a substantial amount of pain and difficult recovery after this type of operation. Anaesthesiologists sometimes use "Regional Anaesthesia" to minimise the pain and help patient recovery after the operation. This involves injecting local anaesthesia into the nerves around the chest wall to effectively numb that part of the chest. There is a variety of different locations on the chest wall where the local anaesthetic can be deposited and no study has measured whether one technique is better than the other in terms of improving patients' recovery experience. Our study compares two new techniques for Regional Anaesthesia after this type of surgery. Participants will be randomly assigned (like tossing a coin) to receive either a SAP (Serratus Anterior Plane) or ESP (Erector Spinae Plane) Block. Both techniques are described within last five years, but have never been compared for chest surgery
|
{
"A": "Arm Label: Erector Spinae Plane Block; Type: ACTIVE_COMPARATOR; Interventions: Procedure: regional anaesthesia with Levobupivicaine 0.25% 30mls with two methods either erector spinae plane block or serratus anterior plane block | Arm Label: Serratus Anterior Plane Block; Type: EXPERIMENTAL; Interventions: Procedure: regional anaesthesia with Levobupivicaine 0.25% 30mls with two methods either erector spinae plane block or serratus anterior plane block | Intervention Type: PROCEDURE; Name: regional anaesthesia with Levobupivicaine 0.25% 30mls with two methods either erector spinae plane block or serratus anterior plane block; Assigned to Arm(s): Erector Spinae Plane Block, Serratus Anterior Plane Block",
"B": "Arm Label: erector spinae block; Type: EXPERIMENTAL; Interventions: Procedure: erector spinae block | Arm Label: serratus anterior block; Type: EXPERIMENTAL; Interventions: Procedure: serratus plane block | Arm Label: intravenous morphine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Morphine Sulfate | Intervention Type: PROCEDURE; Name: serratus plane block; Assigned to Arm(s): serratus anterior block | Intervention Type: PROCEDURE; Name: erector spinae block; Assigned to Arm(s): erector spinae block | Intervention Type: DRUG; Name: Morphine Sulfate; Assigned to Arm(s): intravenous morphine",
"C": "Arm Label: Erector Spinae Plane Block; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Erector Spinae Plane block, Drug: Bupivacaine Hydrochloride, Device: PCA | Arm Label: Control Group; Type: SHAM_COMPARATOR; Interventions: Procedure: Sham block, Device: PCA | Intervention Type: PROCEDURE; Name: Erector Spinae Plane block; Assigned to Arm(s): Erector Spinae Plane Block | Intervention Type: PROCEDURE; Name: Sham block; Assigned to Arm(s): Control Group | Intervention Type: DRUG; Name: Bupivacaine Hydrochloride; Assigned to Arm(s): Erector Spinae Plane Block | Intervention Type: DEVICE; Name: PCA; Assigned to Arm(s): Control Group, Erector Spinae Plane Block",
"D": "Arm Label: Erector Spinae (single injection); Type: EXPERIMENTAL; Interventions: Drug: Erector Spinae (single injection) | Arm Label: Paravertebral (single injection); Type: ACTIVE_COMPARATOR; Interventions: Drug: Paravertebral (single injection) | Intervention Type: DRUG; Name: Erector Spinae (single injection); Assigned to Arm(s): Erector Spinae (single injection) | Intervention Type: DRUG; Name: Paravertebral (single injection); Assigned to Arm(s): Paravertebral (single injection)"
}
|
A
|
[
"NCT03862612",
"NCT04248608",
"NCT03744689",
"NCT03549234"
] | 27,105 |
val
|
NCT03862612
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of Serratus Anterior Plane (SAP) Block Versus Erector Spinae Plane (ESP) Block for Quality of Recovery After Video Assisted Thoracic Surgery : A Randomised Control Trial
Brief Summary: During VATS (Video assisted thoracic surgery) small incisions are made in the patient's chest through which a camera and instruments are inserted to allow a lung operation to be performed. Often patients experience a substantial amount of pain and difficult recovery after this type of operation. Anaesthesiologists sometimes use "Regional Anaesthesia" to minimise the pain and help patient recovery after the operation. This involves injecting local anaesthesia into the nerves around the chest wall to effectively numb that part of the chest. There is a variety of different locations on the chest wall where the local anaesthetic can be deposited and no study has measured whether one technique is better than the other in terms of improving patients' recovery experience. Our study compares two new techniques for Regional Anaesthesia after this type of surgery. Participants will be randomly assigned (like tossing a coin) to receive either a SAP (Serratus Anterior Plane) or ESP (Erector Spinae Plane) Block. Both techniques are described within last five years, but have never been compared for chest surgery
|
{
"A": "Arm Label: ESP group; Type: ACTIVE_COMPARATOR; Interventions: Device: Intravenous morphine patient controlled device, Other: Erector Spinae Plane Block | Arm Label: TPVB group; Type: ACTIVE_COMPARATOR; Interventions: Device: Intravenous morphine patient controlled device, Other: Thoracic Paravertebral Block | Arm Label: Control Group; Type: OTHER; Interventions: Device: Intravenous morphine patient controlled device | Intervention Type: DEVICE; Name: Intravenous morphine patient controlled device; Assigned to Arm(s): Control Group, ESP group, TPVB group | Intervention Type: OTHER; Name: Erector Spinae Plane Block; Assigned to Arm(s): ESP group | Intervention Type: OTHER; Name: Thoracic Paravertebral Block; Assigned to Arm(s): TPVB group",
"B": "Arm Label: Erector Spinae Plane Block; Type: ACTIVE_COMPARATOR; Interventions: Procedure: regional anaesthesia with Levobupivicaine 0.25% 30mls with two methods either erector spinae plane block or serratus anterior plane block | Arm Label: Serratus Anterior Plane Block; Type: EXPERIMENTAL; Interventions: Procedure: regional anaesthesia with Levobupivicaine 0.25% 30mls with two methods either erector spinae plane block or serratus anterior plane block | Intervention Type: PROCEDURE; Name: regional anaesthesia with Levobupivicaine 0.25% 30mls with two methods either erector spinae plane block or serratus anterior plane block; Assigned to Arm(s): Erector Spinae Plane Block, Serratus Anterior Plane Block",
"C": "Arm Label: Patients; Type: N/A; Interventions: N/A",
"D": "Arm Label: Erector Spinae Plane Block; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Erector Spinae Plane Block - Ultrasound guided | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Erector Spinae Plane Block - Ultrasound guided; Assigned to Arm(s): Erector Spinae Plane Block"
}
|
B
|
[
"NCT03480958",
"NCT03862612",
"NCT01467102",
"NCT04370951"
] | 27,106 |
val
|
NCT03863600
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Validation of a Midwifery Model in Palestine
Brief Summary: This study investigate if a midwife-led continuity model of care in Palestine, had impact on rural women's satisfaction with care through the continuum of antenatal, intrapartum and postnatal period.
|
{
"A": "Arm Label: Arm 1: Routine Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Arm 2:Behavioral Intervention with nudges & Facebook; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Arm 2:Behavioral Intervention with nudges & Facebook interaction | Arm Label: Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.; Type: ACTIVE_COMPARATOR; Interventions: Other: Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls. | Intervention Type: BEHAVIORAL; Name: Arm 2:Behavioral Intervention with nudges & Facebook interaction; Assigned to Arm(s): Arm 2:Behavioral Intervention with nudges & Facebook | Intervention Type: OTHER; Name: Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.; Assigned to Arm(s): Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.",
"B": "Arm Label: Midwife-led continuity of care; Type: N/A; Interventions: Behavioral: Midwife-led continuity of care | Arm Label: Regular care; Type: N/A; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Midwife-led continuity of care; Assigned to Arm(s): Midwife-led continuity of care",
"C": "Arm Label: ChroPreg; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: ChroPreg + standard care | Arm Label: Standard care alone; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: ChroPreg + standard care; Assigned to Arm(s): ChroPreg",
"D": "Arm Label: Continuity of midwifery care; Type: OTHER; Interventions: Procedure: Continuity of midwifery care | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Continuity of midwifery care; Assigned to Arm(s): Continuity of midwifery care"
}
|
B
|
[
"NCT04275765",
"NCT03863600",
"NCT03511508",
"NCT03145571"
] | 27,107 |
val
|
NCT03863665
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prevention of Hypertensive Injury to the Brain by Intensive Treatment of Blood Pressure After Intracerebral Haemorrhage
Brief Summary: PROHIBIT-ICH will randomise participants (target=112) to compare a strategy of intensive blood pressure (BP) treatment (target \<120/80 mm Hg) guided by remote telemetric home BP monitoring, versus standard primary care, in adult survivors of small vessel disease-related ICH. The investigators will establish the feasibility and safety of the intervention, the efficacy of BP reduction, and explore whether it reduces the progression of SVD-related injury on brain MRI.
|
{
"A": "Arm Label: Telemetric Bluetooth-enabled home BP monitors; Type: EXPERIMENTAL; Interventions: Device: A&D BP Digital Blood Pressure Monitor (UA-767PBT-Ci) CE Declaration UA-767PBT-Ci | Arm Label: Standard clinical care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: A&D BP Digital Blood Pressure Monitor (UA-767PBT-Ci) CE Declaration UA-767PBT-Ci; Assigned to Arm(s): Telemetric Bluetooth-enabled home BP monitors",
"B": "Arm Label: Direct Oral Anticoagulant (DOAC); Type: EXPERIMENTAL; Interventions: Drug: Apixaban 5 MG | Arm Label: Left Atrial Appendage Closure (LAAC); Type: EXPERIMENTAL; Interventions: Device: left atrial appendage closure | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Apixaban 5 MG; Assigned to Arm(s): Direct Oral Anticoagulant (DOAC) | Intervention Type: DEVICE; Name: left atrial appendage closure; Assigned to Arm(s): Left Atrial Appendage Closure (LAAC)",
"C": "Arm Label: Start oral anticoagulant (OAC); Type: EXPERIMENTAL; Interventions: Drug: Apixaban, Drug: Rivaroxaban, Drug: Edoxaban, Drug: Dabigatran, Drug: Acenocoumarol, Drug: Phenindione, Drug: Warfarin | Arm Label: Do not start oral anticoagulant (OAC); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Apixaban; Assigned to Arm(s): Start oral anticoagulant (OAC) | Intervention Type: DRUG; Name: Rivaroxaban; Assigned to Arm(s): Start oral anticoagulant (OAC) | Intervention Type: DRUG; Name: Edoxaban; Assigned to Arm(s): Start oral anticoagulant (OAC) | Intervention Type: DRUG; Name: Dabigatran; Assigned to Arm(s): Start oral anticoagulant (OAC) | Intervention Type: DRUG; Name: Acenocoumarol; Assigned to Arm(s): Start oral anticoagulant (OAC) | Intervention Type: DRUG; Name: Phenindione; Assigned to Arm(s): Start oral anticoagulant (OAC) | Intervention Type: DRUG; Name: Warfarin; Assigned to Arm(s): Start oral anticoagulant (OAC)",
"D": "Arm Label: Study I (AF); Type: N/A; Interventions: N/A | Arm Label: Study II (ICH); Type: N/A; Interventions: N/A"
}
|
A
|
[
"NCT03863665",
"NCT03243175",
"NCT03153150",
"NCT02513316"
] | 27,108 |
val
|
NCT03864549
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effect of Oral Probiotics on Glycemic Control of Women With Gestational Diabetes Mellitus - Randomized, Double Blind, Placebo Controlled Trial, Phase 4
Brief Summary: Scientific background: Uncontrolled gestational diabetes mellitus (GDM) is associated with severe maternal and neonatal morbidities. Treatment of GDM is multidisciplinary and includes lifestyle changes and medications. However, the efficacy of these treatments is limited due to poor motivation, daily painful blood tests and multiple injections.
Probiotic supplements were shown to modulate the gut microbiome by reducing the adverse metabolic effects associated with pathogenic microbial colonization. Promising effects on glycemic control and insulin resistance in non-pregnant diabetic patients were reported. However, the effect of probiotics on glycemic control in GDM has not been elucidated.
Objectives: To examine the effect of a mixture of probiotic strains given daily on maternal glycemic parameters, and pregnancy outcomes among women with GDM.
Working hypothesis: Oral administration of probiotics will be effective in glucose control of patients with GDM and their neonates without causing significant adverse effects.
Type of research and methods of data collection: A prospective randomized, double blind, placebo controlled trial. Women newly diagnosed with GDM will be recruited and followed in the GDM clinic and Maternal-Fetal Medicine ward (including the research clinic) at Emek Medical Center. They will be divided into a research group, receiving the probiotic formula Femina II and a control group, receiving a placebo (2 capsules/day) until delivery. Glycemic control will be evaluated by daily glucose charts. After 2 weeks of diet and probiotic/placebo treatment and thereafter, pharmacotherapy will be started in case of poor glycemic control according to the daily glucose charts. Blood tests for glycated molecules will be performed. Fetal well-being and growth will be assessed. The primary outcomes are:
1. The rate of women requiring medications for glycemic control
2. Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products.
|
{
"A": "Arm Label: Nutritional counseling & self blood glucose monitoring; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: nutritional counseling, Behavioral: self blood glucose monitoring | Arm Label: No treatment; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: nutritional counseling; Assigned to Arm(s): Nutritional counseling & self blood glucose monitoring | Intervention Type: BEHAVIORAL; Name: self blood glucose monitoring; Assigned to Arm(s): Nutritional counseling & self blood glucose monitoring",
"B": "Arm Label: Probiotic; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo | Arm Label: Fish oil; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo | Arm Label: Probiotics and Fish oil; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Comparison of probiotics, fish oil and their combination to placebo; Assigned to Arm(s): Fish oil, Placebo, Probiotic, Probiotics and Fish oil",
"C": "Arm Label: Probiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Probiotics | Arm Label: Probiotics + Dietary counseling; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary counselling and probiotics | Arm Label: Dietary counseling + placebo; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary counselling and placebo | Arm Label: Prebiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Prebiotics | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo capsules | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Dietary counselling and placebo; Assigned to Arm(s): Dietary counseling + placebo | Intervention Type: BEHAVIORAL; Name: Dietary counselling and probiotics; Assigned to Arm(s): Probiotics + Dietary counseling | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo capsules; Assigned to Arm(s): Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotics; Assigned to Arm(s): Probiotics | Intervention Type: DIETARY_SUPPLEMENT; Name: Prebiotics; Assigned to Arm(s): Prebiotics",
"D": "Arm Label: probiotic femina II; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Femina II | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Femina II; Assigned to Arm(s): probiotic femina II | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo"
}
|
D
|
[
"NCT00069576",
"NCT01922791",
"NCT00167700",
"NCT03864549"
] | 27,109 |
val
|
NCT03865485
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: RISE- Prevention of Child Mental Health Problems in Southeastern Europe - Adapt, Optimize, Test and Extend Parenting for Lifelong Health - A Factorial Study (Phase 2 of MOST)
Brief Summary: The aim of this study is to optimize an adapted version of a parenting program, Parenting for Lifelong Health for Young Children (PLH), to meet the specific needs of families in three low- and middle-income countries in Southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova) using a cluster factorial experimental design to select the most efficacious, cost-effective, and scalable intervention components. This study is the second phase of a three-phase research project (www.rise-plh.eu).
The cluster factorial experiment will examine the effectiveness, cost-effectiveness, and implementation of three selected components of the PLH for Children program to inform the selection of the most effective, cost-effective, and implementable components to include in a prevention package prior to testing it in a subsequent RCT. The cluster factorial experiment will be conducted across three Southeastern European country sites. Each site will recruit families with children aged two to nine years who have elevated levels of child behavior problems, including specifically high-risk groups, such as minorities (e.g. Roma families). Program facilitators will be recruited from local agencies and schools. The factorial experimental trial will randomize 16 clusters in each country to one of 8 experimental conditions which consist of any combination of the three components (program length: 5 sessions/10 sessions; engagement booster: high/low; fidelity booster: high supervision/low supervision). The purpose of this factorial experiment is to estimate the main effects of the three intervention components and interactions between the components.
At the end of the cluster factorial experiment, we will develop an optimized version of the program by selecting components or component levels that have the highest level of effectiveness as based on effect size (rather than p-values). We will also take into consideration factors regarding cost-effectiveness and implementation outcomes when designing this optimized intervention package.
|
{
"A": "Arm Label: Length: long; Engagement booster: high; Fidelity booster: high; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Arm Label: Length: long; Engagement booster: high; Fidelity booster: low; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Arm Label: Length: long; Engagement booster: low; Fidelity booster: high; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Arm Label: Length: long; Engagement booster: low; Fidelity booster: low; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Arm Label: Length: short; Engagement booster: high; Fidelity booster:high; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Arm Label: Length: short; Engagement booster: high; Fidelity booster: low; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Arm Label: Length: short; Engagement booster: low; Fidelity booster: high; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Arm Label: Length: short; Engagement booster: low; Fidelity booster: low; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Intervention Type: BEHAVIORAL; Name: Parenting for Lifelong Health (PLH); Assigned to Arm(s): Length: long; Engagement booster: high; Fidelity booster: high, Length: long; Engagement booster: high; Fidelity booster: low, Length: long; Engagement booster: low; Fidelity booster: high, Length: long; Engagement booster: low; Fidelity booster: low, Length: short; Engagement booster: high; Fidelity booster: low, Length: short; Engagement booster: high; Fidelity booster:high, Length: short; Engagement booster: low; Fidelity booster: high, Length: short; Engagement booster: low; Fidelity booster: low",
"B": "Arm Label: TSM arm; Type: EXPERIMENTAL; Interventions: Behavioral: SEHER Intervention delivered by TSM, Behavioral: Tarang AEP | Arm Label: SM arm; Type: EXPERIMENTAL; Interventions: Behavioral: SEHER Intervention delivered by SM, Behavioral: Tarang AEP | Arm Label: Comparison arm Tarang AEP; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Tarang AEP | Intervention Type: BEHAVIORAL; Name: SEHER Intervention delivered by TSM; Assigned to Arm(s): TSM arm | Intervention Type: BEHAVIORAL; Name: SEHER Intervention delivered by SM; Assigned to Arm(s): SM arm | Intervention Type: BEHAVIORAL; Name: Tarang AEP; Assigned to Arm(s): Comparison arm Tarang AEP, SM arm, TSM arm",
"C": "Arm Label: advocacy intervention; Type: EXPERIMENTAL; Interventions: Behavioral: advocacy intervention | Arm Label: Usual community services; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: usual community services | Intervention Type: BEHAVIORAL; Name: advocacy intervention; Assigned to Arm(s): advocacy intervention | Intervention Type: BEHAVIORAL; Name: usual community services; Assigned to Arm(s): Usual community services",
"D": "Arm Label: Immediate; Type: EXPERIMENTAL; Interventions: Behavioral: eHealth for Covid-19 prevention and support | Arm Label: Waitlist; Type: OTHER; Interventions: Behavioral: eHealth for Covid-19 prevention and support | Intervention Type: BEHAVIORAL; Name: eHealth for Covid-19 prevention and support; Assigned to Arm(s): Immediate, Waitlist"
}
|
A
|
[
"NCT03865485",
"NCT02907125",
"NCT01054898",
"NCT04870723"
] | 27,110 |
val
|
NCT03867474
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Mixed-methods, Feasibility Randomized Control Trial of Mindfulness-Based Stress Reduction (MBSR) With Older Adults Living With Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI): a Primary Care Context
Brief Summary: People living with subjective cognitive decline (SCD) or mild cognitive impairment (MCI) experience less efficiency in performing complex everyday tasks, which may result in a general sense of discontentment and decreased satisfaction with their overall functional performance. Additionally, SCD and MCI have been associated with concomitant anxiety, depressive mood, perceived stress, a decrease in emotional well-being and quality-of-life (QoL) among community-dwelling older adults. These concomitant psychosocial issues may result in emotional distress which further exacerbates cognitive decline.
At the present time, there is a lack of evidence that supports pharmacologic interventions to ameliorate concomitant psychosocial issues with this particular population due to medication side-effects, drug-drug interaction and polypharmacy. Consequently, exploring alternative non-pharmacological interventions to assist in ameliorating psychosocial issues is an important consideration. Secondly, evaluating perceived satisfaction on functional performance with those living with SCD and MCI, and assessing interventions that may support this is also worthwhile to pursue. Primary care providers are often the first point of contact when older adults and their families become concerned about memory problems. Health care professionals, on an interdisciplinary Family Health Team (FHT), such as occupational therapists, are well-positioned to holistically address both the psychosocial and functional needs in a client/family centred way with this growing population in primary care. The study proposes to offer a Mindfulness-Based Stress Reduction (MBSR) program, which is an 8-week program that has been shown to be beneficial in alleviating emotional distress among adults living with physical and psychological issues in the general population.
|
{
"A": "Arm Label: Psychological treatment; Type: EXPERIMENTAL; Interventions: Behavioral: Psychological treatment | Arm Label: Cognitive training; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive training | Arm Label: Treatment as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Psychological treatment; Assigned to Arm(s): Psychological treatment | Intervention Type: BEHAVIORAL; Name: Cognitive training; Assigned to Arm(s): Cognitive training",
"B": "Arm Label: PATH; Type: EXPERIMENTAL; Interventions: Behavioral: PATH | Arm Label: ST-CI; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: ST-CI | Intervention Type: BEHAVIORAL; Name: PATH; Assigned to Arm(s): PATH | Intervention Type: BEHAVIORAL; Name: ST-CI; Assigned to Arm(s): ST-CI",
"C": "Arm Label: No Cognitive Rehabilitation; Type: EXPERIMENTAL; Interventions: Behavioral: Computer Brain Fitness Training, Behavioral: Support Group (patient and partner), Behavioral: Wellness Education, Behavioral: Physical Exercise | Arm Label: No Computer Brain Fitness Training; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Rehabilitation, Behavioral: Support Group (patient and partner), Behavioral: Wellness Education, Behavioral: Physical Exercise | Arm Label: No Support Group; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Rehabilitation, Behavioral: Computer Brain Fitness Training, Behavioral: Wellness Education, Behavioral: Physical Exercise | Arm Label: No Wellness Education; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Rehabilitation, Behavioral: Computer Brain Fitness Training, Behavioral: Support Group (patient and partner), Behavioral: Physical Exercise | Arm Label: No Physical Exercise; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Rehabilitation, Behavioral: Computer Brain Fitness Training, Behavioral: Support Group (patient and partner), Behavioral: Wellness Education | Intervention Type: BEHAVIORAL; Name: Cognitive Rehabilitation; Assigned to Arm(s): No Computer Brain Fitness Training, No Physical Exercise, No Support Group, No Wellness Education | Intervention Type: BEHAVIORAL; Name: Computer Brain Fitness Training; Assigned to Arm(s): No Cognitive Rehabilitation, No Physical Exercise, No Support Group, No Wellness Education | Intervention Type: BEHAVIORAL; Name: Support Group (patient and partner); Assigned to Arm(s): No Cognitive Rehabilitation, No Computer Brain Fitness Training, No Physical Exercise, No Wellness Education | Intervention Type: BEHAVIORAL; Name: Wellness Education; Assigned to Arm(s): No Cognitive Rehabilitation, No Computer Brain Fitness Training, No Physical Exercise, No Support Group | Intervention Type: BEHAVIORAL; Name: Physical Exercise; Assigned to Arm(s): No Cognitive Rehabilitation, No Computer Brain Fitness Training, No Support Group, No Wellness Education",
"D": "Arm Label: Intervention (MBSR); Type: EXPERIMENTAL; Interventions: Behavioral: Mindfulness-Based Stress Reduction (MBSR) | Arm Label: Control - Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Mindfulness-Based Stress Reduction (MBSR); Assigned to Arm(s): Intervention (MBSR)"
}
|
D
|
[
"NCT04356924",
"NCT00368940",
"NCT02265757",
"NCT03867474"
] | 27,111 |
val
|
NCT03870503
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Post-partum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial
Brief Summary: The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.
|
{
"A": "Arm Label: Carbetocin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Carbetocin | Arm Label: Oxytocin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Oxytocin | Intervention Type: DRUG; Name: Carbetocin; Assigned to Arm(s): Carbetocin | Intervention Type: DRUG; Name: Oxytocin; Assigned to Arm(s): Oxytocin",
"B": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: MISOPROSTOL; Type: EXPERIMENTAL; Interventions: Drug: Misoprostol | Intervention Type: DRUG; Name: Misoprostol; Assigned to Arm(s): MISOPROSTOL | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: Misoprostol; Type: EXPERIMENTAL; Interventions: Drug: Misoprostol | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Misoprostol | Intervention Type: DRUG; Name: Misoprostol; Assigned to Arm(s): Misoprostol, Placebo",
"D": "Arm Label: oxytocin; Type: ACTIVE_COMPARATOR; Interventions: Drug: oxytocin | Arm Label: oxytocin plus misoprostol; Type: ACTIVE_COMPARATOR; Interventions: Drug: oxytocin, Drug: oxytocin plus misoprostol | Arm Label: Carbetocin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Carbetocin | Intervention Type: DRUG; Name: oxytocin; Assigned to Arm(s): oxytocin, oxytocin plus misoprostol | Intervention Type: DRUG; Name: oxytocin plus misoprostol; Assigned to Arm(s): oxytocin plus misoprostol | Intervention Type: DRUG; Name: Carbetocin; Assigned to Arm(s): Carbetocin"
}
|
D
|
[
"NCT02304055",
"NCT01116050",
"NCT00116480",
"NCT03870503"
] | 27,112 |
val
|
NCT03871023
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Use of Prophylactic Negative Wound Therapy in Emergency and Elective Laparotomy Wounds
Brief Summary: Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. The impact of different types of wound therapy are not clear in the literature.
The hypothesis of this study is that NPWT has the potential to reduce Surgical Site Infections, however no study has compared the most commonly used products against standard dressings.
|
{
"A": "Arm Label: Simple dressing; Type: ACTIVE_COMPARATOR; Interventions: Device: Smith & Nephew PICO Negative wound pressure versus standard dresing, Device: PREVENA Negative pressure wound versus standard dressing | Arm Label: PICO Dressing; Type: ACTIVE_COMPARATOR; Interventions: Device: PREVENA Negative pressure wound versus standard dressing | Arm Label: PREVENA Dressing; Type: ACTIVE_COMPARATOR; Interventions: Device: Smith & Nephew PICO Negative wound pressure versus standard dresing | Intervention Type: DEVICE; Name: Smith & Nephew PICO Negative wound pressure versus standard dresing; Assigned to Arm(s): PREVENA Dressing, Simple dressing | Intervention Type: DEVICE; Name: PREVENA Negative pressure wound versus standard dressing; Assigned to Arm(s): PICO Dressing, Simple dressing",
"B": "Arm Label: Current Standard; Type: ACTIVE_COMPARATOR; Interventions: Device: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing | Arm Label: Negative Pressure Wound Therapy; Type: EXPERIMENTAL; Interventions: Device: Prevena (Negative Pressure Wound Therapy Device) | Intervention Type: DEVICE; Name: Prevena (Negative Pressure Wound Therapy Device); Assigned to Arm(s): Negative Pressure Wound Therapy | Intervention Type: DEVICE; Name: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing; Assigned to Arm(s): Current Standard",
"C": "Arm Label: Prevena device (Group A); Type: EXPERIMENTAL; Interventions: Device: Prevena device (Group A) | Arm Label: Conventional dressing (Group B); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Prevena device (Group A); Assigned to Arm(s): Prevena device (Group A)",
"D": "Arm Label: patients with preventive PICO; Type: ACTIVE_COMPARATOR; Interventions: Device: PICO DRESSING | Arm Label: patients with preventive MEPORE; Type: PLACEBO_COMPARATOR; Interventions: Device: MEPORE dressing | Intervention Type: DEVICE; Name: PICO DRESSING; Assigned to Arm(s): patients with preventive PICO | Intervention Type: DEVICE; Name: MEPORE dressing; Assigned to Arm(s): patients with preventive MEPORE"
}
|
A
|
[
"NCT03871023",
"NCT02084017",
"NCT01698372",
"NCT03576222"
] | 27,113 |
val
|
NCT03871088
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes
Brief Summary: Investigate the clinical subtypes and the biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD.
|
{
"A": "Intervention Type: DRUG; Name: Ethyl-eicosapentanoic acid (ethyl-EPA); Assigned to Arm(s): N/A",
"B": "Arm Label: Omega-3 supplement; Type: EXPERIMENTAL; Interventions: Drug: Omega-3 supplement | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Omega-3 supplement; Assigned to Arm(s): Omega-3 supplement | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: Eicosapentaenoic acid (EPA); Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Omega-3 fatty acids | Arm Label: Docosahexaenoic acid (DHA); Type: EXPERIMENTAL; Interventions: Dietary Supplement: Omega-3 fatty acids | Arm Label: EPA/DHA combination; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Omega-3 fatty acids | Intervention Type: DIETARY_SUPPLEMENT; Name: Omega-3 fatty acids; Assigned to Arm(s): Docosahexaenoic acid (DHA), EPA/DHA combination, Eicosapentaenoic acid (EPA)",
"D": "Arm Label: EPA + DHA; Type: EXPERIMENTAL; Interventions: Dietary Supplement: margarine spread | Arm Label: ALA; Type: EXPERIMENTAL; Interventions: Dietary Supplement: margarine spread | Arm Label: EPA + DHA plus ALA; Type: EXPERIMENTAL; Interventions: Dietary Supplement: margarine spread | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: margarine spread | Intervention Type: DIETARY_SUPPLEMENT; Name: margarine spread; Assigned to Arm(s): ALA, EPA + DHA, EPA + DHA plus ALA, Placebo"
}
|
C
|
[
"NCT00096798",
"NCT02021669",
"NCT03871088",
"NCT00127452"
] | 27,114 |
val
|
NCT03871244
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pilot Optimizing Transfusion Thresholds in Critically-ill Children With Anaemia (P-OpTTICCA): a Pilot Trial for a Large Pragmatic International Parallel Open-label Non-inferiority Randomised Controlled Trial.
Brief Summary: The Pilot Optimizing Transfusion Thresholds in Critically-ill Children with Anaemia (P-OpTTICCA) study is a pilot trial for a large pragmatic international parallel open-label non-inferiority randomised controlled trial. The primary outcome of the pilot study is feasibility.
|
{
"A": "Arm Label: Low transfusion trigger; Type: ACTIVE_COMPARATOR; Interventions: Biological: red blood cell transfusion | Arm Label: High transfusion trigger; Type: ACTIVE_COMPARATOR; Interventions: Biological: red blood cell transfusion | Intervention Type: BIOLOGICAL; Name: red blood cell transfusion; Assigned to Arm(s): High transfusion trigger, Low transfusion trigger",
"B": "Arm Label: Restrictive arm (intervention); Type: EXPERIMENTAL; Interventions: Procedure: Less red blood cell transfusions | Arm Label: Standard care arm (comparator); Type: ACTIVE_COMPARATOR; Interventions: Procedure: More red blood cell transfusion (standard transfusion strategy in PICU) | Intervention Type: PROCEDURE; Name: Less red blood cell transfusions; Assigned to Arm(s): Restrictive arm (intervention) | Intervention Type: PROCEDURE; Name: More red blood cell transfusion (standard transfusion strategy in PICU); Assigned to Arm(s): Standard care arm (comparator)",
"C": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Procedure: red blood cell transfusion | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: red blood cell transfusion | Intervention Type: PROCEDURE; Name: red blood cell transfusion; Assigned to Arm(s): 1, 2",
"D": "Arm Label: Allowed drop in hemoglobin to 4.5-5.5 mmol/L; Type: ACTIVE_COMPARATOR; Interventions: Other: Allowed drop in hemoglobin to 4.5-5.5 mmol/L | Arm Label: Allowed drop in hemoglobin to 5.6-6.5 mmol/L; Type: EXPERIMENTAL; Interventions: Other: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L | Intervention Type: OTHER; Name: Allowed drop in hemoglobin to 4.5-5.5 mmol/L; Assigned to Arm(s): Allowed drop in hemoglobin to 4.5-5.5 mmol/L | Intervention Type: OTHER; Name: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L; Assigned to Arm(s): Allowed drop in hemoglobin to 5.6-6.5 mmol/L"
}
|
B
|
[
"NCT02465125",
"NCT03871244",
"NCT00414713",
"NCT00906295"
] | 27,115 |
val
|
NCT03871244
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pilot Optimizing Transfusion Thresholds in Critically-ill Children With Anaemia (P-OpTTICCA): a Pilot Trial for a Large Pragmatic International Parallel Open-label Non-inferiority Randomised Controlled Trial.
Brief Summary: The Pilot Optimizing Transfusion Thresholds in Critically-ill Children with Anaemia (P-OpTTICCA) study is a pilot trial for a large pragmatic international parallel open-label non-inferiority randomised controlled trial. The primary outcome of the pilot study is feasibility.
|
{
"A": "Arm Label: Restrictive arm (intervention); Type: EXPERIMENTAL; Interventions: Procedure: Less red blood cell transfusions | Arm Label: Standard care arm (comparator); Type: ACTIVE_COMPARATOR; Interventions: Procedure: More red blood cell transfusion (standard transfusion strategy in PICU) | Intervention Type: PROCEDURE; Name: Less red blood cell transfusions; Assigned to Arm(s): Restrictive arm (intervention) | Intervention Type: PROCEDURE; Name: More red blood cell transfusion (standard transfusion strategy in PICU); Assigned to Arm(s): Standard care arm (comparator)",
"B": "Arm Label: Liberal (10 g/dL) Transfusion Strategy; Type: EXPERIMENTAL; Interventions: Biological: Liberal (10 g/dL) Transfusion Strategy | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Biological: Restrictive (Symptomatic) Transfusion Strategy | Intervention Type: BIOLOGICAL; Name: Liberal (10 g/dL) Transfusion Strategy; Assigned to Arm(s): Liberal (10 g/dL) Transfusion Strategy | Intervention Type: BIOLOGICAL; Name: Restrictive (Symptomatic) Transfusion Strategy; Assigned to Arm(s): 2",
"C": "Arm Label: Restrictive Transfusion Strategy; Type: EXPERIMENTAL; Interventions: Procedure: Transfusion | Arm Label: Liberal Transfusion Strategy; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Transfusion | Intervention Type: PROCEDURE; Name: Transfusion; Assigned to Arm(s): Liberal Transfusion Strategy, Restrictive Transfusion Strategy",
"D": "Arm Label: \"liberal\" transfusion triggers; Type: EXPERIMENTAL; Interventions: Other: red blood cell transfusion | Arm Label: \"restrictive\" transfusion triggers; Type: ACTIVE_COMPARATOR; Interventions: Other: red blood cell transfusion | Intervention Type: OTHER; Name: red blood cell transfusion; Assigned to Arm(s): \"liberal\" transfusion triggers | Intervention Type: OTHER; Name: red blood cell transfusion; Assigned to Arm(s): \"restrictive\" transfusion triggers"
}
|
A
|
[
"NCT03871244",
"NCT00071032",
"NCT02619136",
"NCT01393496"
] | 27,116 |
val
|
NCT03871244
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pilot Optimizing Transfusion Thresholds in Critically-ill Children With Anaemia (P-OpTTICCA): a Pilot Trial for a Large Pragmatic International Parallel Open-label Non-inferiority Randomised Controlled Trial.
Brief Summary: The Pilot Optimizing Transfusion Thresholds in Critically-ill Children with Anaemia (P-OpTTICCA) study is a pilot trial for a large pragmatic international parallel open-label non-inferiority randomised controlled trial. The primary outcome of the pilot study is feasibility.
|
{
"A": "Arm Label: Restrictive transfusion strategy; Type: EXPERIMENTAL; Interventions: Procedure: Restrictive transfusion, Biological: red blood transfusion | Arm Label: Liberal transfusion strategy; Type: EXPERIMENTAL; Interventions: Procedure: Liberal transfusion, Biological: red blood transfusion | Intervention Type: PROCEDURE; Name: Restrictive transfusion; Assigned to Arm(s): Restrictive transfusion strategy | Intervention Type: PROCEDURE; Name: Liberal transfusion; Assigned to Arm(s): Liberal transfusion strategy | Intervention Type: BIOLOGICAL; Name: red blood transfusion; Assigned to Arm(s): Liberal transfusion strategy, Restrictive transfusion strategy",
"B": "Arm Label: \"liberal\" transfusion triggers; Type: EXPERIMENTAL; Interventions: Other: red blood cell transfusion | Arm Label: \"restrictive\" transfusion triggers; Type: ACTIVE_COMPARATOR; Interventions: Other: red blood cell transfusion | Intervention Type: OTHER; Name: red blood cell transfusion; Assigned to Arm(s): \"liberal\" transfusion triggers | Intervention Type: OTHER; Name: red blood cell transfusion; Assigned to Arm(s): \"restrictive\" transfusion triggers",
"C": "Arm Label: Restrictive arm (intervention); Type: EXPERIMENTAL; Interventions: Procedure: Less red blood cell transfusions | Arm Label: Standard care arm (comparator); Type: ACTIVE_COMPARATOR; Interventions: Procedure: More red blood cell transfusion (standard transfusion strategy in PICU) | Intervention Type: PROCEDURE; Name: Less red blood cell transfusions; Assigned to Arm(s): Restrictive arm (intervention) | Intervention Type: PROCEDURE; Name: More red blood cell transfusion (standard transfusion strategy in PICU); Assigned to Arm(s): Standard care arm (comparator)",
"D": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tranexamic acid (Exacyl) | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Tranexamic acid (Exacyl); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2"
}
|
C
|
[
"NCT02648113",
"NCT01393496",
"NCT03871244",
"NCT00327106"
] | 27,117 |
val
|
NCT03872193
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effects of Virtual Reality on Transtibial Amputation Ouality of Life,Performance, Balance,Prothesis Adaptation and Gait Outcomes
Brief Summary: The aim of this study is to compare the effects of virtual reality applications on quality of life, performance, balance, prosthesis adaptation and gait parameters in individuals with transtibial amputation. 20 Transtibial amputee were included in study. All participants were using transtibial prothesis with active vacuum system at least 1 year. Participants were divided into two groups. While a group of virtual reality applications were being performed additionally standart physiotherapy, only standard physiotherapy methods were applied in the second group. Balance and gait practices were performed for each group. Individuals were treated for 3 days a week for 4 weeks, and individuals were evaluated before and after treatment. Individuals were evaluated for quality of life, performance, balance, prosthesis adaptation and time-distance parameters of walking.
|
{
"A": "Arm Label: Physio Therapy; Type: EXPERIMENTAL; Interventions: Other: Exercise | Arm Label: Virtual Reality; Type: EXPERIMENTAL; Interventions: Other: Exercise | Intervention Type: OTHER; Name: Exercise; Assigned to Arm(s): Physio Therapy, Virtual Reality",
"B": "Arm Label: Walking Biobehavioral Intervention (EXP); Type: EXPERIMENTAL; Interventions: Behavioral: Walking Biobehavioral Intervention | Arm Label: Attention Control (CTL); Type: ACTIVE_COMPARATOR; Interventions: Other: Attention Control | Intervention Type: BEHAVIORAL; Name: Walking Biobehavioral Intervention; Assigned to Arm(s): Walking Biobehavioral Intervention (EXP) | Intervention Type: OTHER; Name: Attention Control; Assigned to Arm(s): Attention Control (CTL)",
"C": "Arm Label: Exercise, activity, and self-management; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise, Behavioral: Walking Program, Behavioral: Health Self-Management Support | Arm Label: Home and phone visit; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Exercise; Assigned to Arm(s): Exercise, activity, and self-management | Intervention Type: BEHAVIORAL; Name: Walking Program; Assigned to Arm(s): Exercise, activity, and self-management | Intervention Type: BEHAVIORAL; Name: Health Self-Management Support; Assigned to Arm(s): Exercise, activity, and self-management",
"D": "Arm Label: Left transtibial; Type: N/A; Interventions: Device: KinetiGait | Arm Label: Right transtibial; Type: N/A; Interventions: Device: KinetiGait | Arm Label: Left transfemoral; Type: N/A; Interventions: Device: KinetiGait | Arm Label: Right transfemoral; Type: N/A; Interventions: Device: KinetiGait | Arm Label: Provider; Type: N/A; Interventions: Device: KinetiGait | Intervention Type: DEVICE; Name: KinetiGait; Assigned to Arm(s): Left transfemoral, Left transtibial, Provider, Right transfemoral, Right transtibial"
}
|
A
|
[
"NCT03872193",
"NCT04083456",
"NCT01929018",
"NCT04431817"
] | 27,118 |
val
|
NCT03873116
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX7353 as an Oral Treatment for the Prevention of Attacks in Subjects With Hereditary Angioedema
Brief Summary: This is a phase 3, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE who live in Japan.
|
{
"A": "Arm Label: CSL312; Type: EXPERIMENTAL; Interventions: Biological: CSL312 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: BIOLOGICAL; Name: CSL312; Assigned to Arm(s): CSL312 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: 500/1000; Type: EXPERIMENTAL; Interventions: Biological: CINRYZE 500, Biological: CINRYZE 1000 | Arm Label: 1000/500; Type: EXPERIMENTAL; Interventions: Biological: CINRYZE 500, Biological: CINRYZE 1000 | Intervention Type: BIOLOGICAL; Name: CINRYZE 500; Assigned to Arm(s): 1000/500, 500/1000 | Intervention Type: BIOLOGICAL; Name: CINRYZE 1000; Assigned to Arm(s): 1000/500, 500/1000",
"C": "Arm Label: BCX4161 300 mg three times daily; Type: EXPERIMENTAL; Interventions: Drug: BCX4161, Drug: Placebo | Arm Label: BCX4161 500 mg three times daily; Type: EXPERIMENTAL; Interventions: Drug: BCX4161 | Arm Label: Placebo three times daily; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: BCX4161; Assigned to Arm(s): BCX4161 300 mg three times daily, BCX4161 500 mg three times daily | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BCX4161 300 mg three times daily, Placebo three times daily",
"D": "Arm Label: BCX7353 110mg once daily; Type: EXPERIMENTAL; Interventions: Drug: BCX7353 capsules | Arm Label: BCX7353 150mg once daily; Type: EXPERIMENTAL; Interventions: Drug: BCX7353 capsules | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo oral capsule | Intervention Type: DRUG; Name: BCX7353 capsules; Assigned to Arm(s): BCX7353 110mg once daily | Intervention Type: DRUG; Name: BCX7353 capsules; Assigned to Arm(s): BCX7353 150mg once daily | Intervention Type: DRUG; Name: Placebo oral capsule; Assigned to Arm(s): Placebo"
}
|
D
|
[
"NCT04656418",
"NCT02052141",
"NCT02303626",
"NCT03873116"
] | 27,119 |
val
|
NCT03873597
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of Physical Activity Tele-coaching to Optimise Daily Physical Activity Levels in Lung Transplant Recipients
Brief Summary: Lung transplantation is an established treatment for patients with end-stage lung disease. Despite the overall success of the treatment to prolong survival and restore lung function, limitations in exercise capacity in the range of 40-60% of predicted normal values are commonly observed, even up to 1 year following the transplant. These persisting limitations are predominantly owed to skeletal muscle abnormalities including muscle atrophy, weakness and increased fatigability, secondary to prolonged deconditioning
Based on objective accelerometry measurements, lung transplant recipients are markedly inactive in daily life compared to their healthy age-matched counterparts. Locomotor muscle weakness following extended hospital and intensive care unit stay, immunosuppressant medications, and the psychological effects of transplantation contribute to persisting physical inactivity and impaired exercise capacity.
Physical activity is a complex health behaviour that is modified by behavioural change interventions. Such interventions may combine the use of wearable monitors (i.e. step counters) with goal setting to increase daily physical activity. In patients with chronic obstructive pulmonary disease (COPD), use of a semi-automated tele-coaching intervention consisting of a step-counter and smartphone application, in combination with behavioural strategies (identification of barriers, goal setting, self-efficacy, motivation, self-monitoring and feedback) increases both daily physical activity levels and quality of life. However, the effectiveness of tele-coaching to induce meaningful improvements in daily steps to transpire into enhanced post-surgery outcomes and improve recovery is yet to be investigated in lung transplant recipients.
Alongside physical activity promotion, incorporation of behavioural strategies are also important in terms of reversing physical inactivity in patients with chronic lung diseases. These strategies address barriers to physical activity including low self-motivation and self-efficacy, and constitute an important component in the management of chronic diseases to improve long term engagement in activities of daily living.
Accordingly, this study will assess the feasibility and clinical efficacy of physical activity tele-coaching to enhance daily physical activity levels within a population at high risk for post-surgical complications. The intervention combines usual care with tele-coaching, which is designed to embed behavioural change and remote coaching to adhere to simple daily physical activity tasks. Behavioural strategies targeted at improving physical activity levels will be applied to all patients prior to hospital discharge, to promote more active lifestyle choices.
|
{
"A": "Arm Label: Rehabilitation + Lifestyle Counseling; Type: EXPERIMENTAL; Interventions: Procedure: Rehabilitation including structured exercise training | Arm Label: Lifestyle Counseling; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Physical Activity Counseling | Intervention Type: PROCEDURE; Name: Rehabilitation including structured exercise training; Assigned to Arm(s): Rehabilitation + Lifestyle Counseling | Intervention Type: PROCEDURE; Name: Physical Activity Counseling; Assigned to Arm(s): Lifestyle Counseling",
"B": "Intervention Type: PROCEDURE; Name: Pulmonary rehabilitation programme; Assigned to Arm(s): N/A",
"C": "Intervention Type: BEHAVIORAL; Name: exercise training; psychosocial support; Assigned to Arm(s): N/A",
"D": "Arm Label: Tele-coaching + Usual Care; Type: EXPERIMENTAL; Interventions: Behavioral: Tele-coaching + Usual Care | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Tele-coaching + Usual Care; Assigned to Arm(s): Tele-coaching + Usual Care"
}
|
D
|
[
"NCT00395889",
"NCT00129350",
"NCT00753155",
"NCT03873597"
] | 27,120 |
val
|
NCT03873688
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effects of Expiratory Muscle Training on Cough Efficacy in Children and Adolescents With Cystic Fibrosis
Brief Summary: Cystic fibrosis (CF) is an autosomal recessive genetic disease characterized by recurrent airway infections, affecting many systems including lung, pancreas and sweat glands. Cough is an important defense mechanism for clearing the secretions that increase in respiratory diseases. There have been studies investigating the effect of expiratory muscle training on disease groups such as chronic obstructive pulmonary disease, multiple sclerosis, parkinson's disease, and the elderly and healthy individuals. Studies that evaluating effects of expiratory muscle training in cystic fibrosis are limited in the literature. The aim of this study was to evaluate the effect of cough strength in children and adolescents with CF and the effect of expiratory muscle training program on cough strength, exercise capacity, respiratory muscle strength and quality of life.
|
{
"A": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Physical activity | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Wellness | Intervention Type: BEHAVIORAL; Name: Physical activity; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Wellness; Assigned to Arm(s): 2",
"B": "Arm Label: Experimental Group; Type: EXPERIMENTAL; Interventions: Other: expiratory muscle training | Arm Label: Sham Group; Type: SHAM_COMPARATOR; Interventions: Other: expiratory muscle training | Intervention Type: OTHER; Name: expiratory muscle training; Assigned to Arm(s): Experimental Group, Sham Group",
"C": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: VX-445/TEZ/IVA TC; Type: EXPERIMENTAL; Interventions: Drug: VX-445/TEZ/IVA, Drug: IVA | Intervention Type: DRUG; Name: VX-445/TEZ/IVA; Assigned to Arm(s): VX-445/TEZ/IVA TC | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): VX-445/TEZ/IVA TC | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Arm Label: GExp; Type: EXPERIMENTAL; Interventions: Device: Inspiratory muscle training | Arm Label: GCon; Type: ACTIVE_COMPARATOR; Interventions: Device: Inspiratory muscle training | Intervention Type: DEVICE; Name: Inspiratory muscle training; Assigned to Arm(s): GCon, GExp"
}
|
B
|
[
"NCT00142688",
"NCT03873688",
"NCT03525444",
"NCT03737630"
] | 27,121 |
val
|
NCT03874585
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Text Messaging-Based Smoking Cessation Program for Homeless Youth
Brief Summary: Unaccompanied homeless youth smoke at much higher rates than non-homeless adolescents and young adults. Many homeless youth smokers are motivated to quit; yet, strategies specifically developed for this vulnerable population are lacking. This study will develop and pilot test a text messaging intervention (also known as a TMI) to help homeless youth quit smoking. Text messaging can provide ongoing support for homeless youth during a quit attempt, which is important given that these youth tend to be highly mobile and lack regular access to health services. Participants in this study will be homeless youth who currently smoke and are motivated to quit smoking. All participants will receive a 30-minute group-based smoking cessation counseling session and a nicotine replacement product. Half of these smokers will also receive the TMI, for 6 weeks following the group counseling session, which will provide ongoing support for quitting. The main goal of this study is to investigate whether receiving the TMI results in greater reductions in cigarette smoking over a 3-month period compared to receiving the group counseling session alone.
|
{
"A": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: Varenicline plus Motivational Interviewing counseling | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Other: Varenicline without counseling | Intervention Type: OTHER; Name: Varenicline plus Motivational Interviewing counseling; Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: Varenicline without counseling; Assigned to Arm(s): 2",
"B": "Arm Label: Hospital phone counseling; Type: EXPERIMENTAL; Interventions: Behavioral: Telephone Counseling | Arm Label: Fax-to-quit; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Fax-to-quit | Intervention Type: BEHAVIORAL; Name: Telephone Counseling; Assigned to Arm(s): Hospital phone counseling | Intervention Type: BEHAVIORAL; Name: Fax-to-quit; Assigned to Arm(s): Fax-to-quit",
"C": "Arm Label: Integrated Intensive Smoking + Alcohol; Type: ACTIVE_COMPARATOR; Interventions: Drug: nicotine patch plus nicotine gum/lozenge, Behavioral: Intensive Alcohol Intervention | Arm Label: Usual Care; Type: PLACEBO_COMPARATOR; Interventions: Drug: nicotine patch plus nicotine gum/lozenge | Intervention Type: DRUG; Name: nicotine patch plus nicotine gum/lozenge; Assigned to Arm(s): Integrated Intensive Smoking + Alcohol, Usual Care | Intervention Type: BEHAVIORAL; Name: Intensive Alcohol Intervention; Assigned to Arm(s): Integrated Intensive Smoking + Alcohol",
"D": "Arm Label: Standard Condition; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Group counseling and nicotine replacement | Arm Label: Enhanced Condition; Type: EXPERIMENTAL; Interventions: Behavioral: Group counseling, nicotine replacement, and text messaging support | Intervention Type: BEHAVIORAL; Name: Group counseling and nicotine replacement; Assigned to Arm(s): Standard Condition | Intervention Type: BEHAVIORAL; Name: Group counseling, nicotine replacement, and text messaging support; Assigned to Arm(s): Enhanced Condition"
}
|
D
|
[
"NCT00786149",
"NCT01363245",
"NCT01932996",
"NCT03874585"
] | 27,122 |
val
|
NCT03875482
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary: The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.
|
{
"A": "Arm Label: Risankizumab; Type: EXPERIMENTAL; Interventions: Drug: Risankizumab | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo solution for risankizumab | Intervention Type: DRUG; Name: Risankizumab; Assigned to Arm(s): Risankizumab | Intervention Type: DRUG; Name: Placebo solution for risankizumab; Assigned to Arm(s): Placebo",
"B": "Arm Label: UCB4940 8 mg; Type: EXPERIMENTAL; Interventions: Drug: UCB4940 | Arm Label: UCB4940 40 mg; Type: EXPERIMENTAL; Interventions: Drug: UCB4940 | Arm Label: UCB4940 160 mg; Type: EXPERIMENTAL; Interventions: Drug: UCB4940 | Arm Label: UCB4940 480 mg; Type: EXPERIMENTAL; Interventions: Drug: UCB4940 | Arm Label: UCB4940 640 mg; Type: EXPERIMENTAL; Interventions: Drug: UCB4940 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: UCB4940; Assigned to Arm(s): UCB4940 160 mg, UCB4940 40 mg, UCB4940 480 mg, UCB4940 640 mg, UCB4940 8 mg | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: Placebo (Part A); Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo for risankizumab | Arm Label: Risankizumab 75 mg (Part A); Type: EXPERIMENTAL; Interventions: Drug: risankizumab, Drug: placebo for risankizumab | Arm Label: Risankizumab 150 mg (Part A); Type: EXPERIMENTAL; Interventions: Drug: risankizumab | Intervention Type: DRUG; Name: risankizumab; Assigned to Arm(s): Risankizumab 150 mg (Part A), Risankizumab 75 mg (Part A) | Intervention Type: DRUG; Name: placebo for risankizumab; Assigned to Arm(s): Placebo (Part A), Risankizumab 75 mg (Part A)",
"D": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 50 mg etanercept; Type: ACTIVE_COMPARATOR; Interventions: Drug: 50 mg etanercept | Arm Label: 80 mg ixekizumab Dosing Regimen 2; Type: EXPERIMENTAL; Interventions: Drug: 80 mg ixekizumab | Arm Label: 80 mg ixekizumab Dosing Regimen 1; Type: EXPERIMENTAL; Interventions: Drug: 80 mg ixekizumab | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: 50 mg etanercept; Assigned to Arm(s): 50 mg etanercept | Intervention Type: DRUG; Name: 80 mg ixekizumab; Assigned to Arm(s): 80 mg ixekizumab Dosing Regimen 1, 80 mg ixekizumab Dosing Regimen 2"
}
|
A
|
[
"NCT03875482",
"NCT02529956",
"NCT03000075",
"NCT01646177"
] | 27,123 |
val
|
NCT03875482
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary: The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.
|
{
"A": "Arm Label: BMS-986165 Dose 1; Type: EXPERIMENTAL; Interventions: Drug: BMS-986165 | Arm Label: BMS-986165 Dose 2; Type: EXPERIMENTAL; Interventions: Drug: BMS-986165 | Arm Label: BMS-986165 Dose 3; Type: EXPERIMENTAL; Interventions: Drug: BMS-986165 | Arm Label: BMS-986165 Dose 4; Type: EXPERIMENTAL; Interventions: Drug: BMS-986165 | Arm Label: BMS-986165 Dose 5; Type: EXPERIMENTAL; Interventions: Drug: BMS-986165 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo for BMS-986165 | Intervention Type: DRUG; Name: BMS-986165; Assigned to Arm(s): BMS-986165 Dose 1, BMS-986165 Dose 2, BMS-986165 Dose 3, BMS-986165 Dose 4, BMS-986165 Dose 5 | Intervention Type: DRUG; Name: Placebo for BMS-986165; Assigned to Arm(s): Placebo",
"B": "Arm Label: Risankizumab; Type: EXPERIMENTAL; Interventions: Drug: Risankizumab | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo solution for risankizumab | Intervention Type: DRUG; Name: Risankizumab; Assigned to Arm(s): Risankizumab | Intervention Type: DRUG; Name: Placebo solution for risankizumab; Assigned to Arm(s): Placebo",
"C": "Arm Label: M1095 (Sonelokimab) 30mg; Type: EXPERIMENTAL; Interventions: Drug: M1095 (Sonelokimab) | Arm Label: M1095 (Sonelokimab) 60mg; Type: EXPERIMENTAL; Interventions: Drug: M1095 (Sonelokimab) | Arm Label: M1095 (Sonelokimab) 120mg - regimen 1; Type: EXPERIMENTAL; Interventions: Drug: M1095 (Sonelokimab) | Arm Label: M1095 (Sonelokimab) 120mg - regimen 2; Type: EXPERIMENTAL; Interventions: Drug: M1095 (Sonelokimab) | Arm Label: Placebo / M1095 (Sonelokimab) 120mg; Type: PLACEBO_COMPARATOR; Interventions: Drug: M1095 (Sonelokimab), Drug: Placebo | Arm Label: Secukinumab; Type: ACTIVE_COMPARATOR; Interventions: Drug: Secukinumab | Intervention Type: DRUG; Name: M1095 (Sonelokimab); Assigned to Arm(s): M1095 (Sonelokimab) 120mg - regimen 1, M1095 (Sonelokimab) 120mg - regimen 2, M1095 (Sonelokimab) 30mg, M1095 (Sonelokimab) 60mg, Placebo / M1095 (Sonelokimab) 120mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo / M1095 (Sonelokimab) 120mg | Intervention Type: DRUG; Name: Secukinumab; Assigned to Arm(s): Secukinumab",
"D": "Arm Label: Ixekizumab; Type: EXPERIMENTAL; Interventions: Drug: Ixekizumab, Drug: Placebo | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Ixekizumab, Drug: Placebo | Intervention Type: DRUG; Name: Ixekizumab; Assigned to Arm(s): Ixekizumab, Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Ixekizumab, Placebo"
}
|
B
|
[
"NCT02931838",
"NCT03875482",
"NCT03384745",
"NCT02718898"
] | 27,124 |
val
|
NCT03877198
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Cross-over Trial in the Effect of Automated Oxygen Control Devices on the Distribution of Oxygen Saturation in Preterm Infants
Brief Summary: Premature infants often receive respiratory support and supplemental oxygen for a prolonged period of time during their admission in the NICU. While maintaining the oxygen saturation within a narrow target range is important to prevent morbidity, manual oxygen titration can be very challenging. Automatic titration by a controller has been proven to be more effective. However, to date the performance of different controllers has not been compared. The proposed randomized crossover trial Comparing Oxygen Controllers in Preterm InfanTs (COCkPIT) is designed to compare the effect on time spent within target range. The results of this trial will help determining which algorithm is most successful in controlling oxygen, improve future developments in automated oxygen control and ultimately reduce the morbidity associated with hypoxemia and hyperoxemia.
|
{
"A": "Arm Label: Automated FiO2 control; Type: EXPERIMENTAL; Interventions: Device: Automated FiO2 Control | Arm Label: Manual Adjustment; Type: PLACEBO_COMPARATOR; Interventions: N/A | Intervention Type: DEVICE; Name: Automated FiO2 Control; Assigned to Arm(s): Automated FiO2 control",
"B": "Arm Label: IntellO2; Type: EXPERIMENTAL; Interventions: Device: IntellO2 | Arm Label: Manual; Type: ACTIVE_COMPARATOR; Interventions: Other: Manual control | Intervention Type: DEVICE; Name: IntellO2; Assigned to Arm(s): IntellO2 | Intervention Type: OTHER; Name: Manual control; Assigned to Arm(s): Manual",
"C": "Arm Label: CLiO2; Type: EXPERIMENTAL; Interventions: Device: Automated oxygen control by the CLiO2 algorithm | Arm Label: Oxygenie; Type: EXPERIMENTAL; Interventions: Device: Automated oxygen control by the Oxygenie algorithm | Intervention Type: DEVICE; Name: Automated oxygen control by the CLiO2 algorithm; Assigned to Arm(s): CLiO2 | Intervention Type: DEVICE; Name: Automated oxygen control by the Oxygenie algorithm; Assigned to Arm(s): Oxygenie",
"D": "Arm Label: Manual oxygen control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Closed-loop automated oxygen control; Type: OTHER; Interventions: Device: Closed-loop automated oxygen control (Oxygenie, SLE 6000) | Intervention Type: DEVICE; Name: Closed-loop automated oxygen control (Oxygenie, SLE 6000); Assigned to Arm(s): Closed-loop automated oxygen control"
}
|
C
|
[
"NCT01942473",
"NCT02074774",
"NCT03877198",
"NCT05030337"
] | 27,125 |
val
|
NCT03877393
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 12-week, Randomized, Double-blind, and Placebo-controlled Study Evaluating the Effect of Probiotic Supplementation on the Mental Status, Inflammation, And Intestinal Barrier in Major Depressive Disorder Patients Using Gluten-free or Gluten-containing Diet
Brief Summary: More and more evidence confirms the relationship between the gut-brain-microbiota axis and the symptoms of mood disorders. A potential pathway connecting the intestines and the brain in depression is inflammation. Interventions for reducing inflammation and restoring the integrity of the intestinal mucosa are promising approaches in patients with major depressive disorder (MDD). Gut dysbiosis and the diet containing gluten are potential factors may be factors that negatively affect the communication between intestinal and brain. Gluten has a high immunogenic potential and affinity for the intestinal mucosa layer. In patients with an abnormal reaction to gluten, the elimination diet led to improved mood symptoms. However, the relationship between gluten and depression is still poorly understood. Intestinal microbiota can affect the digestion of gluten and reduce its immunogenic potential. Studies have shown that probiotic supplementation has an anti-inflammatory effect, can lead to changes in intestinal permeability and alleviate the symptoms of depression. This evidence supports the need for co-therapy, including the elimination of gluten and the restoration of intestinal eubiosis to reduce inflammation and modulate the gut-brain-microbiota axis. The objective of the SANGUT study is to determine the impact of interventions concerning the gut-brain-microbiota axis (probiotic supplementation, gluten-free diet and their combination) on the mental state, markers of inflammation and markers of intestinal permeability in adult patients with MDD. The study will last 12 weeks and consist of four visits (V): V0 - Screening (Day 0), V1 - Baseline (up to 1 week after Screening), V2 (six weeks after Baseline), V3 - End of the study (12 weeks after Baseline). The main hypothesis is that probiotic supplementation and/or a gluten-free diet will reduce the symptoms of depression, lower the level of inflammatory markers and favourably affect the integrity of the intestinal mucosal barrier.
|
{
"A": "Arm Label: Gluten-free diet; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Gluten-free diet | Intervention Type: DIETARY_SUPPLEMENT; Name: Gluten-free diet; Assigned to Arm(s): Gluten-free diet",
"B": "Arm Label: Group 1; Type: EXPERIMENTAL; Interventions: Other: Normal gluten containing bread | Arm Label: Group 2; Type: EXPERIMENTAL; Interventions: Other: Bread with reduced gliadins content | Arm Label: Group 3; Type: EXPERIMENTAL; Interventions: Other: Bread with reduced ATIs content | Arm Label: Group 4; Type: EXPERIMENTAL; Interventions: Other: Bread with reduced overall protein content | Intervention Type: OTHER; Name: Normal gluten containing bread; Assigned to Arm(s): Group 1 | Intervention Type: OTHER; Name: Bread with reduced gliadins content; Assigned to Arm(s): Group 2 | Intervention Type: OTHER; Name: Bread with reduced ATIs content; Assigned to Arm(s): Group 3 | Intervention Type: OTHER; Name: Bread with reduced overall protein content; Assigned to Arm(s): Group 4",
"C": "Arm Label: PRO-GFD; Type: EXPERIMENTAL; Interventions: Combination Product: Probiotic supplementation + gluten-free diet | Arm Label: PLA-GFD; Type: PLACEBO_COMPARATOR; Interventions: Combination Product: Placebo supplementation + gluten-free diet | Arm Label: PRO-GD; Type: EXPERIMENTAL; Interventions: Combination Product: Probiotic supplementation + gluten-containing diet | Arm Label: PLA-GD; Type: PLACEBO_COMPARATOR; Interventions: Combination Product: Placebo supplementation + gluten-containing diet | Intervention Type: COMBINATION_PRODUCT; Name: Probiotic supplementation + gluten-free diet; Assigned to Arm(s): PRO-GFD | Intervention Type: COMBINATION_PRODUCT; Name: Placebo supplementation + gluten-free diet; Assigned to Arm(s): PLA-GFD | Intervention Type: COMBINATION_PRODUCT; Name: Probiotic supplementation + gluten-containing diet; Assigned to Arm(s): PRO-GD | Intervention Type: COMBINATION_PRODUCT; Name: Placebo supplementation + gluten-containing diet; Assigned to Arm(s): PLA-GD",
"D": "Arm Label: gluten-containing diet; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Active comparator, gluten-free diet; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Gluten-free diet | Intervention Type: DIETARY_SUPPLEMENT; Name: Gluten-free diet; Assigned to Arm(s): Active comparator, gluten-free diet"
}
|
C
|
[
"NCT00677495",
"NCT02308397",
"NCT03877393",
"NCT01116505"
] | 27,126 |
val
|
NCT03878329
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Prospective Trial of Telemedicine Based Remote Home Monitoring After Liver Transplantation
Brief Summary: A significant opportunity exists to involve patients and their caregivers in more effective perioperative care and transition to home for transplant patients. Stakeholders were engaged through the University of Cincinnati Liver Transplant Program to prioritize changes in improving post transplant care. The initial findings indicated that increasing "care between visits" is the top priority for patients for improving function, quality of life and independence. Building on existing telehealth research, an enhanced home management program (HMP) to leverage and improve patient self-care following liver transplantation was developed, specifically by improving adherence, reducing readmissions and improving the transition from hospital to home. The improvement of care may have profound effect in the first 90 days after transplant on important long-term health parameters that affect clinical outcomes such as depression, weight gain, blood pressure control and diabetes management. With patient engagement, a randomized controlled trial is proposed comparing traditional provider-based care vs. traditional care with HMP. These two arms will need 50 patients in each arm with a 0.5 year follow up. Patients have said that the primary outcomes are quality of life, function and independence. To that end, the primary study outcomes are assessment of adherence, readmissions (90-day), patient satisfaction. The HMP model will advise providers, health care systems, and transplant centers how to improve patient care, especially among those at greatest risk of poor outcomes specifically minorities and those of low socioeconomic status.
|
{
"A": "Arm Label: Standard of Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: TMITT; Type: ACTIVE_COMPARATOR; Interventions: Other: Transplant Medication Information Teaching Tool | Intervention Type: OTHER; Name: Transplant Medication Information Teaching Tool; Assigned to Arm(s): TMITT",
"B": "Arm Label: 1 with pharmaceutical intervention; Type: EXPERIMENTAL; Interventions: Other: Pharmaceutical Intervention | Arm Label: 2 without pharmaceutical intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Pharmaceutical Intervention; Assigned to Arm(s): 1 with pharmaceutical intervention",
"C": "Arm Label: Prograf®; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tacrolimus - Prograf® twice daily formulation | Arm Label: Advagraf®; Type: EXPERIMENTAL; Interventions: Drug: Tacrolimus - Advagraf® once daily formulation | Intervention Type: DRUG; Name: Tacrolimus - Prograf® twice daily formulation; Assigned to Arm(s): Prograf® | Intervention Type: DRUG; Name: Tacrolimus - Advagraf® once daily formulation; Assigned to Arm(s): Advagraf®",
"D": "Arm Label: standard of care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: remote home monitoring; Type: EXPERIMENTAL; Interventions: Behavioral: remote home monitoring | Intervention Type: BEHAVIORAL; Name: remote home monitoring; Assigned to Arm(s): remote home monitoring"
}
|
D
|
[
"NCT01826721",
"NCT02402140",
"NCT01334333",
"NCT03878329"
] | 27,127 |
val
|
NCT03880032
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan
Brief Summary: In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder and major depression in mothers in late pregnancy and the postnatal period. Investigators will evaluate the impact of the intervention on fetal and infant growth restriction as well as examine how the impact of the intervention is mediated (to elucidate mechanisms) and/or modified (to help optimize future adaptations of the program) by various social factors. A cost-effectiveness evaluation will shed light on the costs and benefits of intervention components in relation to outcomes, enabling policy-makers and public health planners to scale up this intervention according to resource budgeting requirements.
|
{
"A": "Arm Label: Footlength Card; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Footlength Card | Arm Label: No Footlength Card; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Footlength Card; Assigned to Arm(s): Footlength Card",
"B": "Arm Label: Cognitive Behavioral Therapy Intervention for Anxiety; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioral Therapy Intervention for Anxiety | Arm Label: Enhanced Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy Intervention for Anxiety; Assigned to Arm(s): Cognitive Behavioral Therapy Intervention for Anxiety",
"C": "Arm Label: Postpartum Visit 3-4 Weeks; Type: EXPERIMENTAL; Interventions: Behavioral: Postpartum Visit 3-4 Weeks | Arm Label: Postpartum Visit 6-8 Weeks; Type: EXPERIMENTAL; Interventions: Behavioral: Postpartum Visit 6-8 Weeks | Intervention Type: BEHAVIORAL; Name: Postpartum Visit 3-4 Weeks; Assigned to Arm(s): Postpartum Visit 3-4 Weeks | Intervention Type: BEHAVIORAL; Name: Postpartum Visit 6-8 Weeks; Assigned to Arm(s): Postpartum Visit 6-8 Weeks",
"D": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Relaxation; Type: EXPERIMENTAL; Interventions: Behavioral: Relaxation | Intervention Type: BEHAVIORAL; Name: Relaxation; Assigned to Arm(s): Relaxation"
}
|
B
|
[
"NCT02802332",
"NCT03880032",
"NCT03165838",
"NCT01971216"
] | 27,128 |
val
|
NCT03880032
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan
Brief Summary: In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder and major depression in mothers in late pregnancy and the postnatal period. Investigators will evaluate the impact of the intervention on fetal and infant growth restriction as well as examine how the impact of the intervention is mediated (to elucidate mechanisms) and/or modified (to help optimize future adaptations of the program) by various social factors. A cost-effectiveness evaluation will shed light on the costs and benefits of intervention components in relation to outcomes, enabling policy-makers and public health planners to scale up this intervention according to resource budgeting requirements.
|
{
"A": "Arm Label: Mother Touch Program; Type: EXPERIMENTAL; Interventions: Other: Mothers Touch Program | Arm Label: Usual care Program; Type: OTHER; Interventions: Other: Usual Care Program | Intervention Type: OTHER; Name: Mothers Touch Program; Assigned to Arm(s): Mother Touch Program | Intervention Type: OTHER; Name: Usual Care Program; Assigned to Arm(s): Usual care Program",
"B": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: RLPT | Intervention Type: BEHAVIORAL; Name: RLPT; Assigned to Arm(s): Intervention",
"C": "Arm Label: Philani Intervention Program; Type: EXPERIMENTAL; Interventions: Behavioral: Philani Intervention Program | Arm Label: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Philani Intervention Program; Assigned to Arm(s): Philani Intervention Program",
"D": "Arm Label: Cognitive Behavioral Therapy Intervention for Anxiety; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioral Therapy Intervention for Anxiety | Arm Label: Enhanced Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy Intervention for Anxiety; Assigned to Arm(s): Cognitive Behavioral Therapy Intervention for Anxiety"
}
|
D
|
[
"NCT03715218",
"NCT03448289",
"NCT00996528",
"NCT03880032"
] | 27,129 |
val
|
NCT03880032
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan
Brief Summary: In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder and major depression in mothers in late pregnancy and the postnatal period. Investigators will evaluate the impact of the intervention on fetal and infant growth restriction as well as examine how the impact of the intervention is mediated (to elucidate mechanisms) and/or modified (to help optimize future adaptations of the program) by various social factors. A cost-effectiveness evaluation will shed light on the costs and benefits of intervention components in relation to outcomes, enabling policy-makers and public health planners to scale up this intervention according to resource budgeting requirements.
|
{
"A": "Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Other: Current collaborative care protocol | Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: Training in management of children's mental health problems | Intervention Type: OTHER; Name: Training in management of children's mental health problems; Assigned to Arm(s): Intervention | Intervention Type: OTHER; Name: Current collaborative care protocol; Assigned to Arm(s): Control",
"B": "Arm Label: Cognitive Behavioral Therapy Intervention for Anxiety; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioral Therapy Intervention for Anxiety | Arm Label: Enhanced Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy Intervention for Anxiety; Assigned to Arm(s): Cognitive Behavioral Therapy Intervention for Anxiety",
"C": "Arm Label: Self Help Plus; Type: EXPERIMENTAL; Interventions: Behavioral: Self Help Plus | Arm Label: Enhanced Treatment As Usual; Type: OTHER; Interventions: Other: Enhanced Treatment As Usual | Intervention Type: BEHAVIORAL; Name: Self Help Plus; Assigned to Arm(s): Self Help Plus | Intervention Type: OTHER; Name: Enhanced Treatment As Usual; Assigned to Arm(s): Enhanced Treatment As Usual",
"D": "Arm Label: Waitlist-Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Common Elements Treatment Approach; Type: EXPERIMENTAL; Interventions: Behavioral: Common Elements Treatment Approach | Intervention Type: BEHAVIORAL; Name: Common Elements Treatment Approach; Assigned to Arm(s): Common Elements Treatment Approach"
}
|
B
|
[
"NCT03144739",
"NCT03880032",
"NCT03571347",
"NCT01459068"
] | 27,130 |
val
|
NCT03880565
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Advanced REperfusion STrategies for Refractory Cardiac Arrest (The ARREST Trial)
Brief Summary: This is a Phase II, single center (Under the Center for Resuscitation Medicine at the University of Minnesota Medical School), partially blinded, prospective, intention to treat, safety and efficacy clinical trial, randomizing adult patients (18-75 years old) with refractory ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) out-of hospital cardiac arrest (OHCA) who are transferred by emergency medical services (EMS) with ongoing mechanical cardiopulmonary resuscitation (CPR) or who are resuscitated to receive one of the 2 local standards of care practiced in our community: 1) Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation or 2) Standard Advanced Cardiac Life Support (ACLS) Resuscitation
|
{
"A": "Arm Label: ECMO arm; Type: EXPERIMENTAL; Interventions: Device: ECMO (Quadrox®, Jostra®, Maquet®) | Arm Label: conventional arm; Type: ACTIVE_COMPARATOR; Interventions: Other: conventional care | Intervention Type: DEVICE; Name: ECMO (Quadrox®, Jostra®, Maquet®); Assigned to Arm(s): ECMO arm | Intervention Type: OTHER; Name: conventional care; Assigned to Arm(s): conventional arm",
"B": "Arm Label: Intensive care survivors; Type: N/A; Interventions: N/A",
"C": "Arm Label: CCPR protocol; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: ECPR protocol; Type: EXPERIMENTAL; Interventions: Procedure: Extracorporeal cardiopulmonary resuscitation (ECPR) | Intervention Type: PROCEDURE; Name: Extracorporeal cardiopulmonary resuscitation (ECPR); Assigned to Arm(s): ECPR protocol",
"D": "Arm Label: ECMO Facilitated Resuscitation; Type: EXPERIMENTAL; Interventions: Device: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation | Arm Label: Standard ACLS Resuscitation; Type: OTHER; Interventions: Device: Standard Advanced Cardiac Life Support (ACLS) Resuscitation | Intervention Type: DEVICE; Name: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation; Assigned to Arm(s): ECMO Facilitated Resuscitation | Intervention Type: DEVICE; Name: Standard Advanced Cardiac Life Support (ACLS) Resuscitation; Assigned to Arm(s): Standard ACLS Resuscitation"
}
|
D
|
[
"NCT01470703",
"NCT02225938",
"NCT03101787",
"NCT03880565"
] | 27,131 |
val
|
NCT03881150
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effectiveness of a Hybrid Cardiac Rehabilitation Program for Coronary Artery Disease Patients. Randomized, Multicenter, Non-inferiority Clinical Trial in a Low-resource Setting. HYCARET Study
Brief Summary: This clinical trial aim to evaluate if the prevention of recurrent cardiovascular events is not inferior in the hybrid mobile and exercise-based cardiac rehabilitation programs in comparison to the standard cardiac rehabilitation program.
|
{
"A": "Arm Label: Family-Centered Empowerment Model; Type: EXPERIMENTAL; Interventions: Other: Family-centered empowerment model | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Other: Control | Intervention Type: OTHER; Name: Family-centered empowerment model; Assigned to Arm(s): Family-Centered Empowerment Model | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): Control",
"B": "Intervention Type: OTHER; Name: Peer Support; Assigned to Arm(s): N/A",
"C": "Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Behavioral: HITCM+CP | Arm Label: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: HITCM only | Intervention Type: BEHAVIORAL; Name: HITCM+CP; Assigned to Arm(s): Arm 1 | Intervention Type: BEHAVIORAL; Name: HITCM only; Assigned to Arm(s): Arm 2",
"D": "Arm Label: Hybrid Cardiac Rehabilitation; Type: EXPERIMENTAL; Interventions: Other: Comprehensive assessment, Other: Counseling, Other: Exercise sessions in hybrid program, Other: Transition to unsupervised phase | Arm Label: Standard Cardiac Rehabilitation; Type: ACTIVE_COMPARATOR; Interventions: Other: Comprehensive assessment, Other: Group education, Other: Exercise sessions in standard program | Intervention Type: OTHER; Name: Comprehensive assessment; Assigned to Arm(s): Hybrid Cardiac Rehabilitation, Standard Cardiac Rehabilitation | Intervention Type: OTHER; Name: Counseling; Assigned to Arm(s): Hybrid Cardiac Rehabilitation | Intervention Type: OTHER; Name: Group education; Assigned to Arm(s): Standard Cardiac Rehabilitation | Intervention Type: OTHER; Name: Exercise sessions in hybrid program; Assigned to Arm(s): Hybrid Cardiac Rehabilitation | Intervention Type: OTHER; Name: Exercise sessions in standard program; Assigned to Arm(s): Standard Cardiac Rehabilitation | Intervention Type: OTHER; Name: Transition to unsupervised phase; Assigned to Arm(s): Hybrid Cardiac Rehabilitation"
}
|
D
|
[
"NCT02402582",
"NCT00275340",
"NCT00555360",
"NCT03881150"
] | 27,132 |
val
|
NCT03881657
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Sí Texas: Improving Access to Integrated Care for Rio Grande Valley Residents With Severe & Persistent Mental Illness
Brief Summary: This study evaluated whether patients with severe and persistent mental illness (SPMI) who received coordinated co-located behavioral health and primary care services were more likely to improve health outcomes after 12 months compared to SPMI patients who receive only behavioral health services from the local mental health authority (LMHA) Tropical Texas Behavioral Health (TTBH).The study employed a randomized control trial (RCT) design where intervention participants receiving integrated behavioral health were compared to control participants receiving the usual care provided within an LMHA for SPMI patients. Patients were placed in each group using a randomized number process. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data was subsequently collected at 6-month and 12-month follow-up points.
|
{
"A": "Arm Label: Collaborative depression care; Type: EXPERIMENTAL; Interventions: Behavioral: Collaborative depression care management | Intervention Type: BEHAVIORAL; Name: Collaborative depression care management; Assigned to Arm(s): Collaborative depression care",
"B": "Arm Label: IMPACT; Type: EXPERIMENTAL; Interventions: Other: IMPACT | Arm Label: Care as Usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: IMPACT; Assigned to Arm(s): IMPACT",
"C": "Arm Label: Collaborative Stepped Care; Type: EXPERIMENTAL; Interventions: Other: Collaborative Stepped Care Intervention | Arm Label: Enhanced Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Enhanced Usual Care | Intervention Type: OTHER; Name: Collaborative Stepped Care Intervention; Assigned to Arm(s): Collaborative Stepped Care | Intervention Type: OTHER; Name: Enhanced Usual Care; Assigned to Arm(s): Enhanced Usual Care",
"D": "Arm Label: Intervention Group; Type: EXPERIMENTAL; Interventions: Behavioral: Reverse Colocated Integrated Care | Arm Label: Control Group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Usual Care | Intervention Type: BEHAVIORAL; Name: Reverse Colocated Integrated Care; Assigned to Arm(s): Intervention Group | Intervention Type: BEHAVIORAL; Name: Usual Care; Assigned to Arm(s): Control Group"
}
|
D
|
[
"NCT02069912",
"NCT01561105",
"NCT00446407",
"NCT03881657"
] | 27,133 |
val
|
NCT03881813
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effectiveness of Two Types of Fixed Lingual Retainers in Preventing Mandibular Incisor Relapse
Brief Summary: The study evaluates effectiveness of two types of fixed retainers in post orthodontic patients. Half of the subjects are randomly allocated Group 1 retainer (FRC) and other half is given Group 2 retainer (MSW) and followed for a period of one year.
|
{
"A": "Arm Label: Fiber reinforced composite retainers; Type: EXPERIMENTAL; Interventions: Device: Orthodontic retainers | Arm Label: Multistranded stainless steel retainers; Type: EXPERIMENTAL; Interventions: Device: Orthodontic retainers | Intervention Type: DEVICE; Name: Orthodontic retainers; Assigned to Arm(s): Fiber reinforced composite retainers, Multistranded stainless steel retainers",
"B": "Arm Label: Receive electronic reminder; Type: EXPERIMENTAL; Interventions: Other: Electronic reminder | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Electronic reminder; Assigned to Arm(s): Receive electronic reminder",
"C": "Arm Label: Conventional; Type: EXPERIMENTAL; Interventions: Device: Vacuum Formed Thermoplastic Retainers Constructed On 3D Reconstructed Orthodontic Study Model | Arm Label: 3D; Type: EXPERIMENTAL; Interventions: Device: Vacuum Formed Thermoplastic Retainers Constructed On 3D Reconstructed Orthodontic Study Model | Intervention Type: DEVICE; Name: Vacuum Formed Thermoplastic Retainers Constructed On 3D Reconstructed Orthodontic Study Model; Assigned to Arm(s): 3D, Conventional",
"D": "Arm Label: Thermoplastic Retainer; Type: EXPERIMENTAL; Interventions: Other: orthodontic appliance | Arm Label: Hawley Retainer; Type: ACTIVE_COMPARATOR; Interventions: Other: orthodontic appliance | Intervention Type: OTHER; Name: orthodontic appliance; Assigned to Arm(s): Hawley Retainer, Thermoplastic Retainer"
}
|
A
|
[
"NCT03881813",
"NCT03224481",
"NCT02866617",
"NCT03683862"
] | 27,134 |
val
|
NCT03887468
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Dialysis Adequacy and Clotting Complications During Anticoagulation-free Hemodialysis Using a Heparin-grafted Dialyzer and a Citrate-enriched Dialysate: a Prospective Randomized Crossover Study. (EvoCit-HD Study)
Brief Summary: After providing informed consent, patients will be randomized to either the intervention treatment ("EvoCit procedure") or the control treatment ("EvoHep procedure").
After randomization, each study arm consists of four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol. After the last dialysis treatment of the fourth treatment week and after a long interdialytic interval, patients will crossover to the alternative hemodialysis procedure. After crossover, the study will be completed with, again, four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol.
|
{
"A": "Arm Label: Tinzaparin; Type: EXPERIMENTAL; Interventions: Drug: Tinzaparin, Drug: Placebo (for Unfractionated Heparin) | Arm Label: Unfractionated Heparin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Unfractionated Heparin, Drug: Placebo (for Tinzaparin) | Intervention Type: DRUG; Name: Tinzaparin; Assigned to Arm(s): Tinzaparin | Intervention Type: DRUG; Name: Unfractionated Heparin; Assigned to Arm(s): Unfractionated Heparin | Intervention Type: DRUG; Name: Placebo (for Tinzaparin); Assigned to Arm(s): Unfractionated Heparin | Intervention Type: DRUG; Name: Placebo (for Unfractionated Heparin); Assigned to Arm(s): Tinzaparin",
"B": "Arm Label: LMWH arm; Type: EXPERIMENTAL; Interventions: Drug: Nadroparin | Arm Label: UFH arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Unfractionated heparin | Intervention Type: DRUG; Name: Nadroparin; Assigned to Arm(s): LMWH arm | Intervention Type: DRUG; Name: Unfractionated heparin; Assigned to Arm(s): UFH arm",
"C": "Arm Label: \"EvoCit\"; Type: ACTIVE_COMPARATOR; Interventions: Device: EvoCit | Arm Label: \"EvoHep\"; Type: ACTIVE_COMPARATOR; Interventions: Device: EvoHep | Intervention Type: DEVICE; Name: EvoCit; Assigned to Arm(s): \"EvoCit\" | Intervention Type: DEVICE; Name: EvoHep; Assigned to Arm(s): \"EvoHep\"",
"D": "Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: law molecular weigth heparin | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: unfractioned heparin | Intervention Type: DRUG; Name: law molecular weigth heparin; Assigned to Arm(s): A | Intervention Type: DRUG; Name: unfractioned heparin; Assigned to Arm(s): B"
}
|
C
|
[
"NCT01930396",
"NCT02957877",
"NCT03887468",
"NCT00669721"
] | 27,135 |
val
|
NCT03887676
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Placebo-controlled Trial of ARBaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD
Brief Summary: This study will examine the safety and efficacy of arbaclofen vs. placebo on social function in children and adolescents with Autism Spectrum Disorder (ASD).
|
{
"A": "Arm Label: Placebo for AChEI and Choline; Type: PLACEBO_COMPARATOR; Interventions: Drug: Indistinguishable placebo tablets, matching both donepezil and choline | Arm Label: AChEI and Choline; Type: EXPERIMENTAL; Interventions: Drug: Acetyl-Choline Esterase Inhibitors and Choline supplements | Intervention Type: DRUG; Name: Acetyl-Choline Esterase Inhibitors and Choline supplements; Assigned to Arm(s): AChEI and Choline | Intervention Type: DRUG; Name: Indistinguishable placebo tablets, matching both donepezil and choline; Assigned to Arm(s): Placebo for AChEI and Choline",
"B": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: fluoxetine; Type: EXPERIMENTAL; Interventions: Drug: Fluoxetine | Intervention Type: DRUG; Name: Fluoxetine; Assigned to Arm(s): fluoxetine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: Arbaclofen; Type: ACTIVE_COMPARATOR; Interventions: Drug: Arbaclofen | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Arbaclofen; Assigned to Arm(s): Arbaclofen | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Arm Label: Sertraline Liquid Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Sertraline Liquid Placebo | Arm Label: Sertraline Active Medication; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sertraline | Intervention Type: DRUG; Name: Sertraline Liquid Placebo; Assigned to Arm(s): Sertraline Liquid Placebo | Intervention Type: DRUG; Name: Sertraline; Assigned to Arm(s): Sertraline Active Medication"
}
|
C
|
[
"NCT01098383",
"NCT00183339",
"NCT03887676",
"NCT02385799"
] | 27,136 |
val
|
NCT03887676
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Placebo-controlled Trial of ARBaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD
Brief Summary: This study will examine the safety and efficacy of arbaclofen vs. placebo on social function in children and adolescents with Autism Spectrum Disorder (ASD).
|
{
"A": "Arm Label: Arbaclofen; Type: ACTIVE_COMPARATOR; Interventions: Drug: Arbaclofen | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Arbaclofen; Assigned to Arm(s): Arbaclofen | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: Oxytocin; Type: EXPERIMENTAL; Interventions: Drug: Intranasal Oxytocin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Intranasal Oxytocin; Assigned to Arm(s): Oxytocin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: Trichuris Suis Ova (TSO); Type: EXPERIMENTAL; Interventions: Drug: Trichuris Suis Ova | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Trichuris Suis Ova | Intervention Type: DRUG; Name: Trichuris Suis Ova; Assigned to Arm(s): Placebo, Trichuris Suis Ova (TSO)",
"D": "Arm Label: Intranasal Oxytocin (Syntocinon); Type: EXPERIMENTAL; Interventions: Drug: Intranasal Oxytocin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Intranasal Oxytocin; Assigned to Arm(s): Intranasal Oxytocin (Syntocinon) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo"
}
|
A
|
[
"NCT03887676",
"NCT01337687",
"NCT01040221",
"NCT01908205"
] | 27,137 |
val
|
NCT03887676
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Placebo-controlled Trial of ARBaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD
Brief Summary: This study will examine the safety and efficacy of arbaclofen vs. placebo on social function in children and adolescents with Autism Spectrum Disorder (ASD).
|
{
"A": "Arm Label: Arbaclofen; Type: ACTIVE_COMPARATOR; Interventions: Drug: Arbaclofen | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Arbaclofen; Assigned to Arm(s): Arbaclofen | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Intervention Type: DRUG; Name: Risperidone; Assigned to Arm(s): N/A",
"C": "Arm Label: Intranasal Oxytocin (Syntocinon); Type: EXPERIMENTAL; Interventions: Drug: Intranasal Oxytocin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Intranasal Oxytocin; Assigned to Arm(s): Intranasal Oxytocin (Syntocinon) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Arm Label: De Novo; Type: EXPERIMENTAL; Interventions: Drug: Aripiprazole | Arm Label: Rollover Placebo; Type: EXPERIMENTAL; Interventions: Drug: Aripiprazole | Arm Label: Rollover Aripiprazole; Type: EXPERIMENTAL; Interventions: Drug: Aripiprazole | Intervention Type: DRUG; Name: Aripiprazole; Assigned to Arm(s): De Novo, Rollover Aripiprazole, Rollover Placebo"
}
|
A
|
[
"NCT03887676",
"NCT00005014",
"NCT01908205",
"NCT00365859"
] | 27,138 |
val
|
NCT03887910
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Northwell Health Visits: A Family Connects Pilot Implementation at Northwell Health
Brief Summary: Northwell Health Visits (NHV) is a three year pilot replication of the evidence-based model, Family Connects, which is a brief universal Nurse Practitioner home visiting program for new mothers and their infants. We seek to compare outcomes among mothers and infants enrolled in the NHV enhanced intervention arm, those enrolled in the NHV screening-only arm, and those in the control arm. NHV will follow a three- armed randomized control trial design.
|
{
"A": "Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: CHW-Visit; Type: EXPERIMENTAL; Interventions: Behavioral: Delivery of a Post-Partum Package | Arm Label: CHW-Phone; Type: EXPERIMENTAL; Interventions: Behavioral: Delivery of a Post-Partum Package | Intervention Type: BEHAVIORAL; Name: Delivery of a Post-Partum Package; Assigned to Arm(s): CHW-Phone, CHW-Visit",
"B": "Arm Label: Postpartum Contraceptives offered to Intervention Clusters; Type: EXPERIMENTAL; Interventions: Other: Offer of Participant's Choice of Contraception Method | Arm Label: Routine Care offered to Control Clusters; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Offer of Participant's Choice of Contraception Method; Assigned to Arm(s): Postpartum Contraceptives offered to Intervention Clusters",
"C": "Arm Label: Enhanced Intervention; Type: EXPERIMENTAL; Interventions: Other: Enhanced Intervention | Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: Intervention | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Enhanced Intervention; Assigned to Arm(s): Enhanced Intervention | Intervention Type: OTHER; Name: Intervention; Assigned to Arm(s): Intervention",
"D": "Arm Label: Durham Connects Eligible Group; Type: EXPERIMENTAL; Interventions: Other: Durham Connects | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Durham Connects; Assigned to Arm(s): Durham Connects Eligible Group"
}
|
C
|
[
"NCT02104635",
"NCT04005391",
"NCT03887910",
"NCT01406184"
] | 27,139 |
val
|
NCT03887910
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Northwell Health Visits: A Family Connects Pilot Implementation at Northwell Health
Brief Summary: Northwell Health Visits (NHV) is a three year pilot replication of the evidence-based model, Family Connects, which is a brief universal Nurse Practitioner home visiting program for new mothers and their infants. We seek to compare outcomes among mothers and infants enrolled in the NHV enhanced intervention arm, those enrolled in the NHV screening-only arm, and those in the control arm. NHV will follow a three- armed randomized control trial design.
|
{
"A": "Arm Label: Enhanced Intervention; Type: EXPERIMENTAL; Interventions: Other: Enhanced Intervention | Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: Intervention | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Enhanced Intervention; Assigned to Arm(s): Enhanced Intervention | Intervention Type: OTHER; Name: Intervention; Assigned to Arm(s): Intervention",
"B": "Arm Label: experimental group; Type: EXPERIMENTAL; Interventions: Behavioral: breastfeeding education, Behavioral: personal hygiene education, Behavioral: nutrition education, Behavioral: fatigue education, Behavioral: sleep education, Behavioral: pilates exercises education | Arm Label: control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: breastfeeding education; Assigned to Arm(s): experimental group | Intervention Type: BEHAVIORAL; Name: personal hygiene education; Assigned to Arm(s): experimental group | Intervention Type: BEHAVIORAL; Name: nutrition education; Assigned to Arm(s): experimental group | Intervention Type: BEHAVIORAL; Name: fatigue education; Assigned to Arm(s): experimental group | Intervention Type: BEHAVIORAL; Name: sleep education; Assigned to Arm(s): experimental group | Intervention Type: BEHAVIORAL; Name: pilates exercises education; Assigned to Arm(s): experimental group",
"C": "Arm Label: Philani Intervention Program; Type: EXPERIMENTAL; Interventions: Behavioral: Philani Intervention Program | Arm Label: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Philani Intervention Program; Assigned to Arm(s): Philani Intervention Program",
"D": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: RLPT | Intervention Type: BEHAVIORAL; Name: RLPT; Assigned to Arm(s): Intervention"
}
|
A
|
[
"NCT03887910",
"NCT04084275",
"NCT00996528",
"NCT03448289"
] | 27,140 |
val
|
NCT03887962
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Trial of Virtual Reality Biofeedback in Patients With Motor Neglect From Chronic Pain or Cerebrovascular Disease
Brief Summary: Motor neglect describes a loss of function without a loss of strength, reflexes or sensation. Motor neglect has been described in patients with traumatic brain injury, stroke and chronic pain conditions, e.g. complex regional pain syndrome. These conditions affect hundreds of thousands of patients in the UK each year and motor neglect is a significant obstacle in their rehabilitation towards a good outcome. By focussing on improving motor neglect, outcomes including function and quality of life for these groups of patients may significantly improve.
Motor neglect is potentially reversible. Rehabilitation using repetition, feedback and motivation are beneficial for optimal outcome. Current protocols use face-to-face physical therapies which can not optimise intensity due to a lack of resources. Furthermore, engagement with exercise is recognised to be poor, in part, due to a lack of attention. Innovative technologies may well improve engagement. Furthermore, telemedicine, or remote delivery of healthcare, offer opportunities in resource management, which can be delivered through the use of such innovative technologies.
Virtual reality systems have been designed and utilised in rehabilitation in various conditions, e.g post-stroke, cerebral palsy and Parkinson's disease. Studies demonstrate improved function in both upper and lower limbs. Potentially more effective treatments for motor neglect utilising such technology are therefore available but need more formal evaluation.
This protocol describes a Phase II randomised controlled trial for both in-patients and out-patients requiring rehabilitation with motor neglect from neurological causes (stroke, traumatic brain injury) and chronic pain conditions (Complex Regional Pain Syndromes, chronic low back pain and referred leg pain (sciatica)). The intervention will be a novel interactive virtual reality system using established technology and tailored software used in conjunction with a treadmill. The control group will be the same screen showing random static images whilst on the treadmill. Rehabilitation for each group will be offered in 3-4 sessions per week for 2 weeks. Each session will last about 30 minutes supervised by a physiotherapist. Follow-up will be by questionnaire at weeks 2, 6 and 12 and by face-to-face consultation at weeks 2 and 12.
|
{
"A": "Arm Label: Virtual Environment feedback; Type: EXPERIMENTAL; Interventions: Device: Virtual Environment Biofeedback | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Device: Treadmill walking with no Virtual Environment Biofeedback | Intervention Type: DEVICE; Name: Virtual Environment Biofeedback; Assigned to Arm(s): Virtual Environment feedback | Intervention Type: DEVICE; Name: Treadmill walking with no Virtual Environment Biofeedback; Assigned to Arm(s): Control",
"B": "Arm Label: Arm A Anodal tDCS and prismatic adaptation; Type: EXPERIMENTAL; Interventions: Device: transcranial direct current stimulation (tDCS) | Arm Label: Arm B: control; Type: PLACEBO_COMPARATOR; Interventions: Device: Control: placebo stimulation | Intervention Type: DEVICE; Name: transcranial direct current stimulation (tDCS); Assigned to Arm(s): Arm A Anodal tDCS and prismatic adaptation | Intervention Type: DEVICE; Name: Control: placebo stimulation; Assigned to Arm(s): Arm B: control",
"C": "Arm Label: Vibratory perturbed task-specific movement training; Type: EXPERIMENTAL; Interventions: Other: Vibratory perturbed task-specific movement training, Other: Sensorimotor training | Arm Label: Traditional task-oriented facilitation; Type: ACTIVE_COMPARATOR; Interventions: Other: Traditional task-oriented facilitation, Other: Sensorimotor training | Intervention Type: OTHER; Name: Vibratory perturbed task-specific movement training; Assigned to Arm(s): Vibratory perturbed task-specific movement training | Intervention Type: OTHER; Name: Traditional task-oriented facilitation; Assigned to Arm(s): Traditional task-oriented facilitation | Intervention Type: OTHER; Name: Sensorimotor training; Assigned to Arm(s): Traditional task-oriented facilitation, Vibratory perturbed task-specific movement training",
"D": "Arm Label: Intervention-Control (IC); Type: EXPERIMENTAL; Interventions: Behavioral: Optokinetic stimulation and cueing-based reading therapy (OKS-READ), Behavioral: General neuropsychological treatment | Arm Label: Control-Intervention (CI); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Optokinetic stimulation and cueing-based reading therapy (OKS-READ), Behavioral: General neuropsychological treatment | Intervention Type: BEHAVIORAL; Name: Optokinetic stimulation and cueing-based reading therapy (OKS-READ); Assigned to Arm(s): Control-Intervention (CI), Intervention-Control (IC) | Intervention Type: BEHAVIORAL; Name: General neuropsychological treatment; Assigned to Arm(s): Control-Intervention (CI), Intervention-Control (IC)"
}
|
A
|
[
"NCT03887962",
"NCT02213640",
"NCT03798340",
"NCT04273620"
] | 27,141 |
val
|
NCT03889821
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Does Mindfulness Training Enhance Early Evidence-based Parent-coaching Interventions for Autism Spectrum Disorder?: A Randomized Controlled Trial
Brief Summary: Caregivers of children with autism spectrum disorder (ASD) report higher levels of depression and distress than caregivers of typically developing children as well as children with other developmental disabilities. The proposed work tests a novel treatment paradigm that blends Mindfulness Based Stress Reduction (MBSR) with an empirically supported and manualized parent training program (Parent-Implemented Early Start Denver Model \[P-ESDM\]). We hypothesize that directly treating parental distress, while simultaneously providing evidence-based parent training, may greatly enhance child-focused intervention and provide benefits that resonate across the family.
|
{
"A": "Arm Label: Child-focused Treatment; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Parent-implemented Early Start Denver Model | Arm Label: Child- and Parent-focused Treatment; Type: EXPERIMENTAL; Interventions: Behavioral: Parent-implemented Early Start Denver Model, Behavioral: Mindfulness Based Stress Reduction | Intervention Type: BEHAVIORAL; Name: Parent-implemented Early Start Denver Model; Assigned to Arm(s): Child- and Parent-focused Treatment, Child-focused Treatment | Intervention Type: BEHAVIORAL; Name: Mindfulness Based Stress Reduction; Assigned to Arm(s): Child- and Parent-focused Treatment",
"B": "Arm Label: Parenting Mindfully Program; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting Mindfully Program | Arm Label: Parent Education Program; Type: ACTIVE_COMPARATOR; Interventions: Other: Parent Education Program | Intervention Type: BEHAVIORAL; Name: Parenting Mindfully Program; Assigned to Arm(s): Parenting Mindfully Program | Intervention Type: OTHER; Name: Parent Education Program; Assigned to Arm(s): Parent Education Program",
"C": "Arm Label: lifestyle; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Lifestyle counseling | Arm Label: therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle counseling, Behavioral: Parenting Mindfully for Health (PMH) | Intervention Type: BEHAVIORAL; Name: Lifestyle counseling; Assigned to Arm(s): lifestyle, therapy | Intervention Type: BEHAVIORAL; Name: Parenting Mindfully for Health (PMH); Assigned to Arm(s): therapy",
"D": "Arm Label: AMOR Method; Type: EXPERIMENTAL; Interventions: Behavioral: The AMOR Method | Arm Label: Wait List; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: The AMOR Method; Assigned to Arm(s): AMOR Method"
}
|
A
|
[
"NCT03889821",
"NCT02038231",
"NCT01974102",
"NCT03513419"
] | 27,142 |
val
|
NCT03890978
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Improving Exclusive Breastfeeding Via Mobile Phone Text Messages: a Randomized Controlled Trial in Southern Jordan
Brief Summary: World Health Organization (2001) recommended that infants should be exclusively breastfed for the first 6 months and could be continued in the second year of life or longer. The rate of exclusive breastfeeding (EBF) in Jordan is in progressive decline. In 2002 the EBF rate among babies less than 6 months old was 26.7% and unfortunately this rate dropped to 22% in 2007 and to 23% in 2012. In Jordan, 68% of babies receive breast milk within 24 hours of birth and the large majority continues to do so for 12.5 months, but EBF rates are very low. While health and nutrition experts recommend that introduction of complementary foods should start only when an infant is six months old, other liquids such as water, juice, and formula milk are being introduced to most Jordanian infants in the first couple of months . Thus, urgent attention is directed towards improving exclusive breastfeeding rates during the first six months of life.Despite scientific evidence concerning the benefits of breast milk, the practice of EBF is still uncommon in Jordan. Even with the consolidation of numerous strategies to promote breastfeeding and the general public health recommendation that infants should be exclusively breastfed during the first six months of life, the duration of breastfeeding in Jordan is in progressive decline and the percentage of infants exclusively breastfed for the first six months of life is still low and worrisome. A review of previous studies in Jordan, showed that most of these are descriptive studies focused on studying the factors affecting the rate of EBF and the reasons why women stop breastfeeding their children. There is no study on improving EBF for women in Jordan so far. To date there have been no interventions using mobile phones to improve breastfeeding and other feeding practices in Jordan. The aim of this research is to improve the EBF rates and duration through using a mobile phone-based EBF promotion (Text message). A randomized controlled trial with follow-up from recruitment until 6 months post-delivery will be conducted to implement EBF promotion intervention using mobile phone text messages in southern Jordan, and evaluate its impact on breastfeeding practices. The intervention group will receive EBF promotional messages and the control group will receive child health care-related messages (except breastfeeding messages) from the time of discharge until 6 months post delivery.
|
{
"A": "Arm Label: intervention; Type: EXPERIMENTAL; Interventions: Other: promotional Exclusive breastfeeding text messages | Arm Label: control; Type: OTHER; Interventions: Other: promotional Exclusive breastfeeding text messages | Intervention Type: OTHER; Name: promotional Exclusive breastfeeding text messages; Assigned to Arm(s): control, intervention",
"B": "Arm Label: Individualized, interactive SMS; Type: EXPERIMENTAL; Interventions: Behavioral: Individualized, interactive short messaging intervention | Arm Label: Standard care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Individualized, interactive short messaging intervention; Assigned to Arm(s): Individualized, interactive SMS",
"C": "Arm Label: Cell-phone assisted; Type: EXPERIMENTAL; Interventions: Device: Cell-phone | Arm Label: control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Cell-phone; Assigned to Arm(s): Cell-phone assisted",
"D": "Arm Label: mHealth; Type: EXPERIMENTAL; Interventions: Other: mHealth | Arm Label: No mHealth; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: mHealth; Assigned to Arm(s): mHealth"
}
|
A
|
[
"NCT03890978",
"NCT02627365",
"NCT03135288",
"NCT02376023"
] | 27,143 |
val
|
NCT03890978
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Improving Exclusive Breastfeeding Via Mobile Phone Text Messages: a Randomized Controlled Trial in Southern Jordan
Brief Summary: World Health Organization (2001) recommended that infants should be exclusively breastfed for the first 6 months and could be continued in the second year of life or longer. The rate of exclusive breastfeeding (EBF) in Jordan is in progressive decline. In 2002 the EBF rate among babies less than 6 months old was 26.7% and unfortunately this rate dropped to 22% in 2007 and to 23% in 2012. In Jordan, 68% of babies receive breast milk within 24 hours of birth and the large majority continues to do so for 12.5 months, but EBF rates are very low. While health and nutrition experts recommend that introduction of complementary foods should start only when an infant is six months old, other liquids such as water, juice, and formula milk are being introduced to most Jordanian infants in the first couple of months . Thus, urgent attention is directed towards improving exclusive breastfeeding rates during the first six months of life.Despite scientific evidence concerning the benefits of breast milk, the practice of EBF is still uncommon in Jordan. Even with the consolidation of numerous strategies to promote breastfeeding and the general public health recommendation that infants should be exclusively breastfed during the first six months of life, the duration of breastfeeding in Jordan is in progressive decline and the percentage of infants exclusively breastfed for the first six months of life is still low and worrisome. A review of previous studies in Jordan, showed that most of these are descriptive studies focused on studying the factors affecting the rate of EBF and the reasons why women stop breastfeeding their children. There is no study on improving EBF for women in Jordan so far. To date there have been no interventions using mobile phones to improve breastfeeding and other feeding practices in Jordan. The aim of this research is to improve the EBF rates and duration through using a mobile phone-based EBF promotion (Text message). A randomized controlled trial with follow-up from recruitment until 6 months post-delivery will be conducted to implement EBF promotion intervention using mobile phone text messages in southern Jordan, and evaluate its impact on breastfeeding practices. The intervention group will receive EBF promotional messages and the control group will receive child health care-related messages (except breastfeeding messages) from the time of discharge until 6 months post delivery.
|
{
"A": "Arm Label: mhealth intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Mhealth intervention | Arm Label: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Mhealth intervention; Assigned to Arm(s): mhealth intervention",
"B": "Arm Label: intervention; Type: EXPERIMENTAL; Interventions: Other: promotional Exclusive breastfeeding text messages | Arm Label: control; Type: OTHER; Interventions: Other: promotional Exclusive breastfeeding text messages | Intervention Type: OTHER; Name: promotional Exclusive breastfeeding text messages; Assigned to Arm(s): control, intervention",
"C": "Arm Label: Standard of Care (SoC); Type: NO_INTERVENTION; Interventions: N/A | Arm Label: SoC + iTab; Type: ACTIVE_COMPARATOR; Interventions: Device: SoC + iTab | Intervention Type: DEVICE; Name: SoC + iTab; Assigned to Arm(s): SoC + iTab",
"D": "Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Intervention | Arm Label: Enhanced Standard of Care; Type: EXPERIMENTAL; Interventions: Behavioral: Enhanced Standard of Care | Arm Label: Traditional Standard of Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Traditional Standard of Care | Intervention Type: BEHAVIORAL; Name: Intervention; Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: Enhanced Standard of Care; Assigned to Arm(s): Enhanced Standard of Care | Intervention Type: BEHAVIORAL; Name: Traditional Standard of Care; Assigned to Arm(s): Traditional Standard of Care"
}
|
B
|
[
"NCT02579785",
"NCT03890978",
"NCT01761643",
"NCT03662165"
] | 27,144 |
val
|
NCT03890978
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Improving Exclusive Breastfeeding Via Mobile Phone Text Messages: a Randomized Controlled Trial in Southern Jordan
Brief Summary: World Health Organization (2001) recommended that infants should be exclusively breastfed for the first 6 months and could be continued in the second year of life or longer. The rate of exclusive breastfeeding (EBF) in Jordan is in progressive decline. In 2002 the EBF rate among babies less than 6 months old was 26.7% and unfortunately this rate dropped to 22% in 2007 and to 23% in 2012. In Jordan, 68% of babies receive breast milk within 24 hours of birth and the large majority continues to do so for 12.5 months, but EBF rates are very low. While health and nutrition experts recommend that introduction of complementary foods should start only when an infant is six months old, other liquids such as water, juice, and formula milk are being introduced to most Jordanian infants in the first couple of months . Thus, urgent attention is directed towards improving exclusive breastfeeding rates during the first six months of life.Despite scientific evidence concerning the benefits of breast milk, the practice of EBF is still uncommon in Jordan. Even with the consolidation of numerous strategies to promote breastfeeding and the general public health recommendation that infants should be exclusively breastfed during the first six months of life, the duration of breastfeeding in Jordan is in progressive decline and the percentage of infants exclusively breastfed for the first six months of life is still low and worrisome. A review of previous studies in Jordan, showed that most of these are descriptive studies focused on studying the factors affecting the rate of EBF and the reasons why women stop breastfeeding their children. There is no study on improving EBF for women in Jordan so far. To date there have been no interventions using mobile phones to improve breastfeeding and other feeding practices in Jordan. The aim of this research is to improve the EBF rates and duration through using a mobile phone-based EBF promotion (Text message). A randomized controlled trial with follow-up from recruitment until 6 months post-delivery will be conducted to implement EBF promotion intervention using mobile phone text messages in southern Jordan, and evaluate its impact on breastfeeding practices. The intervention group will receive EBF promotional messages and the control group will receive child health care-related messages (except breastfeeding messages) from the time of discharge until 6 months post delivery.
|
{
"A": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: SMS reminder; Type: EXPERIMENTAL; Interventions: Behavioral: SMS reminder | Arm Label: SMS reminder + Unconditional Incentive; Type: EXPERIMENTAL; Interventions: Behavioral: SMS reminder, Behavioral: Unconditional Incentive | Intervention Type: BEHAVIORAL; Name: SMS reminder; Assigned to Arm(s): SMS reminder, SMS reminder + Unconditional Incentive | Intervention Type: BEHAVIORAL; Name: Unconditional Incentive; Assigned to Arm(s): SMS reminder + Unconditional Incentive",
"B": "Arm Label: intervention; Type: EXPERIMENTAL; Interventions: Other: promotional Exclusive breastfeeding text messages | Arm Label: control; Type: OTHER; Interventions: Other: promotional Exclusive breastfeeding text messages | Intervention Type: OTHER; Name: promotional Exclusive breastfeeding text messages; Assigned to Arm(s): control, intervention",
"C": "Arm Label: Text Message; Type: EXPERIMENTAL; Interventions: Other: Text Message | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Text Message; Assigned to Arm(s): Text Message",
"D": "Arm Label: texting group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: text messages focused on smoking cessation and pregnancy | Arm Label: control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: text messages focused on smoking cessation and pregnancy; Assigned to Arm(s): texting group"
}
|
B
|
[
"NCT02904642",
"NCT03890978",
"NCT01186575",
"NCT03024606"
] | 27,145 |
val
|
NCT03890978
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Improving Exclusive Breastfeeding Via Mobile Phone Text Messages: a Randomized Controlled Trial in Southern Jordan
Brief Summary: World Health Organization (2001) recommended that infants should be exclusively breastfed for the first 6 months and could be continued in the second year of life or longer. The rate of exclusive breastfeeding (EBF) in Jordan is in progressive decline. In 2002 the EBF rate among babies less than 6 months old was 26.7% and unfortunately this rate dropped to 22% in 2007 and to 23% in 2012. In Jordan, 68% of babies receive breast milk within 24 hours of birth and the large majority continues to do so for 12.5 months, but EBF rates are very low. While health and nutrition experts recommend that introduction of complementary foods should start only when an infant is six months old, other liquids such as water, juice, and formula milk are being introduced to most Jordanian infants in the first couple of months . Thus, urgent attention is directed towards improving exclusive breastfeeding rates during the first six months of life.Despite scientific evidence concerning the benefits of breast milk, the practice of EBF is still uncommon in Jordan. Even with the consolidation of numerous strategies to promote breastfeeding and the general public health recommendation that infants should be exclusively breastfed during the first six months of life, the duration of breastfeeding in Jordan is in progressive decline and the percentage of infants exclusively breastfed for the first six months of life is still low and worrisome. A review of previous studies in Jordan, showed that most of these are descriptive studies focused on studying the factors affecting the rate of EBF and the reasons why women stop breastfeeding their children. There is no study on improving EBF for women in Jordan so far. To date there have been no interventions using mobile phones to improve breastfeeding and other feeding practices in Jordan. The aim of this research is to improve the EBF rates and duration through using a mobile phone-based EBF promotion (Text message). A randomized controlled trial with follow-up from recruitment until 6 months post-delivery will be conducted to implement EBF promotion intervention using mobile phone text messages in southern Jordan, and evaluate its impact on breastfeeding practices. The intervention group will receive EBF promotional messages and the control group will receive child health care-related messages (except breastfeeding messages) from the time of discharge until 6 months post delivery.
|
{
"A": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Text message; Type: ACTIVE_COMPARATOR; Interventions: Other: SMS reminder message | Arm Label: Text message and voice call; Type: ACTIVE_COMPARATOR; Interventions: Other: Voice call + SMS message | Intervention Type: OTHER; Name: SMS reminder message; Assigned to Arm(s): Text message | Intervention Type: OTHER; Name: Voice call + SMS message; Assigned to Arm(s): Text message and voice call",
"B": "Arm Label: ISAP SMS; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: ISAP SMS | Arm Label: No ISAP SMS; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: ISAP SMS; Assigned to Arm(s): ISAP SMS",
"C": "Arm Label: intervention; Type: EXPERIMENTAL; Interventions: Other: promotional Exclusive breastfeeding text messages | Arm Label: control; Type: OTHER; Interventions: Other: promotional Exclusive breastfeeding text messages | Intervention Type: OTHER; Name: promotional Exclusive breastfeeding text messages; Assigned to Arm(s): control, intervention",
"D": "Arm Label: One time standard verbal counseling; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: SMS Reminders; Type: EXPERIMENTAL; Interventions: Behavioral: Short message service | Intervention Type: BEHAVIORAL; Name: Short message service; Assigned to Arm(s): SMS Reminders"
}
|
C
|
[
"NCT02662595",
"NCT03705455",
"NCT03890978",
"NCT01859546"
] | 27,146 |
val
|
NCT03890978
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Improving Exclusive Breastfeeding Via Mobile Phone Text Messages: a Randomized Controlled Trial in Southern Jordan
Brief Summary: World Health Organization (2001) recommended that infants should be exclusively breastfed for the first 6 months and could be continued in the second year of life or longer. The rate of exclusive breastfeeding (EBF) in Jordan is in progressive decline. In 2002 the EBF rate among babies less than 6 months old was 26.7% and unfortunately this rate dropped to 22% in 2007 and to 23% in 2012. In Jordan, 68% of babies receive breast milk within 24 hours of birth and the large majority continues to do so for 12.5 months, but EBF rates are very low. While health and nutrition experts recommend that introduction of complementary foods should start only when an infant is six months old, other liquids such as water, juice, and formula milk are being introduced to most Jordanian infants in the first couple of months . Thus, urgent attention is directed towards improving exclusive breastfeeding rates during the first six months of life.Despite scientific evidence concerning the benefits of breast milk, the practice of EBF is still uncommon in Jordan. Even with the consolidation of numerous strategies to promote breastfeeding and the general public health recommendation that infants should be exclusively breastfed during the first six months of life, the duration of breastfeeding in Jordan is in progressive decline and the percentage of infants exclusively breastfed for the first six months of life is still low and worrisome. A review of previous studies in Jordan, showed that most of these are descriptive studies focused on studying the factors affecting the rate of EBF and the reasons why women stop breastfeeding their children. There is no study on improving EBF for women in Jordan so far. To date there have been no interventions using mobile phones to improve breastfeeding and other feeding practices in Jordan. The aim of this research is to improve the EBF rates and duration through using a mobile phone-based EBF promotion (Text message). A randomized controlled trial with follow-up from recruitment until 6 months post-delivery will be conducted to implement EBF promotion intervention using mobile phone text messages in southern Jordan, and evaluate its impact on breastfeeding practices. The intervention group will receive EBF promotional messages and the control group will receive child health care-related messages (except breastfeeding messages) from the time of discharge until 6 months post delivery.
|
{
"A": "Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Mobile phone reminder | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Mobile phone reminder | Intervention Type: BEHAVIORAL; Name: Mobile phone reminder; Assigned to Arm(s): Control, Intervention",
"B": "Arm Label: Kilkari; Type: EXPERIMENTAL; Interventions: Other: Kilkari | Arm Label: Comparison; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Kilkari; Assigned to Arm(s): Kilkari",
"C": "Arm Label: intervention; Type: EXPERIMENTAL; Interventions: Other: promotional Exclusive breastfeeding text messages | Arm Label: control; Type: OTHER; Interventions: Other: promotional Exclusive breastfeeding text messages | Intervention Type: OTHER; Name: promotional Exclusive breastfeeding text messages; Assigned to Arm(s): control, intervention",
"D": "Arm Label: Cell-phone assisted; Type: EXPERIMENTAL; Interventions: Device: Cell-phone | Arm Label: control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Cell-phone; Assigned to Arm(s): Cell-phone assisted"
}
|
C
|
[
"NCT03367130",
"NCT03576157",
"NCT03890978",
"NCT03135288"
] | 27,147 |
val
|
NCT03891082
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Comparative Study Between Bakri Balloon and B Lynch Suture Used to Control Primary Postpartum Hemorrhage After Cesarean Section
Brief Summary: Hundred (100) patients with primary postpartum hemorrhage during caesarean section due to atonic uterus will be recruited for this study.and randomized to either B lynch or Bakeri Ballon
B-Lynch:
A 70 mm round bodied hand needle on which a No. 2 absorbable suture is mounted is used to puncture the uterus 3 cm from the right lower edge of the uterine incision and 3 cm from the right lateral border. The mounted No. 2 absorbable suture is threaded through the uterine cavity to emerge at the upper incision margin 3 cm above and approximately 4 cm from the lateral border (because the uterus widens from below upwards). The absorbable suture now visible is passed over to compress the uterine fundus approximately 34 cm from the right cornual border. The absorbable suture is fed posteriorly and vertically to enter the posterior wall of the uterine cavity at the same level as the upper anterior entry point. The absorbable suture is pulled under moderate tension assisted by manual compression exerted by the first assistant. The length of the absorbable suture is passed back posteriorly through the same surface marking as for the right side, the suture lying horizontally. The absorbable suture is fed through posteriorly and vertically over the fundus to lie anteriorly and Research Template 7 Final Version: 1/6/2018 vertically compressing the fundus on the left side as occurred on the right. The needle is passed in the same fashion on the left side through the uterine cavity and out approximately 3 cm anteriorly and below the lower incision margin on the left side. The two lengths of absorbable suture are pulled taught assisted by bi-manual compression to minimize trauma and to achieve or aid compression. During such compression the vagina is checked that the bleeding is controlled. As good hemostasis is secured and whilst the uterus is compressed by an experienced assistant the principal surgeon throws a knot (double throw) followed by two or three further throws to secure tension. The lower transverse uterine incision is now closed in the normal way, in two layers, with or without closure of the lower uterine segment peritoneum. BALLOON INSERTION Insert the balloon portion of the catheter in the uterus; making certain that the entire balloon is inserted past the cervical canal and internal ostium. NOTE: Avoid excessive force when inserting the balloon into the uterus. Place a Foley catheter in patient bladder to collect and monitor urine output. To ensure maintenance of correct placement and maximize tamponade effect, the vaginal canal may be packed with iodine or antibiotic soaked vaginal gauze at this time.
|
{
"A": "Arm Label: With Bakri balloon; Type: EXPERIMENTAL; Interventions: Device: Bakri balloon | Arm Label: Without Bakri balloon; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Routine care | Intervention Type: PROCEDURE; Name: Routine care; Assigned to Arm(s): Without Bakri balloon | Intervention Type: DEVICE; Name: Bakri balloon; Assigned to Arm(s): With Bakri balloon",
"B": "Arm Label: Bakri balloon group; Type: ACTIVE_COMPARATOR; Interventions: Device: Bakri balloon | Arm Label: Condom loaded Foley's catheter group; Type: ACTIVE_COMPARATOR; Interventions: Device: Condom loaded foley's catheter | Intervention Type: DEVICE; Name: Bakri balloon; Assigned to Arm(s): Bakri balloon group | Intervention Type: DEVICE; Name: Condom loaded foley's catheter; Assigned to Arm(s): Condom loaded Foley's catheter group",
"C": "Arm Label: B-Lynch; Type: ACTIVE_COMPARATOR; Interventions: Procedure: B-Lynch | Arm Label: Bakri balloon; Type: ACTIVE_COMPARATOR; Interventions: Procedure: BALLOON INSERTION | Intervention Type: PROCEDURE; Name: B-Lynch; Assigned to Arm(s): B-Lynch | Intervention Type: PROCEDURE; Name: BALLOON INSERTION; Assigned to Arm(s): Bakri balloon",
"D": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention; Type: OTHER; Interventions: Device: non-pneumatic anti-shock garment | Intervention Type: DEVICE; Name: non-pneumatic anti-shock garment; Assigned to Arm(s): Intervention"
}
|
C
|
[
"NCT01980173",
"NCT02430155",
"NCT03891082",
"NCT00488462"
] | 27,148 |
val
|
NCT03891368
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Controlled Trial of a Learning Collaborative to Implement Health Promotion in Mental Health
Brief Summary: Healthcare organizations have increasingly formed quality-improvement Learning Collaboratives to improve care for specific populations; however, there are few data on the effectiveness of this strategy compared to conventional training approaches. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to typical implementation consisting of site training and one-on-one individual technical assistance (TA). The investigators hypothesize that VLC compared to TA will be associated with greater Program Participation, Program Fidelity, and a greater proportion of participants achieving clinically significant weight loss.
|
{
"A": "Arm Label: Intervention Group; Type: EXPERIMENTAL; Interventions: Behavioral: Reverse Colocated Integrated Care | Arm Label: Control Group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Usual Care | Intervention Type: BEHAVIORAL; Name: Reverse Colocated Integrated Care; Assigned to Arm(s): Intervention Group | Intervention Type: BEHAVIORAL; Name: Usual Care; Assigned to Arm(s): Control Group",
"B": "Arm Label: IMPACT; Type: EXPERIMENTAL; Interventions: Other: IMPACT | Arm Label: Care as Usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: IMPACT; Assigned to Arm(s): IMPACT",
"C": "Arm Label: Virtual Learning Collaborative; Type: EXPERIMENTAL; Interventions: Other: Virtual Learning Collaborative | Arm Label: Technical Assistance; Type: ACTIVE_COMPARATOR; Interventions: Other: Technical Assistance | Intervention Type: OTHER; Name: Virtual Learning Collaborative; Assigned to Arm(s): Virtual Learning Collaborative | Intervention Type: OTHER; Name: Technical Assistance; Assigned to Arm(s): Technical Assistance",
"D": "Arm Label: Arm 1; Type: OTHER; Interventions: Behavioral: Life Goals Collaborative Care | Intervention Type: BEHAVIORAL; Name: Life Goals Collaborative Care; Assigned to Arm(s): Arm 1"
}
|
C
|
[
"NCT03881657",
"NCT01561105",
"NCT03891368",
"NCT01244854"
] | 27,149 |
val
|
NCT03892915
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Depression Care to Improve Adherence to Prevention of Mother-to-Child-Transmission (PMTCT) Care Continuum & Pregnancy Outcomes
Brief Summary: Cluster randomized controlled trial to compare the effects of task-shifted, evidence-based depression care vs. usual care on adherence to each step of the prevention of mother-to-child-transmission (PMTCT) care cascade at 8 antenatal care (ANC) clinics in Uganda.
|
{
"A": "Arm Label: ARM 1: Component-Based Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Common Elements Treatment Approach | Arm Label: ARM 2: Community Group Therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Narrative Community Group Therapy | Arm Label: ARM 3: Standby group; Type: OTHER; Interventions: Other: Standby group | Intervention Type: BEHAVIORAL; Name: Common Elements Treatment Approach; Assigned to Arm(s): ARM 1: Component-Based Intervention | Intervention Type: BEHAVIORAL; Name: Narrative Community Group Therapy; Assigned to Arm(s): ARM 2: Community Group Therapy | Intervention Type: OTHER; Name: Standby group; Assigned to Arm(s): ARM 3: Standby group",
"B": "Arm Label: Waitlist-Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Common Elements Treatment Approach; Type: EXPERIMENTAL; Interventions: Behavioral: Common Elements Treatment Approach | Intervention Type: BEHAVIORAL; Name: Common Elements Treatment Approach; Assigned to Arm(s): Common Elements Treatment Approach",
"C": "Arm Label: Depression Care; Type: EXPERIMENTAL; Interventions: Combination Product: evidence-based depression treatment | Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: COMBINATION_PRODUCT; Name: evidence-based depression treatment; Assigned to Arm(s): Depression Care",
"D": "Arm Label: Task-sharing approach to group therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Task-sharing approach to group therapy | Arm Label: Enhanced standard of care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Enhanced standard of care | Intervention Type: BEHAVIORAL; Name: Task-sharing approach to group therapy; Assigned to Arm(s): Task-sharing approach to group therapy | Intervention Type: BEHAVIORAL; Name: Enhanced standard of care; Assigned to Arm(s): Enhanced standard of care"
}
|
C
|
[
"NCT01856673",
"NCT01459068",
"NCT03892915",
"NCT02039973"
] | 27,150 |
val
|
NCT03894462
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effectiveness of a Targeted Brief Intervention for Recent Suicide Attempt Survivors
Brief Summary: Effective, brief, low-cost interventions for individuals who attempt suicide are needed to save lives and achieve the goals of the National Strategy for Suicide Prevention. In response to a National Institute for Mental Health (NIMH) Notice of Interest, this time-sensitive proposal leverages an existing federal investment in Zero Suicide to test the effectiveness of a highly promising new treatment for recent suicide attempt survivors and learn how it works. If hypotheses are supported, the study will provide evidence of a brief, practical, and cost-effective therapy that reduces suicide reattempts in a real-world health setting.
|
{
"A": "Arm Label: Culturally adapted therapy (C-MAP); Type: EXPERIMENTAL; Interventions: Behavioral: Culturally adapted therapy (C-MAP) | Arm Label: Treatment as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Culturally adapted therapy (C-MAP); Assigned to Arm(s): Culturally adapted therapy (C-MAP)",
"B": "Arm Label: therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive behavioural therapy | Arm Label: Standard treatment; Type: ACTIVE_COMPARATOR; Interventions: Other: Standard treatment | Intervention Type: BEHAVIORAL; Name: Cognitive behavioural therapy; Assigned to Arm(s): therapy | Intervention Type: OTHER; Name: Standard treatment; Assigned to Arm(s): Standard treatment",
"C": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Omacor® | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Omacor® | Arm Label: 3; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Omacor®; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 3",
"D": "Arm Label: Zero Suicide Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Zero Suicide Usual Care | Arm Label: Zero Suicide Usual Care + ASSIP; Type: EXPERIMENTAL; Interventions: Behavioral: Attempted Suicide Short Intervention Program | Intervention Type: BEHAVIORAL; Name: Attempted Suicide Short Intervention Program; Assigned to Arm(s): Zero Suicide Usual Care + ASSIP | Intervention Type: BEHAVIORAL; Name: Zero Suicide Usual Care; Assigned to Arm(s): Zero Suicide Usual Care"
}
|
D
|
[
"NCT02742922",
"NCT00980824",
"NCT00437099",
"NCT03894462"
] | 27,151 |
val
|
NCT03894462
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effectiveness of a Targeted Brief Intervention for Recent Suicide Attempt Survivors
Brief Summary: Effective, brief, low-cost interventions for individuals who attempt suicide are needed to save lives and achieve the goals of the National Strategy for Suicide Prevention. In response to a National Institute for Mental Health (NIMH) Notice of Interest, this time-sensitive proposal leverages an existing federal investment in Zero Suicide to test the effectiveness of a highly promising new treatment for recent suicide attempt survivors and learn how it works. If hypotheses are supported, the study will provide evidence of a brief, practical, and cost-effective therapy that reduces suicide reattempts in a real-world health setting.
|
{
"A": "Arm Label: Zero Suicide Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Zero Suicide Usual Care | Arm Label: Zero Suicide Usual Care + ASSIP; Type: EXPERIMENTAL; Interventions: Behavioral: Attempted Suicide Short Intervention Program | Intervention Type: BEHAVIORAL; Name: Attempted Suicide Short Intervention Program; Assigned to Arm(s): Zero Suicide Usual Care + ASSIP | Intervention Type: BEHAVIORAL; Name: Zero Suicide Usual Care; Assigned to Arm(s): Zero Suicide Usual Care",
"B": "Arm Label: Body Acceptance Program; Type: EXPERIMENTAL; Interventions: Behavioral: Body Acceptance Program | Arm Label: Waitlist control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Body Acceptance Program; Assigned to Arm(s): Body Acceptance Program",
"C": "Arm Label: Presence of SUD with BCBT; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioral Therapy | Arm Label: Presence of SUD with TAU; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Absence of SUD with BCBT; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioral Therapy | Arm Label: Absence of SUD with TAU; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy; Assigned to Arm(s): Absence of SUD with BCBT, Presence of SUD with BCBT",
"D": "Arm Label: Dialectical Behaviour Therapy-6 months; Type: EXPERIMENTAL; Interventions: Behavioral: Dialectical Behaviour Therapy-6 months | Arm Label: Dialectical Behaviour Therapy-12 months; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Dialectical Behaviour Therapy-12 months | Intervention Type: BEHAVIORAL; Name: Dialectical Behaviour Therapy-6 months; Assigned to Arm(s): Dialectical Behaviour Therapy-6 months | Intervention Type: BEHAVIORAL; Name: Dialectical Behaviour Therapy-12 months; Assigned to Arm(s): Dialectical Behaviour Therapy-12 months"
}
|
A
|
[
"NCT03894462",
"NCT03541824",
"NCT04168645",
"NCT02387736"
] | 27,152 |
val
|
NCT03894462
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effectiveness of a Targeted Brief Intervention for Recent Suicide Attempt Survivors
Brief Summary: Effective, brief, low-cost interventions for individuals who attempt suicide are needed to save lives and achieve the goals of the National Strategy for Suicide Prevention. In response to a National Institute for Mental Health (NIMH) Notice of Interest, this time-sensitive proposal leverages an existing federal investment in Zero Suicide to test the effectiveness of a highly promising new treatment for recent suicide attempt survivors and learn how it works. If hypotheses are supported, the study will provide evidence of a brief, practical, and cost-effective therapy that reduces suicide reattempts in a real-world health setting.
|
{
"A": "Arm Label: Intensive Outpatient CBT; Type: EXPERIMENTAL; Interventions: Behavioral: Intensive Outpatient CBT | Arm Label: Standard Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard Care | Intervention Type: BEHAVIORAL; Name: Intensive Outpatient CBT; Assigned to Arm(s): Intensive Outpatient CBT | Intervention Type: BEHAVIORAL; Name: Standard Care; Assigned to Arm(s): Standard Care",
"B": "Arm Label: Immediate Functional Imagery Training (FIT); Type: EXPERIMENTAL; Interventions: Behavioral: Functional Imagery Training (FIT) | Arm Label: Delayed Functional Imagery Training (FIT); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Functional Imagery Training (FIT); Assigned to Arm(s): Immediate Functional Imagery Training (FIT)",
"C": "Arm Label: F-SPS Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: F-SPS+UC | Arm Label: Enhanced Usual Care (EUC); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: EUC | Intervention Type: BEHAVIORAL; Name: F-SPS+UC; Assigned to Arm(s): F-SPS Intervention | Intervention Type: BEHAVIORAL; Name: EUC; Assigned to Arm(s): Enhanced Usual Care (EUC)",
"D": "Arm Label: Zero Suicide Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Zero Suicide Usual Care | Arm Label: Zero Suicide Usual Care + ASSIP; Type: EXPERIMENTAL; Interventions: Behavioral: Attempted Suicide Short Intervention Program | Intervention Type: BEHAVIORAL; Name: Attempted Suicide Short Intervention Program; Assigned to Arm(s): Zero Suicide Usual Care + ASSIP | Intervention Type: BEHAVIORAL; Name: Zero Suicide Usual Care; Assigned to Arm(s): Zero Suicide Usual Care"
}
|
D
|
[
"NCT01732601",
"NCT02914847",
"NCT03488602",
"NCT03894462"
] | 27,153 |
val
|
NCT03898310
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
Brief Summary: The risk of urinary tract infection (UTI) following female incontinence surgery ranges between 6-48%. The literature has shown mixed results of the therapeutic efficacy of cranberry extract to prevent UTI in females, with some promising preliminary work in the prevention of UTI's following gynecologic surgery. The researchers will conduct a study of the effect of cranberry extracts on preventing urinary tract infections following mid urethral slings, which are the most common urinary incontinence procedures.
|
{
"A": "Arm Label: BMI <30; Type: N/A; Interventions: N/A | Arm Label: BMI 30-39; Type: N/A; Interventions: N/A | Arm Label: BMI >40; Type: N/A; Interventions: N/A",
"B": "Arm Label: Ajust sling; Type: EXPERIMENTAL; Interventions: Procedure: Ajust system, Procedure: TVT/TVT-O | Arm Label: TVT/TVT-O, polypropylne slings; Type: EXPERIMENTAL; Interventions: Procedure: Ajust system, Procedure: TVT/TVT-O | Intervention Type: PROCEDURE; Name: Ajust system; Assigned to Arm(s): Ajust sling, TVT/TVT-O, polypropylne slings | Intervention Type: PROCEDURE; Name: TVT/TVT-O; Assigned to Arm(s): Ajust sling, TVT/TVT-O, polypropylne slings",
"C": "Arm Label: Cranberry Extract Capsules; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Cranberry extract capsules | Arm Label: Placebo Capsules; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo capsule | Intervention Type: DIETARY_SUPPLEMENT; Name: Cranberry extract capsules; Assigned to Arm(s): Cranberry Extract Capsules | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo capsule; Assigned to Arm(s): Placebo Capsules",
"D": "Arm Label: Treatment; Type: EXPERIMENTAL; Interventions: Drug: Nitrofurantoin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Nitrofurantoin; Assigned to Arm(s): Treatment | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo"
}
|
C
|
[
"NCT00980486",
"NCT01754558",
"NCT03898310",
"NCT00734968"
] | 27,154 |
val
|
NCT03899259
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
Brief Summary: The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).
|
{
"A": "Arm Label: Dupilumab; Type: EXPERIMENTAL; Interventions: Drug: Dupilumab | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Dupilumab; Assigned to Arm(s): Dupilumab | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: 4 Milligram (mg) Baricitinib; Type: EXPERIMENTAL; Interventions: Drug: Baricitinib, Drug: Placebo | Arm Label: 2 mg Baricitinib; Type: EXPERIMENTAL; Interventions: Drug: Baricitinib, Drug: Placebo | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 4 mg Baricitinib Maximum Extended Enrollment (MEE); Type: EXPERIMENTAL; Interventions: Drug: Baricitinib, Drug: Placebo | Arm Label: 2 mg Baricitinib MEE; Type: EXPERIMENTAL; Interventions: Drug: Baricitinib | Arm Label: Placebo MEE; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Baricitinib; Assigned to Arm(s): 2 mg Baricitinib, 2 mg Baricitinib MEE, 4 Milligram (mg) Baricitinib, 4 mg Baricitinib Maximum Extended Enrollment (MEE) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2 mg Baricitinib, 4 Milligram (mg) Baricitinib, 4 mg Baricitinib Maximum Extended Enrollment (MEE), Placebo, Placebo MEE",
"C": "Arm Label: Phototherapeutic; Type: EXPERIMENTAL; Interventions: Radiation: ultraviolet A (UVA) | Arm Label: Conventional therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Triamcinolone Acetonide | Intervention Type: RADIATION; Name: ultraviolet A (UVA); Assigned to Arm(s): Phototherapeutic | Intervention Type: DRUG; Name: Triamcinolone Acetonide; Assigned to Arm(s): Conventional therapy",
"D": "Arm Label: Hydrocortisone 1%; Type: EXPERIMENTAL; Interventions: Drug: Hydrocortisone 1% | Arm Label: Clobetasol Propionate 0.05%; Type: EXPERIMENTAL; Interventions: Drug: Clobetasol Propionate 0.05% | Intervention Type: DRUG; Name: Hydrocortisone 1%; Assigned to Arm(s): Hydrocortisone 1% | Intervention Type: DRUG; Name: Clobetasol Propionate 0.05%; Assigned to Arm(s): Clobetasol Propionate 0.05%"
}
|
B
|
[
"NCT03359356",
"NCT03899259",
"NCT01559584",
"NCT01453686"
] | 27,155 |
val
|
NCT03900455
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effectiveness of the Use of a Polyurethane Foam Multilayer Dressing in the Sacral Area, in Addition to Standard Healthcare, to Prevent the Onset of Pressure Ulcer in Patients at Risk. Multicentric Randomized Controlled Trial
Brief Summary: The aim of the present study was to assess whether the application of a multilayered dressing made of hydrocellular polyurethane foam conformed to the sacral area (MSP) in addition to standard preventive care reduces the rate of pressure ulcer (PU) and their severity in population at risk admitted in acute care Hospital.
|
{
"A": "Arm Label: skin care arm of where evidence-based practices in the implementation guide; Type: EXPERIMENTAL; Interventions: Other: skin care arm of where evidence-based practices in the implementation guide | Arm Label: hydrocolloid (Convatec Granuflex-extra thin) dressing; Type: EXPERIMENTAL; Interventions: Device: hydrocolloid (Convatec Granuflex-extra thin) dressing | Arm Label: control; Type: OTHER; Interventions: Other: control | Intervention Type: OTHER; Name: skin care arm of where evidence-based practices in the implementation guide; Assigned to Arm(s): skin care arm of where evidence-based practices in the implementation guide | Intervention Type: DEVICE; Name: hydrocolloid (Convatec Granuflex-extra thin) dressing; Assigned to Arm(s): hydrocolloid (Convatec Granuflex-extra thin) dressing | Intervention Type: OTHER; Name: control; Assigned to Arm(s): control",
"B": "Arm Label: Hyper-oxigenated fatty acid; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hyper-oxigenated fatty acid | Arm Label: Olive oil's Cream; Type: EXPERIMENTAL; Interventions: Other: Olive oil's cream | Intervention Type: DRUG; Name: Hyper-oxigenated fatty acid; Assigned to Arm(s): Hyper-oxigenated fatty acid | Intervention Type: OTHER; Name: Olive oil's cream; Assigned to Arm(s): Olive oil's Cream",
"C": "Arm Label: Mepilex® Border; Type: EXPERIMENTAL; Interventions: Device: Mepilex® Border Sacrum and Mepilex® Border Heel | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Mepilex® Border Sacrum and Mepilex® Border Heel; Assigned to Arm(s): Mepilex® Border",
"D": "Arm Label: Hydrocellular polyurethane foam multilayer dressing; Type: EXPERIMENTAL; Interventions: Device: Hydrocellular polyurethane foam multilayer dressing, Procedure: Standard preventive care | Arm Label: standard preventive care; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Standard preventive care | Intervention Type: DEVICE; Name: Hydrocellular polyurethane foam multilayer dressing; Assigned to Arm(s): Hydrocellular polyurethane foam multilayer dressing | Intervention Type: PROCEDURE; Name: Standard preventive care; Assigned to Arm(s): Hydrocellular polyurethane foam multilayer dressing, standard preventive care"
}
|
D
|
[
"NCT04682925",
"NCT01595347",
"NCT02295735",
"NCT03900455"
] | 27,156 |
val
|
NCT03903172
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Post-partum Non-pharmacologic Pain Management
Brief Summary: This study aims to examine whether use of an abdominal binder for postpartum patients after vaginal delivery can effectively manage their pain and reduce the need for pharmacologic analgesics. The investigators hypothesize that use of an abdominal binder will decrease patient pain as reported on a visual analog scale of one to ten, and will decrease quantity of pain medications given. The study will be conducted at the Berry Women's Center at Miami Valley Hospital. Potential eligible participants will be approached regarding the study on admission to labor and delivery. The investigators will recruit 130 participants that will be randomized to two study arms, standard care and standard care plus abdominal binder with 65 participants in each study arm. Data will be collected prospectively while participants are admitted, and through review of electronic medical records. Potential benefits of this study include investigation of a cost-effective method for pain management that could improve patient comfort and reduce need for medications.
|
{
"A": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo oral capsule, Drug: Paracetamol | Arm Label: Ginger; Type: EXPERIMENTAL; Interventions: Drug: Ginger, Drug: Paracetamol | Arm Label: Paracetamol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Paracetamol | Intervention Type: DRUG; Name: Ginger; Assigned to Arm(s): Ginger | Intervention Type: DRUG; Name: Placebo oral capsule; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Paracetamol; Assigned to Arm(s): Ginger, Paracetamol, Placebo",
"B": "Arm Label: Lifestyle Intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Balance after Baby Lifestyle Intervention Program | Arm Label: Post-gestational diabetes mellitus (GDM) Follow-up Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Balance after Baby Lifestyle Intervention Program; Assigned to Arm(s): Lifestyle Intervention group",
"C": "Arm Label: Post-partum primi and multiparous women; Type: EXPERIMENTAL; Interventions: Device: Leboride | Arm Label: Post-partum women that have already begun breast feeding; Type: EXPERIMENTAL; Interventions: Device: Leboride | Intervention Type: DEVICE; Name: Leboride; Assigned to Arm(s): Post-partum primi and multiparous women, Post-partum women that have already begun breast feeding",
"D": "Arm Label: Binder Arm; Type: EXPERIMENTAL; Interventions: Device: Abdominal binder | Arm Label: Standard of Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Abdominal binder; Assigned to Arm(s): Binder Arm"
}
|
D
|
[
"NCT03617900",
"NCT01158131",
"NCT02399774",
"NCT03903172"
] | 27,157 |
val
|
NCT03903978
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy and Effectiveness of a Self-applied Online Program to Promote Resilience and Coping Skills in University Students in Three Spanish-speaking Countries: Study Protocol for a Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effectiveness and efficiency of this intervention protocol applied to three populations of Spanish-speaking university students (Spain, Argentina and Mexico). The purpose of this paper is to present the protocol designed to carry out the randomised controlled study (RCT).
|
{
"A": "Arm Label: Mindful Response to Adversity; Type: EXPERIMENTAL; Interventions: Behavioral: Mindful response to adversity brief training | Arm Label: Strength-based approach to adversity; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Strengths-based response to adversity brief training | Intervention Type: BEHAVIORAL; Name: Mindful response to adversity brief training; Assigned to Arm(s): Mindful Response to Adversity | Intervention Type: BEHAVIORAL; Name: Strengths-based response to adversity brief training; Assigned to Arm(s): Strength-based approach to adversity",
"B": "Arm Label: Group therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Manualized Therapy | Arm Label: Control Group; Type: OTHER; Interventions: Behavioral: Control Group | Intervention Type: BEHAVIORAL; Name: Manualized Therapy; Assigned to Arm(s): Group therapy | Intervention Type: BEHAVIORAL; Name: Control Group; Assigned to Arm(s): Control Group",
"C": "Arm Label: Mental Training for Surgeons; Type: EXPERIMENTAL; Interventions: Behavioral: Mindfulness Based Stress Reduction - modified | Arm Label: The Mind of a Surgeon; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Active listening and reading | Intervention Type: BEHAVIORAL; Name: Mindfulness Based Stress Reduction - modified; Assigned to Arm(s): Mental Training for Surgeons | Intervention Type: BEHAVIORAL; Name: Active listening and reading; Assigned to Arm(s): The Mind of a Surgeon",
"D": "Arm Label: CORE condition; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioral Therapy | Arm Label: Healthy lifestyle; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Healthy lifestyle | Arm Label: Waiting List Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy; Assigned to Arm(s): CORE condition | Intervention Type: BEHAVIORAL; Name: Healthy lifestyle; Assigned to Arm(s): Healthy lifestyle"
}
|
D
|
[
"NCT04064372",
"NCT02540473",
"NCT03141190",
"NCT03903978"
] | 27,158 |
val
|
NCT03903978
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy and Effectiveness of a Self-applied Online Program to Promote Resilience and Coping Skills in University Students in Three Spanish-speaking Countries: Study Protocol for a Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effectiveness and efficiency of this intervention protocol applied to three populations of Spanish-speaking university students (Spain, Argentina and Mexico). The purpose of this paper is to present the protocol designed to carry out the randomised controlled study (RCT).
|
{
"A": "Arm Label: CORE condition; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioral Therapy | Arm Label: Healthy lifestyle; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Healthy lifestyle | Arm Label: Waiting List Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy; Assigned to Arm(s): CORE condition | Intervention Type: BEHAVIORAL; Name: Healthy lifestyle; Assigned to Arm(s): Healthy lifestyle",
"B": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: yoga, Behavioral: cognitive therapy | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: cognitive therapy, Behavioral: wellness | Intervention Type: BEHAVIORAL; Name: yoga; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: cognitive therapy; Assigned to Arm(s): 1, 2 | Intervention Type: BEHAVIORAL; Name: yoga; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: wellness; Assigned to Arm(s): 2",
"C": "Arm Label: ACT; Type: EXPERIMENTAL; Interventions: Behavioral: Acceptance Therapy (ACT) | Arm Label: CBT; Type: ACTIVE_COMPARATOR; Interventions: Other: Cognitive Behavioral Therapy (CBT) | Intervention Type: BEHAVIORAL; Name: Acceptance Therapy (ACT); Assigned to Arm(s): ACT | Intervention Type: OTHER; Name: Cognitive Behavioral Therapy (CBT); Assigned to Arm(s): CBT",
"D": "Arm Label: Intervention group 4s (mindfulness); Type: EXPERIMENTAL; Interventions: Behavioral: Mindfulness and Mindful Self-Compassion | Arm Label: Intervention group 8s (mindfulness); Type: EXPERIMENTAL; Interventions: Behavioral: Mindfulness and Mindful Self-Compassion | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Mindfulness and Mindful Self-Compassion; Assigned to Arm(s): Intervention group 4s (mindfulness), Intervention group 8s (mindfulness)"
}
|
A
|
[
"NCT03903978",
"NCT00492310",
"NCT01525420",
"NCT03629457"
] | 27,159 |
val
|
NCT03903978
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy and Effectiveness of a Self-applied Online Program to Promote Resilience and Coping Skills in University Students in Three Spanish-speaking Countries: Study Protocol for a Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effectiveness and efficiency of this intervention protocol applied to three populations of Spanish-speaking university students (Spain, Argentina and Mexico). The purpose of this paper is to present the protocol designed to carry out the randomised controlled study (RCT).
|
{
"A": "Arm Label: CORE condition; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioral Therapy | Arm Label: Healthy lifestyle; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Healthy lifestyle | Arm Label: Waiting List Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy; Assigned to Arm(s): CORE condition | Intervention Type: BEHAVIORAL; Name: Healthy lifestyle; Assigned to Arm(s): Healthy lifestyle",
"B": "Arm Label: MBT therapy plus treatment as usual; Type: EXPERIMENTAL; Interventions: Other: Mentalization-Based Group Therapy for Adolescents | Arm Label: Treatment as usual alone; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Mentalization-Based Group Therapy for Adolescents; Assigned to Arm(s): MBT therapy plus treatment as usual",
"C": "Arm Label: Inpatient Adaptation of DBT; Type: EXPERIMENTAL; Interventions: Behavioral: Inpatient Adaptation of DBT | Arm Label: Outpatient DBT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: standard outpatient DBT | Intervention Type: BEHAVIORAL; Name: standard outpatient DBT; Assigned to Arm(s): Outpatient DBT | Intervention Type: BEHAVIORAL; Name: Inpatient Adaptation of DBT; Assigned to Arm(s): Inpatient Adaptation of DBT",
"D": "Arm Label: TFP; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Transference-Focused Psychotherapy | Arm Label: ECP; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: treatment by experienced community psychotherapists | Intervention Type: BEHAVIORAL; Name: Transference-Focused Psychotherapy; Assigned to Arm(s): TFP | Intervention Type: BEHAVIORAL; Name: treatment by experienced community psychotherapists; Assigned to Arm(s): ECP"
}
|
A
|
[
"NCT03903978",
"NCT02771691",
"NCT01904227",
"NCT00714311"
] | 27,160 |
val
|
NCT03904056
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: ETDRS Panretinal Photocoagulation (PRP) Combined With Intravitreal Ranibizumab (IVR) Versus Retinal Photocoagulation Targeted to Ischemic Retina Combined With IVR for the Treatment of Proliferative Diabetic Retinopathy
Brief Summary: Purpose: To compare panretinal photocoagulation (PRP) as described in ETDRS Study combined with intravitreal injection of ranibizumab (IVR) (ETDRS-PRP group) and retinal photocoagulation targeted to ischemic retina combined with IVR (ISQ-RP group) in patients with proliferative diabetic retinopathy (PDR).
Design: Randomized prospective clinical trial. Methods: Patients with PDR were assigned to receive either PRP plus IVR (20 eyes) or retinal photocoagulation targeted to ischemic areas plus IVR (20 eyes). ETDRS best-corrected visual acuity (BCVA), central subfield macular thickness (CSFT) measured by optical coherence tomography (OCT) were performed at baseline and every 4 weeks through week 48. Area of fluorescein leakage from active new vessels (FLA) was measured every 12 weeks. Full-field electroretinography (ERG) was recorded at baseline and after 3 months.
|
{
"A": "Arm Label: ETDRS-PRP group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: ETDRS-PRP group | Arm Label: ISQ-RP group; Type: EXPERIMENTAL; Interventions: Procedure: ISQ-RP | Intervention Type: PROCEDURE; Name: ISQ-RP; Assigned to Arm(s): ISQ-RP group | Intervention Type: PROCEDURE; Name: ETDRS-PRP group; Assigned to Arm(s): ETDRS-PRP group",
"B": "Arm Label: Anti-VEGF+Deferred PRP; Type: EXPERIMENTAL; Interventions: Drug: 0.5-mg Ranibizumab, Other: Deferred panretinal photocoagulation | Arm Label: Prompt PRP; Type: ACTIVE_COMPARATOR; Interventions: Other: Prompt Panretinal Photocoagulation | Intervention Type: OTHER; Name: Prompt Panretinal Photocoagulation; Assigned to Arm(s): Prompt PRP | Intervention Type: DRUG; Name: 0.5-mg Ranibizumab; Assigned to Arm(s): Anti-VEGF+Deferred PRP | Intervention Type: OTHER; Name: Deferred panretinal photocoagulation; Assigned to Arm(s): Anti-VEGF+Deferred PRP",
"C": "Arm Label: Panretinal photocoagulation; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Panretinal photocoagulation | Arm Label: Bevacizumab + Panretinal Photocoagulation (PRP); Type: EXPERIMENTAL; Interventions: Procedure: Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of Bevacizumab | Intervention Type: PROCEDURE; Name: Panretinal photocoagulation; Assigned to Arm(s): Panretinal photocoagulation | Intervention Type: PROCEDURE; Name: Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of Bevacizumab; Assigned to Arm(s): Bevacizumab + Panretinal Photocoagulation (PRP)",
"D": "Arm Label: Intravitreous 2 mg aflibercept injections; Type: ACTIVE_COMPARATOR; Interventions: Drug: 2-mg Intravitreous Aflibercept Injection | Arm Label: Prompt vitrectomy plus panretinal photocoagulation; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Prompt Vitrectomy Plus Panretinal Photocoagulation | Intervention Type: DRUG; Name: 2-mg Intravitreous Aflibercept Injection; Assigned to Arm(s): Intravitreous 2 mg aflibercept injections | Intervention Type: PROCEDURE; Name: Prompt Vitrectomy Plus Panretinal Photocoagulation; Assigned to Arm(s): Prompt vitrectomy plus panretinal photocoagulation"
}
|
A
|
[
"NCT03904056",
"NCT01489189",
"NCT01389505",
"NCT02858076"
] | 27,161 |
val
|
NCT03904745
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer
Brief Summary: Uterine contraction has a negative impact on implantation and pregnancy rates. Inhibition of oxytocin receptors decreases uterine contraction frequency both on pregnant and non-pregnant women. Atosiban has been studied as an oxytocin antagonist to decrease uterine contraction frequency in order to increase implantation and pregnancy rates in assisted reproduction. Previous studies have studied 37,5mg total dose which was used both before and during embryo transfer, and found atosiban to be effective in increasing implantation and pregnancy rates. We aim to use a single dose of 6,75mg atosiban before embryo transfer, in order to decrease the dose and cost and possibly introduce a simpler protocol. Our study will also be the first randomized clinical study which investigates the effect of atosiban on frozen-thawed embryo transfer cycles.
|
{
"A": "Arm Label: Nolasiban 900 mg; Type: EXPERIMENTAL; Interventions: Drug: Nolasiban | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Nolasiban; Assigned to Arm(s): Nolasiban 900 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: Atosiban used before embryo transfer; Type: EXPERIMENTAL; Interventions: Drug: Atosiban | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Atosiban; Assigned to Arm(s): Atosiban used before embryo transfer",
"C": "Arm Label: Atosiban; Type: ACTIVE_COMPARATOR; Interventions: Drug: Atosiban | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Normal saline | Intervention Type: DRUG; Name: Atosiban; Assigned to Arm(s): Atosiban | Intervention Type: DRUG; Name: Normal saline; Assigned to Arm(s): Placebo",
"D": "Arm Label: Atosiban; Type: ACTIVE_COMPARATOR; Interventions: Drug: Atosiban | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Atosiban; Assigned to Arm(s): Atosiban | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo"
}
|
B
|
[
"NCT03758885",
"NCT03904745",
"NCT01501214",
"NCT01673399"
] | 27,162 |
val
|
NCT03904745
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer
Brief Summary: Uterine contraction has a negative impact on implantation and pregnancy rates. Inhibition of oxytocin receptors decreases uterine contraction frequency both on pregnant and non-pregnant women. Atosiban has been studied as an oxytocin antagonist to decrease uterine contraction frequency in order to increase implantation and pregnancy rates in assisted reproduction. Previous studies have studied 37,5mg total dose which was used both before and during embryo transfer, and found atosiban to be effective in increasing implantation and pregnancy rates. We aim to use a single dose of 6,75mg atosiban before embryo transfer, in order to decrease the dose and cost and possibly introduce a simpler protocol. Our study will also be the first randomized clinical study which investigates the effect of atosiban on frozen-thawed embryo transfer cycles.
|
{
"A": "Arm Label: Atosiban; Type: ACTIVE_COMPARATOR; Interventions: Drug: Atosiban | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Atosiban; Assigned to Arm(s): Atosiban | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo",
"B": "Arm Label: Metformin; Type: EXPERIMENTAL; Interventions: Drug: Metformin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Metformin | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Metformin, Placebo",
"C": "Arm Label: atosiban; Type: EXPERIMENTAL; Interventions: Drug: atosiban | Arm Label: 0.9% salain; Type: PLACEBO_COMPARATOR; Interventions: Drug: 0.9% saline | Intervention Type: DRUG; Name: atosiban; Assigned to Arm(s): atosiban | Intervention Type: DRUG; Name: 0.9% saline; Assigned to Arm(s): 0.9% salain",
"D": "Arm Label: Atosiban used before embryo transfer; Type: EXPERIMENTAL; Interventions: Drug: Atosiban | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Atosiban; Assigned to Arm(s): Atosiban used before embryo transfer"
}
|
D
|
[
"NCT01673399",
"NCT03086005",
"NCT02893722",
"NCT03904745"
] | 27,163 |
val
|
NCT03905551
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effect of Exercise Rehabilitation Regimes in Combination With Changes in Dialysis Procedures in Aspects Related to Quality of Life and Health in End Stage Renal Disease Patients
Brief Summary: Despite the tremendous advances in dialysis technology, hemodialysis (HD) is a significant challenge for dialysis patients and quality of their lives\[2\]. Research has shown for years that dialysate fluid temperature and especially the typical dialysis (TD) temperature at (37°C) are complicated by hemodynamic instability which leading to an increased risk of heat-induced hypotension causing patient discomfort and increased mortality.
Cold dialysis (CD) is defined as the reduction of dialysis fluid temperature to 35-36°C, approximately 1°C below the typical dialysate temperature which ranges between 37-38°C. A number of studies have reported beneficial effects of CD on maintaining hemodynamic stability, minimizes hypotension and exerts a protective effect over major organs including the heart and brain. In addition, current evidence showed the protective effect of CD in cardiac performance during the dialysis session. As the investigators know until today cardiovascular mortality is an important issue for nephrologists that care for ESRD patients, however, many other benefits have been observed on patients' overall health and quality of life levels by used of CD.
The above-mentioned benefits of CD in the hemodynamic stability and the general quality of life of the patients are highlighted even further due to the ever-increasing adoption of intradialytic exercise programs. It has been well established that intradialytic exercise leads to benefits of physiological, functional, and psychological deterioration, which commonly accrues as a consequence of biological aging, catabolic illness, and a sedentary lifestyle, factors that may all contribute to the progressive decline of vitality and quality of life commonly observed in ESRD patients.
However, despite a strong rationale for the implementation of intradialytic exercise programs and the aforementioned benefits of CD, the separate and combined effects of these protocols in aspects related to quality of life and health in ESRD patients have not been investigated to date.
The aim of the current clinical study was to assess the effect of exercise rehabilitation regimes in combination with changes in dialysate temperature in aspects related to quality of life and health in end-stage renal disease patients receiving hemodialysis.
|
{
"A": "Arm Label: Tianjiu (auto-moxibustion); Type: EXPERIMENTAL; Interventions: Other: Tianjiu | Arm Label: Non-Tianjiu (Non auto-MO); Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo (non-Tianjiu) | Intervention Type: OTHER; Name: Tianjiu; Assigned to Arm(s): Tianjiu (auto-moxibustion) | Intervention Type: OTHER; Name: Placebo (non-Tianjiu); Assigned to Arm(s): Non-Tianjiu (Non auto-MO)",
"B": "Arm Label: Standard Dialysis; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Typical Dialysis, Procedure: Exercise | Arm Label: Cold Dialysis; Type: EXPERIMENTAL; Interventions: Procedure: Cold Dialysis, Procedure: Exercise | Intervention Type: PROCEDURE; Name: Cold Dialysis; Assigned to Arm(s): Cold Dialysis | Intervention Type: PROCEDURE; Name: Typical Dialysis; Assigned to Arm(s): Standard Dialysis | Intervention Type: PROCEDURE; Name: Exercise; Assigned to Arm(s): Cold Dialysis, Standard Dialysis",
"C": "Arm Label: Conventional hemodialysis; Type: ACTIVE_COMPARATOR; Interventions: Device: Conventional hemodialysis | Arm Label: Frequent hemodialysis; Type: EXPERIMENTAL; Interventions: Device: Frequent hemodialysis | Intervention Type: DEVICE; Name: Conventional hemodialysis; Assigned to Arm(s): Conventional hemodialysis | Intervention Type: DEVICE; Name: Frequent hemodialysis; Assigned to Arm(s): Frequent hemodialysis",
"D": "Arm Label: Exercise training; Type: EXPERIMENTAL; Interventions: Other: Exercise | Arm Label: No exercise; Type: PLACEBO_COMPARATOR; Interventions: Other: Usual Treatment | Intervention Type: OTHER; Name: Exercise; Assigned to Arm(s): Exercise training | Intervention Type: OTHER; Name: Usual Treatment; Assigned to Arm(s): No exercise"
}
|
B
|
[
"NCT02210377",
"NCT03905551",
"NCT00264758",
"NCT01721551"
] | 27,164 |
val
|
NCT03905551
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effect of Exercise Rehabilitation Regimes in Combination With Changes in Dialysis Procedures in Aspects Related to Quality of Life and Health in End Stage Renal Disease Patients
Brief Summary: Despite the tremendous advances in dialysis technology, hemodialysis (HD) is a significant challenge for dialysis patients and quality of their lives\[2\]. Research has shown for years that dialysate fluid temperature and especially the typical dialysis (TD) temperature at (37°C) are complicated by hemodynamic instability which leading to an increased risk of heat-induced hypotension causing patient discomfort and increased mortality.
Cold dialysis (CD) is defined as the reduction of dialysis fluid temperature to 35-36°C, approximately 1°C below the typical dialysate temperature which ranges between 37-38°C. A number of studies have reported beneficial effects of CD on maintaining hemodynamic stability, minimizes hypotension and exerts a protective effect over major organs including the heart and brain. In addition, current evidence showed the protective effect of CD in cardiac performance during the dialysis session. As the investigators know until today cardiovascular mortality is an important issue for nephrologists that care for ESRD patients, however, many other benefits have been observed on patients' overall health and quality of life levels by used of CD.
The above-mentioned benefits of CD in the hemodynamic stability and the general quality of life of the patients are highlighted even further due to the ever-increasing adoption of intradialytic exercise programs. It has been well established that intradialytic exercise leads to benefits of physiological, functional, and psychological deterioration, which commonly accrues as a consequence of biological aging, catabolic illness, and a sedentary lifestyle, factors that may all contribute to the progressive decline of vitality and quality of life commonly observed in ESRD patients.
However, despite a strong rationale for the implementation of intradialytic exercise programs and the aforementioned benefits of CD, the separate and combined effects of these protocols in aspects related to quality of life and health in ESRD patients have not been investigated to date.
The aim of the current clinical study was to assess the effect of exercise rehabilitation regimes in combination with changes in dialysate temperature in aspects related to quality of life and health in end-stage renal disease patients receiving hemodialysis.
|
{
"A": "Arm Label: Exercise; Type: EXPERIMENTAL; Interventions: Other: Exercise | Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Exercise; Assigned to Arm(s): Exercise",
"B": "Arm Label: Cognitive training; Type: ACTIVE_COMPARATOR; Interventions: Other: Cognitive training | Arm Label: Exercise training; Type: ACTIVE_COMPARATOR; Interventions: Other: Exercise training | Arm Label: Combined cognitive and exercise training; Type: ACTIVE_COMPARATOR; Interventions: Other: Combined cognitive and exercise training | Arm Label: Standard of Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Cognitive training; Assigned to Arm(s): Cognitive training | Intervention Type: OTHER; Name: Exercise training; Assigned to Arm(s): Exercise training | Intervention Type: OTHER; Name: Combined cognitive and exercise training; Assigned to Arm(s): Combined cognitive and exercise training",
"C": "Arm Label: Standard Dialysis; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Typical Dialysis, Procedure: Exercise | Arm Label: Cold Dialysis; Type: EXPERIMENTAL; Interventions: Procedure: Cold Dialysis, Procedure: Exercise | Intervention Type: PROCEDURE; Name: Cold Dialysis; Assigned to Arm(s): Cold Dialysis | Intervention Type: PROCEDURE; Name: Typical Dialysis; Assigned to Arm(s): Standard Dialysis | Intervention Type: PROCEDURE; Name: Exercise; Assigned to Arm(s): Cold Dialysis, Standard Dialysis",
"D": "Arm Label: Aerobic exercise; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise | Arm Label: Resistance; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise | Arm Label: Combined aerobic and resistance; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise | Arm Label: Flexibility; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Exercise | Intervention Type: BEHAVIORAL; Name: Exercise; Assigned to Arm(s): Aerobic exercise, Combined aerobic and resistance, Flexibility, Resistance"
}
|
C
|
[
"NCT03027778",
"NCT03616535",
"NCT03905551",
"NCT02234232"
] | 27,165 |
val
|
NCT03906864
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Integrated Care Pathway for Hip Fractures in a Subacute Rehabilitation Setting
Brief Summary: The effectiveness of integrated care pathways for hip fractures in sub-acute rehabilitation settings is not known. The study objective was to assess if a hip fracture integrated care pathway at a sub-acute rehabilitation facility would result in better functional outcomes, shorter length of stay and fewer institutionalisations. A randomised controlled trial on an integrated care pathway was conducted for hip fracture patients in a sub-acute rehabilitation setting. The study supports the use of integrated care pathways in sub-acute rehabilitation settings to reduce length of stay whilst achieving the same functional gains.
|
{
"A": "Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Other: Care Pathway | Intervention Type: OTHER; Name: Care Pathway; Assigned to Arm(s): Intervention group",
"B": "Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Experimental group; Type: EXPERIMENTAL; Interventions: Other: Interdisciplinary intervention program | Intervention Type: OTHER; Name: Interdisciplinary intervention program; Assigned to Arm(s): Experimental group",
"C": "Arm Label: GFC: Geriatric Fracture Center; Type: N/A; Interventions: N/A | Arm Label: UCC: Usual Care Center; Type: N/A; Interventions: N/A",
"D": "Arm Label: Care pathway teams.; Type: EXPERIMENTAL; Interventions: Behavioral: Care pathway. | Arm Label: Usual care teams.; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Care pathway.; Assigned to Arm(s): Care pathway teams."
}
|
A
|
[
"NCT03906864",
"NCT01052636",
"NCT02297581",
"NCT01435538"
] | 27,166 |
val
|
NCT03907410
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial
Brief Summary: Improving adherence to inhaled corticosteroids (ICS) medication in urban minority pediatric populations is a clinical and population health priority. Financial incentives have been shown as a compelling method to engage a high-risk asthma population in regular ICS use, but whether and how adherence can be maintained and lead to sustained high adherence trajectories is unknown.
|
{
"A": "Arm Label: Active Feedback; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Active Feedback | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Active Feedback | Intervention Type: BEHAVIORAL; Name: Active Feedback; Assigned to Arm(s): Active Feedback, Control",
"B": "Arm Label: Intervention Arm; Type: EXPERIMENTAL; Interventions: Other: ASTHMAXcel App | Arm Label: Usual Care Arm; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: ASTHMAXcel App; Assigned to Arm(s): Intervention Arm",
"C": "Arm Label: Arm 1: Incentives, plus reminders & feedback (IRF); Type: EXPERIMENTAL; Interventions: Other: Nominal Financial Incentives, Other: Daily Adherence Reminders/Adherence Performance Feedback | Arm Label: Arm 2: Reminders & feedback ONLY; Type: ACTIVE_COMPARATOR; Interventions: Other: Daily Adherence Reminders/Adherence Performance Feedback | Arm Label: Arm 3 (Control); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Nominal Financial Incentives; Assigned to Arm(s): Arm 1: Incentives, plus reminders & feedback (IRF) | Intervention Type: OTHER; Name: Daily Adherence Reminders/Adherence Performance Feedback; Assigned to Arm(s): Arm 1: Incentives, plus reminders & feedback (IRF), Arm 2: Reminders & feedback ONLY",
"D": "Arm Label: Feedback and alarms; Type: EXPERIMENTAL; Interventions: Device: Activated Smartinhaler or Smartturbo, Other: Feedback of adherence data | Arm Label: No feedback or alarms; Type: ACTIVE_COMPARATOR; Interventions: Device: Deactivated Smartinhaler or Smartturbo | Intervention Type: DEVICE; Name: Activated Smartinhaler or Smartturbo; Assigned to Arm(s): Feedback and alarms | Intervention Type: OTHER; Name: Feedback of adherence data; Assigned to Arm(s): Feedback and alarms | Intervention Type: DEVICE; Name: Deactivated Smartinhaler or Smartturbo; Assigned to Arm(s): No feedback or alarms"
}
|
C
|
[
"NCT01529697",
"NCT03930381",
"NCT03907410",
"NCT02451709"
] | 27,167 |
val
|
NCT03907462
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults
Brief Summary: The SMART 2.0 study is a 24-month trial designed to evaluate the impact of the intervention with technology and personal health coaching or with technology alone on objectively measured weight among overweight young adults in a university setting over 24 months compared to a control group. The investigators hypothesize that both interventions will significantly improve weight compared to the control group, and the group receiving personal health coaching will experience the greatest improvement.
|
{
"A": "Arm Label: Treatment One; Type: EXPERIMENTAL; Interventions: Behavioral: SMART 2.0 | Arm Label: Treatment Two; Type: EXPERIMENTAL; Interventions: Behavioral: SMART 2.0 | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: SMART 2.0; Assigned to Arm(s): Treatment One, Treatment Two",
"B": "Arm Label: Experimental: Group Sessions; Type: EXPERIMENTAL; Interventions: Behavioral: Group Sessions, Behavioral: Feedback, Behavioral: Self-monitoring | Arm Label: Active Comparator: Self-Monitoring; Type: EXPERIMENTAL; Interventions: Behavioral: Self-monitoring | Arm Label: Experimental: Feedback; Type: EXPERIMENTAL; Interventions: Behavioral: Feedback, Behavioral: Self-monitoring | Intervention Type: BEHAVIORAL; Name: Group Sessions; Assigned to Arm(s): Experimental: Group Sessions | Intervention Type: BEHAVIORAL; Name: Feedback; Assigned to Arm(s): Experimental: Feedback, Experimental: Group Sessions | Intervention Type: BEHAVIORAL; Name: Self-monitoring; Assigned to Arm(s): Active Comparator: Self-Monitoring, Experimental: Feedback, Experimental: Group Sessions",
"C": "Arm Label: Arm 1; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Use of PDA + support to reduce weight and pain | Arm Label: Arm 2; Type: EXPERIMENTAL; Interventions: Behavioral: MOVE! level 2 group weight loss counseling | Intervention Type: BEHAVIORAL; Name: Use of PDA + support to reduce weight and pain; Assigned to Arm(s): Arm 1 | Intervention Type: BEHAVIORAL; Name: MOVE! level 2 group weight loss counseling; Assigned to Arm(s): Arm 2",
"D": "Arm Label: Obesity Prevention; Type: EXPERIMENTAL; Interventions: Behavioral: Obesity Prevention | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Obesity Prevention; Assigned to Arm(s): Obesity Prevention"
}
|
A
|
[
"NCT03907462",
"NCT02829632",
"NCT00371462",
"NCT00938535"
] | 27,168 |
val
|
NCT03907865
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Clinical Efficacy of Topical Hydrocortisone 0.335% (Softacort®) in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation
Brief Summary: Dry eye disease (DED) is a highly prevalent ocular condition and induces a significant burden to the affected patients. Regardless of the underlying etiology, DED is associated with increased inflammation of the entire ocular surface including the adnexa, conjunctiva and cornea. As such, there is evidence from in vitro, animal and clinical studies that this inflammatory response of the ocular surface plays a pathophysiological key role in the development of DED. The Dry Eye Workshop 2007 (DEWS) therefore suggests the use of anti-inflammatory drugs such as corticosteroids, cyclosporine or others when topical lubricants alone are not sufficient. Recently, Softacort® eye drops containing 0.335% hydrocortisone have gained marketing authorization for the treatment of ocular surface inflammation. This formulation offers several advantages that make them potentially interesting for the treatment of DED. First, the formulation is preservative-free, which is of special importance in patients with DED, since it has been shown that preservatives are detrimental for the ocular surface. Further, hydrocortisone has the advantage that in comparison to other glucocorticoid derivatives, it features poor solubility. This means that corneal penetration is low, which is a desired effect in the treatment of ocular surface inflammation. Because of the poor penetration through thecornea, elevation of intraocular pressure and cataract formation, which are common side effect of corticosteroid treatment, have not been observed with Softacort® to date, also favoring the use of this agent in DED. The aim of the present study is to investigate whether treatment with Softacort® improves ocular surface inflammation as well as clinical signs and symptoms associated with DED in patients who are already taking topical lubricants for at least three months.
|
{
"A": "Intervention Type: DRUG; Name: Lotemax; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Restasis; Assigned to Arm(s): N/A",
"B": "Arm Label: Lotemax with warm compress group; Type: EXPERIMENTAL; Interventions: Drug: topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage | Arm Label: warm compress only group; Type: ACTIVE_COMPARATOR; Interventions: Other: warm compress only group | Intervention Type: DRUG; Name: topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage; Assigned to Arm(s): Lotemax with warm compress group | Intervention Type: OTHER; Name: warm compress only group; Assigned to Arm(s): warm compress only group",
"C": "Arm Label: KPI-121 0.25% Ophthalmic Suspension; Type: ACTIVE_COMPARATOR; Interventions: Drug: KPI-121 | Arm Label: Vehicle; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: KPI-121; Assigned to Arm(s): KPI-121 0.25% Ophthalmic Suspension | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Vehicle",
"D": "Arm Label: intense; Type: EXPERIMENTAL; Interventions: Drug: Softacort | Arm Label: standard; Type: EXPERIMENTAL; Interventions: Drug: Softacort | Intervention Type: DRUG; Name: Softacort; Assigned to Arm(s): intense, standard"
}
|
D
|
[
"NCT00407043",
"NCT01692652",
"NCT02188160",
"NCT03907865"
] | 27,169 |
val
|
NCT03909347
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: PLAN: Dementia Literacy Education and Navigation for Korean Elders With Probable Dementia and Their Caregivers
Brief Summary: Studies have shown that ethnic-racial minority elders are more likely to be neglected from appropriate dementia care in time than the white counterparts. Among minorities group, Korean Americans (KAs) are the 4th largest and one of the most rapidly growing Asian subpopulations and have been characterized as under-resourced and underserved population of dementia care. This research is being done to understand how an education and navigation support program led by trained community health workers (CHWs) helps Korean American elders with probable dementia and the Korean American elders' caregivers. In a 2-arm randomized controlled trial (RCT) with 288 dyads, the investigators' aims are to (1) test the effect of a community-based intervention delivered by trained CHWs for undiagnosed KA elders with probable dementia and the KA elders' caregivers, (2) evaluate the effect of the PLAN on improving caregiver's dementia literacy, self-efficacy in dementia care and service use, social support, depression, and quality of life at 6 months in comparison to usual care, and (3) examine whether the effect of PLAN differs across age, sex, English proficiency and education caregiver subgroups. Exploratory Aim 1 is to test the effect of PLAN on Korean elders with probable dementia and caregiver development of a plan regarding dementia care at 6 months in comparison to usual care. The other two Exploratory Aims are to test the applicability of this study in another environment: Exploratory Aim 2: Using an equity-informed human-centered design framework, scale PLAN for implementation in ethnic daycare and Exploratory Aim 3: Pilot test the feasibility and acceptability of PLAN in ethnic adult daycare.
Aim 1 and Exploratory Aim test the following hypotheses: (1) Korean elders with probable dementia who receive the PLAN will have higher rates of linkage to medical service for dementia than those in the control group (Aim 1) and (2) Korean elders with probable dementia and the KA elders' caregivers who receive the PLAN will have higher rates of having a plan for dementia care than those in the control group (Exploratory Aim). Aim 2 tests the following hypothesis: Caregivers in the PLAN group will have higher dementia literacy, self-efficacy in dementia care and service use, social support, and quality of life, and lower depression than those in the control group.
|
{
"A": "Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Placebo | Arm Label: Intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Educational Intervention, Behavioral: Placebo | Intervention Type: BEHAVIORAL; Name: Educational Intervention; Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: Placebo; Assigned to Arm(s): Control, Intervention",
"B": "Arm Label: PLAN (intervention); Type: EXPERIMENTAL; Interventions: Behavioral: PLAN | Arm Label: Standard of care (control); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard of Care | Intervention Type: BEHAVIORAL; Name: PLAN; Assigned to Arm(s): PLAN (intervention) | Intervention Type: BEHAVIORAL; Name: Standard of Care; Assigned to Arm(s): Standard of care (control)",
"C": "Arm Label: Diabetes Telemonitoring (DTM); Type: EXPERIMENTAL; Interventions: Behavioral: Diabetes Telemonitoring | Arm Label: Comprehensive Outpatient Management (COM); Type: ACTIVE_COMPARATOR; Interventions: Other: Comprehensive Outpatient Management | Intervention Type: OTHER; Name: Comprehensive Outpatient Management; Assigned to Arm(s): Comprehensive Outpatient Management (COM) | Intervention Type: BEHAVIORAL; Name: Diabetes Telemonitoring; Assigned to Arm(s): Diabetes Telemonitoring (DTM)",
"D": "Arm Label: Walking Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Walking Intervention | Arm Label: Wait-list control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Walking Intervention; Assigned to Arm(s): Walking Intervention"
}
|
B
|
[
"NCT01127737",
"NCT03909347",
"NCT03960424",
"NCT02181062"
] | 27,170 |
val
|
NCT03909659
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized-Controlled Trial to Determine the Effects on Blood Pressure of A Reduced-sodium Added-potassium Salt Substitute Among Adults With Hypertension in India
Brief Summary: Blood pressure is a key modifiable risk factor for cardiovascular disease in India. Drug therapies are highly effective and are recommended by local guidelines to reduce the risks of serious cardiovascular complications. Behavioural approaches to blood pressure control based upon sodium reduction are also recommended but there are no interventions proven effective in India.
Mean sodium intake in India is about 5g/day (equivalent to about 12.5g salt) which is, more than double World Health Organization (WHO) recommendations. Reduced sodium, added potassium salt substitutes have favourable effects on blood pressure in settings where discretionary salt use is high, but have not been tested in India. This single-site, Salt Substitute on blood pressure in India Study will investigate the effects of reduced sodium added potassium salt substitution on blood pressure in rural areas where hypertension is a prevalent disease problem and additional, scalable and affordable interventions are required. The primary objective is to assess the effects of salt substitute on SBP at 3 months follow-up. The secondary objectives are to determine effects on DBP, urinary sodium and potassium levels and to determine acceptability of the salt substitute.
The study will be a double-blinded, randomized-controlled trial done in the Hyderabad region amongst adult volunteers with a history of hypertension diagnosed by a health professional. The main exclusion criteria will be known serous kidney disease or use of potassium containing medications by the individual or others living in the household. Written informed consent will be obtained from potential participants followed by baseline data collection. Eligible individuals will then be assigned at random to receive double-blind salt or salt substitute which will be used to replace all dietary salt used for cooking and seasoning over the next 3 months. Follow-up will be at one and three months after randomisation for blood pressure, urinary electrolytes and acceptability of the intervention.
|
{
"A": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Dietary sodium reduction; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary sodium reduction | Intervention Type: BEHAVIORAL; Name: Dietary sodium reduction; Assigned to Arm(s): Dietary sodium reduction",
"B": "Arm Label: Normal Salt; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Regular Salt | Arm Label: Salt Substitute; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Salt Substitute | Intervention Type: DIETARY_SUPPLEMENT; Name: Regular Salt; Assigned to Arm(s): Normal Salt | Intervention Type: DIETARY_SUPPLEMENT; Name: Salt Substitute; Assigned to Arm(s): Salt Substitute",
"C": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Reduced-sodium added-potassium salt substitute; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary sodium reduction | Intervention Type: BEHAVIORAL; Name: Dietary sodium reduction; Assigned to Arm(s): Reduced-sodium added-potassium salt substitute",
"D": "Arm Label: Na salt; Type: PLACEBO_COMPARATOR; Interventions: Other: Regular salt | Arm Label: K salt; Type: ACTIVE_COMPARATOR; Interventions: Other: Potassium-enriched salt | Arm Label: K/Mg salt; Type: ACTIVE_COMPARATOR; Interventions: Other: Potassium and magnesium-enriched salt | Intervention Type: OTHER; Name: Regular salt; Assigned to Arm(s): Na salt | Intervention Type: OTHER; Name: Potassium-enriched salt; Assigned to Arm(s): K salt | Intervention Type: OTHER; Name: Potassium and magnesium-enriched salt; Assigned to Arm(s): K/Mg salt"
}
|
C
|
[
"NCT02092090",
"NCT01429246",
"NCT03909659",
"NCT02910427"
] | 27,171 |
val
|
NCT03909815
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Do Dual Mobility Cups Prevent Dislocation After Total Hip Arthroplasty Performed Due to Femoral Neck Fracture? a Registry-based, Pragmatic, Randomized Controlled Trial Comparing Dual Mobility with Standard Cups
Brief Summary: Our aim is to develop a strategy that reduces the risk of dislocations after total hip arthroplasty surgery performed due to femoral neck fracture. We therefore perform a register-nested, pragmatic, randomized controlled trial to investigate the safety and efficacy of dual mobility cups that were designed to minimize the risk of dislocation in the large and fragile group of elderly patients with femoral neck fractures.
|
{
"A": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Device: Total hip arthroplasty | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Device: Hemi-arthroplasty | Intervention Type: DEVICE; Name: Total hip arthroplasty; Assigned to Arm(s): 1 | Intervention Type: DEVICE; Name: Hemi-arthroplasty; Assigned to Arm(s): 2",
"B": "Arm Label: Cemented femoral stem; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Cemented femoral stem | Arm Label: Uncemented femoral stem; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Uncemented femoral stem | Intervention Type: PROCEDURE; Name: Uncemented femoral stem; Assigned to Arm(s): Uncemented femoral stem | Intervention Type: PROCEDURE; Name: Cemented femoral stem; Assigned to Arm(s): Cemented femoral stem",
"C": "Arm Label: Control group; Type: ACTIVE_COMPARATOR; Interventions: Device: Cemented hemiarthroplasty | Arm Label: Treatment group; Type: ACTIVE_COMPARATOR; Interventions: Device: Cemented total hip arthroplasty | Intervention Type: DEVICE; Name: Cemented total hip arthroplasty; Assigned to Arm(s): Treatment group | Intervention Type: DEVICE; Name: Cemented hemiarthroplasty; Assigned to Arm(s): Control group",
"D": "Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Device: Dual mobility cup | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Device: Standard cup | Intervention Type: DEVICE; Name: Dual mobility cup; Assigned to Arm(s): Intervention | Intervention Type: DEVICE; Name: Standard cup; Assigned to Arm(s): Control"
}
|
D
|
[
"NCT00556842",
"NCT02247791",
"NCT02246335",
"NCT03909815"
] | 27,172 |
val
|
NCT03909815
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Do Dual Mobility Cups Prevent Dislocation After Total Hip Arthroplasty Performed Due to Femoral Neck Fracture? a Registry-based, Pragmatic, Randomized Controlled Trial Comparing Dual Mobility with Standard Cups
Brief Summary: Our aim is to develop a strategy that reduces the risk of dislocations after total hip arthroplasty surgery performed due to femoral neck fracture. We therefore perform a register-nested, pragmatic, randomized controlled trial to investigate the safety and efficacy of dual mobility cups that were designed to minimize the risk of dislocation in the large and fragile group of elderly patients with femoral neck fractures.
|
{
"A": "Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Device: Dual mobility cup | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Device: Standard cup | Intervention Type: DEVICE; Name: Dual mobility cup; Assigned to Arm(s): Intervention | Intervention Type: DEVICE; Name: Standard cup; Assigned to Arm(s): Control",
"B": "Arm Label: Gamma nail, fracture stabilization, better walking; Type: ACTIVE_COMPARATOR; Interventions: Device: gamma nail stryker | Intervention Type: DEVICE; Name: gamma nail stryker; Assigned to Arm(s): Gamma nail, fracture stabilization, better walking",
"C": "Arm Label: Conservative Treatment for Impacted Femoral Neck Fracture; Type: EXPERIMENTAL; Interventions: Procedure: Surgical Treatment for Impacted Femoral Neck Fracture | Intervention Type: PROCEDURE; Name: Surgical Treatment for Impacted Femoral Neck Fracture; Assigned to Arm(s): Conservative Treatment for Impacted Femoral Neck Fracture",
"D": "Arm Label: Cemented femoral stem; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Cemented femoral stem | Arm Label: Uncemented femoral stem; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Uncemented femoral stem | Intervention Type: PROCEDURE; Name: Uncemented femoral stem; Assigned to Arm(s): Uncemented femoral stem | Intervention Type: PROCEDURE; Name: Cemented femoral stem; Assigned to Arm(s): Cemented femoral stem"
}
|
A
|
[
"NCT03909815",
"NCT01238068",
"NCT04219943",
"NCT02247791"
] | 27,173 |
val
|
NCT03911037
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Granulocyte Colony Stimulating Factor Therapy In Decompensated Cirrhosis Of Liver: A Double Blinded Single Centre Randomised Controlled Trial
Brief Summary: Cirrhosis of liver is a leading cause of morbidity and mortality worldwide. Complications like ascites, spontaneous bacterial peritonitis, variceal bleed, hepatic encephalopathy, hepatorenal syndrome (HRS) and hepatocellular carcinoma (HCC) portend a poor prognosis and further decreases survival in these patients. The major causes of cirrhosis include excessive alcohol consumption, viral hepatitis and non- alcoholic fatty liver disease.
Currently the only definitive treatment option for cirrhosis is liver transplantation which is limited in its applicability due to donor shortage, exorbitant costs and lack of widespread availability. Moreover, it requires lifelong immunosuppression and has considerable long term side effects including chronic renal failure, post-transplant lymphoproliferative disease and cardiovascular complications.
The ability of stem cells to differentiate into multiple cellular lineages makes one speculate that stem cells can be used for tissue repair and regeneration when tissue-resident stem cells become overwhelmed. It has been shown that in response to acute or chronic liver damage, bone marrow derived stem cells can spontaneously populate the liver and differentiate into hepatic cells, thereby contributing to hepatic regeneration. Thus, apart from hepatocytes and intrahepatic stem cells, bone marrow derived stem cells also participate in the liver regeneration process.
Currently, there are two methods to mobilize stem cells from the bone marrow to the liver. One is administration of cytokines like granulocyte-colony stimulating factor (G-CSF) and the other is the isolation of stem cells from the marrow and their injection into the hepatic artery or portal vein after purification. The latter is probably more cumbersome and may be potentially risky due to the underlying coagulation abnormalities in cirrhotic patients. Improved liver histology and survival has been noted in patients with cirrhosis following mobilization of bone marrow stem cells by granulocyte-colony stimulating factor (G-CSF).
Three recent studies have demonstrated G-CSF induced mobilization of bone marrow stem cells (CD34 cells) in peripheral blood and their subsequent increase in liver tissue and improved survival in patients with alcoholic hepatitis and ACLF. However, there is a paucity of data on whether G-CSF improves survival and prognosis in patients with decompensated cirrhosis.
Verma, Singh et al have shown in an open label trial that there was significantly better 12 month transplant free survival in ( GCSF+ Growth hormone + standard medical therapy group ) and ( G CSF + standard medical therapy group ) as compared to standard medical therapy group alone. CD 34+ cells at day 6 of therapy increased as compared to baseline. There was also a significant decrease of clinical scores, improvement in nutrition, better control of ascites, reduction in liver stiffness, lesser episodes of infection as well as improvement in QOL scores in the treatment groups having G CSF as compared to baseline.
In a recent study by Newsome et al, a multicentre, open label randomized phase 2 trial, patients were randomized to standard care, treatment with subcutaneous G CSF or treatment with G CSF for 5 days followed by leukaphersis and IV infusion of CD 133 positive haematopoietic stem cells. They did not find any difference in MELD score over time in all 3 treatment groups. Serious adverse effects were more common in the G CSF groups than in standard treatment group.
In a study by Kedarisetty CK et al. a significantly larger proportion of patients with decompensated cirrhosis given a combination of G-CSF \& Darbopoietin α survived for 12 months more than patients given only placebo ( 68% vs. 26.9%; P = 0.001 ). The combination therapy also reduced liver severity scores and sepsis to a greater extent than placebo.
In view of the conflicting results of the above studies and no studies on the use of multiple courses of GCSF in patients with decompensated cirrhosis in a double blind manner, the present study was undertaken to assess the safety and efficacy of G-CSF in patients with decompensated cirrhosis in the form of a double blinded RCT.
|
{
"A": "Arm Label: G-CSF group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Granulocyte Colony Stimulating Factor | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Normal Saline | Intervention Type: DRUG; Name: Granulocyte Colony Stimulating Factor; Assigned to Arm(s): G-CSF group | Intervention Type: DRUG; Name: Normal Saline; Assigned to Arm(s): Placebo",
"B": "Arm Label: Standard Medical therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: standard medical therapy | Arm Label: G-CSF; Type: EXPERIMENTAL; Interventions: Drug: standard medical therapy, Drug: G-CSF | Arm Label: G-CSF and NAC; Type: EXPERIMENTAL; Interventions: Drug: standard medical therapy, Drug: G-CSF, Drug: n-Acetylcysteine | Intervention Type: DRUG; Name: standard medical therapy; Assigned to Arm(s): G-CSF, G-CSF and NAC, Standard Medical therapy | Intervention Type: DRUG; Name: G-CSF; Assigned to Arm(s): G-CSF, G-CSF and NAC | Intervention Type: DRUG; Name: n-Acetylcysteine; Assigned to Arm(s): G-CSF and NAC",
"C": "Arm Label: prednisolone or pentoxifylline + pegfiltrastim; Type: EXPERIMENTAL; Interventions: Drug: Standard of care + pegfiltrastim | Arm Label: prednisolone or pentoxifylline; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard of care | Intervention Type: DRUG; Name: Standard of care + pegfiltrastim; Assigned to Arm(s): prednisolone or pentoxifylline + pegfiltrastim | Intervention Type: DRUG; Name: Standard of care; Assigned to Arm(s): prednisolone or pentoxifylline",
"D": "Arm Label: Standard Medical Therapy + G CSF Therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: G-CSF | Arm Label: Standard Medical Therapy + Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: G-CSF; Assigned to Arm(s): Standard Medical Therapy + G CSF Therapy | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Standard Medical Therapy + Placebo"
}
|
D
|
[
"NCT01036932",
"NCT02971306",
"NCT02776059",
"NCT03911037"
] | 27,174 |
val
|
NCT03911401
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Vehicle Controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment to the Vehicle in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)
Brief Summary: To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in pediatric patients with Atopic Dermatitis (AD).
|
{
"A": "Arm Label: GW870086X; Type: OTHER; Interventions: Drug: GW870086X | Intervention Type: DRUG; Name: GW870086X; Assigned to Arm(s): GW870086X",
"B": "Arm Label: Roflumilast Cream 0.05%; Type: ACTIVE_COMPARATOR; Interventions: Drug: Roflumilast Cream 0.05% | Arm Label: Roflumilast Cream 0.15%; Type: ACTIVE_COMPARATOR; Interventions: Drug: Roflumilast Cream 0.15% | Arm Label: Vehicle Cream; Type: PLACEBO_COMPARATOR; Interventions: Drug: Vehicle Cream | Intervention Type: DRUG; Name: Roflumilast Cream 0.05%; Assigned to Arm(s): Roflumilast Cream 0.05% | Intervention Type: DRUG; Name: Roflumilast Cream 0.15%; Assigned to Arm(s): Roflumilast Cream 0.15% | Intervention Type: DRUG; Name: Vehicle Cream; Assigned to Arm(s): Vehicle Cream",
"C": "Arm Label: Vehicle Control (VC) Period: Vehicle Cream BID; Type: PLACEBO_COMPARATOR; Interventions: Drug: Vehicle cream | Arm Label: VC Period: Ruxolitinib 0.75% Cream BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib cream | Arm Label: VC Period: Ruxolitinib 1.5% Cream BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib cream | Arm Label: Long-Term Safety (LTS) Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib cream | Arm Label: LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib cream | Arm Label: LTS Period: Ruxolitinib 0.75% Cream BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib cream | Arm Label: LTS Period: Ruxolitinib 1.5% Cream BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib cream | Intervention Type: DRUG; Name: Ruxolitinib cream; Assigned to Arm(s): LTS Period: Ruxolitinib 0.75% Cream BID, LTS Period: Ruxolitinib 1.5% Cream BID, LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID, Long-Term Safety (LTS) Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID, VC Period: Ruxolitinib 0.75% Cream BID, VC Period: Ruxolitinib 1.5% Cream BID | Intervention Type: DRUG; Name: Vehicle cream; Assigned to Arm(s): Vehicle Control (VC) Period: Vehicle Cream BID",
"D": "Arm Label: 0.3% OPA-15406; Type: EXPERIMENTAL; Interventions: Drug: 0.3% OPA-15406 | Arm Label: 1% OPA-15406; Type: EXPERIMENTAL; Interventions: Drug: 1% OPA-15406 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebos | Intervention Type: DRUG; Name: 0.3% OPA-15406; Assigned to Arm(s): 0.3% OPA-15406 | Intervention Type: DRUG; Name: 1% OPA-15406; Assigned to Arm(s): 1% OPA-15406 | Intervention Type: DRUG; Name: Placebos; Assigned to Arm(s): Placebo"
}
|
D
|
[
"NCT00549497",
"NCT03916081",
"NCT03745651",
"NCT03911401"
] | 27,175 |
val
|
NCT03911583
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effectiveness of PUSH Notifications From a Mobile App for Improving the Body Composition of Overweight or Obese Women. Protocol of a Three-armed Clinical Assay
Brief Summary: A clinical three-armed assay has been established to permit an evaluation of the effectiveness of implementing PUSH notifications in the actions orientated towards improving body composition through the establishment of dietary patterns and an increase in physical activity.
|
{
"A": "Arm Label: Control: Lifestyle counseling; Type: ACTIVE_COMPARATOR; Interventions: Other: Control: Lifestyle counseling | Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Other: Intervention group, Other: Control: Lifestyle counseling | Intervention Type: OTHER; Name: Intervention group; Assigned to Arm(s): Intervention group | Intervention Type: OTHER; Name: Control: Lifestyle counseling; Assigned to Arm(s): Control: Lifestyle counseling, Intervention group",
"B": "Arm Label: Experimental: Group Sessions; Type: EXPERIMENTAL; Interventions: Behavioral: Group Sessions, Behavioral: Feedback, Behavioral: Self-monitoring | Arm Label: Active Comparator: Self-Monitoring; Type: EXPERIMENTAL; Interventions: Behavioral: Self-monitoring | Arm Label: Experimental: Feedback; Type: EXPERIMENTAL; Interventions: Behavioral: Feedback, Behavioral: Self-monitoring | Intervention Type: BEHAVIORAL; Name: Group Sessions; Assigned to Arm(s): Experimental: Group Sessions | Intervention Type: BEHAVIORAL; Name: Feedback; Assigned to Arm(s): Experimental: Feedback, Experimental: Group Sessions | Intervention Type: BEHAVIORAL; Name: Self-monitoring; Assigned to Arm(s): Active Comparator: Self-Monitoring, Experimental: Feedback, Experimental: Group Sessions",
"C": "Arm Label: HABIT Group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: HABIT | Arm Label: TRE Group; Type: EXPERIMENTAL; Interventions: Behavioral: TRE | Intervention Type: BEHAVIORAL; Name: TRE; Assigned to Arm(s): TRE Group | Intervention Type: BEHAVIORAL; Name: HABIT; Assigned to Arm(s): HABIT Group",
"D": "Arm Label: Control Group (CG); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Control Group (CG) | Arm Label: Moderate physical activity group (MPA); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Moderate physical activity group (MPA) | Arm Label: Intense physical activity group (IPA); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Intense physical activity group (IPA) | Intervention Type: BEHAVIORAL; Name: Control Group (CG); Assigned to Arm(s): Control Group (CG) | Intervention Type: BEHAVIORAL; Name: Moderate physical activity group (MPA); Assigned to Arm(s): Moderate physical activity group (MPA) | Intervention Type: BEHAVIORAL; Name: Intense physical activity group (IPA); Assigned to Arm(s): Intense physical activity group (IPA)"
}
|
D
|
[
"NCT03175614",
"NCT02829632",
"NCT04465721",
"NCT03911583"
] | 27,176 |
val
|
NCT03911713
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.
|
{
"A": "Arm Label: Ivacaftor; Type: ACTIVE_COMPARATOR; Interventions: Drug: IVA, Drug: Placebo | Arm Label: VX-561: 25 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-561, Drug: Placebo | Arm Label: VX-561: 50 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-561, Drug: Placebo | Arm Label: VX-561: 150 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-561, Drug: Placebo | Arm Label: VX-561: 250 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-561, Drug: Placebo | Intervention Type: DRUG; Name: VX-561; Assigned to Arm(s): VX-561: 150 mg, VX-561: 25 mg, VX-561: 250 mg, VX-561: 50 mg | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Ivacaftor | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): VX-561: 150 mg, VX-561: 25 mg, VX-561: 250 mg, VX-561: 50 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Ivacaftor",
"B": "Arm Label: ELX/TEZ/IVA; Type: EXPERIMENTAL; Interventions: Drug: ELX/TEZ/IVA, Drug: IVA | Intervention Type: DRUG; Name: ELX/TEZ/IVA; Assigned to Arm(s): ELX/TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): ELX/TEZ/IVA",
"C": "Arm Label: Ataluren; Type: EXPERIMENTAL; Interventions: Drug: Ataluren | Intervention Type: DRUG; Name: Ataluren; Assigned to Arm(s): Ataluren",
"D": "Arm Label: LUM/IVA; Type: EXPERIMENTAL; Interventions: Drug: VX-809, Drug: VX-770 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: VX-809; Assigned to Arm(s): LUM/IVA | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: VX-770; Assigned to Arm(s): LUM/IVA"
}
|
A
|
[
"NCT03911713",
"NCT03525574",
"NCT02107859",
"NCT02514473"
] | 27,177 |
val
|
NCT03912233
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis
Brief Summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121 combination therapy in subjects with cystic fibrosis (CF).
|
{
"A": "Arm Label: ELX/TEZ/IVA; Type: EXPERIMENTAL; Interventions: Drug: ELX/TEZ/IVA, Drug: IVA | Intervention Type: DRUG; Name: ELX/TEZ/IVA; Assigned to Arm(s): ELX/TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): ELX/TEZ/IVA",
"B": "Arm Label: Part 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Part 1: VX-121/TEZ/VX-561 TC - Low Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-121, Drug: TEZ, Drug: VX-561 | Arm Label: Part 1: VX-121/TEZ/VX-561 TC - Medium Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-121, Drug: TEZ, Drug: VX-561 | Arm Label: Part 1: VX-121/TEZ/VX-561 TC - High Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-121, Drug: TEZ, Drug: VX-561 | Arm Label: Part 2: TEZ/IVA; Type: ACTIVE_COMPARATOR; Interventions: Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 2: VX-121/TEZ/VX-561 TC - High Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-121, Drug: TEZ, Drug: VX-561 | Intervention Type: DRUG; Name: VX-121; Assigned to Arm(s): Part 1: VX-121/TEZ/VX-561 TC - High Dose, Part 1: VX-121/TEZ/VX-561 TC - Low Dose, Part 1: VX-121/TEZ/VX-561 TC - Medium Dose, Part 2: VX-121/TEZ/VX-561 TC - High Dose | Intervention Type: DRUG; Name: TEZ; Assigned to Arm(s): Part 1: VX-121/TEZ/VX-561 TC - High Dose, Part 1: VX-121/TEZ/VX-561 TC - Low Dose, Part 1: VX-121/TEZ/VX-561 TC - Medium Dose, Part 2: VX-121/TEZ/VX-561 TC - High Dose | Intervention Type: DRUG; Name: VX-561; Assigned to Arm(s): Part 1: VX-121/TEZ/VX-561 TC - High Dose, Part 1: VX-121/TEZ/VX-561 TC - Low Dose, Part 1: VX-121/TEZ/VX-561 TC - Medium Dose, Part 2: VX-121/TEZ/VX-561 TC - High Dose | Intervention Type: DRUG; Name: TEZ/IVA; Assigned to Arm(s): Part 2: TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Part 2: TEZ/IVA | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Part 1: Placebo",
"C": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 150 mg Ivacaftor q12h; Type: EXPERIMENTAL; Interventions: Drug: Ivacaftor | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): 150 mg Ivacaftor q12h | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Arm Label: Part A: ELX/TEZ/IVA; Type: EXPERIMENTAL; Interventions: Drug: ELX/TEZ/IVA, Drug: IVA | Arm Label: Part B: ELX/TEZ/IVA; Type: EXPERIMENTAL; Interventions: Drug: ELX/TEZ/IVA, Drug: IVA | Intervention Type: DRUG; Name: ELX/TEZ/IVA; Assigned to Arm(s): Part A: ELX/TEZ/IVA, Part B: ELX/TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Part A: ELX/TEZ/IVA, Part B: ELX/TEZ/IVA"
}
|
B
|
[
"NCT04545515",
"NCT03912233",
"NCT00909532",
"NCT04537793"
] | 27,178 |
val
|
NCT03914027
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Feasibility & Effect of a Tele-rehabilitation Program in Pulmonary Sarcoidosis
Brief Summary: Pulmonary sarcoidosis (PS) is defined as a multisystem granulomatous disorder of unknown cause affecting different vital organs, especially the lungs.
PS manifest in reduction of pulmonary function. Overall symptoms lead to poor physical conditioning contributing to a vicious cycle of more physical inactivity.
Treatment of sarcoidosis is usually limited to patient symptoms. Progressive fibrosis sometimes can lead to respiratory failure and ultimately, pulmonary transplantation.
Physical training shows promising evidence of a positive effect on PF. No defined training program with regard to exercise frequency, duration or intensities exists.
PS is a relatively rare disease and patients are scattered in great geographically areas,.It is difficult to organize targeted group training with supervised physical training, convenient for patients and affordable for the public health sector. Tele-rehabilitation (TR) seems to be a good approach to reach patients in low inhabited areas, going from health care to self-care, empowering patient's awareness of their disease and increasing the flexibility patients need to acquire healthier behaviors.
Preliminary evaluations from TR initiatives in Scotland showed tele-rehabilitation to be more cost effective with patients living in remote areas than with the outreach- or centralized model.
No studies on the feasibility effect of TR in PS exists. The study is a prospective randomized controlled trial investigating the effects of tele-rehabilitation in patients with PS compared to standard practice. 24 patients with PS will be randomized in two groups, trained by tele-rehabilitation for 12 weeks and afterwards followed for 6 months. The control group will follow the usual control program for PS patients that only involves outpatient visits approximately every 3rd month. No specific PS rehabilitation program exists. The intervention group will receive TR in the form of video consultations- and chat sessions with a real physiotherapist and workout sessions with a virtual physiotherapist agent. They will also train with virtual reality glasses or tablets that show the actual exercises in the training program.
Patients will be tested with pulmonary function, physical, anxiety and quality of life parameters, all at baseline, after 12 weeks of intervention, 3 and 6 months after cessation of the program.
|
{
"A": "Arm Label: Intervention group \"tele-rehabilitation\"; Type: EXPERIMENTAL; Interventions: Behavioral: Virtual Autonomous Physiotherapist Agent (VAPA) | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Virtual Autonomous Physiotherapist Agent (VAPA) | Intervention Type: BEHAVIORAL; Name: Virtual Autonomous Physiotherapist Agent (VAPA); Assigned to Arm(s): Control, Intervention group \"tele-rehabilitation\"",
"B": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Telerehabilitation | Intervention Type: BEHAVIORAL; Name: Telerehabilitation; Assigned to Arm(s): Intervention",
"C": "Arm Label: Telehealth program; Type: OTHER; Interventions: Other: Telehealth program | Arm Label: Usual care; Type: OTHER; Interventions: Other: Usual care | Intervention Type: OTHER; Name: Telehealth program; Assigned to Arm(s): Telehealth program | Intervention Type: OTHER; Name: Usual care; Assigned to Arm(s): Usual care",
"D": "Arm Label: Targeted self-management barrier support; Type: EXPERIMENTAL; Interventions: Behavioral: Self-management barrier support | Arm Label: Guided COPD education; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Basic COPD Education | Intervention Type: BEHAVIORAL; Name: Self-management barrier support; Assigned to Arm(s): Targeted self-management barrier support | Intervention Type: BEHAVIORAL; Name: Basic COPD Education; Assigned to Arm(s): Guided COPD education"
}
|
B
|
[
"NCT03548181",
"NCT03914027",
"NCT01724684",
"NCT04533412"
] | 27,179 |
val
|
NCT03914027
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Feasibility & Effect of a Tele-rehabilitation Program in Pulmonary Sarcoidosis
Brief Summary: Pulmonary sarcoidosis (PS) is defined as a multisystem granulomatous disorder of unknown cause affecting different vital organs, especially the lungs.
PS manifest in reduction of pulmonary function. Overall symptoms lead to poor physical conditioning contributing to a vicious cycle of more physical inactivity.
Treatment of sarcoidosis is usually limited to patient symptoms. Progressive fibrosis sometimes can lead to respiratory failure and ultimately, pulmonary transplantation.
Physical training shows promising evidence of a positive effect on PF. No defined training program with regard to exercise frequency, duration or intensities exists.
PS is a relatively rare disease and patients are scattered in great geographically areas,.It is difficult to organize targeted group training with supervised physical training, convenient for patients and affordable for the public health sector. Tele-rehabilitation (TR) seems to be a good approach to reach patients in low inhabited areas, going from health care to self-care, empowering patient's awareness of their disease and increasing the flexibility patients need to acquire healthier behaviors.
Preliminary evaluations from TR initiatives in Scotland showed tele-rehabilitation to be more cost effective with patients living in remote areas than with the outreach- or centralized model.
No studies on the feasibility effect of TR in PS exists. The study is a prospective randomized controlled trial investigating the effects of tele-rehabilitation in patients with PS compared to standard practice. 24 patients with PS will be randomized in two groups, trained by tele-rehabilitation for 12 weeks and afterwards followed for 6 months. The control group will follow the usual control program for PS patients that only involves outpatient visits approximately every 3rd month. No specific PS rehabilitation program exists. The intervention group will receive TR in the form of video consultations- and chat sessions with a real physiotherapist and workout sessions with a virtual physiotherapist agent. They will also train with virtual reality glasses or tablets that show the actual exercises in the training program.
Patients will be tested with pulmonary function, physical, anxiety and quality of life parameters, all at baseline, after 12 weeks of intervention, 3 and 6 months after cessation of the program.
|
{
"A": "Arm Label: Tool + Self-management Support Program; Type: EXPERIMENTAL; Interventions: Device: Tool, Behavioral: Self-management Support Program | Arm Label: Self- management Support Program; Type: EXPERIMENTAL; Interventions: Behavioral: Self-management Support Program | Arm Label: Care as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Tool; Assigned to Arm(s): Tool + Self-management Support Program | Intervention Type: BEHAVIORAL; Name: Self-management Support Program; Assigned to Arm(s): Self- management Support Program, Tool + Self-management Support Program",
"B": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Telerehabilitation | Intervention Type: BEHAVIORAL; Name: Telerehabilitation; Assigned to Arm(s): Intervention",
"C": "Arm Label: Experimental - CPW (Urban); Type: N/A; Interventions: Other: Clinical Pathway (CPW) | Arm Label: Experimental - CPW (Rural); Type: N/A; Interventions: Other: Clinical Pathway (CPW) | Arm Label: Control - Standard Care (Urban); Type: N/A; Interventions: N/A | Arm Label: Control - Standard Care (Rural); Type: N/A; Interventions: N/A | Intervention Type: OTHER; Name: Clinical Pathway (CPW); Assigned to Arm(s): Experimental - CPW (Rural), Experimental - CPW (Urban)",
"D": "Intervention Type: BEHAVIORAL; Name: Intermediate care package; Assigned to Arm(s): N/A"
}
|
B
|
[
"NCT01867970",
"NCT03914027",
"NCT03075709",
"NCT00129779"
] | 27,180 |
val
|
NCT03914313
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effects of Robotic Neurorehabilitation Plus Virtual Reality on Attention Process and Executive Functions in Patients With Chronic Stroke: a Randomized Controlled Trial
Brief Summary: Stroke can be classified as ischemic, i.e. due to the lack of blood flow, and haemorrhagic, caused by bleeding. Stroke results in focal signs and symptoms, with a devastating impact on a patient and his family. Although robotic rehabilitation is very useful in improving motor function, there is no a clear evidence on its role in improving cognitive abilities, which are often compromised in stroke patients.
To this end, the investigators designed a randomized controlled experimental study on stroke patients, with the aim of evaluating the effects of robotic neurorehabilitation using Lokomat with and without virtual reality on cognitive functioning in stroke patients, compared to traditional therapy.
|
{
"A": "Arm Label: CO-OP; Type: EXPERIMENTAL; Interventions: Behavioral: CO-OP | Arm Label: Attention Control; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Attention Control | Intervention Type: BEHAVIORAL; Name: CO-OP; Assigned to Arm(s): CO-OP | Intervention Type: BEHAVIORAL; Name: Attention Control; Assigned to Arm(s): Attention Control",
"B": "Arm Label: Guided Training; Type: EXPERIMENTAL; Interventions: Behavioral: Guided Training | Arm Label: Directed Training; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Directed Training | Intervention Type: BEHAVIORAL; Name: Guided Training; Assigned to Arm(s): Guided Training | Intervention Type: BEHAVIORAL; Name: Directed Training; Assigned to Arm(s): Directed Training",
"C": "Arm Label: Robotic Treatment plus VR; Type: EXPERIMENTAL; Interventions: Device: Robotic Treatment plus VR | Arm Label: Robotic treatment without VR; Type: ACTIVE_COMPARATOR; Interventions: Device: Robotic Treatment plus VR | Arm Label: Conventional treatment; Type: ACTIVE_COMPARATOR; Interventions: Device: Robotic Treatment plus VR | Intervention Type: DEVICE; Name: Robotic Treatment plus VR; Assigned to Arm(s): Conventional treatment, Robotic Treatment plus VR, Robotic treatment without VR",
"D": "Arm Label: Self-Management group-intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Self-Management group-intervention | Arm Label: Standard Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard Care | Intervention Type: BEHAVIORAL; Name: Self-Management group-intervention; Assigned to Arm(s): Self-Management group-intervention | Intervention Type: BEHAVIORAL; Name: Standard Care; Assigned to Arm(s): Standard Care"
}
|
C
|
[
"NCT02755805",
"NCT02766400",
"NCT03914313",
"NCT02289287"
] | 27,181 |
val
|
NCT03914898
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Nurse-Led Intervention Programme on Compassion Fatigue, Burnout, Compassion
Brief Summary: Nurses are at risk in terms of burnout and empathic fatigue. Therefore, efforts to protect the mental health of nurses are very important. It is stated that the studies conducted are mostly descriptive and not interventional.
In addition, the evidence levels of interventional studies are low.
|
{
"A": "Arm Label: Group therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Manualized Therapy | Arm Label: Control Group; Type: OTHER; Interventions: Behavioral: Control Group | Intervention Type: BEHAVIORAL; Name: Manualized Therapy; Assigned to Arm(s): Group therapy | Intervention Type: BEHAVIORAL; Name: Control Group; Assigned to Arm(s): Control Group",
"B": "Arm Label: Continuous intensivist staffing model; Type: N/A; Interventions: Other: Alternative Intensivist staffing models. | Arm Label: Discontinuous intensivist staffing model; Type: N/A; Interventions: Other: Alternative Intensivist staffing models. | Intervention Type: OTHER; Name: Alternative Intensivist staffing models.; Assigned to Arm(s): Continuous intensivist staffing model, Discontinuous intensivist staffing model",
"C": "Arm Label: Nurse led intervention group; Type: EXPERIMENTAL; Interventions: Other: Nurse led intervention group | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Nurse led intervention group; Assigned to Arm(s): Nurse led intervention group",
"D": "Arm Label: Mental Training for Surgeons; Type: EXPERIMENTAL; Interventions: Behavioral: Mindfulness Based Stress Reduction - modified | Arm Label: The Mind of a Surgeon; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Active listening and reading | Intervention Type: BEHAVIORAL; Name: Mindfulness Based Stress Reduction - modified; Assigned to Arm(s): Mental Training for Surgeons | Intervention Type: BEHAVIORAL; Name: Active listening and reading; Assigned to Arm(s): The Mind of a Surgeon"
}
|
C
|
[
"NCT02540473",
"NCT01145443",
"NCT03914898",
"NCT03141190"
] | 27,182 |
val
|
NCT03914898
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Nurse-Led Intervention Programme on Compassion Fatigue, Burnout, Compassion
Brief Summary: Nurses are at risk in terms of burnout and empathic fatigue. Therefore, efforts to protect the mental health of nurses are very important. It is stated that the studies conducted are mostly descriptive and not interventional.
In addition, the evidence levels of interventional studies are low.
|
{
"A": "Arm Label: Intervention Group; Type: EXPERIMENTAL; Interventions: Behavioral: ACTr (Acceptance and Commitment Training) | Arm Label: Wait-list control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: ACTr (Acceptance and Commitment Training); Assigned to Arm(s): Intervention Group",
"B": "Arm Label: Mobile Video Counseling; Type: EXPERIMENTAL; Interventions: Behavioral: Stress management counseling | Arm Label: Offline Counseling; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Stress management counseling | Arm Label: Selfcare; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Stress management counseling; Assigned to Arm(s): Mobile Video Counseling, Offline Counseling",
"C": "Arm Label: Nurse led intervention group; Type: EXPERIMENTAL; Interventions: Other: Nurse led intervention group | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Nurse led intervention group; Assigned to Arm(s): Nurse led intervention group",
"D": "Arm Label: Mindful Awareness Practices (MAPs); Type: EXPERIMENTAL; Interventions: Behavioral: Mindful Awareness Practices (MAPs) | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Mindful Awareness Practices (MAPs); Assigned to Arm(s): Mindful Awareness Practices (MAPs)"
}
|
C
|
[
"NCT03759795",
"NCT03256682",
"NCT03914898",
"NCT03613441"
] | 27,183 |
val
|
NCT03914898
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Nurse-Led Intervention Programme on Compassion Fatigue, Burnout, Compassion
Brief Summary: Nurses are at risk in terms of burnout and empathic fatigue. Therefore, efforts to protect the mental health of nurses are very important. It is stated that the studies conducted are mostly descriptive and not interventional.
In addition, the evidence levels of interventional studies are low.
|
{
"A": "Arm Label: Intensive Group Analytic Psychotherapy; Type: EXPERIMENTAL; Interventions: Behavioral: Intensive Group Analytic Psychotherapy | Arm Label: Intensive GCBT; Type: EXPERIMENTAL; Interventions: Behavioral: Intensive transdiagnostic cognitive-behavioral group therapy | Arm Label: Wait-list control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Intensive Group Analytic Psychotherapy; Assigned to Arm(s): Intensive Group Analytic Psychotherapy | Intervention Type: BEHAVIORAL; Name: Intensive transdiagnostic cognitive-behavioral group therapy; Assigned to Arm(s): Intensive GCBT",
"B": "Arm Label: Nurse led intervention group; Type: EXPERIMENTAL; Interventions: Other: Nurse led intervention group | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Nurse led intervention group; Assigned to Arm(s): Nurse led intervention group",
"C": "Arm Label: Intervention Group; Type: EXPERIMENTAL; Interventions: Behavioral: ACTr (Acceptance and Commitment Training) | Arm Label: Wait-list control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: ACTr (Acceptance and Commitment Training); Assigned to Arm(s): Intervention Group",
"D": "Arm Label: 1; Type: NO_INTERVENTION; Interventions: Behavioral: Dialectical Cognitive Therapy | Intervention Type: BEHAVIORAL; Name: Dialectical Cognitive Therapy; Assigned to Arm(s): 1"
}
|
B
|
[
"NCT02126787",
"NCT03914898",
"NCT03759795",
"NCT00481000"
] | 27,184 |
val
|
NCT03914898
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Nurse-Led Intervention Programme on Compassion Fatigue, Burnout, Compassion
Brief Summary: Nurses are at risk in terms of burnout and empathic fatigue. Therefore, efforts to protect the mental health of nurses are very important. It is stated that the studies conducted are mostly descriptive and not interventional.
In addition, the evidence levels of interventional studies are low.
|
{
"A": "Arm Label: Nurse led intervention group; Type: EXPERIMENTAL; Interventions: Other: Nurse led intervention group | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Nurse led intervention group; Assigned to Arm(s): Nurse led intervention group",
"B": "Arm Label: Sudarshan Kroya Yoga (SKY); Type: EXPERIMENTAL; Interventions: Other: Sudarshan Kriya Yoga (SKY) | Arm Label: Health Enhancement Program (HEP); Type: ACTIVE_COMPARATOR; Interventions: Other: Health Enhancement Program | Intervention Type: OTHER; Name: Sudarshan Kriya Yoga (SKY); Assigned to Arm(s): Sudarshan Kroya Yoga (SKY) | Intervention Type: OTHER; Name: Health Enhancement Program; Assigned to Arm(s): Health Enhancement Program (HEP)",
"C": "Arm Label: Short-term Compassion Fatigue Resiliency Program; Type: EXPERIMENTAL; Interventions: Behavioral: Compassion Fatigue Resiliency Program (CFRP) | Arm Label: Long-term Compassion Fatigue Resiliency Program; Type: EXPERIMENTAL; Interventions: Behavioral: Compassion Fatigue Resiliency Program (CFRP) | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Compassion Fatigue Resiliency Program (CFRP); Assigned to Arm(s): Long-term Compassion Fatigue Resiliency Program, Short-term Compassion Fatigue Resiliency Program",
"D": "Arm Label: Intervention Group; Type: EXPERIMENTAL; Interventions: Behavioral: ACTr (Acceptance and Commitment Training) | Arm Label: Wait-list control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: ACTr (Acceptance and Commitment Training); Assigned to Arm(s): Intervention Group"
}
|
A
|
[
"NCT03914898",
"NCT04368676",
"NCT04372303",
"NCT03759795"
] | 27,185 |
val
|
NCT03916081
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% and ARQ-151 Cream 0.15% Administered QD (Quaque Die) in Adolescent and Adult Subjects With Atopic Dermatitis
Brief Summary: The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.
|
{
"A": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: E6005 | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: E6005; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2",
"B": "Arm Label: Crisaborole ointment 2%; Type: EXPERIMENTAL; Interventions: Drug: Crisaborole ointment 2% | Intervention Type: DRUG; Name: Crisaborole ointment 2%; Assigned to Arm(s): Crisaborole ointment 2%",
"C": "Arm Label: Prevalent case of atopic dermatitis; Type: N/A; Interventions: Other: No intervention | Arm Label: Controls; Type: N/A; Interventions: Other: No intervention | Intervention Type: OTHER; Name: No intervention; Assigned to Arm(s): Controls, Prevalent case of atopic dermatitis",
"D": "Arm Label: Roflumilast Cream 0.05%; Type: ACTIVE_COMPARATOR; Interventions: Drug: Roflumilast Cream 0.05% | Arm Label: Roflumilast Cream 0.15%; Type: ACTIVE_COMPARATOR; Interventions: Drug: Roflumilast Cream 0.15% | Arm Label: Vehicle Cream; Type: PLACEBO_COMPARATOR; Interventions: Drug: Vehicle Cream | Intervention Type: DRUG; Name: Roflumilast Cream 0.05%; Assigned to Arm(s): Roflumilast Cream 0.05% | Intervention Type: DRUG; Name: Roflumilast Cream 0.15%; Assigned to Arm(s): Roflumilast Cream 0.15% | Intervention Type: DRUG; Name: Vehicle Cream; Assigned to Arm(s): Vehicle Cream"
}
|
D
|
[
"NCT01179880",
"NCT03356977",
"NCT03823794",
"NCT03916081"
] | 27,186 |
val
|
NCT03924089
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of an Oral Nutritional Supplement on Nutritional and Functional Status, Biological Markers (Inflammation and Oxidative Stress, Intestinal Microbiota, Circulating microRNA and Its Target Genes) in Malnourished Hemodialysis Patients.
Brief Summary: Malnutrition in hemodialysis patients is frequent and it is associated with a reduction in muscular mass, strength, functional capacity and quality of life, with an increment in inflammatory and oxidative markers, and with a dysregulation of circulating miRNAs and its target genes.
Animal and human studies have reported that some dietary components (macronutrients, micronutrients and other bioactive substances) might restore these altered features.
Thus, we hypothesized that the intake of an oral nutritional supplement (ONS) specifically developed for malnourished hemodialysis patients enriched with functional nutrients (extra virgin olive oil, omega 3 fatty acids, whey protein, antioxidants, carnitine, and with or without probiotics) vs. individualized diet recommendations might:
* Improve nutritional status (visceral proteins, muscular mass), functional capacity and quality of life.
* Reduce inflammatory and oxidative markers, and modulate the circulating levels of some miRNAs and the expression of its target genes on cells. miRNAs may be useful biomarkers to check the response to a nutritional intervention in malnourished hemodialysis patients.
The present study is a randomized, multicenter, parallel-group trial with 3 groups, open to the intake of ONS or individualized diet recommendations, but double-blind to the intake of probiotics. Inclusion criteria comprised adult subjects (\>18 y/o) undergoing hemodialysis more than 6 months previous at inclusion and at least one of these caloric malnutrition criteria: a) involuntary weight loss \>5% in 3 months or \>10% in 6 months; b) serum albumin \< 3.5 g/dl or prealbumin \<28 mg/dl; c) body mass index (BMI) \< 23 kg/m2; d) muscular mass loss \>5% in 3 months or \>10% in 6 months.
The study duration is 6 months, and comprises 4 visits (screening, basal, 3 months and 6 months). A nutritional examination that included anthropometric measurements, handgrip strength measured by a hand dynamometer, body composition assessed by bioelectrical impedance analysis (BIA) and a 5 days dietary record; quality of life evaluation by the "12-item short form health survey"; the presence of symptoms of depression and anxiety (Hospital Anxiety and Depression Scale); assessment of functional status by the "Barthel" test, the "Short Physical Performance Battery" and the "International Physical Activity Questionnaire"; and blood and stool samples will be obtained for each participant in each study visit (except screening visit).
|
{
"A": "Arm Label: Oral nutritional supplement with probiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Oral nutritional supplement with probiotics | Arm Label: Oral nutritional supplement without probiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Oral nutritional supplement without probiotics | Arm Label: Individualized dietary recommendations; Type: ACTIVE_COMPARATOR; Interventions: Other: Dietary recommendations | Intervention Type: DIETARY_SUPPLEMENT; Name: Oral nutritional supplement with probiotics; Assigned to Arm(s): Oral nutritional supplement with probiotics | Intervention Type: DIETARY_SUPPLEMENT; Name: Oral nutritional supplement without probiotics; Assigned to Arm(s): Oral nutritional supplement without probiotics | Intervention Type: OTHER; Name: Dietary recommendations; Assigned to Arm(s): Individualized dietary recommendations",
"B": "Arm Label: Glucose solution; Type: ACTIVE_COMPARATOR; Interventions: Drug: PD solution containing glucose | Arm Label: Glucose and L-carnitine solution; Type: EXPERIMENTAL; Interventions: Drug: PD solution containing glucose and L-carnitine | Intervention Type: DRUG; Name: PD solution containing glucose; Assigned to Arm(s): Glucose solution | Intervention Type: DRUG; Name: PD solution containing glucose and L-carnitine; Assigned to Arm(s): Glucose and L-carnitine solution",
"C": "Arm Label: UCR; Type: ACTIVE_COMPARATOR; Interventions: Device: UCR | Arm Label: UTR; Type: ACTIVE_COMPARATOR; Interventions: Device: UTR | Arm Label: conventional dialysis; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: UCR; Assigned to Arm(s): UCR | Intervention Type: DEVICE; Name: UTR; Assigned to Arm(s): UTR",
"D": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: L-Carnitine | Intervention Type: DRUG; Name: L-Carnitine; Assigned to Arm(s): 1"
}
|
A
|
[
"NCT03924089",
"NCT00755456",
"NCT01416753",
"NCT00322322"
] | 27,187 |
val
|
NCT03924089
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of an Oral Nutritional Supplement on Nutritional and Functional Status, Biological Markers (Inflammation and Oxidative Stress, Intestinal Microbiota, Circulating microRNA and Its Target Genes) in Malnourished Hemodialysis Patients.
Brief Summary: Malnutrition in hemodialysis patients is frequent and it is associated with a reduction in muscular mass, strength, functional capacity and quality of life, with an increment in inflammatory and oxidative markers, and with a dysregulation of circulating miRNAs and its target genes.
Animal and human studies have reported that some dietary components (macronutrients, micronutrients and other bioactive substances) might restore these altered features.
Thus, we hypothesized that the intake of an oral nutritional supplement (ONS) specifically developed for malnourished hemodialysis patients enriched with functional nutrients (extra virgin olive oil, omega 3 fatty acids, whey protein, antioxidants, carnitine, and with or without probiotics) vs. individualized diet recommendations might:
* Improve nutritional status (visceral proteins, muscular mass), functional capacity and quality of life.
* Reduce inflammatory and oxidative markers, and modulate the circulating levels of some miRNAs and the expression of its target genes on cells. miRNAs may be useful biomarkers to check the response to a nutritional intervention in malnourished hemodialysis patients.
The present study is a randomized, multicenter, parallel-group trial with 3 groups, open to the intake of ONS or individualized diet recommendations, but double-blind to the intake of probiotics. Inclusion criteria comprised adult subjects (\>18 y/o) undergoing hemodialysis more than 6 months previous at inclusion and at least one of these caloric malnutrition criteria: a) involuntary weight loss \>5% in 3 months or \>10% in 6 months; b) serum albumin \< 3.5 g/dl or prealbumin \<28 mg/dl; c) body mass index (BMI) \< 23 kg/m2; d) muscular mass loss \>5% in 3 months or \>10% in 6 months.
The study duration is 6 months, and comprises 4 visits (screening, basal, 3 months and 6 months). A nutritional examination that included anthropometric measurements, handgrip strength measured by a hand dynamometer, body composition assessed by bioelectrical impedance analysis (BIA) and a 5 days dietary record; quality of life evaluation by the "12-item short form health survey"; the presence of symptoms of depression and anxiety (Hospital Anxiety and Depression Scale); assessment of functional status by the "Barthel" test, the "Short Physical Performance Battery" and the "International Physical Activity Questionnaire"; and blood and stool samples will be obtained for each participant in each study visit (except screening visit).
|
{
"A": "Arm Label: Corn Starch; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Corn starch | Arm Label: Fiber; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Fiber | Intervention Type: DIETARY_SUPPLEMENT; Name: Fiber; Assigned to Arm(s): Fiber | Intervention Type: DIETARY_SUPPLEMENT; Name: Corn starch; Assigned to Arm(s): Corn Starch",
"B": "Arm Label: probiotic; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Probiotic | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotic; Assigned to Arm(s): probiotic | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): placebo",
"C": "Arm Label: Oral nutritional supplement with probiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Oral nutritional supplement with probiotics | Arm Label: Oral nutritional supplement without probiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Oral nutritional supplement without probiotics | Arm Label: Individualized dietary recommendations; Type: ACTIVE_COMPARATOR; Interventions: Other: Dietary recommendations | Intervention Type: DIETARY_SUPPLEMENT; Name: Oral nutritional supplement with probiotics; Assigned to Arm(s): Oral nutritional supplement with probiotics | Intervention Type: DIETARY_SUPPLEMENT; Name: Oral nutritional supplement without probiotics; Assigned to Arm(s): Oral nutritional supplement without probiotics | Intervention Type: OTHER; Name: Dietary recommendations; Assigned to Arm(s): Individualized dietary recommendations",
"D": "Arm Label: Probiotic; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Probiotic | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotic; Assigned to Arm(s): Probiotic"
}
|
C
|
[
"NCT01186276",
"NCT01752803",
"NCT03924089",
"NCT01735591"
] | 27,188 |
val
|
NCT03924739
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Nurse-coordinated Integrated Care Model to Support Decision-making and Self-care in Patients With Atrial Fibrillation: A Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effects of a nurse-coordinated, empowerment-based integrated care model on self-care behaviors and psychosocial outcomes in patients with atrial fibrillation (AF), and to explore how this intervention affects the self-care behaviors and quality of life from the patients' perspective.
Stroke prevention by oral anticoagulants (OAC) and control of arrhythmia and risk factors remain the cornerstones of AF management. However, under-prescription, non-adherence to treatment, and suboptimal anticoagulation control limit the efficacy of OACs. The poor abilities of patients regarding the self-control of arrhythmia and risk factors further contributes to worse outcomes. According to the World Health Organization, the best approach to chronic disease management involves the empowerment of patients to become active self-care agents. The literature indicates that a multifaceted, nurse-coordinated care model integrating all important care components with an empowerment approach could most effectively and actively engage patients in self-care.
This mixed-methods study comprises a randomized controlled trial and an exploratory qualitative study. A total of 392 community-dwelling patients aged ≥65 years with a confirmed diagnosis of AF, a high stroke risk, and no OAC treatment will be recruited from the medical outpatient clinics of a university-affiliated teaching hospital. The patients will be randomly allocated to intervention or control groups, which will receive treatment via the nurse-coordinated integrated care model or standard care, respectively. We hypothesize that compared to patients receiving standard care, AF patients exposed to the nurse-coordinated care model will be more likely to achieve compatible patient and physician decisions regarding the use of OAC, as well as better changes in medication adherence, anxiety, depression and health-related quality of life both immediately and 6 months post intervention.
This study will uniquely adopt an empowerment-based approach to equip patients as active agents in AF management through a nurse-coordinated integrated care model that comprehensively addresses their needs. The findings will advance our knowledge of patients' self-care behaviors in the context of AF and will provide a new model of care to improve health outcomes in this population.
|
{
"A": "Arm Label: AF Clinic; Type: EXPERIMENTAL; Interventions: Other: AF Clinic | Arm Label: Care as Usual; Type: ACTIVE_COMPARATOR; Interventions: Other: Care as Usual | Intervention Type: OTHER; Name: AF Clinic; Assigned to Arm(s): AF Clinic | Intervention Type: OTHER; Name: Care as Usual; Assigned to Arm(s): Care as Usual",
"B": "Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Nurse-coordinated integrated care model for AF | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Nurse-coordinated integrated care model for AF; Assigned to Arm(s): Intervention group",
"C": "Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: Educational Intervention | Arm Label: control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Educational Intervention; Assigned to Arm(s): Intervention",
"D": "Arm Label: Nurse Practitioner Led-Care; Type: EXPERIMENTAL; Interventions: Other: Nurse Practitioner Led-Care | Arm Label: Cardiologist Led-Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Cardiologist Led-Care | Intervention Type: OTHER; Name: Nurse Practitioner Led-Care; Assigned to Arm(s): Nurse Practitioner Led-Care | Intervention Type: OTHER; Name: Cardiologist Led-Care; Assigned to Arm(s): Cardiologist Led-Care"
}
|
B
|
[
"NCT00753259",
"NCT03924739",
"NCT02082548",
"NCT02745236"
] | 27,189 |
val
|
NCT03924739
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Nurse-coordinated Integrated Care Model to Support Decision-making and Self-care in Patients With Atrial Fibrillation: A Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effects of a nurse-coordinated, empowerment-based integrated care model on self-care behaviors and psychosocial outcomes in patients with atrial fibrillation (AF), and to explore how this intervention affects the self-care behaviors and quality of life from the patients' perspective.
Stroke prevention by oral anticoagulants (OAC) and control of arrhythmia and risk factors remain the cornerstones of AF management. However, under-prescription, non-adherence to treatment, and suboptimal anticoagulation control limit the efficacy of OACs. The poor abilities of patients regarding the self-control of arrhythmia and risk factors further contributes to worse outcomes. According to the World Health Organization, the best approach to chronic disease management involves the empowerment of patients to become active self-care agents. The literature indicates that a multifaceted, nurse-coordinated care model integrating all important care components with an empowerment approach could most effectively and actively engage patients in self-care.
This mixed-methods study comprises a randomized controlled trial and an exploratory qualitative study. A total of 392 community-dwelling patients aged ≥65 years with a confirmed diagnosis of AF, a high stroke risk, and no OAC treatment will be recruited from the medical outpatient clinics of a university-affiliated teaching hospital. The patients will be randomly allocated to intervention or control groups, which will receive treatment via the nurse-coordinated integrated care model or standard care, respectively. We hypothesize that compared to patients receiving standard care, AF patients exposed to the nurse-coordinated care model will be more likely to achieve compatible patient and physician decisions regarding the use of OAC, as well as better changes in medication adherence, anxiety, depression and health-related quality of life both immediately and 6 months post intervention.
This study will uniquely adopt an empowerment-based approach to equip patients as active agents in AF management through a nurse-coordinated integrated care model that comprehensively addresses their needs. The findings will advance our knowledge of patients' self-care behaviors in the context of AF and will provide a new model of care to improve health outcomes in this population.
|
{
"A": "Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Nurse-coordinated integrated care model for AF | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Nurse-coordinated integrated care model for AF; Assigned to Arm(s): Intervention group",
"B": "Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Behavioral: HITCM+CP | Arm Label: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: HITCM only | Intervention Type: BEHAVIORAL; Name: HITCM+CP; Assigned to Arm(s): Arm 1 | Intervention Type: BEHAVIORAL; Name: HITCM only; Assigned to Arm(s): Arm 2",
"C": "Arm Label: Peer-mentoring; Type: EXPERIMENTAL; Interventions: Other: Peer-mentoring | Intervention Type: OTHER; Name: Peer-mentoring; Assigned to Arm(s): Peer-mentoring",
"D": "Arm Label: Enhanced Usual Care (EUC) exercise group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Enhanced Usual Care Group | Arm Label: HEART Camp (HC) Intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: HEART Camp (HC) Intervention Group | Intervention Type: BEHAVIORAL; Name: Enhanced Usual Care Group; Assigned to Arm(s): Enhanced Usual Care (EUC) exercise group | Intervention Type: BEHAVIORAL; Name: HEART Camp (HC) Intervention Group; Assigned to Arm(s): HEART Camp (HC) Intervention group"
}
|
A
|
[
"NCT03924739",
"NCT00555360",
"NCT04507529",
"NCT01658670"
] | 27,190 |
val
|
NCT03925155
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Trial to Investigate if a Pre-operative Wash With Chlorhexidine vs Povidone-iodine Vaginal Scrub Decreases Infectious Morbidity in Patients Undergoing Cesarean Section After Ruptured Membranes
Brief Summary: The objective of this study is to investigate if the rate of infectious morbidity is decreased with the use of chlorhexidine or povidone-iodine vaginal scrub before cesarean section after ruptured membranes.
|
{
"A": "Arm Label: Chlorhexidine-alcohol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Chlorhexidine-alcohol | Arm Label: Povidine-iodine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Povidine-iodine | Arm Label: Saline; Type: PLACEBO_COMPARATOR; Interventions: Drug: Sterile saline | Intervention Type: DRUG; Name: Chlorhexidine-alcohol; Assigned to Arm(s): Chlorhexidine-alcohol | Intervention Type: DRUG; Name: Povidine-iodine; Assigned to Arm(s): Povidine-iodine | Intervention Type: DRUG; Name: Sterile saline; Assigned to Arm(s): Saline",
"B": "Arm Label: povidone iodine; Type: OTHER; Interventions: Drug: povidone- iodine solution. | Arm Label: CONTROL; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: povidone- iodine solution.; Assigned to Arm(s): povidone iodine | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): CONTROL",
"C": "Arm Label: Chlorhexidine gluconate vaginal scrub; Type: EXPERIMENTAL; Interventions: Drug: EZ scrub vaginal chlorhexidine 4% solution | Arm Label: Povidone-iodine vaginal scrub; Type: ACTIVE_COMPARATOR; Interventions: Drug: 10% provodine-iodine vaginal preparation | Intervention Type: DRUG; Name: EZ scrub vaginal chlorhexidine 4% solution; Assigned to Arm(s): Chlorhexidine gluconate vaginal scrub | Intervention Type: DRUG; Name: 10% provodine-iodine vaginal preparation; Assigned to Arm(s): Povidone-iodine vaginal scrub",
"D": "Arm Label: Bathing; Type: EXPERIMENTAL; Interventions: Other: preoperative bathing with antiseptic | Arm Label: No bathing; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: preoperative bathing with antiseptic; Assigned to Arm(s): Bathing"
}
|
C
|
[
"NCT03640507",
"NCT01437228",
"NCT03925155",
"NCT03544710"
] | 27,191 |
val
|
NCT03926065
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Lunchtime Meal Feeding Study for Preschool Children
Brief Summary: The aim of the study is to determine the effect of varying both the palatability and portion size of vegetables served to preschool children at a meal on the outcomes of food and energy intake at the meal.
|
{
"A": "Arm Label: Preschool Health Promotion Education Program; Type: EXPERIMENTAL; Interventions: Behavioral: Preschool Health Promotion Education Program | Arm Label: Control:Standard Curriculum; Type: OTHER; Interventions: Behavioral: Preschool Health Promotion Education Program | Intervention Type: BEHAVIORAL; Name: Preschool Health Promotion Education Program; Assigned to Arm(s): Control:Standard Curriculum, Preschool Health Promotion Education Program",
"B": "Arm Label: Program SI! educational intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Program SI! educational intervention | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Program SI! educational intervention; Assigned to Arm(s): Program SI! educational intervention",
"C": "Arm Label: parent intervention plus gym lessons; Type: EXPERIMENTAL; Interventions: Behavioral: parent-focused intervention, Behavioral: twice weekly gym lessons | Arm Label: gym lessons only; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: twice weekly gym lessons | Intervention Type: BEHAVIORAL; Name: parent-focused intervention; Assigned to Arm(s): parent intervention plus gym lessons | Intervention Type: BEHAVIORAL; Name: twice weekly gym lessons; Assigned to Arm(s): gym lessons only, parent intervention plus gym lessons",
"D": "Arm Label: Standard Palatability and Standard Portion Size; Type: EXPERIMENTAL; Interventions: Other: Plain Vegetables Served in 100% Portion Size | Arm Label: Standard Palatability and Larger Portion Size; Type: EXPERIMENTAL; Interventions: Other: Plain Vegetables Served in 200% Portion Size | Arm Label: Enhanced Palatability and Standard Portion Size; Type: EXPERIMENTAL; Interventions: Other: Enhanced Vegetables Served in 100% Portion Size | Arm Label: Enhanced Palatability and Larger Portion Size; Type: EXPERIMENTAL; Interventions: Other: Enhanced Vegetables Served in 200% Portion Size | Intervention Type: OTHER; Name: Plain Vegetables Served in 100% Portion Size; Assigned to Arm(s): Standard Palatability and Standard Portion Size | Intervention Type: OTHER; Name: Plain Vegetables Served in 200% Portion Size; Assigned to Arm(s): Standard Palatability and Larger Portion Size | Intervention Type: OTHER; Name: Enhanced Vegetables Served in 100% Portion Size; Assigned to Arm(s): Enhanced Palatability and Standard Portion Size | Intervention Type: OTHER; Name: Enhanced Vegetables Served in 200% Portion Size; Assigned to Arm(s): Enhanced Palatability and Larger Portion Size"
}
|
D
|
[
"NCT02343341",
"NCT01579708",
"NCT00987532",
"NCT03926065"
] | 27,192 |
val
|
NCT03926065
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Lunchtime Meal Feeding Study for Preschool Children
Brief Summary: The aim of the study is to determine the effect of varying both the palatability and portion size of vegetables served to preschool children at a meal on the outcomes of food and energy intake at the meal.
|
{
"A": "Arm Label: Standard Palatability and Standard Portion Size; Type: EXPERIMENTAL; Interventions: Other: Plain Vegetables Served in 100% Portion Size | Arm Label: Standard Palatability and Larger Portion Size; Type: EXPERIMENTAL; Interventions: Other: Plain Vegetables Served in 200% Portion Size | Arm Label: Enhanced Palatability and Standard Portion Size; Type: EXPERIMENTAL; Interventions: Other: Enhanced Vegetables Served in 100% Portion Size | Arm Label: Enhanced Palatability and Larger Portion Size; Type: EXPERIMENTAL; Interventions: Other: Enhanced Vegetables Served in 200% Portion Size | Intervention Type: OTHER; Name: Plain Vegetables Served in 100% Portion Size; Assigned to Arm(s): Standard Palatability and Standard Portion Size | Intervention Type: OTHER; Name: Plain Vegetables Served in 200% Portion Size; Assigned to Arm(s): Standard Palatability and Larger Portion Size | Intervention Type: OTHER; Name: Enhanced Vegetables Served in 100% Portion Size; Assigned to Arm(s): Enhanced Palatability and Standard Portion Size | Intervention Type: OTHER; Name: Enhanced Vegetables Served in 200% Portion Size; Assigned to Arm(s): Enhanced Palatability and Larger Portion Size",
"B": "Arm Label: Behavioral: Nutrition assistance; Type: EXPERIMENTAL; Interventions: Behavioral: Nutrition assistance | Arm Label: Behavioral: Children's environmental health; Type: EXPERIMENTAL; Interventions: Behavioral: Children's environmental health | Intervention Type: BEHAVIORAL; Name: Nutrition assistance; Assigned to Arm(s): Behavioral: Nutrition assistance | Intervention Type: BEHAVIORAL; Name: Children's environmental health; Assigned to Arm(s): Behavioral: Children's environmental health",
"C": "Arm Label: Enhanced Go NAPSACC; Type: EXPERIMENTAL; Interventions: Behavioral: Enhanced Go NAPSACC | Arm Label: Basic Go NAPSACC; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Basic Go NAPSACC | Intervention Type: BEHAVIORAL; Name: Enhanced Go NAPSACC; Assigned to Arm(s): Enhanced Go NAPSACC | Intervention Type: BEHAVIORAL; Name: Basic Go NAPSACC; Assigned to Arm(s): Basic Go NAPSACC",
"D": "Arm Label: Usual Head Start Exposure; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Parents of Preschoolers Series (POPS); Type: EXPERIMENTAL; Interventions: Behavioral: Parents of Preschoolers Series | Arm Label: POPS + Incredible Years Series (IYS); Type: EXPERIMENTAL; Interventions: Behavioral: Parents of Preschoolers Series, Behavioral: Incredible Years Series | Intervention Type: BEHAVIORAL; Name: Parents of Preschoolers Series; Assigned to Arm(s): POPS + Incredible Years Series (IYS), Parents of Preschoolers Series (POPS) | Intervention Type: BEHAVIORAL; Name: Incredible Years Series; Assigned to Arm(s): POPS + Incredible Years Series (IYS)"
}
|
A
|
[
"NCT03926065",
"NCT03560050",
"NCT03938103",
"NCT01398358"
] | 27,193 |
val
|
NCT03927534
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of a Mindful Eating Program to Reduce Emotional Eating in Patients Suffering From Overweight or Obesity in Primary Care Settings: a Cluster Randomized Controlled Clinical Trial Protocol
Brief Summary: Mindfulness-Based Interventions have been applied in different fields to improve physical and psychological health. However, little is known about its applicability and effectiveness in Spanish adults with overweight and obesity. The aim of the present study protocol is to evaluate the feasibility and efficacy of an adapted MBI programme to reduce emotional eating in adults with overweight and obesity in primary care (PC) settings.
|
{
"A": "Arm Label: Standard lifestyle intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard lifestyle intervention | Arm Label: Mind-body lifestyle intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Mind-body lifestyle intervention | Intervention Type: BEHAVIORAL; Name: Mind-body lifestyle intervention; Assigned to Arm(s): Mind-body lifestyle intervention | Intervention Type: BEHAVIORAL; Name: Standard lifestyle intervention; Assigned to Arm(s): Standard lifestyle intervention",
"B": "Arm Label: Stress reduction; Type: EXPERIMENTAL; Interventions: Behavioral: Transcendental Meditation | Arm Label: health education; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Health Education | Intervention Type: BEHAVIORAL; Name: Transcendental Meditation; Assigned to Arm(s): Stress reduction | Intervention Type: BEHAVIORAL; Name: Health Education; Assigned to Arm(s): health education",
"C": "Arm Label: Experimental; Type: EXPERIMENTAL; Interventions: Behavioral: Mindful Eating | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Mindful Eating; Assigned to Arm(s): Experimental",
"D": "Arm Label: Diet Education; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Carbohydrate-restricted diet | Arm Label: Diet Education + Mindfulness; Type: EXPERIMENTAL; Interventions: Behavioral: Carbohydrate-restricted diet, Behavioral: Mindfulness | Intervention Type: BEHAVIORAL; Name: Carbohydrate-restricted diet; Assigned to Arm(s): Diet Education, Diet Education + Mindfulness | Intervention Type: BEHAVIORAL; Name: Mindfulness; Assigned to Arm(s): Diet Education + Mindfulness"
}
|
C
|
[
"NCT02603601",
"NCT01299935",
"NCT03927534",
"NCT03207711"
] | 27,194 |
val
|
NCT03928132
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Integrating Sex and Gender Considerations Into a Continuing Professional Development Activity on Diabetes and Depression: Protocol for a Non-Randomized Controlled Trial
Brief Summary: People with type 2 diabetes are twice as likely to experience depression as nondiabetic individuals, and depression in turn increases the risk of diabetes. Clinical care for patients for either condition usually fails to consider the impact of sex and gender on tests, diagnosis and treatment, and evidence on these impacts is limited. The investigators aim to assess the impact of a continuing professional education activity (CPD) on diabetes and depression that includes considerations of sex and gender on the clinical behaviours of French-speaking healthcare professionals in Canada.
In a non-randomised controlled trial, the investigators are assessing the impacts of two CPD activities on depression and diabetes, one that includes considerations of sex and gender, and an identical one that omits sex and gender considerations, on French-speaking healthcare professionals' self-reported clinical behaviors regarding sex and gender considerations post-intervention and at 3 months. Data collection will occur in three distinct locations in Canada. Project development, data collection and analysis and dissemination of results will all integrate considerations of sex and gender. The process of creating a CPD activity that integrates considerations of sex and gender could be scaled up to other CPD activities in other clinical subjects and in other minority languages.
|
{
"A": "Arm Label: Clinical Management; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: CBT + WBT; Type: EXPERIMENTAL; Interventions: Behavioral: CBT in combination with WBT and life style modification | Intervention Type: BEHAVIORAL; Name: CBT in combination with WBT and life style modification; Assigned to Arm(s): CBT + WBT",
"B": "Arm Label: CPD Workshop on Depression and Diabetes; Type: EXPERIMENTAL; Interventions: Behavioral: CPD Workshop on Depression and Diabetes | Arm Label: CPD Workshop on Depression and Diabetes II; Type: SHAM_COMPARATOR; Interventions: Behavioral: CPD Workshop on Depression and Diabetes | Intervention Type: BEHAVIORAL; Name: CPD Workshop on Depression and Diabetes; Assigned to Arm(s): CPD Workshop on Depression and Diabetes, CPD Workshop on Depression and Diabetes II",
"C": "Arm Label: Virtual MBCT Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Adapted MBCT | Arm Label: Virtual Health Enhancement Control; Type: EXPERIMENTAL; Interventions: Behavioral: Cardiac Health Enhancement | Intervention Type: BEHAVIORAL; Name: Adapted MBCT; Assigned to Arm(s): Virtual MBCT Intervention | Intervention Type: BEHAVIORAL; Name: Cardiac Health Enhancement; Assigned to Arm(s): Virtual Health Enhancement Control",
"D": "Arm Label: Lifestyle counseling; Type: EXPERIMENTAL; Interventions: Behavioral: CALM-D Intervention | Intervention Type: BEHAVIORAL; Name: CALM-D Intervention; Assigned to Arm(s): Lifestyle counseling"
}
|
B
|
[
"NCT00998400",
"NCT03928132",
"NCT04799899",
"NCT01739205"
] | 27,195 |
val
|
NCT03928717
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Text-Based Adherence Game for Young People Living With HIV in Ghana
Brief Summary: This study will develop and evaluate a game-based, text message intervention to promote adherence to HIV care among young people living with HIV (YPLH) in Ghana. Intervention development will be guided by feedback from YPLH, their treatment supporters, and clinic staff, consultation with a mobile health services team, and Social Action Theory. Patient participants will be recruited from an urban HIV clinic in Accra, Ghana to complete a randomized pilot of the intervention. All participants will receive a brief adherence counseling session and complete three assessments over the course of 12 months following enrollment. During this time, intervention participants will receive text messages and phone calls from a semi-automated text message system, clinic staff, and other individuals in their life (e.g., family, friends, and partners) who they have identified as supportive of their treatment. The study will provide a wealth of knowledge about YPLH in Ghana, a group vulnerable to poor treatment outcomes, and provide preliminary data on a novel adherence promotion intervention.
|
{
"A": "Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Contraceptive text messages | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Other: Text messages not about contraception | Intervention Type: BEHAVIORAL; Name: Contraceptive text messages; Assigned to Arm(s): Intervention | Intervention Type: OTHER; Name: Text messages not about contraception; Assigned to Arm(s): Control",
"B": "Arm Label: mhealth intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Mhealth intervention | Arm Label: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Mhealth intervention; Assigned to Arm(s): mhealth intervention",
"C": "Arm Label: Control; Type: SHAM_COMPARATOR; Interventions: Behavioral: Wise app with fitness reminders | Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Wise app with medication adherence reminders | Intervention Type: BEHAVIORAL; Name: Wise app with medication adherence reminders; Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: Wise app with fitness reminders; Assigned to Arm(s): Control",
"D": "Arm Label: Text-Based Adherence Game; Type: EXPERIMENTAL; Interventions: Behavioral: Text-Based Adherence Game, Behavioral: Standard of Care (SOC) | Arm Label: Standard of Care (SOC); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard of Care (SOC) | Intervention Type: BEHAVIORAL; Name: Text-Based Adherence Game; Assigned to Arm(s): Text-Based Adherence Game | Intervention Type: BEHAVIORAL; Name: Standard of Care (SOC); Assigned to Arm(s): Standard of Care (SOC), Text-Based Adherence Game"
}
|
D
|
[
"NCT02905461",
"NCT02579785",
"NCT03205982",
"NCT03928717"
] | 27,196 |
val
|
NCT03928717
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Text-Based Adherence Game for Young People Living With HIV in Ghana
Brief Summary: This study will develop and evaluate a game-based, text message intervention to promote adherence to HIV care among young people living with HIV (YPLH) in Ghana. Intervention development will be guided by feedback from YPLH, their treatment supporters, and clinic staff, consultation with a mobile health services team, and Social Action Theory. Patient participants will be recruited from an urban HIV clinic in Accra, Ghana to complete a randomized pilot of the intervention. All participants will receive a brief adherence counseling session and complete three assessments over the course of 12 months following enrollment. During this time, intervention participants will receive text messages and phone calls from a semi-automated text message system, clinic staff, and other individuals in their life (e.g., family, friends, and partners) who they have identified as supportive of their treatment. The study will provide a wealth of knowledge about YPLH in Ghana, a group vulnerable to poor treatment outcomes, and provide preliminary data on a novel adherence promotion intervention.
|
{
"A": "Arm Label: WelTel SMS service; Type: EXPERIMENTAL; Interventions: Behavioral: WelTel SMS service | Arm Label: Standard care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: WelTel SMS service; Assigned to Arm(s): WelTel SMS service",
"B": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Text message; Type: ACTIVE_COMPARATOR; Interventions: Other: SMS reminder message | Arm Label: Text message and voice call; Type: ACTIVE_COMPARATOR; Interventions: Other: Voice call + SMS message | Intervention Type: OTHER; Name: SMS reminder message; Assigned to Arm(s): Text message | Intervention Type: OTHER; Name: Voice call + SMS message; Assigned to Arm(s): Text message and voice call",
"C": "Arm Label: Stepwise intervention; Type: EXPERIMENTAL; Interventions: Other: Customized text message invitation ( Step 1a), Other: Customized automatic phone call invitation (Step 1b), Other: Secretary phone call (Step 2), Other: Health professional face-to-face appointment (Step 3) | Arm Label: Written Letter; Type: ACTIVE_COMPARATOR; Interventions: Other: Written Letter | Intervention Type: OTHER; Name: Customized text message invitation ( Step 1a); Assigned to Arm(s): Stepwise intervention | Intervention Type: OTHER; Name: Customized automatic phone call invitation (Step 1b); Assigned to Arm(s): Stepwise intervention | Intervention Type: OTHER; Name: Secretary phone call (Step 2); Assigned to Arm(s): Stepwise intervention | Intervention Type: OTHER; Name: Health professional face-to-face appointment (Step 3); Assigned to Arm(s): Stepwise intervention | Intervention Type: OTHER; Name: Written Letter; Assigned to Arm(s): Written Letter",
"D": "Arm Label: Text-Based Adherence Game; Type: EXPERIMENTAL; Interventions: Behavioral: Text-Based Adherence Game, Behavioral: Standard of Care (SOC) | Arm Label: Standard of Care (SOC); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard of Care (SOC) | Intervention Type: BEHAVIORAL; Name: Text-Based Adherence Game; Assigned to Arm(s): Text-Based Adherence Game | Intervention Type: BEHAVIORAL; Name: Standard of Care (SOC); Assigned to Arm(s): Standard of Care (SOC), Text-Based Adherence Game"
}
|
D
|
[
"NCT01630304",
"NCT02662595",
"NCT03122275",
"NCT03928717"
] | 27,197 |
val
|
NCT03928717
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Text-Based Adherence Game for Young People Living With HIV in Ghana
Brief Summary: This study will develop and evaluate a game-based, text message intervention to promote adherence to HIV care among young people living with HIV (YPLH) in Ghana. Intervention development will be guided by feedback from YPLH, their treatment supporters, and clinic staff, consultation with a mobile health services team, and Social Action Theory. Patient participants will be recruited from an urban HIV clinic in Accra, Ghana to complete a randomized pilot of the intervention. All participants will receive a brief adherence counseling session and complete three assessments over the course of 12 months following enrollment. During this time, intervention participants will receive text messages and phone calls from a semi-automated text message system, clinic staff, and other individuals in their life (e.g., family, friends, and partners) who they have identified as supportive of their treatment. The study will provide a wealth of knowledge about YPLH in Ghana, a group vulnerable to poor treatment outcomes, and provide preliminary data on a novel adherence promotion intervention.
|
{
"A": "Arm Label: Text-Based Adherence Game; Type: EXPERIMENTAL; Interventions: Behavioral: Text-Based Adherence Game, Behavioral: Standard of Care (SOC) | Arm Label: Standard of Care (SOC); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard of Care (SOC) | Intervention Type: BEHAVIORAL; Name: Text-Based Adherence Game; Assigned to Arm(s): Text-Based Adherence Game | Intervention Type: BEHAVIORAL; Name: Standard of Care (SOC); Assigned to Arm(s): Standard of Care (SOC), Text-Based Adherence Game",
"B": "Arm Label: Stepwise intervention; Type: EXPERIMENTAL; Interventions: Other: Customized text message invitation ( Step 1a), Other: Customized automatic phone call invitation (Step 1b), Other: Secretary phone call (Step 2), Other: Health professional face-to-face appointment (Step 3) | Arm Label: Written Letter; Type: ACTIVE_COMPARATOR; Interventions: Other: Written Letter | Intervention Type: OTHER; Name: Customized text message invitation ( Step 1a); Assigned to Arm(s): Stepwise intervention | Intervention Type: OTHER; Name: Customized automatic phone call invitation (Step 1b); Assigned to Arm(s): Stepwise intervention | Intervention Type: OTHER; Name: Secretary phone call (Step 2); Assigned to Arm(s): Stepwise intervention | Intervention Type: OTHER; Name: Health professional face-to-face appointment (Step 3); Assigned to Arm(s): Stepwise intervention | Intervention Type: OTHER; Name: Written Letter; Assigned to Arm(s): Written Letter",
"C": "Arm Label: 1. One way SMS messages.; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: SMS messages and automated calls | Arm Label: 2. Two Way SMS messages; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: SMS messages and automated calls | Arm Label: 3. One way automated calls.; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: SMS messages and automated calls | Arm Label: 4.Two way interactive automated calls; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: SMS messages and automated calls | Arm Label: 5. Control Arm; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: SMS messages and automated calls; Assigned to Arm(s): 1. One way SMS messages., 2. Two Way SMS messages, 3. One way automated calls., 4.Two way interactive automated calls",
"D": "Arm Label: Text-based VMMC follow-up; Type: EXPERIMENTAL; Interventions: Other: Text-based follow-up | Arm Label: Routine VMMC follow-up care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Text-based follow-up; Assigned to Arm(s): Text-based VMMC follow-up"
}
|
A
|
[
"NCT03928717",
"NCT03122275",
"NCT03341195",
"NCT03119337"
] | 27,198 |
val
|
NCT03930199
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users
Brief Summary: The goal of this research is to analyze data from smartphone-based and wearable sensors, using advanced machine-learning and data-mining techniques, and to combine this information with performance-based measures, participant-reported measures, and structured interviews to create a clinical toolbox to (i) identify individuals who exhibit reduced prosthesis use (compared to expected usage levels based on K-level designation and/or participant goals of community mobility and social interaction), (ii) identify prosthetic/physical and psychological factors that limit prosthesis use, and (iii) determine the effect of targeted interventions to increase prosthesis use and facilitate achievement of participant goals. Objective sensor-based measurement of home and community activities will allow for the correlation of real-world function to in-clinic assessments and to monitor changes resulting from rehabilitation interventions in real time. Machine-learning and data mining techniques will be used to identify a subset of measures from this toolbox that sensitively and accurately reflect real-world function, enabling clinicians to predict and assess activity and provide effective interventions to optimize prosthesis use. The goal of this project, to improve overall performance with respect to activities of daily living and other real-world activities, thus addresses the Fiscal Year 2017 (FY17) Orthotics and Prosthetics Outcomes Research Program (OPORP) Focus Area of Orthotic or Prosthetic Device Function.
|
{
"A": "Arm Label: Early PABC Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Physical Activity Behavior Change (PABC) | Arm Label: Wait-List Control Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Physical Activity Behavior Change (PABC) | Intervention Type: BEHAVIORAL; Name: Physical Activity Behavior Change (PABC); Assigned to Arm(s): Early PABC Intervention, Wait-List Control Intervention | Intervention Type: BEHAVIORAL; Name: Physical Activity Behavior Change (PABC); Assigned to Arm(s): Early PABC Intervention, Wait-List Control Intervention",
"B": "Arm Label: EBAR Program; Type: EXPERIMENTAL; Interventions: Other: EBAR Program | Arm Label: Wait List Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: EBAR Program; Assigned to Arm(s): EBAR Program",
"C": "Arm Label: Not Meeting Mobility Goals; Type: EXPERIMENTAL; Interventions: Other: Needs-based intervention (physical, psychological, or both) | Intervention Type: OTHER; Name: Needs-based intervention (physical, psychological, or both); Assigned to Arm(s): Not Meeting Mobility Goals",
"D": "Arm Label: SMART & Peer Support; Type: EXPERIMENTAL; Interventions: Device: Self-Management for Amputee Rehabilitation using Technology [SMART] | Intervention Type: DEVICE; Name: Self-Management for Amputee Rehabilitation using Technology [SMART]; Assigned to Arm(s): SMART & Peer Support"
}
|
C
|
[
"NCT02738086",
"NCT00126126",
"NCT03930199",
"NCT04120038"
] | 27,199 |
val
|
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