TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Home Polygraphic Recording With Telemedicine Monitoring for Diagnosis and Treatment of Sleep Apnea in Stroke (HOPES)
Brief Summary: Study Objectives:

Meta-analyses report a high prevalence of moderate to severe sleep apnea of more than 50% in stroke patients, with adherence rates for CPAP therapy of only 30%.

The primary objective of this study is to determine whether CPAP adherence in stroke patients with obstructive sleep apnea can be improved by a CPAP training strategy during rehabilitation combined with a telemedicine monitoring system after discharge.

The secondary objective is to compare recording quality as well as subjective and objective sleep data of non-attended level III polygraphy, polysomnography and telemetric CPAP data in the management of sleep apnea in stroke.

Further the investigators aim to study changes in nocturnal systolic blood pressure due to CPAP therapy with the pulse transit time method.

Finally, the investigators intend to study the relationship between CPAP compliance, sleep and medical and neurorehabilition outcome parameters.

Design:

Single-blind, mono-center, randomized controlled trial on standard CPAP treatment as compared with CPAP treatment with a telemedicine monitoring system in stroke patients with moderate to severe OSA.

Setting: Neurorehabilitation center in Vienna, Austria

Patients: Adult subacute (1 to 12 months post stroke) stroke patients 18-70 yrs of age) with moderate to severe OSA (apnea hypopnea index (AHI) ≥ 15/hr) determined by non-attended polysomnography (AHI) ≥ 15/hr of sleep) or level III polygraphy (AHI) ≥ 30/hr of out-of-center sleep testing (OCST), who undergo successful CPAP training and titration (goal AHI\< 10) at the neurorehabilitation unit.

Interventions: Patients will be randomized to either standard care with an autotitrating CPAP device or an autotitrating CPAP device that transmits physiologic information (i.e., adherence, air leak, residual AHI) daily to a website that will be reviewed by their homecare provider. If any problems are identified, the patient will be contacted by his homecare provider by telephone. Neurologists performing sleep and neurological scoring will be blinded to the randomization.

Measurements: Recording of the different measuring systems, subjective and objective sleep quality, CPAP adherence after 3 months and 1 year in hours used per night, systolic BP determined by means of a non-linear algorithm and an individual one-point calibration of the pulse transit time obtained with a cuff-based BP measuring system (SOMNOmedics GmbH, Germany) and neurorehabilitation outcome parameters as Barthel Index, Timed Up and Go Test.


Options:
A: objective sleep pattern (90 days)
B: CPAP usage (12-week)
C: CPAP adherence in minutes used per night (after 3 months)
D: CPAP adherence at 3 months (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, 52-weeks Study to Demonstrate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab Injections With 2 mL Pre-filled Syringes (300 mg) in Adult Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary: The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.


Options:
A: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) (Week 16)
B: Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment (12 weeks); Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment (12 weeks)
C: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16); Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 (Week 16)
D: Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Baseline and 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, 52-weeks Study to Demonstrate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab Injections With 2 mL Pre-filled Syringes (300 mg) in Adult Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary: The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.


Options:
A: Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment (12 weeks); Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment (12 weeks)
B: Long-term Safety and Tolerability of Secukinumab (Week 268)
C: Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100) (Week 12)
D: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast
Brief Summary: To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla).


Options:
A: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo (12 weeks)
B: Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 (0-12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (0 - 12 Weeks)
C: Percentage of Participants With a PASI 75 Response at Week 12 (Baseline and week 12)
D: Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) (Week 12); Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1) (Week 12); Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1) (Up to Week 12); Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1) (Up to Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast
Brief Summary: To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla).


Options:
A: Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. (Week 12)
B: Percentage of Participants With a PASI 75 Response at Week 12 (Baseline and week 12)
C: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
D: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast
Brief Summary: To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla).


Options:
A: Percentage of Participants With a PASI 75 Response at Week 12 (Baseline and week 12)
B: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 (Week 24)
C: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)
D: Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68 (Week 68)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Evaluate Freezed-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients
Brief Summary: Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is present in 40% of cases. It has a very early onset and this coagulopathy is associated with increased mortality. It must be detected and treated early, as illustrated by the military medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma (FFP) requires a thawing step.The French army has encouraged the development of a freeze-dried plasma of innovative because viral inactivation and universal blood grouping, well tolerated, with a reduced risk of TRALI. This sophisticated therapeutic product can be administered after 6 minutes of reconstitution without the need for cross-matching. Nevertheless, its used is currently reserved for military purpose in overseas operations and needs to be evaluated for civil use. To this end, the investigators need to evaluate the impact on coagulopathy of an immediate availability of plasma.


Options:
A: Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects. (From administration of Haemocomplettan® P until 24 hours later)
B: fibrinogen concentration (clauss) (45 minutes after the admission on day 1 after trauma)
C: Bleeding Scores (intra-operatively and up to 24 hours postoperatively)
D: Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed (At 1 and 4 hours after the end of infusion); Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR) (30 minutes after end of infusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Subjects With Alzheimer's Disease
Brief Summary: This study aims to examine the safety and efficacy of suvorexant (MK-4305) to improve sleep in individuals with Alzheimer's disease (AD). The primary hypothesis for the study is that suvorexant is superior to placebo in improving insomnia as measured by change from baseline in polysomnography (PSG)-derived total sleep time (TST) at Week 4.


Options:
A: Polysomnography parameters: sleep structure, respiratory, limb movements (onset, 3 and 6 months of treatment)
B: Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Direct Observation (Change from baseline at 2 and 8 weeks)
C: Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4 (Baseline and Week 4); Percentage of Participants Who Experienced One or More Adverse Events (Up to 6 weeks); Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Up to 4 weeks)
D: Total sleep time at night and amplitude of the sleep wake rhythm. (7 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Subjects With Alzheimer's Disease
Brief Summary: This study aims to examine the safety and efficacy of suvorexant (MK-4305) to improve sleep in individuals with Alzheimer's disease (AD). The primary hypothesis for the study is that suvorexant is superior to placebo in improving insomnia as measured by change from baseline in polysomnography (PSG)-derived total sleep time (TST) at Week 4.


Options:
A: Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4 (Baseline and Week 4); Percentage of Participants Who Experienced One or More Adverse Events (Up to 6 weeks); Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Up to 4 weeks)
B: Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3 (Baseline and Month 3); Number of Participants With an Adverse Event (AE) During 3-Month DB TRT Phase (Up to 3 months); Number of Participants Who Discontinued Study Drug Due to an AE Occurring During 3-Month DB TRT Phase (Up to 3 months)
C: Pittsburgh Sleep Quality Index (8 weeks)
D: Change from Baseline in Nighttime Total Sleep Time (Baseline, 14 days follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Effects of Combined Exercise and Oscillatory Positive Expiratory Pressure Therapy on Sputum Properties and Lung Diffusion Capacity in Cystic Fibrosis: a Randomized Crossover Trial
Brief Summary: The investigators aim to compare a single bout of moderately intense cycling exercise incorporating Flutter® breathing maneuvers with a single bout of moderately intense cycling exercise alone on sputum viscoelasticity (primary endpoint) and the diffusion capacity of the lungs in adult patients with cystic fibrosis.

The investigators further aim to analyze the short-term variability of resting diffusion capacity of carbon monoxide (DLCO) and nitric oxide (DLNO) in patients with cystic fibrosis.


Options:
A: Wet sputum production (45 minutes)
B: Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1) (Baseline - immediately post exercise - 45min post exercise)
C: Hospital Length of Stay (Admission to Discharge)
D: Lung Clearance Index (90 minutes post treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Effects of Combined Exercise and Oscillatory Positive Expiratory Pressure Therapy on Sputum Properties and Lung Diffusion Capacity in Cystic Fibrosis: a Randomized Crossover Trial
Brief Summary: The investigators aim to compare a single bout of moderately intense cycling exercise incorporating Flutter® breathing maneuvers with a single bout of moderately intense cycling exercise alone on sputum viscoelasticity (primary endpoint) and the diffusion capacity of the lungs in adult patients with cystic fibrosis.

The investigators further aim to analyze the short-term variability of resting diffusion capacity of carbon monoxide (DLCO) and nitric oxide (DLNO) in patients with cystic fibrosis.


Options:
A: Hospital Length of Stay (Admission to Discharge)
B: Physical activity (Measured at baseline, 6, and 12 months)
C: Respiratory muscle endurance (Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1))
D: Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1) (Baseline - immediately post exercise - 45min post exercise)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Effects of Combined Exercise and Oscillatory Positive Expiratory Pressure Therapy on Sputum Properties and Lung Diffusion Capacity in Cystic Fibrosis: a Randomized Crossover Trial
Brief Summary: The investigators aim to compare a single bout of moderately intense cycling exercise incorporating Flutter® breathing maneuvers with a single bout of moderately intense cycling exercise alone on sputum viscoelasticity (primary endpoint) and the diffusion capacity of the lungs in adult patients with cystic fibrosis.

The investigators further aim to analyze the short-term variability of resting diffusion capacity of carbon monoxide (DLCO) and nitric oxide (DLNO) in patients with cystic fibrosis.


Options:
A: Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1) (Baseline - immediately post exercise - 45min post exercise)
B: Relative (Percent) Change From Baseline in Maximal Oxygen Consumption (VO2max) During Cardiopulmonary Exercise Testing (CPET) at Week 24 (Baseline, Week 24)
C: Change in glucose tolerance (Measured at baseline, after 8 and 16 weeks.)
D: weight of sputum that was expectorated (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer
Brief Summary: This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.


Options:
A: Invasive disease-free survival (Up to 10 years)
B: Bone mass-lumbar spine and hip (DEXA) (baseline, 12 months)
C: Cancer related fatigue (Change from baseline to 16 weeks, 1 year, 2 years, and 5 years post baseline)
D: Change in weight (6 months); change in weight (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Metabolic Abnormalities in Patients With Schizophrenia: Adjunctive Low-dose Metformin in Patients With Schizophrenia and Metabolic Abnormalities
Brief Summary: Metformin has been used for alleviating metabolic abnormalities in patients with schizophrenia. Until now, the lowest dose of metformin to treat metabolic abnormalities in clozapine-treated patients is 1000 mg/d. The aim of this study was to determine whether a lower dosage of metformin, such as 500 mg/d, is effective for improving metabolic profiles in clozapine-treated patients with pre-existing metabolic abnormalities.

Methods:

In this 12-week, randomized, double-blind, placebo-controlled trial, metformin 500 mg/d or 1000 mg/d or a placebo was prescribed to clozapine-treated patients with schizophrenia having pre-existing metabolic abnormalities. The recruited patients underwent physical and laboratory evaluations at week-4, week-8, and week-12.


Options:
A: The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their (Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8); Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function. (Beginning and end of study)
B: body weight change (24 weeks)
C: Changes in body weight (baseline; week-4; week-8; week-12)
D: Glucose tolerance (Baseline - 16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure.A Comparative Study
Brief Summary: 300 recurrent implantation failure patients will be alternatively assigned to assisted hatching , endometrial scratch , and no treatment ,100 patients in each group


Options:
A: Clinical pregnancy rate (12 weeks)
B: improvement in ongoing implantation rates (When a fetal heartbeat is detected for each patient. (8 weeks after implantation).)
C: Live birth rate per initiated cycle (up to 42 days of a live birth)
D: number of patients with positive pregnancy test (2 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Ketamine vs. Methohexital Anesthesia for Improvement of Major Depressive Disorder in Electroconvulsive Therapy
Brief Summary: The purpose of this prospective randomized clinical trial is to determine if patients receiving ketamine as a part of general anesthesia during electroconvulsive therapy (ECT) rather than standard of care will have improvement in symptoms of depression after a course of ECT treatments. The investigators hypothesize that utilization of ketamine for induction of general anesthesia during ECT treatments will improve symptoms of depression better than standard care.

This study is ONLY open to patients eligible to receive healthcare services through the Department of Veterans Affairs at the VA Puget Sound, which means service in the active military, naval or air service or separation under any condition other than dishonorable. Qualifications for VA health care benefits can be found at va.gov.


Options:
A: Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores (6 weeks)
B: Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs) (Up to 7 days following the last dose of study drug (Up to 23 days)); Part 1: Number of Participants With Serious Adverse Events (SAEs) (Up to 30 days following the last dose of study drug (Up to 46 days)); Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug (Up to the last dose of study drug (Up to 16 days)); Part 2: Number of Participants With AEs (Up to 7 days following the last dose of study drug (Up to 35 days)); Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug (Up to the last dose of study drug (Up to 28 days))
C: Change in Depression Patient Health Questionnaire 9 (PHQ9) Scoring (Change from Baseline Score 24 hours prior to starting ECT to PHQ9 score 72 hours following last ECT session)
D: Change from Day 1 (baseline) to Day 2 in the Montgomery Asberg Depression Rating Scale (MADRS) total score in the double-blind treatment phase (Day 1 (baseline), Day 2)

Answer: C