TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation - Targeting High vs. Low Normal Values
Brief Summary: The COMACARE trial is a pilot multicenter randomized trial to assess the feasibility and effect on brain injury markers of targeting low or high normal arterial oxygen tension (PaO2), arterial carbon dioxide tension (PaCO2) and mean arterial pressure (MAP) in comatose, mechanically ventilated patients after out-of-hospital cardiac arrest. Using factorial design, participants are randomized at admission to intensive care unit to one of eight groups targeting either low or high normal values of PaO2, PaCO2 and MAP for 36 h. In this way, investigators will be assessing the feasibility and effect of all three variables at the same time.

The primary outcome is serum concentration of neuron-specific enolase (NSE) at 48 h after cardiac arrest. Feasibility outcome is between-group separation in PaO2, PaCO2 and MAP levels. Secondary outcomes include continuous monitoring of cerebral oxygenation, EEG and ECG for 48 h, the levels of NSE, S100B and cardiac troponin at randomization and 24, 48 and 72 h after cardiac arrest and neurological assessment at 6 months after cardiac arrest.


Options:
A: Death (Day 28)
B: Composite Primary Outcomes (30 days)
C: Daily Delta Sequential Organ Failure Assessment Score (14 days)
D: Neuron-specific enolase (NSE) serum concentration (48 hour after cardiac arrest)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation - Targeting High vs. Low Normal Values
Brief Summary: The COMACARE trial is a pilot multicenter randomized trial to assess the feasibility and effect on brain injury markers of targeting low or high normal arterial oxygen tension (PaO2), arterial carbon dioxide tension (PaCO2) and mean arterial pressure (MAP) in comatose, mechanically ventilated patients after out-of-hospital cardiac arrest. Using factorial design, participants are randomized at admission to intensive care unit to one of eight groups targeting either low or high normal values of PaO2, PaCO2 and MAP for 36 h. In this way, investigators will be assessing the feasibility and effect of all three variables at the same time.

The primary outcome is serum concentration of neuron-specific enolase (NSE) at 48 h after cardiac arrest. Feasibility outcome is between-group separation in PaO2, PaCO2 and MAP levels. Secondary outcomes include continuous monitoring of cerebral oxygenation, EEG and ECG for 48 h, the levels of NSE, S100B and cardiac troponin at randomization and 24, 48 and 72 h after cardiac arrest and neurological assessment at 6 months after cardiac arrest.


Options:
A: Myocardial Infarct Size (At 72 hours post infarct)
B: all-cause mortality (day 28)
C: Neuron-specific enolase (NSE) serum concentration (48 hour after cardiac arrest)
D: Chest pain measured with VAS (1 h)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multiple-Center, Multiple-Dose, Randomized, Active Comparator-Controlled, Double-Masked, Parallel Group, 36-Week Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO6867461 Administered Intravitreally in Patients With Diabetic Macular Edema
Brief Summary: This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. The study will consist of a treatment period (20 weeks) and an observational period (up to 16 weeks). Treatment naive participants will be randomized in a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in a 1:1 ratio to Arms A and C.


Options:
A: Functional Macular Evaluation (24 weeks)
B: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations (From Baseline through Week 56)
C: Mean Change From Baseline in BCVA Letter Score at Week 24, in Treatment-Naive Participants (Baseline, Week 24)
D: Fluorescein leakage area of active new vessels (FLA) (48 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT), Substudies: MRI, Cognitive
Brief Summary: An investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial to determine the effect of more intensive blood pressure control provided by a fixed low-dose combination blood pressure lowering pill ("Triple Pill") strategy on top of standard of care, on time to first occurrence of recurrent stroke in patients with a history of stroke due to intracerebral haemorrhage.


Options:
A: Recurrent Stroke (Average of 6 years)
B: Composite of all fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events (within 24 months after randomization.)
C: Time to the first occurrence of cerebral hemorrhage (time since randomization; follow-up period is 1.0 to 5.5 years); Time to the first occurence of composite cardiovascular events (time since randomization; follow-up period is 1.0 to 5.5 years)
D: BP Study: Efficacy (3 months from randomisation); BP Study: Feasibility (3 months from randomisation); BP Study: Safety (3 months from randomisation); Imaging Study: Efficacy (12 months from randomisation); Imaging Study: Safety (12 months from randomisation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective , Multicenter , Randomized, Controlled, Parallel-group , Open-label Trial Evaluating Benefits of High Flow Nasal Cannula (HFNC) Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients
Brief Summary: The aim of this study is to determine whether High Flow nasal cannula (HFNC) oxygen is more efficient than the standard High Flow face mask (HFFM) for preoxygenation before orotracheal intubation after crash induction in non severely hypoxemic patients


Options:
A: Severe desaturation as defined by a pulse oxymetry below 80% (through five minutes after preoxygenation period)
B: The partial pressure of carbon dioxide (pCO2) (From start to end of THRIVE(20 minutes)); The partial pressure of oxygen(PO2) (From start to end of THRIVE(20 minutes))
C: lowest pulse oxymetry (SpO2) during intubation (From the beginning of the endotracheal intubation procedure (beginning of laryngoscopy, immediately after induction) to completed orotracheal intubation (airway catheterization). Usual duration is inferior to 10 minutes)
D: to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask. (4 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Clinical Cost-effectiveness of Two Primary Mental Health Service Frameworks in Yogyakarta, Indonesia
Brief Summary: This study is a cluster randomised controlled trial, which aims to examine the short-term strategy of addressing treatment gap through increasing primary mental health service capacity. This study aims to compare after 6 months and 12 months, the effectiveness of a specialist model of mental health care and an enhanced usual care (task-sharing) framework, in terms of reducing mental health symptoms, reducing disability, and improving quality of life, as well as the health services costs (and potentially societal costs) associated with these outcomes in 400 patients.


Options:
A: depression (On completion of intervention and six months post-intervention)
B: The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory (0 months, 1 month, 6 months)
C: Change in Health of Nations Outcomes Scale (HoNOS) score from baseline (Baseline, 6 months and 12 months); Change in Clinical Interview Schedule Revised (CIS-R) score from baseline (Baseline, 6 months and 12 months)
D: Depressive disorder and suicidality (Q3 2016 after an average of 1.5 years of follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Polyphenol-rich Plant Extract on Attention-Deficit Hyperactivity Disorder (ADHD): A Randomized, Double Blind, Placebo and Active Product Controlled Multicenter Trial.
Brief Summary: This double blind, randomised controlled trial examines the effect of a commercially available nutritional supplement on behaviour of ADHD patients, as well as on their physical and psychiatric co-morbidities, and level of oxidative stress and immune activity, as compared to placebo and standard pharmaceutical treatment for ADHD.


Options:
A: Differences detected on the time evolution of BP both in two arms of intervention (5 weeks)
B: Summed ADHD score of the ADHD-Rating Scale as rated by teachers (10 weeks)
C: Change in Endothelial Function Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase (Delta "lnRHI") (Intervention period of 4 weeks)
D: The primary objective of this study is to evaluate the effects of treatment with Pycnogenol® on endothelial function in subjects with stable coronary artery disease. (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Polyphenol-rich Plant Extract on Attention-Deficit Hyperactivity Disorder (ADHD): A Randomized, Double Blind, Placebo and Active Product Controlled Multicenter Trial.
Brief Summary: This double blind, randomised controlled trial examines the effect of a commercially available nutritional supplement on behaviour of ADHD patients, as well as on their physical and psychiatric co-morbidities, and level of oxidative stress and immune activity, as compared to placebo and standard pharmaceutical treatment for ADHD.


Options:
A: Attention Deficit Hyperactivity Disorder Rating Scale Based on DSM-IV Criteria (ADHD-RS-IV) Total Score. (Last week of 3-week treatment period assessed at Visit 5.)
B: Summed ADHD score of the ADHD-Rating Scale as rated by teachers (10 weeks)
C: Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks); Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint (DB baseline, DB endpoint)
D: Number of Participants With Adverse Events, Serious Adverse Events and Deaths. (Week 40 - Week 66)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Three Different Teaching Methods in Behavioural Therapy Program for Female Overactive Bladder: A Randomized Controlled Trial
Brief Summary: Researchers aimed to identify the effectiveness of three methods of patient education for behavioral therapy (BT), including verbal instructions combined with a leaflet on a structured training program of BT, only verbal instructions on a structured training and only a leaflet on a structured BT training. Therefore, a randomized controlled trial was designed to compare effectiveness of those methods of patient education in BT based on the two validated patient- reported outcome measures (PROMs) for women with overactive bladder.

Idiopathic overactive bladder (iOAB) symptoms in female patients are perceived as normal, which does not threaten life and not require to be treated immediately. It is necessary to raise the awareness of iOAB on women. The education and consultancy role of continence nurses is important in the treatment and care of urinary incontinence (UI) associated with iOAB. In the study, it was seen that the training to be provided to patients is helpful regardless of the teaching method used. Also it was found that the method of verbal instructions in the form of a structured training plus giving a leaflet to patient is the most effective method of BT for female iOAB.


Options:
A: "Much Better" or "Very Much Better" on PGI-I at 3 Months (Outcome was measured at three months following randomization.); No Bothersome Stress Incontinence Symptoms at 3 Months (Outcome was measured at three months following randomization.)
B: Urogenital Distress Inventory (UDI-6) (baseline to 6 or 8 weeks); Incontinence Impact Questionnaire (IIQ-7) (baseline to 6 or 8 weeks)
C: Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries. (Every 6 months for 4 years)
D: Mean number of incontinence episodes (Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Three Different Teaching Methods in Behavioural Therapy Program for Female Overactive Bladder: A Randomized Controlled Trial
Brief Summary: Researchers aimed to identify the effectiveness of three methods of patient education for behavioral therapy (BT), including verbal instructions combined with a leaflet on a structured training program of BT, only verbal instructions on a structured training and only a leaflet on a structured BT training. Therefore, a randomized controlled trial was designed to compare effectiveness of those methods of patient education in BT based on the two validated patient- reported outcome measures (PROMs) for women with overactive bladder.

Idiopathic overactive bladder (iOAB) symptoms in female patients are perceived as normal, which does not threaten life and not require to be treated immediately. It is necessary to raise the awareness of iOAB on women. The education and consultancy role of continence nurses is important in the treatment and care of urinary incontinence (UI) associated with iOAB. In the study, it was seen that the training to be provided to patients is helpful regardless of the teaching method used. Also it was found that the method of verbal instructions in the form of a structured training plus giving a leaflet to patient is the most effective method of BT for female iOAB.


Options:
A: Urogenital Distress Inventory (UDI-6) (baseline to 6 or 8 weeks); Incontinence Impact Questionnaire (IIQ-7) (baseline to 6 or 8 weeks)
B: UI reduction (12 months)
C: Urinary incontinence score assessed with ICIQ-SF questionnaire (one year post partum)
D: Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire (Week 10-14 gestation (baseline), week 36-39 (after intervention))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement
Brief Summary: The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.


Options:
A: Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study (Randomized Controlled Trial - 24 months Continued Access Study - 12 months)
B: Death (1 Year); Composite of Death and Recurrence Hospitalization. (duration of study)
C: Combined rate of death from any cause, myocardial infarction, and stroke (1 year)
D: All-cause Death or Disabling Stroke to Two Years (2 Years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement
Brief Summary: The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.


Options:
A: Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study (Randomized Controlled Trial - 24 months Continued Access Study - 12 months)
B: Change in physical capacity (1,4,12 months)
C: All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure) (1 year)
D: Proportion of patients willing to undertake cardiac rehabilitation following TAVR. (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Mindfulness to Improve Psychological Distress After Critical Illness
Brief Summary: Many survivors of the intensive care unit (ICU) suffer from persistent symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD). In this study, the investigators will test the impact of mindfulness to address this distress.


Options:
A: Percent of Eligible Participants Who Provided Consent (pre-randomization); Percent of Eligible Participants Who Provide Informed Consent and Were Randomized (randomization); Client Satisfaction Questionnaire (CSQ) Score (1 month post-randomization); System Usability Scale (SUS) (1 month post-randomization); Percent of Randomized Participants Who Drop Out of Study (baseline, end of study (approx. 4 months)); Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews (baseline, end of study (approx. 4 months)); Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys (baseline, end of study (approx. 4 months)); Percentage of Self-directed MBT Sessions Attended by Eligible Participants (baseline, end of study (approx. 4 months)); Visual Analog Satisfaction Scale (after intervention completion, up to 8 weeks post-randomization); Number of Participant Clicks on Study Website (baseline, end of study (approx. 4 months))
B: PTSS-14 (Post Traumatic Stress Symptoms) (3 months post discharge from ICU)
C: Diagnosis of Post Traumatic Stress Disorder (3 months post critical illness)
D: PTSD ratings (Measured at Year 1); Substance use (Measured at Year 1); General functioning reports (Measured at Year 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke
Brief Summary: The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized to traditional caregiver education or a web based intervention for the duration of stroke survivor therapy. By learning the best way to involve family members in therapy, investigators hope to decrease the harmful effects of stroke.


Options:
A: Barthel Index (Change from Baseline to 2, 4, 12 and 22 weeks)
B: blood pressure (12 months)
C: physical scale of the Stroke Impact Scale 3.0 (before discharge from acute care, four weeks after discharge from the hospital or rehabilitation (in case of referral to a medical rehabilitation) immediately before randomization (baseline assessment), and 12 months after randomization)
D: Wolf Motor Function Test (WMFT) (Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)); Motor Activity Log (MAL) Score (Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)); Family Caregiver Conflict Scale (FCCS) Score (Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)); Center for Epidemiologic Studies Depression Scale (CES-D) Score (Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: TOwards Prepared Mums (TOP-mums), for a Healthy Start: A Lifestyle Intervention to Reduce Overweight and Smoking in Women With a Pregnancy Wish to Prevent Perinatal Morbidity
Brief Summary: This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish who have a high risk on perinatal morbidity because of overweight or obesity. Half of the patients will receive the lifestyle intervention while the other half will receive usual care. It is hypothesized that an effective lifestyle intervention directed towards healthy living, including reduction of overweight or obesity and, if applicable, smoking reduction, health problems in mothers and their offspring can be prevented.


Options:
A: Clinical Pregnancy Rates (1 year)
B: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)
C: Clinical pregnancy will be obtained from evidence of gestational sac on ultrasound exam at 6 weeks of amenorrhea either after the first ART attempts (3 to 12 months after the initial visit)
D: Reduction in body weight (From baseline to 6 weeks postpartum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fit For Function: A Community Wellness Program for Persons With Stroke
Brief Summary: Building on an earlier pilot study, this randomized controlled trial will compare the effectiveness of a 12 week community YMCA-based wellness program specifically designed for people with stroke (Fit for Function) to a standard YMCA membership.


Options:
A: Change in the Reintegration to Normal Living Index (RNL) from baseline (baseline, 12 weeks, 24 weeks)
B: electromyography (EMG ) activity of Tibialis Anterior Muscle. (1 years)
C: change in function before/after tDCS (Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months)
D: Change of TMS (transcranial magnetic stimulation) measurement of cortical excitability (within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fit For Function: A Community Wellness Program for Persons With Stroke
Brief Summary: Building on an earlier pilot study, this randomized controlled trial will compare the effectiveness of a 12 week community YMCA-based wellness program specifically designed for people with stroke (Fit for Function) to a standard YMCA membership.


Options:
A: Change in the Reintegration to Normal Living Index (RNL) from baseline (baseline, 12 weeks, 24 weeks)
B: Feasibility (6 weeks)
C: Motor Assessment Scale (18 months after inclusion)
D: upper limb motor function (6 weeks)

Answer: A