TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: School-Based Asthma Therapy: Stage 2 Effectiveness Study
Brief Summary: Asthma is the most common chronic illness of childhood, and hospitalization rates are increasing. In the US, impoverished children and children from minority ethnic and racial backgrounds suffer disproportionately from asthma. While National Heart, Lung, and Blood Institute (NHLBI) guidelines recommend daily preventive medications for all children with mild persistent to severe persistent asthma, studies indicate that many children in the US who should receive preventive medications are not receiving them. The overall goal of this project is to target an ethnically diverse population of inner-city schoolchildren with asthma and explore a school-based program to reduce asthma morbidity. We hypothesize that children receiving a comprehensive school-based intervention will experience less asthma-related morbidity compared to children receiving usual care. Our comprehensive school-based intervention consists of both administration of recommended preventive asthma medications in school (with dose adjustments according to NHLBI guidelines) and an environmental tobacco smoke (ETS) reduction program in the home for smoke-exposed children. Our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who receive the school-based intervention with ETS reduction will experience less asthma morbidity than those who receive usual care.


Options:
A: Change in baseline asthma self efficacy after 3 weeks (participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.)
B: Quality of life (6 months); Asthma Control (6 months)
C: Number of Symptom Free Days (Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February))
D: Asthma-related morbidity (Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: School-Based Asthma Therapy: Stage 2 Effectiveness Study
Brief Summary: Asthma is the most common chronic illness of childhood, and hospitalization rates are increasing. In the US, impoverished children and children from minority ethnic and racial backgrounds suffer disproportionately from asthma. While National Heart, Lung, and Blood Institute (NHLBI) guidelines recommend daily preventive medications for all children with mild persistent to severe persistent asthma, studies indicate that many children in the US who should receive preventive medications are not receiving them. The overall goal of this project is to target an ethnically diverse population of inner-city schoolchildren with asthma and explore a school-based program to reduce asthma morbidity. We hypothesize that children receiving a comprehensive school-based intervention will experience less asthma-related morbidity compared to children receiving usual care. Our comprehensive school-based intervention consists of both administration of recommended preventive asthma medications in school (with dose adjustments according to NHLBI guidelines) and an environmental tobacco smoke (ETS) reduction program in the home for smoke-exposed children. Our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who receive the school-based intervention with ETS reduction will experience less asthma morbidity than those who receive usual care.


Options:
A: Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period (Last 10 weeks of the treatment period (Weeks 16-26))
B: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)
C: Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period (At the end of treatment, 4-6 years from baseline assessment)
D: Number of Symptom Free Days (Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Behavioral and Drug Treatment of Overactive Bladder in Men
Brief Summary: The primary aim of this project is to evaluate the effectiveness of combined behavioral + drug therapy compared to behavioral treatment alone and drug therapy alone as a way to improve outcomes in the treatment of OAB symptoms in men. We hypothesize that combined therapy will result in better outcomes than either behavioral or drug therapy alone. The second aim is to compare two methods of implementing combined therapy: simultaneously as initial therapy vs. stepped therapy, in which therapies are combined following initial behavioral or drug therapy alone. The third aim is to examine the costs and cost-effectiveness of combined behavioral + drug therapy compared to behavioral or drug therapy alone.


Options:
A: urgencyepisodes (after 2 month (end of study)); urgeincontinence (after 2 month (studyend)); VAS score from ICI_OAB_Q (after 2 month (studyend))
B: Evaluation of subjective cure (At the end of 3 months of supervised treatment)
C: Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) (From Baseline to 6 Weeks); Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward) (Change from 6 weeks to 12 weeks); Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward) (Baseline to 12 weeks)
D: Change in Incontinent Episodes Immediately Post-treatment (Baseline and immediately post-treatment - week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Behavioral and Drug Treatment of Overactive Bladder in Men
Brief Summary: The primary aim of this project is to evaluate the effectiveness of combined behavioral + drug therapy compared to behavioral treatment alone and drug therapy alone as a way to improve outcomes in the treatment of OAB symptoms in men. We hypothesize that combined therapy will result in better outcomes than either behavioral or drug therapy alone. The second aim is to compare two methods of implementing combined therapy: simultaneously as initial therapy vs. stepped therapy, in which therapies are combined following initial behavioral or drug therapy alone. The third aim is to examine the costs and cost-effectiveness of combined behavioral + drug therapy compared to behavioral or drug therapy alone.


Options:
A: UI reduction (12 months)
B: Urinary incontinence score assessed with ICIQ-SF questionnaire (one year post partum)
C: Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) (From Baseline to 6 Weeks); Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward) (Change from 6 weeks to 12 weeks); Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward) (Baseline to 12 weeks)
D: Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire (Week 10-14 gestation (baseline), week 36-39 (after intervention))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Comparison Between Two Surgical Techniques With Acellular Dermal Matrix Graft in the Treatment of Gingival Recessions
Brief Summary: The aim of this study is to test a surgical technique for the treatment of gingival recessions. The hypothesis of the study is to promote greater root coverage and better healing.


Options:
A: Percentage of root coverage (6 months)
B: Percentage of root coverage (6 months)
C: Recession Reduction (6 months)
D: percentage of root coverage (6 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of IN.PACT Admiral(TM) Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease
Brief Summary: The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral® drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel) from the balloon surface into the vessel walls. This drug absorption is intended to limit the chances and the entity of artery re-narrowing over time.


Options:
A: angiographic late lumen loss (6 months)
B: Primary Patency (12 Month); Primary Safety Composite (12 month)
C: angiographic binary restenosis (12 months)
D: Angiographic Late Lumen Loss (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Nursing Intervention to Enhance Comfort and Promote Psychological Well-Being in Children During and Following PICU Hospitalization: A Pilot Study
Brief Summary: Children who become critically ill and require Pediatric Intensive Care Unit (PICU)hospitalization may develop negative psychological outcomes following discharge. This pilot study will test a nursing intervention that seeks to promote child comfort, sleep and psychological well-being during and following PICU hospitalization.

Study objectives are to:

1. test the feasibility and acceptability of a PICU comfort care intervention that can be administered by nursing staff
2. examine the feasibility and acceptability of data collection procedures
3. pilot test outcome measures
4. determine effect sizes to inform sample size calculation for a future multi-centred randomized controlled trial (RCT).

The intervention will take place in the PICU, and consists of a parental soothing activity followed by a quiet period in which earmuffs are placed over the child's ears to block noise. Children's sleep time and comfort level will be monitored in the PICU, and the investigators will follow them for 3 months post-discharge to examine the effects of the intervention on psychological well-being.


Options:
A: Acceptability and feasibility of the comfort intervention (Time 1: Pediatric Intensive Care Unit, post-intervention: Time 2: Hospital Ward; Time 3: 3 months post-discharge)
B: Richmond Agitation-Sedation Scale (RASS) (3 days)
C: delirium outcome (duration of ICU stay(average duration 5 days))
D: Average Daily Dexmedetomidine mcg/kg/Day (from time of first acupuncture/sham treatment till time of extubation); Average Daily Morphine Equivalents (mg/kg/Day) (from time of first acupuncture/sham treatment till time of extubation); Average Daily Midazolam Equivalents (mg/kg/Day) (from time of first acupuncture/sham treatment till time of extubation); Average Daily Sedation Score (from time of first acupuncture/sham treatment till time of extubation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Double-blind, Randomized, Parallel-Group, Placebo-Controlled Study to Assess the Clinical Effect of Droxidopa in the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients With Parkinson's Disease
Brief Summary: This is a study to evaluate the effects of an investigational drug, Droxidopa, in participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's disease. Droxidopa is being studied to determine the effects on blood pressure changes upon standing up (orthostatic challenge). Symptoms and activity measurements, including patient reported falls, will be evaluated to determine the effectiveness of the study drug.

Symptoms of NOH may include any of the following:

* Dizziness, light-headedness, feeling faint or feeling like you may blackout
* Problems with vision (blurring, seeing spots, tunnel vision, etc.)
* Weakness
* Fatigue
* Trouble concentrating
* Head \& neck discomfort (the coat hanger syndrome)
* Difficulty standing for a short time or a long time
* Trouble walking for a short time or a long time

The study duration is a maximum of approximately 14 weeks including up to 2 weeks for screening, up to 2 weeks for proper dose finding, followed by an 8 week treatment period and a follow-up visit after 2 weeks. A sufficient number of patients will be screened to allow approximately 211 randomized patients. An extension study is also available to continue treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored by Chelsea Therapeutics and is enrolling by invitation only.


Options:
A: Step Length During Gait (Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks); Walking Speed During Gait (Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks)
B: Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3) (Baseline, 16 weeks); Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration (Baseline and 16 weeks); Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work) (Baseline, 16 weeks); Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6) (Baseline, 16 weeks); Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work) (Baseline, 16 weeks)
C: Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary (Baseline and Weeks 4, 8, 12, and 16)
D: 306A Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ) (Baseline, Week 8); 306B Efficacy: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1) (Baseline, Week1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Protocol for an Randomised Controlled Trial of Smoking Cessation Success Rate With or Without a Genetic Test, "Respiragene", to Assess Lung Cancer Risk - an Exploratory Study
Brief Summary: Professor RP Young (Associate Professor of Medicine and Molecular Medicine, School of Biological Sciences, University of Auckland) and his team have developed a reliable genetic test "Respiragene" based on 20 single nucleotide polymorphisms that can be used (together with details of personal and family history) to calculate a smoker's lifetime risk of developing lung cancer. The expectation is that whatever the score (estimated lifetime risk will vary from 5% to 50%) the result will counter "optimism bias" of the smoker and encourage smoking cessation and this assumption is supported by previous research on similar tests and smoking cessation. The investigators plan to recruit two groups of subjects for smoking cessation but only one group will have the Respiragene test. Eight weekly smoking cessation sessions will be carried out at a Surrey primary care medical centre and will follow the usual format for National Health Service smoking cessation clinics using Champix (varenicline), counselling and the carbon monoxide breath meter but with added: evaluation questionnaires, fagerstrom nicotine addiction score, salivary cotinine (metabolite of nicotine) test. The main outcome measures will be estimation of smoking cessation at 4 weeks and six months after the completion of the seven smoking cessation sessions. Successful smoking cessation has to be confirmed by negative salivary cotinine at 4 weeks and six months and questionnaires will be used to estimate the influence of the Respiragene test compared with standard procedures such as counselling and the carbon monoxide breath readings.


Options:
A: Biologically confirmed tobacco cessation (6 months)
B: The primary measure of results will be the differences in smoking cessation rates between intervention and control groups (12 months after been conducted the intervention)
C: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)
D: Number of subjects versus controls who are non-smokers at 4 weeks and six months after completion of smoking cessation clinic (Nine months (from recruitment to completion))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-II: A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage
Brief Summary: The specific aims of this study are to:

1. Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset.
2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the subjects' quality of life as measured by EuroQol at 3 months.
3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of hematoma expansion (defined as increase from baseline hematoma volume of at least 33%) and in the change from baseline peri-hematoma volume at 24 hours on the serial computed tomographic (CT) scans.
4. Assess the safety of the intensive treatment relative to the standard treatment in the proportion of subjects with treatment-related serious adverse events (SAEs) within 72 hours.


Options:
A: the prevention of recurrent stroke. (Until the first recurrent stroke reaches a total of 339 between the two groups)
B: changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). (0, 12, 24 months)
C: Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization (90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization)
D: Number of participants with composite of major CVD events (4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-II: A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage
Brief Summary: The specific aims of this study are to:

1. Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset.
2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the subjects' quality of life as measured by EuroQol at 3 months.
3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of hematoma expansion (defined as increase from baseline hematoma volume of at least 33%) and in the change from baseline peri-hematoma volume at 24 hours on the serial computed tomographic (CT) scans.
4. Assess the safety of the intensive treatment relative to the standard treatment in the proportion of subjects with treatment-related serious adverse events (SAEs) within 72 hours.


Options:
A: The main outcome measurement will be the modified Rankin scale at 3 months after the SAH, compared between patients who were randomized to induced hypertension and patients who were randomized to no induced hypertension. (assessed three months after the SAH)
B: Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization (90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization)
C: Cerebral vasospasm-related morbidity and mortality of all-causes as defined by the protocol (Within 6 weeks post-aSAH)
D: Death or major disability (defined by the modified Rankin scale) at 6 months (6 months); The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Telephone Contact and Professional Coordination for Preventing Recurrent Suicidal Acts
Brief Summary: The prevention of recurrent suicidal about people who have made a suicide attempt is a major strand in the prevention of suicide. It is estimated that 10-15 % of people who made a suicide attempt die by suicide. Recidivism rate of suicide increases even faster than the subject is close to the index suicide attempt. A one month recurrence rate is 5 %, 12-25 % at one year. Most people who made a suicide attempt receive ambulatory monitoring. On this population, there is a low adherence to care.

The main objective of the study is to test the effectiveness of a prevention program of recurrent suicidal acts for people who made a suicide attempt.

The secondary objectives of this study are the assessment of adherence to care; the identification of sub - populations benefiting most from this program; the evaluation of the possible generalization level of the program (eligibles persons rate) and its feasibility level.


Options:
A: suicidal act frequency (12 months)
B: Change in BHS Scores (Baseline, 6 weeks, and 12 weeks)
C: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)
D: Borderline Symptoms (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Telephone Contact and Professional Coordination for Preventing Recurrent Suicidal Acts
Brief Summary: The prevention of recurrent suicidal about people who have made a suicide attempt is a major strand in the prevention of suicide. It is estimated that 10-15 % of people who made a suicide attempt die by suicide. Recidivism rate of suicide increases even faster than the subject is close to the index suicide attempt. A one month recurrence rate is 5 %, 12-25 % at one year. Most people who made a suicide attempt receive ambulatory monitoring. On this population, there is a low adherence to care.

The main objective of the study is to test the effectiveness of a prevention program of recurrent suicidal acts for people who made a suicide attempt.

The secondary objectives of this study are the assessment of adherence to care; the identification of sub - populations benefiting most from this program; the evaluation of the possible generalization level of the program (eligibles persons rate) and its feasibility level.


Options:
A: Acceptability- attendance rates (Five weeks); Safety- adverse experiences (Five weeks); Feasibility - completion rate of assessments (Five weeks)
B: Number of suicide reattempts in every group (6 months)
C: treatment adherence, defined as outpatient mental health clinic attendance (6-month, and 12-month)
D: suicidal act frequency (12 months)

Answer: D