TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles
Brief Summary: The investigators will try to assess the effect of endometrial injury preceding the intrauterine insemination cycle on the pregnancy rates compared to cycles with luteal phase support and the control group.


Options:
A: pregnancy rates (individual outcome will be evaluated within 8 weeks after IVF treatment. Over all outcome will be evaluated after 3 years.)
B: Clinical Pregnancy Rate (Five weeks gestation, as dated from the egg retrieval)
C: Ongoing pregnancy rate (pregnancy at 10-12 weeks)
D: Pregnancy Rate (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Ph 3 Multicenter OL Treatment-optimized RDBPC Forced-withdrawal, Parallel Grp Study to Evaluate Safety & Efficacy of Evening Dosed HLD200, a Novel DR/ER Formulation (DELEXIS) of MPH HCl in Children Aged 6-12 With ADHD in Classroom Setting
Brief Summary: This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a laboratory classroom setting. This study has a 6-week open-label treatment optimization period followed by a one week randomized, double-blind, placebo-controlled test phase.


Options:
A: Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR (Baseline to Month-2)
B: Swanson, Kotkin, Agler, M-Flynn and Pelham Combined Score (SKAMP CS) - Model-adjusted Average of All Post-dose Time Points Assessed During a Laboratory Classroom Test Day (Visit 9). (12-hours from 8:00 am to 8:00 pm)
C: Conners' Global Index - Parent Version (CGI-P) (Once weekly during the medication trial); Conner's Global Index - Teacher Version (CGI-T) (Once weekly during the medication trial)
D: SNAP-IV teacher form score in ORADUR®-Methylphenidate vs. placebo (2 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Positive Expiratory Pressure for the Treatment of Acute Asthma Exacerbations in Children: A Randomized Controlled Trial
Brief Summary: Asthma is a leading cause of emergency department (ED) visits for children. A novel way of treating asthma is the use of positive expiratory pressure (PEP). Positive expiratory pressure works by creating pressure in the lungs to keep airways open and to clear mucus from the lungs. PEP is already used in the treatment of asthma at the investigators institution, but studies evaluating the efficacy of PEP therapy in asthma exacerbations do not exist. This study plans to learn more about the use of PEP therapy in the treatment of asthma exacerbations in children in the emergency department. Specifically, the study aims to evaluate if PEP therapy reduces the severity of asthma exacerbations in children and if it reduces the need for additional therapies and admission to the hospital. This study will be a randomized control trial comparing children who receive standard therapy to those who receive standard therapy plus PEP therapy in the treatment of asthma exacerbations. Children age 2 to 18 years presenting to the ED with moderate to severe asthma exacerbations will be included in the study. Reduction in clinical asthma severity will be measured by change in the Pulmonary Asthma Score (the respiratory severity score used at the investigators institution). The need for additional therapies and hospitalization will also be evaluated.


Options:
A: The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) (baseline over the first 60 minutes)
B: Spirometry (6 months)
C: The primary efficacy analysis will be based on a change in FEV1, expressed as percent of predicted, at Hour 3 when compared to FEV1, expressed as percent of predicted, at the qualifying/screening timepoint. (Hour 3)
D: Change in Pulmonary Asthma Score (PAS) (0-30 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Group Based Parental Support Within Child Health Service - Group Leadership
Brief Summary: All parents in Sweden are offered group based parental support within Child Health Service (CHS) but only 40% participate. Nurses feel insecure in their group leadership and express a need for education in group leadership and group dynamics. Most CHC nurses do not have formal education or training in group leadership and the aim of this study was to evaluate a group based education program in group leadership for Child Health Care (CHC) nurses.


Options:
A: Percentage of adherence of opportunities for hand hygiene (march 2008, october 2008, may 2009, november 2009)
B: Goal Setting and Attainment (18 months (3 measurements at 6-month intervals))
C: Change in experience of group leadership (2 weeks before and 6 months after the education); Relevance and experience of the education in group leadership (After completed intervention, intervention has an expected average duration of 12 weeks.); Change in experience of group leadership and relevance and experience of the education in group leadership (6 months after the education)
D: Supportive leadership behaviour questionnaire for assessing head nurses performance (10 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing Physical Activity in Stroke Survivors Using STARFISH, an Interactive Mobile Phone Application: a Randomised Controlled Study
Brief Summary: The aim of the study is to compare physical activity in stroke survivors who have undertaken a four month physical activity intervention using the STARFISH application with a control group receiving four months of usual care.


Options:
A: Systolic Blood Pressure (12 months)
B: Glucose area under the curve (0 weeks and 2 weeks)
C: Change in the mean number of steps per day (Baseline, 4 months, 6 months)
D: Motor Assessment Scale (18 months after inclusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing Physical Activity in Stroke Survivors Using STARFISH, an Interactive Mobile Phone Application: a Randomised Controlled Study
Brief Summary: The aim of the study is to compare physical activity in stroke survivors who have undertaken a four month physical activity intervention using the STARFISH application with a control group receiving four months of usual care.


Options:
A: Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE) (before and after 4 weeks intervention)
B: Systolic Blood Pressure (12 months)
C: Change in the mean number of steps per day (Baseline, 4 months, 6 months)
D: upper limb motor function (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Substance Abuse Treatment to HIV Care (SAT2HIV): The Motivational Interviewing-based Brief Intervention (MIBI) Experiment
Brief Summary: To test the effectiveness of a single 20-30 minute motivational interviewing-based brief intervention for substance use within HIV/AIDS settings.


Options:
A: Discontinuation of consumption of prescription drugs (one year); Reduction of consumption of prescription drugs (one year); Utilization of formal help (one year)
B: Days of Primary Substance Use (4 weeks post randomization); Number of Substance-related problems (4 weeks post randomization); Times engaging in risky behaviors (4 weeks post randomization); Days of Substance Use Treatment (4 weeks post randomization); ART Medication Adherence (4 weeks post randomization)
C: Drug use (Six Months)
D: Drinks per drinking day (6 months); Rate of effective contraception (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Vaginal Cleansing Before Cesarean Delivery to Reduce Infection: A Randomized Trial
Brief Summary: The purpose of this study is to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.


Options:
A: Number of Participants With Surgical Site Infection (30 days)
B: Post-intervention Aerobic Bacterial Colony Counts (From intervention to 7 days post); Post-intervention Anaerobic Bacterial Colony Counts (From intervention to 7 days post)
C: Number of Participants With Surgical Site Infection (up to 6 weeks postpartum)
D: Composite Postoperative Infectious Morbidity (30 days postoperatively)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke
Brief Summary: The objective of the study is to evaluate the effectiveness of transcranial direct current stimulation (tDCS) integrated with wrist robot-assisted treatment. In detail, the anodal stimulation on the impaired hemisphere will be used associated with a robotic treatment.


Options:
A: Fugl-Meyer Assessment score (2 months post-stimulation)
B: Functional Independence measured by Barthel Index (Change for functional independence at 4 months)
C: Change in compound motor score slope at week 4 (week 4 after treatment start); Change in alpha-band coherence between the affected motor cortex and the rest of the brain (Week 4)
D: Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection) (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy and Safety of the Dried Biological Amnion Graft Following Hysteroscopic Lysis for the Prevention of Postoperative Adhesions in Patients With Intrauterine Adhesions
Brief Summary: To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions.


Options:
A: Visual analogue scale for pain; Patient satisfaction
B: second diagnostic hysteroscopy (postoperation three to four months)
C: Ongoing pregnancy (18 months)
D: Installation time and operating time. (the length of the operation); Check for adhesions during follow-up. (After 6 weeks, during follow-up visit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Mixed-methods Evaluation of Sit-stand Workstations in an Office Setting: a Randomised Controlled Trial
Brief Summary: The purpose of this study is to investigate whether a device that allows office workers to sit or stand whilst working can reduce their sitting time at work and improve their health over 8 weeks.


Options:
A: To assess the effectiveness of a 6-month primary care intervention to reduce diary hours of Sitting time in overweight and obese patients, as well as to increase their weekly caloric spend (Baseline-6-9-12 and 18 month)
B: Change from baseline in workplace sitting time at 4 and 8 weeks (Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks))
C: Physical Activity (Measured 5 times over 13 months, for seven days each time. Time points = baseline, 1-2weeks, 3 months, 6 months and 12 months)
D: Change in objective measure of degree of physical activity (baseline, 12 weeks, 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Mixed-methods Evaluation of Sit-stand Workstations in an Office Setting: a Randomised Controlled Trial
Brief Summary: The purpose of this study is to investigate whether a device that allows office workers to sit or stand whilst working can reduce their sitting time at work and improve their health over 8 weeks.


Options:
A: duration of prolonged sitting (5 days)
B: Incidence of CHD and other lifestyle related diseases after ten years (2012)
C: change in physical activity (4 months)
D: Change from baseline in workplace sitting time at 4 and 8 weeks (Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Mixed-methods Evaluation of Sit-stand Workstations in an Office Setting: a Randomised Controlled Trial
Brief Summary: The purpose of this study is to investigate whether a device that allows office workers to sit or stand whilst working can reduce their sitting time at work and improve their health over 8 weeks.


Options:
A: Daily sitting time (baseline and 23 weeks)
B: Incidence of CHD and other lifestyle related diseases after ten years (2012)
C: Change from baseline in workplace sitting time at 4 and 8 weeks (Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks))
D: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Mixed-methods Evaluation of Sit-stand Workstations in an Office Setting: a Randomised Controlled Trial
Brief Summary: The purpose of this study is to investigate whether a device that allows office workers to sit or stand whilst working can reduce their sitting time at work and improve their health over 8 weeks.


Options:
A: Change from baseline in workplace sitting time at 4 and 8 weeks (Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks))
B: Reduced total time spend sitting at work (1 month); Reduced number of prolonged siting periods (>30 min) (1 month); Increased number of breaks from sitting time (1 month)
C: Percentage of patients with recurrence(s) of lower back pain (number of related days of sick leave) over 12 months and 24 months (12 and 24 months)
D: Change from baseline in physical activity and sedentariness at 12 months (Baseline, 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway
Brief Summary: Viral self-limiting infections in respiratory organs among children are common in primary care. Serious infections have low prevalence and are challenging to distinguish from self-limiting infections.

Prescription of antibiotics in primary care is still high but stable since 2009 in Norway, and 90% of all antibiotics are prescribed in primary care.

C-reactive protein (CRP) has been especially popular in Norway for point-of-care testing in primary care, but its role in ruling-out serious infections and the cut-off value for prescribing antibiotics has been discussed a lot.

The aim of this study is to identify if pretesting with CRP of all children 0-6 year with fever or respiratory symptoms at Out-of-Hours Services will affect the prescription of antibiotics and the referral to hospital for children.


Options:
A: days with significant impairment due to acute respiratory tract infection (14 to 28 days after infection)
B: duration of antibiotic therapy expressed in days of therapy (Between Day 1 and Day 30)
C: Antibiotic prescription rate (24 hours)
D: Antibiotic prescribing rate (12 months); Prolonged duration prescribing rate (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® as an Active Control in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Brief Summary: Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.


Options:
A: Mean Change From Baseline in Post-dose Trough FEV1 (Baseline, 26 weeks)
B: Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI (Up to Week 52)
C: FEV1 AUC0-4 (at Week 24); Change From Baseline in Morning Pre-dose Trough FEV1 (at Week 24)
D: Moderate and severe COPD exacerbation rate over 52 weeks of treatment (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® as an Active Control in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Brief Summary: Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.


Options:
A: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One Second (FEV1) at Day 84 (Baseline and Day 84)
B: FEV1 AUC0-4 (at Week 24); Change From Baseline in Morning Pre-dose Trough FEV1 (at Week 24)
C: Adjusted Rate of Moderate or Severe Exacerbations (52-week treatment period)
D: The primary efficacy variable was forced expiratory volume in one second (FEV1). There were two co-primary endpoints: FEV1 area under the curve for the time period 0 to 12 hours [FEV1 AUC (0-12)] and peak FEV1 measured after 6 weeks of treatment.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis
Brief Summary: A Randomized, Double-blind, Placebo Controlled Trial of Certolizumab Pegol in Women with Refractory Interstitial Cystitis/Bladder Pain Syndrome


Options:
A: IC/BPS Symptoms Change With Overall Global Response Assessment (GRA) (Week 2)
B: Change from Baseline in Average Mean Daily Pain (MDP) Score at Week 12 (Baseline and Week 12)
C: Change From Baseline in the Average Daily Bladder Pain Score (e-Diary) (Baseline to Week 6)
D: Change From Baseline in Average Daily Pain Score at Week 6 (Baseline, Week 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Allopurinol Compared With Allopurinol Administered Alone in Adult Subjects With Gout
Brief Summary: This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects of RDEA3170 administered in combination with allopurinol compared with allopurinol administered alone in adult subjects with gout.


Options:
A: Percentage of Participants With Primary Major Adverse Cardiovascular Events (MACE) Composite (75% Interim Analysis) (Up to last dose of study drug (approximately 83 months)); Percentage of Participants With Primary MACE Composite (Final Analysis) (Up to last dose of study drug (approximately 83 months))
B: Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)); Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)); Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%)) (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)); Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%)) (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)); Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)); Cohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)); Cohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%)) (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)); Cohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%)) (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose))
C: Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6. (6 months)
D: Percentage of Participants Experiencing ≥ 1 Gout Flare During Phase 3 (Phase III of the study (weeks 49-72 of study duration))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Glial Regulators for Treating Comorbid Posttraumatic Stress and Substance Abuse Disorders
Brief Summary: Examine the effects of N-acetylcysteine on PTSD symptoms, craving and substance use in veterans with PTSD and comorbid substance use disorders.


Options:
A: Alcohol Craving (2 hours)
B: PTSD Symptoms (8 weeks)
C: PTSD symptoms (four months); PTSD Diagnosis (4 months)
D: CAPS Recurrent Distressing Dreams Item (This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.); Pittsburgh Sleep Quality Index (PSQI) (This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.); Clinical Global Impression of Change (CGIC) (This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: rEduction of oXygen After Cardiac arresT (EXACT): a Pilot Study
Brief Summary: This Phase 2 study aims to determine the feasibility of paramedic titration of oxygen delivery in adult patients who have been resuscitated from OHCA.


Options:
A: Mortality in ICU (30 days)
B: oxygen saturation ≥90% (baseline)
C: Surgical wound infection (14 days after surgery)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: rEduction of oXygen After Cardiac arresT (EXACT): a Pilot Study
Brief Summary: This Phase 2 study aims to determine the feasibility of paramedic titration of oxygen delivery in adult patients who have been resuscitated from OHCA.


Options:
A: oxygen saturation ≥90% (baseline)
B: N/A
C: Myocardial Infarct Size (At 72 hours post infarct)
D: Mortality in ICU (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Proyecto Madrileño Sobre el Manejo de la Enfermedad Pulmonar Obstructiva Crónica Con Telemonitorización a Domicilio. (Multicentre Project on the Home Telemonitoring of Patients With Severe Chronic Obstructive Pulmonary Disease).
Brief Summary: The purpose of the study is to verify the clinical effectiveness of a managed home telemonitoring program in patients with severe COPD against usual clinical practice, as measured by the decrease in the number of exacerbations, number of hospitalizations, hospital days and emergency room visits in a 12 month period

The primary endpoint of effectiveness is "severe exacerbations avoided."

The main hypothesis is that patients with severe or very severe COPD patients managed with a home telehealth program have better outcomes than patients managed according to usual clinical practice.


Options:
A: The number of ED presentations (1 year after randomization.)
B: Number of unscheduled hospital days (up to 12 months)
C: To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged with oxygen and/or home mechanical ventilation (HMV) with high risk of hospital readmission. (3 years)
D: Number of hospitalizations due to exacerbation of COPD avoided (1 year)

Answer: D