TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.


Options:
A: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Number of Participants With Treatment Emergent Adverse Events (3 months); Pharmacokinetics Parameter : Skin Flux of INCB018424 (Days 8, 15, 22, and 28); Pharmacokinetics Parameter : Bioavailability of INCB018424 (Days 8, 15, 22, and 28)
B: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
C: Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT (112 and 140 days)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.


Options:
A: Visual Analog Scale (6 weeks)
B: Compensate the roughness of the skin Compensate sensory symptoms (4 weeks)
C: 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)
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: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Phase II Two-Arm, Randomized Clinical Trial of Concomitant Immunotherapy (With Interferon-Alpha and Retinoic Acid) and Radiation Therapy for the Treatment of Advanced Cervical Cancer in India
Brief Summary: The study objective:

* To evaluate the response and survival rates after treating stage III cervical cancer with retinoic acid and interferon-α combined with radiotherapy in the study group.
* To evaluate the response and survival rates after treating stage III cervical cancer patients with concomitant cisplatin and radiotherapy in the control group.
* To evaluate the safety and tolerability of the combination of retinoic acid, interferon-α and radiation therapy compared with concomitant chemo-radiation therapy.
* To determine if there is an immune response to Human Papillomavirus (HPV) by estimating serum IgG1 and IgG2 antibodies against E7 proteins of HPV types 16 and 18 before and after treatment.

The study hypothesis:

* The response rates and survival rates of retinoic acid and interferon-α combination with radiation will be better than chemo-radiation to treat stage III cervical cancer.
* Treatment with the retinoic acid, interferon-α and radiation combination therapy will be less toxic and better tolerated than chemo-radiation therapy.


Options:
A: Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) (During radiation therapy and up to 6 weeks post radiation therapy)
B: proctitis and cystitis (3 years)
C: Quality of Life (6 weeks after completion of radiotherapy)
D: Survival (3 years or death)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Mild to Moderately Severe Bronchiolitis - A Double Blind Randomized Controlled Trial.
Brief Summary: To assess the efficacy of nebulized 3% hypertonic saline in improving clinical severity scores among children aged 6 weeks to 24 months with bronchiolitis.


Options:
A: Respiratory Assessment Change Score (RACS) (Baseline and 1 hour)
B: Length of Stay in the Study-LOS--Intention to Treat Analysis (Time of first study treatment until time of discharge); Length of Stay in the Study-LOS by Per Protocol Analysis (Time of first study treatment until time of discharge)
C: Mean Change in Clinical Severity Score (2 hours)
D: Time to 'fit for discharge' (This was judged to be when the infant was feeding adequately [taking >75% of usual intake] and was in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Mild to Moderately Severe Bronchiolitis - A Double Blind Randomized Controlled Trial.
Brief Summary: To assess the efficacy of nebulized 3% hypertonic saline in improving clinical severity scores among children aged 6 weeks to 24 months with bronchiolitis.


Options:
A: Time to 'fit for discharge' (This was judged to be when the infant was feeding adequately [taking >75% of usual intake] and was in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.)
B: Mean Change in Clinical Severity Score (2 hours)
C: Change in Bronchiolitis Severity Score (Baseline and up to 24 hours of hospital stay)
D: Length of Stay in the Study-LOS--Intention to Treat Analysis (Time of first study treatment until time of discharge); Length of Stay in the Study-LOS by Per Protocol Analysis (Time of first study treatment until time of discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK 580299) in Healthy Adult Chinese Female Subjects
Brief Summary: This study is designed to evaluate the immunogenicity and safety of GSK Biologicals' human papillomavirus (HPV) vaccine in adult female subjects aged 26-45 years. One group of subjects will receive the HPV vaccine and the other group will receive an active control (GSK Biologicals' hepatitis B vaccine). Immunogenicity data of the HPV group will be compared with those from the HPV group included in the NCT00779766 study (aged 18-25 years).


Options:
A: Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18 (One month after third vaccination (Month 7))
B: Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (At Month 7)
C: Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen. (From Month 6 up to Month 48)
D: Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis) (From Day 1 until >=30 cases accumulate, up to Month 54 in the base study); Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (End-of-study Update) (Up to Month 54 in the base study); Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58 (4 weeks postdose 3 in the base study); Base Study: Percentage of Participants With One or More Adverse Event (Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)); Base Study: Percentage of Participants With One or More Injection-site Adverse Event (Up to Day 5 after any vaccination); Base Study: Percentage of Participants With One or More Non-injection-site (Systemic) Adverse Event (Up to Day 15 after any vaccination); Base Study: Percentage of Participants With One or More Vaccine-related Adverse Event (Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)); Base Study: Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event (Up to Month 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center, Double-blind, Randomized, Placebo-controlled Study of Selective 11 Beta-HSD1 Inhibition With RO5093151 for 12 Weeks to Investigate Efficacy, Safety and Pharmacokinetics of RO5093151 in Non-alcoholic Fatty Liver Disease and Its Metabolic Consequences.
Brief Summary: This multi-center, double-blind, randomized, placebo-controlled study will evaluate the change in liver fat content, pharmacokinetics and safety of RO5093151 in patients with non-alcoholic fatty liver disease. Patients will be randomized to receive either daily oral doses of RO5093151 or matching placebo. The anticipated time on study treatment is 12 weeks.


Options:
A: Alaninaminotransferase(ALT) (12 weeks)
B: Grade of steatosis as judged by repeat biopsy (6 mo)
C: Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment. (baseline and 96 weeks)
D: Change of liver fat content measured by magnetic resonance spectroscopy (MRS) (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Leisure Time Physical Activity Intervention on the Overweight and the Obesity in Schoolchildren. The Cuenca's Study
Brief Summary: The purpose of this study is to evaluate the effectiveness of a recreational physical activity intervention (RPAI) for reducing the prevalence of overweight/obesity and other cardiovascular risk factors


Options:
A: pedometer-derived step count (baseline and every 3 months)
B: Fitness (Day 0, Day 120)
C: Skin-fold thickness (1 year)
D: Daily physical activity > 60 minutes (4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Leisure Time Physical Activity Intervention on the Overweight and the Obesity in Schoolchildren. The Cuenca's Study
Brief Summary: The purpose of this study is to evaluate the effectiveness of a recreational physical activity intervention (RPAI) for reducing the prevalence of overweight/obesity and other cardiovascular risk factors


Options:
A: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)
B: increased physical activity (4 months)
C: Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment (0, 3 months); Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment (0, 3 months); Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment (0, 3 month)
D: Skin-fold thickness (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Web-based Smoking Cessation Intervention: Transition From Inpatient to Outpatient
Brief Summary: This project, "Web-based Smoking Cessation Intervention: transition from inpatient to outpatient," addresses smoking among hospitalized patients, whose rates are higher than among the general population. Hospitalization offers a unique opportunity to intervene, as it requires temporary abstinence and patients are focused on health concerns. Hypotheses: A tailored web-based and e-message smoking cessation program for current smokers that, upon hospital discharge, transitions the patient to continue a quit attempt when home will be effective. Further, the investigators hypothesize that this approach will be cost-effective. Specific Aims: 1. To test the effectiveness of a web-based smoking cessation intervention. 2. To determine the cost-effectiveness of this approach. Research Design - Methods: A randomized two-arm follow-up design will be used to test the effectiveness of an evidence- and theoretically-based smoking cessation program designed for post-hospitalization. Patients randomized to this arm will be contacted by hospital staff, trained as 'transition coaches,' to engage in Decide2Quit, an interactive web-based program that offers personalized and tailored messages, e-group support, and text messages promoting tobacco abstinence. All hospitalized patients will receive standardized smoking cessation materials. As well, physicians can order nicotine replacement therapy via the hospital's electronic order system. The investigators primary outcome is biologically confirmed and self-reported tobacco abstinence at 6 months follow-up; the investigators will also assess self-reported quit rates at 3 and 12 months and variables hypothesized to predict quit success. We will measure health care utilization and quality of life to allow testing the cost-effectiveness of this program conducted from the perspective of a hospital, health care payers, patients and society. Significance of results: At study completion the investigators will know whether imbedding smoking cessation into usual hospital care, with minimal hospital-staff burden, and an interactive web-based tailored intervention program is an effective way to reduce smoking rates among hospitalized patients, and if it is cost-effective. This program will be an "off the shelf approach that could be disseminated easily.


Options:
A: Smoking Abstinence (12 months); Treatment Utilization for Smoking Cessation (12 months)
B: 7-day point prevalence abstinence at 3 months (3 months post baseline); 7-day point prevalence abstinence at 6 months (6 months post baseline); 7-day point prevalence abstinence at 12 months (12 months post baseline)
C: Smoking abstinence (6 months)
D: 7-day point prevalence abstinence (Measured at Months 3, 6, and 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 mcg and 5 mcg Once Daily) Over 12 Weeks as add-on Controller Therapy on Top of Usual Care in Adolescents (12 to 17 Years Old) With Severe Persistent Asthma
Brief Summary: The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma.

The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment.

Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints, and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy on top of usual care in this patient population.


Options:
A: Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period (Day 1 to Week 26 of the Treatment Period)
B: Total Number of Asthma Exacerbations (52 Weeks)
C: Peak FEV1 Within 3 Hours Post-dose Response (24 weeks); Trough FEV1 Response (24 weeks); The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821) (24 weeks)
D: FEV1 peak0-3 Change From Baseline (Baseline and 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 mcg and 5 mcg Once Daily) Over 12 Weeks as add-on Controller Therapy on Top of Usual Care in Adolescents (12 to 17 Years Old) With Severe Persistent Asthma
Brief Summary: The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma.

The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment.

Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints, and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy on top of usual care in this patient population.


Options:
A: FEV1, (Forced expiratory volume in the 1st second).
B: Pre-dose FEV1 (Forced Expiratory Volume in the first second) (at Week 26); Reduction of moderate and severe asthma exacerbations rate (Week 0 to Week 52)
C: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
D: FEV1 peak0-3 Change From Baseline (Baseline and 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Alliance for Quality of Life in Long Term Care: The Effects of a Walking Program on Balance, Falls and Well Being in Individuals Residing in Long-term Care
Brief Summary: The purpose of this study is to assess the effectiveness of a regular walking program (which inevitably involves human interaction) compared to a usual care condition and to a human interaction condition (without the extra walking program) in individuals residing in Long-Term Care (LTC). Outcomes of interest include: balance, strength, mobility, endurance, walking distance; rate and severity of falls; activities of daily living; mood and behaviour.

It is hypothesized that participants taking part in the walking program will demonstrate maximal benefits compared to the no treatment control group (usual care) and the participants who will only receive social interaction. It is expected that benefits of the walking program will include decreased fall rates, and improved balance, endurance, strength, mood, behaviour, activities of daily living and quality of life indices. Given research findings that the addition of pleasant activities improves resident mood (Teri et al, 1997; 2003), it is expected that participants in the social interaction only group will demonstrate improvements in mood and other indices of quality of life.


Options:
A: Number of actually stopped or adjusted drugs (Patients will be followed for the duration of hospital stay, an expected average of 14 days.)
B: Change in falls rate (3 months from baseline measures, 6 months from baseline, 9 months from baseline)
C: Body balance. (at 6 weeks)
D: Falls (Eight months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Haemodynamic Assessment at Primary Caesarean Section After Administration of Carbetocin Versus Oxytocin: a Doubleblind Randomized Trail
Brief Summary: The purpose of this study is to evaluate the immediate effects of carbetocin and oxytocin on maternal hemodynamic parameters (heart rate and blood pressure) in a non-invasive setup (TaskeForce®-Monitor) during primary Caesarean section.


Options:
A: postpartum hemorrhage-1 (after delivery of baby); postpartum hemorrhage-2 (after delivery of the baby); postpartum hemorrhage-3 (after delivery of the baby)
B: Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment (baseline to discharge (2 - 3 days)); Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage (Initial hospital discharge (2-3 days)); Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors (baseline to discharge (2-3 days))
C: Maximal uterine tone (within the first 5 minutes after cord clamping)
D: Immediate hemodynamic effects of carbetocin and oxytocin (1 day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Haemodynamic Assessment at Primary Caesarean Section After Administration of Carbetocin Versus Oxytocin: a Doubleblind Randomized Trail
Brief Summary: The purpose of this study is to evaluate the immediate effects of carbetocin and oxytocin on maternal hemodynamic parameters (heart rate and blood pressure) in a non-invasive setup (TaskeForce®-Monitor) during primary Caesarean section.


Options:
A: The primary outcome measure is the response of effective uterine contraction as either satisfactory or unsatisfactory as determined by the obstetrician blinded to the oxytocin infusion dose. (3 minutes)
B: screening of Cessation of bleeding (screening until 24 hours after placenta disconnection); time duration to stop bleeding in the case of post-cesarean section (24 hours)
C: Immediate hemodynamic effects of carbetocin and oxytocin (1 day)
D: Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment (baseline to discharge (2 - 3 days)); Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage (Initial hospital discharge (2-3 days)); Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors (baseline to discharge (2-3 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cosmesis and Body Image After Single Port Laparoscopic or Conventional Laparoscopic Cholecystectomy: A Double Blinded Randomised Controlled Trial
Brief Summary: Laparoscopic Cholecystectomy (LC) is the treatment of choice for symptomatic gallstone disease. Single-port access cholecystectomy (SL) has been recently introduced using only one, trans-umbilical placed port. The method has been denominated as ''scarless.'' However, it is unknown whether SL significantly improves body and cosmesis images as well as the quality of life (QoL), reported directly by the patients. Furthermore SL promises to reduce postoperative pain and to be cost-effective due a faster postoperative recovery.

The aim of this Double Blind Randomized Controlled Trial (RCT) is to demonstrate whether SL is superior to LC in improving patients', body and cosmesis images as well as QoL and to analyse cost-efficiency.

Based on the sample size calculations, a total of 110 patients will be randomised to either LC or SL. The primary endpoint will be the cosmetic score. Costs, pain, time to convalescence, quality of life and complications and will also be compared as secondary endpoints.

This study will provide evidence-based patient-oriented information regarding the SL procedure and its further use.


Options:
A: Cosmesis, body image and quality of life scale (at 1 month)
B: Operative Time (1 day)
C: Postoperative pain (24h)
D: Cosmetic Score (6 weeks postoperatively)

Answer: D