TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Stay Healthy In Nature Everyday: a Randomized Controlled Trial of the Effect of Family Nature Outings on Stress and Physical Inactivity in a Low Income Population
Brief Summary: The SHINE study is a randomized controlled study of the effect of a park-based family support group on multiple outcomes (including stress and physical activity) in a low income population.


Options:
A: Improved dietary quality (Baseline- 24 months); Increased physical activity (Baseline- 24 months)
B: Number of students obtaining lunch per day by National School Lunch Program (NSLP) eligibility (5 months); Number of fruits and vegetables served per day (5 months)
C: Change in Stress (3 months); Change in Stress (1 month)
D: Feasibility of study (3 years); Acceptability of program (6 weeks); Acceptability of study participation (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study
Brief Summary: This study will test the effects of a sedentary behavior intervention on low back pain in working adults. The behavioral intervention will include the use of a sit-stand desk and a wrist-worn activity prompter that will notify participants when they have been sedentary for too long.


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: Low Back Pain Disability (6 months); Usual Low Back Pain (6 months)
C: Change in total weekly minutes of physical activity as measured by the 7-Day PAR (Physical Activity Recall), from Baseline to 6-months and 12-months. (Baseline, 6 months, and 12 months)
D: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study
Brief Summary: This study will test the effects of a sedentary behavior intervention on low back pain in working adults. The behavioral intervention will include the use of a sit-stand desk and a wrist-worn activity prompter that will notify participants when they have been sedentary for too long.


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: Change in Occupational Physical Activity From Baseline to 16 Weeks (Baseline and 16 weeks)
C: 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)
D: Low Back Pain Disability (6 months); Usual Low Back Pain (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum in Healthy Third-trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred Antibodies in Preventing RSV Disease in Their Infants
Brief Summary: The purpose of this study is to determine the efficacy of maternal immunization with the RSV F vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia through the first 90 days of life in infants.


Options:
A: Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI) (From Day 1 through Day 151)
B: Cumulative incidence of recurrent wheezing confirmed by physicians (two years)
C: Incidence of medically significant RSV LRTI with either hypoxemia (SpO2 <95% at sea level or <92% at altitudes >1800 meters) or tachypnea in infants through 90 days of life (Delivery to 90 days after delivery)
D: Readmission to either infirmary/observation or hospital or PICU during 3 weeks of follow-up after discharge (3 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum in Healthy Third-trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred Antibodies in Preventing RSV Disease in Their Infants
Brief Summary: The purpose of this study is to determine the efficacy of maternal immunization with the RSV F vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia through the first 90 days of life in infants.


Options:
A: Incidence of medically significant RSV LRTI with either hypoxemia (SpO2 <95% at sea level or <92% at altitudes >1800 meters) or tachypnea in infants through 90 days of life (Delivery to 90 days after delivery)
B: Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1 (Day 14 after dosing through end of surveillance period (approximately 7 months))
C: To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children (Day 28); Reactogenicity evaluations (REs) from administration of study vaccine through 28 days post-dosing (Day 28 post final vaccination); Adverse events (AEs) from administration of study vaccine through 28 post-dosing (Day 28 post final vaccination); Serious adverse events (SAEs) from administration of study vaccine through 28 days post-dosing (Day 180)
D: Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) (From Day 2 to Day 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Open-label, Multicenter Trial of Avelumab (MSB0010718C) as a Third-line Treatment of Unresectable, Recurrent, or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Brief Summary: The purpose of this study was to demonstrate superiority of treatment with avelumab plus best supportive care (BSC) versus physician's choice (chosen from a pre-specified list of therapeutic options) plus BSC.


Options:
A: Overall Survival Time (OS) (Randomization up to 27.5 months)
B: Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus (Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)); Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) (Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)); Overall Survival (OS) in All Participants (Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months))
C: Overall Survival (OS) (From randomization up to 627 days)
D: Overall Survival (OS) (From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Intradermic vs Habitual Skin Closure Technique in Open Appendicectomy.
Brief Summary: To compare the results associated with two different skin closure techniques in open appendectomy. 200 patients were included after acute appendicitis diagnosis in emergency department. They were grouped randomly into two groups: patients who would receive skin closure with skin closure by an unique absorbable intradermic stitch (Group A) and another that would receive a habitual technique consistent in non absorbable separated stitches (Group B). General characteristics like gender, age, body mass index (IMC), comorbidities and allergies were registered. Days of evolution (DOE) until surgery, use of antibiotics previously, complicated or uncomplicated appendicitis, surgery time and wound complications like skin infection, dehiscence, seroma or abscess were registered in each case too,


Options:
A: Scar Quality at 6 Months Postoperative (6 months); Time to Perform Wound Closure (intraoperatively)
B: Perfusion of Wound Closure (Surgical Point of Care)
C: Surgical site infection (30 days after the operative procedure)
D: Decrease in wound complications after appendectomy (1-30 days after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of DHA On Reducing Early Preterm Birth (ADORE Trial)
Brief Summary: The purpose of this study is to determine if giving a larger amount of DHA than currently included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks of pregnancy).


Options:
A: Occurrence of Early Preterm Birth (<34 weeks gestation) (Baseline to 34 Weeks); Occurrence of Early Preterm Birth (<34 weeks gestation) (Baseline to 34 weeks); Maternal and infant adverse and serious adverse events (Enrollment to 30 days past last birth)
B: Persistent wheeze 0 to 3 years of age (3 years)
C: Gestational Diabetes Mellitus (GDM) (24-28 weeks of gestation); Macrosomia (At birth); Prevalence of insulin resistance (At birth)
D: Percentage of Total Fatty Acids by Weight (at time of birth); Gestational Age (at time of birth); Birth Weight (at time of birth); Birth Length (at time of birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Motivation Matters! Randomized Clinical Trial of Theory Based SMS to Support Treatment as Prevention in High-Risk Women
Brief Summary: The study aims to develop and evaluate the efficacy and causal mechanisms of an interactive SMS intervention to optimize individual health and secondary HIV prevention benefits of ART in HIV-positive FSWs.


Options:
A: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)
B: Initiation of Long acting reversible contraception method (6 months)
C: Plasma HIV-1 viral load (six months)
D: Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) (Recruitment +8 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Motivation Matters! Randomized Clinical Trial of Theory Based SMS to Support Treatment as Prevention in High-Risk Women
Brief Summary: The study aims to develop and evaluate the efficacy and causal mechanisms of an interactive SMS intervention to optimize individual health and secondary HIV prevention benefits of ART in HIV-positive FSWs.


Options:
A: Plasma HIV-1 viral load (six months)
B: Proportion of women who received a Pap smear within 6 months from the date when the study randomization began. (6 months after randomization of study)
C: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)
D: Smoking status by collecting an expired carbon monoxide breath sample (3-Month Follow-Up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Motivation Matters! Randomized Clinical Trial of Theory Based SMS to Support Treatment as Prevention in High-Risk Women
Brief Summary: The study aims to develop and evaluate the efficacy and causal mechanisms of an interactive SMS intervention to optimize individual health and secondary HIV prevention benefits of ART in HIV-positive FSWs.


Options:
A: Short-term Exclusive Breastfeeding (24-hour recall) (Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week); Long-term Exclusive Breastfeeding (24-hour recall) (Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week)
B: Influenza Immunization: Pediatric (March 31, 2011); Influenza Immunization: Pregnant Women (by December 31, 2011); Influenza Immunization: Delayed Pediatric (March 31, 2012)
C: Plasma HIV-1 viral load (six months)
D: Vaccines received (Electronic Health Record) (up to a year of follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Clinical Trial Comparing Endovenous Laser Ablation and Mechanochemical Ablation (ClariVein®) in the Management of Superficial Venous Insufficiency
Brief Summary: A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation (ClariVein®) in the management of superficial venous insufficiency.


Options:
A: Generic Quality of life - Short Form-36 (1 week, 6 weeks, 3 months, 1 year, 2 years)
B: Intra-procedural Pain (Up to end of intervention); Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment. (At 1 year)
C: Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585). (5 years)
D: Ulcer Healing - 12 w (12 weeks); Ulcer Healing - 24 w (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Clinical Trial Comparing Endovenous Laser Ablation and Mechanochemical Ablation (ClariVein®) in the Management of Superficial Venous Insufficiency
Brief Summary: A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation (ClariVein®) in the management of superficial venous insufficiency.


Options:
A: Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) (Week 8)
B: Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score) (8 weeks)
C: The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks (Baseline to 8 weeks)
D: Intra-procedural Pain (Up to end of intervention); Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment. (At 1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Clinical Trial Comparing Endovenous Laser Ablation and Mechanochemical Ablation (ClariVein®) in the Management of Superficial Venous Insufficiency
Brief Summary: A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation (ClariVein®) in the management of superficial venous insufficiency.


Options:
A: cumulative probability of recurrent varicose vein within 24 months after treatment (24 months)
B: Intra-procedural Pain (Up to end of intervention); Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment. (At 1 year)
C: Obliteration of varicose vein and/ or absence of reflux (>0.5 sec. of retrograde flow over >10cm) along the treated segment of the great saphenous vein (GSV) at 12 and 52 weeks. (52 weeks)
D: Comparative Duplex Ultrasound (Immediately Post-procedure)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma
Brief Summary: This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC).

Participants will be randomized (1:1) to treatment with tivozanib or sorafenib.

Participants will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor \[programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor\] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent).

All participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability.

Pharmacokinetic (PK) analyses are also included in study.


Options:
A: progression-free rate (at 48 weeks post-treatment)
B: Objective Response Rate (ORR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) (Tumor restaging performed at 8 weeks following baseline, responding or stable participants restaged at 8 week intervals, up to 12 months.)
C: Progression-free Survival (PFS) of Subjects With Advanced Renal Cell Cancer (RCC) Randomized to Treatment With Tivozanib or Sorafenib (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks.)
D: Progression-free Survival (PFS) (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks (up to approximately 5 years))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Center, Prospective, Randomized, Double Blind, Placebo-controlled, Three-way Cross-over Study of the Analgesic Effects of Midazolam Versus Placebo With Fentanyl as an Active Control in Human Volunteers
Brief Summary: This study evaluates analgesic properties of midazolam compared to placebo and fentanyl. Each participant will receive all three drugs (midazolam, fentanyl, placebo) on three different occasions (study visits) and the effect on different pain stimuli will be tested.


Options:
A: SNAP-IV teacher form score in ORADUR®-Methylphenidate vs. placebo (2 weeks)
B: Postoperative pain - VAS (24 hours); Postoperative pain - PCA (24 hours)
C: The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit. (7 weeks)
D: Change in pain ratings (0-100) to a suprathreshold heat pain stimulus (3.5 Minutes after end of infusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blinded, Active-controlled 2-way Cross Over Trial to Assess the Effects of 6 Weeks Treatment of Once Daily Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Delivered by RESPIMAT Inhaler Compared With Tiotropium Delivered by RESPIMAT Inhaler on Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6 weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.


Options:
A: Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain) (Change from baseline to 12 months)
B: Change in 6-Minute Walk Test Distance (6MWT) (baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up))
C: Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose (Day 43, 60 minutes post-dose after 6 weeks of each treatment)
D: Change From Baseline in Endurance Time (Seconds) (Week 3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blinded, Active-controlled 2-way Cross Over Trial to Assess the Effects of 6 Weeks Treatment of Once Daily Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Delivered by RESPIMAT Inhaler Compared With Tiotropium Delivered by RESPIMAT Inhaler on Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6 weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.


Options:
A: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169 (1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169); Trough FEV1 Response on Day 170 (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170); Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274). (Day 169)
B: Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose (Day 43, 60 minutes post-dose after 6 weeks of each treatment)
C: Percentage Change in Exercise Tolerance From Baseline at 2 Weeks (Baseline and after 2 weeks with each treatment)
D: Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (Baseline and at Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Graceful Lifestyle Changes Intervention Study for Women With PCOS and Infertility
Brief Summary: The purpose of this study is to help women with PCOS to improve their symptoms and ovulation rate through a lifestyle intervention program which introduces a specific diet, a physical activity regimen and mindfulness exercises to improve psychological well-being and overall health.


Options:
A: Pregnancy rate (14 moths)
B: Ovulation Occurence (12 weeks); Ovulation Frequency (12 weeks)
C: Ovulation (6 weeks after starting the intervention)
D: Ovulation Rate (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)
Brief Summary: This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell NHL. The dose and schedule of JCAR017 will be evaluated and modified, as needed, for safety and antitumor activity. We will also determine how long the modified T cells stay in the patient's body and how well JCAR017 works in treating patients with non-Hodgkin's lymphoma whose disease has come back or has not responded to treatment.


Options:
A: Count of Participants Who Experienced Adverse Events (28 days post last infusion of Durvalumab, up to 1 year); Dose Limiting Toxicity (DLT) Rates (28 days post first infusion of Durvalumab (for participants in Group 1) or 28 days post infusion of JCAR (for participants in Group 2)); Highest Treatment Dose Administered on Study (28 days); Maximum JCAR014 Cmax by Flow Cytometry (Up to 12 months); Area Under the Curve (AUC) of JCAR014 by Flow Cytometry (Up to 28 days); Maximum JCAR014 Cmax in Blood by Quantitative Polymerase Chain Reaction (qPCR) Analysis (Up to 12 months); AUC of JCAR014 Cells by qPCR Analysis (Up to 28 days); Time to Loss of JCAR014 Detection in Blood by qPCR Analysis (Up to 12 months, +/- 30 days)
B: Treatment-related adverse events (AEs) as assessed by CTCAE v4.03 (Up to 730 days after the final JCAR017 infusion); Dose-limiting toxicities of JCAR017 (28 days after first (single-dose schedule) or second (2-dose schedule) JCAR017 infusion); Objective response rate (ORR) (24 months)
C: Response rate and toxicity (6 months)
D: Occurrence of study related adverse events (2 years)

Answer: B