TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of Insect Repellent and Insecticide Treated Nets Against Malaria, JE & Dengue in Rural Communities in Lao PDR
Brief Summary: Rural communities involved in agriculture are often at highest risk of insect-borne diseases in Southeast (SE) Asia.

Skin-applied insect repellents may prove a useful means of reducing mosquito-borne diseases for those people working outdoors in high risk areas.

This trial is evaluating the use of insect repellent (20% diethyltoluamide) to reduce incidence of malaria, Japanese Encephalitis and Dengue. The investigators will recruit up to 1000 households from 100 villages in rural Laos. In each house the investigators shall recruit up to 5 individuals. Half of households will be randomised to repellent, half to a placebo. All individuals will be provided with insecticide treated bed nets for use at night. All household occupants will be followed for 7 months to record malaria cases by Rapid Diagnostic Test every month. Blood spots will be collected at start and end of study to measure Japanese Encephalitis and Dengue. All positive cases will be promptly treated. Outcome will be reduction in number of malaria cases (primary outcome) and Dengue/Japanese Encephalitis (secondary outcomes).


Options:
A: Change from baseline in malaria prevalence at 6 months (6 months)
B: Malaria parasite (P. falciparum and/or P. vivax)through microscopic detection
C: Plasmodium spp. infection diagnosed by RDT (Assessed weekly, longitudinally over 12 months)
D: reduction in malaria incidence (monthly over 7 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of Insect Repellent and Insecticide Treated Nets Against Malaria, JE & Dengue in Rural Communities in Lao PDR
Brief Summary: Rural communities involved in agriculture are often at highest risk of insect-borne diseases in Southeast (SE) Asia.

Skin-applied insect repellents may prove a useful means of reducing mosquito-borne diseases for those people working outdoors in high risk areas.

This trial is evaluating the use of insect repellent (20% diethyltoluamide) to reduce incidence of malaria, Japanese Encephalitis and Dengue. The investigators will recruit up to 1000 households from 100 villages in rural Laos. In each house the investigators shall recruit up to 5 individuals. Half of households will be randomised to repellent, half to a placebo. All individuals will be provided with insecticide treated bed nets for use at night. All household occupants will be followed for 7 months to record malaria cases by Rapid Diagnostic Test every month. Blood spots will be collected at start and end of study to measure Japanese Encephalitis and Dengue. All positive cases will be promptly treated. Outcome will be reduction in number of malaria cases (primary outcome) and Dengue/Japanese Encephalitis (secondary outcomes).


Options:
A: Malaria cases (6 months)
B: reduction in malaria incidence (monthly over 7 months)
C: Change from baseline in malaria prevalence at 6 months (6 months)
D: Malaria parasite (P. falciparum and/or P. vivax)through microscopic detection

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Based Obesity Prevention Among Black Women
Brief Summary: This study will evaluate the efficacy of a behavioral intervention, designed to prevent weight gain among overweight and low obese (25-34.9 kg/m2) Black women (aged 25-44), compared to usual care.


Options:
A: Change in BMI. We have set a target of BMI maintenance among those randomized to the intervention condition. (6, 12 and 18 months post baseline)
B: Study Recruitment: Interest in Participation (Baseline); Study Recruitment: Screened for Eligibility (Baseline); Study Recruitment: Eligibility (Baseline); Study Recruitment: Enrollment (Baseline); Retention (Week 24); Treatment Satisfaction/Acceptability (Week 24)
C: Weight (6 months post randomization)
D: Weight maintenance 12 months after weight loss intervention (15 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Based Obesity Prevention Among Black Women
Brief Summary: This study will evaluate the efficacy of a behavioral intervention, designed to prevent weight gain among overweight and low obese (25-34.9 kg/m2) Black women (aged 25-44), compared to usual care.


Options:
A: Changes in the Physical Component Summary of the SF-12 Health Survey (Baseline and 6 months); Changes in the Mental Component Summary of the SF-12 Health Survey (Baseline and 6 months)
B: Change in BMI. We have set a target of BMI maintenance among those randomized to the intervention condition. (6, 12 and 18 months post baseline)
C: Smoking Abstinence (12 weeks); Smoking Abstinence (2 weeks)
D: Change from baseline in depression outcome at 6-months (6-months from enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Perioperative Administration of Pregabalin for Pain After Mastectomy
Brief Summary: The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following total mastectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be VNRS at 1 week and 1 month after operation.


Options:
A: Average Pain Score at Rest (48 hours); Average Pain Score With Coughing the First Morning Following Surgery (First morning following surgery); Average Pain Score With Coughing on Second Morning After Surgery (Second morning after surgery)
B: VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study. (six months)
C: Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. (1, 6, 24, 48 hour); Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. (1, 6, 24, 48 hour)
D: pain score (4 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Vitamin D Supplementation to Improve Neonatal Health Outcomes in Dhaka, Bangladesh: Preliminary Dose-finding and Safety Study
Brief Summary: This is a preliminary study of oral vitamin D3 supplementation in pregnant and non-pregnant women of reproductive age in Bangladesh. The primary objective of the study is to identify a dose of vitamin D3 that can safely be administered during pregnancy to improve the vitamin D status of the mother and infant.


Options:
A: Persistent wheeze (0 to 3 years of age)
B: 25-hydroxyvitamin D concentration (6 scheduled timepoints during supplementation period); Serum calcium concentration (albumin-corrected) (6 scheduled timepoints during supplementation period); Urine calcium: creatinine ratio (7-8 scheduled timepoints during supplementation period)
C: Change in T-cell cytokine expression (16-20 wks, 26-28 wks, and 36 wks gestation)
D: Differences in maternal bone mass changes postpartum between supplemented and placebo groups (2, 5 and 12 months postpartum); Differences in fetal growth and infant bone mass between supplemented and placebo groups (2nd and 3rd trimester gestation and 2 mo postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Open-Label, Randomized Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer
Brief Summary: The goal of this study was to determine the effect on overall survival and progression free survival by adding iniparib (BSI-201/SAR240550) to the combination of gemcitabine/carboplatin in adult patients with triple negative breast cancer (estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative).

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the poly (ADP-ribose) polymerase (PARP) inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.


Options:
A: Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants (Baseline up to approximately 34 months); PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1) (Baseline up to approximately 34 months); Overall Survival (OS) in All Randomized Participants (Baseline until death due to any cause (up to approximately 58 months)); OS in Participants With Detectable PD-L1 (Baseline until death due to any cause (up to approximately 58 months))
B: Progression-Free Survival (PFS) (Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for PFS was 34 months.)
C: progression free survival (until cut-off date established from deaths rate); Overall survival (until cut-off date established from deaths rate)
D: Objective Response Rate (ORR) (From randomization until data cutoff date (01 Sep 2016))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Double-Blind, Double-Dummy, Randomized, Parallel Group Dose Finding Study To Investigate the Safety and Tolerability of YM150 in Subjects With Non-Valvular Atrial Fibrillation and to Compare the Safety and Tolerability With Warfarin
Brief Summary: The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150 in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and tolerability data.


Options:
A: Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE) (From randomization up to the end of the treatment period (minimum of 6 months))
B: Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period (Baseline to Week 12)
C: Incidence of major and clinically relevant non-major bleeding events (Double-blind treatment period (variable, up to 16 months))
D: Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period (Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhanced Self-Efficacy Training For Informal Cancer Caregivers
Brief Summary: The goal of this study is to examine the effects of an enhanced caregiver training protocol that not only teaches informal caregivers knowledge and skills for managing patient symptoms, but also provides strategies for managing their own psychological distress. The investigators anticipate this training will increase caregivers' self-efficacy and improve important caregiver outcomes (depression, anxiety, burden, quality of life) and patient outcomes (symptom distress/intensity, depression, anxiety, and quality of life). The study will compare the effects of this protocol to an education control condition that equates for interventionist time and attention.


Options:
A: Self-efficacy in symptom management (One month)
B: Caregiver Quality of Life Index - Cancer (4 weeks); Perceived Stress Scale (4 weeks); Hospital Anxiety and Depression Scale (4 weeks); Basic Psychological Needs Scale (4 weeks); Healthcare Climate Questionnaire (4 weeks); Perceived Competence Scale (4 weeks); Interpersonal Support Evaluation List (4 weeks); Benefit Finding (4 weeks); Satisfaction and Feedback Questionnaire (4 weeks)
C: Change in the mean score of distress (Hospital Anxiety Depression Scale) (Baseline, after 3, 6 and 9 months); Change in the mean score of distress (Psychological distress scale used in the Quebec Health Survey) (Baseline, after, 3, 6 and 9 months)
D: PROMIS Physical Functioning (6 months); PROMIS Satisfaction With Social Roles (6 months); PROMIS Anxiety (6 months); PROMIS Depression (6 months); PROMIS Fatigue (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Based Obesity Prevention Among Blacks
Brief Summary: The purpose of this study is to examine whether pedometer step count recommendations (10,000 steps/day versus an adaptive recommendation) are differentially associated with the primary outcome of adherence to the pedometer-based physical activity regimen and the secondary outcomes of change in physical activity and body mass index (BMI).


Options:
A: Sodium intake (12 months); Fruit/vegetable intake (12 months); Physical activity (12 months)
B: Adherence to the pedometer-based physical activity regimen (24 weeks post baseline)
C: Physical activity measured by accelerometry. (3 months post-randomisation)
D: Feasibility of Using Facebook and Text Messaging to Deliver a Physical Activity Program to African American Women (Post Intervention (up to 8 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Development, Validation and Evaluation of an Adult and Pediatric Eosinophilic Esophagitis Activity Index: A Prospective Multicenter Study
Brief Summary: Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease of the esophagus affecting children and adults. The most frequent symptoms are swallowing difficulties and thoracic pain. The disease has first been described in the 1980s and is found with rapidly increasing frequency mainly in industrialized countries. The factors that lead to EoE are until now incompletely understood, of importance, the disease is found more frequently in men and patients suffering from allergic diseases (e.g., Asthma). So far there exists no activity index to define the severity of EoE; such an index is urgently needed for future clinical trials to determine the efficacy of current and future therapies. The investigators' 3-year project, carried out in cooperation with international EoE experts, aims at the development of an activity index for adult and pediatric EoE patients that will be used in future clinical trials as well as observational studies.


Options:
A: Development of an EE Activity Index (12 months)
B: 1. Reduction of eosinophils in the oesophagus 2. Safety and tolerability of mepolizumab
C: Rate of histological remission (2 weeks (LOCF)); Change in the mean numbers of eos (2 weeks (LOCF))
D: Watson Dysphagia Scale Score (WDS) (Two months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to evaluate NEVANAC in patients with diabetic retinopathy who developed macular edema (ME) within 90 days following cataract surgery.


Options:
A: Percentage of patients who develop macular edema within 90 days following cataract surgery (Time to event)
B: The incidence of CME was evaluated by retinal foveal thickness on optical coherence tomography (OCT) (After 1 week, 4 weeks, 12 weeks after surgery)
C: Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery (3 Months)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy (SMART) in Asthma Patients Across Asia: SMARTASIA
Brief Summary: The purpose of this study is to compare whether Symbicort Maintenance \& Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation.


Options:
A: The primary outcome for comparison across treatment groups was the mean value of morning PEF measured during the last 2 weeks of treatment (weeks 23-24)
B: Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level (Baseline and 12 weeks)
C: Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes (60 min)
D: Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1. (End of 12-week treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Phase II Trial of Cediranib (AZD2171) Versus Placebo in Addition to Cisplatin/Gemcitabine Chemotherapy for Patients With Advanced Biliary Tract Cancers
Brief Summary: As a result of our previous NCRN study (ABC-02) cisplatin and gemcitabine (CisGem) is likely to become the international standard of care for patients with advanced biliary tract cancer (submitted: ASCO 2009).

This study, ABC-03, will determine whether the addition of cediranib(an oral Vascular Endothelial Growth Factor Receptor inhibitor) to CisGem will improve the time to disease progression in this patient group.


Options:
A: Progression Free Survival (up to 1032 days)
B: Progression free survival (six months)
C: objective response rate (baseline and every 8 weeks)
D: Progression-free survival rate at 6 months (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Endovascular Coiling.
Brief Summary: The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at either 5 mg/h or 15 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH), reduces the incidence of cerebral vasospasm-related morbidity and all-cause mortality within 6 weeks post-aSAH treated by endovascular coiling.

The primary endpoint of the study is the occurrence of cerebral vasospasm-related morbidity, and mortality of all-causes within 6 weeks post-aSAH, defined by at least one of the following:

1. Death (all causes).
2. New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm.
3. Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm.
4. Administration of a valid rescue therapy in the presence of confirmed cerebral vasospasm on angiography (DSA or CTA).

An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components.


Options:
A: A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS) (90 days)
B: 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)
C: Cerebral vasospasm-related morbidity and mortality of all-causes as defined by the protocol (Within 6 weeks post-aSAH)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Discontinuation Study of XL184 in Subjects With Advanced Solid Tumors
Brief Summary: This is a Phase 2 study to evaluate the efficacy and safety of cabozantinib (XL184) in subjects with selected advanced tumor types.


Options:
A: progression free survival (12 months)
B: Progression-Free Survival (PFS) (Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months))
C: Peritoneal adhesion ORR (pORR) (3weeks after the last treatment)
D: Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only (From initial dose through final study visit up to 44 months); Bone Scan Response (BSR) - NRE, CRPC (From initial dose through final study visit up to 15 months); Progression-Free Survival (PFS) - Randomized Stage, RDT Cohorts Only (From initial dose through final study visit up to 44 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Discontinuation Study of XL184 in Subjects With Advanced Solid Tumors
Brief Summary: This is a Phase 2 study to evaluate the efficacy and safety of cabozantinib (XL184) in subjects with selected advanced tumor types.


Options:
A: progression free survival (6 months from randomization)
B: Progression-free survival based on investigator assessment using RECIST and clinical findings (Assessed within 12 months following completion of accrual)
C: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018)
D: Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only (From initial dose through final study visit up to 44 months); Bone Scan Response (BSR) - NRE, CRPC (From initial dose through final study visit up to 15 months); Progression-Free Survival (PFS) - Randomized Stage, RDT Cohorts Only (From initial dose through final study visit up to 44 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Discontinuation Study of XL184 in Subjects With Advanced Solid Tumors
Brief Summary: This is a Phase 2 study to evaluate the efficacy and safety of cabozantinib (XL184) in subjects with selected advanced tumor types.


Options:
A: N/A
B: investigator-determined progression-free survival (every 12 weeks until progression or up to 30 months (whichever occurs first))
C: Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only (From initial dose through final study visit up to 44 months); Bone Scan Response (BSR) - NRE, CRPC (From initial dose through final study visit up to 15 months); Progression-Free Survival (PFS) - Randomized Stage, RDT Cohorts Only (From initial dose through final study visit up to 44 months)
D: PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. (First drug administration to date of disease progression or death whichever occurs first , upto 29 months); PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis). (First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months)

Answer: C