TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Randomized, Double Blind, Placebo Controlled, Dose Escalation, and Bioavailability Study Evaluating the Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Subjects With Cystic Fibrosis
Brief Summary: Evaluate the safety and tolerability of VX-659 in healthy subjects


Options:
A: Safety and Tolerability assessments as determined by number of subjects with adverse events (AEs) and serious adverse events (SAEs) (from baseline up to Day 50)
B: Changes in adverse events (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal laboratory (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal vital signs, ECG or physical examination (at screening and at each study visit up to day 43 which is the final FU visit)
C: Cohort 1: Safety and Tolerability Based on Adverse Events (AEs) (Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)); Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs) (Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)); Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs (Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)); Cohort 1: Absolute Change From Day 14 in Sweat Chloride at Day 21 (Cohort 1: Day 14, Day 21); Cohort 2 And 3: Absolute Change From Day 28 in Sweat Chloride at Day 56 (Cohort 2 and 3: Day 28, Day 56); Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56 (Cohort 4: Baseline, Day 56)
D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Randomized, Double Blind, Placebo Controlled, Dose Escalation, and Bioavailability Study Evaluating the Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Subjects With Cystic Fibrosis
Brief Summary: Evaluate the safety and tolerability of VX-659 in healthy subjects


Options:
A: Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 105 (Study 105)); Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs (Day 1 up to Week 105 (Study 105))
B: Safety and Tolerability assessments as determined by number of subjects with adverse events (AEs) and serious adverse events (SAEs) (from baseline up to Day 50)
C: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Baseline up to Week 100)
D: Maximum Observed Concentration (Cmax) of VX-659, TEZ, and IVA (Day 1 and Day 15); Observed Pre-Dose Concentration (Ctrough) of VX-659, TEZ, and IVA (Day 8 and Day 15); Area Under the Concentration Versus Time Curve From Time 0 to 6 Hours (AUC0-6h) of VX-659, TEZ, and IVA (Day 1 and Day 15)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: iQuit Mindfully: A Randomized Controlled Trial of Mindfulness-based Smoking Cessation Enhanced With Mobile Technology
Brief Summary: The purpose of this study is to investigate text messaging as a way to enhance mindfulness-based treatment for smoking cessation.


Options:
A: Change in impulsive eating (TFEQ-R18 "uncontrolled eating" subscale) (From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.)
B: Point prevalence abstinence at 6 months (6 months after beginning treatment)
C: In-clinic and ambulatory blood pressure (Measured at Month 4)
D: Smoking Abstinence (End of Treatment (8 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: iQuit Mindfully: A Randomized Controlled Trial of Mindfulness-based Smoking Cessation Enhanced With Mobile Technology
Brief Summary: The purpose of this study is to investigate text messaging as a way to enhance mindfulness-based treatment for smoking cessation.


Options:
A: Number of Participants With Smoking Abstinence (4 weeks post quit day (one week following the end of treatment)); Smoking Abstinence (26 weeks post quit day); Smoking Abstinence (4 weeks post quit day (one week following the end of treatment))
B: Smoking Abstinence (End of Treatment (8 weeks))
C: 30-day Point Prevalence Abstinence, Complete-case (12 months post randomization)
D: smoking cessation: 7-day point prevalence abstinence (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Breastfeeding Education and Support Intervention on Timely Initiation and Exclusive Breastfeeding in Southwest Ethiopia: a Cluster Randomized Controlled Trial.
Brief Summary: The purpose of this study is to develop and test Breastfeeding Education and Support Intervention for improving timely initiation and Exclusive Breastfeeding rate.

Infant mortality rates are still high in Ethiopia. Breastfeeding (BF) is regarded as the simplest and least expensive strategy for reduction of infant mortality rates. Ethiopia does not meet the international recommendation for exclusive breastfeeding (EBF) for the first six months of life. Community-based educational and support interventions provided prenatally and postnatally are effective in increasing BF rates. However, there is paucity of such information in Ethiopia.


Options:
A: Use of iron-folic acid supplements (IFA tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016); Use of calcium supplements (Calcium tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016); Dietary diversity during pregnancy (Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016); Dietary micronutrient intakes (Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016); Coverage of maternal nutrition intervention (1 year)
B: Change in Length-for-age Z scores (LAZ) at 3, 6, 12, 18 and 24 months age of children in intervention vs. comparison arms, compared to the baseline LAZ at 7 days of birth. (1, 3, 6, 9, 12, 15, 18, 21 and 24 months of child's age)
C: Breastfeeding intensity at 1,3, and 6 months (1,3, and 6 months after birth of the baby)
D: Exclusive breastfeeding (at six month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Zahra Teymuri, Zahedan University of Medical Sciences
Brief Summary: The purpose of this study was to evaluate the effects of stabilization exercises on pain, disability and pelvic floor muscles function in patients with lumbopelvic pain.


Options:
A: Prematurity (Women will be interviewed at hospital soon after birth (up to 2 days after delivering))
B: Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations. (week 36-38 of pregnancy)
C: pain (6 weeks); Disability (6 weeks); Pelvic Floor Muscle activity (6 weeks); Abdominal muscles(Transverse Abdominis,Internal Oblique,External Oblique) thickness (6 weeks); Multifidus muscle thickness and crass section area(S1 level) (6 weeks)
D: Placental weight (At delivery); Fetal birth weight (At delivery); Change from baseline in maternal gestational weight (38-42 weeks of gestation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Glycine Powder Air-Polishing Combined With Scaling and Root Planing in the Treatment of Periodontitis and Halitosis: A Randomized Clinical Study
Brief Summary: The aim of this clinical study was to evaluate the clinical efficacy of using perio flow adjunctively with mechanical instrumentation on periodontal parameters and halitosis.

Sixty patients who presented with 4-6-mm probing pocket depth (PPD) were recruited for the study. Patients were randomly assigned to glycine powder air-polishing (GPAP) or control groups. For both groups PPDscores were recorded at the baseline and 1 month. Volatile sulphur compound (VSC) values were measured by a halimeter at the baseline, immediately after treatment, and at 7 days, 14 days and 1 month.


Options:
A: Volatile sulfur compounds (VSCs) (5 weeks)
B: Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with organoleptic measurements. (4 hours)
C: Periodontal Pocket Depth (PPD) (30 day.)
D: Oral malodor (7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Blinded Trial Comparing Vaginal Estrogens on Pelvic Organ Prolapse Patients
Brief Summary: To evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security.


Options:
A: The proportion of subjects using the pessary and have very much or much improvement on the patient impression of improvement questionnaire at 1 year between the vaginal estrogen group and the placebo group. (up to 1year after randomization)
B: Evaluate the histopathological effects on endometrium after each treatment (48 days); Compare the endometrial thickness measured by ultrassound after each treatment (48 days)
C: "Much Better" or "Very Much Better" on PGI-I at 3 Months (Outcome was measured at three months following randomization.); No Bothersome Stress Incontinence Symptoms at 3 Months (Outcome was measured at three months following randomization.)
D: Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Patient Centered-Care: A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse (OPTIMA Trial)
Brief Summary: This trial evaluates two standard of care treatments for opioid addiction: methadone and buprenorphine/naloxone. In order to improve patient care, the study will address real-world treatment conditions, including strict regulations for methadone dosing (i.e. initially dispensed daily at the pharmacy until stabilisation) vs. flexible take-home dosing for buprenorphine/naloxone. The OPTIMA study is designed with the intention to support patient-provider decision-making and evaluate health related outcomes with the overall aim of improving treatment outcomes through enhancing patient-centered approaches in clinical care.


Options:
A: Opioid use as determined by the Timeline Follow Back measure (from 2006-2009 to 2011-2016)
B: Opioid Use (24 weeks)
C: HIV Risk Events (Change from Baseline in HIV Risk Events at Months 3, 6, 9 and 12)
D: The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids (weeks 1-16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse
Brief Summary: A prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse:

1. Via single-port.
2. Via multi-port.


Options:
A: Primary outcome: operative time from incision to closure. (Primary outcome: will be obtained immediately at the end of each procedure.)
B: Comparison of surgical time (Up to four months (2 weeks before surgery until 3 months post-surgery).)
C: Surgical Success (24 months); Anatomic Failure (24 months); Urinary Distress Inventory at 6 Months (6 months)
D: Cumulative Failure (6 Months through 36 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure (CONNECT-HF)
Brief Summary: CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of a customized, multifaceted, health system-level quality-improvement (QI) program compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics.


Options:
A: Time-to-first HF rehospitalization or death during the 12-months post-discharge (12-months after discharge); Improvement in an opportunity-based composite score of adherence to quality metrics for HF. (Baseline to 12 months post discharge)
B: Self-reported use of modern contraceptives at 18 months of interventions. (At 18 months of intervention)
C: Receipt of Recommended Preventive Care Services (At 12 months post enrollment)
D: Reach (Entire 6 month early or delayed implementation phase); Effectiveness - Ask (6 month early implementation phase); Effectiveness - Goal Setting (6 month early implementation phase); Effectiveness - Assistance (6 month early implementation phase); Effectiveness - Referred (6 month early implementation phase)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of a Low Protein Content Formula Fed to Full Term Healthy Infants in the First Months of Life: a Randomized Controlled Trial
Brief Summary: This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.


Options:
A: Growth velocity of formula regimen 1 and 2 versus WHO growth curve (0-6 months); Growth velocity (g/day) of formula regimen 1 and 2 versus a human milk (HM)-fed comparator group (0-6 months)
B: Weight gain (1- 365 days)
C: Evaluate weight (enrollment, 2 months and 4 months); Evaluate lenght (enrollment 2 months and 4 months); Evaluate head circumference (enrollment 2 months and 4 months); Evaluate body composition (fat mass and fat free mass) (enrollment, 2 months and 4 months); Evaluate weight increase (2 months, 4 months); Evaluate gastrointestinal tolerance (2 months and 4 months); Evaluate occurence of adverse events (2 months and 4 months)
D: Mean rank stool consistency at 14 days of age (14 days of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improvement of Postural Control and Motor Function by Vojta Therapy in Early Stroke Rehabilitation of Stroke Patients - a Pilot Study and New Approach in Stroke Rehabilitation
Brief Summary: Stroke is the major cause for permanent disability in adults. It is still unclear, which physiotherapeutic approaches are most effective. The Bobath-concept is one of the most widely used approaches in stroke rehabilitation within the western world, although several studies have failed to demonstrate superiority and showed partially even inferiority compared to other physiotherapy approaches. The Vojta therapy is based on a completely different approach - the reflex locomotion. However to date no study has been performed for stroke. We designed a randomized clinical trial (RCT) to compare Vojta and conventional physiotherapy in patients with acute ischemic (AIS) or hemorrhagic stroke (ICH). This RCT will be the first trial to investigate improvement of postural control due to Vojta therapy in early rehabilitation of stroke patients, which is a very new approach in stroke-rehabilitation.


Options:
A: Motor Assessment Scale (18 months after inclusion)
B: Change in Upper Limb function (Baseline and posttest (an average of 2 weeks from baseline))
C: Safety of the intervention as assessed by frequency of adverse events (2 weeks)
D: Improvement of postural control measured with the trunc control test (TCT) on day 9 after admission to the hospital (Day 1-9 after admission to hospital (+/- 1))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Brief Summary: The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction


Options:
A: Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. (Up to 27.8 months.)
B: Change in low-density lipoprotein cholesterol (52-weeks); Change in glycated hemoglobin (52-weeks)
C: Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF) (Up to 21.9 months)
D: Change in left ventricular (LV) Mass by Cardiac MRI at 52 weeks (Baseline and 52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
Brief Summary: The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.


Options:
A: Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (Time from randomisation up to end of follow-up (scheduled at week 109))
B: Primary Efficacy Outcome MACE Events (Time to first event. Information collected during study period (anticipated to be up to 7.5 years).); Primary Safety Outcome MACE Events (Time to first event. Information collected during study period (anticipated to be up to 7.5 years).)
C: Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. (Up to 38.2 months)
D: Progression of Albuminuria (Up to 3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).

After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.

The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.


Options:
A: Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery (Up to approximately 27-30 weeks); Event-free Survival (EFS) as assessed by Investigator (Up to approximately 8 years)
B: Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is). (At the time of definitive surgical removal, up to 28 weeks); Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is). (At the time of definitive surgical removal, up to 28 weeks)
C: pathological complete response (pCR= ypT0/is ypN0) (18 weeks (time window + 3 weeks)); Only for those patients randomized for the supportive anemia treatment: frequency of patients reaching hemoglobin (Hb) levels ≥ 11g/dl 6 weeks after treatment start of a first episode of anemia grade ≥2 (18 weeks (time window + 3 weeks))
D: Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry. (Post surgery based on upto 36-week treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Ideal Sedation for Stroke Thrombectomy
Brief Summary: The Ideal Sedation for Stroke Thrombectomy (ISST) registry will answer the key questions whether sedation with intubation and paralytics is feasible and whether it delays the time to recanalization in comparison with conscious sedation alone. As a pilot registry, it is anticipated to enroll 40 acute stroke patients requiring mechanical thrombectomy over 12-18 months. Following enrollment, data will be collected prospectively from medical records and from patients' visits.


Options:
A: Randomization potential (20 weeks)
B: composite of functional independence at 3 months and absence of medical complication occurring by day 7 after endovascular therapy for anterior circulation AIS (Day 90)
C: Time interval between groin puncture and final recanalization (6 months or at study completion)
D: Growth of DWI lesion (48-72 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Low-dose Aspirin on Fetal Weight of Idiopathic Asymmetrically Intrauterine Growth Restricted Fetuses With Abnormal Umbilical Doppler Indices
Brief Summary: Intrauterine growth restriction refers to a fetus that has failed to get a specific measures by a gestational age. Asymmetric type of Intrauterine growth restriction is known by normal sized head with smaller abdomen.It is important to recognize the growth restricted fetuses, because these fetuses may have fetal or neonatal complications.

When blood flow is increased, the oxygen and nutrients will deliver good to the fetus. The role of low-dose aspirin therapy in management of intrauterine growth restriction is controversial. It has been used, in many studies, in prevention of intrauterine growth restriction especially in women at high risk of pre-eclampsia or obstetrical antiphospholipid syndrome.


Options:
A: Estimated fetal weight (6 weeks)
B: Live Birth (after delivery)
C: Pregnancy rate (Five weeks after embryo transfer)
D: Delivery with preterm-preeclampsia (Before 37 weeks of gestation)

Answer: A