TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese
Brief Summary: To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing.


Options:
A: Groin Wound Complication (30 days)
B: Early Complications of Vascular Zone (2 weeks)
C: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)
D: Post-operative wound infection (6 weeks post-operative)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese
Brief Summary: To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing.


Options:
A: Time to Complete Wound Closure (42 days)
B: Incidence of wound management complications (90 days); Incidence of wound management complications in groups treated with different types of postopNPWT (90 days)
C: superficial site infection via southampton scoring system (higher score - worse outcome) (5 days); Wound Dehisence (5 days)
D: Post-operative wound infection (6 weeks post-operative)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis
Brief Summary: The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant (FMT) for treating patients with mild to moderate Ulcerative Colitis (UC). Even with the expanding choices of medication for UC, physicians and patients are still in search of highly effective and safe medications with minimal side effects. FMT has been approved for the treatment of a bacterial infection called Clostridium difficile. In this setting, FMT has been proven to be an effective and safe alternative therapy with zero reported serious adverse events from patients that have had this treatment.

The providers that are conducting this study hypothesize that delivering microbes from a healthy human gut can help treat the damages caused by UC. This is done by "transplanting" fecal material, which contains a highly complex and dense community of healthy microbes, including bacteria, fungi and viruses. This collection of microbes is referred to as a microbiome. Preliminary studies suggest that alteration of the microbiome can help treat UC.


Options:
A: Recurrence of CDI up to 8 Weeks (Up to Week 8)
B: Asses Endoscopic Stages of the Colon Pre/Post FMT (2 years); Asses Biologic Inflammatory Markers (2 years); Review and Track Patient reported Outcomes via Validated Questionnaires (2 Years)
C: Feasibility (Composite Measure) (30 weeks)
D: Monthly Recruitment Rate (30 weeks); Dropout Rate Post Enrolment (30 weeks); Rate of Patient Protocol Adherence (30 weeks); Rate of Adverse Events (30 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Problem-solving Based Bibliotherapy Program for Family Caregivers of People With Psychotic Disorders
Brief Summary: This proposed randomized controlled trial will test the effectiveness of a problem-solving based bibliotherapy program (PSBBP) for Chinese family caregivers in psychotic disorders (not more than 5 years onset). A repeated-measures, three-group design will be used to evaluate and compare the effects between two treatment groups(PSBBP and psycho-education group) and routine outpatient service and family support (control group) for 198 randomly selected family caregivers of outpatients with psychotic disorders over a 24-month follow-up.

Before the 3-arm trial to be conducted, a pilot parallel-group randomised controlled trial with a similar study design to the later three-arm randomised controlled trial (Phase 2) will be conducted at one psychiatric outpatient clinic in Hong Kong. Receiving an additional funding from local government, another pilot two-arm trial will also be conducted for family caregivers of people with first-episode psychosis in the community to support and inform the 3-arm randomised controlled trial.


Options:
A: Transition to psychotic disorder (12 Months)
B: Scale Of Prodromal Symptoms total score (8 weeks)
C: Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (6 months (for Phases 1 and 2) after completion of intervention); Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (12 months (for Phases 1 and 2) after completion of intervention); Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (24 months (for Phase 2 only) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (6 months (for Phases 1 and 2) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (12 months (for Phases 1 and 2) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (24 months (for Phase 2 only) after completion of intervention)
D: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nitrous Oxide for Pain Management of Intrauterine Device Insertion
Brief Summary: The purpose of this study is to determine whether Nitrous Oxide is effective in achieving pain control and satisfaction among nulliparous women getting the intrauterine device (IUD).


Options:
A: Mean Maximum Procedural Pain Scores (2 minutes after the procedure.)
B: Evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an intervention to improve the IUD insertion experience for both patient and provider. (over one year)
C: Mean Pain Score During IUD Insertion (Day 1)
D: Change in Pain From Baseline to IUD Insertion (change in pain score from baseline (before IUD insertion) to time of IUD insertion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.


Options:
A: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 (Baseline, Week 4 and Week 8 of each treatment period)
B: Treatment Period 1 (Treatment Cohorts): Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 100)
C: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (From Day 1 Through Safety Follow-up (up to Day 75 for Part 1 and up to Day 85 for Part 2)); Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline Through Day 29)
D: Number of Participants With Treatment Emergent Adverse Events. (84 days of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.


Options:
A: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
B: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 (Baseline, Week 4 and Week 8 of each treatment period)
C: Safety assessments based on clinical evaluations, laboratory assessments, and adverse events. (28 Days)
D: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.


Options:
A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
B: Safety and Tolerability of N91115 (21 Days); Pharmacokinetics: Day 1 AUClast (Day 1); Pharmacokinetics: AUCtau Day 14 (Day 14); Pharmacokinetics: Day 1 Plasma Cmax Values (Day 1); Pharmacokinetics: Plasma Cmax Values on Day 14 (Day 14)
C: 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)
D: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 (Baseline, Week 4 and Week 8 of each treatment period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.


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: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 (Baseline, Week 4 and Week 8 of each treatment period)
C: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 52); Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 86)
D: Absolute Change in Lung Clearance Index 2.5 (LCI2.5) Through Week 8 (From baseline through Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Boston Scientific Clinical Trial of Renal Denervation Using the Vessix Reduce™ Catheter and Vessix™ Generator for the Treatment of HyperTensioN: REINFORCE
Brief Summary: The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™ Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8 weeks when compared to a masked procedure (renal angiogram).


Options:
A: Mean diurnal systolic blood pressure assessed by ABPM (Baseline to 6 months); Cost-effectiveness evaluation (1 year)
B: Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline (3 months post-randomization)
C: Office Systolic Blood Pressure Reduction (Baseline to 6 months)
D: OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks (Through 8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Dietary Supplement on Endothelial Function in Volunteers With Light to Moderate Hypertension - a Randomised, Double-blind, Placebo Controlled Cross-over Study
Brief Summary: The effect of a combination product (Verum ) with L-arginine, Pycnogenol, vitamin K2, R-(+)-alpha-lipoic acid and vitamins B6, B12 and folic acid is investigated in a double blind placebo-controlled cross-over study. Volunteers with hypertension and hyperhomocysteinemia are randomly assigned to the dietary supplement or placebo.


Options:
A: The primary objective of this study is to evaluate the effects of treatment with Pycnogenol® on endothelial function in subjects with stable coronary artery disease. (8 weeks)
B: Changes in visual function (At baseline and again at six months)
C: Change in Endothelial Function Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase (Delta "lnRHI") (Intervention period of 4 weeks)
D: Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12. (three months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Late LTP-like Plasticity Effects of tDCS in Subacute Stroke Patients
Brief Summary: Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have limited effects on motor recovery. Therefore, investigating new potential therapeutic approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive electrical stimulation where a weak current is applied through electrodes over the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which can last up to one day with late LTP-like plasticity protocols in a polarity and site-specific manner, and (2) facilitate motor learning and stroke recovery. So far, several pilot studies have reported beneficial results from tDCS in both subacute and chronic stroke patients, but it's still unclear how tDCS should be repeated over multiple days to optimally enhance recovery and training effects. Using a late LTP-like plasticity protocol could increase effectiveness of standard clinical care rehabilitation sessions and thus enhance the effects of rehabilitation. Therefore, the investigators want to investigate how late LTP-like plasticity tDCS affects rehabilitation in subacute stroke patients. The outcome of this study can provide important guidelines on effective motor therapy during stroke rehabilitation.

Objective: Identify the effect of late LTP-like plasticity on motor rehabilitation during the subacute phase after stroke.

Study design: Double-blinded, randomized between-subjects trials. Study population: Subacute stroke patients. Main study parameters/endpoints: The primary outcome measure is the upper limb motor function during the subacute phase after stroke.


Options:
A: Fugl-Meyer Assessment (upper extremity subscale) (0-, 4- week)
B: Motor Assessment Scale (18 months after inclusion)
C: Change from baseline in Upper Extremity Fugl Meyer Assessment (Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks)
D: Change of Fugl-Meyer assessment (FMA) score (Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Late LTP-like Plasticity Effects of tDCS in Subacute Stroke Patients
Brief Summary: Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have limited effects on motor recovery. Therefore, investigating new potential therapeutic approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive electrical stimulation where a weak current is applied through electrodes over the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which can last up to one day with late LTP-like plasticity protocols in a polarity and site-specific manner, and (2) facilitate motor learning and stroke recovery. So far, several pilot studies have reported beneficial results from tDCS in both subacute and chronic stroke patients, but it's still unclear how tDCS should be repeated over multiple days to optimally enhance recovery and training effects. Using a late LTP-like plasticity protocol could increase effectiveness of standard clinical care rehabilitation sessions and thus enhance the effects of rehabilitation. Therefore, the investigators want to investigate how late LTP-like plasticity tDCS affects rehabilitation in subacute stroke patients. The outcome of this study can provide important guidelines on effective motor therapy during stroke rehabilitation.

Objective: Identify the effect of late LTP-like plasticity on motor rehabilitation during the subacute phase after stroke.

Study design: Double-blinded, randomized between-subjects trials. Study population: Subacute stroke patients. Main study parameters/endpoints: The primary outcome measure is the upper limb motor function during the subacute phase after stroke.


Options:
A: change in motor function before/after tDCS (Baseline (>6 months after stroke), immediately after intervention (30min of tDCS), 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks)
B: Upper Extremity Fugl-Meyer (2 weeks); Upper Extremity Fugl-Meyer (3 months); Upper Extremity Fugl-Meyer (1 year after stroke)
C: Change from baseline in Upper Extremity Fugl Meyer Assessment (Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks)
D: Postural control (After 5 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Policy to Practice: Statewide Rollout of YMCA Childhood Obesity Standards
Brief Summary: The investigators long term-goal is to help YMCA programs across the nation successfully acheive the Y of USA "Healthy Eating and Physical Activity Standards". Our objective here is threefold. First, the investigators will work with South Carolina YMCA leadership to achieve the "Healthy Eating and Physical Activity Standards" and implement our HEPA Strategies in YMCA programs across the state, evaluate the uptake of and adherence to the standards and strategies, and identify factors that influence their implementation. Second, the investigators will evaluate the impact of acheiving the standards on children's MVPA and the serving and consumption of FV and water during the programs. Third, the investigators will evaluate the costs associated with and the cost-effectiveness of meeting the standards in terms of improvements in activity and healthy eating.


Options:
A: Body mass index (Baseline, 3 and 6 months)
B: Change in proportion of children meeting physical activity policy (Baseline, Fall of Year 2, and Fall of Year 3)
C: N/A
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Medical Admission of ELDERly Patients (≥75yrs) to Either Fast Track or Traditional Inward Hospitalisation. A Randomised Controlled Trial
Brief Summary: To evaluate differences in health outcomes among elderly patients (age ≥ 75 years) treated in a Quick Diagnostic Unit (QDU) compared to the Department of Internal Medicine (DIM). A QDU is a medical Short Stay Unit (SSU).


Options:
A: Cost of Index Hospitalization (Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours)
B: All cause mortality (90 days)
C: The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. (Index Hospitalization through 90 days)
D: Therapeutic efficacy: Length of stay (Duration of Initial Hospitalization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mediterranean Diet: A New Nutritional Approach for the Treatment of Normal Weight Women With Polycystic Ovary Syndrome (PCOS)?
Brief Summary: Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women characterized by chronic anovulation, hyperandrogenism and insulin resistance. Available guidelines recommend lifestyle intervention although they do not suggest the best dietetic regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the effectiveness of two nutritional protocols, namely Mediterranean Diet and standardized normocaloric Diet in normal weight women with PCOS.


Options:
A: improvement in insulin resistance measured by HOMA index (6 months)
B: Change in Daily Servings of Fruits and Vegetables (Baseline and 6 months)
C: Primary Outcome Measures Described Below (December 2011)
D: Non-alcoholic Fatty Liver Disease Ultrasonography Score (Six months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II, Open-label, Uncontrolled, Single-dose, Dose-ascending, Multi-centre Trial Investigating an Adeno-associated Viral Vector Containing a Codon-optimized Human Factor IX Gene (AAV5-hFIX) Administered to Adult Patients With Severe or Moderately Severe Hemophilia B
Brief Summary: This study evaluates how safe gene therapy treatment with AAV5-hFIX is in adult patients with severe or moderately severe hemophilia B and severe bleeding type.


Options:
A: Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings (Baseline up to Week 52); Number of Participants With Clinically Significant Change From Baseline in Vital Signs (Baseline up to Week 52); Number of Participants With Clinical Laboratory Abnormalities Reported as TEAE (Baseline up to Week 52); Number of Participants With Drug -Related TEAEs and Serious Adverse Events (SAEs) (Baseline up to Week 52); Number of Participants With Positive Immune Reponses Against Adeno-associated Virus Vector (AAV) Capsid (Baseline up to Week 52); Number of Participants Who Reached > 150% Vector-derived FIX:C Activity Level After SPK-9001 Infusion (Baseline up to Week 52); Number of Participants With FIX Inhibitor (Baseline up to Week 52); Incremental Recovery of FIX Product (Day 0 and Week 52)
B: Number of Participants With Adverse Events (From AMT-060 infusion through end of study (5 years post-dose))
C: N/A
D: Occurrence of FVIII Inhibitor Development (Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26)

Answer: B