TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Pivotal Response Group Treatment for Parents of Young Children With Autism
Brief Summary: This is a research study examining the effectiveness of pivotal response treatment group (PRTG) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. The purpose of this study is to further examine the effectiveness of teaching pivotal response treatment to parents of children with autism in a group format. To determine the effectiveness of pivotal response training group (PRTG) it will be compared to another parent education group by conducting a randomized controlled 12-week trial.


Options:
A: Receptive language skills (Pre-tx, Post-tx, and 6 month follow up); Expressive language skills (Pre-tx, Post-tx, and 6 month follow up)
B: Cognitive Assessment - Mullen Scales of Early Learning (MSEL) (Before treatment begins and at the 6 month follow up); Language Assessment - Reynell Developmental Language Scales (Before treatment begins and at 6 month follow up)
C: Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks (Baseline, 12 weeks)
D: Behavioral profiles (6 to 12 months); Immune markers (6 to 12 months); Sleep/EEG findings (6 to 12 months); Neuroimaging findings (6 to 12 months); Other laboratory findings (6 to 12 months); Genetic abnormalities (6 to 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Metformin as Adjunct Therapy for Overweight Adolescents With Type 1 Diabetes
Brief Summary: The objective of the proposed research is to evaluate the efficacy and safety of the use of metformin in addition to standard insulin therapy in overweight and obese children and adolescents, age 12-\<20 years, with type 1 diabetes for at least 1 year. Secondary objectives are to assess the effect of metformin on C-peptide levels, a measure of how much insulin is still being produced by the beta cells of the pancreas, and on vascular dysfunction. In addition, an ancillary study is planned to assess if metformin will improve tissue-specific insulin resistance in type 1 diabetes using a hyperinsulinemic euglycemic clamp.


Options:
A: Change in BMI Standard Deviation Score (baseline to 6 months)
B: Adiposity (Yearly for 15 years)
C: Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c. (0-26 weeks)
D: weight loss (kg) (after 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: "EXHALE" A Randomized Clinical Trial Comparing the Effects of a 12 Week Supervised Exercise Intervention Versus Usual Care for Advanced Stage Lung Cancer Patients.
Brief Summary: The aim of this study is to evaluate the effect of twelve weeks of a physical and psycho-social program consisting of: supervised, structured exercise training in a group of advanced lung cancer patients (cardio and strength training, relaxation training) twice weekly. Primary outcome is (VO2peak). The hypotheses are that patients who undergo this intervention will increase maximal oxygen uptake (VO2peak), strength (1RM), functional capacity (6MWD) and quality of life (HRQOL) and reduce the level of anxiety and depression compared to those who do not.


Options:
A: QoL: Physical Well-Being (FACT-L) (assessed after 12 weeks of enrolement); General Fatigue (MFI) (assessed after 12 weeks of enrolement)
B: Change in inspiratory muscle strength (Before surgery, 5.postoperative day, 2 weeks after surgery)
C: Systemic inflammation measured by c-reactive protein. (12 weeks)
D: VO2peak (baseline and after 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study to Evaluate the Efficacy and Safety of AQX-1125 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Mediated by the Src Homology-2-domain-containing Inositol 5' Phosphatase [SHIP1] Pathway
Brief Summary: The primary objective of this study is to evaluate the effect of 6 weeks of treatment with once daily administration of AQX-1125 compared to placebo on average daily pain in subjects with interstitial cystitis/bladder pain syndrome (IC/BPS), during and after treatment, using a standardized 11-point numerical rating scale (NRS) pain score recorded by electronic diary


Options:
A: Change of the O'Leary-Sant symptom score (Baseline and 1 month)
B: Change From Baseline in the Average Daily Bladder Pain Score (e-Diary) (Baseline to Week 6)
C: Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2 (12 weeks)
D: Change From Baseline in Average Daily Pain Score at Week 6 (Baseline, Week 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: ASSESSING THE IMPACT OF WATER FILTERS AND IMPROVED COOK STOVES ON DRINKING WATER QUALITY AND INDOOR AIR POLUTION: A RANDOMISED CONTROLED TRIAL IN RWANDA
Brief Summary: DelAgua Health and Development, Manna Energy and the Rwanda Ministry of Health are collaborating on a project financed by carbon credits that will distribute household-based water filters and high-efficiency cook stoves to approximately 700,000 households in Rwanda. Prior to the full roll out of the campaign, the implementers are conducting a pilot project among 2000 households in western Rwanda. The objectives of this pilot evaluation are to document the delivery of the intervention to the intervention population, assess coverage and uptake of the intervention target households and conduct a 5-month randomised controlled trial among 500 households to assess the impact of the intervention on drinking water quality and indoor air quality.


Options:
A: Reduction in dysentery and non-dysentery diarrhoeal disease in children under five years old (Duration of the study)
B: diarrhoea morbidity (monthly visits for 12 months)
C: Thermotolerant coliforms in household drinking water (5 months)
D: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Endometrial Biopsy on the Outcome of In Vitro Fertilization (IVF) /Intra-Cytoplasmic Sperm Injection (ICSI) Treatment (Endoscratch): A Feasibility Pilot Study
Brief Summary: This study aims to see if taking a small sample from the lining of the womb (the 'scratch') before starting in vitro fertilization (IVF) treatment can influence the chance of getting pregnant and having a healthy, term baby.

This study also aims to explore why an embryo is not accepted or indeed rejected by the lining of the womb. This will be analysed by carefully looking at the sample taken from the lining of the womb under the microscope and analysing the levels of natural killer (NK) cells. These cells are thought to regulate the implantation process and to be altered in some women with infertility and miscarriage.


Options:
A: A difference in the term (37 completed weeks of gestation), singleton live birth rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. (Approximately 9 months after completion of the last procedure of the last study participant.)
B: Live Birth (1 year)
C: Clinical pregnancy rate (6 months)
D: Clinical pregnancy rate (10 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Endometrial Biopsy on the Outcome of In Vitro Fertilization (IVF) /Intra-Cytoplasmic Sperm Injection (ICSI) Treatment (Endoscratch): A Feasibility Pilot Study
Brief Summary: This study aims to see if taking a small sample from the lining of the womb (the 'scratch') before starting in vitro fertilization (IVF) treatment can influence the chance of getting pregnant and having a healthy, term baby.

This study also aims to explore why an embryo is not accepted or indeed rejected by the lining of the womb. This will be analysed by carefully looking at the sample taken from the lining of the womb under the microscope and analysing the levels of natural killer (NK) cells. These cells are thought to regulate the implantation process and to be altered in some women with infertility and miscarriage.


Options:
A: Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3 (weeks 1-3)
B: Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. (Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks)
C: A difference in the term (37 completed weeks of gestation), singleton live birth rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. (Approximately 9 months after completion of the last procedure of the last study participant.)
D: implantation rate (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Endometrial Biopsy on the Outcome of In Vitro Fertilization (IVF) /Intra-Cytoplasmic Sperm Injection (ICSI) Treatment (Endoscratch): A Feasibility Pilot Study
Brief Summary: This study aims to see if taking a small sample from the lining of the womb (the 'scratch') before starting in vitro fertilization (IVF) treatment can influence the chance of getting pregnant and having a healthy, term baby.

This study also aims to explore why an embryo is not accepted or indeed rejected by the lining of the womb. This will be analysed by carefully looking at the sample taken from the lining of the womb under the microscope and analysing the levels of natural killer (NK) cells. These cells are thought to regulate the implantation process and to be altered in some women with infertility and miscarriage.


Options:
A: improvement in ongoing implantation rates (When a fetal heartbeat is detected for each patient. (8 weeks after implantation).)
B: implantation rate (4 weeks)
C: A difference in the term (37 completed weeks of gestation), singleton live birth rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. (Approximately 9 months after completion of the last procedure of the last study participant.)
D: Impact of next generation sequencing on the embryos produced from IVF on implantation rates (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Endometrial Biopsy on the Outcome of In Vitro Fertilization (IVF) /Intra-Cytoplasmic Sperm Injection (ICSI) Treatment (Endoscratch): A Feasibility Pilot Study
Brief Summary: This study aims to see if taking a small sample from the lining of the womb (the 'scratch') before starting in vitro fertilization (IVF) treatment can influence the chance of getting pregnant and having a healthy, term baby.

This study also aims to explore why an embryo is not accepted or indeed rejected by the lining of the womb. This will be analysed by carefully looking at the sample taken from the lining of the womb under the microscope and analysing the levels of natural killer (NK) cells. These cells are thought to regulate the implantation process and to be altered in some women with infertility and miscarriage.


Options:
A: Implantation ratio (Six months); Clinical pregnancy ratio (six months); Live birth ratio (six months)
B: Clinical pregnancy rate (4 weeks after embryo transfer)
C: Pregnancy rates (1 year)
D: A difference in the term (37 completed weeks of gestation), singleton live birth rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. (Approximately 9 months after completion of the last procedure of the last study participant.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Application for Self-Monitoring of Cardiovascular Risk
Brief Summary: Patients who recently suffered a heart attack will use a smart-phone/computer application during cardiac rehabilitation to reduce their risk of a future attack, their re-hospitalizations, their cost of care, and increase their quality of life.


Options:
A: Percentage of subjects who completed all tasks in the application. (Baseline to 3 months)
B: Medication adherence (12 months); Exercise frequency (12 months)
C: Effectiveness measured by exercise testing and control of cardiovascular risk factors (During 12 months)
D: Change in total volume of weekly active energy expenditure (3 and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Application for Self-Monitoring of Cardiovascular Risk
Brief Summary: Patients who recently suffered a heart attack will use a smart-phone/computer application during cardiac rehabilitation to reduce their risk of a future attack, their re-hospitalizations, their cost of care, and increase their quality of life.


Options:
A: exercise capacity as reported in total time on the exercise test using the BRUCE protocol (16 months)
B: Mortality rate (10-year)
C: Percentage of subjects who completed all tasks in the application. (Baseline to 3 months)
D: Change in Mean Daily Steps (Baseline and end of Maintenance Period at Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Study of Antithymocyteglobulin in Haploidentical Hematopoietic Stem Cell Transplantation for Acute Graft-versus-host Disease Prophylaxis
Brief Summary: The purpose of this study is to compare the incidences of GVHD and viral infections in haploidentical hematopoietic stem cell transplant recipients receiving different dose of antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. Our first objective was to investigate the optimal dose of ATG for aGVHD and second object was to evaluate the effect of different dose of ATG on post-transplant viral infection.


Options:
A: Incidence of Epstein-Barr virus(EBV) viremia (1 year)
B: cumulative incidence of cGVHD (cumulative incidence of cGVHD through study competition, an average of 24 months)
C: Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit (Cycle 7 Day 1 (each cycle was comprised of 4 weeks))
D: comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic SCT from HLA-identical siblings with or without anti-T-lymphocyte-globulin at 2 years after transplantation (2 years after transplantation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Task-oriented Circuit Training Associated With Transcranial Direct Current Stimulation (tDCS) for Gait Improvement in Chronic Stroke Patients . A Randomized Controlled Trial
Brief Summary: Stroke is one of the major causes of disability in the Western world. Initially gait is the most affected function, 80% of patients lose this ability.

Rehabilitation in stroke patients improves walking abilities in terms of gait and related gait activities, though six months after stroke many patients are significantly disabled.

Recently, a prospective study of 205 stroke patients showed that approximately 21% of patients have a significant decrease of mobility between the first and the third year after stroke. The main finding showed that inactivity was the most important factor for the mobility decline.

Evidence about effects of direct current brain stimulation on motor recovery function of lower limb are still little, some show that quadriceps strength after stimulation of damaged M1 area increased. Another study where tDCS was associated with robotic gait training did not report any effect compared to treatment alone. It is necessary to define if a different dosage of stimulation or the association of tDCS with gait training can improve walking and if further studies are required to investigate their effectiveness.

The aim of this clinical trial is to test the possibility of gait improvement through the association of tDCS with a specific task-oriented circuit training for walking abilities, balance and mobility.


Options:
A: Change from baseline in walking abilities, balance and mobility in Six minutes walking test (6MWT) (1)A week prior to treatment beginning 2) the week after treatment end 3) three months follow up.)
B: Upper Extremity Fugl-Meyer (2 weeks); Upper Extremity Fugl-Meyer (3 months); Upper Extremity Fugl-Meyer (1 year after stroke)
C: Disability (three months)
D: Fatigue relief (assessed by the Fatigue Severity Scale) (4 months after the stroke)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Task-oriented Circuit Training Associated With Transcranial Direct Current Stimulation (tDCS) for Gait Improvement in Chronic Stroke Patients . A Randomized Controlled Trial
Brief Summary: Stroke is one of the major causes of disability in the Western world. Initially gait is the most affected function, 80% of patients lose this ability.

Rehabilitation in stroke patients improves walking abilities in terms of gait and related gait activities, though six months after stroke many patients are significantly disabled.

Recently, a prospective study of 205 stroke patients showed that approximately 21% of patients have a significant decrease of mobility between the first and the third year after stroke. The main finding showed that inactivity was the most important factor for the mobility decline.

Evidence about effects of direct current brain stimulation on motor recovery function of lower limb are still little, some show that quadriceps strength after stimulation of damaged M1 area increased. Another study where tDCS was associated with robotic gait training did not report any effect compared to treatment alone. It is necessary to define if a different dosage of stimulation or the association of tDCS with gait training can improve walking and if further studies are required to investigate their effectiveness.

The aim of this clinical trial is to test the possibility of gait improvement through the association of tDCS with a specific task-oriented circuit training for walking abilities, balance and mobility.


Options:
A: Behavioural Inattention Test (BIT) (Change in BIT score between the baseline sessions average and score measured at week 11)
B: Change in Upper Limb function (Baseline and posttest (an average of 2 weeks from baseline))
C: Change from baseline in walking abilities, balance and mobility in Six minutes walking test (6MWT) (1)A week prior to treatment beginning 2) the week after treatment end 3) three months follow up.)
D: Upper Extremity Fugl-Meyer (2 weeks); Upper Extremity Fugl-Meyer (3 months); Upper Extremity Fugl-Meyer (1 year after stroke)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: NCI Young Adult Smoking Cessation Evaluation
Brief Summary: Background:

- Researchers want to see how well the QuitTXT text-message program helps smokers ages 18 29 stop smoking. This is part of a larger online stop-smoking program by the National Cancer Institute. The QuitTXT program is a 2-week countdown to the smoker s quit date with 6 weeks of follow-up messages. Program participants will receive texts on their cell phones, including tips, information, and motivational messages, and then fill out surveys.

Objectives:

- To study how well the QuitTXT program helps smokers ages 18 29 stop smoking.

Eligibility:

- Adults ages 18 29 who have smoked on at least 5 of the past 30 days and who want to stop smoking in the next 30 days.

Design:

* Participants will receive a certain number of text messages during the 8-week study. They will receive between 0 to 5 messages per day (or up to a total of 130 messages).
* Participants will first fill out a survey about their smoking and quitting experiences. Then they will choose a date to quit smoking (a quit date ) between 2 and 3 weeks after this survey.
* Participants will take four other surveys online, one during the program and three more after they ve completed the program. Each survey will take about 10 20 minutes and asks about their smoking habits and views on smoking and quitting. Each survey will be sent by email, with reminders sent by email or telephone.
* Participants will receive an iTunes or Amazon gift card for completing each survey honestly.


Options:
A: Point prevalence abstinence at 6 months (6 months after beginning treatment)
B: Quit smoking status (1, 3, and 6 month follow up)
C: Longest duration of abstinence (Week 24)
D: The change in smoking prevalence between baseline and 24 months of follow-up between the two groups measured via questionnaires. (24 months post intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-component Intervention to Increase Physical Activity in Preschool Children
Brief Summary: The study addresses a critical public health problem, childhood obesity, by testing a physical activity intervention in the types of preschools that millions of children attend. Information gained in this study may lead to adoption of preschool policies and instructional practices that increase physical activity and reduce the risk of obesity in preschool children.


Options:
A: Change in EPAO-SR Scores from Baseline to Post-intervention (Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention))
B: Change in Nutrition and Physical Activity Policies (Baseline, Year 1, Year 2)
C: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)
D: Change in Minutes of Moderate-to- Vigorous Physical Activity (MVPA) (Measured at baseline and 10 months for each wave of data collection)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: HALT Progression of Polycystic Kidney Disease Study B
Brief Summary: The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR \>60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years.

Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.


Options:
A: Primary Efficacy Analysis of Total Kidney Volume (mITT Set, Multiple Imputation) (Baseline, Month 24)
B: Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death. (Patients followed for 5-8 years with average of 6.5 years follow up)
C: Total Kidney Volume (Baseline, week 24, 52, 104, and 156); Renal Function Test (eGFR) (Baseline, Week 24, 48, 104, and 156)
D: Safety Assessments Based on Vital Signs, Electrocardiogram (ECG's), Clinical Laboratory Tests, Physical Examinations Are Reported as Adverse Events (AEs) Upon Study Physician Discretion. (AEs were recorded from screening (ICF was signed) until 7-Day follow-up)

Answer: B