TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis
Brief Summary: The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).


Options:
A: The primary outcome of the randomized trial is remission of UC defined as a Mayo score < 3 with an endoscopic Mayo score = 0 at the end of the trial Transplant Therapy in Ulcerative Colitis (9 weeks)
B: Efficacy of FMT (On year)
C: diversity and steady state of the stool (6 months)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy
Brief Summary: This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.


Options:
A: Left ventricular function and measures of pathologic remodeling (i.e., thickness-to-dimension ratio) assessed using standard 2-dimensional, M-mode, and Doppler echocardiogram (Baseline); Differences in serum biomarkers (particularly cardiac troponins and natriuretic peptides) (Baseline)
B: To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors. (25 years)
C: -To evaluate the efficacy and safety of doxorubicin with or without dexrazoxane; -To determine the efficacy of hyperfractionated radiation plus standard intrathecal chemotherapy compared with intensive intrathecal chemotherapy alone in standard risk patients.; -To compare the relative efficacy and toxicity of E.coli and Erwinia asparaginase; -To compare the relative efficacy and toxicity of cranial radiation delivered in once-daily versus twice-daily fractions in high risk patinets.
D: Diffusing capacity of the lungs for carbon monoxide (DLCO) (One year post therapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of a Supervised Physical Exercise Program as a Alternative on the Control of Maternal Gestational Weight Gain
Brief Summary: An estimated two-thirds to three- quarters of women experience gestational weight gain outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30% inadequate gain. Not gaining the adequate weight gain is strongly associated with several maternal and fetal complications..


Options:
A: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
B: 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)
C: Difference in scores on a pelvic floor knowledge questionnaire at 6 weeks postpartum between intervention and control groups (At 6 weeks post-partum)
D: Maternal gestational weight gain (40-42 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of a Supervised Physical Exercise Program as a Alternative on the Control of Maternal Gestational Weight Gain
Brief Summary: An estimated two-thirds to three- quarters of women experience gestational weight gain outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30% inadequate gain. Not gaining the adequate weight gain is strongly associated with several maternal and fetal complications..


Options:
A: Maternal gestational weight gain (40-42 weeks)
B: Maternal Weight Change (baseline to 2 weeks post partum)
C: Maternal outcome: preterm labor, weight gain, preeclampsia, gestational diabetes Perinatal outcome: birthweight, Apgar scores, body composition, admission at neonatal intensive care unit (nine months)
D: Cesarean Section (At delivery); Preeclampsia/Pregnancy Induced Hypertension (Delivery); Gestational Diabetes Mellitus (Delivery); Large for Gestational Age (Delivery); Neonatal Intensive Care Unit (Within 1 month postpartum); Gestational Weight Gain (Gestational week 35)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of a Supervised Physical Exercise Program as a Alternative on the Control of Maternal Gestational Weight Gain
Brief Summary: An estimated two-thirds to three- quarters of women experience gestational weight gain outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30% inadequate gain. Not gaining the adequate weight gain is strongly associated with several maternal and fetal complications..


Options:
A: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
B: Urinary incontinence score assessed with ICIQ-SF questionnaire (one year post partum)
C: Maternal gestational weight gain (40-42 weeks)
D: Fecal Incontinence Quality of Life (FIQOL) (baseline (2-weeks post delivery) to completion (12-weeks post delivery))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Gestational Diabetes. The Rol of Exercise in the Prevention
Brief Summary: To assess the effectiveness of an exercise program developed during pregnancy (land/aquatic activities) aerobic and muscular tonification, on control to the prevention to Gestational Diabetes. And to assess if excessive maternal weight gain is an influence in the diagnostic.


Options:
A: Primary outcome: meeting the postpartum weight goal (through 12 months postpartum)
B: prevention gestational diabetes (weeks 24-30)
C: Birth weight as assessed by z-scores (At birth)
D: Excessive weight gain during pregnancy (2007-2023)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Continuous Dialysis Technique Associated With Adsorption Capacity Membranes in Patients With Sepsis Associated - Acute Kidney Injury.
Brief Summary: Septic patients with acute kidney injury (SA-AKI) requiring continuous renal replacement therapies (CRRT) present high mortality due to systemic inflammatory response, cytokine liberation, and finally multiorgan dysfunction. Cytokine plasmatic elimination with continuous venovenous hemofiltration (CVVH) presents frequent complications, known as "dialytrauma", and a high resource cost both technical and human. The study primary end-point is to demonstrate a longer filter life with the use of continuous venovenous hemodialysis (CVVHD) respect to CVVH, both modalities employing the same adsorption capacity membrane. As secondary end-points investigators will try to demonstrate less dialytrauma events of CVVHD respect to CVVH. In order to achieve these objectives investigators have designed a proof of concept exploratory trial that will include those patients whom present SA-AKI meeting CRRT initiation criteria. During the first 72 hours investigators will measure plasmatic elimination capacity of main cytokines, and other clinical and prognostic relevant molecules. Investigators will also measure hemodynamic, respiratory, and metabolic parameters. Adverse effects related to CRRT ("dialytrauma") will also be registrated. Finally, investigators will analyze 90 days survival. Demonstration of a minor complication rate (longer filter patency with less dialytrauma events) with a similar immunomodulating capacity and with its consequent lower cost, should settle the based evidence principles that recommend the use of CVVHD asociated to an adsorption capacity membrane in patients with SA-AKI whom need CRRT.


Options:
A: Death (90 days)
B: Technical CRRT efficiency (72 hours)
C: Time to Occurrence of Selected Prismaflex® System Alarms/Conditions (Up to 120 hours post CRRT treatment initiation)
D: We will study the feasibility of recruiting ther target population, administering the study therapies according to pre-defined protocols and following patients for clinical endpoints. (60 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis
Brief Summary: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of tocilizumab in participants with GCA. The study will consist of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week open label long-term follow-up period (Part 2). In Part 1 of the study eligible participants will be randomized to receive either tocilizumab every week (qw) or every 2 weeks (q2w) or placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52, participants in remission will stop study treatment and enter long-term follow-up, whereas participants with disease activity or flares will receive open-label tocilizumab or other treatment at the discretion of the investigator for a maximum period of 104 weeks.


Options:
A: Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28 (Up to Day 28)
B: Percent Change From Baseline in CRP Levels at Day 4 in Participants With Serum IL-6 Level Greater Than the ULN (Phase 2) (Baseline and Day 4); Percentage of Participants With at Least a 1-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale in Participants With Critical COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 1) (Day 22); Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 2) (Day 22)
C: Time to improvement on a 7-point ordinal scale as compared to baseline (14 days or discharge)
D: Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper) (Week 52)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis
Brief Summary: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of tocilizumab in participants with GCA. The study will consist of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week open label long-term follow-up period (Part 2). In Part 1 of the study eligible participants will be randomized to receive either tocilizumab every week (qw) or every 2 weeks (q2w) or placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52, participants in remission will stop study treatment and enter long-term follow-up, whereas participants with disease activity or flares will receive open-label tocilizumab or other treatment at the discretion of the investigator for a maximum period of 104 weeks.


Options:
A: Evaluation of clinical status (Day 15 of the trial)
B: Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper) (Week 52)
C: Mechanical Ventilation or Death (28 days)
D: Survival without needs of ventilator utilization at day 14. Group 1 (14 days); WHO progression scale <=5 at day 4. Group 1. (4 days); Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14. Group 2. (14 days); WHO progression scale at day 4. Group 2. (4 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Zinc Sulphate and Zinc Amino Acid Chelate in Prevention Acute Diarrhea and Acute Respiratory Infection, Medellín 2012
Brief Summary: Acute respiratory infection and acute diarrhea are among the most prevalent diseases of childhood increase the burden of morbidity and mortality in children under 5 years.

Among the possible strategies for its prevention is important to count on good nutritional status for use in developing a good immune response to infections. Zinc deficiency has been shown to favor the development of infections and has been considered a real public health problem.

Within the zinc compounds used are zinc amino acid chelate and zinc sulphate, the first that has shown evidence of being better absorbed and tolerated.

We propose a study showing the effectiveness of zinc amino acid chelate and zinc sulphate in the prevention of acute diarrheal disease and acute respiratory infection.


Options:
A: To evaluate innate and adaptive immune response.; Future occurrence of acute diarrhoea, ARI and impetigo.
B: Fetal loss, low birth weight and pre-term birth. (Delivery)
C: Incidence acute diarrheal disease and acute respiratory infection (Up to 16 weeks)
D: L:M ratio at 1.5 months (1.5 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Zinc Sulphate and Zinc Amino Acid Chelate in Prevention Acute Diarrhea and Acute Respiratory Infection, Medellín 2012
Brief Summary: Acute respiratory infection and acute diarrhea are among the most prevalent diseases of childhood increase the burden of morbidity and mortality in children under 5 years.

Among the possible strategies for its prevention is important to count on good nutritional status for use in developing a good immune response to infections. Zinc deficiency has been shown to favor the development of infections and has been considered a real public health problem.

Within the zinc compounds used are zinc amino acid chelate and zinc sulphate, the first that has shown evidence of being better absorbed and tolerated.

We propose a study showing the effectiveness of zinc amino acid chelate and zinc sulphate in the prevention of acute diarrheal disease and acute respiratory infection.


Options:
A: Incidence acute diarrheal disease and acute respiratory infection (Up to 16 weeks)
B: Death among children 1-36 months of age
C: all cause hospitalizations in comparison to infants receiving placebo. (November 2004 to August 2007); illnesses requiring visits to healthcare providers. (November 2004 to August 2007)
D: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Zinc Sulphate and Zinc Amino Acid Chelate in Prevention Acute Diarrhea and Acute Respiratory Infection, Medellín 2012
Brief Summary: Acute respiratory infection and acute diarrhea are among the most prevalent diseases of childhood increase the burden of morbidity and mortality in children under 5 years.

Among the possible strategies for its prevention is important to count on good nutritional status for use in developing a good immune response to infections. Zinc deficiency has been shown to favor the development of infections and has been considered a real public health problem.

Within the zinc compounds used are zinc amino acid chelate and zinc sulphate, the first that has shown evidence of being better absorbed and tolerated.

We propose a study showing the effectiveness of zinc amino acid chelate and zinc sulphate in the prevention of acute diarrheal disease and acute respiratory infection.


Options:
A: Plasma zinc concentration (1 month)
B: Incidence acute diarrheal disease and acute respiratory infection (Up to 16 weeks)
C: Total absorbed zinc (10 days)
D: Diarrhea; Pneumonia; Febrile illness; Growth; Development; Activity

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
Brief Summary: To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.


Options:
A: Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment. (baseline and 96 weeks)
B: Alaninaminotransferase (ALT) (28 weeks); Liver fibrosis (28 weeks)
C: Liver enzyme (1year)
D: Plasma lipids profile (Four weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
Brief Summary: To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.


Options:
A: The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. (24 weeks)
B: episodes of cholangitis (6 months after intervention)
C: Time To The First Breakthrough Overt HE Episode (Baseline up to 6 Months (168 days))
D: Alaninaminotransferase (ALT) (28 weeks); Liver fibrosis (28 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E
Brief Summary: Background:

* Non-alcoholic fatty liver disease (NAFLD) is an excess accumulation of fat in the liver cells. It is associated with obesity, high blood pressure, high cholesterol, and diabetes. Some people with NAFLD only have excess fat in the liver. However, other people may develop a worse form of NAFLD with liver injury and scarring. This form, called non-alcoholic steatohepatitis (NASH), can lead to liver failure, liver cancer, and death. Not much is known about why some people develop NASH and others do not.
* Lifestyle changes such as diet, exercise, and weight loss can decrease the liver damage in NAFLD. Some studies show that vitamin E can also help treat NAFLD. The dose of vitamin E used in these studies is almost 40 times the recommended amount of vitamin E intake from food. It is unclear whether a lower dose could achieve the same effect. Researchers also want to study how vitamin E works at different doses to treat NAFLD.

Objectives:

* To find out the most effective dose of vitamin E to treat NAFLD.
* To gain a better understanding of how NAFLD and NASH develop, and predict who will respond to treatment.

Eligibility:

- Individuals at least 18 years of age with suggestion of non-alcoholic fatty liver disease.

Design:

* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
* For the first 12 weeks of the study, participants will meet with a nutritionist. They will have personalized diet and exercise plans. Treatment will be monitored with diaries and questionnaires to fill out at home. Participants will also wear a pedometer to measure physical activity.
* After the 12-week period, participants will have a full physical examination with the following tests:
* Blood tests
* Glucose tolerance tests
* Imaging studies (DEXA scan and magnetic resonance imaging)
* Liver and fatty tissue biopsy
* Two weeks after the tests, participants will start vitamin E treatment. They will take up to two pills a day, taken with fat-containing foods.
* 4 weeks after starting treatment they will have a repeat full evaluation with imaging tests, blood work, and liver and fat biopsies.
* Participants who are taking vitamin E will take it for up to 120 weeks. They will have monitoring visits every 8 to 12 weeks. At the end of 120 weeks, they will have another full evaluation, with imaging tests, blood work, and liver and fat biopsies.


Options:
A: Liver Histology (Kleiner's et al Criteria, Hepatology 2005) (18 months)
B: Liver enzyme (1year)
C: Biochemical: Number of Patients With Normal Transaminases at End of Treatment. (24 weeks); Physiological: Absolute Change in Liver Fat (Baseline and 24 weeks)
D: Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo) (Baseline and 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing Physical Activity in Stroke Survivors Using STARFISH, an Interactive Mobile Phone Application: a Feasibility Study
Brief Summary: There is good evidence of the effectiveness of regular physical activity in the primary and secondary prevention of stroke. STARFISH is a smartphone-based application designed as a behavioural change intervention to encourage the user to become more physically active. The study will investigate if using STARFISH for 6 weeks can increase physical activity in people after stroke. Subjects will be randomised to the STARFISH intervention or a control group. Control subjects will not have access to their daily activity count.


Options:
A: Adherence (8 weeks)
B: The number of steps taken per day by participants in each group (at baseline & at 6 weeks post randomisation)
C: Incident Cancer (12/31/2030); All cause and disease specific mortality (12/31/2030); Chronic diseases (12/31/2030)
D: VO2-peak, strength, walking, activities of daily living (baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline.)

Answer: B