TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiovascular Intervention Improvement Telemedicine Study
Brief Summary: Cardiovascular disease (CVD) is the leading cause of death in the United States; more than 80% of veterans have \> 2 risk factors for CVD. Our study is one of the first to examine the implementation of a tailored behavioral/educational self-management intervention in primary care clinics designed to improve CVD risk. The proposed study could result in a leap forward in CVD risk management among veterans for several reasons: 1) ) This is a novel extension of our previous interventions that have demonstrated improved BP, now designed to address multiple chronic conditions contributing to CVD risk, particularly hyperlipidemia and diabetes. The study focuses on both multiple CVD-related risk factor management and medication management 2) The intervention is multi-behavioral; it addresses patients' various health behavior (e.g., smoking, diet, and medication adherence). 3) Components of the intervention will include specific recommendations and transportability of intervention application software and tracking packages that will allow clinic managers to implement the intervention if it is effective.


Options:
A: Glowcap bottle openings/Medication Adherence (6 months)
B: Combined adherence endpoint (at Visit 2 (follow-up visit after 3 months of intervention period))
C: Blood Pressure Control (Baseline, 6 months, 12 months, 18 months); Mean Systolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months); Mean Diastolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months)
D: Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (Baseline); Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (6 months); Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, 6-week, Open-Label, Study Evaluating The Safety, Tolerability, and Efficacy of Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
Brief Summary: Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.


Options:
A: To evaluate the efficacy of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia. (12 weeks)
B: To see if mean extrapyramidal symptoms measure will change significantly from baseline to endpoint for the whole group and if the mean change in EPS measure is significantly different between quetiapine 1200mg daily group and quetiapine 600mg daily group (8 weeks)
C: Time to Relapse of Psychotic Symptoms During 6 Weeks (6 Weeks)
D: Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients (Weeks 0, 3, 4, 6, 8, 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, 6-week, Open-Label, Study Evaluating The Safety, Tolerability, and Efficacy of Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
Brief Summary: Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.


Options:
A: Time to Exacerbation of Psychotic Symptoms/Impending Relapse (Baseline of the depot maintenance phase to the end of the study (Week 52))
B: Time to Relapse of Psychotic Symptoms During 6 Weeks (6 Weeks)
C: Withdrawal from allocated treatment within 3 months.
D: Positive Symptom Item Scores by Week and Treatment Group (Baseline and every two weeks for 16 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Placebo-controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin® (Terlipressin) (The REVERSE Study)
Brief Summary: This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.


Options:
A: Treatment Success (Day 14)
B: Renal function at the beginning and at the end of therapy (two weeks)
C: Survival
D: Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal (within 14 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Placebo-controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin® (Terlipressin) (The REVERSE Study)
Brief Summary: This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.


Options:
A: Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal (within 14 days)
B: Renal function at the beginning and at the end of therapy (two weeks)
C: Treatment Success (Day 14)
D: The primary end point of the study was serum creatinine less than 1.5 mg (15 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Placebo-controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin® (Terlipressin) (The REVERSE Study)
Brief Summary: This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.


Options:
A: Mortality (18 months)
B: Mortality or dialysis-dependency (90 days)
C: Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal (within 14 days)
D: To evaluate complications (renal failure, hepatic encephalopathy, hyponatremia, infection and gastrointestinal bleeding) in patients with cirrhosis awaiting for liver transplant. (When 97 patients are included (% of the whole population))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Placebo-controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin® (Terlipressin) (The REVERSE Study)
Brief Summary: This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.


Options:
A: Treatment Success (Day 14)
B: The primary end point of the study was serum creatinine less than 1.5 mg (15 days)
C: Renal function at the beginning and at the end of therapy (two weeks)
D: Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal (within 14 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea - Randomised, Double-blind, Placebo-controlled Trial
Brief Summary: When patients in hospitals receive antibiotics they often develop diarrhoea. The consequences may be grave for the patient. Thus far, no preventive measure is available. The investigators hypothesize that the apathogenic yeast Saccharomyces boulardii, administered in addition to the antibiotic, may prevent episodes of diarrhoea or may lead to less pronounced diarrhoea. To test this hypothesis, the investigators are carrying out a clinical trial in 1520 adult patients in several hospitals.


Options:
A: To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients. (Up to 40 days)
B: Incidence of Participants With Diarrhea by Parental Report (14 days)
C: Determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular will improve the heart function (immediately after heart surgery in patients with LVSD)
D: Total Number of Antibiotic-associated Diarrhea Episodes (29 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Two Riboflavin Dosing Regimens for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus or Ectasia
Brief Summary: The purpose of this study is to evaluate the effectiveness of using riboflavin and UV light to treat progressive keratoconus or post-refractive corneal ectasia.


Options:
A: Change in Maximum Keratometry From Baseline to 6 Months After Treatment (6 months)
B: Best corrected visual acuity (at six months after surgery)
C: K-max (Changes from baseline in Kmax at 12 months); Corneal Endothelial Cell Density (Changes from baseline in ECD at 12 months)
D: Visual acuity (1 year); Keratometry measurements (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
Brief Summary: The purpose of this study is to determine whether noninvasive brain stimulation associated with motor learning offers an additional benefit than motor learning alone in patients with stroke.

The investigators hypothesis is that active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) will induce a greater motor function improvement as compared with sham tDCS combined with CIMT.


Options:
A: Jebsen Taylor Hand Function Test (2 weeks); Cortical Excitability (1 hour); Cortical Oscillations - EEG (15 minutes)
B: Functional motor recovery assessed by a composite endpoint (one for upper limbs and one for lower limbs) (After one year of treatment)
C: JTT (crossover design, four different sessions with four different interventions)
D: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
Brief Summary: The purpose of this study is to determine whether noninvasive brain stimulation associated with motor learning offers an additional benefit than motor learning alone in patients with stroke.

The investigators hypothesis is that active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) will induce a greater motor function improvement as compared with sham tDCS combined with CIMT.


Options:
A: change in function before/after tDCS (Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months)
B: Jebsen Taylor Hand Function Test (2 weeks); Cortical Excitability (1 hour); Cortical Oscillations - EEG (15 minutes)
C: Wolf Motor Function test (immediately before and immediately after treatment); Fugl-Meyer Assessment (immediately before and immediately after treatment)
D: Change from baseline in Upper Extremity Fugl Meyer Assessment (Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial Evaluating the Efficacy of Silverlon® in Preventing Surgical Site Infection Following Colorectal Surgery
Brief Summary: This clinical study is a prospective, randomized, controlled trial of patients undergoing elective colorectal surgical procedures that receive an abdominal skin incision of at least 6 cm. Treatment with Silverlon® will be compared to standard postoperative dressings of 4x4 Gauze and paper tape. Patients will be randomized with a 1:1 treatment allocation ratio to receive either 1) Silverlon® or 2) standard postsurgical dressing. Neither the Investigators nor the participants will be blinded to the treatment modality after randomization.

Silver has long been known to have antimicrobial properties. It interacts with structural proteins and DNA, inhibiting bacterial replication and causing fatal structural changes within the cell wall. It has broad antimicrobial activities and unlike antibiotics, it is rarely associated with microbial resistance. Silverlon® is a silver-nylon dressing specifically designed for surgical wounds to prevent the development of surgical site infections. It is an easy to use product with no known microbial resistance or adverse effects. The efficacy of Silverlon® in preventing surgical site infections has been shown in several retrospective studies but as of yet has not been tested in a prospective fashion. The objective of this study is to perform a prospective, randomized, clinical trial directly comparing the incidence of surgical site infections in patients treated with Silverlon® to standard postoperative dressing following elective colorectal surgery


Options:
A: Surgical Site Infection (Day of surgery up to 30 days post operatively)
B: Incisional Surgical site infection (30 postoperative days)
C: Device remains localized over corneal incision (24 hours post operative)
D: The rate of patients with a Surgical site infection (30 days after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Hepatitis C Translating Initiatives for Depression Into Solutions
Brief Summary: Chronic infection with hepatitis C (CHC) is a common and expensive condition, and it disproportionately affects Veterans. Treatment with antiviral therapy reduces liver disease progression and improves health related quality of life. However, \~70% of Veterans with CHC are considered ineligible for antiviral treatment. Most of these patients are excluded due to the presence of co-existing depression and substance use. The proposed project will adapt and adopt an evidence-based collaborative depression care model in CHC clinics. By removing the leading contraindication for antiviral treatment, this project will potentially yield benefits that go far beyond the obvious quality of life benefit from antidepressant therapy itself.


Options:
A: Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment (12 months); Depression Care: Treatment Response (Baseline and 12 months); Depression Care: Depression Remission (Baseline and 12 months); Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months (From Baseline to 12 months)
B: 1) Antidepressant prescribing, 2) Medication adherence, 3) Treatment response and remission, 4) Health status and health related quality of life
C: Adherence to Antidepressant Medication (At 3 and 6 months)
D: Percentage of Participants With Depression Treatment Response (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfusion of Fresh Frozen Plasma in Non-bleeding ICU Patients
Brief Summary: With the aim to restrict inappropriate fresh frozen plasma (FFP) transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of intensive care (ICU) patients undergoing an invasive procedure. The objective is to assess the effectiveness and costs of omitting prophylactic FFP transfusion compared to current practice of prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy.


Options:
A: Bleeding within 24 hours after cvc application; other complications within the first 24 hours
B: 24-hour Mortality (First 24 hours after ED admission); 30-day Mortality (First 30 days after ED admission); Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE) (From time of ED admission, for up to 72 hours)
C: Volume of transfused plasma during surgery (5 years)
D: Procedure-related relevant bleeding, occurring within 24 hours after the procedure. (24 hours after the procedure)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: De-escalation After Natalizumab Treatment With Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis
Brief Summary: Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young adults. The management of MS-patients requires treatment with disease-modifying agents, monoclonal antibodies such as natalizumab or immunosuppressants. Natalizumab showed good efficacy and is approved for treatment of relapsing MS with a number of restrictions due to safety issues. Cognitive data related to natalizumab treatment are still scarce. Interferon-beta-1b is approved for high-frequency, subcutaneous (sc) administration in the treatment of multiple sclerosis. It reduces the relapse rate, severity, hospitalisation and the disease activity as seen on MRI.

This is a pilot study to explore the concept of de-escalating natalizumab treatment to interferon-beta-1b e.o.d compared to continuous treatment with natalizumab in patients with relapsing-remitting multiple sclerosis previously treated with natalizumab for 12 months. The study is designed as prospective, controlled, randomized, rater-blinded, parallel-group, two arm, mono-centric including patients of the Ticino Cohort. One arm will be treated with Interferon-beta 1b 250mcg given subcutaneously every other day, the other with Natalizumab 300 mg given intravenously (i.v.), every four weeks. The treatment duration is 12 months, the follow-up period 12 months. The time to first on-study relapse will be compared between the to treatment arms (primary outcome). Other efficacy parameter include clinical and radiological parameters, patient reported outcome on quality of life and fatigue. Safety is assessed by reports of adverse events.


Options:
A: Small effect of an intervention (immediate after completion of study); Moderate effect of an intervention (immediate after completion of study); Large effect of an intervention (immediate after completion of study)
B: Annualized Confirmed Relapse Rate (From randomization to end of study (Week 108))
C: Number of Days Until First On-study Relapse (12 months)
D: The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24. (Weeks 12, 16, 20, and 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: De-escalation After Natalizumab Treatment With Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis
Brief Summary: Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young adults. The management of MS-patients requires treatment with disease-modifying agents, monoclonal antibodies such as natalizumab or immunosuppressants. Natalizumab showed good efficacy and is approved for treatment of relapsing MS with a number of restrictions due to safety issues. Cognitive data related to natalizumab treatment are still scarce. Interferon-beta-1b is approved for high-frequency, subcutaneous (sc) administration in the treatment of multiple sclerosis. It reduces the relapse rate, severity, hospitalisation and the disease activity as seen on MRI.

This is a pilot study to explore the concept of de-escalating natalizumab treatment to interferon-beta-1b e.o.d compared to continuous treatment with natalizumab in patients with relapsing-remitting multiple sclerosis previously treated with natalizumab for 12 months. The study is designed as prospective, controlled, randomized, rater-blinded, parallel-group, two arm, mono-centric including patients of the Ticino Cohort. One arm will be treated with Interferon-beta 1b 250mcg given subcutaneously every other day, the other with Natalizumab 300 mg given intravenously (i.v.), every four weeks. The treatment duration is 12 months, the follow-up period 12 months. The time to first on-study relapse will be compared between the to treatment arms (primary outcome). Other efficacy parameter include clinical and radiological parameters, patient reported outcome on quality of life and fatigue. Safety is assessed by reports of adverse events.


Options:
A: Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 (At the end of month 24)
B: Number of Days Until First On-study Relapse (12 months)
C: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)
D: Annualized Relapse Rate (ARR) (Baseline up to 2.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL). A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus.
Brief Summary: This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.


Options:
A: Change in low-density lipoprotein cholesterol (52-weeks); Change in glycated hemoglobin (52-weeks)
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 Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) (From randomisation until completion of the planned treatment period, up to 1040 days.)
D: Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin) (Week 0, Week 26)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Innovative Home Stroke Rehabilitation and Monitoring System
Brief Summary: The purpose of this research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations. The robotic-based home therapy intervention will produce significantly greater improvement in upper extremity motor function than Usual and Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation program at the end of 8 weeks of home therapy.


Options:
A: Physical Function as Measured by Telephone Version of FIM (6-month)
B: Motor Activity Log - 14, Amount of Use sub scale (Post-intervention (6 weeks))
C: The distance on the 6 minute walking test (6MWT) (6 minutes)
D: Action Research Arm Test (ARAT) (End of treatment at 8 weeks post enrolment)

Answer: D