TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Safety and Short-Term Efficacy of Aliskiren in the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study
Brief Summary: Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in the world. Current treatment with angiotensin converting enzyme (ACE) inhibitor and angiotensin receptor blocker (ARB) is not entirely effective. Aliskiren, a direct renin inhibitor, acts on the rate limiting step of the renin-angiotensin axis. In addition to lowering the blood pressure, recent study in diabetic nephropathy suggests an independent anti-proteinuric effect. The investigators plan to conduct a randomized placebo-control cross-over study to evaluate the safety and efficacy of aliskiren in the treatment of IgA nephropathy. The investigators plan to recruit 57 patients with biopsy-proven IgA nephropathy and persistent proteinuria despite conventional therapy. They will be randomized to aliskiren for 16 weeks or no treatment, followed by cross over to the other arm after a washout period. Proteinuria, albuminuria, renal function, serum and urinary markers will be quantified. This study will explore the potential anti-proteinuric effect of aliskiren in the treatment of IgA nephropathy, which has no specific treatment at present.


Options:
A: change in the degree of proteinuria (16 weeks)
B: Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36 (Baseline (Day 1) and at Week 36)
C: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
D: Patients reaching full clinical remission of their disease (at the end of the 3 year study period.); GFR loss of 15 ml/min or higher from baseline GFR (at the end of the 3 year study period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-based Intervention to Enhance Signing of Organ Donor Cards
Brief Summary: The purpose of this study is to determine the effect of a 5-minute video intervention regarding organ donation and transplantation on increasing the number of organ donor cards signed in Northeastern Ohio Bureau of Motor Vehicles (OBMV) branches and on willingness to donate organs while living. The investigators hypothesize that persons in the intervention group will sign more donor cards and be more willing to donate organs while living than persons in the control group.


Options:
A: psychological distress (6 weeks post-donation); somatic/physical health perceptions (6 weeks post-donation); interpersonal relationship quality and distress (6 weeks post-donation); quality of life (6 weeks post-donation); psychological distress (3 months post-donation); somatic/physical health perceptions (3 months post-donation); interpersonal relationship quality and distress (3 months post-donation); quality of life (3 months post-donation)
B: Proportion of participants who consent to donate organs (1 Day)
C: Proportion of signed donor cards (One day)
D: Number of Participants With Live Kidney Donor Activation Events (24 months post randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT)
Brief Summary: The primary objective of the study was to assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation included the following major components:

* An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in Study 201.
* An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.
* An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP after a 6-month washout period.
* An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during Study 201.

The secondary objective is to assess the durability of the effect of DAC HYP on multiple sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.


Options:
A: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate (Core treatment period between 48 - 152 weeks depending on time of enrollment)
B: Number of Participants With Treatment-emergent Adverse Events (AEs) (Up to 72 weeks); Number of Participants With Abnormalities in Vital Signs (Up to Week 72); Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities (Up to 72 Weeks); Number of Participants With Abnormalities in Blood Chemistry Laboratory Data (Up to 72 Weeks); Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline (Up to 72 weeks)
C: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
D: Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression (Day 1 to 12 months); Annualized Rate of Confirmed Relapses Comparing Early Starters to Delayed Starters Estimated by Negative Binomial Regression (Day 1 up to 6.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Double-blinded, Placebo-controlled Study of N-acetylcysteine Plus Deferoxamine for Patients With Hypotension as Prophylaxis for Acute Renal Failure
Brief Summary: Oxidative stress is associated with kidney damage in several different situations, including hypotension. In animal models it has been shown that the combination of n-acetylcysteine plus deferoxamine is superior to its isolate use in the treatment of several diseases. Thus the investigators aimed to determine if the administration of n-acetylcysteine plus deferoxamine could prevent renal failure in critical ill patients who develops hypotension.


Options:
A: Development of acute renal failure (28 days)
B: Rise in creatinine above baseline (7 days postoperatively)
C: Proportion of patients developing an increase in serum creatinine greater than 25% from baseline to peak level within first five postoperative days.
D: Maximum percent decline in calculated creatinine clearance (Cockcroft-Gault formula) in first 72 hours following surgery. (72 hours following surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Anodal & Cathodal tDCS for Treatment of Resistant Auditory Hallucinations in Schizophrenia
Brief Summary: The purpose of this study is to determine whether trans Direct Current Stimulation (tDCS) is effective in the treatment of auditory hallucinations in schizophrenia.


Options:
A: 1.Auditory hallucinations Rating Scale developed by Hoffman and colleagues (2003) 2.SAPS 3.CGI 4.SANS 5.GAF (Prospective)
B: Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score) (105 Days)
C: Auditory hallucinations measured by Auditory Hallucination Rating Scale (Hoffman et al., 2003) (before, after 1 week of treatment and 2 times follow up (1 & 3 months))
D: Clinical Global Impression; (November 2007)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 5 to 6-year-old Children.
Brief Summary: This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children 5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine according to the "3-5-11" month schedule recommended in Italy.

In this study, MMRV vaccine will also be co-administered to all children.


Options:
A: N/A
B: Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups. (31 days following the second dose of Havrix®); Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups (31 days following the second dose of Havrix®); Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V→HAV Groups (42 days following the administration of M-M-R®II and VARIVAX®); Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups (42 days following administration of M-M-R®II and VARIVAX®)
C: Number of Subjects With Booster Responses to Diphteria and Tetanus (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.); Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL) (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.); Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3 (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.)
D: Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations (At Month 1, one month post-vaccination); Anti-poliovirus Types 1, 2 and 3 Antibody Titres (At Month 1, one month post-vaccination); Number of Seroprotected Subjects Against Polio Types 1, 2 and 3 (At Month 1, one month post-vaccination); Number of Seropositive Subjects for Anti-D and Anti-T Antibodies (At Month 1, one month post-vaccination)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy and Safety of Fosfomycin Plus Imipenem for the Treatment of Methicillin-resistant Staphylococcus Aureus (MRSA) Infective Endocarditis.
Brief Summary: The study evaluates the efficacy and safety of fosfomycin and imipenem for the treatment of methicillin-resistant staphyloccocus aureus infective endocarditis in comparison to vancomycin, the standard therapy.


Options:
A: Proportion of patients with negative blood cultures. (7 days)
B: Death (From the index procedure till the end of the follow-up period (December 2017))
C: To demonstrate that daptomycin is not inferior to comparator in the treatment of S. aureus bacteremia and IE as assessed by the Independent External Adjudication Committee (IEAC) Outcome at Test of Cure (TOC) in the Intention-to-Treat (ITT) population.
D: The primary endpoint is a composite endpoint including all cause mortality, unplanned cardiac surgery, embolic events and relapse of positive blood cultures with the primary pathogen (Approximately 7 months. From randomisation until 6 months after end of study medication)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of Kinrix® Co-administered With Varivax®
Brief Summary: The purpose of the study is to evaluate the immunogenicity and safety of Kinrix when co-administered with varicella (Varivax® \[varicella virus vaccine live\], Merck and Company) and (measles mumps rubella) MMR vaccines, compared to Kinrix co-administered with MMR vaccine alone. Both Kinrix and the second dose of Varivax are indicated in children 4-6 years of age, and there is great potential for the vaccines to be given concurrently. The aim of this trial is to demonstrate that co-administered Varivax does not negatively affect the immunogenicity or reactogenicity of Kinrix.


Options:
A: Number of Subjects With Booster Responses to Diphteria and Tetanus (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.); Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL) (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.); Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3 (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.)
B: Immunogenicity: To provide information concerning the immunogenicity of IPV vaccine administrated intradermally as a booster vaccination. (30 days post-vaccination); Safety: To provide information concerning the safety after booster intradermal administration of IPV vaccine (30 days post-vaccination and entire study duration)
C: Number of Subjects With Any and Grade 3 Solicited Local Symptoms (During the 4-day (Days 0-3) post-vaccination period); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (During the 4-day (Days 0-3) post-vaccination period); Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) (During the 31-day (Days 0-30) post-vaccination period); Number of Subjects With Serious Adverse Events (SAEs) (During the entire study period (from Day 0 to Month 1))
D: Number of Subjects Reporting Solicited Local Symptoms (During the 4-day follow-up period after each dose of study vaccine.); Number of Subjects Reporting Solicited General Symptoms (During the 4-day follow-up period after each dose of study vaccine.); Number of Subjects Reporting Unsolicited Adverse Events (AEs) (During the 31-days follow-up period after each dose of the study vaccine.); Number of Subjects Reporting Serious Adverse Events (SAEs) (During the entire study period (from Dose 1 up to one month following last vaccine dose).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Interdisciplinary Comprehensive Arm Rehab Evaluation (ICARE) Stroke Initiative
Brief Summary: This study is about arm and hand recovery after a stroke. The investigators are testing an experimental arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines challenging, intensive and meaningful practice of tasks of the participant's choice compared to two standard types of therapy (usual and customary arm therapy totaling 30 hours and usual and customary arm therapy for a duration indicated on the therapy prescription). A second objective is to characterize current outpatient arm therapy (dosage \& content) following stroke for individuals who are eligible for ICARE. Eligible candidates must have had a stroke affecting an arm within the last 106 days.


Options:
A: Difference in physical activity scale for the elderly (24 months)
B: Gait speed and Barthel Index (BI) (co-primary endpoint) (3 months post stroke vs baseline)
C: Community Balance and Mobility Scale (Pre treatment and Post treatment (6 weeks))
D: Wolf Motor Function Test (WMFT) Log-transformed Time (Baseline to 1 year post-randomization); Wolf Motor Function Test Time (Baseline to 1 year post-randomization); Stroke Impact Scale (SIS) Hand Function Subscale Score. (Baseline to 1 year post-randomization); Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization) (Baseline to 1 year post-randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PNU-100480 (PF-02341272) After First Time Administration Of Ascending Oral Doses To Healthy Adult Subjects Under Fed And Fasted Conditions
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PNU-100480 (PF-02341272) after a single dose in healthy adult volunteers.


Options:
A: To evaluate the safety and tolerability of ascending oral doses of PNU-100480 administered as extemporaneously prepared suspension (EPS) over 14 and 28 days in healthy adult volunteers. (Monitor adverse events daily; safety eval pre-dose, specified times , discharge, follow-up/as needed)
B: Proportion of Patients With Sterile Sputum Cultures (8 weeks)
C: The Time to Sputum Culture Conversion at Week 8 (Stage 1) (Week 8, Stage 1); The Time to Sputum Culture Conversion at Week 24 (Stage 2) (Week 24, Stage 2)
D: Evaluation of safety and tolerability of escalating single oral doses of PNU-100480. (Daily, Days 1-3 or 4, and 7-14 days after dosing.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Study of Different Pain Scores in Single Transumbilical Incision Laparoscopic Cholecystectomy Versus Classic Laparoscopic Cholecystectomy
Brief Summary: The attempt to further reduce the operative trauma in laparoscopic cholecystectomy led in new techniques, as Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single Incision Laparoscopic Surgery (SILS). These new techniques are considered as painless procedures, but there are not any publications to study a possible different pain score in new techniques versus classic laparoscopic cholecystectomy. In this randomized controlled study the researchers have investigated the pain scores, the incidence of nausea and vomiting and analgesics request after the procedure.


Options:
A: Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test. (3-6 weeks)
B: Postoperative Quality of Life (QoL) (one month)
C: SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores
D: overall morbidity rate (at 60 days from surgery) (60 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Study of Different Pain Scores in Single Transumbilical Incision Laparoscopic Cholecystectomy Versus Classic Laparoscopic Cholecystectomy
Brief Summary: The attempt to further reduce the operative trauma in laparoscopic cholecystectomy led in new techniques, as Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single Incision Laparoscopic Surgery (SILS). These new techniques are considered as painless procedures, but there are not any publications to study a possible different pain score in new techniques versus classic laparoscopic cholecystectomy. In this randomized controlled study the researchers have investigated the pain scores, the incidence of nausea and vomiting and analgesics request after the procedure.


Options:
A: pain score (Postoperative first 24 hours); Intraoperative complications (Average of 70 minutes)
B: SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores
C: Pain After Surgery (12 hours post-surgery)
D: number of patients with improvement in semen parameters and resolution of testicular pain (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia
Brief Summary: The aim of this study is to assess the efficacy and safety of autologous transplantation of bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with non-revascularizable critical limb ischemia.


Options:
A: Therapy Success (6 months)
B: adverse events (6 months); ankle-brachial systolic pressure index (3 mo); transcutaneous oxygen value (mm Torr) (3 mo); quality of life (questionnaires) (3 mo)
C: Angiographic evaluation of angiogenesis and vasculogenesis at target limb (3 months)
D: The safety of MultiGeneAngio will be assessed by monitoring adverse events (Up to 15 years after treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases
Brief Summary: At the moment, most of efforts to prevent non-transmissible chronic diseases at population level have been centered in promoting healthful behaviors like physical activity, consumption of fruits and vegetables, and discouraging from the consumption of tobacco and alcohol in adult population, but the results have been little hopeful. In the last years, manifold studies have indicated the relation between metabolic alterations and of the fetal growth with the development of non-transmissible chronic diseases in adult age. More recently, it has been proposed that maternal factors (endothelial function, oxidative stress and alterations in adipokines) and placental ones (mitochondrial dysfunction) are the precursory mechanisms of fetal metabolic alterations and of the later development of non-transmissible chronic diseases. Also, it has been suggested that possibly supplementation with micronutrients and the physical exercise during the gestation can regulate these maternal and placental factors. For the reasons just mentioned, it is necessary to clarify if these proposed factors are related to fetal metabolic alterations and if the supplementation during the gestation with micronutrients and/or the physical exercise can regulate them, which would be an early and novel alternative to fortify the prevention of non-transmissible chronic diseases in the population.

Purpose

1. To evaluate the effect of associated both the maternal and placental metabolic factors to non-transmissible chronic diseases in newborn.
2. To evaluate the effect of the physical exercise and the complementation with micronutrients during the pregnancy either in the endothelial function, the levels of adipokines, the oxidative stress of the mother and the newborn, as in the placental mitochondrial function and the anthropometry of newborn.


Options:
A: Hamilton score during the 29 weeks trial (1 week)
B: Endothelium-dependent flow mediated dilation (Baseline / week 32-36 of gestation)
C: Participant HbA1c levels (one year); Participant cardiovascular risk index (one year)
D: Change in body weight and the trend in body weight over time (Measured at Month 6 and Years 1 and 2)

Answer: B