TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of the MedSentry System on Medication Adherence for Patients With Congestive Heart Failure: A Pilot Study
Brief Summary: The goal of this pilot study to evaluate the effect of the MedSentry system, a multi-faceted medication adherence device and reminder system, on medication adherence and clinical outcomes in heart-failure (HF) patients. We will also evaluate the usability and satisfaction derived from using this system.

We hypothesize that:

1. The use of the MedSentry system will improve medication adherence in patients with a discharge diagnosis of HF.
2. The improvement in adherence correlates with fewer hospitalizations and emergency department (ED) visits.
3. The improvement in adherence correlates with better health-related quality of life.


Options:
A: Cardiac Medication Use (3 and 12 months)
B: Geriatric Depression Scale (12 months); Physical Performance Test (PPT) (12 months); SF-36 Health Survey (12 months); Mental Mental Status Exam (MMSE) (12 months); Hospitalization (12 month enrollment period); Hospital Days (12 Month Enrollment Period); Emergency Department Visits (12 month Enrollment Period); Medicare Costs (12 Month Enrollment Period)
C: Medical Outcomes Study (MOS) "Adhere" (3 months)
D: Patients with confirmed DRA after discharge from the index hospitalisation (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Active-Controlled, Parallel Group, Double-Blind Study to Compare the Efficacy and Safety of Tramadol HCl/Acetaminophen ER and IR in Subjects Who Complain of Moderate to Severe Postoperative Pain
Brief Summary: The purpose of this study is to compare the efficacy and safety of extended release (ER) tramadol hydrochloride (HCl)/acetaminophen with immediate release (IR) tramadol HCl/acetaminophen in participants with moderate to severe (very serious, life threatening) postoperative pain.


Options:
A: Safety and tolerability of COV155 (Up to 35 days)
B: Change in 100mm Pain VAS (baseline throgh week 8)
C: Sum of Pain Intensity Difference (SPID) at Hour 48 (Hour 48)
D: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Determination of Changes in Total Body Stores of Vitamin A in Response to Orange Maize Consumption by Zambian Children
Brief Summary: Determination of liver stores of vitamin A will be determined before and after consumption of high pro-vitamin A orange maize, compared to low provitamin A white maize.


Options:
A: Mortality, morbidity (1 year)
B: Pregnancy-related mortality and all cause mortality (Continuous)
C: childhood mortality rate at age 1-6
D: Vitamin A status changes (After the intervention, which is approximately 3 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Determination of Changes in Total Body Stores of Vitamin A in Response to Orange Maize Consumption by Zambian Children
Brief Summary: Determination of liver stores of vitamin A will be determined before and after consumption of high pro-vitamin A orange maize, compared to low provitamin A white maize.


Options:
A: All-cause, Pregnancy-related Mortality (Deaths during pregnancy through 12 weeks postpartum)
B: Vitamin A status changes (After the intervention, which is approximately 3 months.)
C: intestinal parasitic infections (6 months)
D: Naïve T-cells in peripheral blood (measured once at 52 - 104 weeks of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy
Brief Summary: The goal of this study is to characterize the function and efficacy of the bioactive nutrient, vitamin D, in relation to infection and inflammatory status across pregnancy. The three specific aims of this study are 1) To address the impact of maternal vitamin D status on inflammation and infections across pregnancy using retrospective data, 2) To address the impact of vitamin D supplementation on maternal vitamin D status, inflammation and infections across pregnancy using prospective data and 3) To assess the impact of maternal vitamin D status during pregnancy on inflammatory mediators at the level of the placenta.


Options:
A: Serum 25-hydroxyvitamin D in pregnant women and cord blood (Change from 1st through 2nd trimester and at delivery)
B: Change in Vitamin D status, infections and inflammation across pregnancy after Vitamin D supplementation (Entry into study, mid-gestation and delivery)
C: Infant Length-for-Age Z-Scores with Prenatal Supplementation (1 year of age); Infant Length-for-Age Z-Scores with Postpartum Supplementation (1 year of age)
D: Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) (0 to 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer
Brief Summary: The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either carboplatin or gemcitabine for patients with triple negative breast cancer.


Options:
A: disease-free survival (5 year)
B: Pathological complete response of breast and lymph nodes (ypT0 ypN0; primary endpoint) (24 weeks (time window -3 weeks))
C: Comparison: pCR in nab-paclitaxel/carboplatin vs. nab-paclitaxel/gemcitabine (After 12 weeks of therapy); Comparison: pCR in responders vs. non-responders (After 12 weeks of therapy)
D: Invasive Disease Free Survival (IDFS) (From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 3, MULTI SITE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF 2 ORAL DOSES OF CP-690,550 IN ASIAN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
Brief Summary: The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.


Options:
A: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 (Week 0 to Week 12)
B: Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16 (Week 16); Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 (Week 16)
C: Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT (112 and 140 days)
D: Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline (Baseline to Week 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 3, MULTI SITE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF 2 ORAL DOSES OF CP-690,550 IN ASIAN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
Brief Summary: The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.


Options:
A: The changes in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the carotid artery and ascending aorta in patients randomized to adalimumab as compared to patients randomized to standard non-systemic therapy. (Day -10 to -1, Day 105)
B: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) (Week 16)
C: Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16 (Week 16); Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 (Week 16)
D: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 3, MULTI SITE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF 2 ORAL DOSES OF CP-690,550 IN ASIAN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
Brief Summary: The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.


Options:
A: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)
B: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo (12 weeks)
C: Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16 (Week 16); Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 (Week 16)
D: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 3, MULTI SITE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF 2 ORAL DOSES OF CP-690,550 IN ASIAN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
Brief Summary: The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.


Options:
A: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 (Week 12); Participants With IGA Mod 2011 0 or 1 at Week 12 (Week 12)
B: Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16 (Week 16); Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 (Week 16)
C: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Number of Participants With Treatment Emergent Adverse Events (3 months); Pharmacokinetics Parameter : Skin Flux of INCB018424 (Days 8, 15, 22, and 28); Pharmacokinetics Parameter : Bioavailability of INCB018424 (Days 8, 15, 22, and 28)
D: Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score (Week 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects
Brief Summary: The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA \< 50 copies/mL at Week 48.


Options:
A: Measure the number of infants who have HBV infection at the age of 28 weeks (From the date of birth to age of 28 weeks); Assessment of the safety and tolerability of TDF, measure the number of participants and paired infants with adverse events (From the date of randomization until 28 weeks of postpartum.)
B: Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm (Week 48)
C: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (Week 48)
D: Percentage of Infants With Hepatitis B Infection at 6 Months of Age (6 months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I Study of Cellular Immunotherapy Using Central Memory-Enriched T Cells Lentivirally Transduced to Express a CD19-Specific, CD28-Costimulatory Chimeric Receptor and a Truncated EGFR Following Peripheral Blood Stem Cell Transplantation for Patients With High-Risk Intermediate Grade B-Lineage Non-Hodgkin Lymphoma
Brief Summary: This phase I trial studies the side effects and best dose of genetically modified T-cells following peripheral blood stem cell transplant in treating patients with recurrent or high-risk non-Hodgkin lymphoma. Giving chemotherapy before a stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant may stop this from happening. Giving an infusion of the donor's T cells (donor lymphocyte infusion) later may help the patient's immune system see any remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect)


Options:
A: maximum tolerated dose (MTD) (2 years); safety (2 years)
B: Percent of participants recieving pembrolizumab per protocol schedule (21 days after first pembrolizumab infusion); Dose Timing part: Incidence of dose limiting toxicities (DLTs) (21 days after first pembrolizumab infusion); Expansion part: Overall response rate (ORR) (3 month post tisagenlecleucel infusion)
C: Objective response rate (3 months)
D: Adverse events attributed to Tcm adoptive transfer as reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Up to 15 years); MTD of CD19-CAR-specific/truncated EGFR lentiviral vector-transduced autologous T cells based on dose limiting toxicities (Up to day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Methodology Issues in a Tailored Light Treatment for Persons With Dementia
Brief Summary: Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia


Options:
A: Age (4 weeks); Gender (4 weeks); Educational level (4 weeks); Cognitive status- Screening (4 weeks); Severe cognitive status- Screening (4 weeks); Cognitive status- Level (4 weeks); Cognitive domains (4 weeks); Depression in Dementia (4 weeks); Mood and behaviour (4 weeks); Agitation (4 weeks); Anxiety (4 weeks); Sleep-disturbed behaviours (4 weeks); Sleep-Actigraphy (4 weeks); Disease severity in advanced stages of dementia. (4 weeks); Mood and behaviour during, preceding and immediately after the sessions (4 weeks); Mean Heart rate (4 weeks); Percentage of Oxygen saturation (4 weeks)
B: Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4 (Baseline and Week 4); Percentage of Participants Who Experienced One or More Adverse Events (Up to 6 weeks); Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Up to 4 weeks)
C: Sleep Disturbance (Change from Baseline (week 0) and intervention (week 4)); Agitation (Change from Baseline (week 0) and intervention (week 4)); Depression (Change from Baseline (week 0) and intervention (week 4))
D: Change From Baseline in Nighttime Total Sleep Time (Baseline, 14 days follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: A randomized controlled study is performed to address the question of whether the topical application of a novel fibrin sealant, Evicel (Johnson \& Johnson Wound Management, Ethicon, Somerville, NJ) in patient undergoing total knee replacement (TKR) reduce the perioperative blood loss and the need for allogenic blood transfusion compared to a control group. We hypothesize that fibrin sealant decrease the drop in post-operative hemoglobin level after total knee replacement.


Options:
A: Number of Patients Managed With Blood Transfusion (daily during hospital stay (an expected average of 4 days))
B: Fall in post-operative hemoglobin level after total knee replacement (First 7 days after surgery)
C: Blood loss as calculated from change in haematocrit
D: Postoperative Bloodloss (Day 1 after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Parallel Study With an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men
Brief Summary: The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.


Options:
A: Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12 (Week 12)
B: Changes in Physical Performance Measured by an Exercise Testing Regimen (baseline and 6 months)
C: Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF) (Week 0, week 8, week 11, week 14)
D: Change from baseline on the total score of the AMS rating scale (Month 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Evaluating the Safety and Effectiveness of the remedē® System in Patients With Central Sleep Apnea
Brief Summary: The primary purpose of this prospective, multicenter, randomized trial is to evaluate the safety and effectiveness of therapy delivered by the remedē® system in subjects with moderate to severe central sleep apnea and optimal medical management, compared to outcomes in randomized control subjects receiving optimal medical management and implanted but inactive remedē® systems.


Options:
A: exercise capacity (1 week); Quality of Life (1 week)
B: All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation (time to first event, assessed for up to 70 weeks)
C: Changes in Central Apnea Index (baseline and six days)
D: The Proportion of Participants Experiencing a Reduction in Apnea-hypopnea Index (AHI) (6 months); Freedom From Related Serious Adverse Events Within 12 Months (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Deconstruction of Human Milk Oligosaccharides and Lipids
Brief Summary: This observational study is designed to determine how sugars, lipids and proteins in breast milk vary among mothers; is affected by maternal diet, health and microbiota and vary over the course of lactation. Additionally, the study is designed to determine how the structure and composition of complex milk sugars, maternal health status and diet influence the development and maintenance of infant gut microflora.


Options:
A: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
B: Postnatal day when enteral feeding exceeded at 100ml/kg/day (From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth)
C: Human milk glycans (Change from day 2 to day 366)
D: Necrotizing enterocolitis (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Deconstruction of Human Milk Oligosaccharides and Lipids
Brief Summary: This observational study is designed to determine how sugars, lipids and proteins in breast milk vary among mothers; is affected by maternal diet, health and microbiota and vary over the course of lactation. Additionally, the study is designed to determine how the structure and composition of complex milk sugars, maternal health status and diet influence the development and maintenance of infant gut microflora.


Options:
A: NEC onset (6 weeks)
B: Human milk glycans (Change from day 2 to day 366)
C: Feeding tolerance (Change from Full Enteral Feeding (FEF) Day 1 (start of FEF defined as achieving 150ml/day/kg of enteral feeding and discontinuation of parenteral feeding) and FEF Day 21 (approximately 5 weeks after enrollment))
D: Necrotizing enterocolitis (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission: A Multi-center, Double Blinded, Randomized, Placebo Controlled Study
Brief Summary: The purpose of this study is to determine whether infliximab can favourably and safely be discontinued in patients with Crohn's disease in sustained complete clinical, biochemical, and endoscopic remission on infliximab.

Further to examine the clinical utility of measuring levels/activity of infliximab and activity of anti-infliximab Ab in patients in sustained complete remission, in order to investigate whether pharmacoimmunological data can predict the clinical outcome and rationalize therapeutic management of these patients with respect to continuation or discontinuation of infliximab therapy. Additional, to investigate the optimal time-point, out of three, to measure this activity.


Options:
A: co-primary efficacy end points (2 ans)
B: Time to relapse after discontinuation of IFX (48 weeks)
C: Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice. (24 months)
D: Proportion of patients with response at week 12, i.e. CDAI decrease of 70 or more for patients with luminal disease, or reduction of 50 percent or more from base line in the number of draining fistulas for patients with fistulising disease. (12 weeks); Total expenses related to Crohn's disease during the study (inclusion to week 12). (12 weeks)

Answer: B