TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Wise App Trial for Improving Health Outcomes in People Living With HIV
Brief Summary: The overall goal of this study is to design a user-centered design app linked to a smart pill box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong theoretical framework building on earlier user-centered design work and integrating a real-time monitoring device, this work has the potential to improve ART adherence in PLWH and have a sustainable public health impact.


Options:
A: Change in ART Adherence - Clever Cap (Up to 6 months)
B: MV Coverage at 12 months of age (12 months of age)
C: HIV-1 Viral Load (log10 Transformed) (Past 90 days); Self-reported Medication Adherence (Past 30 days)
D: HPV completion rate (One Year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study to Evaluate the Safety and Efficacy of OMS721 for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and Adolescents
Brief Summary: The purpose of this study is to evaluate the platelet count change from baseline and safety of OMS721 in adults and adolescents with atypical hemolytic uremic syndrome (aHUS). The study will also evaluate pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody response (ADA).


Options:
A: The effect of OMS721 as measured by platelet count change from baseline (26 weeks)
B: Proportion Of Participants With Normalization Of Lactate Dehydrogenase (LDH) Levels (Day 29 through Day 183); Percentage Of Participants Who Achieved Transfusion Avoidance (TA) (Baseline through Day 183)
C: Proportion of Patients With Complete TMA Response (Through 26 weeks)
D: Percentage of Patients With TMA Event-free Status (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks); Percentage of Patients With Complete TMA Response (Through 26 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sequential Infusion of Anti-CD19 and Anti-CD20 Chimeric Antigen Receptor(CAR) T Cells Against Relapsed and Refractory B-cell Lymphoma
Brief Summary: Cluster of differentiation antigen 19(CD19) specifically presents in B lymphocyte cell lines steadily,while not in most normal tissue,including pluripotent hematopoietic stem cells.Cluster of differentiation antigen 20(CD20) presents in 90% of B-cell lymphomas.CD19 antigen is a well-established target for B-cell lymphomas treatment as well as CD20 antigen.Both CD19-targeting CAR T Cells and CD20-targeting CAR T Cells can be used as adoptive cellular immunotherapies for B-cell lymphomas.Though two kinds of single target treatments were proved can induce recession of B-cell lymphomas, the risk of cancer cells to escape and tumor recurrence are still existed. There are no report about combination transfer of two kinds of single target treatments.This research aimed emphasis on safety and therapeutic efficacy evaluation,as well as if combination transfer can decrease recurrence rate.


Options:
A: Safety as assessed by dose limiting toxicities (DLTs) (28 days); Determination of maximum tolerated dose and proposed recommended Phase 2 dose (24 weeks)
B: The types and Incidence of adverse events (Up to 12 months)
C: Study related adverse events (24 weeks)
D: Overall complete remission rate (Half a year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT: Effect of Coaching on Mid-Career Physician Well-Being, Job Satisfaction, and Fulfillment
Brief Summary: The study will assess the effect of individualized professional coaching for mid-career family medicine and general internal medicine physicians on burnout, job satisfaction, and professional fulfillment.


Options:
A: Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003) (Up to 3 months)
B: Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks (Baseline and after 4, 8 weeks later)
C: The Anxiety Disorder Scale (A week); The Grief Inventory (A week); The Coping Mechanisms Scale (A week); The Psychiatric Morbidity Scale (A week); The Physical Symptoms Scale (A week); The Insomnia Scale (A week); The Binge Eating Scale (A week); The Burnout Inventory (A week); Alcohol use (A week); Drug use (A week)
D: Change in Maslach Burnout Inventory score (6 month); Change in Physician Job Satisfaction Scale score (6 month); change in Empowerment at Work Scale score (6 month); change in Utrecht Work Engagement score (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT: Effect of Coaching on Mid-Career Physician Well-Being, Job Satisfaction, and Fulfillment
Brief Summary: The study will assess the effect of individualized professional coaching for mid-career family medicine and general internal medicine physicians on burnout, job satisfaction, and professional fulfillment.


Options:
A: Change in executive function: National Institutes of Health Examiner battery (Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.)
B: Change in Maslach Burnout Inventory score (6 month); Change in Physician Job Satisfaction Scale score (6 month); change in Empowerment at Work Scale score (6 month); change in Utrecht Work Engagement score (6 months)
C: Change from baseline compassion fatigue at 1 and 6 months assessed by compassion fatigue subscale of Professional quality of life scale (Data collected before the program starts and one months after the end of the program and six months); Change from baseline burnout at 1 and 6 months assessed by burnout subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months); Change from baseline compassion satisfaction at 1 and 6 months assessed by compassion satisfaction subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months)
D: Change in level of stress per Perceived Stress Scale (PSS) (Baseline and at 2 months (immediately post-intervention))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Lifestyle Interventions With Mindfulness-based Strategies in Type 2 Diabetes
Brief Summary: Type 2 diabetes mellitus (T2DM) is the most expensive chronic disease in the U.S.

Lifestyle modification is central to T2DM management, but long-term adherence to dietary recommendations is difficult. A key challenge is the difficulty of coping with cravings for high carbohydrate or sugar-laden foods in an environment where these foods are tempting and widely available. One mechanism by which mindfulness may increase long-term dietary adherence is by better equipping individuals with skills to experience food cravings and difficult emotions without eating in response. Such approaches seek to strengthen abilities to be non-judgmentally aware of, tolerate, and respond skillfully to food cravings and difficult emotions without reacting impulsively or maladaptively. The investigators hypothesize that improved ability to manage food cravings and emotional eating is a key mechanism through which mindfulness-enhancements can improve dietary adherence. The study will test a mindfulness-based intervention (MBI) for improving dietary adherence. Although the particular diet employed is not the focus of this study, the study will use a diet with about 10% of calories from carbohydrate as: (1) it induces a low level of ketone production, which will be used as a biomarker for dietary adherence; (2) prior studies suggest it improves metabolic parameters in T2DM, including glycemic control.


Options:
A: Adherence to implementing a meditation program in the perioperative period (Baseline through 1 month post surgery)
B: frequency of eating in response to cravings (primary mechanistic outcome) (change from baseline to 6 months)
C: Progression of albuminuria (1,2,3,4 and 5 year)
D: Change from Baseline in Toronto Mindfulness Scale at 8 weeks (baseline and 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity, Reactogenicity and Safety Study of Pediarix®, Hiberix® and Prevenar 13® Co-administered With Two Different Formulations of GSK Biologicals' HRV Vaccine (444563) in Healthy Infants 6-12 Weeks of Age
Brief Summary: The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed lyophilized formulation of the HRV vaccine when co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age


Options:
A: Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Immunogenicity in Terms of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Immunogenicity in Terms of Anti-pneumococcal Serotypes (Anti-PnPS) Antibody Concentrations. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 0.15 µg/mL. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 1.0 µg/mL. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Subjects With Seroresponse to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies. (At Month 5 (One month after Dose 3 of co-administered vaccines))
B: Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml (6, 10, 14 and 18 weeks)
C: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain (From 2 weeks after the last vaccine or placebo dose up to 1 year of age)
D: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains (From Month 1 ½ to Month 21)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Primary Minimal Change Nephropathy: a Randomized Open-labeled Non-inferiority Study on Prednisolone and Vitamin D
Brief Summary: Traditionally MCN is treated with a high dose of prednisolone, which induces remission in 60-90% of patients. Prednisolone treatment contains numerous side effects and the current dose is empiric. Given the lack of efficacy evidence and the risk associated with the currently accepted treatment regimen there is a need to characterize the outcome in MCN further, and to establish new, and potentially less toxic treatment regimens.

The aim is to examine if treatment with reduced dose of prednisolone in combination with activated vitamin D is as effective as standard high dose prednisolone in achieving remission and preventing relapse in MCN, and if reduced dose prednisolone is associated with fewer side effects compared to standard dose. Furthermore, the study will examine the influence of prednisolone metabolism on the efficacy and side effects of prednisolone in the treatment of MCN.


Options:
A: Remission (4 to 16 weeks)
B: Time to first relapse (5 months); Assessment of steroid induced morbidity (5 months)
C: complete remission (within 4 weeks)
D: Relapse of nephrotic syndrome during 12 months after randomization (12 month period following randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial Evaluating the Effectiveness of Three Interventions Programs to Improve Functionality and Decrease Fear of Falling in the Elderly
Brief Summary: Fear of falling is a major health problem among community-dwelling older adults that may contribute to avoidance of activities that they are capable of performing. Studies show that the fear of falling may lead to a continual, complex decline in older adults that includes a loss of auto efficacy, restriction of physical activities and social participation, physical frailty, falls and disability. Apart from these effects, the fear of falling may also have financial implications for health care systems and the general public. Several interventions have been shown to reduce fear of falling with multifactorial interventions, including physical and behavioral components, being most successful. Behavioral components usually comprise strategies to reduce catastrophic thinking and fear-related avoidance behaviors while physical components usually comprise falls prevention exercise programs. However, multifactorial programs are not always feasible or preferred by older people. In this framework, the objective of this works is to assess the effects (benefits and effectiveness) of three interventions programs (Tai Chi, postural control exercises and behavioral therapy intervention) to improve functionality and decrease fear of falling in older people living in the community.


Options:
A: Primary outcomes are number of falls and falls rates as well as number and incidence of injurious falls measured by monthly fall calendars (24 months)
B: Fear of falling (Prospective change from baseline to end of intervention (8 weeks)); Functional mobility (Prospective change from baseline to end of intervention (8 weeks))
C: Fear of falling (2 months (primary)); Activity avoidance (2 months (primary))
D: Change from baseline in Geriatric Depression Scale (GDS) (Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CareToy Observational Study: Early Identification of Infants at Risk of Cerebral Palsy
Brief Summary: This observational study aims to early identify, through a rigorous and standardized follow-up, infants at high risk for Cerebral Palsy. After the consent agreement firmed by the parents, infants born at term or preterm with ultrasonographic evidence of brain injury considered at risk for neurodevelopmental disorders will be strictly monitored during the first months of life performing a periodic neurological assessment (Prechtl's General Movement (GMA) and the Hammersmith Infant Neurological Examination) at term age and around 3 months of post term age. Moreover, to study more accurately the brain injury early identified by ultrasonographic brain exam, around 6 weeks of post-term age the enrolled infants will perform, as recommended in infants at risk, brain Magnetic Resonance (RM).

Thanks to the high predictability power of the combination of the clinical observation with the neuroimaging infants at high risk of CP will be early detect. Selected infants, considered at high risk for CP will have the opportunity to perform an home based and family centered early intervention later than 3 post term age.


Options:
A: Length of Stay (From Infant's birth to discharge from NICU)
B: Fidgety Movements at 12 weeks (post-term age) (12 weeks post-term age)
C: Changes on Infant Motor Profile (IMP) (T0(baseline, 1week before beginning of Study period);T1 (within 1 week after the end of the first training/control period; before the cross-over); T2 (within 1 week after the end of the second training/control 2nd period, after cross-over), T3: 18 months)
D: neurodevelopmental outcome (one year corrected age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mifepristone and Misoprostol Versus Misoprostol Alone for Uterine Evacuation After Early Pregnancy Failure: a Randomized Double Blind Placebo-controlled Comparison (Triple M Trial)
Brief Summary: This study aims to compare whether a combination of two drugs (Mifepristone and misoprostol) are superior compared to using only one of these drugs (Misoprostol) as medical treatment for a miscarriage. Women in whom early pregnancy failure, 6-14 weeks postmenstrual, is ultrasonographically confirmed qualify for this study.

It is expected that the combination of Mifepristone and Misoprostol is more effective in reaching complete evacuation, and therefore can prevent more invasive treatment such as curettage.


Options:
A: Complete abortion without recourse to surgical intervention (follow up visit 7 days after initial treatment)
B: Progressive intrauterine pregnancy > 22 WA (Until 2 years post surgery)
C: Complete evacuation (six weeks after initial treatment)
D: -The main outcome measures will be the induction time, defined as the time from placement of the first dose of misoprostol until the time of delivery of the fetus. (48 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mifepristone and Misoprostol Versus Misoprostol Alone for Uterine Evacuation After Early Pregnancy Failure: a Randomized Double Blind Placebo-controlled Comparison (Triple M Trial)
Brief Summary: This study aims to compare whether a combination of two drugs (Mifepristone and misoprostol) are superior compared to using only one of these drugs (Misoprostol) as medical treatment for a miscarriage. Women in whom early pregnancy failure, 6-14 weeks postmenstrual, is ultrasonographically confirmed qualify for this study.

It is expected that the combination of Mifepristone and Misoprostol is more effective in reaching complete evacuation, and therefore can prevent more invasive treatment such as curettage.


Options:
A: efficacy
B: Complete evacuation (six weeks after initial treatment)
C: Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment. (Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done); Gestational Sac Expulsion by the Second Follow-up Visit at Day 8 (Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)); Gestational Sac Expulsion by the 30-day Telephone Call (30 Days); Uterine Asperation (30 Days)
D: Number of surgical evacuation in each group (during de study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Organ and Tissue Donation Registration in Family Physician Offices: a Pragmatic Stepped-wedge Cluster Randomized Controlled Registry Trial (RegisterNow Trial)
Brief Summary: This study evaluates the effects of using reception staff to prompt patients by providing a pamphlet and an opportunity to register in the waiting room via a mobile tablet on deceased organ donor registration rates.


Options:
A: Donor registration status at 7 days (7 days)
B: The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. (one year)
C: Knowledge about Living Kidney Donation (3 weeks)
D: Proportion of participants who consent to donate organs (1 Day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Controlled by Conventional BCG, Dose-escalation Phase I Study, to Evaluate Safety, Tolerability and Immunogenicity of a Mycobacterium Bovis BCG (Bacillus Calmette-Guérin) Vaccine, 1331 Danish Strain, Live Attenuated and Recombinant for the Expression of Human Respiratory Syncytial Virus Nucleoprotein (N) in Healthy Males Within 18 and 50 Years of Age
Brief Summary: Human respiratory syncytial virus (hRSV) is the main cause of lower respiratory tract infection in children under one year of age. This study will evaluate the safety, tolerability and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine that expresses the human Respiratory Syncytial Virus Nucleoprotein (N), in adult males (18 to 50 years of age).


Options:
A: To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children (Day 28); Reactogenicity evaluations (REs) from administration of study vaccine through 28 days post-dosing (Day 28 post final vaccination); Adverse events (AEs) from administration of study vaccine through 28 post-dosing (Day 28 post final vaccination); Serious adverse events (SAEs) from administration of study vaccine through 28 days post-dosing (Day 180)
B: Number of Subjects With Required Adverse Events Grade II, III, and IV, Laboratory Adverse Events Grade II, III, and IV, and Severe Considered Adverse Events Related to the Vaccine. (Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study))
C: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)
D: Secondary infection with influenza of the household members who are healthy at the start of the study

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Isometric Preoperative Exercise on Vascular Caliber and the Maturation of Autologous Arteriovenous Fistulas. Randomized Clinical Trial
Brief Summary: A good vascular access (VA) is vital for hemodialysis (HD) patients. The start of HD with autologous arteriovenous fistula (AVF) means higher survival, lower sanitary costs and complications. The distal forearm AVF is known as the best option but not all patients are good candidates for this surgery, and there is a primary failure rate between 20 and 50% published in literature.

The choice of the optimal AVF for each patient is conditioned mainly by the anatomical and hemodynamic characteristics of the artery and the vein chosen to perform the anastomosis. These characteristics can be modified by performing physical exercise Some vascular access guidelines suggest the performance of isometric exercises in the pre and postoperative period of the AVF confection. However, there is very little data in literature on the possible efficacy of preoperative exercise, although small published observational studies point to an improvement in the venous and arterial caliber. Regarding the postoperative exercises, they do seem to improve maturation, however the degree of evidence in literature is low and there is no consensus on the exercise protocol to follow.

We present an open-label, multicenter, prospective, controlled and randomized study in order to evaluate the usefulness of preoperative isometric exercise (PIE) in pre-dialysis patients or in prevalent HD with indication of performing a new AVF. The randomization will be 1: 1, one group of patients will perform PIE for 8 weeks and the other group of patients will be a control group. The main purpose will be to evaluate if there is a lower rate of primary failure in the PIE group compared with control group.


Options:
A: Increasing the diameter of the cephalic vein (8 weeks of training for each patient)
B: Impact of PIE on AVF primary failure comparing the control group and the PIE group. (12 weeks after AVF surgery (visit 6))
C: Brachial artery flow-mediated dilatation (6 weeks)
D: Hemodynamics in the fistula artery and vein, pre and post AV fistula formation (22 weeks)

Answer: B