TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementation of VA Womens Health Patient Aligned Care Teams WH-PACTs
Brief Summary: VA has undertaken a major initiative to transform care through implementation of Patient Aligned Care Teams (PACTs). Based on the patient-centered medical home (PCMH) concept, PACT aims to improve access, continuity, coordination and comprehensiveness using team-based care that is patient-driven and patient-centered. However, how VA should adapt PACT to meet the needs of special populations, such as women Veterans, is yet to be worked out. The main goal of this study was to develop and test an evidence-based quality improvement (EBQI) approach to adapting and implementing PACT for women Veterans, incorporating comprehensive women's health care in gender-sensitive care environments, thereby accelerating achievement of PACT tenets for women Veterans and reducing persistent gender disparities in VA quality of care.


Options:
A: Increased linkages between low income families and established services in their communities (Baseline, 12-month, 24-month, 36-month follow-up)
B: Change of documentation of aspirin therapy in patients with ischemic vascular disease. (Baseline, 3, 6, 9, 12, and 15 months from baseline); Change of documentation of blood pressure in patients with a diagnosis of hypertension. (Baseline, 3, 6, 9, 12, and 15 months from baseline); Change of documentation of blood pressure in patients with adequately controlled blood pressure. (Baseline, 3, 6, 9, 12, and 15 months from baseline); Change of documentation of fasting LDL in patients with a fasting LDL at or below the LDL goal. (Baseline, 3, 6, 9, 12, and 15 months from baseline); Change of documentation of patients who had a fasting LDL test performed and prescribed a statin based on risk. (Baseline, 3, 6, 9, 12, and 15 months from baseline); Change of documentation of patients screened about tobacco use. (Baseline, 3, 6, 9, 12, and 15 months from baseline)
C: Change in Child Body Mass Index (BMI) Z-score (Post intervention (9 months after baseline))
D: WH-PACT Achievement (Baseline to 24-month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Options: Group Psychotherapy for HIV-positive Depressed Perinatal Women.
Brief Summary: Although there is a significant burden of depression among HIV-positive women in Tanzania, there is a critical gap between the needs of this population and the integration of mental health and PMTCT-plus services. The long-term intent of the research is to bridge this gap with the overall goal to examine the potential for successful integration of enhanced mental health care and brief group interventions among HIV-positive women receiving PMTCT-plus services and to evaluate a combination of evidence-based approaches for treatment of depression in this vulnerable population in Tanzania.


Options:
A: Remission (i.e. recovery from depression) (6 months post child birth)
B: Depressive disorder and suicidality (Q3 2016 after an average of 1.5 years of follow-up)
C: Post Traumatic Stress Disorder- Reaction Index (RI) (Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.)
D: the DCM intervention results in improved outcomes compared with CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels (e.g., greater reduction in depressive symptoms) (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diabetes Self-Management & Support LIVE (Learning in Virtual Environments)
Brief Summary: The purpose of this study is to determine whether participation in virtual environment which incorporates real-time diabetes self management and support (DSMT/S) is associated with positive changes in behavior and metabolic outcomes as compared to traditional web-based DSMT/S.


Options:
A: Change in Dietary Intake (18 months); Change in Physical Activity (18 months)
B: Program satisfaction, behavioral and emotional outcomes. (3, 6, 9, 12 months after implementation of intervention)
C: % of patients reaching goal HbA1C (<7) (2 years after enrollment); % of patients with BP goal (<130/80) (Two years after enrollment); % of patients with LDL at goal (<100) (2 years after enrollment); % of patients at goal for all three parameters (HbA1C <7, BP <130/80, LDL <100) (2 years after enrollment)
D: Changes in decisional conflict (baseline and 3 month post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylaxis of Thromboembolism in Critically Ill Patients Using Combined Intermittent Pneumatic Compression(IPC) and Pharmacologic Prophylaxis Versus Pharmacologic Prophylaxis Alone: A Multicenter Randomized Controlled Trial
Brief Summary: Patients admitted to the intensive care unit are at high risk of developing clots in the veins of the lower extremities. The objective of this study is to examine whether the use of a device that provides intermittent compression to the legs in addition to the use of low-dose blood thinners, provides an additional protection when compared to the use of blood thinners alone. Patients who are admitted to the intensive care unit are receiving low-dose blood thinners to prevent clots are candidates for this study. Patients who are enrolled will continue to receive blood thinners but some will additionally receive the leg compression. The additional use of leg compression may provide protection from clots. The main side effect is possible skin abrasions but this is usually mild. The study is sponsored by King Abdullah International Medical Research Center(KAIMRC) and King Abdulaziz City for Science and Technology(KACST) and will be conducted in several hospitals in Saudi Arabia, Canada, Australia, Brazil and possibly other countries. The study started July 2014 and is to continue for 4 years.


Options:
A: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)
B: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)
C: Event Free Survival (6 years)
D: Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound (28 days from randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylaxis of Thromboembolism in Critically Ill Patients Using Combined Intermittent Pneumatic Compression(IPC) and Pharmacologic Prophylaxis Versus Pharmacologic Prophylaxis Alone: A Multicenter Randomized Controlled Trial
Brief Summary: Patients admitted to the intensive care unit are at high risk of developing clots in the veins of the lower extremities. The objective of this study is to examine whether the use of a device that provides intermittent compression to the legs in addition to the use of low-dose blood thinners, provides an additional protection when compared to the use of blood thinners alone. Patients who are admitted to the intensive care unit are receiving low-dose blood thinners to prevent clots are candidates for this study. Patients who are enrolled will continue to receive blood thinners but some will additionally receive the leg compression. The additional use of leg compression may provide protection from clots. The main side effect is possible skin abrasions but this is usually mild. The study is sponsored by King Abdullah International Medical Research Center(KAIMRC) and King Abdulaziz City for Science and Technology(KACST) and will be conducted in several hospitals in Saudi Arabia, Canada, Australia, Brazil and possibly other countries. The study started July 2014 and is to continue for 4 years.


Options:
A: incidence of VTE (up to 30 days after operation)
B: Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound (28 days from randomization)
C: Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound (time of discharge from the hospital or death, up to 45 days)
D: Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes (Treatment period : up to day 36+/-6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Placebo Controlled Double Blind Crossover Trial of Metformin for Brain Repair in Children with Cranial-Spinal Radiation for Medulloblastoma
Brief Summary: A placebo controlled double blind crossover trial of metformin in 30 children treated with radiation for medulloblastoma - the most common malignant brain tumour. The investigators used tests of thinking and learning and brain imaging techniques to examine whether metformin can enhance cognition or promote brain repair following radiation-induced brain injury.


Options:
A: Stroop Test (Change from baseline at 6 months)
B: Cognitive Decline (4 months)
C: Feasibility: Medication Adherence (Outcome 2 (Week 35)); Safety: Frequency of Adverse Events (AE) (Outcome 2 (Week 35))
D: Memory impairment (as assessed by the HVLT-r) (1-10 years after treatment); Neurocognitive function (1-10 years after treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Proteomic Prediction and Renin Angiotensin Aldosterone System Inhibition Prevention Of Early Diabetic nephRopathy In TYpe 2 Diabetic Patients With Normoalbuminuria
Brief Summary: This is a prospective, multicenter, randomized, double blind, placebo-controlled and a prospective observational study.

This study will be conducted at 15 study centers in various European countries. 1777 participant between 18 to 75 years old with Type 2 diabetes mellitus and normoalbuminuria participate in the study. The study period is 2 - 4.5 years (excluding the 6 week screening period). Depending on the risk score of the urinary protein pattern, participants have been stratified into an observational group or an interventional group. Participants with the low risk pattern (observational group) attend visits annually after screening and baseline. Participants with the high risk pattern (interventional group) attend study visits every 13 weeks after screening and baseline.

The interventional group has been allocated into one treatment group either receiving spironolactone or placebo. A placebo is a medicine without a pharmaceutical substance. The allocation to one of the two treatment groups has been done by a random distribution procedure established before the study start.

The results of the urine sample from the Screening visit has been analysed and the urine proteomic pattern is determined to be either low- or high risk pattern and will determine the further study program.

Participants with a low-risk pattern (observational group):

During the study period, participants attend an annual project visit, were regular diabetes care is performed and three urine samples are analysed for albuminuria.

Participants with a high-risk pattern (intervention group):

Participants with a high-risk pattern have been randomized to either spironolactone treatment or placebo. The treatment is one tablet for oral use to be taken once a day for the entire study period. Four times each year (every 13th week) a study visit is conducted including examination of three urine samples for albuminuria.

This study aims to:

1. Confirm in a prospective multicenter study of normoalbuminuric type 2 DM patients that the urinary proteome test identifies patients with a high risk for development of microalbuminuria.
2. Demonstrate the clinical utility of the test by showing that aldosterone blockade in high-risk patients can reduce progression to microalbuminuria in comparison to placebo, on the top of standard treatment in a randomized double-blind, placebo-controlled multicenter study.


Options:
A: Change of of Systolic Blood Pressure (4 months); Change of Diastolic Blood Pressure (4 months)
B: Albuminuria (Screening, (Low-risk: year 1, 2 and 3), (high-risk: week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156))
C: Proteinuria reduction (bi-monthly)
D: Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 (Baseline and Day 90)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT for the Treatment of Hemodialysis Catheter-Related Bacteremia
Brief Summary: Patients who undergo hemodialysis via a tunneled catheter often develop bloodstream infections that arise from the catheter. There are several management options for treatment of such an infection, though the best option is not clearly delineated. Standard of care options include exchanging the catheter for a new one over a guide-wire and instilling a high concentration of an antibiotic directly into the catheter lumen. The investigators are planning to treat hemodialysis catheter bloodstream infections by one of two strategies: 1. Use of a novel antibiotic lock solution Or 2. Changing out the infected catheter for a new one. Both these options have comparable cure rates as shown in the medical literature. After obtaining informed consent, patients will be randomized to either treatment arm and will continue to receive all other standard medical care.

Specific Aim: To conduct a randomized clinical trial to demonstrate that the use of a novel antibiotic lock solution (consisting of N-acetylcysteine, tigecycline and heparin) is non-inferior to guide-wire exchange in the treatment of hemodialysis catheter-related bacteremia.


Options:
A: Treatment Success (28 days)
B: The number of major catheter-related infections (CRI) defined as either catheter-related clinical sepsis without bloodstream infection or catheter-related bloodstream infection (CRBSI), during the ICU stay (after renal replacement therapy session)
C: Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days (Up to 12 months)
D: infection free survival (45 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy and Safety of Ferriprox® for the Treatment of Transfusional Iron Overload in Patients With Sickle Cell Disease or Other Anemias
Brief Summary: This research is being done so that we can look at the safety and efficacy of deferiprone in people with sickle cell disease or other anemias. Deferiprone is a drug that removes iron from the body. We will be comparing deferiprone with deferoxamine, another drug that removes iron from the body.


Options:
A: Overall Safety as Measured by Frequency of Adverse Events (28 weeks); Overall Safety as Measured by Changes in Laboratory Values From Baseline (baseline (BL), 30 weeks)
B: Change From Baseline in Liver Iron Concentration (LIC) (Change from baseline to Week 52)
C: Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)
D: determine the time and number of transfusion units as well as amount of infused iron that will lead to appearance of LPI >0.2 or TSAT>50 % , serum ferritin ≥ 500 ng/ml in the studied thalassemic patients which warrant start of iron chelation (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Role of Immune-pineal Axis in Fibromyalgia: Noradrenergic Modulation and Chronotherapeutic Aspects
Brief Summary: Fibromyalgia is a common condition in clinical medical practice, characterized by diffuse musculoskeletal pain. Sleep disorders, chronic fatigue, depression, intestinal disorders and headache are also commonly associated with the syndrome .

Although the etiology of this syndrome is not well defined yet, it means involve multiple mechanisms, including low levels of serotonin, increased substance P in cerebrospinal fluid and altered circadian variation in sympathetic - parasympathetic balance, consistent with changes in sympathetic hyperactivity at night .

The immune - pineal system, formed by the integration of the adrenergic and immune systems pineal gland, appears to be involved in the genesis of the dysfunctions found in fibromyalgia. Melatonin is secreted by the pineal gland and has promoter activity of sleep. Studies show that melatonin and its precursors , serotonin and tryptophan are reduced in patients with fibromyalgia.

The present study aims to evaluate the relationship of immune - pineal system in the process of fibromyalgia , since dysfunction of this axis appears to govern the cascading events that participate in the pathophysiological process of this disease.


Options:
A: Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6 (Baseline, week 6); Change from Baseline in Pain Pressure Threshold (PPT) at week 6 (Baseline, week 6); Change from Baseline Brain-derived neurotrophic factor at week 6 (Baseline, week 6)
B: Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4 (4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)); Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6 (7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d))
C: Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score (Baseline, Week 14)
D: Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale (NRS) (Baseline, Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Role of Immune-pineal Axis in Fibromyalgia: Noradrenergic Modulation and Chronotherapeutic Aspects
Brief Summary: Fibromyalgia is a common condition in clinical medical practice, characterized by diffuse musculoskeletal pain. Sleep disorders, chronic fatigue, depression, intestinal disorders and headache are also commonly associated with the syndrome .

Although the etiology of this syndrome is not well defined yet, it means involve multiple mechanisms, including low levels of serotonin, increased substance P in cerebrospinal fluid and altered circadian variation in sympathetic - parasympathetic balance, consistent with changes in sympathetic hyperactivity at night .

The immune - pineal system, formed by the integration of the adrenergic and immune systems pineal gland, appears to be involved in the genesis of the dysfunctions found in fibromyalgia. Melatonin is secreted by the pineal gland and has promoter activity of sleep. Studies show that melatonin and its precursors , serotonin and tryptophan are reduced in patients with fibromyalgia.

The present study aims to evaluate the relationship of immune - pineal system in the process of fibromyalgia , since dysfunction of this axis appears to govern the cascading events that participate in the pathophysiological process of this disease.


Options:
A: Percentage of Participants With Less Than 11 Tender Points at Month 6 (Month 6); Percentage of Participants With Less Than 11 Tender Points at Month 12 (Month 12)
B: Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire (Baseline, 6, 12, 18 and 24 weeks)
C: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
D: Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6 (Baseline, week 6); Change from Baseline in Pain Pressure Threshold (PPT) at week 6 (Baseline, week 6); Change from Baseline Brain-derived neurotrophic factor at week 6 (Baseline, week 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Role of Immune-pineal Axis in Fibromyalgia: Noradrenergic Modulation and Chronotherapeutic Aspects
Brief Summary: Fibromyalgia is a common condition in clinical medical practice, characterized by diffuse musculoskeletal pain. Sleep disorders, chronic fatigue, depression, intestinal disorders and headache are also commonly associated with the syndrome .

Although the etiology of this syndrome is not well defined yet, it means involve multiple mechanisms, including low levels of serotonin, increased substance P in cerebrospinal fluid and altered circadian variation in sympathetic - parasympathetic balance, consistent with changes in sympathetic hyperactivity at night .

The immune - pineal system, formed by the integration of the adrenergic and immune systems pineal gland, appears to be involved in the genesis of the dysfunctions found in fibromyalgia. Melatonin is secreted by the pineal gland and has promoter activity of sleep. Studies show that melatonin and its precursors , serotonin and tryptophan are reduced in patients with fibromyalgia.

The present study aims to evaluate the relationship of immune - pineal system in the process of fibromyalgia , since dysfunction of this axis appears to govern the cascading events that participate in the pathophysiological process of this disease.


Options:
A: Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6 (Baseline, week 6); Change from Baseline in Pain Pressure Threshold (PPT) at week 6 (Baseline, week 6); Change from Baseline Brain-derived neurotrophic factor at week 6 (Baseline, week 6)
B: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
C: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
D: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer
Brief Summary: The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy


Options:
A: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) (Up to 28 days in Cycle 1); Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)); Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)); ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015))
B: Progression Free Survival (PFS) Rate at Month 6 (Month 6)
C: Progression-Free Survival in Participants With PD-L1 Expression >= 5% (From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months))
D: Investigator-assessed Objective Progression-free Survival (PFS) (Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months))

Answer: C