TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: St. Vincent's Screening To Prevent Heart Failure (STOP-HF) Study Using Natriuretic Peptides to Identify and Prevent Progression of Left Ventricular Dysfunction in Community Based, Asymptomatic, At-risk Individuals.
Brief Summary: The STOP-HF study is a prospective, randomized, controlled trial recruiting asymptomatic individuals with risk factors for left ventricular dysfunction from 50 primary care clinics in Dublin and south east Ireland. It is designed to determine whether using natriuretic peptide measurement as a screening tool following a general cardiovascular risk factor screen will reduce the prevalence and severity of ventricular dysfunction in conjunction with specialist follow-up at St. Vincent's University Hospital.


Options:
A: Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events (One year)
B: Prevalence and severity of LVD (5 year)
C: CV Death or Heart Failure Hospitalization (24 Months)
D: To use the Triage touch to determine the optimal frequency of home BNP testing and the changes in BNP concentrations that correlate with clinical HF decompensations and related adverse events in at-risk HF patients. (Day 5, Day 30 and Day 60)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Encouraging Safe Sexual Practices Among Youth Using Cash Rewards: A Randomized Trial in the Kilombero/Ulanga Districts, Tanzania
Brief Summary: This project evaluates the effect of a combined economic and psycho-social intervention to reduce risky sexual activity and its consequences. The main hypothesis to be tested is that risky sexual activity and resulting sexually transmitted infections (STIs) can be reduced through an intervention of counseling, regular STI testing, and positive reinforcement using cash rewards. The intervention is being implemented in a population of young people in rural Tanzania where more conventional behavioral change interventions have had limited effect in battling a generalized HIV epidemic.


Options:
A: Number of Participants Completing Secondary School [Sit 10th Standard Exam] (May-August 2016 (cohort one) and May-August 2017 (cohort two)); Number of Participants Married [by Trial End Line] (May-August 2016 (cohort one) and May-August 2017 (cohort two))
B: Prevalence of sexually transmitted infections measured in laboratory testing (Chlamydia, Gonorrhea, Syphilis, Trichomonas, Mycoplasma genitalium, HSV-2, HIV) (4, 8, and 12 months)
C: Self-report of Ever Having Sexual Intercourse (24 months post-intervention)
D: Sexually Transmitted Infections (18 months); Schooling (12 months/24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Heliox and Posture Optimize Action of Nebulization With Bronchodilators for Asthma Attacks. Randomized Trial.
Brief Summary: The purpose of this study is to verify that nebulization with bronchodilators associated with heliox gas (helium + oxygen) and the posture of a leaning forward truck is effective in patients with an asthma attack.


Options:
A: Spirometry (6 months)
B: Change in Pulmonary Asthma Score (PAS) (0-30 minutes)
C: The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) (baseline over the first 60 minutes)
D: The primary efficacy analysis will be based on a change in FEV1, expressed as percent of predicted, at Hour 3 when compared to FEV1, expressed as percent of predicted, at the qualifying/screening timepoint. (Hour 3)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Weaning Process in Elderly Intubated Patients Submitted to Inspiratory Muscle Training
Brief Summary: Background: the objective of the present inquiry was to evaluate the weaning process in intubated older people subjected to inspiratory muscle training and to correlate the predictors of ventilatory interruption with its success.

Methods: the patients were divided randomly into an experimental group (EG, n=14; age=82±4 years) that received conventional physiotherapy plus inspiratory muscle training (IMT) with threshold IMT® and a control group (CG, n=14; age=81±6 years) that received only conventional physiotherapy. The predictors evaluates were the maximum inspiratory pressure (MIP) and the index of Tobin (IT). The protocol for muscle training consisted of an initial load of 30% MIP, which was increased by 10% daily; training was administered for five minutes, twice a day, seven times a week with supplemental oxygen for the entire period from the decision to wean up to extubation.


Options:
A: Diaphragm mobility (Diaphragm mobility at first session and after two weeks of treatment.)
B: N/A
C: Change from baseline in dyspnea at 4th day (At baseline and at the 4th day of the study)
D: Measurement of the MIP

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Combined Strategy Addressed to Practitioners and COPD Patients: Information Feed-back and Health Education, to Improve Clinical Control and Quality of Life
Brief Summary: Main objective:

Evaluate the effectiveness of a combined strategy addressed to health care workers and patients, in relation to improving clinical control and patient's quality of life.It includes a feed-back about the health status of the patients, an education plan addressed to practitioners based in a CPG and in health education


Options:
A: Difference i patients' assessment of Clinical COPD Questionnaire (CCQ) before the intervention and 18 months later. (1-2 months before the intervention and 18 months after the intervention); Difference in questionnaire about knowledge in COPD (questionnaire created by the research group)among the general practitioners that receive the education. (Immediately before the intervention and 12 months later.)
B: Change in Respiratory Specific Health Related Quality of life (HRQoL) (3 months)
C: Quality of life (Saint George's Respiratory Questionnaire (SGRQ) (Beginning of the intervention and at the end (12 months after))
D: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Fixed-Dose, Randomized, Double-Blind, Placebo-Controlled Study of LY2216684 in Pediatric Patients With Attention Deficit/Hyperactivity Disorder
Brief Summary: The primary purpose of your child's participation in this study is to determine whether LY2216684 can help pediatric patients with attention-deficit/hyperactivity disorder (ADHD); and assess the safety of LY2216684 and any side effects that might be associated with it.


Options:
A: Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 (Baseline, 8 weeks); Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 in Stimulant Naive Methylphenidate Group (Baseline, 8 weeks)
B: Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items (end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.)
C: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.
D: Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day. (Baseline and 4 weeks); Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM. (Baseline and 4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Fixed-Dose, Randomized, Double-Blind, Placebo-Controlled Study of LY2216684 in Pediatric Patients With Attention Deficit/Hyperactivity Disorder
Brief Summary: The primary purpose of your child's participation in this study is to determine whether LY2216684 can help pediatric patients with attention-deficit/hyperactivity disorder (ADHD); and assess the safety of LY2216684 and any side effects that might be associated with it.


Options:
A: Systolic Blood Pressure (Baseline and 6 months); Diastolic Blood Pressure (Baseline and 6 months); Pulse Rate (Baseline and 6 months); Electrocardiogram Results (QTcF Interval) (Baseline and 6 months); Post Sleep Questionnaire (PSQ) Quality of Sleep (6 months); Weight (Baseline and 6 months); Dermal Reactions (6 months)
B: Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. (8-10 weeks); Sleep Duration (8-10 weeks)
C: Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 (Baseline, 8 weeks); Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 in Stimulant Naive Methylphenidate Group (Baseline, 8 weeks)
D: Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day. (Baseline and 4 weeks); Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM. (Baseline and 4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: ESCAPE-SHF: A Double-blind, Double-dummy, Randomized, Multicenter, Parallel Group Study to Evaluate the Effects of Aliskiren, Ramipril and Combination Treatment on Plasma Concentration of Angiotensin II in Patients With Decompensated Systolic Heart Failure
Brief Summary: In addition to the blood pressure lowering effects of aliskiren, it may have beneficial effects on blocking the so called RAAS (renin-angiotensin-aldosterone system) at the tissue level. An increase of angiotensin II is associated with progression of heart failure. Although the use of ACE-inhibitors in heart failure shows clinical benefit, an increase in angiotensin II due to an angiotensin II "escape" phenomenon is not desirable. It is not yet known if a direct renin inhibitor can reduce or even prevent the angiotensin II escape phenomenon associated with the use of an ACE-inhibitor. Therefore the study tested the effects of ramipril, aliskiren and the combination of both on levels of angiotensin II in the blood in patients with systolic heart failure


Options:
A: Venous Angiotensin II Levels After 12 Weeks of Treatment (Baseline. 12 Weeks (Day 84, period 2))
B: Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12 (Baseline and Week 12)
C: To measure the tolerability and effectiveness of MK8141 in lowering 24-hour mean ambulatory blood pressure versus placebo after 4 weeks of treatment. (after 4 weeks of treatment)
D: Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization (up to End of Study (78 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial of Stay-Active Care and Manual Therapy Versus Stay-Active Care Only in Subacute Low Back Pain in a Primary Health Care Setting. The Gotland Low Back Pain Study
Brief Summary: A randomized controlled trial over a 10-week period with a two-year follow-up. The objectives were to compare effects of manual therapy in addition to the stay-active concept versus the stay-active concept only in low back pain patients recruited from primary health care. 160 outpatients with acute or subacute low back pain with or without pain radiation into the legs (70 women, 90 men, ages 20-55 years) were recruited from a geographically defined area and randomly allocated to stay-active care with or without muscle stretching, or to manual therapy with or without specific corticosteroid injections in addition to the stay-active concept. Pain, disability rating index, and sickness absence measures were used as outcome at 10-week follow-up and sickness absence was measured at two-year follow-up.


Options:
A: Change from baseline on the Modified Oswestry Disability Index (ODI) (Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months); Change from baseline on the Numeric Pain Rating Scale (NPRS) (Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months)
B: Oswestry Disability Index (3 months)
C: Sick leave (2 years)
D: Change in functional limitations and symptoms measured with the Oswestry Disability Index (ODI) version 2.1 (Change from baseline at 1-week, 1-month, 3-month and 6-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
Brief Summary: The primary study hypothesis wasthat a two-dose human papillomavirus (HPV) vaccine regimen would offer similar immunogenicity and protection as that of a three-dose regimen to girls against persistent HPV infection and cervical neoplasia caused by HPV types included in the vaccine. The Government of India stopped vaccination in all the HPV vaccine trials in the country in April 2010 due to reasons not related to this study.


Options:
A: Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 (At Month 7); Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) (At Month 7)
B: Median Florescent Intensities (MFI) of the Total Antibodies to Vaccine-included HPV Types (16/18/6/11) at Different Time Points (Month 7 (for 3-dose and 2-dose groups), 12 (for 2 doses by default and single-dose groups), 18, 36, 48); Frequency of Persistent HPV 16/18/6/11 Infection. (From date of marriage through to 7 years of follow-up); Frequency of HPV 16/18-associated Precancerous Lesions and Cancer. (Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen)
C: Demonstration of lot-to-lot consistency in terms of immunogenicity of 3 lots of HPV-16/18 vaccine.; Demonstration of non-inferiority in terms of immunogenicity of the HPV vaccine produced with a revised manufacturing process compared to the HPV vaccine produced with a previous manufacturing process
D: Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (One month after the third vaccine dose); Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies (One month after the third vaccine dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
Brief Summary: The primary study hypothesis wasthat a two-dose human papillomavirus (HPV) vaccine regimen would offer similar immunogenicity and protection as that of a three-dose regimen to girls against persistent HPV infection and cervical neoplasia caused by HPV types included in the vaccine. The Government of India stopped vaccination in all the HPV vaccine trials in the country in April 2010 due to reasons not related to this study.


Options:
A: Incident cervical infection with HPV-16 and/or HPV-18
B: Median Florescent Intensities (MFI) of the Total Antibodies to Vaccine-included HPV Types (16/18/6/11) at Different Time Points (Month 7 (for 3-dose and 2-dose groups), 12 (for 2 doses by default and single-dose groups), 18, 36, 48); Frequency of Persistent HPV 16/18/6/11 Infection. (From date of marriage through to 7 years of follow-up); Frequency of HPV 16/18-associated Precancerous Lesions and Cancer. (Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen)
C: Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) (Before and one month after vaccination with Boostrix); Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies (Before and one month after vaccination with Boostrix); Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies (Before and one month after vaccination with Menactra)
D: the immunogenicity of HPV vaccination in patients with immune system disorders. The immunogenicity of HPV vaccination in patients will be compared to healthy controls, measured by antibody levels against HPV serotype 16 & 18. (0, 3, 7, 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Assessment of the Safety and Feasibility of Administering T-Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With B-Cell Lymphoma
Brief Summary: Background:

The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with B cell lymphomas or leukemias that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patient s white blood cells with a retrovirus that has the gene for anti-cluster of differentiation 19 (CD19) incorporated in the retrovirus.

Objective:

The purpose of this study is to determine a safe number of these cells to infuse and to see if these particular tumor-fighting cells (anti-CD19 cells) cause tumors to shrink.

Eligibility:

- Adults age 18-70 with B cell lymphomas or leukemias expressing the CD19 molecule.

Design:

Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed

Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti-CD19 cells. Leukapheresis is a common procedure, which removes only the white blood cells from the patient.

Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy and the anti-CD19 cells. They will stay in the hospital for about 4 weeks for the treatment.

Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.


Options:
A: Proportion of participants with treatment-emergent adverse events (AEs) (From initiation of study treatment to 12 months following CAR-T infusion, approximately 15 months); Proportion of participants who experience a dose-limiting toxicity (DLT) (From initiation of study treatment to 30 days following CAR-T infusion)
B: Overall Response Rate (ORR) (From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months))
C: Phase I: Determination of the maximum tolerated dose (MTD); Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI
D: Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma (Scans performed at 6 weeks, 12 weeks and every 3-6 months for approximately 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Grains Reduce Adiposity and Improve Nutrition Study (GRAINS) Increased Whole Grain Intake - Beneficial Effects on Visceral Adiposity, Vascular Function and Glucose Metabolism/Insulin Resistance
Brief Summary: Whole grain intake beneficially affects body weight, body fat and glucose metabolism, and the investigators' previous work has shown that a high whole grain intake significantly reduced body fat in the abdominal region as measured by dual energy X-ray absorptiometry (DEXA) compared to a refined grain intake. Additional research is needed with regard to the mechanisms by which whole grains may affect visceral adiposity and the adipokines, which have been associated with risk for insulin resistance and type 2 diabetes. Therefore the proposed study aims to address these issues and in addition, includes exploratory work with adipocytes in cell culture to evaluate the effects of whole grains on adipocyte function.

Hypothesis:

There will be a greater reduction in visceral adiposity, indicators of insulin resistance (HOMA score), improvement in inflammatory status and improvement in adipokine levels after six weeks of a weight stable period and after six weeks of weight loss in subjects consuming 6-9 servings compared to 0 servings of whole grains per day.


Options:
A: change from baseline in Hb1Ac concentration Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection (baseline, 30 days, 6 months and 1 year); changes from baseline in insulin resistance Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection (baseline, 30 days, 6 months and 1 year)
B: Body Composition (Week 6 and 12 - End of diet period 1 and 2)
C: Microbiota diversity (one year); Inflammation, CRP (2 months)
D: Weight Loss

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease
Brief Summary: The purpose of this study is to compare the effects of the consumption of two different dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular events of persons with coronary disease.


Options:
A: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
B: Weight loss (2 years)
C: Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years. (Seven Years)
D: Change in body weight (measured at Year 2)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease
Brief Summary: The purpose of this study is to compare the effects of the consumption of two different dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular events of persons with coronary disease.


Options:
A: Changes in Mediterranean diet scale (6, 12, and 24 months)
B: Glucose metabolism (Study weeks 0); Glucose metabolism (12 weeks); Glucose metabolism (24 weeks)
C: Composity of Major Cardiovascular Events (up to 48 month)
D: Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years. (Seven Years)

Answer: D