TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adolescent Adherence to Hormonal Contraception
Brief Summary: The purpose of this study is to determine whether contraceptive compliance by young women can be improved through expanded counseling by a health educator at the initial clinic visit as compared with standard care.


Options:
A: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)
B: Adherence to ART and HIV RNA suppression (6,12 months)
C: Average number of missed pills per cycle (3 months)
D: MEMS Adherence (12 months follow up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adolescent Adherence to Hormonal Contraception
Brief Summary: The purpose of this study is to determine whether contraceptive compliance by young women can be improved through expanded counseling by a health educator at the initial clinic visit as compared with standard care.


Options:
A: Re-infection with a non-viral sexually transmitted infection (1 year)
B: Unprotected vaginal and anal sex (Baseline); Unprotected vaginal and anal sex (6 month follow-up); Unprotected vaginal and anal sex (12-month follow-up)
C: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)
D: contraception (past 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adolescent Adherence to Hormonal Contraception
Brief Summary: The purpose of this study is to determine whether contraceptive compliance by young women can be improved through expanded counseling by a health educator at the initial clinic visit as compared with standard care.


Options:
A: continuation into the fourth cycle (four months)
B: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)
C: Pregnancy (AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year)
D: Pearl Index up to 3 Years (Up to 3 years); Pearl Index for LCS16 up to 5 Years (Up to 5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of MBSR in Early Stage Breast Cancer Recovery
Brief Summary: The purpose of this study was two-fold: (i) to assess whether MBSR favorably influences psychological status, quality of life, stress hormones, and immune status in breast cancer survivors; and (ii) to explore possible mechanisms by which MBSR may favorably influence these outcomes, in particular, through reduction in fear of breast cancer recurrence and associated perceived stress. Both objectives were studied at the critical transition time immediately following completion of surgical, radiation and/or chemotherapy therapy for breast cancer.


Options:
A: Disease-free Survival (DFS) (Unitil the end of study with a median follow up of 75 months)
B: To evaluate the efficacy of the MBSR(BC) program in improving psychological and physical symptoms, quality of life and measures of immune function and a stress hormone (cortisol) (Baseline, 6 weeks and 12 weeks)
C: The efficacy of Mindfulness Based Stress Reduction on mood disorders (up to 5 years follow up)
D: To assess whether MBSR favorably influences psychological status (anxiety, perceived stress, depression), quality of life, and immune status (among post-treatment breast cancer survivors) (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of MBSR in Early Stage Breast Cancer Recovery
Brief Summary: The purpose of this study was two-fold: (i) to assess whether MBSR favorably influences psychological status, quality of life, stress hormones, and immune status in breast cancer survivors; and (ii) to explore possible mechanisms by which MBSR may favorably influence these outcomes, in particular, through reduction in fear of breast cancer recurrence and associated perceived stress. Both objectives were studied at the critical transition time immediately following completion of surgical, radiation and/or chemotherapy therapy for breast cancer.


Options:
A: To evaluate the efficacy of the MBSR(BC) program in improving psychological and physical symptoms, quality of life and measures of immune function and a stress hormone (cortisol) (Baseline, 6 weeks and 12 weeks)
B: Pain (From baseline until 6 months)
C: To assess whether MBSR favorably influences psychological status (anxiety, perceived stress, depression), quality of life, and immune status (among post-treatment breast cancer survivors) (6 weeks)
D: Change in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B+4) (8 weeks, 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of MBSR in Early Stage Breast Cancer Recovery
Brief Summary: The purpose of this study was two-fold: (i) to assess whether MBSR favorably influences psychological status, quality of life, stress hormones, and immune status in breast cancer survivors; and (ii) to explore possible mechanisms by which MBSR may favorably influence these outcomes, in particular, through reduction in fear of breast cancer recurrence and associated perceived stress. Both objectives were studied at the critical transition time immediately following completion of surgical, radiation and/or chemotherapy therapy for breast cancer.


Options:
A: Sexuality problems (Baseline); Intimacy problems. (Baseline); Sexuality problems (T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group)); Sexuality problems (T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group)); Sexuality problems (T3: 3 months after T2 (intervention group)); Intimacy problems. (T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group)); Intimacy problems. (T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group)); Intimacy problems. (T3: 3 months after T2 (intervention group)); Sexuality problems (T4: 6 months after T3 (intervention group)); Intimacy problems (T4: 6 months after T3 (intervention group))
B: Physical Function (14 months)
C: To assess whether MBSR favorably influences psychological status (anxiety, perceived stress, depression), quality of life, and immune status (among post-treatment breast cancer survivors) (6 weeks)
D: Change in Quality of Life (Baseline, 3 and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism
Brief Summary: The purpose of this study is to increase the understanding of the effect of Hyperbaric Oxygen Treatment (HBOT) on the behavior and functioning of children with autism. The main goal of this study is to demonstrate that HBOT is safe and tolerable in autistic children, and to measure the effect of HBOT on specific chemicals in their blood that may play a role in the child's behavior.


Options:
A: Standardized Measures; In addition to the direct measures of behavior described above, standardized intelligence and adaptive assessments will be conducted prior to the initiation of HBOT. These will include:; ADI/ADOS; WPPSI-III (2-6 years) /WASI (6+ years); Vineland Adaptive Behavior Scale (VABS); Subjective Questionnaires; Aberrant Behavior Checklist; Clinical Global Impression; ATEC; Selected sections of the APEQ; BRIEF; Parenting Stress Index; Repetitive Behavior Scale; A side effect questionnaire; Thoughtful House Caregiver diary
B: Neurologic evaluation (2 and 4 months)
C: Blinded Therapist Autism Diagnostic Observation Schedule (ADOS); Blinded Therapist Aberrant Behavior Checklist (ABC-C); Blinded Physician Clinical Global Impression Severity Score (CGI); Parental Autism Treatment Evaluation Checklist (ATEC)
D: Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score (Baseline, 8 Weeks from baseline, and 20 Weeks from baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Arterial pH on N-balances of Patients Undergoing Automated Peritoneal Dialysis
Brief Summary: This study will test the hypothesis that by slightly lowering the acidity of blood (or increasing the pH), dialysis patients utilize protein and amino acids more efficiently.


Options:
A: Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death) (Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years)
B: N-balances (20 days)
C: a composite of mortality with the change over 12 months in left ventricular mass (12 months); a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. (12 months)
D: all cause mortality (entire follow up (until dead or end of study, 1-7 years))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety/Tolerability of Methylphenidate Transdermal System (MTS) for Before-School Dysfunction in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Brief Summary: The purpose of this study is to investigate the effectiveness of a medication skin patch called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a placebo patch. We want to find out how well it treats ADHD during the early morning hours before a child leaves for school or summertime routines.


Options:
A: 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)
B: N/A
C: Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted) (Hour 4 of the of the Lab School Day during Double-Blind Assessment Period); Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct) (Hour 4 of the Lab School Day During the Double-Blind Assessment Period)
D: 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.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety/Tolerability of Methylphenidate Transdermal System (MTS) for Before-School Dysfunction in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Brief Summary: The purpose of this study is to investigate the effectiveness of a medication skin patch called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a placebo patch. We want to find out how well it treats ADHD during the early morning hours before a child leaves for school or summertime routines.


Options:
A: Postoperative pain - VAS (24 hours); Postoperative pain - PCA (24 hours)
B: Pain Scores on Standardized Experimental Pain Testing (baseline and 1 hour pain measurement)
C: Number of Participants With Adverse Events, Serious Adverse Events and Deaths. (Week 40 - Week 66)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period
Brief Summary: Delirium (acute confusion) is a highly prevalent condition among hospitalized elders with substantial morbidity within the hospital and beyond. Particular patient populations are at high risk for poor outcomes after an episode of delirium. Patients with hip and other long bone fractures are at increased risk of developing delirium (acute confusion) which impedes functional recovery. This is a pilot study to test the tolerability and efficacy of donepezil, a cholinesterase inhibitor medication used commonly in persons with dementia, for the prevention of new or worsening delirium in aged hip and other long-bone fracture patients. Additional purposes involve gathering a small amount of patients' serum to better understand the pathophysiology of delirium in this population.

The purposes of this pilot study are to determine: 1) the safety and tolerability a cholinesterase inhibitor medication) in aged hip and long bone fracture patients, 2) To obtain estimates of subject accrual and preliminary estimates of effect size on the development of new delirium symptoms to allow for planning of a larger, definitive trial, 3) To better understand the underlying causes of delirium by examining whether a measure of blood anticholinergic activity relates to the incidence and persistence of delirium symptoms, and 4) To explore the interaction between anticholinergic activity, donepezil therapy, and delirium symptoms.


Options:
A: Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG) (7 days postoperatively)
B: Percentage of Participants With Delirium Using the CAM Over Time (Baseline, hospital interviews, weeks 2, 4 and 6)
C: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
D: Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation (an average of 4 to 6 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Trial of a Clinical Algorithm to Predict the Loading Dose of Phenprocoumon
Brief Summary: Oral anticoagulation is often initiated in hospitalized patients. Although the therapeutic range of phenprocoumon is narrow, the individual drug demands unfortunately vary greatly between persons. Our group recently developed two dosing algorithms for the initiation of anticoagulation based on clinical predictors such as age, gender, body weight and laboratory values.

The aim of the proposed study is to prospectively evaluate the efficacy and safety of these two algorithms in medical and orthopedic inpatients, as well as in a group of outpatients and possibly in a geriatric collective.


Options:
A: The number of patients that complete recommended laboratory monitoring within one week and twenty five days after intervention.; The study will evaluate the time to completion of the recommended labs.; The study will also evaluate PCP and patient experiences with the interventions in order to refine the interventions in the future.
B: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)
C: rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period (after 30 days)
D: The 2 different doses used are non-inferior to each other

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multidimensional Intervention in Early Osteoarthritis (The Knee Study)
Brief Summary: Osteoarthritis (OA) is the most common joint-related disease and most prevalent form of arthritis in the United States. Pain relievers and anti-inflammatory medications are the most commonly prescribed treatments for OA. These medications, however, cannot completely alleviate OA symptoms. Additional recommended strategies for managing OA include physical and occupational therapy, exercise, and patient education. This study will compare the effectiveness of a physical training program, a self-management training program, and a program including both physical and self-management training for improving physical function in people with early stage knee OA.


Options:
A: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
B: Pain (Baseline and 12-month follow-up)
C: Knee function, as measured by the ERGOS machine (Measured at baseline and Months 9 and 24)
D: Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) from Baseline to 12-months. (Baseline and 12-months); Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) at 18-months post Baseline. (post Baseline,18-months); Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) at 24-months post Baseline. (post Baseline, 24-months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comprehensive Magnetic Resonance of Peripheral Arterial Disease
Brief Summary: The purpose of this study is to develop new ways of imaging fatty blockages in the leg arteries to improve upon techniques used now and to develop new ways of understanding how new treatments may affect the disease.


Options:
A: Plaque Volume (2 years); Perfusion Index (2 years); Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau. (2 years)
B: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline and Week 12); Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 (Baseline and Weeks 10 and 12)
C: Change from baseline in low density lipoprotein cholesterol after 12 weeks
D: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II, Randomized, Double-Blinded, Placebo-Controlled Study of the Safety and Efficacy of Intramyocardial Injection of Autologous Human Mesenchymal Stem Cells (MSCs) in Patients With Chronic Ischemic Left Ventricular Dysfunction Secondary to Myocardial Infarction (MI) Undergoing Cardiac Surgery for Coronary Artery Bypass Grafting (CABG)
Brief Summary: Heart attacks are a leading cause of death in both men and women in the United States. When a person has a heart attack, blood is unable to reach a certain area of the heart, and if the blood supply is not re-established quickly, that area of the heart can suffer permanent damage. While recovery from a heart attack can be managed through medications and lifestyle changes, these treatments can not reverse the original damage to the heart. Current research is focusing on the development of cell-based therapies using stem cells to repair organs that have been irreversibly damaged by disease. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown promise for heart repair. This study will evaluate the safety and effectiveness of injecting MSCs into the heart to repair and restore heart function in people who have had a heart attack and who are having heart surgery for coronary artery bypass grafting (CABG).


Options:
A: Number of Patients With Serious Adverse Events (12 Months)
B: Troponin samples (1 day after cell injection); Number of patients with adverse events at short term (within 1 week after cell injection); Number of patients with adverse events at mid/long term (up to 12 months after cell injection)
C: Changes in left ventricular ejection fraction from baseline to 6 months' follow-up (3 year)
D: Change in global left ventricular function (measured by quantitative left ventricular angiography)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia: A Randomized, Double-blinded, Placebo-controlled Study
Brief Summary: One dose of either gabapentin or placebo will be given to patients prior to thoracotomy. Patients will also receive an epidural infusion, intravenous patient-controlled analgesia with fentanyl, oral acetaminophen and intravenous ketorolac as needed to achieve optimal analgesia. Pain ratings and supplemental medication use will be recorded for 48 hours and will also be assessed at 3 months postoperatively to determine whether the patients who received gabapentin had improved analgesia and/or required less supplemental medication than the placebo group.


Options:
A: Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. (1, 6, 24, 48 hour); Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. (1, 6, 24, 48 hour)
B: occurrence of chronic pain (3 months)
C: Average Pain Score at Rest (48 hours); Average Pain Score With Coughing the First Morning Following Surgery (First morning following surgery); Average Pain Score With Coughing on Second Morning After Surgery (Second morning after surgery)
D: Pain intensity (0-10 numerical rating scale)

Answer: C