TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations (Back to Health)
Brief Summary: A randomized controlled trial for chronic low back pain in predominantly minority populations with three treatment arms: yoga, physical therapy, and education. Four cohorts of participants will be randomized in a 2:2:1 ratio (yoga:physical therapy:education). Primary outcomes are pain intensity and measure of disability; secondary outcomes are pain medication use, treatment adherence, and health-related quality of life.


Options:
A: Intensity of pain, measured at baseline, 90, and 180 days later (6 months); Disability, measured at baseline, 90, and 180 days later (6 months); Sick leave, measured at baseline, 90, and 180 days later (6 months)
B: N/A
C: Change from Baseline in Average Pain intensity in previous week (12 wks); Change from Baseline in Modified Roland Morris questionnaire for Back pain specific disability (12 wks)
D: Average pain intensity during exercises using the numeric pain rating scale (Day 1); Time spent thinking of the pain using a numeric rating scale (Day 1)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations (Back to Health)
Brief Summary: A randomized controlled trial for chronic low back pain in predominantly minority populations with three treatment arms: yoga, physical therapy, and education. Four cohorts of participants will be randomized in a 2:2:1 ratio (yoga:physical therapy:education). Primary outcomes are pain intensity and measure of disability; secondary outcomes are pain medication use, treatment adherence, and health-related quality of life.


Options:
A: Back-related function (6 months); Pain (6 months)
B: Change from Baseline in Average Pain intensity in previous week (12 wks); Change from Baseline in Modified Roland Morris questionnaire for Back pain specific disability (12 wks)
C: N/A
D: Average pain intensity (up to 12 weeks); Modified Roland Morris Disability Questionnaire for back pain-specific disability (up to 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations (Back to Health)
Brief Summary: A randomized controlled trial for chronic low back pain in predominantly minority populations with three treatment arms: yoga, physical therapy, and education. Four cohorts of participants will be randomized in a 2:2:1 ratio (yoga:physical therapy:education). Primary outcomes are pain intensity and measure of disability; secondary outcomes are pain medication use, treatment adherence, and health-related quality of life.


Options:
A: Change from Baseline in Average Pain intensity in previous week (12 wks); Change from Baseline in Modified Roland Morris questionnaire for Back pain specific disability (12 wks)
B: Pain Scores (Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up)
C: Change from baseline in low back pain (Baseline, 6 weeks, 12 weeks, 24 weeks); Change from baseline in back-related function (Baseline, 6 weeks, 12 weeks, 24 weeks)
D: Back-related function (6 months); Pain (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Project Dulce: Developmental Understanding and Legal Collaboration for Everyone
Brief Summary: Project Dulce is designed to test a new approach to delivering family support, in the context of the primary care medical home. The target population to be served is infants between birth and 6 months old and their families who receive primary care at Boston Medical Center. A dulce family partner will reach infants and families through their routine health care visits during their first six months of life and provide them with support for unmet legal needs, screen infants for developmental problems, screen families for mental health problems, and improve families' knowledge of child development. The control group will receive training on safe sleep and safe transportation for their newborn.


Options:
A: Primary Outcome (3/1/2011-2/29/2012)
B: Parental Vaccine Hesitancy Measure (Change from Baseline in Parental Hesitancy at 6 months)
C: Change from baseline in number of child maltreatment protective factors available to caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Caregivers Assessment of Protective Factors" (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later); Change from baseline in number and amount of income supports available to and accessed by caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Self-Report Family Inventory" + supplementary questions on $ value (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later); Change from baseline in social capital available to caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Social Network Grid" (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later); Change from baseline in parental stress at 6 months, as measured by the "Parenting Stress Index (PSI) - long form" (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later); Change from baseline in parenting and child-rearing attitudes of child's caregiver at 6 months, as measured on the "Adult-Adolescent Parenting Inventory(AAPI-2)" (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later)
D: Receipt of influenza vaccine during pregnancy (Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Diabetes Prevention Strategies in Women With GDM
Brief Summary: The main goal of this study is to examine the comparative effectiveness of diabetes prevention strategies in women with Gestational Diabetes Mellitus (GDM) on the control of the following conditions: obesity, hyperglycemia, hypertension and depression. This randomized lifestyle intervention study will be conducted at Kaiser Permanente Northern California. Women in the intervention will receive a letter on gestational weight gain during pregnancy and in the postpartum period, a curriculum of individualized lifestyle counseling via telephone, augmented with e-mail and an interactive Web site. Patients randomized to the usual care arm will receive the standard-care telephone calls from the Perinatal Center during pregnancy and the Center's printed educational materials postpartum. Outcomes will be assessed through the electronic medical record and patient surveys conducted during pregnancy and at 6-weeks, 6- months and 1-year postpartum.


Options:
A: Primary outcome: meeting the postpartum weight goal (through 12 months postpartum)
B: Body Mass Index standard deviation score (On average 2.9 years of age)
C: Gestational weight gain (4 years)
D: Cesarean Section (At delivery); Preeclampsia/Pregnancy Induced Hypertension (Delivery); Gestational Diabetes Mellitus (Delivery); Large for Gestational Age (Delivery); Neonatal Intensive Care Unit (Within 1 month postpartum); Gestational Weight Gain (Gestational week 35)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy
Brief Summary: The object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.


Options:
A: Complete response (CR: no emetic episodes and no rescue medication) rate in acute and delayed nausea and vomiting
B: No Emetic Episodes and No Rescue Medication (>24 to 120 hours post chemotherapy)
C: Patient diary recording nausea, emesis, food ingestion, and rescue therapy (From initiating administration of anticancer agents to day 6 (120 hours))
D: Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC) (25 to 120 hours after initiation of MEC); Percentage of Participants With Infusion-site Thrombophlebitis (Day 1 through Day 17, inclusive); Percentage of Participants With Severe Infusion-site Reactions (Day 1 through Day 17, inclusive)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Computer Assisted Training in Vestibular Rehabilitation for Older Patients With Vestibular Dysfunction
Brief Summary: BACKGROUND A Cochrane review from 2003 found that about 30% of people 65 years or older each year fall and that number is even higher for elder people living in institutions. Falls are the cause of 95% of all hip fractures, resulting in prolonged hospitalization and prolonged disability. In patients who are referred to the emergency room after unexplained fall, a study of 564 patients showed that 80% of the patients had vestibular symptoms characterized by balance problems, nausea, impairment, vomiting, and dizziness. 41% of the patients had dizziness suggesting a dysfunctional vestibular system called vestibular dysfunction. In patients with vestibular dysfunction, vestibular rehabilitation (VR) can reduce fall risk. Several studies show however that the elderly has a decreased compliance in relation to the performance of home exercise.

A solution to support the older vestibular rehabilitation process and to maintain the achieved level of functionality after the rehabilitation process is the computer-training program "Move It To Improve It" (MITII). Based on individual studies and tests therapists develop a personalized rehabilitation program permanently corrected, modified and adjusted. The system generates feedback to the therapists at hospital with information about the person's daily training and scores of individual exercises. The Web cam makes it possible to make video footage and pictures to be used in the feedback information. The system also establish direct communication between users and therapists. The web community provide the framework for a telerehabilitation system, which means that the hospital can service more users in the same period.

The ph.d. consist of three studies which has the purposes:

To compare a computer exercise program (Mitii) with conservative home-training according to printed instructions in the rehabilitation of patients with vistibular dysfunction in an outpatient clinic To investigate whether the effect of vestibular rehabilitation is preserved three months after the completion of supervised training in an outpatient clinic for specific vestibular rehabilitation and whether a computer assisted home training program (Mitii) is superior to printed instructions in this respect To evaluate patient experience and barriers for the use fo the computer assisted rehabilitation of patients with vestibular dysfunction


Options:
A: Dizziness Handicap Inventory (DHI) (3 min); 6 m walking test preferred velocity (5 min)
B: Vertigo-related quality of life (Improvement at follow-up (12 months after treatment))
C: Self-reported measures of dizziness (Measured at beseline, 12 weeks and 1 year.)
D: Static balance will be measured by the "One leg Stand test" (16 weeks of rehabilitation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open, Parallel, Multi-center Trial to Evaluate Weight Loss Efficacy of Smart Care Service in Obese Patients With Metabolic Syndrome.
Brief Summary: A randomized, open, parallel, multi-center trial to evaluate weight loss efficacy of Smart Care Service in obese patients with metabolic syndrome.


Options:
A: weight loss (six months)
B: Weight Change from Baseline to 24 weeks (0 and 24 weeks)
C: Weight reduction (1 year)
D: Changes from baseline BMI (At baseline (0 years) and followed for 2 years); Changes from baseline Fatty mass (At baseline (0 years) and followed for 2 years); Changes from baseline Free-fatty mass (At baseline (0 years) and followed for 2 years); Changes from baseline Muscular Mass (At baseline (0 years) and followed for 2 years); Changes from baseline Corporal Water (At baseline (0 years) and followed for 2 years); Adherence to dietary pattern will be also measured through personal interview (At baseline (0 years) and followed for 2 years); Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire) (At baseline (0 years) and followed for 2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain
Brief Summary: People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.


Options:
A: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data (Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
B: Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) (End of Period (includes both Visits 5 and 9))
C: A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary (Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study))
D: Number of Participants With Loss of Therapeutic Response. (13 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multi-center Study to Assess Safety and Tolerability of Different Oral Doses of BAY94-8862 in Subjects With Stable Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease Versus Placebo (Part A) or Versus Placebo and Spironolactone (Part B)
Brief Summary: A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally


Options:
A: Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date (Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)); Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) (Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011))
B: Proteinuria reduction (bi-monthly)
C: Change of serum potassium (4 weeks)
D: Changes in left ventricular mass on cardiac MRI and arterial stiffness (assessed by pulse wave velocity). (9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma
Brief Summary: This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.


Options:
A: Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants (From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months))
B: Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm (12 weeks after the completion of therapy)
C: locoregional recurrence-free survival (2 years); number of patients with grade 3 toxicity or more (2 years)
D: Disease Free Survival (DFS) (Up to 5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia
Brief Summary: The aim of this prospective study was to evaluate the activity, safety and the duration of the response of low dose rituximab associated with standard oral prednisone as first line therapy in newly diagnosed warm autoimmune hemolytic anemia and cold hemagglutinin disease, and as second line therapy in warm autoimmune hemolytic anemia relapsed after standard oral prednisone. Further aim was to correlate the clinical response to biological parameters (cytokine and anti-erythrocyte antibody production in cultures).


Options:
A: Percentage of Participants Achieving Durable Response of Improvement in Hemoglobin (Hgb) (Up to Week 20 of the double-blind period)
B: Frequency of complete and partial responses (CR/PR) (6 months)
C: LDH (From baseline to 26 weeks)
D: overall response (month +2)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Is Interdisciplinary Intervention for Patients Sicklisted With Musculoskeletal Pain More Effective in Helping Patients Back to Work Than Than The Less Resource Demanding Brief Intervention Method?
Brief Summary: Musculoskeletal pain is very common in the normal population, and the reason for about 50 % of the long term sickness absence in Norway. Most of these patients have common, but troublesome subjective health complaints where pathological findings are absent or substantially less than expected compared to the reported intensity of the complaints. Psychosocial factors are important in the development of chronic complaints. In a large meta-analysis job satisfaction was found to be associated with mental health and subjective physical health. Individual factors are also important. Uncertainty related to the understanding of pain mechanisms, treatment strategies and management contribute to the problem.

Among patients sicklisted for musculoskeletal complaints, low back pain is the largest diagnose group. Most of these patients also have many other complaints. Previous studies have shown that for low back pain patients a brief intervention at a spine clinic with examination, information, reassurance, and encouragement to engage in physical activity as normal as possible, had significant effect in reducing sick leave. Other studies have shown that multidisciplinary rehabilitation for chronic low back pain has effect on sick leave. A Danish study from Arbeidsmiljøinstituttet report that interdisciplinary treatment for patients sicklisted for musculoskeletal complaints, had effect on socio-economic costs, pain, and function.

A treatment team consisting of various professionals is expensive, and in this study we will compare the simple, standardized brief intervention model with the more resource demanding interdisciplinary treatment for patients sicklisted for musculoskeletal complaints.

Research question / hypothesis: An interdisciplinary treatment model for musculoskeletal complaints - is it beneficial for reducing sickness absence?


Options:
A: Change in Sickness leave 1 year after inclusion (At 12 months after baseline)
B: Efficiency of the 3 programs (One year)
C: return to work rate (week)
D: Self-reported number of sick-days (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of High-Dose Valacyclovir Versus Once Daily Valacyclovir on Herpes Simplex Virus Type 2 Genital Shedding in Herpes Simplex Virus-2 Seropositive Adults
Brief Summary: On 13 August 2008, this trial was submitted to ClinicalTrials.gov as modification to NCT00362297. On 28 April 2011, the two records were split for administrative purposes and each trial was given its own unique study record. Please refer to the "History of Changes" on posting NCT00362297 for a detailed summary of the modifications.

The purpose of the research study is to evaluate the effectiveness of high-dose valacyclovir compared to once daily valacyclovir for reduction of asymptomatic HSV-2 genital shedding in persons with genital herpes.

The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an effective form of birth control.

Involvement in the study will last 11-weeks and you will be asked to visit the clinic every 2-weeks. At each visit, you will be given medication to take daily (either once daily valacyclovir or high dose valacyclovir; you will receive both medications at some point during this study). We will ask you to give a blood sample for liver, kidney and blood count testing at each visit. There will be a total of 8 study visits and each visit will last approximately 30 minutes. We will ask that you complete a daily symptom diary and collected daily home swabs 4-times a day, everyday during the study. Each daily home swab will take less than 3 minutes to perform.


Options:
A: HIV acquisition; safety of circumcision
B: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Valacyclovir as Compared to Once-daily Valacyclovir. (11 weeks)
C: Serologically confirmed HIV infection (Throughout study)
D: Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation (4 weeks)

Answer: B