TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Seamos Activas: Increasing Physical Activity Among Latinas
Brief Summary: The overarching goal of this project is to develop a culturally congruent intervention to increase levels of physical activity among sedentary Latinas (i.e., Latina/Hispanic women). The first phase will involve culturally and linguistically modifying an existing evidenced-based intervention, founded on the Transtheoretical Model and Social Cognitive Theory, to target sedentary Latinas. Then, we will conduct a pilot randomized clinical trial to test whether the culturally-modified individually tailored intervention increases physical activity levels in comparison to standard care comprised of bilingual health education booklets.


Options:
A: Self-Reported physical activity (Baseline, 3 months, and 6 months)
B: Overall Screening Adherence (12 months)
C: Change from Baseline in Mean steps/day at 3 months (3 months); Change from Baseline in Mean Steps/day at 1 month (1 month)
D: Time Specific Interdialytic Weight Gain (Baseline) (Baseline); Time Specific Interdialytic Weight Gain (8 Weeks) (8 weeks); Time Specific Interdialytic Weight Gain (12 Weeks) (12 weeks); Time Specific Interdialytic Weight Gain (16 Weeks) (16 weeks); Time Specific Dietary Sodium Intake (Baseline) (Baseline); Time Specific Dietary Sodium Intake (8 Weeks) (8 weeks); Time Specific Dietary Sodium Intake (16 Weeks) (16 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) (Baseline to 8 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) (Baseline to 16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Seamos Activas: Increasing Physical Activity Among Latinas
Brief Summary: The overarching goal of this project is to develop a culturally congruent intervention to increase levels of physical activity among sedentary Latinas (i.e., Latina/Hispanic women). The first phase will involve culturally and linguistically modifying an existing evidenced-based intervention, founded on the Transtheoretical Model and Social Cognitive Theory, to target sedentary Latinas. Then, we will conduct a pilot randomized clinical trial to test whether the culturally-modified individually tailored intervention increases physical activity levels in comparison to standard care comprised of bilingual health education booklets.


Options:
A: Self-Reported physical activity (Baseline, 3 months, and 6 months)
B: Weigtreduction; Increase in maximum oxygen uptake; Change in foodintake; Change in self-reported activity
C: Waist Circumference (Month 9); Body Weight (nine month); Body Weight (4 month); Waist Circumference (4 month)
D: Change in the number of incontinent episodes (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Seamos Activas: Increasing Physical Activity Among Latinas
Brief Summary: The overarching goal of this project is to develop a culturally congruent intervention to increase levels of physical activity among sedentary Latinas (i.e., Latina/Hispanic women). The first phase will involve culturally and linguistically modifying an existing evidenced-based intervention, founded on the Transtheoretical Model and Social Cognitive Theory, to target sedentary Latinas. Then, we will conduct a pilot randomized clinical trial to test whether the culturally-modified individually tailored intervention increases physical activity levels in comparison to standard care comprised of bilingual health education booklets.


Options:
A: Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.
B: 7-Day Physical Activity Recall (7-Day PAR) (6 months)
C: Physical activity level (7-day Physical Activity Recall [PAR]) (six months from the start of the intervention)
D: Self-Reported physical activity (Baseline, 3 months, and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Seamos Activas: Increasing Physical Activity Among Latinas
Brief Summary: The overarching goal of this project is to develop a culturally congruent intervention to increase levels of physical activity among sedentary Latinas (i.e., Latina/Hispanic women). The first phase will involve culturally and linguistically modifying an existing evidenced-based intervention, founded on the Transtheoretical Model and Social Cognitive Theory, to target sedentary Latinas. Then, we will conduct a pilot randomized clinical trial to test whether the culturally-modified individually tailored intervention increases physical activity levels in comparison to standard care comprised of bilingual health education booklets.


Options:
A: 7-Day Physical Activity Recall (7-Day PAR) (6 months)
B: Physical activity level
C: Self-Reported physical activity (Baseline, 3 months, and 6 months)
D: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Seamos Activas: Increasing Physical Activity Among Latinas
Brief Summary: The overarching goal of this project is to develop a culturally congruent intervention to increase levels of physical activity among sedentary Latinas (i.e., Latina/Hispanic women). The first phase will involve culturally and linguistically modifying an existing evidenced-based intervention, founded on the Transtheoretical Model and Social Cognitive Theory, to target sedentary Latinas. Then, we will conduct a pilot randomized clinical trial to test whether the culturally-modified individually tailored intervention increases physical activity levels in comparison to standard care comprised of bilingual health education booklets.


Options:
A: Change in BMI z-score (Baseline (0 months) and 9 months)
B: Physical Activity (Accelerometer) (0, 6, 12, 18, 24 months)
C: change in physical activity (4 months)
D: Self-Reported physical activity (Baseline, 3 months, and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Seamos Activas: Increasing Physical Activity Among Latinas
Brief Summary: The overarching goal of this project is to develop a culturally congruent intervention to increase levels of physical activity among sedentary Latinas (i.e., Latina/Hispanic women). The first phase will involve culturally and linguistically modifying an existing evidenced-based intervention, founded on the Transtheoretical Model and Social Cognitive Theory, to target sedentary Latinas. Then, we will conduct a pilot randomized clinical trial to test whether the culturally-modified individually tailored intervention increases physical activity levels in comparison to standard care comprised of bilingual health education booklets.


Options:
A: This randomized controlled trial was designed to assess the effectiveness of a primary care physical activity intervention, in increasing adherence to physical activity in general population, as well as their self-reported physical activity. (baseline-3-6-12-18)
B: Physical activity measured by accelerometry. (3 months post-randomisation)
C: Absolute level of physical activity: (Assessed at baseline, 6, 12 and 24-month follow-up as kcals/wk expenditure based on survey self-report, validated against activity monitor data in a random sub-sample.); Maintenance of physical activity (Physical activity level relative to baseline assessed at all follow-ups 6, 12, 24 months.)
D: Self-Reported physical activity (Baseline, 3 months, and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Vitamin D and Calcium on Bone in Pediatric HIV
Brief Summary: We have observed that vitamin D deficiency, as evidenced by low serum 25(OH)D concentrations, is common in children and adolescents with HIV infection. To determine whether vitamin D and calcium supplementation improve bone mineral content (BMC) and bone mineral density (BMD) in HIV-infected children and adolescents, we propose a double-blind, randomized, placebo-controlled trial comparing supplementation with oral vitamin D and calcium to placebo.

The specific aims of this project are to:

1. Determine the effect of vitamin D and calcium supplementation on bone mineral accrual in HIV-infected children.

   We hypothesize that BMC and BMD will increase to a greater extent in HIV-infected children who receive supplementation with vitamin D and calcium. This hypothesis will be tested by comparing changes in BMC and BMD, measured by dual energy x-ray absorptiometry (DXA), after one and two years of treatment in HIV-infected children and adolescents receiving vitamin D and calcium supplementation compared to those receiving placebo.
2. Determine the effect of HIV infection and vitamin D and calcium supplementation on indices of mineral metabolism and markers of bone turnover.

   We hypothesize that indices of mineral metabolism and markers of bone formation and resorption will return toward normal in HIV-infected children and adolescents who are randomized to receive vitamin D and calcium supplementation. We will test these hypotheses by comparing longitudinal changes in indices of mineral metabolism and bone turnover markers in HIV-infected children and adolescents receiving vitamin D and calcium supplement versus those receiving placebo
3. Evaluate if vitamin D stores are a determinant of bone mass in HIV infected children and adolescents receiving HAART.

We hypothesize that vitamin D stores, as assessed by serum 25-hydroxyvitamin D levels, are an important determinant of bone mass in HIV-infected children and adolescents receiving HAART. We will test this hypothesis by evaluating whether measurements of bone mass are associated with vitamin D stores, as measured by serum 25-hydroxyvitamin D levels and other indices of mineral metabolism, in treated HAART-treated HIV-infected children and adolescents.


Options:
A: The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip (Weeks 0 and 48)
B: Vitamin D Supplementation Safety (12 months)
C: Total Body Bone Mineral Content (Entry, 12 and 24 months)
D: To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection. (Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Evaluation of a Follow on Formula Supplemented With Lactobacillus Salivarius CECT5713
Brief Summary: The aim of the trial is to evaluate safety of a follow on formula supplemented with Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was carried out. Eighty six months old children were recruited by the department of pediatrics of Hospital Univeristario San Cecilio. Children were divided in two groups that consumed a follow on formula supplemented or not with the probiotic strain during 6 months. Fecal samples were obtained at the recruitment, at 3 months and at the end of the trial. In addition revision by the pediatrician was performed once a month and possible adverse effects were recorded both by the pediatrician and by parents.


Options:
A: Incidence of infectious diseases
B: Common infections in children
C: Adverse reactions (3 months and 6 months)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Telephone Care Coordination for Smokers in Mental Health Clinics
Brief Summary: The purpose of this study is to evaluate whether a smoking cessation telephone care coordination program is effective and feasible in VA Mental Health Clinics.


Options:
A: Point prevalence abstinence (12 months)
B: Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) (6 months after enrollment)
C: smoking quit rate change from baseline at 3-month follow-up (3-month follow-up); smoking quit rate change from baseline at 6-month follow-up (6-month follow-up)
D: Smoking Cue Reactivity on Quit Day (4-weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Telephone Care Coordination for Smokers in Mental Health Clinics
Brief Summary: The purpose of this study is to evaluate whether a smoking cessation telephone care coordination program is effective and feasible in VA Mental Health Clinics.


Options:
A: 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). (2 years)
B: Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During 90-session intervention period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During 90-session intervention period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During 90-session intervention period); Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During the 6-month follow-up period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During the 6-month follow-up period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During the 6-month follow-up period)
C: Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) (6 months after enrollment)
D: Tobacco Abstinence (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacokinetics of Implanon in Obese Women
Brief Summary: Prior studies examining the pharmacokinetics, safety, and efficacy of the new etonogestrel-containing single rod implantable contraceptive device, Implanon, did not include women who exceeded 130% of ideal body weight. Yet, as these women comprise a significant portion of the U.S. population, studies of Implanon in obese women are essential. The proposed study represents an important first step in addressing the lack of data on Implanon in obese women. We aim to examine the pharmacokinetics of Implanon in obese women during the first 6 months of use and to provide data on the acceptability, side effect profile, and ease of insertion, palpation, and removal in these women. We also aim to collect samples for future validation studies of the use of the blood spot (finger-stick blood sample on filter paper) as a method of determining plasma etonogestrel.


Options:
A: To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women. (6 months)
B: Pearl Index up to 3 Years (Up to 3 years); Pearl Index for LCS16 up to 5 Years (Up to 5 years)
C: Serum Etonogestrel Level (Up to 12 months)
D: LNG Steady State at Baseline and Then Post-randomization (baseline (2 months) and post-randomization (4 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Observational Trial to Monitor the Incidence of Congenital Malformations in Infants of Women With an Ongoing Pregnancy After Controlled Ovarian Hyperstimulation Using Puregon® (recFSH)/Orgalutran® (Ganirelix) Followed by IVF/ICSI, or a Long Protocol With a GnRH Agonist as Historical Controls.
Brief Summary: The primary purpose of this study is to collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian stimulation with recombinant follicle stimulating hormone /ganirelix followed by in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI), and to compare this incidence with that of a group of women who used a long protocol with a gonadotropin releasing hormone agonist as historical controls.


Options:
A: cost of treatment (One month)
B: Incidence of late progesterone rise on the day of HCG triggering (Up to delivery (2010))
C: To collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian hyperstimulation. (In both cohorts a follow-up pediatric evaluation was scheduled within 6 months post-partum)
D: Frequency of Ovarian Hyperstimulation Syndrome (OHSS) (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB01L1 in Healthy Volunteers
Brief Summary: The purpose of this phase I trial is to evaluate safety and tolerability of GHB01L1 administered as single dose intranasal aerosol for vaccination against influenza A (H1N1) virus.

This study is performed further to assess local and systemic immune response and to analyse pharmacokinetics (shedding) of a single dose GHB01L1 aerosol administered intranasally.


Options:
A: Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. (Up to 6 days after each vaccination.); Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine. (Upto Day 224 post vaccination)
B: Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years (Pre-vaccination (Day 0) and day 21 post-vaccination); Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years (Pre-vaccination (Day 0) and Day 21 post-vaccination); Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years (Days 0 to 7 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years (Days 0 to 7 post-vaccination)
C: The primary objective of safety and tolerability of GHB01L1 administered as single dose intranasal aerosol will be evaluated by clinical signs and symptoms as well as laboratory tests. (Beginning with signing Informed Consent through 30 days after study end)
D: The appearance among patients of symptomatic laboratory-confirmed influenza. (Influenza season Nov-Apr. Within 72 hours of illness onset throat swab specimens will be obtained from participants with influenza like illness (ILI).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sleep-directed Hypnosis As A Complement To CPT In Treating PTSD
Brief Summary: Sleep impairment is the most often reported of the 17 PTSD symptoms and is considered one of the most refractory to treatment. This study proposes the use of sleep-directed hypnotherapy to address sleep issues as a complementary element to empirically supported Cognitive Processing Therapy (CPT) in treating PTSD in sexual and physical assault survivors. Specifically the study aims to: 1) compare the results of sleep-directed hypnosis plus CPT with CPT only, 2) to assess the relationship between sleep and PTSD symptoms, 3) to examine relationships between sleep improvement, PTSD symptom improvement, and the therapeutic elements (hypnosis, exposure, cognitive therapy) to determine mechanisms of action in the intervention, 4) to assess the relationship between sleep and physical reactivity to trauma-related cues and to other stimuli.


Options:
A: Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores (2 weeks post-treatment)
B: PTSD (Before session, middle, end, one year follow-up, 18 month follow-up)
C: Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention (Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).); PTSD Symptom Checklist-5 (PCL-5): Change in Mean Total Score From Baseline to 3-month Post-intervention (Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).)
D: Clinician Assessed Severity of PTSD (Baseline, 16, 24 and 32 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sleep-directed Hypnosis As A Complement To CPT In Treating PTSD
Brief Summary: Sleep impairment is the most often reported of the 17 PTSD symptoms and is considered one of the most refractory to treatment. This study proposes the use of sleep-directed hypnotherapy to address sleep issues as a complementary element to empirically supported Cognitive Processing Therapy (CPT) in treating PTSD in sexual and physical assault survivors. Specifically the study aims to: 1) compare the results of sleep-directed hypnosis plus CPT with CPT only, 2) to assess the relationship between sleep and PTSD symptoms, 3) to examine relationships between sleep improvement, PTSD symptom improvement, and the therapeutic elements (hypnosis, exposure, cognitive therapy) to determine mechanisms of action in the intervention, 4) to assess the relationship between sleep and physical reactivity to trauma-related cues and to other stimuli.


Options:
A: Change in PTSD symptoms (PTSD Symptom Scale Interview) (Change in PTSD symptoms from baseline to 3 months post intervention)
B: Intimate partner violence (One year)
C: Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores (2 weeks post-treatment)
D: Drug abstinence

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Low-Carbohydrate Mediterranean Diet or Low-Fat Diet in Newly-Diagnosed Type 2 Diabetic Patients
Brief Summary: The major environmental factors that increase the risk of type 2 diabetes, presumably in the setting of genetic risk, are overnutrition and a sedentary lifestyle, with consequent overweight and obesity. The high rate of weight regain has limited the role of lifestyle interventions as an effective means of controlling glycemia long term. The aims of the present study were: 1) To compare the effectiveness and safety of two nutritional protocols - namely low-carbohydrate Mediterranean diet or low-fat diet - in newly-diagnosed, drug-naive overweight patients with type 2 diabetes mellitus. The primary aim of the study was the effect on hemoglobin A1c levels; secondary aims were time to introduction of the first hypoglycemic agent, prevalence of the metabolic syndrome, percentage of patients meeting ADA goals for risk factors (HbA1c, blood pressure, LDL-cholesterol, percentage of patients with HbA1c \< 7%.


Options:
A: N/A
B: Change in Hemoglobin A1C (A1C) (Baseline, 12 weeks and 24 weeks)
C: Hemoglobin A1c (Every sixth month)
D: N/A

Answer: C