TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera Versus Darboepoetin Alfa for the Maintenance of Haemoglobin Levels in Renal Transplant Recipients With Chronic Renal Anaemia.
Brief Summary: This two arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Options:
A: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 25-36)
B: The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range (Weeks 16-28)
C: Median Time to First Cardiovascular Event (Up to 4 years)
D: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence
Brief Summary: The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence. The study includes a 6-month blinded sham-controlled phase, followed by an open-label phase.


Options:
A: Number of incontinence episodes Assess number of incontinence episodes. (Will be assessed every four weeks during a twelve-week period)
B: Proportion of subjects with an average of 3 or more SCBM per week (12 weeks)
C: FI - number of FI episodes per week and/or number of days with FI per week. Constipation - number of bowel movements per week; &/or decrease defecations requiring straining; &/or decrease defecations where there was incomplete emptying (Annually)
D: Percentage of Participants Who Are Responder50. (6 months after last blinded treatment); Percentage of Participants Who Are Responder25. (12 months after last treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pivotal, Randomized, Double-blind, Vehicle-controlled Study to Evaluate WR 279,396 and Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)
Brief Summary: This study will test the ability of the topical cream WR 279,396 to treat the skin lesions caused by the parasite called leishmania. WR 279,396 is an antibiotic preparation that contains paromomycin + gentamicin. This cream will be compared to the effect of a topical cream containing paromomycin alone and to a placebo cream that contains no antibiotics. Therefore, this study will have three groups of patients, and they will be assigned to one of these treatments randomly. The study will be carried out without the patient or the physician knowing which cream is being used for which patient. The goal is to determine if WR 279,396 cream or the paromomycin cream is better than placebo, and if WR 279,396 is better than paromomycin alone.


Options:
A: Final Clinical Cure Rate (Day 42, 98, and 168)
B: Final cure rate at six months after the end of treatment
C: Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days) (180 days); Safety of WR 279,396 (AEs and SAEs) (180 days)
D: Wound closure time (75 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pivotal, Randomized, Double-blind, Vehicle-controlled Study to Evaluate WR 279,396 and Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)
Brief Summary: This study will test the ability of the topical cream WR 279,396 to treat the skin lesions caused by the parasite called leishmania. WR 279,396 is an antibiotic preparation that contains paromomycin + gentamicin. This cream will be compared to the effect of a topical cream containing paromomycin alone and to a placebo cream that contains no antibiotics. Therefore, this study will have three groups of patients, and they will be assigned to one of these treatments randomly. The study will be carried out without the patient or the physician knowing which cream is being used for which patient. The goal is to determine if WR 279,396 cream or the paromomycin cream is better than placebo, and if WR 279,396 is better than paromomycin alone.


Options:
A: Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure (Assessment of cure is made at 2 months after treatment)
B: Final cure rate at six months after the end of treatment
C: Final Clinical Cure Rate (Day 42, 98, and 168)
D: (1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens.; (2) To compare the efficacy of injectable paromomycin to amphotericin B with regards to final cure rates.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial
Brief Summary: Recurrent miscarriage is a prevalent reproductive problem that affects many couples who are trying to establish a family. This clinical study will evaluate the effectiveness of intravenous immunoglobulin (IVIG) in improving the live birth rate in couples who suffer from secondary recurrent miscarriage. This study will help in providing an answer to the question of whether IVIG is helpful in secondary recurrent miscarriage.


Options:
A: Continuation of viable pregnancy beyond 20 weeks gestation (20 weeks gestation)
B: Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies (20 weeks gestation)
C: Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) (pregnancy > 24weeks gestation)
D: Fetal loss (From 12 weeks to 42 weeks gestational age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Acute Voiding Difficulty After Radical Proctectomy for Rectal Cancer With Tamsulosin
Brief Summary: Various adrenergic blockers are used for acute voiding difficulty after proctectomy. Recently, a selective alpha5-adrenergic blocker, Tamsulosin has been reported to have benefit in reducing urinary symptom score and in reducing the rate of intermittent self-catheterization for patients with rectal cancer after radical proctectomy.

This study is to evaluate the efficacy of pharmacologic prevention to ameliorate the incidence of postoperative urinary dysfunction.


Options:
A: Hospital stay (4 weeks)
B: Urinary retention (inability to void) (6 hours after removal of urinary catheter)
C: Re-insertion rate of urinary catheter after removal (after removal of urinary catheter)
D: time to return of normal bladder function (5 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Email-Based Diet and Activity Promotion in Worksites
Brief Summary: The objective of this study is to test the effectiveness of an email-based diet and physical activity intervention on increasing physical activity and fruit and vegetable consumption and decreasing intake of saturated and trans fats and added sugars.


Options:
A: weight loss (12 weeks)
B: Physical activity (walking time, sitting time, physical activity level in leisure time) (12 weeks)
C: change in physical activity (4 months)
D: Aerobic Fitness; Resting Blood Pressure; Body Fatness; Blood Lipids; C-reactive Protein

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Email-Based Diet and Activity Promotion in Worksites
Brief Summary: The objective of this study is to test the effectiveness of an email-based diet and physical activity intervention on increasing physical activity and fruit and vegetable consumption and decreasing intake of saturated and trans fats and added sugars.


Options:
A: Average steps per day (6 weeks)
B: Acceptability and feasibility (3 weeks)
C: change in physical activity (4 months)
D: Change in objective measure of degree of physical activity (baseline, 12 weeks, 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Email-Based Diet and Activity Promotion in Worksites
Brief Summary: The objective of this study is to test the effectiveness of an email-based diet and physical activity intervention on increasing physical activity and fruit and vegetable consumption and decreasing intake of saturated and trans fats and added sugars.


Options:
A: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)
B: non-exercise activity (Measured constantly during the entire control period and measured constantly during the entire intervention period and the two periods were compared to determine change in non-exercise activity)
C: duration of prolonged sitting (5 days)
D: change in physical activity (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Email-Based Diet and Activity Promotion in Worksites
Brief Summary: The objective of this study is to test the effectiveness of an email-based diet and physical activity intervention on increasing physical activity and fruit and vegetable consumption and decreasing intake of saturated and trans fats and added sugars.


Options:
A: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
B: change in physical activity (4 months)
C: Framingham heart risk score (1 year)
D: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Email-Based Diet and Activity Promotion in Worksites
Brief Summary: The objective of this study is to test the effectiveness of an email-based diet and physical activity intervention on increasing physical activity and fruit and vegetable consumption and decreasing intake of saturated and trans fats and added sugars.


Options:
A: change in physical activity (4 months)
B: Biochemically verified smoking cessation rates at 6 months post-quit date
C: Quit Rate (30-day Follow-Up); Quit Rate (6-Month Follow-Up)
D: Physical Activity (Measured 5 times over 13 months, for seven days each time. Time points = baseline, 1-2weeks, 3 months, 6 months and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Email-Based Diet and Activity Promotion in Worksites
Brief Summary: The objective of this study is to test the effectiveness of an email-based diet and physical activity intervention on increasing physical activity and fruit and vegetable consumption and decreasing intake of saturated and trans fats and added sugars.


Options:
A: Change from baseline in workplace sitting time at 4 and 8 weeks (Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks))
B: change in physical activity (4 months)
C: non-exercise activity (Measured constantly during the entire control period and measured constantly during the entire intervention period and the two periods were compared to determine change in non-exercise activity)
D: Incidence of CHD and other lifestyle related diseases after ten years (2012)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Email-Based Diet and Activity Promotion in Worksites
Brief Summary: The objective of this study is to test the effectiveness of an email-based diet and physical activity intervention on increasing physical activity and fruit and vegetable consumption and decreasing intake of saturated and trans fats and added sugars.


Options:
A: change in physical activity (4 months)
B: BMI and aerobic fitness (1 schoolyear)
C: Physical Activity (Accelerometer) (0, 6, 12, 18, 24 months)
D: Self-Reported physical activity (Baseline, 3 months, and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh
Brief Summary: This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants.


Options:
A: Severe Anemia
B: Change in weight in 2 years
C: nutritional status (9 months)
D: Dual Sugar Absorption Test (12 weeks); Dual Sugar Absorption Test (24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh
Brief Summary: This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants.


Options:
A: Change in weight in 2 years
B: Severe Anemia
C: Understanding of key findings (30 minutes)
D: nutritional status (9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Study on Efficacy and Safety of Clino-san® in the Management of Vaginal Dryness in Breast Cancer Patients
Brief Summary: 1. Although after treatment for breast cancer such as chemotherapy or hormonal therapy, urogenital atrophy is common, the patients are seldomly treated for several reasons. Management of this problem is important for improving quality of life.
2. "Clino-san" is a kind of vaginal lubricant with pH 5 which is similar pH of premenopausal vaginal discharge. After randomization of patients, they are treated with Clino-san or placebo 3 times/week for 12 weeks.
3. We check the vaginal symptoms, vag dryness severity score, and ultrasonography at baseline, 4, 8, and 12 weeks of treatment.


Options:
A: Overall mood (Up to 6 months)
B: To evaluate the efficacy of a multicomponent biobehavioral psychosocial telephone counseling (PTC) intervention for cervical cancer survivors, compared to usual care (10 years)
C: vaginal dryness score (for 12 weeks)
D: Prevention of Entry Dyspareunia With Non-hormonal Therapy (During Phase II (0-4 weeks) and during Phase III (5-12 weeks)); Location of Pain in Postmenopausal Dyspareunia (Enrollment visit)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: AUDs and PTSD Treatment for Victims of Partner Violence
Brief Summary: The goal of this study is to evaluate a psychotherapy for PTSD and substance use disorders among women who have experienced domestic violence. The hypothesis is that women who receive present-focused, integrated treatment will have greater PTSD symptom reduction and have less substance use after treatment than women in the control condition who will receive supportive therapy based on a 12-step approach.


Options:
A: The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components. (6 weeks post randomization)
B: CAPS for PTSD symptoms and ASI for substance use (pre, mid treatment, post, 3-month follow-up, 6-month follow-up)
C: Reducing children's exposure to Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Patterns of Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Reducing Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.)
D: Change in partner violence victimization (summary score) (baseline to 12 months); Change in reproductive coercion (summary score) (baseline to12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: AUDs and PTSD Treatment for Victims of Partner Violence
Brief Summary: The goal of this study is to evaluate a psychotherapy for PTSD and substance use disorders among women who have experienced domestic violence. The hypothesis is that women who receive present-focused, integrated treatment will have greater PTSD symptom reduction and have less substance use after treatment than women in the control condition who will receive supportive therapy based on a 12-step approach.


Options:
A: PTSD Symptoms (90 Days, 180 days); HIV Medication Adherence (% Adherent) (180 days)
B: summing totals of 17 DSM-IV symptoms (10 weeks)
C: CAPS for PTSD symptoms and ASI for substance use (pre, mid treatment, post, 3-month follow-up, 6-month follow-up)
D: Sleep Latency (SL) (After 8 weeks of study participation); Minutes of Wake After Sleep Onset (WASO) (After 8 weeks of study participation); Sleep Efficiency (SE) (After 8 weeks of study participation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room
Brief Summary: Does polyethylene occlusive wrap applied immediately after delivery to infants born at less than 28 weeks gestation decrease all-cause mortality measured at discharge compared with the standard of care as determined by the Neonatal Resuscitation Program guidelines (i.e. drying under radiant heat)?


Options:
A: N/A
B: Axillary temperature 36.5-37.5 degrees Celsius (1-4 hours)
C: Axillary temperature taken on admission to the NICU (immediately after total body wrap and wrap removal) and again 1 hour later
D: Death to discharge or at six months corrected gestational age (discharge or six months corrected gestational age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Macronutrient Intake - Carbohydrate
Brief Summary: Cardiovascular disease (CVD) and diabetes are health conditions that are strongly influenced by a person's diet. Although the best diet to prevent CVD and diabetes is uncertain, reducing intake of saturated and transunsaturated fats is known to help lower cardiovascular risk. However, even diets low in these fats can vary widely in other energy providing nutrients, particularly carbohydrates. This study will determine the effects of a higher versus lower carbohydrate diet, each with a high or low glycemic index (GI) composition, on risk factors for CVD and diabetes.


Options:
A: body mass index (change from baseline to 12 months)
B: Systolic blood pressure (SBP), Low Density Lipoproteins (LDL) cholesterol, High Density Lipoproteins (HDL) cholesterol, triglycerides, and insulin sensitivity (Measured at Week 5 of each dieting period)
C: N/A
D: Blood Flow in Brain Areas of Intake Control. (4 hours postprandial)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Proactive Tobacco Treatment for Diverse Veteran Smokers
Brief Summary: Tobacco use is the leading cause of premature death in the United States and disproportionately affects Veterans and certain racial/ethnic minority groups. Most smokers are interested in quitting; however, current tobacco use treatment approaches are reactive and require smokers to initiate treatment or depend on the provider to initiate smoking cessation care. As a result, most smokers do not receive comprehensive, evidence-based treatment for tobacco use that includes intensive behavioral counseling along with pharmacotherapy. Proactive tobacco treatment integrates population-based treatment (i.e., proactive outreach) and individual-level treatment (i.e., smoking cessation counseling and pharmacotherapy) to address both patient and provider barriers to comprehensive care.


Options:
A: Motivation to quit smoking, utilization of available resources, smoking cessation rate (1 year)
B: Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence (12 months after randomization)
C: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
D: Quit line re-enrollment (At 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CARdiorenal REScue Study in Acute Decompensated Heart Failure: CARRESS
Brief Summary: Heart failure is a serious condition in which the heart's ability to pump blood through the body is impaired, often making a person feel weak or fatigued. When a person's condition worsens to the point of hospitalization, that person is said to have acute decompensated heart failure (ADHF). Abnormal kidney function in association with cardiac distress, known as cardiorenal syndrome, is a common complication of heart failure and causes further medical problems and need for hospitalization. While there are various effective treatments for heart failure, more research is needed to determine the best treatment for targeting both ADHF and cardiorenal syndrome. This study will compare the safety and effectiveness of ultrafiltration versus standard medical drug therapy in improving renal function and relieving fluid buildup in people hospitalized with ADHF and cardiorenal syndrome.


Options:
A: Change in Serum Creatinine (Change from Baseline to Day 4); Change in Weight (Change from Baseline to Day 4)
B: Cardiac death and rehospitalization for HF (180 days)
C: Evaluate the number and percentage of eligible patients who are discharged on optimal therapy. Evaluate all HF indicators recommended by JCAHO and CMS.
D: number of hospitalizations for heart failure (End of study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Studying of Acupuncture for Bell's Palsy According to Different Stages
Brief Summary: The purpose of this trial will certify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy


Options:
A: The changes in the pain score. (wk52)
B: Nepean Dyspepsia Index (4 weeks)
C: House-Brackmann scale （Global Score） (a week)
D: Change from Baseline in numerical rating scale of back pain (Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.)

Answer: C