TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient and Provider Interventions for Managing Osteoarthritis in Primary Care
Brief Summary: Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of disability among veterans. Many veterans with OA have significant pain and functional limitations, even though they receive some medical care for their OA. Efforts are needed to help veterans to improve OA-related outcomes. This study will examine a comprehensive approach to helping veterans manage their OA-related symptoms, in the context of a VA clinical setting. The study examines an intervention aimed at helping veterans with behaviors that are known to improve OA-related pain and function (such as exercise, weight management, and coping with pain), as well as helping providers to implement evidence-based recommendations for clinical care. The intervention is relatively low cost and easy to disseminate, with the patient component being telephone based. Therefore, if effective, this intervention could be implemented widely across the VA healthcare system.


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: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (0, 4, 10, 16 months)
C: EQ5D (At baseline and at follow-up after 6 months); Arthritis self-efficacy scale (At baseline and at follow up after 6 months); One-leg rising from sitting to standing (At baseline and at follow up after 6 months); Grip Ability Test (At baseline and at follow up after 6 months)
D: Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) (12-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence
Brief Summary: The purpose of this study is to determine if subsensory stimulation (amplitude) will maintain same continence in patients treated with Sacral Nerve Stimulation (SNS) for faecal incontinence as stimulation with amplitude at sensory threshold.


Options:
A: 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)
B: Percentage of Participants Who Are Responder50. (6 months after last blinded treatment); Percentage of Participants Who Are Responder25. (12 months after last treatment)
C: Proportion of subjects with an average of 3 or more SCBM per week (12 weeks)
D: Number of incontinence episodes Assess number of incontinence episodes. (Will be assessed every four weeks during a twelve-week period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) Parameters After the Administration of Ketamine, Two Doses of AZD6765 and Placebo
Brief Summary: This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in EEG.


Options:
A: Change in MADRS Total Score From Baseline to Week 6 (6 weeks)
B: To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score (Baseline to week 3)
C: Montgomery-Asberg Depression Rating Scale (MADRS) (Measured daily for 12 days, where the endpoint is the primary outcome)
D: qEEG assessed through the gamma bands (Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit
Brief Summary: The investigators hypothesized that an enriched focus on mother-infant bonding during a newborn's hospitalization in the Neonatal Intensive Care Unit would reduced the rate maternal postpartum smoking relapse and would prolong the duration of breastfeeding in mothers who had quit smoking during or just prior to pregnancy.


Options:
A: Participant smoking status. (6 and 12 month follow-up)
B: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
C: Duration of smoke-free status (8 weeks postpartum); Duration of breastfeeding (8 weeks postpartum)
D: The primary endpoint will be 6M of abstinence measured 18M after enrollment. (18M)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin With Sulfonylurea Treatment in Patients With Type 2 Diabetes During Ramadan Fasting
Brief Summary: This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.


Options:
A: Change in HbA1c (Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan))
B: Proportion of Participants With at Least One Symptomatic Hypoglycemic Event (30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10))
C: Hypoglycemia (29 days of Ramadan); Hyperglycemia (29 days of Ramadan)
D: Change in HbA1c (%) (Glycosylated Haemoglobin) (From week 0 to end of Ramadan (day 29 of Ramadan))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Tolerability of Bevacizumab Plus Paclitaxel vs. Bevacizumab Plus Metronomic Cyclophosphamide and Capecitabine as First-Line Therapy in Patients With HER2-Negative Metastatic or Locally Recurrent Breast Cancer - A Multicenter, Randomized Phase III Trial.
Brief Summary: RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as paclitaxel, cyclophosphamide, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether bevacizumab is more effective when given together with paclitaxel or cyclophosphamide and capecitabine in treating patients with breast cancer.

PURPOSE: This randomized phase III trial is studying the side effects of giving bevacizumab together with paclitaxel and to see how well it works compared with giving bevacizumab together with cyclophosphamide and capecitabine as first-line therapy in treating women with locally advanced, recurrent, or metastatic breast cancer.


Options:
A: Incidence of grade 3-5 adverse events (Documentation of AE observed during trial treatment and in follow-up until resolution)
B: Pathologic complete response
C: Determination of pCR rates (2010)
D: Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013) (Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years); Progression Free Survival (Maintenance Phase Data Cutoff October 4, 2013) (Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SBIRT in New Mexico
Brief Summary: The purpose of this study is to compare the effectiveness in reducing drug use and its associated problems of a brief intervention for drug use delivered by a behavioral health counselor as compared to a brief intervention delivered by a computerized intervention.


Options:
A: Use of illicit drugs in the past 30 days (baseline, 3, 6, 9, and 12 months); Enrollment in formal substance abuse treatment (baseline up to 2 years post-intervention); Medical, legal, employment, social, and psychiatric outcomes (baseline, 3, 6, 9, and 12 months)
B: Number of cannabis-abstinent days in past month (Baseline, 6 months, 10 months)
C: Health of Nations Outcome Scale (HONOS) (Baseline, 6 months, 12 months, 18 months,)
D: Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score (3 months post-baseline); Hair Testing (3 month post-baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk
Brief Summary: The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.


Options:
A: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
B: Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
C: Incidence of Poor Graft Function After Kidney Transplant (7 days after transplant)
D: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. (From randomisation to individual end of observation, up to 4.6 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk
Brief Summary: The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.


Options:
A: HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment (Baseline and 24 weeks)
B: Effect of glucose and glucose-insulin infusion on plasma IGF-I and IGFBP-1 during hemodialysis (From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis)
C: Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment (24 weeks)
D: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. (From randomisation to individual end of observation, up to 4.6 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk
Brief Summary: The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.


Options:
A: Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) (From randomisation until completion of the planned treatment period, up to 1040 days.)
B: Composite of cardiovascular events which were defined as death from a cardiovascular cause, death from any cause, nonfatal myocardial infarction, nonfatal stroke or arterial revascularization
C: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. (From randomisation to individual end of observation, up to 4.6 years)
D: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk
Brief Summary: The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.


Options:
A: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. (From randomisation to individual end of observation, up to 4.6 years)
B: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
C: HbA1c (Recorded at baseline (week 0), week 12, week 24 and week 36)
D: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhanced Behavioral Intervention to Improve Long-Term Weight Loss in Young Adults
Brief Summary: The prevalence of obesity in young adults has been increasing, and excessive body weight have been linked to numerous chronic conditions including cardiovascular disease, diabetes, many forms of cancer, and numerous musculoskeletal problems. This study will focus of the development and evaluation of interventions that may be appropriate for young adults (age 18-35 years) to improve weight loss outcomes following a 24 month intervention. The primary aim of this study is to examine whether an enhanced weight loss intervention (EWLI) that includes technology components results in improved weight loss in young adults (18-35 years of age) compared to a standard behavioral weight loss intervention (SBWP) over a period of 24 months. Eligible participants will also be assessed for body composition, body fat distribution, fitness, physical activity, dietary intake, and behavioral/psychosocial measures that may be predictive of behavior change. Assessments will occur at 0, 6, 12, 18, and 24 months. Subjects will participate in a 24 month behavioral weight loss program that includes a reduction in energy intake and moderate-to-vigorous intensity exercise (progressively increasing from 100 to 300 minutes per week). The technologies added to EWLI are text messaging, a wearable device that provides feedback on physical activity, and access to a website to monitor dietary behaviors.


Options:
A: For adults: body weight loss maintenance (6 Month)
B: N/A
C: weight change (Change from baseline to 24 months)
D: weight loss at 12 weeks; Fat loss at 12 weeks; Lean mass change at 12 weeks

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Endometrial Injury Prior Ovulation Induction for Assisted Reproductive Techniques: a Randomized Controlled Trial
Brief Summary: The objective of this study is to evaluate the effect of endometrial injury performed prior ovulation induction for assisted reproductive techniques main outcomes.


Options:
A: Implantation ratio (Six months); Clinical pregnancy ratio (six months); Live birth ratio (six months)
B: Clinical pregnancy rate (6 months)
C: Implantation Rate,Chemical pregnancy rate, Clinical pregnancy rate (One year)
D: Live Birth (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Endometrial Injury Prior Ovulation Induction for Assisted Reproductive Techniques: a Randomized Controlled Trial
Brief Summary: The objective of this study is to evaluate the effect of endometrial injury performed prior ovulation induction for assisted reproductive techniques main outcomes.


Options:
A: Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3 (weeks 1-3)
B: Implantation Rate,Chemical pregnancy rate, Clinical pregnancy rate (One year)
C: Levels of progesterone in the mid-luteal phase. (up to 1-1½years.)
D: Live Birth (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Endometrial Injury Prior Ovulation Induction for Assisted Reproductive Techniques: a Randomized Controlled Trial
Brief Summary: The objective of this study is to evaluate the effect of endometrial injury performed prior ovulation induction for assisted reproductive techniques main outcomes.


Options:
A: Live Birth (1 year)
B: implantation rate (4 weeks)
C: Live Birth (up to 9 months or time of birth)
D: Delivery rate (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Endometrial Injury Prior Ovulation Induction for Assisted Reproductive Techniques: a Randomized Controlled Trial
Brief Summary: The objective of this study is to evaluate the effect of endometrial injury performed prior ovulation induction for assisted reproductive techniques main outcomes.


Options:
A: implantation rate (16 days from eggretrieval)
B: Live Birth (1 year)
C: PRIMARY OUTCOME MEASURE:IMPLANTATION RATE; (9 MONTHS)
D: Implantation ratio (Six months); Clinical pregnancy ratio (six months); Live birth ratio (six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Suture Techniques to Reduce the Incidence of The inCisional Hernia
Brief Summary: The objective of the study is reduction of the incidence of the most frequent complication of abdominal surgery, incisional hernia. In this multi center double-blinded prospective randomized controlled trial, in which a new suture technique using small bites is compared with the traditionally applied large bites (mass closure) technique for midline incisions.


Options:
A: The number of wound infections (30 days after the operation)
B: Incisional hernia or burst abdomen within 12 months (12 months)
C: Incisional hernia occurrence within one year after operation clinical and/or radiographically detected (one year)
D: Frequency of wound infection (Within the first 30 days after surgery); Frequency of incisional hernia (One year after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Activity of Mefloquine Against Urinary Schistosomiasis
Brief Summary: Urinary schistosomiasis is a debilitating disease in Central Africa and pregnant women are frequently suffering from this condition. Mefloquine is currently investigated as preventive treatment against malaria in pregnancy and mefloquine is also known to exert activity against schistosomiasis. The investigators want to test the hypothesis whether mefloquine may active against urinary schistosomiasis when used as preventive treatment against malaria in pregnancy.


Options:
A: STH transmission interruption (5 years (Three years of drug administration and two years of surveillance))
B: Reduction of egg excretion (6 weeks after second IPTp)
C: Mean (± standard deviation) weight gain (kg) (Change between birth and six months of age)
D: Severe Anemia

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randonized Control Trial of a Brain Preservation Diet in Preventing Congnitive Decline in Odl Age Hostel Residents
Brief Summary: Dementia is a major cause of disabilities in older people. If the onset of dementia can be delayed by preventive measures, the burden of the disease to the society can be greatly reduced. It is now recognised that dietary factors are related to the incidence of dementia. High intake of vegetables, fruit and fish are protective while high intake of saturated fat and salt (via its effect on blood pressure) are detrimental to risk of dementia.

The investigators therefore propose to perform a randomized controlled trial of dietetic interventions in old age hostels in Hong Kong. Twelve old age hostels under the Tung Wah Group will be randomly assigned to intervention or control groups. The intervention group will receive dietetic interventions by 2 weekly small group discussion with the residents, modification of menu and publicity. The daily diet to be implemented consists of the following principles: 1. fresh fruit 2 portions, 2. vegetables 4 portions, 3. fish, 4. white meat, 5. sodium intake \< 100 mmol/L, 6. six glasses of water. In the control group. The dietician will give two health talks and advice on menu only.

The primary outcome is the incidence of questionable dementia in those who are normal at baseline and the incidence of dementia in those who have questionable dementia at baseline. The categorisation will be performed by trained research assistant after administering a structured questionnaire. Change in mini-mental examination score and SF36 quality of life scores are secondary outcomes. Food records over three days for each subject are recorded every three months, to ensure that the brain preservation diet has been adhered to. Half of the subjects will be randomly assigned to have blood and urine tests at baseline and at one year, in order to examine the health effects of dieting.


Options:
A: To detect a significant difference in energy intake of 48kJ/200 kcal between the groups at 5% significance level and with 80% power. (5 days to 3 weeks intervention)
B: Assessment of nutritional status with the Mini nutritional Assessment (MNA) (Baseline and every 4 weeks, up to 24 weeks)
C: cognitive decline (33 months)
D: Nutritional status; Quality of life; Physical performance

Answer: C