TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Lipid-based Nutrient Supplements (LNS) for Pregnant and Lactating Women and Their Infants
Brief Summary: In Ghana, low micronutrient intakes among pregnant women are a major problem. The standard nutritional intervention during pregnancy is iron-folic acid tablets, but adherence is low. The investigators have pioneered the use of multiple micronutrient-fortified semi-solid pastes called Lipid-based Nutrient Supplements (LNS) (made using vegetable oil, groundnut, milk, sugar, and micronutrients), and the investigators' previous studies show that the approach could have great potential for use by pregnant and lactating women.

This study aims to evaluate the effects of LNS-P\&L designed for pregnant and lactating women and LNS-20gM designed for infants. Pregnant women (n=864) randomly selected from ante-natal clinics in Yilo and Manya Krobo districts of Ghana will be randomized to receive daily (a) Group 1: Iron/ Folic Acid tablets during pregnancy, and a tablet containing calcium (Ca) only (akin to a placebo) during lactation (6 mo), (b) Group 2: Multiple Micronutrient tablets during pregnancy and the first six months of lactation, or (c) Group 3: LNS-P\&L during pregnancy and lactation, whilst their infants receive LNS-20gM daily from 6 to 18 months. There are two primary outcomes namely:

1. Maternal primary outcome: Birth length
2. Child primary outcome: Child length-for-age z-score at 18 mo.

The investigators hypothesize that a) mean birth length and length-for-age at 18 mo will be greater in children whose mothers are in Group 2 than those whose mothers are in Group 1, and b) children whose mothers are in Group 3 will have greater birth length and length-for-age at 18 mo than the children in either of the other two groups.


Options:
A: N/A
B: Weight gain during the 12-week follow-up (in grams)
C: Postpartum weight loss between delivery and 28 weeks (between delivery and 28 weeks); Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.) (birth to 28 weeks); Exclusive breastfeeding and breastfeeding cessation by 28 weeks (birth to 28 weeks)
D: Maternal primary outcome is child length at birth (0 - 48 hr after birth); Child primary outcome is child length-for-age Z-score (LAZ, based on WHO 2006 growth standards) at 18 months of age (18 months after birth)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Hypertension in Patients With Pre-hypertension: PREVER-prevention Study
Brief Summary: The incidence of hypertension in individuals with pre-hypertension was 80% in ten years in a study conducted in Southern Brazil. The effectiveness of non-drug interventions to prevent hypertension is low in the long term. It may be hypothesized that a population-based drug intervention could reduce relevantly the burden of hypertension and cardiovascular disease.

Diuretics are at least as efficacious as other blood pressure-lowering drugs, are well tolerated, have longer duration of action and the advantage of very low cost to be used in a population intervention. Chlorthalidone is the more efficacious agent. Its main limitation is to induce hypokalemia in a proportion of patients, an adverse effect that can be antagonized by a potassium-sparing diuretic, as amiloride.

A study with this objective is therefore recommendable in Brazil, in order to support a plan of precocious intervention in individuals with pre-hypertension. Such a study was demanded and funded by the Health and Technology Ministries in Brazil.


Options:
A: Incidence of hypertension, by blood pressure ≥ 140/90 mmHg in individuals without diabetes or ≥ 135/85 mmHg in participants with diabetes. (18 months); Adverse events. (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG (18 months)
B: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
C: N/A
D: diabetes; death

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Hypertension in Patients With Pre-hypertension: PREVER-prevention Study
Brief Summary: The incidence of hypertension in individuals with pre-hypertension was 80% in ten years in a study conducted in Southern Brazil. The effectiveness of non-drug interventions to prevent hypertension is low in the long term. It may be hypothesized that a population-based drug intervention could reduce relevantly the burden of hypertension and cardiovascular disease.

Diuretics are at least as efficacious as other blood pressure-lowering drugs, are well tolerated, have longer duration of action and the advantage of very low cost to be used in a population intervention. Chlorthalidone is the more efficacious agent. Its main limitation is to induce hypokalemia in a proportion of patients, an adverse effect that can be antagonized by a potassium-sparing diuretic, as amiloride.

A study with this objective is therefore recommendable in Brazil, in order to support a plan of precocious intervention in individuals with pre-hypertension. Such a study was demanded and funded by the Health and Technology Ministries in Brazil.


Options:
A: Incidence of hypertension, by blood pressure ≥ 140/90 mmHg in individuals without diabetes or ≥ 135/85 mmHg in participants with diabetes. (18 months); Adverse events. (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG (18 months)
B: All strokes (fatal and non-fatal) (Duration of trial)
C: stroke; new or recurrent transient ischemic attack; new or recurrent acute myocardial infarction; new occurrence or exacerbation of heart failure; new occurrence or exacerbation angina pectoris; dissecting aneurysm of the aorta; lower limb arterial obstruction; transition to dialysis; doubling of plasma creatinine (Cr) levels
D: Change from baseline in diastolic blood pressure after 52 weeks

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Hypertension in Patients With Pre-hypertension: PREVER-prevention Study
Brief Summary: The incidence of hypertension in individuals with pre-hypertension was 80% in ten years in a study conducted in Southern Brazil. The effectiveness of non-drug interventions to prevent hypertension is low in the long term. It may be hypothesized that a population-based drug intervention could reduce relevantly the burden of hypertension and cardiovascular disease.

Diuretics are at least as efficacious as other blood pressure-lowering drugs, are well tolerated, have longer duration of action and the advantage of very low cost to be used in a population intervention. Chlorthalidone is the more efficacious agent. Its main limitation is to induce hypokalemia in a proportion of patients, an adverse effect that can be antagonized by a potassium-sparing diuretic, as amiloride.

A study with this objective is therefore recommendable in Brazil, in order to support a plan of precocious intervention in individuals with pre-hypertension. Such a study was demanded and funded by the Health and Technology Ministries in Brazil.


Options:
A: Incidence of hypertension, by blood pressure ≥ 140/90 mmHg in individuals without diabetes or ≥ 135/85 mmHg in participants with diabetes. (18 months); Adverse events. (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG (18 months)
B: diabetes; death
C: 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)
D: Composite of fatal and non-fatal stroke (During the study period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial Comparing Axillary Dissection "by Principle" and Axillary Dissection Based on the Histological Result of the Sentinel Node, in Patients With Breast Carcinoma of Small Size
Brief Summary: The purpose of this study is to evaluate the disease free and overall survival of patients with breast carcinomas of small size, i.e., not greater than 2.0 cm and with clinically non palpable axillary lymph nodes, undergoing either conservative surgery and axillary dissection, or a similar treatment for the primary tumor and rapid analysis of the sentinel lymph node, the result of which determines axillary node dissection or its avoidance is based.


Options:
A: disease free survival, overall survival (every 6 months for the first 5 years and every 8 months afterwards)
B: Overall Survival (5 years)
C: N/A
D: Axillary recurrence rate (from randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Internet Support for Cancer Patients on Health Outcomes, Health Care Utilization and Costs: A Randomized Clinical Trial
Brief Summary: Being diagnosed and treated for cancer is usually associated with severe physical symptoms, impaired functional status, complex emotional, psychosocial and existential issues and substantial worries. Failure to help patients with their problems and worries can unnecessarily delay patients' recovery and rehabilitation, lead to chronic functional impairments, anxiety and depression and prolong patients' needs for health care and social services. The objectives of this interdisciplinary, international research project that includes collaboration with HELFO (The Norwegian Health Economy Administration), are to test and compare, in a randomized, controlled trial (RCT), the effects of (1) a practice-integrated online patient-provider communication (OPPC) service including access to asking questions to HELFO, (2) a multi-component Interactive Health Communication Application (IHCA) called WebChoice, and (3) usual care on: patient outcomes, health care and social services use and costs. Breast cancer patients undergoing treatment at three different hospitals in Norway will be randomized into two experimental and one control groups and will be followed with 5 repeated measures over one year. The proposed study will contribute to innovative methods and technologies that can radically improve patient-provider communication, care quality, and continuity of care. The two interventions tested in this study, the OPPC service with and without additional features of WebChoice, represent new forms of interactions and information sharing between patients and clinicians where patients can get seamless access to communication and information services from where and whenever they need it. This could significantly contribute to reducing unnecessary suffering, less fragmented health care, better efficiency, patient safety, patient satisfaction and have an impact on patients' health services utilization. The investigators' work addresses, therefore, important health policy goals with the potential for considerable societal gains.


Options:
A: Score of Asthma Control Questionnaire (baseline and over a year)
B: Severity and duration of symptom distress (At baseline and at 2, 4, 6, 8 and 12 months); Anxiety and depression (At baseline an at 2, 4, 6, 8 and 12 months)
C: The proportion of control and intervention subjects who are current on EACH individual indicated preventive service (Annual for three years); The proportion of control and intervention subjects who are current on ALL indicated preventive services (Annual for three years); The mean score for intervention and control subjects for quality of clinician communication (CAPHS-CGS questions 14-20); and frequency with which patients report sharing medical decisions (CAHPS questions SD 1-3) (Annual for three years)
D: Comparison of change in diabetes quality of care between intervention and usual care group. (6 months follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Higher Than Maximum 450IU Gonadotropin Dose on Patient Outcomes in an In-Vitro Fertilization Setting: a Randomized Controlled Non-infertility Trial
Brief Summary: This goal of this study is to evaluate the outcomes from in vitro fertilization cycles where a 450 IU daily dose of gonadotropins is administered compared to those where a 600 IU daily dose is administered for women who are at risk of a poor ovarian response in order to determine if one dose or the other results in improved cycle outcomes.


Options:
A: Number of Oocytes Retrieved (Day of oocyte retrieval (up to Day 18 after start of stimulation))
B: Ongoing Pregnancy Rate (10-11 weeks after blastocyst transfer); Ongoing Implantation Rate (10-11 weeks after blastocyst transfer)
C: Number of metaphase II oocytes retrieved during the course of one treatment cycle (2 years)
D: Number of good-quality blastocysts on Day 5 after oocyte retrieval (On Day 5 after oocyte retrieval)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Higher Than Maximum 450IU Gonadotropin Dose on Patient Outcomes in an In-Vitro Fertilization Setting: a Randomized Controlled Non-infertility Trial
Brief Summary: This goal of this study is to evaluate the outcomes from in vitro fertilization cycles where a 450 IU daily dose of gonadotropins is administered compared to those where a 600 IU daily dose is administered for women who are at risk of a poor ovarian response in order to determine if one dose or the other results in improved cycle outcomes.


Options:
A: Number of metaphase II oocytes retrieved during the course of one treatment cycle (2 years)
B: Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set (10-11 weeks after embryo transfer at the blastocyst stage); Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set (10-11 weeks after embryo transfer at the blastocyst stage)
C: Ongoing Pregnancy Rate (10-11 weeks after blastocyst transfer); Ongoing Implantation Rate (10-11 weeks after blastocyst transfer)
D: Number of patients obtaining 5-12 oocytes during COH (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison Between Diuretics and Angiotensin-receptor Blocker Agents in Patients With Stage I Hypertension: PREVER-treatment Study
Brief Summary: High blood pressure is the major risk factor for Cardiovascular disease (CVD). The prevalence of hypertension in Brazil was established in population-based studies conducted in different cities and States, varying from 22.3 to 44% of adults.

The benefit of drug treatment of hypertension to prevent major cardiovascular events was consistently demonstrated in a large series of clinical trials controlled by placebo.

Diuretics are at least as efficacious as other blood pressure-lowering drugs, are well tolerated, have longer duration of action and the advantage of very low cost to be used in a population intervention. Chlorthalidone is the more efficacious agent. Its main limitation is to induce hypokalemia in a proportion of patients, an adverse effect that can be antagonized by a potassium-sparing diuretic, as amiloride.

A study comparing diuretic with an ARB agent is therefore recommendable in Brazil, in order to support the decisions of the Health Secretary in regard to blood pressure agents supply for the Brazilian population. Such a study was demanded and funded by the Health and Technology Ministries in Brazil.


Options:
A: Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event (For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]))
B: Blood Pressure Response (Delta BP (After 18 Weeks of Medication - Baseline)). (baseline to 18 weeks of treatment)
C: Blood pressure variation and proportion of use of add-on drugs (18 months); Adverse events (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. (18 monyhs)
D: A composite of fatal and non-fatal cardiovascular events. (first event); Achievement of target blood pressure (< 140 mmHg/90 mmHg). (time course)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison Between Diuretics and Angiotensin-receptor Blocker Agents in Patients With Stage I Hypertension: PREVER-treatment Study
Brief Summary: High blood pressure is the major risk factor for Cardiovascular disease (CVD). The prevalence of hypertension in Brazil was established in population-based studies conducted in different cities and States, varying from 22.3 to 44% of adults.

The benefit of drug treatment of hypertension to prevent major cardiovascular events was consistently demonstrated in a large series of clinical trials controlled by placebo.

Diuretics are at least as efficacious as other blood pressure-lowering drugs, are well tolerated, have longer duration of action and the advantage of very low cost to be used in a population intervention. Chlorthalidone is the more efficacious agent. Its main limitation is to induce hypokalemia in a proportion of patients, an adverse effect that can be antagonized by a potassium-sparing diuretic, as amiloride.

A study comparing diuretic with an ARB agent is therefore recommendable in Brazil, in order to support the decisions of the Health Secretary in regard to blood pressure agents supply for the Brazilian population. Such a study was demanded and funded by the Health and Technology Ministries in Brazil.


Options:
A: Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks (Baseline, 8 weeks, 16 weeks, and 24 weeks); Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24 (Baseline to 24 weeks)
B: Blood pressure variation and proportion of use of add-on drugs (18 months); Adverse events (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. (18 monyhs)
C: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
D: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Structured Management of Patients With Suspicion of Appendicitis Using a Clinical Score and Selective Imaging
Brief Summary: Patients with acute abdominal pain and suspicion of appendicitis are common. The management of these patients is controversial with large variations between hospitals. The clinical diagnosis is regarded as insufficient necessitating the use of diagnostic techniques like ultrasound, computerized tomography and diagnostic laparoscopy. However, the role of these diagnostic techniques is not clear.

This aim of this prospective interventional study is to analyze the impact of the implementation of a clinical score to improve the clinical diagnosis and to serve as a basis for a structured management of these patients by comparison of the results after the implementation of the score with that of a baseline period. In the group of patients with indeterminate diagnosis according to the clinical score, the value of diagnostic imaging will be evaluated and compared with a period of in-hospital observation by randomization. The hypothesis is that a clinical score will decrease the use of unnecessary diagnostic imaging and unnecessary admissions to hospital for observation.


Options:
A: sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient. (immediate reading + blinded reading within 48 hours)
B: The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis (Up to 10 years)
C: rate of intra abdominal infections in both therapeutic strategies (30 days)
D: Proportion of negative appendectomies (During the hospital admission)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I Study of GW685698X-A Randomized, Double Blind, Placebo Controlled, Parallel-group, Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Dose From a Novel Dry Powder Device in Healthy Japanese Male Subjects.
Brief Summary: This is a randomized, double blind, placebo controlled, parallel-group, repeat dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dose from a novel dry powder device in healthy Japanese male subjects.


Options:
A: safety: adverse events, vital sign, ECGs, and clinical laboratory test; PK： Cmax, tmax and AUC(0-t); PD: serum cortisol
B: Maximum heart rate (over 4 hours after dosing.); Blood pressure changes (over 12 hours.); Electrocardiogram changes (over 12 hours.); Change in peak expiry flow rate changes (over 24 hours.); Change in serum cortisol concentration changes (over 24 hours)
C: Mean Annual Rate of Moderate or Severe COPD Exacerbations (Up to 54 weeks)
D: Change From Baseline in Clinic Trough Forced Expiratory Volume in One Second (FEV1) at the End of Treatment Phase A (Visit 6/Day 29) (Baseline and Day 29)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mentor Mothers: A Sustainable Family Intervention in South African Townships
Brief Summary: The purpose of this study is to test a mother-to-mother intervention during pregnancy and after delivery with Mothers Living with HIV (MLH)in South Africa. We hypothesize that the intervention will enhance the adjustment of the children of MLH by improving the health and mental health of MLH which benefits their children, as well as the MLH.


Options:
A: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)
B: Posttraumatic Diagnostic Scale (PDS/PSS-I). (Symptoms will be assessed at pre-treatment-point and post-treatment-point (up to 6-month follow-ups)); The Patient Health Questionnaire-9 (PHQ-9) (At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups); The Hopkins Symptom Checklist-25 (HSCL-25) (At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups); Perceived Stress Scale-4 (At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups)
C: Intimate partner violence (One year)
D: Change in telomerase activity (pre-intervention (baseline) and post-intervention (5.5 months later))

Answer: A