TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Prenatal Nutritional Supplementation on Birth Outcome in Hounde District, Burkina Faso
Brief Summary: Low birth weight (LBW; birth weight\<2,500g) is the most important determinant of mortality and morbidity in the neonatal period. It is also a very important factor in predicting nutritional status, health and development in childhood. It even influences health in adult life, contributing to the vicious cycle of disease and poverty. The high rate LBW in DCs represents therefore a major public health problem. Maternal chronic energy deficiency is assumed to be a major determinant of the problem in these countries along with prenatal micronutrient deficiencies. A large body of recent evidence points out that multiple micronutrient supplementation as such has only a modest beneficial effect on fetal growth. Therefore, it is expected that providing these multiple micronutrients in a food supplement covering energy requirement needs of pregnant women will have an effect of public health importance on children's health.

This study has the objective of improving children's health by improving birth outcome and fetal growth through the provision of a food supplement enriched in multimicronutrients during pregnancy.

This research includes 2 constituents:

1. a pilot phase during which dietary behavior of pregnant women is assessed as a component for optimal fetal growth
2. a randomized, placebo-controlled trial, including 1300 pregnant women aimed at testing 2 hypotheses: supplementing pregnant women with a food supplement containing a multivitamin-minerals mix will improve fetal growth; improved fetal growth will have a positive effect on health and growth during infancy.

The trial is planned in Hounde District, Burkina Faso, in collaboration with Centre Muraz, which plays a leader role in research and services providing at the district level and in policy recommendations at the national level. This will ensure that the study findings are incorporated into on-going district programs with possible replication at the national level. The research lasts from February 2006 to August 2009.


Options:
A: Change from baseline in the micronutrient status in the study subjects at 6 months (6 months)
B: N/A
C: Weight, length and Rohrer index at birth, and gestational duration in singleton pregnancies. (At birth); Mortality, morbidity and growth during the first year of life (Monthly during infancy)
D: Weight gain during the 12-month follow-up (in grams)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Prenatal Nutritional Supplementation on Birth Outcome in Hounde District, Burkina Faso
Brief Summary: Low birth weight (LBW; birth weight\<2,500g) is the most important determinant of mortality and morbidity in the neonatal period. It is also a very important factor in predicting nutritional status, health and development in childhood. It even influences health in adult life, contributing to the vicious cycle of disease and poverty. The high rate LBW in DCs represents therefore a major public health problem. Maternal chronic energy deficiency is assumed to be a major determinant of the problem in these countries along with prenatal micronutrient deficiencies. A large body of recent evidence points out that multiple micronutrient supplementation as such has only a modest beneficial effect on fetal growth. Therefore, it is expected that providing these multiple micronutrients in a food supplement covering energy requirement needs of pregnant women will have an effect of public health importance on children's health.

This study has the objective of improving children's health by improving birth outcome and fetal growth through the provision of a food supplement enriched in multimicronutrients during pregnancy.

This research includes 2 constituents:

1. a pilot phase during which dietary behavior of pregnant women is assessed as a component for optimal fetal growth
2. a randomized, placebo-controlled trial, including 1300 pregnant women aimed at testing 2 hypotheses: supplementing pregnant women with a food supplement containing a multivitamin-minerals mix will improve fetal growth; improved fetal growth will have a positive effect on health and growth during infancy.

The trial is planned in Hounde District, Burkina Faso, in collaboration with Centre Muraz, which plays a leader role in research and services providing at the district level and in policy recommendations at the national level. This will ensure that the study findings are incorporated into on-going district programs with possible replication at the national level. The research lasts from February 2006 to August 2009.


Options:
A: Birth weight (Within 48 hours (or back calculated from later measurements).); Birth length (Within 48 hours (or back calculated from later measurements)); Child linear growth status at 24 months (24 months)
B: Weight gain during the 12-week follow-up (in grams)
C: N/A
D: Weight, length and Rohrer index at birth, and gestational duration in singleton pregnancies. (At birth); Mortality, morbidity and growth during the first year of life (Monthly during infancy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intervention About Breastfeeding and Complementary Feeding in Adolescent Mothers and Their Grandmothers
Brief Summary: The purpose of this study is to determine whether counseling sessions on breastfeeding for adolescent mothers and their grandmothers in the maternity ward and at home are effective in to improve the exclusive and total breastfeeding rates during the first six month, as well as the convenient timing of supplementary feeding introduction.


Options:
A: Frequency of exclusive and total breastfeeding (First year)
B: Infant Feeding Questionnaire (4 weeks)
C: Exclusive breastfeeding (EBF) among children 0-6 months of age (4 years after baseline); Child anthropometry (height, weight) among children 24-48 months of age (4 years after baseline); Complementary feeding among children 6-23.9 months of age (4 years after baseline); Anemia among children 6-23.9 months (4 years after baseline)
D: Exclusive Breastfeeding Rate (3 months postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intervention About Breastfeeding and Complementary Feeding in Adolescent Mothers and Their Grandmothers
Brief Summary: The purpose of this study is to determine whether counseling sessions on breastfeeding for adolescent mothers and their grandmothers in the maternity ward and at home are effective in to improve the exclusive and total breastfeeding rates during the first six month, as well as the convenient timing of supplementary feeding introduction.


Options:
A: Prevalence of underweight among children 0-23 months; Prevalence of stunting among children 0-23 months; Prevalence of wasting among children 0-23 months; Prevalence of anemia among children 12-23 months
B: Excessive weight gain (0-6 months)
C: Weight-for-Length Percentile (Weight and length were measured at both pre-treatment (when infant was 3 months of age) and post-treatment (when infant was 9 months of age).); Appetite Regulation (The BEBQ was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).); Fruit and Vegetable Variety (The Block Food Frequency Questionnaire was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).)
D: Frequency of exclusive and total breastfeeding (First year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intervention About Breastfeeding and Complementary Feeding in Adolescent Mothers and Their Grandmothers
Brief Summary: The purpose of this study is to determine whether counseling sessions on breastfeeding for adolescent mothers and their grandmothers in the maternity ward and at home are effective in to improve the exclusive and total breastfeeding rates during the first six month, as well as the convenient timing of supplementary feeding introduction.


Options:
A: Change in BMI Percentile (baseline and 12 months)
B: N/A
C: Frequency of exclusive and total breastfeeding (First year)
D: School-time and total daily MVPA (5 months and 1.5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intervention About Breastfeeding and Complementary Feeding in Adolescent Mothers and Their Grandmothers
Brief Summary: The purpose of this study is to determine whether counseling sessions on breastfeeding for adolescent mothers and their grandmothers in the maternity ward and at home are effective in to improve the exclusive and total breastfeeding rates during the first six month, as well as the convenient timing of supplementary feeding introduction.


Options:
A: Frequency of exclusive and total breastfeeding (First year)
B: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
C: BMI percentile at 3 years (3 years)
D: Percent of infants sleeping 5 consecutive hours at night at 2 months of age (2.5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intervention About Breastfeeding and Complementary Feeding in Adolescent Mothers and Their Grandmothers
Brief Summary: The purpose of this study is to determine whether counseling sessions on breastfeeding for adolescent mothers and their grandmothers in the maternity ward and at home are effective in to improve the exclusive and total breastfeeding rates during the first six month, as well as the convenient timing of supplementary feeding introduction.


Options:
A: Study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeeding in mothers
B: Frequency of exclusive and total breastfeeding (First year)
C: Proportion of women who exclusively breastfeed to 6 months (The outcome will be measured when the infant is 6-7 months old.)
D: Breastfeeding Initiation (Three days postpartum); Positive parenting behavior (Parent Child Observation Guide) (4 months postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intervention About Breastfeeding and Complementary Feeding in Adolescent Mothers and Their Grandmothers
Brief Summary: The purpose of this study is to determine whether counseling sessions on breastfeeding for adolescent mothers and their grandmothers in the maternity ward and at home are effective in to improve the exclusive and total breastfeeding rates during the first six month, as well as the convenient timing of supplementary feeding introduction.


Options:
A: Infant weight for height (One year after study entry)
B: Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum (60 months); Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined (60 months)
C: Frequency of exclusive and total breastfeeding (First year)
D: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Extension, Multicentre, Multi-international Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Brief Summary: Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.


Options:
A: 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12 (Baseline and week 12)
B: Number of Participants With Treatment-emergent Adverse Events (TEAE) (From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years); Number of Participants With Death (From baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit))
C: Safety and tolerability (12 weeks treatment)
D: Pulmonary artery mean pressure at rest (Peak change from baseline within 6 hours after a single dose of study drug)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Extension, Multicentre, Multi-international Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Brief Summary: Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.


Options:
A: Number of Participants With Treatment-emergent Adverse Events (TEAE) (From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years); Number of Participants With Death (From baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit))
B: Number of Participants With Adverse Events (AEs) (Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period))
C: Number of Patients Reaching a 6-Minute Walk Test (6MWT) Distance ≥ 380 Meters (at 16 weeks and at 28 weeks of a stepped approach to therapy)
D: Pulmonary Artery Systolic Pressure (PASP)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Balloon Pump Assisted Coronary Intervention Study
Brief Summary: This study will test the hypothesis that elective use of the Intra-Aortic Balloon Pump (IABP) in patients undergoing high-risk Percutaneous Coronary Intervention (PCI) will reduce the rate of in-hospital major adverse cardiac and cerebrovascular events compared to patients who are managed without planned insertion of IABP.


Options:
A: death, myocardial infarction or refractory (up to and including Day 9); major bleeding (Up to Day 9)
B: Cardiac index (within 1 hour after device implantation)
C: Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization. (30 days +/- 10 days)
D: Major Adverse Cardiac and Cerebrovascular Events (Hospital discharge or 28 days following PCI, whichever occurs sooner)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Radioembolization With Yttrium-90 Microspheres for Intermediate or Advanced HCC (Hepatocellular Carcinoma) Not Eligible to Curative Approach. A Phase II-b Study.
Brief Summary: Rationale: Patients diagnosed with hepatocellular carcinoma (HCC) at an intermediate or advanced stage (according to the BCLC classification system) are not amenable of curative treatment. According to EASL and AASLD guidelines patients with an intermediate stage HCC are treated with trans-arterial chemoembolization (TACE) while patients with an advanced stage HCC are treated with molecular targeted drugs or other combinations according to their liver function. The median survival expected for patients in intermediate-advanced stages ranges from 11 to 20 months.

Purpose of the Study: The purpose of this prospective phase II study is to determine whether or not Radioembolization with Yttrium-90 microspheres (TheraSphere®) provides an anti-tumoral effect and a sensible benefit in terms of time-to-progression (TTP) and survival in patients with good liver function (Child A-B7) and a confirmed diagnosis of Intermediate or Advanced (because of the presence of neoplastic portal thrombosis) Hepatocellular Carcinoma (HCC).


Options:
A: Median overall survival time (36 months)
B: Time to Progression (TTP) in Patients Treated With TACE and Y90 (Up to 6 yrs)
C: Time to progression (TTP) (At 1, 3, 6, 12 months and every 6 months thereafter)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study of Velcade (Bortezomib) Dexamethasone (VD) Versus Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Brief Summary: Primary objective:

* Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD.

Secondary objectives:

* Compare the following parameters following 4 cycles of VD or VTD induction treatment:

  * CR rate+ very good partial remission (VGPR) rate
  * Overall remission rate (CR + VGPR + partial remission (PR) rate)
  * K/l light chain ratio in patients in CR.
  * Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization).
* Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell transplantation (ASCT).


Options:
A: To compare the CR rate (with negative or positive immunofixation) obtained with VAD or the Velcade®/dexamethasone combination used as induction treatment in patients up to the age of 65 with newly diagnosed MM, at the end of this induction treatment
B: Time to progression
C: N/A
D: The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Deep Vein Thrombosis (DVT)
Brief Summary: The primary objective of this study is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism \[VTE\] (i.e., Pulmonary thromboembolism \[PE\] and Deep Vein Thrombosis \[DVT\])) and safety of GSK576428 as the initial treatment in subjects with acute symptomatic DVT in an open-label design.


Options:
A: The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
B: Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
C: Graft patency (28 days)
D: Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters (Day 183); Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion (Day 183 to Day 188)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Deep Vein Thrombosis (DVT)
Brief Summary: The primary objective of this study is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism \[VTE\] (i.e., Pulmonary thromboembolism \[PE\] and Deep Vein Thrombosis \[DVT\])) and safety of GSK576428 as the initial treatment in subjects with acute symptomatic DVT in an open-label design.


Options:
A: The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
B: Number of Patients With Clinically Relevant Bleeding Events (prior to day 90 +/- 5)
C: Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
D: The primary aim of the study is to compare the major hemorrhage risk between the use of LMWH plus thrombolytic treatment and UFH plus thrombolytic in the treatment of acute massive PE. (7 day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Double-Blinded, Randomised Controlled Trial of Doppler-Optimised Fluid Balance in Elective Colectomy Within an ERAS Protocol
Brief Summary: Perioperative fluid management has been historically dictated by outdated, contradictory concepts. Excessive or inadequate fluid administration around surgery is deleterious and hence goal-directed fluid therapy using Oesophageal Doppler-derived cardiac indices is preferable to optimize tissue perfusion. Previous studies in this area have been hampered by lack of standardization in other aspects of perioperative care and none have explored the impact of individualized fluid therapy on post-operative fatigue.The investigators proposed a study involving 80 patients having open/ laparoscopic colonic surgery to investigate the effect of Oesophageal Doppler guided fluid administration intraoperatively compared to current best practice of fluid restriction. The investigators have an optimized peri-operative care pathway established at the Manukau Surgical Centre (MSC), Middlemore Hospital. All patients will be cared for under the Enhanced Recovery After Surgery (ERAS) multimodal care plan therefore ensuring that all other aspects of care besides intraoperative fluid administration remain homogenous. Outcomes will include post-operative recovery, clinical outcomes as well as physiological data with follow-up to 30 days.


Options:
A: The primary outcome measure is the duration of postoperative hospital stay. (at days 1,2, and 5, as well as at ICU discharge, and hospital discharge.)
B: incidence of intraoperative hypovolemia (intraoperative)
C: Preload independent state (6 hours)
D: Post-operative functional recovery (7 day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Different Diets Containing Different Proportions of Carbohydrates in the Treatment of Gestational Diabetes Mellitus: A Randomized Clinical Trial
Brief Summary: There is evidence that controlling total amount of carbohydrates is a strategy for controlling glucose levels in diabetes mellitus. There is not major evidence that any given macronutrient percentage may be recommended to treat a woman with Gestational Diabetes Mellitus (GDM). In the investigators' country, insulin is the second-line treatment once medical nutrition therapy (MNT) has failed to control glucose levels during pregnancy. Insulin treatment is more expensive and not as well accepted as MNT. The investigators have designed a randomized-controlled trial to assess whether a diet with 40% total calories from carbohydrates may reduce the need of insulin treatment in women with gestational diabetes, without having unfavourable pregnancy outcomes, in comparison with a diet with 55% total calories from carbohydrates.


Options:
A: Need of insulin treatment for GDM (Day of delivery)
B: number of gestational diabetes cases diagnosed with OGTT (24-28th weeks gestation); difference in HOMA values (from first trimester to OGTT)
C: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
D: Mean Fetal Weight at Birth (Immediately after delivery of fetus)

Answer: A