TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Intermittent Preventive Treatment and Home Based Management of Malaria in a Rural Area of The Gambia
Brief Summary: Malaria in African countries remains an important cause of mortality and morbidity among young children. The global malaria control strategies include prompt treatment with an effective antimalarial drug, vector control using ITNs or curtains, indoor residual spraying (IRS), and intermittent preventive treatment. However, individually these interventions provide only imperfect protection. Thus, there is a need to investigate whether additional control measures provide added benefit in reducing mortality and morbidity. Therefore, 1312 children under 5 years of age living in villages and hamlets near Farafenni, The Gambia, which form part of the rural Farafenni Demographic Surveillance system (FDSS) in North Bank Region(NBR) were randomly allocated to receive IPTc or placebo from village health workers based in primary health care villages. Treatment with a single dose of sulfadoxine /pyrimethamine plus three doses of amodiaquine or placebo was given to all study subjects at monthly intervals on three occasions during the months of September, October and November. In addition, VHWs were trained to administer treatment with coartem to children if they develop symptoms compatible with malaria during the malaria transmission season. The primary end point was the incidence of clinical attacks of malaria detected during the study.


Options:
A: Prevalence of anaemia (Hb <112g/L) (March 2006)
B: Malaria incidence (the number of study subjects seen at the OPD clinic with clinical malaria during the surveillance period). (During the surveillance period (September to December 2008))
C: Efficacy:; The proportion of children with at least one episode of anemia from 3 to 18 months of life; The proportion of children with at least one episode of malaria from 3 to 18 months of life; Safety:; The proportion of children with at least one episode of an adverse event; The proportion of children with at least one episode of a serious adverse event; Rebound:; The proportion of children with at least one episode of anemia from 18-30 months of life, the proportion of children with at least one episode of malaria from 18-30 months of life
D: Incidence of clinical malaria (2008-2009)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Zinc Supplementation, Provided as Either a Liquid Zinc Solution or Dispersible Tablets, on Plasma Zinc Concentration Among Young Burkinabe Children
Brief Summary: The study aims to compare the effects of two different formulations of zinc supplements on plasma zinc concentrations among young Burkinabe children.


Options:
A: Plasma zinc concentration (3 weeks)
B: IQ score (Aug 2007-Jan 2008)
C: Plasma zinc concentration (3 weeks)
D: To evaluate innate and adaptive immune response.; Future occurrence of acute diarrhoea, ARI and impetigo.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Partially-blind Phase III Randomised Trial of Fulvestrant (Faslodex) With or Without Concomitant Anastrozole (Arimidex) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-steroidal Aromatase Inhibitors
Brief Summary: A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.


Options:
A: Clinical Benefit Rate (assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years)
B: Time to Disease Progression (TTP)
C: Progression-free survival (every 3 months during treatment and, at time of discontinuation from treatment)
D: Time to Tumor Progression (Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Intermediate Care Clinics for Diabetes
Brief Summary: The aim of this trial is to assess the effectiveness of intermediate care clinics for diabetes, compared to usual care.


Options:
A: The percentage of participants reaching target control of HbA1c (7.0), and blood pressure (<140/80) and cholesterol (<4 mmol/l), (18 months)
B: difference in change in systolic BP between the intervention and usual care groups (6 months)
C: Hemoglobin A1c (Baseline, 6 months)
D: %HbA1c (at inclusion and at one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Intermediate Care Clinics for Diabetes
Brief Summary: The aim of this trial is to assess the effectiveness of intermediate care clinics for diabetes, compared to usual care.


Options:
A: Adjusted Change in Pain-related Function (Roland Disability Score) (12 months)
B: The percentage of participants reaching target control of HbA1c (7.0), and blood pressure (<140/80) and cholesterol (<4 mmol/l), (18 months)
C: Depressive symptoms reduction (Measured at months 6 and 12)
D: Depression Severity (2 week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Does a Nasal Instillation of Miglustat Normalize the Nasal Potential Difference in Cystic Fibrosis Patients Homozygous for the F508del Mutation? A Randomized, Double Blind Placebo-controlled Study.
Brief Summary: The purpose of this study is to investigate within a short delay the effect of nasal instillation of Miglustat on nasal potential difference in cystic fibrosis patients homozygous for the F508del mutation.


Options:
A: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 8 (Study Baseline, Through Week 8)
B: change in response to Chloride-free solution and isoproterenol ( reflecting chloride transport) (change from baseline ( visit 1) and placebo to miglustat instillation)
C: Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 1 (4 hours post-morning dose on Day 1); Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 14 (4 hours post-morning dose on Day 14); Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to End of Dosing Interval (AUCtau) of Lumacaftor (LUM) and Ivacaftor (IVA) (Day 14 (pre-morning dose, 4, 6, 12, and 24 hours post-morning dose for LUM; pre-morning dose, 2, 4, 6, 12 hours post-morning dose for IVA)); Part B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 26)
D: Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in treatment period up to safety follow-up (up to 28 days)); Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)); Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part E: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part F: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Does a Nasal Instillation of Miglustat Normalize the Nasal Potential Difference in Cystic Fibrosis Patients Homozygous for the F508del Mutation? A Randomized, Double Blind Placebo-controlled Study.
Brief Summary: The purpose of this study is to investigate within a short delay the effect of nasal instillation of Miglustat on nasal potential difference in cystic fibrosis patients homozygous for the F508del mutation.


Options:
A: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
B: change in response to Chloride-free solution and isoproterenol ( reflecting chloride transport) (change from baseline ( visit 1) and placebo to miglustat instillation)
C: Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48 (From Baseline to Week 48)
D: Part A: Observed Plasma Concentrations From 3-4 Hours (C3-4hr) of LUM and IVA (Day 1 and Day 15); Part A: Observed Pre-dose Plasma Concentration (Ctrough) of LUM and IVA (Pre-dose at Day 8 and Day 15); Part B : Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 26)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preoperative Oral Supplementation With Carbohydrate and Branched-chain Amino Acid-enriched Nutrient Improves Postoperative Quality of Life in Patients Undergoing a Hepatectomy
Brief Summary: The aims of this study are (1) to study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery, and (2) To investigate the postoperative quality of life (QOL) in receiving peri-operatively branched-chain amino acids enriched nutrient-mixture in patients who undergone the hepatic management for hepatocellular carcinoma (HCC) with chronic liver disease.


Options:
A: To study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery. (3-6 months)
B: complications until 30 days after surgery according to the zurich classification (30 days postoperative)
C: protein balance (two days after surgery)
D: Morbidity and mortality after open infrarenal aortic aneurysm repair (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preoperative Oral Supplementation With Carbohydrate and Branched-chain Amino Acid-enriched Nutrient Improves Postoperative Quality of Life in Patients Undergoing a Hepatectomy
Brief Summary: The aims of this study are (1) to study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery, and (2) To investigate the postoperative quality of life (QOL) in receiving peri-operatively branched-chain amino acids enriched nutrient-mixture in patients who undergone the hepatic management for hepatocellular carcinoma (HCC) with chronic liver disease.


Options:
A: Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery) (Number of hours post surgery)
B: To study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery. (3-6 months)
C: improved patients' nutritional and physiological status, fatigue score, as well as patients' health related quality of life. (while in the waiting list for liver transplantation)
D: Factor V at day 3 after surgery (day 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-centre, Randomised, Single-blind, Parallel Group Controlled Trial, Testing the Growth Promoting Effect of Long-term Complementary Feeding of Infants With Different Doses and Formulations of Lipid-based Nutrient Supplements (LNS)
Brief Summary: The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to infants and their guardians in Malawi and Ghana. In the present trial, the investigator aim to identify the lowest growth-promoting daily dose of modified LNS. Additionally, the investigators will test a hypothesis that LNS that does not contain milk promotes growth as well as milk-containing LNS when given for 12 months at a 10-40 g daily dose to 6-18 month old infants in rural Malawi.


Options:
A: Change in length-for-age Z-score (LAZ, based on WHO 2005 MGRS) between enrollment and 18 months of age (Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)); Incidence of serious adverse events during the study period (12 months after enrollment (age 18 months))
B: Weight gain during the 12-week follow-up (in grams)
C: Acceptability of at least one Ready -to-Use Complementary Food supplement (7 days)
D: Birth weight (approx 20 weeks after enrollment (within 48 hours)); Newborn length (At 1 week of age); Length for age Z-score (LAZ) at 18 months of age (12 months after enrollment (age 18 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-centre, Randomised, Single-blind, Parallel Group Controlled Trial, Testing the Growth Promoting Effect of Long-term Complementary Feeding of Infants With Different Doses and Formulations of Lipid-based Nutrient Supplements (LNS)
Brief Summary: The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to infants and their guardians in Malawi and Ghana. In the present trial, the investigator aim to identify the lowest growth-promoting daily dose of modified LNS. Additionally, the investigators will test a hypothesis that LNS that does not contain milk promotes growth as well as milk-containing LNS when given for 12 months at a 10-40 g daily dose to 6-18 month old infants in rural Malawi.


Options:
A: 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)
B: Change in length-for-age Z-score (LAZ, based on WHO 2005 MGRS) between enrollment and 18 months of age (Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)); Incidence of serious adverse events during the study period (12 months after enrollment (age 18 months))
C: Birth weight (approx 20 weeks after enrollment (within 48 hours)); Newborn length (At 1 week of age); Length for age Z-score (LAZ) at 18 months of age (12 months after enrollment (age 18 months))
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Human Recombinant Erythropoietin (HrEPO) in Asphyxia Neonatorum: A Pilot Trial
Brief Summary: In this prospective trial the investigators plan to study the efficacy of erythropoietin as a therapeutic agent in neonates who suffer from brain injury following perinatal asphyxia.


Options:
A: Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls. (during infusions: first 18 postnatal days)
B: Neurodevelopmental outcomes (6 months); EEG changes (2-3 weeks); MRI of the brain (3 weeks)
C: Number of participant with adverse reaction (12 weeks from the day of treatment)
D: Serious adverse event (14 days of life)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of MEDI3414 in Adults
Brief Summary: The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy adults.


Options:
A: The primary endpoint for efficacy is the first episode in the first season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.
B: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C). (Days 1- 8); Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 15); Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 29); Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 57)
C: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C). (Days 1-8); Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 15); Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 29); Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 57)
D: To compare the families of children in the target schools with families of children in the control schools with respect to workdays lost by adults and school days lost by children. (7 days after each vaccination)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of MEDI3414 in Adults
Brief Summary: The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy adults.


Options:
A: Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza (one influenza season - 2007-2008)
B: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C). (Days 1-8); Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 15); Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 29); Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 57)
C: To measure anti-influenza systemic and mucosal antibody responses 4 weeks after administration of influenza vaccine (LAIV) to healthy subjects aged 18-49 and to compare responses in subjects receiving Lactobacillus GG (LGG) versus placebo (4 weeks)
D: Incidence of culture confirmed influenza-like illness due to virus strains matching the vaccine during the interval from November to April following treatment.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of MEDI3414 in Adults
Brief Summary: The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy adults.


Options:
A: The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group. (Day 28-35)
B: laboratory-confirmed influenza infection (Dec to June each year for 3 years)
C: Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains). (Through 7 to 9 months post-vaccination)
D: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C). (Days 1-8); Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 15); Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 29); Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 57)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Orientation and Mobility Training on Mobility, Participation and Quality of Life in Older Adults With Visual Impairments: a Randomised Controlled Trial
Brief Summary: The purpose of this study is:

1. to develop a standardised orientation and mobility training (O\&M-training) in the use of an identification/symbol cane by older adults with low vision, and;
2. to evaluate this newly developed standardised O\&M-training with respect to effectiveness and feasibility in a randomised controlled trial.


Options:
A: Participant enrollment, recruitment and retention. (Ongoing for18 months after start of recruitment.)
B: Depression (4 months)
C: Static Balance (Week 0 and Week 8.)
D: activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS)) (5 and 17 weeks); distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ)) (5 and 17 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Orientation and Mobility Training on Mobility, Participation and Quality of Life in Older Adults With Visual Impairments: a Randomised Controlled Trial
Brief Summary: The purpose of this study is:

1. to develop a standardised orientation and mobility training (O\&M-training) in the use of an identification/symbol cane by older adults with low vision, and;
2. to evaluate this newly developed standardised O\&M-training with respect to effectiveness and feasibility in a randomised controlled trial.


Options:
A: Depression (6 Months)
B: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)
C: Visual field (6 months)
D: activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS)) (5 and 17 weeks); distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ)) (5 and 17 weeks)

Answer: D