TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety During Use of Paediatric Triple Chamber Bag Formulas, Administered IV at a Weight Dependant Dose During 5 Consecutive Days, in Paediatric Patients up to 18 Years Requiring Parenteral Nutrition.
Brief Summary: The primary objective of this study was to provide daily information on the performance safety of the Ped3CB in practical therapeutic use in pediatric patients.


Options:
A: Fecal microbiota measured at each visit (8 weeks)
B: Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula (14 days)
C: Total RBC glutathione (0 days, 7 days, 60 days)
D: Practical handling,ease of use and safety information (number of participants with adverse events) (measurements were taken on day 0-5 and up to day 10 on preterms and through 2 days after the last infusion of study product)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Impact of the Programa de Apoyo Alimentaria
Brief Summary: The Programa de Apoyo Alimentaria (PAL) started in 2003 and is targeted to communities in Mexico that do not receive benefits from other federal food aid programs, have less than 2,500 inhabitants and a high level of marginalization. Marginalization is a term used in Mexico for the multidimensional assessment of poverty in a community.

When the program started in 2003 it provided beneficiary households either a cash transfer of 150 Mexican pesos (equivalent to approximately 14 USD at the time) per month or a monthly food basket with a cost to the program of 150 pesos. The size of the cash transfer and the amount of food was the same for all households, i.e. no adjustments for family size or composition were made. The basket contained a number of staple and basic food products and powdered whole milk (Liconsa), which is fortified with Zn, Fe, Vitamin C, and folate (Table 1). The composition of the food basket conformed to the Mexican norm for food aid programs (NOM-169-SSA1-1998), which states that food transfers need to provide at least 20% of the recommended daily energy and protein requirements. Beneficiary households were required to attend nutrition and health education sessions and had to participate in program related logistic activities in order to receive the benefits. These program conditionalities, however, were not strictly enforced.

A community randomized controlled intervention trial was used to evaluate the impact of the intervention. A random sample of 208 rural communities was drawn from the pool of eligible communities in 8 of the poorest states in the South/Eastern region of Mexico (Chiapas, Guerrero, Oaxaca, Quintana Roo, Tabasco, Campeche, Yucatan and Veracruz). Within each community a random sample of 33 households was selected. The baseline survey was conducted from October 2003 to April 2004. After baseline data collection, the 208 selected communities (6,687 households) randomly assigned to one of four study groups: food basket without education (52 communities, 1657 households), food basket with education (52 communities, 1680 households), cash transfer with education (53 communities, 1687 communities) or control (51 communities, 1663 households). Treatment allocation was carried out by the Ministry of Social Development.


Options:
A: Linear growth in children below 3 years of age (Measured 50 months after randomization (endline survey 2019))
B: Change from Baseline in nutritionally related biochemical measures at 22 months (At baseline and 22 months)
C: Child nutritional status
D: Recovery rate in the outpatient therapeutic program (At 6 week)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Impact of the Programa de Apoyo Alimentaria
Brief Summary: The Programa de Apoyo Alimentaria (PAL) started in 2003 and is targeted to communities in Mexico that do not receive benefits from other federal food aid programs, have less than 2,500 inhabitants and a high level of marginalization. Marginalization is a term used in Mexico for the multidimensional assessment of poverty in a community.

When the program started in 2003 it provided beneficiary households either a cash transfer of 150 Mexican pesos (equivalent to approximately 14 USD at the time) per month or a monthly food basket with a cost to the program of 150 pesos. The size of the cash transfer and the amount of food was the same for all households, i.e. no adjustments for family size or composition were made. The basket contained a number of staple and basic food products and powdered whole milk (Liconsa), which is fortified with Zn, Fe, Vitamin C, and folate (Table 1). The composition of the food basket conformed to the Mexican norm for food aid programs (NOM-169-SSA1-1998), which states that food transfers need to provide at least 20% of the recommended daily energy and protein requirements. Beneficiary households were required to attend nutrition and health education sessions and had to participate in program related logistic activities in order to receive the benefits. These program conditionalities, however, were not strictly enforced.

A community randomized controlled intervention trial was used to evaluate the impact of the intervention. A random sample of 208 rural communities was drawn from the pool of eligible communities in 8 of the poorest states in the South/Eastern region of Mexico (Chiapas, Guerrero, Oaxaca, Quintana Roo, Tabasco, Campeche, Yucatan and Veracruz). Within each community a random sample of 33 households was selected. The baseline survey was conducted from October 2003 to April 2004. After baseline data collection, the 208 selected communities (6,687 households) randomly assigned to one of four study groups: food basket without education (52 communities, 1657 households), food basket with education (52 communities, 1680 households), cash transfer with education (53 communities, 1687 communities) or control (51 communities, 1663 households). Treatment allocation was carried out by the Ministry of Social Development.


Options:
A: Recovery rate in the outpatient therapeutic program (At 6 week)
B: Growth (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months); Hemoglobin (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months)
C: Child nutritional status
D: Cumulative incidence of child wasting (3-monthly until 24 months after inclusion); Incremental cost-effectiveness ratio (24 months after inclusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Supplementation and Male Infertility: The Copenhagen Bone-Gonadal Study a Double Blinded Randomized Clinical Trial
Brief Summary: Today, it is evident that vitamin D (VD) has more widespread effects than the classical actions related to bone mineralization and calcium homeostasis1. VD deficiency results in impaired reproductive performance in various species of animals, and recently the investigators have shown that the VD receptor (VDR), activating (CYP2R1, CYP27A1, CYP27B1) and inactivating (CYP24A1) enzymes are expressed in the human testis, epididymis, seminal vesicle, prostate and spermatozoa. Our following functional studies showed that VD increases intracellular calcium in mature spermatozoa, and hence may be important not only for spermatogenesis but also for sperm maturation. A new, and yet unpublished cross sectional study of 300 young healthy Danish men showed that men with lower levels of serum VD have significantly lower number of normally developed and motile spermatozoa. Hitherto, most cases of male infertility have been classified as "idiopathic", and infertile couples have been referred to symptomatic treatment at infertility clinics. These fertility treatments are often physically demanding for the female partner as well as expensive for the health care system. Any treatment that might improve semen quality of involuntary infertile men would be beneficial both for the infertile couples and the society in general. Our findings that VD may play a role for human semen quality have not yet been tested clinically. However, if VD supplementation proves efficient this opens for the first time for a causal, safe and cheap treatment of at least some cases of "idiopathic" impaired semen quality. The investigators believe our new human data supported by the results from the VD deficient and VDR KO animal studies and the high proportion of VD deficient Danish men provide sufficient evidence to initiate a randomized clinical trial of VD supplementation to infertile men. Infertile men have also have unfavorable altered levels of sex hormones and higher mortality than fertile men. Since VD deficiency is associated with increased mortality, regulation of aromatase, immune system, bone metabolism, glucose metabolism, cardiovascular system etc. our suggested clinical trial may also be able to evaluate several secondary endpoints in addition to the potential effect on semen quality.


Options:
A: Ongoing pregnancy rate (15 months)
B: Thiol oxido-reductive index levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Thiol oxido-reductive index levels. (up to three months.)
C: semen quality (150 days); sperm motility (150 days); sperm morphology (150 days); sperm concentration (150 days); total sperm count (150 days); semen volume (150 days)
D: Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate (4 weeks to 9 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Femoral Artery In-Stent Restenosis (FAIR) Trial
Brief Summary: Comparison of recurrent-restenosis rates 6 months after angioplasty of in-stent restenoses or in-stent reocclusions in the superficial femoral artery (SFA) using either a standard balloon (Admiral Xtreme, Invatec) or a paclitaxel-eluting balloon (In.Pact™ Admiral, Invatec).


Options:
A: primary patency rate (6 months)
B: Duplex-ultrasound determined recurrent restenosis in the superficial femoral artery (SFA) (6 month)
C: Percentage diameter stenosis (6 months)
D: Primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) and without target lesion revascularization (TLR) within 12 months. (1 year); Proportion of subjects who experience serious device-related adverse events within 30 days post-procedure (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E, Against Severe Rotavirus Gastroenteritis in Infants
Brief Summary: The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10\^5.0 FFU, against severe rotavirus gastroenteritis, in comparison with a placebo in India.


Options:
A: Number of Subjects Reporting Any Serious Adverse Events (SAEs). (From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo)
B: Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus (Up to 2 years of age)
C: Immunogenicity (7 months)
D: Laboratory-confirmed episode of severe rotavirus gastroenteritis (From 28 days post-Dose 3 until 117 cases are accrued or when all participating infants reach 2 years of age if 117 cases are not attained)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E, Against Severe Rotavirus Gastroenteritis in Infants
Brief Summary: The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10\^5.0 FFU, against severe rotavirus gastroenteritis, in comparison with a placebo in India.


Options:
A: Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus (Up to 2 years of age)
B: 116E rotavirus vaccine (6,10 and 14 weeks)
C: Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea (Within the 15-day solicited follow-up period after any dose)
D: Number of Subjects Reporting Any Serious Adverse Events (SAEs). (From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E, Against Severe Rotavirus Gastroenteritis in Infants
Brief Summary: The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10\^5.0 FFU, against severe rotavirus gastroenteritis, in comparison with a placebo in India.


Options:
A: Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.
B: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay (3-6 weeks after the last vaccination); Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay (3-6 weeks after the last vaccination); Geometric Mean Serum Anti-rotavirus IgA Titer (3-6 weeks after the last dose of vaccine)
C: Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus (Up to 2 years of age)
D: Number of Subjects Reporting Any Serious Adverse Events (SAEs). (From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Getting Physical on Cigarettes: Exercise and Smoking Cessation - Preventing Relapse
Brief Summary: Adult female smokers will participate in an exercise-aided smoking cessation program, and will then be randomized into one of four cessation maintenance conditions: (a) Exercise Maintenance only (b) Exercise Maintenance + Relapse Prevention Booklets(c) Relapse Prevention Booklets + Contact and (d) Contact Control. Primary follow-up outcome is smoking behaviour. Secondary outcomes include exercise behaviour, Physiological measures (body composition (Dual-emission X-ray absorptiometry; DXA), vascular health (stiffness, endothelial function, carotid plaque volume), physical fitness), and Psychological measures (self-regulatory cognitions related to exercise adherence \[exercise, scheduling, barrier, relapse, and concurrent self-regulatory self-efficacy\]).

The hypotheses detailed below are specific to the randomization of participants into the following 4 groups:

1. Exercise Maintenance only
2. Exercise Maintenance + Relapse Prevention Booklets
3. Relapse Prevention Booklets + Contact
4. Contact Control

Hypothesis 1: Compared to quitters in the contact control condition, quitters exposed to a home-based lifestyle exercise maintenance intervention (Exercise Maintenance only and Exercise Maintenance + Relapse Prevention Booklets) will demonstrate significantly greater exercise adherence and fitness levels, as well as significantly less weight gain and smoking relapse rates following exercise-aided smoking cessation program termination.

Hypothesis 2: Compared to quitters in the contact control condition, quitters exposed to relapse information only (Relapse Prevention Booklets + Contact) will experience significantly less smoking relapse following exercise-aided smoking cessation program termination.

Due to the novelty and exploratory nature of the respective prevention programs, no hypotheses are specified with respect to which prevention program (exercise maintenance or relapse prevention information) will be superior to the other, or whether the additive benefits (i.e., exercise maintenance plus relapse prevention information) will be superior to one prevention program alone.


Options:
A: Evaluation of smoking cessation verified by expired air carbon monoxide (12 weeks after baseline)
B: Smoking Behaviour (56 weeks post participant start date)
C: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
D: Number of participants with 7-day point prevalence smoking abstinence (52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study
Brief Summary: To analyze the weight gain of very low birth weight infants during a minimum period of three weeks before 36 weeks postmenstrual age when infants are fed with breast milk that has been individually fortified.


Options:
A: growth during first three weeks of intervention (first three weeks during intervention before 36 weeks of gestation)
B: growth (from inclusion at postmentrual age <32 weeks until 36 weeks)
C: Weight gain (From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA))
D: Daily growth velocity (g/kg/day) (From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study
Brief Summary: To analyze the weight gain of very low birth weight infants during a minimum period of three weeks before 36 weeks postmenstrual age when infants are fed with breast milk that has been individually fortified.


Options:
A: Weight gain due to fat mass (4 weeks)
B: Weight gain (29 days)
C: growth (from inclusion at postmentrual age <32 weeks until 36 weeks)
D: Caloric content of human milk (Daily until 36 weeks corrected gestational age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Brief Summary: The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.


Options:
A: To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein. (2 & 6 weeks after AVF creation)
B: N/A
C: Change to diameter of vein (Initial assessment and 6 weeks after surgery)
D: Primary AVF patency. (12 months after AVF creation); Number of participants with adverse events as a measure of safety and tolerability of PRT-201. (12 months after AVF creation.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Brief Summary: The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.


Options:
A: Primary AVF patency. (12 months after AVF creation); Number of participants with adverse events as a measure of safety and tolerability of PRT-201. (12 months after AVF creation.)
B: Arteriovenous Fistulae Maturation (6 months)
C: N/A
D: Access flow monthly for 3 months and 6th month (0,1st,2nd,3rd and 6th months) and Echocardiographic parameters at 6th month ( 0 and 6th months) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Health Benefits Associated With Consumption of Solar Disinfection of Drinking Water by Children Under Age 5 Years, With Particular Emphasis on Dysentery and Childhood Diarrhoea
Brief Summary: SODISWATER was a health impact assessment study investigating the effect of sunlight to inactivate microbial pathogens in drinking water. This study was carried out by observing whether children younger than 5 years old who drink solar disinfected water were healthier than those who did not. Health was measured by how often the children had diarrhoea or dysentery.

Caregivers for the participants were given plastic bottles to place in the sun, water samples were then collected from these plastic bottles to be analyzed. They were also requested to fill in diarrhea diaries.

TESTABLE RESEARCH HYPOTHESES:

Health Impact Assessment: Children who use solar disinfected water will have:

(a) lower morbidity due to non-bloody diarrhoea and bloody diarrhoea (c) increased growth rates (d) lower mortality (e) increased family productivity (f) decreased care-giver burden (g) increased school attendance


Options:
A: Thermotolerant coliforms in household drinking water (5 months)
B: 1. To estimate the cumulative risk of infant infection at 6 weeks, 9 months, and 18 months of age among breast fed infants. The anticipated outcome is a transmission rate of <6% at 6 weeks and <8% at 18 months of age. (6 weeks, 9 months, 18 months)
C: Dysentery disease rate (12 month); Diarrhoea disease rate (12 months)
D: Reduction in dysentery and non-dysentery diarrhoeal disease in children under five years old (Duration of the study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Multi-center Clinical Study：Bevacizumab for Neovascular Age-related Macular Degeneration
Brief Summary: Age-related macular degeneration (AMD) is one of primary blinding eye disease among people over 65 years in China. The anti-VEGF antibody treatment is proved useful for Neovascular Age-related Macular Degeneration (nAMD) by many studies. Bevacizumab is the only available low-cost type of anti-VEGF drug currently in China. This study is a multi-center, randomized trial of Bevacizumab effective dose and safety for nAMD. This study is to explore the effective therapeutic approach that the majority of patients in China can bear establishing a suitable treatment for China.


Options:
A: EDTRS visual acuity score (0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week)
B: N/A
C: N/A
D: N/A

Answer: A