TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of an Intrahospital Exercise Program in Functional Capacity of Old Inpatients
Brief Summary: Background The Activity in GEriatric acute CARe (AGECAR) is a randomized control trial to assess the effectiveness of an intrahospital strength and walk program during short hospital stays for improving functional capacity of patients aged 75 years or older.


Options:
A: Glittre test (up to 9 months)
B: Mobility using the de Morton Mobility Index (DEMMI) (Admittance (baseline), discharge, 4 weeks after discharge (primary analysis), and 26 weeks after discharge)
C: Muscle mass (lean mass) (Change from baseline in muscle mass at 3 month after discharge)
D: Recover basal functional capacity (During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Partial Oral Treatment of Endocarditis
Brief Summary: Background Current management of infective endocarditis include admission and treatment with parenteral antibiotics for 4 weeks - 6 weeks. Resource demands and psychological issues of present management strategy make it highly relevant to seek for alternative more lenient alternatives. Experiences with oral treatment are only sporadically described, but observational data suggest that oral treatment could be a feasible option. The investigators have in 2010 treated 12 endocarditis patients with partial oral antibiotics with a 100% success rate.

Study design The POET study is a Danish multicenter, prospective, randomized, open label study. The primary aim is to show non-inferiority of partial oral treatment with antibiotics of endocarditis compared to full parenteral treatment. Stable patients (n=400) with streptococci, staphylococci or enterococci infecting the mitral valve or the aortic valve will be included. After a minimum of 10 days of parenteral treatment, patients will be randomized to oral therapy or parenteral therapy. Special recommendations for oral treatment have been developed based on expected minimal inhibitory concentrations and pharmacokinetic calculations. Patients will be followed for 6 months after completion of antibiotic therapy. The primary endpoint is a composition of all cause mortality, unplanned cardiac surgery, embolic events and relapse of positive blood cultures with the primary pathogen.


Options:
A: The primary endpoint is a composite endpoint including all cause mortality, unplanned cardiac surgery, embolic events and relapse of positive blood cultures with the primary pathogen (Approximately 7 months. From randomisation until 6 months after end of study medication)
B: Death (From the index procedure till the end of the follow-up period (December 2017))
C: To demonstrate that daptomycin is not inferior to comparator in the treatment of S. aureus bacteremia and IE as assessed by the Independent External Adjudication Committee (IEAC) Outcome at Test of Cure (TOC) in the Intention-to-Treat (ITT) population.
D: Proportion of patients with negative blood cultures. (7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants
Brief Summary: Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.


Options:
A: Time to reach full feeds (First 40 days after birth)
B: Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC). (6 months post-pullthrough); Severity of Clinical Episodes of HAEC (6 months)
C: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)
D: Postnatal day when enteral feeding exceeded at 100ml/kg/day (From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants
Brief Summary: Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.


Options:
A: NEC onset (6 weeks)
B: Postnatal day when enteral feeding exceeded at 100ml/kg/day (From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth)
C: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)
D: Human milk glycans (Change from day 2 to day 366)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants
Brief Summary: Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.


Options:
A: Time to reach full feeds (First 40 days after birth)
B: Postnatal day when enteral feeding exceeded at 100ml/kg/day (From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth)
C: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)
D: Probiotics Prevent Hirschsprung's Disease Associated Entercolitis (two years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants
Brief Summary: Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.


Options:
A: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
B: NEC onset (6 weeks)
C: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)
D: Postnatal day when enteral feeding exceeded at 100ml/kg/day (From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants
Brief Summary: Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.


Options:
A: Postnatal day when enteral feeding exceeded at 100ml/kg/day (From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth)
B: incidence of feeding intolerance (28 days); time to reach full enteral feedings sustained for 72 hours. (72 hours)
C: NEC onset (6 weeks)
D: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh
Brief Summary: Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breastmilk antibodies, changes in gut microbiota, and genetic susceptibility.

Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral polio and rotavirus vaccines in children in Bangladesh.

Secondary Objectives: 1) to determine the impact of an IPV (inactivated polio vaccine) boost on the efficacy of OPV (oral polio vaccine) and 2) to determine the efficacy of Rotarix oral rotavirus vaccine to prevent rotavirus diarrhea

The polio and rotavirus randomized clinical trials are embedded as secondary objectives within the exploratory study of tropical enteropathy. The primary and secondary outcome measures are relevant to the randomized clinical trials.


Options:
A: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) (25 days following week 52 visit); Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial) (Birth to one year)
B: Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.
C: Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs
D: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain (From 2 weeks after the last vaccine or placebo dose up to 1 year of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh
Brief Summary: Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breastmilk antibodies, changes in gut microbiota, and genetic susceptibility.

Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral polio and rotavirus vaccines in children in Bangladesh.

Secondary Objectives: 1) to determine the impact of an IPV (inactivated polio vaccine) boost on the efficacy of OPV (oral polio vaccine) and 2) to determine the efficacy of Rotarix oral rotavirus vaccine to prevent rotavirus diarrhea

The polio and rotavirus randomized clinical trials are embedded as secondary objectives within the exploratory study of tropical enteropathy. The primary and secondary outcome measures are relevant to the randomized clinical trials.


Options:
A: Percentage of subjects with vaccine take (At 2 months post-Dose 2)
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: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) (25 days following week 52 visit); Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial) (Birth to one year)
D: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain (From 2 weeks after the last vaccine or placebo dose up to 1 year of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh
Brief Summary: Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breastmilk antibodies, changes in gut microbiota, and genetic susceptibility.

Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral polio and rotavirus vaccines in children in Bangladesh.

Secondary Objectives: 1) to determine the impact of an IPV (inactivated polio vaccine) boost on the efficacy of OPV (oral polio vaccine) and 2) to determine the efficacy of Rotarix oral rotavirus vaccine to prevent rotavirus diarrhea

The polio and rotavirus randomized clinical trials are embedded as secondary objectives within the exploratory study of tropical enteropathy. The primary and secondary outcome measures are relevant to the randomized clinical trials.


Options:
A: To evaluate innate and adaptive immune response.; Future occurrence of acute diarrhoea, ARI and impetigo.
B: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) (25 days following week 52 visit); Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial) (Birth to one year)
C: - To measure the impact of zinc and vitamin A on the duration of diarrheal illness (Weekly home visits for 6 months)
D: Change in length and length-for-age Z-score (9 to 18 mo of age); Change in weight and weight-for-age Z-score (9 to 18 mo of age); Incidence of diarrhea and laboratory-confirmed malaria infection (9 to 18 mo of age); Change in plasma zinc concentration (9 to 18 mo of age); Change in body composition (9 to 18 mo of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh
Brief Summary: Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breastmilk antibodies, changes in gut microbiota, and genetic susceptibility.

Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral polio and rotavirus vaccines in children in Bangladesh.

Secondary Objectives: 1) to determine the impact of an IPV (inactivated polio vaccine) boost on the efficacy of OPV (oral polio vaccine) and 2) to determine the efficacy of Rotarix oral rotavirus vaccine to prevent rotavirus diarrhea

The polio and rotavirus randomized clinical trials are embedded as secondary objectives within the exploratory study of tropical enteropathy. The primary and secondary outcome measures are relevant to the randomized clinical trials.


Options:
A: Safety of Rotavin-M1 vaccine in healthy adult volunteers (3 months)
B: Immunogenicity (7 months)
C: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) (25 days following week 52 visit); Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial) (Birth to one year)
D: Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo (Within 42 days following any dose of RotaTeq™/placebo); Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination (At least 14 days following the 3rd vaccination through the first full rotavirus season)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect and Mechanism of Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With DM Who Receive Surgical Treatment
Brief Summary: This study is to investigate the effect of gastrectomy on remission of type 2 diabetes in patients with gastric cancer and type 2 diabetes, to investigate the mechanism of blood glucose alteration and intestinal hormonal signaling by the reconstruction methods, and to evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in gastric cancer patients with diabetes.


Options:
A: the incidence of Roux stasis syndrome (3 month after surgery)
B: Effects of quality of life (The quality of life questionnaire was conducted at six months after surgery.)
C: Blood sugar stabilization after gastrectomy (three months after surgery)
D: The time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction (within 2 hours after surgery); change of potential of hydrogen ( pH) in remnant stomach (1-6 days after surgery); the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction (within 2 hours after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Neuromuscular Training With Whole Body Vibration in Older People: A Randomized Multicentre Clinical Trial With Blinded to Evaluator
Brief Summary: This is a randomized, multicentre, and parallel clinical trial with blinded to evaluator.

The principal hypothesis is that whole-body vibration training plus exercise improves the body balance and prevents falls more than only exercise training in institutionalized older people. The number needed of patients is 160 (80 per group).


Options:
A: Falls (1 year)
B: Body balance. (at 6 weeks)
C: Patient falls over 15 months
D: Risk of fall (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1 Study to Evaluate Safety and Reactogenicity of a Vietnamese Rotavirus Vaccine (Rotavin-M1 at 10e6.3FFU/Dose) Among Healthy Adults in Vietnam
Brief Summary: The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.


Options:
A: Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
B: Safety of Rotavin-M1 vaccine in healthy adult volunteers (3 months)
C: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) (25 days following week 52 visit); Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial) (Birth to one year)
D: Number of Participants With Any Severity of Rotavirus Gastroenteritis (From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1 Study to Evaluate Safety and Reactogenicity of a Vietnamese Rotavirus Vaccine (Rotavin-M1 at 10e6.3FFU/Dose) Among Healthy Adults in Vietnam
Brief Summary: The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.


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 Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Immunogenicity in Terms of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Immunogenicity in Terms of Anti-pneumococcal Serotypes (Anti-PnPS) Antibody Concentrations. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 0.15 µg/mL. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 1.0 µg/mL. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Subjects With Seroresponse to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies. (At Month 5 (One month after Dose 3 of co-administered vaccines))
C: Any adverse event in adult cohort (Up to two weeks after single dose of vaccine or placebo); Serious adverse events in adult cohort (Up to two weeks after single dose of vaccine or placebo); Any adverse event in infant cohort (Up to one month after 3 doses of vaccine or active control); Serious adverse events in infant cohort (Up to one month after 3 doses of vaccine or active control)
D: Safety of Rotavin-M1 vaccine in healthy adult volunteers (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1 Study to Evaluate Safety and Reactogenicity of a Vietnamese Rotavirus Vaccine (Rotavin-M1 at 10e6.3FFU/Dose) Among Healthy Adults in Vietnam
Brief Summary: The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.


Options:
A: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains (From Month 1 ½ to Month 21)
B: Safety of Rotavin-M1 vaccine in healthy adult volunteers (3 months)
C: Endpoints : Safety/immunogenicity.Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Visit 6 in the group receiving of HRV vaccine concomitantly with OPV versus placebo group.
D: Occurrence of RV GE

Answer: B