TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Amoxycillin Versus Placebo for Resolution of Otitis Media With Effusion and Prevention of Acute Otitis Media With Perforation in Aboriginal Infants: a Randomised Controlled Trial.
Brief Summary: This clinical trial was conducted in a population where tympanic membrane perforation occurs in 60% infants in the first year of life. Nasopharyngeal colonisation (nasal contamination) with pathogenic bacteria occurs within weeks of life and predicts persistent middle ear infection throughout childhood. The trial aimed to assess whether twice daily antibiotics commencing at first detection of middle ear effusion would cure the infection and/or prevent disease progression, compared to placebo.

The study was conducted in three remote Aboriginal communities in the Northern Territory of Australia. The annual birth cohort was 45.

Aboriginal infants were seen as soon as possible after birth, and at 2 weekly intervals until middle ear effusion was detected by pneumatic otoscopy and tympanometry. Following consent, infants were randomised to either amoxycillin(50 mg/kg/d BD) or placebo equivalent for up to 24 weeks, or until normal middle ear status was detected at 2 consecutive monthly scheduled examinations. At monthly examinations the infant also had a general health check, parents were interviewed, child's medical record was reviewed, and nasopharyngeal swabs were collected.


Options:
A: - number of acute otitis media; - quality of life issues
B: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
C: Proportion of children with middle ear effusion (end of intervention); Proportion of study visits at which middle ear effusion detected (during intervention)
D: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Amoxycillin Versus Placebo for Resolution of Otitis Media With Effusion and Prevention of Acute Otitis Media With Perforation in Aboriginal Infants: a Randomised Controlled Trial.
Brief Summary: This clinical trial was conducted in a population where tympanic membrane perforation occurs in 60% infants in the first year of life. Nasopharyngeal colonisation (nasal contamination) with pathogenic bacteria occurs within weeks of life and predicts persistent middle ear infection throughout childhood. The trial aimed to assess whether twice daily antibiotics commencing at first detection of middle ear effusion would cure the infection and/or prevent disease progression, compared to placebo.

The study was conducted in three remote Aboriginal communities in the Northern Territory of Australia. The annual birth cohort was 45.

Aboriginal infants were seen as soon as possible after birth, and at 2 weekly intervals until middle ear effusion was detected by pneumatic otoscopy and tympanometry. Following consent, infants were randomised to either amoxycillin(50 mg/kg/d BD) or placebo equivalent for up to 24 weeks, or until normal middle ear status was detected at 2 consecutive monthly scheduled examinations. At monthly examinations the infant also had a general health check, parents were interviewed, child's medical record was reviewed, and nasopharyngeal swabs were collected.


Options:
A: Proportion of children with middle ear effusion (end of intervention); Proportion of study visits at which middle ear effusion detected (during intervention)
B: Number of visits to health clinic (Two years after randomisation)
C: Non B type tympanogram (one month)
D: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Amoxycillin Versus Placebo for Resolution of Otitis Media With Effusion and Prevention of Acute Otitis Media With Perforation in Aboriginal Infants: a Randomised Controlled Trial.
Brief Summary: This clinical trial was conducted in a population where tympanic membrane perforation occurs in 60% infants in the first year of life. Nasopharyngeal colonisation (nasal contamination) with pathogenic bacteria occurs within weeks of life and predicts persistent middle ear infection throughout childhood. The trial aimed to assess whether twice daily antibiotics commencing at first detection of middle ear effusion would cure the infection and/or prevent disease progression, compared to placebo.

The study was conducted in three remote Aboriginal communities in the Northern Territory of Australia. The annual birth cohort was 45.

Aboriginal infants were seen as soon as possible after birth, and at 2 weekly intervals until middle ear effusion was detected by pneumatic otoscopy and tympanometry. Following consent, infants were randomised to either amoxycillin(50 mg/kg/d BD) or placebo equivalent for up to 24 weeks, or until normal middle ear status was detected at 2 consecutive monthly scheduled examinations. At monthly examinations the infant also had a general health check, parents were interviewed, child's medical record was reviewed, and nasopharyngeal swabs were collected.


Options:
A: Proportion of children with middle ear effusion (end of intervention); Proportion of study visits at which middle ear effusion detected (during intervention)
B: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment (6 weeks)
C: Number of visits to health clinic (Two years after randomisation)
D: Non B type tympanogram (one month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Amoxycillin Versus Placebo for Resolution of Otitis Media With Effusion and Prevention of Acute Otitis Media With Perforation in Aboriginal Infants: a Randomised Controlled Trial.
Brief Summary: This clinical trial was conducted in a population where tympanic membrane perforation occurs in 60% infants in the first year of life. Nasopharyngeal colonisation (nasal contamination) with pathogenic bacteria occurs within weeks of life and predicts persistent middle ear infection throughout childhood. The trial aimed to assess whether twice daily antibiotics commencing at first detection of middle ear effusion would cure the infection and/or prevent disease progression, compared to placebo.

The study was conducted in three remote Aboriginal communities in the Northern Territory of Australia. The annual birth cohort was 45.

Aboriginal infants were seen as soon as possible after birth, and at 2 weekly intervals until middle ear effusion was detected by pneumatic otoscopy and tympanometry. Following consent, infants were randomised to either amoxycillin(50 mg/kg/d BD) or placebo equivalent for up to 24 weeks, or until normal middle ear status was detected at 2 consecutive monthly scheduled examinations. At monthly examinations the infant also had a general health check, parents were interviewed, child's medical record was reviewed, and nasopharyngeal swabs were collected.


Options:
A: Non B type tympanogram (one month)
B: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
C: Treatment response (1 months)
D: Proportion of children with middle ear effusion (end of intervention); Proportion of study visits at which middle ear effusion detected (during intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Amoxycillin Versus Placebo for Resolution of Otitis Media With Effusion and Prevention of Acute Otitis Media With Perforation in Aboriginal Infants: a Randomised Controlled Trial.
Brief Summary: This clinical trial was conducted in a population where tympanic membrane perforation occurs in 60% infants in the first year of life. Nasopharyngeal colonisation (nasal contamination) with pathogenic bacteria occurs within weeks of life and predicts persistent middle ear infection throughout childhood. The trial aimed to assess whether twice daily antibiotics commencing at first detection of middle ear effusion would cure the infection and/or prevent disease progression, compared to placebo.

The study was conducted in three remote Aboriginal communities in the Northern Territory of Australia. The annual birth cohort was 45.

Aboriginal infants were seen as soon as possible after birth, and at 2 weekly intervals until middle ear effusion was detected by pneumatic otoscopy and tympanometry. Following consent, infants were randomised to either amoxycillin(50 mg/kg/d BD) or placebo equivalent for up to 24 weeks, or until normal middle ear status was detected at 2 consecutive monthly scheduled examinations. At monthly examinations the infant also had a general health check, parents were interviewed, child's medical record was reviewed, and nasopharyngeal swabs were collected.


Options:
A: Treatment response (1 months)
B: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
C: Number of visits to health clinic (Two years after randomisation)
D: Proportion of children with middle ear effusion (end of intervention); Proportion of study visits at which middle ear effusion detected (during intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia A Double Blind, Placebo Controlled, Study in Diabetic and Non-diabetic Patients
Brief Summary: The investigators propose confirm and extend the findings of open studies on the apparent efficacy of bone-marrow derived mononuclear cells for the induction of arteriogenesis in patients with severe claudication or critical leg ischemia and pay special attention to the influence of diabetic disease on the outcome of the study and to the possible pro-atherogenic/ pro-inflammatory effects of BM-MNC injections.


Options:
A: major amputation (six months)
B: Number of participants with treatment-related adverse events occurring during the enrollment period as assessed by the Investigator using the MeDRA scale. (Primary follow up in a 6 month period)
C: Limb salvage/wound healing at t=6 months; Pain free walking distance (6 months)
D: The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Safety and Reactogenicity of FluBlok, Trivalent Recombinant Influenza Vaccine, and Comparison of the Immunogenicity, Efficacy and Effectiveness of FluBlok to a Licensed Egg-Grown Influenza Vaccine in Adults Aged 50 to 64
Brief Summary: The purpose of this study was to evaluate and compare the safety, reactogenicity, immunogenicity, relative efficacy and effectiveness of FluBlok to a licensed trivalent influenza vaccine (TIV)in healthy adults age 50-64 years.


Options:
A: Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs) (Reactogenicity days 0-7 following immunization; other AEs days 0-28 following immunization)
B: CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection (2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009)
C: Safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine by estimating the incidence of reported Adverse Events, Serious Adverse Events or Adverse Events of Special Interest in a cohort of actively monitored vaccinated subjects (Within 3 weeks and 6 weeks after vaccine administration)
D: Safety (local and systemic reactogenicity, laboratory tests and AEs. (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: There is today a growing need for culturally adapted initiatives among immigrants to prevent and treat T2D. Others have failed to increase the level of physical activity in this sedate group. The investigators believe this is due to missing assistance and lack of influence from the Pakistani milieu. To improve this, a culturally adapted physical activity will be established in this project in close cooperation with the Pakistanis themselves.

Through this program it is the investigators' goal to increase their physical activity level and prevent lifestyle diseases among Pakistanis in Oslo with a high risk of developing these diseases.


Options:
A: Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.
B: 7-Day Physical Activity Recall (7-Day PAR) (6 months)
C: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)
D: Physical activity level

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: There is today a growing need for culturally adapted initiatives among immigrants to prevent and treat T2D. Others have failed to increase the level of physical activity in this sedate group. The investigators believe this is due to missing assistance and lack of influence from the Pakistani milieu. To improve this, a culturally adapted physical activity will be established in this project in close cooperation with the Pakistanis themselves.

Through this program it is the investigators' goal to increase their physical activity level and prevent lifestyle diseases among Pakistanis in Oslo with a high risk of developing these diseases.


Options:
A: Physical activity measured by accelerometry. (3 months post-randomisation)
B: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)
C: Physical activity level
D: This randomized controlled trial was designed to assess the effectiveness of a primary care physical activity intervention, in increasing adherence to physical activity in general population, as well as their self-reported physical activity. (baseline-3-6-12-18)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: There is today a growing need for culturally adapted initiatives among immigrants to prevent and treat T2D. Others have failed to increase the level of physical activity in this sedate group. The investigators believe this is due to missing assistance and lack of influence from the Pakistani milieu. To improve this, a culturally adapted physical activity will be established in this project in close cooperation with the Pakistanis themselves.

Through this program it is the investigators' goal to increase their physical activity level and prevent lifestyle diseases among Pakistanis in Oslo with a high risk of developing these diseases.


Options:
A: Physical activity level
B: Absolute level of physical activity: (Assessed at baseline, 6, 12 and 24-month follow-up as kcals/wk expenditure based on survey self-report, validated against activity monitor data in a random sub-sample.); Maintenance of physical activity (Physical activity level relative to baseline assessed at all follow-ups 6, 12, 24 months.)
C: Self-Reported physical activity (Baseline, 3 months, and 6 months)
D: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Study of Oral Probiotics Reduce the Incidence and Severity of Necrotizing Enterocolitis for Very Low Birth Weight Infants -Multi-Center Randomized Control Trial
Brief Summary: We investigate the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis (NEC) for very low birth weight (VLBW) infants.A prospective, masked, multi-center randomized control trial will be conducted level III neonatal center to evaluate the beneficial effects of probiotics for NEC among VLBW (\<1500 g) infants. VLBW infants who start to feed enterally are eligible and are randomized into 2 groups after parental informed consents were obtained. Infants in the study group are fed with Infloran (Lactobacillus acidophilus and Bifidobacterium bifidus) with breast or formula milk twice daily for 6 weeks. Infants in the control group are fed with breast or formula milk alone. The clinicians caring for the infants are blinded to the group assignment. The primary outcome measurement is death or NEC (≧stage 2).


Options:
A: Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples. (2 months)
B: Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition (at D14 and D21.)
C: The primary outcome measurement was death or NEC (≧stage 2) (From April 1, 2005 to May 30, 2007)
D: Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants (up to 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Study of Oral Probiotics Reduce the Incidence and Severity of Necrotizing Enterocolitis for Very Low Birth Weight Infants -Multi-Center Randomized Control Trial
Brief Summary: We investigate the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis (NEC) for very low birth weight (VLBW) infants.A prospective, masked, multi-center randomized control trial will be conducted level III neonatal center to evaluate the beneficial effects of probiotics for NEC among VLBW (\<1500 g) infants. VLBW infants who start to feed enterally are eligible and are randomized into 2 groups after parental informed consents were obtained. Infants in the study group are fed with Infloran (Lactobacillus acidophilus and Bifidobacterium bifidus) with breast or formula milk twice daily for 6 weeks. Infants in the control group are fed with breast or formula milk alone. The clinicians caring for the infants are blinded to the group assignment. The primary outcome measurement is death or NEC (≧stage 2).


Options:
A: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
B: Necrotizing enterocolitis (8 weeks)
C: Number of deaths and episodes of nosocomial sepsis among probiotic exposed and non-exposed preterm infants (From birth to discharge from the NICU or death. Average time 2 months.)
D: The primary outcome measurement was death or NEC (≧stage 2) (From April 1, 2005 to May 30, 2007)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multi-center, Open-Label, Randomized Trial of Gemcitabine/ Carboplatin, With or Without BSI-201, in Patients With ER, PR and HER2-negative Metastatic Breast Cancer
Brief Summary: The purpose of this clinical trial was to determine whether combining iniparib (BSI-201) with standard chemotherapy in estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer patients improve clinical benefit compared to treatment with standard chemotherapy alone.

Based on data generated by BiPar/Sanofi, it was concluded that iniparib does not possess characteristics typical of the poly (ADP-ribose) polymerase (PARP) inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.


Options:
A: Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment (Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months))
B: Objective Response Rate (ORR) (From randomization until data cutoff date (01 Sep 2016))
C: Clinical benefit rate (until cut-off date established so that all patients were evaluable for primary outcome measure)
D: progression free survival (until cut-off date established from deaths rate); Overall survival (until cut-off date established from deaths rate)

Answer: C