TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Ventilation Tubes Versus no Ventilation Tubes for Recurrent Acute Otitis Media or Chronic Otitis Media With Effusion in 9 to 36 Month Old Greenlandic Children - a Randomised Clinical Trial
Brief Summary: The prevalence of otitis media among Greenlandic children is one of the highest in the world and twenty per cent of schoolchildren have impaired hearing in the frequencies for normal speech. Yet, there are no national guidelines to ensure prevention and treatment of recurrent acute otitis media and chronic otitis media with effusion and impaired hearing in Greenlandic children. International studies from the developed part of the world have shown that otitis prone children may benefit from tubulation of the tympanic membrane. However, it is unknown if these results can be applied to Greenlandic children.

This PhD project will conduct a randomised controlled trial comparing tubulation of the tympanic membrane, in Greenlandic children aged 9-36 months with recurrent acute otitis media and/or chronic otitis media with effusion, to conservative treatment. The children will be followed for two years. Outcome measures will include number of visits to health clinics, number of tympanic membrane perforations, number of episodes with acute otitis media according to medical records, Quality of life, measured by the validated questionnaires OM6 and Caregiver Impact Questionnaire, number of episodes where per oral or intravenous antibiotics have been administered according to medical records and serious adverse events

The trial will be conducted in collaboration with the Greenlandic health authorities and Copenhagen Trial Unit.

With this trial the investigators hope to decrease the number of episodes with acute otitis media, the number of Greenlandic children with chronic perforations of the tympanic membrane and hearing impairment and increase quality of life.

The results will add important knowledge to the effect of ventilation tube treatment also in an international aspect. There are to date only less than a handful of high quality studies concerning this issue on an international basis. The study will be among the first addressing this problem among populations with high risk of otitis media and is also of interest to other indigenous populations and the developing part of the world.


Options:
A: Non B type tympanogram (one month)
B: Treatment response (1 months)
C: Number of visits to health clinic (Two years after randomisation)
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: A Multi-centre, Randomised, Placebo Controlled, Double Blinded, Multiple Dose Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects (Explorer™3)
Brief Summary: This trial is conducted globally. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab administered subcutaneously to haemophilia A subjects.


Options:
A: Percentage of Participants With a Total Annualized Bleeding Rate (ABR) of Zero for Second Six Months (Day 183 to Day 364 (6 months))
B: Number of adverse events (AEs) (From first trial drug administration (day 1) to 11 weeks after the first trial product administration)
C: Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units) (52 weeks after treatment start for patients on prophylaxis); Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units) (28 weeks after treatment start on on-demand treatment)
D: Number of Bleeds During 6 Month Treatment Period (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind Placebo-Controlled Randomized Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenone After Renal Transplantation : Effect on Graft Function at 3 Months.
Brief Summary: Assess the impact of eplerenone (initiated within 2 hours prior to patient departure to the operating room and administered for 4 days during the post-operative period) on graft function evaluated by the measurement of glomerular filtration rate at 3 months - variable strongly associated with long-term graft survival.


Options:
A: Peritoneal fibrosis (6 months)
B: CV Death or Hospitalization for Heart Failure (up to 5 years)
C: Safety - Number of Participants With Serum Potassium >6.5 mEq/L (0 - 40 weeks); Safety - Participants With Serious Hypotension (0 - 40 weeks); Study Drug Tolerability (0 - 36 weeks); Efficacy - Change in Mitral Annular E' Velocity (Baseline to 36 weeks); Feasibility of Conducting a Full-scale Mortality-powered Trial (0 - 40 weeks)
D: Iohexol clearance (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Maximizing Adherence and Retention for Women and Infants in the Context of Option B+
Brief Summary: This is a 2x2 factorial cluster randomized trial of two interventions to improve retention and adherence for women and infants on Option B+. The overall goal is to determine which intervention (or combination of interventions) maximizes antiretroviral therapy (ART) adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya at 20 low-resource primary health care facilities and associated communities supported by Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS Relief (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune deficiency syndrome, (HIV) human immunodeficiency virus) . The investigators will assess both process and outcome indicators using a 2x2 factorial design, in which equal numbers of clusters will be randomized to one of the interventions (community-based mentor mothers or theory-based mobile text messages), both interventions, or standard of care. The interventions will be added to fully integrated high quality HIV and antenatal, maternal, neonatal, and child health (ANC/MNCH) services already offered at these sites.


Options:
A: Unprotected sex, no contraceptive (6-week post-baseline (in the past 6 weeks)); Unprotected sex, no highly effective contraceptive (6-week post-baseline (in the past 6 weeks))
B: Excessive weight gain (0-6 months)
C: Immunization Rate (12 months)
D: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Maximizing Adherence and Retention for Women and Infants in the Context of Option B+
Brief Summary: This is a 2x2 factorial cluster randomized trial of two interventions to improve retention and adherence for women and infants on Option B+. The overall goal is to determine which intervention (or combination of interventions) maximizes antiretroviral therapy (ART) adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya at 20 low-resource primary health care facilities and associated communities supported by Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS Relief (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune deficiency syndrome, (HIV) human immunodeficiency virus) . The investigators will assess both process and outcome indicators using a 2x2 factorial design, in which equal numbers of clusters will be randomized to one of the interventions (community-based mentor mothers or theory-based mobile text messages), both interventions, or standard of care. The interventions will be added to fully integrated high quality HIV and antenatal, maternal, neonatal, and child health (ANC/MNCH) services already offered at these sites.


Options:
A: Adherence to PrEP (Baseline to Week 48)
B: Rate of Premature birth (before 37 weeks gestation)
C: Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) (3 months); Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis) (3 months); Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment) (12 months); Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis) (12 months); Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL) (12 months); Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month) (12 months)
D: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Maximizing Adherence and Retention for Women and Infants in the Context of Option B+
Brief Summary: This is a 2x2 factorial cluster randomized trial of two interventions to improve retention and adherence for women and infants on Option B+. The overall goal is to determine which intervention (or combination of interventions) maximizes antiretroviral therapy (ART) adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya at 20 low-resource primary health care facilities and associated communities supported by Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS Relief (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune deficiency syndrome, (HIV) human immunodeficiency virus) . The investigators will assess both process and outcome indicators using a 2x2 factorial design, in which equal numbers of clusters will be randomized to one of the interventions (community-based mentor mothers or theory-based mobile text messages), both interventions, or standard of care. The interventions will be added to fully integrated high quality HIV and antenatal, maternal, neonatal, and child health (ANC/MNCH) services already offered at these sites.


Options:
A: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)
B: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)
C: Percent of children immunized (Up to 12 months of age)
D: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Maximizing Adherence and Retention for Women and Infants in the Context of Option B+
Brief Summary: This is a 2x2 factorial cluster randomized trial of two interventions to improve retention and adherence for women and infants on Option B+. The overall goal is to determine which intervention (or combination of interventions) maximizes antiretroviral therapy (ART) adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya at 20 low-resource primary health care facilities and associated communities supported by Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS Relief (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune deficiency syndrome, (HIV) human immunodeficiency virus) . The investigators will assess both process and outcome indicators using a 2x2 factorial design, in which equal numbers of clusters will be randomized to one of the interventions (community-based mentor mothers or theory-based mobile text messages), both interventions, or standard of care. The interventions will be added to fully integrated high quality HIV and antenatal, maternal, neonatal, and child health (ANC/MNCH) services already offered at these sites.


Options:
A: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
B: Vaccines received (Electronic Health Record) (up to a year of follow up)
C: Change in average monthly number of infant DBS HIV tests (Baseline and 6 mos (endline)); Change in average monthly number of maternal postpartum HIV tests (Baseline and 6 mos (endline)); Change in average monthly number of DPT1 doses administered (Baseline and 6 mos (endline))
D: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Maximizing Adherence and Retention for Women and Infants in the Context of Option B+
Brief Summary: This is a 2x2 factorial cluster randomized trial of two interventions to improve retention and adherence for women and infants on Option B+. The overall goal is to determine which intervention (or combination of interventions) maximizes antiretroviral therapy (ART) adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya at 20 low-resource primary health care facilities and associated communities supported by Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS Relief (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune deficiency syndrome, (HIV) human immunodeficiency virus) . The investigators will assess both process and outcome indicators using a 2x2 factorial design, in which equal numbers of clusters will be randomized to one of the interventions (community-based mentor mothers or theory-based mobile text messages), both interventions, or standard of care. The interventions will be added to fully integrated high quality HIV and antenatal, maternal, neonatal, and child health (ANC/MNCH) services already offered at these sites.


Options:
A: Acceptability of at least one method of effective contraception (4 months)
B: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)
C: Vaccines received (Electronic Health Record) (up to a year of follow up)
D: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cooking With Kids 2.0: Plus Parents and Play
Brief Summary: Fuel for Fun: Cooking with Kids Plus Parents and Play (FFF), is an integrated research, extension, and education project targeting 4th grade students. Its long-term goal of reducing the risk of childhood obesity will be addressed by promoting healthful food and activity environments, policies and behaviors through: 1) building and testing the efficacy of a 4th grade comprehensive school- and family-based intervention, 2) applying it to an after-school setting to broaden its reach, and, 3) disseminating both versions through outreach.


Options:
A: Change of BMI Z-score for preschoolers (Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up)
B: Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices (From Baseline Up to 8 months)
C: Change from baseline in physical activity level at 12-weeks (Baseline, 6-weeks and 12-weeks after study initiation)
D: Change in Fruit and Vegetable Consumption at School Lunch (assessed 4 times each 9-month school year; once prior to intervention beginning (i.e., September), approximately 10 weeks and then 20 weeks later, and finally once after the intervention ends (i.e., May).); Change in Student Activity Level (assessed 3 times over 1 year; initially prior to the intervention beginning (i.e., September), a 2nd time once the intervention ends (i.e., May), and then again at the beginning of the following school year (i.e., September))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cooking With Kids 2.0: Plus Parents and Play
Brief Summary: Fuel for Fun: Cooking with Kids Plus Parents and Play (FFF), is an integrated research, extension, and education project targeting 4th grade students. Its long-term goal of reducing the risk of childhood obesity will be addressed by promoting healthful food and activity environments, policies and behaviors through: 1) building and testing the efficacy of a 4th grade comprehensive school- and family-based intervention, 2) applying it to an after-school setting to broaden its reach, and, 3) disseminating both versions through outreach.


Options:
A: Change in self-esteem from baseline to 20-weeks (Change from baseline to 20-weeks); Change in grit from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Global Happiness from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Commitment to School from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Sense of Belonging at School from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Physical Activity from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Self-efficacy from baseline to 20-weeks (Change from baseline to 20-weeks)
B: Change in body mass index (BMI) (Baseline, Month 3)
C: Change in Fruit and Vegetable Consumption at School Lunch (assessed 4 times each 9-month school year; once prior to intervention beginning (i.e., September), approximately 10 weeks and then 20 weeks later, and finally once after the intervention ends (i.e., May).); Change in Student Activity Level (assessed 3 times over 1 year; initially prior to the intervention beginning (i.e., September), a 2nd time once the intervention ends (i.e., May), and then again at the beginning of the following school year (i.e., September))
D: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cooking With Kids 2.0: Plus Parents and Play
Brief Summary: Fuel for Fun: Cooking with Kids Plus Parents and Play (FFF), is an integrated research, extension, and education project targeting 4th grade students. Its long-term goal of reducing the risk of childhood obesity will be addressed by promoting healthful food and activity environments, policies and behaviors through: 1) building and testing the efficacy of a 4th grade comprehensive school- and family-based intervention, 2) applying it to an after-school setting to broaden its reach, and, 3) disseminating both versions through outreach.


Options:
A: Change in Fruit and Vegetable Consumption at School Lunch (assessed 4 times each 9-month school year; once prior to intervention beginning (i.e., September), approximately 10 weeks and then 20 weeks later, and finally once after the intervention ends (i.e., May).); Change in Student Activity Level (assessed 3 times over 1 year; initially prior to the intervention beginning (i.e., September), a 2nd time once the intervention ends (i.e., May), and then again at the beginning of the following school year (i.e., September))
B: Body Mass Index (one year)
C: Change in body mass index (BMI) z-score (Up to 2 years)
D: Change in The Environment and Policy Assessment and Observation tool (EPAO) score (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Acupuncture Pre-treatment Combined With Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome
Brief Summary: This is a study protocol for a multicenter, randomized, and controlled trial. In this protocol, we present a randomized controlled trial comparing acupuncture pretreatment followed by letrozole vs letrozole alone in polycystic ovary syndrome (PCOS) women with anovulatory infertility. The high prevalence of insulin resistance (IR) in women with PCOS women is considered to be one of the major pathophysiological changes of PCOS, leading to anovulatiory infertility. A study has shown that electro-acupuncture could significantly improve insulin sensitivity. The effect of acupuncture pretreatment on anovulatory PCOS women followed by ovulation induction has not been investigated before. A total of 384 patients enrolled in this study will be randomized into one of two groups. The treatment group: a 16 week acupuncture pretreatment followed by 4 cycles of letrozole and the control group: 4 cycles of letrozole alone. The primary outcome is the live birth rate. We postulate that acupuncture pretreatment followed by letrozole results in a higher live birth rate when compared with letrozole alone.


Options:
A: Live Birth (as few as 5 months, up to 16 months)
B: Pregnancy rate (14 moths)
C: Ovulation (6 weeks after starting the intervention)
D: Live birth rate (Up to 18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Acupuncture Pre-treatment Combined With Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome
Brief Summary: This is a study protocol for a multicenter, randomized, and controlled trial. In this protocol, we present a randomized controlled trial comparing acupuncture pretreatment followed by letrozole vs letrozole alone in polycystic ovary syndrome (PCOS) women with anovulatory infertility. The high prevalence of insulin resistance (IR) in women with PCOS women is considered to be one of the major pathophysiological changes of PCOS, leading to anovulatiory infertility. A study has shown that electro-acupuncture could significantly improve insulin sensitivity. The effect of acupuncture pretreatment on anovulatory PCOS women followed by ovulation induction has not been investigated before. A total of 384 patients enrolled in this study will be randomized into one of two groups. The treatment group: a 16 week acupuncture pretreatment followed by 4 cycles of letrozole and the control group: 4 cycles of letrozole alone. The primary outcome is the live birth rate. We postulate that acupuncture pretreatment followed by letrozole results in a higher live birth rate when compared with letrozole alone.


Options:
A: Live birth rate (Up to 18 months)
B: Pregnancy rate (14 moths)
C: Ovulation Rate (3 months)
D: Ovulation Occurence (12 weeks); Ovulation Frequency (12 weeks)

Answer: A