TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
Brief Summary: Vitamin D can be made in the skin by exposure to sunlight and can be found in certain foods. Vitamin D levels are alarmingly low in many North American children. Several health issues have been linked with low vitamin D. These include colds caused by viruses and asthma attacks. However, no study has determined whether vitamin D supplementation can reduce the risk of these conditions in young children where they are most common and most severe.

The goals of this study are to determine whether wintertime high dose vitamin D supplementation of preschoolers can prevent colds and asthma attacks. The investigators also aim to work out how much money would be saved by the health care system and society if preschoolers were routinely supplemented with Vitamin D during the winter. The investigators believe that preschoolers receiving 'high dose' vitamin D supplementation during the wintertime will be less likely to have colds, asthma attacks, and low vitamin D levels and will be less likely to use the medical system and keep their parents away from work.


Options:
A: serum Vitamin D (3 months)
B: Days to a Severe Asthma Exacerbation (48 weeks)
C: Number of Laboratory confirmed upper respiratory tract infections (Up to 8 months)
D: Reduction of allergic bronchial inflammation (Up to 3 months); Reduction of allergic bronchial inflammation (Up to 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
Brief Summary: Vitamin D can be made in the skin by exposure to sunlight and can be found in certain foods. Vitamin D levels are alarmingly low in many North American children. Several health issues have been linked with low vitamin D. These include colds caused by viruses and asthma attacks. However, no study has determined whether vitamin D supplementation can reduce the risk of these conditions in young children where they are most common and most severe.

The goals of this study are to determine whether wintertime high dose vitamin D supplementation of preschoolers can prevent colds and asthma attacks. The investigators also aim to work out how much money would be saved by the health care system and society if preschoolers were routinely supplemented with Vitamin D during the winter. The investigators believe that preschoolers receiving 'high dose' vitamin D supplementation during the wintertime will be less likely to have colds, asthma attacks, and low vitamin D levels and will be less likely to use the medical system and keep their parents away from work.


Options:
A: Treatment Failure (Twenty-eight week intervention period from randomization until end of trial.)
B: Time to first upper respiratory tract infection (One year); Time to first severe asthma exacerbation (One year)
C: Number of Laboratory confirmed upper respiratory tract infections (Up to 8 months)
D: Time to first upper respiratory tract infection (One year); Time to first moderate / severe COPD exacerbation (One year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
Brief Summary: Vitamin D can be made in the skin by exposure to sunlight and can be found in certain foods. Vitamin D levels are alarmingly low in many North American children. Several health issues have been linked with low vitamin D. These include colds caused by viruses and asthma attacks. However, no study has determined whether vitamin D supplementation can reduce the risk of these conditions in young children where they are most common and most severe.

The goals of this study are to determine whether wintertime high dose vitamin D supplementation of preschoolers can prevent colds and asthma attacks. The investigators also aim to work out how much money would be saved by the health care system and society if preschoolers were routinely supplemented with Vitamin D during the winter. The investigators believe that preschoolers receiving 'high dose' vitamin D supplementation during the wintertime will be less likely to have colds, asthma attacks, and low vitamin D levels and will be less likely to use the medical system and keep their parents away from work.


Options:
A: Change from baseline in stereotypic behaviour from the aberrant behaviour checklist (Day 1 and day 140)
B: Bacille-Calmette-Guerin (BCG) vaccine efficacy (2 months); Bacille-Calmette-Guerin (BCG) vaccine efficacy (6 months); Bacille-Calmette-Guerin (BCG) vaccine efficacy (1 year)
C: Number of Laboratory confirmed upper respiratory tract infections (Up to 8 months)
D: length of hospital stay (3 to 5 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol
Brief Summary: The purpose of this study is to determine if pretreatment with Estrogen can assist in the planning and programming of In Vitro Fertilization treatments.


Options:
A: Frequency of Ovarian Hyperstimulation Syndrome (OHSS) (3 years)
B: cost of treatment (One month)
C: To collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian hyperstimulation. (In both cohorts a follow-up pediatric evaluation was scheduled within 6 months post-partum)
D: ovum pickup rate that took place between Sunday to Thursday without a compromise (a year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Middle Eastern Immigrant Population At-risk for Diabetes; Contributing Risk Factors and the Efficiency and Cost-effectiveness of a Culturally Adopted Lifestyle Intervention Program - the MEDIM Study.
Brief Summary: An increasing proportion of Sweden's population comprises non-European immigrants, who constitute a high risk-population for T2D. Numbering almost 9,000 individuals, Iraqi citizens represent the largest immigrant group in Malmoe and are identified as a risk group for Type 2 Diabetes (T2D) in whom genetic and lifestyle factors probably play significant roles in the development of T2D.

Several studies have shown that adoption of an active lifestyle by at-risk individuals dramatically reduces the risk of T2D. However, there are currently no established methods for providing support to high-risk individuals from different cultural and social backgrounds to help them adopt beneficial lasting lifestyle changes. Instead of just waiting for Iraqi high-risk individuals to develop T2D, this project will implement and assess lifestyle intervention programs aimed at reducing the risk of developing T2D and tailored to individuals with a different social and cultural background.

The study thus seeks to optimize preventive action in health care and aims to facilitate the adoption of permanent changes in lifestyle in high-risk patients, taking account of cultural and social barriers.

Since T2D is associated with a sedentary lifestyle and develops earlier in men than women and an average 10 years earlier in immigrants from the Middle East than in native Swedes, it is crucial to study pathogenic mechanisms triggering T2D development in relation to sex, lifestyle and ethnic background. The results will provide the basis for deciding how health care providers can actively work to prevent T2D and other lifestyle-associated diseases in this high-risk population that has not been studied before.


Options:
A: Body weight (4 months); Physical activity (4 months); Caloric intake (4 month)
B: enhancing rates of family communication, donor evaluations, and transplantation (6 months)
C: Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score (9 months); Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) (9 months)
D: Number of participants who adhere to mammography and Papanicolaou(Pap) test screening guidelines (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Ablation-based Atrial Fibrillation Rhythm Control Versus Rate Control Trial in Patients With Heart Failure and High Burden Atrial Fibrillation
Brief Summary: Atrial fibrillation and heart failure are two common heart conditions that are associated with an increase in death and suffering. When both of these two conditions occur in a patient the patient's prognosis is poor. These patients have poor life quality and are frequently admitted to the hospital. The treatment of atrial fibrillation in heart failure patients is extremely challenging. Two options for managing the atrial fibrillation are permitting the atrial fibrillation to continue but controlling the heart rate, or to convert the atrial fibrillation rhythm back to normal and try to maintain the heart in sinus rhythm. Until now, the method to keep the patient in normal sinus rhythm is with antiarrhythmic drugs. Studies using antiarrhythmic drugs to control the rhythm failed to show any survival benefit when compared with permitting the patient to be in atrial fibrillation. In the last few years, new development in techniques and technologies now enable catheter ablation (cauterization of tissue in the heart with a catheter) to be a successful treatment in abolishing atrial fibrillation and that this approach is better than antiarrhythmic drug to control the rhythm. However, there has not been any long-term study to determine whether catheter ablation to abolish atrial fibrillation in heart failure patients would reduce mortality or admissions for heart failure.

This study is to compare the effect of catheter ablation-based atrial fibrillation rhythm control to rate control in patients with heart failure and high burden atrial fibrillation on the composite endpoint of all-cause mortality and heart failure events defined as an admission to a healthcare facility for \> 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic and an increase in chronic heart failure therapy. This study may have a dramatic impact on the way the investigators manage these patients with atrial fibrillation and heart failure and may improve the outlook and well being of these patients.


Options:
A: Composite of all-cause mortality and heart failure events (Baseline to a minimum of 24 months)
B: Freedom from AF (18 months)
C: Recurrence of Atrial Fibrillation (One year)
D: Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)% (baseline and 6 months); Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) (Baseline); Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Daily Feeding of Food Sources of Cryptoxanthin (CX) and Beta-carotene (BC) on Plasma and Breast Milk Concentrations of CX, BC, and Retinol (VA) in Lactating Women With Marginal Vitamin A Status
Brief Summary: The study will assess the relative bioavailability and bioefficacy of cryptoxanthin (CX) and beta-carotene (BC) from food sources for increasing breast milk carotenoid and retinol concentrations in lactating Bangladeshi women.


Options:
A: Change in carotenoids in serum and breast milk (1 and 3 weeks)
B: All-cause, Pregnancy-related Mortality (Deaths during pregnancy through 12 weeks postpartum)
C: Pregnancy-related mortality and all cause mortality (Continuous)
D: Breast milk immune regulators (Four months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: RadIal Versus Femoral Randomized InvEstigation in ST Elevation Acute Coronary Syndrome
Brief Summary: Prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of net adverse clinical outcomes (NACE) of transfemoral vs. transradial approach for the treatment of patients with ST-elevation acute coronary syndrome (STEACS) undergoing primary angioplasty


Options:
A: Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out. (96 hours after randomization)
B: N/A
C: Net Adverse Clinical Event (30-day)
D: Composite of Death, Myocardial (re-) Infarction, or Stroke (180 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tai Chi and Aerobic Exercise for Fibromyalgia
Brief Summary: The investigators will conduct a large randomized controlled trial comparing the effectiveness of Tai Chi mind-body exercise and standard-of-care aerobic exercise for fibromyalgia. In addition, the investigators will determine the optimal frequency and duration of a Tai Chi intervention for short and long-term effectiveness.


Options:
A: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)
B: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
C: Overall impact of fibromyalgia (Participants will be followed over 24 weeks)
D: Change in Fibromyalgia Impact Questionnaire (FIQ) from baseline to 24 weeks (Week 0, Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tai Chi and Aerobic Exercise for Fibromyalgia
Brief Summary: The investigators will conduct a large randomized controlled trial comparing the effectiveness of Tai Chi mind-body exercise and standard-of-care aerobic exercise for fibromyalgia. In addition, the investigators will determine the optimal frequency and duration of a Tai Chi intervention for short and long-term effectiveness.


Options:
A: Change in Fibromyalgia Impact Questionnaire (FIQ) from baseline to 24 weeks (Week 0, Week 24)
B: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)
C: Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire) (6 months)
D: Pain (10 sessions, in 5 weeks, 2 times a week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Giving BCG Vaccine at Birth to Low Birth-weight Infants on Development of Allergy and Asthma in Childhood - Follow up of a Randomised Trial in Guinea-Bissau
Brief Summary: The prevalence of asthma and allergic diseases is increasing worldwide. Infections and vaccinations in childhood may have an impact on the subsequent development of asthma and allergy. In Guinea-Bissau, the investigators previously found that Bacille Calmette-Guérin (BCG) vaccine was associated with reduction in atopy. Since then the investigators have conducted a randomised trial of BCG vaccine given at birth to low birth-weight infants. The present study aims to follow up children enrolled in the BCG randomised trial to assess for asthma and allergy later in childhood. Based on previous observations, the investigators expect children allocated to receive BCG at birth will have a reduction in allergy profile when compared to children who did not receive BCG at birth.


Options:
A: Skin prick test (Single observation at time of consent - DAY 1)
B: Mortality; Morbidity
C: Pregnancy-related mortality and all cause mortality (Continuous)
D: Frequency of circulating Tregs expressing gut homing receptors in infant participants. (17 week post-supplementation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Giving BCG Vaccine at Birth to Low Birth-weight Infants on Development of Allergy and Asthma in Childhood - Follow up of a Randomised Trial in Guinea-Bissau
Brief Summary: The prevalence of asthma and allergic diseases is increasing worldwide. Infections and vaccinations in childhood may have an impact on the subsequent development of asthma and allergy. In Guinea-Bissau, the investigators previously found that Bacille Calmette-Guérin (BCG) vaccine was associated with reduction in atopy. Since then the investigators have conducted a randomised trial of BCG vaccine given at birth to low birth-weight infants. The present study aims to follow up children enrolled in the BCG randomised trial to assess for asthma and allergy later in childhood. Based on previous observations, the investigators expect children allocated to receive BCG at birth will have a reduction in allergy profile when compared to children who did not receive BCG at birth.


Options:
A: Exclusive Breastfeeding Rates in Burkina Faso (at 3 months of age); Infant Morbidity, 2 Week Diarrhoea Prevalence (at 3 months of age); Exclusive Breastfeeding Rates in Uganda (at 3 months of age); Exclusive Breastfeeding Rates in South Africa (at 3 months of age)
B: Skin prick test (Single observation at time of consent - DAY 1)
C: Pregnancy-related mortality and all cause mortality (Continuous)
D: Thymus size measured by ultrasound (through 15 wk of age); peripheral blood naive T-helper lymphocyte concentration (through 15 wk of age); T-cell receptor excision circle (TREC) level in peripheral blood mononuclear cells (PBMC) (through 15 wk of age); T-cell response to BCG (Bacillus Calmette-Guérin; to protect against tuberculosis) and oral polio virus (OPV) immunization (through 15 wk of age); Antibody response to oral polio virus (OPV) immunization (through 15 wk of age); T-cell and antibody response to tetanus toxoid (TT) and hepatitis B virus (HBV) vaccinations given at 6, 10 and 14 wk of age (through 15 wk of age); bacterial translocation to blood (through 15 wk of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial: Chinese Auriculotherapy With and Without Protocol on Stress and Quality of Life in Nursing Professionals
Brief Summary: The purpose of this study is to assess stress levels and quality of life in the nursing team of Samaritan Hospital and evaluate the effectiveness of Chinese auriculotherapy used with and without closed protocol on reducing the stress levels and improvement of life quality.


Options:
A: stress levels (75 days)
B: Degree of occupational stress (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)); Degree of occupational stress (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)); Degree of burnout (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)); Degree of Self-Compassion (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG))
C: Average daily mood (7 days); Patient Health Questionnaire-9 (PHQ-9) (4 months)
D: change in self reported Stress symptoms (Baseline, 1 month, 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of Gain- Versus Loss-framed Health Messages to Improve Oral Health Among Iranian Adolescents:A Randomized Controlled Trial
Brief Summary: This study explores the effectiveness of message framing, loss-framed vs. gain-framed messages on oral health in Iran.


Options:
A: Children's height and weight (HAZ,WAZ and BAZ) (6 months)
B: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)
C: Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.
D: changes in frequencies of dental brushing and flossing (changes from baseline, two weeks after the intervention and six months follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #576 - VA Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D)
Brief Summary: The overall purpose is to determine research based 'next-steps' for outpatients with major depressive disorder who have not had satisfactory outcomes to standard 'first-step' treatments. The primary objective is to compare the acute (up to 12 weeks) treatment effectiveness of augmenting an antidepressant with aripiprazole or with bupropion-slow release (SR) vs. switching treatment to bupropion-SR monotherapy on symptom remission in Veterans with Major Depressive Disorder (MDD) who have not achieved optimal response after an adequate trial on antidepressant (a selective serotonin reuptake inhibitor \[SSRI\] or serotonin and norepinephrine reuptake inhibitor \[SNRI\] or mirtazapine) monotherapy. The secondary objectives are to compare the acute (up to 12 weeks) and long term (up to 36 weeks) efficacy, safety, effects on functioning, suicidality, quality of life, anxiety and other associated symptoms, costs and cost-effectiveness of each of the three treatments.


Options:
A: Rate of Protocol Remission of Symptoms of Major Depressive Disorder (During acute phase (12 weeks))
B: Observer-rated depression severity (PHQ-9) (9 weeks)
C: Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline to Week 4)
D: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10 (Baseline to Week 10)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of a Trainings Program on ADL Performance, Physical Fitness, Wellbeing, and Nocturnal Cramp in Elderly People
Brief Summary: Ageing is related to a decrease in physical fitness, disability and age related symptoms like nocturnal leg cramps (NLC). Our research is focused on the enhancement of physical activity and mobility to increase physical fitness and decrease disability and nocturnal cramp in older adults.


Options:
A: Improvement in QOL questionnaires (3 months); Lack of deterioration in portal hypertension (3 months)
B: Physical fitness (six weeks); ADL performance (six weeks); Well being (six weeks); Nocturnal cramps (Six weeks)
C: Difference in the average number of muscle cramps per week between magnesium and placebo treatments (3 weeks)
D: Number of documented episodes of NLC (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease
Brief Summary: This is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months or until taliglucerase alfa is commercially available to the subject at the discretion of the Sponsor.


Options:
A: Spleen Volume (Spleen Volume at Baseline and Months 12, 24, and 36)
B: Change From Baseline in Spleen Volume Measured by MRI. (Baseline and 9 months)
C: Spleen Volume (60 months)
D: Hemoglobin (Every 3 months for 12 months)

Answer: C