TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Life Enhancing Activities for Family Caregivers (LEAF)
Brief Summary: Life Enhancing Activities for Family Caregivers is a six-week program designed to increase positive affect in people who care for a family member with dementia. The intervention consists of 6 weekly one-hour sessions conducted one-on-one with a trained facilitator to teach simple skills that are practiced at home in a study-supplied workbook. The program is preceded and followed by a 30-45 minute questionnaire. Follow-up assessments will be conducted at 1-month, 3-months, and 6-months post intervention.

Primary hypothesis is that experimental subjects who participate in LEAF will demonstrate significantly greater improvements in psychological outcomes and will engage in more problem focused and positive appraisal forms of coping compared to the wait-list control condition.


Options:
A: Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year (Baseline to one year)
B: Repeated measures of the modified version of the Differential Emotions Scale (DES) (Izard, 1977) (Baseline and weeks 6 and 10; 3-months and 6-months post)
C: Depressive Symptoms (Change from baseline through study completion, an average of about 5 months)
D: Center for Epidemiological Studies Depression scale (Pre- and post-training, 3 months and 6 months); Spielberger State-Trait Anger and Anxiety Scales (Pre-and post-training, 3 months and 6 months); Perceived Stress Scale (Pre- and post-training, 3 months and 6 months); Pittsburgh Sleep Quality Index (Pre-and post-training, 3 months and 6 months); Heart rate and blood pressure at rest and during recall of caregiver situation (Pre-and post-training, 3 months and 6 months); Salivary cortisol upon awakening, 30 minutes later, and prior to going to bed at night (Pre-and post-training, 3 months and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment
Brief Summary: In the near future more than 20% of the European population will be over 65 years old and the prevalence of obstructive sleep apnea (OSA) in this aged population is known to be higher than 50%. OSA is a risk factor for cognitive dysfunction in middle-aged subjects, but the relationship between cognitive impairment and sleep breathing disorders (SBD) in the elderly has scarcely been observed.

The aim of this study is to investigate cognitive performance in elderly OSA patients, the corresponding brain morphology changes and biological markers and their reversibility with continuous positive airway pressure (CPAP) treatment.


Options:
A: Average hours of CPAP use per night: experimental pathway vs. traditional pathway (3 months)
B: Number of hours of use per day of CPAP (Six month)
C: Structural and functional brain changes (at baseline and after 3 months of treatment)
D: Efficacy of the extra- and intra-hospital programs using DNP or PSG, taking as primary variable the Epworth scale. (Before and after 6 months of follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Do Insulin Secretion or Genotype Pattern Predict Low Fat vs Low Carb Weight Loss Success?
Brief Summary: Genomics research is advancing rapidly, and links between genes and obesity continue to be discovered and better defined. A growing number of single nucleotide polymorphisms (SNPs) in multiple genes have been shown to alter an individual's response to dietary macronutrient composition. Based on prior genetic studies evaluating the body's physiological responses to dietary carbohydrates or fats, the investigators identified multi-locus genotype patterns with SNPs from three genes (FABP2, PPARG, and ADRB2): a low carbohydrate-responsive genotype (LCG) and a low fat-responsive genotype (LFG). In a preliminary, retrospective study (using the A TO Z weight loss study data), the investigators observed a 3-fold difference in 12-month weight loss for initially overweight women who were determined to have been appropriately matched vs. mismatched to a low carbohydrate (Low Carb) or low fat (Low Fat) diet based on their multi-locus genotype pattern. The primary objective of this study is to confirm and expand on the preliminary results and determine if weight loss success can be increased if the dietary approach (Low Carb vs. Low Fat) is appropriately matched to an individual' s genetic predisposition (Low Carb Genotype vs. Low Fat Genotype) toward those diets.


Options:
A: Change from baseline in weight at 12 months (Baseline and 12 months)
B: Change in Weight (Baseline, 24 months)
C: Weight loss (3 months, 6 months, 12 months)
D: Percent Change in Body Weight From Baseline to 12 Weeks (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Do Insulin Secretion or Genotype Pattern Predict Low Fat vs Low Carb Weight Loss Success?
Brief Summary: Genomics research is advancing rapidly, and links between genes and obesity continue to be discovered and better defined. A growing number of single nucleotide polymorphisms (SNPs) in multiple genes have been shown to alter an individual's response to dietary macronutrient composition. Based on prior genetic studies evaluating the body's physiological responses to dietary carbohydrates or fats, the investigators identified multi-locus genotype patterns with SNPs from three genes (FABP2, PPARG, and ADRB2): a low carbohydrate-responsive genotype (LCG) and a low fat-responsive genotype (LFG). In a preliminary, retrospective study (using the A TO Z weight loss study data), the investigators observed a 3-fold difference in 12-month weight loss for initially overweight women who were determined to have been appropriately matched vs. mismatched to a low carbohydrate (Low Carb) or low fat (Low Fat) diet based on their multi-locus genotype pattern. The primary objective of this study is to confirm and expand on the preliminary results and determine if weight loss success can be increased if the dietary approach (Low Carb vs. Low Fat) is appropriately matched to an individual' s genetic predisposition (Low Carb Genotype vs. Low Fat Genotype) toward those diets.


Options:
A: Systolic blood pressure (SBP), Low Density Lipoproteins (LDL) cholesterol, High Density Lipoproteins (HDL) cholesterol, triglycerides, and insulin sensitivity (Measured at Week 5 of each dieting period)
B: weight change (Change from baseline to 24 months)
C: Weight; measured at each study visit; Percent body fat; measured at each study visit
D: Change from baseline in weight at 12 months (Baseline and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of an E-learning Tool on Patient Satisfaction, Knowledge and Medication Adherence in Solid Organ Transplantation: A Randomized Controlled Trial
Brief Summary: Solid organ transplant recipients (SOTR) must follow complex medication regimens and require a substantial amount of education for effective self-management. The current standard of care for post-transplant medication teaching is a Self Medication education program conducted in hospital by the pharmacist. The Transplant Medication Information Teaching Tool (TMITT) is a web-based e-learning tool for SOTR developed at the Toronto General Hospital. The ability to control the content, sequence, pace and timing of education in order to achieve personal learning objectives, as well as the opportunity for ongoing review and reinforcement of information, may be an attractive, convenient and effective teaching modality.

SOTR will be randomly assigned to receive the standard of care or the standard of care plus the TMITT intervention. Primary objectives are to compare patient satisfaction and medication knowledge between the two groups at baseline and 3 months using modified versions of previously published questionnaires. Medication adherence as measured by a multidimensional approach including both subjective and objective components, will also be compared at 3 months. Our hypothesis is that an education strategy that includes both the standard pharmacist teaching followed by a tailored online e-learning intervention post-discharge will lead to improved patient satisfaction, knowledge and medication adherence.


Options:
A: Change in Medication Knowledge Score from baseline to 3 months (Baseline and 3 months)
B: Medication adherence measured on validated scales and questionnaires (6 months)
C: Compliance (1 year)
D: change from baseline BMI at 8 months (8th month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of an E-learning Tool on Patient Satisfaction, Knowledge and Medication Adherence in Solid Organ Transplantation: A Randomized Controlled Trial
Brief Summary: Solid organ transplant recipients (SOTR) must follow complex medication regimens and require a substantial amount of education for effective self-management. The current standard of care for post-transplant medication teaching is a Self Medication education program conducted in hospital by the pharmacist. The Transplant Medication Information Teaching Tool (TMITT) is a web-based e-learning tool for SOTR developed at the Toronto General Hospital. The ability to control the content, sequence, pace and timing of education in order to achieve personal learning objectives, as well as the opportunity for ongoing review and reinforcement of information, may be an attractive, convenient and effective teaching modality.

SOTR will be randomly assigned to receive the standard of care or the standard of care plus the TMITT intervention. Primary objectives are to compare patient satisfaction and medication knowledge between the two groups at baseline and 3 months using modified versions of previously published questionnaires. Medication adherence as measured by a multidimensional approach including both subjective and objective components, will also be compared at 3 months. Our hypothesis is that an education strategy that includes both the standard pharmacist teaching followed by a tailored online e-learning intervention post-discharge will lead to improved patient satisfaction, knowledge and medication adherence.


Options:
A: Change in Medication Knowledge Score from baseline to 3 months (Baseline and 3 months)
B: The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. (one year)
C: Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention (1 month)
D: referral to a nephrologist (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Luteal Phase Support With Vaginal Progesterone on the Clinical Pregnancy Rate in Intrauterine Insemination Cycles Stimulated With Gonadotrophins: a Prospective Randomized Multicentre Study.
Brief Summary: The objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of the luteal phase will be recorded (secondary outcome) in order to detect luteal phase defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase prolongation in case of luteal phase support which may be a burden for the patients waiting for the outcome of the treatment.


Options:
A: ongoing pregnancy rate (1 year)
B: Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3 (weeks 1-3)
C: clinical pregnancy rate per IUI cycle (by ultrasound at ± 5 to 6 weeks after IUI)
D: A difference in the term (37 completed weeks of gestation), singleton live birth rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. (Approximately 9 months after completion of the last procedure of the last study participant.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a New Health Care Organization Model in Primary Care for Chronic Cardiovascular Disease Patients Based on a Multifactorial Intervention: The PROPRESE Randomized Controlled Trial.
Brief Summary: The purpose of this study is to determine whether a multifactorial primary care intervention based on chronic models can improve the level of control and reduce the number of hospital admissions in patients with ischemic heart disease.


Options:
A: Child BMI (3 years)
B: Change from baseline Number of hospitalizations/cause at 12 months (Baseline and 12 months)
C: Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group) (half year after intervention); Costs of both Implementation strategies (half year after intervention)
D: Percent of Participants With Poor Mental Health Quality of Life, MCS12≤ 40 (6 months follow-up); Percent of Participants With PHQ-9 Score ≥ 10 (6 months follow-up); Percent of Participants With Poor Mental Health Quality of Life, MCS12≤ 40 (12 months follow-up); Percent of Participants With Poor Mental Health Quality of Life, MCS12≤ 40 (36 months follow-up); Percent of Participants With PHQ-8 Score ≥ 10 (36 months follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: New Media Obesity Treatment in Community Health Centers
Brief Summary: This purpose of this trial is to determine whether a 12-month eHealth behavioral intervention that includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls, and primary care physician (PCP) counseling will produce greater weight change at 12 months than a standard primary care control.


Options:
A: Weight change (Baseline - 12 months)
B: Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry (Phase II baseline to 1 month, 2 months and 4 months (end of treatment)); Delay Discounting (Adjusting Amount Task) (Phase II baseline to 1 month, 2 months and 4 months (end of treatment)); Delay Discounting (Monetary Choice Questionnaire) (Phase II baseline to 2 months and 4 months (end of treatment))
C: Weight Loss (Omron Weight Balance) (12 weeks)
D: Mediterranean diet compliance (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: New Media Obesity Treatment in Community Health Centers
Brief Summary: This purpose of this trial is to determine whether a 12-month eHealth behavioral intervention that includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls, and primary care physician (PCP) counseling will produce greater weight change at 12 months than a standard primary care control.


Options:
A: Weight change (Baseline - 12 months)
B: Serum estrone concentrations as measured by radioimmunoassay (At baseline and 12 months timepoint)
C: N/A
D: The occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death (Every 12 months, at the end of the study.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: It is estimated that around 50 000 women die every year due to consequences of unsafe abortion (Singh et al, 2009). A majority of these deaths occur in low-income countries where access to safe abortion care is limited. Unplanned pregnancy and unsafe abortion thus place a huge burden on scarce medical resources. Any improvement in Comprehensive Abortion Care (CAC) would mean important improvements for the concerned women and their families (Singh, 2006) as well as for the societies at large. Recommended improvements concern increased access to the safest and most cost-effective methods such as medical abortion provided at primary level facilities (Singh et al, 2009). A Cochrane Review concludes that most randomised controlled trials within the field of medical abortion are conducted in high-income settings with good access to emergency health care services (Kulier et al, 2004). A simplified regime for medical abortion, which could be used at primary level facilities, would contribute to the reduction of maternal mortality and morbidity related to unsafe abortions globally. However, there is a knowledge gap in order to determine if a simplified follow up of medical abortion is equally effective as the standard procedure in a low-income setting. The results will provide evidence-based information to be used in revising training and service delivery guidelines' in order to reduce maternal mortality and morbidity in both low and high-income setting.


Options:
A: Complete abortion (30 days)
B: efficacy
C: Efficacy (At 10-14 days follow up)
D: Complete abortion (14 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life.

The aim of this study is to test the effects of tDCS combined with upper extremity robot-assisted therapy on stroke survivors.


Options:
A: Change in Upper Extremity Fugl Meyer Assessment (6 weeks from baseline); Percentage of Sessions With Adverse Events (Post treatment (6 weeks from baseline).)
B: Ambulatory function measured by the Six Minute Walk Test (Rehabilitation discharge (average 4-5 weeks post admission))
C: Fugl-Meyer Upper Extremity (A week prior to treatment beginning)
D: Fugl-Meyer Upper Extremity (FM-UE) (from baseline to day 3 post-training)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life.

The aim of this study is to test the effects of tDCS combined with upper extremity robot-assisted therapy on stroke survivors.


Options:
A: Fugl-Meyer Upper Extremity (A week prior to treatment beginning)
B: Behavioural Inattention Test (BIT) (Assessed at the recruitment interview (week 0) and at the exit interview (8 weeks after the intervention)); Neglect Test Battery (Assessed at 2 separate pre-intervention baseline sessions at least 1 week apart. Re-assessed following the intervention at intervals of 1, 2, 4 and 8 weeks.)
C: Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Rivermead Motor Assessment Battery (RMAB) (reporting a change on motricity of gross function, arm, leg and trunk at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months)
D: Upper Extremity Fugl-Meyer (2 weeks); Upper Extremity Fugl-Meyer (3 months); Upper Extremity Fugl-Meyer (1 year after stroke)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Different Strategies for Preventing Severe Acute Malnutrition in Niger: a Pragmatic Trial
Brief Summary: Options for large-scale preventive distributions include fortified blended flours, ready-to-use foods and direct cash transfer either alone or in combination with family protective rations. Finding the most appropriate strategy is essential to prevent child malnutrition in countries like Niger with annual hunger gaps. Here, the investigators compare different preventive strategies on the incidence of acute malnutrition among children 6 to 23 months.


Options:
A: Incidence of severe acute malnutrition (15 months)
B: Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate (1 year); Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations (1 year); Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month (1 year)
C: Sexually Transmitted Infections (18 months); Schooling (12 months/24 months)
D: Food security as measured by the value of food consumption through a household questionnaire (6 months); Dietary diversity as measured by dietary diversity index and food consumption score through a household questionnaire (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Different Strategies for Preventing Severe Acute Malnutrition in Niger: a Pragmatic Trial
Brief Summary: Options for large-scale preventive distributions include fortified blended flours, ready-to-use foods and direct cash transfer either alone or in combination with family protective rations. Finding the most appropriate strategy is essential to prevent child malnutrition in countries like Niger with annual hunger gaps. Here, the investigators compare different preventive strategies on the incidence of acute malnutrition among children 6 to 23 months.


Options:
A: Birth weight (approx 20 weeks after enrollment (within 48 hours)); Newborn length (At 1 week of age); Length for age Z-score (LAZ) at 18 months of age (12 months after enrollment (age 18 months))
B: Incidence of severe acute malnutrition (15 months)
C: Weight gain during the 12-week follow-up (in grams)
D: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Controlling Myopia Progression With Soft Contact Lenses
Brief Summary: This study is to investigate whether novel soft contact lens optical designs can slow myopia progression


Options:
A: Axial length (every 6 monthly in 2 years)
B: Spherical Equivalent Refractive Error (Baseline and every 6 months post-baseline for 2 years)
C: Spherical equivalent refractive error (i.e. myopia severity) (Baseline - 24-months)
D: Cycloplegic autorefraction (Baseline, 6, 12, 18, and 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Myopia Progression After Ceasing Myopia Control Contact Lens Wear
Brief Summary: This is a continuation study for subjects who were previously fit with test or control lenses; all will stop wearing their study lenses assigned in the previous study and will start to wear an FDA-approved marketed spherical soft contact lens.


Options:
A: Axial Length of the Eye (Baseline and every 6 months post-baseline up to 18 months); Spherical Equivalent Refractive Error (Baseline and every 6 months up to 18 months)
B: the change in spherical equivalent (SE) (SE measured at 3, 6, 9, 12 months.)
C: Global Self-Worth Scale from the Self-Perception Profile for Children (3 years)
D: Cycloplegic refraction (1 year)

Answer: A