TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Duloxetine 60 mg Versus Placebo in Patients With Chronic Osteoarthritis and Knee Pain in Japan
Brief Summary: The main purpose of this study is to evaluate the efficacy of the study drug known as duloxetine in participants with chronic osteoarthritis (OA) and knee pain in Japan.


Options:
A: Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score (Baseline, Week 14)
B: Brain Regional Gray Matter Density (2 weeks)
C: Assessing Visual Analog Scale Score Change in Patients (0.,4., and 12. weeks); Neuropthic Pain Diagnostic Questionnaire (DN4) (0.,4, and 12. weeks); Assessing Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score Change in Patients (0., 4. and 12. weeks)
D: Change in Brain Gray Matter Volume (16 weeks compared to baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Laparoscopic Versus Open Gastrectomy for Gastric Cancer, a Multicenter Prospectively Randomized Controlled Trial (LOGICA-trial)
Brief Summary: This is the first randomized controlled trial comparing laparoscopic and open gastrectomy for resectable gastric cancer in a Western population. The hypothesis is that laparoscopic gastrectomy will result in a lower post-operative burden by means of shorter post-operative hospital stay. Secondarily that laparoscopic gastrectomy is hypothesized to be associated with lower post-operative morbidity and readmissions, higher cost-effectiveness, and better post-operative quality of life, with similar mortality and oncologic outcomes, compared to open gastrectomy. The study starts on 1 December 2014. Inclusion and follow-up will take three and five years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient.


Options:
A: noncompliance rate (postoperative 1 week)
B: 5 year disease free survival (1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years)
C: Post-operative hospital stay (During admission, an expected average of 2 weeks)
D: Extent of lymph node dissection (two weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy
Brief Summary: The goal of REMEDIUM project is to develop personalized stem cell therapy for patients with chronic heart failure due to dilated cardiomyopathy (DCM). The main focus of the project is (1) on repetitive administration of cell therapy that would allow for long-lasting improvements in heart function and outcome in this patient population. In parallel, the investigators aim to (2) develop a standardized patient-specific stem cell product that could be cryopreserved and stored in a stem cell bank for prolonged time periods, and used for therapeutic application when clinically indicated. By using a unique multimodality imaging platform, the goal of this project is also to (3) define standardized clinical criteria that would serve as a guideline for evaluation of the effects of stem cell therapy in future clinical trials and everyday clinical settings. Finally, to improve the clinical implementation of cell therapy,the investigators aim to (4) develop a stem cell delivery technique that could be used to treat both left and right and ventricular failure and could be implemented in a standardized fashion designed for a widespread clinical use.


Options:
A: Change in left ventricular ejection fraction (baseline and 1 year)
B: Heart Failure Mortality (5 years); Changes in Left Ventricular Ejection Fraction (5 years)
C: Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation (one month post-catheterization)
D: Safety will be assessed by: post-procedure assessments, physical exam, vital signs, laboratory tests, and adverse events including MACE (Major Adverse Cardiac Event) occurrences. (Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Nutrition Education Package in Improving Feeding Practices, Dietary Adequacy and Growth of Infants and Young Children in Rural Tanzania
Brief Summary: Building on the success of community-based peer education and counselling in breastfeeding, it is possible to address young child feeding and health practices in the surveyed district. Opportunities that can optimise success and encourage behaviour change in the district include mothers willingness to modify some feeding options; support of family members; seasonal availability and accessibility of foods; established set-up of village peers and existence of health centres and health staff in some villages. This study has developed a feasible, context-specific nutrition education package for use in rural Tanzania. The package is composed of 4 components, namely 1) education and counselling of mothers, 2) training of community-based nutrition counsellors, 3) sensitisation meetings with health staff and family members, and 4) supervision of community-based nutrition counsellors. The intervention will use a parallel cluster-randomised controlled trial design where infants will be recruited when aged 6 months and followed up for 9 months. The intervention expects to provide information and, where appropriate, recommendations to strengthen the nutrition component in the health education programme of the Tanzania child health services.

The study hypothesises that the nutrition education package will be more effective than the routine health education in improving feeding practices, dietary adequacy and growth of infants and young children. Specific objectives of the study include:

* To evaluate the effectiveness of a nutrition education package on feeding practices and dietary adequacy
* To determine the effectiveness of a nutrition education package in improving growth and health of infants and young children
* To document the process of implementation of the nutrition education package to promote optimal feeding and health practice


Options:
A: Change in Infant Growth (Baby is less than 2 months; baby is 3 months; baby is 6 months)
B: Linear growth: Mean change from baseline in length-for-age Z-scores at at 9-, 12- and 15-months-old (Length-for-age Z-scores: Baseline (6 months-old), Month 9, Month 12 and Month 15)
C: Exclusive breastfeeding (EBF) among children 0-6 months of age (4 years after baseline); Child anthropometry (height, weight) among children 24-48 months of age (4 years after baseline); Complementary feeding among children 6-23.9 months of age (4 years after baseline); Anemia among children 6-23.9 months (4 years after baseline)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Nutrition Education Package in Improving Feeding Practices, Dietary Adequacy and Growth of Infants and Young Children in Rural Tanzania
Brief Summary: Building on the success of community-based peer education and counselling in breastfeeding, it is possible to address young child feeding and health practices in the surveyed district. Opportunities that can optimise success and encourage behaviour change in the district include mothers willingness to modify some feeding options; support of family members; seasonal availability and accessibility of foods; established set-up of village peers and existence of health centres and health staff in some villages. This study has developed a feasible, context-specific nutrition education package for use in rural Tanzania. The package is composed of 4 components, namely 1) education and counselling of mothers, 2) training of community-based nutrition counsellors, 3) sensitisation meetings with health staff and family members, and 4) supervision of community-based nutrition counsellors. The intervention will use a parallel cluster-randomised controlled trial design where infants will be recruited when aged 6 months and followed up for 9 months. The intervention expects to provide information and, where appropriate, recommendations to strengthen the nutrition component in the health education programme of the Tanzania child health services.

The study hypothesises that the nutrition education package will be more effective than the routine health education in improving feeding practices, dietary adequacy and growth of infants and young children. Specific objectives of the study include:

* To evaluate the effectiveness of a nutrition education package on feeding practices and dietary adequacy
* To determine the effectiveness of a nutrition education package in improving growth and health of infants and young children
* To document the process of implementation of the nutrition education package to promote optimal feeding and health practice


Options:
A: HIV (Last 3 months); Hypertension (Last 3 months); Asthma (Last 3 months); Diabetes (Last 3 months); Epilepsy (Last 3 months); Mental Health (Last 3 months); Malnutrition (Last 3 months); Tuberculosis (Last 3 months); Family Planning (Last 3 months); Antenatal Care (Last 3 months)
B: Number of death in children aged 6 to 59 months (12 months)
C: Difference in the under-five child mortality rate between the two study arms (36 months)
D: Linear growth: Mean change from baseline in length-for-age Z-scores at at 9-, 12- and 15-months-old (Length-for-age Z-scores: Baseline (6 months-old), Month 9, Month 12 and Month 15)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Assessment of a New Physiotherapy Protocol for Gait Recovery After Stroke Based on Clinical and Functional Criteria
Brief Summary: The purpose of this study was to identify and evaluate the effect of a new protocol of physiotherapy to retrain walking ability after stroke in subjects older than fifty-five. This protocol was composed of specific, clearly defined and reproducible techniques, based on clinical and functional criteria.


Options:
A: Change in the Function In Sitting Test (FIST) from baseline to after 10-12 treatment sessions (baseline, immediately after 10-12 treatments); Change in the Function In Sitting Test (FIST) from baseline to 1 month after second assessment (baseline,1 month after second assessment)
B: Change in Anterior Trunk Displacement (Baseline, 1 hour (after completing 1st feedback condition) and 2 hours (after completing 2nd feedback condition))
C: The change in Tinetti Performance Oriented Mobility Assessment (week 0, week 5, and week 9)
D: Barthel Index (up to 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study aimed to compare dobutamine stress echocardiography (DES) with computed tomography coronary angiography (CTCA) in patients with undergoing intermediate to high risk noncardiac surgery.


Options:
A: Major Adverse Cardiac and Cerebrovascular Events (MACCEs) (up to 90 days after surgery)
B: N/A
C: N/A
D: Diagnostic accuracy of DES vs. CTCA in the prediction of the postoperative hard cardiac events in patients undergoing intermediate to high risk noncardiac surgeries (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder
Brief Summary: This study compares the efficacy of embedding avatars into an online self-management program that teaches OAB behavioral therapy on OAB-related quality of life, symptoms, self-efficacy, and adherence versus the same program without avatars


Options:
A: 24-hour Voiding Frequency (post-treatment (week 8))
B: Change from baseline in average number of urinations per patient per day at Week 12
C: Overactive bladder- health related quality of life (OAB HRQOL) (Baseline and at one, six, and 12 weeks)
D: Difference in the % of patients maintaining persistence between no intervention and HEI group (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility and Accuracy of a Novel Xpert Cartridge for Rapid Molecular Detection of Drug Resistant Mycobacterium Tuberculosis in Sputum
Brief Summary: Consenting adults will be interviewed for demographic and medical information, and then will be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis.


Options:
A: Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH and ETH resistance detection (Day 1); Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for fluoroquinolone resistance detection (Day 1); Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for second-line injectable resistance detection (Day 1)
B: Treatment time (Up to 8 weeks)
C: Sensitivity and specificity (10 months)
D: Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases (2 months after enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility and Accuracy of a Novel Xpert Cartridge for Rapid Molecular Detection of Drug Resistant Mycobacterium Tuberculosis in Sputum
Brief Summary: Consenting adults will be interviewed for demographic and medical information, and then will be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis.


Options:
A: Rates of TB treatment initiation (48 hours)
B: Sensitivity and specificity (10 months)
C: Correlation between baseline clinical characteristics and presence of microbiologically confirmed active tuberculosis. (Two years); Comparison of ART outcome in patients taking concomitant anti-tuberculosis therapy and those only taking ART. (Three years)
D: All-cause mortality (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Influence of Once-daily Versus Twice-daily Immunosuppressive Regimen on Drug Compliance in Patients After Renal Transplantation
Brief Summary: The main objective of this study was to compare the drug compliance in patients after renal transplantation under once or twice-daily tacrolimus-based immunosuppressive regimen.

The rationale for this study is to access the influence of once-daily prolonged-release tacrolimus versus standard twice-daily tacrolimus on drug compliance in renal transplantation recipients base on the assumption that once-daily dosing regimen may help to improve drug compliance.


Options:
A: Drug adherence (at 6 months after enrollment)
B: 12-week immunosuppression medication adherence (12 weeks)
C: basal assessment of adherence with immunosuppressive medication scale (12 months)
D: Rx Pill Count (1 year - 1.5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double Blind, Placebo Controlled Trial Comparing the Impact of a Combined Package of Interventions vs Placebo in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
Brief Summary: Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.


Options:
A: "negative nutritional outcome" of a child (6 months follow-up)
B: Hemoglobin concentration (End of the 30-day fortification period)
C: Dual Sugar Absorption Test (12 weeks); Dual Sugar Absorption Test (24 weeks)
D: Acceptability of iron and folic acid (IFA) syrup (Endline (Up to 5 months)); Acceptability of micronutrient powders (MNP) (Endline (Up to 5 months)); Preference for vitamin supplementation (Endline (Up to 5 months)); Vitamin supplementation compliance (Baseline, Endline (Up to 5 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double Blind, Placebo Controlled Trial Comparing the Impact of a Combined Package of Interventions vs Placebo in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
Brief Summary: Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.


Options:
A: nutritional status (9 months)
B: Dual Sugar Absorption Test (12 weeks); Dual Sugar Absorption Test (24 weeks)
C: Number of children who remain well-nourished (Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema) (12 months)
D: Mean (± standard deviation) weight gain (kg) (Change between birth and six months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery: A Follow up Study on Brain Reorganization, Motor Performance of Upper Extremity, Daily Function, and Activity Participation
Brief Summary: We hypothesize that (1) the hybrid therapy will induce greater improvements on some health-related outcomes compared to other therapies; (2) such benefits will retain at 6-month follow-up; (3) better motor control and brain reorganization will be found in the hybrid therapy than the other therapies; (4) correlations will be found between brain activity and movement kinematics/health-related outcomes.


Options:
A: Change scores of Fugl-Meyer Assessment (FMA) (Baseline, 2 weeks, 4 weeks, 16 weeks, and 28 weeks); Change scores of Wolf Motor Function Test (WMFT) (Baseline, 2 weeks, and 4 weeks); Change scores of Motor Activity Log (MAL) (Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks); Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0) (Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks); Change scores of Revised Nottingham Sensory Assessment (rNSA) (Baseline, and 4 weeks)
B: Improvement of postural control measured with the trunc control test (TCT) on day 9 after admission to the hospital (Day 1-9 after admission to hospital (+/- 1))
C: Wolf Motor Function test (immediately before and immediately after treatment); Fugl-Meyer Assessment (immediately before and immediately after treatment)
D: the score-change of the Functional Independence Measure (FIM) assessment for daily living function (baseline, 2-week, 4-week and three months after stroke)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery: A Follow up Study on Brain Reorganization, Motor Performance of Upper Extremity, Daily Function, and Activity Participation
Brief Summary: We hypothesize that (1) the hybrid therapy will induce greater improvements on some health-related outcomes compared to other therapies; (2) such benefits will retain at 6-month follow-up; (3) better motor control and brain reorganization will be found in the hybrid therapy than the other therapies; (4) correlations will be found between brain activity and movement kinematics/health-related outcomes.


Options:
A: change in function before/after tDCS (Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months)
B: Change scores of Fugl-Meyer Assessment (FMA) (Baseline, 2 weeks, 4 weeks, 16 weeks, and 28 weeks); Change scores of Wolf Motor Function Test (WMFT) (Baseline, 2 weeks, and 4 weeks); Change scores of Motor Activity Log (MAL) (Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks); Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0) (Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks); Change scores of Revised Nottingham Sensory Assessment (rNSA) (Baseline, and 4 weeks)
C: Fugl-Meyer Assessment Upper Extremity (6 weeks)
D: Change in Upper Limb function (Baseline and posttest (an average of 2 weeks from baseline))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Assertive Community Treatment With Cognitive Behavioral Therapy and Social Skills Training for Schizophrenia.
Brief Summary: This project is an effectiveness trial comparing two psychosocial treatments for schizophrenia: Assertive Community Treatment (ACT) + Cognitive Behavioral Social Skills Training (CBSST) v. ACT, alone.


Options:
A: Independent Living Skills Survey (ILSS) (Baseline, 18 mos.)
B: Clinical, neuropsychological, and functional outcomes (Measured at Years 1 and 3)
C: Social Functioning (Measured at baseline and Months 9 and 21)
D: Labor Market Participation in Ordinary Paid Employment, or Education. (1 year (2016))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multi-center, Randomized Trial of Fecal Microbiota Transplantation (FMT) Delivered by Capsule vs Colonoscopy in the Management of Recurrent Clostridium Difficile Infection (CDI)
Brief Summary: Delivery of FMT by upper route, including gastroscopy, nasogastric/ nasojejunal tube, and lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized successfully. Endoscopic delivery requires significant health care utilization and associated cost. Therefore, it is extremely desirable if FMT can be infused by a non invasive modality, which would significantly reduce patient discomfort, procedure related risks and health care costs, while offering similar efficacy to colonoscopic delivery in the range of 90%.


Options:
A: Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment (8 weeks)
B: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)
C: Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) (8 weeks after last assigned study treatment)
D: Proportion of patients without recurrent CDI (12 weeks after treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Soft Bifocal Contact Lens Myopia Control
Brief Summary: This study will evaluate the use of two different bifocal contact lens add powers to prevent further nearsighted progression in children ages 7 to 11 years old. It is theorized that the profile of the bifocal lenses will decrease the amount of change in nearsightedness that the children experience.


Options:
A: Cycloplegic autorefraction (Baseline, 6, 12, 18, and 24 months)
B: Refractive Error Progression (3 years)
C: the progression of myopia degree, axial length elongation of eye
D: Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (Baseline to 3 years); Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Soft Bifocal Contact Lens Myopia Control
Brief Summary: This study will evaluate the use of two different bifocal contact lens add powers to prevent further nearsighted progression in children ages 7 to 11 years old. It is theorized that the profile of the bifocal lenses will decrease the amount of change in nearsightedness that the children experience.


Options:
A: Refractive Error Progression (3 years)
B: N/A
C: Cycloplegic autorefraction (Baseline, 6, 12, 18, and 24 months)
D: N/A

Answer: A