TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Studies have shown that Intermittent preventive treatment in infants (IPTi) with Sulfadoxine-pyrimethamine (SP)reduced the incidence of clinical malaria and anemia without modifying infants' serological response to EPI vaccines. Thus IPTi was seen as a potential public health tool of great benefit to the children of Africa and a logical addition to the Immunization Plus package. The objectives of this operational researcher were

* to develop an implementation model for IPTi in the health care system in Mali
* to assess its impact on the EPI vaccines and other health interventions coverage
* and on molecular makers of resistance to SP


Options:
A: Efficacy:; The proportion of children with at least one episode of anemia from 3 to 18 months of life; The proportion of children with at least one episode of malaria from 3 to 18 months of life; Safety:; The proportion of children with at least one episode of an adverse event; The proportion of children with at least one episode of a serious adverse event; Rebound:; The proportion of children with at least one episode of anemia from 18-30 months of life, the proportion of children with at least one episode of malaria from 18-30 months of life
B: Maternal malaria at delivery (Delivery)
C: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)
D: Hemoglobin (9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Studies have shown that Intermittent preventive treatment in infants (IPTi) with Sulfadoxine-pyrimethamine (SP)reduced the incidence of clinical malaria and anemia without modifying infants' serological response to EPI vaccines. Thus IPTi was seen as a potential public health tool of great benefit to the children of Africa and a logical addition to the Immunization Plus package. The objectives of this operational researcher were

* to develop an implementation model for IPTi in the health care system in Mali
* to assess its impact on the EPI vaccines and other health interventions coverage
* and on molecular makers of resistance to SP


Options:
A: Immunization coverage (12 months); Timeliness of receipt of scheduled immunization (12 months)
B: Attendance for Early infant diagnosis (EID) of HIV (1 year); Early identification of HEI at Reproductive and Child Health (RCH) Clinic (1 year); Antenatal care (ANC) visits (1 year); Facility delivery (1 year); Post natal care (PNC) visits (1 year); Nevirapine (NVP) at delivery (1 year)
C: Excessive weight gain (0-6 months)
D: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Studies have shown that Intermittent preventive treatment in infants (IPTi) with Sulfadoxine-pyrimethamine (SP)reduced the incidence of clinical malaria and anemia without modifying infants' serological response to EPI vaccines. Thus IPTi was seen as a potential public health tool of great benefit to the children of Africa and a logical addition to the Immunization Plus package. The objectives of this operational researcher were

* to develop an implementation model for IPTi in the health care system in Mali
* to assess its impact on the EPI vaccines and other health interventions coverage
* and on molecular makers of resistance to SP


Options:
A: Completion of 3 Doses of Pentavalent Vaccine (8 months of age)
B: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)
C: 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)
D: visits by nurse midwife; prenatal exams, tetanus vaccinations, & iron tablets received by pregnant women; infant vaccinations; educational scholarships and fees for children; occurrence of village council meetings; development work in villages

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylaxis Against Thromboembolic Disease Following Orthopaedic Surgeries on Extremities
Brief Summary: The purpose of this research is to find a better way to prevent the post operative development of clots in the deep veins of the legs (also called Deep Vein Thrombosis or DVT). DVT causes redness, swelling, and pain in the involved leg(s). Long-term complications may include permanent swelling and pain of the leg(s), and even skin ulcers around the ankle. If clots form in a leg after surgery, and break off, they can move to the lungs and block the pulmonary artery (also called Pulmonary Emboli or PE). With PE there can be chest pain, chest tightness, shortness of breath, coughing up blood, heart failure, and occasionally death.

Doctors have studied ways to reduce these complications. These studies led to the development of drugs which interfere with your body's clotting processes. However, it is still unclear which drug and which drug schedule is best. This study will evaluate two of the standard FDA approved drugs using different dosing schedules.


Options:
A: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
B: Primary Outcome based upon intent to treat: Composite outcome of (28 days); Ultrasound or venogram confirmed deep vein thrombosis. (28 days); Lung scan, pulmonary angiogram or CTA confirmed pulmonary embolus. (28 days); Death due to TED (28 days)
C: Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE) (From randomization up to the end of the treatment period (minimum of 6 months))
D: Incidence of Any Adjudicated Bleeding Events (14 days); Incidence of Adverse Events (1 month); Incidence of Adverse Drug Reactions (1 month); Plasma Concentration of DU-176b (14 days); Plasma Concentration of D21-2393 (14 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis
Brief Summary: The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.


Options:
A: Number of Participants With Improvement of Signs and Symptoms of UC at 12 Weeks (12 weeks)
B: Proportion of subject who were relapse free after 6 months of treatment (6 months)
C: Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8 (Week 8)
D: Number of Participants With Clinical Response (Week 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Duloxetine 60 mg Once Daily Versus Placebo in Patients With Chronic Low Back Pain
Brief Summary: The purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain.


Options:
A: Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score (Baseline, Week 14)
B: Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score (baseline, 12 weeks)
C: Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores (Baseline, Week 1); Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 2); Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 3); Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 4); Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 5); Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 6); Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 7); Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 8); Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 9); Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 10); Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 11); Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 12); Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 13)
D: Brain Regional Gray Matter Density (2 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison
Brief Summary: LTBI Treatment is effective in prison


Options:
A: Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children (Through to week 96); Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children (Through to week 96)
B: COMPLETE RATE OF LTBI TREATMENT (1.5 year)
C: Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication (up to one year)
D: to compare the compliance; to compare the side effects

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenously Administered MEDI-563, A Humanized Anti-interleukin-5 Receptor Alpha Monoclonal Antibody, on Asthma Control Following Acute Exacerbations in Adults
Brief Summary: The study will evaluate the effect of two intravenous dose regimens of benralizumab (MEDI-563) on the proportion of adult subjects with asthma exacerbations who required an urgent healthcare visit for treatment of an acute asthma exacerbation.


Options:
A: Late asthmatic response (LAR) (Day 92)
B: Rate of Asthma Exacerbations Over the 48 Week Treatment Period (48 weeks)
C: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second (Baseline and Week 24); Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months (Baseline to Week 24)
D: Percentage of Participants With Asthma Exacerbations at Week 12 (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenously Administered MEDI-563, A Humanized Anti-interleukin-5 Receptor Alpha Monoclonal Antibody, on Asthma Control Following Acute Exacerbations in Adults
Brief Summary: The study will evaluate the effect of two intravenous dose regimens of benralizumab (MEDI-563) on the proportion of adult subjects with asthma exacerbations who required an urgent healthcare visit for treatment of an acute asthma exacerbation.


Options:
A: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL (Immediately following the first administration of study drug through Study Week 48.)
B: Maximum Percentage Decrease in Forced Expiratory Volume in 1 Second (FEV1) at 3 to 7 Hours Post Allergen Challenge (Days 42 and 84 at pre-allergen challenge and at 180, 240, 300, 360, and 420 minutes (3-7 hours) post allergen challenge); Time-Adjusted Area Under the Curve for the Percent Decrease From Pre-Allergen Challenge in Forced Expiratory Volume in 1 Second (FEV1) From 3 to 7 Hours Post Allergen Challenge (Days 42 and 84 at pre-challenge and at 180, 240, 300, 360, and 420 minutes (3-7 hours) post challenge)
C: Percentage of Participants With Asthma Exacerbations at Week 12 (Week 12)
D: Rate of asthma exacerbations during the 52-week placebo-controlled period (weeks 0-52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Evaluation of Cosmetic Outcome and Surgical Site Infection Rates of Coated VICRYL* Plus Antibacterial (Polyglactin 910) Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery
Brief Summary: This is a 90-day study to evaluate cosmetic outcome and Surgical Site Infection in approximately 100 patients from 6 centers in China undergoing scheduled modified radical mastectomy for breast cancer.


Options:
A: Scar Quality at 6 Months Postoperative (6 months); Time to Perform Wound Closure (intraoperatively)
B: Surgical site infection (30 days after the operative procedure)
C: Mean Score on Cosmetic Outcome Visual Analog Scale (VAS) (30 days (+/- 5) post-operative)
D: Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery. (4-8 weeks post-surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimization of Intravenous Ketamine for Treatment-Resistant Depression: A Randomized, Placebo-Controlled, Triple-masked, Clinical Trial
Brief Summary: Existing treatments for major depressive disorder (MDD) generally take weeks to months to exert their maximal benefit. There is an urgent need to develop rapid-acting treatments for MDD. Ketamine, a high-affinity N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, has been used as a standard intravenous (IV) anesthetic agent for many years in both pediatric and adult patients. Beyond its well-established role in anesthesia and pain management, there is emerging evidence that ketamine may have rapid antidepressant properties for patients with severe mood disorders.

In this study we are investigating whether ketamine can have an antidepressant effect compared to midazolam. Midazolam has similar anesthetic effects compared to ketamine but has not been shown to be an antidepressant, and is therefore acting as an active control in this study.

The study period can last up to 8 weeks, depending on your response to the study medication. There are two required overnight stays in our Research Commons as part of this study.


Options:
A: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Day 14 (Day 1 and Day 14)
B: Hamilton Rating Scale for Depression - 6 Items (A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1, & 3)
C: The primary objective is to determine whether an antidepressant effect can be achieved in patients with Treatment Resistant Depression determined by a change from baseline in the MADRS total score. (Change from Baseline)
D: MADRS (24 hours post-infusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Vision Depression Prevention Trial for Age Related Macular Degeneration
Brief Summary: This randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL (VITAL), will test the efficacy of collaborative low vision rehabilitation (LVR) to prevent depressive disorders in Age-Related Macular Degeneration (AMD). In this innovative intervention, a low vision occupational therapist collaborates with a low vision optometrist to develop and implement a care plan based on a subject's vision status, rehabilitation potential, and personal rehabilitation goals. An independent rater masked to treatment assignment will assess depressive disorders meeting DSM-IV criteria (primary outcome) and targeted vision function and vision-related quality of life (secondary outcomes) at baseline and then at 4 months to evaluate short-term effects (main trial end point) and at 12 months to evaluate long-term effects.


Options:
A: Executive Function Composite Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort. (after 15 weeks of treatment)
B: Feasibility - enrollment of 1-2 participants per month (One year)
C: Depression (4 months)
D: Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16) (Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Vision Depression Prevention Trial for Age Related Macular Degeneration
Brief Summary: This randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL (VITAL), will test the efficacy of collaborative low vision rehabilitation (LVR) to prevent depressive disorders in Age-Related Macular Degeneration (AMD). In this innovative intervention, a low vision occupational therapist collaborates with a low vision optometrist to develop and implement a care plan based on a subject's vision status, rehabilitation potential, and personal rehabilitation goals. An independent rater masked to treatment assignment will assess depressive disorders meeting DSM-IV criteria (primary outcome) and targeted vision function and vision-related quality of life (secondary outcomes) at baseline and then at 4 months to evaluate short-term effects (main trial end point) and at 12 months to evaluate long-term effects.


Options:
A: activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS)) (5 and 17 weeks); distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ)) (5 and 17 weeks)
B: Depression (4 months)
C: Participant enrollment, recruitment and retention. (Ongoing for18 months after start of recruitment.)
D: VA LV VFQ-48 Reading Domain Scores (4 months from baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Vision Depression Prevention Trial for Age Related Macular Degeneration
Brief Summary: This randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL (VITAL), will test the efficacy of collaborative low vision rehabilitation (LVR) to prevent depressive disorders in Age-Related Macular Degeneration (AMD). In this innovative intervention, a low vision occupational therapist collaborates with a low vision optometrist to develop and implement a care plan based on a subject's vision status, rehabilitation potential, and personal rehabilitation goals. An independent rater masked to treatment assignment will assess depressive disorders meeting DSM-IV criteria (primary outcome) and targeted vision function and vision-related quality of life (secondary outcomes) at baseline and then at 4 months to evaluate short-term effects (main trial end point) and at 12 months to evaluate long-term effects.


Options:
A: Depression (4 months)
B: Comparison of Changes in Visual Reading Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire (changes from baseline to 4 months later)
C: Visual field (6 months)
D: Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]); Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months])

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients With Bronchiectasis
Brief Summary: The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Bronchiectasis (Brx) and if so how it compares to placebo (a substance which does not have any action).


Options:
A: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). (Baseline and 29 days)
B: Rate of Graded Pulmonary Exacerbations (52 weeks)
C: The primary endpoint of this study is a reduction in cough at 6 months compared to baseline as measured by the Leicester Cough Questionnaire score. (6 months)
D: Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline (End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.); Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline (End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.); 24-hour Sputum Weight(g) (Baseline and day 28); Slow Vital Capacity (SVC) (Baseline and day 28); Forced Expiratory Volume in 1 Second (FEV1) (Baseline and day 28); Forced Vital Capacity (FVC) (Baseline and day 28); Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%) (Baseline and day 28); Morning Peak Expiratory Flow (PEF) (Last 7 days on treatment); Evening Peak Expiratory Flow (PEF) (Last 7 days on treatment); Bronkotest Diary Card Signs and Symptoms (Last 7 days on treatment); St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) (Baseline and day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction: The Step-in-AMI Trial (Short TErm Psychotherapy IN Acute Myocardial Infarction)
Brief Summary: Psychosocial factors play an important role in the pathophysiology of acute myocardial infarction (AMI), but it is not known if psychotherapy is beneficial after the contemporary treatment of AMI consisting of medical and interventional therapy.

The investigators have designed a randomized, controlled study to assess the effects of short-term psychotherapy (STP) on the clinical outcomes of patients who have undergone an emergency percutaneous coronary intervention (PCI) post-AMI.


Options:
A: Average blood pressure (Measured at Months 2 and 6); Impact of Event Scales (IES) (Measured at Months 2 and 6)
B: The cumulative incidence of new cardiological events and the occurrence of new medical pathologies (5 years)
C: cardiovascular mortality; non fatal re-MI; angina requiring hospitalization; urgent revascularization procedures; hospitalization for heart failure; non fatal stroke
D: Low-density lipoprotein (LDL)cholesterol (Baseline and 12 months); Blood pressure (baseline and 12 months); Body Mass Index (baseline and 12 months); Psychological Well-Being (Baseline and 12 months)

Answer: B