TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Control of Myopia Progression in Myopic Children Using Simultaneous Vision Approach
Brief Summary: To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression in Hong Kong schoolchildren using simultaneous vision approach.


Options:
A: Spherical equivalent refraction determined by cycloplegic autorefraction
B: Changes in axial length in 2 years (Every 6 months for a period of 2 years)
C: Progression of myopia, determined by cycloplegic autorefraction
D: The changes of cycloplegic refractive errors (every 6 months for 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Outcome of Stage-specific Early Intervention for Psychosis in Hong Kong: A Randomized Controlled Study
Brief Summary: One of the commonly adopted strategies in improving outcome in psychotic disorders is by focused, specific and intensive intervention in the initial few years of the disorder. However the effects of intervention and the optimal duration of intervention have seldom been examined in randomized studies. This study uses a randomized controlled study design to investigate the effectiveness of stage-specific case-management in improving outcome of first episode psychotic disorders. It also addresses whether two years of case-management is less effective than four years of case-management over a four year period. A total of 360 subjects, who aged 25 above, and diagnosed with first episode psychotic disorders, will be and randomized into 3 groups: (1) standard care alone without case management, (2) two-year case management, (3) four-year case management. All groups will receive usual standard care treatment. This four-year follow-up study will assess symptoms, functioning, quality of life as well as health economics data.


Options:
A: Functioning (social and occupational) (baseline, 6-month, 12-month, 24-month, 36-month, 48-month)
B: Prognosis of patients. (6 months)
C: Number of Patients Hospitalized (1 year after enrollment)
D: Relapses (9 months); Positive and negative symptoms (change from baseline at 9 month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Assessment of Delirium in Mechanically Ventilated Patients Undergoing Daily Awakening From Sedation
Brief Summary: The overall purpose of this trial is to assess the relationship between a daily awakening from sedation and the prevalence of delirium, and in doing so better characterize delirium in the ICU.


Options:
A: Individual Physical Function and Mental Health domains from SF-36 (for participants who complete the phone surveys); 6-minute walk distance and memory evaluation (for participants who attend the study visits) (Measured at Months 6 and 12)
B: Duration of delirium (3 months)
C: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))
D: Delirium (Daily)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study Characterizing the Impact of Different Therapeutic Strategies on Event Occurrence at 2 Years, 5 Years, 10 Years, and 15 Years, According to Prognostic Groups in Patients With Hodgkin Lymphoma
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs in different combinations may kill more cancer cells. It is not yet know which treatment regimen is more effective in treating Hodgkin lymphoma.

PURPOSE: This phase III trial is studying three different therapy regimens to compare how well they work in treating patients with previously untreated Hodgkin lymphoma.


Options:
A: Progression-free survival
B: Progression-free survival (up to 5 years after randomisation)
C: Response (24 weeks)
D: Event-free survival (treatments evaluation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study Characterizing the Impact of Different Therapeutic Strategies on Event Occurrence at 2 Years, 5 Years, 10 Years, and 15 Years, According to Prognostic Groups in Patients With Hodgkin Lymphoma
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs in different combinations may kill more cancer cells. It is not yet know which treatment regimen is more effective in treating Hodgkin lymphoma.

PURPOSE: This phase III trial is studying three different therapy regimens to compare how well they work in treating patients with previously untreated Hodgkin lymphoma.


Options:
A: Progression Free Survival (5 years)
B: Event-free survival (treatments evaluation)
C: Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD (36 Months); 36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation. (at 36 months)
D: Progression free survival (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Inactivated Poliomyelitis Vaccine Poliorix Administered as a Booster Dose at 18-24 Months of Age in Healthy Toddlers in China.
Brief Summary: The study will evaluate the safety and reactogenicity of PoliorixTM given as a single booster dose to Chinese children at 18-24 months of age.


Options:
A: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 (At Month 3, one month after the third vaccine dose)
B: The non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1 2 and 3) one month after the three-dose primary vaccination (1 Month Post-vaccination)
C: Number of Subjects With Any and Grade 3 Solicited Local Symptoms (During the 4-day (Days 0-3) post-vaccination period); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (During the 4-day (Days 0-3) post-vaccination period); Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) (During the 31-day (Days 0-30) post-vaccination period); Number of Subjects With Serious Adverse Events (SAEs) (During the entire study period (from Day 0 to Month 1))
D: Immunogenicity: To provide information concerning the immunogenicity of IPV vaccine administrated intradermally as a booster vaccination. (30 days post-vaccination); Safety: To provide information concerning the safety after booster intradermal administration of IPV vaccine (30 days post-vaccination and entire study duration)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Inactivated Poliomyelitis Vaccine Poliorix Administered as a Booster Dose at 18-24 Months of Age in Healthy Toddlers in China.
Brief Summary: The study will evaluate the safety and reactogenicity of PoliorixTM given as a single booster dose to Chinese children at 18-24 months of age.


Options:
A: Neutralizing antibody titers ≥8 (1/dil) against each of the 3 poliovirus serotypes (types 1, 2 and 3) after the 3 dose primary vaccination series. (1 month post-dose 3 (primary vaccination series))
B: Number of Subjects With Any and Grade 3 Solicited Local Symptoms (During the 4-day (Days 0-3) post-vaccination period); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (During the 4-day (Days 0-3) post-vaccination period); Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) (During the 31-day (Days 0-30) post-vaccination period); Number of Subjects With Serious Adverse Events (SAEs) (During the entire study period (from Day 0 to Month 1))
C: Seroconversion by measuring level of poliovirus antibodies in serum. Also, measure of virus titer in stools to indirectly assess the level of intestinal mucosal immunity
D: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 (At Month 3, one month after the third vaccine dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study to Test the Feasibility and the Efficacy of the German Language Adapted PRO-SELF© Plus Pain Control Program, an Educational Intervention Directed at Patients and Their Family Caregivers to Reduce Cancer Pain and Related Symptoms
Brief Summary: The purpose of this pilot study is to refine and test an advanced and adapted German version of the PRO-SELF© Plus Pain Control Program (PCP), an educational intervention directed at cancer pain patients and their families to enhance their pain self management abilities, and to calculate effect sizes for the planning of a sufficiently powered randomized controlled trial (RCT).


Options:
A: Symptom cluster (4 weeks); Fatigue (4 weeks); Pain (4 weeks); Sleep disturbance (4 weeks)
B: average and worst pain as reported daily by patients on a scale from 0 (no pain) to 10 (worst imaginable pain) (measured daily for 10 weeks and in week 14 and 22)
C: Change in Patient Health Questionnaire-8 (baseline, 2 and 6 weeks post-intervention); Change in Generalized Anxiety Disorder 7-item scale (baseline, 2 and 6 weeks post-intervention)
D: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)
Brief Summary: Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and children.


Options:
A: Asthma or Recurrent Wheeze in First 3 Years of Life (First 3 years of life.); Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. (32-38 weeks gestation)
B: Infant Length-for-Age Z-Scores with Prenatal Supplementation (1 year of age); Infant Length-for-Age Z-Scores with Postpartum Supplementation (1 year of age)
C: serum 25-hydroxyvitamin D concentration, (3 time poits up to 6 months (0-3-6 months))
D: Number of Participants with D- deficiency or access (at 40 (+/-2 weeks) PMA (postmenstrual age)); Number of Participants with D- deficiency or access (at 4 weeks of age); Number of Participants with D- deficiency or access (At 35 (+/-2 weeks) PMA (postmenstrual age)); Number of Participants with D- deficiency or access (At 52 (+/-2 weeks) PMA (postmenstrual age))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)
Brief Summary: Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and children.


Options:
A: Amount of calcium supplement ingested (8 weeks after ANC consultation, during which recruitment into the study occurred)
B: Persistent wheeze (0 to 3 years of age)
C: Asthma or Recurrent Wheeze in First 3 Years of Life (First 3 years of life.); Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. (32-38 weeks gestation)
D: Infant Length-for-Age Z-Scores with Prenatal Supplementation (1 year of age); Infant Length-for-Age Z-Scores with Postpartum Supplementation (1 year of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)
Brief Summary: Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and children.


Options:
A: Asthma or Recurrent Wheeze in First 3 Years of Life (First 3 years of life.); Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. (32-38 weeks gestation)
B: Proportion of participants experiencing maternal HIV progression (Second Trimester until 12 months post partum); Proportion of small-for-gestational age infants (Birth); Proportion of stunted infants (height-for-age z-score < -2) (12 months postpartum (1 year of age))
C: Change in T-cell cytokine expression (16-20 wks, 26-28 wks, and 36 wks gestation)
D: Serum 25-hydroxyvitamin D concentration (Maternal: during 3rd trimester; Neonatal (cord blood))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance
Brief Summary: Hypothesis

1. Study method achieves lower requirement for medications
2. Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
3. Study method results in reduction in medication-related (cardiorespiratory) complications, faster turn around of patients, compared with conventional colonoscopy
4. Study method improves bowel preparation and increases polyp pickup rate

Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic VA patients is being promoted (VHA directive). Compliance with this Directive will result in an increased number of VA patients undergoing colonoscopy. The demand for colonoscopy far exceeds the capacity available to perform the procedure in the VA system. The conventional practice for colonoscopy at VA facilities across the country is to perform colonoscopy under conscious sedation with air insufflation. Efficiency is governed by the fact that sedated patients require time and space for recovery and these are major limiting factors in the current setting for the use of colonoscopy for CRC screening.

Methods that maintain a high success rate and good patient assessment improve overall compliance for surveillance colonoscopy. Our preliminary experience showed that patients are able to complete successful colonoscopy without sedation in 52% of cases when colonoscopy was aided by a water infusion in lieu of air insufflation method. In this group of patients, the shortened recovery time means a quick turn around of patient and a more efficient endoscopy service. Patients are able to communicate better with the staff and physician regarding their problem and discharge instructions, and not subjected to the amnesic effect of sedation. Next day follow-up of patient by telephone contact which requires commitment of staff time can be obviated.

If this randomized study confirms the success of our preliminary findings and this technique is adopted by more endoscopists, a larger number of VA patients may benefit from less sedation complications and at the same time allow for more efficient colonoscopy screening services.


Options:
A: Proportion of Patients Without Pain (up to 12 months)
B: Colonoscopy Success With Minimal Sedation (At the time of the procedure)
C: Primary outcome - success of cecal intubation without sedation (1 year)
D: Increments of medications used for sedation (duration of procedure)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: AG-013736 (AXITINIB) FOR THE TREATMENT OF METASTATIC RENAL CELL CANCER
Brief Summary: The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.


Options:
A: Probability Rates of Progression-free Survival at 9 Months (At 9 months after randomisation.); Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120) (At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15.)
B: Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation (From date of first dose to date of last dose plus 100 days (assessed up to March 2016, approximately 49 months))
C: Progression Free Survival (PFS): First-Line Participants (Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)); Progression Free Survival (PFS): Second-Line Participants (Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103))
D: Progression-free Survival (PFS) (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks (up to approximately 5 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: AG-013736 (AXITINIB) FOR THE TREATMENT OF METASTATIC RENAL CELL CANCER
Brief Summary: The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.


Options:
A: Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1 (From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)); Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) (From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)); Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) (From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months))
B: Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) (First dose of study drug (Cycle 1 Day 1) to end of first 4 weeks of therapy (Cycle 1)); Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 (RP2) Dose (First dose of study drug (Cycle 1 Day 1) to end of Cycle 2 (1 cycle = 28 days/4 weeks)); Phase 2: Progression-Free Survival (PFS) (Date of randomization into Phase 2 (Cycle 1 Day 1) to the date of first documentation of disease progression or death (whichever occurred first), assessed up to data cutoff date (13 Jun 2014), up to approximately 2 years and 3 months)
C: Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants (From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)); Overall Survival (OS) in PD-L1 Positive Participants (From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months))
D: Progression Free Survival (PFS): First-Line Participants (Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)); Progression Free Survival (PFS): Second-Line Participants (Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Closed-Loop Delivery of Propofol and Remifentanil: Sparing Effect of Dexmedetomidine
Brief Summary: The main objective if to evaluate the sparing effect of dexmedetomidine on the doses of propofol and remifentanil.


Options:
A: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required. (2 hourly and before each rescue treatment dose during the treatment period and the 48-hour follow-up); Duration of mechanical ventilation (Start and stop times of mechanical ventilation while the patient is treated in the ICU)
B: administered doses of propofol and of remifentanil during anesthesia (end of anesthesia)
C: The percentage of subjects requiring rescue midazolam to achieve and/or maintain proper sedation levels throughout the study drug infusion (At baseline and 15 minutes after starting study drug (prior to topicalization), and every 3 minutes thereafter throughout study drug infusion, at the end of topicalization, and prior to administration of any rescue medication.)
D: PONV During the First 24 Hours After Bariatric Surgery (24 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Closed-Loop Delivery of Propofol and Remifentanil: Sparing Effect of Dexmedetomidine
Brief Summary: The main objective if to evaluate the sparing effect of dexmedetomidine on the doses of propofol and remifentanil.


Options:
A: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)
B: hemodynamic changes (In hospital)
C: administered doses of propofol and of remifentanil during anesthesia (end of anesthesia)
D: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving the Quality of Asthma Care Using the Internet
Brief Summary: It is important for people with asthma to become involved in their asthma care and management. This study will evaluate an interactive Web site that provides tailored feedback and information to asthma patients and encourages them to ask their doctor specific questions about their asthma care.


Options:
A: Patient Adherence to Inhaled Corticosteroids (ICS) (1 year)
B: MDI use Competence in Clinic (1 day); MDI use Competence at home (8 weeks)
C: device monitored adherence rate (up to 6 months)
D: Asthma control - as measured by the Asthma Control Test (Measured at Year 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: St. Vincent's Screening To Prevent Heart Failure (STOP-HF) Study Using Natriuretic Peptides to Identify and Prevent Progression of Left Ventricular Dysfunction in Community Based, Asymptomatic, At-risk Individuals.
Brief Summary: The STOP-HF study is a prospective, randomized, controlled trial recruiting asymptomatic individuals with risk factors for left ventricular dysfunction from 50 primary care clinics in Dublin and south east Ireland. It is designed to determine whether using natriuretic peptide measurement as a screening tool following a general cardiovascular risk factor screen will reduce the prevalence and severity of ventricular dysfunction in conjunction with specialist follow-up at St. Vincent's University Hospital.


Options:
A: Prevalence and severity of LVD (5 year)
B: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
C: Heart failure rehospitalisation rate;; combined endpoint death or heart failure rehospitalisation;
D: Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group. (minimum of one year)

Answer: A