TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Proyecto Madrileño Sobre el Manejo de la Enfermedad Pulmonar Obstructiva Crónica Con Telemonitorización a Domicilio. (Multicentre Project on the Home Telemonitoring of Patients With Severe Chronic Obstructive Pulmonary Disease).
Brief Summary: The purpose of the study is to verify the clinical effectiveness of a managed home telemonitoring program in patients with severe COPD against usual clinical practice, as measured by the decrease in the number of exacerbations, number of hospitalizations, hospital days and emergency room visits in a 12 month period

The primary endpoint of effectiveness is "severe exacerbations avoided."

The main hypothesis is that patients with severe or very severe COPD patients managed with a home telehealth program have better outcomes than patients managed according to usual clinical practice.


Options:
A: Effectiveness of an Tele Respiratory Rehabiltation program (TeleRehab) in the maintenance of benefits after an intensive respiratory rehabilitation program evaluated through the 6 m Walking test and health quality questionnaires after 12 months (One Year)
B: Change in 6-Minute Walk Test Distance (6MWT) (baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up))
C: Number of hospitalizations due to exacerbation of COPD avoided (1 year)
D: Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge (6 months post-discharge from hospitalization following COPD exacerbation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Proyecto Madrileño Sobre el Manejo de la Enfermedad Pulmonar Obstructiva Crónica Con Telemonitorización a Domicilio. (Multicentre Project on the Home Telemonitoring of Patients With Severe Chronic Obstructive Pulmonary Disease).
Brief Summary: The purpose of the study is to verify the clinical effectiveness of a managed home telemonitoring program in patients with severe COPD against usual clinical practice, as measured by the decrease in the number of exacerbations, number of hospitalizations, hospital days and emergency room visits in a 12 month period

The primary endpoint of effectiveness is "severe exacerbations avoided."

The main hypothesis is that patients with severe or very severe COPD patients managed with a home telehealth program have better outcomes than patients managed according to usual clinical practice.


Options:
A: Change in physical activity (Baseline and 12 months follow-up)
B: Number of hospitalizations due to exacerbation of COPD avoided (1 year)
C: Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score (9 months); Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) (9 months)
D: Change from baseline in Shuttle Walk test at 6 weeks (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-invasive Positive Pressure Ventilation for the Treatment of Severe Stable Chronic Obstructive Pulmonary Disease
Brief Summary: Assessment of the effect and safety of noninvasive positive pressure ventilation for severe stable chronic obstructive pulmonary disease


Options:
A: Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment (8 weeks)
B: Time to death or repeat AHRF with need of NIV (1 year)
C: Health related quality of life measured by the Chronic Respiratory Questionnaire
D: Severe Respiratory Insufficiency (SRI) Questionnaire (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-invasive Positive Pressure Ventilation for the Treatment of Severe Stable Chronic Obstructive Pulmonary Disease
Brief Summary: Assessment of the effect and safety of noninvasive positive pressure ventilation for severe stable chronic obstructive pulmonary disease


Options:
A: Exercise Duration (Time Walked on the Constant Workrate Treadmill Test) (baseline and 12 weeks)
B: Change in physical activity (Baseline and 12 months follow-up)
C: Cardiovascular risk and diabetes testing (During the first year of the trial); Systolic blood pressure (During the first year of the trial)
D: Severe Respiratory Insufficiency (SRI) Questionnaire (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Phase 3 Study Evaluating TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Gastric Cancer Refractory to Standard Treatments
Brief Summary: The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.


Options:
A: The primary endpoint is the Progression-free survival (PFS) according to RECIST V1.1. (Average time period: up to one year (participants are followed until progression or death))
B: Overall Survival (OS) (From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months))
C: Progression free survival (8 weeks)
D: Overall Survival (OS) (2.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploratory/Proof of Principle Microbiota Study
Brief Summary: This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.


Options:
A: Study to assess the allergic symptoms, using a questionnaire. (5 months)
B: Death or late-onset sepsis (At hospital discharge)
C: Fecal microbiota measured at each visit (8 weeks)
D: Weight Gain (4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Open-label, Drug-Drug Interaction Study to Assess the Steady State Pharmacokinetics of N91115 Alone and in the Presence of Multiple Dose Administration of Rifampin in Healthy Adult Subjects (SNO-5)
Brief Summary: The present study is designed to assess the effects of Rifampin on the pharmacokinetics of N91115 in healthy subjects.


Options:
A: Assess the Potential Effects of Rifampin on N91115 Steady State Area Under the Curve (AUC) Values (On Study Day 14)
B: Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 105 (Study 105)); Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs (Day 1 up to Week 105 (Study 105))
C: The sum of responses in nasal potential difference (NPD) after perfusion with isoproterenol and chloride-free buffer (TCS: Total Chloride Secretion), in the presence of amiloride. (Change from baseline (pre-dose on Day 1) to end-of-treatment (Day 8))
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Open-label, Drug-Drug Interaction Study to Assess the Steady State Pharmacokinetics of N91115 Alone and in the Presence of Multiple Dose Administration of Rifampin in Healthy Adult Subjects (SNO-5)
Brief Summary: The present study is designed to assess the effects of Rifampin on the pharmacokinetics of N91115 in healthy subjects.


Options:
A: Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 105 (Study 105)); Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs (Day 1 up to Week 105 (Study 105))
B: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
C: Assess the Potential Effects of Rifampin on N91115 Steady State Area Under the Curve (AUC) Values (On Study Day 14)
D: Cohort 1: Safety and Tolerability Based on Adverse Events (AEs) (Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)); Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs) (Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)); Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs (Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)); Cohort 1: Absolute Change From Day 14 in Sweat Chloride at Day 21 (Cohort 1: Day 14, Day 21); Cohort 2 And 3: Absolute Change From Day 28 in Sweat Chloride at Day 56 (Cohort 2 and 3: Day 28, Day 56); Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56 (Cohort 4: Baseline, Day 56)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Open-label, Drug-Drug Interaction Study to Assess the Steady State Pharmacokinetics of N91115 Alone and in the Presence of Multiple Dose Administration of Rifampin in Healthy Adult Subjects (SNO-5)
Brief Summary: The present study is designed to assess the effects of Rifampin on the pharmacokinetics of N91115 in healthy subjects.


Options:
A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
B: Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 105 (Study 105)); Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs (Day 1 up to Week 105 (Study 105))
C: Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in treatment period up to safety follow-up (up to 28 days)); Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)); Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part E: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part F: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29)
D: Assess the Potential Effects of Rifampin on N91115 Steady State Area Under the Curve (AUC) Values (On Study Day 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Open-Label Phase 1b/2 Trial of Lenvatinib (E7080) Plus Pembrolizumab in Subjects With Selected Solid Tumors
Brief Summary: This is an open-label Phase 1b/2 trial of lenvatinib (E7080) plus pembrolizumab in participants with selected solid tumors. Phase 1b will determine and confirm the maximum tolerated dose (MTD) for lenvatinib in combination with 200 milligrams (mg) (intravenous \[IV\], every 3 weeks \[Q3W\]) pembrolizumab in participants with selected solid tumors (i.e. non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, melanoma or leiomyosarcoma). Phase 2 (Expansion) will evaluate the safety and efficacy of the combination in 7 cohorts at the MTD from Phase 1b (lenvatinib 20 mg/day orally + pembrolizumab 200 mg Q3W, IV).


Options:
A: Progression-free Survival (PFS) (Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years)
B: Progression-free Survival (PFS) (From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941).)
C: PFS (2 years)
D: Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib (Cycle 1 (21 days)); Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) of Lenvatinib (Cycle 1 (21 days)); Objective Response Rate (ORR) Based on Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) Version 1.1 at Week 24 (Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of the First French Psychoeducational Program on Unipolar Depression: Study Protocol for a Randomized Controlled Trial.
Brief Summary: Background. Major Depressive Disorder (MDD) is highly prevalent and was associated with greater morbidity, mortality (including suicide), and healthcare costs. By 2030, MDD will become the leading cause of disability in high-income countries. Notably, among patients with a previous experience of a major depressive episode, it was indeed estimated that up to 85% of those patients will suffer from relapse. Two main factors were associated with a significantly higher risk of relapse: poor medication adherence and low self-efficacy in disease management. Interestingly, these issues could become the targets of psychoeducational programs for chronic diseases. Indeed psychoeducational program for depression are recommended in international guidelines, but have not yet been proposed in France.

Methods/Design: The investigators propose to evaluate the first French psychoeducational program for depression named "ENVIE" in a multicenter randomized controlled trial. Its aim is to educate patients on the latest knowledge on depression and effective treatments through didactic and interactive sessions. Patients will experiment the latest innovating psychological skills (from acceptance and commitment therapy) to cope with depressive symptoms and maintain motivation in behavioral activation. In total, 332 unipolar non-chronic (\< 2 years) outpatients with moderate to severe depression, without psychotic features, will be randomly allocated to the add-on ENVIE program (N=166) or to a waiting list (N=166). The follow-up will last 15 months and include 5 assessment visits (enrollment, 3, 6, 9, 12, 15 months).

Discussion. If the proposed trial shows the effectiveness of the intervention, but also an increased remission rate in depressed outpatients at 15-months post-inclusion, in addition to improved treatment adherence in patients, it will further promotes arguments in favor of a wide dissemination of psychoeducational programs for depression.


Options:
A: Rate of remission of index episode at 15-months without relapse during follow-up (15 months after enrollment)
B: Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression) (20 weeks after randomization (after acute treatment phase))
C: Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) (Through month 18 of treatment); Number of Participants in Recovery According to the LIFE and HRSD (Through 36 months of treatment); Number of Participants in Recurrence According to the LIFE and HRSD (Measured up to Month 36 from recovery)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
Brief Summary: The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.


Options:
A: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set (Baseline (Day 1), Week 16)
B: Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils (Baseline and 16 weeks); Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells (Baseline and 16 weeks)
C: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Month 12); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Month 12)
D: Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline (Baseline (Day 1), Weeks 20-24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Observer Blinded, Controlled Trial to Evaluate the Safety and Immunogenicity of a New Formulation of Euvichol® (Killed Bivalent Whole Cell Oral Cholera Vaccine Manufactured by EuBiologics Co. Ltd.) in Healthy Individuals
Brief Summary: * Number of doses and intervals: Two doses, 2 weeks apart
* Method of administration: Oral administration
* Volume of vaccine to be administered: 1.5 mL/dose
* Observational period: 4 weeks (2 weeks after each dose)
* Number of visits: 3 visits

  1. Visit 1: Screening and enrollment (1st dosing)
  2. Visit 2: 2nd dosing 2 weeks after 1st dose (14+3 days)
  3. Visit 3: 2 weeks after the 2nd dose (28+3 days), end of subject participation. This study will be carried out in healthy adults and children, at two sites, enrollment will be competitive between the sites. Subjects will be stratified according to age into adults (18\~40 years of age) and children (1\~17 years of age). According to the pre-generated randomization list, the participants will be randomized to the test or comparator groups (Visit 1) and will be given either the test vaccine or the comparator vaccine. For immunogenicity assessment, blood sample will be taken at Visit 1 (prior to vaccination), Visit 2 (prior to vaccination), and at the end-of-study Visit (Visit 3). For Safety assessment: the participants will be observed for 30 minutes post vaccination and instructed to record solicited adverse events that occur up to 6 days after vaccination on the participant diary card.

This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine administrator will remain blinded and will not handle the investigational product.


Options:
A: Number of participants with vaccine related reactogenicity as assessed by study personnel (Within 30 minutes after administration of vaccine); Number of participants with solicited adverse events as assessed by study personnel (Within 7 days after administration of vaccine); Number of participants with unsolicited adverse event including serious adverse event as assessed by study physician (Within 6 months after administration of vaccine); Number of participants showing seroconversion against sero group V. cholerae O1 (7 days after administration of vaccine)
B: Receipt of 2 complete or nearly complete swallowed doses of oral cholera vaccine (after completion of the vaccination campaign)
C: Number of individuals vaccinated with two dose of oral cholera vaccine. (Six months from initiation of vaccination); Decrease number of cholera cases in intervention arm compared to non-intervention arm. (Two years after completion of vaccination)
D: Immunogenicity endpoint for Inaba O1 (28 days); Immunogenicity endpoint for Ogawa O1 (28 days); Immunogenicity endpoint O139 (28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity
Brief Summary: Using a previously created weight management program for adolescents, the intervention will be implemented through school-based health centers (SBHC) and will be delivered by SBHC providers trained in Motivational Interviewing. Students at intervention school sites will be compared to students at control school sites. All students will have baseline, 1 year, and 2 year follow-up to assess if students in the intervention school sites will have improved risk factor profile for metabolic syndrome, improved nutrition and increased physical activity when compared with students at control school sites.


Options:
A: Change in the prevalence of overweight and obesity (Baseline, Month 9)
B: Behavioural determinants of physical activity and nutrition by determinant questionnaire (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Physical activity, physical fitness and sedentarity (questionnaire and accelerometer) (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Food intake by 24h recall (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention)
C: Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study (Baseline to two years); Change in Physical Activity (Baseline to two years); Change in Reported Added Sugar Intake (Baseline to two years); Change in Reported Fruit, Vegetables, and Legume Intake (Not Including Potatoes) (Baseline to two years); Change in BMI Z-score (Baseline to two years); Change in HOMA-IR (Baseline to two years)
D: Change From Baseline in Percent Students Eating the School Breakfast Per School (Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to determine if a program of physical activity, nutritional supplements and relaxation techniques is effective at decreasing post operative complications in frail colorectal cancer patients undergoing resection.


Options:
A: Oswestry Disability Index (ODI) (Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
B: Six Minute Walk Test (6MWT) (up to 8 weeks after surgery)
C: 6 Minute Walk Test (baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks)
D: Post operative complications (30 days after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to determine if a program of physical activity, nutritional supplements and relaxation techniques is effective at decreasing post operative complications in frail colorectal cancer patients undergoing resection.


Options:
A: Post operative complications (30 days after surgery)
B: The incidence of postoperative complications, classified by Clavien Scale (Time Frame: 30days or the postoperative hospital stay if longer than 30 days)
C: 6 Minute Walk Test (baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks)
D: Recovery measured as physical recovery measured in questionnaire (4-6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement-mediated Disorders. A Single/Multiple Ascending Dose Phase 1 Study.
Brief Summary: Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in NHVs, Part C, a multiple dose (MD) study in patients with a complement-mediated disorder, and Part E, a multiple dose (MD) study in patients with cold agglutinin disease previously treated with BIVV009 within the scope of a BIVV009 clinical trial or named patient program use. Note: For parts A-C as well as at the start of part E, study drug was named TNT009. The study drug name is changed to BIVV009 with final version Final 15.0 of the clinical study protocol.


Options:
A: Drug-related Adverse Event profile of BIVV009 (6 weeks)
B: The cumulative total methylprednisolone doses and rate of remission.
C: Primary Safety Endpoint (1 year)
D: Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment (2 years)

Answer: A