TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Molecular Driven Phase II Trial of Carboplatin-Paclitaxel-Bevacizumab vs Carboplatin-Paclitaxel-Bevacizumab-Rucaparib vs Carboplatin-Paclitaxel-Rucaparib, Selected According to HRD Status, in Patients With Advanced (Stage III B-C-IV) Ovarian, Primary Peritoneal and Fallopian Tube Cancer Preceded by a Phase I Dose Escalation Study on Rucaparib-Bevacizumab Combination
Brief Summary: This trial is a randomized, open-label Phase I-2 multi-center study designed to evaluate the effect of Carboplatin-Paclitaxel-Bevacizumab (in combination and maintenance) vs Carboplatin-Paclitaxel-Bevacizumab-Rucaparib (Rucaparib only in maintenance) vs Carboplatin-Paclitaxel-Rucaparib (Rucaparib only in maintenance) on progression-free survival in patients with advanced high grade ovarian cancer treated according to HRD status . The trial will test the hypothesis that Carboplatin-Paclitaxel-Bevacizumab-Rucaparib and the Carboplatin-Paclitaxel-Rucaparib arms will improve the progression-free survival in comparison to standard Carboplatin-Paclitaxel-Bevacizumab in HRD negative (HR proficient) patients and that Carboplatin-Paclitaxel-Bevacizumab-Rucaparib will improve PFS with respect to Carboplatin-Paclitaxel-Rucaparib in HRD positive patients. The randomized phase of the study will be preceded by a single arm Phase I study which will be conducted only in the National Cancer Institute of Milan, aiming at evaluating the MTD of the combination Rucaparib-Bevacizumab. Once the MTD has been reached, the randomized study will start.


Options:
A: Phase I Primary Objective: MTD (4 months); Phase II Primary Objective: PFS (from the date of randomization to the date of documented progression disease, recurrence or death (whichever occurs first), assessed up to 64 months)
B: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator (Up to ~38 months)
C: Progression-Free Survival (PFS): Independent Radiologist Review (From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years)
D: Progression-Free Survival (8 Months on average)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Molecular Driven Phase II Trial of Carboplatin-Paclitaxel-Bevacizumab vs Carboplatin-Paclitaxel-Bevacizumab-Rucaparib vs Carboplatin-Paclitaxel-Rucaparib, Selected According to HRD Status, in Patients With Advanced (Stage III B-C-IV) Ovarian, Primary Peritoneal and Fallopian Tube Cancer Preceded by a Phase I Dose Escalation Study on Rucaparib-Bevacizumab Combination
Brief Summary: This trial is a randomized, open-label Phase I-2 multi-center study designed to evaluate the effect of Carboplatin-Paclitaxel-Bevacizumab (in combination and maintenance) vs Carboplatin-Paclitaxel-Bevacizumab-Rucaparib (Rucaparib only in maintenance) vs Carboplatin-Paclitaxel-Rucaparib (Rucaparib only in maintenance) on progression-free survival in patients with advanced high grade ovarian cancer treated according to HRD status . The trial will test the hypothesis that Carboplatin-Paclitaxel-Bevacizumab-Rucaparib and the Carboplatin-Paclitaxel-Rucaparib arms will improve the progression-free survival in comparison to standard Carboplatin-Paclitaxel-Bevacizumab in HRD negative (HR proficient) patients and that Carboplatin-Paclitaxel-Bevacizumab-Rucaparib will improve PFS with respect to Carboplatin-Paclitaxel-Rucaparib in HRD positive patients. The randomized phase of the study will be preceded by a single arm Phase I study which will be conducted only in the National Cancer Institute of Milan, aiming at evaluating the MTD of the combination Rucaparib-Bevacizumab. Once the MTD has been reached, the randomized study will start.


Options:
A: Efficacy: Progression Free Survival (PFS) (An average of 30 months for each participant); Safety: Number of Evacuations Per Day (Evacuation were collected daily for the first four weeks of treatment of experimental drugs)
B: Phase I Primary Objective: MTD (4 months); Phase II Primary Objective: PFS (from the date of randomization to the date of documented progression disease, recurrence or death (whichever occurs first), assessed up to 64 months)
C: Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment (From randomization of the first patient until 32.5 months later, assessed every 8 weeks)
D: Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) (From randomization through September 17, 2010 (up to 3 years, 5 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label, Phase 3 Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Subjects With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).
Brief Summary: The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).


Options:
A: Progression-free Survival (PFS) (Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)); Percentage of Participants With Progression Free Survival Events (Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization))
B: PFS (Progression Free Survival) (Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.)
C: Progression Free Survival (PFS) (Up to 2 years 10 months)
D: Progression Free Survival (PFS) (Time from study entry to the time of documented disease progression or death. The analysis was event driven, performed at 2.5 years after the last patient enrolled;up to 4 years.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-blind, Placebo-controlled, Multi-Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of SHR-1314 With Expanded Dose Finding in Subjects With Moderate-to-severe Plaque Psoriasis
Brief Summary: This is a multi-regional, randomized, double-blind, placebo-controlled, clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SHR-1314 in adults with moderate-to-severe plaque psoriasis.


Options:
A: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) (Week 16)
B: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16)
C: Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Week 12)
D: Number of Participants With Clinically Significant Events (Part A) (From baseline through 24 weeks); Pharmacokinetics (PK) of SHR-1314 (Part A) (From baseline through 24 weeks); Pharmacokinetics (PK) of SHR-1314 (Part A) (From baseline through 24 weeks); Percentage of Participants With Anti-SHR-1314 Antibodies (Part A) (From baseline through 24 weeks); Percentage of subjects who achieve Psoriasis Area Severity Index (PASI) score 75 (Part B) (From baseline through 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma
Brief Summary: Primary end points:

This clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing Intrauterine System (LNG-IUS, Mirena®) in the fertility-sparing treatment of atypical endometrial hyperplasia and early endometrial carcinoma, including pathology response and pregnancy outcome.

Second end points:

To analyze the appearances of side-effects.


Options:
A: Regression of hyperplasia related to treatment arm after 6 months of therapy (Six months)
B: Regression and remission rate of endometrial hyperplasia (3 month)
C: Pathological response rate (From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months); Pathological response time (From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months)
D: Pathologic Response (6-12 months); Pregnancy Rate (7-144 months); Live Birth Rate (16-144 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial Comparing Two Different Bladder Instillation Treatments for Interstitial Cystitis/Bladder Pain Syndrome
Brief Summary: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a condition that results in long-term bladder and pelvic pain. IC/BPS affects women more often than men. How the disorder develops is not completely known. Bladder instillation is a commonly used treatment in which a mixture of different ingredients are passed into the bladder to help IC/BPS symptoms. There is room to learn more about bladder instillations and which ingredients in them work best. The purpose of this study is to compare the effectiveness of a bladder instillation that contains a steroid (triamcinolone acetonide) to a bladder instillation that does not contain a steroid to treat IC/BPS in women. The study hypothesis is that women with IC/BPS treated with bladder instillations that contain a steroid will have improved outcomes compared to women treated with bladder instillations that do not contain a steroid.


Options:
A: Change from Baseline in Average Mean Daily Pain (MDP) Score at Week 12 (Baseline and Week 12)
B: Change of the O'Leary-Sant symptom score (Baseline and 1 month)
C: Change From Baseline in Mean Average Daily Pain Score at Week 8 (Baseline, Week 8)
D: Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire (Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Compassion Meditation and ReliefLink App for Suicidal, Low-Income, African Americans
Brief Summary: The purpose of this study is to conduct a pilot randomized controlled trial (RCT) with low-income, suicidal African American women and men that compares the relative effectiveness of compassion meditation (CM) versus a support group (SG) .


Options:
A: BSSI score (Day 3)
B: Change in Beck Scale for Suicide Ideation (BSS) score (Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3))
C: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)
D: Suicide Mortality Rates (Study Completion (2 years))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Compassion Meditation and ReliefLink App for Suicidal, Low-Income, African Americans
Brief Summary: The purpose of this study is to conduct a pilot randomized controlled trial (RCT) with low-income, suicidal African American women and men that compares the relative effectiveness of compassion meditation (CM) versus a support group (SG) .


Options:
A: Suicide Events (Measured after 6 months of treatment)
B: Change in Beck Scale for Suicide Ideation (BSS) score (Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3))
C: Deliberate Self-Harm Inventory Youth version (DSHI-Y) (Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended)
D: Time to Fatal or Non-fatal Suicide Attempt or Self-Harm (18 Months after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Compassion Meditation and ReliefLink App for Suicidal, Low-Income, African Americans
Brief Summary: The purpose of this study is to conduct a pilot randomized controlled trial (RCT) with low-income, suicidal African American women and men that compares the relative effectiveness of compassion meditation (CM) versus a support group (SG) .


Options:
A: Suicide repetition (or death by suicide) (12 months)
B: Client Satisfaction Questionnaire (CSQ) (14 weeks); Cornell Services Index (CSI) (baseline, 14 weeks)
C: Change in Beck Scale for Suicide Ideation (BSS) score (Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3))
D: Occurrence of suicidal event assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Developing and Validating Clinical Efficacy for Obesity Digital CBT Model
Brief Summary: The aim of the present study is to develop and validate the effects of a new cognitive behavioral therapy (CBT) using digital healthcare mobile apps such as Noom Coach and InBody.


Options:
A: Patients' subjective assessment of usability of the PRECIOUS system (At the end of the test (Session 5, week 12)); Satisfaction with the PRECIOUS system (At the end of the test (Session 5, week 12)); User's acceptance of the PRECIOUS system (At the end of the test (Session 5, week 12)); Effectiveness of the PRECIOUS system (At the end of the test (Session 5, week 12))
B: Change from Baseline (Baseline, at 8 weeks, at 6 months)
C: Weight change (Baseline, 6, 12, and 24 months)
D: Body Mass Index (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Antioxidant (Androferti) Treatment on Sperm DNA Integrity
Brief Summary: Increased sperm DNA Fragmentation Index implies decreased male fertility in vivo and in vitro. There is need for developing new strategies for improvement of male fertility. The study aims to investigate whether high sperm DNA Integration Index can be treated by use of antioxidants.


Options:
A: sperm motility (12 weeks)
B: DFI_3 (Change in DNA Fragmentation Index from Baseline to 3 months); DFI_6 (Change in DNA Fragmentation Index from Baseline to 6 months)
C: Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate (4 weeks to 9 month)
D: Live Birth Rate (up to 15 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of McGrath Videolaryngoscopy and Direct Laryngoscopy for Intubation in Patients With Morbid Obesity in Non-cardiac Surgery
Brief Summary: Our goal is to compare conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for endotracheal intubation in very morbidly obese patients undergoing non-cardiac surgery. Specifically, we propose to test the primary hypotheses that videolaryngoscopy improves visualization of the vocal cords, defined with modified Cormack and Lehane classification, compared to direct laryngoscopy.


Options:
A: Incidence of post operative sore throat (0 hours after surgery); Incidence of post operative sore throat (6 hours after surgery); Incidence of post operative sore throat (12 hours after surgery); Incidence of post operative sore throat (24 hours after surgery); Severity of post operative sore throat (0 hours after surgery); Severity of post operative sore throat (6 hours after surgery); Severity of post operative sore throat (12 hours after surgery); Severity of post operative sore throat (24 hours after surgery); Mean arterial pressure after endotracheal intubation (1 minute after surgery); Mean arterial pressure after endotracheal intubation (2 minutes after surgery); Mean arterial pressure after endotracheal intubation (3 minutes after surgery); Mean arterial pressure after endotracheal intubation (4 minutes after surgery); Mean arterial pressure after endotracheal intubation (5 minutes after surgery)
B: Delta NoL (From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient)
C: Classification of Glottis Visualization (At intubation)
D: CERVICAL MOTIONS (January 2011 and December 2012)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Open-label Study to Evaluate the Efficacy of Smartphone Application in Patients With Type 2 Diabetes
Brief Summary: Since diabetes is a chronic disease closely related to unhealthy lifestyle, the improvement and management of living habits are as significant as medical care with regard to the disease. In addition, this is regarded as the most effective method for prevention and treatment of diabetes. However, many diabetic patients are now reported to lack proper management in Korea with a low level of compliance with treatment instruction. In that sense, it is urgently necessary to develop a program in which diabetic patients are able to effectively manage their own blood glucose at home, and to grasp the real state of self-blood glucose measurement. Accordingly, a system to manage diabetes using electronic equipment such as mobile phone or the Internet is currently being developed and studied, for the effective management of diabetes with the help of highly evolving information technology. These investigators have developed a diabetes management program that provides an optimal solution based on a mobile device and software, so that individual patients can undergo a regular blood glucose test and achieve improvement and constant management of living habits by being properly informed of how to manage diabetes. This clinical study was designed to evaluate the effectiveness and efficacy of the application through the comparison between usual medical care and additional care using the smartphone application, targeting patients with type 2 diabetes who lack blood glucose control. This study is targeted at the subjects who are being treated at this hospital's endocrinology, are using a smartphone, and voluntarily signed the informed consent form (ICF). The subjects who pass the subject eligibility evaluation provide information regarding assessment items and demographic information using the smartphone application and questionnaire. Based on the information given by subjects, the medical team offers a management system that supports and improves the existing treatment process of diabetes using the application developed on its own. The feasibility and effectiveness of the management using the application are evaluated through the result values of the laboratory tests performed during the subject's usual medical care.


Options:
A: 1. ADEs; 2. duration of ameliorable medication side effects; 3. health goal adherence rates; 4. diabetes outcomes; 5. familial risk factor documentation rates; 6. user satisfaction surveys; 7. user metrics
B: hemoglobin A1c levels (at six months)
C: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)
D: Hemoglobin A1c (6 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Parallel Group, Randomized Clinical Trial of Direct Intra-arterial Thrombectomy Versus Intravenous Thrombolysis With Intra-arterial Thrombectomy for Patients With Large Vessel Occlusion of the Anterior Circulation
Brief Summary: Background: Intravenous thrombolysis (IVT) combined with mechanical thrombectomy (MT) has been proven safe and effective in patients with acute ischemic stroke (AIS) of anterior circulation large vessel occlusion (LVO). Despite recanalization, a considerable proportion of patients do not recover. The incidence of symptomatic intracerebral hemorrhage (sICH) was similar between combined IVT plus MT and IVT, suggesting that this complication could not be attributed to the MT, but rather to pre-treatment with IVT. Meanwhile, the incidence of intracranial atherosclerosis stenosis (ICAS) is higher in Asians. It is not clear whether patients with ICAS benefit from pretreatment with alteplase or not and how ICAS modifies treatment effect.

Objective: To assess whether direct MT is non-inferior compared to combined IVT plus MT in patients with AIS due to an anterior circulation LVO, and to assess treatment effect modification by presence of ICAD.

Study design: This is a parallel group, RCT of direct MT compared to combined IVT plus MT, using a non-inferiority design. The trial has observer blinded assessment of the primary outcome and of neuro-imaging at baseline and follow up. The trial will be executed in collaboration with MRCLEAN NO-IV investigators.

Study population: Patients with AIS of anterior circulation VLO confirmed by CTA. Initiation of IVT must be feasible within 4.5 hours from symptom onset. Age must be 18 or over and NIHSS 2 or more.

Main outcomes: The full distribution of the mRS at 3 months. Secondary outcomes: 1. death within 90 +/- 14 days; 2. pre-interventional reperfusion assessed on first intracranial DSA; 3. eTICI19 score on final angiography of MT; 4. score on the NIHSS at 24 +/- 6 hours and 5-7 days, or at discharge; 5. recanalization rate at 24-72h by CTA; 6. Final lesion volume at 5-7 days on NCCT20; 7. score on the EuroQoL 5-dimensions 5-level (EQ5D-5L)21 and Barthel index22 at 90 +/- 14 days; 8. dichotomous clinical outcome on the mRS at 90 +/- 14 days.


Options:
A: Complete recanalization percentage (Immediately after the revascularization procedure is completed)
B: 90-day global disability assess via the modified Rankin Scale score (mRS) (2 years)
C: 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS). (90 days)
D: mRS (the modified Rankin Scale) (3 months after procedure)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre, Double Blind, Randomised Sham-Controlled Trial of 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (Modulate-LBP)
Brief Summary: Multicentre, randomised, double-blinded, sham-controlled trial with parallel economic evaluation. Patients will be allocated 1:1 to activated 10kHz SCS plus usual care (intervention) or sham 10kHz SCS plus usual care (control) and followed up to 6 months.


Options:
A: Mean VAS Back Pain (7 Day Subject VAS Pain Diary) (6 months post randomisation)
B: Changes in pain (6 months)
C: The difference of Visual-analogue scale (VAS) between the experimental group and the control group (13 weeks)
D: Visual Analogue Scale (12 months); Oswestry Disability Index (12 months); Adverse Events (12 months); Number of pain medication (12months); Quality of life scale (12months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre, Double Blind, Randomised Sham-Controlled Trial of 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (Modulate-LBP)
Brief Summary: Multicentre, randomised, double-blinded, sham-controlled trial with parallel economic evaluation. Patients will be allocated 1:1 to activated 10kHz SCS plus usual care (intervention) or sham 10kHz SCS plus usual care (control) and followed up to 6 months.


Options:
A: Evaluation of pain (28 days)
B: Visual Analog Scale (VAS) on Back Pain (12 weeks)
C: Percent pain relief obtained during the one-month follow-up compared to baseline; The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period
D: Mean VAS Back Pain (7 Day Subject VAS Pain Diary) (6 months post randomisation)

Answer: D