TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An uMbrella Study of BIomarker-driven Targeted Therapy In Patients With Platinum-resistant Recurrent OvariaN Cancer(AMBITION)
Brief Summary: This study is a pilot study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer. More specifically, this is a randomized, multi-center, open label, phase II study for Homologous Recombination Deficiency(HRD)+ patients and a biomarker-driven multiple-arm phase II study for Homologous Recombination Deficiency(HRD)- patients.

This study will consist of a number of study modules (substudies), each evaluating the antitumor activity of targeted agents in patients whose tumors express specific phenotype relevant to the molecules under investigation.


Options:
A: To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer (every 8 weeks)
B: Overall Objective Response (1 year after end inclusion)
C: objective response rate by RECIST 1.1 (6 months after treatment initiation)
D: Overall Survival (Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An uMbrella Study of BIomarker-driven Targeted Therapy In Patients With Platinum-resistant Recurrent OvariaN Cancer(AMBITION)
Brief Summary: This study is a pilot study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer. More specifically, this is a randomized, multi-center, open label, phase II study for Homologous Recombination Deficiency(HRD)+ patients and a biomarker-driven multiple-arm phase II study for Homologous Recombination Deficiency(HRD)- patients.

This study will consist of a number of study modules (substudies), each evaluating the antitumor activity of targeted agents in patients whose tumors express specific phenotype relevant to the molecules under investigation.


Options:
A: Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS) (Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.)
B: Progression free survival (30 months)
C: objective response rate by RECIST 1.1 (6 months after treatment initiation)
D: Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria (The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An uMbrella Study of BIomarker-driven Targeted Therapy In Patients With Platinum-resistant Recurrent OvariaN Cancer(AMBITION)
Brief Summary: This study is a pilot study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer. More specifically, this is a randomized, multi-center, open label, phase II study for Homologous Recombination Deficiency(HRD)+ patients and a biomarker-driven multiple-arm phase II study for Homologous Recombination Deficiency(HRD)- patients.

This study will consist of a number of study modules (substudies), each evaluating the antitumor activity of targeted agents in patients whose tumors express specific phenotype relevant to the molecules under investigation.


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: Progression-free survival
C: objective response rate by RECIST 1.1 (6 months after treatment initiation)
D: Peritoneal adhesion ORR (pORR) (3weeks after the last treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An uMbrella Study of BIomarker-driven Targeted Therapy In Patients With Platinum-resistant Recurrent OvariaN Cancer(AMBITION)
Brief Summary: This study is a pilot study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer. More specifically, this is a randomized, multi-center, open label, phase II study for Homologous Recombination Deficiency(HRD)+ patients and a biomarker-driven multiple-arm phase II study for Homologous Recombination Deficiency(HRD)- patients.

This study will consist of a number of study modules (substudies), each evaluating the antitumor activity of targeted agents in patients whose tumors express specific phenotype relevant to the molecules under investigation.


Options:
A: Efficacy by progression free survival (PFS1) (phase up to a total of 15 months)
B: Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days)
C: objective response rate by RECIST 1.1 (6 months after treatment initiation)
D: Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) (At 28 days); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I) (At 28 Days); Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II) (Time from start of treatment to time of objective disease progression, assessed up to 5 years); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T). (At 28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Mixture of New Probiotic Strains in the Colonization of the Gastrointestinal Tract of Preterm Infants.
Brief Summary: An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 \& Bifidobacterium PS10402 in premature infants from 28 weeks + 0 days to 30 weeks + 6 days of gestation.

The study duration will be 2 months, which includes 8 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.


Options:
A: Weight (g) (From 4 to 6 weeks after inclusion)
B: Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples. (2 months)
C: Number of deaths and episodes of nosocomial sepsis among probiotic exposed and non-exposed preterm infants (From birth to discharge from the NICU or death. Average time 2 months.)
D: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD
Brief Summary: PRIME goal is to early detect and treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD). This is important since COPD accelerates aging and represents major burden worldwide and in Portugal, mainly due to its frequent AECOPD. Pulmonary rehabilitation (PR) is an effective strategy of its management but it is scarce. When AECOPD are early detected and treated, it optimizes patients' outcomes and reduces the burden of COPD, especially if PR is used. However, up to date, there is no model to predict AECOPD for clinical practice. The lung microbiota shows promise to overcome this barrier and inform on COPD trajectory and will be investigated. In addition, despite of most AECOPD being managed in the community, PR is mainly available in hospitals and less than 1% of patients are having access. Thus, community-based PR will be implemented and a clinical decision tool developed for prioritizing who will most benefit from PR, enhancing evidence-based access to PR.


Options:
A: Changes in COPD-patients self reported-health, their evaluation of the health system and in the distribution of health resources. (14 months)
B: Characterize COPD Disease Severity in Clinical Practice (2 years); Characterize COPD Disease Activity in Clinical Practice (2 years)
C: Change in exercise tolerance (Up to 6 months); Change in lung microbiota (Up to 6 months)
D: Percentage of prescriptions of penicillin for respiratory tract infections (Two years); Percentage of prescriptions of TMP/SMX for lower urinary tract infections in adults (Two years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect and Mechanism of wCST-LL Based Precision Rehabilitation Nursing on Motor Dysfunction After Acute Stroke
Brief Summary: Ischemic stroke is the main cause of disability in the world. More than 70% of stroke patients show various degrees of neural function impairment. Motor rehabilitation in acute phase is beneficial for improving patient's structure and function of corticospinal tract. However, it is difficult to obtain effective rehabilitation during the acute phase of stroke because of the insufficiency of professional rehabilitation therapists in stroke wards in China.The present study is to verify that nursing-directed rehabilitation can compensate for the shortage of professional rehabilitation therapists. Our previous study indicated that nursing-directed motor function rehabilitation provided more obvious effect on stroke patients with a weighted corticospinal tract lesion load (wCST-LL) smaller than 2ml. We assume that implementing rehabilitation nursing based on the wCST-LL can realize nursing-directed, wCST-LL-based precision motor rehabilitation during acute phase of ischemic stroke.The present study is to conduct randomized clinical trial to confirm the effect of nursing-directed precision rehabilitation for motor function in acute stroke patients grouped by wCST-LL, and to evaluate the effect of this precision rehabilitation by using functional scale, and to explore the histopathologic mechanism of the precision rehabilitation nursing by mean of neuroelectrophysiology and neuroimaging examination. This study might provide theoretical support for motor rehabilitation in patients during acute phase of stroke.


Options:
A: Change in Upper Extremity Fugl Meyer Assessment (6 weeks from baseline); Percentage of Sessions With Adverse Events (Post treatment (6 weeks from baseline).)
B: Community Balance and Mobility Scale (Pre treatment and Post treatment (6 weeks))
C: Changes in cortical excitability measures (Measured for approximately 6 weeks)
D: Change of motor function (0 week and 1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Risky Drinking and PTSD After Sexual Assault: A Web-Based Intervention
Brief Summary: Sexual assault victimization is a common and particularly harmful form of trauma that is associated with increased risk for high-risk drinking and other conditions of public health concern, such as PTSD. Given evidence that sexual assault survivors who have low social support or receive negative social reactions to sexual assault disclosure are more likely to experience PTSD and drinking problems, improving social support is a novel target for intervention. The proposed study will attempt to prevent the onset of high-risk drinking and PTSD in sexual assault survivors by developing and testing a web-based early intervention aimed at increasing contact with social supporters and mitigating the harm of negative social reactions; ultimately, results will contribute to advancing the field's understanding of the potential for social support to mitigate the harm of trauma.


Options:
A: Problem Drinking Scores at Baseline and 3 Weeks (Baseline, post-intervention (3 weeks after baseline)); Problem Drinking Scores at Baseline and 3 Months (Baseline, 3 month follow-up); Posttraumatic Stress Symptom Severity Score at Baseline and 3 Weeks (Baseline, post-intervention (3 weeks after baseline)); Posttraumatic Stress Symptom Severity Score at Baseline and 3 Months (Baseline, 3 month follow-up)
B: Change in PTSD symptoms (PTSD Symptom Scale Interview) (Change in PTSD symptoms from baseline to 3 months post intervention)
C: Change in Pittsburgh Sleep Quality Index total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU); Change in Modified PTSD Symptom Scale - Self Report total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU)
D: Alcohol Use Interview (Past month); Alcohol Use Self-Report (Past month); Posttraumatic Stress Disorder Severity (PTSD) Interview (Past two weeks); Posttraumatic Stress Disorder Severity (PTSD) Self-Report (Past two weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Risky Drinking and PTSD After Sexual Assault: A Web-Based Intervention
Brief Summary: Sexual assault victimization is a common and particularly harmful form of trauma that is associated with increased risk for high-risk drinking and other conditions of public health concern, such as PTSD. Given evidence that sexual assault survivors who have low social support or receive negative social reactions to sexual assault disclosure are more likely to experience PTSD and drinking problems, improving social support is a novel target for intervention. The proposed study will attempt to prevent the onset of high-risk drinking and PTSD in sexual assault survivors by developing and testing a web-based early intervention aimed at increasing contact with social supporters and mitigating the harm of negative social reactions; ultimately, results will contribute to advancing the field's understanding of the potential for social support to mitigate the harm of trauma.


Options:
A: Problem Drinking Scores at Baseline and 3 Weeks (Baseline, post-intervention (3 weeks after baseline)); Problem Drinking Scores at Baseline and 3 Months (Baseline, 3 month follow-up); Posttraumatic Stress Symptom Severity Score at Baseline and 3 Weeks (Baseline, post-intervention (3 weeks after baseline)); Posttraumatic Stress Symptom Severity Score at Baseline and 3 Months (Baseline, 3 month follow-up)
B: summing totals of 17 DSM-IV symptoms (10 weeks)
C: Change of Points on Impact of event scale before and after Lifespan Integration treatment after a sexual trauma (3 weeks)
D: Number of Participants Who Engage in Mental Health Treatment (Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.); Center for Epidemiological Studies Depression Scale (Baseline (pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams in Patients Older Than 75 Years Undergoing High-risk Elective Surgery
Brief Summary: In the world, 230 million surgeries are performed every year and US data indicates that more than a third of patients who undergo surgery are older than 65 years, in which between 10 and 70% develop postoperative delirium (POD). Patients who develop POD have poor outcomes, such as a longer hospital stay, a deterioration in functional and cognitive status, high mortality rates, and an increase in health costs.

Delirium is an entity that in a significant percentage is preventable, thus preventing the development of POD is fundamental. In fact, in older adults hospitalized in the no surgical ward, the implementation of non-pharmacological prevention measures of delirium has consistently shown to significantly prevent the development of this condition. However, limited information is available about the usefulness of non-pharmacological intervention protocols applied in the perioperative context to prevent POD.

The main aim of this project is to determine whether the application of non-pharmacological measures during the perioperative period prevents POD in elderly patients undergoing highly complex elective surgeries.

The hypothesis is that the application of these measures decreases the incidence of delirium in this population.


Options:
A: Delirium (5 days); Subsyndromal delirium (5 days)
B: Postoperative delirium rate within 7 days after surgery (7 days after surgery)
C: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
D: Recruitment rate (Up to 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams in Patients Older Than 75 Years Undergoing High-risk Elective Surgery
Brief Summary: In the world, 230 million surgeries are performed every year and US data indicates that more than a third of patients who undergo surgery are older than 65 years, in which between 10 and 70% develop postoperative delirium (POD). Patients who develop POD have poor outcomes, such as a longer hospital stay, a deterioration in functional and cognitive status, high mortality rates, and an increase in health costs.

Delirium is an entity that in a significant percentage is preventable, thus preventing the development of POD is fundamental. In fact, in older adults hospitalized in the no surgical ward, the implementation of non-pharmacological prevention measures of delirium has consistently shown to significantly prevent the development of this condition. However, limited information is available about the usefulness of non-pharmacological intervention protocols applied in the perioperative context to prevent POD.

The main aim of this project is to determine whether the application of non-pharmacological measures during the perioperative period prevents POD in elderly patients undergoing highly complex elective surgeries.

The hypothesis is that the application of these measures decreases the incidence of delirium in this population.


Options:
A: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
B: Compliance with recommendations for intraoperative temperature management (1 day); Compliance with recommendations for intraoperative blood glucose management (1 day); Assess the usability of the Anesthesiology Control Tower (ACT) for an operating suite (2 years)
C: Delirium (5 days); Subsyndromal delirium (5 days)
D: Reduction in the incidence of Post-Operative Delirium (%) (Post-Operative Period (Day 0 through Day 7 or Discharge, whichever comes first))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Subjects With Relapsed/Refractory Large B-Cell Lymphoma
Brief Summary: The primary objectives of this study are:

Phase 1: To evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward into Phase 2

Phase 2: To evaluate the efficacy of axicabtagene ciloleucel and utomilumab as measured by complete response rate in participants with refractory large B-cell lymphoma


Options:
A: Percentage of Enrolled Participants Who Actually Get Treated (4-5 weeks after the first dose)
B: To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in adult patients with B-ALL. (2 years)
C: Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma (Scans performed at 6 weeks, 12 weeks and every 3-6 months for approximately 2 years)
D: Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose Limiting Toxicities (DLTs) (Up to 28 days); Phase 2: Complete Response (CR) Rate (Up to 1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunization Schedule Alert Platform: Determining ISAP SMS Efficacy in Improving Childhood Immunization Timeliness and Completeness in Nigeria
Brief Summary: The ISAP study is investigating the efficacy of SMS messages in improving routine childhood Immunization timeliness and completeness in Nigeria.


Options:
A: 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)
B: Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) (Recruitment +8 months)
C: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)
D: Change in Exclusive Breastfeeding Rate (2 weeks after birth); Change in Exclusive Breastfeeding Rate (3 months after birth); Change in Exclusive Breastfeeding Rate (6 months after birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunization Schedule Alert Platform: Determining ISAP SMS Efficacy in Improving Childhood Immunization Timeliness and Completeness in Nigeria
Brief Summary: The ISAP study is investigating the efficacy of SMS messages in improving routine childhood Immunization timeliness and completeness in Nigeria.


Options:
A: Influenza Immunization: Pediatric (March 31, 2011); Influenza Immunization: Pregnant Women (by December 31, 2011); Influenza Immunization: Delayed Pediatric (March 31, 2012)
B: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)
C: HPV completion rate (One Year)
D: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunization Schedule Alert Platform: Determining ISAP SMS Efficacy in Improving Childhood Immunization Timeliness and Completeness in Nigeria
Brief Summary: The ISAP study is investigating the efficacy of SMS messages in improving routine childhood Immunization timeliness and completeness in Nigeria.


Options:
A: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)
B: MEMS Adherence (12 months follow up)
C: Exclusive breastfeeding duration (Six months)
D: Mammogram receipt (1 week)

Answer: A