TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: PGT for Aneuploidy Does Not Enhance Live Birth in Young Patients (≤35 Years): a Randomized Controlled Trial of Single Blastocyst Frozen Embryo Transfers (ClinicalTrials.Gov ID: NCT03095053)
Brief Summary: Introduction Embryo aneuploidy is likely the leading cause of implantation failure in IVF cycles. Since the inception of IVF, non-invasive morphology based scoring has been the most widely used embryo selection method, resulting in relatively low embryo implantation rates. Our understanding of the optimal conditions required for in vitro embryo culture in IVF has advanced significantly over the past two decades. The implementation of improved in vitro embryo culture technologies (i.e., culture media and incubators) has resulted in an increase in the number of good quality embryos and consequently in increased numbers of blastocysts. While blastocyst transfers have seemingly improved the reproductive outcomes of IVF, they still remain suboptimal. The main objective of this randomized controlled trial (RCT) will be to investigate whether preimplantation genetic testing (i.e., PGT with comprehensive chromosome screening (CCS)) for aneuploidy is a superior embryo selection method, with the live birth outcomes of euploid blastocyst frozen embryo transfers (FET) compared with the LB outcomes of unknown-ploidy blastocyst FET, with blastocysts selected on (standard) morphological score.

Methods This RCT will be conducted at a single private IVF centre performing routine segmented-IVF, with intracytoplasmic sperm injection (ICSI), blastocyst freeze-all, and artificial frozen embryo transfer (art-FET). Normo-ovulatory infertile patients, with maternal age ≤35 years and at least two blastocysts with a morphology score of 2BB cryopreserved, will be randomized by computer-generated randomized allocation to either the PGT or morphology arm of the trial. All transfers will be single embryo transfers (SET), with only the first FET cycles following freeze-all to be analyzed.

Consent and Ethics Akdeniz University Medical Faculty Clinical Research Ethics Committee has approved the trial (reference number: 2015/399), with anonymized results to be released in ClinicalTrials.gov. All patients will provide informed consent, which included an agreement for the use of anonymised data for research and SET.


Options:
A: live born delivery rate (at birth of the child)
B: The Percentage of Patients With a Live Birth (>20 weeks gestation)
C: Sustained Implantation Rate Per Embryo Transferred (Within 1 year)
D: To improve live birth rates. (up to 1 year after birth); To assess the prediction value of having no euploid oocytes in future ART cycles. (Up to 1 year after birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of Body Shadow in Improving Virtual Reality Rehabilitation: Preliminary Data From BTS Nirvana
Brief Summary: Purpose of the article: aim of the present study was to detect the differences between the presence or not of body shadows during a virtual reality (VR) training with BTS NIRVANA (BTsN). Materials and methods: In this pilot study, we enrolled 20 post-stroke rehabilitation inpatients, who underwent a neurocognitive-rehabilitative training consisting of 24 sessions (three times a week for 8 weeks) of BTsN. All the patients were randomized into two groups: Semi-immersive virtual training with (S-IVTSgroup) or without (S-IVTgroup) body shadows.

Each participant was evaluated before (T0), and immediately (T1) after the end of the training by a skilled neuropsychologist through the administration of a complete battery, and by a skilled neurologist to assess motor functions.


Options:
A: Motor impairment of the upper limb (Change from Baseline in motor impairment of the upper limb at 4 weeks)
B: Change scores of Montreal Cognitive Assessment (MoCA) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Memory Scale - Third Edition (WMS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Useful Field of View (UFOV) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop Color-Word test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
C: Montreal Cognitive Assessment Test (MoCA) (Six months)
D: Frontal Assessment Battery (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Topical Paromomycin Cream For Bolivian Cutaneous Eishmaniasis: A Controlled Study
Brief Summary: This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb) to placebo for L braziliensis in Bolivia.


Options:
A: Number of patients with reduction in 50% in the diameters of the ulcers and lesions skin (Two months after the end of the treatment)
B: Definitive cure (3 months after treatment)
C: Final Clinical Cure for Index Lesions (Initial clinical cure by day 63 and no relapse by day 168)
D: Change of Lesion size (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Subjects Assessed to be at Imminent Risk for Suicide
Brief Summary: The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.


Options:
A: Memory tests (Before ECT, after 6 ECT treatments, at the end of the ECT course)
B: Young Mania Rating Scale; Hamilton Depression Rating Scale (HAM-D), 17-item version Hamilton Rating Scale for Anxiety (HAM-A).; Clinical Global Impression Scale CGI-BP (41); Affective Morbidity Index (42)
C: The primary objective is to determine whether an antidepressant effect can be achieved in patients with Treatment Resistant Depression determined by a change from baseline in the MADRS total score. (Change from Baseline)
D: Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose (Last Observation Carried Forward [LOCF] Data): Double-blind (DB) Treatment Phase (Baseline (Day 1, predose) and 24 hours first post dose (Day 2)); Change From Baseline in Clinical Global Impression-Severity of Suicidality - Revised (CGI-SS-R) Scale at 24 Hours Post First Dose (LOCF Data): DB Treatment Phase (Baseline (Day 1, predose) and 24 hours first post dose (Day 2))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Subjects Assessed to be at Imminent Risk for Suicide
Brief Summary: The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.


Options:
A: Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose (Last Observation Carried Forward [LOCF] Data): Double-blind (DB) Treatment Phase (Baseline (Day 1, predose) and 24 hours first post dose (Day 2)); Change From Baseline in Clinical Global Impression-Severity of Suicidality - Revised (CGI-SS-R) Scale at 24 Hours Post First Dose (LOCF Data): DB Treatment Phase (Baseline (Day 1, predose) and 24 hours first post dose (Day 2))
B: Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores (6 weeks)
C: 17-item Hamilton Depression Rating Scale (week 0, 2, 4, 6); Remission rate (week 0, 2,4, 6); GAF(Global Assessment of Function) (Week 0, 2, 4, 6)
D: Change in Montgomery Asberg Depression Rating Scale (MADRS) (From baseline to Week 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
Brief Summary: Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms of Neonatal Abstinence Syndrome


Options:
A: Length of Hospitalization (Up to 4 months)
B: Finnegan Neonatal Abstinence Scoring System (14 days); Duration of Treatment (120 days)
C: Length of Hospital Stay (assessed at hospital discharge, approximately 7-30 days)
D: Length of treatment (From initiation of medical treatment through last dose of medication given, up to 100 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
Brief Summary: Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms of Neonatal Abstinence Syndrome


Options:
A: Sublingual Buprenorphine safety and tolerability in the neonate (Index hospitalization)
B: Methadone and EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) blood concentration (Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).)
C: Length of Treatment (Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.)
D: Length of Hospitalization (Up to 4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
Brief Summary: Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms of Neonatal Abstinence Syndrome


Options:
A: Cumulative dose of morphine required to treat NAS. (14 days of age); Highest dose of morphine required to treat NAS. (14 days of age)
B: combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. (corrected age of 18 months)
C: Length of Hospitalization (Up to 4 months)
D: Change in Infant Movement between Mattress ON and Mattress OFF (control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.); Change in Infant Breathing between Mattress ON and Mattress OFF (control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.); Change in Infant Heart Rate between Mattress ON and Mattress OFF(control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile App-treatment of Mixed and Urgency Urinary Incontinence in Women - a Randomized Controlled Study
Brief Summary: The purpose of this study is to determine whether a comprehensive treatment programme for self-management of mixed and urgency urinary incontinence via a mobile app is effective.


Options:
A: Change from baseline in average number of urinations per patient per day at Week 12
B: 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). (Two years); 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success) (Two years)
C: International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) (15 weeks)
D: Evaluation of subjective cure (At the end of 3 months of supervised treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile App-treatment of Mixed and Urgency Urinary Incontinence in Women - a Randomized Controlled Study
Brief Summary: The purpose of this study is to determine whether a comprehensive treatment programme for self-management of mixed and urgency urinary incontinence via a mobile app is effective.


Options:
A: Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire (Week 10-14 gestation (baseline), week 36-39 (after intervention))
B: International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) (15 weeks)
C: Change in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) (baseline to 12 weeks)
D: Change in Incontinent Episodes Immediately Post-treatment (Baseline and immediately post-treatment - week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Study of CD19/CD20 tanCAR T Cells in Relapsed and/or Chemotherapy Refractory B-cell Leukemias and Lymphomas
Brief Summary: RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells.

PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to chemotherapy.


Options:
A: Adverse events attributed to Tcm adoptive transfer as reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Up to 15 years); MTD of CD19-CAR-specific/truncated EGFR lentiviral vector-transduced autologous T cells based on dose limiting toxicities (Up to day 28)
B: Number of Participants Who Experienced an Adverse Event Meeting the Dose-Limiting Toxicity Definition (Initial CAR T cell infusion through 30 days post infusion); Number of Participants With an MRD Negative Complete Remission After Initial CAR T Cell Infusion (Initial CAR T cell infusion through Day 63 post infusion assessment (+/- 14 days)); Number of Participants Who Have a Releasable Cell Product Generated (Up to 28 days per manufacturing attempt)
C: maximum tolerated dose (MTD) (2 years); safety (2 years)
D: Occurrence of study related adverse events (Until week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, D46/NS2/N/ΔM2-2-HindIII, Lot RSV#011B, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age
Brief Summary: The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants and children 6 to 24 months of age.

This study was a companion study to CIR 313.


Options:
A: Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups (Day 0 to Day 112); Assessment of the safety (Day 0 to Day 182)
B: Number of Participants With Solicited Adverse Events (AEs) by Grade (Measured from Day 0 through Day 28); Number of Participants With Unsolicited AEs by Grade (Measured from Day 0 through Day 28); Number of Participants With Serious Adverse Events (SAEs) (Measured from Day 0 through Day 56); Number of Participants Infected With RSV Vaccine Virus (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28 for nasal washes, and at Days 0, 56 for serum RSV-neutralizing antibodies); Peak Titer of Vaccine Virus Shed (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28); Duration of Vaccine Virus Shedding in Nasal Washes (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28. Last day positive is reported.); Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titer (Measured at Day 0 and Day 56); Serum Antibody Responses to RSV F Glycoprotein as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) (Measured at Day 56)
C: Incidence of medically significant RSV LRTI with either hypoxemia (SpO2 <95% at sea level or <92% at altitudes >1800 meters) or tachypnea in infants through 90 days of life (Delivery to 90 days after delivery)
D: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Noninvasive Ventilation for Preterm Neonates With Respiratory Distress Syndrome: a Multi-center Randomized Controlled Trial
Brief Summary: The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in premature infants with RDS．


Options:
A: Difference in time (min) required to normalize the respiratory distress (modified Silverman score = 0, no need for oxygen, RF < 50 bpm and SaO2 > 92%) between the two ventilatory modes (Within the first 6 hours after birth)
B: Duration of Invasive Mechanical Ventilation (up to 8 weeks); Ventilator-free Days (up to 8 weeks); Number of Babies With Reintubation (up to 8 weeks)
C: Failure of assignmed non-invasive mode post randomization to NIHFV or BP-CPAP (72 hours)
D: Number of Participants Who Required Intubation (during the first 7 days after birth)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin Versus Low-molecular-weight Heparin (LMWH) and Aspirin in Women With Antiphospholipid Syndrome and Pregnancy Loss
Brief Summary: The APPLE pilot trial is a feasibility study that is a multicentre, open-label, randomized controlled trial. Pregnant women with antiphospholipid syndrome (APS) and a history of late (≥10 weeks gestation) or recurrent early (2 \<10 weeks) pregnancy loss will be recruited.

Eligible and consenting subjects will be assigned to one of two study arms: open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin (ASA) daily until delivery, or open-label low-dose aspirin daily from randomization until delivery.


Options:
A: Successful pregnancy outcome
B: placental syndrome or thromboembolic event (9 months)
C: Study Feasibility: Mean Recruitment Rate Per Center Per Month (24 months)
D: Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) (pregnancy > 24weeks gestation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin Versus Low-molecular-weight Heparin (LMWH) and Aspirin in Women With Antiphospholipid Syndrome and Pregnancy Loss
Brief Summary: The APPLE pilot trial is a feasibility study that is a multicentre, open-label, randomized controlled trial. Pregnant women with antiphospholipid syndrome (APS) and a history of late (≥10 weeks gestation) or recurrent early (2 \<10 weeks) pregnancy loss will be recruited.

Eligible and consenting subjects will be assigned to one of two study arms: open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin (ASA) daily until delivery, or open-label low-dose aspirin daily from randomization until delivery.


Options:
A: Study Feasibility: Mean Recruitment Rate Per Center Per Month (24 months)
B: Successful pregnancy outcome
C: Fetal loss (From 12 weeks to 42 weeks gestational age)
D: placental syndrome or thromboembolic event (9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin Versus Low-molecular-weight Heparin (LMWH) and Aspirin in Women With Antiphospholipid Syndrome and Pregnancy Loss
Brief Summary: The APPLE pilot trial is a feasibility study that is a multicentre, open-label, randomized controlled trial. Pregnant women with antiphospholipid syndrome (APS) and a history of late (≥10 weeks gestation) or recurrent early (2 \<10 weeks) pregnancy loss will be recruited.

Eligible and consenting subjects will be assigned to one of two study arms: open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin (ASA) daily until delivery, or open-label low-dose aspirin daily from randomization until delivery.


Options:
A: Study Feasibility: Mean Recruitment Rate Per Center Per Month (24 months)
B: Fetal loss (From 12 weeks to 42 weeks gestational age)
C: Pregnancy outcome: livebirths (>37 weeks of gestation), premature livebirths (> 24, but <37 weeks of gestation) (gestational weeks >37 and gestational weeks > 24, but <37)
D: Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) (pregnancy > 24weeks gestation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin Versus Low-molecular-weight Heparin (LMWH) and Aspirin in Women With Antiphospholipid Syndrome and Pregnancy Loss
Brief Summary: The APPLE pilot trial is a feasibility study that is a multicentre, open-label, randomized controlled trial. Pregnant women with antiphospholipid syndrome (APS) and a history of late (≥10 weeks gestation) or recurrent early (2 \<10 weeks) pregnancy loss will be recruited.

Eligible and consenting subjects will be assigned to one of two study arms: open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin (ASA) daily until delivery, or open-label low-dose aspirin daily from randomization until delivery.


Options:
A: Study Feasibility: Mean Recruitment Rate Per Center Per Month (24 months)
B: Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) (pregnancy > 24weeks gestation)
C: Pregnancy outcome: livebirths (>37 weeks of gestation), premature livebirths (> 24, but <37 weeks of gestation) (gestational weeks >37 and gestational weeks > 24, but <37)
D: pregnancy loss (during first 20 weeks of gregnancy)

Answer: A