TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid for the Treatment of Postpartum Haemorrhage: An International Randomised, Double Blind, Placebo Controlled Trial
Brief Summary: The WOMAN trial is a large pragmatic randomised double-blind, placebo controlled trial to quantify the effects of the early administration of tranexamic acid on death, hysterectomy and other relevant outcomes. 20,000 adult women, after delivery who have clinically diagnosed postpartum haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent. Additionally, TWO nested studies will be conducted in a subset of women trial participants. The first nested study (ETAC) aims to evaluate the effect of tranexamic acid (TXA) on markers of coagulation in 400 women randomised to the WOMAN trial. The second nested study (ETAPLAT) aims to evaluate the haemostatic effect and antithrombotic effect of TXA in 128 women randomised to the WOMAN trial.


Options:
A: Maternal death due to PPH or invasive procedures due to PPH (After delivery and before discharge from facility (usually within 48 hours after delivery)); Treatment of postpartum infection among women diagnosed with PPH (Within 4 weeks after delivery)
B: Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon. (24 hours)
C: the incidence of postpartum hemorrhage (24 hour)
D: The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described. (up to 42 days after randomisation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid for the Treatment of Postpartum Haemorrhage: An International Randomised, Double Blind, Placebo Controlled Trial
Brief Summary: The WOMAN trial is a large pragmatic randomised double-blind, placebo controlled trial to quantify the effects of the early administration of tranexamic acid on death, hysterectomy and other relevant outcomes. 20,000 adult women, after delivery who have clinically diagnosed postpartum haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent. Additionally, TWO nested studies will be conducted in a subset of women trial participants. The first nested study (ETAC) aims to evaluate the effect of tranexamic acid (TXA) on markers of coagulation in 400 women randomised to the WOMAN trial. The second nested study (ETAPLAT) aims to evaluate the haemostatic effect and antithrombotic effect of TXA in 128 women randomised to the WOMAN trial.


Options:
A: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). (Death, discharge or four weeks post randomisation whichever occurs first.)
B: The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described. (up to 42 days after randomisation)
C: Incidense of transfusion with allogenic blood products (During hospital stay or until 6 weeks postintervention)
D: Need for additional treatment after initial PPH study treatment (all additional interventions recorded following initial uterotonic treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid for the Treatment of Postpartum Haemorrhage: An International Randomised, Double Blind, Placebo Controlled Trial
Brief Summary: The WOMAN trial is a large pragmatic randomised double-blind, placebo controlled trial to quantify the effects of the early administration of tranexamic acid on death, hysterectomy and other relevant outcomes. 20,000 adult women, after delivery who have clinically diagnosed postpartum haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent. Additionally, TWO nested studies will be conducted in a subset of women trial participants. The first nested study (ETAC) aims to evaluate the effect of tranexamic acid (TXA) on markers of coagulation in 400 women randomised to the WOMAN trial. The second nested study (ETAPLAT) aims to evaluate the haemostatic effect and antithrombotic effect of TXA in 128 women randomised to the WOMAN trial.


Options:
A: The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described. (up to 42 days after randomisation)
B: Multiple Organ Failure (MOF) (Variable until 24h on ICU at the end of the IMP-administration)
C: efficacy endpoint (the volumes of allogeneic blood products, volumes of cumulative drainage within 24 h and 48 h and 5 days (from the time of fibrinogen concentrate administration until the 5th postoperative day)
D: The primary outcome is death from haemorrhage (within 5 days of randomisation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid for the Treatment of Postpartum Haemorrhage: An International Randomised, Double Blind, Placebo Controlled Trial
Brief Summary: The WOMAN trial is a large pragmatic randomised double-blind, placebo controlled trial to quantify the effects of the early administration of tranexamic acid on death, hysterectomy and other relevant outcomes. 20,000 adult women, after delivery who have clinically diagnosed postpartum haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent. Additionally, TWO nested studies will be conducted in a subset of women trial participants. The first nested study (ETAC) aims to evaluate the effect of tranexamic acid (TXA) on markers of coagulation in 400 women randomised to the WOMAN trial. The second nested study (ETAPLAT) aims to evaluate the haemostatic effect and antithrombotic effect of TXA in 128 women randomised to the WOMAN trial.


Options:
A: Incidense of transfusion with allogenic blood products (During hospital stay or until 6 weeks postintervention)
B: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). (Death, discharge or four weeks post randomisation whichever occurs first.)
C: The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described. (up to 42 days after randomisation)
D: Clinical parameters: intensity of the hemorrhage, before and one hour after the end of the rhuFVIIa infusion (use of a graduated blood collector bag device). (1 hour); Any transfusion (number of units and volume) of red blood cells, platelet or fresh frozen plasma. Haemodynamics-related parameters (non-invasive arterial pressure,heart rate, diuresis,..). (7 Hours); Biological parameters:packed red cell volume, hemoglobin, etc. (12 hours); Therapeutic interventions aiming at controlling postpartum hemorrhage: selective arterial embolization, ligation of hypogastric arteries, hysterectomy. (Day 1)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid for the Treatment of Postpartum Haemorrhage: An International Randomised, Double Blind, Placebo Controlled Trial
Brief Summary: The WOMAN trial is a large pragmatic randomised double-blind, placebo controlled trial to quantify the effects of the early administration of tranexamic acid on death, hysterectomy and other relevant outcomes. 20,000 adult women, after delivery who have clinically diagnosed postpartum haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent. Additionally, TWO nested studies will be conducted in a subset of women trial participants. The first nested study (ETAC) aims to evaluate the effect of tranexamic acid (TXA) on markers of coagulation in 400 women randomised to the WOMAN trial. The second nested study (ETAPLAT) aims to evaluate the haemostatic effect and antithrombotic effect of TXA in 128 women randomised to the WOMAN trial.


Options:
A: postpartum hemorrhage (day 2)
B: The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described. (up to 42 days after randomisation)
C: A composite of life-threatening bleeding, major bleeding, and critical organ bleeding (30 days after randomization); A composite of MINS, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism. (30 days after randomization); For patients in the blood pressure management arm: A composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest. (30 days after randomization)
D: Incidence of PPH (24 hours after birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label (Part One) and a Randomized, Double-blind, Placebo-Controlled (Part Two) Study of the Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Pediatric Patients With Autism
Brief Summary: The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.


Options:
A: Change From Baseline in Social Communication Deficits as Measured by Social Responsiveness Scale 2 (SRS-2) (Baseline, Week 12); Percentage of Participants with Suicidality, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) (Baseline up to Week 12); Percentage of Participants With Adverse Events (From Baseline up to Week 18)
B: Extent of Absorption of Memantine (Part One) (Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose); Change in Total Raw Score of Social Responsiveness Scale (From Baseline to Week 12)
C: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)
D: Rate of Recruitment (19 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label (Part One) and a Randomized, Double-blind, Placebo-Controlled (Part Two) Study of the Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Pediatric Patients With Autism
Brief Summary: The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.


Options:
A: Extent of Absorption of Memantine (Part One) (Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose); Change in Total Raw Score of Social Responsiveness Scale (From Baseline to Week 12)
B: N/A
C: Clinical Global Impression - Severity (Week 12); Clinical Global Impression - Improvement (Week 12)
D: Aberrant Behavior Checklist - Social Withdrawal Subscale (Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label (Part One) and a Randomized, Double-blind, Placebo-Controlled (Part Two) Study of the Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Pediatric Patients With Autism
Brief Summary: The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.


Options:
A: N/A
B: Clinical Global Impression-Improvement Scale (CGI-I) (Baseline to 12 weeks)
C: Extent of Absorption of Memantine (Part One) (Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose); Change in Total Raw Score of Social Responsiveness Scale (From Baseline to Week 12)
D: Clinical Global Impressions Scale - Improvement - Social (6 Weeks); Repetitive Behavior Scale - Revised (6 Weeks); Diagnostic Analysis of Nonverbal Accuracy, Paralanguage Test (6 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label (Part One) and a Randomized, Double-blind, Placebo-Controlled (Part Two) Study of the Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Pediatric Patients With Autism
Brief Summary: The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.


Options:
A: Developmental Neuropsychological Assessment (NEPSY) Apraxia and Repetition of Nonsense Words Subtests (Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial)); Expressive Vocabulary Test (EVT) (Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial))
B: Extent of Absorption of Memantine (Part One) (Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose); Change in Total Raw Score of Social Responsiveness Scale (From Baseline to Week 12)
C: Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) (Baseline (Visit 1) to week 12)
D: Montgomery-Asberg Depression Rating Score (MADRS) (Baseline & week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II Study of Docetaxel Followed by Vandetanib (ZD6474) vs. Docetaxel Plus Vandetanib in Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more effective when given alone or together with vandetanib.

PURPOSE: This randomized phase II trial is studying docetaxel given together with or without vandetanib to see how well it works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.


Options:
A: overall survival (18 months)
B: Percentage of Participants With an Overall Response Rate (an average of 126 days for ovarian; 71 days for TNBC; for crossover intervention, pts stayed on study for an avg of 134 days for ovarian; 50 days for TNBC.); Progression Free Survival (Ovarian cancer patients stayed on study for an average of 126 days and triple-negative breast cancer patients for an average of 71 days.)
C: ORR (Up to 2 years); PFS (Up to 2 years)
D: Progression Free Survival (PFS) (Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II Study of Docetaxel Followed by Vandetanib (ZD6474) vs. Docetaxel Plus Vandetanib in Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more effective when given alone or together with vandetanib.

PURPOSE: This randomized phase II trial is studying docetaxel given together with or without vandetanib to see how well it works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.


Options:
A: Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (after 6 weeks (2 cycles))
B: 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)
C: Overall Survival (Up to five years)
D: Progression Free Survival (PFS) (Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate Efficacy and Safety of Deferasirox in Non-transfusion-dependent Thalassemia Patients With Iron Overload
Brief Summary: CICL670A2209: This study will evaluate the safety and efficacy of deferasirox in non-transfusion dependent thalassemia patients with iron overload. Patients will be treated either with active treatment (deferasirox) or placebo for 12 months (core study phase). Patients who complete the core study phase will be offered to continue their study with the active treatment (deferasirox) in a 12 months extension phase. During the core and extension, the effects of treatment on iron overload in the liver will be evaluated using magnetic resonance imaging (MRI) assessments.

CICL670A2209E1: A one-year open-label extension to a randomized, double-blind, placebo-controlled, phase II study to evaluate efficacy and safety of deferasirox in non-transfusion dependent thalassemia patients with iron overload (Thalassa).


Options:
A: Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event (up to 5 years)
B: Core Study: Change in Liver Iron Concentration (LIC) From Baseline to Week 52 (Baseline, Week 52); Extension Study: Percentage of Participants Reaching a Liver Iron Concentration (LIC) < 5 mg Fe/g dw From Core Baseline to End of Extension Study (Core Baseline to End of Extension Study (up to 24 months))
C: Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)
D: Area Under the Curve of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Half-Life of Deferasirox (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Clearance/Bioavailability of Deferasirox in Patients With Poor Response to Deferasirox Compared to Patients With Good Response After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy
Brief Summary: The investigators main hypothesis is that the stone free rate will be much higher (95%) in patients treated with PCNL than patients treated with ESWL where stone free rate is (60%) to determine which treatment is safe and prevent less stone recurrence.


Options:
A: Stone free rate (SFR) (The primary endpoint was the SFR at 3-months after surgery.)
B: SFR (3 month)
C: The primary objective of this study is to compare the stone-free status after Extracorporeal Shock Wave Lithotripsy (ESWL) and Percutaneous Nephrolithotomy (PCNL) for kidney stones 10-20 mm in size. (Within 3 months of enrollment)
D: The change in urine NGAL/Cr value (2 hours preoperative and 2 hours postoperatively)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Activating Collaborative CIS Support Via Targeted Provider Mailing
Brief Summary: RATIONALE: Receiving a reminder letter from their doctor with questions to ask the Cancer Information Service may be more effective than a standard reminder letter in helping patients who have had an abnormal Pap test keep their follow-up colposcopy appointment.

PURPOSE: This randomized clinical trial is studying a personalized letter with Cancer Information Service support to see how well it works compared with a standard reminder letter in women scheduled for colposcopy after an abnormal Pap test.


Options:
A: Number of Participants Completing a Self-sampling Test (2 to 6 months)
B: Patient Satisfaction in the 2 Interventions (within 6 months of PAP); CIS Experience of Patients in Arm II and the Effect of the Intervention on Their Follow-up Colposcopy (within 6 months of PAP)
C: Participant attends cervical cancer screening (Within 7 months of the intervention)
D: Proportion of Patients Who Receive a Pap Test at End of Follow up (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-masked Clinical Trial of Buspirone in the Treatment of 2- 6 Year Old Children With Autistic Disorder
Brief Summary: The purpose of this study is to evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children aged 2-6 years as measured by the change from baseline in the Autism Diagnostic Observation Schedule (ADOS) Composite Total scores compared to placebo at 6 months.


Options:
A: To evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children 2-6 years measuring the change from baseline in ADOS (Autism Diagnostic Observation Schedule) Composite Total scores compared to placebo at 6 months. (Baseline 1, Week 24)
B: Percentage of Patients Relapsing by Week 16 (From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment)
C: ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score (Baseline and 8 weeks)
D: Mean Post-baseline Aberrant Behavior Checklist Irritability Score, Parent Report, Double-blind Phase (Weeks 1, 2, 3, 4, 6, and 8); Odds of Improvement as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2) (Weeks 1, 2, 3, 4, 6 and 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-masked Clinical Trial of Buspirone in the Treatment of 2- 6 Year Old Children With Autistic Disorder
Brief Summary: The purpose of this study is to evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children aged 2-6 years as measured by the change from baseline in the Autism Diagnostic Observation Schedule (ADOS) Composite Total scores compared to placebo at 6 months.


Options:
A: Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment. (Baseline; Week 4)
B: To evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children 2-6 years measuring the change from baseline in ADOS (Autism Diagnostic Observation Schedule) Composite Total scores compared to placebo at 6 months. (Baseline 1, Week 24)
C: Social Responsiveness Scale (SRS) Change (Completed at Baseline and Week 11); Social Responsiveness Scale (SRS) at Follow-Up (Completed at Week 22)
D: hyperactivity, impulsiveness, and distractibility

Answer: B