TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the Efficiency of a Treatment by Bumetanide in a Population of Autistic Children
Brief Summary: The purpose of this study is to determine if a treatment by bumetanide presents an efficiency at the level of the neuronal maturation in the autism


Options:
A: Child Autism Rating Scale score (day 0 to day 90)
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: Changes in the Irritability Subscale of the Larger ABC (Abberent Behavior Checklist) That Occur From Baseline to 10 Weeks (baseline to 10 weeks)
D: hyperactivity, impulsiveness, and distractibility

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV, Unicenter, Randomized, Double-Blind, Parallel-Group, Comparaty Study of Intravenous and Oral Iron vs Placebo in Patient Under Extracorporeal Circulation in Cardiovascular Surgery
Brief Summary: Anaemia is a common postoperative problem of cardiovascular surgery after cardiopulmonary bypass (CPB). Because of this the need for hemoderived blood transfusions is high. The purpose of this study was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact of the iron on the transfusion rate in postoperative cardiovascular surgery under extracorporeal circulation.


Options:
A: Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL (Any time between baseline and the end of study or time to intervention)
B: Efficacy of maintenance treatment of iron deficiency (8 months)
C: Change in peak VO2 from baseline to week 18
D: Haemoglobin and Hematocrit values (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV, Unicenter, Randomized, Double-Blind, Parallel-Group, Comparaty Study of Intravenous and Oral Iron vs Placebo in Patient Under Extracorporeal Circulation in Cardiovascular Surgery
Brief Summary: Anaemia is a common postoperative problem of cardiovascular surgery after cardiopulmonary bypass (CPB). Because of this the need for hemoderived blood transfusions is high. The purpose of this study was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact of the iron on the transfusion rate in postoperative cardiovascular surgery under extracorporeal circulation.


Options:
A: Change in peak VO2 from baseline to week 18
B: Haemoglobin and Hematocrit values (2 years)
C: Risk of blood transfusion or death (From randomisation until 30-days following the index operation); Blood transfusion rate (including repeat transfusions) (From randomisation until 30-days following the index operation)
D: Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Memantine in Adult Autism Spectrum Disorder
Brief Summary: The purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise specified (NOS).


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: Clinical Global Impression-Improvement Scale (CGI-I) (Baseline to 12 weeks)
C: Clinical Global Impression-Scale(CGI-S) (12 weeks)
D: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effect of Cranberry Capsules on the Occurrence of Urinary Tract Infections During Post-acute Rehabilitation of Spinal Cord Injured Patients
Brief Summary: The purpose of this study is to establish whether cranberry capsules reduce rates of urinary tract infections during initial rehabilitation immediately after spinal cord injury.


Options:
A: Change of the intestinal and urinary microbiome (3 months to 12 months)
B: Participants With Clinically-diagnosed and Treated UTI's. (From surgery to post-op visit, approximately 6 weeks post surgery)
C: UTI Recurrence (Variable for each participant over course of up to one year)
D: Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation (At end of study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week Trial Investigating the Dosing Flexibility, Efficacy and Safety of NN1250 in Subjects With Type 1 Diabetes With a 26-week Extension (Begin™: Flex T1)
Brief Summary: This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with type 1 diabetes.


Options:
A: Absolute change of glycosylated hemoglobin (HbA1c) (from baseline to week 24)
B: Glycosylated Haemoglobin A1c (HbA1c) (after 52 weeks of treatment)
C: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment (Week 0, Week 26); Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes (Week 0 to Week 52 + 7 days follow up); Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes (Week 0 to Week 52 + 7 days follow up)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients
Brief Summary: The purpose of this study is to find out if burn injured patients do better receiving fewer blood transfusions than what is traditionally given. We traditionally provide blood transfusions to maintain a hemoglobin level, which is an indicator of the level of red blood cells that carry oxygen in your body, to above 10 g/dl (g/dl stands for grams per deciliter and is the standard measurement used to indicate the level of red blood cells in your blood). However, a preliminary study indicated that maintaining the hemoglobin level to above 7-8 g/dl with less blood transfusion, as compared to a hemoglobin level of 10 g/dl and above, would reduce the occurrence of blood infection, duration on the respirator and length of hospital stay, yet would achieve similar survival in both groups.


Options:
A: In-hospital death (In-hospital); Recurrent myocardial infarction (MI) (In-hospital); New or worsening heart failure (In-hospital)
B: Mortality at the 45th day (45 days)
C: Incidence of Blood Stream Infection (1 week after randomization and weekly thereafter through discarge from hospital)
D: A Composite of In-hospital Postoperative Morbidity and Mortality (After surgery until hosptal discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients
Brief Summary: The purpose of this study is to find out if burn injured patients do better receiving fewer blood transfusions than what is traditionally given. We traditionally provide blood transfusions to maintain a hemoglobin level, which is an indicator of the level of red blood cells that carry oxygen in your body, to above 10 g/dl (g/dl stands for grams per deciliter and is the standard measurement used to indicate the level of red blood cells in your blood). However, a preliminary study indicated that maintaining the hemoglobin level to above 7-8 g/dl with less blood transfusion, as compared to a hemoglobin level of 10 g/dl and above, would reduce the occurrence of blood infection, duration on the respirator and length of hospital stay, yet would achieve similar survival in both groups.


Options:
A: Incidence of Blood Stream Infection (1 week after randomization and weekly thereafter through discarge from hospital)
B: Cost-effectiveness ratio at 30 days (30 days)
C: Total Number of Units Transfused (From randomization until discharge from admission for delivery, an average of 2-3 days)
D: Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (Up to hospital discharge or postoperative day 28 (whichever occurs first))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients
Brief Summary: The purpose of this study is to find out if burn injured patients do better receiving fewer blood transfusions than what is traditionally given. We traditionally provide blood transfusions to maintain a hemoglobin level, which is an indicator of the level of red blood cells that carry oxygen in your body, to above 10 g/dl (g/dl stands for grams per deciliter and is the standard measurement used to indicate the level of red blood cells in your blood). However, a preliminary study indicated that maintaining the hemoglobin level to above 7-8 g/dl with less blood transfusion, as compared to a hemoglobin level of 10 g/dl and above, would reduce the occurrence of blood infection, duration on the respirator and length of hospital stay, yet would achieve similar survival in both groups.


Options:
A: In-hospital death (In-hospital); Recurrent myocardial infarction (MI) (In-hospital); New or worsening heart failure (In-hospital)
B: FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status (Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion)
C: Mean Post-operative hemoglobin (longitudinal outcome) (Day 0 - 15)
D: Incidence of Blood Stream Infection (1 week after randomization and weekly thereafter through discarge from hospital)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients
Brief Summary: The purpose of this study is to find out if burn injured patients do better receiving fewer blood transfusions than what is traditionally given. We traditionally provide blood transfusions to maintain a hemoglobin level, which is an indicator of the level of red blood cells that carry oxygen in your body, to above 10 g/dl (g/dl stands for grams per deciliter and is the standard measurement used to indicate the level of red blood cells in your blood). However, a preliminary study indicated that maintaining the hemoglobin level to above 7-8 g/dl with less blood transfusion, as compared to a hemoglobin level of 10 g/dl and above, would reduce the occurrence of blood infection, duration on the respirator and length of hospital stay, yet would achieve similar survival in both groups.


Options:
A: Occurrence of a composite endpoint (90 days)
B: Incidence of Blood Stream Infection (1 week after randomization and weekly thereafter through discarge from hospital)
C: Incidence of death or major neurodevelopmental impairment (24 months of age corrected for prematurity)
D: Total Number of Units Transfused (From randomization until discharge from admission for delivery, an average of 2-3 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
Brief Summary: The purpose of the investigators study is to investigate the effects of coffee on the return of bowel function and appetite, length of hospital stay, and complications after elective open colectomy in a prospective randomized trial. The primary efficacy endpoint is time to first bowel movement.


Options:
A: Time to return to active bowel movements (participants will be followed for the duration of hospital stay)
B: Small bowel transit time (6 hours)
C: Time to first bowel movement (patients postoperative in hospital stay (mean 6 days))
D: time to flatus (two days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Falls With RENEW in Older Adults Who Have Fallen
Brief Summary: This clinical trial will compare the effects of a high intensity Resistance Exercise via Negative Work (RENEW) vs. Traditional resistance exercise (TRAD) as part of a mult-component exercise and fall-reduction program on muscle conditioning; falling risks; as well as the fall incidence in older adults who have fallen. We anticipate that muscle conditioning will mediate the effect of RENEW on falling risks and fall incidence.


Options:
A: Incidence of serious fall-related injuries and of all injurious falls including those leading to more moderate injuries (2 years)
B: Fall incidence, which is measured by monthly fall registration cards
C: The Number of Days Survived Without a Fall Over the 1 Year Duration of the Study (12 months)
D: Falls rate (6 months post intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Parallel-Group, Dose-Ranging Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Antiviral Activity of VX-222 and Telaprevir in Combination With and Without Peginterferon-Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C
Brief Summary: The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection.

This study will include an Investigational Phase and Extension Phase. These phases will contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the Investigational Phase of this study. Subjects who fail treatment during the Investigational Phase will have the option to enter the Extension Phase at which point they will be eligible to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks.

Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based combination therapy. The components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. If enacted, up to 25 patients are expected to enroll in each additional treatment arm.

If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.


Options:
A: Percentage of Participants Experiencing Treatment Emergent Adverse Events (First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)); Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities (First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)); Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline (Baseline; Days 4, 5, 6, 7, 8, 10, and 17)
B: Safety and Tolerability (40 weeks)
C: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants (Posttreatment Week 12); Percentage of Participants With Sustained Virologic Response at 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 12 weeks)
D: Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12) (Post treatment 12 week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer
Brief Summary: A new notion"Fast Track Multi-Discipline Treatment" for colorectal cancer is thought with several benefits such as shorter hospitalization stay and less costs. This randomized study aims to compare the differences between conventional and Fast Track Multi-Discipline Treatment for colorectal cancer in hospitalization day, complications, costs and quality of life.


Options:
A: median length of stay (participants will be followed for the duration of hospital stay, an expected average of 2 weeks.)
B: hospitalization day (6-month post surgery)
C: Shorter Length Of Hospitalization (LOH) (Up to 4 weeks after surgery)
D: Length of Hospitalization Post-operation (up to 12 months); The Total Cost (RMB) (12 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients With Mucinous Epithelial Ovarian or Fallopian Tube Cancer (MEOC)
Brief Summary: This randomized phase III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.


Options:
A: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)
B: Proportion of patients with objective response rate with recurrent endometrial cancer with mutated ARID1A (3 years); Proportion of patients with objective response rate with recurrent ovarian cancer with mutated ARID1A (3 years)
C: 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))
D: Overall Survival (Up to five years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients With Mucinous Epithelial Ovarian or Fallopian Tube Cancer (MEOC)
Brief Summary: This randomized phase III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.


Options:
A: Overall Survival (Up to five years)
B: Primary objective: Determination of the progression-free survival (PFS) of patients treated with topotecan and sorafenib versus topotecan and placebo (18 months)
C: Progression-free Survival (3 years)
D: Progression free survival (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating PTSD in Patients With Borderline Personality Disorder
Brief Summary: Individuals with borderline personality disorder (BPD) are the quintessential multi-problem patients, often presenting to treatment with numerous dysfunctional behaviors and comorbid diagnoses. Dialectical Behavior Therapy (DBT) is a comprehensive, cognitive-behavioral treatment for BPD that has been shown effective in reducing the primary problems it is designed to treat; namely, the frequency and severity of self-injurious and suicidal behavior, maintenance in treatment, and severe problems in living. However, the DBT treatment manual does not currently include a protocol specifying when or how to treat posttraumatic stress disorder (PTSD), a comorbid diagnosis that is prevalent in BPD patients and may maintain or exacerbate BPD criterion behaviors. Similarly, many of the existing treatment outcome studies for PTSD have excluded suicidal, substance abusing, and multiply diagnosed patients, thereby making it difficult to determine the generalizability of these approaches to individuals with BPD. The research proposed here is focused on the development of a protocol based on Prolonged Exposure therapy to treat PTSD in BPD patients that can be integrated into standard DBT, as well as the initial evaluation of this protocol's feasibility, acceptability, and efficacy. The treatment development and pilot testing process will occur in two phases, including measure development and standardization of the treatment protocol via clinical pre-testing (Phase 1); and pilot and feasibility testing of the intervention via a randomized controlled trial (RCT) comparing standard DBT + PTSD Protocol to standard DBT Only (Phase 2). Information gathered during the pilot RCT will be used to inform the design and conduct of a subsequent full-scale RCT. This research has the potential to significantly expand and improve upon the most empirically supported treatment currently available for BPD, while also demonstrating that exposure treatments for PTSD can be implemented safely and effectively in a BPD population.


Options:
A: Functioning Assessment Scale Test (FAST) (up to three years)
B: Change from baseline Adult Suicidal Ideation at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Measurement of Hopelessness at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Interpersonal Needs at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Service Utilization at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Suicidality at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months)
C: The number of contacts with mental health services appropriate to the patient's needs. (3 months)
D: PTSD Symptom Scale - Interview (Pre-treatment, 4-, 8-, 12-, and 15-months); Suicide Attempt Self-Injury Interview (Pre-treatment, 4-, 8-, 12-, and 15-months)

Answer: D