TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of Imiquimod 5 % Cream for the Treatment of Hemangioma in Infancy
Brief Summary: Hemangiomas of infancy, the most common benign tumors of infancy, are congenital or early infancy lesions characterized by a rapid postnatal growth, with high expression of angiogenic stimulators for 9-18 months, followed by slow regression for 5-9 years. Current therapies for the hemangiomas are usually restricted to more severe forms due to the risks of adverse effects, inconvenience and cost. Nevertheless, a substantial amount of the psychological discomfort and morbidity can be caused by untreated hemangiomas, especially those in the face.

Recently, Imiquimod 5% cream has emerged as a safe an effective drug for several skin conditions that benefit from modulation of the activity of the immune system, such as common warts and various forms of the skin pre-cancerous and cancerous lesions. Small case reports series have suggest that it could also be useful in hemangiomas, possibly through the inhibition of the angiogenesis by local IFN production.This is a small, open label study of 16 patients to document the efficacy of the Imiquimod 5% cream in the treatment of hemangioma of infancy (primary outcome). IFN and plasma drug levels, as well as clinical examinations and blood studies, will be carried out to evaluate safety of the treatment (secondary outcome). bFGF and VEGF will be measured in blood and urine in order to study the diagnostic and predictive value of these pro-angiogenic factors in the response of hemangiomas to the treatment with Imiquimod (secondary outcome).

The study is a phase II clinical trial of a once a day application of Imiquimod 5% cream, 3 to 7 times per week for a maximum of four months. The study held at the Dermatology Clinic of Sainte-Justine Hospital, and was completed within a 20 months timeframe after IRB approval.


Options:
A: Hemangioma outcome (1 year)
B: Decrease in Size of Hemangioma (Length x Width) in Square mm (4-5 months after initiating therapy)
C: Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs. (6 months); Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs. (6 months)
D: To document the efficacy of Imiquimod 5% cream in the treatment of hemangioma of infancy. (Cream is applied for 4 months. Visits occured at month 1, 2, 4, and 8.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled, Double-blind, Phase IV Trial to Assess the Efficacy of a Traditional Swedish Smokeless Tobacco Product ("Snus") to Reduce or Replace Cigarette Smoking Among Adult Smokers in Serbia
Brief Summary: The study aims to establish if a low-nitrosamine, smokeless tobacco product (Swedish snus) can help adult smokers to reduce and eventually completely quit smoking.


Options:
A: Smoking reduction defined as a reduction in self-reported number of smoked cigarettes per day >50% compared to base-line, verified by a reduction in CO in exhaled air of >1 ppm compared to base-line (6 months)
B: Preoperative Carbon Monoxide Levels (the morning of surgery); Exhaled CO Level Measured Immediately Prior to Surgery (The median time from study assessment at POE to surgery was 1 day with an interquartile range of 1 to 3 days.)
C: smoking cessation (52 weeks)
D: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled, Double-blind, Phase IV Trial to Assess the Efficacy of a Traditional Swedish Smokeless Tobacco Product ("Snus") to Reduce or Replace Cigarette Smoking Among Adult Smokers in Serbia
Brief Summary: The study aims to establish if a low-nitrosamine, smokeless tobacco product (Swedish snus) can help adult smokers to reduce and eventually completely quit smoking.


Options:
A: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline (week-12); Sustained smoking abstinence at week-12 (week 12)
B: Continuous Abstinence From Smoking at Ten Weeks Post-quit (May 2009)
C: Smoking reduction defined as a reduction in self-reported number of smoked cigarettes per day >50% compared to base-line, verified by a reduction in CO in exhaled air of >1 ppm compared to base-line (6 months)
D: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Single Dose Intravenous Casopitant in Combination With Ondansetron and Dexamethasone for the Prevention of Oxaliplatin Induced Nausea and Vomiting.
Brief Summary: This a Phase III trial designed to determine if IV casopitant plus dexamethasone and ondansetron is more effective in the prevention of vomiting and nausea then dexamethasone and ondansetrone alone following the administration of moderately emetogenic oxaliplatin-based chemotherapy.


Options:
A: Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1 (25-120 hours)
B: Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting) (0-24h, 24-120h , 0-120h following chemotherapy)
C: Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen (0 to 120 hours in the first cycle of chemotherapy)
D: Percentage of Patients With Adverse Events (Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 24 weeks assuming 6 chemotherapy cycles given every 4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 2, 16 WEEK, MULTICENTER, RANDOMIZED, DOUBLE BLIND PLACEBO CONTROLLED, PARALLEL GROUP PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PF-04383119 FOR THE TREATMENT OF PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS
Brief Summary: The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.


Options:
A: Change From Baseline in Average Daily Pain Score at Week 6 (Baseline, Week 6)
B: Change from baseline in pain intensity (1 week followed by 1, 3, and 6 months after BoNTA injection); Change from baseline of intensity of bladder bother symptoms (within 1 week, at 3 months and 6 months); Change from baseline of quality of life (within 1 week, at 3 months and 6 months)
C: Markedly/Moderately Improved on Global Response Assessments (Week 9 (one week after last treatment))
D: Change of the O'Leary-Sant symptom score (OSS, including ICSI and ICPI) (Baseline and 1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Interventions for Abused, Suicidal Black Women
Brief Summary: This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.


Options:
A: Changes in Stages of Change Questionnaire, which measures motivation (3 months); Changes in Reasons for Living Inventory (3 months); Changes in State Hope Scale (3 months); Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness. (3 months); Changes in Beck Scale for Suicide Ideation (3 months); Suicide Attempt Self-Injury Count (3 months)
B: Change in Beck Scale for Suicide Ideation (BSS) score (Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3))
C: Change in Beck Scale for Suicide Ideation Score (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Suicide Attempt Index (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Index of Spouse Abuse Score (Baseline, Week 10, Post-treatment Months 6 and 12)
D: suicide reattempt (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Interventions for Abused, Suicidal Black Women
Brief Summary: This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.


Options:
A: Parasuicidal behaviour (intermittent)
B: Change in Beck Scale for Suicide Ideation Score (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Suicide Attempt Index (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Index of Spouse Abuse Score (Baseline, Week 10, Post-treatment Months 6 and 12)
C: Suicide Attempts (Assessed bimonthly)
D: Columbia Suicide-Severity Rating Scale (C-SSRS; Posner et al., 2006; Posner et al. 2008). (Baseline and 1, 3, and 6 month follow-up assessments)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Interventions for Abused, Suicidal Black Women
Brief Summary: This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.


Options:
A: Change in Beck Scale for Suicide Ideation Score (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Suicide Attempt Index (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Index of Spouse Abuse Score (Baseline, Week 10, Post-treatment Months 6 and 12)
B: Repeat suicide attempts (Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion)
C: Parasuicidal behaviour (intermittent)
D: Acceptability of the intervention assessed by the number of therapy sessions completed by participants in the intervention arm. (2 years); Incidence of Treatment-Emergent Adverse Events as assessed by the adverse experiences in psychotherapy self-reported measure (2 years); Feasibility of the intervention assessed by the number of assessments completed by participants in the intervention arm (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: CBT Augmentation of SSRI Treatment for Geriatric GAD
Brief Summary: This study will assess whether adding cognitive behavioral therapy to the antidepressant escitalopram is effective in reducing anxiety in older adults with generalized anxiety disorder.


Options:
A: Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) (Through month 18 of treatment); Number of Participants in Recovery According to the LIFE and HRSD (Through 36 months of treatment); Number of Participants in Recurrence According to the LIFE and HRSD (Measured up to Month 36 from recovery)
B: Hamilton Rating Scale for Anxiety (Measured at Months 6 (Open Label), 12 (Double-Blind), and 18 (Double-Blind Relapse))
C: Hamilton Anxiety Rating Scale (56 weeks); Penn State Worry Questionnaire (56 weeks)
D: Number of patients who fully discontinued their antidepressant medication after 6 months. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early and Late Cardiac Effects of Arteriovenous Fistula Creation for Haemodialysis in End-stage Renal Failure and Their Possible Attenuation
Brief Summary: The primary objective is to determine if the use of losartan, an angiotensin II receptor blocker, can attenuate left ventricular hypertrophy, independent of its antihypertensive effects, in patients with near end stage chronic kidney disease (CKD) who have an arteriovenous fistula created.

Secondary outcomes include the impact of the medication on BNP and hyperkalaemia


Options:
A: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
B: Postoperative Atrial Fibrillation (Measured from admission to the ICU until discharge from hospital)
C: left ventricular hypertrophy (3 months)
D: Change in left ventricular ejection fraction, as assessed by cardiac MRI (Baseline and end of study (up to 72 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of PTSD in Recently Battered Women Living in Shelters
Brief Summary: This study will evaluate the effectiveness of a brief cognitive behavioral treatment, Helping to Overcome PTSD through Empowerment, in treating abused women with post-traumatic stress disorder who are living in shelters.


Options:
A: Severity of mental health symptoms (previous 4 weeks)
B: PTSD symptom severity (Measured at Month 8)
C: Reducing children's exposure to Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Patterns of Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Reducing Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.)
D: Change in telomerase activity (pre-intervention (baseline) and post-intervention (5.5 months later))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Comparison Between Intravaginal Dinoprostone Intravaginal Misoprostol and Transcervical Balloon Catheter for Labour Induction
Brief Summary: This is a randomised study aimed at comparing the currently most frequently used prostaglandin dinoprostone to two other methods, the cheaper and perhaps more effective prostaglandin misoprostol and a transcervical catheter. 592 women were recruited and randomised to one of the three methods. The main outcome measures were time to delivery, rate of instrumental deliveries and maternal neonatal outcome. Our hypothesis was that misoprostol would be superior to the other methods.

The main finding of our trial was that the catheter showed the shortest induction to delivery interval. There were no differences between the two other prostaglandins. No differences in maternal and neonatal outcome was found


Options:
A: Caesarean section rate for non-reassuring fetal status. (Up to 2 days after cervical ripening)
B: Time from treatment start to delivery (At delivery)
C: Time Of Start Of Induction Of Labor To Delivery (Hours)
D: Time From Induction of Labor Until Delivery (Time from induction to delivery (average 14.2 hours))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Comparison Between Intravaginal Dinoprostone Intravaginal Misoprostol and Transcervical Balloon Catheter for Labour Induction
Brief Summary: This is a randomised study aimed at comparing the currently most frequently used prostaglandin dinoprostone to two other methods, the cheaper and perhaps more effective prostaglandin misoprostol and a transcervical catheter. 592 women were recruited and randomised to one of the three methods. The main outcome measures were time to delivery, rate of instrumental deliveries and maternal neonatal outcome. Our hypothesis was that misoprostol would be superior to the other methods.

The main finding of our trial was that the catheter showed the shortest induction to delivery interval. There were no differences between the two other prostaglandins. No differences in maternal and neonatal outcome was found


Options:
A: feasibility of randomised Induction of Labour Trial in Out-patient setting (12 months)
B: Rate of vaginal delivery within 24 hours (within 24 hours)
C: Average Time in Hours From Insertion of the Catheter Until Delivery (At the end of the study)
D: Time from treatment start to delivery (At delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Placebo Controlled Trial of Sertraline and Interpersonal Psycho-Therapy for Postpartum Depression
Brief Summary: This study will evaluate the effectiveness of antidepressant medication alone and interpersonal psychotherapy alone in treating women with postpartum depression.


Options:
A: Hamilton Depression Rating Scale (HAM-D) (Measured at baseline; post-treatment; and Months 3 and 6 of follow-up)
B: depression (12 weeks)
C: EPDS (3 and 6 months)
D: Depressive symptoms, social functioning, and health (Measured at Months 3, 6, and 12 postpartum); Preferences for depression treatment (Measured at baseline and Month 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg) Administered Orally Once Daily Over 24 Weeks, With an Open-label Extension to One Year (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With a Sulphonylurea
Brief Summary: The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Options:
A: The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. (Baseline and 104 weeks)
B: Change From Baseline in HbA1c at Week 12 (12 weeks); Change From Baseline in HbA1c at Week 26 (26 weeks); Examination of Long-term Safety of Linagliptin (52-week Treatment) (52 weeks)
C: HbA1c Change From Baseline to Week 24 (Baseline and week 24)
D: HbA1c Change From Baseline at Week 52 (Baseline and week 52); HbA1c Change From Baseline at Week 104 (Baseline and week 104)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid(TM))(MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy
Brief Summary: This randomized phase III trial studies melphalan and prednisone with thalidomide to see how well it works compared to melphalan and prednisone together with lenalidomide in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as melphalan and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Thalidomide and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It is not yet known whether melphalan and prednisone are more effective when given together with thalidomide or lenalidomide in treating multiple myeloma.


Options:
A: Overall survival
B: Response Rate; Progression Free Survival; Event Free Survival
C: Time to tumor progression (TTP) (Up to 3 years)
D: Progression-Free Survival (PFS) (Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Acclimatization Mechanisms During Ascent to 7500m. Effects of Ascent Protocol on Acute Mountain Sickness and Cardiorespiratory Physiology
Brief Summary: The trial evaluates the role of ascent protocol on acute mountain sickness and cardio-respiratory physiology during an ascent to Muztagh Ata (7546m). Two groups of mountaineers ascend with different acclimatization time to the summit. The prevalence and severity of symptoms of acute mountain sickness are evaluated along with physiologic variables.


Options:
A: Change in Optic Nerve Sheath Diameter by Ultrasonography (Optic Nerve Sheath Diameter: baseline, 24 hours.)
B: Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude (After 6 weeks of study treatment, during high altitude visit)
C: acute mountain sickness (during ascent)
D: Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen). (The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Acclimatization Mechanisms During Ascent to 7500m. Effects of Ascent Protocol on Acute Mountain Sickness and Cardiorespiratory Physiology
Brief Summary: The trial evaluates the role of ascent protocol on acute mountain sickness and cardio-respiratory physiology during an ascent to Muztagh Ata (7546m). Two groups of mountaineers ascend with different acclimatization time to the summit. The prevalence and severity of symptoms of acute mountain sickness are evaluated along with physiologic variables.


Options:
A: Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude (After 6 weeks of study treatment, during high altitude visit)
B: incidence of acute mountain sickness (2 days)
C: acute mountain sickness (during ascent)
D: Acute mountain sickness, cumulative incidence (day 3 at 3200 m)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Acclimatization Mechanisms During Ascent to 7500m. Effects of Ascent Protocol on Acute Mountain Sickness and Cardiorespiratory Physiology
Brief Summary: The trial evaluates the role of ascent protocol on acute mountain sickness and cardio-respiratory physiology during an ascent to Muztagh Ata (7546m). Two groups of mountaineers ascend with different acclimatization time to the summit. The prevalence and severity of symptoms of acute mountain sickness are evaluated along with physiologic variables.


Options:
A: Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude (After 6 weeks of study treatment, during high altitude visit)
B: acute mountain sickness (during ascent)
C: Pulmonary Artery Systolic Pressure (PASP)
D: prevention of high altitude pulmonary edema

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 250mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma Symptomatic on Low-Dose ICS Therapy
Brief Summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.


Options:
A: Maximum heart rate (over 4 hours after dosing.); Blood pressure changes (over 12 hours.); Electrocardiogram changes (over 12 hours.); Change in peak expiry flow rate changes (over 24 hours.); Change in serum cortisol concentration changes (over 24 hours)
B: Mean change from baseline (pre-dose) FEV1 in trough (mean of the FEV1 values obtained 23 and 24 hours after dosing) FEV1 (on going)
C: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
D: The primary efficacy measure will be mean change from baseline at Week 8 (last assessment on treatment using last observation carried forward) in tough (AM or PM pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1)

Answer: C