TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Case Management for Early Psychosis: is Two Year an Optimal Duration? A Randomized Controlled Study
Brief Summary: A total of 160 subjects, who aged 18-35 and had completed the first 2 years of case management in the EASY programme will be randomized in 1:1 ratio into either (1) receiving an additional year of case management, or (2) terminating case management for the next 12 months. The current study aims to investigate whether an additional year of case management in year 3 will confer additional benefits in outcome, in terms of functioning, symptoms, quality of life and health economics.


Options:
A: Functioning (social and occupational) (baseline, 6-month, 12-month, 24-month, 36-month, 48-month)
B: Prognosis of patients. (6 months)
C: Functioning (social and occupational) (baseline, 12-month)
D: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Household-based Chlorination of Drinking Water to Prevent Diarrhoeal Disease: a Randomized, Placebo-controlled Trial in India Using Sodium Dichloroisocyanurate (NaDCC) Tablets
Brief Summary: The proposed study is a 12-month double-blinded, randomized, placebo-controlled trial to determine if the impact of treating water with chlorine at the household level is effective in preventing diarrhea among young children. For more than a century, chlorine has be used to treat water in municipal systems in developed countries. Lack of infrastructure has prevented its use in lower-income settings. NaDCC is a tablet form of chlorine that has been used for more than 30 years in emergencies and has recently been approved for routine treatment of drinking water by the WHO and US Environmental Protection Agency. The placebo will consist of the food-grade ingredients in the effective tablet, without the chlorine. Study participants will be supplied with tablets (intervention or placebo) and instructed to use the same to treat their water daily. Monthly follow-up visits will assess diarrhoea morbidity and weight-for-age Z scores in \<5s. Chlorine residual and bacteriological quality of water stored in the home will be measured each month. The study will also assess the impact of the intervention on absenteeism from school and work and on health care expenditure for diarrhoea.


Options:
A: Use of LifeStraw Family for children under 2 and all household members (One year)
B: diarrhoea morbidity (monthly visits for 12 months)
C: Reduction in dysentery and non-dysentery diarrhoeal disease in children under five years old (Duration of the study)
D: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomized Double-Blind Placebo-Controlled Trial of the Omega-3 Fatty Acids Eicosapentaenoic (EPA) and Docosahexaenoic Acid (DHA) in Pediatric Sickle Cell Disease (SCD)
Brief Summary: The purpose of the study is to determine the effectiveness of LOVAZA (fish oil capsules) to decrease inflammation in children and adolescents with Sickle Cell Disease (SCD). It has been found that besides the damage caused by sickle red blood cells themselves, the inflammatory response that occurs in SCD patients could potentially play a significant role in the occurrence of painful episodes or pain crises. The investigators will also study whether the subject/caregiver feels that there is an improvement in the child's quality of life by taking the medication. Besides the effect of LOVAZA on inflammation,the investigators are also testing whether the drug will have a beneficial effect on blood clotting ability (which is known to be increased in SCD) and on the anemia (low red blood cells) that is part of the disease entity.


Options:
A: The Number of Occurrences of Sickle Cell Crises (48 weeks)
B: Total Parenteral Opioid Use in IV Morphine Equivalents (Post study drug delivery to discharge from the hospital (Up to 8 days))
C: Gardos Channel Activity (12 weeks after randomization); Nitric Oxide (12 weeks after randomization); Mean Corpuscular Hemoglobin Concentration (12 weeks after randomization)
D: To determine whether supplementation with LOVAZA will exert an anti-inflammatory effect by decreasing levels of the inflammatory biomarker high sensitivity C Reactive Protein (hsCRP) in children and adolescents with Sickle Cell Disease (SCD). (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Quality of Life Among Children With Congenital Heart Disease
Brief Summary: Congenital heart diseases (CHD) are the first cause of congenital malformations with an incidence of 8 for 1000 births. Within the two past decades prenatal diagnosis has had a great impact on CHD prevalence. France was the first country to show the impact of prenatal diagnosis on the lowering prevalence of the most severe CHD, the hypoplastic left heart syndrome. Since the 90's, great advances in pediatric cardiac surgery, intensive care and cardiac catheterization have led to lower mortality and morbidity in this population. Prevalence of " GUCH ", grown-ups with congenital heart disease has thus been significantly increasing. For all these reasons and as the investigators can also see in other many chronic diseases, new questions about the quality of life of these patients arise among patients, parents/future parents, doctors, patients associations, and public health organizations. In 2007 French government promoted a national public health plan for "improvement of the quality of life among patients suffering from chronic illnesses". First step of such a program is to correctly evaluate this quality of life. Indeed the concept of "quality of life" (QoL) remains subjective and difficult to appreciate and measure. Its analysis requires the use of validated questionnaires. Few questionnaires are available in Europe, especially in pediatrics. Few studies in this population have been led and no comparative study to a control randomized group has been published. The investigators study aims to analyze in the investigators tertiary care center in pediatric cardiology the QoL among 8 to 18 year old French patients with CHD using a validated questionnaire (Kidscreen™) and to compare it to same aged healthy children. The investigators secondarily intend to :- validate the French version of one reference pediatric QoL questionnaire used in most publications in the USA (PedsQL™). - compare the QoL to the severity of the CHD using a published semi-quantitative score.- compare the QoL to the severity of the CHD using the results of routine exercise tests (VO2 max) performed routinely in the investigators center. The investigators hypothesis are that :- Quality of life of most common and not severe CHD is close to that of healthy children. - QoL of severe CHD is not so well correlated to severity of CHD.- PedsQL™ is a simple questionnaire which can be used in France in routine follow-up of children with CHD.


Options:
A: Cardiac MRI Right Ventricular Ejection Fraction (6 and 12 months); Cardiopulmonary exercise capacity (6 and 12 months)
B: Consent rate (1 year); Enrolment rate (1 year); Adherence rate (1 year); Completion rate (1 year); Attrition rate (1 year); Acceptability questionnaire (Investigator-generated satisfaction questionnaire) (1 year)
C: Maximal inspiratory pressure in kilopascal (12 weeks)
D: Quality of Life questionnaire (one day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Double Blind, Dose Escalating/ De Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of a Single Dose of Sustained Release Encapsulated Bupivacaine (SKY0402) in the Management of Postoperative Pain in Subjects Undergoing Inguinal Hernia Repair
Brief Summary: The primary objective of this study was to determine the appropriate dose of SKY0402 for the management of postoperative pain following inguinal hernia repair. This study evaluated the safety, efficacy, and pharmacokinetics of SKY0402 compared with a 100 mg dose of bupivacaine HCl for the treatment of postoperative pain in subjects undergoing inguinal hernia repair. Study drug was administered by surgical wound infiltration at the end of the hernia repair procedure.


Options:
A: The Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours for Subjects Receiving SKY0402 vs. Placebo. (72 hours)
B: Time to First Use of Supplemental Pain Medication (Through 96 hours postdose)
C: Total Opioid Burden (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefits - Total Cost of Hospitalization (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefits - Length of Stay (LOS) (Wound closure at time hospital discharge order is written or Day 30, whichever is sooner)
D: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores Through Postoperative Day 4 (0 to 96 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study
Brief Summary: This investigation is designed with the hypothesis that combined PV Antral Isolation and Ablation of Complex Fractionated Electrograms (PVI+CFE) approach will offer a higher success rate compared to the Wide Circumferential Pulmonary Vein Antrum Isolation (PVI) approach and to the Combined PV Antral Isolation and Empiric Linear Ablation (PVI+Lines) approach.


Options:
A: Freedom from AF (18 months)
B: Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) (From randomization until completion of the planned treatment phase, up to 1403 days.)
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. (From date of enrollment until time-to-first event over a median follow-up of 48.5 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study
Brief Summary: This investigation is designed with the hypothesis that combined PV Antral Isolation and Ablation of Complex Fractionated Electrograms (PVI+CFE) approach will offer a higher success rate compared to the Wide Circumferential Pulmonary Vein Antrum Isolation (PVI) approach and to the Combined PV Antral Isolation and Empiric Linear Ablation (PVI+Lines) approach.


Options:
A: Survival Free of Atrial Fibrillation (6 -12 months)
B: Freedom from AF (18 months)
C: Difference in ejection fraction between groups (6 months)
D: Recurrence of Atrial Fibrillation (One year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: IRB-HSR# 13957: IV Lidocaine for Patients Undergoing Primary Breast Cancer Surgery: Effects on Postoperative Recovery and Cancer Recurrence
Brief Summary: The purpose of this study is to determine whether a local anesthetic drug (lidocaine) given during anesthesia intravenously (IV) through a needle in your vein,), can:

1. Help decrease pain after surgery.
2. Have you need less pain medication.
3. Have less side effects like nausea and vomiting following your surgery.
4. Help to prevent chronic pain.
5. Affect recurrence of cancer after surgery.


Options:
A: analgesic consumption of level 3 in the two treated groups (24 hours)
B: opiate consumption (hospital discharge/ days 0-7)
C: To estimate the immediate postoperative analgesic effect of the association ketamine IV-thoracic epidural with regard to the use of the only epidural (24 months)
D: Quality of recovery 40(QoR-40) score (24hours after operation day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: IRB-HSR# 13957: IV Lidocaine for Patients Undergoing Primary Breast Cancer Surgery: Effects on Postoperative Recovery and Cancer Recurrence
Brief Summary: The purpose of this study is to determine whether a local anesthetic drug (lidocaine) given during anesthesia intravenously (IV) through a needle in your vein,), can:

1. Help decrease pain after surgery.
2. Have you need less pain medication.
3. Have less side effects like nausea and vomiting following your surgery.
4. Help to prevent chronic pain.
5. Affect recurrence of cancer after surgery.


Options:
A: analgesic consumption of level 3 in the two treated groups (24 hours)
B: Quality of recovery 40(QoR-40) score (24hours after operation day)
C: VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study. (six months)
D: opiate consumption (hospital discharge/ days 0-7)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: IRB-HSR# 13957: IV Lidocaine for Patients Undergoing Primary Breast Cancer Surgery: Effects on Postoperative Recovery and Cancer Recurrence
Brief Summary: The purpose of this study is to determine whether a local anesthetic drug (lidocaine) given during anesthesia intravenously (IV) through a needle in your vein,), can:

1. Help decrease pain after surgery.
2. Have you need less pain medication.
3. Have less side effects like nausea and vomiting following your surgery.
4. Help to prevent chronic pain.
5. Affect recurrence of cancer after surgery.


Options:
A: Quality of recovery 40(QoR-40) score (24hours after operation day)
B: Hospital stay (end of hospitalisation)
C: opiate consumption (hospital discharge/ days 0-7)
D: time from end of surgery to first sign of bowel function (stool or flatus) (follow-up after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis (TOACT)
Brief Summary: Background: Endovascular thrombolysis, with or without mechanical clot removal (ET), may be beneficial for a subgroup of patients with cerebral venous sinus thrombosis (CVT), who have a poor prognosis despite treatment with heparin. Published experience with ET is promising, but only based on case series and not on controlled trials.

Objective: The main objective of the TO-ACT trial is to determine if ET improves the functional outcome of patients with a severe form of CVT

Study design: The TO-ACT trial will be designed as a multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) trial.

Study population: Patients are eligible if they have a radiologically proven CVT, a high probability of poor outcome (defined by presence of one or more of the following risk factors: mental status disorder, coma, intracranial hemorrhagic lesion or thrombosis of the deep cerebral venous system) and the responsible physician is uncertain if ET or standard anti-coagulant treatment is better.

Intervention: Patients will be randomized to receive either ET or standard therapy (therapeutic doses of heparin). ET consists of local application of alteplase or urokinase within the thrombosed sinuses, and/or mechanical thrombectomy. Glasgow coma score, NIH stroke scale and relevant laboratory parameters will be assessed at baseline.

Endpoints: The primary endpoint is the modified Rankin scale (mRS) at 12 months. The most important secondary outcomes are the mRS, mortality and recanalization rate at 6 months. Major intra- and extracranial hemorrhagic complications within one week following the intervention are the principal safety outcome. Results will be analyzed according to the "intention-to-treat" principle. Assessment of study endpoints will be carried out according to standardized questionnaires by a blinded neurologist or research nurse who is not involved in the treatment of the patient.

Study size: To detect a 50% relative reduction in mRS≥2 (from 40 to 20%), 164 patients (82 in each treatment arm) have to be included (two-sided alpha, 80% power).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Included patients may benefit directly from ET. Complications of ET, most notably intracranial hemorrhages, constitute the most important risk of the study.


Options:
A: Number of Participants With 0 or 1 on Modified Rankin Scale (90 days); Number of Participants With Symptomatic Intracranial Hemorrhage Within 48 Hours of tPA Administration (48-hours)
B: Favorable clinical outcome (modified Rankin score 0-1) (12 months after randomization)
C: Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality (90 days)
D: Safety of nadroparine or heparin (DAY 3,7,30,90); Efficacy of nadroparine or heparin (DAY 3,7, 30, 90)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Brief Summary: The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.


Options:
A: PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. (First drug administration to date of disease progression or death whichever occurs first , upto 29 months); PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis). (First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months)
B: Progression-Free Survival (8 Months on average)
C: ORR (Up to 2 years); PFS (Up to 2 years)
D: progression free survival (6 months from randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Brief Summary: The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.


Options:
A: Progression-free Survival(PFS) (up to 2 years)
B: Progression-Free Survival (8 Months on average)
C: Adverse events, clinically significant changes in laboratory results, ECG, and vital signs, to be measured throughout the study.; Pharmacokinetic Profile of AMG 386 - blood levels of AMG 386 to be measured throughout the study.
D: Investigator-assessed Progression-free Survival (PFS) (From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Brief Summary: The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.


Options:
A: investigator-determined progression-free survival (every 12 weeks until progression or up to 30 months (whichever occurs first))
B: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011); Progression Free Survival (PFS; Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011)
C: Overall survival (After follow-up is complete (year 3-4 of the trial))
D: Progression-Free Survival (8 Months on average)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function
Brief Summary: Basic strength training for the neck/shoulder muscles can decrease intensity of neck/shoulder pain, but it is uncertain whether training should focus directly on the upper trapezius - which is most often tender - or on the lower compartments and serratus anterior.

We hypothesize that strengthening exercise for the lower and middle trapezius as well as the serratus anterior will decrease intensity of neck/shoulder pain among office workers


Options:
A: Reduction in number of days per month with headache and shoulders pain after 6 months.Proportion of subjects with more than 4 days with headache and shoulder pain at the baseline that will have reduction in pain frequency of more than 50%, after 6 months (6 months)
B: Neck/shoulder pain (December 2010)
C: Neck Pain (Up to 10 months)
D: Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS) (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of an Internet-based Guided Self-help Training for Chronic Tinnitus: A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine the efficacy of a cognitive behavioral guided self-help training provided via the internet on tinnitus distress in a German sample.


Options:
A: The Tinnitus Functional Index (Assessed at baseline and 8 weeks post-intervention)
B: Tinnitus Functional Index (TFI) (Change will be assessed at 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2). The change will be assessed at every test moment.)
C: Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007) (18 months); MINI-Tinnitus Questionnaire (Mini-TQ; Hiller & Goebel, 2004) (18 months)
D: Tinnitus Questionnaire German Version; Tinnitus diary

Answer: C