TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfusion Triggers in Cardiac Surgery
Brief Summary: A high proportion of patients having cardiac surgery receive red cell transfusions. Yet, the investigators do not know whether transfusions are beneficial and they may be associated with harm. It is thus important to determine when a transfusion is required. The investigators will conduct a small pilot study at St. Michael's Hospital to address this issue. Patients having cardiac surgery will be allocated to one of two transfusion strategies with endpoints being compliance with the transfusion strategy and clinical outcome. The results of this study will be used to design a large definitive multicentered trial of these two transfusion strategies.


Options:
A: Overall adherence to the transfusion strategies defined as adherence to the transfusion strategies in 90% of patients in more than 90% of their days in hospital. (Day of surgery through to hospital discharge.)
B: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
C: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
D: Glasgow Outcome Scale (at 6 months after injury)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison for Laparoscopically Assisted and Open Surgery for Advanced Rectal Cancer After Preoperative Chemoradiation- Randomized Prospective Trial
Brief Summary: The investigators designed the randomized prospective trial of comparing open and laparoscopic resection in locally advanced rectal cancer after preoperative chemoradiation in order to determine the oncologic and functional efficacy of laparoscopic rectal resection.


Options:
A: Disease free survival (3 years)
B: locoregional recurrence rate (3 years post operatively)
C: Primary endpoint is cancer free survival at three years.
D: Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay (1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer.
Brief Summary: The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.


Options:
A: overall survival (9 months)
B: Survival rate at 6 months (6 months)
C: Overall Survival (OS) (Baseline until death or at least 1 year after the randomization of last participant)
D: Progression-Free Survival (From the time of randomization until progression of disease or death (up to 30 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Percutaneous Transluminal Balloon Angioplasty (PTA) and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia
Brief Summary: The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal balloon angioplasty (PTA).


Options:
A: Freedom From Target Lesion Revascularization (TLR) (6 months); Freedom From Major Adverse Events (MAE) (30 days)
B: The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim. (6 months)
C: Safety: Freedom from death at 30 days post-procedure. Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure. (30 Day, 6 Month, and 12 Month)
D: (re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass (5 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Percutaneous Transluminal Balloon Angioplasty (PTA) and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia
Brief Summary: The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal balloon angioplasty (PTA).


Options:
A: The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim. (6 months)
B: Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound) (12 months)
C: Rate of sustained clinical improvement at 12 months follow up. Sustained clinical improvement is defined as: Upward shift of at least +1 (for Rutherford category 3) or +2 (for Rutherford categories 4 and 5) on the Rutherford scale. (12 months)
D: Angiographic Binary Restenosis (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Simvastatin Reduces Plasma Osteoprotegerin in Type 2 Diabetic Patients With Microalbuminuria
Brief Summary: Diabetes is associated with dyslipidaemia leading to generalized atherosclerosis, cardiovascular disease (CVD) and nephropathy. Osteoprotegerin (OPG), a glycoprotein involved in bone homeostasis, has been implicated in the pathogenesis leading up vessel calcification. Furthermore, CVD in diabetics is associated with increased levels of OPG.

Aim: To investigate whether low dose simvastatin treatment (10-20 mg/day) reduces circulating levels of OPG as well as adhesion molecules (VCAM-1; vascular cell adhesion molecule-1, ICAM; intercellular cell adhesion molecule).


Options:
A: Relative reduction in circulating osteoprotegerin levels (18 weeks)
B: Time to of a major coronary event: 1) non-fatal acute myocardial infarction 2) coronary death 3) resuscitated cardiac arrest
C: Key Outcome as Per Statistical Analysis Plan = Major Atherosclerotic Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo (Median follow-up 4.9 years)
D: Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) (Up to approximately 9 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone Infusion in Community-acquired Pneumonia
Brief Summary: The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.


Options:
A: Time to clinical stability (30 days)
B: Rate of non-response to empiric antimicrobial treatment (5 days)
C: Clinical efficacy at the end of treatment
D: length of hospital stay (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone Infusion in Community-acquired Pneumonia
Brief Summary: The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.


Options:
A: Septic shock (14 days)
B: length of hospital stay (30 days)
C: Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria (28 days)
D: Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone Infusion in Community-acquired Pneumonia
Brief Summary: The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.


Options:
A: Time to clinical stability (30 days)
B: Length of stay in ICU and length of stay in the hospital. (2 years)
C: length of hospital stay (30 days)
D: 90-day mortality (90 day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Open-label Study of Efficacy and Safety of Miltefosine or Thermotherapy vs Glucantime for Cutaneous Leishmaniasis in Colombia.
Brief Summary: Cutaneous leishmaniasis (CL) is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence the last two decades. It is estimated that in 2005, about of 20,000 new cases of CL were diagnosed in Colombia.

So far, pentavalent antimony compounds have been considered the treatment of choice with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their adverse events and disadvantages. Previous studies have shown that miltefosine could be a potential alternative of treatment for CL.

The main objective of this study is to evaluate the efficacy and safety of miltefosine or thermotherapy for the treatment for CL. In this study the efficacy of oral treatment of miltefosine 150 mg/day for 28 days or a thermotherapy device used for one session at 50 celsius degrees during 30 seconds will be compared with the standard treatment of intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (GlucantimeÒ) for 20 days in CL parasitologically proven patients.

This trial will be conducted according to the International approved GCP (Good Clinical Practice) guidelines.


Options:
A: Complete Clinical Response (Until 6 months posttreatment); Failure (Until 3 months posttreatment)
B: Time to healing; Reduction of scaring
C: Cure rate or complete cicatrization of the ulcer. (6 months)
D: Complete clinical cure (six months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke
Brief Summary: Hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor outcome. But the modalities of glucose lowering are still debated. This study will test the efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous insulin in acute ischemic stroke.


Options:
A: Percentage of patients in the glucose target range within 24 hours of the initiation of treatment. (24 hours)
B: Mortality (28 day); Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])
C: all-cause mortality (90 days)
D: mortality

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Paclitaxel Coated Balloon Catheter for Inhibition of Restenosis in Femoropopliteal Arteries (PACCOCATH - FEM I)
Brief Summary: The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty.


Options:
A: Primary Patency (12 Month); Primary Safety Composite (12 month)
B: angiographic late lumen loss (6 months)
C: Event-free Survival (6 months)
D: Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA) (12 months or at Target Lesion Revascularization (TLR) time); Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients (12 months); Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR) (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Evaluation of Open vs. Laparoscopic Operation of Ventral Incisional Eventrations. A Swedish Multicenter Study
Brief Summary: This purpose of this study is to compare the recovery after an operation of an incisional hernia within the limits of the rectus muscles of the abdominal wall. The use of a mesh in the repair of a postoperative hernia is considered obligatory. Placement of a retromuscular mesh is done by open or laparoscopic surgery. Focus is on the recovery phase assuming a less painful recovery after a laparoscopic procedure.


Options:
A: Postoperative pain VAS 0-100 mm (1 year)
B: recurrence rate after hernia surgery (5 years)
C: compare mid and long term results in terms of hernia recurrence (3 years after surgery)
D: Postoperative pain recorded in SF-36 (3 weeks after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Investigation of the Antidepressant Effects of the Selective NR2B Antagonist MK-0657 in Major Depression
Brief Summary: Purpose : This study will determine whether MK-0657, a selective NR2B Antagonist, can quickly improve symptoms of depressed mood, psychomotor retardation, poor motivation and reduced enjoyment of things in patients with major depression.

MK-0657 decreases the activity of a brain receptor called NMDA, which the chemical glutamate binds to, possibly inducing a rapid antidepressant response. People between 18 and 55 years of age who have major depression of at least 4 weeks' duration and have not been helped by two antidepressants approved for major depression may be eligible for this study. Women who are able to have children are excluded. Participants are admitted to the NIH Clinical Center for two study phases, as follows. Phase I (1 to 2 weeks): Patients are tapered off their current medications. Phase II (7 weeks): Patients are randomly assigned to take either MK-0657 or placebo (look-alike capsules with no active ingredient) by mouth for 12 days. At some point during the second part this phase, patients who had been taking MK-0657 are switched over to placebo and those who had been taking placebo are switched to MK-0657. Participants undergo the following procedures during the study:Physical examination twice (at the beginning and at the end of the study) Electrocardiogram (ECG) four times Blood tests about six times Rating scales up to 28 times to assess the effects of MK-0657 on mood and thinking Blood pressure measurements three times a day.

Study examines the effectiveness of a new medication, targeting a system called glutamate, will improve depression when compared with placebo.


Options:
A: Montgomery-Asberg Depression Rating Scale (MADRS) (Measured daily for 12 days, where the endpoint is the primary outcome)
B: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Day 14 (Day 1 and Day 14)
C: Change in depression score (14 days)
D: Observed and laboratory-confirmed safety (four weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults Patients
Brief Summary: The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.


Options:
A: N/A
B: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
C: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)
D: Antibiotic use; Length of stay in hospital

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults Patients
Brief Summary: The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.


Options:
A: All cause mortality (28 days)
B: the risk of disease specific failure (within 1 month COPD)
C: days with significant impairment due to acute respiratory tract infection (14 to 28 days after infection)
D: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults Patients
Brief Summary: The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.


Options:
A: Proportion of Appropriateness of Antimicrobial Prescriptions in each group. (10-month period)
B: mortality/survival (28 day)
C: Change in performance between hospitals in the intervention and hospitals in the control group on the proportion of prophylaxis administered within the recommended timeframes.
D: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults Patients
Brief Summary: The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.


Options:
A: All cause mortality (28 days)
B: Duration of antibiotic therapy for the first episode of infection (28 days); Total antibiotic exposure days per 1,000 days (28 days); Days alive without antibiotics (28 days)
C: mortality/survival (28 day)
D: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults Patients
Brief Summary: The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.


Options:
A: mortality/survival (28 day)
B: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)
C: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
D: Cure of respiratory infection (21 days after inclusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Determination of RDA for Vitamin D in Caucasian and African American Women
Brief Summary: The purpose of this study is to examine the effects of several doses of vitamin D on hormones related to bone, calcium absorption, bone density and muscle strength.


Options:
A: rate of falls compared between treatment arms
B: The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens. (12 months)
C: N/A
D: Changes in Serum 25-hydroxyvitamin D (25OHD) and parathyroid hormone (PTH) levels (Baseline, 6months,12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: NEUROCOM: Cognitive Training for Patients With First Episode Schizophrenia
Brief Summary: The study examines the effect of cognitive training on cognitive functioning and everyday competencies of patients with schizophrenia.

120 patients are expected to be included in this randomized controlled trial running at two sites in Denmark starting January 2007 The effect of a 16-week, manualized program of cognitive training integrated in a comprehensive psychosocial treatment (OPUS) for first-episode schizophrenia patients is compared with the effect of standard treatment (OPUS). A six month follow-up assessment is conducted to investigate a possible long-term learning effect of cognitive training.

Blinded assessments include the MATRICS Consensus Cognitive Battery and a co-primary outcome measure of cognitive improvement: A translated version of the UCSD Performance-based Skills Assessment (UPSA) adjusted to a Danish context.

The cognitive training consists of four modules focusing on the domain of attention, executive functioning, learning and memory. Module 1 and 2 are based on computer-assisted training tasks, and the following modules focus on more practical everyday tasks and calendar training. Cognitive training takes place twice a week and every other week the patient and trainer engage in a dialogue on the patient's cognitive difficulties, motivational goals and his/her progress in competence level.

The use of errorless learning principles, scaffolding and attentional externalisation aims at improving the patients' performance on cognitive and everyday tasks by learning to apply compensation techniques as well as limiting dysfunctional uses of available cognitive ressources (i.e. excessive self-focus, rumination).

The study will provide MATRICS Consensus Cognitive Battery results from a relatively large Danish sample of first-episode schizophrenia and contribute with valuable normative data on the UPSA.

It is hypothesized that cognitive training integrated in OPUS treatment enhances both cognitive and everyday competence of patients more than OPUS treatment alone. Expectations are that cognitive training will demonstrate a small to moderate effect on cognitive functioning and a moderate effect on everyday functioning as measured with the UPSA. Moreover, patients allocated to cognitive training are expected to show an improvement in self-esteem.


Options:
A: USCD Performance-Based Skills Assessment (2009)
B: Functioning (social and occupational) (baseline, 12-month)
C: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up
D: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Chronic Hemodialysis Without Systemic Heparinization : a Randomized Study
Brief Summary: Conventional hemodialysis requires transient systemic anticoagulation to prevent blot clotting after contact with the extracorporeal circuit. However, low molecular weight heparin (LMWH) or unfractioned heparin are contra-indicated in dialysis patients at risk for hemorrhagic complications. In this setting, several procedures theoretically allow dialysis without systemic heparinization, but randomized studies to compare them are lacking. The gold standard is the use of iterative rises of the extra corporeal circuit with isotonic saline (" rises "). Two emerging procedures are increasingly used : continuous pre-dilution of the arterial line (" pre-dilution ") and the use of a specific dialysis membrane (NEPHRAL 400 ST) coated with heparin immediately before use (" heparin adsorption ").


Options:
A: Rate of major, clinically important non-major or minor bleeding (26 weeks)
B: Need for stopping the meeting for coagulation of the circuit of dialysis: -either complete coagulation of the circuit (during dialises); or coagulation partial of the circuit (a clot is noted in the lines or the trap with bubbles (during dialeses); -or increase in the venous pressure (statement) of the circuit of more than 50 that is to say increase in the venous pressure (statement) of the circuit of more than 50 % beyond its initial value (during the dialeses)
C: CRRT-filter life span in hours (during continuous renal replacement therapy up to 1 year); Overall survival in a 90day follow-up period (90 days)
D: Patency of hemodialysis circuit (20 weeks)

Answer: B