TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients
Brief Summary: The purpose of this study is to investigate whether the anabolic potentials of insulin may be used to reverse the catabolic effects of hemodialysis in non-diabetic patients with end-stage renal failure.


Options:
A: Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 (Baseline, week 18)
B: Effect of glucose and glucose-insulin infusion on plasma IGF-I and IGFBP-1 during hemodialysis (From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis)
C: Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF) (Baseline , Week 12 (LOCF))
D: Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (From randomisation to individual end of trial date (maximum patient year observation: 2.75 years))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Intensive Exercise Training Compared to Inactive Controls on Coronary Collateral Circulation and Plaque Composition in Patients With Significant Stable Coronary Artery Disease
Brief Summary: Exercise training in patients with coronary artery disease is able to correct several risk factors. Furthermore endothelial function can be improved.

There are some hinds for improved collateral circulation after exercise training, nevertheless there is no study showing significant improvement/ increase in coronary collaterals. This might be due to technique of collateral measurement. Therefore we conduct a study were coronary blod flow before and after 4 weeks of exercise training were measured.


Options:
A: The primary-endpoint is empowerment to reach self-care goals after 5 years (At baseline and after 5 years)
B: Physical performance (6 months)
C: coronary collateral blod flow (4 weeks)
D: Change in VO2peak (day1); Change in VO2peak (month 2 + 14 days); Change in VO2peak (month 4 + 14 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Intensive Exercise Training Compared to Inactive Controls on Coronary Collateral Circulation and Plaque Composition in Patients With Significant Stable Coronary Artery Disease
Brief Summary: Exercise training in patients with coronary artery disease is able to correct several risk factors. Furthermore endothelial function can be improved.

There are some hinds for improved collateral circulation after exercise training, nevertheless there is no study showing significant improvement/ increase in coronary collaterals. This might be due to technique of collateral measurement. Therefore we conduct a study were coronary blod flow before and after 4 weeks of exercise training were measured.


Options:
A: Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period (0, 12 and 52 weeks)
B: cardiovascular mortality; non fatal re-MI; angina requiring hospitalization; urgent revascularization procedures; hospitalization for heart failure; non fatal stroke
C: coronary collateral blod flow (4 weeks)
D: flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Study Examining the Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-Assisted Laparoscopic Radical Prostatectomy
Brief Summary: To date, there is a lack of consensus concerning the optimal timing for removal of the urethral catheter, its related complications, the effectiveness in prophylactic drug use to reduce complication, and the patient reported outcomes (quality of life) after robot-assisted laparoscopic prostatectomy (RALP). The purpose of this study is to determine the impact of tamsulosin on voiding patterns following early urethral catheter removal after RALP for prostate cancer.


Options:
A: Post-operative urinary retention requiring re-catheterisation (1 day following urethral catheter removal)
B: Urinary retention (6 hours after discharge from PACU)
C: Urinary retention (inability to void) (6 hours after removal of urinary catheter)
D: The incidence of acute urinary retention (within the 30 days after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of High and Low Intensity Intervention for Smoking Cessation During Pregnancy
Brief Summary: The aim of this clinical trial is to test whether offering pregnant smokers a high intensity intervention for smoking cessation increases the rate of smoking cessation at the third trimester of pregnancy, compared to low intensity intervention for smoking cessation that is the usual care, control condition.


Options:
A: Cotinine validated quit rates.
B: Participants' Smoking Status (around the 32nd week of gestation.); The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention. (At the baseline and at the 32nd week of gestation)
C: Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. (6 months from participant's quit date)
D: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of High and Low Intensity Intervention for Smoking Cessation During Pregnancy
Brief Summary: The aim of this clinical trial is to test whether offering pregnant smokers a high intensity intervention for smoking cessation increases the rate of smoking cessation at the third trimester of pregnancy, compared to low intensity intervention for smoking cessation that is the usual care, control condition.


Options:
A: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (36 weeks gestation)
B: Participants' Smoking Status (around the 32nd week of gestation.); The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention. (At the baseline and at the 32nd week of gestation)
C: seven-day point prevalence smoking abstinence (28 weeks gestation and 12 months post-randomization)
D: Smoking Behavior (Self-report Confirmed by Expired Breath CO) (8 week follow up); Urinary Cotinine (8 week follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting
Brief Summary: Patients undergoing aortic valve replacement (AVR) surgery with coronary artery bypass grafting (CABG) are at risk of left ventricular dysfunction. The aim of the study is to describe the haemodynamic effects of levosimendan in comparison to placebo in patients undergoing elective aortic valve replacement (AVR) together with coronary artery bypass grafting (CABG) surgery. The study is randomized, double-blinded, placebo-controlled and will be carried out in Heart Center.

Twenty four patients will be randomized into two groups of 12. The treatment group will receive 24 hour infusion of levosimendan preoperatively where as the placebo group will receive an identical infusion of thiamine coloured glucose. The splanchnic perfusion will be measured by the means of vena hepatica cannulation. CircMon B202 (JR Medical Ltd, Tallinn, Estonia) is used for the measurement of whole-body impedance cardiography derived heart rate, cardiac index, left cardiac work index, systemic vascular resistance index (SVRI), and extracellular water (ECW). Surgical procedure, anaesthesia and cardio protection will be carried out as in standard care. Echo cardiography will be done pre- and postoperatively. Haemodynamics will be recorded hourly and mixed venous saturation every fourth hour for 24 hours.


Options:
A: Length of ICU stay (two weeks)
B: blood pressure (up to 5 days)
C: To demonstrate that inhaled milrinone administered before CPB is superior to placebo in reducing the severity of difficult separation from bypass (End of CPB)
D: Number of Dual Efficacy Endpoint Events (30 days); Number of Quad Efficacy Endpoint Events (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized,Placebo-controlled,Double-blind Trial of Phyllanthus Urinaria (Hepaguard®) in Adults With Nonalcoholic Steatohepatitis
Brief Summary: Nonalcoholic fatty liver disease is one of the most common chronic liver diseases worldwide. Nonalcoholic steatohepatitis (NASH) is the active form of the disease which runs a progressive course and may result in liver cirrhosis and liver cancer. However, there is yet proven treatment for this disorder. In cell line and animal studies, we have shown that Phyllanthus urinaria can ameliorate NASH by reducing oxidative stress and lipid accumulation. Phyllanthus (Hepaguard) has been used widely by patients with chronic liver diseases, but the efficacy in NASH has not been confirmed in humans.

This study is divided into two parts. In part 1, 60 patients with histology-confirmed NASH will be randomized to receive Hepaguard or placebo for 24 weeks to test the efficacy. Endpoints will be assessed at week 24. The aim of part 2 is to test the durability of Hepaguard. Forty patients originally on Hepaguard will be randomized again to continue Hepaguard for another 24 weeks or stop the treatment. The endpoints at week 48 will be further analyzed.


Options:
A: The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. (24 weeks)
B: Regression of white matter lesion load in terms of numbers and size in the brain (1 to 2 years)
C: Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo) (Baseline and 12 weeks)
D: Histologic NAFLD activity score (week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluid and Nutrition in Elective Hip Surgery
Brief Summary: The purpose of this study is to determine whether fluid or glucose administration before hip replacement surgery minimizes postoperative muscle breakdown (catabolism), fatigue and disturbances in carbohydrate metabolism.


Options:
A: Change in Insulin Sensitivity (Percent) (Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM).)
B: protein balance (two days after surgery)
C: Safety parameters reflecting pathophysiological functions of the liver (day -1, 0, 1, and 7); Gastrointestinal tolerance (day 0 before and 6-8h after surgery); Metabolic parameters in serum, liver and muscle tissue (on day -1, 0, 1, and 7)
D: To study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery. (3-6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The ACTIVE Intervention to Improve Hospice Care
Brief Summary: The ACTIVE Intervention to Improve Hospice Caregiver Pain Management The major goal of this project is to implement and test this promising intervention in three hospice programs. The mixed methods evaluation of this randomized controlled trial (RCT) will provide evidence-based data for a tested intervention manual that hospice staff members can use to integrate the intervention into their practices.


Options:
A: Software/user problems (6 months); functionality problems (6 months); workload (6 months); medication chart review (6 months); practical problems (6 months); GPs that refuse (6 months); non-consenting eligible residents (n) (6 months); Non-consenting proxies for eligible residents (n) (6 months); Optimeds completion (6 months)
B: Satisfaction With Social Participation (Baseline (T0), at 5 (T1), 10 (T2), 15 (T3), 20 (T4) and 25 (T5) months); Hearing-Specific Health-Related Quality of Life (Baseline, at 5, 10, 15, 20 and 25 months)
C: Change of hospital admissions (21 months)
D: Caregiver Perceptions of Pain Medicine Questionaire (Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The ACTIVE Intervention to Improve Hospice Care
Brief Summary: The ACTIVE Intervention to Improve Hospice Caregiver Pain Management The major goal of this project is to implement and test this promising intervention in three hospice programs. The mixed methods evaluation of this randomized controlled trial (RCT) will provide evidence-based data for a tested intervention manual that hospice staff members can use to integrate the intervention into their practices.


Options:
A: symptoms related to posttraumatic stress disorder
B: Caregiver Perceptions of Pain Medicine Questionaire (Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure)
C: family decision-making self-efficacy (at 8 weeks after the intervention)
D: Number of empathic statements and responses to patients' expressions of negative emotion (Postintervention audio recordings and follow-up surveys)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: MIND-USA Study: Modifying the Impact of ICU-Associated Neurological Dysfunction
Brief Summary: The long-term objective of the MIND-USA (Modifying the Impact of ICU-Induced Neurological Dysfunction-USA) Study is to define the role of antipsychotics in the management of delirium in vulnerable critically ill patients. We and others have shown that delirium is an independent predictor of more death, longer stay, higher cost, and long-term cognitive impairment often commensurate with moderate dementia. The rapidly expanding aging ICU population is especially vulnerable to develop delirium, with 7 of 10 medical and surgical ICU patients developing this organ dysfunction. Antipsychotics are the first-line pharmacological agents recommended to treat delirium, and over the past 30 years they gained widespread use in hospitalized patients globally prior to adequate testing of efficacy and safety for this indication. Haloperidol, the most commonly chosen antipsychotic, is used by over 80% of ICU doctors for delirium, while atypical antipsychotics are prescribed by 40%. Antipsychotics safety concerns include lethal cardiac arrhythmias, extrapyramidal symptoms, and the highly publicized increased mortality associated with their use in non-ICU geriatric populations. The overarching hypothesis is that administration of typical and atypical antipsychotics-haloperidol and ziprasidone, in this case-to critically ill patients with delirium will improve short- and long-term clinical outcomes, including days alive without acute brain dysfunction (referred to as delirium/coma-free days or DCFDs) over a 14-day period; 30-day, 90-day, and 1-year survival; ICU length of stay; incidence, severity, and/or duration of long-term neuropsychological dysfunction; and quality of life at 90-day and 1-year. To test these hypotheses, the MIND-USA Study will be a multi-center, double-blind, randomized, placebo-controlled investigation in 561 critically ill, delirious medical/surgical ICU patients who are (a) on mechanical ventilation or non-invasive positive pressure ventilation or (b) in shock on vasopressors. In each group (haloperidol, ziprasidone, and placebo), 187 patients will be enrolled and treated until delirium has resolved for 48 hours or to 14 days (whichever occurs first) and followed for 1 year.


Options:
A: Delirium/Coma-free Days (DCFDs) (14 days)
B: Hospital Mortality to Day 60. (60 days after randomization)
C: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)
D: delirium- and coma-free days (within the first 14 days after randomisation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)
Brief Summary: Background:

- Secondary-progressive multiple sclerosis (SP-MS) is the chronic phase of multiple sclerosis (MS). The majority of people who have relapsing-remitting MS eventually develop SP-MS. There are currently no effective treatments for SP-MS. Researchers are interested in determining whether the drug rituximab, which is used to treat rheumatoid arthritis and some types of cancer, is able to target certain white blood cells that are thought to play a role in the progression of SP-MS. To ensure that the rituximab will reach the brain and spinal cord, participants will receive it by intravenous drip and by intrathecal injection (through a lumbar puncture into the cerebrospinal fluid).

Objectives:

- To evaluate the safety and effectiveness of combined intravenous and intrathecal rituximab in individuals with secondary-progressive multiple sclerosis.

Eligibility:

- Individuals between 18 and 65 years of age who have been diagnosed with SP-MS and have been off any form of immunosuppressive therapy for at least 3 months.

Design:

- The study will involve a 1-year pretreatment baseline series of visits, followed by a 2-year treatment period. Participants will provide blood samples throughout treatment as directed by the study researchers, and additional studies may be performed during the study period if participants consent to further investigation.


Options:
A: Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months); Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months)
B: Percent Brain Volume Change (PBVC) From Baseline to Week 48 Using a Repeated Measures ANCOVA Model (Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48 and including early termination visits); Percent Brain Volume Change (PBVC) From Baseline to Weeks 24 and 48 (Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48)
C: Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period (Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm)
D: Delay to disability deterioration as assessed by the Expanded Disability Status Scale (EDSS: 0.5 or 1 point increase, depending on baseline score) (every 4 weeks for one year, then every 8 weeks for one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)
Brief Summary: Background:

- Secondary-progressive multiple sclerosis (SP-MS) is the chronic phase of multiple sclerosis (MS). The majority of people who have relapsing-remitting MS eventually develop SP-MS. There are currently no effective treatments for SP-MS. Researchers are interested in determining whether the drug rituximab, which is used to treat rheumatoid arthritis and some types of cancer, is able to target certain white blood cells that are thought to play a role in the progression of SP-MS. To ensure that the rituximab will reach the brain and spinal cord, participants will receive it by intravenous drip and by intrathecal injection (through a lumbar puncture into the cerebrospinal fluid).

Objectives:

- To evaluate the safety and effectiveness of combined intravenous and intrathecal rituximab in individuals with secondary-progressive multiple sclerosis.

Eligibility:

- Individuals between 18 and 65 years of age who have been diagnosed with SP-MS and have been off any form of immunosuppressive therapy for at least 3 months.

Design:

- The study will involve a 1-year pretreatment baseline series of visits, followed by a 2-year treatment period. Participants will provide blood samples throughout treatment as directed by the study researchers, and additional studies may be performed during the study period if participants consent to further investigation.


Options:
A: Number of Disease-free Patients (Baseline through 24 months)
B: To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.
C: Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months); Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months)
D: Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab (Up to 10 months); Percentage of Participants Using Rituximab Off-Label (Up to 10 months)

Answer: C