TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: FOAM-study Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins: a Randomized Controlled Study
Brief Summary: Varicose vein disease is a common health problem, which causes much discomfort to patients.

Nowadays treatment modalities for greater saphenous veins include surgery and duplex guided foam sclerotherapy. These are two equally accepted and applied treatments for the same patient population.

Choice of treatment often depends on the referral preference of the General Practitioner. Until now data are missing which treatment is more cost effective. The current proposal aims at comparing the effects, costs and patient preferences between duplex guided foam sclerotherapy and surgery in the treatment of greater varicose veins.


Options:
A: Recanalization or reflux of the treated venous trunk (at 1 and 12 months)
B: Change in intensity of hyper pigmentation using a scale of 0 to 10 (One week, one month and six months after surgery); Change in extension of hematoma using a scale of 0 to 10 (One week, one month and six months after surgery); Change in aesthetic results using a scale of 0 to 10 (One week, one month and six months after surgery); Change in pain levels using a scale of 0 to 10 (One week, one month and six months after surgery); Change in intensity of skin burns using a scale of 0 to 10 (One week, one month and six months after surgery); Change in presence of sensitivity alteration (One week, one month and six months after surgery); Change in presence of thrombophlebitis (One week, one month and six months after surgery); Change in presence of resection or occlusion of the great saphenous vein (One month, six months and 12 months after surgery); Change in presence of reflux in the sapheno-femoral junction and in the great saphenous vein (One month, six months and 12 months after surgery); Change in presence of complications (One month, six months and 12 months after surgery)
C: Occlusion rate (up to 5 years)
D: cumulative probability of recurrent varicose vein within 24 months after treatment (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
Brief Summary: This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC


Options:
A: To estimate the treatment effect as measured by progression free survival (PFS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo. (The time frame will be event driven and will occur when 100 subjects have experienced a PFS event (radiographic disease progression or death).)
B: Overall Survival (From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).)
C: Progression-free survival after two lines of chemotherapy, defined as the time duration from randomization until progression after two lines of chemotherapy or death whatever the cause in the absence of progression or last-follow-up
D: Overall survival

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Distress on the IVF Outcome
Brief Summary: Stress is a primary reason why in vitro fertilization (IVF) patients drop out of treatment, and it may have a detrimental impact on pregnancy rates, yet there is minimal published research on the efficacy of structured skills-based psychological interventions with assisted reproductive technology (ART) patients. The objective of this study is to determine if women who are randomized to a mind/body (MB) program prior to starting their first IVF cycle will have higher pregnancy rates than controls (C).

This is a randomized, controlled prospective study conducted at a private academically-affiliated infertility clinic and includes 143 women ages 40 and below scheduled to undergo their first IVF cycle. Subjects are randomized via computer generated random numbers table to a 10 session mind/body program or a control group and followed for two IVF cycles. The primary outcome measure is clinical pregnancy rate.


Options:
A: Clinical Pregnancy Rates (1 year)
B: Improvement in ovulatory cycling (24 months)
C: Cumulative ongoing pregnancy rate (COPR) within 12 months after randomisation (12 months)
D: Live birth (Approximately 10-16 months after randomization, depending on study group.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pediatric Hemiplegia: Synergistic Treatment Using rTMS and CIT
Brief Summary: The strategy in rehabilitating pediatric hemiplegia is to overcome "developmental disuse". Disruption of the excitability in the non-stroke hemisphere, with resultant increased excitability (disinhibition) in the stroke hemisphere, can be achieved with low-frequency repetitive transcranial magnetic stimulation (rTMS), a noninvasive method of stimulating targeted areas of the brain. Furthermore, the disruptive effects of low-frequency rTMS can be increased and prolonged by preceding it with 6-Hz priming stimulation. We have recently demonstrated the safety of this priming/low-frequency rTMS in adults with stroke and we are currently engaged in an NIH-funded study exploring the effectiveness, mechanism and safety of serial treatments of rTMS combined with motor learning training. Very little research, however, has been attempted on interventions to promote brain reorganization and recovery in hemiplegia in children. Thus, this study will determine the effectiveness, mechanism, and safety of 5 treatments of 6-Hz primed low-frequency rTMS applied to the non-stroke hemisphere and combined with constraint induced therapy (CIT) to promote recovery of the paretic hand. Fifteen children with pediatric hemiplegia, age 8 -16 years, at each of two pediatric medical facilities (total N = 30), will be randomly assigned to one of two treatment groups that will receive treatment for 2 weeks. The rTMSreal/CIT group will receive alternating days of the real rTMS and CIT for 5 treatments of each. The rTMSsham/CIT group will receive alternating days of sham rTMS with real CIT for 5 treatments of each. Subjects will be tested at pretest and posttest. The hypotheses are: 1) the rTMS treatment will show no serious side effects, 2) both groups will show improvement in hand function but the rTMSsham/CIT group will show significantly greater improvement, 3) the rTMSreal/CIT group will also show significantly greater improvements in brain reorganization measured by paired-pulse TMS testing, cortical silent period testing, and fMRI. The proposed research is important because very little research on rehabilitation-induced brain reorganization has been done in pediatric hemiplegia. It is innovative because it applies a technique never used before, i.e. 6-Hz primed low-frequency rTMS combined with CIT. The potential impact of this research is a radical change to pediatric rehabilitation that accomplishes a higher functional recovery.


Options:
A: N/A
B: Arm Use Test (Four months for each patient)
C: Canadian Occupational Performance Measure (COPM). (Completed 2 weeks or less before treatment day 1); Canadian Occupational Performance Measure (COPM) (Completed day 5 after treatment day 10); Canadian Occupational Performance Measure (COPM) (Completed 2 months after treatment day 10); Canadian Occupational Performance Measure (COPM) (Completed 6 months after treatment day 10)
D: Hand function assessment (Pretest, posttest)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Clinical Trial for Development of Guidelines of Adequate Blood Pressure Lowering in the Subacute Ischemic Stroke Patients Due to Intracranial Atherosclerosis
Brief Summary: To develop adequate blood pressure (BP) lowering strategy after subacute ischemic stroke patients with symptomatic severe intracranial atherosclerosis.

Primary hypothesis of this study is that aggressive BP control (lowering systolic BP between 110mmHg and 120mmHg) will not increase the ischemic lesion volumes in hemisphere compared to modest BP lowering (lowering systolic BP between 130mmHg and 140mmHg) in the patients with symptomatic severe intracranial atherosclerosis.


Options:
A: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
B: changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). (0, 12, 24 months)
C: Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI) (Screening to 24 weeks)
D: the prevention of recurrent stroke. (Until the first recurrent stroke reaches a total of 339 between the two groups)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Clinical Trial for Development of Guidelines of Adequate Blood Pressure Lowering in the Subacute Ischemic Stroke Patients Due to Intracranial Atherosclerosis
Brief Summary: To develop adequate blood pressure (BP) lowering strategy after subacute ischemic stroke patients with symptomatic severe intracranial atherosclerosis.

Primary hypothesis of this study is that aggressive BP control (lowering systolic BP between 110mmHg and 120mmHg) will not increase the ischemic lesion volumes in hemisphere compared to modest BP lowering (lowering systolic BP between 130mmHg and 140mmHg) in the patients with symptomatic severe intracranial atherosclerosis.


Options:
A: To evaluate changes from baseline in Left Ventricular Mass at 24M (24 months)
B: Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI) (Screening to 24 weeks)
C: changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). (0, 12, 24 months)
D: First occurrence of death or nonfatal myocardial infarction (MI) or nonfatal stroke

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Intervention in Cystic Fibrosis Exacerbation
Brief Summary: Individuals with cystic fibrosis (CF) develop chronic lung infections and suffer intermittent acute exacerbations of their lung disease. Most exacerbations are not treated until they cause increased symptoms, and patients seek medical attention. This proposal details a study of home lung function and symptom monitoring. Subjects will be randomly assigned to one of two groups: 1) home monitoring, in which spirometry and symptoms are recorded; or 2) standard care. The home monitoring data will be transmitted electronically to the study center. If spirometry or symptoms have deteriorated substantially, treatment for a CF pulmonary exacerbation will be initiated. It is anticipated that use of home monitoring will lead to earlier, more reliable recognition and treatment of exacerbations, which will translate into better lung health.


Options:
A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
B: Change in FEV1 (12 months)
C: Change in forced expiratory volume in 1 second (FEV1; in % predicted using the average of two baseline measurements) from baseline to 6 months in the intervention group compared to controls. (baseline and 6 months)
D: Change in forced expiratory volume in 1 second (FEV1) (%predicted) (Baseline to 3 months and Baseline to 6 months); Change in peak oxygen uptake (% predicted) (Baseline to 3 months and Baseline to 6 months); Change in number of steps per day (Baseline to 3 months and Baseline to 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Intervention in Cystic Fibrosis Exacerbation
Brief Summary: Individuals with cystic fibrosis (CF) develop chronic lung infections and suffer intermittent acute exacerbations of their lung disease. Most exacerbations are not treated until they cause increased symptoms, and patients seek medical attention. This proposal details a study of home lung function and symptom monitoring. Subjects will be randomly assigned to one of two groups: 1) home monitoring, in which spirometry and symptoms are recorded; or 2) standard care. The home monitoring data will be transmitted electronically to the study center. If spirometry or symptoms have deteriorated substantially, treatment for a CF pulmonary exacerbation will be initiated. It is anticipated that use of home monitoring will lead to earlier, more reliable recognition and treatment of exacerbations, which will translate into better lung health.


Options:
A: Health related self-efficacy (8 months)
B: Number of inpatient hospital days in the home monitoring group compared to the routine clinical care group (up to 12 months)
C: Change in FEV1 (12 months)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Port vs. Single-port Cholecystectomy
Brief Summary: The aim of this study is to compare results of the new surgical strategy to the traditional 4-ports technique for cholecystectomy in a randomized controlled trial (RCT). In particular we are going to investigate the procedures in terms of overall morbidity, while taking into considerations skin-incision's related morbidity, postoperative pain and cosmetic results which are the hypothetical benefits of the new approach. Other parameters are supposed to be unchanged, considering evidences from recent literature.

Surgical procedures:

4 ports cholecystectomy (4PC): a 12mmHg pneumoperitoeum is created either by a 10mm umbilical Hasson's port or by a Verress needle followed by a 10mm umbilical port insertion; further one 10mm and two 5mm ports are placed according to the preferred technique.

Single Port Access cholecystectomy (SPC): the single-port device is inserted through the umbilicus, by means of an adeguate incision, as the only access to the abdominal cavity. A trans-abdominal suture in right hypochondrium is placed through the gallbladder wall of the fundus to retract it.

Primary endpoint: overall morbidity rate (at 60 days from surgery)

Secondary endpoints:

1. skin-incision's related morbidity rate (at 60 days from surgery)
2. perioperative pain
3. cosmetic results
4. long-term morbidity (12 months)
5. intraoperative time
6. "conversion SPC to 4PC" rate
7. "conversion to laparotomy" rate
8. hospital stay


Options:
A: overall morbidity rate (at 60 days from surgery) (60 days)
B: Parietal complications after surgery (infection and hernia) (One year)
C: Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test. (3-6 weeks)
D: Postoperative Quality of Life (QoL) (one month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo and Active-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
Brief Summary: The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.


Options:
A: Reduction in the agitation score (90 minutes)
B: Change from baseline in total PANSS score to the end of the double-blind phase.
C: Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. (Baseline to Week 6)
D: For 100 subjects with incomplete response to adequate treatment with clozapine, the primary objective is to determine if risperidone augmentation of clozapine is superior to augmentation with placebo, using the outcome measure of total PANSS score

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo and Active-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
Brief Summary: The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.


Options:
A: Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. (Baseline to Week 6)
B: Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 (Baseline to Week 26)
C: Time to recurrence, defined as the time between randomization to treatment in the double-blind period and the first documentation of a recurrence.
D: For patients in remission while on maintenance medication, the study investigates whether medication discontinuation can be reached in 12 months following a first episode illness.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
Brief Summary: The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.


Options:
A: Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline to Week 6)
B: For patients in remission while on maintenance medication, the study investigates whether medication discontinuation can be reached in 12 months following a first episode illness.
C: Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study. (6 weeks)
D: Time From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse in Phase C. (From randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Adductor-Canal-Blockade on Morphine Consumption, Pain and Mobilisation After Total Knee Arthroplasty
Brief Summary: The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing morphine consumption and pain, and at the same time improving mobilisation after total knee arthroplasty.


Options:
A: Total morphine consumption (0-24 hours postoperative)
B: Pain during 45 degrees active flexion of the knee (1 hour postoperative)
C: Change i muscle strength of the quadriceps muscle, after the blockade (0 and 120 minutes)
D: Quadriceps muscle strength (MVIC) difference between the ACB and FNB after total knee arthroplasty. (Baseline, 6, 24, 48 hours and at 6 month after nerve block performance)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1b/2 Fixed-dose Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Chronic Lymphocytic Leukemia
Brief Summary: The purpose of this study is to establish the safety and efficacy of orally administered PCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.


Options:
A: Number of Participants With Treatment Emergent Adverse Events (AEs) (From first dose to within 30 days of last dose of PCI-32765)
B: Overall Response Rate (The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months)
C: Determination of dose limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase two dose (RPTD), and lead-in period regimen (Lead-in period (2-5 weeks) plus 3 weeks of study drug administration at the designated cohort dose (continuous dosing)); Number of subjects with adverse events (First 16 weeks of study drug administration and every 4 weeks thereafter (continuous dosing for an anticipated maximum duration of 9 months)); Determination of plasma peak concentration (Cmax) of ABT-199 (Up to Week 24 for ABT-199); Determination of trough concentration (Ctrough) of ABT-199 (Up to Week 24 for ABT-199); Determination of area under the concentration versus time curve (AUC) of ABT-199 (Up to Week 24 for ABT-199)
D: Time to Progression (At least 24 months following completion of therapy, an average of 5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multifaceted Prompting Intervention for Urban Children With Asthma
Brief Summary: The overall goal of this project is to evaluate whether a multifaceted prompting intervention, administered in the urban primary care office setting, reduces morbidity among urban children with asthma. This study builds on our experience with a pilot study in two urban continuity clinics, in which we found that prompting clinicians about asthma severity and care guidelines at the time of an office visit resulted in improved preventive care delivery to inner-city children. This type of prompting program has the potential to substantially improve care for impoverished children with asthma, and we propose to establish: 1) whether these findings can be replicated in a similar study including a larger sample of urban children from different types of practices, and 2) whether the positive effects can be enhanced by more specific prompting directed towards both the provider and the caregiver and by providing practice-level supports and feedback. We hypothesize that children receiving a multifaceted prompting intervention (MPI) will experience less asthma-related morbidity (defined by symptom-free days at the 2-month follow-up) compared to children receiving usual care. Our secondary hypothesis is that children receiving the MPI will receive improved preventive asthma care (defined by guideline-based corrective actions taken at the index visit) compared to children receiving usual care.


Options:
A: ER visits (18 months)
B: Symptom Free Days (2 month follow-up assessment)
C: Hemoglobin A1c (0, 3, 6, 12, 18, 24, 30 months)
D: Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up (Baseline, 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Strategies to Prevent Methicillin-resistant Staphylococcus Aureus Skin and Soft Tissue Infections in Military Trainees
Brief Summary: This cluster-randomized prospective study will evaluate the effect of hygiene-based intervention strategies on the incidence of overall SSTI and MRSA-associated SSTI among military trainees. The proposed interventions used singly or in combination include standardized training and education, and weekly chlorhexidine showers.


Options:
A: Number of individuals vaccinated with two dose of oral cholera vaccine. (Six months from initiation of vaccination); Decrease number of cholera cases in intervention arm compared to non-intervention arm. (Two years after completion of vaccination)
B: Incidence of Skin and Soft Tissue Infection (SSTI) (At the end of the 20 month study); Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI (At the end of the 20 month study)
C: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)
D: secondary influenza infection (7 days)

Answer: B