TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Study of LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients
Brief Summary: The aim of this prospective randomized study was to investigate if the LigaSure vessel sealing system can reduce the operation duration and the postoperative drainage amount in patients undergoing neck dissection.


Options:
A: Spinal accessary nerve function (2 years)
B: Quality of Life (1-year post treatment)
C: Overall survival
D: Opreation Duration (1 day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Study of LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients
Brief Summary: The aim of this prospective randomized study was to investigate if the LigaSure vessel sealing system can reduce the operation duration and the postoperative drainage amount in patients undergoing neck dissection.


Options:
A: Opreation Duration (1 day)
B: Overall Survival (5 years)
C: Quality of Life (1-year post treatment)
D: Recurrence-free survival (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the Implementation of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older
Brief Summary: The primary objective of this study is to evaluate the impact of the implementation of collaborative pharmaceutical care on drug support at admission for patients 65 years of age and older.

This is a cluster-randomized study with a stepped-wedge design. Clusters correspond to participating centers. A randomly selected center is crossed-over into the intervention every fifteen days after the start of inclusions.


Options:
A: Drug Related Problems (DRP) (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Mortality (6-month after inclusion); Average length of the hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Readmissions (6-month after inclusion); Average cost of hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days)
B: Number of patients with at least one preventable medication error (Day 1 (medical prescription at hospital admission)); Number of patients with at least one preventable medication error (Phase 2 (maximum 105 days))
C: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
D: Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, As-randomized Analysis (19-month study period. All order sessions placed by randomized clinicians during the study period were included in the analysis. The time frame for each participant varied.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the Implementation of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older
Brief Summary: The primary objective of this study is to evaluate the impact of the implementation of collaborative pharmaceutical care on drug support at admission for patients 65 years of age and older.

This is a cluster-randomized study with a stepped-wedge design. Clusters correspond to participating centers. A randomly selected center is crossed-over into the intervention every fifteen days after the start of inclusions.


Options:
A: Number Who Discontinued Medication Within First 6 Study Months (Measured at Six Months)
B: Number of patients with at least one preventable medication error (Day 1 (medical prescription at hospital admission)); Number of patients with at least one preventable medication error (Phase 2 (maximum 105 days))
C: Diabetic nephropathy (Four years); Combined cardiovascular endpoint (Eight years); Total mortality (13 years); Years of life years gained (21 years)
D: Medication Appropriateness Index (MAI) score (Change from baseline MAI score at 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the Implementation of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older
Brief Summary: The primary objective of this study is to evaluate the impact of the implementation of collaborative pharmaceutical care on drug support at admission for patients 65 years of age and older.

This is a cluster-randomized study with a stepped-wedge design. Clusters correspond to participating centers. A randomly selected center is crossed-over into the intervention every fifteen days after the start of inclusions.


Options:
A: Time in hospital during 30 days after admission to the ED (30 days)
B: Number of patients with at least one preventable medication error (Day 1 (medical prescription at hospital admission)); Number of patients with at least one preventable medication error (Phase 2 (maximum 105 days))
C: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) (12-months)
D: Improvement of drug prescribing (Participants will be followed for the duration of hospital stay, an expected average of 12 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transobturator Versus Single Incision Slings: 1 Year Results of a Randomized Control Trial
Brief Summary: A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling


Options:
A: Objective Stress Urinary Incontinence (1 year)
B: to assess efficacy between tot with minisling in cure in women with stress urinary incontinence (one year)
C: Objective cure as defined by the cough test at one year from surgery (one year)
D: Percentage of Participants With Negative Cough Stress Test (CST) (four years); Patient Global Impression of Improvement (PGI-I) Score (four years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fear of Cancer Recurrence (FoR) Trajectory During Radiation Treatment and Follow-up Into Survivorship of 100 Breast Cancer patients-a Pilot Study
Brief Summary: This pilot study concentrates on studying the trajectory of breast cancer patient's fear of recurrence (FoR) over the course of radiation therapy. The aim is to collect repeated ratings of 100 breast cancer patient's FoR over the course of their treatment. It is hypothesized that cancer patient's FoR level will rise on nearing the termination of the in radiotherapy treatment, and radiotherapist-patient interaction modifies the development of patient's FoR.


Options:
A: Patient satisfaction with nurse communication during the Mini-AFTERc intervention (1 week post intervention)
B: Fear of Recurrence Level-ACCRE FCR (6-8 weeks after treatment)
C: Change in FACIT-TS questionnaire score (Baseline, 6 months)
D: Quality of life as measured by Functional Assessment of Cancer Therapy-Palliative care version (FACT-Pal) at baseline, one month, and every three months thereafter (Baseline, one month, every three months); Symptom management as measured by Edmunton Symptom Assessment Scale at baseline, one month, and every three months thereafter (Baseline, one month, every three months); Health care utilization by a chart review of days in hospital, ICU, ER visits at baseline, one month, and every three months thereafter (Baseline, one month, every three months); Correlate preferences for care and care received as measured by After Death Bereaved Family Member Interview with a family member of the deceased (Baseline, one month, every three months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Short-term Effects of Animal-assisted Therapy on the Rehabilitation Process of Brain-injured Patients at REHAB Basel
Brief Summary: The purpose is to investigate whether animal-assisted therapy has positive biopsychosocial effects on patients with brain injuries. This study investigates the short-term biopsychosocial effects that occur when animals are present during therapy sessions in comparison to therapy sessions without animals, observing a group of 25 patients over 24 therapy sessions. While half of the sessions are held in presence of an animal and half without, they are as comparable as possible with respect to content and setting. In this study, patients who are in a slightly advanced rehabilitation process, assessed via their function profile, are investigated.


Options:
A: Barthel Index (Change from Baseline to 2, 4, 12 and 22 weeks)
B: Change from baseline in the Montreal Cognitive Assessment (Baseline, End (4-6 weeks) and 8-weeks follow-up)
C: Social Functioning: Total Social Behavior (6 weeks)
D: Stroke Self-efficacy questionnaire (Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: As cancer mortality rates improve in Asia, there is an increasing focus on patient-reported outcomes and survivorship issues. In view of the numerous medication and psychosocial issues that are commonly faced by early-stage breast cancer survivors, it deems important to develop and conduct specific interventional programs to mitigate these problems. In the literature, it is well recognized that psychosocial interventions are effective to manage emotional distress and quality of life, with the evidence clearly clustered in studies on female patients with breast cancer. One meta-analysis suggested that psycho-oncologic interventions including individual psychotherapy, group psychotherapy, psychoeducation, relaxing training can produce positive effects on emotional distress, anxiety and depression, and health-related QOL.

The investigators hypothesize that a significant reduction in anxiety, improvement of cognition and improvement of health-related quality of life among those who receive psycho-education, in comparison to those in the usual care. Hence, this randomized trial is designed to assess the effectiveness of a psycho-educational group (PEG) intervention on supportive care and survivorship issues, which include anxiety, depression, cognitive function, toxicities management of cancer- or treatment- related physical symptoms, and health-related quality of life in early-stage breast cancer patients.


Options:
A: Change in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B+4) (8 weeks, 6 months)
B: Severity of anxiety, as measured using Beck Anxiety Inventory (Within one month after the program); Quality of life (Within one month after the program)
C: Self image and communication(using standardized instruments)
D: Hospital Anxiety and Depression Scale (change from baseline to one month post-intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock
Brief Summary: The Oxiris® filter is a registered product for CRRT already safely used in routine care.

In in vitro experiments, the Oxiris® filter has been demonstrated to adsorb endotoxin and cytokines. Compared to conventional filters this may be advantageous in patients with severe sepsis but neither decreased levels of endotoxin and cytokines nor an improved outcome has been demonstrated with clinical use.

But there are so far little clinical data on the oXiris® filter on humans. The oXiris® filter will be investigated in a double blind randomized crossover setting against a traditional filter (ST150). Either filter will be used for 24 hours after which it will be changed to the opposite filter for another 24 hours.

Arterial blood samples will be drawn at start and then 1, 3, 8, 16 and 24 hours after the start of each filter, and analyzed for endotoxin (EAA assay), TNF-α, IL-1β, IL-6 and IL-10 (ELISA) levels. Standard blood tests will be analyzed simultaneously. Data concerning mode and settings of CRRT, heart rate, blood pressure, medication, data concerning ventilatory support and pathogen will be registered.

Primary endpoint: Levels of endotoxin and cytokines will be compared using Student's paired t-test on AUC values for each 24-hour period.


Options:
A: endotoxin level in blood (change from baseline to 48 hours)
B: To compare the clearance of urea and creatinine by renal replacement therapy (RRT) using continuous venovenous hemofiltration versus continuous venovenous hemodialysis. (48 hours)
C: the time of 1st membrane exchange (the time of 'filter is clotted')
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis
Brief Summary: Outpatient (phase 2) pulmonary rehab is an important, but mostly underutilized intervention to improve physical function in patients with idiopathic pulmonary fibrosis (IPF). Of those individuals who complete phase 2 pulmonary rehab, only a small cohort continues with any type of maintenance exercise therapy (phase 3). This is largely due to personal factors, such as access to transportation, weather, scheduling difficulties, and cost.

Little is known about how to enhance physical activity among patients with IPF. In addition, no studies have investigated the long-term maintenance strategies of physical training in patients with IPF. Thus, the purpose of this study is to test the feasibility and effectiveness of a home-based, pulmonary rehab program for patients with IPF. A randomized, blinded, clinical trial (RCT) design with two arms -- Wii Fit Plus exergame program and cognitive video gaming, with no active whole body movement involved - will be used to investigate the benefits of a home-based exergame program on improving pulmonary-related function and symptoms in patients with IPF.


Options:
A: Annual Rate of Decline in Forced Vital Capacity - Overall Population (Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)); Annual Rate of Decline in Forced Vital Capacity - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only (Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits))
B: Functional exercise capacity
C: Functional performance (12 weeks)
D: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks (52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis
Brief Summary: Outpatient (phase 2) pulmonary rehab is an important, but mostly underutilized intervention to improve physical function in patients with idiopathic pulmonary fibrosis (IPF). Of those individuals who complete phase 2 pulmonary rehab, only a small cohort continues with any type of maintenance exercise therapy (phase 3). This is largely due to personal factors, such as access to transportation, weather, scheduling difficulties, and cost.

Little is known about how to enhance physical activity among patients with IPF. In addition, no studies have investigated the long-term maintenance strategies of physical training in patients with IPF. Thus, the purpose of this study is to test the feasibility and effectiveness of a home-based, pulmonary rehab program for patients with IPF. A randomized, blinded, clinical trial (RCT) design with two arms -- Wii Fit Plus exergame program and cognitive video gaming, with no active whole body movement involved - will be used to investigate the benefits of a home-based exergame program on improving pulmonary-related function and symptoms in patients with IPF.


Options:
A: Change in physical activity (Baseline and 12 months follow-up)
B: Change in 6-minute walk test (Baseline, 8 weeks and 12 months)
C: Functional performance (12 weeks)
D: Treatment Adherence (10 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vaginal Administration of Alpha Lipoic Acid vs Progesterone for the Subchorionic Hematoma Treatment
Brief Summary: The aim of this study was to compare the therapeutic efficacy of lipoic acid versus progesterone by vaginal administration on subchorionic hematoma resorption in women at the first trimester of pregnancy with threatened miscarriage.


Options:
A: The chance of miscarriage before 20 weeks of gestation (At 20 weeks of gestation)
B: Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. (48 hours); Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus. (48 hours)
C: Preterm delivery (37 weeks of gestation) (6 mo. after end of recruitment)
D: Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination (T1 (20 days); T2 (40 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vaginal Administration of Alpha Lipoic Acid vs Progesterone for the Subchorionic Hematoma Treatment
Brief Summary: The aim of this study was to compare the therapeutic efficacy of lipoic acid versus progesterone by vaginal administration on subchorionic hematoma resorption in women at the first trimester of pregnancy with threatened miscarriage.


Options:
A: Ongoing pregnancy rate (12 weeks)
B: Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination (T1 (20 days); T2 (40 days))
C: Continuation of viable pregnancy beyond 20 weeks gestation (20 weeks gestation)
D: The frequency of spontaneous abortion before 28 weeks (14 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With Familial Mediterranean Fever: A Randomized Trial
Brief Summary: It was aimed to examine the efficacy and safety of once daily dosage schema of colchicine in pediatric patients with FMF compared to twice daily dosage schema.

In this 24-week, multicentric, randomized, controlled, noninferiority trial, pediatric patients newly diagnosed with FMF, carrying homozygote or compound heterozygote mutation and did not receive any treatment, were included. Patients were randomly assigned using block randomization method to receive treatment with once or twice daily doses. Clinical and laboratory characteristics and medication side effects were recorded and compared between groups. The study complied with Good Clinical Practice and the Consolidated Standards for Reporting of Trials (CONSORT) statement.


Options:
A: Mor severity scoring system (At baseline and every 12 weeks, up to 24 weeks. Change in disease severity as assessed by the Mor severity scoring system.); Adverse events (up to 24 weeks)
B: To measure the effect of canakinumab on the frequency of FMF attacks defined as percentage of patients with at least 50% reduction in the attack frequency during 3 month treatment period. (12 weeks)
C: To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks. (attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each)); To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo. (12 months of entire study length)
D: Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours (Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With Familial Mediterranean Fever: A Randomized Trial
Brief Summary: It was aimed to examine the efficacy and safety of once daily dosage schema of colchicine in pediatric patients with FMF compared to twice daily dosage schema.

In this 24-week, multicentric, randomized, controlled, noninferiority trial, pediatric patients newly diagnosed with FMF, carrying homozygote or compound heterozygote mutation and did not receive any treatment, were included. Patients were randomly assigned using block randomization method to receive treatment with once or twice daily doses. Clinical and laboratory characteristics and medication side effects were recorded and compared between groups. The study complied with Good Clinical Practice and the Consolidated Standards for Reporting of Trials (CONSORT) statement.


Options:
A: Mor severity scoring system (At baseline and every 12 weeks, up to 24 weeks. Change in disease severity as assessed by the Mor severity scoring system.); Adverse events (up to 24 weeks)
B: Number of patients with less than a mean of one FMF attack per month (4 months)
C: Change From Baseline to Week-6 (Part A) Endpoint in Mean Key Symptom Score (KSS) (Baseline (Days -21 to -1) and Week 6 (Days 21-42)); Mean Change in Key Symptom Score (KSS) From Week 15 to Week 24 (During the Randomized Withdrawal Phase or Part B) (Week 15 through Week 24 (randomized withdrawal))
D: To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks. (attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each)); To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo. (12 months of entire study length)

Answer: A