TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Individual Placement and Support (IPS) Enhanced With Cognitive Remediation and Social Skills Training in Denmark: a Randomized Controlled Trial
Brief Summary: The purpose of this study is to investigate the efficacy of IPS in Denmark and compare effects of 1. Individual Placement and Support (IPS) vs. 2. IPS + cognitive remediation and work-related social skills training vs. 3. standard intervention, among individuals with severe mental illness.


Options:
A: Hours in competitive employment or education (Measured at 18 month)
B: Labor Market Participation in Ordinary Paid Employment, or Education. (1 year (2016))
C: UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity) (3 months)
D: Clinical, neuropsychological, and functional outcomes (Measured at Years 1 and 3)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Assessment of the effect of hyperoxia and hypertonic saline on survival in patients with septic shock Hyperoxia and hypertonic saline may have beneficial effects on organ perfusion and oxygenation and may reduce the organ failure occurences. To date, only scarce data are available. Side effects are not well described. Therefore we designed a randomized clinical trial in order to assess the early administration of hypertonic saline and oxygen in the very early beginning of septic shock.


Options:
A: Neuron-specific enolase (NSE) serum concentration (48 hour after cardiac arrest)
B: Mortality in ICU (30 days)
C: Surgical wound infection (14 days after surgery)
D: all-cause mortality (day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Assessment of the effect of hyperoxia and hypertonic saline on survival in patients with septic shock Hyperoxia and hypertonic saline may have beneficial effects on organ perfusion and oxygenation and may reduce the organ failure occurences. To date, only scarce data are available. Side effects are not well described. Therefore we designed a randomized clinical trial in order to assess the early administration of hypertonic saline and oxygen in the very early beginning of septic shock.


Options:
A: Surgical wound infection (14 days after surgery)
B: all-cause mortality (day 28)
C: oxygen saturation ≥90% (baseline)
D: Chest pain measured with VAS (1 h)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Brief Summary: A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.


Options:
A: Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria (Baseline until disease progression or death up to approximately 3.75 years)
B: Progression Free Survival (PFS) (Up to 2 years 10 months)
C: Progression-free Survival (PFS) (Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)); Percentage of Participants With Progression Free Survival Events (Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization))
D: PFS (Progression Free Survival) (Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label Safety Study of COV155 in Subjects With Osteoarthritis or Chronic Low Back Pain
Brief Summary: A study to show the safety of COV155 in patients with osteoarthritis of the knee or hip or moderate to severe chronic low back pain.


Options:
A: Safety and tolerability of COV155 (Up to 35 days)
B: Change in 100mm Pain VAS (baseline throgh week 8)
C: ‡Pain Normalized Score (8 weeks)
D: Sum of Pain Intensity Difference (SPID) at Hour 48 (Hour 48)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Posttraumatic Symptoms in IDF Soldiers Using Attention Bias Modification (ABM): A Randomized Controlled Trial
Brief Summary: Military deployment to combat zones involves exposure to trauma at a higher than average rate and therefore presents a unique opportunity to study predisposing factors to posttraumatic stress reactions and test strategies designed to prevent and ameliorate posttraumatic symptoms. Decades of scientific research on the origins of resilience and vulnerability to combat-related posttraumatic stress symptoms revealed various predisposing and protective factors. All these factors however, offer limited opportunity for systematic pre-deployment prevention efforts. Considering the magnitude of psychological adjustment difficulties encountered by combat personnel in deployment and the limited access to existing evidence-based therapies for PTSD, the development and testing of a novel evidence-based and theory-driven prevention protocol for these problems is of considerable significance. The current study translates cognitive-neuroscience knowledge and attention bias modification research into a novel computerized training tool that could be easily delivered to soldiers during different stages of the deployment cycle. If proved efficacious in reducing risk for posttraumatic symptoms ABMT could be integrated into the Army's resilience training program. Thus, we propose a longitudinal double-blind randomized controlled study of ABMT in soldiers. We will assess attention bias and symptoms before deployment, will randomly assign soldiers to either 8 ABMT sessions, 4 ABMT sessions, 8 Placebo training sessions, or no training. Following 6 months of deployment to combat zone symptoms will be assessed again.


Options:
A: level of depression (Baseline to 3 months)
B: Perceived Stress (3 months post-intervention)
C: Resilience - Brief Resilience Scale (BRS) (20 weeks); General Health - General Health Questionnaire (GHQ-12). (20 weeks)
D: Changes in PTSD symptoms(PCL) (Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat); Probable PTSD diagnosis(CAPS) (Four months after combat)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Perioperative Inspiratory Oxygen Fraction - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)
Brief Summary: Aim: to investigate the effect of a high inspiratory oxygen fraction (FiO2) given during and after laparotomy procedures on occurrence of a subsequent, new or recurrent, cancer diagnosis at a long-term follow-up.

Background: A high inspiratory oxygen fraction (FiO2 = 0.80) has been linked to prevention of surgical site infection, but the Danish randomized clinical multicenter trial, the PROXI trial, found no difference in frequency of surgical site infection. In fact, long-term mortality was significantly increased with a hazards ratio of 1.30 in patients receiving 80% oxygen, and this appeared to be statistically significant in patients undergoing cancer surgery, but not in non-cancer patients.

At this point, no convincing mechanism explains the observed increased mortality after hyperoxia, as the long-term pathophysiological effects of oxygen are not fully understood.

Primary hypothesis of this follow-up study of the PROXI trial: Use of 80% oxygen increase the frequency of patients with a subsequent, new or recurrent, cancer.


Options:
A: N/A
B: Surgical wound infection (30 days)
C: Frequency of patients with the composite outcome measure of either a subsequent, new or recurrent, cancer registration or a new histological specimen showing any neoplasm (36-60 months after randomization)
D: Surgical wound infection (14 days after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: CLINPCT Study: Clinical Reassessment Versus Procalcitonin-guided Algorithm in Order to Reduce Antibiotic Consumption in Community-acquired Pneumonia
Brief Summary: CLINPCT study is a prospective, randomized, controlled, open intervention clinical trial including adult patients admitted in the emergency department with community-acquired pneumonia. The objective of this clinical trial is to compare two strategies: clinical reassessment and procalcitonin guided diagnostic and therapeutic strategy in patients with community-acquired pneumonia. In the clinical reassessment arm, antibiotherapy is systematically started in the emergency department. The continuation, the discontinuation or the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to evaluate the possibility to stop the current antibiotherapy based on criteria for clinical stability defined by the Infectious Diseases Society of America (Temperature ≤37.8°C, Heart rate ≤100 beats/min, Respiratory rate ≤24 breaths/min, Systolic blood pressure ≥90 mm Hg, Arterial oxygen saturation ≥90% or pO2 ≥60 mm Hg on room air). In the procalcitonin arm, initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately life-threatening disease. If the algorithm is overruled and antibiotics are given, an early discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs defined above.


Options:
A: Proportion of patients receiving any antibiotic (2 weeks)
B: duration of antibiotic therapy expressed in days of therapy (Between Day 1 and Day 30)
C: Antibiotic prescribing rate (12 months); Prolonged duration prescribing rate (12 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Neonatal Abstinence Syndrome: Evaluation of Efficacy of Phenobarbital in Combination With Either Methadone or Diluted Deodorized Tincture of Opium as Stabilizing and Tapering Regiments
Brief Summary: This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs for the difference in the length of treatment. This is a randomized, open-label comparison of phenobarbital and methadone versus phenobarbital and diluted deodorized tincture of opium (dDTO) where phenobarbital is the initial drug used to stabilize neonatal withdrawal.


Options:
A: Length of Treatment With Opioid Medication (Up to 12 months)
B: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))
C: Length of Treatment (Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.)
D: Hospital length of stay (Up to hospital discharge, an anticipated average of 4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Intervention in Infants
Brief Summary: The study is a randomized, controlled, double blinded study evaluating the effect of recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years of age, on growth, bone development, neurologic and cognitive development, frequence of infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2 years of age.


Options:
A: Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) (0 to 6 months)
B: Growth (2 years of age); Neurologic and cognitive development (At 2 years of age); Frequency of allergic symptoms and infection (At 2 years of age); Development of immunoregulation (At 2 years of age); Bone mineral density (2 years of age)
C: Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase (end of winter)
D: The number of days of detectable milk vitamin D concentrations (28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Intervention in Infants
Brief Summary: The study is a randomized, controlled, double blinded study evaluating the effect of recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years of age, on growth, bone development, neurologic and cognitive development, frequence of infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2 years of age.


Options:
A: Serum interleukin-6 (At trial entry and 7 days after daily vitamin D supplementation therapy); Serum tumor necrosis-alpha (At trial entry and 7 days after daily vitamin D supplementation therapy)
B: Change From Baseline in Serum 25OHD (During the 7-month follow-up period)
C: Growth (2 years of age); Neurologic and cognitive development (At 2 years of age); Frequency of allergic symptoms and infection (At 2 years of age); Development of immunoregulation (At 2 years of age); Bone mineral density (2 years of age)
D: Change in CD4 percent associated with vitamin D supplementation in HIV-infected children (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: International Validation and Testing of a Supplementary Questionnaire Module for Assessment of Oral and Dental Health in Cancer; the QLQ-OH17
Brief Summary: Assessment of oral and dental problems is seldom routine in clinical oncology, despite the potential negative impact of these problems on nutritional status, social function and quality of life (QoL). A brief, assessment tool for oral/dental health and related QoL-issues to improve symptom management has been requested. The present study will be conducted on behalf of and with support from the European Organisation for Research and Treatment of Cancer - (EORTC) Quality of Life Group (QLG). The study represents phase IV, the final step, in the development of an international, symptom specific questionnaire module, focusing on oral and dental problems in relation to cancer and its treatment. Phase I-III of this stepwise development process was conducted from 2008 to 2011, as an international collaboration and conducted according to the guidelines for module development set forth by the EORTC QLG. The resulting module, the QLQ-OH17, is now subject to an international field testing and validation study as described in this project description.

The present version of the QLQ-OH17 consists of 17 items conceptualized into four multi-item scales (pain/discomfort, xerostomia, eating and information) and three single items related to use of dentures and future worries. The aim of the present study is to conduct phase IV; an international field study to confirm the psychometric properties of the QLQ-OH17


Options:
A: Oral morbidity (Up to two years)
B: SCL-90r Depression and anxiety subscales (baseline - 12 months)
C: To evaluate the efficacy of the MBSR(BC) program in improving psychological and physical symptoms, quality of life and measures of immune function and a stress hormone (cortisol) (Baseline, 6 weeks and 12 weeks)
D: Change in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B+4) (8 weeks, 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training: A Randomized Clinical Trial
Brief Summary: The purpose of the study is to make a head-to-head comparison of weight loss and interval training as methods of secondary prevention in overweight patients with ischemic heart disease.


Options:
A: Physical performance (6 months)
B: Functional Capacity Assessed by Changes in Total Distance Walked in the Incremental Shuttle Walk Test (Functional capacity measured by walked distance in the ISWT at 6 months)
C: Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period (0, 12 and 52 weeks)
D: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: (Baseline, 6 and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training: A Randomized Clinical Trial
Brief Summary: The purpose of the study is to make a head-to-head comparison of weight loss and interval training as methods of secondary prevention in overweight patients with ischemic heart disease.


Options:
A: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: (Baseline, 6 and 12 months)
B: Maximal oxygen consumption (At baseline and after 6 months)
C: Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period (0, 12 and 52 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: N/A
Brief Summary: The purpose of this study is to compare three methods of delivering behavioral weight loss treatment.Participants are randomly assigned to one of three 18-month weight loss treatments (group, individual, or smartphone treatment). Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months. Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months. Assessment visits are conducted at baseline, 6, 12, and 18 months.


Options:
A: weight reduction (at 6 months)
B: Change in Weight (Baseline, 1 month, 3 months)
C: Weight Loss (Change from baseline to 18-months.)
D: Study Recruitment: Interest in Participation (Baseline); Study Recruitment: Screened for Eligibility (Baseline); Study Recruitment: Eligibility (Baseline); Study Recruitment: Enrollment (Baseline); Retention (Week 24); Treatment Satisfaction/Acceptability (Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women
Brief Summary: Additional testosterone undecanoate can improve female sexual function in postmenopausal women which one aspects of quality of life. The dose adjustment can reduce incidence of adverse effects and low cost of treatment with effective outcome.


Options:
A: Relief of vaginal symptoms (over 12 months of treatment); Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels
B: female sexual function index score (8 weeks)
C: Mean change from baseline in number of daily moderate to severe hot flushes.; Mean change from baseline in daily hot flush severity.; Mean change from baseline in vulvovaginal atrophy symptoms.
D: Clinical symptoms (after 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility and Effectiveness of Telehealth in Patients With Chronic Obstructive Pulmonary Disease in Taiwan
Brief Summary: Recent studies have demonstrated the promising potential that telehealth has in management of chronic disease. For COPD patients, implementation of telehealth reduced readmissions, emergency room visits, and exacerbations and was cost-effective. Telehealth as a method of delivering healthcare to remote, resource-deprived areas is not lacking in evidence of benefit; however, the situation about its more widespread use for monitoring purposes is much less clear. To date, most of the studies dealing with telehealth in COPD were conducted in countries covering vast territories. Therefore, it needs to be investigated whether telehealth conveys similar advantages for COPD patients in a small island country.


Options:
A: Daily number of steps (changes from baseline to 3 months)
B: Training time (3 month)
C: 6MWT -12 weeks (12 weeks afte baseline)
D: Number of Participants with Hospital Readmission at 6 months (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility and Effectiveness of Telehealth in Patients With Chronic Obstructive Pulmonary Disease in Taiwan
Brief Summary: Recent studies have demonstrated the promising potential that telehealth has in management of chronic disease. For COPD patients, implementation of telehealth reduced readmissions, emergency room visits, and exacerbations and was cost-effective. Telehealth as a method of delivering healthcare to remote, resource-deprived areas is not lacking in evidence of benefit; however, the situation about its more widespread use for monitoring purposes is much less clear. To date, most of the studies dealing with telehealth in COPD were conducted in countries covering vast territories. Therefore, it needs to be investigated whether telehealth conveys similar advantages for COPD patients in a small island country.


Options:
A: Cardiovascular risk and diabetes testing (During the first year of the trial); Systolic blood pressure (During the first year of the trial)
B: Number of unscheduled hospital days (up to 12 months)
C: Number of Participants with Hospital Readmission at 6 months (6 months)
D: 6-Minute walk distance (Six months)

Answer: C