TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Proteus Discover to Enable Improved Clinical Outcomes in Subjects With Uncontrolled Hypertension and Type 2 Diabetes Mellitus: A Pilot Study
Brief Summary: The purpose of this study was to evaluate the efficacy of a new digital health offering, Proteus Discover to lower blood pressure and glycated hemoglobin in patients with uncontrolled hypertension and type 2 diabetes.


Options:
A: Week 4 Change in Systolic Blood Pressure (4 weeks)
B: Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack (Day 1); Diagnosed with CVD: Myocardial infarction, stable coronary artery disease (SCAD) also referred as angina (pectoris), other ischaemic heart disease and/or past revascularisation procedures (Day 1); Diagnosed with symptomatic heart failure: New York Heart Association Functional Classification (NYHA) (group IIIV) and/or left ventricular ejection fraction (LVEF) greater than or equal to 50 percent, LVEF 40-49 percent and LVEF less than 40 percent) (Day 1); Diagnosed with asymptomatic heart failure (Day 1); Hospitalisation for heart failure (Day 1); Diagnosed with cardiac arrhythmia: Atrial fibrillation or flutter, ventricular tachycardia and/or ventricular fibrillation (Day 1); Diagnosed with aortic diseases: Aortic dissection, aortic aneurysms and/or thromboembolic aortic disease (Day 1); Diagnosed with peripheral artery disease: Asymptomatic peripheral arterial disease (PAD) defined as Low Ankle-Brachial Index (less than 0.90) or pulse abolition, claudication, limb ischemia and/or non-traumatic amputation (Day 1); Diagnosed with carotid artery disease (Day 1)
C: Diabetes Control (Baseline, 3months, 6months)
D: Patient is receiving a statin (July 2009 to April 2010)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smart Phone Medication Adherence Saves Kidneys--SMASK
Brief Summary: Investigators will employ a 2-arm Randomized Controlled Trial (RCT) design with the subject as the unit of randomization and analysis. Kidney transplant recipients having uncontrolled hypertension will be enrolled into a screening phase to measure medication non-adherence. Each subject will use an electronic pill tray for 1 month without any reminder functions activated. Non-adherent subjects who remain uncontrolled will be randomly assigned to SMASK or Standard Care (SC). SC will continue to use the pill tray with reminders turned off and will receive attention control texts with healthy lifestyle information. SMASK will have the reminder functions of the electronic pill tray activated and will receive a Bluetooth blood pressure monitor and an app to collect the data and send to researchers.

Subjects in the second phase will participate in 4 more evaluations at months 1, 3, 6, 12 post randomization. Research staff will measure resting blood pressure and heart rate.


Options:
A: Incidence of Rejection (2 Years)
B: Medication Adherence (six months)
C: Incidence of clinical or subclinical allograft injury at any timepoint as assessed by the appearance of de novo donor specific anti-HLA antibody (dnDSA) OR biopsy proven allograft rejection. (9 months); Change in Patient Reported Transplant Symptoms (Baseline, 2.5 months, 4.5 months, 7 months, 9 months); Change in Patient Reported Medication Adherence and Barriers (Baseline, 2.5 months, 4.5 months, 7 months, 9 months); Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) as a measure of safety (2 weeks, 2.5 months, 4.5 months, 5 months, 7 months, 9 months); Change in Patient Reported Distress (Baseline, 2.5 months, 4.5 months, 7 months, 9 months)
D: Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Monitoring Device for Patients With Cancer Treated Using Oral Therapeutics
Brief Summary: The emergence of oral delivery in cancer therapeutics is expected to result in an increased need for better coordination between all treatment stakeholders, mainly to ensure adequate treatment delivery to the patient. There is significant interest in the nurse navigation program's potential to improve transitions of care by improving communication between treatment stakeholders and by providing personalized organizational assistance to patients. The use of health information technology is another strategy aimed at improving cancer care coordination that can be combined with the NN program to improve remote patient follow-up. However, the potential of these two strategies combined to improve oral treatment delivery is limited by a lack of rigorous evidence of actual impact.

The investigators are conducting a large scale randomized controlled trial designed to assess the impact of a navigation program denoted CAPRI that is based on two Nurse Navigators and a web portal ensuring coordination between community and hospital as well as between patients and navigators, versus routine delivery of oral anticancer therapy. The primary research aim is to assess the impact of the program on treatment delivery for patients with metastatic cancer, as measured by Relative Dose Intensity. The trial involves a number of other outcomes, including toxic side effects, patient quality of life and patient experience . An economic evaluation adopting a societal perspective will be conducted, in order to estimate those health care resources' used. A parallel process evaluation will be conducted to describe implementation of the intervention


Options:
A: systolic blood pressure (change from baseline to 12-month of follow-up)
B: Relative dose intensity (Assessed every 30 days from randomization up to 6 months)
C: Safety and quality of health care (1 year)
D: Delay before expertise by a dermatologist (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial on Radical Upfront Surgery in Advanced Ovarian Cancer
Brief Summary: This study consists of three parts, whereas Part 1 and Part 2 are performed in Germany only, and Part 3 is a multinational trial.

All patients with suspicion of advanced ovarian cancer are detected in the participating study centers in a pre-screening. The study centers will register all patients with suspected ovarian cancer in a screening log. After the patients have given informed consent, they can be enrolled in different parts of the study.

TRUST-Trial: This part compares two strategies in the therapy of advanced ovarian cancer. En detail, this part of the trial will evaluate if one of two strategies of timing surgery within the therapeutic procedures may show any significant advances in terms of overall survival over the other.


Options:
A: Evaluation and comparison of early surgical complications of primary surgery and Interval debulking surgery. (thirty days); Evaluation and comparison of late surgical complications of primary surgery and Interval debulking surgery (six months); Evaluation of the progression free survival (PFS) (Thirty-six months)
B: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)
C: Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually
D: overall survival (OS) (Patients will be followed up for a minimum of 5 years after registration/randomisation or until death)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial on Radical Upfront Surgery in Advanced Ovarian Cancer
Brief Summary: This study consists of three parts, whereas Part 1 and Part 2 are performed in Germany only, and Part 3 is a multinational trial.

All patients with suspicion of advanced ovarian cancer are detected in the participating study centers in a pre-screening. The study centers will register all patients with suspected ovarian cancer in a screening log. After the patients have given informed consent, they can be enrolled in different parts of the study.

TRUST-Trial: This part compares two strategies in the therapy of advanced ovarian cancer. En detail, this part of the trial will evaluate if one of two strategies of timing surgery within the therapeutic procedures may show any significant advances in terms of overall survival over the other.


Options:
A: overall survival (OS) (Patients will be followed up for a minimum of 5 years after registration/randomisation or until death)
B: proportion of clinical complete remission
C: Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually
D: Evaluation and comparison of early surgical complications of primary surgery and Interval debulking surgery. (thirty days); Evaluation and comparison of late surgical complications of primary surgery and Interval debulking surgery (six months); Evaluation of the progression free survival (PFS) (Thirty-six months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty: A Randomized Controlled Trial
Brief Summary: This study evaluates the peri-articular tranexamic acid injection in total knee arthroplasty which is an alternative route of administration for blood loss reduction. Half of participants will receive intravenous tranexamic acid injection, while the other half will receive peri-articular tranexamic acid injection during total knee arthroplasty.


Options:
A: Blood loss as calculated from change in haematocrit
B: Number of Patients Managed With Blood Transfusion (daily during hospital stay (an expected average of 4 days))
C: The volume of postoperative blood loss in the drain (48 hours after the operation); Changes from baseline hemoglobin concentrations (48 hours after the operation); unit of blood transfusion (48 hours after the operation)
D: Blood Loss (Post operative day 3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: 12 Weeks Weight Loss Study Using Feedback Messages Delivered Via Smartphone
Brief Summary: Brief Summary: This randomized clinical pilot will test the feasibility of having individuals self-monitor for 12 weeks and based on what the participants record be given feedback messages. The investigator will use this information to refine the questions and data collection procedures for the larger study.

Participants will be randomized into 3 groups

* self-monitoring only
* self-monitoring w/ feedback messages
* self-monitoring w/feedback messages and group sessions Feedback messages will be delivered up to 4 times per day using a different schedule. The group sessions will be held in the 2nd, 4th and 8th week of the 12-week study.

All participants will be asked to complete questionnaires and 2 assessment visits at baseline and 12 weeks.


Options:
A: weight reduction (at 6 months)
B: Change in weight (12 weeks)
C: Change in physical activity from baseline to 8-months (three assessment periods: baseline, 4-months, and 8-months); Feasibility and acceptability of the Smartphone delivered physical activity program (4-months)
D: Number of days diet is self-monitored (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clarithromycin as Adjuvant to Periodontal Debridement in the Treatment of Generalized Aggressive Periodontitis: Randomized Clinical Trial
Brief Summary: To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.


Options:
A: Clinical Attachment Level (6 months)
B: Change in probing pocket depth (PD) (baseline, 4weeks, 8weeks and 12weeks)
C: probing depth (six months)
D: Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clarithromycin as Adjuvant to Periodontal Debridement in the Treatment of Generalized Aggressive Periodontitis: Randomized Clinical Trial
Brief Summary: To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.


Options:
A: Percentage of sites showing attachment loss ≥ 1.3 mm over a 27.5-months period (27.5-months period (six measurements))
B: The Primary Outcome Variable Was Probing Depth. (6-months)
C: Clinical Attachment Level (6 months)
D: Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clarithromycin as Adjuvant to Periodontal Debridement in the Treatment of Generalized Aggressive Periodontitis: Randomized Clinical Trial
Brief Summary: To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.


Options:
A: All-cause Mortality Rate in Children Aged 1-60 Months (24 Months); All-cause Mortality Rate in Children Aged 1-60 Months (36 months)
B: Clinical Attachment Level (6 months)
C: Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (1 year); Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? (1 year)
D: Change in FEV1 From Baseline to End of Treatment at Day 168 (change from baseline to day 168)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Anesthesiology Control Tower: Feedback Alerts to Supplement Treatments (ACTFAST)
Brief Summary: This study is a pragmatic, comparative effectiveness trial that will randomize approximately 12,000 adult surgical patients on an operating room (OR) level to a control or to an intervention group. All OR clinicians will have access to decision support software within the OR as a part of enhanced standard intraoperative care. The ACT will monitor patients in both groups and will provide additional support to the clinicians assigned to intervention ORs.


Options:
A: Reduction in the incidence of Post-Operative Delirium (%) (Post-Operative Period (Day 0 through Day 7 or Discharge, whichever comes first))
B: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)
C: Compliance with recommendations for intraoperative temperature management (1 day); Compliance with recommendations for intraoperative blood glucose management (1 day); Assess the usability of the Anesthesiology Control Tower (ACT) for an operating suite (2 years)
D: Functional status:Barthel Index. (through study completion, an average of 3 months); Mini-Nutritional Assessment scores (MNA) (through study completion, an average of 3 months); Mini Mental State Examination scores (MMSE) (through study completion, an average of 3 months); Frailty rates and transition between frailty states (through study completion, an average of 3 months); Postoperative delirium incidence rate [Confusion Assessment Method (CAM)] (through study completion, an average of 3 months); Postoperative bowel dysmotility (through study completion, an average of 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Anesthesiology Control Tower: Feedback Alerts to Supplement Treatments (ACTFAST)
Brief Summary: This study is a pragmatic, comparative effectiveness trial that will randomize approximately 12,000 adult surgical patients on an operating room (OR) level to a control or to an intervention group. All OR clinicians will have access to decision support software within the OR as a part of enhanced standard intraoperative care. The ACT will monitor patients in both groups and will provide additional support to the clinicians assigned to intervention ORs.


Options:
A: Delirium incidence (% participants) (Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
B: Functional status:Barthel Index. (through study completion, an average of 3 months); Mini-Nutritional Assessment scores (MNA) (through study completion, an average of 3 months); Mini Mental State Examination scores (MMSE) (through study completion, an average of 3 months); Frailty rates and transition between frailty states (through study completion, an average of 3 months); Postoperative delirium incidence rate [Confusion Assessment Method (CAM)] (through study completion, an average of 3 months); Postoperative bowel dysmotility (through study completion, an average of 3 months)
C: Postoperative delirium rate within 7 days after surgery (7 days after surgery)
D: Compliance with recommendations for intraoperative temperature management (1 day); Compliance with recommendations for intraoperative blood glucose management (1 day); Assess the usability of the Anesthesiology Control Tower (ACT) for an operating suite (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation
Brief Summary: This clinical trial studies the use of omega-3 fatty acid supplementation in preventing aromatase inhibitor-induced toxicity in patients with stage I-III breast cancer. An omega-3 supplementation may help relieve moderate to severe bone pain and improve joint symptoms caused by aromatase inhibitor-induced arthralgias.


Options:
A: Difference in mean change in joint pain between HA and placebo groups (14 weeks)
B: Change in pain score based on the Brief Pain Inventory (BPI) (Baseline to up to 6 months)
C: Disease-free Survival (5-year estimate reported at a median follow-up of 72 months)
D: assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase; evaluate change in pain measured by Brief Pain Inventory score; evaluate endpoint of patient-reported improvement on the Patient's Global Impression of Improvement scale

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Manual Specific Approach to the Suboccipital Area on Pain, Range of Motion, Disability and Clinical Significance of Changes on Patients With Chronic Mechanical Neck Pain and Rotation Deficit of the Upper Cervical Spine
Brief Summary: There are different inhibition suboccipital techniques, usually adjuvant of physiotherapy, for treatment of patients with chronic neck pain. In our clinical practice, a favorable effect is observed on patients with chronic neck pain, but there are no published studies evaluating the results of this techniques on pain, mobility and disability.

The objective of this trial is to evaluate if the suboccipital manual techniques, provides further improvement in pain intensity, neck disability, range of motion, on patients with chronic mechanical neck pain and rotation deficit of the upper cervical spine, being treated with physiotherapy. For this purpose, investigators conduct a double-blind (patient and evaluator) randomized controlled trial, in a Public Primary Care Center.

Seventy four subjects will be randomized (computer application) into three groups: Mobilization Group, Maintained pressure Group and Control Group. All the three groups receive the same protocolized physiotherapeutic treatment during three weeks and, additionally, the Mobilization Group receives six sessions (two sessions in a week during three weeks) of translational dorsal glide mobilization technique grade III of the atlanto-occipital joint and the Maintained pressure Group receives six sessions (two sessions in a week during three weeks) of pressure maintained suboccipital Inhibition technique. The Control Group receives the protocolized physiotherapeutic treatment only.

Pain intensity (VAS), Neck Disability Index (NDI), Range of motion (CROM), will be measured at baseline, after treatment period, and three months after discharge from treatment. After discharge for treatment the patient subjective opinion about their evolution will be collected through a Global Rating of Change (GROC) scale, and evaluation of headache disability (HIT-6).


Options:
A: Change in Neck pain intensity as measured by Visual Analog Scale (Change from baseline neck pain intensity at 4 weeks)
B: Changes in Pain intensity (Baseline -3 weeks - 3 months)
C: Pain Intensity (T2 (84 days))
D: Headache days change from baseline for cervicogenic headache (0, 6, 12, 24, 39, 52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Technology and Online Tools to Improve Asthma Control in Adolescents
Brief Summary: This project will preliminarily validate CampAir, an empirically-based dynamic e-health intervention (based on the evidence-based ASMA) to assist adolescents with uncontrolled asthma to learn how to manage their illness and improve their asthma control. In addition to developing a highly novel product for adolescents with asthma, the research proposed for this project will address unique scientific questions. Despite the high asthma prevalence among adolescents, few interventions have specifically targeted adolescents. This study is innovative in that it is among the few to focus on adolescents, who are often overlooked by the healthcare system. This research will assess factors associated with successful implementation of CampAir, thereby providing new information regarding how e-health interventions can be effectively developed and implemented for use with adolescents with asthma.


Options:
A: Product Evaluation (Once per module (One Evaluation per week for seven weeks))
B: Night Wakenings Due to Asthma (To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up).)
C: Proportion of Eligible Children who Participate in Study (End of enrollment: estimated 2 years after beginning active enrollment.); Participant Drop-out Rates (After final outcome measures are collected: up to 2 1/2 years from beginning of active enrollment.); Session Completion Rates (After final participant has completed study: estimated 2 1/2 years after beginning active enrollement.); Program Satisfaction Survey (End of Study Participation: up to 5 months from initial enrollment.); Barriers to offering the Intervention in Selected Schools (End of enrollment: estimated 2 years after beginning active enrollment.); Child Depression Inventory (Pre and Post Intervention: baseline, up to 4 months later.); State-Trait Anxiety Inventory for Children (Pre and Post Intervention: baseline, up to 4 months later.); Perceived Stress Scale (Pre and post intervention: baseline, up to 4 months later.); Pediatric Asthma Quality of Life Questionnaire (Pre and Post Intervention: baseline, up to 4 months later.); Asthma Self-Management Scale (Pre and Post Intervention: baseline, up to 4 months later.); KIDCOPE (Pre and Post Intervention: baseline, up to 4 months later.); Measure of Current Status (MOCS - Adapted) (Pre and Post Intervention: baseline, up to 4 months later.); Change in Asthma Health from Baseline (Pre to post-intervention: baseline, up to 4 months later.)
D: Pulmonary functioning (FEV-1, FVC) (Measured at study entry and Months 7 (post treatment) and 12); Hospital and emergency department utilization (for asthma exacerbation) (Measured at study entry and Months 7 (post treatment) and 12)

Answer: B