TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face
Brief Summary: Lentigo malignant (LM) is an intraepidermal melanocytic proliferation occurring on photoexposed skin. In our project, this term applies both to Dubreuilh's melanosis and to Dubreuilh's intraepidermal melanoma. It consequently excludes invasive melanoma. Although surgery is the treatment of choice, it remains without consensus on the margins (5 mm or 10 mm) excision for a localized tumor on the face.

Several studies have shown that imiquimod, activating local immunity by interferon production, induced LM or MLM regression and could also decrease the frequency of relapses.

The principal aim of our project is to study the effect of imiquimod versus placebo in pre-operative neoadjuvant treatment aimed at reducing both surgical margins, as from the first surgical procedure, and the frequency of short and medium term recurrence of LM. Furthermore, the improvement in patient quality of life could also be significant.


Options:
A: The primary endpoint is the margin of resection. Success is defined by an extralesional excision as from the first surgical procedure performed with a healthy tissue margin of 5 mm. (10 weeks)
B: Safety of patients as measured by the adherence to the timelines in the study protocol (6 months); Feasability of patients as measured by the adherence to the timelines in the study protocol (6 weeks)
C: Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review (Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months))
D: Overall Survival (assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15); Recurrence Free Survival (assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial.
Brief Summary: Shoulder tip and abdominal pain following laparoscopic procedures are well recognized as causes of post-operative morbidity. This prospective, double-blind, randomized controlled trial attempts to reduce post-operative pain in patients undergoing laparoscopic surgery by implementing a simple intra-operative technique.

Patients who undergo elective laparoscopic cholecystectomy for gallbladder disease or laparoscopic inguinal hernia repair will be recruited to the trial. Patients will be randomized to either the current standard (control group) or to receive an intervention to remove residual CO2. In the intervention group the pneumo-peritoneum will be removed, at the end of the operation, by placing the patient in the Trendelenburg position and utilising a pulmonary recruitment maneuver consisting of two manual inflations to a maximum pressure of 60 cm H2O. In the control group residual pneumo-peritoneum will be evacuated at the end of the procedure by passive decompression via the open operative ports.


Options:
A: the severity and frequency of shoulder-tip pain after laparoscopic surgery (the first 48 hours after the surgery)
B: pain scores at varying time points pot operatively (48 hours)
C: Shoulder Pain (within 14 days)
D: The degree of shoulder pain after gynecologic laparoscopy (During the first 24hours after surgery; 1,6, 12, 24hr)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)
Brief Summary: This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.


Options:
A: Insulin Resistance and Insulin Secretion (1 year)
B: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. (From randomisation to individual end of observation, up to 4.6 years)
C: Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (Time from randomisation up to end of follow-up (scheduled at week 109))
D: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)
Brief Summary: This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.


Options:
A: Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) (Baseline , Week 24)
B: HbA1c Change From Baseline to Week 24 (Baseline and week 24)
C: Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (Time from randomisation up to end of follow-up (scheduled at week 109))
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)
Brief Summary: This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.


Options:
A: Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (Time from randomisation up to end of follow-up (scheduled at week 109))
B: Change of global myocardial function from baseline to 6 months of follow-up. (Recruitment period: 4,5 years. Follow-up assessment: 1 year. Analyses and reporting: 6 months. Overall duration: 6 years.)
C: Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years))
D: Primary Efficacy Outcome MACE Events (Time to first event. Information collected during study period (anticipated to be up to 7.5 years).); Primary Safety Outcome MACE Events (Time to first event. Information collected during study period (anticipated to be up to 7.5 years).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovery and Aftercare in Post Intensive Care Therapy Patients - The RAPIT Study. The Effectiveness and Experiences of a Follow-up Program for Danish Mechanically Ventilated ICU Patients: A Pragmatic Randomized Controlled Multicentre Trial.
Brief Summary: In 2010 alone were admitted 33,361 patients for treatment in Danish intensive care units. There is evidence to former intensive care patients have a significant symptom burden that affect recovery, function and activity for up to several years after admission to the intensive care unit. For the individual patient involves the low quality of life, delayed recovery, prolonged illness and healing process, and increased mortality. It requires that health professionals should provide support so patients quicker return to their usual life. Follow-up interviews with the staff after hospitalization in ICU have been shown to support the patient and identify individual needs and symptoms that can lead to more realistic expectations and increased well-being after admission in ICU. Follow-up in Denmark is being inconsistent in both the number of hospitals that offer this service, and in the offered type of service. Follow-up interviews with and without diaries suggest to improve physical and mental well-being and health, with limited scientific evidence of the efficacy of these interventions. We will investigate the effect of a standardized follow-up program after admission to the intensive care unit, consisting of written information, patient photos taken during hospitalization and three follow-up calls compared with standard care (discharge without follow-up).

During a clinical study conducted in several intensive care units in Denmark examined whether follow-up calls can improve patients' well-being and health, as well as the meaning of the follow-up program has on the patient's everyday life in the first year after hospitalization in the ICU.

The investigation contribute knowledge to the international research by revealing symptom burden and efficacy of a follow-up program for up to 1 year after admission to the ICU in order to be able to target rehabilitation efforts and improved the quality of life. It will be innovative to use the results from a clinical study as a foundation for a database, and the method can serve as a precedent for evidence-based introduction of guidelines, database registration and create the groundwork for future research in intensive care. This study is expected to be profitable to society by preventing frequent readmissions, reduce medication costs and fewer referrals to specialists and have a positive effect on retention to the labor market. This will provide overall better use of society's expenses.


Options:
A: N/A
B: Hospital Anxiety and Depression Scale Score (3 & 6 months post-randomization)
C: Diagnosis of Post Traumatic Stress Disorder (3 months post critical illness)
D: Quality of Life (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Decision Making Among Treatment Alternatives for Abnormal Uterine Bleeding (AUB)
Brief Summary: The purpose of this study is to determine if using a computer survey about preferences for treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient satisfaction with clinical care and decision making. This study is a two-part study. The first pilot tests the computerized tool to ensure it is understood by patients, then the second part is a randomized study (computerized tool versus usual care) to see if improvements are made in satisfaction and if there are reductions in decision regret.


Options:
A: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)
B: Differences in patient-reported satisfaction between treatment groups (6 weeks); Differences in decision regret between treatment groups (6 weeks)
C: Informed choice (2 weeks post intervention); Involvement in screening decision (2 weeks post intervention)
D: Multiple CVD risk factor control targets (42 months after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 4 Exercise Training in Aspects of Fatigue in Patients Receiving Dialysis Therapy
Brief Summary: The purpose of the current study is to investigate whether changes in patients' sleep quality and quantity will be followed by improvements in parameters related to physical and mental fatigue in patients receiving hemodialysis therapy.

More specific, the current project will investigate the effect of a 9 months intradialytic exercise training in aspects related to fatigue, quality of life and depression.


Options:
A: Feasibility - Screen:Enrollment Ratio (Screening); Adherence to Assigned Treatment Arm (4 months); Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] (Assessed every 2 weeks over 4 months); Mean Duration (in Minutes) of Recovery From Dialysis Treatments (Assessed every 2 weeks; Data averaged over 16 weeks)
B: Change from baseline in Physical Component Summary of Kidney Disease Quality of Life-36 questionnaire at 6 weeks, 12 weeks, and 24 weeks. (Baseline, 6 weeks, 12 weeks, and 24 weeks)
C: Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 4); Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 8); Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 12)
D: Levels of Fatigue (9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy
Brief Summary: The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel


Options:
A: Objective Response Rate (ORR) (From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)); Overall Survival (OS) (Up to 96 months)
B: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
C: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) (Up to 28 days in Cycle 1); Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)); Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)); ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015))
D: Overall Survival (assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15); Recurrence Free Survival (assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Brief Summary: The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma


Options:
A: Progression Free Survival (PFS) (From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)); Overall Survival (OS) (From randomization to date of death (Assessed up to September 2016, approximately 39 months)); Rate of Overall Survival (6, 12, and 24 months); Rate of Progression-Free Survival (6, 12, and 24 months)
B: Overall Survival (OS) (From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.); Overall Survival (OS) Rate (From randomization to 6 months and or to 12 months)
C: Recurrence-Free Survival (RFS) (24 months after last participant was randomized (data cutoff date of 30 April 2019))
D: Best Response Rate (Partial Response [PR] + Complete Response [CR]) (Up to 12 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: IPS-MA - a Randomized Clinical Trial Examining the Effect of a Modified IPS Intervention in Addition to Treatment As Usual Versus Treatment As Usual Alone for Individuals with Mood or Anxiety Disorders
Brief Summary: The aim of the present study, is to evaluate the effect of a supported employment intervention, IPS-modified for people with mood and anxiety (IPS-MA) on employment or education, when offered to people with onset mood or anxiety disorders who are not likely to be able to return to work within three month.

The hypothesis is that the IPS-MA method is associated with a shorter recovery period and more people returning to work or education, compared to treatment as usual.


Options:
A: Competitive employment or education (24 months)
B: Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation (Baseline and Week 8 or FOT)
C: Psychological symptoms (Change from baseline to after treatment (6-9 weeks), 3 and 12 months)
D: HAM-D17 (Before and after 3 months intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Caregivers/Healthy Children
Brief Summary: Background: Many unhealthy dietary and physical activity habits that foster the development of obesity are established by the age of five. Presently, approximately 70 percent of children in the United States are currently enrolled in early childcare facilities, making this an ideal setting to implement and evaluate childhood obesity prevention efforts. We describe here the methods for conducting an obesity prevention intervention randomized trial in the child care setting.

Methods/Design: A randomized, controlled obesity prevention trial in 28 low-income, ethnically diverse child care centers located throughout Miami-Dade County, FL is currently being conducted over two years (2010-present) to test the efficacy of an intervention that poises teachers and parents as lifestyle change agents. The Healthy Caregivers-Healthy Children (HC2) program includes a curriculum focusing specifically on healthy food choices, increased exercise, and role modeling. The program targets food policy changes throughout the school, and via the child, caregiver, and teacher. Major outcome measures include child body mass index percentile and z score, fruit and vegetable and other nutritious food intake, and amount of physical activity.

Discussion: Although few attempts have been made to prevent obesity during the first years of life, this period may represent the best opportunity for obesity prevention. Findings from this investigation should inform both the fields of childhood obesity prevention and early childhood research about the effects of an obesity prevention program housed in the childcare setting. (H1) A child care center-based obesity prevention intervention program that includes a teacher and parent nutritional gatekeeper and role modeling program will be more effective in maintaining BMI in 3-5 year olds compared to a control group.

(H2) Role modeling (teacher and parent) will be identified as a significant mediator in preventing obesity among intervention children versus controls.

(H3) A child care center-based multi-level obesity prevention intervention program will improve child nutrition (increased consumption of fruits and vegetables, decreased consumption of sweetened beverages) and increase physical activity level compared to a control group.


Options:
A: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)
B: Fidelity to WISE Evidence-Based Practices using the WISE fidelity observational measure (Through study completion, an average of 2 years)
C: 1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle. (3 years)
D: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)

Answer: D