TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Multicentre, Open Label Study to Evaluate the Efficacy of the Combination of Lanreotide Autogel 120mg and Temozolomide in Patients With Progressive Gastro-entero-pancreatic Neuroendocrine Tumours (GEP-NET) G1/G2 - A Pilot-Study
Brief Summary: The purpose of the study is to evaluate the efficacy and tolerability of the combination of Lanreotide Autogel 120 mg and Temozolomide in patients with progressive gastro-entero-pancreatic neuroendocrine tumours (GEP-NET) graded as G1 or G2 (G1/G2). All progressive tumours classified according to Response Evaluation Criteria In Solid Tumours (RECIST, 1.1).


Options:
A: Disease Control Rate (DCR) After 6 Months (6 months)
B: Progression Free Survival (PFS) (up to approx. 18 months)
C: Change of standardized uptake value of 68Ga-DOTA-TATE before and after the treatment in metastatic neuroendocrine tumors (1 year); the safety of 3.7GBq of 177Lu-DOTA-EB-TATE with and without amino acid infusion. (1 year)
D: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period (First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.1 Weeks)); Primary: Percent Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels (Baseline and 12 Weeks); Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Extension Period (First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 52.6 Weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Neoadjuvant and Adjuvant Dabrafenib and Trametinib in Patients With Clinical Stage III Melanoma (Combi-Neo)
Brief Summary: This is a single arm phase II trial focused on how dabrafenib and trametinib before and after surgery works in treating patients with stage IIIB-C melanoma that has a specific mutation in the BRAF gene. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving dabrafenib and trametinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving dabrafenib and trametinib after surgery may kill any remaining tumor cells.


Options:
A: Relapse-free survival (RFS) (Up to 1 year)
B: Recurrence-Free Survival (RFS) (24 months after last participant was randomized (data cutoff date of 30 April 2019))
C: The alteration in magnitude of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood (12 weeks from baseline); Safety as measured by SUSARs. (12 weeks from baseline); The alteration in breadth of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood (12 weeks from baseline); Feasibility as measured adherence to the timelines in the study protocol. (12 weeks from baseline)
D: The proportion of viable melanoma tissue, compared to baseline, in dissected lymph node and / or in-transit tumour tissue after 12 weeks of neoadjuvant treatment. (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Neoadjuvant and Adjuvant Dabrafenib and Trametinib in Patients With Clinical Stage III Melanoma (Combi-Neo)
Brief Summary: This is a single arm phase II trial focused on how dabrafenib and trametinib before and after surgery works in treating patients with stage IIIB-C melanoma that has a specific mutation in the BRAF gene. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving dabrafenib and trametinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving dabrafenib and trametinib after surgery may kill any remaining tumor cells.


Options:
A: Relapse-free survival (RFS) (Up to 1 year)
B: Major Pathologic Response (MPR) (54 weeks)
C: 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))
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Selective or Stepwise Removal of Deep Caries in Deciduous Molars: A Multi-center Randomized Controlled Trial
Brief Summary: Background: For treating deep caries lesions, selective or stepwise, i. e. one- and two-step incomplete excavation seems advantageous compared with complete caries removal. However, current evidence regarding the success, as defined by not requiring any re-treatments, or survival of teeth after different excavations is insufficient for definitive recommendation, especially when treating deciduous teeth. Moreover, restoration integrity has not been comparatively analyzed longitudinally, and neither patients', dentists' or parents' preferences nor the clinical long-term costs emanating from both initial and re-treatments have been reported yet.

Our primary hypothesis is that success rates differ significantly between selectively and stepwise excavated teeth. Secondary hypotheses are that restoration integrity is assumed to significantly differ between selectively and stepwise excavated teeth.


Options:
A: The survival of the tooth with vital pulp and without apical radiolucency. The x-ray evaluation and the clinical sensibility test are carried out by a blinded observer. (1 year after inclusion in the CAP-2)
B: restauration evaluation (18 months)
C: Proportion of Subjects With All Caries Arrested (Two years); Prevalence of Dental Caries as Measured by a Clinical Oral Examination (Participants were evaluated biannually over a total of four years or until lost to follow-up, whichever occurred first.)
D: Success (re-intervention required no/yes) (36 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment
Brief Summary: This is a study describing changes in inflammation of the airways in asthmatics before and after smoking cessation and steroid treatment.


Options:
A: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))
B: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)
C: reducers (week-24 from baseline)
D: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to 30 days after last dose of study treatment or up to Week 16); Number of Participants With Psychiatric Adverse Events (Baseline up to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) (Baseline to Week 12); Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) (Baseline to Week 24); Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase (Week 1 to Week 12 (Treatment phase)); Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase (Week 13 to Week 24 (Post treatment phase)); Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline (Bsl) to Week 12); Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline to Week 24); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1 (Baseline, Week 1); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12 (Baseline, Week 12); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24 (Baseline, Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment
Brief Summary: This is a study describing changes in inflammation of the airways in asthmatics before and after smoking cessation and steroid treatment.


Options:
A: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
B: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))
C: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
D: 7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8) (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment
Brief Summary: This is a study describing changes in inflammation of the airways in asthmatics before and after smoking cessation and steroid treatment.


Options:
A: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline (week-12); Sustained smoking abstinence at week-12 (week 12)
B: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)
C: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))
D: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment
Brief Summary: This is a study describing changes in inflammation of the airways in asthmatics before and after smoking cessation and steroid treatment.


Options:
A: Rating of urges to smoke 1-week after the target quit (1 week)
B: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))
C: N/A
D: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment
Brief Summary: This is a study describing changes in inflammation of the airways in asthmatics before and after smoking cessation and steroid treatment.


Options:
A: Quit Rate (4 months)
B: Validated smoking cessation (6 months)
C: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))
D: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment
Brief Summary: This is a study describing changes in inflammation of the airways in asthmatics before and after smoking cessation and steroid treatment.


Options:
A: 6 Month Smoking Abstinence (6 months after smoking quit date); 12 Month Smoking Abstinence (12 months after smoking quit date)
B: Quit Rate (Study weeks 6 through 9)
C: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
D: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment
Brief Summary: This is a study describing changes in inflammation of the airways in asthmatics before and after smoking cessation and steroid treatment.


Options:
A: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))
B: Tobacco use abstinence (26 week)
C: Long term abstinence (one year)
D: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment
Brief Summary: This is a study describing changes in inflammation of the airways in asthmatics before and after smoking cessation and steroid treatment.


Options:
A: Days of abstinence following the programmed lapse (7 days)
B: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
C: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
D: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Herbal Galactogogues: a Double-blinded, Placebo-controlled Randomized Trial.
Brief Summary: The purpose of this study is to assess the effectiveness of a commercially available product containing a combination of Silybum marianum and Galega officinalis to support continuation or augmentation of breast milk production.


Options:
A: a.successful initiation of lactation as determined by lactogenesis II markers, maternal perception and timing c.timing of successful establishment of lactogenesis II (within the first two weeks postpartum)
B: Percentage of mothers who exclusively breastfeed their child (At 6 weeks postpartum)
C: Incident Type 2 Diabetes (baseline to 12 years postpartum)
D: The Main Outcome Variable of This Study is the Quantity of Milk Produced. ("Day 0" , "Day 8")

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Changes in Function, Cervical Range of Motion and Pinch Grip Force After Physical Therapy in Carpal Tunnel Syndrome: A Randomized Clinical Trial
Brief Summary: This randomized clinical trial will investigate changes in hand function, active cervical range of motion and pinch grip force after the application of physical therapy in women with carpal tunnel syndrome (CTS). The purpose of this study is to compare changes in function, cervical range of motion and pinch grip force induced after the application of a physical therapy program including manual therapies targeted to those areas related to the median nerve or after endoscopic surgery in women with CTS at medium and long-term follow-up. The hypothesis is that manual therapy is more effective for increasing cervical range of motion and pinch grip force, but similarly effective for improving function, than surgical treatment in women with CTS.


Options:
A: Changes in the intensity of pain symptoms between baseline and follow-up periods (Baseline and 1, 3, 6 and 12 months after the intervention)
B: Changes in hand function between baseline and follow-up periods (Baseline and 1, 3, 6 and 12 months after the intervention)
C: Percentage of Participants Achieving Sustained Remission Rate At Week 104 (Week 104)
D: Carpal Tunnel Syndrome Assessment Questionnaire- function scale (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise in the Dialysis Unit: a Randomized Factorial Pilot Study on the Feasibility and Safety of Intradialytic Exercise
Brief Summary: The primary aim of this pilot study is to evaluate the feasibility and safety of four different types of intradialytic exercise (exercise performed during dialysis) programs: resistance, aerobic, combined resistance and aerobic, and flexibility (attention control). The secondary aim of the study is to estimate the effect of aerobic and resistance exercise, each compared with the attention control on: health-related quality of life, tests of physical performance, strength, and physical activity outside of the dialysis unit. The results of this study will be used to inform the planning of a full-scale efficacy study.


Options:
A: The composite risk score (at entry and after 10 months)
B: The number of participants with an adverse event (Change from baseline to 12 weeks); Adherence to the exercise protocol (At 12 weeks); The number of dropouts (At the end of the study, 6 months); Human activity profile (Change from baseline to 12 weeks); The number of participants who adopted the other group's exercise (Change from baseline and 12 weeks); The proportion of patients that would continue their current intradialytic exercise program after the study is over. (At the end of the study, 6 months.)
C: Physical Activity (Baseline and 12 weeks)
D: Assessment of Quality of Life (QoL) modification by the KIDNEY DISEASE QUALITY OF LIFE (KDQOL)questionary (6 months); Assessment of functional capacity by Six-Minute Walking test and Sit-to-Stand-to-sit test (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The primary objective of the investigators study was to design a comprehensive and medically accurate contraception counseling mobile health application and evaluate the effects of this contraception counseling application on the contraceptive methods that patients selected and their knowledge of that method.


Options:
A: Contraception choice (Participants were followed for the duration of their clinic visit which was up to one day)
B: Confirmed HBV and HCV test uptake (enrollment - 4 weeks after enrollment)
C: Rate of Enrollment (Month 12); Acceptability of the mHealth application (Month 12)
D: Smoking status by collecting an expired carbon monoxide breath sample (3-Month Follow-Up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Coaching to Reduce Disparities for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study examined whether health coaches can improve the management of chronic obstructive pulmonary disease (COPD) in a population of vulnerable patients cared for in 'safety-net' clinics. The study is designed as a randomized controlled trial for patients with moderate to severe COPD. Patients were randomized into a health coaching group and a usual care group. Those in the health coaching group received 9 months of active health coaching. Outcome variables were measured at baseline and after 9 months


Options:
A: Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT (Up to 1 week after the transplant education day)
B: Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score (9 months); Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) (9 months)
C: Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36) (Baseling, 12month, 24month)
D: Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale) (same day as HIV test counseling (cross-sectional study))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Coaching to Reduce Disparities for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study examined whether health coaches can improve the management of chronic obstructive pulmonary disease (COPD) in a population of vulnerable patients cared for in 'safety-net' clinics. The study is designed as a randomized controlled trial for patients with moderate to severe COPD. Patients were randomized into a health coaching group and a usual care group. Those in the health coaching group received 9 months of active health coaching. Outcome variables were measured at baseline and after 9 months


Options:
A: Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score (9 months); Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) (9 months)
B: Chronic Respiratory Disease Questionnaire (CRQ) (12 weeks)
C: 30 day readmission rate (30 days)
D: inflammatory cytokines (6 months); C-reactive protein (CRP) (6 months); Incremental shuttle walk test (ISWT) (6 months); spirometry (6 months); strength of limb muscles (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Coaching to Reduce Disparities for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study examined whether health coaches can improve the management of chronic obstructive pulmonary disease (COPD) in a population of vulnerable patients cared for in 'safety-net' clinics. The study is designed as a randomized controlled trial for patients with moderate to severe COPD. Patients were randomized into a health coaching group and a usual care group. Those in the health coaching group received 9 months of active health coaching. Outcome variables were measured at baseline and after 9 months


Options:
A: Readmission rate (6 month)
B: Adverse events (Evaluation at 12 months.)
C: Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge (1 month)
D: Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score (9 months); Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) (9 months)

Answer: D