TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Understanding and Appraising the New Medicine Service in England
Brief Summary: About 25% medicines prescribed for long term conditions are not taken as directed, and approximately 15% people receiving a new medicine take few, if any, doses. The New Medicine Service (NMS) is a community pharmacy service that started in England in October 2011 which involves the pharmacist providing additional support to patients starting a new medicine for some breathing problems (asthma \& COPD), high blood pressure, adult onset diabetes or medicines which reduce blood clotting. It aims to improve the way patients take their medicines improving outcomes and reducing costs to the National Health Service (NHS).

The investigators will assess the effectiveness and cost effectiveness of the NMS using a research study where some people will receive the NMS, and some won't, so The investigators can look at the effect of the NMS on problems with their medicines, medicines taking and use of the NHS in general. Data will be collected in the East Midlands, South Yorkshire and London areas.

The investigators will recruit 500 patients from a range of different pharmacies and follow them up at six, ten and twenty six weeks after starting their new medicine to assess effects on medicines taking behaviour, patients' reported problems with medicines, referrals to their General Practitioner (GP) and use of NHS resources. The investigators will compare the data gathered from this study with that being collected routinely by all pharmacies in England to provide wider estimates of cost effectiveness.

The investigators will also explore how the NMS service is being implemented by pharmacies. A sample of patients from the main study will be followed in more detail. This will involve recording the consultations with the pharmacist and also interviewing patients about their experience of the service. The investigators will interview the patients GP to investigate their views of the service. The investigators will also try to understand why people decline the invitation for the NMS


Options:
A: Health related quality of life (Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up)
B: Changes in the use of NIV (At baseline and 18 months after baseline); Sustainability (36 months after training is completed); Acceptability and feasibility of the educational training (At 18 months after baseline); Penenetration of training (18 months after training is completed); Changes in Respiratory Therapist Job Autonomy (Pre-training (baseline), 12 months after training, 36 months after training); Changes in team functionality (Pre-training (baseline), 12 months after training, 36 months after training)
C: Chronic Obstructive Pulmonary Disease Self-Efficacy Scale (from baseline and at the end of the third months)
D: Medicines adherence (Change in adherence from 6 weeks to 10 weeks and 26 weeks); Cost effectiveness (6 months); Operation of the NMS (1 year from first recruited patient)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Understanding and Appraising the New Medicine Service in England
Brief Summary: About 25% medicines prescribed for long term conditions are not taken as directed, and approximately 15% people receiving a new medicine take few, if any, doses. The New Medicine Service (NMS) is a community pharmacy service that started in England in October 2011 which involves the pharmacist providing additional support to patients starting a new medicine for some breathing problems (asthma \& COPD), high blood pressure, adult onset diabetes or medicines which reduce blood clotting. It aims to improve the way patients take their medicines improving outcomes and reducing costs to the National Health Service (NHS).

The investigators will assess the effectiveness and cost effectiveness of the NMS using a research study where some people will receive the NMS, and some won't, so The investigators can look at the effect of the NMS on problems with their medicines, medicines taking and use of the NHS in general. Data will be collected in the East Midlands, South Yorkshire and London areas.

The investigators will recruit 500 patients from a range of different pharmacies and follow them up at six, ten and twenty six weeks after starting their new medicine to assess effects on medicines taking behaviour, patients' reported problems with medicines, referrals to their General Practitioner (GP) and use of NHS resources. The investigators will compare the data gathered from this study with that being collected routinely by all pharmacies in England to provide wider estimates of cost effectiveness.

The investigators will also explore how the NMS service is being implemented by pharmacies. A sample of patients from the main study will be followed in more detail. This will involve recording the consultations with the pharmacist and also interviewing patients about their experience of the service. The investigators will interview the patients GP to investigate their views of the service. The investigators will also try to understand why people decline the invitation for the NMS


Options:
A: Medicines adherence (Change in adherence from 6 weeks to 10 weeks and 26 weeks); Cost effectiveness (6 months); Operation of the NMS (1 year from first recruited patient)
B: Lung function after 2 weeks of treatment
C: Overall Discrepancy Rate (4-week Treatment Period); Overall Quartile Discrepancy Rate (4-week Treatment Period); Overall Discrepancy Size (4-week Treatment Period); End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population) (4-week Treatment Period)
D: The percentage of selected patients receiving anti-tabacco counseling recorded by the GPs in the labeled patients' medical records. (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)
Brief Summary: This research is being done to compare the physical and quality of life benefits of two different types of exercise- tai chi versus strength training- for female cancer survivors who have had chemotherapy. Each exercise- tai chi and strength training- will be compared to participants in a group that performs flexibility and relaxation exercises, which is expected to have different benefits than either tai chi or strength training.


Options:
A: Falls (Baseline up to 12 months)
B: Specific aim 1: To determine whether there are any changes in lymphedema in breast cancer survivors who participate in a one-year randomized exercise intervention of twice-weekly strength training, as compared to a non-exercising group. (1 year)
C: Mean change in quality of life from baseline to week 12 (12 weeks)
D: Physical function (baseline, 3, 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Probiotics and Allergic Diseases
Brief Summary: Many studies had demonstrated that probiotics could be applied in the prevention and adjuvant treatment for allergic diseases. In this study, we investigate the effects of Lactobacillus paracasei GMNL-133(LP), Lactobacillus fermentum GM-090 (LF), and Lactobacillus paracasei GMNL-133(LP) with Lactobacillus fermentum GM-090 (LF) combination products used for adjuvant treatment of atopic dermatitis and asthma.


Options:
A: The Effects of probiotics in improving life quality and symptomatic severity (2 years)
B: Allergic disease (Incidence until 2 years of age)
C: episodes of wheezing, drug use (inhalative steroids and betamimetics), hospital treatment (October 2002 - October 2004)
D: severity of atopic dermatitis (March 2007 - July 2008)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Diabetic Macular Edema (The BRDME Study)
Brief Summary: The primary objective is to demonstrate the non-inferiority of bevacizumab to ranibizumab in the treatment of patients with DME (OCT central area thickness \> 275 μm) as determined by the change in best-corrected visual acuity (BCVA) in the study eye from baseline to month 6.


Options:
A: Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year (Baseline to 1-year); Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69 (Baseline to 1-year); Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69 (Baseline to 1-year)
B: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12 (Baseline through the end of study (Month 12))
C: visual acuity; central macular thickness
D: Best Corrected Visual Acuity (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation
Brief Summary: The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.


Options:
A: Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events. (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (From baseline to 3 months post-procedure)
B: To provide confirmation that renal denervation is safe and feasible. (3 years)
C: Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence (up to 12 months)
D: Change in atrial fibrillation burden (from Baseline and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation
Brief Summary: The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.


Options:
A: Change in Office Systolic Blood Pressure (Baseline to 6 months post-randomization)
B: Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence (up to 12 months)
C: Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) (From baseline to 6 months post-procedure)
D: Freedom of AF or other atrial arrhythmias (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis
Brief Summary: The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.


Options:
A: Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response (12 weeks)
B: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)
C: Long-term Safety and Tolerability of Secukinumab (Week 268)
D: Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R (Week 16 of Period R)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis
Brief Summary: The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.


Options:
A: Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response (12 weeks)
B: Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks (12 weeks); Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1 (12 weeks)
C: Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 (0-12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (0 - 12 Weeks)
D: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis
Brief Summary: The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.


Options:
A: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)
B: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
C: Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at Week 52. (Baseline, Week 52)
D: Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis
Brief Summary: The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.


Options:
A: Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. (Twelve Weeks)
B: Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response (12 weeks)
C: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)
D: Percentage of Participants With a PASI 75 Response at Week 12 (Baseline and week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis
Brief Summary: The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.


Options:
A: Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 (Week 16)
B: Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response (12 weeks)
C: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) (Week 16); Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B) (Week 44)
D: Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA]) (Week 12); Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI]) (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Oropharyngeal Exercises on Snoring Intensity, Symptoms, Upper Airway Anatomy and Collapsability of Upper Airway Awake and Asleep in Patients With Primary Snoring and Mild to Moderate Obstructive Sleep Apnea
Brief Summary: Randomized study of patients with primary snore, mild and moderate obstructive sleep apnea. Protocol include 40 patients randomized to oropharyngeal exercise or use of nasal dilator, breathing exercise and nasal lavage. The objectives are study the effects of therapy on oropharyngeal in a series of clinical and physiologic and anatomic variables, changes on snore and quality of sleep using Pharyngeal Critical Pressure, Magnetic Resonance, Negative expiratory pressure and snore analyses. Hypothesis that the therapy group (oropharyngeal exercises) will have more modifications compared to the control group.


Options:
A: Snoring Intensity (12 weeks); Snoring Rate (12 weeks)
B: objective sleep pattern (90 days)
C: Apnea-hypopnea index (3 months)
D: Upper airway collapsability (3 months); Images from magnetic resonance (3 months); Negative expiratory pressure (3 months); Snore (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Korean Multicenter, Randomized, Double-Blind, Clinical Trial to Evaluate the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapies (MEC, Non-AC Regimes) With Broad Range of Tumor Types (KMEC Study)
Brief Summary: This is an efficacy and safety study to compare aprepitant with ondansetron for the prevention of nausea and vomiting in the first cycle of moderately emetogenic chemotherapy (MEC) in participants with solid tumors. MECs include a number of commonly used cancer chemotherapeutic drugs including: oxaliplatin-based, irinotecan-based, and carboplatin-based regimens.

The primary hypothesis of this study is that the Aprepitant Regimen is superior to the Control (ondansetron) Regimen with respect to the percentage of participants with No Vomiting Overall (in the 120 hours following initiation of MEC) in participants with solid tumors.


Options:
A: Number of Patients Who Reported No Vomiting (Overall phase (0-120 hours post initiation of MEC) in Cycle 1.)
B: Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting) (0-24h, 24-120h , 0-120h following chemotherapy)
C: The Percentage of Participants With No Vomiting - Overall Stage (Hour 0 on Day 1 to Day 5 (approximately 120 hours))
D: Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen (0 to 120 hours in the first cycle of chemotherapy)

Answer: C