TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Physician-Based Trial to Increase Colorectal Cancer Screening in Chinese
Brief Summary: The objective of this study is to test whether a culturally-tailored in-office based intervention have impact on increasing Chinese physician's recommendation of colorectal cancer (CRC) screening to their nonadherent Chinese patients.

Special aims are to:

1. Evaluate the efficacy of a culturally-tailored physician intervention on increasing non-adherent Chinese American's patients' CRC screening rate.
2. Identify factors that mediate or moderate the intervention effects. For example, patients who hold an eastern cultural view or are less acculturated will be more likely to benefit from the intervention than patients who hold a western view or who are more acculturated.


Options:
A: Receipt of CRC screening (12 months)
B: Proportion of enrolled patients who attend for their assigned screening test (Immediate)
C: total communication score (2 weeks after information was given)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phonoaudiologic Therapy as an Adjunct to the Continuous Positive Airway Pressure Treatment on Patients With Obstructive Sleep Apnea Syndrome
Brief Summary: Objective: to evaluate the effects of a speech therapy exercises program in the treatment of Obstructive Sleep Apna Syndrome (OSAS) patients based on the clinical and polysomnography (PSG) parameters.

Methods: 80 patients with OSAS will be evaluated: men, 25-65 years old, body mass index \< 35 kg/m2 and scores of Epworth Sleepiness Scale \> 9. Patients will be divided into four groups: I: 20 patients with OSAS underwent speech therapy; II: 20 patients with OSAS underwent placebo therapy of Speech Therapy; III: 20 patients starting treatment with CPAP underwent speech therapy; IV: 20 patients starting treatment with CPAP without speech therapy or placebo. The speech therapy include isometric and isotonic exercises to improve posture, mobility and muscle tone of the soft palate, pharyngeal constrictor muscles, tip and base of tongue, cheeks and lips. Placebo therapy includes relaxation exercises and stretching neck, without therapeutic purpose. Both therapies are applied for three months, three times a day, lasting 20 minutes each session. During the treatment, the subjects will be monitored in weekly meetings, for orientation and description of the exercises and return of the fulfilled exercises diary. The subjects will also be followed at the CPAP clinic in returns after one week, a month and at the end of the study. Conduct assessments before and after treatment and after twenty one days washout, including: assessing the upper airway, anthropometric investigation of the facial skeleton and speech of Orofacial, questionnaires (Epworth Sleepiness Scale, FOSQ, General Segment and use of CPAP, WHOQOL-BREF, snoring), Psychomotor Vigilance Test and PSG.


Options:
A: Adherence to positive airway pressure (PAP) therapy (3 months after treatment initiation)
B: Apnea-Hypopnea Index (Baseline and 180 Days)
C: Cost (Medical service use and cost will be collected every 3 months for the entire observation period. Thus the shortest duration of follow-up in the study is anticipated to be 3 months, while the longest will be 2.25 years.)
D: objective sleep pattern (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phonoaudiologic Therapy as an Adjunct to the Continuous Positive Airway Pressure Treatment on Patients With Obstructive Sleep Apnea Syndrome
Brief Summary: Objective: to evaluate the effects of a speech therapy exercises program in the treatment of Obstructive Sleep Apna Syndrome (OSAS) patients based on the clinical and polysomnography (PSG) parameters.

Methods: 80 patients with OSAS will be evaluated: men, 25-65 years old, body mass index \< 35 kg/m2 and scores of Epworth Sleepiness Scale \> 9. Patients will be divided into four groups: I: 20 patients with OSAS underwent speech therapy; II: 20 patients with OSAS underwent placebo therapy of Speech Therapy; III: 20 patients starting treatment with CPAP underwent speech therapy; IV: 20 patients starting treatment with CPAP without speech therapy or placebo. The speech therapy include isometric and isotonic exercises to improve posture, mobility and muscle tone of the soft palate, pharyngeal constrictor muscles, tip and base of tongue, cheeks and lips. Placebo therapy includes relaxation exercises and stretching neck, without therapeutic purpose. Both therapies are applied for three months, three times a day, lasting 20 minutes each session. During the treatment, the subjects will be monitored in weekly meetings, for orientation and description of the exercises and return of the fulfilled exercises diary. The subjects will also be followed at the CPAP clinic in returns after one week, a month and at the end of the study. Conduct assessments before and after treatment and after twenty one days washout, including: assessing the upper airway, anthropometric investigation of the facial skeleton and speech of Orofacial, questionnaires (Epworth Sleepiness Scale, FOSQ, General Segment and use of CPAP, WHOQOL-BREF, snoring), Psychomotor Vigilance Test and PSG.


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

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Lower Limb Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation
Brief Summary: The purpose of this study was to investigate whether lower limb ischaemic preconditioning can improve renal function in patients undergoing living donor kidney transplantation


Options:
A: In-hospital death (Postoperative 30 days); Myocardial infarction (Postoperative 30 days); Stroke (Postoperative 30 days); Respiratory failure (Postoperative 30 days); Renal dysfunction (Postoperative 30 days); Renal failure (Postoperative 30 days); Cardiogenic shock (Postoperative 30 days); Gastrointestinal complication (Postoperative 30 days)
B: postoperative serum troponin I levels (postoperatibe 1, 6, 12, 24, 48, 72 hr)
C: Myocardial injury after PCI. (24 hours)
D: Plasma Creatine Concentration of the Recipients (within the first 3days after the operation); Urinary Output of the Recipients Postoperatively (within the first 3days after the operation); Plasma Concentration of NGAL in the Recipients (within the first 24hours after the operation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 vs Placebo as Part of a Treatment Regimen Including Peginterferon α-2a and Ribavirin in Treatment-naïve, Genotype 1 Hepatitis Cinfected Subjects
Brief Summary: The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alpha-2a and ribavirin as part of their treatment.


Options:
A: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)
B: Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR) (Weeks 4 and 12); Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24) (Follow-up Week 24); Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died (From start of study treatment (day 1) up to follow-up Week 48)
C: Percentage of Participants Achieving SVR12 (Post-treatment Week 12); Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 12)
D: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 vs Placebo as Part of a Treatment Regimen Including Peginterferon α-2a and Ribavirin in Treatment-naïve, Genotype 1 Hepatitis Cinfected Subjects
Brief Summary: The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alpha-2a and ribavirin as part of their treatment.


Options:
A: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) (Follow-up Week 12)
B: Part 1: Rapid Virological Response (RVR) (4 weeks); Part 2: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 52 weeks); Part 3 and 4: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 36 weeks)
C: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)
D: Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population. (At Follow-up Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Pilot Study: the Effect of Dry Cupping on Pain and Sensory Thresholds in the Treatment of Chronic Non Specific Neck Pain
Brief Summary: The study aims to investigate the influence of 5 dry cupping treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group at T0 (Day 0). At T1 (Day 7)the investigators evaluate the neck pain (VAS), the neck related disability (NDI), pain related to movement (PRTM) and the quality of life (SF36). To investigate neurophysiological effects of cupping we also measure mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain threshold (PPT) at pain related and control areas. The treatment group then receives 5 cupping treatments over a period of two weeks. After the cupping series resp. a waiting period for the waiting list control group (T2, Day 25) all measurements from T1 are repeated (VAS, NDI, PRTM, SF36, MDT, PPT, VDT). At last, a pain and medication diary is filled in by the patients from T0(Day 0) until T2 (Day 25). The investigators hypothesize, that cupping treatment is effective against neck pain (diary, VAS, NDI, PRTM, SF36) and that it leads to changes on perceptual level (MDT, VDT, PPT), when compared to the waiting list control group.


Options:
A: Improvement in neck related dysfunction (4 weeks); Improvement in pain levels (4 weeks)
B: Numeric pain rating scale (NPRS) (Baseline); Numeric pain rating scale (NPRS) (post 3 weeks); Pain pressure threshold (baseline); Pain pressure threshold (post 3 weeks); Thoracic ROM (Baseline); Thoracic ROM (post 3 weeks)
C: Pain intensity (at T2 (Day 25))
D: Change in Numeric Pain Rating Scale (NPRS) (Week 0, 1, 2, 3, 13, 25)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23
Brief Summary: This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.


Options:
A: Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment (Baseline and 52 weeks); Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment (Baseline and 76 weeks)
B: Change From Baseline in A1C at Week 26 (Excluding Rescue Approach) (Baseline and Week 26); Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach) (Up to Week 106); Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach) (Up to Week 104)
C: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26)
D: Change From Baseline in HbA1c at Week 30 (Week 0 to Week 30)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23
Brief Summary: This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.


Options:
A: Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin) (Week 0, Week 26)
B: Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke (up to 5.2 years); Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. (up to 5.2 years)
C: Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. (Up to 27.8 months.)
D: Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment (Baseline and 52 weeks); Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment (Baseline and 76 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Active-control, Double-blind, Double-dummy Study to Evaluate the Efficacy and Safety of Tafenoquine for the Treatment of Plasmodium Vivax in Adults
Brief Summary: This Phase II study is designed to determine whether a single 600 mg dose or 400mg/day for 3 days of tafenoquine is efficacious, and well tolerated for clearing P. vivax malaria infection (blood schizontocidal and gametocytocidal activity) and preventing P. vivax relapse (hypnozoite eradication). It will also further establish the safety and tolerability of these doses of tafenoquine.


Options:
A: Proportion of participants in the TQ group having retinal changes from Baseline in Central subfield thickness and Central retinal lesion thickness (Baseline and Day 90(follow-up)); Proportion of participants in the TQ group having retinal changes from Baseline in Total macular volume (Baseline and Day 90(follow-up)); Proportion of participants in the TQ group having retinal changes from Baseline in Ellipsoid zone disruption (Baseline and Day 90(follow-up)); Proportion of participants in the TQ group having retinal changes from Baseline in abnormal auto-fluorescence patterns (Baseline and Day 90(follow-up))
B: Percentage of Participants With Clinically Relevant Hemolysis. (Up to Day 180); Percentage of Female Participants With Moderate Glucose-6 Phosphate Dehydrogenase (G6PD) Deficiency Experiencing Clinically Relevant Hemolysis. (Up to Day 180)
C: Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate (28 Days)
D: Number of Participants With Recurrence-free Efficacy at 6 Months Post Dose (6 months post dose)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Active-control, Double-blind, Double-dummy Study to Evaluate the Efficacy and Safety of Tafenoquine for the Treatment of Plasmodium Vivax in Adults
Brief Summary: This Phase II study is designed to determine whether a single 600 mg dose or 400mg/day for 3 days of tafenoquine is efficacious, and well tolerated for clearing P. vivax malaria infection (blood schizontocidal and gametocytocidal activity) and preventing P. vivax relapse (hypnozoite eradication). It will also further establish the safety and tolerability of these doses of tafenoquine.


Options:
A: Recurrence of P. vivax (52 weeks)
B: Incidence rate (per person-year) of symptomatic recurrent P. vivax (12 months)
C: Pharmacokinetic Parameters of Primaquine and Carboxyprimaquine in breast milk. Area Under Curve (AUC) (13 Days. Time Frame: predose, 0,1,2,3,4,6,8,12,24,72 hours; Day 7, Day 13 post-dose)
D: Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate (28 Days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Chronic Care Model Based QI Program to Improve the Care of Patients With CKD
Brief Summary: The goal of this study is to evaluate the impact of a chronic care model (CCM) based quality improvement program on 1) outcomes for patients with chronic kidney disease (CKD) and 2) adherence to CKD guidelines. This pilot study will evaluate the feasibility of a CCM based quality improvement program for patients with CKD and assess potential mechanisms for the intervention's effect.

Hypothesis: Implementing a CCM based quality improvement program including system level support in the form of collaborative care, a CKD registry, and provider education will 1) reduce systolic BP in patients with poorly controlled hypertension, 2) increase the percentage of patients appropriately monitored for metabolic complications, and 3) decrease the rate of catheter use in patients initiating dialysis.


Options:
A: Change in Body mass index (BMI) (Baseline, 6 and 9 month follow-up.)
B: Behavior change (6 month -12 months post-partum)
C: Adherence with care (one year)
D: Systolic Blood Pressure (SBP) (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Chronic Care Model Based QI Program to Improve the Care of Patients With CKD
Brief Summary: The goal of this study is to evaluate the impact of a chronic care model (CCM) based quality improvement program on 1) outcomes for patients with chronic kidney disease (CKD) and 2) adherence to CKD guidelines. This pilot study will evaluate the feasibility of a CCM based quality improvement program for patients with CKD and assess potential mechanisms for the intervention's effect.

Hypothesis: Implementing a CCM based quality improvement program including system level support in the form of collaborative care, a CKD registry, and provider education will 1) reduce systolic BP in patients with poorly controlled hypertension, 2) increase the percentage of patients appropriately monitored for metabolic complications, and 3) decrease the rate of catheter use in patients initiating dialysis.


Options:
A: Percent of patients that are at least 80% adherent (Medication possession rate > 0.8) to antihypertensives and statins (One year from inclusion)
B: Systolic Blood Pressure (SBP) (one year)
C: systolic blood pressure (6 months)
D: Adherence to inhaled corticosteroid medication (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Chronic Care Model Based QI Program to Improve the Care of Patients With CKD
Brief Summary: The goal of this study is to evaluate the impact of a chronic care model (CCM) based quality improvement program on 1) outcomes for patients with chronic kidney disease (CKD) and 2) adherence to CKD guidelines. This pilot study will evaluate the feasibility of a CCM based quality improvement program for patients with CKD and assess potential mechanisms for the intervention's effect.

Hypothesis: Implementing a CCM based quality improvement program including system level support in the form of collaborative care, a CKD registry, and provider education will 1) reduce systolic BP in patients with poorly controlled hypertension, 2) increase the percentage of patients appropriately monitored for metabolic complications, and 3) decrease the rate of catheter use in patients initiating dialysis.


Options:
A: Systolic Blood Pressure (SBP) (one year)
B: Referral for Kidney Transplantation (One Year)
C: Knowledge of increased risk donor kidney transplants (1 week)
D: referral to a nephrologist (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Chronic Care Model Based QI Program to Improve the Care of Patients With CKD
Brief Summary: The goal of this study is to evaluate the impact of a chronic care model (CCM) based quality improvement program on 1) outcomes for patients with chronic kidney disease (CKD) and 2) adherence to CKD guidelines. This pilot study will evaluate the feasibility of a CCM based quality improvement program for patients with CKD and assess potential mechanisms for the intervention's effect.

Hypothesis: Implementing a CCM based quality improvement program including system level support in the form of collaborative care, a CKD registry, and provider education will 1) reduce systolic BP in patients with poorly controlled hypertension, 2) increase the percentage of patients appropriately monitored for metabolic complications, and 3) decrease the rate of catheter use in patients initiating dialysis.


Options:
A: Change in Pain, Sexual Dysfunction, and Depression Symptoms (12 months)
B: The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. (one year)
C: Progression of albuminuria (1,2,3,4 and 5 year)
D: Systolic Blood Pressure (SBP) (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dry Needling Versus Strain Counterstrain Technique: Pilot Study Comparing Effects Over the Upper Trapezius Myofascial Trigger Point
Brief Summary: This study investigates the effect of two different techniques (dry needling and Strain-counterstrain manual technique) on the upper trapezius myofascial trigger point (MTP). Subjects with active or latent MTP in this location of the muscle will be identified and will be randomly assigned to one out of three groups: dry needling, strain-counterstrain or placebo manual technique. Pain pressure threshold, provoked pain, pain at rest, neck disability and electromyography (EMG) activity of the upper trapezius will be registered before and after six sessions of treatment.


Options:
A: Pain Pressure Threshold (6 sessions)
B: Numeric pain rating scale (NPRS) (Baseline); Numeric pain rating scale (NPRS) (post 3 weeks); Pain pressure threshold (baseline); Pain pressure threshold (post 3 weeks); Thoracic ROM (Baseline); Thoracic ROM (post 3 weeks)
C: Pain Intensity (T2 (84 days))
D: Neck Disability Index (NDI) (baseline and post intervention 2 weeks)

Answer: A