TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Food Incentives for TB Treatment Compliance in East Timor
Brief Summary: This study will examine whether food is a cost-effective method for improving treatment compliance for TB patients in Timor Leste. Our hypothesis is that the provision of locally available, locally acceptable, cheap and highly nutritious food at the clinic will encourage patients to come for daily directly observed treatment, and thus improve the chance of TB cure and decrease the chance of the development of TB drug resistance. Primary outcome will be successful completion of treatment and secondary outcomes will include treatment compliance and clinical and biological measures of nutritional improvement.


Options:
A: Pill count (18 months)
B: proportion of patients who successfully complete TB treatment and achieve cure.
C: N/A
D: Improved Warfarin Adherence/% Timeout of Target INR Range (six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Food Incentives for TB Treatment Compliance in East Timor
Brief Summary: This study will examine whether food is a cost-effective method for improving treatment compliance for TB patients in Timor Leste. Our hypothesis is that the provision of locally available, locally acceptable, cheap and highly nutritious food at the clinic will encourage patients to come for daily directly observed treatment, and thus improve the chance of TB cure and decrease the chance of the development of TB drug resistance. Primary outcome will be successful completion of treatment and secondary outcomes will include treatment compliance and clinical and biological measures of nutritional improvement.


Options:
A: Proportion of pulmonary TB patients who are culture negative at 1 month (1 month); Difference in improvement in composite clinical endpoint comprising weight, cough clearance and FEV1 at 2 months. (2 months)
B: Change in Z score for weight and improvement in X ray film (6 months)
C: Proportion of pulmonary TB patients who are culture negative in sputum in week 4 (week 4); Difference in improvement in clinical endpoints consisting of cough clearance, percentage chest x-ray clearance, fever remission and weight increase upto 8 weeks. (8 weeks)
D: proportion of patients who successfully complete TB treatment and achieve cure.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Relapse Prevention Trial in Top End Aboriginal People With Chronic Mental Illness
Brief Summary: A new treatment for indigenous people with mental illness in remote communities has been developed. The study hypothesis is that this new treatment will result in better outcomes for clients and carers than the outcomes of clients and carers who do not receive the treatment. The treatment is a combination of a talking treatment and sharing of stories about mental health. The treatment will be delivered to the client with their chosen carer and with the local Aboriginal Mental Health Worker or Health Worker. The treatment will be given by the research team - a psychiatrist and an indigenous research officer. The trial will compare two groups of clients - a control group which is receiving 'treatment as usual', and the group which receives the new treatment. Measures of social functioning and symptoms of mental illness will be administered at base line and every six months for two years.


Options:
A: Number of cannabis-abstinent days in past month (Baseline, 6 months, 10 months)
B: Substance use and function questionnaire (2 years)
C: Health of Nations Outcome Scale (HONOS) (Baseline, 6 months, 12 months, 18 months,)
D: Cannabis use reduction in the follow-up (Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up.); Improvement in the development of psychotic disorder (Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up); Changes in the components of the endogenous cannabinoid system (Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up); Normalizing the possible alterations in the endogenous cannabinoid system (Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Relapse Prevention Trial in Top End Aboriginal People With Chronic Mental Illness
Brief Summary: A new treatment for indigenous people with mental illness in remote communities has been developed. The study hypothesis is that this new treatment will result in better outcomes for clients and carers than the outcomes of clients and carers who do not receive the treatment. The treatment is a combination of a talking treatment and sharing of stories about mental health. The treatment will be delivered to the client with their chosen carer and with the local Aboriginal Mental Health Worker or Health Worker. The treatment will be given by the research team - a psychiatrist and an indigenous research officer. The trial will compare two groups of clients - a control group which is receiving 'treatment as usual', and the group which receives the new treatment. Measures of social functioning and symptoms of mental illness will be administered at base line and every six months for two years.


Options:
A: Craving for cannabis (1 hour)
B: Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score (3 months post-baseline); Hair Testing (3 month post-baseline)
C: abstinence, defined as no evidence of cannabis use during the past 4 weeks as evidenced by self report and a negative urine screen; number of times a cannabis product was used in the past 4 weeks; retention rate (at the end of treatment)
D: Health of Nations Outcome Scale (HONOS) (Baseline, 6 months, 12 months, 18 months,)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Relapse Prevention Trial in Top End Aboriginal People With Chronic Mental Illness
Brief Summary: A new treatment for indigenous people with mental illness in remote communities has been developed. The study hypothesis is that this new treatment will result in better outcomes for clients and carers than the outcomes of clients and carers who do not receive the treatment. The treatment is a combination of a talking treatment and sharing of stories about mental health. The treatment will be delivered to the client with their chosen carer and with the local Aboriginal Mental Health Worker or Health Worker. The treatment will be given by the research team - a psychiatrist and an indigenous research officer. The trial will compare two groups of clients - a control group which is receiving 'treatment as usual', and the group which receives the new treatment. Measures of social functioning and symptoms of mental illness will be administered at base line and every six months for two years.


Options:
A: Rate of LDL cholesterol control (< 100 mg/dL) (12 months); Rate of blood pressure control (< 130/80 mmHg) (12 months); Rate of HbA1c control (<7%) (12 months)
B: Health of Nations Outcome Scale (HONOS) (Baseline, 6 months, 12 months, 18 months,)
C: completion of colorectal cancer screening (1 year)
D: Patient adherence (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Drug Elution and DIstal Protection During Percutaneous CoronAry Intervention in sT Elevation Myocardial InfarctiON. Acronym: Dedication
Brief Summary: The purpose of this study is to evaluate the clinical, echocardiographic and angiographic outcome of distal protection in the infarct related coronary artery and implantation of drug eluting versus bare metal stents in patients with ST-elevation myocardial infarctions treated acutely with percutaneous coronary intervention.


Options:
A: In segment Late Lumen Loss (6 months post index procedure)
B: ST segment resolution (90 min); Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up). (immediately after and at 8 month follow up)
C: MACE (12 months)
D: The evaluation of the degree of ST-segment resolution after the mechanical intervention. (90 minutes after last balloon inflation); The cumulative rate of death for any cause, reinfarction and target vessel revascularisation (8 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Elective Versus Therapeutic Neck Dissection in the Treatment of Early Node Negative Squamous Cell Carcinoma of the Oral Cavity
Brief Summary: Cervical nodal metastasis is the single most important prognostic factor in head and neck cancers. Appropriate management of the neck is therefore of paramount importance in the treatment of these cancers. While it is obvious that the positive neck must be treated, controversy has always surrounded the clinically node negative neck with respect to the ideal treatment policy.The situation is difficult with regards to early cancers of the oral cavity (T1/T2). These cancers are usually treated with surgery where excision is through the per-oral route. Elective neck dissection in such a situation is an additional surgical procedure with its associated costs, prolonged hospitalization and may be unnecessary in as high as 80% of patients who finally turn out to be pathologically node negative. Should the neck be electively treated or there be a wait and watch policy? Current practice is that the neck is always addressed whenever there is an increased propensity to cervical metastasis or when patient follow-up is unreliable.

There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.

Primary Objective:

To demonstrate whether elective neck dissection (END) is equal or superior to the wait and watch policy i.e.

therapeutic neck dissection (TND) in the management of the clinically No neck in early T1 /T2 cancers of the oral cavity.

Secondary Objective:

1. Does Ultrasound examination have any role in the routine initial workup of a node negative patient?
2. How are patients ideally followed up -does sonography have a role or is clinical examination sufficient.
3. Is assessment of tumor thickness by the surgeon at the time of initial surgery accurate -Is there a correlation
4. Identify histological prognostic factors in the primary that may help identify a sub-set of patients at an increased risk for cervical metastasis.


Options:
A: Nodal recurrence rate (24 months after the surgery)
B: Overall Survival (5 years)
C: Recurrence-free survival (5 years)
D: Overall survival

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Elective Versus Therapeutic Neck Dissection in the Treatment of Early Node Negative Squamous Cell Carcinoma of the Oral Cavity
Brief Summary: Cervical nodal metastasis is the single most important prognostic factor in head and neck cancers. Appropriate management of the neck is therefore of paramount importance in the treatment of these cancers. While it is obvious that the positive neck must be treated, controversy has always surrounded the clinically node negative neck with respect to the ideal treatment policy.The situation is difficult with regards to early cancers of the oral cavity (T1/T2). These cancers are usually treated with surgery where excision is through the per-oral route. Elective neck dissection in such a situation is an additional surgical procedure with its associated costs, prolonged hospitalization and may be unnecessary in as high as 80% of patients who finally turn out to be pathologically node negative. Should the neck be electively treated or there be a wait and watch policy? Current practice is that the neck is always addressed whenever there is an increased propensity to cervical metastasis or when patient follow-up is unreliable.

There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.

Primary Objective:

To demonstrate whether elective neck dissection (END) is equal or superior to the wait and watch policy i.e.

therapeutic neck dissection (TND) in the management of the clinically No neck in early T1 /T2 cancers of the oral cavity.

Secondary Objective:

1. Does Ultrasound examination have any role in the routine initial workup of a node negative patient?
2. How are patients ideally followed up -does sonography have a role or is clinical examination sufficient.
3. Is assessment of tumor thickness by the surgeon at the time of initial surgery accurate -Is there a correlation
4. Identify histological prognostic factors in the primary that may help identify a sub-set of patients at an increased risk for cervical metastasis.


Options:
A: Opreation Duration (1 day)
B: Overall Survival (5 years)
C: Survival rate (Up to 5 years)
D: Recurrence-free survival (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial To Assess The Impact Of Loco-Regional Treatment On Survival Of Patients With Metastatic Breast Cancer At First Presentation
Brief Summary: Traditionally metastatic breast cancer patients are not offered loco-regional treatment except in cases of fungation or bleeding. However, scientific evidence for such omission of loco-regional treatment in metastatic breast cancer patients is lacking. On one hand, studies have shown that removal of primary tumor at times leads to complete disappearance of metastases and improvement in survival in renal cell carcinoma patients. However, such studies have never been performed in other solid tumors. On the other hand, there is a strong body of evidence in experimental settings that show that removal of primary tumor allows growth of metastasis. There is lack of similar data in humans in clinical settings. Offering loco-regional treatment in metastatic breast cancer patients in a setting of randomized controlled trial will help in improving survival of such patients and understanding the natural history of breast cancer.


Options:
A: Overall survival (3 years); Progression free survival (3 years)
B: Survival (participants will be followed until death (expected median survival 31 months for surgery group))
C: Progression-Free Survival (PFS) Determined by an Independent Review Facility (Tumor assessments every 9 weeks from randomization to IRF-determined PD or death from any cause, whichever occurred first, up to the primary completion date (up to 3 years, 3 months))
D: Measure: all cause mortality (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting. A Prospective Randomized Clinical Trial.
Brief Summary: Gastric emptying is delayed after cardiac surgery, but the efficacy of the nasogastric (NG) tube in preventing distension and reducing vomiting is unclear. Nasogastric (NG) tubes are routinely used in patients undergoing surgery. They are presumed to reduce postoperative nausea and vomiting (PONV) and to lessen the risk of aspiration by reducing residual gastric volumes; however, their insertion and use is not however without potentially serious complications. Existing literature does not address their efficacy in reducing PONV after cardiac surgery. However, current evidence suggests that up to 50% of patients in this group suffer significant nausea and vomiting. The objective of this study is to determine whether NG tubes should continue to be inserted routinely during cardiac surgery to reduce PONV.


Options:
A: Postoperative Functional mobility; Restricting factors for functional mobility
B: Hemoglobin difference (14 days)
C: Composite score of any one of the following events occurring 6 months after cardiac surgery: (1) all-cause mortality; (2) myocardial infarction; (3) new onset renal failure requiring dialysis; or (4) new focal neurological deficit (stroke). (Within 6 months after cardiac surgery.)
D: Primary outcome measures will be the incidence and severity of postoperative nausea and vomiting as well as paint while the patient is in the CVICU

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind Comparison of Lithium Monotherapy Versus Lithium Plus Divalproex for the Outpatient Management of Hypomania/Mania in Patients With Rapid Cycling Bipolar Disorder Comorbid With Substance Abuse/Dependence
Brief Summary: This study will determine the efficacy and safety of combination therapy with divalproex and lithium for treating mania in people with rapid cycling bipolar disorder and a substance abuse disorder.


Options:
A: Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment. (Week 13)
B: Time to Treatment for Emerging Symptoms of a Mood Relapse (Up to 6 months)
C: Effectiveness of topiramate to reduce cocaine use(assessed by a combination of self-report of use and urine assays for benzoylecgonine, the major metabolite of cocaine). (Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment))
D: Proportion of Cocaine Positive Urine Samples Per Treatment Condition (Urine samples collected 3 times weekly from week 1 through 26)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The PAL Trial (Physical Activity and Lymphedema)
Brief Summary: The purpose of the PAL trial is to increase the understanding of the experiences of long-term breast cancer survivors.

Study hypothesis: Strength training will not increase the rate of lymphedema or worsen lymphedema as compared to the non-exercising control participants.


Options:
A: 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)
B: Cognitive-psychosocial functions (3 and 6 months)
C: change in physical activity (baseline to 3 months); change in physical activity (3 mos to 6 months); change in physical activity (6 months to 12 months)
D: Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36) (baseline, 3, 6, and 12 months); Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The PAL Trial (Physical Activity and Lymphedema)
Brief Summary: The purpose of the PAL trial is to increase the understanding of the experiences of long-term breast cancer survivors.

Study hypothesis: Strength training will not increase the rate of lymphedema or worsen lymphedema as compared to the non-exercising control participants.


Options:
A: psychosocial well-being (as assessed by the EORTC-QLQ C30 Quality of life core questionnaire by the European Organization of Research and Treatment in Cancer (EORTC-QLQ C30) and the Profile of Mood States Short form (POMS-SF) (baseline, 1 month follow-up, 6 month follow-up, 12 month follow-up)
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: Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL) (Baseline to up to 6 months); Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months); Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months)
D: Stimulated ln (TNF-a) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-6) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-1b) (Immediately post-treatment and 3 months post-treatment); MFSI-SF Fatigue (Immediately post-treatment and 3 months post-treatment); Vitality, SF-36 (Immediately post-treatment and 3 months post-treatment); CES-D (Immediately post-treatment and 3 months post-treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The PAL Trial (Physical Activity and Lymphedema)
Brief Summary: The purpose of the PAL trial is to increase the understanding of the experiences of long-term breast cancer survivors.

Study hypothesis: Strength training will not increase the rate of lymphedema or worsen lymphedema as compared to the non-exercising control participants.


Options:
A: Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores. (12 months)
B: Change from Baseline in Arthralgia Severity (6 months); Change from Baseline in Arthralgia Severity (12 months)
C: 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)
D: Disease-free Survival (5-year estimates, reported at a median follow-up of 67 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The PAL Trial (Physical Activity and Lymphedema)
Brief Summary: The purpose of the PAL trial is to increase the understanding of the experiences of long-term breast cancer survivors.

Study hypothesis: Strength training will not increase the rate of lymphedema or worsen lymphedema as compared to the non-exercising control participants.


Options:
A: 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)
B: Mean change in quality of life from baseline to week 12 (12 weeks)
C: Physical function (baseline, 3, 6 months)
D: Falls (Baseline up to 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The PAL Trial (Physical Activity and Lymphedema)
Brief Summary: The purpose of the PAL trial is to increase the understanding of the experiences of long-term breast cancer survivors.

Study hypothesis: Strength training will not increase the rate of lymphedema or worsen lymphedema as compared to the non-exercising control participants.


Options:
A: 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)
B: HRQOL urinary irritative score (12 month)
C: change in physical activity (6 months)
D: Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex. (10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').)

Answer: A