TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Suicide Risk Associated With Weight Loss
Brief Summary: The purpose of this study is to examine the efficacy of an intervention aimed at promoting a healthy lifestyle and reducing risk factors associated with eating pathology, nonsuicidal self-injury, and suicidal behavior. We are also interested in assessing whether this intervention has the potential to prevent future symptoms of eating problems and self-harm urges and behaviors. The broader goal of this research is to identify factors that may help us better understand the prevention of self-harm behaviors and develop more effective treatments for these problems.


Options:
A: Columbia Suicide Severity Rating Scale Number of Participants Reporting Presence of Suicidal Behaviors (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); Columbia Suicide Severity Rating Scale Number of Suicidal Behaviors (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); The Number of Participants Reporting Columbia Suicide Severity Rating Scale Suicidal Ideation Categories as Most Severe (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); Columbia Suicide Severity Rating Scale Suicidal Ideation Intensity Scale Total Score (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); Number of Participants With Readmissions (Assessed on a monthly basis for 6 months follow-up.)
B: Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up (Pre-assessment and post-assessment (after intervention or two weeks from baseline))
C: drinking - measured using the TLFB (12 weeks); craving - measured using the OCDS (12 weeks); aggression - measured using the STAE (12 weeks)
D: EPs during BART (Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Suicide Risk Associated With Weight Loss
Brief Summary: The purpose of this study is to examine the efficacy of an intervention aimed at promoting a healthy lifestyle and reducing risk factors associated with eating pathology, nonsuicidal self-injury, and suicidal behavior. We are also interested in assessing whether this intervention has the potential to prevent future symptoms of eating problems and self-harm urges and behaviors. The broader goal of this research is to identify factors that may help us better understand the prevention of self-harm behaviors and develop more effective treatments for these problems.


Options:
A: Beck scale for suicidal ideation (six months)
B: Re-presentation to hospital with suicide attempt and/or suicidal ideations (7 days post intervention); Re-presentation to hospital with suicide attempt and/or suicidal ideations (14 days post intervention); Re-presentation to hospital with suicide attempt and/or suicidal ideations (30 days post intervention); Re-presentation to hospital with suicide attempt and/or suicidal ideations (90 days post intervention); Death by suicide rates (24 months post intervention)
C: Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up (Pre-assessment and post-assessment (after intervention or two weeks from baseline))
D: Scale for Suicide Ideation Index (SSI) (Over 8 weeks of treatment); Columbia Suicide Severity Rating Scale (C-SSRS): the Suicidal Ideation Scale (8 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Suicide Risk Associated With Weight Loss
Brief Summary: The purpose of this study is to examine the efficacy of an intervention aimed at promoting a healthy lifestyle and reducing risk factors associated with eating pathology, nonsuicidal self-injury, and suicidal behavior. We are also interested in assessing whether this intervention has the potential to prevent future symptoms of eating problems and self-harm urges and behaviors. The broader goal of this research is to identify factors that may help us better understand the prevention of self-harm behaviors and develop more effective treatments for these problems.


Options:
A: Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up (Pre-assessment and post-assessment (after intervention or two weeks from baseline))
B: Repetition of self-harm (Three months); Change scores on the Suicide Behaviors Questionnaire from baseline (Baseline and three months)
C: suicide reattempt (6 months)
D: Change in Beck Scale for Suicide Ideation Score (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Suicide Attempt Index (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Index of Spouse Abuse Score (Baseline, Week 10, Post-treatment Months 6 and 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Nifedipine Versus Intravenous Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa: Randomized Controlled Trial.
Brief Summary: Antepartum hemorrhage is defined as bleeding from or within the female genital tract, occurring from 28+0 weeks of pregnancy and till delivery of the fetus. it occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity and mortality worldwide


Options:
A: N/A
B: Prolongation of pregnancy (interval from time of randomization to time of delivery) for 48 hours (48 hours)
C: Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization (Two weeks after enrolled and randomized, up to 37 weeks of pregnancy)
D: The duration of prolongation of gestation (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor: a Randomized Controlled Trial
Brief Summary: Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors.

Different strategies have been studied for prevention of spontaneous PTB (SPTB) in randomized controlled trials (RCTs), including progesterone, cerclage, cervical pessary, as well as lifestyle modification, such as smoking cessation, diet, aerobic exercise, and nutritional supplements. Most successful effort to reduce the incidence of SPTB have focused on asympatomatic women with risk factors, such as prior SPTB or short cervix. However, most SPTB occur in symptomatic women, i.e. women with preterm labor (PTL). Women with arrested PTL are at increased risk of SPTB.

The cervical pessary is a silicone device that has been used to prevent SPTB. The leading hypotheses for its mechanisms are two: that the pessary helps to keep the cervix closed, and that the pessary changes the inclination of the cervical canal so that the pregnancy weight is not directly above the internal os.

The aim of the study is to assess the efficacy of pessary in reducing preterm birth in women with arrested preterm labor


Options:
A: Pre-term Birth (at the time of delivery)
B: Child's birth and survival（rate） (34+0 weeks)
C: Spontaneous preterm birth (SPTB) <34 weeks (Less than 34 weeks gestation)
D: Number of Subjects Experiencing Preterm Birth (Before 37 weeks gestation (20 0/7 - 36 6/7 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of the Effect of Replacing Sugar-sweetened Beverages With Non-nutritive Sweetened Beverages or Water on Gut Microbiome and Metabolic Outcomes: STOP Sugars NOW Trial
Brief Summary: Health authorities recommend a reduction in added sugars from sugar-sweetened beverages (SSBs) due to risk of obesity and diabetes. As a sugar-reduction strategy, finding the ideal SSB replacement is of the utmost importance. Those who are already consuming SSBs might not easily replace it with water and therefore non-nutritive sweetened beverages (NSBs) present a sweetened alternative, though guidelines recommend water instead of NSBs as a replacement for SSBs. Recent evidence suggests that saccharine, a non-nutritive sweetener, which is not found in NSBs, might induce glucose intolerance by altering gut microbiota in humans. It is currently not known if replacing SSBs with NSBs (which contain low-calorie sweeteners other than saccharine) or water will have any effect on the human gut microbiota and any downstream diabetic risk. The investigators plan to undertake a randomized controlled cross-over trial in 75 healthy adults to assess the effect of replacing SSBs with equal amounts of NSBs or water for 4 weeks on the composition and diversity of human gut microbiota, changes in glucose tolerance and total body fat in those who regularly drink SSBs. Each participant will act as their own control receiving each of the three interventions of SSB, NSB and water for four weeks in random order, each period separated by a four-week wash-out period. All study visits will occur at the Clinical Nutrition and Risk Factor Modification Centre at St. Michael's Hospital. This study will contribute to knowledge that will inform dietary guidelines and public policy with regards to the best possible replacement for SSBs. It will also shed light on the potential mechanism of the adverse effects of NSBs and if the replacement of SSBs by NSBs or water are in fact similar with respect to their effect on gut bacteria and any downstream diabetic risk.


Options:
A: Changes in the acute metabolic and hormonal response (glucose, insulin, leptin, active ghrelin, triglycerides, uric acid) (Baseline and 10 weeks); Changes in fat content of skeletal muscle and liver (Baseline and 10 weeks)
B: Change of de novo lipogenesis: palmitate tracer-to-tracee ratios by gas chromatography-mass spectrometry. (22 hours at Baseline and 4-week Intervention)
C: Physical Activity Energy Expenditure (kJ/Day or kcal/Day) (7 days (across 12 weeks) - Primary outcome at week 4)
D: Gut microbiome composition measured by 16S rRNA gene sequencing (Week 0 and week 4 of each intervention); 75g OGTT derived plasma glucose iAUC (Week 0 and week 4 of each intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Active-controlled, Double-blinded, Double-dummy, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Dialysis Subjects Treated With Erythropoiesis-Stimulating Agents (ESAs)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of molidustat in comparison to darbepoetin alfa in dialysis subjects with renal anemia who are treated with Erythropoiesis-Stimulating Agents (ESAs).


Options:
A: The mean Hb level during the evaluation period (From week 33 to 36); The change in mean Hb level during the evaluation period from baseline (Baseline and week 33 to 36)
B: Modeled Hgb Change From Baseline Over 4 Weeks of Treatment (Baseline (average of Week -2, -1 and Day 1) and Week 4)
C: Change in Hb from baseline to the average level (Weeks 7 to 9 inclusive.)
D: Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) (Baseline, Week 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Non-medical Health Worker (NMHW) Led Counseling on Common Mental Disorders in Rural Mid-western Nepal
Brief Summary: Psychological treatments may be provided by non-medical health workers (NMHW) to increase accessibility. Task shifting of screening and treatment of non-communicable diseases to non-medical health workers is both effective and cost-effective. A recent review included five randomized controlled trials to assess effectiveness of NMHW provided psychological interventions to treat common mental disorders and depression, and all five trials found the intervention beneficial over usual treatment.

The aim of this study is to assess the effectiveness of psychosocial counselling as practiced by non-medical psychosocial counsellors in improving the outcomes of persons with common mental disorders in a primary health care setting.

Patients with psychosocial distress will be randomized to receive either counseling + enhanced usual care or enhanced usual care by health workers. The hypothesis is that adding psychosocial counselling to enhanced usual care, will be more effective than enhanced care alone in reducing the symptoms of depression, anxiety and posttraumatic stress disorder and in improving day-to-day functioning of clients receiving services in primary health care settings.

If proven effective, non-medical health worker led counseling could be an affordable treatment to alleviate psychological suffering and improve functional capacity of Nepalese people.


Options:
A: Change from baseline post traumatic stress symptoms at 6 months (baseline and 6 month follow up); Change from baseline depression symptoms at 6 months (baseline and 6 month follow up); Change from baseline hope at 6 months (baseline and 6 month follow up)
B: Appetitive aggression (sumscore; 0-60 indicating higher levels) (Change from baseline to 3-5 and 6-9 months post treatment); Current violent behavior (sumscore; 0-96 indicating more acts) (Change from baseline to 3-5 and 6-9 months post treatment)
C: Parenting practices (One month and six months post-intervention)
D: The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory (0 months, 1 month, 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Non-medical Health Worker (NMHW) Led Counseling on Common Mental Disorders in Rural Mid-western Nepal
Brief Summary: Psychological treatments may be provided by non-medical health workers (NMHW) to increase accessibility. Task shifting of screening and treatment of non-communicable diseases to non-medical health workers is both effective and cost-effective. A recent review included five randomized controlled trials to assess effectiveness of NMHW provided psychological interventions to treat common mental disorders and depression, and all five trials found the intervention beneficial over usual treatment.

The aim of this study is to assess the effectiveness of psychosocial counselling as practiced by non-medical psychosocial counsellors in improving the outcomes of persons with common mental disorders in a primary health care setting.

Patients with psychosocial distress will be randomized to receive either counseling + enhanced usual care or enhanced usual care by health workers. The hypothesis is that adding psychosocial counselling to enhanced usual care, will be more effective than enhanced care alone in reducing the symptoms of depression, anxiety and posttraumatic stress disorder and in improving day-to-day functioning of clients receiving services in primary health care settings.

If proven effective, non-medical health worker led counseling could be an affordable treatment to alleviate psychological suffering and improve functional capacity of Nepalese people.


Options:
A: Psychosocial Stress: Insecurity (Regional Measure) (11 weeks); Psychosocial stress: Distress (Regional Measure) (11 weeks); Psychosocial Stress (International Measure) (11 weeks)
B: depression (pre, post and 6 months post treatment)
C: The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory (0 months, 1 month, 6 months)
D: Change of depression symptom from baseline at 3 and 6 months (0-3-6 months); Change of anxiety symptom from baseline at 3 and 6 months (0-3-6 months); Change of chronic pain symptom from baseline at 3 and 6 months (0-3-6 months); Change of anger from baseline at 3 and 6 months (0-3-6 months); Change of PTSD symptom from baseline at 3 and 6 months (0-3-6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Non-medical Health Worker (NMHW) Led Counseling on Common Mental Disorders in Rural Mid-western Nepal
Brief Summary: Psychological treatments may be provided by non-medical health workers (NMHW) to increase accessibility. Task shifting of screening and treatment of non-communicable diseases to non-medical health workers is both effective and cost-effective. A recent review included five randomized controlled trials to assess effectiveness of NMHW provided psychological interventions to treat common mental disorders and depression, and all five trials found the intervention beneficial over usual treatment.

The aim of this study is to assess the effectiveness of psychosocial counselling as practiced by non-medical psychosocial counsellors in improving the outcomes of persons with common mental disorders in a primary health care setting.

Patients with psychosocial distress will be randomized to receive either counseling + enhanced usual care or enhanced usual care by health workers. The hypothesis is that adding psychosocial counselling to enhanced usual care, will be more effective than enhanced care alone in reducing the symptoms of depression, anxiety and posttraumatic stress disorder and in improving day-to-day functioning of clients receiving services in primary health care settings.

If proven effective, non-medical health worker led counseling could be an affordable treatment to alleviate psychological suffering and improve functional capacity of Nepalese people.


Options:
A: EPDS (3 and 6 months)
B: Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI (Post-intervention and 3 month)
C: The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory (0 months, 1 month, 6 months)
D: depression (On completion of intervention and six months post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Preoperative Bathing With Chloroxylenol on the Incidence of Post Caesarean Section Surgical Site Infection at Mbarara Regional Referral Hospital: A Randomized Controlled Trial
Brief Summary: Surgical site infection (SSI) is the commonest hospital-acquired infection globally, and prevalence is much higher in the low-income countries. Caesarean delivery carries a 5-20 fold risk for developing postpartum sepsis. SSIs cause significant morbidity, prolonged hospitalization and mortality. Simple and inexpensive interventions like preoperative bathing need to be studied, to assess their impact on surgical site infection rates.


Options:
A: Postpartum Endometritis (30 day postoperative)
B: Composite Postoperative Infectious Morbidity (30 days postoperatively)
C: Post-intervention Aerobic Bacterial Colony Counts (From intervention to 7 days post); Post-intervention Anaerobic Bacterial Colony Counts (From intervention to 7 days post)
D: Surgical site infection (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery: A Randomized Double-blind Sham-controlled Crossover Trial
Brief Summary: Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surgery. In traditional SCS therapies, the objective has been to replace the pain sensation with paresthesia. The anticipation is that the electrical current alters pain processing by masking the sensation of pain with a comfortable tingling or paresthesia. Although patients mostly cope with paresthesia, a significant proportion reports that the sensation is unpleasant.

'Burst' SCS utilizes complex programming to deliver high-frequency stimuli. This SCS technique seems to provide paresthesia-free stimulation, resulting in better pain relief of low back and leg pain then traditional tonic stimulation.

The widespread use of SCS has not been backed by solid evidence. The absence of placebo-controlled trials has long been an important point of criticism, but due to the nature of the intervention with sensation of paresthesia, studies with placebo control have so far not been considered possible. When 'burst' SCS is used the stimulation is often unnoticed by the patient, allowing comparison with placebo stimulation.

The aim of this randomized double-blind sham-controlled crossover trial is to evaluate the efficacy of 'burst' spinal cord stimulation for chronic radicular pain following spine surgery.


Options:
A: Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups (6 months post randomization)
B: The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.
C: Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
D: Change from baseline in disease-specific functional outcome between active burst stimulation and placebo stimulation periods (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery: A Randomized Double-blind Sham-controlled Crossover Trial
Brief Summary: Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surgery. In traditional SCS therapies, the objective has been to replace the pain sensation with paresthesia. The anticipation is that the electrical current alters pain processing by masking the sensation of pain with a comfortable tingling or paresthesia. Although patients mostly cope with paresthesia, a significant proportion reports that the sensation is unpleasant.

'Burst' SCS utilizes complex programming to deliver high-frequency stimuli. This SCS technique seems to provide paresthesia-free stimulation, resulting in better pain relief of low back and leg pain then traditional tonic stimulation.

The widespread use of SCS has not been backed by solid evidence. The absence of placebo-controlled trials has long been an important point of criticism, but due to the nature of the intervention with sensation of paresthesia, studies with placebo control have so far not been considered possible. When 'burst' SCS is used the stimulation is often unnoticed by the patient, allowing comparison with placebo stimulation.

The aim of this randomized double-blind sham-controlled crossover trial is to evaluate the efficacy of 'burst' spinal cord stimulation for chronic radicular pain following spine surgery.


Options:
A: Mean VAS Back Pain (7 Day Subject VAS Pain Diary) (6 months post randomisation)
B: Oxford Shoulder Score (6 months post randomisation)
C: Pain intensity measured on a weighted NRS according to Jensen and a PGIC for pain measured on a 7-point Likert scale. (6 months)
D: Change from baseline in disease-specific functional outcome between active burst stimulation and placebo stimulation periods (12 months)

Answer: D