TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Suicidal Adults With Alcohol or Drug Use Problems: A New Hospital-based Treatment
Brief Summary: Individuals with alcohol or drug use problems who are hospitalized for suicide attempt are at high risk for reattempt. This treatment development study adapts a promising outpatient intervention to prevent suicide reattempt in order to administer it during hospitalization to individuals with alcohol and drug use problems, and to test the adapted intervention in a pilot randomized controlled trial.


Options:
A: suicide reattempt (6 months)
B: Client Satisfaction Questionnaire (Immediately following Brief Intervention)
C: PTSD Symptoms (CAPS, SCID, PDS, IESR) (1.5 years)
D: Changes in score of Affective Lability Scale (Baseline and then weekly for 12 weeks); Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder (Baseline and then weekly for 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Suicidal Adults With Alcohol or Drug Use Problems: A New Hospital-based Treatment
Brief Summary: Individuals with alcohol or drug use problems who are hospitalized for suicide attempt are at high risk for reattempt. This treatment development study adapts a promising outpatient intervention to prevent suicide reattempt in order to administer it during hospitalization to individuals with alcohol and drug use problems, and to test the adapted intervention in a pilot randomized controlled trial.


Options:
A: Repeat Suicide Attempts (1, 3, 6, and 12 months)
B: Clinical Global Impression (CGI) (Day 0); Suicide Intent Scale (Day 0); Montgomery-Asberg depression rating scale (Day 0)
C: suicide reattempt (6 months)
D: Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr (Screening, 6 weeks, 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Suicidal Adults With Alcohol or Drug Use Problems: A New Hospital-based Treatment
Brief Summary: Individuals with alcohol or drug use problems who are hospitalized for suicide attempt are at high risk for reattempt. This treatment development study adapts a promising outpatient intervention to prevent suicide reattempt in order to administer it during hospitalization to individuals with alcohol and drug use problems, and to test the adapted intervention in a pilot randomized controlled trial.


Options:
A: Existence of a suicide (6 months); Existence of a suicide (13 months)
B: Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months (Baseline, 6 month and 12 month follow up)
C: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)
D: suicide reattempt (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors.
Brief Summary: The purpose of this study is to determine whether Medroxyprogesterone Acetate (MPA) administration in follicular phase prevents premature luteinization with equal efficiency as GnRH antagonists and otains similar clinical results in oocyte donation.


Options:
A: Ongoing pregnancy (12 weeks of gestation)
B: donor ovarian response (1 month)
C: live birth rate (10 months for group A, 12 months for group B)
D: Compare number of oocytes using GnRH antagonist versus PMA. (36 hours: from triggering until Oocyte retrieval)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects on Oxidative Stress and Platelet Activation of Traditional Cigarettes, E-cigarettes and IQOS Cigarettes: A Randomized in Vivo Study.
Brief Summary: Electronic cigarettes (E-cigarettes) and new heat-not-burn tobacco products such as IQOS®, an electronic device that heats a cigarette-like stick without combustion, are a modern and technological surrogate of traditional tobacco cigarettes (T-cigarettes), that are entering in the commercial market. While the negative effects of the traditional cigarette are well known, little data are reported in scientific literature on the risks on the health by these new smoking devices. Endothelial dysfunction evaluated by flow-mediated dilatation (FMD), oxidative stress and platelet activation have been recognized as a hallmark of preclinical systemic atherosclerosis and as a useful marker to stratify the risk of cardiovascular disease in patients at risk or with established clinically significant atherosclerosis. Since no data are reported about the effects of these new smoking device on oxidative stress, platelet activation and FMD, the investigators designed a human study assessing if these new smoking devices have effects on healthy smokers.


Options:
A: Toxicant Exposure (6 weeks)
B: Endothelial dysfunction (up to 24 weeks); Oxidative stress (up to 24 weeks)
C: Number of Participants With Smoking Cessation (12 WEEK)
D: Traditional smoking cessation rate (5 years); Change from baseline in the number of traditional cigarette smoked (6, 12, 24, 36 and 60 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects on Oxidative Stress and Platelet Activation of Traditional Cigarettes, E-cigarettes and IQOS Cigarettes: A Randomized in Vivo Study.
Brief Summary: Electronic cigarettes (E-cigarettes) and new heat-not-burn tobacco products such as IQOS®, an electronic device that heats a cigarette-like stick without combustion, are a modern and technological surrogate of traditional tobacco cigarettes (T-cigarettes), that are entering in the commercial market. While the negative effects of the traditional cigarette are well known, little data are reported in scientific literature on the risks on the health by these new smoking devices. Endothelial dysfunction evaluated by flow-mediated dilatation (FMD), oxidative stress and platelet activation have been recognized as a hallmark of preclinical systemic atherosclerosis and as a useful marker to stratify the risk of cardiovascular disease in patients at risk or with established clinically significant atherosclerosis. Since no data are reported about the effects of these new smoking device on oxidative stress, platelet activation and FMD, the investigators designed a human study assessing if these new smoking devices have effects on healthy smokers.


Options:
A: smoking cessation (52 weeks)
B: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)
C: Number of Participants With Smoking Cessation (12 WEEK)
D: Endothelial dysfunction (up to 24 weeks); Oxidative stress (up to 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects on Oxidative Stress and Platelet Activation of Traditional Cigarettes, E-cigarettes and IQOS Cigarettes: A Randomized in Vivo Study.
Brief Summary: Electronic cigarettes (E-cigarettes) and new heat-not-burn tobacco products such as IQOS®, an electronic device that heats a cigarette-like stick without combustion, are a modern and technological surrogate of traditional tobacco cigarettes (T-cigarettes), that are entering in the commercial market. While the negative effects of the traditional cigarette are well known, little data are reported in scientific literature on the risks on the health by these new smoking devices. Endothelial dysfunction evaluated by flow-mediated dilatation (FMD), oxidative stress and platelet activation have been recognized as a hallmark of preclinical systemic atherosclerosis and as a useful marker to stratify the risk of cardiovascular disease in patients at risk or with established clinically significant atherosclerosis. Since no data are reported about the effects of these new smoking device on oxidative stress, platelet activation and FMD, the investigators designed a human study assessing if these new smoking devices have effects on healthy smokers.


Options:
A: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)
B: Change in Metabolic Syndrome Prevalence (Changes in the prevalence of Metabolic Syndrome from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years)
C: Toxicant Exposure (6 weeks)
D: Endothelial dysfunction (up to 24 weeks); Oxidative stress (up to 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects on Oxidative Stress and Platelet Activation of Traditional Cigarettes, E-cigarettes and IQOS Cigarettes: A Randomized in Vivo Study.
Brief Summary: Electronic cigarettes (E-cigarettes) and new heat-not-burn tobacco products such as IQOS®, an electronic device that heats a cigarette-like stick without combustion, are a modern and technological surrogate of traditional tobacco cigarettes (T-cigarettes), that are entering in the commercial market. While the negative effects of the traditional cigarette are well known, little data are reported in scientific literature on the risks on the health by these new smoking devices. Endothelial dysfunction evaluated by flow-mediated dilatation (FMD), oxidative stress and platelet activation have been recognized as a hallmark of preclinical systemic atherosclerosis and as a useful marker to stratify the risk of cardiovascular disease in patients at risk or with established clinically significant atherosclerosis. Since no data are reported about the effects of these new smoking device on oxidative stress, platelet activation and FMD, the investigators designed a human study assessing if these new smoking devices have effects on healthy smokers.


Options:
A: Intervention effect on Flow-mediated dilatation (FMD) assessed via ultrasound (%FMD). (6 months following quit day.)
B: Electronic cigarette use (weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks); electronic cigarette acceptability (Baseline, week 2, week6, week 10 and week 24); Respiratory symptoms (weekly measures from baseline to 10 weeks and at 24 weeks); Cotinine (Baseline, week 2, 6, 10 and 24); Nitrosamines (Baseline and at 6 week); Side effects of antipsychotics (weekly the first 10 weeks and at 24 weeks); Withdrawal symptoms (weekly the first 10 weeks and at 24 weeks); Respiratory symptoms (weekly the first 10 weeks and at 24 weeks)
C: Endothelial dysfunction (up to 24 weeks); Oxidative stress (up to 24 weeks)
D: Change in pulmonary health (dry cough, breath shortness, mouth irritation) index (baseline, 6 months, 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Coordinated Rehabilitation in Acute Phase After Hip Fracture - a Model for Increased Patient Participation.
Brief Summary: Background Studies have shown that patients with hip fracture treated in a Comprehensive Geriatric Care (CGC) unit report better results in comparison to orthopaedic care. Furthermore, involving patients in their healthcare by encouraging patient participation can result in better quality of care and improved outcomes. To our knowledge no study has been performed comparing rehabilitation programmes within a CGC unit during the acute phase after hip fracture with focus on improving patients' perceived participation and subsequent effect on patients' function.

Method A prospective, controlled, intervention performed in a Comprehensive Geriatric Care (CGC) unit and compared with standard CGC. A total of 126 patients with hip fracture were recruited who were prior to fracture; community dwelling, mobile indoors and independent in personal care. Intervention Group (IG): 63 patients, mean age 82.0 years and Control Group (CG): 63 patients mean age 80.5 years. Intervention: coordinated rehabilitation programme with early onset of patient participation and intensified occupational therapy and physiotherapy after hip fracture surgery. The primary outcome measure was self-reported patient participation at discharge. Secondary outcome measures were: TLS-BasicADL; Bergs Balance Scale (BBS); Falls Efficacy Scale FES(S); Short Physical Performance Battery (SPPB) and Timed Up and Go (TUG) at discharge and 1 month and ADL staircase for instrumental ADL at 1 month.


Options:
A: Quality of life (2 years)
B: Self-rated degree of patient participation in rehabilitation (At discharge from in-patienten rehabilitation, on average 14 days)
C: Mobility (1, 4 and 12 months after surgery)
D: Quality of life (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3b, Multicenter, Prospective, Randomized, Double Blind, Placebocontrolled Study to Reduce Incidence of Pre-dialysis Hyperkalemia With Sodium Zirconium Cyclosilicate (DIALIZE)
Brief Summary: The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia in patients on hemodialysis.


Options:
A: Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 (21 to 28 Days)
B: Change in Serum Potassium From Part A Baseline to Part A Week 4 (Part A Baseline to Part A Week 4); Change in Serum Potassium From Part B Baseline (Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L)
C: Percentage of Responders (Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15.); Percentage of Responders When Accounting for Missing Central Laboratory Serum Potassium Data (Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15.)
D: Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). (22 Days; Maintenance Phase Days 8 - 29, inclusive.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Culture Free Diagnosis and Follow-up of Multidrug Resistant Tuberculosis Patients
Brief Summary: Recent advances in molecular diagnostics of tuberculosis, especially the GeneXpert Mycobacterium tuberculosis/Rifampicin test have reduced the time to diagnose Rifampicin Resistant Tuberculosis (RR-TB) but only rifampicin resistance is diagnosed, leading to presumptive diagnosis of resistance to isoniazid and maybe other drugs. Thus in low and middle income countries, most drug sensitivity testing relies on phenotypic drug resistance testing, which takes up to 4 months. In addition, currently, culture on monthly sputum samples is recommended by the World Health Organization for follow-up of Rifampicin Resistant Tuberculosis patients under treatment. Unfortunately, culture is often not locally available and samples need to be transported from field to culture laboratories. The associated transport delays lead to high rates of contamination and false negative culture, particularly in laboratories in low resource settings. Many gaps for the diagnosis and management of RR-TB patients still need to be addressed and the DIAMA project (DIAgnostics for Multidrug resistant tuberculosis in Africa) study aims to address some of them.


Options:
A: Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH and ETH resistance detection (Day 1); Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for fluoroquinolone resistance detection (Day 1); Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for second-line injectable resistance detection (Day 1)
B: Validation of Deeplex test (4 years); Validation of GeneXpert 2nd line (4 years); Validation of MolBio TrueNat for INH, FQ and BDQ (4 years); Validation of FDA microscopy (4 years); Validation of GeneXpert Ct value (4 years)
C: Treatment time (Up to 8 weeks)
D: Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay (Day 1)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitively-Based Compassion Training (CBCT) for the Improvement of Health Related Quality of Life, Fear of Illness Recurrence, Compassion and Self-compassion in Breast Cancer Survivors Sample
Brief Summary: There is a growing number of evidence of how mindfulness training enhances psychological and physical well-being and coping strategies in patients with oncological illnesses. However, there are very few studies analyzing the efficacy of Compassion-Based Interventions on breast cancer survivors.

The goal of this study is to analyze enrollment, participant satisfaction and adherence to program and differences in psychological well-being, health related quality of life, fear of illness recurrence, compassion and self-compassion variables after a Compassion-Based Intervention in a Spanish breast cancer survivor sample.

This study is a randomized clinical trial of a secularized intervention called Cognitively-Based Compassion Training (CBCT). Subjects (n = 58) were randomly assigned to CBCT (n = 28) or a treatment as usual control group (TAU) (n = 28). Participants in the CBCT intervention condition were asked to meet weekly for a two (2) hour long session during two months. Pre-post-intervention and six month follow-up measures took place to evaluate: psychological well-being (somatic, depressive, and anxious symptomatology), health related quality of life (physical, social, emotional, and functional); psychological stress, coping strategies and triggering cognitions linked to cancer recurrence fear, self-compassion, compassion and mindfulness and awareness in both intervention and wait list groups.

CBCT is a promising and potentially useful intervention to enhance physical and emotional well-being in breast cancer survivors. Nevertheless, future randomized trials are needed and a process of cultural adaptation required.


Options:
A: Hospital Anxiety and Depression Scale (change from baseline to one month post-intervention)
B: Change in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B+4) (8 weeks, 6 months)
C: The efficacy of Mindfulness Based Stress Reduction on mood disorders (up to 5 years follow up)
D: Change in quality of life (T0: before chemotherapy (week 0); T1: in the middle of chemotherapy (i.e. week 4 to 10); T2: three weeks after last cycle of chemotherapy (i.e. week 13 to 20).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Two Different Treatments for Lower Pore Renal Stone: Microperc Vs FURS
Brief Summary: This is a prospect, randomized control trial to evaluate merits between microperc and FURS for lower pole renal stone


Options:
A: Number of patients stone free SFR 4 (1 month from treatment)
B: SFR (3 month)
C: The change in urine NGAL/Cr value (2 hours preoperative and 2 hours postoperatively)
D: Analgesic demand (Postoperative 24 hours); Stone clearance (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Two Different Treatments for Lower Pore Renal Stone: Microperc Vs FURS
Brief Summary: This is a prospect, randomized control trial to evaluate merits between microperc and FURS for lower pole renal stone


Options:
A: To assess the value of tranexamic acid (12 months)
B: The change in urine NGAL/Cr value (2 hours preoperative and 2 hours postoperatively)
C: Stone free rate (SFR) (The primary endpoint was the SFR at 3-months after surgery.)
D: SFR (3 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Two Different Treatments for Lower Pore Renal Stone: Microperc Vs FURS
Brief Summary: This is a prospect, randomized control trial to evaluate merits between microperc and FURS for lower pole renal stone


Options:
A: The primary outcome is death from haemorrhage (within 5 days of randomisation)
B: The change in urine NGAL/Cr value (2 hours preoperative and 2 hours postoperatively)
C: To assess the value of tranexamic acid (12 months)
D: SFR (3 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda
Brief Summary: This study examines the impact and cost associated with Suubi4Her, an innovative combination intervention that aims to prevent HIV risk behaviors among 15-17 year-old girls living in communities heavily affected by poverty and HIV/AIDS in Uganda. Participants will be randomly assigned at the school level into one of three study conditions: 1) Savings (Youth Development Accounts - YDA) - with a 1:1 incentive match rate - for education and microenterprise development; 2) Savings (YDA) + Multiple Family Groups intervention; 3) Control condition receiving standard health and sex education provided in schools. The intervention will last for 24 months. Assessments will be conducted at baseline, 12, 24 and 36 months. Assessments will include biologically confirmed STIs, proportion of HIV infections during the study period, and for HIV+ participants markers for ART adherence. The study aims to examine the impact of the Suubi4Her intervention on behavioral health functioning, and protecting adolescent girls against known HIV risk factors. The study will also examine the cost-effectiveness of each intervention condition.


Options:
A: Change from baseline Mental health distress at 18 months (Baseline and 18 months post baseline)
B: Patient Health Questionnaire (PHQ-9) (8 weeks); WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) (8 weeks)
C: Proportion With STIs From Baseline to Follow-up Assessments (Baseline); Proportion With STIs From Baseline to Follow-up Assessments (12 months)
D: Remission (i.e. recovery from depression) and depressive symptoms, assessed by the PHQ-9 (6 months post-child birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections
Brief Summary: Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain. But needle handling during the procedure may cause pain and discomfort to the patient. At the local skin anesthesia step, local anesthetics injection to the muscle layer along the needle pathway as well as the subcutaneous layer may reduce the procedural pain. In addition, it can reduce the injection site pain that may occur after the procedure.


Options:
A: Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale (1 month after the start of treatment); Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale (3 months from the start of treatment); Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale (1 month from the start of treatment); Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale (3 months from the start of treatment)
B: Procedural Pain score (NRS) (Immediately after the procedure)
C: Radicular Pain Visual Analogue Scale (VAS) Score change from baseline (Baseline, 4 weeks, 8 weeks, 12 weeks post injection)
D: Numerical Rating Leg Pain Score (1 month)

Answer: B