TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Imaginator: a Pilot of a Brief Functional Imagery Training Intervention for Self-harm in Young People, Supported by a Smart-phone 'App'
Brief Summary: Self-harm has substantial personal impacts as well as costs on the National Health Service (NHS). Around 13-17% of young people report experiences of self-harm. In Cambridgeshire, this is a significant issue with the number of admissions to hospital for self-harm in young people being higher than the United Kingdom (UK) average. Treating underlying mental illness can lead to a reduction in self-harm, but these are long interventions for complex disorders and many people who self-harm are not under treatment for mental illness. Moreover, young people struggle to access traditional mental health services where these therapies are delivered. No short interventions specifically tailored for young people have been developed so far.

The Imaginator project aims to address the urgent need for an effective and innovative short-term therapy for self-harm in young people. The investigators will pilot a new imagery-based psychological intervention for young people aged 16-25 who experience repetitive self-harm. Mental imagery (the experience of "seeing through the mind's eye") can carry intense emotions (positive and negative), and imagining something can facilitate behaviour. Imagery-based therapies have proven useful (i) for problems that feature intense, hard to manage emotions such as those associated with self-harm, and (ii) for promoting healthy behaviour. Our new intervention called Functional Imagery Training will support young people to imagine more adaptive behaviours to cope with the emotional distress that triggers self-harm, and motivate them to reduce self-harm. Imaginator will comprise of just two sessions followed by phone support over three months.

Moreover, the investigators will address the challenge of young people accessing and staying in therapy by using a smartphone app to support the therapy, as apps are widely used and favoured by this age group. The app will enable participants to continue with the strategies they have learnt in therapy by themselves, thus ensuring a potential longer-term benefit and self-empowerment.


Options:
A: Reduced Self-harm (3 months)
B: Repeat suicide attempts (Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion)
C: Deliberate Self-harm Inventory (DSHI; Gratz, 2001) and Lifetime Suicide Attempt Self-Injury interview (LSASI; formerly Lifetime Parasuicide Count, Linehan MM, Comtois KA, unpublished manuscript, 1996) (baseline; 10 weeks; 20 weeks; 3 month follow up)
D: Suicidal thoughts or attempts (Measured at Year 2)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Imaginator: a Pilot of a Brief Functional Imagery Training Intervention for Self-harm in Young People, Supported by a Smart-phone 'App'
Brief Summary: Self-harm has substantial personal impacts as well as costs on the National Health Service (NHS). Around 13-17% of young people report experiences of self-harm. In Cambridgeshire, this is a significant issue with the number of admissions to hospital for self-harm in young people being higher than the United Kingdom (UK) average. Treating underlying mental illness can lead to a reduction in self-harm, but these are long interventions for complex disorders and many people who self-harm are not under treatment for mental illness. Moreover, young people struggle to access traditional mental health services where these therapies are delivered. No short interventions specifically tailored for young people have been developed so far.

The Imaginator project aims to address the urgent need for an effective and innovative short-term therapy for self-harm in young people. The investigators will pilot a new imagery-based psychological intervention for young people aged 16-25 who experience repetitive self-harm. Mental imagery (the experience of "seeing through the mind's eye") can carry intense emotions (positive and negative), and imagining something can facilitate behaviour. Imagery-based therapies have proven useful (i) for problems that feature intense, hard to manage emotions such as those associated with self-harm, and (ii) for promoting healthy behaviour. Our new intervention called Functional Imagery Training will support young people to imagine more adaptive behaviours to cope with the emotional distress that triggers self-harm, and motivate them to reduce self-harm. Imaginator will comprise of just two sessions followed by phone support over three months.

Moreover, the investigators will address the challenge of young people accessing and staying in therapy by using a smartphone app to support the therapy, as apps are widely used and favoured by this age group. The app will enable participants to continue with the strategies they have learnt in therapy by themselves, thus ensuring a potential longer-term benefit and self-empowerment.


Options:
A: Change in self-injury attentional bias as measured by a Dot Probe Paradigm (The Dot Probe Paradigm will be administered immediately preceding the mindfulness or control conditions and immediately following the mindfulness or control conditions)
B: Reduced Self-harm (3 months)
C: PTSD Symptom Scale - Interview (Pre-treatment, 4-, 8-, 12-, and 15-months); Suicide Attempt Self-Injury Interview (Pre-treatment, 4-, 8-, 12-, and 15-months)
D: Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr (Screening, 6 weeks, 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Chlorhexidine Gluconate vs Povidone-Iodine Vaginal Cleansing Solution Prior to Cesarean Delivery: A Randomized Comparator Controlled Trial
Brief Summary: Endometritis, an infection of the uterus in the postpartum period, has been shown to complicate the postoperative course of a cesarean delivery in 6% to 27% of cases. Vaginal cleansing prior to cesarean delivery has been shown to minimize the presence of micro-organisms and risk of infection. Although povidone-iodine is the most commonly used anti-septic for surgical preparation of the vagina, it is not an ideal agent due to it's diminished efficacy in acidic vaginal pH and in the presence of blood. Chlorhexidine gluconate, on the other hand, has demonstrated superior disinfectant properties in several clinical trials, as compared to povidone iodine. In this randomized, comparator controlled, study the investigators will be comparing chlorhexidine gluconate vs povidone iodine for intrapartum vaginal preparation in women undergoing non-emergent cesarean delivery.


Options:
A: Postpartum Endometritis (30 day postoperative)
B: Postoperative wound infection (0-14 days postpartum)
C: Number of Patients With Surgical Site Infection (4 weeks after cesarean delivery)
D: Number of Participants With Surgical Site Infection (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial
Brief Summary: To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in the first 28 days after birth in extremely preterm infants receiving human milk.


Options:
A: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
B: Time to reach full feeds (First 40 days after birth)
C: Number of days alive and receiving full enteral feeding (birth to 28 days)
D: incidence of feeding intolerance (28 days); time to reach full enteral feedings sustained for 72 hours. (72 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation in Real Life Conditions of Sacubitril-valsartan Combination in Patients With Chronic Heart Failure and Sleep Apnea Syndrome
Brief Summary: Chronic Heart Failure (CHF) is a frequent pathology burdened with mortality and significant morbidity. Sleep apnea syndrome (SAS) is frequently associated with CHF in 20% to 75% of cases. Treatment of SAS is however inconsistently associated with a decline in the morbidity and mortality. To date, the CHF medical treatments have been reported to be inconsistently efficient in the treatment of SAS.

SACUBITRIL-VALSARTAN (ENTRESTO®) is a new treatment of CHF recently indicated class I, level B in the recent European Society of Cardiology (ESC) guidelines 2016 on CHF. PARADIGM-HF trial demonstrated that morbidity and mortality can be improved with SACUBITRIL-VALSARTAN. In comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalisation for CHF by 20% with a 16% reduction in all-cause mortality.

The purpose of the research is the evaluation of SACUBITRIL-VALSARTAN combination in CHF patients presenting sleep apnea syndrome. A three months real life observational trial is performed. A measure of the Apnea Hypopnea Index is realised before and after 3 months of SACUBITRIL-VALSARTAN treatment. A concomitant evaluation of cardiological and quality of life parameters is realized.


Options:
A: The Proportion of Participants Experiencing a Reduction in Apnea-hypopnea Index (AHI) (6 months); Freedom From Related Serious Adverse Events Within 12 Months (12 months)
B: All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation (time to first event, assessed for up to 70 weeks)
C: Changes in Apnea-Hypopnea Index as compared to baseline (0 month to 3 months)
D: Changes in Central Apnea Index (baseline and six days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Web-Based CBT for Women Veterans With PTSD
Brief Summary: The purpose of this study is to evaluate an online PTSD intervention that was adapted for women Veterans, called DElivery of Self TRaining and Education for Stressful Situations-Women Veterans version (DESTRESS-WV). The intervention consists of structured online sessions as well as weekly brief phone calls for additional support with a study coach. Women Veterans with PTSD who are eligible will be randomized to receive either DESTRESS-WV or phone monitoring only for 8 weeks. Participants will be assessed immediately post-treatment as well as at 12 and 24 weeks post-treatment. Investigators hypothesize that participants randomly assigned to DESTRESS-WV will have a greater decrease in severity of PTSD symptoms compared to those randomly assigned to phone monitoring only.


Options:
A: First Adjudicated Serious Fall-Related Injury (Enrollment through last completed follow-up or death interview (max 44 months))
B: Change in PTSD Checklist (PCL-5) (Baseline, Post-treatment (8-12 weeks after baseline), 3-months post-treatment, 6-months post-treatment)
C: PTSD Checklist (PCL) (Baseline and 6 weeks, 12 weeks, and 18 weeks post randomization)
D: concerns about falling (baseline, 5 months and 12 months); avoidance of activities due concerns about falling (baseline, 5 months and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China's Community Hypertension Care: Study Protocol for a Randomized Controlled Trial
Brief Summary: This three arm study is to compare the effects of a coordinated PCP-Cardiologist Telemedicine Model (PCTM) with usual care and self-care in community hypertension management in China.


Options:
A: Difference in Change in Systolic Blood Pressure- 12 Months (12 months)
B: Changes in mean SBP (From baseline (T1) to 12 months (T3))
C: Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (Baseline); Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (6 months); Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (12 months)
D: Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg (6 months); Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China's Community Hypertension Care: Study Protocol for a Randomized Controlled Trial
Brief Summary: This three arm study is to compare the effects of a coordinated PCP-Cardiologist Telemedicine Model (PCTM) with usual care and self-care in community hypertension management in China.


Options:
A: Change in VR-12 Mental Component Summary Scores (Six months)
B: Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score (Baseline to Month 9); Skindex-16 Change Scores Baseline to Month 3 - Composite Score (Baseline to Month 3); Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score (Baseline to Month 9); Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score (Baseline to Month 3); Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score (Baseline to Month 9); Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score (Baseline to Month 3); Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores (Baseline to Month 9); Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score (Baseline to Month 3)
C: Relative dose intensity (Assessed every 30 days from randomization up to 6 months)
D: Changes in mean SBP (From baseline (T1) to 12 months (T3))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China's Community Hypertension Care: Study Protocol for a Randomized Controlled Trial
Brief Summary: This three arm study is to compare the effects of a coordinated PCP-Cardiologist Telemedicine Model (PCTM) with usual care and self-care in community hypertension management in China.


Options:
A: Framingham 10-year risk index (1 year)
B: The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. (1 year)
C: Changes in mean SBP (From baseline (T1) to 12 months (T3))
D: The proportion of subjects who attain the LDL-C levels set as targets by the Guidelines for Management of Dyslipidaemias and CVR (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Single, Double and Triple Dose Pentamidine (7mg/kg) for Patients With Cutaneous Leishmaniasis Caused by L. Guyanensis: a Pilot Study
Brief Summary: Introduction: Up to the present, have been few studies with pentamidine in the Americas; and there is no consensus regarding the dose used.

Objectives: To evaluate the use of pentamidine in single dose, double and triplo in the treatment of cutaneous leishmaniasis.

Methods: Clinical trial of phase II pilot study with 159 patients. Pentamidine will be used at a dose of 7 mg/kg, in three arms: single dose, double dose and triple dose. They will be also assessed the safety and adverse effects. The sic will be reviewed one, two and six months after the end of the treatments.


Options:
A: Occurrence of dose-limiting toxicity; Adverse events
B: Change of Lesion size (6 months)
C: Number of patients with reduction in 50% in the diameters of the ulcers and lesions skin (Two months after the end of the treatment)
D: Bidirectional measurements will be taken of the subjects' lesions at each visit and will be categorized as active or healed by a dermatologist. (90 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Cardiac REhabilitation Improve Functional, Independence, Frailty and Emotional outCOmes Following Trans Catheter Aortic ValvE Replacement?
Brief Summary: The aim of this pilot study is to assess function, independence, frailty and emotional status in 30 patients who have been accepted for TAVI. All patients will attend clinic for review at 4 weeks post implant and at that stage, 15 patients will be randomised to undertake a cardiac rehabilitation programme and the remaining 15 patients will receive standard of care. All patients will return to clinic at 3 months and 6 months post implant and undertake the functional, independence, frailty and emotional testing again.


Options:
A: Death (1 Year); Composite of Death and Recurrence Hospitalization. (duration of study)
B: All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure) (1 year)
C: Proportion of patients willing to undertake cardiac rehabilitation following TAVR. (6 months)
D: Improvement in mean daily number of steps (Improvement between baseline (during the last preoperative month) and first 3 (and 12) months after discharge.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multicenter, Randomized Double-blind Study Examining the Safety and Efficacy of Using the Evoke™ Spinal Cord Stimulator (SCS) System With Feedback to Treat Patients With Chronic Pain of the Trunk and/or Limbs.
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.


Options:
A: Number of Participants With Composite Endpoint Success (3 months)
B: Global Pain VAS Visual Analogic Scale (VAS) (Month 3)
C: Change in Multidimensional Pain Inventory (MPI)-SCI average activity score (Baseline, 9 months); Motor recovery as measured by EMG (Up to 9 months); Motor recovery as measured by dynamometry (Up to 9 months)
D: The Difference in Responders Between Both Groups (6 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Evaluate an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care
Brief Summary: The investigators propose a three-arm, pragmatic, cluster-randomized clinical trial based in primary care. Participating Primary Care Providers (PCPs) will be randomized to usual care or one of two intervention arms. The first intervention will evaluate the efficacy of an automated CDSS that utilizes the electronic health record (EHR) to facilitate triple marker test ordering, guideline implementation and BP management, compared with usual care, among patients with previous documentation of eGFRcreat \<60 ml/min/1.73m2. The second intervention goes a step further, and will evaluate whether a CDSS plus a follow-up telephone call from a pharmacist (CDSS PLUS) can improve BP management and patient CKD and NSAID toxicity knowledge among the patients with CKD, compared with CDSS alone. The primary clinical outcome is BP level, with secondary outcomes related to processes of care and patient knowledge.


Options:
A: Patient Adherence (Test Completion) (12 months post-intervention)
B: Changes in decisional conflict (baseline and 3 month post intervention)
C: Number of Participants Who Used Dual Contraception or Safer Conception Method (Month 12)
D: Change in blood pressure from enrollment (Investigators will follow patients up to 2 years after measures)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Buying Time: Improving Sleep to Promote Cognitive Function in Older Adults
Brief Summary: The purpose of this study is to investigate whether a comprehensive group education combined with a lifestyle "activation" program that includes (a) sleep hygiene course, (b) physical activity promotion, and (c) bright light therapy, can improve both sleep quality and cognitive function among 96 community-dwelling older adults.


Options:
A: To measure the differences between galantamine and donepazil for sleep and attention, explore methods of measuring sleep in patients with Alzheimer's Disease (AD)and their caregivers and attention in AD patients; GI tolerance
B: Nocturnal Sleep Length at 1 Month (1 month)
C: Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) (Quarterly over 6 months)
D: Change from baseline in sleep quality as measured by Motion Watch 8 at 3 and 6 months (Baseline, 3 months, and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Regorafenib in Relapsed Glioblastoma REGOMA Study Randomized, Controlled Open-label Phase II Clinical Trial
Brief Summary: This study aims to evaluate the role of Regorafenib in prolonging the overall survival of glioblastoma multiforme patients who progressed after surgery and Stupp regimen with or without bevacizumab.


Options:
A: Progression Free Survival (PFS) (6 months after randomization)
B: Overall Survival (7 years)
C: Progression Free Survival (PFS) time (5 years)
D: Overall survival (From the date of randomization to 18 months or to the date of death from any cause)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Subjects With Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Brief Summary: The primary objective of phase 1 is to evaluate the safety of KTE-C19 and atezolizumab combination regimens.

The primary objective of phase 2 is to evaluate the efficacy of KTE-C19 and atezolizumab, as measured by complete response rate in participants with refractory diffuse large B-cell lymphoma (DLBCL).

Participants who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968 (NCT05041309).


Options:
A: Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) (Baseline up to 21 days); Phase 1 and 2: Complete Response Rate (CRR) (From enrollment until first occurrence of CR or PR (maximum duration: 6.2 years))
B: Phase 1 Study: Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs) (First infusion date of axicabtagene ciloleucel up to 30 days); Phase 2 Pivotal Study (Cohorts 1 and 2): Overall Response Rate (ORR) as Assessed by Investigator Per Revised International Working Group (IWG) Response Criteria for Malignant Lymphoma (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 7.7 years)); Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 6.8 years)); Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 5.4 years)); Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.4 years)); Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.1 years))
C: Number of Subjects With an Overall Response (i.e. Either Complete Response or Partial Response) Evaluated at Three Months Post Infusion. (3 months)
D: Objective response rate (3 months)

Answer: A