cyrilzakka/clinical-trials huggingface dataset:
Dream2Heal: An Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia

The primary objective of this feasibility study is to assess the feasibility and acceptability, and potential clinical significance of an adaptive stepped-care intervention for improving sleep quality among Chinese cancer patients with mild-to-moderate sleep disturbance, using a sequential multiple assessment randomized controlled trial (SMART) design.

The primary objective of this feasibility study is to assess the feasibility and acceptability, and potential clinical significance of an adaptive stepped-care intervention for improving sleep quality among Chinese cancer patients with mild-to-moderate sleep disturbance, using a sequential multiple assessment randomized controlled trial (SMART) design. First, the investigators will test the effect of a low intensity web-based cognitive behavioural therapy for insomnia (CBT-I) intervention (iDream2Heal; iD2H), in comparison to a low intensity web-based exercise intervention (Easy Exercise; eEX). Secondly, this study aims to explore if a stepped-up face to face, therapist led CBT-I intervention (D2H) is more effective for patients who continue to have sleep disturbance, in comparison to an augmented intervention, in which is a combined, web-based intervention that covers the content of both iD2H and eEX interventions.

Eligibility Criteria:
Inclusion Criteria:

* Cantonese- or Mandarin-speaking Chinese patients diagnosed with curable breast, colorectal, or gynaecological cancer
* Completed treatment (except endocrine therapy) within two years
* Presenting with Pittsburgh Sleep Quality Index (PSQI) score of 6 to 11 indicating mild-to-moderate sleep disturbance

Exclusion Criteria:

* Diagnosis of metastatic cancer
* Current diagnosis of psychiatric disorder
* Current diagnosis of another sleep disorder,
* Have received psychological treatment specifically for sleep disturbance
Use of Financial Incentives to Increase Live Kidney Donor Follow-up Compliance

This study evaluates whether using small financial incentives increases patient compliance with nationally-mandated living kidney donor follow-up at 6-months, 1-year, and 2-years after donation. Half of participants will receive a financial incentive (mailed gift card) after completing required follow-up activities (brief questionnaire and lab draw), while the other half will be asked to complete the required follow-up activities but will not receive a financial incentive (current standard of care).

Living kidney donors account for nearly a third of kidney transplants performed in the United States each year. While donor nephrectomy poses minimal post-surgical risk, donors face a small but measurable increase in the risk of developing kidney failure and other chronic diseases (including hypertension, chronic kidney disease, and diabetes) in the long-term. Routine screening presents an opportunity for the early detection and management of chronic conditions.

Transplant hospital reporting requirements mandate the submission of laboratory and clinical data at 6-months, 1-year, and 2-years after kidney donation, but less than 50% of hospitals are able to comply. Transplant hospitals commonly cite barriers such as donor inconvenience, direct and indirect costs to donors, donors not wanting to return to the program, and the burden of data collection. Tools to improve donor engagement and strategies that mitigate patient and administrative burden are needed.

Financial incentives have been employed in many realms of healthcare to change health-related behaviors. Financial incentives include a variety of rewards that have an economic value for the recipient, including cash payments, coupons, goods, and services, and have been shown to positively influence both simple (i.e. accomplished through a single action) and complex (i.e. accomplished repeatedly over a period of time, often involving sustained lifestyle modifications) health-related behaviors. However, prior work suggests that the effectiveness of financial incentives in achieving health behavior often varies based on the characteristics of the population and health behavior of interest and may decrease over time.

Given that patient-level factors are commonly cited by transplant hospitals as barriers to compliance with federally-mandated donor follow-up thresholds, financial incentives might be a valuable tool to promote patient engagement in post donation monitoring efforts. However, given the uncertainty in the literature, a randomized controlled trial is necessary to evaluate the effectiveness of using financial incentivization to promote patient compliance with follow-up care in this setting.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years)
* Have undergone live donor nephrectomy at the Johns Hopkins Hospital Comprehensive Transplant Center (MDJH) or the University of Maryland Medical Center Transplant Center (MDUM).

Exclusion Criteria:

* International live kidney donors
* Non-English speaking live kidney donors
NOLA (NeuWave Observational Liver Ablation) Registry

This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.

This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System. The data gathered from participating sites will be available to be analyzed to develop ablation parameter guidance for ablation approaches under varying patient liver tissue conditions and liver lesions.

This is an "umbrella registry," which was included as an optional component in other NEUWAVE studies; hence, data from consenting patients who are or will be enrolled in other NEUWAVE soft tissue liver lesion ablation studies will be included in this registry. All other patients will be enrolled and followed prospectively, enrolled retrospectively with prospective, longitudinal follow up, or enrolled retrospectively with all retrospective follow up.

Enrollment for this study will include up to 1,500 patients throughout the world who underwent or are scheduled to undergo microwave ablation of one or more soft tissue liver lesions using the NEUWAVE Microwave Ablation System or the NEUWAVE Microwave Ablation System with Ablation Confirmation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent or are scheduled to undergo a microwave ablation of one or more liver lesions with the NEUWAVE Microwave Ablation System per the device's Instructions for Use (IFU).
2. Patients with signed informed consent (or waiver approved by IRB/EC) who are willing to comply with the assessment schedule, and willing to have data included in the database.
3. Patients greater than or equal to 22 years old at the time of informed consent (or waiver approved by IRB/EC).

Exclusion Criteria:

1. Patients with a life expectancy of less than 1 year, in the opinion of the treating physician.
2. Use of microwave ablation purely as a transection tool, rather than focused liver lesion ablation.
3. Patient is currently participating, or planning to participate, in another NeuWave/Ethicon-funded clinical trial or registry studying microwave ablation in the liver. Note: roll-over patients from previous NeuWave trials are permitted.
Assessing Lung Inhomogeneity During Ventilation for Acute Hypoxemic Respiratory Failure

Mechanical ventilation can cause damage by overstretching the lungs, especially when the lungs are collapsed or edematous. Raising ventilator pressures can reduce lung collapse and this can prevent overstretching from mechanical ventilation. It remains uncertain how much pressure (PEEP - positive end-expiratory pressure) should be used on the ventilator and how to identify patients who will benefit from higher ventilator pressures vs. lower ventilator pressures. The investigators are using a unique new imaging technology, electrical impedance tomography (EIT), to study this problem and to determine the safest and most effective ventilator pressure level. The results of this study will inform future trials of higher vs. lower PEEP strategies in mechanically ventilated patients.

Patients participating in this physiological cross-over randomized trial will undergo a series of PEEP maneuvers designed to assess lung recruitability, PEEP responsiveness, and optimal PEEP. EIT imaging and esophageal manometry will be employed throughout the protocol to quantify the effect of PEEP on lung function. Patients will be randomized to be ventilated at PEEP levels supplied by the ExPRESS strategy or by the EIT hyperdistention/collapse algorithm. The biological response will be assessed by measuring serum cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Acute (≤7 days) hypoxemia with PaO2:FiO2 ratio less than or equal to 200 mm Hg
* Oral endotracheal intubation and mechanical ventilation
* Bilateral airspace opacities on chest radiograph or CT

Exclusion Criteria:

* Contraindication to EIT electrode placement (burns, chest wall bandaging limiting electrode placement)
* Contraindication to esophageal catheter placement (recent upper GI surgery, actively bleeding esophageal varices)
* Respiratory failure predominantly due to cardiogenic cause or fluid overload
* Ongoing hemodynamic instability (requiring 2 vasopressor agents by continuous infusion AND rising vasopressor infusion rate requirements in the previous 8 hours)
* Ongoing ventilatory instability (P/F \< 70 mm Hg, pH \< 7.2; ventilator driving pressures, PEEP, or FiO2 increasing by more than 25% in previous 30 minutes)
* Intracranial hypertension (suspected or diagnosed by medical team)
* Known or suspected pneumothorax recognized within previous 72 hours
* Bronchopleural fistula
* Bridge to lung transplant
* Recent lung transplantation (within previous 6 weeks)
* Attending physician deems the transient application of high airway pressures (\>40 cm H2O) to be unsafe
Diagnostic of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis

The TOTEM study is a single-center study designed to evaluate the performance of the D-lactate assay in cerebrospinal fluid (CSF) for the diagnosis of ventriculostomy-related nosocomial meningitis. The study will be conducted in the neurosurgical intensive care unit of the Toulouse University Hospital, in patients with a suspected diagnosis of ventriculostomy-related nosocomial meningitis.

For each study participant, an additional CSF sample will be taken from the ventriculostomy during the routine sampling performed for the diagnosis of nosocomial meningitis. This sample will be stored at -80°C. Assays of D-lactate, procalcitonin (PCT), and pro-inflammatory cytokines (IL-1, IL-6, IL-8, TNFa) will be performed serially on these CSF samples.

If the CSF sample taken at inclusion does not meet the criteria for nosocomial meningitis, a second sample will be taken 48 to 96 hours later to reassess the cellularity of the CSF. Finally, the end-of-participation visit takes place after 4 weeks. Two neurosurgical reanimators will retrospectively diagnose nosocomial meningitis, or the absence of meningitis, according to the information from the patient's medical records.

Eligibility Criteria:
Inclusion Criteria:

* Age ⩾ 18 years.
* Patient with an external ventriculostomy implanted at the Toulouse University Hospital.
* Patient suspected of nosocomial meningitis due to a febrile syndrome (in the absence of any other identified infectious site), headache, nausea, lethargy, change in neurological status, meningeal syndrome, epileptic event and cutaneous or subcutaneous inflammation at the ventriculostomy site of insertion.
* Patient having expressed oral consent, after free and informed information.
* Patient affiliated to a social security scheme.

Exclusion Criteria:

* Diagnosis of community meningitis.
* Proven or suspected meningitis and/or ventriculitis during the previous month.
* Diagnosis of nosocomial meningitis made in another medical centre prior to admission.
* Short bowel syndrome.
* Acute mesenteric ischaemia.
* End-stage renal failure (GFR \< 15 ml/min/m2).
* Peritoneal dialysis.
* Patient participating in another research protocol with an exclusion period still in progress.
* Pregnant or breastfeeding woman.
* Patient under guardianship or trusteeship, persons placed under the protection of justice
Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent

Post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and efficacy of Inspiron Sirolimus Eluting Coronary Stent at the treatment of "real-world" patients.

Up to 5.0000 patients with native coronary arteries lesions with diameter between 2.5 and 4.0 mm and 34 mm of length treated solely with the Inspiron Sirolimus Eluting Coronary Stent.

Stent implantation should be performed according to the Instructions for Use and according to the local practice. It is recommended that ECG and cardiac enzymes are collected before and after procedure. Dual anti-platelet therapy is recommended for at least 6 months after procedure.

Patients will be followed at 30 days, 1 and 2 years after procedure.

Eligibility Criteria:
Inclusion Criteria:

* alll patients that have been treated with the Inspiron Sirolimus Eluting Stent older and 18 years

Exclusion Criteria:

* Safein Vein or Left Internal Mammary artery Grafts
The Effect of Bevacizumab on Corneal Neovascularization

Eight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography.

To evaluate the effect of repeated subconjunctival bevacizumab (Avastin®, Roche, Rio de Janeiro, Brazil) on inflammatory corneal neovascularization.

Eight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography.

Eligibility Criteria:
Inclusion Criteria:

* Corneal Neovascularization
* Stable lesion

Exclusion Criteria:

* Diabetes
* Autoimmune diseases
A Pilot Study of Remote Monitoring to Improve Health Related Quality of Life of Men Following Prostate Cancer Treatment.

The purpose of this study is to determine the feasibility of using digital technology and remote monitoring to track health-related measures in men following prostate cancer treatment. Half of the participants will receive tools to monitor their activity and weight, as well as personalized feedback on these measures, while the other half will receive standard of care. Health related quality of life measure will be collected from both groups.

The purpose of this study is to determine the feasibility of using digital technology and remote monitoring to track health-related measures in men following prostate cancer treatment. All participants will complete a health-related quality of life survey each month for 3 months. The digital survey will be administered on a programmed tablet. The participants in the intervention group will also receive an activity sensor and weight scale. Health state data from this group will be generated over a 3-6 month period and remotely monitored. These data will be used to provide personalized feedback regarding the participant's progress towards established goals. Health-related quality of life will be compared between participants in the intervention group, who receive (1) tools to monitor their activity and weight and (2) personalized feedback, versus participants in the control group, who receive standard of care. The potential improved adherence to healthy behaviors of the participants receiving personalized feedback may translate to to improved health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have localized prostate cancer.
* Participants must have received treatment at Johns Hopkins
* Participants must be classified as overweight (body mass index ≥ 25).
* Participants must have wi-fi in their homes.

Exclusion Criteria:

* Anyone who is unable to give informed consent will be excluded
* Anyone who is physically unable to participate in physical activity will be excluded.
Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children

Purpose of this study: assess the maximum tolerated bolus dose of erythritol, delivered in a clear beverage, compared with placebo (saccharose) in 4-6 year old children.

The study is a randomized placebo-controlled, double-blind cross-over trial designed to determine the gastrointestinal (GI) responses and maximum tolerated dose of erythritol in young children as a single oral dose in a beverage in-between meals.

The children were divided into 4 dose groups. In each group of children, only one dose level was tested such that each child was exposed to only a single dose level versus placebo. The erythritol dose started at 5 grams and was increased by 10 g between each group of children only if the preceding dose level was found to have no significant GI tolerance effects. The effects on faecal parameters and gastrointestinal complaints were recorded in order to determine the threshold dose. After finding a significant difference in tolerance between erythritol and placebo in the 25 g dose cohort, a protocol amendment was approved allowing the investigators to study a dose of 20 g.

Test materials were prepared by Cargill, Vilvoorde, Belgium and supplied in bottles containing 250 mL of a noncarbonated fruit-flavoured (two flavours: strawberry and orange) clear drink sweetened with erythritol at four different dose levels: 5, 15, 20 and 25 g (equivalent to 2, 6, 8 and 10% w/v erythritol, respectively). Placebo was supplied in an identical manner but prepared with common nutritive carbohydrates (saccharose and maltodextrin) and providing an equivalent sweetness to that of the corresponding erythritol beverages (i.e.: 1.4, 4.2, 5.6 and 7% w/v).

In total 185 healthy young children aged 4-6 years were recruited at three clinical investigation centres after informed consent of both parents; 184 completed the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age 4 to 6 years at Study D1 (day of consumption of the first beverage)
* Body Mass Index ³ 13 kg/m²
* Accustomed to having breakfast
* Having a regular defecation frequency inferior or equal to two per day
* Able to drink 250 mL within 15 minutes
* Toilet-trained / able to use a potty (both at day and night)
* Informed consent of both person entitled to parental rights
* Person entitled to parental rights affiliated to the French social security

Exclusion Criteria:

* Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before D1 of the study
* Participation in any non-invasive clinical trial up to 30 days before D1 of this study, including blood sampling and/ or, intravenous, inhalatory administration of substances
* Having a history of medical or surgical events that may significantly affect the study outcome, such as gastric and digestive diseases
* Any current metabolic or endocrine disease, including diabetes mellitus
* Use of medication, including antibiotics, laxatives and steroids
* Regular gastrointestinal complaints, such as stomach upsets, diarrhoea, constipation, flatulence, abdominal colic
Dapagliflozin Effects on Epicardial Fat

The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on the fat of the heart.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, as defined by ADA criteria
* HbA1c \< 8% measured at least 1 week prior to the study
* BMI ≥27 kg/m2
* Pre-treatment with Metformin as monotherapy
* Age \> 18 and \< 65 years old
* Normal and stable hemodynamic status

Exclusion Criteria:

* Known contra-indications to Farxiga, in accordance with risks and safety information included in the latest updated Prescribing Information
* Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
* Insulin dependent or treated type 2 diabetes
* Current use of other SGLT2 inhibitors, Glucagon Like Peptide -1 (GLP- 1) analogs or Dipeptidyl Peptidase 4 (DPP4) inhibitors
* Glomerular Filtration Rate (GFR) \< 60 mL/min/1.73 m2
* Signs or symptoms of hypovolemia
* Patients with poor glycemic control (HbA1c ≥ 8%) will be excluded to maximize long-term patient retention without need
* History of diabetes ketoacidosis
* Patients with active bladder cancer or with a prior history of bladder cancer
* Acute or chronic infective, including genital mycotic infections
* Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure
* Clinical or laboratory evidences of chronic active liver diseases
* Acute or chronic infective diseases
* Cancer or chemotherapy
* Current use of systemic corticosteroids or in the 3 months prior this study
* Known or suspected allergy to Dapagliflozin, excipients, or related products
* Pregnant, breast-feeding or the intention of becoming pregnant
* Females of childbearing potential who are not using adequate contraceptive methods
Transition From Alendronate to Romosozumab (AMG 785)

The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated with alendronate.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women, defined as no vaginal bleeding or spotting for ≥ 12 months
* Low bone mineral density at screening \[defined by a bone mineral density (BMD) T-score ≤ -2.0 and ≥ -4.0 at the lumbar spine (L1 to L4; or BMD T-score of evaluable vertebrae), total hip, or femoral neck\]
* Currently taking alendronate (70 mg weekly or equivalent) exclusively for ≥ 1 year with verbal agreement that the subject has taken ≥ 80% of their doses with good tolerance

Exclusion Criteria:

* History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50; or recent bone fracture within 6 months prior to screening
* History of metabolic or bone disease such as Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
* Vitamin D deficiency (defined as 25-OH-VitD levels \< 20 ng/mL)
Perfluorocarbon Perfused Vitrectomy and 3D Vitrectomy System in Advanced Diabetic Retinopathy

To investigate the feasibility and advantages of using perfluorocarbon liquid (PCL) perfusion to remove vitreous during suction-cutting vitrectomy using a dual, dynamic drive (3D)technology. In complicated surgeries in advanced diabetic retinopathy and retinal detachment


Eligibility Criteria:
Inclusion Criteria:

* Advanced diabetic retinopathy with retinal detachment

Exclusion Criteria:

* Retinal detachments of more than 6 months