rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Facilitating Safe Transition to Home for Preterm Infants - a National Database Study
Status: Recruiting

Preterm infants (i.e. born before 37 completed weeks of pregnancy) often require additional care and are admitted to neonatal units. Readiness for discharge home typically requires a level of physiological maturity, such that an infant is: 1) able to breathe spontaneously without additional support; 2) able to maintain body temperature; 3) able to take all nutritional requirements orally; 4) weighs ≥1700 grams and is consistently gaining weight.

Staying in the hospital longer than necessary can be detrimental to infants, stressful for families, and costly to the NHS. Reducing the length of stay by just one day would be meaningful to parents and could save the UK National Health Service (NHS) almost £25million per year. Currently little is known about whether, how long and why preterm infants stay in hospital beyond the point at which they are physiologically ready for discharge.

This study will use data from babies' medical records from the whole of England and Wales to identify the age and postmenstrual age when preterm infants reach each of the physiological barriers to discharge and identify which physiological discharge barrier requires preterm infants to remain in hospital the longest. The study will quantify the difference between the time preterm infants become physiologically ready for discharge and actual discharge home and describe factors associated with extended stays.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Infants admitted to neonatal units that contribute data to the NNRD who are: Born at <37 completed weeks' gestational age Born from 01 January 2016 to 31 December 2022 Admitted to neonatal care for >48 hours Discharged home alive - HealthyVolunteers: No - Gender: All - MinimumAge: 22 Weeks - MaximumAge: 36 Weeks - StdAgeList: Child - StudyPopulation: The study population will include all infants born at <37 weeks gestational age who are admitted to a neonatal unit in England and Wales which contributes data to the National Neonatal Research Database (NNRD). - SamplingMethod: Probability Sample
Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions
Status: Recruiting

Aim To determine the feasibility and safety of 3 fractions of high dose rate (HDR) brachytherapy with interstitial needles for cervical cancer in the outpatient setting

Primary objective To determine the clinical outcome (2-yr local control rate, loco-regional control rate, progression free survival and overall survival)

Secondary objective To determine the long-term toxicities of this regimen based on CTCAE v5

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  21 years old and above Histologically proven squamous cell carcinoma, adenocarcinoma, adenosquamous or poorly differentiated cervical cancer Clinically or radiologically stage IB - IVA cervical cancer based on TNM 8th Edition ECOG performance status 0, 1, or 2 To complete external beam radiotherapy and brachytherapy in NUH Written, voluntary informed consent Patients must be accessible for follow up and management in NUH  Exclusion Criteria:  Post operative cervical cancer cases Pregnant or breastfeeding women - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: As cervical cancer patients are females, we will only be recruiting female patients. - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult
Effect of Progressive Muscle Relaxation Exercises Versus Pilates Exercises on Postnatal Low Back Pain
Status: Not yet recruiting

This study was conducted to compare between the effect of progressive muscle relaxation exercises and the effect of pilates exercises on postnatal low back pain

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ages were ranged from 25 to 35 years old and their body mass index (BMI) did not exceed 30kg/m2. They were postnatal by three months. The number of parity of all women was ranged from (1-3) times.  Exclusion Criteria:  previous trauma to the spine, pelvis and lower limbs, previous history of spinal surgery (such as spinal fusion surgery, vertebroplasty, or - --kyphoplasty), congenital spinal deformities, history of spinal tumors, ankylosing spondylitis, osteoporosis other spondyloarthritis - HealthyVolunteers: No - Gender: Female - MinimumAge: 25 Years - MaximumAge: 35 Years - StdAgeList: Adult
Digital Health Navigation for Latino Patients With Type II Diabetes
Status: Not yet recruiting

The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes. The main question it aims to answer is: Can providing digital literacy training during a hospital admission can help patients with their after-hospital care by using the patient portal and telehealth? Participants will receive digital literacy training by a digital navigator that focuses on the main patient portal functions. Researchers will compare patients who receive digital literacy training to those who receive standard of care (educational sheet) to see if it impacts their use of the patient portal after discharge.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Self-identified Latino adult patients with type II diabetes Admitted to general medicine floors at Brigham and Women's Hospital Preferred language: English or Spanish  Exclusion Criteria:  Critical illness dementia, delirium, or other condition that limits ability to participate in education and consent process - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.
Status: Not yet recruiting

The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  In order to be eligible to participate in this study, subjects must meet all of the following criteria:  Presenting with a Stage IV pressure ulcers requiring treatment of excision, bony debridement and flap coverage. Operative candidate for flap surgery. Presence of focal osteomyelitis as suggested by imaging to show extent of infection. Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan. Adults ≥ 18 years in age at the time of treatment. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures. Ability of the subject or legal authorized representative to provide voluntary, signed and dated informed consent prior to any study-related procedures.  Exclusion Criteria:  Subjects who meet any of the following criteria will be excluded from participating in this study:  Reasons contributing to pressure ulcer cannot be addressed. Patients receiving primary closure Severe immunological compromised patients as determined by the clinician. Patients with diffuse or widespread pelvic osteomyelitis that is not amenable to adequate margins for debridement. Current or recent history (within last 2 years) of active substance abuse (e.g., recreational drugs, narcotics, or alcohol) that in the judgement of the investigator, may compromise the participant's safety/recovery or ability to follow the trial procedures. Current smoker. Diabetic patient with Hba1C level above 9. Allergy to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (Vancomycin), or aminoglycoside antibiotics (Gentamicin). Concurrent involvement in a study of another investigational product. Pregnant or planning to become pregnant during study period. Flexion contractures where patient cannot passively get full extension. Uncontrolled muscle spasms. Unable to comply with bedrest restriction. Unable to provide consent. Fecal or urinary incontinence with contamination of the wound. Unable to achieve wheelchair and cushion offloading of pressure wound prior to surgery - as demonstrated by pressure mapping. Investigator considers the participant to be clinically malnourished. Any conditions with known hypercalcemia (> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism). Investigator believes trial participation may compromise safety of the participant or trial results. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Boosting Resources for Tracheostomy Care at Home
Status: Not yet recruiting

The goal of this trial is to advance our understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main questions it aims to answer are:

How can we support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home?
How can we leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge?

Caregiver participants will be randomly assigned to receive Trach Me Home (gold standard discharge program) or Trach Me Home with additional components. Caregiver participants will complete three surveys over the course of 6 months. Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge (primary outcome) and fewer hospital readmissions at 6 months than those in Trach Me Home arm.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Lead or primary adult caregiver (18 or older) of infants or children (0-17 years old) with tracheostomy who are planning for discharge to home, including children who are dependent on ventilator  Exclusion Criteria:  Patients transferred to other hospital or facility (and/or not discharged to home during study period) Primary caregiver unable to read or write in English, Spanish, Mandarin, or Arabic Not planning to reside in the U.S. for at least 12 months after discharge - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Exercise-based Cardiac Rehabilitation in Patients With Aortic Stenosis After Transcatheter Aortic Valve Implantation
Status: Not yet recruiting

Aortic valve stenosis (AS) is the most common valve disease among older individuals. In symptomatic AS, mortality is high, and the only treatment that improves prognosis and survival is transcatheter aortic valve implantation (TAVI). TAVI is a growing treatment in Sweden, allowing previously inoperable older patients with AS, who are often frail and have comorbidities, to receive intervention. This results in the need for postoperative cardiac rehabilitation for patients treated with TAVI. Previous systematic reviews and meta-analyses examining the effect of physiotherapist-led exercise-based cardiac rehabilitation (PT-X) after TAVI have shown that participation in PT-X can improve physical fitness (the highest measured oxygen uptake (VO2peak)), walking distance, walking speed, and health-related quality of life (HR-QoL). However, the included studies are limited, and there is selection bias, resulting in low evidence. Therefore, access to PT-X is currently almost non-existent in Sweden. As more patients undergo TAVI, it is crucial to investigate whether PT-X after TAVI can further improve physical fitness, HR-QoL, and reduce hospital admissions in older individuals with AS.

Objective: Primary, to investigate whether participation in PT-X after TAVI can impact physical fitness, physical activity level, and health-related quality of life. Secondary, to study the prevalence of frailty and the number of hospital admissions during the first postoperative year after TAVI.

Expected outcome: If patients with AS who have undergone TAVI can improve physical fitness, it could potentially strengthen the evidence and optimize the patient's physical capabilities. Increased access to PT-X and awareness of frailty in these patients could reduce the risk of falls and possibly the number of hospital readmissions. This would decrease healthcare consumption and improve the patient's quality of life.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aortic stenosis treated with TAVI.  Exclusion Criteria:  Patients who, due to another disability, cannot perform the study protocol for physical fitness, PT-X, or complete the questionnaires included in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult
The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
Status: Recruiting

Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups.

This study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.

The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years and ≤90 years Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma The tumor is suitable for resection (according to neurosurgeon) Written informed consent  Exclusion Criteria:  Tumors of the cerebellum, brainstem, or midline Medical reasons precluding MRI (e.g., pacemaker) Inability to give written informed consent Secondary high-grade glioma due to malignant transformation from low-grade glioma Clinical data unavailable for the newly diagnosed setting - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with recurrent glioblastoma will be recruited from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals, located in Europe and the United States. The study is carried out by centers from the ENCRAM Consortium. - SamplingMethod: Non-Probability Sample
Imputation of Arterial Oxygen Partial Pressures Using Pulse Oximetry
Status: Not yet recruiting

The goal of this is prospective cohort study is to to study the relationship between PaO2 and SpO2 in the overall population undergoing general anesthesia in the OT. Secondary aims include studying the relationship between PaO2 and SpO2 in elderly and obese patients undergoing general anesthesia in the OT, validating the derivation of PaO2 from SpO2 using formulas derived by Rice et al. (2009), Pandharipande et al. (2009), and Gadrey et al. (2019) in patients undergoing general anesthesia in the OT, and, if the derivation formulas were not valid, to derive a formula for patients undergoing general anesthesia in the OT.

The included blood samples are arterial blood sample collected for ABGs analysis through either an arterial catheter or an arterial blood puncture in adult patients (Age >18 years) undergoing general anesthesia regardless of the acuity of the surgery (elective, emergency, or lifesaving), the hemodynamic stability of the patient, or the comorbidities. Patients undergoing cardiac or thoracic surgeries will be excluded.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age >18 years Undergoing general anesthesia  Exclusion Criteria:  Patients undergoing cardiac or thoracic surgeries will be excluded. - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The included blood samples are arterial blood sample collected for ABGs analysis through either an arterial catheter or an arterial blood puncture in adult patients (Age >18 years) undergoing general anesthesia regardless of the acuity of the surgery (elective, emergency, or lifesaving), the hemodynamic stability of the patient, or the comorbidities. Patients undergoing cardiac or thoracic surgeries will be excluded. - SamplingMethod: Non-Probability Sample
Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness
Status: Recruiting

Patients with acute severe brain injury are usually admitted to the Intensive Care Unit. A substantial proportion of these patients will have disorders of consciousness (DOC) after interruption of sedation. It is difficult to reliably predict neurological outcome in these patients. Dependent on the extent of permanently damaged brain areas, DOC in patients with acute severe brain injury may improve or persist, eventually evolving into a minimal conscious state (MCS) or unresponsive wakefulness syndrome (UWS). These conditions are accompanied by long term severe disability. In current practice, the decision to withdraw life-sustaining support is made by interpreting the results of repeated bedside neurological examination and conventional CT-brain imaging. Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult. In this prospective observational cohort study we aim to identify patients with a good neurological outcome.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All patients that are admitted to the ICU with the following criteria will be eligible for inclusion:  Severe brain injury (GCS ≤ 8) as a result of:  Traumatic brain injury Ischemic cerebrovascular accident Intracranial hemorrhage Meningo-encephalitis Subarachnoid hemorrhage Age ≥ 18 years old Written informed consent from legal representatives  Exclusion Criteria:  A potential subject who meets any of the following criteria will be excluded from participation in this study:  Absence of informed consent Moribund at ICU admission Progressive neurodegenerative disease Pre-admission life expectancy ≤ 6 months based on comorbidity GCS has been > 8 prior to inclusion Impossible to include within 24 hours after brain injury - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All patients with acute severe brain injury admitted to the ICU of at least 18 years old. - SamplingMethod: Non-Probability Sample
CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention
Status: Recruiting

In Ease Asia clinical trials, P2Y12 inhibitor (ticagrelor or clopidogrel) monotherapy after 3-month dual antiplatelet therapy (DAPT) resulted in a lower incidence of clinically significant bleeding, without increasing risk of major adverse cardiac and cerebrovascular events, even if acute coronary syndrome (ACS) following complex percutaneous coronary intervention (PCI) when compared with standard DAPT. Although better understood "East Asian Paradox", finding the right CYP2C19 genotype-guided P2Y12 inhibitor selection to balance maintaining ischaemic prevention and less bleeding remains a topic in real-world clinical practice.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinical Criteria:  Patients aged between 18-80 years old. Patients with ACS (UA/NSTEMI/STEMI) undergoing PCI. Patients will be treated with DAPT (P2Y12 inhibitors+aspirin) for at least 3 months. Patients are willing to provide a DNA sample (via blood draw) for CYP2C19 genotyping. Patients provide written informed consent before enrollment.  Angiographic Criteria (meet at least 1 of the following characteristics):  Thrombotic target lesion. Calcified target lesion requiring rotational atherectomy or intravascular lithotripsy Multivessel (≥2 vessels) disease will be treated. Multi-target lesions (≥3 lesions) will be treated. Multi-stent (≥3 stents) will be implanted. Total stent length≥60 mm. Bifurcation lesion requiring at least 2 stents. PCI for left main. PCI for chronic total occlusion. PCI for bypass graft.  Exclusion Criteria:  Patient with known CYP2C19 genotype before randomization. Anticipated discontinuation of clopidogrel or ticagrelor within the 12-month follow-up period. Planned surgery within 90 days. Requiring oral anticoagulation therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism) Intracranial/gastrointestinal/urogenital bleeding within 6 months. Active bleeding or bleeding diathesis, thrombocytopenia (platelet <100,000/mL) or hemoglobin <10 g/dL Hepatic dysfunction (serum liver enzyme>3 times the normal limit) Renal failure (eGFR <15 ml/min/1.73m2 or requiring dialysis) Concomitant therapy with a strong CYP3A4 inhibitor or inducer Life expectancy < 1 year - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
MIVetsCan: Can-Coach Trial (Phase 2)
Status: Not yet recruiting

The goal of the MIVetsCan Can-Coach Trial is to test four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  United States Veteran Experiencing chronic pain (pain lasting 3 or more months) Moderate to severe chronic pain Are planning or currently using cannabidiol (CBD) or cannabis products for pain management Able to read and speak English sufficiently to allow for informed consent and active participation in the educational intervention sessions Willingness to attend all study visits (conducted virtually) Willingness to fill out periodic assessments via smartphone to assess symptom status and cannabis use (protocol has more details)  Exclusion Criteria:  Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English) Participant states participant is pregnant Current diagnosis or past history of a psychotic disorder (schizophrenia spectrum, except substance/medication -induced or due to another condition) Current diagnosis or past history of bipolar disorder Unable to attend study visits Risk for imminent harm - Suicidal ideation or wish to die as assessed with the Positive and Negative Suicide Ideation (PANSI) questionnaire and further risk assessment by study team members Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult