cyrilzakka/clinical-trials huggingface dataset:
Impact of Sleep Apnea on Diabetic Foot Wound.

Sleep apnea syndrome (SAS) is a common comorbidity of type 1 and type 2 diabetes. A low transcutaneous oxygen tension (PtcO2) measured on the foot is pejorative prognostic factor for the healing of a diabetic foot wound. SAS causes intermittent nocturnal hypoxia and sympathetic overactivity. The investigators hypothesized that SAS could be a factor reducing the PtcO2.Therefore, the main objective of this study is to assess the variation in PtcO2 between the end of the night and midday in patients with -or at risk of- diabetic foot wound according to the presence or not of sleep apnea syndrome.The secondary objective is to address the microvascularisation of diabetic patients having foot wounds according to their status regarding sleep apnea syndrome.

The study is observational, cross-sectional. Presence of sleep apnea syndrome will be assessed on the same night than the main outcome, that is the difference in PtcO2 between 5:00 AM and 12:00AM. Microvascularisation will be assessed by Laser Speckle Contrast Imaging Analysis (LASCA).

Sample size is estimated at 60 patients based on previous revascularisation studies having PtcO2 as main outcome.

An intermediary analysis is planned after 40 inclusions.

Eligibility Criteria:
Inclusion Criteria:

* Types 1 or 2 or MODY diabetes with diabetic foot wound (or at risk of foot wound stage 2 and 3 (see reference PMID:18442189).
* Patients covered by social insurance

Exclusion Criteria:

* Patients with sleep apnea syndrome previously treated by positive airway pressure therapy.
* Patients previously treated by additional oxygen therapy. Patient with unstable psychiatric disease
Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib

Infants with an estimated gestational age \< 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are delivered in a setting where an incubator is not available, will be randomized to either standard protocol of open crib or mylar-lined cardboard cot for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care.

Following parental consent, preterm infants with an estimated gestational age \< 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are in the newborn ICU in a setting where an incubator is not available, will be randomized to to transfer either standard protocol of open crib or mylar-lined cardboard cot when their temperatures are stable for transfer. The infants will remain in the cot or crib for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care, including WHO warm chain thermoregulation guidelines of early and exclusive breastfeeding, appropriate bundling and Kangaroo Mother Care as continuously as possible.

If at any point a babies becomes moderately (32.0-35.9° C) or severely hypothermic (\< 32.0° C), an extra blanket will be added to their bodies and a hat placed on their heads.

Eligibility Criteria:
Inclusion Criteria:

* Estimated gestational age \< 36 6/7 weeks
* Hospitalized in the newborn ICU at University Teaching Hospital
* Nursed in an incubator for at least 24 hours
* Thought to be ready to be weaned from incubator by the clinical staff

Exclusion Criteria:

* Major congenital anomalies
* Requiring ongoing respiratory support
* Suspected sepsis
The Effects of Aerobics Training on Balance in Patients With Multiple Sclerosis

Standing Balance, with and without blindfold, will be measured on patients with Multiple Sclerosis using a Biodex Balance Scale.

A Twelve week intervention with one non impact aerobics group and one control group will be performed.

Standing balance will then be retested on all subjects and the results will be statistically compared.

Standing Balance will be tested in 4 phases:

* On a firm surface eyes open
* On a frim surface eyes blindfolded
* On a foam surface eyes open
* On a foam surface eyes blindfolded

The aerobics classes will be conducted by a NIA (Non Impact Aerobics) instructor and will be a combination of tai chi, slow movement dancing, stretching and modified yoga stretches.

Eligibility Criteria:
Inclusion Criteria:

* Patients that were diagnosed by a neurologist with Relapsing Remitting Multiple Sclerosis.
* EDSS scale between 1 and 6.
* Patients that are able to travel to and from a 12 week program location.

Exclusion Criteria:

* Patients that were diagnosed by a neurologist with primary or secondary progressive multiple sclerosis.
* EDSS scale above 6
Topical Timolol for the Treatment of Benign Vascular Periocular Lesions

The purpose of this research is to find out if the use of topical timolol 0.5% solution applied twice daily will help to shrink rosacea lesions around the eye.

Benign vascular tumors of the eyelid are common causes of ocular morbidity. Capillary hemangiomas in children cause refractive and occlusive amblyopia. In adults, Rosacea-associated eyelid telangiectasis and sclerosis can result in keratitis and corneal neovascularization. Corticosteroid therapy of benign vascular lesions risks sight-threatening complications including central retinal artery occlusion and significant systemic morbidity. Alternatively, oral and intravenous beta-blockers have been reported to induce regression of benign vascular lesions. One recent report documented efficacy of topical timolol in treating a large capillary hemangioma of the eyelid in a child. Topical application reduces systemic side effects of beta-blockers including bradycardia, hypotension, heart block, and bronchospasm. This one-year prospective case-control series will investigate whether topical Timolol 0.5% solution applied twice daily causes significant regression of benign vascular periocular lesions.

Eligibility Criteria:
Inclusion Criteria:

* Presence of a benign vascular periocular lesion

Exclusion Criteria:

* Allergy to timolol or beta-blocker class of drugs
* Lesion characteristics concerning for atypia or malignancy including madarosis, ulceration, and recurrence after previous surgery.
* Intraocular Pressure less than 10 mm Hg
Smart Watch Insights for Prevention of Exacerbations and Enhance Rehabilitation - Movement Study

Aims of the study:

1. To deliver a scalable wellbeing programme to the local population of Imperial College Healthcare NHS Trust, focusing on movement.
2. To describe the natural history of long-term conditions using digital data from a smartwatch.
3. To identify digital information that is routinely collected by a smart watch that can be used to predict outcomes in patients with long term conditions.
4. To identify factors that determine whether participants engage with and improve in a movement programme.

Adult patients who are registered to the Imperial NHS Care Information Exchange (CIE), an NHS patient-facing electronic health record, are eligible to participate in the study. Participants will receive a smart watch for self-monitoring of their movement and wellbeing and be asked to wear the device as much as possible. They will be asked to download a smartphone application called Connected Life, which displays movement and information on heart rate, breathing and oxygen levels to both the participant and the research team (digital data). Participants will receive secure login details for the Connected Life application from the research team, to ensure data privacy. The research team will look at participants' health records, and attempt to identify associations between the digital data and clinical information. This will allow the research team to identify digital data that predicts the onset and natural history of long term conditions, which may potentially allow for earlier diagnosis for future patients. The primary outcome of the study is the identification of trends in movement based on step-count data recorded by the smartwatch.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years
* Registered with the patient-facing electronic health record (Care Information Exchange)

Exclusion Criteria:

* Unwilling or unable to provide informed consent
* Arm or wrist injury or condition prohibiting the safe use of a smartwatch
* Any visual impairment preventing the use of the smartwatch or smartphone application.
Telemonitoraggio Domiciliare Della Saturazione Arteriosa di Ossigeno in Pazienti COVID-19

The COVID-19 pandemic created an urgent need to implement digital health solutions for remote clinical management of infected patients who could be monitored at home. The Gemelli Polyclinic in Rome provided a digital health program (SATCOV) to monitor at home newly diagnosed COVID-19 patient, or after an early discharge from the COVID units.

A digital application and a wireless oximeter were provided to patients. Oxygen saturation, heart rate and body temperature were monitored. The aim is to evaluate the feasibility and safety of the oxygen saturation telemonitoring in COVID-19 patients.

Clinicians personalized their remote assistance defining specific alerts for each patient and/or required a timely hospitalization in a dedicated COVID unit if necessary.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (age\>18)
* confirmed diagnosis of Sars-CoV-2 infection by a positive nasopharyngeal and oropharyngeal swab (PCR or rapid test)
* clinical condition compatible with hospital discharge (for recoving COVID group) or home management (for ongoing COVID group)

Exclusion Criteria:

* non-autonomous patients
* patients without a smartphone and home internet connection
* patients unable to refer to emergency room in less than 2 hours or unable to observe home isolation
* the presence of severe comorbidities that could compromise the safety of telemonitoring
Efficacy of Telerehabilitation in Patients With Degenerative Meniscal Injury

The aim of the study is to compare the home exercise program performed with video-based telerehabilitation in patients with degenerative meniscal injury, and the home exercise program performed with one-on-one training in the hospital with conventional methods.

Conventional rehabilitation (CR) practices will be applied to the first study group. Telerehabilitation (TR) application will be applied to the second study group. It is aimed to evaluate the patients in terms of pain, functionality, quality of life and exercise compliance.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 - 65 years
* Having been diagnosed with degenerative meniscus injury by an orthopedist by MRI examination
* Having signed the consent form

Exclusion Criteria:

* Situations that will prevent assessments or communication with the individual
* Having an operation due to degenerative meniscus injury problem
* Orthopedic and neurological problems that would prevent evaluation and/or treatment
Screening for Delirium in Older Inpatients

Two-arm parallel-randomized pilot study and to collect data at the Department of Geriatric Medicine at Aalborg University Hospital. The aim is to assess the feasibility of a future randomized controlled study comparing Danish versions of 3D-CAM and 4AT in an acute medical setting. The primary objective is to assess 1) feasibility of obtaining informed consent and recruiting older adults within 24 hours of admission (or surgery) at the Department of Geriatric Medicine, Department of Acute Medicine, or Department of Orthopedic Surgery. Secondary objectives are 2a) to compare feasibility of recruitment and testing in the three different departments, 2b) to inform a preliminary evaluation of validity and reliability of the Danish version of screening instruments, and 2c) to obtain data on variance to support calculating sample size for a full-scale RCT.

We will recruit participants through a consecutive sampling of all potentially eligible patients. Recruitment will take place in three different settings: the Department of Geriatric Medicine, the Department of Acute Medicine, and the Department of Orthopedic Surgery. One week will be allocated for recruitment in each setting.

Potentially delirious patients often have impaired cognitive status. Therefore, the process of recruitment and informed consent is critically important and poses a central issue of feasibility to be assessed in this study.

It cannot be known with certainty whether patients are delirious prior to inclusion into the study, and even among delirious patients, there are considerable circadian fluctuations (as this is a hallmark of the condition), meaning that patients may have lucid moments during the day where they are cognitively intact and may be able to give informed consent.

Generally, informed consent will be sought from participants when possible. In case they are permanently or temporarily unable to give informed consent, informed consent will be sought from next of kin. Due to the short time in the study for each participant, it is not anticipated that participants will regain the ability to give informed consent during the study. However, if they do, new informed consent will be obtained from the participant. The number of potential participants at each step will be documented to assess problems with feasibility.

Eligibility Criteria:
Inclusion Criteria:

* Age over 80 years
* Admission or surgery within the last 24 hours

Exclusion Criteria:

* Unable to obtain contact to next of kin for informed consent within time-frame
Opioid Rotation From Morphine to Methadone in Treatment of Non-malignant Pain

Patients with non-malignant pain are switched from morphine to methadone with a nine-months' follow-up.

Twelve patients with poor pain control or unacceptable side effects during treatment with morphine were switched to methadone and followed for nine months in this open prospective study. Primary outcomes were patient preference for opioid and pain control while physical, cognitive and role functioning were secondary outcomes. The morphine dose was decreased by 1/3 daily and was replaced with an equianalgesic dose of methadone over a three-day period. During switching and a one-week dose titration period, patients were given additional methadone if required. During dose titration one patient experienced sedation requiring naloxone. Four patients were switched back to morphine due to poor pain control, drowsiness or sweating. Seven patients preferred long-term (\>nine months) treatment with methadone and reported reduced pain and improved functioning while cognition was not improved. This study brings novel information on the long-term consequences for pain control, health-related quality of life and cognitive functioning with a switch from morphine to methadone in the treatment of chronic non-malignant pain.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of age
* non-malignant chronic pain
* morphine use

Exclusion Criteria:

* addiction
* kidney disorders
Pharmacokinetics of a Single Oral Dose of 1,800 mg Red Vine Leaf Extract (Antistax®)

To describe the plasma and urinary pharmacokinetics of quercetin glucuronide and kaempferol glucuronide after the administration of a single peroral dose of 1,800mg Red Vine Leaf Extract (Antistax®). Additionally, the trial evaluated the safety and tolerability of this dose in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* male or female (if female: either of non-childbearing potential or taking adequate contraceptive measures)
* caucasian
* age: 18 to 40 years old
* body mass index (BMI): 18-28 kg x m-2
* subjects who - on the basis of extensive pre-trial investigation - could be considered to be healthy
* subjects who were willing and capable to confirm written consent to enrolment after ample information has been provided

Exclusion Criteria:

* if female: positive pregnancy test upon recruitment
* subjects with any relevant clinical abnormality (as based on extensive medical history, physical examination, vital signs)
* subjects with chronic or relevant acute infections
* subjects with therapy-requiring allergies (including drug allergies)
* subjects with suspicion of hypersensitivity to the investigational medication
* subjects with any clinically relevant laboratory abnormality (including positive results for hepatitis and HIV serology)
* subjects who had received any medication within 1 week prior to trial start or during the trial, except for hormonal contraceptives (females) or thyroid hormone replacement after thyroidectomy
* subjects who had taken a drug with a long half-life (≥ 24 hours) within one month before enrolment in the trial
* subjects who participated in a trial with a novel investigational medication within the last 8 weeks before the start of the present trial
* subjects who participated in a trial with a registered compound within the last 4 weeks before the start of the present trial
* subjects who donated blood or plasma within the last 4 weeks before the start of the present trial
* subjects who smoked more than 15 cigarettes per day and subjects who were not willing or able to abstain from smoking from 12:00 hours before and during the profiling days
* subjects known or suspected to be (social) drug dependent, incl. those drinking more than 60 g alcohol per day and who were not willing to abstain from alcohol during the active trial phase
* subjects adhering to a diet (i.e. vegetarian) or lifestyle (including extreme physical activities such as competitive sports and weight lifting) that might interfere with the investigation
* subjects known or suspected not to comply with the trial directives and/or known or suspected not to be reliable or trustworthy
* subjects known or suspected not to be capable of understanding and evaluating the information that is given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed
Screening for High-risk Chronic Obstructive Pulmonary Disease

This study is a multicenter cross-sectional study design aimed at screening risk factors for the combination of disease and syndrome in high-risk individuals with chronic obstructive pulmonary disease (COPD).

Targeting high-risk populations for chronic obstructive pulmonary disease (COPD), targeted at key issues such as unclear risk factors and lack of prevention and treatment plans, high-risk population screening was conducted to identify risk factors. This study is expected to detect at least 3600 high-risk individuals with early-stage chronic obstructive pulmonary disease. The incidence rate of high-risk individuals in the early stage of chronic obstructive pulmonary disease is 30%, which means the total screening population is 12000 cases.

Eligibility Criteria:
Inclusion Criteria:

* According to the Diagnosis and Treatment Guidelines for Chronic Obstructive Pulmonary Disease (Revised in 2021), a multi-stage cluster random sampling method was used to select individuals from representative administrative villages with a history of chronic cough or sputum production, breathing difficulties, recurrent lower respiratory tract infections, and/or exposure to potential risk factors for chronic obstructive pulmonary disease.
* The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.

Exclusion Criteria:

* Patients who are delirious, have impaired consciousness, dementia, various psychiatric disorders, etc., and cannot be accurately informed of their basic physical condition.
* Patients who, in the opinion of the investigator, are not suitable for participation in this study.
Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers

The primary objective of this study is to evaluate the feasibility and acceptability of obtaining repeated measurements of lean muscle mass, physical function, and biological aging in children receiving active cancer therapy. The secondary objective is to evaluate the feasibility of using the D3-creatine dilution method (D3Cr) to measure skeletal muscle mass in children with cancer.

Assessments will be collected at diagnosis, once during active treatment, and end of treatment in coordination with routine imaging to monitor changes in study outcomes during active cancer treatment. Key sociodemographic, treatment and health-related factors will be abstracted from the medical record.


Eligibility Criteria:
Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

1. Ages 8-21 years at the time of cancer diagnosis
2. Must have a newly diagnosed malignant solid tumor or lymphoma.
3. Participant is expected to undergo cancer treatment with either chemotherapy, radiation, immunotherapy, or other biologically targeted therapy.
4. Participants will undergo routine imaging with either computed tomography (CT), or Magnetic Resonance Imaging (MRI) of the chest or abdomen, or whole-body positron emission tomography (PET) scan.
5. Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.
6. English or Spanish speaking
7. Subject is willing and able to comply with study procedures.
8. Since the patient is undergoing active cancer therapy, must obtain approval from the treating physician.

Exclusion Criteria All subjects meeting any exclusion criteria at baseline will be excluded from study participation.

1. Prior history of cancer
2. Treatment with surgical excision alone
3. Planned palliative treatment.
4. Subject has elected to forgo chemotherapy or radiotherapy.
5. Any diagnosis of leukemia.
6. Clinical concerns that the treating clinician feels would preclude participation in the study.
7. Subject has a pacemaker or bilateral joint prosthesis that would prevent undergoing BIA assessment.
8. Unwilling to sign informed consent.
9. Speak a language other than English or Spanish.
Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement

In this pilot study, investigators aim to identify patients undergoing TAVR who are at elevated risk for adverse clinical events due to decreased exertional capacity and physical deconditioning. Investigators aim to determine if monitored pre-procedural physical therapy is safe in these patients. Lastly, investigators aim to assess the efficacy of prehabilitation

1. to improve physical functioning by the time of TAVR and to sustain benefit through 30 days post-procedure; and
2. to determine its effect on post-procedural length-of-stay, clinical outcomes, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be ambulatory (with or without an assist device)
* Subject has severe aortic stenosis and is felt an appropriate candidate for TAVR by the Heart Team.
* Subject requires 6.0 seconds or longer to complete a 15ft walk test
* Subject must be able to move between sitting and standing without assistance from another person.
* Subject has adequate iliac and femoral arterial anatomy to allow for TAVR via transfemoral access
* Subject is 18 years of age or greater
* Subject is willing to give consent and participate in the study

Exclusion Criteria:

* Subject is incapable of following instructions
* Subject is unable to meet the minimum required physical therapy visits
* Subject has other medical conditions rendering it unsafe, in the opinion of the Principal Investigator and physical therapy staff, to perform a 6 Minute Walk Test or physical therapy conditioning prior to TAVR
* Subject has significant severe un-revascularized epicardial coronary disease.