cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Benefit of the Mobility Assistance System (SAM) on Transfer Independence for a Reimbursement Request

This is a randomized, cross-over, multi-center, intention-to-treat, open-label study to assess the impact of the SAM Ergonom light (SAM) device on independence when transferring from the supine to the sitting position at the edge of the bed in a population of individuals with an inability to transfer independently from the supine to the sitting position in bed, compared with the use of a raising arm.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and over
* Unable to transfer from lying to sitting independently
* Requiring technical assistance or the help or supervision of a third party
* Using a medical bed
* In-patient care for a minimum of 3 weeks in a medical or rehabilitation facility
* Having freely consented to participate
* Affiliated with a social security scheme or entitled to benefits

Exclusion Criteria:

* Non-consolidated spinal or pelvic fracture
* Degenerative shoulder
* Cardiovascular disorders caused by physical exertion
* Joint pain localized to dorsolumbar spine
* Behavioural disorders (opposition, agitation, dementia)
* Invalid patient (disability, low tonicity), agitated, not lucid (confused, disoriented) at risk of falling, requiring physical restraint with bed rails on medical prescription
* Functional inability to move independently
* Cognitive impairment affecting reliability of response to questionnaires
* Motor or algic incapacity of the 2 upper limbs not allowing the use of a technical aid (lifting frame or SAM) to ensure transfer from lying to sitting position in bed
* Patient less than 146 cm tall
* Patient weighing less than 30 kg or more than 200 kg
* Patient with a mattress incompatible with the OS'CARE device
* Mattress length less than 190 cm or greater than 200 cm, and width less than 85 cm or greater than 120 cm

In addition, vulnerable persons covered by articles L. 1121-5 to 8 and L. 1122-1-2 of the French Public Health Code are excluded from the study:

* Pregnant, parturient or breast-feeding women
* Persons deprived of their liberty by judicial decision (including guardianship, curatorship and safeguard of justice) or administrative decision
* Persons under psychiatric care or admitted to a health or social institution for purposes other than research.
* Person in an emergency situation unable to give prior consent
Long Term Outcome of Extracorporeal Membrane Oxygenation Patients in China

Outcomes and Long-term Quality-of-life of Patients requiring Extracorporeal Membrane Oxygenation are not known in china. A prospective study survey will be performed to assess the long-term outcome of these patients.

Patients admitted to ICUs and treated with extracorporeal membrane oxygenation from March 1,2015 to March 1,2019 were screened . Pre-Ecmo clinical parameters(diagnose,APACHE-II, SOFA,indications,expected mortality) and related treatment conditions(duration of ICU stay, duration of ECMO,duration of mechanical ventilation,ventilation conditions,prone ventilation,ECMO complications )will be used to assess the severity and curative effect of these patients.Short Form-36 Health Status Questionnaire,EuroQol-5 Dimensions and St. George's Respiratory Questionnaire(SGRQ) will deliver in these survivors ,which are used to assess the physical and mental health ,as well as the social adaptation. Finally a comprehensive assessment will be obtained to describe the outcomes and long-term quality-of-life of patients treated With ECMO.

Eligibility Criteria:
Inclusion Criteria:

* require extracorporeal membrane oxygenation

Exclusion Criteria:

* irreversible disease
Healthy Thai Project With Bangkoknoi Model: Fatless Community

The goal of this interventional study is to make people in a community realize negative effects of obesity on health, and how to tackle it by adopting a lifestyle modification for weight reduction. Adults aged 20 years old or more with obesity (BMI ≥ 25 kg/m2) or waist circumference ≥ 80 cm in women and ≥ 90 cm in men were recruited. All participants received an educational session of lifestyle modification for weight reduction on the first day of study. Participants were then assigned to either continuously receive education (video clips and infographics) via application LINE, or no further education. The main questions it aims to answer are:

1. Whether or not an educational session of lifestyle modification leads to weight reduction.
2. Whether or not a weight loss by a continuous education via an online application is more effective than not receiving it.


Eligibility Criteria:
Inclusion Criteria:

* Obesity (BMI ≥ 25 kg/m2)
* Waist circumference ≥ 80 cm in women and ≥ 90 cm in men

Exclusion Criteria:

* Contraindications for bioelectrical impedance analysis
* Active cancer
* No available health data
Prediction of Bleeding Risk After Anticoagulant Therapy for Atrial Fibrillation Based on Proteomics and Metabolomics

Objectives: Atrial fibrillation (AF) is the most common arrhythmia. Anticoagulation with warfarin or new oral anticoagulants in patients with AF can significantly reduce thromboembolic events. However, due to the lack of bleeding risk predictors of oral anticoagulants, the bleeding risk of patients with AF cannot be accurately evaluated. The purpose of this study is to screen biomarkers that can predict bleeding in patients with AF through proteomics and metabolomics, and construct the protein metabolic network pathway of anticoagulant bleeding in patients with AF.

Design: AF patients treated with oral anticoagulants were enrolled in this study. Blood samples were centrifuged and the supernatant was stored in the refrigerator at - 80 ℃. All patients were followed up for one year to determine whether bleeding occurred after oral anticoagulants. Proteomic data were obtained by LC-MS/MS Analysis-DIA platform. Metabolomic data were obtained by UPLC-QTOF/MS platform. All of the omics data were used to compare proteins/enzymes with metabolic pathways. Quantitative changes of individual metabolites and proteins were calculated and graphed using the KEGG mapping tools.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or above
2. Admission with atrial fibrillation or clinic visit for atrial fibrillation
3. Receive routine anticoagulant therapy;
4. Signing the consent form

Exclusion Criteria:

1. Pregnant women;
2. Lactating women;
3. Severe mitral stenosis;
4. Severe impairment of liver function;
5. Severe renal insufficiency;
6. Thyroid dysfunction requiring treatment;
7. Have a history of severe bleeding within five years, such as intracerebral hemorrhage and gastrointestinal bleeding.
Effects of Tourniquet Use on Physical Function and Performance in Primary Total Knee Arthroplasty

Background:

Osteoarthritis (OA) is the most common joint disease that causes symptomatic health problems in the elderly population. For some patients with knee OA, total knee arthroplasty (TKA) may be the only option that offers the possibility of reestablishing the patient's life quality.

Surgery of TKA usually takes place in a complete bloodless field established by a tourniquet around the thigh. The method aims to reduce blood loss and give the surgeon better visibility during the operation. The method is, however, not without side effects as patients often experience severe pain and swollen leg in the time after surgery. Furthermore, has the method shown decidedly muscle- and nerve damage followed by prolonged rehabilitation and reduced physical function.

It is, however, possible to perform the operation without the use of the tourniquet.

Aim and hypothesis:

The aim of the present study is to assess the effects of tourniquet use in TKA on physical function, early rehabilitation, pain and opioid consumption.

Hypotheses H1: TKA without tourniquet leads to better physical function and early rehabilitation.

H2: TKA without tourniquet causes less pain and opioid consumption H3: Recovery of mechanical lower limb function post TKA is faster without use of tourniquet.

Methods:

80 patients (40 in each group) all eligible for TKA will be consecutively recruited and randomized to A) TKA without tourniquet, B) TKA with tourniquet. Subjects will be evaluated before the operation (baseline) and 14 days, 3, 6 and 12 months after the operation.

The primary outcome will be the change from baseline to 3 months in self-administered knee-function (KOOS-ADL subscale). Further, will we examine a number of pre-specified secondary outcomes, which include self-rated knee-related pain, symptoms, difficulty with sports and leisure activities, and quality of life. In addition, muscle function, physical performance, and the use of pain medication will be studied

Impact of the project:

The project design of this study will enable analyses for determining the impact of operating without tourniquet and whether such an intervention can in fact improve physical function, performance and quality of life within TKA patients. The results may impact notably on the patient level and possible redefine current surgical strategies. The societal perspective of the project is to remobilize patients faster, which may reduce hospital services and absence from work.


Eligibility Criteria:
Inclusion Criteria:

* Knee Osteoarthritis both clinically and radiologically according to the "Ahlbäck classification system".
* Patients who can tolerate spinal anesthesia

Exclusion Criteria:

* Patients with rheumatoid arthritis.
* Patients with BMI \> 35.
* History of major knee operations.
* Malignancy.
* Known muscle disease.
* History of deep vain thrombosis (DVT), or other blood coagulation disorders.
* Symptomatic bilateral OA, with planned surgery of the contra lateral knee within a year.
Relationships of Executive Functions, Severity of Psychiatric Symptoms With Response to Therapy

This study was conducted to investigate the moderating role of executive functions in the relationship between the severity of psychiatric symptoms and response to therapy. The statistical population of this study was all outpatients with anxiety disorders and depression who referred to psychiatric clinics.

This study was conducted to investigate the moderating role of executive functions in the relationship between the severity of psychiatric symptoms and response to drug therapy in depressed and anxious patients. The statistical population of this study was all outpatients with anxiety disorders and depression who referred to psychiatric clinics. 164 participants completed Outcome Questionnaire, Brief Symptom Inventory, and Behavior Rating Inventory of Executive Function (BRIEF).

Eligibility Criteria:
Inclusion Criteria:

receiving a diagnosis of anxiety and depression disorders, age over 18 years, and taking drug medication prescribed by psychiatrists for at least one month.-

Exclusion Criteria:

* having psychotic disorders, age under 18 years and absence from treatment.
A Comparative Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Adult Smokers and Non Smokers

Smokers are at higher risk of developing Erectile dysfunction (ED) independent of age and comorbidities. Sildenafil is a cytochrome p3A4 (CYP3A4) substrate used for enhancing the erectile function in males. The study purpose is to determine the effect of smoking on male sexual function based on the international index of erectile function score (IIEF) and investigate the effect of smoking (Cigarettes or marijuana) on the pharmacokinetics and pharmacodynamics of sildenafil.

The study is a randomized, single dose, one way, open label, parallel study in thirty-six (36) subjects randomized into three groups;group(1) included twelve(12) healthy non-smoker males, group(2) included twelve(12) healthy smokers (Cigarettes) and group(3) included twelve(12) healthy smokers (marijuana).

Each group received a single dose of Viagra 50 mg film coated tablet (Sildenafil 50 mg) Blood samples were collected at the following sampling intervals: pre-dose administration, 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8,10, 12 and 24 hours post dose.

Blood samples were centrifuged and plasma was separated and stored at -80 degree Celsius till time of analysis.

Plasma concentrations of sildenafil were determined by liquid chromatography tandem mass spectrometry (LC/MS/MS)

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Age 18-55 years.
* Ideal weight with ideal body mass index(BMI).
* Non-contributory history and normal physiological examination.
* Laboratory data within normal limits.
* Performance and compliance.
* The subjects should be without known history of alcohol or drug abuse problems
* Subjects who are cigarette smokers
* Subjects who are cannabis smokers
* Subjects who are non-smokers

Exclusion Criteria:

* A known hypersensitivity to the drug.
* Gastrointestinal diseases.
* Auto immune diseases.
* Renal diseases or dysfunction.
* Cardiovascular disease of any type.
* Pancreatic disease including diabetes.
* Hepatic disease.
* Hematological, osteopathic, or pulmonary disease.
* History of alcoholism or drug abuse.
* Serious Psychological illness.
* Positive HIV.
* Abnormal (out of range) laboratory values.
* Subject who have taken any medication less than two weeks of the trials starting date.
* Subject who have donated blood or who have been in multiple dosing studies requiring a large volume of blood (more than 500 ml) to be drawn within six weeks preceding the start of the trials.
QUality of Control and slEep in Children With diabeteS, Using New Technology

The study is an open label single centre randomised cross over study to evaluate the impact of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin administration (640G® with the Smart Guard feature) versus the use of the same pump for insulin administration with 'only' continuous glucose measurements (not interacting with the pump, Freestyle Libre ® ) on the time in glucose target , in hypo- and hyperglycemia. Exploratory endpoints are the effect on sleep and quality of life in children with type 1 diabetes and their caregivers.

Optimising metabolic control in children with Type 1Diabetes Mellitus (T1DM) is essential to prevent late complications. Fear of nocturnal hypoglycemia is pervasive amongst parents of children with T1DM, leading to a heightened vigilance by parents to control regularly their children's blood sugar values or to check the sensor information during the night. This leads to chronic sleep interruption and to lack of sleep as well in the parents as in their children with diabetes.

In this study, the impact of new technologies on glucose time in target , hypo fear and quality of life will be evaluated, using continuous interstitial glucose measurements either with a direct impact on insulin administration (640G medtronic pump (R)) and with alerts , or without impact on insulin administration and without alerts.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Duration of diabetes ≥ 6 months
* Insulin pump treatment ≥ 6 months
* HbA1c ≤ 11%
* Parental written informed consent

Exclusion Criteria:

. No parental consent

* Physical or psychological disease likely to interfere with an appropriate conduct of the study
* Current drug therapy knowing to interfere with glucose metabolism
* Chronic sleep medication in the primary caregiver or the patient -
Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System

Functional electrical stimulation is a modality of motor rehabilitation that consists of the programmed application of bursts of electrical current to the affected neuromuscular region that aims to improve muscle strength, increase the range of motion, facilitate movement control and decrease spasticity. The present study aimed to measure the changes in the biomechanics of the gait of people with Stroke after training with functional electrical stimulation for the lower extremities.

Stroke is one of the leading causes of mortality, morbidity and disability in adults in developed countries. Survivors may suffer several neurological deficits or deficiencies, such as hemiparesis, communication disorders, cognitive deficits and visuospatial perception disorders. Hemiplegia is a par loss of hemi-body voluntary motricity following a brain injury, usually resulting in alterations of the locomotor system with persistent disorders of movement and posture. Hemiplegia significantly affects gait performance. Gait recovery is an important objective in the rehabilitation program for stroke patients.The currently available treatment techniques include classical techniques of gait rehabilitation, functional electrical stimulation, electromechanic devices, robotic devices and brain-computer interfaces, among others.The evidence suggest that the combination of different rehabilitation strategies is more effective than conventional rehabilitation techniques alone. Technology-based rehabilitation methods such as robotic devices need more research to demonstrate their effects on gait recovery.

The present study aimed to identify the changes in the gait characteristics of subjects with stroke after a treatment program with FES for the lower extremities through instrumental gait analysis.

Eligibility Criteria:
Inclusion Criteria:

* unilateral lower extremity paresis
* haemorrhagic or ischemic stroke
* a minimum of six months after the acute infarction/onset of the disease
* full passive range of motion in lower extremity or at least at neutral position
* be able to stand freely
* be able to walk with or without aid for at least 20 meters in less than 2 minutes

Exclusion Criteria:

* peripheral nervous system pathology
* epilepsy
* weight over 100 kg
* no cognitive ability to follow the study instructions
* pregnancy
* use of implanted devices
* instable lower extremity joints or fixed contracture
Use of Brain Oxygen Tension Level and Cleaved-tau Protein to Detect Vasospasm After SAH

The purpose of this study is to investigate if brain oxygen levels, levels of a specific protein in the cerebrospinal fluid and blood (Cleaved-tau protein), and brain blood flow can predict spasm of brain blood vessels after bleeding in the brain from a ruptured aneurysm.

Rupture of a cerebral aneurysm causes subarachnoid hemorrhage (SAH). Blood in the subarachnoid space of the brain can cause irritation of the cerebral blood vessels, leading to constriction of these vessels, a phenomenon known.as vasospasm. Cerebral vasospasm can cause stroke and possibly death. Of all the patients with SAH, approximately 20-40% will suffer from clinical vasospasm and more than 60% of those patients will never get back to their previous functional status. Tools to identify early vasospasm and thus early treatment could greatly decrease the morbidity and mortality following SAH.

Cleaved tau protein is a neuronal marker that has been detected in blood and CSF of stroke patients early in its time course. Since vasospasm can lead to stroke, the purpose of this project is to determine whether increase in cleaved tau protein in blood and/or CSF can predict early stroke from vasospasm. Changes in brain oxygen tension measured by a brain tissue oxygen monitor and cerebral blood flow measured by CT perfusion will be correlated with cleaved tau protein levels and clinical status. Utilizing statistical analysis the levels of Cleaved tau protein, brain oxygen and blood flow during hospitalization will be correlated with patient outcome. Through this study we hope to identify increase in cleaved tau protein and decrease in cerebral blood flow and oxygenation as predictors of early vasospasm. Early detection and treatment of vasospasm could decrease the stroke rate in SAH patients and therefore be of great benefit to society.

Eligibility Criteria:
Inclusion Criteria:

* Patients with subarachnoid hemorrhage
* Patients with external ventricular drains

Exclusion Criteria:

* Patients in whom consent is not attainable
Efficacy and Safety of Different Doses of Rivaroxaban in Elderly Chinese Patients With Nonvalvular Atrial Fibrillation

From January 2023 to December 2025, 300 elderly patients with nonvalvular atrial fibrillation in Drum Tower Hospital Affiliated to Medical Scholl of Nanjing University will be enrolled to compare the efficacy and safety of rivaroxaban-H, rivaroxaban-M and rivaroxaban-L dose in elderly patients after 24-month follow-up.

To explore the appropriate dose of rivaroxaban to prevent stroke in elderly Chinese patients with nonvalvular atrial fibrillation in order to improve the effectiveness and safety of anticoagulation therapy. From January 2023 to December 2025, 300 elderly patients with nonvalvular atrial fibrillation in Drum Tower Hospital Affiliated to Medical Scholl of Nanjing University will be enrolled to compare the efficacy and safety of rivaroxaban-H, rivaroxaban-M and rivaroxaban-L dose in elderly patients after 24-month follow-up. The efficacy indexes include stroke, non-CNS systemic embolism, fatal stroke, transient ischemic attack and myocardial infarction, and the safety indexes include major bleeding, non-major clinically relevant bleeding, minor bleeding events.

Eligibility Criteria:
Inclusion Criteria:

* Age≥75 years
* Chinese patient: male or female
* Patients had to be diagnosed as nonvalvular atrial fibrillation (NVAF)

Exclusion Criteria:

* Patients with anemia (hemoglobin\<100g/L), known human immunodeficiency virus infection, female patients who were pregnant or lactating and patients for whom warfarin was contraindicated, were also excluded
* Patients with calculated creatine clearance vulue\<30ml/min
* Patients expected to chronically use a non-steroidal anti-inflammatory agent (except for external preparations) and those treated with a strong cytochrome P4503A4 inhibitor (eg, ketoconazole, clarithromycin, or protease inhibitors) or a strong cytochrome P450 3A4 inducer (eg, rifampicin) during the trial
Islet Transplantation in Type 1 Diabetic Patients

Our hypothesis is that a successful clinical islet transplant program can be established at the University of Wisconsin using a steroid -free, sirolimus- and low dose tacrolimus - based immunosuppressive drug regimen (Edmonton protocol). We intend to answer the following research questions: 1) will treatment of islet transplant recipients with thiazolidinediones (i.e. pioglitazone) enhance post-transplant islet function and reduce the number of islets necessary to achieve adequate metabolic control? 2) which type 1 diabetic patients are optimal candidates for islet transplantation (i.e. islet transplant alone or islet after kidney transplantation)? 3) Can cadaver donor pancreases, which are ordinarily discarded and not used for pancreas transplantation be used for islet transplantation?


Eligibility Criteria:
Inclusion Criteria:

* 16 Type I insulin-dependent diabetic subjects ages 18-60,(8 who have received a prior kidney or liver transplant and have stable renal function, and 8 who have labile glucose regulation and who have failed a trial of intensive exogenous insulin therapy and who have preserved native renal function)

Exclusion Criteria:

* untreated proliferative diabetic retinopathy;
* HgbA1C \>12%; creatinine clearance \< 80 ml/minute or macroalbuminuria \> 0.3 gm/24 hrs;
* presence of panel reactive antibodies \>20%