cyrilzakka/clinical-trials huggingface dataset:
Body Composition, Glucose Metabolism, Insulin Resistance and Gene Expression in Muscle Cells in Healthy Overweight Women

In this study, we will clarify the degree of insulin resistance and characterise muscle glucose metabolism and gene expression in a group of overweight healthy women. The study will clarify how overweight influences body glucose metabolism and thereby in the long-run increases the risk for developing type 2 diabetes. Moreover, the study may clarify why some overweight women develop hormone disorders and diabetes while others remain healthy.

The study is essential as many patients suffer from diseases aggravated by overweight. In addition, a genetic disposition for diabetes or polycystic ovary syndrome may give rise to the disease if the patient gains weight. It is therefore important that weight-matched control subjects are included in projects with overweight patients.

This clinical trial includes 10 overweight women with regular hormones and normal level of male sex hormone. The patients included must be healthy, take no medications influencing the study results. The subjects must take no contraceptive pills or receive any other hormone treatment.

In connection with the investigation, the following will be carried out on all patients: clinical examination, blood tests, hyperinsulinaemic euglycaemic clamp, muscle biopsies, bone scan.

The purpose of the study is to gain more knowledge of how overweight influences women's risk of developing hormone diseases and diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Regular menses, i.e. cyclus length 25-34 days
* Premenopausal
* Ferrimann-Gallway score \< 2
* BMI \> 27 kg/m2
* normal total testosterone value \< 3.5 nmol/l

Exclusion Criteria:

* Age \<18 years
* Contraceptive pills within the past 3 months
* Postmenopausal (increased FSH)
* Diabetes mellitus
* Endocrine or other disease requiring treatment
* Eating disorder or other psychiatric history
* Drug use known to influence parameters investigated in this trial
* Pregnancy
Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)

The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO and to demonstrate superiority of the STARFlex® device compared to best medical therapy.


Eligibility Criteria:
Major Inclusion Criteria:

* Age 18-60 years inclusive.
* Positive contrast valsalva bubble study by trans-esophageal echocardiogram (TEE) for patent foramen ovale (PFO), with or without atrial septal aneurysm.
* Stroke or clinically definite TIA (contact study coordinator).
* Be able to comply with follow up over two years.
* Be competent to, or have a legal guardian competent to, provide informed consent following full disclosure of risks and benefits of both treatment arms by a study investigator.
* Venous access capable of accepting a 10F minimum vascular sheath.
* Have, or be willing to, discontinue hormonal based contraceptive use prior to enrollment and for the term of the study.
* Has cardiac anatomy based on enrollment echocardiogram that will allow for placement of the implant if randomized to the implant arm.
* Note: Additional inclusion criteria may apply. Contact study coordinator or principal investigator for details.

Post-randomization - device patients only

* The size of the PFO (measured by indentation with a soft balloon) must be amenable to selection of a STARFlex device.

Major Exclusion Criteria:

* Carotid artery stenosis \> 50%.
* Intracranial stenosis \> 50% appropriate to symptoms.
* Complex aortic arch atheroma with high risk features for embolism
* Aortic arch, carotid or vertebral artery dissection.
* Mitral or aortic valve stenosis, vegetation, or calcification \> 5 mm mitral annular calcification (MAC) thickness.
* Active pregnancy.
* Active infections (contact study coordinator).
* Active infective endocarditis or bacteremia.
* Prosthetic heart valves in any location.
* Anterior MI within 3 months of neurological event.
* Chronic atrial fibrillation
* Thrombus in, or occluded, venous access route.
* Contraindication to heparin, aspirin, clopidogrel, or warfarin, or a known medical condition that requires continuous warfarin.
* Patient enrolled in another investigation study where clinical endpoint interference may occur.
* Permanent pacemaker or inferior vena cava (IVC) filter.
* Serum creatinine \> 2.0 mg/dL
* Patients with known vasculitis or neurologic disorder.
* Baseline modified Rankin score of 3 or more.
* Hypercoagulopathies requiring long-term warfarin.
* Note: Additional exclusion criteria may apply.
Evaluation of the Quantra System in a Surgical Oncological Population

This study will monitor coagulation parameters during the perioperative course of cancer surgical procedures using the Quantra System with the QPlus Cartridge.

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra QPlus Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed iin parallel yielding six parameters that depict the functional status of a patient's coagulation system.

The oncologic surgical population presents unique challenges to providers who must distinguish between a cancer patient's increased tendency toward both thrombosis and hemorrhage. This single site prospective observational study in oncologic patients will give an insight into the coagulation status of critically ill cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \>= 18 years
* Subject is diagnosed with cancer and is scheduled for surgical resection
* Subject is willing to participate, and he/she or a Legally Authorized Representative (LAR) has signed a consent form
* Surgical procedure to be performed has an anticipated blood loss (\>500mL) based on historical data

Exclusion Criteria:

* Subject is younger than 18 years
* Subject or a subject's LAR is unable to provide written informed consent
* Subject is undergoing an emergent procedure.
* Subject is pregnant, has active liver disease, or severe renal dysfunction (creatinine clearance (CrCL)\<30 mL/min)
* Subject has an extremely low platelet count (\<40,000/uL)
* Subject is currently enrolled in a distinct study that might confound the results of the proposed study
* Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks
Yoga for Young Adults Affected by Cancer

Yoga may enhance physical and psychological outcomes among young adults affected by cancer. Yet, yoga has rarely been studied in this population. We developed and piloted a yoga program, which is now ready for implementation and evaluation. This single-group, mixed-methods project will explore effectiveness and implementation of the yoga program.


Eligibility Criteria:
Inclusion Criteria:

1. Adult aged 18 years or older;
2. Diagnosed with cancer between the ages of 18-39 years;
3. At any stage of their cancer experience (i.e., on- or off-treatment);
4. Able to safely engage in yoga, as assessed by completing the Get Active Questionnaire and obtaining medical clearance (if indicated).
5. Willing and able to complete informed consent, questionnaires, physical assessments, and an interview in English.

Exclusion Criteria:

1. Previous enrolment in the study, to avoid contamination and/or ceiling effects.
Social History and Glaucoma Progression

The objective of this study is to predict of glaucoma progression. By imaging of the retinal nerve fiber layer RNFL, optic nerve head (ONH) and macular measurements using spectral-domain OCT (SD-OCT) instruments

Glaucoma is a multifactorial optic neuropathy characterized by structural damage of retinal ganglion cells (RGCs) and their axons that is associated with vision loss and may lead to irreversible blindness. Because glaucomatous damage is irreversible and effective treatment is available to halt further damage, glaucoma management should be optimized with precise micrometer-scale quantifications of ocular structures that improve detection of the disease and its progression. The introduction of OCT technology more than 20 years ago provided in vivo detailed visualization of the optic nerve head (ONH) and retina and enabled the quantitative evaluation of these tructures. Circumpapillary retinal nerve fiber layer (RNFL) thickness is a common OCT measurement that provides comprehensive evaluation of all RGCs in an eye as they converge into the ONH.

When measured with spectral-domain OCT, the RNFL has been shown to differentiate between healthy and glaucomatous eyes. The steady evolution of OCT technology has led to imaging with better resolution, higher scanning speeds, and advanced imaging patterns that has improved the reliability of OCT measurements and allowed for detection of minute changes that can improve the sensitivity of progression detection. Assessment of glaucoma progression usually is based on event or trend analysis. Event-based progression determines when a measurement exceeds a pre-established threshold for change from baseline. Trend-based analysis quantifies the rate of a parameter's progression over time.

Eligibility Criteria:
Inclusion Criteria:

* IOP measurements more than 21 mmHg
* Open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width)
* Glaucomatous visual field defects consistent with glaucomatous optic disc changes.
* Eyes with baseline macular and ONH OCT images and ONH photograps

Exclusion Criteria:

* Participants with significant retinal disease.
* non-glaucomatous optic neuropathy.
* anomalous discs
* any retinal pathology.
* history of cataract or glaucoma surgery will not be exclusion criteria.
Yoga Training and Retinal Vasculature

This study will compare the impact of a novel high-speed, cued yoga program to a standard yoga program on retinal microvasculature, cognition and neuromuscular function.


Eligibility Criteria:
Inclusion Criteria:

1. 60-90 years of age;
2. Montreal Cognitive Assessment (MoCA) \> 23
3. no memory loss complaints

Exclusion Criteria:

1. uncontrolled cardiovascular or neuromuscular diseases that prevent participation in a training program;
2. cerebrovascular disease;
3. documented HIV infection or other immunodeficiency syndrome;
4. any systemic inflammatory or autoimmune conditions such as rheumatoid arthritis, systemic lupus erythematosus, or other serious concomitant medical illness;
5. a history of ocular surgeries (except for cataract surgery more than 6 months ago) or other ocular diseases;
6. bilateral moderate or severe cataracts;
7. refractive errors of myopia, hyperopia and/or astigmatism more than 6.0 Diopters
Influence of Beta Blockers on Prognosis in Patients With Acute Myocardial Infarction Complicated With Normal Ejection Fraction

To understand the effect of beta blockers on the prognosis of patients with acute myocardial infarction with preserved ejection fraction.

The use of beta blockers is an important component of drug therapy for myocardial infarction, but in some exceptional cases, evidence-based evidence for their use is insufficient, and we seek to understand the prognostic impact of beta blockers on patients enrolled in long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute myocardial infarction

Exclusion Criteria:

* Previous history of heart failure admission Killip class \> I class cancer pregnant
Functional Dyspepsia Treatment Using Virtual Reality

The purpose of this study is to evaluate the effectiveness of using virtual reality to treat gastrointestinal symptoms related to functional dyspepsia.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of dyspepsia thought to represent functional dyspepsia, meeting Rome IV criteria
* Had an upper endoscopy and assessment for Helicobacter pylori; if a patient is found to have H. pylori, treatment with confirmed eradication (by stool antigen test or urea breath test) will be required before the patient is eligible for study inclusion.
* Patients will be considered for the study if they have undergone a complete history and physical examination during a previously scheduled consultation/evaluation visit with a gastroenterologist in the Mayo Clinic Florida General GI or Motility clinic.

Exclusion Criteria:

* Symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, type I diabetes, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), or patients have known uncontrolled GERD, esophagitis, eosinophilic esophagitis, or untreated H. pylori.
* Patients with gastroparesis or cyclic vomiting syndrome.
* Patients with prior surgery to the esophagus, stomach or duodenum.
* Patients taking opioids.
* Patients with motion sickness, vertigo, or a seizure disorder
* IBS symptoms are not predominant.
Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty

The aim of this study is to assess the effectiveness of Sublingual Sufentanil Tablets System (SSTS, Zalviso ®) to control postoperative pain after total knee arthroplasty in the context of early rehabilitation program.

SSTS is a novel patient controlled analgesia system wich does not require intravenous access, potentially improving pain control and promoting mobilization.

SSTS will be randomly compared to nurse-driven oral Oxycodone.

Even with multimodal analgesia (combining local anesthetic infiltration, corticosteroids, non-steroidal anti-inflammatory drugs and acetaminophen), total knee arthroplasty is associated with acute moderate-to-severe postoperative pain requiring opioids treatment. We compare the efficacy of SSTS and oral Oxycodone in this context.

After written informed consent, patients will be randomly assigned postoperatively to SSTS or Oral oxycodone group at a ratio 1:1. Pain scores, mobilization and patient satisfaction will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years)
* Scheduled for unilateral total knee arthroplasty under spinal anesthesia
* American Society of Anesthesiologists (ASA) class 1-3

Exclusion Criteria:

* Contraindication to medication used in our multimodal analgesia protocol (solumedrol, celecoxib, acetaminophen, ropivacaine)
* Allergy to study medications
* History of addiction or preoperative chronic use of opioids
* Unicompartmental or revision knee replacement
A Single Intraarticular Injection of Platelet-Rich Plasma on Pain and Physical Function in Patients With Ankle OA

Platelet-rich plasma (PRP) has been reported to be an effective treatment for knee osteoarthritis (OA). The application in ankle OA has rarely been investigated. The aim was to evaluate the efficacy and safety of a single intraarticular injection of PRP for the treatment of patients with ankle OA.

Methods: In a prospective study, patients with symptomatic ankle OA for at least 6 months were recruited. Patients received a single injection of 3-ml of PRP into symptomatic ankles. The primary outcome was the change from baseline in the visual analog scale (VAS) pain score (0-10cm) at 6 months. Secondary outcomes included the Ankle Osteoarthritis Scale (AOS) score, American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score, single leg stance test (SLS), use of rescue analgesics and patient satisfaction. Adverse events were recorded during the study.

Patients were followed at 1, 3 and 6 months postinjection .

Eligibility Criteria:
Inclusion Criteria:

* Age of at least twenty years
* Ankle pain lasted for at least 6 months, despite conservative treatment or inability to tolerate the side effects of medications
* Ankle radiographs taken within 6 months (reviewed by the senior author) were equivalent to grade 1-4 osteoarthritis by the Kellgren Lawrence grading system
* Average ankle pain of \> 3cm on a 10-cm visual analog scale (VAS)
* Radiological evidence of bilateral ankle osteoarthritis was accepted if VAS pain in the contralateral ankle was \< 3 cm
* Normal activity level, not bedridden or confined to a wheelchair, able to walk 30 meters without the aid of a walker, crutches or cane
* No use of physical therapy or changes in shoes or orthotic devices during the study

Exclusion Criteria:

* Pregnancy or lactation in women
* Lower leg trauma in a location other than within the ankle
* Previous surgery involving the spine, hip or knee
* The presence of an active infection of the ankle
* Surgery involving the affected ankle within the previous 12 months
* Intraarticular steroid or hyaluronate injection in the ankle within the previous 6 months
* Treatment with anticoagulants or immunosuppressives
* History of rheumatoid arthritis, gout, or other inflammatory arthropathy
* The presence of visual or vestibular impairments
* Poor health status (such as a neoplasm, diabetes mellitus, or paresis) that would interfere with the assessments
Metabolomic Study of All-age Cardiomyopathy

This study aims to 1)characterize the differentially expressed metabolites between cardiomyopathy patients and healthy controls,2)identify the specific biomarkers associated with outcomes or risk evaluation in patients with different cardiomyopathies in a follow-up of a cohort and 3)to determine whether differentially expressed may affect the pathological process of cardiomyopathies . Standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of blood plasma.

The aim of this study is to analyze metabolomic profile of patients with cardiomyopathy in order to identify biochemical markers with risk stratification and prognostic value. Clinical data of enrolled patients regarding demographics, cardiovascular risk factors，clinical lab data and previous cardiovascular disease will be recorded. Follow up will be at 3 months,6 months,9 months,1 year and 3 years and will be performed by clinical recordings or phone call when necessary. Blood samples of patients with cardiomyopathy are taken when they enrolled. Serum samples will be analyzed by Liquid Chromatograph Mass Spectrometer/Mass Spectrometer.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who was diagnosed as cardiomyopathy by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.
2. Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures

Exclusion Criteria:

1. Endocrine disease known to cause heart muscle disease (including infants of diabetic mothers)
2. History of rheumatic fever
3. Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure)
4. HIV infection or born to an HIV positive mother
5. Kawasaki disease
6. Immunologic disease
7. Uremia, active or chronic
8. Abnormal ventricular size or function that can be attributed to intense 9.physical training or chronic anemia

10.Chronic arrhythmia, unless there are studies documenting inclusion criteria prior to the onset of arrhythmia (except a patient with chronic arrhythmia, subsequently ablated, whose cardiomyopathy persists after two months is not to be excluded) 11.Malignancy 12.Pulmonary parenchymal or vascular disease (e.g., cystic fibrosis, cor pulmonale, or pulmonary hypertension) 13.Ischemic coronary vascular disease 14.Association with drugs (e.g., growth hormone, corticosteroids, cocaine) or other diseases known to cause hypertrophy
Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin and Empagliflozin or Dapagliflozin in Healthy Male Adults

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg after Oral Administration in Healthy Male Adults


Eligibility Criteria:
Inclusion Criteria:

* Health Male Volunteers (Age : 19\~55 years)
* Body Weight≥55kg, 18.5≤BMI\<25.0

Exclusion Criteria:

* galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Allergy or Drug hypersensitivity
* Clinically significant Medical History
* AST, ALT \> Upper Normal Range\*1.25, eGFR\<60mL/min/1.73㎡
* Drink during clinical trial period
* Smoking during clinical trial period
* Grapefruit/Caffeine intake during clinical trial period
* No Contraception
Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.

Interest of continuing systemic chemotherapy or not , after a short initial treatment (6 weeks) in patients who are in response or stable disease("Discontinuation design ")of patients with metastatic oesophageal cancer of squamous cell type

The secondary aims would be to study : toxicity, the overall survival rate, a study of costs and quality of life.

As the data in litterature does not provide the basis for well-argued statistical hypothesis, it is suggested to randomize 30 patients per arm. An IDMC will come to a decision after the inclusion of 10, 20 ans 40 patients on the efficacy and the toxicity profile and on whether to maintain the current clinical position, justifying randomisation . In order to take into account any possible effects of prior concomitant radiochemotherapy, patient will be stratified according to whether they have already undergone chemotherapy or radiochemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an histologically proven epidermoid cancer of the oesophagus
* Patients with metastatic disease that can be measured or evaluated according to the RECIST criteria, and located outside of previously irradiated fields
* Patients who may or may not have undergone radiochemotherapy
* Patients who have not received chemotherapy for metastatic disease
* ≥ 18 ans
* Performance Status (ECOG) ≤ 2
* People who are covered by private or state health insurance
* Informed consent signed by the patient

Exclusion Criteria:

* Other evolutive malignant tumor
* Infection with HIV-1, HIV-2 or chronic hepatitis B or C
* Cerebral metastasis or known meningeal tumor
* Any unstable chronic diseases that could risk the safety or the compliance of te patient
* Women who are pregnant or breastfeeding. Women must not breastfeed for at least 6 months after administration of Bevacizumab
* Patients unable to undergo the follow-up of the trial for geographical, social or psychological reasons

For the randomized part

Inclusion criteria :

* Non-progressive disease after the 6 first weeks of chemotherapy
* Performance Status (ECOG) ≤ 2
Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.

The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric. This surveillance includes an "all-comers" prospective cohort of pediatric (\<22 years of age) patients implanted according to the IFU with the EXCOR® Pediatric.

The Advanced Cardiac Therapies Improving Outcomes Network (Action) database will be used for the surveillance. The network was developed to determine best practice and improve quality in the pediatric mechanical circulatory support field. The registry Protocol and Manual of Operations will be followed by participating pediatric transplant hospitals. Quality assurance of the data will be monitored by the registry's data coordinating center.

Eligibility Criteria:
Inclusion Criteria:

* Transplant eligible
* Implanted with EXCOR Pediatric per IFU

Exclusion Criteria:

* Having any contradictions for user per IFU