cyrilzakka/clinical-trials huggingface dataset:
Thrombin Generation as a New Test for Anticoagulation Management in Patients With ECMO

ECMO (Extracorporeal Membrane Oxygenation) is a circulatory assistance device aiming at maintaining or restoring cardiopulmonary circulation. Complications of this device are mainly hemorrhagic, related to coagulopathy induced by the initial pathology or by the device itself, or thrombotic and ischemic. One of the major challenges is therefore the management of a suitable curative anticoagulation, sufficient to limit the activation of hemostasis du to the ECMO, but reasonable to prevent hemorrhagic complications. To date, there is no standardized and validated protocol for the management of anticoagulation of patients under ECMO. The thrombin generation may be a valuable test to manage anticoagulation of patients with ECMO.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age ≥ 18 years old
* Implantation of a veno-arterial or veno-venous ECMO during hospitalization in intensive care
* Informed consent

Exclusion Criteria:

* Patient on veno-arterial ECMO after cardiac, cardiopulmonary surgery or after insertion of a left or biventricular cardiac assist device
* Contraindication to curative anticoagulation
* Congenital hemostasis disorder or anatomical abnormality predisposing to hemorrhage (hemophilia, constitutional thrombocytopathies, Willebrand disease, hereditary hemorrhagic telangiectasia, etc.)
* History of heparin-induced thrombocytopenia
* Moribund patient at the day of inclusion
* Do Not Resuscitate decision
* Subject under the protection of justice
* Subject under guardianship or curatorship
* Pregnancy
* Breastfeeding
ROSA Total Knee Investigational Testing Authorization Study

This is a prospective, single-center clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona Total Knee components using the ROSA Total Knee Robotic System or conventional instrumentation.

The primary objective of this study is to collect and compare clinical outcomes and surgical data using the ROSA Total Knee robotic instrumentation and conventional instrumentation in primary total knee arthroplasty.

The assessments will include: Planned vs actual component positioning; Workflow efficiency; Patient safety based on incidence and frequency of adverse events; Clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is a minimum of 18 years of age
2. Pre-op component positioning and sizing plan prior to surgery
3. Independent of study participation, patient is a candidate for primary TKA using the commercially available Persona knee components implanted in accordance with product labeling
4. Patient has participated in this study-related Informed Consent process
5. Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form
6. Patient is willing and able to complete scheduled study procedures and follow-up evaluations

Exclusion Criteria:

1. Patient is currently participating in any other surgical intervention studies or pain management studies
2. Patient has underwent contralateral UKA or TKA within the last 18 months
3. Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)
4. Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation)
5. Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
6. Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Obesity. A Randomized Controlled Trial

The investigators hypothesized that hypnosis is an alternative technique that could be applied to help patients with obesity to lose weight.

The possibility that a self-conditioning technique (self-hypnosis) added to traditional approach (diet, exercise and behavioral recommendations) will be effective in determining weight loss with respect to the traditional approach in subjects with a body mass index (BMI) between 35 and 50 kg/m2 will be studied.

Obesity is a serious health concern. Most lifestyle interventions fail over time; indeed, overeating often involves loss of control and compulsive behaviors.

Hypnosis could increase the ability to control emotional impulses. Self-conditioning techniques borrowed from hypnosis (self-hypnosis) increase self-control and self-management of emotions. Recent hypnosis techniques with a rapid-induction phase allow the trained patients to go into self-hypnosis in a few minutes and to repeat the experience in complete autonomy, employing a short time of the day only.

Eligibility Criteria:
Inclusion Criteria:

* Able to give written informed consent
* BMI between 35 and 50 kg/m2
* Age 20-70 years

Exclusion Criteria:

* Current or previous mental disorders and/or on any psychotropic drug
* Insulin treatment
* Candidates for bariatric surgery
* Current (or discontinued for less than 6 months) treatment with anti-obesity drugs
* Patients at risk of heart failure, edema, ascites (heart diseases, chronic liver diseases, nephrotic syndrome, renal failure)
* Patients with untreated or uncompensated thyroid diseases
Paxlovid in the Treatment of COVID-19 Patients With Uremia

This study is a single-center, open-label, randomized controlled clinical study to evaluate the effect of Paxlovid on the virus-negative time and disease progression in uremic patients infected with SARS-CoV-2 (omicron variants).

This study will enroll maintenance hemodialysis patients infected with SARS-CoV-2 (omicron variants).

After signing the informed consent form, the qualified subjects will be randomly stratified 1:1 to standard-of-care (SOC) or SOC plus Paxlovid for five days.


Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent. Age ≥ 18 years old. COVID-19 (nucleic acid test positive) was diagnosed before randomization. At least 1 symptom or sign of COVID-19 at the time of being enrolled into the study(symptoms and signs related to COVID-19 including cough, expectoration, dyspnea, fever, chills, fatigue, muscle soreness, diarrhea, headache, sore throat, stuffy nose, runny nose, etc.).

Exclusion Criteria:

* History of active liver disease, including chronic or active hepatitis B or C, primary biliary cirrhosis, Child-Pugh B or C, or acute liver failure.

HIV infection and the viral load is greater than 400 copies/ml. Suspected or confirmed active systemic infections that may have an impact on the study evaluation except for COVID-19.

Acute heart failure, respiratory failure, severe chronic kidney disease, and cardiovascular disease caused by uremia-related complications.

Allergic to any ingredients of Paxlovid.
Study of AffloVest in At-Risk Respiratory Patients During COVID-19 Pandemic

The purpose of the study is to investigate the addition of high frequency chest wall oscillation (HFCWO) therapy to the prescribed care regimen to support the diaphragm during airway clearance among post-COVID patients with COPD and chronic productive cough as a way to limit the advancement of pulmonary symptoms and need for critical services during recovery from COVID-19.

Thirty study participants in New York City who meet inclusion criteria will be recruited from Mount Sinai's COVID-19 Post-Recovery Center of Excellence and Respiratory Institute. Fifteen subjects (determined by the last digit of their medical record number) will receive a HFCWO device (AffloVest), digital thermometer, pulse oximeter, and spirometer at their home. Participants will be trained remotely to use the AffloVest and spirometer. In addition all subjects will be asked to complete a series of online mental health and respiratory symptom assessments via REDCap. A 15 patient control group meeting inclusion criteria will be recruited from the Mount Sinai COVID-19 Post-Recovery Center of Excellence and Respiratory Institute using the same screening process. This group will not receive the HFCWO intervention but will receive a digital thermometer, pulse oximeter, and spirometer at their home (with training via telehealth), asked to complete all REDCap and respiratory symptom assessments. Consent for both groups will be obtained by a Mount Sinai clinician-researcher.

Study Duration Approximately 30 days plus 60 and 90-day check in

Objectives To investigate the addition of HFCWO therapy to the prescribed care regimen to support the diaphragm during airway clearance among post-COVID patients with COPD and chronic productive cough as a way to limit the advancement of pulmonary symptoms and need for critical services during recovery from COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females ≥18 years
* Existing diagnosis of COPD for \>6 months
* Chronic productive cough
* Radiographic evidence of flattening of the diaphragm
* Prior COVID-19 diagnosis
* Clinically followed by Mount Sinai COVID-19 Post Recovery and Respiratory Institute.
* Ability to provide informed consent
* Ability to read and fill out survey questionnaires via REDCap (surveys will be available in English and Spanish)
* Access to a home computer, tablet, or smartphone

Exclusion Criteria:

* Presenting with hypoxia (02 sat \<90%)
* Acute COVID-19 infection
* Home oxygen dependent
* Established diagnosis of cystic fibrosis
* History of osteoporosis or rib fracture
* Active Hemoptysis
* Pneumothorax
Impact of the Implementation of a Clinical Pharmacy Bundle on Intensive Care Unit Patient Outcomes and Cost Expenditures

The aim of this before-after study was to assess the impact of a clinical pharmacy bundle of care activities on patient outcomes (length of hospital stay as a primary endpoint) and cost expenditure in two French ICUs.


Eligibility Criteria:
Inclusion Criteria:

* Intensive Care Unit patients on weekdays
Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis

Multiple sclerosis (MS) is a chronic inflammatory disease associated with central nervous system (CNS) demyelination and subsequent axonal degeneration. Multiple sclerosis exhibits an unpredictable and variable clinical course.

Multiple sclerosis plaques contain numerous types of cells and infiltrating macrophages have been identified to contribute significantly to demyelination in both clinical MS and animal models of MS. Granulocyte-macrophage colony-stimulating factor (GM CSF) stimulates proliferation and activation of macrophages, monocytes, neutrophils, eosinophils, dendritic cells and microglia with subsequent induction of proinflammatory biomolecules.

Therefore blocking GM CSF activity might be a therapeutic approach for the treatment of MS.

Recent clinical studies demonstrated a possible dysregulation of the balance of pro and anti inflammatory lymphocytes, which may contribute to the pathogenesis of MS.

It was shown in animal models of EAE that during the disease effect or phase GM CSF sustained neuroinflammation via myeloid cells that infiltrate the CNS proving an essential role of GM CSF in encephalitogenicity.

Eligibility Criteria:
Key Inclusion Criteria:

Outpatients with a diagnosis of RRMS or SPMS, who are currently not being treated and who have at least 1 of the following:

* At least 1 documented relapse within 1 year before Screening, or
* Two documented relapses within the past 2 years before Screening, or
* A new gadolinium (Gd)-enhancing lesion on magnetic resonance imaging (MRI) T1-weighted imaging within 1 year before Screening, or
* A new T2 lesion on MRI within 1 year before Screening. The patient must have 10 or less, Gd-enhancing lesions per T1-weighted MRI at Screening as assessed by a central reader.

The patient must be able and willing to ambulate, with an Expanded Disability Status Scale (EDSS) score of ≥ 2.0 and ≤ 6.5 at both the Screening Visit and the Baseline Visit

Key Exclusion Criteria:

1. A patient with primary progressive MS (PPMS)
2. A patient who has previously received at any time any of the following

   * B-cell or T-cell depleting therapies
   * Cytotoxic agents, any immunosuppressive/immunomodulating agents
3. A patient who has not stabilized, in the opinion of the investigator
4. A patient with any medical condition or uncontrolled disease states other than MS requiring or likely to require systemic treatment with corticosteroids or other immune compromising agents
5. A patient with current or a history of major chronic inflammatory autoimmune diseases other than MS
6. A patient with any type of infection
7. Patients on chronic prophylactic or suppressive antibiotic, antifungal,or antiviral agents
8. A patient with a history of tuberculosis.
9. A patient with any signs of excretory hepatic or kidney dysfunction
10. A patient with a positive test for Hepatitis B or Hepatitis C
HIIT + RT on Body Composition and Gut Microbiota in Postmenopausal Women (PACWOMan)

Postmenopausal women, as men, are more prone to central or android obesity than premenopausal women. Recently, some studies have shown that obesity is associated with gut microbiota dysbiosis and gut microbiota could be responsible of fat mass accumulation. Moreover, abdominal fat mass accumulation is associated with an increase of cardiovascular disease risks.

Recent studies suggest that physical activity may positively alter gut microbiota composition. Accumulating evidence suggests that high intensity interval training (HIIT) is an effective strategy for reducing body fat of overweight individuals, especially at the abdominal level. Resistance Training (RT) is associated with increased muscle mass and strength gain in main muscle groups. Thus, RT is also an interesting modality to fight against deconditioning and autonomy loss with age.

The aim of the study was to observed the effects of a 12-week high intensity interval training (HIIT) combined with resistance training (RT) program on gut microbiota and body composition changes in postmenopausal women.

It is hypothesized that HIIT +RT will improve gut microbiota and body composition (including whole body and (intra)-abdominal fat mass) in a concomitant and parallel way.

The aim of the study was to observed the effects of a 12-week high intensity interval training (HIIT) combined with resistance training (RT) program on gut microbiota and body composition changes in postmenopausal women.

30 postmenopausal women will be randomly assigned to HIIT + RT (n= 15) group or Control group (n=15).

HIIT+RT: Each subject performed HIIT protocol consisted of repeated 60 cycles of speeding up for 8 s followed by pedalling slowly for 12 s (20min) Then they performed a single set of 10 exercises with 1 or 2min resting period between exercises. The set consisted of 8-12 repetitions at about 80% maximum repetition (1RM).

Control group : (no training program) Subjects will keep their life style.

Faecal microbiota and body composition will be measured before and after the intervention (3 months).

The investigators will examine the effects of HIIT + RT programs on:

Body composition : total-abdominal and visceral fat mass, total fat free mass and muscle mass Faecal concentration of short chain fatty acids Total fat free mass (and appendicular fat free mass) (DEXA) Glycemic profile (plasma HbA1c, plasma glucose, plasma insulin) Lipid profile (TG, HDL, LDL, total cholesterol) Aerobic capacity (VO2 max) Muscular capacity (fatigability, isometric and dynamic strenght)

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* BMI ≥ 25 and \< 40
* Able to follow an exercise protocol
* Eating behavior and physical activity stable since at least 3 month

Exclusion Criteria:

* Subject not able to perform exercise after medical examination
* Subject not able to perform bicycle exercise (pains)
* Use of β-blocker
* Medical treatment that could interfere with the different outcome measures (antibiotics)
* Hormonal Replacement Therapy (HRT)
Metabolic and Neurofunctional Responses to Breakfasts

This study aims at assessing the effects of glucose and different types of breakfast on metabolic and neurofunctional responses in healthy individuals.

Twelve healthy subjects, on a stable diet, in a randomized-crossover fashion, received either a 50 g glucose load (control) or one of these breakfast:

B1: milk (125ml) and cereals (30g); B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g); B3: milk (125ml), bread (50g), apple (150g) and hazelnut cream chocolate (15g). Prior and upon completion of each tolerance test, an EEG was performed to measure frontal P300-evoked potentials.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5 - 24.9 kg/m2
* normal glucose tolerance
* stable diet

Exclusion Criteria:

* type 1 and type 2 diabetes
* impaired glucose tolerance
* dyslipidemia
* metabolic syndrome
Noninterventional Observational Prospective Longitudinal Study of the Incidence of Ulcerative Colitis and Crohn's Disease Among the Adult Population of the Republic of Kazakhstan

The NUCaCD study aims to develop a reliable registry of patients suffering inflammatory bowel diseases in the Republic of Kazakhstan.

The NUCaCD aims to study the prevalence of inflammatory bowel diseases in the Republic of Kazakhstan and create a reliable database, which will greatly facilitate future planning of the volume of health resources needed to address these diseases management and will help to optimize preventive measures and will support future research to better understand the etiology, new options treatment and factors affecting prognosis, relapses, development of complications and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Availability of a signed informed consent form; or the presence of a disinterested witness if the patient is unable to examine and sign the consent form due to illiteracy or disability (for example, in the case of blindness);
* The patient has a documented diagnosis of ulcerative colitis or Crohn's disease (endoscopy, histology, if indicated by radiation diagnostics);
* Patients who have applied for treatment or are already taking treatment from a gastroenterologist / coloproctologist, including inpatients;
* Citizenship of the Republic of Kazakhstan (or resides).

Exclusion Criteria:

* Patient takes part in an interventional clinical trial;
* Patient is unable to follow the schedule of the visits;
* Any condition that the PI believes would prevent a study participant from participating in the study.
Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections

The objective of this study was to obtain data on the safety, tolerability and compliance with Zithromax in children with bacterial infections of the upper and lower respiratory tract.

Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.

Eligibility Criteria:
Inclusion Criteria:

* Patients with respiratory tract infections that received azithromycin according to the approved SPC as this was a non-interventional study.

Exclusion Criteria:

* According to the approved Summary of Product Characteristics (SPC) for Azithromycin as this was a non interventional study.
Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF)

This study will evaluate the effect of ledipasvir/sofosbuvir (LDV/SOF) treatment on the pharmacokinetics (PK) and renal safety of tenofovir in the form of tenofovir alafenamide (TAF). Subjects living with human immunodeficiency virus (HIV) who are receiving tenofovir-based antiretroviral therapy (in the form of tenofovir disoproxil fumarate \[TDF\]), and are also taking a ritonavir- or cobicistat-boosted protease inhibitor will be invited to participate.

The study will consist of five visits: a screening visit, three abbreviated 4-hour pharmacokinetic visits, and one end-of-study follow-up visit.

Subjects will also be asked to use a Wisepill device, which will track medication adherence throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Between 18-70 years of age
* Have been taking TDF and a ritonavir- or cobicistat-boosted protease inhibitor as part of standard care for treatment of HIV

Exclusion Criteria:

* eGFR \< 30 mL/min
* Pregnant or planning pregnancy
* Breastfeeding
* Any medical, social, or mental-health issue(s) that, in the opinion of the investigators, could interfere with study participation or the study outcomes
* Signs or symptoms of decompensated liver disease
* Hepatitis B infection
* Medications that may cause unwanted drug interactions with ledipasvir/sofosbuvir or emtricitabine/tenofovir alafenamide
* Unwillingness or inability to comply with study procedures
* Chronic hepatitis C infection
A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD)

A real world study to determine the effectiveness of a patient support service to aid COPD patients in their self management.

The purpose of the study is to evaluate a digital health wellness support tool for patients in primary care with COPD using a smart mobile app, patient web portal and technology attached to the patients SABA reliever inhaler. Using the patients pre-defined COPD self management plan, the active arm of the study complete a daily diary (EXACT PRO) and record their daily SABA inhaler usage. After defining a health and symptom score baseline over a two week period, any significant deviations in SABA reliever use or daily diary scoring will alert patients that they may be having a change in their symptoms and advise them to refer to their self management plan and if they need to start their rescue medication. The primary outcome measure for the study is a 25% reduction in unplanned COPD hospital admissions (n=250 completing the study in each arm).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD
* FEV1/FVC ratio \>0.3-\<0.7 and FEV1 \> 30% post-bronchodilator
* Prescribed either ICS, LABA and or LAMA at dose for COPD
* Exacerbations reported within the last 12 months requiring treatment with \>1 systemic steroid and/or antibiotics, OR hospitalisation within last 12 months due to exacerbation, OR have received \>12 SABA prescriptions in previous 12 months
* Patient has a self management plan which includes use of an oral steroid at a dose within NICE guidelines, and additionally antibiotics as appropriate.

Exclusion Criteria:

* Symptomatic asthma or seasonal allergic rhinitis leading to hospitalisation in previous 12 months
* Patients unable to use a mobile phone
Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures

Feasibility study to advance the development of NeuRx Diaphragm Pacing System (DPS) for the intended use of stimulating the diaphragm to provide respiratory assistance in patients at risk of prolonged mechanical ventilation in the Intensive Care Unit (ICU).

This is a prospective, open-label, single-center study to examine the feasibility of the TransLoc DPS electrode placement and removal. Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes) and will be followed until electrode removal up to seven days post-procedure. Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing a surgical procedure with expected admission to the hospital.
* Patient is undergoing a laparoscopic, open abdominal, or open chest surgical procedure that allows access to the diaphragm.
* Negative pregnancy test if the patient is a female of child-bearing potential.
* Patient is at least 18 years of age.
* Informed consent has been obtained from the patient or designated representative.

Exclusion Criteria:

* Patient has an implanted cardiac defibrillator.
* Patient is pregnant or breastfeeding.
* The patient is involved in another clinical study that could influence the safety or outcome measures of this study.