cyrilzakka/clinical-trials huggingface dataset:
Determination of in Vivo Ultrafiltration Coefficient (KUF) in Patients With Chronic Kidney Disease (CKD)

The purpose of this study is to determine the in-vivo ultrafiltration coefficient for different sizes of xevonta High-Flux dialyzers following FDA guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from patient or parents/ guardian.
* Subject age \>= 18
* Effective blood flow 350 ml/min and dialysate flow of 500 ml/min
* On hemodialysis for a minimum of 3 months
* Use of Cimino- or Gore-tex shunts
* Routine dialysis-treatment for 240 min
* Documented dialysis adequacy parameter that has been stable for past 3 months
* Plan to dialyze at participating hemodialysis centre for at least 3-months duration.
* Free from any currently known unusual clotting or access problems
* Hepatitis B surface antigen (HbsAg) negative, documented within the past 90 days or Hepatitis B surface antibody (anti-HBs) positive.
* Anti Hepatitis C Virus (Anti-HCV) negative, documented within the past 90 days
* Anti Human Immunodeficiency Virus (Anti HIV) negative, documented within the past 90 days
* Hematocrit (HCT) between 25 and 40% or haemoglobin (Hb) not less than 8 g/dL, as documented 14 days prior to the first treatment

Exclusion Criteria:

* Patients who are unable to tolerate an effective blood flow of 350 ml/min
* Patients using catheter for dialysis
* Pregnant or nursing woman. Women of childbearing potential must agree to avoid pregnancy during the study period by use of hormonal contraception (implantable; patch; oral) and/ or double-barrier methods (any double combination of: IUD; condom with spermicidal gel; diaphragm; sponge; cervical cap)
* Previous plan for extended absences from the participating hemodialysis centre
* Expected to be transplanted (living related donor) within the maximum of 3 months for the study period
* Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
Optometric Follow-up After Cataract Surgery

This study will investigate the effectiveness of an optometric follow up of cataract surgery versus an ophthalmic surgeon follow up. It will investigate patient satisfaction,safety and cost.

The study will be a mixed-methods study, including a randomized controlled trial in which participants are randomized after cataract surgery to follow up to be consultant led follow up or conducted by a trained optometrist 4-6 weeks following surgery. All participants will then return 6 months after surgery for an additional follow-up visit with an ophthalmologist other than the operating surgeon with patient healthcare satisfaction (main outcome), cost-effectiveness and safety outcomes being measured. A subset of patients and local clinicians will also take part in a one-time, individual, semi-structured interview.

This research will test an alternative model of aftercare for cataract surgeries, which may reduce patient waiting time and inconvenience. In turn, this could help improve patient satisfaction and reduce costs for both patients and the National Health Service (NHS).

Participants will be recruited by operating surgeons. The research will take place in the hospital/clinic/optometrists' offices.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cataract surgery in 1st or 2nd eye for age-related cataract, in the Belfast Trust and Southern Trust
* Willing to participate and give informed consent.

Exclusion Criteria:

* Patients judged by operative surgeon to be of high risk of loss of visual acuity in the operative eye (e.g. end stage glaucoma etc.). Note that patients with ocular comorbidity and previous surgery will not be routinely excluded, nor will monocular patients.
* Patients that were not referred by an optometrist.
The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition

Chronic utilization of bio-incompatible peritoneal dialysis (PD) solution has been implicated as a cause of progressive loss of peritoneal permeability and recurrent fluid overload in PD patients. Previous studies show that PD solution with neutral pH and low GDP resulted in a superior profile of PD effluent mesothelial cell marker and a lower degree of systemic inflammation as compared to conventional PD solution. The investigators propose a prospective randomized control study to compare the arterial stiffness, nutrition and body fluid status between PD patients treated with conventional solution and those with neutral pH low GDP solution. The investigators plan to study 100 new PD patients. They will be randomized to be treated with neutral pH low GDP solution or conventional solution. All patients will be followed for 52 weeks. In addition to routine clinical measurements, the investigators will measure their body water composition by bioimpedance spectroscopic method, arterial pulse wave velocity by pressure transduction method, as well as radiographic parameters of intravascular volume status, based on the routine chest radiograph. The study would help to define the clinical benefit of biocompatible PD solution.

(see above)

Eligibility Criteria:
Inclusion Criteria:

* new adult continuous ambulatory peritoneal dialysis (CAPD) patients, both diabetic and non-diabetic

Exclusion Criteria:

* unlikely to survive, planned to have elective living-related kidney transplant, or transfer to other renal center within 6 months
Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis

In children with acute gastroenteritis (AGE), vomiting often precedes diarrhea. To establish the diagnosis of AGE, enteropathogen detection typically relies on diarrheal stool samples. However, testing requires sufficient stool sample, which may not be easily available. Recent studies suggest that in children presenting to emergency departments with presumed AGE with isolated vomiting, an enteropathogen can be identified using rectal swabs and molecular diagnostic tests. The rate of enteropathogen detection in children with isolated vomiting due to AGE may differ in various populations. Using rectal swabs and molecular diagnostic tests, we plan to assess the proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified.

This will be a prospective cohort study. Children younger than 5 years with presence of ≥3 episodes of vomiting due to presumed AGE, lasting no longer than 7 days before enrolment, will be recruited. A total of 198 participants will be recruited and a rectal swab will be collected. The participants will be contacted 14 days after enrollment to complete a survey regarding symptoms experienced during that period and to identify any additional clinical care.


Eligibility Criteria:
Inclusion Criteria:

* age 0-5-year-old
* presence of ≥3 episodes of vomiting due to presumed AGE at inclusion
* \<7 days of symptoms at the time of inclusion
* signed written informed consent

Exclusion Criteria:

* anticipated inability to complete 14 days follow-up
* history of neutropenia (as rectal swabs are contraindicated)
* critically ill status requiring urgent medical intervention
* inability to provide a rectal swab for testing
* chronic gastrointestinal tract disorders such as inflammatory bowel disease, cystic fibrosis, coeliac disease
* immunodeficiency
Survival in Myelofibrosis Patients After Allogeneic Hematopoietic Stem Cell Transplantation in Five Centers in France

The investigators would like to conduct a retrospective study in five centers in France in the goal to evaluate the survival of patients receiving allogeneic hematopoietic stem cell transplantation for myelofibrosis.

The allogeneic stem cell transplantation is the only curative treatment for myelofibrosis. However, because of complications such as infection, graft-versus-host disease and conditioning toxicity, this procedure is associated with a high morbidity-mortality rate. The discovery of molecular and genetic markers permitted to improve therapeutic strategy and survival of patient in the last few years. In this study, the investigators want to make an overview of survival, incidence of relapse and incidence of acute and chronic graft versus host disease in allogeneic stem cell transplantation for myelofibrosis, in five centers in France, between 2007 and 2017.

Eligibility Criteria:
Inclusion Criteria: adult patients receiving allogeneic hematopoietic stem cell transplantation for myelofibrosis in five centers in France (Nancy, Besancon, Strasbourg, Pitie Salpetriere and Lyon) between 2007 and 2017

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Exclusion Criteria:

* age \< 18 years old
Effectiveness of Occupational Therapy Intervention in Complex Patients

To date, there are no studies that demonstrate that the intervention of Occupational Therapy (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical and functional outcome for the patient.

For this reason, we intend to undertake a study that will allow us to deepen the knowledge about the impact of the OT on in-hospital patients considered "complex" according to the assessment by the Rehabilitation Complexity Scale (RCS ).

Our hypothesis is that the intervention of OT can improve their care by qualified and focused on the needs of the person interventions.

We will therefore first af all to implement an observational pilot study, aimed at defining the characteristics and needs of the population in question, and the OT intervention "protocol". This information will then be used to implement a subsequent randomized controlled trial designed to demonstrate the effectiveness of the OT intervention on the basis of clinically relevant outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* in charge of the rehabilitation ward of the hospital
* defined complexes as assessed by RCS
* consent to the processing of sensitive data for research purposes.

Exclusion Criteria:

* primary psychiatric conditions
* language barrier;
* cognitive impairment
* communicative disability
Psychometric Characterization of Patients With Cardiac Arrhythmias

To investigate the influence of different psychological parameters (e.g. depression, anxiety, personality traits, resilience, tolerance of uncertainty or heart beat perception) on treatment outcome and quality of life in patients with cardiac arrythmias.

This longitudinal observational study examines patients with cardiac arrhythmia (such as atrial fibrillation or atrial flutter) who are undergoing a conventional standard therapy in the Department of Cardiology of the Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin. To examine the impact of psychological symptoms such as anxiety, depression, resilience and risk factors (e.g. neuroticism) on cardiac treatment outcomes, patients are evaluated with a standardized psychological assessment including established questionnaires. The baseline observation is performed before the standard treatment of the arrhythmia (e.g. pharmacological treatment or electrophysiological methods). Follow-up observations are made 3 and 6 month after the cardiological intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age of majority (min. 18 years old)
* no severe cognitive dysfunction
* diagnosed cardiac arrhythmias
* reason of admission is the treatment of cardiac arrhythmia

Exclusion Criteria:

* medium to severe cognitive dysfunction
* doubt on capacity to give consent
Influence of Thoracic Outlet Syndrome Severity on Upper Extremity Function and Neural Integrity

The purpose of this study is to investigate the relationship between the severity of thoracic outlet syndrome and upper extremity function, as well as neural integrity.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Diagnosed with thoracic outlet syndrome
* Willing and able to provide informed consent

Exclusion Criteria:

* History of upper extremity surgery unrelated to thoracic outlet syndrome
* Other upper extremity disorders unrelated to thoracic outlet syndrome
Virtual Reality Exposure Therapy (VRET) in Psychomotor Disadaptation Syndrome

According to demographic projections, by 2040, a quarter of the French population will be over 65. In this age group, the quality and quantity of visual, somaesthetic and vestibular information decline. This weakening of the balancing and the recurrence of falls lead to a restriction of activities of daily living and give rise to a fear of falling.

Psychomotor maladjustment syndrome (PMDS) is a serious consequence of falls. A significant retropulsion when sitting or standing, as well as hypertonia characterize the posturobehavioral component of PMDS. It coexists with a psychological component, marked by a fear of the anterior emptiness. A series of studies inducing fear and experimentally manipulating its intensity demonstrated a greater displacement of the center of pressure when subjects were exposed to elevated platforms. In addition to the subjective evaluation of fear, this emotion can be assessed by heart rate variability.

Despite the existence of standards and metrics adapted to the clinical setting, only one study investigated the association between the number of falls and heart rate variability in patients with neurodegenerative disorders. In recent years, cognitive and behavioral therapies using virtual reality (TERV) have improved balance in patients with cardiovascular disease and Parkinson's disease. Virtual reality (VR) thus appears to be an interesting therapeutic approach to the treatment of psychological as well as postural-behavioral disorders of PDMS. Although the feasibility of a VR intervention has been tested in elderly people (APs) suffering from PMDS, its effect has never been evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with PMDS
* Ability to stand without human or technical assistance
* Falls Efficacy Scale International Short (FES-I short) \> 13
* Functional Reach Test (FRT) score \< 26 cm
* Mini-Mental State Examination (MMSE) score ≥ 20

Exclusion Criteria:

* Patients with disorders that may interfere with immersion in virtual reality (e.g. cerebellar syndromes, Parkinsonian syndromes, hallucinations, sensory or neurocognitive disorders)
* Cybermalaise or cyberkinetosis
Efficacy of Methotrexate in Myasthenia Gravis

Myasthenia gravis is a rare neuromuscular disorder characterized by weakness and fatigability of ocular, bulbar, and extremity musculature. The specific aim of this study is to determine if oral methotrexate is an effective therapy for myasthenia gravis (MG) patients who are prednisone dependent. Patients will be randomized to receive either methotrexate or placebo and those who are entered onto this trial will have symptoms and signs of the disease while on prednisone therapy. The hypothesis is that adding methotrexate therapy in these patients will improve the MG manifestations so that the prednisone dose can be reduced and clinical measures of MG severity will improve.

Funding Source - FDA OOPD


Eligibility Criteria:
Inclusion Criteria:

* Patients must have MGFA MG grades 2, 3, or 4 generalized myasthenia gravis, according to the MGFA classification system
* Elevated acetylcholine receptor antibody (AChR-Ab) titer.
* Patient's signs and symptoms should not be better explained by another disease process.
* Prednisone dose of at least 10 mg/day (or the equivalent in alternate days) and the subject must be on a stable dose of prednisone for 30 days prior to the screening visit.

Exclusion Criteria:

* A history of chronic degenerative, psychiatric, or neurologic disorder other than MG that can produce weakness or fatigue.
* Other major chronic or debilitating illnesses within six months prior to study entry.
* Female patients who are premenopausal and are: (a) pregnant on the basis of a serum pregnancy test, (b) breast-feeding, or (c) not using an effective method of double barrier (1 hormonal plus 1 barrier method or 2 simultaneous barrier methods) birth control (birth control pills, male condom, female condom, intrauterine device, Norplant, tubal ligation, or other sterilization procedures).
* Altered levels of consciousness, dementia, or abnormal mental status.
* Evidence of thymoma on chest CT or MRI. Such a finding could require immediate thymectomy and would preclude entry into the study.
* Thymectomy in the previous three months.
* Patients who have been medicated with azathioprine, cyclosporine, cyclophosphamide, mycophenolate mofetil, IVIg, or other immunosuppressive drugs within the last 60 days.
* Chest X-ray with evidence of tumor, infection, or interstitial lung disease.
* Clinical history of chronic or recurrent infections.
* Daily use of non-steroidal anti-inflammatory drugs (NSAIDs).
* History of renal or hepatic insufficiency or liver enzymes greater than the upper limit of normal.
* History of bone marrow hypoplasia, leucopenia, thrombocytopenia, significant anemia, clinical or laboratory evidence of immunodeficiency syndromes.
* Forced Vital Capacity (FVC) \<50% of predicted.
* MG Grade 1 (ocular only) or 5 (crisis, requiring ventilator).
* Prior use of methotrexate for any condition.
Impact of M184V on the Virological Efficacy to 3TC/DTG (LAMRES)

In view of the prolongation of patients living with HIV's life expectancy, the question of optimization of ART, which is still a life-long treatment, becomes central. While most patients achieve virological success, their treatments often need to be optimized in order to limit adverse events, drugs interactions and to improve adherence. The switch to dual regimen strategies represent one of the approaches for treatment optimization. Indeed, dual therapy regimens have shown non-inferior efficacy vs triple therapy as simplification therapy and more recently also as first line therapy. From the real-life data it emerges that today in simplification strategies, the dual regimen therapies are prescribed even in patients with a history of virological failure. Circulating HIV-1 resistant variants can be archived in viral reservoirs, where they can persist for years and can reemerge in case of therapeutic selective pressure. In particular, previous selection of M184V may have an impact on virological response to 3TC/DTG. There are few data on a direct comparison of 3TC/DTG efficacy in patients harboring or not harboring the M184V. So, there is a need to assess the efficacy of 3TC/DTG in patients with past M184V mutation in a large set of patients followed in clinical setting.

Thus, the investigators propose a retrospective study of patients with HIV-RNA ≤50 copies/mL who were switched to 3TC/DTG in order to compare the virological efficacy of 3TC/DTG in patients with and without a history of M184V detection in a previous resistance genotype. This study aimed to analyze 800 patients switched to DTG/3TC in clinical real setting in large European (France, Italy, Spain) database.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected
* Age ≥ 18 years
* Switched to 3TC/DTG while having HIV-RNA ≤50 copies/mL on any ART regimen
* Followed for at least 1 year after 3TC/DTG switch
* With at least 1 previous genotype
* With at least 1 virological follow-up after switching to 3TC/DTG

Exclusion Criteria:

* No genotypic resistance test available before switching to DTG/3TC
Effect of Elevated Plasma-Free-Fatty-Acids on Renal Hemodynamic Parameters

Type 2 diabetes is frequently associated with elevation of plasma-free fatty acids (FFA). Studies indicate that elevation of plasma-FFA induces insulin resistance and also causes endothelial dysfunction as well as hemodynamic changes which are supposed to be involved in the pathogenesis of diabetic vascular disorders.

Glomerular hyperfiltration, which is associated with glomerular hypertension and hypertrophy, a common finding in the early course of type 1 diabetes as well as type 2 diabetes, plays an important role in the development and progression of diabetic nephropathy. These hemodynamic changes are not well understood, but are most likely induced by dilatation of the (precapillary) glomerular arteriole.

In humans the hemodynamic effect of FFAs has so far been investigated locally in brachial and femoral arteries and recently in the eye and skin, where FFAs induced a pronounced increase in blood flow probably due to a local decrease in vascular resistance.

The aim of the present study is to characterise the hemodynamic effects of FFAs in the kidney. In addition we want to test the hypothesis that FFA-induced changes are mediated via endothelial derived nitric oxide (NO). The results of this study could provide information to what extent elevated FFA-plasma levels contribute to hyperfiltration in the early course of diabetes mellitus. The measurements will be done at baseline and during 4 hour infusion of a triglyceride or placebo infusion, combined with heparin.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 19 and 35 years
* Body mass index between 15th and 85th percentile (Must et al. 1991)
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
The Use of High Concentration Hyaluronic Acid (HA) Transfer Medium in Repeated Implantation Failure (RIF) Patients

This is a pilot study with the aim to investigate the beneficial effect of bicarbonate buffered medium containing hyaluronan and recombinant human albumin (EmbryoGlue®, Vitrolife) in patients with documented repeated implantation failure on live birth per randomized subject as primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* The trial only includes women with a clinical indication for ART with a history of RIF defined as the absence of implantation after two consecutive cycles of IVF, ICSI or frozen embryo replacement cycles where the cumulative number of transferred embryos was no less than four for cleavage-stage embryos and no less than two for blastocysts, with all embryos being of good quality and of appropriate developmental stage.

Furthermore, other specific 'RIF' investigations were performed and treated if necessary:

* Normal hysteroscopy
* Normal karyotype of both parents
* Coagulation screening (Antitrombine II deficiency, Factor VIII augmentation, APC resistance, Factor V + Factor II augmentation, Protein S and C deficiency an homocysteine augmentation)
* Auto-immune screening (Lupus anticoagulant, Rheumatoid Factor, Anti-nuclear antibodies, Anti-cardiolipine antibodies and Glycoprotein-1-antibodies)

Exclusion Criteria:

* • Simultaneous participation in another clinical study

  * Untreated and uncontrolled thyroid dysfunction
  * Tumors of the ovary, breast, uterus, pituitary or hypothalamus
  * Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause
  * Ovarian cysts or enlarged ovaries
  * Malformations of the reproductive organs
  * Moderate or severe hepatic impairment
  * Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy
  * Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation
  * Couples needing TESE/MESA material