cyrilzakka/clinical-trials huggingface dataset:
Sodium Chloride and Protein-Bound Toxin Removal in Hemodiafiltration

An increase of the free fraction may allow a better removal of of protein-bound uremic toxins during dialysis. During predilution hemodiafiltration, the sodium chloride (NaCl) concentration will be increased in the infusion fluid at a target NaCl concentration and the effect on the removal of protein-bound toxins will be determined. Comparisons will be made to standard hemodialysis and hemodiafiltration.

Eight maintenance dialysis patients will be enrolled in a prospective, randomized, crossover trial. HD will be compared with online pre-dilution HDF and HDF at increased plasma ionic strength. The ionic strength will be increased using an infusion fluid with hypertonic \[Na+\] by isovolumetric adding of a 5000 mmol/L NaCl solution. Blood and dialysate flowrates (250 and 575 mL/min, respectively), treatment time (240 min), and high-flux dialyser (surface area 2.1 sqm, PUREMA H) will be always kept identical. Anticoagulation with standard or fractionated heparin will be unchanged adopted from the patients' routinely used regimen. In both HDF modes, the infusion flow rate will be 125 mL/min. In HDF at increased plasma ionic strength, the infusate \[Na+\] will be adjusted to approach 240 mmol/L in plasma entering the dialyser and the dialysate \[Na+\] will be set at the technically feasible minimum of 130 mmol/L. Blood samples will be drawn from the arterial and venous blood lines and, if applicable, from the blood tubing connecting the two dialyzers at 0, 15, 30, 60, 120, 180, and 240 min. Samples at 240 min will be drawn after reducing the blood flow rate to 50 mL/min for 30 s and the dialysate flow turned off. A fraction of the spent dialysate will be continuously collected.

Removal of the free and total fraction of para-cresyl sulfate and indoxyl sulfate will be determined by reduction ratios, dialytic clearances and mass in dialysate

Hemocompatibility will be assessed by WBC and platelet counts, free Hb, LDH, C5a and TAT. \[Na+\] will be monitored in both arterial (i.e. before NaCl infusion) and venous blood of the extracorporeal system.

Eligibility Criteria:
Inclusion Criteria:

* End-stage renal disease
* Maintenance hemodialysis or hemodiafiltration for more than 3 months
* Stable clinical condition
* \> 18 years

Exclusion Criteria:

* Life expectancy less than 1 year
* Pregnancy
* Active infectious disease
Prevalence of Chronic Kidney Disease and Its Association With Clinical Outcome in Patients With Coronary Heart Disease

This is a prospective, multi-center, hospital-based observational study. The aim of the study is to evaluate the prevalence of chronic kidney disease in patients with stable coronar heart disease.

The primary aim of the study is to evaluate the prevalence of chronic kidney disease(CKD) in patients with stable coronary heart disease. The secondary aims include: 1. To evaluate the awareness of CKD in patients with stable coronary heart disease. 2. To find out risk factors that is associated with CKD in these patients. 3. To evaluate the association between CKD and cardiovascular events during one-year's follow-up. Based on sample size estimation, the plan is to recruit 10000 patients from 100 centers. Patients who participate the study will finish one-year's follow up (0 day, 6 months and 12 months after recruitment). During the baseline visit, patients' demographic characters will be collected, and laboratory tests will be performed for urinalysis, renal function, hepatic function, etc. During the 6 months' follow up, MACE(Major adverse cardiovascular events) will be recorded through phone or face to face interview between investigators and patients. MACE include all-cause mortality, cardiovascular mortality, non-fatal myocardial infarction, documented re-hospitalization for unstable angina pectoris, and coronary revascularization (including percutaneous coronary intervention and CABG). During the 12 month's follow up, MACE will be recorded, and laboratory tests will be performed again.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years.
* Patients with clinical evidence of stable coronary heart disease, who meet at least one of the following three criterias:

  a. Stable coronary heart disease with objective evidence of atherosclerosis, either coronary angiography shows ≥50% stenosis of at least one of the coronary main stems or first-level branches, or typical exertional angina pectoris with positive stress tests(ECG stress test, echocardiograph stress test, or stress radionuclide myocardial imaging). b Diagnosed of myocardial infarction at least 3 months before recruitment. c.Coronary revascularization(PCI or CABG) at least 3 months before recruitment.
* Informed consent signed by patients or legal guardians.
* Willing to and capable of being followed up for 1 year.

Exclusion Criteria:

* Non-atherosclerotic coronary heart disease
* Deterioration of heart failure during the past 3 months
* Exposed to contrast agent during the past one month.
* History of amputation
* Pregnancy
* Female patients in menstrual period(still eligible after menstrual period)
* Organ failure other than heart failure and kidney failure
* Comorbid other diseases, and life expectancy \<1 year
* Considered not fit for the study due to other reasons, including but not restricted to : a. Severe infection; b. Acute kidney injury.
Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the HAS Recommendations

Undernutrition is a widely under-diagnosed public health problem, including in pediatrics department. Undernutrition prevalence in pediatrics departments is about 15 to 20%.

Until now, there has been no national consensus on the criteria to be used to diagnose paediatric undernutrition. Until now, assessment focused on a range of non-consensus arguments that allowed the health care team to make its diagnosis. So, in the absence of well-defined criteria, diagnosis was based in part on experience and assesment team.

Since November 2019, the French High Authority of Health (Haute Authorité de Santé - HAS) has suggested recommendations to standardize pediatric undernutrition diagnosis.

The investigators offer to evaluate undernutrition prevalence differences diagnosed according to new HAS criteria compared to the previous diagnostic methodology.

The investigator's secondary aim is to identify profiles of children who do match between the two diagnostics methods.

The investigators will conduct a prospective cohort without change in care.

Following classic patient admission in involved departments, the investigating team moves to the department to collect data.

The measurements and informations collected are no different from those taken in the context of normal care.

All anthropometric measurements correspond to recommendations of good practice. Anthropometric measurements will be carried out by the healthcare team.

With collected data the investigators will evaluate undernutrition for each child, according to the 2 diagnostics methods.

For any diagnosis of undernutrition, the department dietician will be alerted so that the patient can be taken care of so it is done normally.

Data collected are as follows:

Simple demographic characteristics: Age, sex, departmentsand principal diagnosis Anthropometry: weight, height, brachial perimeter, head circumference Birth weight and date of term of pregnancy. Clinical history: all pathologies or clinical events that may be related to a weight variation.

Assessment of ingesta. A non-opposition will be asked

Eligibility Criteria:
Inclusion criteria:

* Patient under 18 years old (HAS 2019)
* Patient admitted to short and long-stay pediatric services at Montpellier University Hospital, other than maternity, neonatal, palliative care or resuscitation and rehabilitation department.

Exclusion criteria:

* Parental or child opposition
* Legal guardian unable to express consent
Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 60 days (30 days for each product).

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an approved Informed Consent form;
* Willing and able to attend all scheduled study visits as required by the protocol;
* Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Current or prior Biofinity contact lens wearer in the past 3 months;
* Monovision contact lens wearer;
* Other protocol-defined exclusion criteria may apply.
Effect of QMix 2in1 as Final Irrigation Protocol on Periapical Healing

Aim: To compare the 12-month radiographic outcome of root canal treatment with and without the additional use of QMix 2-in-1 (Dentsply Tulsa, Maillefer, Ballaigues, Switzerland) irrigation solution.

Methodology: The study included 60 single-rooted teeth with periapical radiolucency of 60 patients, randomized into two groups using randomized block design with block sizes of 10 patients in each. Root canals were prepared with WaveOne Gold files (Dentsply Sirona, Maillefer, Ballaigues, Switzerland) and irrigation was performed with 5 mL 2.5% sodium hypochlorite (NaOCl) using side-vented needles during instrumentation. The final irrigation protocol was performed using 5 mL 2.5% NaOCl (n= 30) or 5 ml QMix 2-in-1 (n=30). Then the root canals were irrigated with 5 mL of distilled water and filled with gutta-percha and AH Plus sealer (Dentsply Sirona), using the cold lateral compaction technique. The patients were recalled after 12 months and evaluated radiographically according to perapical index (PAI) scores. Pre and post-treatment PAI scores were compared and teeth were considered 'healthy' (PAI ≤ 2) or 'diseased' (PAI ≥ 3). The Mann Whitney U test was used to compare the differences between the post-operative and follow-up images of the treatment groups. The Wilcoxon signed rank test was applied to examine the changes in PAI score from baseline to the follow-up evaluation in each group.

This randomized controlled trial was conducted to evaluate radiographic periapical repair after endodontic treatment using QMix 2-in-1 (Dentsply Tulsa, Maillefer, Ballaigues, Switzerland) and NaOCl irrigation in single-rooted teeth with apical periodontitis.

Eligibility Criteria:
Inclusion Criteria:

* necrotic, single root teeth with a periapical lesion (2\>PAI\>5)

Exclusion Criteria:

* pregnant
* had used antibiotics within the previous week
* allergy to local anesthetic agents
* history of intolerance to non-steroidal anti-inflammatory drugs
* had uncontrolled hypertension, uncontrolled diabetes mellitus, chronic renal failure, hematological disease, or had received or were receiving radiotherapy and periodontal bone loss (visualized radiographically)
* open tooth apex
Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension)

To describe the prevalence, incidence and current treatment and procedures patterns in a US pediatric population with PAH in MarketScan database during the period 2010-2013


Eligibility Criteria:
Inclusion Criteria:

* All PAH patients who were in the MarketScan database and who were under age 18 at some time during the years 2010 through 2013

Exclusion Criteria:

Not applicable
Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours

Recent data suggest that sperm cells carry an epigenetic message during spermatogenesis and that this message is crucial for the future development of the embryo. This epigenetic signature is notably represented by methylation of genes subjected to imprinting (GSI) and the methylation of transposable elements (TE). Data on the maintenance of the imprint and of the control of TE accompanying human gametogenesis in a context of adult germinal testicular cancers, seminomas, are extremely fragmentary for tumour tissues and inexistent for gametes.

The aim of this study is to determine whether patients with seminomas in comparison with fertile men carry a higher risk of presenting epigenetic alterations affecting their gametes.

This study is based on the use of an existing collection of biological samples. 90 samples will be selected and split into 3 groups:

* Group 1: 30 sperm samples from patients with seminomatous testicular tumours
* Group 2: 30 sperm samples from fertile patients
* Group 3: 30 sperm samples from infertile patients

After treatment of the samples (thawing, cell sorting and removal of cryoprotectants), they will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* biological samples from persons who have provided written consent
* biological samples of patients over 18 years old
* with testicular tumours/Fertile/Infertile
* Matched for age with patients suffering from testicular tumours

Exclusion Criteria:

* biological samples of persons without national health insurance cover
* biological samples from patients with chronic hepatitis B or C or HIV infection
Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma

The purpose of this study is to compare once and twice daily GW685698 in asthma


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of Asthma
* Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol
* FEV1 between 40-85% predicted
* Currently on short acting beta2 agonist therapy

Key Exclusion Criteria:

* History of life threatening asthma
* Respiratory Infection or oropharyngeal candidiasis
* Asthma exacerbation
* Uncontrolled disease or clinical abnormality
* Allergies
* Taking another Investigational medications or other prohibited medications
The Effect of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients

Hemodialysis is the most commonly used renal replacement therapy for end-stage renal disease (ESRD) patients. At present, more than 553,000 ESRD patients in China are receiving hemodialysis treatment, but the long-term survival rate is low, and the annual mortality rate is as high as 18%. This is significantly related to lower physical activity in hemodialysis patients. Physical inactivity can lead to the decline of cardiopulmonary function and muscle function, the aggravation of daily life restriction and the increased risk of death. The National Kidney Foundation Disease Outcomes Quality Initiative (K/DOQI) recommends physical activity as cornerstone of ESRD rehabilitation. But hemodialysis patients are still living in a physical inactivity state. In the early stage of this study, the Physical Activity Enhancement Scheme (PACES) was developed for hemodialysis patients, that is, taking spaces as the core of physical activity investigation, and encouraging patients to start to improve physical activity. The PACES has been registered on the ClinicalTrials.gov before (number: NCT05189795).

The investigators now plan to evaluate the impact of PACES on physical activity of hemodialysis patients through clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* adult (age≥18) with stable ESRD;
* receiving≥3 months HD;
* receiving HD more than 5 times every two weeks;
* volunteer for participating in this investigation.

Exclusion Criteria:

* are unable to do walk on one's own (severe musculoskeletal pain at rest or with minimal activity precluding walking or stationary cycling; unable to sit, stand or walk unassisted, walking devices such as cane or walker allowed);
* have shortness of breath at rest or with activities of daily living (NYHA Class IV);
* have mental disease, disturbance of consciousness and couldn't cooperate with this investigation.
Alternations in Body Composition of Tonsillectomy Patients During the Recovery Period

The body composition of individuals undergoing tonsillectomy is assessed through bioimpedance-based measurements conducted immediately before the surgery, as well as on the 7th and 21st days during the postoperative period.

In the context of interventions affecting the upper alimentary canal-like tonsillectomy-, it is advisable to adhere to a gentle diet until complete wound healing. Additionally, patients may need to modify their eating habits due to discomfort during swallowing. Physical activity is strictly prohibited during this recovery phase, which poses a risk of muscle loss.

Branched-chain amino acids (BCAAs) play a crucial role in sports nutrition. Unlike other amino acids, BCAAs can be directly utilized by muscles without involving the liver. They serve as an immediate energy source for muscles or contribute to the synthesis of new muscle proteins, helping to prevent muscle loss.

At the same time, the investigators also examined the changes that could be detected in the blood and were possibly related to dietary habits.

Eligibility Criteria:
Inclusion Criteria:

* indication of tonsillectomy
* age between 20-40 years

Exclusion Criteria:

* metabolic diseases,
* haematologic disorders
The Effects of Neprilysin on Glucagon-like Peptide-1

In the current study we wish to investigate the effects on glucagon-like peptide-1 (GLP-1) of a neprilysin inhibitor

Glucagon-like peptide-1(GLP-1) is secreted during a meal and increases glucose induced insulin secretion. The enzyme dipeptidyl peptidase 4(DPP-4) cleaves intact GLP-1 within minutes and DPP-4 inhibitors are therefore used for treatment of diabetic hyperglycemia. A few animal studies have implicated the enzyme neutral endopeptidase 24.11 (24.11) in the degradation of GLP-1 but if this is the case in humans is unknown. We therefore administered a NEP inhibitor, 194mg sacubitril, a DPP-4 inhibitor (sitagliptin 100mg the night before and 100mg 2 hours before), both, or place, to nine healthy men during a standardized meal and measured plasma concentrations of GLP-1

Eligibility Criteria:
Inclusion Criteria:

* men
* body mass index between 20-25

Exclusion Criteria:

* acute diseases within the two weeks
* chronic diseases
* smoker
* alcoholism, drug addiction or recent weight loss
* blood donation within the last 3 months
Improvement on GMFCS Level of Patients With Cerebral Palsy Treated by Repeated Botulinum Toxin-A

The aim of this retrospective, monocenter, observational study is to evaluate the changes in GMFCS levels of children with cerebral palsy (CP) who received repeated Botulinum Toxin-A (BoNT-A) injections in the lower limb(s) with an integrated treatment approach in Kocaeli University Department of PMR and Izmit Rehabilitation Center.

It is generally agreed that children with CP reach their gross motor potential by the age of 3.5-5 and a child or young person over the age of 5 years will not improve their GMFCS level. BoNT-A is an important treatment in children with CP because it is safe in young children and allows combined treatment. The reduction in muscle tone by this selective treatment provides an opportunity to allow and optimize the effects of other treatments including orthoses, casting, conventional therapies and activity based functional trainings. For this reason, BoNT-A injections are always combined with other therapies in Kocaeli University Department of PMR and Izmit Rehabilitation Center. Adjunctive treatments in this department consists of serial casting, orthotics, physical therapy, occupational therapy, cognitive rehabilitation, special educational programs, non invasive brain stimulation with transcranial direct current, neurofeedback, biofeedback, electrical stimulation and other physical therapy modalities, activity based models including functional ambulatory training, constraint induced therapy, bilateral therapy, hippotherapy, music therapy by singing or playing percussive instruments or moving and dancing to music, and robotic rehabilitation. Individualized intensive combined treatment plan was applied by an appropriate neurorehab team to each patient within the department as a half day or full day program usually for 3 weeks starting 1 week or 10 days after BONT-A injections. In thıs retrospective, monocenter, observational study a software database program will be developed and all the present data about the demographic and clinic properties of the patients, all information about BoNT-A injections including safety and applied adjunctive treatments will be entered and reviewed.

Eligibility Criteria:
Inclusion Criteria:

* All children with a diagnosis of cerebral palsy with respect to Rosenbaum criteria
* Children who received at least 2 repeated BoNT-A injections to lower limb(s) as well as an integrated treatment approach (an intensive therapy protocol consisted of a half day or entire day program in Kocaeli University Department of PMR and Izmit Rehabilitation Center) within the last 10 years

Exclusion Criteria:

* Children who did not receive repeated injections
* Children who did not receive an intensive therapy protocol
Do Taping and Orthosis Affect Pain, Gait, or Functionality in Mild Knee Osteoarthritis?

Objective: The aim of this study was to compare the effects of elastic taping, rigid taping, and braces applied to women with mild knee Osteoartritis(OA) on pain, gait, and knee functionality.

Methods: This randomised study included 21 female patients (mean age of 53.81±6.20 years) with bilateral grade 2 knee OA according to the Kellgren \& Lawrence Classification. Pain was evaluated with the visual analog scale, functionality was evaluated with the Western Ontario McMaster Osteoarthritis Index, and the kinetic, kinematic, and spatiotemporal parameters were evaluated using a three-dimensional gait analysis system at baseline (no application) and immediately after the application of elastic taping, rigid taping, and orthoses. The dependent variables were measured after 45 minute the application of four different conditions neutral, elastic taping, rigid taping, and knee brace on each participant with 1-day intervals.

Objective: The aim of this study was to compare the effects of elastic taping, rigid taping, and braces applied to women with mild knee OA on pain, gait, and knee functionality.

Methods: This randomised study included 21 female patients (mean age of 53.81±6.20 years) with bilateral grade 2 knee OA according to the Kellgren \& Lawrence Classification. Pain was evaluated with the visual analog scale, functionality was evaluated with the Western Ontario McMaster Osteoarthritis Index, and the kinetic, kinematic, and spatiotemporal parameters were evaluated using a three-dimensional gait analysis system at baseline (no application) and immediately after the application of elastic taping, rigid taping, and orthoses. The dependent variables were measured after 45 minute the application of four different conditions neutral, elastic taping, rigid taping, and knee brace on each participant with 1-day intervals.

Eligibility Criteria:
Inclusion Criteria:

* bilateral knee OA according to the criteria of the American College of Rheumatology
* had radiographically phase 2 based on the criteria identified by Kellgren \& Lawrence

  -, had active knee pain
* did not receive any knee treatment in the last year
* could understand test and evaluations

Exclusion Criteria:

* experienced lower extremity trauma or underwent surgery
* had phase 3-4 Osteoarthritis
* had any orthopedic or neurologic problem affecting walking
* were allergic to taping
* did not walk independently on their own