cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Effects of Balance Coordination and Strengthening Training on Gait, Mobility and Posture in Children with Low Vision

The aim of this research is to examine and evaluate the effects of balance coordination and strengthening training on gait, mobility and posture in children with low vision

The hypotheses of our study:

H1: Balance coordination and strengthening training has an effect on gait, mobility and posture in children with low vision.

H2: Balance coordination and strengthening training has no effect on gait, mobility and posture in children with low vision.

The aim of this study is to examine and evaluate the effects of balance coordination and strengthening training on gait, mobility and posture in children with low vision.

A total of 22 low-vision individuals were included in the study. Individuals were randomly divided into two groups as Control (n=10) and Study (n=12). The treatment group received 70 min balance (20 min), coordination (20 min) and strengthening (20 min) training 3 days a week for 8 weeks. No additional treatment was applied to the control group. Evaluations were performed before treatment and at the end of 8 weeks.

In the evaluations; Bruininks-Oseretsky Motor Proficiency Test 2 Short Form (BOT2- KF), New York Posture Analysis, Manual November muscle strength assessment, G-Walk Gait Analysis, Independent Mobility Questionnaire (BMA) were used.

Eligibility Criteria:
Inclusion Criteria:

* To be in the age December of 7-14,
* Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease,
* Having been diagnosed with low vision,
* To be able to establish cooperation,
* Volunteering to participate in the study

Exclusion Criteria:

* Not being diagnosed with low vision,
* Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) having an additional disease,
* Not volunteering to participate in the study
The Clinical Validation of a Dried Blood Spot Method for Vancomycin and Creatinine

A widely used antibiotic is vancomycin. To ensure adequate exposure to vancomycin, drug doses are adjusted based on whole-blood concentration measurements, a practice known as therapeutic drug monitoring (TDM). The need for TDM of vancomycin is well established, as described in several national and international guidelines, for dose-optimization in order to achieve successful treatment and to prevent toxicity and reduce microbial resistance. A sampling method for TDM that has become more popular over the recent years is dried blood spotting (DBS). DBS is a design of blood sampling consisting of positioning a drop of capillary blood, preferably taken from the finger, on filter paper. Unlike venous blood sampling (the current gold standard for TDM of vancomycin), DBS seems to have advantages for the patient. The finger prick is less invasive than venipuncture. DBS also enables patients to perform one or multiple finger prick(s) themselves, with the possibility to sample at multiple time points. Due to the fact that vancomycin is nephrotoxic, it would be very efficient and convenient to measure creatinine in the same dried blood spot as the vancomycin. This study is a clinical validation study to validate the DBS assay for vancomycin.


Eligibility Criteria:
Inclusion Criteria:

* Clinical patients
* Aged 18 and over
* Able to understand written information and able to give informed consent
* Treated with vancomycin
* Able and willing to undergo a finger prick for dried blood spot sampling
* Able and willing to fill in a questionnaire

Exclusion Criteria:

* Unable to draw blood samples for study purposes
Position and Predictive Factors of Hypotension in Prone Percutaneous Nephrolithotomy

This study was designed to investigate the effect of position and predictive factors on hypotension in patients performing percutaneous nephrolithotomy. Patients aged \>18 years and ASA I-III who underwent general or regional anaesthesia were included in the study. Percutaneous access was performed in all patients with fluoroscopy in the prone position.

This study was designed to investigate the effect of position and predictive factors on hypotension in patients performing percutaneous nephrolithotomy. Patients aged \>18 years and ASA I-III who underwent general or regional anaesthesia were included in the study. Percutaneous access was performed in all patients with fluoroscopy in the prone position. Age, gender, body mass index(BMI), smoking, type of anaesthesia, duration of anaesthesia and surgery were recorded.

The ECG, SpO2, and non-invasive blood pressure values were recorded intraoperatively. Preoperative and postoperative 12th hour Hb,BUN, Cr,Na,K and Cl were measured in a blood sample. Isotonic was used as an intravenous fluid in all participants. In treatment of hypotension routine ephedrine treatments were recorded.

In the literature, studies in PCNL surgery have focused on data such as method, duration of bleeding and fluoroscopy, electrolyte-metabolic changes, and complications such as fever, hypothermia, pleural damage, and hospital stay. A limited number of studies have focused on bleeding and hemodynamics in comparing surgical methods in the prone and supine positions. the investigators could not find any study comparing systemic disease effects on intraoperative hypotension (hemodynamic parameters) in Prone PCNL surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years and ASA I -III who underwent general or regional anaesthesia were included in the study.

Exclusion Criteria:

* Patients who received preoperative vasopressor, inotropic infusion, erythrocyte and fresh frozen plasma (FFP), anaemia, uncontrolled coagulopathies, pregnancy, immunodeficiency, ASA class IV and emergency surgeries.
Bloodstream Infection Due to Multidrug-Resistant Organisms - Multicenter Study on Determinants of Clinical Outcomes

Continual surveillance of both community-acquired and nosocomial bloodstream infections for specific target organisms. Analysis of comorbidities, complications, bacterial resistance patterns, bacterial genomics (e. g. via WGS and MLST typing) for the determinants of clinical outcomes. The clinical outcomes are investigated both in the short-term (up until discharge) and the long-term (six months after index blood culture by standardized questionnaire). A predictive point-of-care score is to be developed based on these data to define high-risk patient populations requiring more intensive diagnostic and/or treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Informed consent given either by patient or guardian
* Inpatient
* At least one blood culture positive for one of the following bacteria: Staphylococcus aureus, Enterococcus spp., Escherichia coli, Enterobacter spp., Klebsiella spp., Acinetobacter baumannii, Pseudomonas aeruginosa

Exclusion Criteria:

* Less than 18 years old
* Not capable of giving informed consent nor informed consent given by guardian
* Outpatient
* No blood cultures positive for any of the target organisms
Inhaled Iloprost in Mild Asthma

The purpose of the study is to determine if inhaled iloprost given four times daily can improve symptoms and lung function in adults with mild asthma.

Animal studies have suggested that prostacyclin may downregulate allergic inflammation, thus providing the scientific basis for trials of inhaled prostacyclin agonists such as iloprost for the treatment of asthma. This study will examine the tolerability of four times daily iloprost on asthma symptoms and pulmonary function over a two week treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-60
2. History of asthma controlled by inhaled rescue medication (albuterol, levalbuterol etc) and/or inhaled corticosteroids
3. Ability to give informed consent
4. Ability to perform pulmonary function tests
5. Ability to tolerate the initial Ventavis inhalation
6. Ability to comply with the study protocol

Exclusion Criteria:

1. Cigarette smoking
2. Concomitant serious disease such as diabetes, hypertension, coronary heart disease, other lung disease, cancer (other than skin cancer)
3. Pregnancy or lack of contraception (hormonal or barrier)
4. Allergies or intolerance to inhaled iloprost
5. Participation in other ongoing research studies
6. Any psychological problem that the investigators believe might interfere with the conduct of the investigation.
7. Cigarette smoking
8. History of bleeding disorder, use of anticoagulants
9. Viral upper respiratory tract infection within the last 6 weeks
10. Table of upper limit for steroid use Beclomethasone dipropionate HFA-MDI 480 Budesonide DPI 1200 Flunisolide HFA-MDI 640 Fluticasone HFA-MDI 440 Fluticasone DPI 500 Mometasone DPI 440 Triamcinolone 1500 (Table adapted from EPR3, daily doses are in micrograms) Asthmatics requiring higher doses of inhaled corticosteroids than those given above, or using oral steroids, leukotriene modifiers, mast cell stabilizers, omalizumab, theophylline or long acting beta agonists will be excluded.
11. .Any screening laboratory blood test value outside the normal range will exclude the individual from the study, though an isolated abnormal value could be retested at an interval of no less than a week.
Post Market Study for FloShield 10mm Reusable Cannula and Blunt Obturator and Robotic FloShield

This study evaluates the use of the FloShield System with the FloShield 10mm reusable Cannula and Oburator during standard robotic laparoscopic single-site surgery. The study will evaluate the compatibility of the FloShield 10mm Cannula and Oburator with the daVinci® Robotic Surgical System during single-site laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years or older
* Scheduled for a laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy under the care of the study investigator
* Suitable candidate for surgery
* Is able to read and understand the informed consent form and has voluntarily provided written informed consent

Exclusion Criteria:

* Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
* Subjects with known allergy (hypersensitivity) to Docusate Sodium
* Use of Surgiquest AirSeal during the laparoscopic single-site surgery
* Use of humidified insufflation
Sleep-disordered Breathing and Perioperative Atrial Fibrillation in Cardiac Surgery

In patients undergoing elective coronary artery bypass grafting (CABG) surgery, coronary artery disease, sleep-disordered breathing (SDB), atrial fibrillation (AF) perioperative atrial fibrillation and complications will be assessed. The primary objective is to determine, whether SDB patients have a higher rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) within 30 days after surgery compared to those without SDB.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective CABG surgery at the Department of Cardiac and Thoracic Surgery, University Hospital Regensburg.
* Written informed consent

Exclusion Criteria:

* Preoperative use of inotropes or intra aortic balloon pump
* Severe obstructive pulmonary disease
* Patients on oxygen therapy, nocturnal positive airway pressure support or mechanical ventilation
Platelets Induced Vasodilation, in Vitro and in Vivo Study

The aim of the study is to show the implication of platelets in vasodilation using in vivo and in vitro analysis and to compare the effects of placebo, aspirin and Clopidogrel in this interaction platelets/vessels.

The effects of 7 days of each treatment will be compared in healthy subjects and patients with arteriopathy.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria healthy subjects

* Man or Woman 18 years
* Agreement signed
* French health insurance
* Able to understand the study
* Biological haemostatic test normal
* Vascular Doppler of lower limbs normal
* Pressure index \> 1 in both lower limbs

Inclusion criteria healthy subjects

* Man or Woman 18 years
* Agreement signed
* French health insurance
* Able to understand the study
* Biological haemostatic test normal
* Lower limbs arteriopathy (clinical, pressure index, Doppler)

Exclusion Criteria:

* Unable to sign agreement
* Subjects protected by low
* Participation to other study
* Changes of treatment within the 15 days before inclusion
* Chronic treatment with Clopidogrel or drugs against inflammation
* Severe respiratory, cardiac, kidney, hepatic insufficiency
* Haemostatic troubles
* Diabetic neuropathy
* Neurologic desease (Parkinson.....)
* Hypertension
* Symptomatic stomach ulcer
* Anaemia Hb\<11g/l
* Pregnant women or breast feeding
TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study (TE-Prove)

The goal of the TAXUS™ Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study is to evaluate real world clinical outcomes data for the TAXUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.

A prospective, open label, multi-center observational study with an all-comers enrollment approach of approximately 1000 subjects at up to 50 sites in Europe.

Eligibility Criteria:
Inclusion Criteria:

* According to Instructions For Use

Exclusion Criteria:

* Contraindications according to Instructions for Use
Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A

The overall objective is to enroll patients with acquired hemophilia A (AHA) who are prescribed and treated with Obizur, to assess safety, and to describe factors related to safety, utilization and effectiveness in a real-world setting.

This study is a multi-center, uncontrolled, open-label, non-interventional post-marketing safety surveillance study to describe the use of Obizur in patients with acquired hemophilia A (AHA), and secondarily, where data are available, to describe the hemostatic effectiveness and immunogenicity of Obizur.

Patients should be enrolled at the earliest possible time point after initiating Obizur.

In an attempt to collect safety and utilization data on patients treated with Obizur since Food and Drug Administration (FDA) approval in October 2014, Baxalta will make an effort to identify all persons treated with Obizur and to collect data for as many patients as possible.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is ≥18 years of age at the time of informed consent.
2. Participant has AHA, and is being treated/was treated with Obizur.
3. Participant or the participant's legally authorized representative is willing and able to provide informed consent, unless informed consent is not required

Exclusion Criteria:

1. Participant has a known anaphylactic reaction to the active substance, to any of the excipients, or to hamster protein.
2. Participant has a concomitant bleeding disorder(s) other than acquired hemophilia A (AHA).
3. Participant has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of the study.
Obesity and Health-related Quality of Life in Patients Receiving Bariatric Surgery in the UK

United Kingdom National Bariatric Surgery Registry (NBSR) records between 1st June 2017 and 23rd November 2022 were used to identify people undergoing primary bariatric (weight-loss) surgery. People undergoing primary bariatric (weight-loss) surgery with one baseline and at least one follow-up visit within one year from surgery were included. Statistical models were used to estimate the relationship between quality of life as assessed by a questionnaire and body mass index at baseline and over time.

Previous small studies investigating health-related quality of life (HRQoL) following bariatric surgery have demonstrated heterogenous effects. Estimated changes in HRQoL are used to evaluate both clinical- and cost-effectiveness of interventions; which in turn informs commissioning decisions. Understanding HRQoL of patients undergoing bariatric surgery is therefore important for both clinical practice and policymaking.

This study aimed to use National Bariatric Surgery Registry (NBSR) records to investigate the relationship between weight and HRQoL in people undergoing bariatric surgery in the UK. The NBSR is an anonymised, bespoke record of bariatric cases carried out within the National Health Service (NHS) in the UK and Ireland. The analysis plan was prospectively published in March 2022, and it is available here: https://osf.io/6t9rg/.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older)
* undergoing primary bariatric surgery
* with both baseline (pre-operative) and at least one follow-up record.

Exclusion Criteria:

* people undergoing revision surgery
* records that did not include complete EQ-5D scoring (all 5 domains).
* records with implausible values, defined as: BMI \<25 kg/m2 or \>100 kg/m2; height \<1m or \>2.5m; weight \<50kg or \>400kg; age\>100 years.
* records greater than 12 months from surgery date
Associative Memory in Adults With an Autism Spectrum Disorder

The objective of this multidisciplinary project is to explore the deficit of associative memory in ASD (Autistic Spectrum Disorder) that could result from abnormal brain connectivity. The hypothesis of abnormal functioning of the fronto-hippocampal network has been evocated but has never been tested. Hence, the present project will include two complementary assessments conducted on a group of adults aged from 18 to 30 with ASD compared to a control group matched in chronological age and intellectual quotient. The first assessment is devoted to the study of associative memory and its EEG correlates and the second focused on the investigation of perceptual strategies related to associative memory using the technique of Eye-tracking. Both behavioral and imaging data would provide new insights on the relationship between perception and memory in ASD.


Eligibility Criteria:
Inclusion Criteria:

* Adult between 18 and 30 years old
* right handed
* affiliated to the french national health care system
* ASD only for the group of patients

Exclusion criteria :

* mental retardation
* schizophrenia
* ADHD
* brain injury with lost of consciousness
* neurological disease
Perioperative Chemotherapy Compared To Neoadjuvant Chemoradiation in Patients With Adenocarcinoma of the Esophagus

The trial is designed to investigate differences in outcome of patients with esophageal adenocarcinoma and junctional adenocarcinoma treated with perioperative (neoadjuvant + adjuvant) chemotherapy (FLOT) plus surgical resection versus neoadjuvant chemoradiation (CROSS) plus surgical resection.

According to the given evidence a survival benefit of perioperative chemotherapy (periCTX) over Neoadjuvant chemoradiation (neoCRT) for patients with Esophageal adenocarcinomas (EAC) has not been proven in any randomized controlled trials (RCT). Data supporting the value of periCTX have all been obtained in studies including mixed patient cohorts with EAC and gastric adenocarcinoma (GAC). Due to relevant differences of histologic subtype distribution, response to periCTX and survival rates between EAC and GAC there is a clear need to obtain evidence concerning the value of periCTX for EAC. As nowadays periCTX is extensively and successfully applied in clinical practice in patients with EAC there is an obvious need to obtain evidence from a multicentre RCT. Moreover a confirmation of the superior survival rates of the recent RCT on neoCRT should be obtained in a RCT conducted exclusively on EAC. Therefore, this prospective RCT with the primary objective of longterm patient survival comparing periCTX and neoCRT was designed.

Translational Projects:

Project 1+2: Circulating Tumor Cells as Biomarker in EAC CTC laboratories at University of Hamburg and University of Freiburg Project 3: Prognostic and predictive biomarkers in EAC University of Leipzig, UCCL

Eligibility Criteria:
Inclusion criteria:

* Histologically verified adenocarcinoma of the esophagus according to the UICC definition (TNM7)
* Pre-treatment stage cT1N+, M0 or cT2-4a, N0/+, M0
* Age ≥18 years
* No prior abdominal or thoracic radiotherapy
* ECOG Performance status 0-2
* Adequate cardiac function ( Patients with a cardiac history (e.g. myocardial infarction, heart failure, coronary artery disease) should have a cardiology review)
* Adequate bone marrow function (WBC\>3x10\^9/l; Hb\>9g/dl; platelets \>100x10\^9/l)
* Adequate respiratory function. Symptomatic Patients should have pulmonary function tests with FEV1 \>65% of predicted)
* Adequate renal function (GFR \>60ml/min)
* Adequate liver function (serum bilirubin \<1.5x Upper level of Normal (ULN); AST \<2.5x ULN and ALT \<3x ULN (ULN as per institutional standard)
* written informed consent

Exclusion Criteria:

* Tumors of squamous or other non-adenocarcinoma histology
* Patients with advanced inoperable or metastatic esophageal adenocarcinoma
* Stage cT1N0 and cT4b
* Gastric carcinoma
* Prior chemotherapy for cancer,
* Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months)
* Clinical significant lung disease (FEV1 \<65% of predicted)
* Peripheral neuropathy Grade \>1
Effect of Diacerein on Hand Osteoarthritis

Ostearthritis is one of the most common arthritis, affecting more than 30% of aged people world-widely. The disease is characterized by pain and stiffness of the affected joints and is the most common cause of disability in aged people. It commonly affects knee, hip, hand and spine joints. Diacerein is a drug developed specifically for the treatment of osteoarthritis. It has inhibitory effects on interleukin-1 (IL-1) and metalloproteases which are known to play key roles in the pathogenesis of osteoarthritis while exerting no effect on phospholipase A2, cyclooxygenase or lipoxygenase. It showed anti-inflammatory effects on animal models and reduced structural changes in several animal models. Therefore, we investigate the role of diacerein in patients with hand osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Ages over 40 years-old
* Conforming to the classification criteria of American College of Rheumatology\*
* More than 1 tender joints
* Self reported hand pain which is more than 30 mm on the Australian/Canadian Osteoarthritis Hand Index visual analogue scales (VAS) after wash out period of 2 weeks

Exclusion Criteria:

* Pregnant or lactating women
* Previous history of hypersensitivity to Diacerein
* Patients who had taken oral corticosteroid or intraarticular steroid to hand joints within 3 months of enrollment
* Patients who were injected with hyaluronic acid to hand joints within 6 months of enrollment
* Patients who underwent surgery in any joints of the hands
* AST/ALT \> 2x upper normal range
* Serum Cr \> 1.4 mg/dl
* Patients who have severe comorbidities such as severe congestive heart failure or pulmonary disease
* Patients who took oral anticoagulants.
* Patients who refuse to sign the consent form