cyrilzakka/clinical-trials huggingface dataset:
The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support

The purpose of this observational study is to evaluate the performance of the Berlin Heart EXCOR Active driving unit while being used with the approved EXCOR ventricular assist device system.

The study has a prospective, multicenter, international, single arm, observational design.

Study enrollment is expected to take 18 months and subjects will be followed until they reach an outcome or for 45 days on the EXCOR Active driving unit. The overall study duration is expected to be approximately 20 months.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients meeting all indications as specified in the current version of the instructions for use (IFU) of the EXCOR® Active system,
* Age \< 18 years,
* Patient and legal guardian has consented via signature on the study informed consent form,
* Patient is able to get mobilized according to hospital standard and is currently supported with the Ikus driving unit. The decision if a patient is able to get mobilized is at the discretion of the investigator.

Exclusion Criteria:

* Patient has any contraindication as specified in the current version of the IFU of the EXCOR® Active system,
* Patient and/or legal representative has not given written consent to participate in the study (non-consent),
* Females of childbearing age who are not on contraceptives or surgically sterile or who are pregnant.
Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch

The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.


Eligibility Criteria:
Inclusion Criteria:

1. Congenital tracheal deformities: Includes congenital tracheomalacia, congenital tracheobronchial malformations, complete tracheal rings, etc., with severe clinical symptoms and cases where treatment is recommended after evaluation.
2. Acquired tracheal stenosis: Includes tracheal narrowing caused by diseases, endotracheal intubation, or postoperative scar tissue, with severe clinical symptoms and cases where treatment is recommended after evaluation.
3. Tracheal injury or tissue defect caused by trauma or burns: Cases requiring surgical repair.
4. Tracheal tumors: Reconstruction of tracheal tissue following the removal of benign or malignant tumors.

Exclusion Criteria:

1. Patients who are unable to provide informed consent.
2. Pulmonary tumors that can be treated with standard lobectomy.
3. Locally invasive tumors that are unresectable.
4. Presence of contralateral lymph node metastasis.
5. Presence of distant metastasis, except for solitary, resectable brain metastasis.
6. Tracheal lesions amenable to standard resection with direct anastomosis.
7. Preoperative evaluation indicates inability to undergo standard lobectomy.
8. Patients infected with human immunodeficiency virus (HIV) or with other immunodeficiency disorders.
9. Any condition or circumstance deemed by the principal investigator to potentially interfere with the conduct of the trial (e.g., severely impaired cardiopulmonary function, significant liver or kidney dysfunction, poorly controlled diabetes, high-risk groups, or pregnancy).
10. Individuals with concerns about the potential risks of the trial.
Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Type 2 diabetes mellitus and diabetic nephropathy, who have been treated with a stable dose of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
* Glycosylated haemoglobin (HbA1c) ≤10.5%
* Subject with albuminuria

Exclusion Criteria:

* Subjects with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus (Cushing's syndrome, steroidogenic diabetes).
* Serum potassium level \<3.5 or \>5.0 mmol/L
* Subjects who had acute kidney injury within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation
* Subjects with clinically significant hypotension
Clinical Performance Study of the ABTest Card® Device.

The study aims to confirm the performance equivalence of the in vitro diagnostic device ABTest Card®REF with the ABTest Card®NEW device.

Following some changes in the ABTest Card® raw materials, a new validation of the associated clinical performances is required. Raw materials of the ABTest Card® are : Triton, Cleanis, Tween, Yellow, Blue dye and the blood segment opener device.

According to the regulatory text "Common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council", 90% of the results will be derived from the performance study carried out at the DIAGAST laboratory on tube left over and blood bag, and 10% of the results will be derived from the use of the device in a real situation ("at the bedside").

The Regulation 2017/746 (IVDR) on IVDMD, has been effective since May 2022 with transitional periods. The IVDR replaces the current EU Directive (98/79/EC) to ensure a higher level of health and safety for the making available and putting into service of medical devices on the EU market. As the ABTest Card® is already CE marked under Directive 98/79/EC as List IIA product, this study is part of the device's post-marketing performance monitoring.

The purpose of this study is to document and verify the clinical performance of the ABTest Card® device in combination with the new raw materials used for manufacturing (ABTest Card®NEW), by comparing the results obtained with the ABTest Card®REF, already commercialised and used routinely by the study sites.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old for the category marked with \*.
* Undergo capillary blood sampling ;
* Belong to one of the clinical categories:
* Patient in need of blood transfusion without any pathology known to have an impact on transfusion act\* ;
* Patient in need of blood transfusion suffering from congenital erythrocyte pathology (sickle cell anaemia, beta thalassemia)\* ;
* Patient in need of blood transfusion suffering from haematology disease (e.g. cancer), or undergoing haemodialysis\* ;
* Patient with cold agglutinin\* ;
* Premature patient with gestational age \< 37 weeks or newborn ≤27 days old in need of blood transfusion ;
* Newborn eligible for the Guthrie Test ;
* Newborn eligible for the glycaemic test.
* Have health care insurance ;
* Have given his/her written consent (or legal representative in the case of a newborn) ;

Exclusion Criteria:

* Pregnant woman ;
* Person deprived of liberty ;
* Unconscious person ;
* Person under guardianship or trusteeship ;
* For paediatric clinical category: age ≥28 days and \<18 years old.
Walnut Intervention on Metabolic Syndrome (WIMS)

The purpose of this study is to determine whether a daily supplement of 30 grams of walnut is effective in the treatment of metabolic syndrome (MetS).

Metabolic syndrome (MetS), a constellation of metabolic abnormalities including central obesity, dyslipidemia, elevated blood pressure and hyperglycemia, is associated with the development of type 2 diabetes and CVD. It has become one of the major public health challenges in China due to rapidly nutrition transition and the nature of obesity epidemic. Treatment of MetS in China is very important for the prevention of the epidemic of its consequences (such as CVD and type 2 diabetes).

Compelling evidence from recent human studies has demonstrated that diet and lifestyle modifications are effective means in MetS management. Walnut is a complex food source containing high amounts of polyunsaturated fatty acids (PUFA), as well as plant protein, Vitamin E and other substances that may have an impact on health. Therefore, the aim of this study is to investigate the effect of walnut supplementation on the management of MetS in adult Chinese men and women in a randomized, controlled clinical trial. A total of 200 participants with MetS (defined by NCEP-ATPⅢ criteria) will be randomly assigned to a walnut-supplemented diet (30 grams/day) or an isocaloric control diet for 12 weeks. Effects of walnut supplementation will be evaluated by measuring metabolic profile (BMI, blood pressure, total cholesterol, triglyceride, LDL-C and HDL-C, fasting glucose and insulin, HbA1C), inflammatory markers (CRP and IL-6), markers of endothelial function (E-selectin, ICAM-1 and VCAM-1), and fatty acid profile.

Eligibility Criteria:
Inclusion Criteria:

* With metabolic syndrome. Metabolic syndrome was defined based upon the updated National Cholesterol Education Program Adult Treatment Panel III criteria for Asian-Americans as presenting at least 3 of the following components: 1) waist circumference ≥ 90 cm for men or ≥ 80 cm for women; 2) triglycerides ≥1.7mmol/l; 3) HDL cholesterol \<1.03 for men or \<1.30 for women; 4) blood pressure ≥130/85 mmHg, or current use of antihypertentive medications; 5) fasting glucose ≥5.6mmol/l or previously diagnosed type 2 diabetes or on oral antidiabetic agents or insulin.
* Being able to comply with the specified feeding conditions
* Being able to eat walnuts
* Being between the ages of 35 and 60 years

Exclusion Criteria:

* Pregnancy or lactation
* Use of insulin
* Severe kidney disease
* Cardiovascular diseases, stroke, cancer and psychological disorders
* Walnut allergies or frequently eating walnuts or other nuts (\>90 grams/week)
* Drug or alcohol abuse.
A Study to Determine the Efficacy, Safety and Pharmacokinetics of GMI-1271 as Adjunct to Standard of Care for the Treatment of Multiple Myeloma

This study will evaluate GMI-1271, a specific E-selectin antagonist, in multiple myeloma as adjunct to standard of care chemotherapy used to treat this disease.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 years of age
2. Confirmed diagnosis of Multiple Myeloma
3. Subjects with progressive MM who have received at least 1 prior therapy and who have already undergone or are not expected to undergo hematopoietic stem cell transplantation
4. Subjects previously treated with an IMiD-based regimen or ineligible for an IMiD-based treatment regimen
5. Subjects must be receiving treatment with a proteasome inhibitor-based regimen (bortezomib-based or carfilzomib-based)
6. Adequate hepatic, renal, and cardiac function

Exclusion Criteria:

1. Intolerant to bortezomib or carfilzomib
2. Progressing evidence of end organ damage attributed to the underlying disease
3. Plasma cell leukemia
4. Congestive heart failure
5. Acute active infection
6. Non-hematologic malignancy within the past 3 years except: a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, or c) prostate cancer with stable PSA
7. Significant peripheral neuropathy
A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function mutation (F/G and F/RF genotypes).


Eligibility Criteria:
Key Inclusion Criteria:

* Subject has a confirmed diagnosis of CF and is heterozygous for F508del and either a gating or residual function mutation (F/G and F/RF genotypes)
* Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height

Key Exclusion Criteria:

* Clinically significant cirrhosis with or without portal hypertension
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* Solid organ or hematological transplantation

Other protocol defined Inclusion/Exclusion criteria may apply
Improve Screening Criteria for Retinopathy of Prematurity in Two French Center

The aim of the study is to assess whether a delay of the first examination can be safely considered in French population. Secondary objectives are to describe retinopathy of prematurity (ROP) in a population of premature from two French tertiary NICU and to identify co-morbidities associated with the development of severe ROP.

Retinopathy of prematurity (ROP) is a major cause of blindness and visual impairment in children worldwide. Despite a stable incidence over the last decades, improvements in neonatal care and survival of extremely premature lead to an increased screening and follow up of ROP. Retinal examination is painful and can result in clinical deterioration, it also generates significant health care costs. In this way, several studies suggest the need to optimize screening without ignoring severe ROP requiring treatment. Recently, SCREENROP in Canada and SWEDROP studies in Sweden contributed to a modification of the national screening guidelines with a reducing upper limit at 30 weeks of gestational age (GA) and a postponing of the first examination. Because of the population studied, those recommendations cannot be applicable in other countries.

Recommendations in France are to screen infants \< 31 GA or 1250 g, first examination should be performed at PMA 31 in infants \< 27 GA and at 4 weeks postnatal age (PNA) in infants born at 27 GA or more. Our main hypothesis is that a reduction of the screening criteria by decreasing the upper limit of the threshold at 30 GA and/or postponing the first examination is acceptable in a population of premature newborns from two French tertiary NICU. This simplification of the screening modalities could reduced the number of fundus examinations performed, while limiting risks for the patient as well as costs. This study could be a pilot study for a national multicenter trial, with the objective of revising national screening guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Infant with gestational age \< 31 weeks and/or birth weight \< 1250 g
* With at least one retinal examination
* holders of the parental rights informed and not objecting to the study

Exclusion Criteria:

* infants died before 28 days PNA
* infants with hydrocephaly.
* infants with significant congenital malformations or genetic abnormalities.
Effects of Transcutaneous Vagus Nerve Stimulation on Recovery

During the recovery process, the activity of the sympathetic system decreases, while the activity of the parasympathetic system increases. In line with this information, the nervous system can be regulated in a noninvasive and practical way by using transcutaneous auricular vagus nerve stimulation in order to achieve rapid recovery in the athlete after the activity.

In sports where physical loads are high, athletes can usually participate in more than one training or race during the day. Such work increases the athlete's fatigue, affects their performance and can cause serious declines. Therefore, an efficient and effective recovery process after high-intensity work and training that causes a decrease in performance is also very important for the athlete's next performance.

With the start of sports activity or exercise, sympathetic activation in the body increases and after a while reaches a plateau value at maximum activity. With the end of exercise, this time the suppressed parasympathetic activity begins to increase and the sympathetic system returns to a resting state over time.

There are insufficient studies in the literature investigating the use of Transcutaneous Auricular Vagus Nerve Stimulation on the athletic population. Although it is clear that the application has effects on the sympathetic and parasympathetic nervous systems, more clinical research is needed on athletes. In this study, we aimed to investigate the effects of auricular vagus nerve stimulation (VNS) on vagal activity by examining the effect of transcutaneous auricular vagus nerve stimulation on recovery in amateur athletes through applications such as pulse and SpO2, blood pressure, perceived fatigue, and respiratory function tests.

Eligibility Criteria:
Inclusion Criteria:

* Being healthy between the ages of 18-25,
* Volunteering to participate in the study,
* Signing the voluntary consent form,
* Being an amateur football player who continues his/her active sports life,
* Not having an injury that prevents participation in the study.

Exclusion Criteria:

* Having a disease related to the respiratory system,
* Having a disease related to the cardiac system,
* Having any chronic disease and using a medication related to it.
A Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214-02 to Rabeprazole in healthy volunteers.

This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214-02 compared with administration of Rabeprazole in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Age 19\~50 years in healthy volunteers
* BMI is more than 18.0 kg/m\^2 , no more than 27.0 kg/m\^2
* Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator
An Efficacy Study of BCS Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD

The purpose of study is to evaluate the efficacy and safety of Benzalkonium Chloride Solution clearing the oral colonized bacterium in hospitalized patients with COPD.

This a randomized, double-blind, parallel, single-center, exploratory trial. 60 patients will be randomized to two treatments: benzalkonium chloride solution treatment or normal saline treatment.The purpose of study is to evaluate the efficacy and safety of benzalkonium chloride solution clearing the oral colonized bacterium in hospitalized patients with COPD.

Eligibility Criteria:
Inclusion Criteria:

1. COPD patients in hospitalized.
2. Aged from18 to 70 years (including 18 and 70).
3. Patients participating in this trial should sign ICFs.
4. Patients with good understanding, could conduct this study with investigators.

Exclusion Criteria:

1. History of mouthwash allergies, allergic rhinitis or dermatitis.
2. Patients with oral ulcers, severe periodontal disease, oral mucosal lesions or oral cancer, patients received special oral clean.
3. Patients with removable denture.
4. Patients with malignant blood diseases.
5. History of using cytotoxic drugs or biological immunosuppressants ( such as TNF-α inhibitors ).
6. Had used clinical study drugs before 28 days enrollment.
7. Had used clinical study drugs before 28 days enrollment.
Investigation of the Effectiveness of Tele-pulmonary Rehabilitation After Lung Resection

As a result of the review in the literature, no study was found in which tele-pulmonary rehabilitation was applied after physiotherapist-supervised lung resection via video conferencing.

Therefore, in this study, it was planned to investigate the effectiveness of tele-pulmonary rehabilitation in patients diagnosed with lung cancer and undergoing lung resection.

Research; It was planned as a prospective and randomized controlled study. The research universe is Istanbul Kartal Dr. Lütfi Kırdar City Hospital Chest Surgery Clinic will consist of cases with a preliminary diagnosis of lung cancer. The sample of the study, on the other hand, will consist of patients who agreed to participate in the study and who met the inclusion criteria, who were planned for lung resection.

1. Study group (n=18); The treatment features of the tele-pulmonary rehabilitation group via videoconferencing are; Within the scope of the tele-pulmonary rehabilitation program, an exercise program consisting of lower-upper extremity strengthening training and flexibility training, breathing exercises training (diaphragmatic breathing, thoracic expansion exercises and forced expiration) and aerobic exercise training will be created before discharge, exercise session will be followed. Re-evaluation will be done after 8 weeks.Exercise intensity will be planned as 2 days a week with supervision and 1 day without supervision, 3 days a week in total. Exercise safety will be ensured by taking the severity of shortness of breath of the patients as a reference.
2. Control group (n=18); Patients in the tele-pulmonary rehabilitation control group will be given respiratory and aerobic exercise advice before discharge. Re-evaluation will be done after 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 55-75 years diagnosed with lung cancer
* Patients who underwent lobectomy, segmentectomy, bilobectomy, and pneumonectomy by either VATS or thoracotomy surgeries
* Patients who can use phones and make video calls

Exclusion Criteria:

* Patients with heart failure or atrial fibrillation
* Patients with acute infection at the time of assessment
* Patients who have had myocardial infarction in the last six months
* Patients with any comorbidities such as uncontrolled diabetes mellitus and/or hypertension
* Patients with any problem that would limit physical activity
Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

The aim of this study is to evaluate whether performing complex fractionated atrial electrograms ablation improves outcomes in persistent or atrial fibrillation ablation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)
* Presence of atrial fibrillation at the beginning of the procedure

Exclusion Criteria:

* Hypo or hyperthyroidism
* Persistent long-lasting or non-defined duration atrial fibrillation
* Hypertrophic myocardiopathy
* Implantable defibrillation or pacemaker implanted
* Moderate or severe mitral valve disease or mitral prosthetic valve
* Ejection fraction less than 30%
* Left atrial anteroposterior diameter more than 50 mm.
* Previous atrial fibrillation ablation
* Contraindication to anticoagulation
* Left atrium thrombus
* Current infective disease or sepsis
* Pregnant women
* Current unstable angor
* Acute myocardial infarction in last 3 months
* Atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease
* Reduced expectancy of life (less than 12 months)
* Patient participating in another clinical study that investigates a drug or device
* Psychologically unstable patient or denies to give informed consent
* Any cause that contraindicate ablation procedure or antiarrhythmic drug