cyrilzakka/clinical-trials huggingface dataset:
Study of Azithromycin for Lymphocytic Bronchiolitis/Bronchitis After Lung Transplantation

This study investigates the role of azithromycin treatment for lymphocytic bronchitis/bronchiolitis after lung transplantation.

Lymphocytic bronchitis/bronchiolitis is one of the major risk factors for development of chronic rejection/BOS after lung transplantation. There is currently no established treatment available for this condition. There is now mounting evidence that IL-17 producing lymphocytes (TH17) not only participate in chronic allograft rejection/BOS, but are also present within the airway wall during lymphocytic bronchiolitis and that IL-17 mRNA-levels in bronchoalveolar lavage fluid of these patients are upregulated. As such, TH17 may account for the increased BAL neutrophilia seen in these patients, as IL-17 may be responsible for driving IL-8 secretion (a neutrophil-attracting chemokine) from various cell types in the airways. Since azithromycin has previously been shown to reduce both IL-17 induced IL-8 production by human airway smooth muscle cells 'in vitro' and bronchoalveolar IL-8/neutrophil levels in LTx recipients with established BOS, we believe that azithromycin has great potential for treating lymphocytic bronchi(oli)tis by attenuating this TH17/IL-17/IL-8-mediated airway inflammation, possibly even halting the subsequent development of chronic rejection/BOS after lung transplantation. In this study, histologic, spirometric, bronchoalveolar an radiologic features will be investigated in patients treated with confirmed lymphocytic bronchitis/bronchiolitis treated with azithromycin.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Adult (age at least 18 years old at moment of transplantation)
* Able to take oral medication
* Histologic diagnosis of lymphocytic bronchiolitis or bronchitis ('grade B') without concurrent acute cellular allograft rejection 'grade A' ≥2

Exclusion Criteria:

* Severe suture problems (e.g. airway stenosis) requiring lasering or stenting
Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After LASIK: a Randomized Clinical Trial

In this randomized controlled clinical trial, we compare the effects of timolol versus placebo for treatment of myopic regression after LASIK


Eligibility Criteria:
Inclusion Criteria:

* Patients with myopic regression equal or more than 0.5 D with minimum age of 20 years,
* cylinder ≤ -1.00 D,
* corrected distance visual acuity (CDVA) of at least 20/40 were included.

Exclusion Criteria:

* Patients with a history of previous ocular surgery,
* keratoconus or any ectatic corneal disorder,
* keratoconus suspect by topography,
* preoperative corneal opacity,
* any corneal dystrophies,
* presence of pterygium,
* retinal disorders,
* collagen vascular disorders,
* diabetes mellitus,
* glaucoma,
* cataract,
* pregnancy,
* breast feeding
* systemic corticosteroid therapy were excluded.
ETOILE : A Feasibility Study in Pediatric Patient Education

Feasibility study of a therapeutic education program for the patient and his carers, intended for children suffering from acute lymphoblastic leukemia or having received an allograft of hematopoietic stem cells in the pediatric hematology department of Robert Debré hospital ( Paris, APHP). In addition to feasibility, the intermediate effectiveness of the program will be assessed.

This is a pilot feasibility study, of the quasi-experimental before-after, non-randomized, mono-centric type. Feasibility is assessed on process criteria (adoption, reach implementation, satisfaction). Intermediate effectiveness is assessed on the skill level of patients and their caregivers, before, after and at a distance from education. Patients' anxiety levels will also be assessed before, after and at a distance from the program. The level of health literacy will be assessed at the start of the study.

Eligibility Criteria:
Inclusion Criteria:

* Criteria relating to the population studied: child between 0 and 18 years old, followed at Robert Debré hospital (Paris), by a doctor from the hematology and immunology department

  * Of which the 2 holders of parental authority have been informed and have signed the consent
  * Having 1 or 2 caregivers available to accompany him during FTE sessions
  * 1 to 2 of their adult caregivers will be eligible for the ETOILE program and will be included in the study after their consent.
  * Child with acute lymphoblastic leukemia, treated at Robert Debré Hospital (Paris), in the induction or consolidation phase
  * Child going to receive or having received an allograft of hematopoietic stem cells at the Robert Debré hospital (Paris)
  * Beneficiaries of a social security scheme or entitled to it,

Exclusion Criteria:

* Child not mastering the French language,
* Child with physical or cognitive disability to participate in the program,
Prognosis of Patients With Compete Left Bundle Branch Block

The investigators sought to evaluate the morphological and functional changes, risk stratification and prognosis of patients of participants with compete left bundle branch block (CLBBB).

The conduction of this study was largely due to the increased clinical requirement, which reflected the increased awareness among physicians of heart failure due to asynchronous cardiac function caused by CLBBB. The investigators also aim to figure out the time point or CMR parameters for cardiac resynchronization therapy in patients with CLBBB.

The effect of cardiac resynchronization therapy (CRT) for heart failure patients was heterogeneous. Candidate selection was important before intervention. The underlying mechanical dyssynchrony of left ventricular bundle branch block was insufficiently descripted. Earlier study of investigators found novel imaging methods such as cardiovascular magnetic resonance imaging including T1 Mapping and feature tracking imaging can provide more detailed information about regional and global LV function in patients. While the role of new cardiac MR imaging techniques in predicting CRT responses, especially in LBBB patients, is still insufficient. Z Chen et al used T1 mapping technique to quantitatively assess the diffuse fibrosis burden of myocardial in heart failure patients. But they found focal fibrosis burden, not diffuse burden, is associated with a poor response to CRT. Other cardiac MR imaging parameters also showed potential predictors of CRT, such as 16 segment time-to-maximum radial wall thickness , scar locations and RV septal lead placement.In this study cardiovascular magnetic resonance imaging (including T1 Mapping combined with feature tracking imaging ) will be applied to follow up LV function in LBBB patients (with or without intervention) in 10 years to find out prognostic predictors and time point or CMR parameters for cardiac resynchronization therapy in patients with CLBBB.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older and able and willing to consent.
* The patient should present a complete left bundle branch block (LBBB) with QRS duration of \>120ms
* The patients should be in NYHA functional class I, II or III.

Exclusion Criteria:

* No informed consent
* Permanent atrial fibrillation, flutter or tachycardia (\>100 bpm).
* Right bundle branch block
* Recent myocardial infarction, within 40 days prior to enrolment.
* Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days.
* Implanted with a LV assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year.
* Severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated on within study period).
* Complex and uncorrected congenital heart disease.
* Claustrophobia or devices
A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379

This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers

Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 19 to 54 years
* BMI measurement result is 18.0 kg/m2 to 30 kg/m2
* Written informed consent
* Other inclusion criteria, as defined in the protocol

Exclusion Criteria:

* History of clinically significant liver, kidney, blood, digestive, respiratory, endocrine, cardiovascular, neurological, mental, or immune system disorders
* AST or ALT or total bilirubin \> 1.5 times the upper limit of normal range
* History of regular alcohol consumption \> 21 units/week within 6 months at the time of screening
* Participated in a clinical trial within 6 months prior to 1st IP dosing
* Other exclusive inclusion criteria, as defined in the protocol
COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2

The first case of a person infected with SARS-Cov-2 virus can be tracked back on November the 17th, 2019, in China. On March 11, 2020, the World Health Organization (WHO) declared COVID-19 outbreak a pandemic. On April 13, COVID-19 is affecting 210 countries and territories worldwide, about 2 million positive cases have been officially declared along with 115.000 deaths. The real number of infected and deaths is scarily higher, considering that up to 65% people are asymptomatic and thus, not tested.

The percentage of patients with COVID-19 needed for intensive care unit (ICU) varied from 5 to 32% in Wuhan, China. It was up to 9% in Lombardy, Italy. According to available data from Lombardy, 99% of patients admitted to the ICU needed respiratory support (88% invasive ventilation, 11% non invasive ventilation).

The aim of the present investigation is to test the hypothesis whether transcutaneous partial O2 and CO2 pressures may be reliable predictive factors for acute respiratory distress syndrome (ARDS) development in hospitalized clinically stable COVID-19 positive patients and to clarify the role of the Angiotensin Converting Enzyme 2 (ACE2) and its final product, angiotensin 2 (Ang II) in the pathogenesis of this systemic disease.

We also aim to test the hypothesis that plasma concentration of Clara Cell protein (CC16) and surfactant protein D (SPD), which are a biomarkers of acute lung injury, are severely decreased in COVID-19 positive patients and the plasma concentration is related to the severity of lung injury.


Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV2 infection (PCR positive and/or TDM Imaging)

Exclusion Criteria:

* None
Utilizing Free DNA in Embryo Culture for PGT

In the way for developing and optimizing protocol to be used as non- invasive methodology used as routine testing for PGS.

This protocol is to be adapted to replace the using of life embryo cells for genetic testing and aneuploidy study as well as for any type of genetic testing including single gene disorder or HLA typing or study.

Compare 100 embryos studied using NGS for chromosomal aneuploidies, and compare the results came from free media DNA with this results.

Eligibility Criteria:
Inclusion Criteria:

* all abnormal/aneuploidy embryos rejected for embryo transfer.

Exclusion Criteria:

* all embryos had unsuccessful diagnosis with blastomere biopsy.
Measuring Uniformed Servicemembers' Fitness Scores on Creatine Loading and Exercise

The purpose of this study is to compare the physical fitness performance-as measured by the Air Force Physical Fitness Test (PFT)-of subjects that, in conjunction with exercise, will take creatine supplementation over a four week period versus those that do not.

The purpose of this study is to compare the physical fitness performance-as measured by the Air Force Physical Fitness Test (PFT)-of subjects that, in conjunction with exercise, will take creatine supplementation over a four week period versus those that do not. Based on the literature, there is evidence to support that creatine supplementation may increase available levels of muscle phosphocreatine (PCr), an important energy reservoir that is initially expended with intense muscular contraction and then regenerated during episodes of rest. While mechanistically plausible, the effects of creatine on the specific measures of the PFT (push-ups, sit-ups, 1.5 mile run, and abdominal circumference) have not been evaluated. The target population is Active Duty Air Force (ADAF) service members who perform perform the PFT. As such, this represents a population with occupational requirements to maintain their fitness at a designated level. If short-term creatine supplementation does help to improve PFT scores, trainers, commanders, and unit physicians may wish to consider recommending its use. While generally considered safe, additional data will also be collected to evaluate both the qualitative and quantitative side-effects of creatine supplementation over the study period. If the hypothesis is correct and creatine supplementation is shown to be both effective and safe, additional studies may be warranted to evaluate its impact on ADAF service members who have failed the PFT and/or are at risk of being separated from the AF for unsatisfactory fitness performance. In short, this study has the potential to dramatically affect the recommendations and practices of ADAF service members related to use of creatine supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age ≥18
* Willing to exercise five days per week for four weeks, performing each component of the AF PFT at least once per week
* Willing to adhere to a prescribed supplementation regimen, including spaced dosing two times per day
* Able to meet all study follow-up and testing requirements as outlined in section 6.4 of this protocol

Exclusion Criteria:

* History of:
* Chronic kidney dysfunction
* Liver failure
* Rhabdomyolysis
* Compartment syndrome
* Current
* Pregnancy
* Musculoskeletal injury
* Fitness exemption from any component of the AF PFT (e.g. AF 469, "profile")
* Kidney injury
* Diabetes
* Hypertension, requiring medication
* Allergy to rice
* Admission to the hospital within the past 30 days
* Creatine supplementation within the past 90 days
R-Verapamil for the Prophylaxis of Episodic Cluster Headache

This is a double-blinded, randomized, parallel, placebo-controlled phase 2 study to evaluate the safety and efficacy of R-verapamil in the prophylaxis of episodic cluster headache.

Approximately 30 subjects (about 15 per treatment group),will be enrolled and randomized to receive either R-verapamil or placebo for 2 weeks. The study will consist of a 1-week run-in period and a 2-week treatment period (R-verapamil or placebo). The total duration of the study for each treatment group is 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy man or woman between the ages of 18 and 65
* In good health as determined by medical history and medical examination
* Has a diagnosis of episodic cluster headache as defined by the International Classification of Headache Disorders (2nd edition)
* Has a lifetime prevalence of at least 2 prior cluster bouts - Subjects must experience at least 7 attacks/week during the run-in baseline period
* Subjects must have a typical cluster period lasting at least 1 month. Subjects must be present in active cluster period and the expected remaining duration of the cluster cycle must be at least 3 weeks from Baseline Day 1 visit
* Able to differentiate other headache types from cluster headaches
* Is using or agrees to use a medically acceptable form of contraception(female of child-bearing potential)
* Negative urine pregnancy test prior to study entry(female of child-bearing potential)
* Concomitant medication that, in the opinion of the investigator and the patient's general practitioner(GP), do not pose an unacceptable risk based upon the prescribing information for verapamil
* Able to understand and comply with all study requirements
* Written informed consent

Exclusion Criteria:

* Women who are pregnant or lactating
* Subjects who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability
* Use of any drug or having any medical condition which might interact adversely with, or interfere with the action of, the study medication
* The concomitant use of beta blockers
* The consumption of grapefruit juice
* Allergic to or has shown hypersensitivity to verapamil or agents similar to verapamil
* Abuses opioids or has a history of significant drug or alcohol abuse within the past year as determined by investigator
* Has participated in an investigational drug trial in the 30 days prior to the screening visit
* Has liver or kidney disease
* Has a cardiopathology contraindicating verapamil administration
* Subjects with previous adynamic ileus.
* Subjects with chronic cluster headache
* Use of antipsychotic, antidepressants, lithium or other prophylactic treatment less than one month prior to inclusion
Evaluating Clinical Outcomes of Targeted Radiofrequency Ablation and Kyphoplasty (Also Known as Vertebral Augmentation) to Treat Painful Metastatic Vertebral Body Tumors

To evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor ablation (t-RFA) and kyphoplasty (also known as vertebral augmentation) in painful metastatic lesions in the spine.


Eligibility Criteria:
Inclusion Criteria:

* One to 2 painful vertebrae (T1-L5) with evidence of osteolytic metastatic lesion with known primary histology with pathologic fracture(s) at index vertebra by MRI
* Pain score ≥ 4 on the numerical rating pain scale
* Life expectancy of ≥ 6 months

Exclusion Criteria:

* Primary tumors of the bone at index vertebra
* Benign tumors of the bone at index vertebra
* Osteoblastic tumors at index vertebra
* Index vertebra with more than one (1) pedicle involved
* Epidural extension of tumor within 5 mm of the spinal cord or without sufficient room for thermal protective maneuvers
* Spinal cord compression or canal compromise requiring decompression
* Radiation therapy is planned to be started on the index vertebra within 4 weeks post procedure
* Radiation therapy was performed on the index vertebra within 2 months before enrollment
* Major surgery of the spine was performed within 3 months before enrollment
* Index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty
* Additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index vertebra
The Effect of Acupressure on Fatigue in Individuals With Chronic Fatigue Syndrome

Chronic fatigue syndrome is a common problem in society. The treatment of this problem is limited. Acupressure is a treatment method that has become widespread and promising in recent years. For this purpose, the effect of acupressure treatment on chronic fatigue syndrome was investigated.

This study aimed to determine the effectiveness of acupressure technique in individuals with chronic symptoms. In our study, individuals participating in the study will be randomized by the physiotherapist who has received the training of acupressure therapy. The study will be done for a total of 10 sessions for 4 weeks. Individuals' fatigue levels will be measured by Fatigue Severity Scale, their quality of life will be measured by Short Form-36 and depression levels by Beck Depression Inventory. Evaluations will be made at the beginning and at the end of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* 20-45 year old
* Not using any medical treatment,
* Not being included in any physiotherapy program in the last 3 months,
* Does not have any systemic disease,
* Spending at least 4 hours at the computer or desk during the work

Exclusion Criteria:

* Fibromyalgia
* Rheumatoid arthritis
* Open Wound
* Skin Failure
An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity

The purpose of this clinical study is to determine the effectiveness of the Erchonia® GVS in improving the appearance of skin laxity on the abdominal region.

This clinical study is a prospective open-label design with post-study independent blinded outcome analysis to evaluate the efficacy of the Erchonia® GVS Laser in improving the appearance of skin laxity on the abdominal region. Participants will receive 8 treatments over the course of 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subject has signed a written informed consent form.
* Male or female 22 to 70 years of age, inclusive.
* Desire to undergo treatment for skin laxity of the abdomen.
* Subject's score on the skin laxity scale for skin on the abdomen is 1 (mild) or 2 (moderate).
* Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in diet, exercise or medication routine during the course of the study.
* Subject agrees to refrain from taking any medication(s) or supplements(s), whether prescription or OTC, or undergo any procedures indicated for weight loss, or for fat reduction or improving the appearance of the skin in the abdominal area (e.g. liposuction, ultrasound therapy) for the duration of participation in the clinical study.
* Willing to have research photos taken of treatment areas.
* Understands, and is able and willing to comply with all study visits, treatments and evaluations schedules and requirements.
* Females are at least 9 months post-partum.
* Females are post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study and agree to continue to do so for the duration of study participation.

Exclusion Criteria:

* Skin laxity resulting from genetic disorders, including but not limited to Ehlers-Danlos Syndrome.
* History of undergoing a fat reduction procedure (e.g., liposuction, bariatric surgery, abdominoplasty).
* Botulinum toxin or other aesthetic drug injections within the abdomen area within the past 6 months.
* History of any major prior surgery in the abdominal area
* Implanted medical prostheses (such as clips, pins or plates) in or adjacent to the area of intended treatment.
* Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
* Any clinical and significant dermatological skin condition(s) in the intended abdominal treatment area, such as skin infections or rashes, extensive scarring, psoriasis, etc..
* Tattoo or former tattoo at the treatment area.
* Current moderate to heavy tobacco use, defined as smoking 10 or more cigarettes per day (or equivalent use of other nicotine-containing products such as cigars, pipes, chewing tobacco, or e-cigarettes) within the past 6 months
* History of chronic drug or alcohol abuse.
* Pregnant or intending to become pregnant in the next 6 months.
* Currently enrolled in a clinical study of an unapproved investigational drug or device.