cyrilzakka/clinical-trials huggingface dataset:
CLAD Phenotype Specific Risk Factors and Mechanisms

While many patients experience benefits from transplant, complications such as infections and lung rejection may affect long term survival and quality of life. In this study doctors are looking at a complication called Chronic Lung Allograft Dysfunction (CLAD). CLAD is thought to be chronic rejection of the lung by the immune system and is the leading cause of death after lung transplantation.

The purpose of this study is to help doctors determine:

* why some people get CLAD and others do not
* how patients who get CLAD do after CLAD is diagnosed
* how CLAD may affect quality of life

This is an observational, prospective, multicenter study of newly transplanted adult, first lung transplant recipients that will collect longitudinal clinical data, patient reported quality of life (QOL) data, and serial biological samples to determine the risk factors, pathophysiology, and manifestations of restrictive chronic lung allograft dysfunction (RCLAD) and bronchiolitis obliterans syndrome (BOS). Anticipated participant accrual is within three years of study start-up. The total study duration is four years. Participants will be followed a minimum of 1 and a maximum of 4 years.

Eligibility Criteria:
Inclusion Criteria:

Individuals who meet all of the following criteria are eligible for enrollment as study participants:

1. Subject must be able to understand and provide written informed consent and

   -Must be ≥18 years of age at the time of written informed consent.
2. Anticipated listing for lung transplantation OR within 45 days of having received a single or bilateral cadaveric donor lung transplant.

   - Enrollment must occur prior to the start of bronchoscopies eligible for research bronchoalveolar lavage (BAL) sampling.
3. Undergoing first lung transplant operation.
4. Transplant surgery to be performed or performed at enrolling center.

   * Note: Concurrent participation in immune monitoring studies or interventional device trials are permitted.

Exclusion Criteria:

Individuals who meet any of the following criteria are not eligible for enrollment as study participants:

1. Multi-organ recipient.
2. Prior recipients of any solid organ transplant, including prior lung transplant.
3. Prior or concurrent recipient of bone marrow transplant.
4. HIV infection.
5. Any condition which the investigators feel would make it unlikely for the recipient to complete follow up procedures or complete the study.
6. Participation in an investigational drug trial at the time of enrollment visit.
Kinesiophobia Scale for the Upper Extremity

Questionnaires/scales used to evaluate kinesiophobia in the literature are limited and are not specific to the upper extremity in existing scales. For this reason, the primary purpose and subject of the study is to develop a multi-factor kinesiophobia scale specific to shoulder problems.

The study is an observational research. Participants will be interviewed twice in total. All primary and secondary outcomes will be assessed at the first meeting. The second come will be performed within 5-7 days after the first assessment. In the second come, only the new kinesiophobia scale that is intended to be developed will be applied.


Eligibility Criteria:
Inclusion Criteria:

* Tampa Kinesiophobia Score \>37 points
* Presence of traumatological, orthopedic and rheumatological pathology in the upper extremity
* Mini-Mental State Examination score \>24 points

Exclusion Criteria:

* Malignancy,
* Psychiatric drug use,
* Use of painkillers during evaluation periods,
* Those who received physiotherapy before the study (last 6 months),
* Those whose education level is below secondary school level,
Silymarin's Advantage on Graft Effectiveness

The study examines the impact of silymarin supplementation during the early post-transplant period, administering 900 g daily for 30 days under standard treatment. Subsequently, the investigators investigate its impact on graft function, as measured by eGFR (CKD-EPI equation), UACR or UPCR, the development of dnDSA, rejection changes, and histological changes in the 3-month biopsy protocol. At the same time, investigators will investigate the effect of silymarin on metabolic complications-PTDM, DLP, disorders of calcium-phosphate metabolism, and arterial hypertension in the post-transplant period-in comparison with the placebo group. At the same time, investigators will investigate the safety and tolerance of silymarin.


Eligibility Criteria:
Inclusion Criteria:

* First or second kidney transplant recipient
* Deceased or living donor kidney transplant
* Patients receiving standard immunosuppression regimen:
* Tacrolimus or cyclosporine + Mycophenolate mofetil + Corticosteroids
* Body Mass Index (BMI) 18-35 kg/m²
* Willingness to provide informed consent
* Ability to understand and comply with study procedures
* Stable medical condition without significant comorbidities

Exclusion Criteria:

* Multi-organ transplant recipients
* Recipients of ABO-incompatible or highly sensitized transplants
* Active infectious complications at the time of transplantation: HIV, Active hepatitis B or C, Active cytomegalovirus (CMV) infection
* Patients with known liver disease: Cirrhosis, Active hepatitis, ALT or AST \> 2.5 times the upper limit of normal
* Significant cardiovascular disease: Recent myocardial infarction (within 6 months), Unstable angina, Severe heart failure (NYHA Class III or IV)
* Malignancy within the past 5 years (except successfully treated non-melanoma skin cancer)
* Current or recent (within 30 days) participation in another clinical trial
* Pregnancy or planned pregnancy during the study period
* Known allergy or hypersensitivity to silymarin or milk thistle
* Patients taking medications with significant interactions with silymarin:

Anticoagulants, Cytochrome P450 enzyme modulators

* Psychiatric conditions that may interfere with study compliance
* Uncontrolled diabetes mellitus (HbA1c \> 8.5%)
* History of non-compliance with medical treatment
* Patients with known genetic disorders affecting drug metabolism
Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal Rhinitis

This study will assess the safety and tolerability of multiple doses of VAK694 as well as change in symptoms and biomarkers in patients with seasonal allergic rhinitis


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between ages of 18 to 60 in good health
* History of atopy for at least 2 years and positive skin prick test to ragweed allergen

Exclusion criteria:

* History of asthma treated with corticosteroids
* Smokers with a smoking history of \> 10 pack/years or smoking in the past year
* History of chronic obstructive pulmonary disease

Other protocol-defined inclusion/exclusion criteria may apply
Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants

1. Population pharmacokinetics : The purpose of this study is

   - to investigate the population pharmacokinetics of theophylline in premature Korean infants and to assess the influence of demographic and clinical covariates.
2. Metabolomics : The purpose of this study are

   * to predict serum theophylline levels and to assess CYP1A2 activities in premature infants by analyzing urinary metabolites of theophylline
   * to examine which factors affect clearance of theophylline and CYP1A2 activity in premature infants


Eligibility Criteria:
Inclusion Criteria:

* Inborn preterm infants (GA \< 37 weeks)
* Dx : Apnea of prematurity
* Tx : Aminophylline / Theophylline
* Informed consent of parents

Exclusion Criteria:

* Major congenital anomaly
* Expired within 72 hours
* Proven secondary apnea
Is a Pre-contrast Scan Necesary to Diagnose Acute Aortic Syndrome?

Acute Aortic Syndrome (AAS) is a potentially life-threatening cause of sudden, severe chest pain. There are several possible underlying causes, which cannot be distinguished from one another at the bedside.

Current practice is to image this with two CT scans of the chest, one before injection of a contrast dye into the blood stream and then one after.

With the advancement of CT scanner technology, improvements in software interpretation and screen resolution, the investigators hypothesise that performing the contrast scan on its own is diagnostically equivalent to both the pre- and contrast scans

AAS include: a tear in the wall of the main artery from the heart, bleeding directly into this wall, an ulcer in the wall, and excess dilatation and rupture of the main artery wall. These are also treated differently according to where they are in the length of the aorta. It is therefore important to identify precisely the subtype of AAS and its location to allow the clinician to manage the patient appropriately.

Current practice is to image this with two CT scans of the chest, one before injection of a contrast dye into the blood stream and then one after. The one before the contrast is used to determine if there is bleeding within the wall, which would show up as white on this scan. It is currently accepted that the contrast in the artery itself would hide the presence of bleeding within the wall. The other causes are seen primarily on the contrast scan only. Every patient proceeds from the pre-contrast scan to the contrast scan, unless there is a contraindication to the intravenous dye.

The investigators own database search has shown that radiologists protocol the scans according to their own preference and experience (i.e. some do both scans, others the contrast scan only). There is conflicting advice from international professional bodies as to whether to perform the non-contrast scan every time.

Some studies have shown that although the pre-contrast scan is sensitive to picking up bleeding within the wall, it adds nothing more over an increased radiation dose to the patient.

The investigators hypothesise that performing the contrast scan on its own is diagnostically equivalent to both the pre- and contrast scans to look for all 4 of these entities that make up AAS. The investigators also propose that not requiring the pre-contrast scan would have significant savings in patient radiation dose, scanner time, network resources and radiologist time.

Eligibility Criteria:
Inclusion Criteria:

* male and female adult (age\>18) patients presenting with symptoms of AAS who had thoracic aortogram CTs.

Exclusion Criteria:

* age\<18
Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion

The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.

The hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be stopped.

Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of Traumatic Brain Injury (TBI), Subarachnoid Hemorrhage (SAH),Intracranial Hemorrhage (ICH), stroke
* Must require (be on) mechanical ventilation
* must require (have in place) intracranial pressure (ICP) monitoring
* must require (be receiving) continuous IV sedation

Exclusion Criteria:

* Bleeding diathesis
* Glasgow Coma Scale (GCS) \< 5 with fixed pupils
* Pregnant
* elevated ICP that requires deep sedation
* pulmonary instability
* Hx of Ethanol(ETOH) abuse that requires current benzodiazepine treatment for delirium - allergy to propofol or precedex
* status epilepticus
* current neuromuscular blockade
Genistein in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving genistein before surgery may be an effective treatment for pancreatic cancer.

PURPOSE: This randomized phase II trial is studying genistein to see how well it works in treating patients with pancreatic cancer that can be removed by surgery.

OBJECTIVES:

Primary

* To determine changes in microvessel density of the tumor specimen after 2 weeks of treatment with genistein in patients with resectable pancreatic adenocarcinoma.

Secondary

* To evaluate the safety and tolerability of genistein in these patients by looking at the impact of genistein on pancreatic cancer angiogenesis and on the angiogenic factors VEGF, CXCL1, CXCL5, and CXCL8.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive neoadjuvant oral genistein once daily for 2 weeks in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive no specific neoadjuvant therapy. In both arms, patients undergo surgical resection in week 3.

Blood, urine, and tissue samples are collected at baseline and at the time of surgery for laboratory biomarker studies. Samples are analyzed for VEGF, CXCL1, CXCL5, and CXCL8 by ELISA and for genistein by mass spectrometry.

Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18 capable of giving informed consent
* resectable pancreatic mass, known or presumed to be primary pancreatic adenocarcinoma. Patients whose initial biopsy do not show adenocarcinoma will not receive the study drug.
* ECOG preformance status 0-2.
* Negative pregnancy test prior to initiation of treatment and adequate contraception throughout treatment.

Exclusion criteria:

* comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocol
* hypersensitivity to genistein or to any of the excipients of genistein
* prior chemotherapy or radiotherapy for pancreatic adenocarcinoma
* concomitant use of warfarin, tamoxifen, or raloxifene.
* pregnancy or inadequate contraception.
* lactating females
COVID-19 Infection: Exploration of Respiratory Control Center Abnormalities

The purpose of the present study is to determine whether there is a decrease in the emotional response to experimental induction of dyspnea by hypoxic stimulation in subjects with a "neurological" form of COVID-19, compared to healthy controls.

SARS CoV-2 infection causes lung damage that can be severe enough to require artificial ventilation. Clinicians taking care of these patients are surprised by the scant respiratory sensations and emotional responses described by patients. This attenuation of respiratory interoception deprives clinicians of the usual warning signs during respiratory decompensation of dyspnea and its aggravation. It may be the result of central nerve damage. This hypothesis is bolstered by the observation that within the multiple clinical forms of COVID-19 infection there are some "neurological" forms (headache, anosmia, agueusia, dizziness, without respiratory signs and with little or no fever), that are most likely the consequence of olfactory penetration of the virus into the central nervous system (mechanism described for SARS CoV-1).

Eligibility Criteria:
Inclusion Criteria:

* - adult (≥ 18 years old, unprotected);
* for COVID-19 + patients: COVID-19 + diagnosis; with quantitative or qualitative anomalies in taste and smell; first symptoms appeared in less than 21 days
* for healthy subjects: have never presented any sign of COVID ; confirmed by recent negative serology
* understanding French;
* affiliated to social security;
* having a BMI between 20 and 30;
* preferably non-smokers and in the event of recruitment difficulties, smokers but with smoking \<5 packs - year
* signature of the informed consent form

Exclusion Criteria:

* respiratory signs or symptoms (rhinitis, cough, shortness of breath at rest);
* temperature above 37.5 ° C;
* existence of a chronic respiratory pathology (including asthma and COPD in the first row);
* pregnant women ;
* protected minors and adults, persons deprived of their liberty;
* not affiliated to a social security (including AME);
* contraindication to MRI (pace maker, intracranial implants, etc.).
Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy.

The main purpose of this study is to demonstrate that the growth of infants fed with the Test Formula is non-inferior those fed with the Control Formula. The study will also evaluate the gastrointestinal tolerance, quatliy of life and acceptability of the new rice protein-based formula in infants with cow's milk protein allergy (CMPA).


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\]), if applicable)
2. Infant gestational age ≥ 37 completed weeks
3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
4. Singleton birth
5. Infant age ≤ 8 months
6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
7. Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below:

   1. Inconsolable crying, regurgitation, liquid stools or constipation, skin atopic lesion, cow's milk provoked temporary urticaria/angioedema or vomiting, bloody streaks in stool, or respiratory symptoms
   2. For diagnosis based on either a positive IgE blood test, skin prick test or food challenge, only at least 1 symptom from above list needs to be present
8. Infant is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study
9. Infant's parent(s)/LAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol

Exclusion Criteria:

1. History of intolerance to eHF formula
2. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria)
3. Major gastrointestinal disease / abnormalities (other than CMPA)
4. Known or suspected lactose intolerance or malabsorption
5. Known or suspected soy allergy
6. Glucose-galactose malabsorption
7. Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome).
8. Immunodeficiency
9. Persistent wheeze or chronic respiratory disease
10. Severe uncontrolled eczema
11. History of severe anaphylactic reaction (e.g., requiring ≥ 2 doses of epinephrine) to cow's milk or breast milk at any time prior to enrollment
12. Weight-for-age value \< -2 or \> 2 standard deviations from the WHO Child Growth Standards median at enrollment
13. Height-for-age \< -2 or \> 2 standard deviations from the WHO Child Growth Standards median at enrollment
14. Infant's parent has other medical or psychiatric condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study
15. Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment
In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route

We hypothesize that infant and children will show different levels of acceptance of different interfaces while they receive inhaled therapy.

We also hypothesize that children will exhibit different amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery.

Aerosol medicine is widely used in treating pulmonary diseases in children. Delivering drugs via aerosol faces several challenges; some are related to the drug and the delivery methods and others to the patient behavior. The latter are crucial and can significantly affect the lung deposition of the drug. Infants are known to be obligate nose breathers making the transnasal route the natural approach for drug delivery in this age group. Different interfaces are already available in the market and are specifically designed to be used in children to improve the child acceptability of the interface and by the result to improve drug deposition. Due to limitations in the use of radiolabeled aerosols and pharmacokinetics/pharmacodynamics studies in infants and children, in-vitro models were developed. These models still lack biological variability which leads to overestimating lung deposition. So, real life correction factors are needed to improve current in-vitro modeling. Previous unpublished data from our laboratory showed that alignment of the aerosol stream with the nostrils is very important for pulmonary deposition.

Our objectives are to provide real life data of acceptance of different interfaces by infants and children and to provide a real life correction factor to improve current in-vitro modeling.

Eligibility Criteria:
Inclusion Criteria:

* Born at term
* Healthy
* Pacifier user
* Newborn 1-6 week old
* Infants 6-8 month old

Exclusion Criteria:

* Chronic respiratory disease
* Cardiac disease
* Prematurity
* Neurological disease
* Allergy to Normal Saline
* Allergy to any components of the interfaces
Dose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode Psychosis

The purpose of this study is determine the minimal effective dose and the impact on:

1. treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients experiencing the first psychotic episode
2. the final maintenance doses
3. the use of other medications
4. the amount of changes to other antipsychotic medication
5. the number of hospitalization days


Eligibility Criteria:
Inclusion Criteria:

* Patients experiencing their first psychotic episode
* Male or Female
* Aged 15-25

Exclusion Criteria:

* Previous treatment with antipsychotic medication (longer than 1 week)
* History of a clinically significant physical illness
* Organic disorder presenting with psychotic symptoms
How Much Virtual Reality Intervention Improve the Balance of Patients with Cerebral Palsy

The purpose of this clinical study is to investigate how effective virtual reality applications are in adult cerebral palsy rehabilitation.

The main questions it aims to answer are:

Do virtual reality interventions (of Becure Balance and Becure Wesense Systems) improve balance and is this improvement reflected in the clinic? Is there a change in brain functional resting state networks after virtual reality interventions?


Eligibility Criteria:
Inclusion Criteria:

Being diagnosed with unilateral spastic type cerebral palsy (hemiplegic type) / Being between the ages of 18-30 / Being able to walk independently (GMFCS I-II) / Not having Botox application in the last six months / Not using any medication that will affect the study process

Exclusion Criteria:

Having a history of epileptic attacks / Having \>2 spasticity in any joint according to the modified Ashworth scale / Having severe depression according to the Beck Depression Inventory /Having hearing-vision problems
Patient Journey in Hospital With Acute Heart Failure

A multicentre, prospective, observational, hospital-based registry of patients with acute heart failure (AHF) those whose care was guided by a cardiologist in Turkey.

The purpose of this study is to compose a national database of the etiologies, clinical and demographic characteristics, using diagnostic tests, precipitating and risk factors, management of from intensive care unit (ICU) or coronary care unit to hospital discharge, length of stay in the ICU and hospital, in-hospital mortality and discharge medications of hospitalized AHF patients in Turkish population.

The etiologies, precipitating factors, demographics, clinical characteristics, management and outcome of patients admitted in hospital with acute heart failure in Turkish population will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old
* Clinical diagnosis of acute heart failure
* Admitted to the participating hospitals

Exclusion Criteria:

* Patients \<18 years old
* Patients with acute heart failure who are discharged from the emergency room without admission.
* Failure to obtain informed consent