cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Valsartan in Healthy Volunteers

This study is to assess the effect of ASP1585 on pharmacokinetics of valsartan in 2x2 crossover method


Eligibility Criteria:
Inclusion Criteria:

* Body weight: =\<50.0kg, \<80.0kg
* Body mass index: =\<17.6, \<26.4
* Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data

Exclusion Criteria:

* Attending another clinical trial within 120 days before the study
* Blood donation within 90 days (400ml) or 30 days (200ml) before the study
* Receiving any drugs within 7 days before the study
* History of allergy to drugs
* Having GI disorders
* History or complication of liver diseases
* History or complication of heart disease
* History or complication of respiratory diseases
* History or complication of renal diseases
* History or complication of cerebrovascular diseases
Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.

The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.


Eligibility Criteria:
Inclusion criteria:

* Male or female patients, 40 years of age or older.
* Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in one second (FEV1)\< 60% of predicted normal and a post-bronchodilator FEV1/ forced vital capacity (FVC) \<70% at Visit 1
* Documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization.
* Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1.
* Current or ex-smokers with a smoking history of more than 10 pack years.

Exclusion criteria:

* Significant disease other than COPD.
* Clinically relevant abnormal baseline haematology, blood chemistry or creatinine \> x2 ULN will be excluded regardless of clinical condition. ( A repeat laboratory evaluation can be conducted if deemed necessary by the investigator.)
* Current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma
* A diagnosis of thyrotoxicosis
* A history of myocardial infarction within 6 months of screening visit.
* Life-threatening cardiac arrhythmia.
* Known active tuberculosis.
* Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed).
* A history of cystic fibrosis.
* Clinically relevant bronchiectasis.
* Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening
* A history of significant alcohol or drug abuse in the opinion of the investigator.
* Patients who have undergone thoracotomy with pulmonary resection
* Patients being treated with oral or patch ß-adrenergics.
* Patients being treated with oral corticosteroid medication at unstable doses
* Patients being treated with antibiotics for any reasons within 4 weeks of screening visit
* Patients being treated with PDE4 inhibitors within 3 months of screening visit
* Patients who have taken an investigational drug within one month or six half-lives
* Pregnant or nursing women.
* Women of childbearing potential not using a highly effective method of birth control.
Surgical Treatments of Tricuspid Valve Regurgitation After Cardiac Surgery

This study aims to present our center's experience in managing postoperative tricuspid valve regurgitation over the past 25years and to analyze the outcomes of these surgical treatments.


Eligibility Criteria:
Inclusion Criteria:patients who underwent surgical treatment from 1999 to 2023 for tricuspid valve disease following cardiac surgery

Exclusion Criteria: age \<16，severe tricuspid regurgitation secondary to primary pulmonary hypertension, and those with substantial missing case data.
Endoscopic Full-thickness REsection of Residual Colorectal Lesions - The FiRE Study

Adenomatous lesions of the colon are premalignant lesions which have the potential to develop cancer. Therefore adenomas should be resected endoscopically (endo- mucosa resection, EMR). EMR is conducted after submucosal injection of saline which allows to lift the desired lesion prior to resection. In some cases EMR is complicated due to incomplete or failed lifting after the injection of saline. This so- called "non- lifting" sign is a predictor for malignancy of the lesion. Difficult- to- lift polyps are also difficult- to- resect. A higher proportion of these lesions fail to be resected completely using the EMR technique.

Alternatively, an over- the- scope full- thickness resection device (FTRD) can be used in order to resect colonic lesions. The FTRD technique has been described elsewhere (Schmidt et al. Gastroenterology 2014; 147: 740-742.e2). No comparative data exists until now on the performance of FTRD resection compared to standard EMR resection of difficult- to- resect colon adenomas.

In this study the investigators aim to compare the success of FTRD versus EMR of difficult- to- resect adenomatous lesions (≤ 20 mm).


Eligibility Criteria:
Inclusion Criteria:

* patients ≥ 18 years
* adenomatous lesion 10-20 mm in size with expected difficulties regarding EMR (e.g. "non- lifting sign")

Exclusion Criteria:

* patients \< 18 years
* lesions \> 20 mm in size
* high risk carcinomas ("deep submucosal carcinoma")
* American Society of Anesthesiologists (ASA) class IV and higher
Evaluation of Efficacy, Safety and Molecular Mechanism of Pentoxifylline Supplementation in Patients With Hepatic and Obstructive Jaundice

Investigating the efficacy, safety, and molecular mechanism of Pentoxifylline supplementation in improving elevated direct bilirubin level and liver function tests in patients with hepatic and post-hepatic jaundice


Eligibility Criteria:
Inclusion Criteria:

* Patients age 18-70 years old.
* Patients diagnosed with jaundice and increased level direct bilirubin ≥ 3 mg/dL.

Exclusion Criteria:

* Pregnancy.

  * Nursing mothers.
  * Patients with increased indirect bilirubin level.
  * Patients who have Gilbert syndrome or Crigler Najjar syndrome.
  * Patients with Child Paugh C score (10-15 point).
  * History of intolerance and hypersensitivity to Pentoxifylline or to xanthine derivatives such as caffeine, theophylline.
  * Recent hemorrhage.
  * Patients who have risk factors potentially complicated by hemorrhage.
  * Taking anticoagulants or antiplatelet therapy.
Myopia Progression and the Effect of 7-Methylxanthine

7-methylxanthine has been shown to increase the concentration and thickness of collagen fibrils in rabbit sclera. Deficient collagen in the sclera may be the cause of progression of childhood myopia. The study hypothesis is that treatment with 7-methylxanthine will stabilize the sclera and prevent further progression of myopia.

Participants are given tablets of 7-methylxanthine 400 mg per day or placebo tablets for 12 months. Axial length, cycloplegic refraction and corneal curvature is measured, as well as weight, height, blood pressure and heart rate. The participants are interviewed about possible CNS, gastrointestinal, or cardiopulmonal side effects.

Eligibility Criteria:
Inclusion Criteria:

Children in the age 8-13 years with myopia and an axial growth rate of 0.15 mm or more per year.

-

Exclusion Criteria:

Severe general ailment (for example diabetes, epilepsy, psychiatric disease) Eye diseases (for example cataract, keratoconus, chronic iritis, glaucoma)

-
Single Dose Versus Multiple Doses of Dexamethasone in Children With Acute Bronchiolitis

This study is to determine the effectiveness of five-day treatment versus a single dose of oral dexamethasone (corticosteroid) in children between 2 and 24 months of age with a first episode of acute bronchiolitis presenting in the Emergency Department


Eligibility Criteria:
Inclusion Criteria:

* infants 2 to 24 months of age
* acute bronchiolitis, defined as first episode of wheezing with upper respiratory infection and respiratory distress
* moderate to severe baseline disease severity (Respiratory Distress Index (RDAI) score 6 to 15)
* only patients discharged at or shortly after 240 minutes of uniform stabilization therapy will be randomized

Exclusion Criteria:

* previous wheezing and/or bronchodilator therapy
* hospitalization at 240 minutes
* critically ill patients needing airway stabilization
* patients with low or very high baseline disease severity (RDAI \<5 and \>16)
* patients under 8 weeks of age
* patients on corticosteroids prior to arrival at Emergency Department
* contact with varicella within 21 days
* past history of ventilation for greater than 24 hours
* existing cardiopulmonary disease, multisystem disease or immunodeficiency
* insufficient command of the English language
Synthetic Mesh Materials In Sling Surgery

The purpose of this study is to determine the clinical results contributions to surgical success,and complications of mixed type of mesh materials as well as prolen mesh materials in sling surgery in a 3 year follow-up the first time in literature.

Broad based double forced sling operations were performed in 144 patients by using 3 different types of mesh materials between 2004 and 2007. Group I consisted of 48 patients in whom Vypromesh® (Ethicon,USA) was used; Group II consisted of 48 patients in whom Ultrapromesh®( Ethicon,USA) and Group III consisted of 48 patients in whom Prolene light mesh® (Johnson\&Johnson,USA) was used. The data of the patients and the success of the operation were evaluated based on 24hr pad test, ICIQ-SF scoring, and Korman questionnaire analysis.

Main outcome measures:The Ultrapromesh® synthetic sling procedures have lower complications incidence and higher success rates than the other synthetic slings in 3-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Stress urinary incontinence
* Mix urinary incontinence
* Previous failed anti-incontinence surgery
* Previous gynecologic surgery

Exclusion Criteria:

* Urodynamical detrusor overactivity or impaired bladder activity
* Prolaps of pelvic organ
* Urge incontinence
* Neurogenic bladder
* Bladder outlet obstruction
* Urinary fistula, Pregnancy
* Active urinary or vaginal enfection
* Contraindication to anesthesia
* \> 100ml PVR urine volume
fMRI of Theory of Mind in Schizophrenia and Bipolar Disorder

Theory of mind (TOM), a main component of social cognition processes, refers to the capacity to infer one's own and other person's mental states. Deficits in social cognition are found in patients with schizophrenia and bipolar disorder. The purpose of this study is to compare the neurofunctional profiles of schizophrenic patients, bipolar patients and healthy participants during the performance of a TOM task. Results may help to understand the neural bases of the impairments in social cognition in schizophrenia and bipolar disorder, which may in turn help to propose potential new psychosocial therapeutic approaches in these disorders.

Theory of mind (TOM) refer to the cognitive ability to attribute mental states to others, which plays an essential role in social communications and interactions between individuals. In several recent papers, it was shown that TOM is impaired in schizophrenia and bipolar disorder. This impairment strongly affects the quality of life in patients suffering from these disorders. The investigators study aims to explore the neural correlates of TOM in schizophrenic and bipolar patients, in comparison with those of healthy participants. These studies will be conducted on 30 schizophrenic patients, 30 bipolar patients, and 60 healthy participants, matched on age and educational level to each patient group. The investigators expect that the study of combined behavioral (neuropsychological tests) and neuro-anatomical data will allow to understand the pathophysiology of the alteration of social cognition processes in these illnesses.

Eligibility Criteria:
Inclusion Criteria:

Patients :

* Men or women aged from 18 to 65 years-old, right-handed, with a diagnosis of bipolar -disorder or schizophrenia, according to the DSM-5 criteria
* Native French speaker
* No substantial change in treatment for 2 weeks preceding study enrollment
* Able to provide informed written and verbal consent

Healthy Controls :

* Men or women aged from 18 to 65 years-old, right-handed
* Native French speaker
* Able to provide informed written and verbal consent

Exclusion Criteria:

Patients :

* A recent alcohol and/or drug abuse or dependence (in the last six months)
* A significant general medical illness, including neurological disorders or head trauma
* A sensorial impairment uncorrected (visual and/or hearing)
* Contraindication to the use of MRI
* Persons under legal incapacity
* Persons who are not covered by national health insurance

Healthy Controls :

* Severe chronic psychiatric disorders including Bipolar disorder and schizophrenia
* Depression diagnostic according to DSM-5
* A personal or first-degree-relative history of bipolar disorder, schizophrenia or schizoaffective disorder according to DSM-5
* A recent alcohol and/or drug abuse or dependence (in the last six months)
* A significant general medical illness, including neurological disorders or head trauma
* A sensorial impairment uncorrected (visual and/or hearing)
* Contraindication to the use of MRI
* People particularly protected by the law
* Persons who are not covered by national health insurance
Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia

To determine whether a reduced volume hydration regimen will lead to a shorter time to methotrexate clearance when compared to a standard intravenous (IV) hydration regimen.

This study uses a prospective randomized controlled crossover study design. Neither patients nor clinicians are blinded to the standard versus reduced intravenous fluids (IVF) regimen. Patients are randomized to begin with standard volume or reduced volume IVF. Over the course of 4 cycles of High Dose Methotrexate (HDMTX), patients alternate between standard and reduced volume post hydration fluids protocols.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of lymphoma or acute lymphoblastic leukemia
* Candidate for a minimum of 2 cycles HDMTX (5 g/m2) in the inpatient setting
* Creatinine clearance ≥ 65 mL/min by modified Schwartz equation
* Patients of childbearing potential must have a negative pregnancy test (serum or urine)
* Lactating female patients must agree not to nurse a child while on this trial
* All patients and/or their parents or legal guardians must provide written informed consent, with assent provided if applicable

Exclusion Criteria:

* Trisomy 21
* History of dialysis within 30 days prior to study registration or currently on dialysis
* Polyuric renal dysfunction
* Pregnancy
* Known or suspected pleural effusion
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
VESTIBULAR EVOKED MYOGENIC POTENTIALS IN ALTERED GRAVITY

Recently, new clinical testing of saccular and utricular function have been developed and validated, the so-called vestibular-evoked myogenic potentials - VEMP (Brantberg et al. 2009, Cornell et al. 2009, Curthoys 2010, Manzari et al. 2012). Among them, the cervical VEMP (cVEMP) are short-latency electromyographic (EMG) modulations of the contracted sternocleidomastoid muscles in responses to vibration applied on the forehead. The clinical literature suggests that cVEMP are almost entirely saccular in origin (Halmagyi et al 1995).

The aim of our research is to evaluate changes in the otolith function in microgravity and hypergravity using this clinical test. Cervical vestibular-evoked myogenic potentials (cVEMP) will be recorded by surface EMG electrodes in response to bone conducted vibration to specifically assess saccular function (Halmagyi et al 1995). The primary measures will include muscle activity response amplitudes and the stimulus intensity threshold at which the cVEMP is detected.

Given that there is an off-loading of the saccules in microgravity and an increased loading in hypergravity, we hypothesize that there will be a reduction in cVEMP amplitude in microgravity and an increase in cVEMP amplitude in hypregravity compared to normal gravity. These changes in amplitude will be accompanied by changes in the threshold of the stimulus level required to elicit a cVEMP.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 18 to 67
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* With normal cVEMP
* Who have passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Exclusion Criteria:

* Persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Pregnant women (urine pregnancy test for women of childbearing potential)
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease

The goal of this interventional investigation is to compare BUFY01 with SVS20 in the treatment of patients with dry eye disease. The main questions it aims to answer are:

* Is BUFY01 non-inferior to SVS20 in terms of signs of DED?
* Is BUFY01 non-inferior to SVS20 in terms of symptoms of DED?

Participants will be asked to:

* Visit the trial site at 4 different timepoints
* Use the allocated study treatment everyday until the end of the study (during 3 months)
* Be examined by the investigator
* Complete several questionnaires
* Return unused study treatment.

Researchers will compare BUFY01 to SVS20 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.


Eligibility Criteria:
Inclusion Criteria includes:

* At least a 3-month documented history of bilateral dry eye syndrome needing artificial tears;
* At least one eye with Oxford score ≥ 4 and ≤ 9;
* At least one objective sign of tear deficiency (in at least one eligible eye);
* Having a health insurance.

Exclusion Criteria includes:

* Wear of contact lenses starting within the last 2 months;
* Best-corrected visual acuity (BCVA) \< 1/10;
* Severe DED with one of the listed conditions:
* Severe blepharitis;
* Seasonal allergy;
* Any issues of the ocular surface not related to DED;
* History of ocular trauma, infection or inflammation not related to DED;
* History of ocular surgery, including laser surgery;
* Unstable glaucoma;
* Use of artificial tears with preservative within the last 2 weeks;
* Systemic (enteral or parenteral) or local (topical) use of one of the listed medications:
* Known hypersensitivity to any constituent of the study treatments;
* Pregnancy or breastfeeding;
* Participation in another clinical study within the last 90 days;
* Legally restricted autonomy, freedom of decision and action.
A Randomized Comparison Study of Aquacel Ag and Glucan II as Donor Site Dressings

The research will be looking at patient outcomes for healing of donor sites after a split-thickness skin graft procedure for a burn or skin tissue loss. Donor site healing time, infection rate, cosmetic outcome, and patient's rating of pain will be compared between two donor site dressings, Glucan II and Aquacel Ag.


Eligibility Criteria:
Inclusion Criteria:

* Adults over age 18 who have sustained a 1 - 30% total body surface area burn or skin tissue loss and require skin grafting

Exclusion Criteria:

* Individuals under the age of 18.
Elidel-Study: Elidel in Patients With Atopic Dermatitis

Atopic dermatitis is a common disease. Emollients and Elidel have both shown to be effective to treat this disease. The research question is, whether the effective component (Elidel) is better than the emollient to improve the skin function.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Atopic dermatitis on both lower arms at least 1% body surface area.
* Atopic Dermatitis Severity Index (ADSI)-Score \>= 6
* Investigator Global Assessment (IGA)-Score \>= 2

Exclusion Criteria:

* Systemic therapy with immunosuppressive drugs within the past 24 weeks
* Phototherapy against atopic dermatitis.
* Antibiotic therapy against atopic dermatitis.
* Allergy against Elidel.
* Pregnancy
* Nursing
* Skin cancer
Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme

RATIONALE: Bispecific antibodies plus white blood cells may be able to locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of combining bispecific antibodies with white blood cells in treating patients who have recurrent or refractory glioblastoma multiforme.

OBJECTIVES:

* Assess the safety and tolerability of bispecific antibody MDX447 and activated monocytes in patients with recurrent or refractory glioblastoma multiforme.
* Determine the response, time to tumor progression, and overall survival of these patients treated with this regimen.

OUTLINE: This is a dose escalation study.

Patients undergo maximal surgical debulking of the tumor at the time of reservoir placement. Within 2-4 weeks after surgery, patients receive one treatment of intratumoral bispecific antibody MDX447 and activated monocytes. Stable or responding patients may receive a second treatment 1 month later.

Cohorts of 1 or 3 patients receive escalating doses of bispecific antibody MDX447 and activated monocytes until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities.

PROJECTED ACCRUAL: A total of 13 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven glioblastoma multiforme with evidence of epidermal growth factor receptor (EGFR) expression on tumor cell surfaces

  * No astrocytoma, anaplastic astrocytoma, or oligodendroglioma
  * No infratentorial or multifocal tumor
* Recurrence or progression following at least one prior therapy

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* Greater than 2 months

Hematopoietic:

* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin greater than 10 g/dL

Hepatic:

* Bilirubin no greater than 2.0 mg/dL
* ALT, AST, and alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)

Renal:

* Creatinine no greater than 2.0 times ULN

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other medical or psychiatric illness that would preclude study
* No other concurrent malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)

Endocrine therapy:

* Concurrent steroid therapy allowed

Radiotherapy:

* At least 4 weeks since prior radiotherapy

Surgery:

* Not specified