cyrilzakka/clinical-trials huggingface dataset:
Olmesartan Medoxomil and Diabetic Nephropathy

Evaluation of several olmesartan dosages compared to losartan on proteinuria, renal function and inflammatory markers in patients with diabetic nephropathy


Eligibility Criteria:
Inclusion Criteria:

* Male or female European out-patients
* Greater than or equal to 30 years of age
* Type 2 diabetes first diagnosed at greater than or equal to 30 years of age
* Urinary protein excretion between 200-4000 mg/day exclusive
* Mean sitting dBP less than or equal to 110 mgHg
* Medically justifiable to withdraw antihypertensive treatment due to poor tolerability or inefficacy of previous treatment, or verification that treatment is still necessary

Exclusion Criteria:

* Females pregnant, nursing or planning to become pregnant or were of childbearing potential and not using acceptable methods of contraception
* Secondary forms of hypertension other than diabetic nephropathy, malignant hypertension or patients with sitting dBP exceeding 110 mmHg or sitting sBP exceeding 200 mmHg
* ECG evidence of 2nd or 3rd degree AV-block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia
* Presence of significant cardiovascular disease
* Significant cerebrovascular disease, gastrointestinal, haematological or hepatic disease or myocardial infarction in last 12 months or a previous history of any serious underlying disease
* Concurrent renal disease, nephrectomy and/or renal transplant, serum creatinine level greater than or equal to 2.0 mg/dL or creatinine clearance CLCR less than or equal to 50 mL/min
* Clinically significant lab abnormalities (ASAT/SGOT, ALAT/SGPT and γ-GT )
* Serum potassium level \< 2.5 mmol/L or \> 5.5 mmol/L
* Treatment of concurrent indications with drugs or medication which could have influenced BP
* History of hypersensitivity, lack of response or contraindication to Ang II-antagonists, HCTZ or atenolol, or hypersensitivity to related drugs (cross-allergy)
Validation of a Semi-automatized Method to Detect Cyclic Hyperinflation on CT-scan in ARDS

This study aims to validate a semi-automatized method to quantify cyclic hyperinflation on CT-scan of ARDS patients.

The gold standard will be cyclic hyperinflation assessed on the same CT scan, using manual segmentation of the lung.


Eligibility Criteria:
Inclusion Criteria:

* ARDS patients defined by the Berlin definition
* invasive mechanical ventilation with an arterial oxygen pressure (PaO2)/inspired fraction of oxygen (FiO2) ratio ≤ 200 mm Hg
* Indication of CT scan identified by the clinician in charge
* oesophageal catheter already inserted

Exclusion Criteria:

* requirement of contrast agent for a chest CT-scan
* ARDS criteria present for more than 72 hours
* Chronic Obstructive Pulmonary Disease (COPD) on a previous lung function test
* pneumothorax or bronchopleural fistula
* patient without both sedation and neuromuscular blocking agents
* contra-indication to transport to the imaging facility
* treatment with extracorporeal membrane oxygenation or extracorporeal carbon dioxide (CO2) removal
* Latex or curare allergy
* patient previously included in the study
* pregnancy
* patient under limitation of care
* patient under an exclusion period following inclusion in another clinical trial
* patient under a legal protective measure
* patient unaffiliated with social security
* inform consent not obtained by next of kin
Dose-escalation by Hypofractionated Stereotactic Radiotherapy for Brain Metastases in Non Small Cell Lung Cancer

The objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.

The objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.

Eligibility Criteria:
Inclusion Criteria:

* Histology confirmed that it was non-small cell lung cancer
* 1 to 10 brain metastases detected by magnetic resonance imaging (MRI)
* A life expectancy of \>3 months according to the DS GPA.
* KPS ≥70
* Control of the primary lesions (thorax) at the time of SBRT
* 2cm\<Tumor size ≤ 4 cm
* Age of 18-75 years old
* Patients must be able to undergo contrast enhanced MRI for planning
* Adequate bone marrow and organ function

Exclusion Criteria:

* other malignant tumors
* Prior surgery to brain metastasis
* Prior brain radiotherapy
* Non-small cell lung cancer with more than 10 brain metastases detected by MRI
* Contraindication to receiving radiotherapy.
68Ga-NOTA-RM26 PET/CT in Breast Tumor Patients

This is an open-label positron emission tomography/computed tomography(PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in breast tumor patients. 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26A will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including breast cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human breast cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to assess its clinical diagnostic value in patients with breast tumor.

Eligibility Criteria:
Inclusion Criteria:

* patients in suspicion of breast cancer by mammography or ultrasonography,and being able to provide basic information and sign the written informed consent form

Exclusion Criteria:

* The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with GRPR binding
PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study

P-CCROSS is a randomized, prospective monocentric phase 4 study with a crossover study design. The aim of the study is to compare patient satisfaction (by means of questionnaires) and treatment compliance with IVF treatment with CFA (corifollitropin alfa) and PPOS (Progestin-Primed Ovarian Stimulation) versus conventional IVF treatment with a recombinant FSH/GnRH antagonist. The study will also compare patients undergoing elective fertility preservation versus PGT-A (pre-implantation genetic testing for aneuploidy) patients.The study will have a crossover design so that patients will receive both forms of treatment. The investigators will also compare the endocrine profile and ovarian response of CFA/PPOS versus rFSH/GnRH ovarian stimulation cycles.


Eligibility Criteria:
Inclusion Criteria:

* first ovarian stimulation cycle
* aged ≥ 18 and \< 41 years old at the time of first OPU
* Body Mass Index (BMI) ≥ 18 kg/m² and \< 32 kg/m²

Exclusion Criteria:

* contra-indication for ovarian stimulation
* expected poor ovarian response (Bologna Criteria)
* PCOS patients
* refusal to fill out questionnaires before, during and after treatment
* simultaneous participation in another clinical study
* untreated and uncontrolled thyroid dysfunction;
* current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy;
* pregnant or breastfeeding women. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
Xarelto Regulatory Post-Marketing Surveillance

This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip replacement (THR) or total knee replacement (TKR) in the real-life conditions in its registered indication(s) as required by Korean Food and Drug Administration (KFDA).

1. Known and unknown adverse reactions, especially serious adverse reactions
2. Incidence of adverse reactions under the routine drug use
3. Factors that may affect the safety of the drug
4. Factors that may affect the effectiveness of the drug
5. Other safety information related to overuse, drug interaction and laboratory abnormalities
6. Other adverse reactions


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients \>/= 18 years of age who will undergo elective total hip replacement or total knee replacement and receive Xarelto or other pharmacologic standard of care Venous Thromboembolism (VTE) prophylaxis, and who consent to participate in the study

Exclusion Criteria:

* Patients with hypersensitivity to any pharmacologic VTE prophylaxis treatment
* Patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)
* Patients with significant hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
* Pregnant or lactating women
* Patients with hereditary problems of lactose or galactose intolerance (e.g., the Lapp lactase deficiency or glucose-galactose malabsorption)
Chemoablation or Bladder Resection with Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer

The investigartors will conduct a randomized, multinational study with the aim to assess if the efficacy of a dose dense chemoablation with Mitomycin C (MMC) with adjuvant BCG in non-responding patients is superior regarding long term effect compared to standard treatment with trans urethral resection of bladder tumors (TURBT) and adjuvant intravesical instillation therapy in patients with recurrent Ta LG tumors.

The study is a natural follow-up study following the pivotal NICSA trial supported by the Danish Cancer Society that has lead to the initial change in the European guidelines. In order to not only be comparable to current standard, but also to improve clinical outcome and furthermore confirm the previous findings, the investigators here suggest to implement at patient tailored approach through a new multicenter RCT.

The investigators hypothesize that chemoablation with MMC in patients with recurrent Ta LG tumors will result in a permanent low recurrence rate in patients with complete response, whereas patients without complete response can be selected for adjuvant BCG which theoretically is more efficient in this select patient group. This will potentially result in a more favorable long term recurrence free survival (RFS) rate compared to the current standard regimen where all patients are treated with TURBT and adjuvant instillation therapy.

The incidence of bladder cancer in Denmark is almost 2,000 per year. Of these, 75% have non-muscle invasive bladder cancer (NMIBC). The yearly recurrence rate of NMIBC is approximately 35% and the disease is therefore one of the most costly cancers to manage on a per patient basis, due to the cost of operative procedures, follow-up cystoscopies and instillation therapies


Eligibility Criteria:
Inclusion Criteria:

* Tumour recurrence after previous urothelial tumour of Ta low-grade
* Tumours smaller than 2 cm in diameter
* Negative urine cytology (optional)
* ≥18 years of age
* Ability to understand and comprehend the provided written and oral information
* Has provided written consent

Exclusion Criteria:

* Known history of invasive tumour of the bladder (T1+)
* Known history of CIS of the bladder
* Previous MMC or BCG-treatment except for single instillations following previous TURBTs
* Known allergy or intolerance to MMC
* Solid tumour with suspicions of invasion
* Tumour in the bladder neck or urethra
* Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious flat lesions seen at cystoscopy)
* Small bladder volume (less than 100 ml) or incontinence
* Prior radiation therapy to the pelvic area, as radiation affects the bladder function and instillation therapy is a suboptimal treatment for this patient group
* Acute cystitis
* Pregnancy or breast-feeding
* Averse to using secure contraception with regard to men with partners and premenopausal women
Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient

The aim of this study is to demonstrate a significant reduction of at least 25% in opioid consumption at 48 hours of management of severe trauma, while demonstrating non-inferiority in terms of analgesia, in a group of patients receiving a continuous infusion of low dose ketamine compared to a placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adult
* Trauma patient presenting at least 2 lesions in two different regions as defined by the ISS (injury severity score) (Head or neck, Face, Thorax, Abdomen and pelvic contents, Upper limbs or pelvic girdle, Lower limbs, External (any skin surface).
* Patient presenting at least two regional disorders classified as moderate to maximum defined by an AIS (Abbreviated Injury Scale)\> 1.
* Patient having signed an informed consent

Exclusion Criteria:

* Patients with an indication for deep sedation (intracranial hypertension or acute respiratory distress syndrome).
* Patient in whom the infusion could not be started within the first 6 hours of initial treatment.
* Patient whose state of consciousness is incompatible with understanding the protocol.
* Patient with chronic unbalanced arterial hypertension.
* Patient with severe heart failure.
* Patient with a BMI\> 35 kg / m² or a weight of more than 120 kg.
* Patient with chronic analgesic consumption defined by consumption of opioid derivatives for more than a week for an intercurrent illness.
* Presence of a history of chronic pain.
* Presence of a history of epilepsy.
* Presence of a history of psychosis or drug addiction.
* Presence of a history of stroke.
* Patients with an allergy to the molecule or excipients composing ketamine
* Patients with an allergy to the molecule or to the excipients making up sufentanil or paracetamol.
* Pregnant or breastfeeding woman.
* Patient not understanding French.
* Protected adult patient (under guardianship, curatorship or legal protection).
Evaluation of a Free-breathing Cardiac Cine-MRI Sequence With Image Reconstructions by Deep-Learning in Ischemic Heart Disease

Today, MRI is the gold standard for the precise assessment of left ventricular volume and function, but presents the drawback of having a long acquisition time and of generating motion artifacts, in particular respiratory artifacts, requiring repeated sequences in apnea to cover the whole cardiac volume. These apneas are difficult to achieve in patients with ischemic heart disease and may lead to degradation of the images, an increase in the duration of the examination by repeated acquisitions and therefore to diagnostic inaccuracies.

Artificial intelligence, already used in practice in cardiac MRI for automatic segmentation of the heart chambers, improves radiological interpretation with rapid and precise measurements. Deep-learning, which is part of artificial intelligence, would allow the reconstruction of cine-MRI sequences in free breathing, in order to overcome the artifacts from respiratory motions, and the improvement of diagnostic performance while improving examination conditions for patients.

Patients coming for a cardiac MRI for the assessment of ischemic heart disease will be eligible to the protocol. If the patient agrees to participate, a free-breathing cardiac cine-MRI sequence with Deep Learning based image reconstruction will be added to the usual protocol.

No follow-up will be required in this study.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years old
* Ischemic heart disease
* Ability of the subject to understand and express his consent
* Affiliation to the social security scheme

Exclusion Criteria:

* Major obesity (\> 140kg) not allowing the patient to enter the tunnel of the machine whose diameter is less than 70cm
* Under 18 years old
* Pregnant woman
* Known allergy to gadolinium chelates
* Claustrophobia
* Any contraindication to MRI
* Arrhythmia
* Difficulty in holding apneas of more than 10 seconds
IRIS Ultimaster Cohort in the IRIS-DES Registry

The purpose of this study is to evaluate the relative effectiveness and safety of Ultimaster stent compared to other drug eluting stents.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 and more
* Intervention with Ultimaster stent
* Agreed with written informed consent form

Exclusion Criteria:

* Intervention with Ultimaster stent and other drug eluting stent at the same time
* Life expectancy of 1year and under
* Cardiac shock
Clearance and Pharmacokinetics of Antibiotics in Renal Replacement Therapy

This is an observational study that evaluates the dialysis clearance and pharmacokinetics of antibiotics with different protein-bound levels in patients receiving renal replacement therapy. Meropenem, vancomycin and ceftriaxone are selected to represent three typical protein-bound levels, and the primary dialysis methods being studied are intermittent hemodialysis(IHD) and hemodiafiltration(HDF). During and after the dialysis, the drug levels in both plasma and spent dialysate are monitored, but no changes are made to therapy. The study will provide detailed information on the characteristics of the removal kinetics of the three antibiotics during dialysis, and evaluate whether the dosing regimens are the most appropriate to achieve therapeutic targets while minimizing the risk of toxicity.

This prospective, single-center observational study is taken to evaluate the dialysis clearance and pharmacokinetics of antibiotics with three different protein-bound levels in patients receiving renal replacement therapy. As is known that the plasma protein binding rate affects the distribution, metabolism and elimination of the drug in the body, and is also an important factor affecting the removal during dialysis, the study selects meropenem, vancomycin and ceftriaxone, of which the protein-bound levels are respectively 2%, 55% and 85%, to represent three typical protein-bound levels. The primary dialysis methods being studied are intermittent hemodialysis(IHD) and hemodiafiltration(HDF). The dialysis pattern, the antibiotic choice and its dosage for each subject are made on clinical grounds. A total of 16 milliliters of blood and 60 milliliters of spent dialysate are collected from each subject for each dialysis pattern. The study will provide detailed information on the characteristics of the removal kinetics of the three antibiotics during dialysis, and evaluate whether the dosing regimens are the most appropriate to achieve therapeutic targets while minimizing the risk of toxicity.

Eligibility Criteria:
Inclusion Criteria:

* With Age from 18 to 85 years old.
* With weight from 50 to 75 kilograms.
* Requiring dialysis including intermittent hemodialysis(IHD) or hemodiafiltration(HDF).
* Receiving meropenem, vancomycin or ceftriaxone based on clinical grounds.

Exclusion Criteria:

* Patient is during pregnant or lactation period.
* Patient is allergic to meropenem, vancomycin or ceftriaxone.
* Severe hypoproteinemia (serum total protein\<=45g/L) or severe hypoalbuminemia（serum albumin\<20g/L).
* Severe liver dysfunction（ALT\>200U/L or AST\>200U/L).
* The patient himself or his immediate family refuses to sign the informed consent.
Forced Oscillations Technique During a Metacholine Test in Children

Asthma is the most common chronic lung disease in children. It affects more than 1 in 10 children in France. The methacholine bronchial challenge test (MBT) is indicated to assess the probability of asthma suggested by clinical symptoms by measuring the forced expiratory volume in one second (FEV1), after inhalation of a cumulative dose of methacholine. In children, the measurement of FEV1 requires a high level of cooperation from the child, which can be the source of false negatives or no result if this is not obtained. The objective of this study is to evaluate if the measurement of the respiratory function by the forced oscillations technique, allows to predict the variation of the FEV1 obtained


Eligibility Criteria:
Inclusion Criteria:

* Age between 6 and 16 years
* FEV1 \> 60%
* Child referred to the pulmonary function test laboratory for a non-specific bronchial hyperactivity test with methacholine
* Child under treatment with inhaled corticosteroids stopped for at least 3 weeks
* Oral consent from the child and at least one of the legal representatives
* Child affiliated or benefiting from a social security plan

Exclusion Criteria:

* Use of a short-acting beta-adrenergic bronchodilator within the last 6 hours or anticholinergic bronchodilator within the last 12 hours
* Use of a long-acting beta-adrenergic bronchodilator (licensed for use in children) in the past 36 hours
* Upper or lower respiratory tract infections within 3 weeks prior to inclusion
* Epilepsy under treatment
* Subject's participation in another interventional study that may alter respiratory function
* Patient unable to give consent, vulnerable