cyrilzakka/clinical-trials huggingface dataset:
Role of ALiskiren, a Direct Renin Inhibitor, in Preventing Atrial Fibrillation in Patients With a Pacemaker; RALF.

The aim of the study is to find out whether aliskiren reduces atrial fibrillation burden measured with a pacemaker device

The aim of the study is to find out the effect of a direct renin inhibitor, aliskiren, in reduction of AF with patients who have a pacemaker due to sinus node disease and paroxysmal atrial fibrillation.

Hypothesis is that there is a possibility to reduce atrial remodeling due to AF and also to enhance atrial reverse remodeling with aliskiren. The effect of aliskiren to total AF burden will be evaluated from the pacemaker's memory storage.

The main purpose of the study is to find new and safe drug treatments targeting to reduce AF recurrences and related complications in pacemaker patients. Also the aim is to evaluate the feasibility of a modern and highly sophisticated pacemaker system in the evaluation of drug treatment with AF reduction.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 85 years
* sinus node disease and paroxysmal AF
* provided signed informed consent according to the Declaration of Helsinki for study participation
* a previously implanted St. Jude Medical Identity / Victory / Zephyr ADX or any newer model of SJM DDDR pacemaker with ability to record high atrial rates

Exclusion Criteria:

* contraindication for the use of aliskiren
* severe impairment of renal function (serum creatinine \> 160 µmol/L) or patient with solitary kidney or renal transplant or renal artery stenosis
* significant known aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy
* hypersensitivity to aliskiren or to any of the excipients
* concomitant treatment with cyclosporine
* patients with uncontrolled hypertension requiring treatment for hypertension
* systolic blood pressure measured in two separate occasions ≥ 160 mmHg
* diastolic blood pressure in two separate occasions ≥ 100 mmHg
* absolute indication for the use of an RAAS blocker
* chronic, persisting AF (persisting AF at screening with ≥ 4 cardioversions performed beforehand)
* sitting systolic arterial blood pressure of less than 100 mm Hg at the time of randomisation
* need for ventricular pacing more than 30% at the enrolment
* pregnancy and/or lactation
* women of childbearing potential (only postmenopausal women or women after tubal ligation will be allowed)
* other serious disease expected to cause substantial deterioration of patient's health during the next two years
* past or present alcohol or drug abuse
* participation in other clinical trials during the last three months
* suspicion of poor study compliance
ARCANGELO (itAlian pRospective Study on CANGrELOr)

The Sponsor implemented a post-authorisation safety study (PASS), category 3, focused in Acute Coronary Syndrome, in order to collect information about the safety of cangrelor in the real clinical practice, evaluating the safety of the transition to all the oral P2Y12 inhibitors (cangrelor, ticagrelor and prasugrel).


Eligibility Criteria:
Inclusion Criteria:

1. Patients' written informed and privacy consent obtained before or at the end of the PCI procedure according to patients' condition but in any case, prior to collection of any study-related data;
2. Male or female patients aged ≥ 18 years;
3. Patients with acute coronary syndromes undergoing PCI;
4. Patients who are planned to be treated with cangrelor, or who have received treatment with cangrelor.

Exclusion Criteria:

1. Patients with active bleeding or increased risk of bleeding, because of impaired haemostasis and/or irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled severe hypertension;
2. Patients with history of stroke or transient ischaemic attack (TIA);
3. Patients with hypersensitivity to the active substance (cangrelor) or to any of its excipients;
4. Known pregnancy or breast-feeding female patients;
5. Patients with stable angina (SA).
Comparing the Effectiveness of Traditional Physiotherapy Combined With Virtual Reality for Post-Stroke Patients

This study aims to evaluate the effectiveness of combining virtual reality (VR) therapy with traditional physiotherapy in post-stroke rehabilitation. Post-stroke patients often suffer from impairments in motor function, balance, and overall quality of life. While traditional physiotherapy is a widely accepted method for stroke recovery, incorporating VR technology may enhance treatment outcomes by providing an engaging, immersive environment that motivates patients to perform therapeutic movements.

This study will compare the functional and quality-of-life improvements in patients undergoing traditional physiotherapy alone versus those receiving a combination of conventional physiotherapy and VR interventions. By assessing changes in motor function, trunk stability, balance, and quality of life, this research will provide valuable insights into whether VR can be an effective adjunctive tool in post-stroke rehabilitation programs.

Eligibility Criteria:
Inclusion Criteria:

* Stroke, either ischemic or hemorrhagic
* Participants who can ambulate independently or with minimal assistance.
* Participants who were willing \& able to adhere to the study protocol.
* Including participants who were attending follow-up appointments \& completing outcome measures.
* Participants who were able to understand \& provide written informed consent

Exclusion Criteria:

* Existence of additional neurological disorders (such as multiple sclerosis or Parkinson's disease) or serious medical conditions that could prevent participants from participating in the study.
* Participants receiving rehabilitation or rigorous physical treatment in the previous three months were excluded.
* Pregnant women or breastfeeding women.
* Participants who refused to participate in the study or provide informed consent.
An Open Clinical Trial to Assess the Influence of Newly Prescribed Aminobiphosphonates on Arterial Stiffness

The study tries to reveal if aminobisphosphonates influence aside the bone density also the vascular status in the typical elderly patient population

The subjects - starting bisphosphonate treatment due to medical reasons - will be additionally investigated as outpatients (arterial stiffness, applanation tonometry), for each subject 3 individual dates with a duration of approx. 30 min each are scheduled, prior to therapy with bisphosphonate, after 3 and 6 month of treatment

Eligibility Criteria:
Inclusion Criteria:

* Patients starting an aminobisphosphonate therapy due to medical reasons Broca-index: between -20 and +25% who are willing and capable to confirm written consent to enrolment after ample information has been provided

Exclusion Criteria:

* patients with major cardiovascular disease patients participating in another clinical trial 1month prior to inclusion in this study patients unable or unwilling to give informed consent
The Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients

Hypomagnesemia is common in renal transplant recipients and is mainly because of enhanced renal magnesium wasting, caused by immunosuppressive drugs (calcineurin inhibitors). Glucose metabolism disorders, including insulin resistance and decreased insulin secretion, are also prevalent post-transplantation and often precede the development of diabetes. As magnesium supplementation has been demonstrated to increase insulin sensitivity in both diabetic and non-diabetic patients, its potential therapeutic supplementation (post-transplantation) deserves further examination. The hypothesis is that magnesium supplementation in renal transplant recipients exerts a beneficial effect on insulin resistance and/or secretion.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplantation recipients
* \> 18 years of age
* more than 4 months post-transplantation
* Hypomagnesemia \< 1,8 milligram/deciliter on 2 consecutive blood samples (laboratory reference interval 1,7 - 2,55 milligram/deciliter) at least 1 month apart.

Exclusion Criteria:

* Pre-existing diabetes mellitus defined as the intake of anti-diabetic drugs at the time of inclusion
* Biopsy that proves acute rejection and consecutive treatment with corticosteroid boluses less than 2 months before inclusion
* Serum creatinine \> 3 milligram/deciliter
* Active infection (C reactive protein \> 3 milligram/deciliter)
* Severe hypomagnesemia (\< 1,2 milligram/deciliter)
* Hypokalemia (\< 3,5 milli-equivalent/liter)
* Severe hypocalcemia (\< 6,5 milligram/deciliter)
* Intake of digoxin
* Intake of magnesium supplementation up to 2 weeks before randomization.
MITOMICS : a Multi-OMICS Approach for the Diagnosis of Mitochondrial Diseases

MITOMICS aims to determine which RNA-Seq results (from muscle or fibroblasts) are the most informative for the interpretation of VUS identified by WES for patients suspected of mitochondrial myopathy. Analysis of RNA-Seq and WES results will performed with a computational approach using an autoencoder-based method

Mitochondrial diseases (MD) are rare, clinically and genetically extremely heterogeneous, caused by a deficit of energy production via the mitochondria. Mitochondria are dependent on 2 genomes mitochondrial DNA and nuclear DNA, and many pathogenic variants carried by these 2 genomes are responsible for mitochondrial diseases. The diagnostic strategies for MD patients have evolved significantly with the emergence of Next Generation Sequencing (NGS) also accelerating the identification of the responsible gene. However, the diagnostic yield remains limited and requires the development of new approaches. Previous studies showed that WES and RNA-Seq combination improves the diagnosis of MD, essentially by helping in the interpretation of identified VUS.

With MITOMICS project, we will included 66 patients suspected of a mitochondrial myopathy (clinical, histological or biochemical), with a negative mtDNA and WES NGS in trio. For each patient we will sequenced RNA from muscle and fibroblasts. Using a new innovative methology of multi-OMICS integration we will determined which RNA-Seq data (from muscle or fibroblasts) are the most informative for the interpretation of VUS identified by WES for patients suspected of mitochondrial myopathy. The results obtained will allow the interpretation of VUS and the identification of specific molecular signatures.

Eligibility Criteria:
Inclusion Criteria:

* Patients suspected of a mitochondrial disease with muscular signs (clinical, histological or biochemical)
* Patients with negative mtDNA and WES NGS in trio
* Patients with routine muscle and skin biopsies available
* Blood samples from parents and / or relatives available for segregation studies
* Informed consent of the study signed by the patient or the legal representatives of the minor patient or under guardianship
* Patients affiliated to social security

Exclusion Criteria:

* Patients with suspected mitochondrial disease without muscle involvement
* Patients for whom the mtDNA NGS and WES have not been performed
* Patients with suspected mitochondrial disease with causal variant identified
* Refusal to sign the informed consent for the study
* Insufficient amount of frozen material or culture failure for fibroblasts
Observational Study of Endothelial Dysfunction in Phenylketonuria

The purpose of this study is to determine whether adolescent and adult patients with phenylketonuria who are on long-term phenylalanine-restricted diet suffer from endothelial dysfunction.

The aim of the study is the examination of endothelial dysfunction and oxidative stress markers in adolescent and adult patients with phenylketonuria (PKU), in correlation to phenylalanine values und phenylalanine-restricted diet. 25-50 patients with PKU aged ≥16 years of age and a control group of 25 age- and sex-matched healthy volunteers will be included in the study.

Endothelial dysfunction will be measured by venous occlusion plethysmography on the lower legs in the PKU patients and in the control group. Wave velocity, aortic stiffness, and intima media thickness of the common carotid artery will be measured by vicorder and duplex ultrasound scanner in the PKU patients and in the control group. Analyses of phenylalanine metabolites and renal function will be performed only in the PKU patients, analyses of oxidative stress markers in the PKU patients and in the control group. Dietary protocols of the patients with PKU will be calculated for their daily phenylalanine, total protein, and calorie intake. Results of the study will be kept in the medical records and paper case report forms. Data will be analyzed only in pseudonymized form.

Eligibility Criteria:
Inclusion Criteria:

* phenylketonuria due to phenylalanine hydroxylase deficiency
* age ≥16 years

Exclusion Criteria:

* age \<16 years
* pregnancy or maternity
* late-treated phenylketonuria
* phenylketonuria due a defect in BH4 synthesis or BH4 regeneration
Real-life Efficacy of Insulia® Tool in Patients Living with Type 2 Diabetes Treated with Basal Insulin Therapy As Part of a National Telemedicine Program (ETAPES)

The purpose of this study was to evaluate the INSULIA digital tool (automation of basal insulin dose calculation in type 2 diabetes) within the framework of a French national telemedicine experimentation program (ETAPES) in a single-center study.

The assumption is that a better metabolic control with this tool.

Basal insulin titration in people with type 2 diabetes is of major importance to obtain the optimal dose to regulate fasting blood glucose without hypoglycemia.

Significant inertia in treatment optimization has been observed among both general practitioners and diabetologists.

The INSULIA tool (automation of basal insulin dose calculation in type 2 diabetes) within the framework of a French national telemedicine experimentation program (ETAPES) has been supported by the health authorities.

The data collected are of a single-center cohort of adult patients with type 2 diabetes who used this tool between 2018 and 2021.

It is supposed that a better metabolic control with this tool and aimed to understand factors associated with better results.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Patients with type 2 diabetes.
* Initiation or adjustment of basal insulin.
* Prescription of Insulia® for more than 6 months (between august 2018 and june 2021)
* Informed patient not opposed to the research

Exclusion Criteria:

Patient opposed to the research
Bioavailability of Lacidipine and Telmisartan Fixed Dose Combination Tablets Relative to Separate Tablets in Healthy Subjects

Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed dose combination tablets with the separate Telmisartan and Lacidipine tablets.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female Caucasian subjects as determined by results of screening
* Age ≥ 18 and ≤ 50 years
* Broca ≥ - 20 % and ≤ + 20 %
* Written informed consent in accordance with Good Clinical Practice and local legislation given

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Disease of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (≤ 1 month prior to administration or during the trial, except for oral contraceptives)
* Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial except for oral contraceptives)
* Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Blood donation \> 100 ml (≤ 4 weeks prior to administration or during the trial)
* Excessive physical activities (≤ 10 days prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance
* Females only:

  * no reliable contraception (e.g. oral contraceptives, 3-month injection, intrauterine device, sterilisation)
  * pregnancy of breast feeding period
Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma

This clinical study is designed as a randomized, double-blind trial. Subjects with unresectable, metastatic, or recurrent skin melanoma will be randomized to one of the two study groups (BCD-201 group and Keytruda group) at a 1:1 ratio.

The goal of this study is to compare the efficacy and safety of BCD-201 and Keytruda as first-line therapy in subjects with unresectable, metastatic, or recurrent skin melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent;
* Histologically confirmed melanoma;
* Tumor first detected at the stage of advanced unresectable or metastatic disease, or disease progressing during or recurring after previous radical therapy;
* ECOG score 0-1;
* At least one measurable lesion according to RECIST 1.1;
* Laboratory test results consistent with adequate functioning of systems and organs;
* Willingness of men and women of childbearing potential to use highly effective contraceptive methods from the signing of the informed consent form, throughout the study and for 6 months after the administration of the last product dose.

Exclusion Criteria:

* Indications for radical therapy (surgery, radiation therapy);
* Uveal, ocular or mucosal melanoma;
* Active CNS metastases and/or carcinomatous meningitis;
* Subjects with severe concomitant disorders, life-threatening acute complications of the primary disease;
* Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study;
* Active, known or suspected autoimmune disorders (subjects with type 1 diabetes mellitus or hypothyroidism requiring only hormone-replacement therapy and those with skin disorders \[vitiligo, alopecia, or psoriasis\] not requiring systemic therapy are eligible to participate);
* The need for therapy with glucocorticoids or any other drugs with immunosuppressive effects within 14 days prior to randomization;
* History of (non-infectious) pneumonitis requiring glucocorticoid therapy or pneumonitis at the time of screening;
* Hypersensitivity or allergy to any of the pembrolizumab product components;
* Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period.
Trans-Rectal Ultrasound of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking

The purpose of this study is to utilize transrectal ultrasound (TRUS) images of the intact and post-hysterectomy female pelvis in order to provide feasibility information for a Magnetic Resonance Imaging (MRI)-TRUS fusion based 3D needle navigation system for use in image guided brachytherapy. The fusion and needle guidance will be performed using Eigen Health's navigation system that currently provides targeted MR/Ultrasound fusion based prostate biopsies utilizing a proprietary 3D semi-robotic navigation system.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven invasive primary squamous, adenosquamous, or adenocarcinoma of the uterine cervix, (recurrent or medically inoperable) uterine adenocarcinoma.
* Treatment plan must include curative-intent definitive radiation that includes brachytherapy treatments with or without concurrent chemotherapy
* Adults ≥ 18 years of age
* ECOG Performance Status 0-2

Exclusion Criteria:

* Patients with active rectal bleeding or rectal ulcer
Etude rétrospective Monocentrique MATRIX

"Monocentric retrospective study.Analysis of a case series of patients who underwent nail resection with dermal matrix and skin graft reconstruction in the setting of nail bed malignancy.

Objective: To assess patients' quality of life and satisfaction with the function and aesthetics of dermal matrix and skin graft reconstruction of the nail apparatus.

Monocentric retrospective study.Analysis of a case series of patients who underwent nail resection with dermal matrix and skin graft reconstruction in the setting of nail bed malignancy.

Objective: To assess patients' quality of life and satisfaction with the function and aesthetics of dermal matrix and skin graft reconstruction of the nail apparatus.

"


Eligibility Criteria:
Inclusion Criteria:

- Adult patients who have undergone complete nail removal for malignancy - Reconstructed with INTEGRA dermal matrix and total skin graft.

Exclusion Criteria:

-Minor patients -Patients who have undergone complete removal of the nail apparatus for malignancy but have been reconstructed in another way (flap, isolated skin graft)
Dexmedetomidine Versus Propofol Sedation in Flexible Bronchoscopy: A Randomized Controlled Trial

The study will evaluate clinical outcomes during bronchoscopy procedures with dexmedetomidine in comparison to propofol.

The clinical outcomes that will be evaluated are: oxygen saturation, transcutaneous Pco2, blood pressure and complications


Eligibility Criteria:
Inclusion Criteria:

* All patients in the age group 18 to 70 years requiring flexible bronchoscopic evaluation of the airway in the Pulmonary institute at Rabin medical center

Exclusion Criteria:

* known or suspected allergy to any of the study drugs, seizure disorder, renal (with serum creatinine \> 2 mg/dL) or hepatic impairment (elevated liver enzymes \> 2 times normal), haemodynamic instability (bradycardia with HR \< 50 bpm or hypotension with SBP \< 90 mmHg), or seriously ill patients with American Society of Anesthesiologists' physical status above III