cyrilzakka/clinical-trials huggingface dataset:
Medico-economic Impacts of NeLLY Service for Not on Dialysis Severe Chronic Kidney Disease

This medico-economic research project (PRME) aim to analyse NeLLY service efficiency for not on dialysis severe chronic kidney disease (DFG \< 30ml/mn) patients care. NeLLY is a service that includes telemonitoring, educational therapy and support for patients with severe chronic kidney disease.

NeLLY study is a multicentre trial, with stepped wedge randomized controled clusters. 2 strategies will be compared: usual patients follow-up and NeLLY service. The primary endpoint of the study is incremental cost-effectiveness ratio. This 3 years study will include 600 French patients.

NeLLY service, offering telemonitoring, educational therapy and support to patients with severe chronic kidney disease, is based on an app, both for patients and health professionals, named Ap'Telecare (@TMM).

Eligibility Criteria:
Inclusion Criteria:

* patient with chronic kidney disease stage 4
* patient with at least 1 cardiovascular comorbidity and / or diabetes
* patient with internet connexion from home
* patient having given his express consent

Exclusion Criteria:

* dialysed patient
* refusal of patient to take part in the research
* impairment of vital prognosis within a short period
* patient expecting a transplant from a living donor within 6 months
Spine Reference Parameters on EOS Imaging

The lumbar pain caring consists from a 3D reconstruction of the spine obtained to scan or radiography, determining the lumbar pain cause and gravity, to propose a conservative treatment in first intention or a adapted spine surgery in first or second intention (Fritzell and al ., on 2001).

The analysis and the correction of postural disorders pass inevitably by a good knowledge of the not pathological posture. The validation of the acquisition 2D / 3D reconstruction by EOS ™ technology demonstrated its interest for the diagnosis and the lumbar pain caring.

However, the EOS technology ™ is recent and few data were acquired with this technology for healthy population.

So, this clinical study with EOS ™technology would allow to obtain a precise knowledge of the standing skeleton in position (to an asymptomatic adult population), by displaying the gravity constraints on the joints, and the compensation phenomena in normal situation. This functional information for a given age bracket would allow to propose to the patients with lumbar pain, adapted interventions to the gravity constraints considering the skeleton evolution for age bracket.

The main objective of this study is to describe thoraco-lumbar spine characteristics, obtained by EOS ™technology, in a reference population, not presenting spine pathology. It's a monocentric transverse descriptive study. This study allows creating a database of the spine, pelvis and sagittal balance parameters to asymptomatic subjects according to age brackets.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of more than 18 years old
* Both genders
* Woman under efficient contraception (if not menopause)
* EVA \< 2 for the rachis (lumbar vertebra and radiculaire),
* Score ODI ≤ 20 %
* Given informed consent
* Subject with French health system

Exclusion Criteria:

* Pregnant or feeding women
* Subject having a follow-up of the back or a regular back pain,
* Subject presenting lower limbs pathology which can have an echo on the rachis such as a length disparity or a flexum
* Subject with spine and pelvis surgery antecedents.
* Person placed under protection of justice
Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes

The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Sulfonylurea with an extension treatment for up to 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 20 - 75 years old
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
* Patients whose HbA1c is between 7.0% and 10.0%
* Patients who took Sulfonylurea for diabetes over 12 weeks before administration of investigational drug
* Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug

Exclusion Criteria:

* Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
* Patients with Class III/IV heart failure symptoms according to NYHA functional classification
* Patients who are gastrointestinal disorder (diarrhea, vomiting)
* Patients with serious diabetic complications
* Patients who are the excessive alcohol addicts
* Patients with severe hepatic disorder or severe renal disorder
* Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Applying an Artificial Intelligence-Enabled Electrocardiographic System for Reducing Mortality

This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for early detection of clinical deterioration for reducing mortality.


Eligibility Criteria:
Inclusion Criteria:

* Patients in emergency department or inpatient department.
* Patients recieved at least 1 ECG examination.

Exclusion Criteria:

* The patients recieved ECG at the period of inactive AI-ECG system.
A Study to Evaluate the Food-Effect of H3B-6527

This study will be conducted to determine the effect of food on the relative bioavailability of H3B-6527 following administration of a H3B-6527 capsule with and without a meal.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking, healthy male between the ages of 18 and 55 years old
* Body mass index (BMI) \>18 and ≤ 29 kilograms per meters squared (kg/m\^2)
* Participants who have not had a successful vasectomy and are partners of women of childbearing potential must use a medically effective method of contraception with their partner during the study period through 30 days after the last dose of study drug. No sperm donation is allowed during the study period or for 30 days after study drug discontinuation

Exclusion Criteria:

* Participants with clinically significant heart, liver, gastrointestinal, kidney, lung, hormonal, blood, nerve or psychiatric disease or history of gastrointestinal surgery or gall bladder removal that could effect the uptake, distribution or elimination of H3B-6527
* Participants with a history of drug or alcohol misuse within 6 months prior to screening or a positive urine drug test
* Participants diagnosed with acquired immune deficiency syndrome (AIDS), or who test positive for human immunodeficiency virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV)
* Participated in another clinical trial less than 4 weeks prior to dosing or is currently enrolled in another clinical trial
* Received blood products within 4 weeks, or donated blood within 8 weeks, or donated plasma within 1 week prior to the first dose
* Participants used any prescription or over-the-counter drugs within 2 weeks prior to the first dose
Assessment of Volume-targeted Ventilation in Patients With Neuromuscular Disease

Assessment of safety and efficacy of volume-targeted ventilation in patients with neuromuscular disease.

Patients with neuromuscular diseases (NMD) can suffer from breathing difficulties requiring treatment with a breathing device known as non-invasive ventilation (NIV). NIV aims to support the lungs in removing the waste gas, carbon dioxide (CO2). This is important because patients with high CO2 levels tend to have worse clinical outcomes.

NIV delivers different pressures to the airway when the patient breathes in and when they breathe out. Usually, the pressures it delivers are fixed; i.e. they do not change breath-to-breath. Newer technology allows the machine to independently change the pressures, depending on various patient factors it can measure. There are a small number of studies that suggested that these 'auto-titrating' machines may improve control of carbon dioxide but further work is needed. One of these modes allows us to set a target volume that should be delivered to the patient each breath, and the machine changes settings to deliver this target volume, in response to changing patient parameters. We aim to investigate the safety and efficacy of this volume-targeted NIV (VT-NIV), in order to generate data to design a randomised controlled trial to compare VT-NIV with fixed-NIV.

Patients with NMD who use fixed-NIV will be admitted for a two-night stay to our centre. On the first night, their CO2 control will be assessed on their current ventilator. On the second night, they will be switched to the VT-NIV mode. They will be discharged and asked to use the new mode for three months. Individuals with well-controlled CO2 with their usual mode will allow us to assess the safety of VT-NIV, and individuals with poorly-controlled CO2 will allow us to assess its efficacy. At three months, they will attend an outpatient visit, where use of the new mode will be assessed through data download from the machine and completion of questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Slowly progressive neuromuscular disease
* Established on fixed bi-level ventilation
* Documented clinical respiratory stability by supervising clinician (no hospitalizations, respiratory infections or change to ventilator settings in preceding 6 weeks)

Exclusion Criteria:

* Rapidly progressive neuromuscular disease
* Decompensated respiratory failure (pH \< 7.35)
* Pregnancy
* Aged \<18, \>80
* Poor adherence to NIV (\<4hrs per night)
* Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis

This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy.


Eligibility Criteria:
Inclusion Criteria:

* Documented history of pulmonary sarcoidosis for at least 6 months, supported by the following evidence: documented histologically proven diagnosis of sarcoidosis by tissue biopsy and documented evidence of parenchymal lung involvement by historical radiological evidence
* Evidence of symptomatic pulmonary sarcoidosis, as demonstrated by the following criteria: Modified Medical Research Council (MRC) dyspnea scale grade of at least 1 and KSQ-Lung score ≤70
* Patients must be receiving treatment with OCS of ≥ 3 months at Day 1 with a starting dose between ≥ 7.5 and ≤ 25 mg/day ≥ 4 weeks prior to Day 1.
* Body weight ≥ 40 kg and \< 160 kg

Exclusion Criteria:

* Treatment with \> 1 immunosuppressant therapy
* Treatment with biological immunomodulators, such as tumor necrosis factor-alpha (TNF-α) inhibitors or antifibrotics or interleukin inhibitors
* Likelihood of significant pulmonary fibrosis as shown by any 1 or more of the following: High resolution CT fibrosis \> 20% within the last 12 months; FVC percent predicted (FVCPP) \< 50% and KSQ-Lung score \< 30
* In the opinion of the investigator, clinically significant pulmonary hypertension
* Patients with active cardiac, neuro, or renal sarcoidosis requiring organ-specific therapy in the past 2 years
* Patients with cutaneous or ocular sarcoidosis, which in the opinion of the Investigator, are at risk for exacerbation, necessitating OCS rescue or other systemic therapy
* History of Addisonian symptoms that precluded previous OCS taper attempts
* Is an active, heavy smoker of tobacco/nicotine-containing products
* History of anti-synthetase syndrome or Jo-1 positive at Screening
* Patients with active tuberculosis or those currently undergoing treatment for tuberculosis
Prospective Randomized Endovascular Therapy in Multiple Sclerosis

1. To assess the safety of endovascular therapy (balloon angioplasty) for venous stenoses in MS patients with CCSVI as documented by sonographic (extracranial echocolor-Doppler (ECD) and transcranial color Doppler (TCD)
2. To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS).
3. To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and MRI/MRV parameters.
4. To evaluate change in patients self-reported QOL following the therapeutic angioplasty
5. To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic angioplasty are associated with brain changes as measured by functional MRI (fMRI).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years

  * EDSS 0-6.5
  * Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005)
  * Be on treatment with currently FDA approved disease-modifying treatments
  * Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section)
  * Demonstration of venous occlusive disease on cervical MRV
  * Normal renal function: creatinine clearance level of \>60:

Constant= 1.23 for men; 1.04 for women

Exclusion Criteria:

* • Relapse, disease progression and steroid treatment in the 30 days preceding study entry

  * Pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.)
  * Severe peripheral chronic venous insufficiency
  * Abnormal renal function
  * Contrast allergy (anaphylaxis)
  * Not accepting to undergo the endovascular treatment
  * Peripheral Vascular Disease
The Influence of Atorvastatin on the Parameters of Inflammation and the Function of Left Ventricle

The aim of the study was to assess of the influence of atorvastatin on selected indicators of an inflammatory condition, function of the left ventricle and factors affecting the occurrence of undesired events like rehospitalizations and mortality in patients with dilated cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria:

* patients 18 years old or older
* patients who signed informed consent
* patients with dilated cardiomyopathy (according ESC 2007)
* patients who had no significant coronary artery stenoses \>30% on cardiac catheterization

Exclusion Criteria:

* BP ≥140/90 lub \<90/60
* congenital heart disease
* acquired valvular disease except for mitral incompetence secondary to left ventricular dilatation
* New York Heart Association (NYHA) functional class IV
* statin treatment
* preserved hyperactivity of aminotransferases with unexplained etiology,
* muscle disorders which might cause drug-induced myopathy,
* uncontrolled diabetes,
* liver diseases,
* creatinine level \> 2 mg/dl and/or GFR\<30ml/min,
* abuse of alcohol or drugs,
* chronic inflammatory diseases,
* pregnancy or lactation,
* severe hypothyroidism,
* immunosuppressive treatment,
* operation or severe injury during last month
* vaccination during last 3 months
* heart stimulation device or implantable cardioverter defibrillator
* or who didn't write conscious consent
A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)

The purpose of the study is to see how effective JNJ-77242113 is in participants with plaque psoriasis affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
* Candidate for phototherapy or systemic treatment for plaque psoriasis
* Need to meet criteria: Total body surface area (BSA) greater than or equal to (\>=)1 percent (%) at screening and baseline, and investigator global assessment (IGA) (overall) \>=2 at screening and baseline and at least one of the following: scalp-specific investigator global assessment (ss-IGA) score \>=3 at screening and baseline, and/or static physician's global assessment of genitalia (sPGA-G) \>=3 at screening and baseline, and/or physician's global assessment of hands and feet (hf-PGA) score \>=3 at screening and baseline
* Failed to respond to at least 1 topical therapy (example, corticosteroids, calcineurin inhibitors, and/or vitamin D analogs) used for treatment of psoriasis
* Confirmation of plaque psoriasis in a non-special area (example, areas excluding scalp, genital, palmoplantar) at screening and baseline

Exclusion Criteria:

* Nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
* Dermatoses other than plaque psoriasis (such as contact dermatitis) or palmoplantar pustulosis of the palmoplantar area (if hf-PGA \>=3 at baseline)
* Current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
The Safety and Effectiveness of Retrovir in HIV-Infected Patients Who Have Problems Related to the Nervous System

To assess the efficacy of Retrovir (AZT) therapy in the treatment of HIV Ab positive persons with impairments in neuropsychological functioning. To assess the safety, virologic, and immunologic effects of AZT therapy in HIV Ab positive persons with neuropsychological impairment but minimal other symptomatology.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Neuropsychological (NP) impairments more severe than described in the Inclusion Criteria.
* Evidence of nervous system dysfunction being caused by factors other than HIV infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (CNS) infections or neoplasms, e.g., toxoplasmosis, primary or metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and CNS tuberculous infections.
* Lymphoma or other tumor requiring cytotoxic chemotherapy.

Concurrent Medication:

Excluded:

* Other antiretroviral agents.

Patients with the following are excluded:

* AIDS or advanced ARC.
* Neuropsychological (NP) impairments more severe than described above; i.e., defective performance on NP test battery in 3 or more NP areas on the NP screening battery at 2 standard deviations below the mean.
* Evidence of nervous system dysfunction being caused by factors other than HIV infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (CNS) metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and CNS tuberculous infections.

Prior Medication:

Excluded:

* Antiretroviral agents including zidovudine (AZT).

Prior Treatment:

Excluded within 3 months of study entry:

* Blood transfusion.

Impaired performance on a defined neuropsychological test battery.

* Asymptomatic HIV infection.
* Persistent generalized lymphadenopathy (PGL).
* Early AIDS related complex (ARC).
* Seropositive for human immunodeficiency virus (HIV) demonstrated by positive ELISA test and confirmed by Western blot with no or minimal symptomatology or HIV infection.
* Ability to give informed consent or a person with durable power of attorney who can give informed consent.
* Willingness to be followed by the originating medical center for 1 year.

History of drug or alcohol abuse.
Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency

The purpose of the study is to determine the difference between The Breather respiratory muscle trainer and pulmonary rehabilitation in patients with COPD post COVID-19.

The main concern in post COVID-19 patients is the involvement of respiratory system and cardiovascular system which may result in dyspnea, low blood oxygen saturation, and decrease cardiopulmonary efficiency.

In cases of post COVID-19 patients with COPD their state is deconditioned and more critical than normal to be either in the zone of progression or regression or stability as the studies showed that handling of these cases during (3-6 months post-COVID) will prevent these symptoms from becoming permanent.

Eligibility Criteria:
Inclusion Criteria:

1. SPO2 ≥ 93%
2. Their age ranges from 30-40 years old.
3. COPD patients GOLD1 (Mild FEV1≥80% predicted) and GOLD2 (Moderate 50% ≤FEV1\<80%predicted) (Manian, 2019)
4. patients diagnosed as post COVID-19 Pneumonia between 3 and 6 Months ago with CT scan and PCR testing.
5. Their body mass index (BMI) ranged from 20 to 29.9kg/m2.
6. Stable medical cases with dyspnea

Exclusion Criteria:

Patients who will meet one of the following criteria will be excluded from the study:

1. patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure.
2. Sever cases of COPD (FEV1/FVC\< 50%)
3. Mitral or aortic valvular disease, pericardial effusion.
4. Recent myocardial infarction.