cyrilzakka/clinical-trials huggingface dataset:
earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

The aim of this study is to evaluate the effect of early rehabilitation treatment by electroencephalographic neurofeedback on upper limb motor function after stroke.

Researchers will compare :

Interventional group: electroencephalographic neurofeedback + traditional reference rehabilitation programme Control group: SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme


Eligibility Criteria:
Inclusion Criteria:

* Unilateral ischaemic or haemorrhagic stroke
* Adult (18-80 years), both sexes
* Stroke \< 3 weeks
* Upper limb deficit defined by Shoulder Abduction Finger Extension score \<5 on day 3 of stroke; i.e., patients predicted to have incomplete recovery
* No participation-limiting comprehension problems
* With or without homonymous lateral hemianopia; with or without visuospatial hemineglect
* Free, informed and written consent signed by the patient or a member of the patient's family (in the case of a patient who is able to understand the information and give consent but has motor difficulties resulting in an invalid signature).
* Affiliated to french social security

Exclusion Criteria:

* Ischemic or hemorrhagic brain stem and/or cerebellum involvement
* Multiple strokes
* Stroke \< 1 week; in order not to be deleterious by starting active rehabilitation too early after immediate stroke
* Aphasia with major comprehension impairment
* Contraindication to MRI

  * pacemaker or implantable defibrillator,
  * neurosurgical clips,
  * cochlear implants,
  * intra-orbital or encephalic metallic foreign bodies,
  * stents placed less than 4 weeks ago and osteosynthesis devices placed less than 6 weeks ago,
  * claustrophobia.
3/7 Resistance Training Method in Cardiac Rehabilitation

Aim of the clinical monocentric study is to assess the resistance training exercise intervention in patients with Heart Failure with reduced Ejection Fraction (HFrEF) and coronary artery disease that will best improve peak oxygen uptake (Peak Vo2) and leg strength (assessed Isokinetic). The investigators hypothesize that resistance training exercise with induced a high stress metabolic is more important exercise with induced than a lower stress metabolic.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Coronary artery diseases
* Heart failure with reduced ejection fraction

Exclusion Criteria:

* angina
* acutely decompensated heart failure
* electrocardiographic evidence of ischemia
* significant valvular disease
* orthopedic/neurologic disorders that limited exercise
Supported Employment and Skills Training in Conjunction With Pharmacotherapy in Schizophrenia Patients

This study will compare employment support with behavioral skills training to employment support alone in schizophrenia patients taking either risperidone or olanzapine to determine which is more effective in helping the patients maintain a job.

Schizophrenia is a severe mental disorder characterized by disorganized thoughts, difficulty concentrating, and hallucinations. Individuals with schizophrenia often experience reduced emotional, social, and occupational functioning. Data indicate that antipsychotic drug treatment and occupational training and support may be effective in helping people with schizophrenia maintain a stable job. Risperidone and olanzapine are antipsychotic drugs; participants in this study will be taking either risperidone or olanzapine for the duration of the study. This study will provide schizophrenia patients with employment support alone or with behavioral skills training to determine which combination is more effective in helping patients obtain and maintain a job.

At study entry, participants will undergo a clinical and diagnostic evaluation to determine the severity of their schizophrenia. Participants will be tapered off their regular medication for schizophrenia over 4 weeks. At the end of Week 4, they will be randomly assigned to receive either risperidone or olanzapine. Participants will then be assigned an Individual Placement and Support (IPS) specialist to assist them in finding a job. After participants secure a job, they will be randomly assigned to receive IPS either alone or with the Workplace Fundamentals Skills Training Module for 2 years. Participants' risperidone or olanzapine treatment will continue during this 2-year period. Participants will have clinic visits at study entry and Months 7, 12, and 24. At each visit, participants will complete questionnaires and will be interviewed about their schizophrenia symptoms and occupational functioning.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia
* Candidate for maintenance schizophrenia treatment
* Willing to initiate and continue risperidone or olanzapine therapy for the duration of the study

Exclusion Criteria:

* Any serious medical problems other than schizophrenia that would interfere with the study
Prospective Randomized Study of Nasal High Flow in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

The main oxygen therapy to the patients with acute exacerbation of Chronic obstructive pulmonary disease, who are mild to moderate respiratory insufficiency (arterial blood gas analysis showed pH = 7.35, PO2 \< 60mmHg,PaCO2\>45mmHg) or have achieved the traditional noninvasive ventilation support standard but can not tolerate or reject, was nasal catheter, venturi mask and other conventional oxygen therapy. All these inaccurate inhaled oxygen concentration methods with inadequate heating and humidifying lead to poor patient tolerance and adverse reactions such as airway secretions discharge disorders. The high flow nasal respiratory therapy (Nasal high flow, NHF) utilises higher gas flow rates than conventional low-flow oxygen systems. The devices used deliver heated and humidified oxygen at a flow of up to 60 litres per minute via nasal cannulas with low level continous positive airway pressure. This study is a prospective randomized study. AECOPD patients with no severe respiratory failure are treated with NHF and conventional oxygen therapy respectively. The target is that NHF can increase the comfort degree of patients,reduce the rate of endotracheal intubation, and shorten the time of hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* AECOPD patients.
* The results of blood gas analysis showed pH ≥7.35, PO2\< 60mmHg, PaCO2\> 45mmHg.

Exclusion Criteria:

* The study case has been incorporated into the hospital again.
* Refused to the NHF therapy.
* The Glasgow score \< 8.
* Severe organ dysfunction (including liver and kidney dysfunction, decompensated acidosis, upper gastrointestinal bleeding, DIC, etc.)
Striving to Quit-Wisconsin Tobacco Quit Line

This study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates when they are offered to Medicaid BadgerCare Plus members.

Aim 1: To determine the extent to which contingent financial "treatment incentives" (i.e., incentives for biochemical verification visits, treatment engagement, and abstinence) versus "attendance incentives" (i.e., incentives for only attending the biochemical verification visits), increase rates of smoking cessation . Participants will be BadgerCare Plus tobacco users who enroll in Wisconsin Tobacco Quit Line (WTQL) services.

Aim 2: To determine the extent to which treatment incentives vs. attendance incentives increase rates of engagement in smoking cessation treatment through the WTQL when offered to BadgerCare Plus members who smoke.

Aim 3: To determine the cost-effectiveness of the smoking cessation program when paired with treatment incentives and when paired with attendance incentives.

Aim 4: To identify moderating and mediational effects regarding the clinical benefit of incentivized smoking treatment

Aim 5: To determine the reach of an incentivized smoking cessation treatment that depends upon primary care clinic staff, a fax-to-quit referral mechanism and a state quit line.

Eligibility Criteria:
Inclusion Criteria:

* enrollment in Wisconsin Medicaid (BadgerCare Plus)
* resides in study area (one of 25 counties)
* member of participating HMOs
* 18 or older
* English speaking
* has smoked daily (at least 5 cigarettes each day) over the last week
* willingness to attend visits at his/her PCC (primary care clinic) every 6 months (3 times over a 12 month period), provide urine samples, and complete follow-up phone calls
* willingness to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.

Exclusion Criteria:

* not enrolled in Wisconsin Medicaid (BadgerCare Plus)
* not reside in study area
* not a member participating HMOs
* less than 18 years of age
* not English speaking
* does not smoke daily (at least 5 cigarettes each day) over the last week
* not willing to attend visits at his/her PCC (primary care clinic) every 6 months (3 times over a 12 month period), provide urine samples, and complete follow-up phone calls.
* not willing to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.
Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2

This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention.

The enrollment period will be of 65 months (01/jan/2020-30/jun/2025). Sample size will be of 100 patients.


Eligibility Criteria:
Inclusion criteria:

* \>18 years old
* Visceral artery aneurysms, evaluated with computed tomography angiography-CTA- withindication for treatment according to 2020 SVS and 2024 SICVE/SIRM and 2024 CIRSE guidelines. Specifically:

  * Renal artery: \>2 cm if fusiform morphology or all dimensions if sacculary or bifurcation morphology, if in fertile women or in hypertensive patients with renal stenosis
  * Splenic artery: if \>2 cm, or all dimensions in fertile women.
  * Celiac tripod: if \>2 cm.
  * Hepatic artery: if \>2 cm or growth greater than 0.5 cm/year.
  * Superior mesenteric artery, gastric or gastroepiploic artery, pancreaticoduodenal or gastroduodenal arteries, colic arteries, jejunal arteries, and ileal arteries: any size
* anatomical characteristics compatible with the stent DED Instruction for Use (IFU). Specifically:

  * the stent diameter should match the largest diameter of either the proximal or distal vessel of the aneurysm with an oversizing of 1-2 mm according to IFU.
  * the stent length must allow for adequate proximal and distal landing, covering the neck of the aneurysm to 2.5 times the vessel's internal diameter and no less than 15 mm.
* proper adherence to the anticoagulant and antiplatelet pharmacological protocol for the peri-procedural and post-procedural periods. Specifically:

  * all patients should begin dual antiplatelet therapy (DAPT) before surgery (for at least 3 days before the procedure or with a loading dose pre-procedurally).
  * all patients receive systemic anticoagulation during the procedure (Heparin 70 IU/kg to achieve an Activated Clot Time (ACT) \> 250 s).
  * after the procedure, the patient should continue DAPT (e.g., ASA 100 mg daily and Clopidogrel 75 mg daily) for at least 1 month, then continue with single antiplatelet therapy (e.g., ASA 100 mg) indefinitely.

Exclusion Criteria:

* patients who are hemodynamically unstable or show CT signs of rupture or contained rupture of visceral aneurysm
* pregnant or breastfeeding women
* life expectancy less than 2 years
Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury

The purpose of this study is to investigate the safety, effective dosage and treatment of Magnesium Isolycyrrhizinate Injection to cure the acute drug-induced liver injury compared with the Tiopronin Injection.

The pharmacology research shows that Magnesium Isoglycyrrhizinate could significantly decrease the elevation of ALT and AST coursed by carbon tetrachloride, D-galactosamine and Thioacetamide. It could also significantly reduce the injury on the liver coursed by D-galacosamine and immunologic factors. Magnesium Isoglycyrrhizinate with strong anti-inflammatory effect could protect the liver cell and improve the liver function.

Eligibility Criteria:
Inclusion Criteria:

* RACUM ≥6
* ALTs ≥2ULN, but TBiL is ≤ 3 ULN.It may be associated with AST or ALP or TBiL exceed the upper limit of normal
* Liver biochemical abnormalities duration of no more than three months
* Patients need to fully understand and sign the inform consent form.

Exclusion Criteria:

* The liver injury is caused by other diseases, such as virus hepatitis, alcohol and non-alcohol fatty liver disease or the autoimmune liver disease.
* The patients with the acute hepatic failure or hepatic decompensation, such as hepatic encephalopathy, ascites, albumin is ≤ 35g/L, prothrombin time is elongated more than 2 seconds compared to its normal range.
* The value of the TBiL is \> 3ULN.
* The value of serum creatinine is \> 1.5ULN.
* Patients who have severe organic diseases on heart, lungs, brain, kidney and gastrointestinal tract.
* Patients who are taking the drugs that might interfere the trial.
* Patients who are allergic or intolerant to the study drug.
* Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis.
* Patients who are compliant with protocol.
* Women who are pregnant, breast-feeding or with childbearing potential.
* Patients who have attended other clinical trials within 3 months.
* Not appropriate to be included after assessing by the investigators.

ULN=Upper Limited Normal
Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet

To evaluate efficacy of tolterodine extended release formulation compared with immediate release formulation in subjects with symptoms of overactive bladder


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of overactive bladder.

Exclusion Criteria:

* Subjects with significant stress incontinence as determined by the investigator.
* Subjects with recurrent urinary tract infections defined as treated for UTI; 5 times in the last year.
Separate and Combined Extrapancreatic Effects of the Incretin Hormones

The two gut-derived hormones, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) is secreted from intestinal cells in relation to a meal and increase insulin secretion from the pancreas. The hormones also exert effects outside the pancreas, but especially for GIP, these are poorly investigated. Because of this, only GLP-1 based drugs (GLP-1 receptor agonists) are on the market for the treatment of type 2 diabetes and obesity. Nonetheless, a new drug is in clinical development: a combined GIP-GLP-1-receptor agonist (tirzepatide), which has shown better results than GLP-1 alone. The mechanism behind these impressive effects are unknown and in this study, the investigators will look into the exptrapancreatic effects of GIP and GLP-1, separate and combined and thus elucidate the mechanisms of action of this new drug class.


Eligibility Criteria:
Inclusion Criteria:

* Total pancreatectomy
* Caucasians
* Blood haemoglobin \>7 mmol/l for males and \>6.5 mmol/l for females

Exclusion Criteria:

* Pancreatectomy within the last 3 months
* Ongoing chemotherapy or chemotherapy within the last 3 months
* Treatment with GLP-1R agonists within the last 3 months
* Renal impairment (estimated by eGFR \<60 ml/min/1.73 m2) and/or albuminuria
* Calcium related disease, hypo-/hyperthyroidism
* Known significant liver disease, ALT or AST \>3 times normal value or INR outside normal range
* Severe arteriosclerotic heart disease or heart failure (NYHA group III or IV)
* Pregnancy and/or breastfeeding
* Use of more than 14 units of alcohol per week or abuse of narcotics
* Any condition that the investigator feels would interfere with trial participation
Non-pharmacological Treatment for Chronic Back Pain

The working hypothesis is that spa therapy in addition to usual care including home exercises (UCHE) will result in greater improvements in pain reduction, associated disability and quality of life for chronic low back pain patients. It follows that health resource consumption and linked costs should also be reduced. The primary objective of this study is therefore to compare the therapeutic effect of UCHE alone versus spa therapy in addition to UCHE for chronic low back pain.

Secondarily, the study will also (i) evaluate the therapeutic effects specific to each spa-centre, (ii) specifically describe effects among subjects who are currently engaged in a professional activity, (iii) evaluate treatment tolerance as well as (iv) per-patient health resource use and associated costs.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient presenting with chronic low back pain: usual pain of the lumbar region lasting for more than 3 months. This pain may radiate to the buttocks, iliac crest, and does not go past the knee.
* Patient presenting with a current pain intensity on a visual analogue scale (VAS) \> or = 40 mm.
* The patient has signed the informed consent
* The patient is a beneficiary of a social security programme \[national health insurance\]

Exclusion Criteria:

* Patients with secondary low back pain
* Patients with severe depression, psychosis
* Patients who have already had a spa treatment in the previous 6 months
* Patients with a contraindication for spa treatment
* Patients with a professional activity related to hydrotherapy (to avoid any conflict of interest)
* Patients with sciatic pain beyond the knee (sciatica being a non-indication for spa treatment)
* Other treatments that may interact according to the judgment of the investigator
* Patients who live more than 30 km away from the spa
Drug-Drug Interaction Study Assessing Effect of Itraconazole on PF-07321332/Ritonavir in Healthy Participants

The purpose of this study is to estimate the effect of a strong inhibitor of CYP3A4 (itraconazole) on the pharmacokinetics (PK) of PF-07321332/ritonavir in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants who are overtly healthy as determined by medical evaluation including medical history, PE, laboratory tests, vital signs and standard 12 lead ECGs.
2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Female participants must have a negative pregnancy test.
4. BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). -

Exclusion Criteria:

1. Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
3. Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than NYHA 1, underlying structural heart disease, Wolff Parkinson-White syndrome).
4. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
5. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
6. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Advantage of Using Intraoperative Visual Evoked Potentials to Preserve Visual Function During Surgical Procedures Near the Optical Pathways

Visual morbidity (visual acuity and/or visual field deficit) must be taken into account during neurosurgical procedures for lesions near the optical pathways. Part of this morbidity is due to surgical manipulation. There is no validated tool for intraoperative visual monitoring and few publications have studied this issue.

In a preliminary work based on analysis of these publications, we defined technical, anaesthetic and analytical parameters in order to optimise intraoperative visual evoked potentials monitoring. These parameters are special devices used for transpalpebral stimulation, complete intravenous anaesthesia without halogen or nitrous oxide, and pertinent analysis criteria of visual evoked potential (VEP). We suppose that these improvements will increase reliability of intraoperative VEP.

This genuine optimised monitoring in France, set up in association with Metrovision company, should help increasing intraoperative VEP reliability as a monitoring tool for visual pathways function.

In this study, we assess the predictive value of relevant intraoperative variations of VEP (more than 50% variation of latency and amplitude) on the visual prognosis at six months after surgery The visual assessment consisting of a visual field, a visual acuity, and the performance of pattern transient VEP, will be performed by an ophthalmologist before surgery, and at three and six months after surgery. An electroencephalogram with photostimulatory lighting will be used in pre-operative and will validate the absence of photo-induced epilepsy risk.

During the intervention, VEPs associated to an electroretinogram will be performed by a neurosurgeon trained to the use of these tools by Metrovision company:

* Under general anaesthesia, but before any surgery.
* During the surgery, at predetermined surgical times (while performing the craniotomy or the sphenoid opening, at various times during the perioptic lesion dissection, after the lesion resection, when closing).

Eligibility Criteria:
Inclusion Criteria:

* Patients with lesion compressing or near the optical pathways

Exclusion Criteria:

* Patients with photic epilepsy
Clinico-biological Collection of Bone, Calcium and Growth Plate Pathologies

The aim of this project is to set up a biological and clinical collection of patients with progressive bone, calcium and growth plate pathologies.

This collection will provide a better understanding of the mechanisms involved in growth plate and bone damage in these diseases and identify factors predictive of progression and new therapeutic targets.


Eligibility Criteria:
Inclusion Criteria:

* Children (from birth) with growth plate or bone pathology
* Patients affiliated to or benefiting from a social security scheme
* Patients able to receive information about the study and to understand the information form in order to participate in the study. This implies :
* mastery of the French language
* Not being subject to a restriction of rights by the judicial authorities
* Patients or legal representatives having given their consent to participate in the study (expression of non-opposition).

Exclusion Criteria:

* Patients under legal protection (guardianship, curatorship or safeguard of justice)
* Pregnant or breast-feeding women