cyrilzakka/clinical-trials huggingface dataset:
Validation of Naevia Medical in Valvulopathies

The study aims to validate naevia medical, a knowledge-based clinical decision support system (CDSS), for clinical benefit and safety in cases of cardiac valvulopathies. Using a series of retrospective clinical cases of heart valve disease, the research will evaluate the number of appropriate and inappropriate recommendations during baseline measurement (conventional management) and after CDSS activation.

The objective of this study is to validate both the clinical benefit and safety of a knowledge-based clinical decision support system (CDSS), naevia medical, applied to clinical cases of cardiac valvulopathies.

naevia medical aims to bridge the gap between scientific evidence and medical practice by improving adherence to scientific recommendations.

The research aims to establish and verify that the naevia medical product is suitable for its intended purposes and provides the specified intended functionality as outlined by its manufacturer under normal conditions of use. It seeks to verify the clinical benefits of the product compared to conventional management by enhancing healthcare professionals' ability to provide a greater number of scientifically based recommendations tailored to each patient's specific situation. Additionally, the study aims to establish the clinical safety of the product by identifying potential undesirable side effects under normal usage conditions and evaluating whether these effects constitute acceptable risks in relation to the benefits provided.

To achieve these objectives, a clinical research study will be conducted to assess naevia medical's capacity to increase appropriate recommendations and decrease inappropriate recommendations received by patients with valvulopathy, compared to conventional management without support.

The study proposes a pre-test-post-test design with a randomly assigned group, utilizing a longitudinal approach with repeated measures and retrospective validation. Evaluation criteria will focus on the number of appropriate and inappropriate recommendations during baseline measurement (conventional management) and after CDSS activation, using a series of retrospective clinical cases of heart valve disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients randomly selected from those presented during the year 2022 in medical-surgical sessions, with a primary diagnosis of:

  * aortic valve stenosis
  * aortic insufficiency
  * mitral valve stenosis
  * mitral insufficiency (greater than moderate severity)..
* Patients randomly selected from valvulopathy clinic records attended during the year 2022, with a primary diagnosis of

  * aortic valve stenosis
  * aortic insufficiency
  * mitral valve stenosis
  * mitral insufficiency (greater than moderate severity)

Exclusion Criteria:

* Subjects under 18 years old.
* Inability to anonymize the case.
* Clinical cases of valvulopathies in which a complex congenital heart disease coexists.
* Clinical cases that do not meet the minimum data set necessary for decision-making.
* Clinical cases with a primary diagnosis other than valvulopathy.
* Presence of bacterial endocarditis
A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort

This registry aims to provide the first prospective, multicentric database of patients with malignant hypertension. It will allow to assess modern epidemiology of the disease, diversity of current management and care pathway, to deepen our pathophysiological knowledges, to modernize the definition of this form of hypertension and its diagnostic criteria. The network that will emerge will finally lead to the opportunity of setting up therapeutic trials and establishing recommendations based on solid scientific evidence.

Malignant hypertension is the most severe form of high blood pressure, fatal if left untreated. It has not disappeared, with an increasing incidence. Patients with the disease, mainly young (35 to 55 years of age), have an unfavorable cardiovascular prognosis (14% of cardiovascular and renal events at 4 years). Despite these facts, scientific research on the subject remains limited. The definitions and diagnostic criteria have not changed since 1929, and the therapeutic recommendations remain empirical.

This first prospective and multicentric registry will increase and modernize the knowledge of the disease. From these data, diagnostic and therapeutic recommendations based on solid scientific evidence could be developed.

The investigators want to first recruit 500 patients and define their prognosis at 5 years. The impact of the patient's phenotype, type and number of target organs affected will be studied.

A modern definition, adapted to these results, could be proposed. The epidemiology of the disease, the care pathways, the target organ disorders and the management carried out in the centers will be described in detail.

Eligibility Criteria:
Inclusion Criteria:

* Malignant hypertension according to the classic definition (Severe hypertension, above 180/110 associated with severe hypertensive retinopathy)
* Severe hypertension (above 180/110) associated with acute damage of 3 target organ due to high blood pressure

Exclusion Criteria:

* Age \< 18 years old
* Patients who cannot freely give their consent, or patients who refuse to participate
* Dialysis
Comparison of ESP Block Versus Serratus Block

Total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit to the study. The patients randomly divided into two groups. Ultrasound guided Erector spinae plane block (ESP) will perform with 15 ml bupivacaine+ 5 ml lidocaine in Group ESP and ultrasound guided serratus anterior plane (SAP) block will perform with 5 ml bupivacaine+ 5 ml lidocaine in Group SAP. Postoperative pain assessment will apply with 11-point numerical rating scale (NRS) and postoperative analgesic requirement will calculate and record with morphine consumption (patient controlled analgesia).

In this study, total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit. Using with computer randomisation, the patients allocate into two groups. Anaesthesia induction will perform with 2 mg/kg propofol, 0.6 mg/kg rocuronium and 2 microgram/kg fentanil and general anaesthesia will maintain with sevoflurane %1-2 +%40-60 O2-N20 mixture and remifentanil infusion. All of the blocks will perform under general anaesthesia. Ultrasound guided Erector spinae plane block (ESP) will perform with 15 ml bupivacaine+ 5 ml lidocaine in Group ESP and ultrasound guided serratus anterior plane (SAP) block will perform with 5 ml bupivacaine+ 5 ml lidocaine in Group SAP. Postoperative pain, analgesic requirement and complications will evaluate. Postoperative pain assessment will apply with 11-point numerical rating scale (NRS) and postoperative analgesic requirement will calculate and record with morphine consumption (patient controlled analgesia).

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients
* Being volunteer
* Total mastectomy

Exclusion Criteria:

* ASA III and over
* Renal and hepatic failure
* Non Volunteers
* Emergency procedures
Radiation Pneumonitis After SBRT for NSCLC

Aims:

1. Evaluate changes in lung function before and after radiotherapy for patients with NSCLC in stage I-III receiving curatively intended radiotherapy
2. To assess the predictive value of pulmonary function tests for the development of radiation pneumonitis after curative radiotherapy
3. To assess biomarkers in blood samples before, during, and after radiotherapy and correlate to the development of radiation pneumonitis
4. Investigate survival

This prospective longitudinal study planned to include 70 patients with NSCLC in stages I-III who will be its own control group for changes in lung function.

It will be included patients destined to have stereotactic or concomitant chemoradiotherapy in curative intent.

Follow-up will include a physical examination by a pulmonologist, spirometry, determination of the diffusion capacity for carbon monoxide (DLCO), determination of the total lung capacity (TLC), residual volume (RV) and intrathoracic gas volume (ITGV) by body plethysmography, determination of the partial pressure of carbon dioxide (PaCO2) and oxygen (PaO2) by arterial blood gas analysis, the six-minute walking test, the Clinical COPD questionnaire, X-ray and CT scans and blood sample analysis at baseline, 4 to 6 weeks after treatment, and every 3 months thereafter until 12 months after SBRT.

Part of the project is to take blood samples. Specific blood samples will be analyzed to identify biomarkers that could predict the development of radiation-induced lung changes.

Unfortunately, fewer patients than planned were included.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Current lung cancer, not older than 8 weeks
* Received written consent
* Non small cell lung cancer
* Stage IA-IIIA
* Inoperable

Exclusion Criteria:

* Lack of consent
* Operable
* Additional cancer disease
* Small cell lung carcinoma or neuroendocrine lung cancer
External Ventricular Drainage Post-Market Clinical Follow-up Registry

This post-market follow-up registry will capture clinical data specific to the safety and performance of the Integra External Ventricular Drainage Systems and Accessories.

The purpose of this study is to investigate whether the Integra External Ventricular Drainage System listed as part of this study do perform to clinical expectations.

Additionally, this study will focus on the safety of these devices by collecting any device-specific Adverse Events (AEs) or Device deficiencies (DDs) seen when used during standard of care procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable.
2. Patients (of any age) who underwent or who plan to have a procedure with one of the Integra or Codman External Ventricular Drainage System.
3. For patients who have had the EVD System removed prior to study enrollment, have available follow-up data from implant until the EVD System is no longer required for drainage and monitoring of CSF.

Exclusion Criteria:

1. The Patients in whom more than one EVD System were or are intended to be placed.
2. The Patient has sepsis.
3. The Patient has a history of poor wound healing.
4. The patient exhibits signs of scalp infection prior to implantation that would be contraindicated per the IFU.
5. The Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this Registry.
6. The Patient is currently enrolled in another device trial or has been previously entered in this trial.
7. The Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
8. The Patients known to have uncorrected coagulopathy.
9. The Patients with known hypersensitivity to rifampin or clindamycin hydrochloride (prior to implantation of Bactiseal catheters)
Estrogen and Perimenopausal Depression

During perimenopause (the time just prior to menopause), women often notice many biological, psychological, and social changes. In particular, some women experience depressive symptoms during perimenopause that are severe enough to warrant antidepressant medication. Whether or not women with perimenopausal depression respond to antidepressant medication may depend on the level of estrogen in their blood. This study will investigate whether estrogen will help women who only partially respond to antidepressant medications, as well as examine how different doses of estrogen may affect individuals differently.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Unipolar Major Depression, currently taking antidepressants
* HAM-D between 10 and 17

Exclusion Criteria:

* History of Psychosis, breast cancer, smoking, dementia, clotting disorders
* Current substance abuse
The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure

The purpose of this study is to evaluate the efficacy of ranolazine in the prevention of recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved ejection fraction.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female \> 18 years of age;
* Documentation of heart failure and who are in NYHA class II or III;
* Documented history of symptomatic AF \< 6 months in duration at the time of presentation, currently in AF at the time of the external electrical cardioversion, and successfully restored to normal sinus rhythm;
* Percutaneous coronary intervention (PCI) patients who can be placed on anticoagulation with warfarin post-cardioversion (and not on rivaroxaban or dabigatran);
* Demonstration of preserved ejection fraction (EF) by echocardiography;
* Echocardiographic evidence of impaired diastolic filling.

Exclusion Criteria:

* Known history of permanent or long-standing AF (\> 6 months);
* Other acutely reversible causes of AF, including but not limited to: hyperthyroidism, pericarditis, myocarditis or pulmonary embolism;
* Known history of cirrhosis;
* NYHA Class IV;
* Myocardial Infarction, unstable angina, or coronary artery bypass graft surgery within three months prior to screening;
* Percutaneous coronary intervention (PCI) within 4 weeks prior to screening, if these patients need to be placed on rivaroxaban or dabigatran post-cardioversion;
* Clinically significant valvular disease;
* Clinically significant pulmonary disease;
* Stroke within 3 months prior to screening;
* Creatinine clearance \< 30 mL/min as calculated by Cockcroft-Gault formula;
* Use of anti-arrhythmic drugs (Class Ia or IIIc) within 3 months prior to screening;
* Concurrent use of drugs considered strong inhibitors of CYP3A;
* Concurrent use of drugs considered as CYP3A inducers;
* Prior treatment with ranolazine.
Study of the Pathogenesis of Rett Syndrome

OBJECTIVES: I. Extend current knowledge of the phenotype and natural history of Rett syndrome (RS).

II. Continue the search for a cytogenetic and/or DNA marker. III. Study the effects of cholinergic drugs based on preliminary evidence for reduced levels of brain acetylcholine, while continuing supportive care to modify seizures, respiratory abnormalities, and motor disturbances, and improve nutrition, behavior, and learning.

IV. Identify targets for future therapeutic interventions, e.g., growth factors, to influence neurologic recovery.

PROTOCOL OUTLINE: Patients receive a comprehensive clinical evaluation including an ophthalmologic exam; speech, communication, and developmental assessment; nutritional evaluation; neurologic exam; respiratory monitoring; and cytogenetic studies.

Selected patients with malnutrition are given night feedings of Pediasure with Fiber by nasogastric tube. Specific recommendations for feeding techniques and diet are made.

Selected patients with seizures or severe hyperventilation and progressive rigidity are nonrandomly assigned to dextromethorphan or topiramate therapy.

Oral dextromethorphan is maintained 6 months to 1 year; duration of therapy depends on response. Oral topiramate is given for 6 months to 1 year, and Aricept for 6 months to 1 year.

Concurrent anticonvulsants may require dose adjustments while on above protocols. Supportive care for constipation, scoliosis, and weight loss is allowed.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Rett syndrome

Diagnosis confirmed on study
Correlation Between the Efficacy of Neoadjuvant Chemotherapy Combined With Immunotherapy of Operable Thoracic Esophageal Squamous Cell Carcinoma and the Metabolites of Intestinal Flora

This study collects stool, blood, and tumor tissue samples from patients with locally advanced esophageal cancer after receiving Sintilimab and chemotherapy to explore the efficacy and intestinal microbes of chemotherapy combined with neoadjuvant immunotherapy for locally advanced operable thoracic esophageal squamous cell carcinoma The main purpose is the relationship between its metabolites, and it will also explore the changes of intestinal flora diversity and metabolites before and after esophageal squamous cell carcinoma chemotherapy combined with immune neoadjuvant therapy


Eligibility Criteria:
Inclusion Criteria:

* 1) Age ≥18 years old and ≤75 years old; 2) Patients with stage I\~III thoracic esophageal squamous cell carcinoma diagnosed by histopathological examination (excluding mixed adenosquamous carcinoma and other pathological types); 3) ECOG PS score is 0 or 1; 4) It has sufficient organ and bone marrow function.

Exclusion Criteria:

1. Refuse to participate;
2. Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula;
3. Have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody therapy, or any other antibodies targeting T cell costimulation or checkpoint pathways as specific targets or drug;
4. Participate in another interventional clinical study at the same time, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
5. Have received systemic systemic treatment with anti-tumor indications Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration;
6. Have used immunosuppressive drugs within 1 week before enrollment, excluding nasal spray, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (ie no more than 10mg/day prednisone Or equivalent doses of other glucocorticoids), or use hormones to prevent allergy to contrast agents.
REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study

The primary objective is to compare \& evaluate between the treatment groups the changes in decline/reduction of HIV viral load \& increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune placebo groups. Additional objectives include changes in CD4+ \& CD8+ T cell counts along with increased HIV immunity.

This is a 26 subject Multi Center double-blind randomized, Safety \& Efficacy, pediatric HIV/AIDS Phase II study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen and secondarily to examine changes in CD4+ \& CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection \& immunogenicity of Remune. Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune.

Eligibility Criteria:
Inclusion Criteria:

* Children clinically diagnosed with HIV that are 3 months of age to the age 16 years old
* Subjects on any approved FDA antiviral medication except triple cocktail HAART drugs

Exclusion Criteria:

* Truvada
* Triple cocktail HAART drugs
* Healthy subjects
Climatotherapy Versus Topical Combination of Corticosteroids and Salicylic Acid in Treatment of Psoriasis

Psoriasis is a multisystem disease predominately manifested as chronic inflammation of the skin and characterized by scaly, erythematous patches, papules and plaques, which are often pruritic. As chronic disease, psoriasis waxes and wanes throughout patient life time. The disease course is modified with initiation and cessation of treatment, and spontaneous remission is rare. Clinically lesions can be distributed in any part of the body, this leads to impaired consequences on the perception of body image, social relations and in general on quality of life.

The severity of psoriasis is defined by the extent of body surface involvement as well as the involvement of areas that substantially affect daily life such as hands, feet, face and genital region . Approximately 80% of patients have mild to moderate disease and 20% have moderate to severe disease. Although the precise etiology of psoriasis remains unknown, a combination of immunologic, genetic and environmental factors contribute to its development and exacerbation. Psoriasis has multifactorial pathogenesis in which predisposing genetic factors (dysregulation of the immune system and alteration of keratinocytes) and environmental trigger factors (such as local trauma, streptococcal infections, emotional stress, drugs as B-blockers and lithium) interact with each other by triggering a specific immune response mediated by T-lymphocytes.Treatment of psoriasis is still very complex. Several treatments for plaque psoriasis are available as topical medications for mild to moderate cases of psoriasis (corticosteroids, vit D3 analogues, salicylic acid, dithranol etc.). Phototherapy is useful in moderately-severe psoriasis unresponsive to topical therapy alone. Systemic treatment is used for severe forms of psoriasis including immunosuppressive drugs such as methotrexate or cyclosporine, retinoids, etc., and in cases of contraindications or ineffectiveness of these drugs these severe forms of psoriasis can be treated with biological drugs such as adalimumab, etanercept, infliximab, etc.The climatotherapy presents a safe and efficient alternative to conventional therapeutic modality for psoriasis. Climatotherapy treatment is based on healing capacities of natural resources.Climatic treatment includes balneotherapy and sun exposure. Balneotherapy represents a set of methods and practices (bathing, drinking, inhalation, etc.)

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of psoriasis(mild to moderate) .
2. Age 9-60 years

Exclusion Criteria:

1-Patients under 9 years. 2-Patient with severe psoriasis. 3-Skin cancer. 4-Renal insufficiency. 5-Acute infections. 6-Severe hypertension. 7-Skin and systemic diseases worsened by sun exposure. 8-Acute and non controlled concomitant diseases. 9-Ischemic heart diseases or any disease rendering them unable to bathe.
Comparing Different Regional Blocks for Analgesia After Off-pump Cardiac Surgery

This study aims to compare the analgesic effects of erector spinae plane block versus Superficial Parasternal Intercostal Plane Block block along with rectus sheath block after off-pump cardiac surgery

General anaesthesia will be used for all patients. induction by midazolam 0.05-0.1 mg/kg, fentanyl 2-5 µ/kg, propofol 1-2 mg/kg, and atracurium 0.5 mg/kg for intubation. Maintenance by sevoflurane in oxygen-air mixture. regional blocks will be used after the induction of anaesthesia. Intraoperative analgesia will be maintained by fentanyl infusion 1-2 µ/kg/h while morphine sulphate 2.5-5mg will be used as rescue analgesia when pain score\>4 beside acetaminophen 1000 mg /6 hours

Eligibility Criteria:
Inclusion Criteria:

* American Society of anaesthesiologists physical status classification II-III
* Elective off-pump cardiac surgery

Exclusion Criteria:

* Cognitive impairment
* Allergy to local anaesthetics
* Renal and/or hepatic dysfunction
* Ejection fraction\< 45%