cyrilzakka/clinical-trials huggingface dataset:
Innate Immunity Gene Polymorphisms and Yeast Colonization

It is proposed to carry out the study in three medical or surgical intensive care units (ICU) in the CHRU, Lille, and the CHU, Besançon. In all patients admitted to these ICU (see Figure 2), a corrected index of colonisation (CIC) will be determined and blood samples will be taken for genotyping of the lectins MBL, Dectin-1 and Galectin-3 and for serology. Over the duration of hospitalisation (on average 28 days) and weekly, fungal colonisation will be assessed in all patients (according to the CIC), and antibodies to yeast glycans will be determined by a simultaneous multiparametric analysis involving several families of natural or synthetic antigens, and the detection of circulating antigens (mannan and β-1,3 glucan).

Determination of the CIC:

The CIC will be determined on admission and then once a week during hospitalisation. This will be carried out on a fixed day for all patients; we will avoid determining the CIC any closer than 2 days apart. It is not planned in this study to modify the therapeutic strategy of the ICU services. The strains isolated will be stored in glycerol solution at -80°C. The specimens for genetic and serological analysis will be stored centrally in a local mycology laboratory.

Genotyping of lectin genes and TLRs:

Two tubes containing 6 ml of blood in EDTA will be taken from each patient for extraction of DNA

Serological study, detection of antibodies to yeast glycans:

10 ml of whole blood will be taken from each patient on the day of inclusion and over the duration of hospitalisation (maximum total quantity of 40 ml). This will be done on a fixed day for all patients; we will avoid sampling any closer than 2 days apart.

Functional tests on peripheral blood mononuclear cells (PBMCs) Taking into account the fact that the results of genotyping will not be available in real time and the need to work with freshly collected cells, a group size of 50 patients in group 2 (negative CIC over the duration of hospitalisation) and 50 patients in group 3 (negative CIC at admission but positive at hospital discharge) will be analysed.

Stimulation tests will be carried out in the presence of whole yeasts or yeast extracts on sub-populations of cells isolated from 20 ml of peripheral blood in EDTA.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, ≥18 years of age, admitted to medical or surgical ICU for a duration of \>48 h, irrespective of their colonisation status.

Exclusion Criteria:

* -Patient (or their representative) who refuses to participate in the study or to undergo the procedures required for the investigations (mycological sampling in order to determine the CIC, blood sampling for genotyping of DNA and for serology)
* Previous antifungal treatment (in the 15 days preceding admission to the ICU).
* A CIC value based on an insufficient number of sampled sites (\<6).
* Neutropenic patients
* Patients who are receiving immunosuppressants (transplanted, grafted...)
* Patients who do not have universal cover or Social Security cover
Hepatic Artery From Origin to Segmental Branching: a 500 Case CT Study

The origin of the hepatic artery is known to be highly variable, as reported by Michels in 1966 and other authors. This variability has an indisputable impact regarding hepatic, pancreatic and upper gastro-intestinal surgery.

As the investigators go deeper into the liver's parenchyma, full-liver and segment IV studies have also found high levels of variability. Only few cadaveric studies have analyzed the entire liver and with limited sample size.

The current CT technology allows for an accurate analysis of the arterial branching thanks to the 0.625mm voxel.

The aim of this CT study is to describe the anatomy of hepatic arterial segmental branching from the origin of the hepatic artery.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing CT with arterial abdominal imaging

Exclusion Criteria:

* imaging with radiological artefact (movement, biliary prothesis,..)
* hepatic resection (except small non anatomic resections)
The Effect of Awareness-Based Education Given to Individuals With Substance Use Disorder on Self-Efficacy Perception

This study was conducted to determine the effect of mindfulness-based education given to individuals with substance-use disorder according to Self-Efficacy Theory on self-efficacy perception. Sample was 112 (ewperimental group: 56; control group: 56) alpha=0,05 and power=0,80 et the and of study. The experimental group recevied, prepared in accordance with mindfulness, self-efficacy theory psychoeducation program, the control group received routine care. Data were collected 2 times: pretest, 2 month after intervention (for experimental group) and 2 month after pretest (for control group).

Substance use disorders are among the most important problems of our time. It has become a public health problem which is very common in developed and developing countries and affects the individual and the family as well as the society. Treatment of this problem, which leads to important disorders in many parts of individuals' lives, is quite difficult. Primary treatment is carried out by pharmacological methods. In cases where pharmacological methods are not sufficient, treatment is supported with psycho-social methods.

The aim is to identify the effect of mindfulness-based education, which is in accordance with self-efficacy theory, given to individuals who have substance abuse disorders.

The research was planned as a test model with pretest-posttest control groups. Individuals who have been diagnosed with substance abuse in the substance abuse clinic of Turgut Özal Medical Center, and at the Substance Abuse Treatment and Education Centre of Gaziantep 25 Aralık State Hospital formed the core of this study. The research was conducted between January 2018-May 2019. 112 patients, 56 in the treatment and 56 in the control group, participated in the study. Scientific research started after ethical approval. Mindfulness therapy was applied to experimental group patients. For the data collection, the Socio-Demographic Characteristics Questionnaire and Self-Efficacy scale were used. Kolmogorov-smirnov distribution test was used for normal distribution and Cronbach's alpha was used for internal consistency. Percentage, mean and standard deviation in evaluation of patients' demographic data, chi-square test in parametric cases in comparison of control variables of experimental and control groups, Fisher's exact test in non-parametric cases, t-test in dependent groups in comparison of mean scores of experimental and control groups, score in test and control groups in itself. t test was used in independent groups.

Eligibility Criteria:
Inclusion Criteria:

* To be able to communicate,
* 18 years and older,
* Diagnosis of substance use disorder according to the diagnostic criteria in DSM-V,
* No prior training in awareness therapy or self-efficacy theory,

Exclusion Criteria:

* Patients who actively use alcohol or psychoactive substances,
* Those who show withdrawal symptoms due to substance use disorder,
* Psychotic patients due to substance use
* Want to leave the work
* who cannot continue psychoeducation regularly
* low mental capacity
Transversus Thoracic Muscle Plane Combined With Pectoral Nerves Block for Breast Cancer Surgery

This is a prospective, randomized, controlled trial for evaluating the efficacy of addition of transversus thoracic muscle plane block to pectoral nerves block versus pectoral nerves block for quality of recovery scores in breast cancer surgery.

The pectoral nerves (PECS) block cannot block the most internal mammary region, whereas a transversus thoracic muscle plane (TTP) block can. The combination of PECS and TTP blocks may be suitable for breast cancer surgery. We studied patients undergoing breast cancer surgery to assess whether the combination of PECS and TTP blocks provides better postoperative recovery than PECS block alone.

Eligibility Criteria:
Inclusion Criteria:

* female, 18-80 years of age
* American Society of Anesthesiologists physical status I-III
* patients having elective unilateral breast cancer surgery

Exclusion Criteria:

* contraindication to nerve block
* inability to understand or communicate with research personnel
* chronic use of opioids or nonsteroidal anti-inflammatory drugs
* pregnancy
An Observational Study Assessing Effects in Patients With Combination Therapy With Raloxifene/Cholecalciferol

This study examines quality of life and patient satisfaction in postmenopausal women receiving raloxifene to prevent/treat osteoporosis, and vitamin D to reduce risk of fracture using clinical practice data. The purpose of this study is to observe quality of life(QOL), medication compliance and patient satisfaction who got combination therapy with raloxifene/cholecalciferol (raloxifene 60mg + cholecalciferol 800 IU, Rabone D®, Hanmi Pharma, South Korea) for 6 months.

Preventing bone loss is an important concern for women during post-menopausal period. Menopause significantly speeds bone loss and increases the risk for osteoporosis. This study was to investigate the effectiveness on quality of life (QOL), patient satisfaction in postmenopausal women receiving raloxifene/cholecalciferol combination therapy. In addition, we analyzed adverse events to assess the safety profile of this drug.

This study is a multicenter, prospective, non-critical observational study of women receiving raloxifene/cholecalciferol (raloxifene 60mg + cholecalciferol 800 IU, Rabone D®, Hanmi Pharma, South Korea) combination therapy to treat or prevent postmenopausal osteoporosis. Data will be collected from patients receiving routine treatment at about 105 primary, secondary, or tertiary medical institutions in South Korea. Each subject visits the institution according to the protocol that designed the follow-up visits for six months to examine changes in, and factors influencing quality of life (EQ-5D-5L method), patient satisfaction with efficacy and convenience (questionnaire), and safety. This study will approved by the institutions' IRBs and is in compliance with clinical research ethics regulations.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women who need to prevent/treat osteoporosis
* Subject who got raloxifene/cholecalciferol combination therapy prescription with confirmation by the investigator's medical decision
* Subjects who can consent voluntarily

Exclusion Criteria:

* Patients for whom use of raloxifene/cholecalciferol combination therapy is prohibited
* Pregnant women, nursing women or child-bearing aged females deemed capable of pregnancy
Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease

This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.

This study is conducted for Exploration of Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease. This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for cerebral small vessel disease.
* Dysphagia confirmed by Videofluoroscopic Swallowing Study
* Mini-Mental State Examination (MMSE)\<27, indicating the existence of cognitive impairment.
* No history of prior stroke.
* Stable vital signs.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
* Cognitive impairment that might be caused by other diseases, such as Alzheimer's disease.
* Neurological blockade contraindications such as bleeding tendency, blocked site infection.
* Unable to successfully finish the assessment of this study.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females
Rectovestibular Fistula Which Surgical Approaches?

This study was a prospective, randomized, comparative study that included female children with rectovestibular fistulae who were selected from patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital during the period from January 2016 to February 2020. The patients were randomly divided into four groups according to the procedure performed: trans- sphincter anorectoplasty(TSARP), posterior sagittal anorectoplasty, classic anterior sagittal anorectoplasty (ASARP), and modified ASARP.

Background: The management of a vestibular fistula is a challenge for pediatric surgeons. The investigator compared four different operative techniques in terms of postoperative complications, continence, and cosmetic appearance. Patients and methods: This study was a prospective, randomized, comparative study that included female children with rectovestibular fistulae who were selected from patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital during the period from January 2016 to February 2020. The patients were randomly divided into four groups according to the procedure performed: trans- sphincter anorectoplasty(TSARP), posterior sagittal anorectoplasty, classic anterior sagittal anorectoplasty (ASARP), and modified ASARP.

Eligibility Criteria:
Inclusion Criteria:

* Female children aged 6 months to 12 years who had rectovestibular fistulae that had been treated by a single-stage repair were included in this study.

Exclusion Criteria:

* Exclusion criteria were patients with recurrence, previous anorectal surgery.
* Patients with anovestibular fistulae.
* Patients with rectoperineal fistulas.
* Patients with cognitive impairment.
Study of the Therapeutic Effect of Atorvastatin on the Clinical Outcomes in HER2 Negative Breast Cancer Patients"

Statins, a major class of drugs for treatment of hypercholesterolemia, are widely used due to a notable prevention of cardiovascular disease, and accumulating evidence proposes a promising role of statins in breast cancer

Statin has lipid independent effects include inhibition of inflammatory responses, immunomodulatory actions, apoptotic and antiproliferative effects, which might contribute to the suggested anti-tumoral effects of these agents. The epidemiological evidence projecting statins as anticancer agents is variable, depending on the particular type of cancer in question as well as the class of statin used

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed breast cancer any stage confirmed by radiological and pathological or by clinical evaluation undergo surgery or receiving neo/adjuvant chemotherapy treatment
2. Age above 18 years
3. HER2 negative core biopsy
4. Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
5. Patients must be accessible for treatment and follow-up
6. Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2

Exclusion Criteria:

1. Known hypersensitivity reaction to the investigational compounds or incorporated substances
2. patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, cardiac arrhythmia)
A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of a 30-week course of mavacamten and the long-term effects of mavacamten in Japanese participants with symptomatic obstructive hypertrophic cardiomyopathy (HCM).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and greater, body weight ≥ 35kg
* Has adequate acoustic windows to enable accurate transthoracic echocardiograms (TTEs)
* Diagnosed with obstructive hypertrophic cardiomyopathy consistent with current American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Japanese Circulation Society guidelines
* Has documented left ventricular ejection fraction (LVEF) ≥60% NYHA Class II or III

Exclusion Criteria:

* Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy
* History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to Screening
* History of resuscitated sudden cardiac arrest (at any time) or known history of appropriate implantable cardioverter defibrillator (ICD) discharge for life-threatening ventricular arrhythmia within 6 months prior to Screening
* Paroxysmal atrial fibrillation with atrial fibrillation present at the time of Screening.
* Persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate controlled within 6 months prior to Screening
* Treatment (within 14 days prior to Screening) or planned treatment during the study with cibenzoline, disopyramide or ranolazine
* Treatment (within 14 days prior to Screening) or planned treatment during the study with a combination of beta blockers and verapamil or a combination of beta blockers and diltiazem
* Has been successfully treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\]) within 6 months prior to Screening or plans to have either of these treatments during the study
* ICD placement within 2 months prior to Screening or planned ICD placement during the study
* Has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation procedures, or completion
* Prior treatment with cardiotoxic agents such as doxorubicin or similar

Other protocol-defined inclusion/exclusion criteria apply
Aligning Patients and Their Primary Care Providers

This project focuses on improving the patient-provider primary care visit interaction by addressing the need to align patient and provider priorities in a way that incorporates patients' goals and preferences while supporting the clinical work of their providers.

The aim of this clinical trial is to enroll new and/or complex patients and their physicians in a 12-month randomized study. At each scheduled primary care visit during the trial period, Intervention Patients will be provided with a waiting room Tablet loaded with the "Visit Planner" intervention tool designed to support prioritization and discussion of top health care concerns. Control Patients will be given a written educational handout to review. Patient-centered outcomes will be obtained at baseline and after visits using validated survey instruments. Clinical outcomes focus on differences in quality of care. If successful, this approach to aligning patient and provider visit priorities can potentially be disseminated and adapted to a wide variety of different care settings.

Eligibility Criteria:
Inclusion Criteria:

* Kaiser Permanente member with an assigned primary care provider, with at least one quality care gap at baseline (overdue screening tests, elevated risk factor levels, sub-optimal adherence to chronically prescribed medicines, current smoker)
* Patients must be either:

  * 1) relatively new to their provider (0-3 visits in past 18 months) or if associated with their provider for \> 18 months,
  * 2) have evidence for medical complexity (4 or more prescribed medicines, in a chronic disease management program, or recently admitted to hospital or emergency department)

Exclusion Criteria:

* Excluded by their primary care provider
Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines

The purpose of this study is to assess the effect of rosuvastatin (up-titrated to a dose of 40mg/day) compared to placebo on cardiac remodelling, estimated by change in left ventricular ejection fraction on radionuclide ventriculography, at 26 weeks post randomisation from baseline.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent, males or females aged 18 or older, LVEF ≤ 40% assessed by RNVG or contrast ventriculogram or ≤ 35% assessed by TTE within the previous 6 months, LVEF \< 45% as assessed by RNVG during Visit 1, NYHA Class II, III or IV symptoms primarily related to heart failure, ischaemic and non-ischaemic patients and on stable heart failure therapy as defined by physician's best practice.

Exclusion Criteria:

* Key exclusion criteria include acute myocarditis within the last 12 months, diabetes mellitus not controlled by diet, oral therapy or insulin therapy, homozygous familial hypercholesterolaemia, receiving biventricular pacing or expected to receive biventricular pacing in the next 6 months, subjects who normally would be considered for statin therapy in the next 6 months, sever hypertension, history of definite myocardial infarction, cerebrovascular accident, percutaneous transluminal coronary angioplasty or coronary bypass graft within 3 months prior to enrolment in the study, body mass index \< 15, plus others.
Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence

Purpose: To evaluate the sensitivity and specificity of the method for determining the clinical class of chronic venous diseases using the Ivenus application (within C0-C2 according to CEAP).

Materials and methods: Patients who applied to several phlebology clinics for an initial consultation are consistently included in a multicenter prospective study. At the appointment, a doctor with at least 5 years of experience takes photographs of the lower extremities and uploads them to the IVENUS application, which automatically determines the clinical class according to CEAP, without showing the results to the surgeon (blinding). Further, the doctor independently determines the clinical class according to CEAP and enters the data into the register.

The object of the study is a photograph of a certain area of the lower limb.


Eligibility Criteria:
Inclusion Criteria:

* C0-C2 CEAP clinical class;
* Signed consent to take part in investigation.

Exclusion Criteria:

* C3-C6 CEAP clinical class;
* Skin diseases of the lower extremities;
* Immobilization.
Management of Acute Uncomplicated UTIs in Adults by Community Pharmacists

This study is to be conducted in community pharmacies. It involves the use of trained mystery patients to evaluate community pharmacists at baseline and post intervention. The pharmacists will be divided into control and intervention groups using computer generated codes. Those in the intervention group will receive an online training by clinical pharmacists. The training will employ the use of didactic teaching and the use of case studies and simulations covering the diagnosis and management of acute uncomplicated urinary tract infections in adults. Post intervention, mystery patients will revisit the community pharmacists in the control and intervention groups for re-assessment.


Eligibility Criteria:
Inclusion Criteria:

* The superintendent pharmacist, or the pharmacist manager or any other post National Youth Service Corps pharmacist

Exclusion Criteria:

* Interns, and pharmacists undergoing the mandatory National Youth Service Corps program.