cyrilzakka/clinical-trials huggingface dataset:
Preoperative Use of Alprazolam and Hydroxyzine in Anxiety

Patients will be divided into three groups. Group H patients will be given 100 mg Hydroxyzine orally 1 hour before surgery while group A patients will receive 0.5 mg Alprazolam orally. group P will be placebo group. Amsterdam Preoperative Anxiety and Knowledge Scale (APAIS) anxiety scores will be evaluated and recorded 1 hour before surgery. APAIS score will be evaluated again in the the operation room before surgery started. After base measurements of patients are recorded with standard monitoring, spinal block will be performed with 15 mg Heavy Bupivacaine from the L2-L3 or L3-L4 levels of spinal cord in sting position. When T10 level sensory block and Bromage 0-1 neuromusculer block will be occured , surgery will be started. Heart rate, non-invasive arterial blood pressure and the degree of peripheral O2 saturation will be measured at 5 minutes interval throughout the operation. IOWA anesthesia satisfaction scale will also performed to the patients the day after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* sacrococcygeal dermoid cyst patients
* Saceptance of spinal anaesthesia
* between 18-60 years old patients
* ASA I-II

Exclusion Criteria:

* drug allergy
* BMI\>35kg/m2
* psychiatric disorders
* serious renal and hepatic damage
* coagulation disorders
* serious cardiac and respiratory disorderders
* rejection of spinal anesthesia
Compliance Monitoring in Real Time During Opioid Substitution Treatment

The aim of the study is to examine whether electronic compliance monitoring in real time could offer some advantages compared to normal electronic monitoring in opioid substitution treatment. The investigators would also like know whether this method could enable the quick detection of possible problems in medication intakes and/or prevent the abuse or diversion of substitution medications.


Eligibility Criteria:
Inclusion Criteria:

* Opiate dependence
* Suboxone treatment
* Stable substitution medication dose

Exclusion Criteria:

* Chaotic situation in life
Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction

Factors influencing the prognosis of patients with heart failure with preserved ejection fraction (HFpEF) have been extensively studied. Previous studies have found that elevated serum total bilirubin levels are associated with cardiac death, heart failure readmission, and all-cause mortality in patients with chronic heart failure. However, the relationship between direct bilirubin and prognosis in patients with HFpEF is unclear.

Patients with heart failure with preserved ejection fraction account for approximately 50% of all heart failure patients, have approximately 1.4 hospitalisations per year and an annual mortality rate of approximately 15%. Till now, there have no definitively proven therapies that can reduce their morbidity and mortality, HFpEF Patients have a poor prognosis. The current study found that the prognosis of patients with HFpEF may be related to the heterogeneity of the disease, its various phenotypes and multifactorial pathophysiology, which has not been fully elucidated. The current study found that bilirubin is a risk factor for adverse outcomes of various HFpEF-related complications, but the relationship between direct bilirubin and prognosis of HFpEF has not been reported. Therefore the investigators speculate that direct bilirubin is a predictor of prognosis of HFpEF patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged ≥18 years old；
* Diagnosed with HFpEF.

Diagnostic criteria including:

1. left ventricular ejection fraction ≥ 50%;
2. with the symptoms and/or signs of heart failure;
3. Patients in sinus rhythm：BNP≥35pg/ml and/or NT-proBNP≥125pg/ml；Patients with atrial fibrillation：BNP≥105pg/ml and/or NT-proBNP≥365pg/ml.

Exclusion Criteria:

* LVEF less than 49% at any time
Comparison of Different Teaching Methods in Increasing Nursing Students' Competencies for Safe Use of Medical Devices

A significant portion of nursing practice involves the application of technical skills and the use of medical devices. Nowadays, the number and complexity of medical devices in healthcare settings are increasing. Therefore, it is of great importance for nurses to have appropriate knowledge and skills in this field to provide adequate and safe patient care.

Nursing education plays a vital role in equipping student nurses with the necessary knowledge and skills to become competent and reliable healthcare professionals. The use of interactive methods in education has a significant impact on enhancing nursing students' competencies. There is a lack of sufficient research in the literature regarding the effectiveness of teach-back and video-supported instruction on the safe use of medical devices. Hence, this study aims to compare the effectiveness of teach-back and video-supported teaching methods in enhancing nursing students' competencies in the safe use of medical devices.

The research will be conducted between September 2023 and May 2024 in a designated training room at the hospital where the clinical training of senior nursing students takes place. The sample of the study will consist of a total of 105 students, who will be divided into three groups using randomization: a teach-back group (35 students), a video-supported instruction group (35 students), and a control group (35 students). Data will be collected using the Student Information Form, Medical Device Usage Competency Self-Assessment Form, Medical Device Usage Competency Knowledge Test, and Medical Device Usage Competency Observer Evaluation Form. For data analysis, the normality of the data will first be determined using the Shapiro-Wilk normality test. Parametric tests will be used for normally distributed data, while non-parametric tests will be used for non-normally distributed data.

Eligibility Criteria:
Inclusion Criteria:

* Be a senior nursing student
* Be taking the Nursing Care Management course for the first time
* Have no previous work experience as a nurse outside of clinical training
* Have no visual, auditory, cognitive, or perceptual impairments
* Not have received any planned training program or course specifically on the use of infusion pumps, patient monitors, and suction devices
* Have access to an Android phone or computer for the study.

Exclusion Criteria:

* Have graduated from a Health Vocational High School.
* Be taking the Nursing Care Management course for the second time.
* Obtain a score above the predetermined threshold on the knowledge test.
Oncologists Satisfaction With Outcomes of Some Cytotoxic Agents

The study measures the degree of oncology physician satisfaction with the outcomes of some cytotoxic agents.

This is a prospective observational questionnaire based study measuring the degree of satisfaction of medical oncologists with the results of some expensive cytotoxic agents. The study also measures the physician knowledge with the toxicity profile of the tested drugs, pharmaceutical perspectives, methods of administration, adherence to guidelines and the degree of bias of the physicians when prescribing this drugs.

The tested drugs are trastuzumab, lapatinib, sunitinib, m tor inhibitors, sorafenib, cetuximab, panitumumab, bevacizumab, erlotinib, rituximab, imatinib mesylate, gefitinib, abiraterone acetate, cabazitaxel, pertuzumab, fulvestrant, pemetrexate and crizotinib.

The evaluation will be through a predesigned questionnaire ( 30 questions ). The questions are divided into four categories measuring four items, the degree of physician satisfaction with the drugs results and toxicity profile, orientation with pharmaceutical perspectives of the drugs, adherence to guidelines and degree of bias with pharmaceutical companies complements. A predesigned questionnaire based scoring system will categorise the processed data to low, intermediate and high score for each of the four measured topics. The data will be processed and the degree of satisfaction, orientation with pharmaceutical perspectives, adherence to guidelines and degree of bias will be grade to low, moderate or high. Subsequent recommendations for cost effective analysis, physician education and strict auditing measures for drug prescription will be elaborated for the drugs.

NB: The study will be on two waves. The first wave will evaluate 9 drugs and the second wave will evaluate 8 drugs.

Eligibility Criteria:
Inclusion Criteria:

* Physicians ranked from senior resident to professional consultants

Exclusion Criteria:

* Junior residents.
PROPHY-VAP: Prevention of Early Ventilation Acquired Pneumonia (VAP) in Brain Injured Patients by a Single Dose of Ceftriaxone

Ventilation-associated pneumonia (VAP) is the main site of healthcare-associated infections in the brain injured patients, with an incidence rate of 22% to 58%. VAP increases morbi-mortality, length of stay in intensive care and overall management costs. The prevention of ICU nosocomial infections depends on several measures : orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm of water (H2O), maintaining a semi-seated position \>= 30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation. Two randomized study show that administration of antibiotic therapy after intubation reduces the risk of early VAP incidence. However, in clinical practice, its administration solely purposes of limiting VAP occurence is not presently recommended. Indeed, to date no placebo blind controlled study was been realized and the fear of development of bacterial resistance remains stronger than the efficiency of this prevention measure. This aim of the present study is to show by a placebo randomized study that 2g of Ceftriaxone within 8 hours post-intubation after a brain injury decrease the risk of occurence an early VAP.

Ancillary study An ancillary study is performed in 2 centres which routinely practice rectal swabs at admission and discharge of ICU, to survey intestinal flora (CHU of Angers and CHU of Rennes). The goal of this study is to compare the incidence of acquired cephalosporin resistant gram negative bacteria at the discharge of ICU between the 2 groups of patients, receiving or not ceftriaxone.


Eligibility Criteria:
Inclusion Criteria:

* Brain injured patients with a Glasgow scale score ≤ 12 who require ventilation more than 48 hours

Exclusion Criteria:

* Patient with a high risk of death within the 48 first hours after admission,
* Patient intubated for more than12 hours
* Intubation after the 48th hours after admission
* Coverage to cardiopulmonary arrest
* Coma due to a tumor, an infectious disease or a cardiac arrest
* Previous hospitalisation within the last month before admission for coma
* béta-lactamines allergy
* Patient who receive already antibiotics at the admission for a previous infection
* Prophylactic antibiotic due to be done within 24 hours following the randomisation
* Patient Intubated through a tracheal tube with subglottic secretion aspiration
* Patient with a tracheotomy
* Patient or family refuse to be involved in the study
* Use of Ceftriaxone within 2 days before enrolment
* Participation in another research protocol focusing on an anti-infective treatment or on a measure decreasing the risk of infection
* Patients not affiliated to a social security scheme, Pregnant woman or breast-feeding mother, Patients deprived of their liberty by judicial or administrative decision
Effect of High Intensity Interval Training and Ultrasound Cavitation on Lipid Profile in Type 2 Diabetes Patients

The study aim to find out the combined effect of high intensity interval training and ultrasound cavitation on lipid profile in type two diabetic patient with abdominal obesity.

study aim to find out the combined effect of high intensity interval training and ultrasound cavitation on lipid profile in type two diabetic patient with abdominal obesity.Type two diabetic patients with abdominal obesity , randomly assigned into 3 equal groups: 66 patients

1. study group (A) 22 patients : They will receive ultrasound cavitation , HIIT and diatery advice .
2. study group (B) 22 patients : They will receive HIIT and diatery advice .
3. control group 22 patients They will only receive diatery advice.

Eligibility Criteria:
Inclusion Criteria:

* patient with type 2 diabetes.
* waist circumference \>102 cm in male ,\>88 cm in female
* lipid profile range will be (between border line and high risk ).

Exclusion criteria:

Kidney disease Heart disease Lung disease ,Liver disease ,Neurological disorders ,Pregnant women , breast feeding, immune deficiency , cancer Heavy smoker

Exclusion Criteria:

-
Temozolomide as Maintenance Therapy Following Induction Chemotherapy in Extensive Stage Small Cell Lung Cancer

Temozolomide may delay progression in sequence with chemotherapy. This open-label, randomized,multicenter phase II trial was designed to evaluate the role of Temozolomide following 4 or 6 cycles of platinum-based first-line chemotherapy in patients with newly diagnosed estensive-stage SCLC.


Eligibility Criteria:
Inclusion Criteria:

* Cytologically and/or histologically confirmed small-cell lung cancer with extensive-stage disease
* Patients must have measurable disease, this can include brain metastases
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Adequate bone marrow function, as defined by: absolute neutrophil count (ANC) \>1,500/µL; platelets \>100,000/µL; hemoglobin \>=9.0 g/dL
* Normal organ function, defined as follows: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<=2.5 × the upper limit of normal (ULN), or AST and ALT \<=5 × the ULN if liver function abnormalities are due to underlying malignancy; total serum bilirubin \<=1.5 × the ULN; serum creatinine \<=1.5 × the ULN
* the time interval from the data of the last chemotherapy to random must be between 3 and 7 weeks
* Women of childbearing potential and men with partners of childbearing potential must agree to use a form of birth control that is acceptable to their physician to prevent pregnancy during treatment
* Patients must be informed of the investigational nature of this study and sign an informed consent form

Exclusion Criteria:

* Patients who are pregnant or breastfeeding
* Patients receiving other investigational agents
* Patients with leptomeningeal involvement
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
* Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition or HIV-positive patients on combination antiretroviral therapy. However, HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because these patients are at increased risk of lethal infections when treated with marrow- suppressive therapy. Excluding patients on HAART is necessary due to the potential for pharmacokinetic interactions with temozolomide.
Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo

The main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of Praluent.


Eligibility Criteria:
Key Inclusion Criteria:

* Men and women ≥ age 40 years and ≤ age 85 years
* Patients with heterozygous familial hypercholesterolemia (heFH) or with non-familial hypercholesterolemia (non-FH) patients at high or very high cardiovascular risk
* Patients with history of coronary heart disease (CHD) not having adequate control of their hypercholesterolemia with LDL-C ≥70 mg/dL, or all other patients with LDL-C ≥100 mg/dL and be on maximally-tolerated dose of statin (unless they are statin-intolerant)
* Patients must have successfully completed the Motor Screening Task
* Patients must be willing and able to comply with clinic visits and study related procedures
* Patients must provide signed informed consent

Key Exclusion Criteria:

* Patients with known Alzheimer's disease or other dementia, schizophrenia, bipolar disorder, severe depression, cognitive impairment, or patients with a sleep disorder requiring daily pharmacological treatment
* Recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease
* Certain laboratory findings obtained during the screening visit as defined in the protocol
* Any condition or situation, including other significant mental or neurological disorders that, in the investigator's opinion, may confound the study results, or may interfere significantly with the patient's participation in the study
* Pregnant or breastfeeding women
* A positive human immunodeficiency virus (HIV) test

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Multidisciplinary Treatment of Obesity Prior to in Vitro Fertilization: Impact on Global Reproductive Outcomes (PRO-FIV Study)

The aim of the present study is to evaluate the impact of a multidisciplinary treatment of obesity prior to IVF on global reproductive outcomes and maternofetal metabolic and cardiovascular risk factors.

This is a randomized controlled trial in obese infertile women before starting an IVF cycle. The intervention is based on a structured multidisciplinary program in support groups, which includes diet, physical activity and psychological therapy. IVF will be started immediately after this therapy. Patients included in the control group will start an IVF cycle immediately after the randomization. The results of this study may allow the identification of patients who would benefit from obesity treatment, so as to establish appropriate preventive and therapeutic strategies and to reduce the maternal obesity impact in future generations.

The aim of the present study is to evaluate the impact of a multidisciplinary treatment of obesity prior to IVF on global reproductive outcomes and maternofetal metabolic and cardiovascular risk factors.

This is a randomized controlled trial in obese infertile women (body mass index ≥30 kg/m2) before starting an IVF cycle. In the intervention group, the aim is a weight loss of at least 10% in a 16-week period of treatment based on a multidisciplinary approach and support groups, which includes diet, physical activity and psychological therapy. IVF will be started immediately after this period. Patients included in the control group will start an IVF cycle immediately after the randomization. The results of this study may allow the identification of patients who would benefit from obesity treatment, so as to establish appropriate preventive and therapeutic strategies and to reduce the maternal obesity impact in future generations.

Eligibility Criteria:
Inclusion Criteria:

* Obese infertile patients (body mass index ≥ 30 Kg/m2) prior to an in vitro fertilization cycle

Exclusion Criteria:

* Pathological conditions: diabetes type I, Cushing syndrome, premature ovarian failure, uncontrolled thyroidal dysfunction, hepatic and/or renal dysfunction, antiphospholipid syndrome, medical condition that contraindicate ovarian stimulation and/or pregnancy
* Simultaneous practice of another strategy to lose weight
* Physical conditions limiting exercise training
* Patients unable to understand spanish language or to give informed consent
PG Versus TG for Advanced PGC

We conducted a retrospective study on patients with pathological stage II-III PGC who underwent PG or TG from 2013 to 2023. Propensity score-matching was applied to adjust for tumor size and stage between the PG and TG groups at a 1:1 ratio. We evaluated the procedural safety, oncological, and functional outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Proximal gastric adenocarcinoma after total or proximal gastrectomy.

Exclusion Criteria:

* Non-curative resections
* Non-adenocarcinoma histology
* Distally located tumors or middle/proximally located tumors for which distal margin could not be secured by PG
* Remnant gastric cancer
* Clinically T1N0 tumors smaller than 3 cm for which PG was clearly indicated
Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer

This study is for patients with breast cancer that has spread to other tissues and organs. The purpose of this study is to identify patients who may respond favorably to certain types of hormonal therapy. Researchers will study your tumor, which was removed during your breast surgery. They will look for the presence or absence of Androgen (AR) receptors. These tests are for research purposes only. They will not affect the treatment of your breast cancer. The presence or absence of Androgen receptors on the tumor does not alter the therapy that is offered to patients. Recent evidence suggests that AR+ tumors are more likely to be destroyed when treated with androgen drugs. We will ask about 35 ER-/PR- breast cancer patients from Legacy Health System to be in this study. All tests and procedures are done as an outpatient in the doctor's office, a clinic, or at the hospital. The study drug that will be used in this trial is Androxy®, a synthetic androgen hormone. Androgens have been shown to inhibit the growth of some breast cancer cells. Arimidex is an aromatase inhibitor that will be used in conjunction with Androxy to inhibit the in vivo production of estrogen. It is hoped that the combination of these two drugs will inhibit the growth of your tumor and possibly cause it to shrink.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* ER Negative and PR Negative
* Progression of disease in the metastatic setting despite taxane or other chemotherapeutic therapies including Herceptin (patients on Herceptin may continue this therapy while on study)
* Maximized chemotherapy in the metastatic setting or patient experienced side effects contributing to decreased quality of life and elects to defer chemotherapy
* Evaluable disease by either:

  * CT Scan with or without contrast (lesions must be greater than 2 mm)
  * PET Scan, or Bone Scan, or Plain skeletal films
  * Chest wall or skin recurrence (digital photo to capture evaluable disease)
* Evaluable symptoms (pain, shortness of breath, fatigue, anorexia)
* Performance Status of 0, 1, or 2
* Bilateral mammogram performed within one year before registration

Exclusion Criteria:

* Uncontrolled hypercalcemia greater than 11
* Uncontrolled congestive heart failure greater than 2 NYHA class
* Central Nervous System metastasis
* Concomitant steroid use
* Performance Status of greater than 2
* Bilirubin greater than 5.5