cyrilzakka/clinical-trials huggingface dataset:
Glucose Control in Open Heart Surgery

The purpose of the study is to seek if there is difference to state glucose level in 80-120mg/dl or 200mg/dl in patients submitted to open heart surgery

Hyperglycaemia in the intensive care unit and perioperative period has been accused to be one of the causes of worse clinical outcome. It is known that in open heart surgeries the glucose level must be set less than 200mg/dl, but new trials had set the glucose level lower than that: 140mg/dl in some studies and even lower (80-110mg/dl). Our trial had the intention to seek if there is difference setting glucose level in 2 different ones would modifies clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* adult more than 21 years old
* open heart surgery with cardiopulmonary bypass

Exclusion Criteria:

* renal dysfunction
* reoperation
* use of inotropic support
* neurological dysfunction
* chronic pulmonary obstructive disease
* emergency or urgency
Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor

This is a Phase 1, single-center, fixed-sequence, open label, drug-drug interaction study of the effect of multiple daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A, given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations are given after a meal.


Eligibility Criteria:
Inclusion Criteria:

* Be healthy
* Have a BMI of 18 to 32 kg/m2, inclusive and body weight more than 50 kg (110 pounds)
* Be judged to be in good health, based on the results of medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings
* Have suitable veins for multiple venipuncture/cannulation

Exclusion Criteria:

* Have multiple drug allergies, or be allergic to any of the components of mifepristone or itraconazole
* Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
* In the 1 year before study drug administration, have a history of drug or alcohol abuse
* In the 6 calendar months before study drug administration, on average

  * Have smoked more than 5 cigarettes/day
  * Have consumed more than 21 units of alcohol/week (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor)
* In 2 months prior to study drug administration, have donated/lost blood or plasma in excess of 400 mL
* In the 30 days before study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine
Comparison of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine

For patients with symptomatic cholelithiasis, laparoscopic cholecystectomy (LC) is a customary procedure for treatment these days. After LC, patients may experience considerable pain. This study was performed with the objective of comparing the mean duration of analgesia of intraperitoneal bupivacaine with dexmedetomidine to intraperitoneal bupivacaine alone in patients undergoing laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either gender
* Aged between 20 and 70 years
* ASA (American Society of Anesthesiologists Classification) physical status I and II
* Undergoing Laparoscopic Cholecystectomy under general anesthesia

Exclusion Criteria:

* Patients sensitive to local anesthetics
* Patients with acute cholecystitis, choledocholithiasis, or ascending cholangitis (temperature≥38.6°C, serum bilirubin≥1.2mg/dl, and ultrasound showing common bile duct diameter of ≥1cm).
* Patients with uncontrolled diabetes (FBS≥110 mg/dl)
* Uncontrolled blood pressure (SBP≥140 mmHg)
* Ischemic heart disease (EF≤40%)
* Pulmonary dysfunction (FEV≤70 percent of normal)
Ethyl Chloride for NPWT

Negative pressure wound therapy (NPWT) has been shown to improve wound care outcomes for acute and chronic wounds as well as for surgical incision sites. We have found that patients report significant pain during dressing changes specifically with the removal of the clear adhesive drape. Upon review of the literature, there were multiple studies related to pain and the removal of the sponge (filler) but limited studies relating to the pain associated with the removal of the drape. The patient reported pain with drape removal has led to increased psychological stress and decreased compliance with the dressing change protocol. Application of a topical anesthetic to the drape during the dressing change has the potential to decrease the pain experienced by the patient. An FDA approved ethyl chloride spray is a topical anesthetic that can be sprayed onto the outer perimeter of the drape during the dressing change as a means to decrease pain. We hypothesize that the use of ethyl chloride spray will result in patients experiencing less pain leading to decreased psychological stress, improved compliance with dressing changes, and overall improved customer satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* an orthopaedic/trauma wound and/or surgical incision
* treatment with NPWT as a hospital inpatient
* minimum of at least one NPWT dressing changes or discontinuation of NPWT prior to discharge.
* dressing change in enterostomal therapy department

Exclusion Criteria:

* cognitive impairment preventing informed consent
* history of hypersensitivity to cold/vapocoolant
* outpatient NPWT
4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C

The purpose of this study is to determine if taking nitazoxanide alone for 4 weeks followed by 36 weeks of nitazoxanide plus peginterferon is superior to peginterferon plus ribavirin (standard of care) for 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C

Exclusion Criteria:

* Previously failed to respond to at least 12 weeks of peginterferon plus ribavirin combination therapy.
* Unable to take oral medication.
* Females who are either pregnant, breast-feeding or not using birth control.
* Males whose female partners are pregnant or plan to become pregnant.
* Other causes of liver disease (for example, autoimmune hepatitis, decompensated liver disease).
* Patients with HIV, HAV, HBV or HDV.
* Patients with a history of alcoholism or with an alcohol consumption of more than 40 grams per day.
* Patients with hemoglobinopathies (for example, thalassemia major, sickle-cell anemia).
* History of hypersensitivity or intolerance to nitazoxanide or peginterferon.
Evaluation of Healthcare Workers Knowledge Regarding Their Vaccination Status at Melun Hospital

The goal of this observational study is to learn about the rate the of knowledge of own vaccination status among healthcare workers working at Groupe Hospitalier Sud Ile de France. The main question it aims to answer are : knowledge of own vaccination status is less than 50% among healthcare workers working at Groupe Hospitalier Sud Ile de France and the assessment of the relationship between healthcare workers of Groupe Hospitalier Sud Ile de France and vaccination in general.

Healthcare professionals in France are subject to a number of vaccination obligations, and following successive anti-SARS-CoV2 vaccination campaigns, these obligations are under discussion. Even healthcare professionals are reluctant to be vaccinated , particularly in view of annual vaccination rates against seasonal influenza: 22% were vaccinated against seasonal influenza in 2022, and 25.9% knew their general vaccination status.

As part of the national "European Vaccination Week" event organized by the French Ministry of Health and Prevention, we propose a questionnaire designed for hospital healthcare workers to assess their knowledge of their own vaccination status, and evaluate their attitude with vaccination.

The link to the questionnaire will be forwarded to staff e-mail addresses, and it will be administered on a one-off basis. At least 100 professionals will be surveyed. Each participant is expected to complete the questionnaire in 10 minutes, and the total duration of the research is one week.

Eligibility Criteria:
Inclusion Criteria:

* Anyone working at GHSIF

Exclusion Criteria:

* Any person refusing to participate
Longevity, Functional Status and Quality of Life of the Compress® Compliant Pre-Stress System

In the treatment of malignant bone tumors, it may be necessary to remove large areas of the femur. To replace these large parts of missing bone, a prosthesis can be used. One innovative technology developed by Biomet is the Compress® Compliant Pre-Stress System (CPS; Zimmer-Biomet, Warsaw, USA). This fixation device uses compression, via a short traction bar, to stimulate osteointegration at the bone-prosthetic interface, promote hypertrophy of the loaded bone, and avoid stress bypass of the host bone around a stiff intramedullary stem. Young patients cured of tumors have a long life expectancy and a compelling need for prosthetic fixation that is equally durable. Good bone fixation is a prerequisite for implant longevity.

Although the initial results are encouraging, there is a need for additional mid- to long-term survival data from larger patient series showing longevity of the system, as well as reporting of functional outcome. Furthermore, to the best of our knowledge, no study examining the survival of the device using prospective data already exists. In addition, no studies were found examining the quality of life of the patients with the CPS system.

In the treatment of malignant bone tumors, it may be necessary to remove large areas of the femur. To replace these large parts of missing bone, a prosthesis can be used. One innovative technology developed by Biomet is the Compress® Compliant Pre-Stress System (CPS; Zimmer-Biomet, Warsaw, USA). This fixation device uses compression, via a short traction bar, to stimulate osteointegration at the bone-prosthetic interface, promote hypertrophy of the loaded bone, and avoid stress bypass of the host bone around a stiff intramedullary stem. Young patients cured of tumors have a long life expectancy and a compelling need for prosthetic fixation that is equally durable. Good bone fixation is a prerequisite for implant longevity. Since 1999, the CPS has been routinely placed on the orthopedics - UZ Leuven service and, as a result, more than 100 patients have been treated in this way. However, there are only few studies reporting on long-term performance of this system. In addition, limited data reporting functional outcome were found.

Although the initial results are encouraging, there is a need for additional mid- to long-term survival data from larger patient series showing longevity of the system, as well as reporting of functional outcome. Furthermore, to the best of our knowledge, no study examining the survival of the device using prospective data already exists. In addition, no studies were found examining the quality of life of the patients with the CPS system.

Eligibility Criteria:
Inclusion Criteria:

* Patients are/will be operated from 26/08/1999 onwards in UZ Leuven
* Implantation of the Compress Compliant Pre-Stress Device
* Informed consent obtained
* Patients are able to complete the questionnaires
* Age: minimum 7 years old

Exclusion Criteria:

* N/A
Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon

This is a 'first in man' study to demonstrate compliance with the general safety and performance requirements of Regulation (EU) 2017/745 on medical devices (MDR) Annex I as part of the clinical evaluation and for the application of CE-marking. The aim of the study is to evaluate the safety and tolerability of the application and the success rate of the InnoCath AB® hyper-compliant balloon catheter after PTA in peripheral arteries.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Patients with peripheral arterial occlusive disease and intended for endovascular therapy in the SFA and/or popliteal artery pars I/II
* Patients suitable for endovascular therapy in the SFA and/or popliteal artery pars I/II with a hyper-compliant balloon without further luminal widening
* Target vessels with a sufficient "runoff" to the foot with at least one vessel
* Rutherford classification 1-4 if physical and medicinal therapies have not been successful

Exclusion Criteria:

* Aneurysms at the site of inflation
* Application directly in the area of large vessel wall injuries with heavy bleeding
* Rutherford classification 5 and 6
Ultrasound and Pediatric Endotracheal Tube Size

The aim of the present study was to evaluate the ultrasonographic airway measurement in pediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal transverse airway diameter (MTAD) with tube size predicted by different age-related formulas and diameter of little finger.

Previous studies already showed that a prediction of pediatric ETT is possible with the ultrasonographic measurement of the MTAD. In this study measurements are performed at three predefined anatomic structures of the airway with each of These at two airway pressures.

The investigators hypothesize that one of the specific measurements predicts the fitting ETT size better than age-related formulas or diameter of little finger.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent by the legal guadian
* elective surgery requiring endotracheal intubation

Exclusion Criteria:

* missing informed consent
* allergy to ultrasound gel
Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.

Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.

A Multicenter,Randomized,open-label,Phase II Study to Evaluate the Efficacy and Safety of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients with EGFRm+(exon 19 deletion or exon 21 L858R)/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document.
2. Aged at least 18 years old.
3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\~IV).
4. Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) .
5. At least one measurable lesion as defined by RECIST V1.1.
6. ECOG performance status 0 to 1.

Exclusion Criteria:

1. There are mutations of ALK or ROS1.
2. Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.
3. Pregnant or nursing women.
Connective Tissue Diseases and Vitamin D Deficiency

Connective tissue disease (CTD) covers all heterogeneous and broad immunological diseases. These immunological diseases are characterized by inflammation, tissue damage, and abnormal repair. Disorders such as fibrotic tissue or loss of function are seen in the degeneration of the target organ. There is a complex relationship between genetic and environmental factors on the basis of these disorders.

Vitamin D deficiency has been frequently observed in autoimmune diseases such as systemic lupus erythematosus, diabetes mellitus, and rheumatoid arthritis. Vitamin D deficiency is primarily seen with musculoskeletal complaints and is an early warning of osteomalacia. Muscle weakness is most common in the trunk, shoulders and hips. It is characterized by difficulty in climbing stairs, getting up from sitting or lying position, feeling of heaviness in the legs, duck-like gait, difficulty getting up from a chair, fatigue easily, inability to lift objects with arms and hands. Patients experience decreased exercise capacity as a result of pain and muscle weakness. In addition, vitamin D deficiency causes smooth muscle contraction and an increase in airway inflammation. As a result, it was observed that the disease course and symptoms were more severe in CVD patients with vitamin D deficiency. In a study conducted with rheumatoid arthritis patients, the quality of life, physical activity and depression levels of patients with vitamin D deficiency were compared with the control group. The evaluation parameters of rheumatoid arthritis patients were worse than the control group. Vitamin D levels were compared with sleep, anxiety and depression levels in patients with systemic lupus erythematosus. A positive relationship was found between vitamin D deficiency and sleep disturbance level. It has been observed that the life expectancy of patients with connective tissue disease is significantly reduced compared to healthy ones. Exercise capacity and oxygen consumption decreased in these patients.

Outpatient connective tissue disease patients (systemic sclerosis and systemic lupus erythematosus) with stable medical conditions will be referred for physiotherapy and rehabilitation after being examined by the relevant physician. Physiotherapy evaluation will be made by the physiotherapist. In addition; healthy individuals who accepted and gave consent to participate in the study without any chronic disease for the healthy control group will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable general condition treated with standard medical treatment
* Patients between the ages of 18-65

Exclusion Criteria:

* Patients who cannot cooperate with the assessment
* Those who have orthopedic problems or neurological diseases that will affect the evaluation of functional capacity
* Patients with pneumonia or any acute infection at the time of assessment
Safety Study Evaluating Intravenous Infusions of Tigecycline to Treat Acute Myeloid Leukemia

The purpose of this study is to determine whether tigecycline is safe and which dosage is most effective in the treatment of patients with acute myeloid leukemia.

Relapsed and refractory hematologic malignancies have poor responses to standard therapy and are associated with a poor prognosis. For example, relapsed acute myeloid leukemia (AML) is a highly aggressive and resistant disease, particularly when associated with first complete response (CR) duration of less than 12 months. Thus, there is an urgent need for new agents in relapsed and refractory hematologic malignancies such as acute leukemia. In elderly patients, where the tolerance of aggressive induction therapy is often poor and curative options such as bone marrow transplantation HSCT are not available, the need for effective non-aggressive drug regimens for AML is even greater.

Tigecycline is a glycylcycline derivative of tetracycline. Tigecycline is currently indicated for the treatment of complicated skin and skin structure infections, and complicated intra-abdominal infections. This clinical trial is a Phase I dose escalation study of tigecycline in patients with relapsed or refractory AML or those with newly diagnosed disease not eligible for induction chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diagnosis of relapsed or refractory AML for which all potentially curative or standard salvage therapy options have been exhausted; OR AML without prior treatment who are not eligible for induction chemotherapy as defined as age \> or equal to 80 or age \> 70 with poor risk cytogenetics (3 or more abnormalities, -5/del(5q), 3q abnormalities, or -7) or stable co-morbidities that would preclude induction chemotherapy such as LVEF less than 40% and/or DlCO less than 60% expected
* ECOG 0-2 performance status
* Biochemical values within the following range
* Serum creatinine \<2x upper limit of normal
* Total bilirubin \<1.5x upper limit of normal
* AST and ALT \<2x upper limit of normal
* Recovery from non-hematologic toxicity from prior chemotherapy
* Able and willing to provide informed consent

Exclusion Criteria:

* Allergy to tetracycline or minocycline
* Uncontrolled intercurrent illness such as uncontrolled diabetes or active uncontrolled infection
* Active systemic bacterial, fungal, or viral infection
* Concomitant use of linezolid or chloramphenicol that are known to inhibit mitochondrial protein synthesis
* Pregnant or breast feeding
* Known active CNS involvement with AML
* Neurologic symptoms related to uncontrolled illnesses or unexplained causes
* Psychiatric illness that would limit compliance with study
* Receiving systemic chemotherapy other than hydroxyurea to control circulating blast counts. Concomitant hydroxyurea is permitted, but only in the first cycle of therapy
* Prior therapy with tigecycline as an anti-cancer therapy or any use of the drug in the last month
* Use of other investigational anti-leukemic therapy within 14 days of registration
The Lunch Study: the Combined Effects of Food Texture and Energy Density on Intake

Meal size is strongly influenced by a number of external features of the food environment which can promote over-consumption, such as the availability of palatable energy dense foods. The current research aimed to investigate whether natural food-based differences in texture could be used to slow down eating rate and reduce intake from large portions and higher energy dense foods.

A four-session randomised crossover study assessed the effect of faster vs. slower eating rate, achieved through manipulating food texture, on ad-libitum consumption (weight and calories) at a meal, alone and in combination with variations in meal energy-density (higher vs. lower)

The current obesogenic environment is characterized by the abundance of palatable and high energy dense foods. High dietary energy density can promote sustained overcompensation at meal times. On the other hand, eating at a slower rate has been shown to reduce meal size, and food-based texture differences can slow eating rate. It is possible that texture-based differences in eating rate could be used to reduce energy intake in of foods that are higher in energy density.

This study was conducted to quantify the effect of eating rate (fast vs. slow) on ad-libitum consumption of a meal, alone and in combination with variations in meal energy-density (0.57 kcal/g vs 1.01 kcal/g). The meal combinations were as follows:

Meal 1: thin/0.57 kcal; Meal 2: thin/1.01 kcal/g; Meal 3: thick/ 0.57 kcal/g; Meal 4: thick /1.01 kcal/g

Participants consumed the four test meals over four non-consecutive test sessions at the Clinical Nutrition Research Centre, with at least three days washout between each session. Each part followed a completely randomised full crossover design.

The primary objective was to assess ad libitum intake (both kcal and g) of the test meals, depending on the combination of food texture and energy density.

The secondary objectives were to assess the eating rate, oral processing characteristics, changes in rated appetite up to 90 minutes post-consumption and energy intake (kcal) for the rest of the test day (food diary), as a function of the test meal texture and energy density

Eligibility Criteria:
Inclusion criteria:

* Aged between 21 and 50 years
* BMI \< 30 kg/m2

Exclusion criteria:

* Individuals whose body weight has changed more than 5 kilograms in the last 12 months
* People who are taking insulin or medications known to affect glucose metabolism, appetite or energy metabolism
* Individuals who are currently dieting
* People with intolerances or allergies to study foods or test products, e.g. soya, wheat, gluten, cereal, fruits, biscuits, dairy products, rice, vegetable, meat, seafood, sugar and sweetener, gelatin, natural food colourings or flavourings, etc
* Pregnant women