cyrilzakka/clinical-trials huggingface dataset:
Chest Physiotherapy in Tracheotomized Patients

Positive expiratory pressure (PEP) breathing is common for treatment of different lung diseases and can increase lung volume and increase elimination of secretion from the airways. Today there is no evidence whether the treatment is effective or not for patients in the intensive care unit. The purpose of this study is to evaluate if PEP breathing can increase oxygenation for patients in the intensive care unit during weaning from the ventilator after acute respiratory distress syndrome.

PEP breathing will be applied on the tracheal cannula for 15 minutes. Measure of the PEP effect will be done before, during and for 20 minutes after PEP breathing.

Procedure:

To achieve steady state, all subjects are positioned in a semi-recumbent position (30°) for 60 minutes before the start of the intervention and remain in that position during the entire investigation. Subjects are instructed to avoid talking and movements during both steady state and measurements. Airway suctioning (up to 20 kPa) through the tracheal cannula is performed only if there is risk for tube obstruction or if SpO2 decreases below 90%. Frequency of airway suctioning, and number of coughs during the study time are registered. An extra pre-intervention measurement is performed 15 minutes after the first to increase the validity of baseline measurements and control for changes in measured variables due to spontaneous variations.

A PEP device consisting of a one-way valve and exchangeable resistance nipples is used during the PEP breathing treatment. The resistance nipple is chosen at the start of the intervention aiming at an airway pressure of 10-15 cmH2O during tidal breathing (measured with a calibrated manometer). The duration of the PEP treatment is 15 minutes. Complementary oxygen is delivered at the same amount as before the intervention.

Measurements:

The primary outcome is PaO2. Five separate arterial blood samples of 0.7-1.5 ml each (altogether 3.5-7.5 ml for each subject) are drawn from an existing arterial catheter in the radial artery in the left or the right arm by nurses at the ward, and directly analysed.

Subject characteristics are registered from the clinical records, including gender, age, body mass index (BMI), smoking history, duration of invasive ventilation, and length of ICU stay.

Eligibility Criteria:
Inclusion Criteria:

* Tracheostomized participants
* ≥18 years old
* Moderate or severe ARDS during the ICU period, according to the Berlin definition.
* Ability to maintain PaO2 ≥ 67.5mmHg, with supplementary oxygen if needed, during spontaneous breathing for at least three consecutive hours.
* Normal curvature of the spine.

Exclusion Criteria:

* Lack of informed consent
Baseline Investigation of Chronic Hepatitis B Viruses Infections: Who is Eligible for Treated Criteria

Through two-stage stratified cluster sampling, investigators studied the antiviral treatment rate and the main factors affecting the antiviral treatment in community chronic HBV infection-related liver disease population.

Hepatitis B virus (HBV) infection is a major public health problem worldwide. China has the world's largest burden of HBV infection and will be a major contributor towards the global elimination of hepatitis B disease by 2030. While, the antiviral treatment rate and the main factors affecting the antiviral treatment in community chronic HBV infections is still unknown. In response to the above situation, Sampling applied a two-stage stratified cluster sampling design in 16 Districts and 331 Townships. Investigators wanted to know the one who is eligible for treated criteria based on community in 25 and over years old in Beijing.

Eligibility Criteria:
Inclusion Criteria:

* older than 25 years old;
* Residents with medical insurance coverage lived in Beijing more than 6 months .

Exclusion Criteria:

* Persons with pacemakers;
* Pregnant women;
* Persons with ascites;
* The one whose wound was not cured at the right upper abdomen
Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence

The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection.

The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection. The hypothesis is that administration of liposomal bupivacaine at the completion of retropubic suburethral sling procedure will result in decreased postoperative pain compared to no injection. Although multiple routes for sling placement exist, no difference in pain has been found when comparing obturator verses retropubic suburethral sling. Previous trials have investigated varying formulations of injections along the sling pathway in order to reduce complications such as pain and voiding dysfunction. Local anesthesia along the trocar pathway has shown some improvements in pain. Other techniques, however, have varying results. In 2011, the FDA approved liposomal bupivacaine as a single dose wound infiltration for treatment of postoperative pain following hemorrhoidectomy and bunionectomy. Initial studies demonstrated decreased pain compared to placebo, prolonged release in a bimodal distribution, and greater sensory than motor blockade. Additionally, postoperative benefits such as decreased overall pain, decreased opioid use, and increased time to opioid need were observed. Liposomal bupivacaine may also have the advantage of reducing hospital stays and decreasing overall hospital costs. The side effect profile has similar or improved rates of adverse events compared to traditional bupivacaine, a favorable cardiac profile, and no increased risk of poor wound healing. With such promise, we aim to evaluate the use of liposomal bupivacaine to reduce postoperative pain for the placement of slings to treat stress urinary incontinence. The study will be a blinded randomized controlled trial. Patients randomized to receive liposomal bupivicaine, the standard 20ml vial will be diluted with 1 Oml of saline to a reconstituted volume of 30 ml. Those in the control group will receive 30ml of normal saline injected in the same fashion as the study arm.

Eligibility Criteria:
Inclusion Criteria:

* Adults greater than 18 years of age
* Planning for outpatient surgical treatment of stress urinary incontinence with placement of a retropubic suburethral sling under general anesthesia

Exclusion Criteria:

* Pregnant or nursing
* Allergy to bupivacaine
* History of drug/alcohol abuse
* Severe cardiovascular, hepatic, renal disease, or neurological impairment
* Long-acting opioid within 3 days or any opioid use within 24 hours before surgery
* Contraindication to: acetaminophen, oxycodone, and/or non-steroidal anti-inflammatory drugs (NSAID)
* Administration of an investigational drug within 30 days before study
* Chronic pain syndromes
* Daily NSAID/opioid use
* Patients having concomitant procedures or not undergoing general anesthesia
Study to Characterise Patients Receiving Benralizumab in the Framework of an Individualized Access Program in Spain

Observational, retrospective study in adults (≥18 years) with severe asthma (maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2) and eosinophilic phenotype, who at the discretion of the investigator were candidates to receive benralizumab in the individualized access program approved by national health authorities.

Primary Objective: To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma who participated in the individualized access program approved in Spain and received at least one dose of benralizumab.

Secondary Objectives: To describe clinical outcomes in severe eosinophilic asthma patients who received at least three doses of benralizumab in the individualized access program.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥18 years)
* Diagnosis of severe eosinophilic asthma requiring stable treatment of high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller
* Received at least one dose of benralizumab during the individualized access program period (March-December of 2018)
* Informed consent signed

Exclusion Criteria:

* Patients enrolled in a clinical trial who received benralizumab during the same period of the individualized access program
* Refuse to sign the informed consent
Perioperative Mechanical Ventilation and Postoperative Monitoring of IPI

This study evaluates the influence of alveolar recruitment maneuver, protocolized liberation from respiratory support and monitoring of Integrated Pulmonary Index on the duration of the mechanical ventilation and the number of pulmonary complications in the early postoperative period after cardiac surgery.

The outcome of elective off-pump coronary artery bypass grafting (OPCAB) can be significantly compromised due to early postoperative pulmonary complications. The risk of pulmonary complications including acute respiratory distress syndrome (ARDS), atelectases, and early ventilator-associated pneumonia remains inappropriate. Therefore, the maneuvers improving pulmonary aeration and the early restoration of spontaneous breathing activity can be of clinical value. Protocol-driven liberation from mechanical ventilation (CMV) can decrease the duration of CMV as well as the number of pulmonary complications. INTELLiVENT-Assisted spontaneous ventilation (INTELLiVENT-ASV) is a new approach, that may be as effective as conventional protocol-driven liberation from CMV.

In parallel, the thorough postoperative monitoring of pulmonary function during both postoperative mechanical ventilation and spontaneous breathing is also of a great value. One of the novel approaches to respiratory monitoring is Integrated Pulmonary Index (IPI). The Integrated Pulmonary Index merges four vital parameters including end-tidal carbon dioxide (EtCO2), respiratory rate, pulse rate, and oxygen saturation (SpO2) measured by capnography and pulse oximetry into a single index value utilizing fuzzy logic model .

Eligibility Criteria:
Inclusion Criteria:

* Informed consent.
* Elective OPCAB.

Exclusion Criteria:

* Participation in any other study.
* Morbid obesity (BWI \> 40).
* The risk of pneumothorax after alveolar recruitment due to pulmonary emphysema.
* Constant atrial fibrillation with pulse rate exceeding 100/min.
* Inability to breathe easily through the nostrils and thus to gain good quality EtCO2 readings while breathing spontaneously, due to chronic rhinitis.
Exploratory Study of MRI Biomarkers of NASH

Metabolic steatosis disease (NAFLD) is a rapidly growing disease in the world, particularly in industrialized countries.

NAFLD is defined by the presence of fatty liver disease. This is a reversible phenomenon that can be estimated by non-invasive means, such as ultrasound. Non-invasive quantification, on the other hand, requires MRI.

Nonalcoholic steatohepatitis (NASH) is the aggressive form of the disease that promotes the accumulation of fibrosis in the liver, which can progress to cirrhosis and its complications.

Currently there is no non-invasive biomarker of NASH and the diagnosis is based solely on liver biopsy.

There is therefore a need for non-invasive biomarkers of NASH in patients with steatosis to diagnose NASH without the use of liver biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Patient included in the SNIFF cohort of the Angers hospital where there is a suspicion of NASH requiring a biopsy for which an MRI is requested by a hepatologist as part of the initial assessment of the disease.
* Adult patient
* Free, informed and express (oral) consent of the patient to participate in the study

Exclusion Criteria:

* Contraindication to MRI
* Time between the establishment of the Steatosis/NASH status and the MRI greater than 3 months
* Pregnant, parturient and breastfeeding woman
* Person deprived of liberty by judicial or administrative decision
* Person under compulsion to psychiatric care
* Person subject to a legal protection measure
* Person not affiliated or not covered by a social security scheme.
Effect of Triple Combination of Induction, Concurrent and Adjuvant Chemotherapy in High Risk Nasopharyngeal Carcinoma

The investigators aim to evaluate the survival benefit from triple combination of induction, concurrent and aduvant chemotherapy versus concurrent chemotherapy alone for high risk locoregionally advanced nasopharyngeal carcinoma treated with intensity-modulated radiotherapy.

All eligible patients receive intensity-modulated radiotherapy (IMRT) with a total dose of 68 to 70 Gy in 33 fractions to the primary tumor. Patients in the experimental arm receive triple therapy of induction, concurrent and adjuvant chemotherapy. Induction chemotherapy consists of docetaxel 75 mg/m², D1 and cisplatin 25 mg/m², D1-3 every 3 weeks for 2 cycles. Concurrent chemotherapy in the experimental arm consists of cisplatin 25 mg/m², D1-3 every 3 weeks and Xeloda 2000mg/m², D1-14 for 3 cycles. Adjuvant chemotherapy consists of Xeloda 2500mg/m², D1-14 for 2 cycles. Concurrent chemotherapy in the control arm consists of cisplatin 100 mg/m², D1 every 3 weeks for 3 cycles.The primary endpoint is failure-free survival (FFS). Secondary end points include overall survival (OS), locoregional relapse-free survival (LRFS), distant metastasis-free survival (DMFS) and the incidence of grade 3 or higher acute toxicities. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility Criteria:
Inclusion Criteria:

* Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.
* Tumor staged as T4N0-3M0 or T1-3N3M0 (the 2010 UICC/AJCC staging system).
* Pretreatment EBV DNA ≥ 4000 copies/mL.
* Karnofsky scale (KPS) ≥ 70.
* Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥ 100×10E9/L.
* Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and bilirubin ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN.
* Adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×ULN.
* Patients must give written informed consent.

Exclusion Criteria:

* Prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
* Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
* History of previous radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume).
* Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
* Dihydropyrimidine dehydrogenase deficiency.
To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets

To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Atrial Fibrillation and Premature Atrial Complexes in Patients With Ischemic Stroke.

The purpose of this study is to improve secondary prevention of ischemic stroke patients by

1. Estimating prevalence and the prognostic significance of frequent premature atrial complexes in ischemic stroke patients in relation to death, recurrent stroke and atrial fibrillation.
2. Characterize ischemic stroke patients by

   1. Echocardiographic characteristics
   2. Biochemical markers
   3. Plaque composition in the carotid arteries

      * in order to improve risk stratification.

Patients with atrial fibrillation (AF) have a five-fold increased risk of ischemic stroke compared to the general population. Identifying AF can be challenging, but prolonged rhythm monitoring of ischemic stroke patients have shown to enhance detection rates of AF. Therefore it is important to identify predictors of AF to allow targeted screening of patients after ischemic stroke and thereby reduce the recurrent stroke rate. Few former studies have shown an association between excessive numbers of premature atrial complexes (PACs) and AF.

The study population of ischemic stroke patients will at admission undergo following examinations:

1. ECG
2. 48 hours inpatient cardiac telemetry (If not known AF)
3. 24 hours holter monitoring (if not known AF)
4. echocardiogram
5. blood sample
6. CT scan of carotid arteries with contrast made on Dual Energy CT scan.

In the follow-up period, patients will have two visits with 48 hour holter monitoring (after 6 and 12 months, respectively) It will be noticed if patients have any recurrent events, die og developing AF.

The study population will be divided into four groups as follows:

1. patients with new AF at admission
2. patients with known AF
3. patients with frequent PACs
4. patients without frequent PACs. These groups will be compared on baseline characteristics and on outcome as mentioned.

The overall perspective is to make better strategies for detecting occult AF after ischemic stroke to improve secondary stroke prevention care.

Eligibility Criteria:
Inclusion Criteria:

* admitted with ischemic stroke at a single center
* time from diagnose to inclusion maximum 7 days.
* written informed consent or surrogate informed consent eligible
* age \> 18 years.

Exclusion Criteria:

* hemorrhagic stroke
* terminal illness and expected lifespan of less than 6 months.
* any physical or mental condition which make the patients unsuitable for participation in the study.
* known with a pacemaker
* anticoagulation treatment of other reasons than atrial fibrillation.
Defects of Keratinocytes Function in Dermatologic Patients

NOTCH signaling in the skin exerts a pivotal role in the regulation of normal keratinocytes turnover by mediating the balance between proliferation, differentiation, apoptosis and autophagic flux progression. Two skin diseases are characterized by the presence of gene variants that cause an impairment in NOTCH signaling: hidradenitis suppurativa(HS) and Dowling-Degos disease(DDD). To date, both HS and DDD are orphan diseases still lacking of specific treatments. This project aims at improving the current knowledge on the pathogenesis of HS and DDD, by deepening the understandings on the role played by keratinocytes in these pathologies and also by determining why mutations found in the same pathway cause different diseases. This study aimed to obtain in vitro models, derived directly from patients (from hair follicles) and from keratinocytes (HaCaT) cell cultures, for the study of these skin pathologies and also for the testing of novel innovative therapies such as photobiomodulation therapy.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of HS

Exclusion Criteria:

* no informed consent
Serum Level of IL31,33 and 36 in Egyptian Paients With Psoriasis

Evaluating Serum Level Of IL 31 , IL33 and IL36 and Their Correlation with Disease Activity In Patients With Psoriasis In Assuit University Hospital .

* To correlate their levels with disease activity using PASI score .
* To allow better understanding of the pathophysiological mechanism of the disease .

Serum samples will be collected from 45 psoriasis patients and 45 matched healthy individuals. After full history taking and dermatological examination, the disease severity will be assessed using the psoriasis area and severity index (PASI) score. All patients enrolled in our study had no other autoimmune or systemic diseases and underwent no systemic treatment including glucocorticoids, immunosuppressive drugs, or phototherapy at least 1 month before the PASI score evaluation and sample collection period. Wriiten informed consent will be obtained from all the patients and healthy controls.

Assessment of serum interleukin-31 ,33 and 36 concentrations in psoriatic patients Patients and controls Blood samples will collected from psoriatic patients and controls, and will centrifuged for 15 min at 1000 rpm. Next, the serum samples will be subdivided into small aliquots to be stored at -80°C until analysis for cytokine levels. ELISA kits will be used to determine serum IL-31 , 33 and 36

Eligibility Criteria:
Inclusion Criteria:

* Patients with all types of psoriasis.
* healthy volunteers without a family history of psoriasis or other autoimmune disease.

Exclusion Criteria:

* other autoimmune , other chronic inflammatory or systemic diseases.
* cases received glucocorticoids, immunosuppressive drugs at least 1 month before sample collection .
Improving Maintenance Following Very Low Calorie Diet: The Sustain Lost Weight (SLW) Intervention

Obtain a preliminary assessment of the feasibility and acceptability of delivering the sustained lost weight (SLW) intervention in a real-world clinical setting for patients who have completed a 21-week very low calorie diet (VLCD).

Hypothesis: Intervention will be feasible to implement as evidenced by the ability to recruit and retain participants and acceptable to participants as evidenced by self-report of satisfaction with the program and adoption of weight maintenance behaviors.

Secondary Aim: Obtain a preliminary assessment of the effectiveness of the sustained lost weight (SLW) intervention for patients who have completed 21 weeks of a very low calorie diet (VLCD).

Hypothesis: Greater than 75% of participants who receive this novel approach, where maintenance behaviors are individualized based on resting metabolic rate and a physical activity factor, will regain greater or equal to 10 kg. at week 52 follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Completed fast and transition period of the OPTIFAST® program
* Be able to participate fully in all aspects of the study
* Willing to refrain from participating in additional weight loss interventions for the duration of the study
* Willing to provide written informed consent.

Exclusion Criteria:

* Myocardial infarction within 6 months
* Unstable angina
* Stroke
* Chronic steroid use
* Active peptic ulcer disease
* Advanced cirrhosis
* Active hepatitis
* Advanced renal disease
* Active thrombophlebitis
* Recent skeletal fractures
* Use of lithium
* Pancreatitis
* Pregnancy
* Type 1 diabetes mellitus
* History of diabetic ketoacidosis
* Active bulimia nervosa
* Severe depression
* Psychosis
* Substance abuse