cyrilzakka/clinical-trials huggingface dataset:
Oscillating Positive Expiratory Pressure Devices and Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Sputum production increases in acute exacerbation of COPD, both in amount and consistency. It increases airways obstruction and hence delays improvement and prolongs hospital stay. oscillating positive expiratory pressure (OPEP) devices were extensively studied in cystic fibrosis and bronchiectasis. Only seldom studied in chronic bronchitis. This study aims to measure the effects of mucous clearing device in hospitalized patients with acute exacerbation of COPD.

In this study, investigators will investigate the change of objective measurements of lung functions and exercise capacity in addition to subjective measures of quality of life.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients, stages 3-4 according to GOLD guidelines 2016, with post bronchodilator FEV1/FVC \< 70% of predicted and FEV1 \< 50% with exacerbations necessitates hospital admission.
* Smokers or Ex-smokers.
* Able and willing to provide informed signed consent. Able and understanding the correct use of the bronchial clearing device.
* Able to perform effectively spirometry.
* Able and willing to receive the management plane as indicated including systemic steroids if seemed necessary.

Exclusion Criteria:

* Other obstructive pulmonary diseases or those do not fulfill the criteria of COPD diagnosis.
* Nonsmokers.
* Presence of major comorbidity causing organ dysfunction as cardiac (including severe pulmonary hypertension), renal, or liver impairment (not including diabetes, arterial hypertension, or obesity).
* Presence of lobar pneumonia.
* Suspicion of bronchogenic malignancy.
* Any other complication either at admission or during hospital stay as pneumothorax, pulmonary embolism, myocardial infarction, acute coronary syndrome, cerebrovascular accidents, ...
* Patients unable or not willing to provide informed signed consent.
* Patients unable to use the bronchial clearing device.
* Patients unable to perform spirometry.
* Patients unable or not willing to comply to the management plan or the study protocol.
* Patients receiving regular oral steroids or non-selective beta blockers.
Effects of RIC on Cognitive Function and Blood Oxygen Levels in Unacclimatized Adult at High Altitude

Several studies have shown cognitive impairment such as memory, perception and learning skill during ascent to high altitudes. However, few studies have directly investigated the effect of high altitudes exposure on attention-a high-level cognitive function. Remote ischemic conditioning (RIC) is a noninvasive and easy-to-use neuroprotective strategy, It has been proven to be an effective strategy for neuroprotection in ischemic stroke and chronic cerebral ischemia patients.

This study will provide insights into the preliminary proof of principle, safety, cognitive dysfunction and blood oxygen levels protective effects of RIC in Adults Exposing to High Altitude Conditions, and this data will provide parameters for future larger scale clinical trials if efficacious.

Eligibility Criteria:
Inclusion Criteria:

* The age was between 19 and 30 years.
* All participants should meet the criteria which included right-hand dominance, normal or corrected-to-normal vision.
* the RIC group volunteers have no history of intravascular thrombosis in the bilateral upper limbs;
* The high altitude participants move into the high-altitude environment within one month, and the low altitude volunteers have long-term life in low altitude areas.

Exclusion Criteria:

* Severe hepatic or renal dysfunction
* Severe hemostatic disorder or severe coagulation dysfunction
* Any of the following cardiac disease - rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with participation
* Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year
* Patient participating in a study involving other drug or device trial study 7. Patients with existing neurological or psychiatric disease that would confound the neurological or functional evaluations 8. Unlikely to be available for follow-up for 3 months 9. Contraindication for RIC - severe soft-tissue injury, fracture, or peripheral vascular disease in the upper limbs.
Outcomes of Traumatic Arterial Injuries in Upper vs. Lower Extremities

The purpose of this study is to identify and compare the causes of vascular trauma at the extremities, injury characteristics, types of vascular surgical interventions, and the outcomes of traumatic vascular injuries between the upper and lower extremities.

1. Primary patient assessment Patients will be clinically assessed on presentation, and resuscitation protocols will be initiated if signs of hypovolemic shock are present according to Advanced Trauma Life Support guidelines.
2. History and physical examination are the most important components of the diagnostic protocol The presence of hard signs of arterial injury

   * Absent or diminished pulses
   * Active haemorrhage
   * Large, expanding, or pulsatile hematoma
   * Bruit or thrill
   * Distal ischemia is considered an indication for surgery, and no further specific investigative measures will be taken.

   Soft signs of vascular trauma should be noted as well including
   * Small, stable hematoma
   * Unexplained hypotension
   * History of haemorrhage that is no longer present
   * Proximity of injury to major vessels
3. Investigations including:

   * The use of a hand-held Doppler examination as a diagnostic aid
   * Duplex US and CTA for imaging.
   * Lab investigations: Complete blood picture, Coagulation profile and Kidney function tests.

Options of intervention:

All vascular trauma patients will be admitted for operative management and follow up. The specific surgical intervention will be determined by the vascular surgeon according to type, site, and extent of the injury, ranging from ligation of the injured vessel to vascular graft interposition.

An injury to a peripheral artery that does not result in complete transection can be repaired depending on luminal diameter with an interrupted or continuous suturing technique. A complete transection of a peripheral artery is first managed with minimal debridement back to healthy intima at both ends then an end-to-end anastomosis or with an interposition graft of autogenous vein or prosthetics arterial graft.

Eligibility Criteria:
Inclusion Criteria:

* All peripheral arterial injuries of one or more of the extremities.

Exclusion Criteria:

* Vascular injuries limited to the venous system only.
* Vascular injuries limited to thoracic, abdominal, or neck vessels.
A Kynurenine Pathway-based Molecular Imaging Study of Individualized Diagnosis and Treatment for Major Depressive Disorder

Major depressive disorder (MDD) is a chronic disease with high incidence rate, high recurrent rate and need whole course medical management. Varied clinical symptoms and unclear pathogenesis cause a series of clinical problem, such as low diagnostic rate and low effective treatment rate. Based on neuroimmune mechanisms of MDD, our previous study indicates that kynurenine pathway (KP) in serum may be the connections between central immune and peripheral immune, that key factors of KP may change the brain structure and function through affecting the central immune. The core research issue of this project are the inherent associations between metabonomics of inflammatory factors in KP, clinical phenotypes of MDD, and neuroimaging features. This project will focus on first-episode MDD, mass spectrometry analysis of KP factors will be conducted first, also multi-modal neuroimaging techniques will be applied to detect topological characteristics of brain structure and function in MDD and extract standard models, then correlation analyses will be performed between these molecular biological features and multi-dimensional clinical data in order to integrate KP metabonomics, core clinical characteristics (depressed mood, energy loss, interest loss and so on), neuroimaging biomarkers, and finally construct the deep learning based standard diagnostic technique of MDD. Additionally, this project will follow up MDD patients with different core clinical characteristics to certificate the aforementioned diagnostic technique as well as explore optimized treatment for different clinical subtypes.


Eligibility Criteria:
Inclusion Criteria:

1. 18-60 years old;
2. Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
3. Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
4. With enough audio-visual ability and comprehensive ability to accomplish the visits;
5. Be necessary and suitable to accept the treatment of antidepressants;
6. Scored less than 14 on Hamilton's Anxiety Scale (HAMA) and scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);
7. With 2 or more atypical symptoms including significant weight gain or increase in appetite, hypersomnia, leaden paralysis, and a long-standing pattern of interpersonal rejection sensitivity that results in significant social or occupational impairment.

Exclusion Criteria:

1. Severe medical or neurological problems;
2. Previous mania or hypomania episodes;
3. Female patients who are pregnant, planning to be pregnant or breastfeeding;
4. Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality);
5. Had electroconvulsive therapy, modified electroconvulsive therapy or repetitive transcranial magnetic stimulation in the past 6 months;
6. Experienced severe personality disorder, mental retardation, anorexia/bulimia nervosa.
Genetic Predisposition to Food Cue Reactivity in Children

This study assesses the associations between genetic factors, food-cue-related neural reactivity, self-regulatory capacity, eating in the absence of hunger (EAH), and adiposity gain in children.

The investigators will assess the associations between genetic factors, food-cue-related neural reactivity, eating in the absence of hunger (EAH) in response to food cues, and adiposity gain in children. They will also determine whether self-regulatory capacity modifies these associations. The genetic factors explored specifically include FTO, MC4R, polymorphisms in genes involved in dopaminergic pathways, and a composite genetic risk score built from genome-wide obesity-related loci.

\[3/14/2020\]: Study recruitment temporarily halted due to the COVID-19 pandemic

Eligibility Criteria:
Inclusion Criteria:

* English fluency
* Willingness to participate in all study visits

Exclusion Criteria:

* Relevant food allergies or dietary restrictions
* Metal in or on the body
* Claustrophobia
* Psychiatric and neurological disorders
* Relative in the study
* Appetite- or attention-altering medications or disorders
Functional Evaluation After Maxillectomy and Scapular Free Flap Reconstruction

The goal of the study is to analyse the functional and aesthetic outcomes after removal of the maxillar bone and reconstruction with part of the scapular bone for people having maxillary tumor


Eligibility Criteria:
Inclusion Criteria:

* Patient with maxillary sinus tumor
* Treated by maxillectomy with free scapula tip flap reconstruction
* 18 years of age or older

Exclusion Criteria:

* Reconstruction failure
* Carcinomatous recurrence and/or further progression impacting quality of life
* Death
Primary Prevention Habits for the Shoulder: Survey of the Sportsman's Entourage

Purpose: To provide an update on the implementation of prevention among overhead athletes by their entourage.

Materiel and method: This study will be conducted by the means of a questionnaire. The target population consisted of doctors, trainers, physical trainer and physiotherapist.

The questionnaire will be validated by experts in each categorie and published on an online survey website


Eligibility Criteria:
Inclusion Criteria:

* Professions: physiotherapist, doctor, trainer or physical trainer

Exclusion Criteria:

* Other professions
A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients

The objective of this clinical study is to examine acute changes in stability, force allocation, work, and mobility from using a wearable, portable, battery-operated robotic orthosis (the Tibion Bionic Leg) in subacute post-stroke persons undergoing lower extremity physical therapy.

Samples text.

Eligibility Criteria:
Inclusion Criteria:

* Single stroke with residual unilateral lower-extremity weakness
* Subacute post-stroke period (\>3 and \<12 months)
* Eligible to participate to lower extremity physical therapy
* Age 40 years or greater
* Able to ambulate at least 10 meters
* Able to ambulate without a leg brace
* Ambulation speed less than 0.8 meters/second
* Minimum to moderate assist for transfer or ambulation by physical therapist evaluation
* Subject must understand the nature of the study and provide written informed consent prior to enrollment.
* Subject must be willing and able to attend all study sessions

Exclusion Criteria:

* Medically unstable
* Age younger than 40 years
* Acute post-stroke (\< 3 months)
* Chronic post-stroke (\> 12 months)
* Status-post multiple strokes
* Status-post traumatic brain injury
* Ambulation speed greater than 0.8 meters/second
* Currently using a Knee-Ankle-Foot Orthosis (KAFO)
* Not eligible for lower extremity physical therapy
* Concomitant degenerative neurological conditions
* Not able to ambulate at least 10 meters without assistance
* Greater than moderate assist during transfer or ambulation by physical therapist evaluation
* Unable to ambulate without a leg brace
* Unable to follow instructions, complete follow-up, or provide informed consent.
* Currently enrolled in another investigational device or drug trial
Effect of Fenofibrate on Endothelial Function and High-density Lipoproteins (HDL)in Patients With Coronary Heart Disease

Fenofibrate is a drug that acts on the PPAR alpha receptors, increasing HDL-cholesterol and decreasing triglyceride levels. The interaction with these receptors has antiatherogenic actions by regulating the expression con key proteins that participate in vascular inflammation, plaque stability and thrombosis.

Fenofibrate reduces triglycerides and increases HDL-C in plasma. It also decreases small, dense LDL particles. The use of this drug has resulted in improvement of vascular function measured by endothelial function. Our hypotheses state that fenofibrate will improve: endothelial function, improve HDL antioxidant capacity and size distribution towards a predominance of small HDL particles.

Patients with stable coronary heart disease, with LDL-C levels at goal will be invited to participate in this randomized, double blind study to receive either placebo or fenofibrate in addition to their statin therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male patients 18-60 years of age
* Stable coronary heart disease (no cardiovascular event 3 months prior to enrollment)
* Stable lipid-modifying drug therapy (previous 2 months)
* Low-dose statin therapy with LDL-C at goal (\< 100 mg/dl)
* Triglyceride levels 151-500 mg/dl
* HDL-C levels \<40 mg/dl

Exclusion Criteria:

* Diabetes mellitus
* Uncontrolled hypertension Systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg
* Subjects with renal (serum creatinine \>1.5 times the upper limit of normal (ULN)), hepatobiliary (cholelithiasis, biliary cirrhosis, AST and/or ALT \>2x ULN) or active thyroid disease (TSH \>1.5x ULN or \<0.05 uUI/ml)
* Hypersensitivity to fenofibrate or to any other component of its formula
* History of photoallergic reaction or phototoxicity to fenofibrate or ketoprofen
Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients

The aim of the present study is to evaluate the superiority of photopheresis in combination with the standard immunosuppression vs standard immunosuppression alone for the prevention of acute rejection in highly sensitized kidney transplant recipients (cPRA ≥90%).

Unicentric, randomized, open study.


Eligibility Criteria:
Inclusion Criteria:

* Sensitized (cPRA ≥90%) candidates for a deceased-donor kidney transplantation
* Recipients between 18 and 75 years old
* Patients are able to understand and sign informed consent (Annex 1).

Exclusion Criteria:

* Participation in another interventional clinical trial.
* Use of Rituximab or Eculizumab at the time of transplant or in the first 24 hours post-transplant.
* Persons with any dependency on the researcher or employee by the responsible institution or researcher. As well as people detained by legal order.
Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy

The purpose of this study is to determine whether an autologous stem cell infusion through catheterism is safe and effective in the treatment of pediatric dilated cardiomyopathy.

Process:

1. Primary Evaluation

   * Clinical History
   * Echocardiogram to evaluate ejection fraction and other parameters
2. Signing of Informed Consent and clearing doubts
3. Bone Marrow stimulation for 3 consecutive days with G-CSF (Granulocyte Colony Stimulating Factor) applied subcutaneously
4. On the 4th day, in operation room and under sedation: Bone Marrow Harvest performed by hematologists through posterior iliac crests(amount calculated at 8cc/kg, without exceeding 150ml).
5. Recovery room with family members while the cells are being processed in the Hematology Laboratory.
6. Approximately 3 hours after the 1st procedure, the patient re-enters the operation room, which is equipped for cardiac catheterization, so that cardiologists infuse the stem cells through the femoral artery into the coronary arteries which irrigate the heart´s muscle fibers.
7. Patient goes back to the recovery area until the anesthesia effect is gone and can tolerate oral liquids.
8. Clinical and echocardiographic follow-ups at 6 weeks and 6 months after the procedure.

* The Patient will receive standard surgical care, accompanied by a nurse at all times.
* Premedication includes: Omeprazole (gastric protector), Ketorolac (anti-pain and swelling), ondansetron (antivomiting).

Eligibility Criteria:
Inclusion Criteria:

* Ejection fraction less than 35 percent in echocardiogram
* More than 3 months with complete medical treatment without significant improvement
* Complete medical treatment: digitalics, diuretics, vasodilators and beta blockers

Exclusion Criteria:

* Not signing informed consent
* Active infection at enrolling time
* Inadequate G-CSF application
Thoracic Epidurography Different Position

It is known that postoperative pain after thoracotomy or lobectomy is very severe, therefore, intraoperative or postoperative pain management using continuous thoracic epidural catheterization is suggested good option to prevent this complication.

The spread of local anesthetics is influenced by various factors including volume, location of needle insertion, speed of injection, patient position, age, weight and height. However, there are few studies about the effect of different patient position during thoracic epidural catheterization.

This study was designed to evaluate the effect of different patient position affecting thoracic epidurography.

It is known that postoperative pain after thoracotomy or lobectomy is very severe, therefore, intraoperative or postoperative pain management using continuous thoracic epidural catheterization is suggested good option to prevent this complication.

The spread of local anesthetics is influenced by various factors including volume, location of needle insertion, speed of injection, patient position, age, weight and height. However, there are few studies about the effect of different patient position during thoracic epidural catheterization.

Studies of lumbar epidural blockade have shown that lateral position can produce 0-3 segment more to the dependent position compared to the supine position. When the same amount of local anesthetic was injected in supine of sitting position, the most cephalad level of spread was indifferent.

Recent studies showed that neck flexion demonstrated significant cephalad spread of contrast dye in high thoracic epidural blockade.

The purpose of this study was to compare and evaluate the contrast dye spread between different patient position

Eligibility Criteria:
Inclusion Criteria:

* lung cancer
* liver cancer
* stomach cancer
* pancreas cancer

Exclusion Criteria:

* coagulopathy
* infection
* previous spine fusion at thoracic level
Effect of the Enteric Hormone Glucagon-Like Peptide (GLP-2) on the Intestinal Blood Flow in Patients With Short Bowel Syndrome

The aim of the study is to investigate the effect of the enteric hormone Glucagon-like Peptide (GLP-2) on patients with short bowel syndrome

previous studies have shown that GLP-2 increases mesenteric blow flow, we wish to examine the effect of subcutaneus GLP-2 on patients with short bowl syndrome. The patients will single blinded been given 450 nmol GLP-2 and isotonic saline in order to act as their own reference.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnose of short bowel syndrome 4 month of stable fase

Exclusion Criteria:

* activity in IBD
Dermatopharmacokinetic Trial of LEO 90100 Foam

This is a phase 1, single centre trial in Japanese healthy male subjects comparing the amount of active ingredients of LEO 90100 foam and Dovobet® ointment in the stratum corneum.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male subjects, aged 20 to 40 years inclusive

Exclusion Criteria:

* Body Mass Index outside the range 18-25 kg/m²
* Use of any medication (systemic or topical) within 2 weeks of Day 1.
Safety and Efficacy of Ultrasound Guided Vascular Access

Vascular access involves central and peripheral vein accesses and arterial accesses. Central venous catheterization is widely used in clinical practice for diverse purposes, including hemodialysis for end stage renal failure, invasive hemodynamic monitoring, radiological studies, infusion of drugs that cannot be administered via peripheral vessels, administration of parenteral nutrition, vascular access in patients whose peripheral veins are difficult to be catheterized and for miscellaneous purposes that require access to large caliber vessels.

Arterial cannulation is used for invasive arterial pressure monitoring and to ensure access for diagnostic and therapeutic interventions.

In the United States and United Kingdom, guidelines have recommended the use of ultrasound guidance to reduce complications and improve success in central venous catheterization.


Eligibility Criteria:
Inclusion Criteria:

* · Adult patients who need vascular access (arterial or venous)

Exclusion Criteria:

* · Patients with local infection in the area targeted for vascular access.

  * Patients with severe generalized infection and other skin diseases or lesions.
  * patients with history of DVT of the target vein and or pulmonary embolism.
  * Patients with untreated coagulopathy (INR \>1.5 or platelets \<50000mm3)
The Added Value of Bone Microstructure Assessment in the Management of Osteoporotic Bone

1. To assess the clinical utility of trabecular bone score (TBS) on fracture risk prediction including the new version (TBS V4) and future TBS versions at the spine and hip.
2. To assess the clinical utility of TBS software as a potential treatment outcome: sensitivity to change over time and following osteoporosis therapy.
3. To compare TBS to other imaging modalities of bone structure such as quantitative computed tomography (QCT) in fracture risk prediction and response to osteoporosis therapy.


Eligibility Criteria:
Inclusion Criteria: Has had a DEXA scan

* Has had a DEXA scan

Exclusion Criteria:

* Unable to complete DEXA scan