cyrilzakka/clinical-trials huggingface dataset:
A Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma

The primary objective will be to compare the Eurofarma and Alenia formulations regarding their impact on the pulmonary function of mild to moderate persistent asthma patients and the secondary objective will be to compare the three study formulations regarding the clinical control of the symptoms and the patients' compliance to the treatment.

The primary objective will be to compare the Eurofarma and Alenia formulations regarding their impact on the pulmonary function of mild to moderate persistent asthma patients and the secondary objective will be to compare the three study formulations regarding the clinical control of the symptoms and the patients' compliance to the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Sign the ICF;
* ≥ 12 years old;
* Have a diagnosis of mild to moderate persistent asthma diagnosis, as per the GINA classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month with the ACQ-7 test \<3,0;
* Current use of inhaled corticosteroid (equivalent to 1000 µg of beclomethasone dipropionate) whether associated or not with long-term β2 adrenergics and relief medication (salbutamol or equivalent);
* Initial FEV1 of at least 50% of the normal value expected;
* Serum cortisol evaluation within the normal limits

Exclusion Criteria:

* Use of oral or parenteral corticosteroid within the last 3 months before the study;
* Hospitalization needed due to asthma within the last 3 months before the study;
* Active smokers, defined as the consumption of cigarettes, pipes, cigars, or any other form of smoking in any amount within the last 3 months;
* Presence of serious co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatologic, neurological, or psychiatric disease, or chronic respiratory disease other than asthma;
* Recent participation (\<6 months) or expected participation in other clinical trials involving drug products of any nature or in studies consisting of any form of intervention for the treatment of asthma;
* Intolerance or allergy to any component of the drugs evaluated in the study;
* Pregnant or lactating women;
* Chronic use of routine β-blockers orally or intravenously, including ophthalmic solutions.
Exercise and Post-dry Needling Soreness

Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Manual therapies and exercise strategies targeting to decrease post-dry needling soreness need to be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral non-traumatic shoulder pain
* Shoulder pain from at least 6 months
* Shoulder pain of more than 3 points on a NPRS
* Presence of active trigger point in the infraspinatus muscle

Exclusion Criteria:

* bilateral shoulder pain
* younger than 18 or older than 65 years
* shoulder injury
* upper extremity surgery
* fibromyalgia syndrome
* neck or shoulder surgery
* cervical radiculopathy
* whiplash
* any type of intervention for the neck-shoulder the previous year
Genome-wide Study for Disease Susceptibility Gene(s) in Patients With Hand Osteoarthritis

This is a case-control study involving one medical center and one research institute to develop a data-set containing a minimum of 100 osteoarthritis cases, minimum of 100 independent controls of similar gender ratio and a minimum of 100 disease controls (cases with hip and/or knee OA) to associate DNA sequence (allelic) variations in candidate genes with osteoarthritis phenotypes.

This study is intended to begin at the Institute of Biomedical Sciences at Academia Sinica (which includes National Genotyping Center (NGC) and National Clinical Core (NCC)), National Taiwan University Hospital.


Eligibility Criteria:
Exclusion Criteria:

1. Patients with the following diseases will be excluded：Rheumatoid arthritis, Gout arthritis, Psoriatic arthropathy, Hypertrophic osteoarthropathy, Hypermotility syndrome, Hemochromatosis, Post-traumatic OA, Other secondary-form OA and Lupus.
2. The individual is excluded if the hand X-rays show MCP changes compatible with hemochromatosis. The site then is obligated to measure fasting transferrin saturation (FE/TIBC ratio) and if \>55%, the individual is excluded.
3. Have more than 3 swollen MCP joints equal to, or greater than KL grade 2.
4. Be unable to give informed consent.
5. One cannot participate in this study if other members of his or her immediate family have already been recruited (Only one person from each family can participate in the study).
Intraoperative Frozen Section Pathology to Guide Surgical Treatment for Lung Adenocarcinoma (ECTOP-1016)

This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1016). The goal of this clinical trial is to confirm the concordance rate between intra-operative frozen section pathological diagnosis and post-operative paraffin embedded pathological diagnosis, and use this result to guide surgical treatment for early stage (cT1N0M0) lung adenocarcinomas.


Eligibility Criteria:
Inclusion Criteria:

* Patients who sign the informed consent form and are willing to complete the study according to the study protocol;
* No previous history of cancer or pulmonary surgery;
* Solitary lesions or multiple lesions with only one not manifesting as pure ground-glass opacity (GGO) on CT scan;
* Peripheral clinical T1N0M0 patients that are eligible for surgery;
* Non-small cell lung cancer is pathologically diagnosed before or at surgery;
* No radiation therapy or chemotherapy before surgery.

Exclusion Criteria:

* Patients with clinical stages other than T1N0M0;
* The lesion cannot be completely resected;
* Previous history of cancer;
* Patients having received radiation therapy or chemotherapy.
The Effect of Whey Protein Supplementation on Vascular and Cognitive Function in Older Adults

The "hardening of the arteries" observed with aging raises blood pressure and contributes to poor brain blood flow and loss of cognitive function (i.e. attention, memory, solving problems, making decisions). Cognition is the most important determinant of overall health status, quality of life, functional ability and independence in older adulthood. Nutraceutical strategies have received considerable attention as they may improve cardiovascular health with far fewer side effects compared to drugs. In this regard, dairy products are particularly attractive. Higher dairy consumption is associated with lower blood pressure and improved memory in adults. Milk proteins have natural blood pressure lowering effects. Studies conducted in animals have demonstrated that whey protein (a component of milk protein) may also increase artery elasticity. This is important given the strong association between artery elasticity, brain blood flow, and risk for cognitive decline.

The investigators propose to conduct a randomized double-blind placebo controlled study comparing the effects of whey protein supplementation or carbohydrate placebo on measures of artery elasticity, brain blood flow, and cognitive function in older adults. Whey protein may be a novel dietary therapy to improve both artery health and brain health in older adults.

Participants will be randomly assigned to receive either 50 g whey protein isolate or placebo each day for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* ages of 60-85 years

Exclusion Criteria:

* acute or terminal illness
* Montreal Cognitive Assessment \< 26 (indicating dementia)
* myocardial infarction or stroke in the previous 6 months or other symptomatic coronary or peripheral artery disease
* type I or type II diabetes mellitus
* visual impairment
* upper or lower extremity fracture in the previous 6 months
* uncontrolled hypertension (150/90 mm Hg)
* cigarette smoking
* chronic kidney disease (albumin/creatinine ratio (ACR) between 30-300 ug albumin/mg creatinine)
* liver disease
* chronic pulmonary/respiratory disease
* body mass index (kg/m2) \< 21 or \> 32
* recent weight loss or gain greater than 7.5% of body weight within the previous 6 months
* currently supplementing diet with whey protein products
* milk-protein allergy, or allergy to para-aminobenzoic acid (PABA)
* head injury or symptoms of concussion in the past 3 months
Burnout Determinants Among Pediatric Psychiatry Workers During COVID-19 Crisis

Burnout among health workers is at core of our current preoccupations because of the health crisis we're going trough. Indeed, COVID-19 epidemic had terrible consequences not only on global mental health both in adults and children, but also on Health workers mental health. The investigators chose to consider Pediatric Psychiatry workers because of their particular position in this crisis.

The aim of the study is to point out burnout determining factors among Pediatric Psychiatry workers in Occitanie during COVID-19 crisis, by the use of an online questionnaire including the Copenhagen Burnout Inventory.


Eligibility Criteria:
Inclusion criteria:

- Medical doctors, interns, Paramedics (nurse, assistant nurse), Psychologists, Caseworkers working \> 50% in a structure medico socio sanitaire

Exclusion criteria:

- Other persons working in a in a structure medico socio sanitaire
Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study)

Renal hypoxia plays an important role in the development of contrast-induced nephropathy. The purpose of the PRINCIPLE study is to investigate the effect of pretreatment with intravenous nicorandil on the incidence of contrast-induced nephropathy in patients with renal insufficiency undergoing coronary angiography.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 20 years
* Patients undergoing elective coronary angiogram due to documented myocardial ischemia or symptoms of angina
* Estimated Cr clearance ≤60 mL/min by Cockcroft-Gault formula or serum Cr ≥1.1 mg/dL
* Signed written informed consent to participate in the study

Exclusion Criteria:

* Acute myocardial infarction requiring primary or rescue coronary intervention
* Allergic reaction to contrast dye or nicorandil
* Cardiogenic shock or significant hypotension
* Previous use of nicorandil within the preceding 7 days
* Exposure to contrast medium within the preceding 7 days
* Pregnancy or women at age of childbearing potential
* Heart failure (NYHA class III or IV; LV ejection fraction \<40% by echocardiogram)
* Acute renal failure or chronic dialysis
* Mechanical ventilation
* History of kidney transplantation
* Life expectation less than 6 months
* Previous renal artery angioplasty within the last 6 months
* Use of nonsteroidal anti-inflammatory drugs, intravenous use of diuretics, dopamine, mannitol, N-acetylcysteine, ascorbic acid or sodium bicarbonate within 48 hrs before the procedure
* Severe liver disease
Monitoring the EMG Activity and Investigating the Relation Between Occlusal Contact Areas and Occlusal Loads During Light or Heavy Occlusal Forces

Inappropriate occlusal contact may affect the long-term prognosis of prosthodontic rehabilitation. It is suggested to design light or without occlusal contact on implant prostheses when the patient bites with light force, and normal occlusal contact when the patient bites with heavy force. The concept of this "implant-protective occlusion" is based on the difference of movement between implants and natural teeth. However, how much force generated during a light bite or a heavy bite is not clearly defined in the literature. Traditional methods to evaluate the occlusal contacts between antagonist teeth such as wax, silicone, occlusal paper, and occlusal foil cannot evaluate the occlusal force. Recently, modern digital occlusion analysis systems (T-Scan, Dental Prescale II) can evaluate occlusal force on almost normal intermaxillary relation. The objects of this investigation are: (1) to evaluate the effect of difference occlusal forces on the number, distribution and size of occlusal contacts examined by 8μm occlusal foil and Dental Prescale II System (DPS); (2) to analyze the relation between EMG activity and occlusal forces and to identify the magnitude of light and heavy bite force the patients may exert during occlusal examination; (3) to compare the results between habitual chewing side and the other side. Twenty-four subjects will be included in this study. With EMG biofeedback, the subjects will exert 35%、70%、100% of maximum contraction EMG of clenching and the subjects' occlusal contacts will be tested with the 8μm occlusal foil and DPS. Each condition will be tested three times. The subjects will chew gums to confirm their habitual chewing side after the occlusal tests. Numbers, distribution, and size of occlusal contacts will be analyzed and compared. This study may identify the magnitude of perceptual light and heavy occlusal forces and the maximum occlusal force. The results are helpful for setting up the protocol and strategy of occlusal adjustment and to prevent biomechanical complications of dental prostheses.


Eligibility Criteria:
Inclusive criteria:

* full dentition except third molar
* class I occlusion at bilateral canines and first molars (Angle's classification)
* healthy periodontal condition
* can sign consent

Exclusive criteria:

-history of temporomandibular disorders
Transseptal Approach Versus Conventional Left Atrial Approach for Mitral Valve Procedures

Study Objectives/Specific Aims Overall Goal: To compare between transseptal approach and the conventional left atrial approach for mitral valve procedures.

* Objective 1: Assess the intraoperative approach related criteria in valve exposure, cardiopulmonary bypass time and intraoperative complications.
* Objective 2: Assess the outcomes and postoperative results.

Mitral valve diseases are considered among the most prevalent valvular heart diseases that necessitate surgical intervention.

as the Modern international guidelines substantially recommend mitral valve repair whenever possible there is significant decrease in mitral valve replacement rates.

Cardiothoracic surgeons have to face the problem of Making a decision regarding mitral valve repair, reconstruction or replacement which requires excellent valve exposure for precise anatomical definition and manipulation taking in mind cases with specific anatomical challenges.

Since the beginning of modern cardiac surgery only two basic approaches to the mitral valve have been described by Effler who wrote in 1958 " the actual entry into the left atrium may be accomplished in either of two ways : through the Fossa Ovalis by way of the right atrium or through the posterior interatrial groove " Nowadays median sternotomy is still the most commonly used incision for mitral valve surgery which allows the best exposure for the valve through transseptal incision or through Sandergaard's groove.

Although the latter approach is the preferred method for most surgeons the transseptal approach has been revisited in more recent years in various forms by those seeking better exposure of mitral valve especially in cases with difficult anatomy.

In this paper we try to compare the transseptal approach with the conventional left atrial approach for mitral valve procedures to review previous literatures' results and to clarify the effect of using each of the two approaches in preoperative ,intra and postoperative course .

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent mitral valve replacement, mitral valve repair, redo mitral valve replacement, combined mitral and tricuspid procedures, combined mitral surgery and coronary arteries bypass graft at cardiothoracic surgery department Assiut University Hospital.

Exclusion Criteria:

* Patients with congenital mitral valve diseases .
* patient refused to sign the informed consent to be a part in the research .
Quality of Life in Patients With and Without a Parastomal Bulge

It is not well-established whether a parastomal bulge impacts stoma patients HRQoL or if HRQOL differs according to the underlying disease or type of stoma. In this large cross-sectinal study stoma patients with and without a parastomal bulge are asked about their health-related quality of life and stomarelated quality of life. Stoma patients are identified in the danish stoma database and contacted two times by email. Non-responders are sent a paper booklet.

A cross-sectional study of patients registered in the Danish Stoma Database Capital Region (DSDCR), with permanent or temporary enterostoma after surgery performed between 2011 and 2016. Via a unique personal identification number registered in DSDCR patients will be contacted by e-mail using the e-Boks system, an official electronic distribution system covering around 80% of the Danish adult population. The e-mail will contain information about the study and a personal link to SurveyXact, an online survey program allowing for direct electronic data entry by patients. First reminder will be sent after one week and a second reminder again one week later. If necessary, a third reminder additionally three weeks later will be sent to patients by post, including a paper booklet of the questionnaires as described below.

For patients without e-Boks, DSDCR will be linked to the Danish Civil Registration System via the unique personal identification number, providing information on patient's addresses. Information on the study and a paper booklet of questionnaires will be sent to patients by post. A reminder will be sent by post after three weeks if necessary. Hereafter, no further attempts will be made to contact the patients. To include other relevant variables in the analysis of data, data from the Danish Anaesthesia Database (DAD) and the Danish Colorectal Cancer Database will be linked. Quality of life will be assessed using StomaQol and SF-36. Colostomy Impact score will also be obtained. Patients will self-report a parastomal bulge and information such as education, alcohol consumption, physical activity and civil status.

Eligibility Criteria:
Inclusion Criteria:

* permanent active sigmoideostomy, transverseostomy, jejunostomi or ileostomy
* temporary active sigmoideostomy, transverseostomy, jejunostomi or ileostomy

Exclusion Criteria:

* age younger than 18 years
* stoma closure at follow-up
* death
Influence of Edible Marijuana on Endurance Exercise Performance

Lots of people, including athletes and people who like to exercise regularly, enjoy marijuana. Some people believe marijuana might improve their ability to exercise. There are no recent, up-to-date scientific studies to suggest that this belief is right or wrong. The goal of this study is to determine the influence of marijuana on exercise performance.

The purpose of the proposed project is to provide athletes and the scientific community with data pertaining to the acute influence of edible marijuana on exercise performance, and the physiological responses to standardized exercise. Specifically, the investigators wish to determine: 1. The influence of edible marijuana on cardio-respiratory and metabolic responses to standardized cycle ergometer exercise. 2. The influence of edible marijuana on endurance exercise (time-trial) performance.

The investigators wish to determine if edible marijuana, ingested prior to exercise, is ergogenic (improves performance) or ergolytic (decreases performance).

The investigators hypothesize that edible marijuana will be ergolytic.

Eligibility Criteria:
Inclusion Criteria:

* Between the age of 21 and 40.
* Weigh more than 110 pounds
* Habitual user of cannabis; average use of THC minimum of once per month during the previous year
* Prior use of cannabis product containing at least 10 mg of THC with no adverse reaction
* Habitual exerciser: exercised a minimum of 5 days per week, for a minimum of 30-minutes/session, during the previous year.

Exclusion Criteria:

* Identification of a contra-indication to exercise during a 12-lead exercise stress test.
* Pregnant or trying to become pregnant. Breastfeeding.
* Recipient of treatment for psychotic or bipolar disorder during the previous 2 years
* Recipient of treatment for Schizophrenia during the previous 2 years
* Planned surgery scheduled within 2-weeks of study participation
Alpha-1-Antitrypsin-Deficiency in COVID-19

The blood concentrations of alpha-1-antitrypsin are monitored during COVID-19. The clinical course of patients that received AAT infusion for clinical indication is monitored.

The blood concentrations of alpha-1-antitrypsin are monitored during COVID-19. The clinical course of patients that received AAT infusion for clinical indication is monitored. Clinical outcomes, blood inflammatory markers, and virus load are monitored.

Eligibility Criteria:
Inclusion Criteria:

* Infection with SARS-COV2
* Age over 18 years

Exclusion Criteria:

* Unability to consent
* Invasive ventilation
Assessment of the Effectivity of Total-face Mask for Noninvasive Ventilation During Acute Respiratory Failure

Total-face mask may improve the efficacy of NIV compared to conventional face mask in patients with acute respiratory failure due to enhanced tolerance and the allowance of higher airway pressure without massive leaks.MAIN OBJECTIVE: To assess, in acute respiratory failure patients, whether the total-face mask reduce the intubation rate. METHODS: 300 patients admitted in the ICU for acute respiratory failure needing continuous noninvasive mechanical ventilation. The type of mask (total-face vs. conventional face mask) will be randomized. Defined failure criteria and weaning technique will be used.

HYPOTESIS: Total-face mask may improve the efficacy of NIV compared to conventional face mask in patients with acute respiratory failure due to enhanced tolerance and the allowance of higher airway pressure without massive leaks.OBJECTIVES: To assess, in acute respiratory failure patients, whether the total-face mask reduce the intubation rate. Additionally, whether it may improve mask tolerance, skin pressure damage, number of patients receiving higher pressures, or even a reduction in mortality. METHODS: 300 patients admitted in the ICU for acute respiratory failure needing continuous noninvasive mechanical ventilation. The type of mask (total-face vs. conventional face mask) will be randomized. PEEp will be titrated to the best oxygenation and IPAP up to reduce dyspnea and respiratory frequency, with the limits at clinical tolerance and massive leaks. Defined failure criteria and weaning technique will be used. Data to record include clinical parameters and mortality risk score (SAPS II), and physiologic response to NIV (either subjective and objective), technique failures and outcome. EXPECTED RESULTS: The study has been powered to detect a 30% relative improvement in intubation rate from a 35% baseline incidence of intubation in the conventional group.

Eligibility Criteria:
Inclusion Criteria:

* Acute Hypoxemia:PaO2/FiO2 lower than 200 mmHg
* Respiratory rate greater than 30 breaths/min

Exclusion Criteria:

* cardiogenic lung edema
* COPD exacerbation
* Low level of consciousness (GCS \< 13)
* Hemodynamic instability
* Facial damage
* Do-not-intubate orders
* Lack of informed consent