cyrilzakka/clinical-trials huggingface dataset:
Three M Study (Malabsorption, Microbiota, Mini-Gastric Bypass)

Bariatric surgery represents the best therapeutic option to induce sustainable weight loss and to solve serious comorbidities improving the life-expectancy and the quality of life. Actually the choice of the procedure is based on the surgeon's and patients preference . Mini gastric bypass(MGB) is an emerging procedure offering excellent results in terms of weight loss and comorbidities (mainly metabolic) control. On the other hand, recent data indicated that the gut microbiota may mediate some of the beneficial effects of bariatric surgery and changes in the composition and diversity of the gut microbiota have been observed after RY Gastric Bypass (RYGB) in humans as well as in mice. However, there are no prospective investigations on Gut Microbiota changes after MGB, despite the procedure is described as "malabsorptive" and there are no studies comparing gut microbiota shift and malabsorption entity in humans after RYGB vs MGB. Thereafter prospective data on the incidence of bile reflux esophageal lesions after MGB are lacking.

The aim of the present multicentric prospective comparative study is to evaluate malabsorption and gut microbiota shift after laparoscopic RYGB vs MGB at 1 year.


Eligibility Criteria:
Inclusion Criteria:

* BMI 40-55 kg/m2
* Non smokers
* Primary Mini Gastric Bypass or Roux en Y Gastric Bypass without any concomitant surgeries except hiatal hernia repair
* Enrollment in the two study groups will be on the basis of patient choice.

Exclusion Criteria:

* Smokers
* Different bowel measurement (plus or minus 10%).
* Conversion to open surgery, reoperation
* Helicobacter Pylori positive previous or current
* Free PPI 4 weeks before 6th month (after surgery)
* Corticosteroids, vitamine E, fish oil treatment 2 months before surgery
* Anti or pre- biotics treatment 2 months before surgery
* Chronic gastrointestinal diseases or syndromes
* Previous bariatric surgery (intragastric balloon excluded)
* Previous resective bowel surgery
* Previous pancreatic surgery
* Previous Hepato BilioPancreatic surgery
* Gallbladder gallstones
Use of Baked Milk in Oral Immunotherapy for Severe IgE-mediated Cow's Milk Protein Allergic Patients

Oral immunotherapy (OIT) programs for milk, egg and peanut, desensitize patients to their respective allergens and thereby decrease their risk of morbidity and mortality. OIT programs, however, are not without adverse events, particularly in highly sensitive patients. Recently, it has been demonstrated that the administration of baked milk (BM) products to IgE-CMA patients that are non-reactive to BM, can promote tolerance to unheated milk (UM). The goal of our research is to determine whether BM can promote desensitization even in the highly sensitive patient, who reacts to baked milk as well. In a second step, we hypothesize BM-OIT will promote desensitization to unheated milk, as well.

Importance: The change in the risk/benefit ratio of such a program will alter the therapeutic approach to an IgE-CMP allergic patient.

Probable implications to Medicine: BM-OIT will allow highly sensitive patients to tolerate milk products, decreasing their risk of life-threatening reactions. Furthermore, analysis of the immune modulation parameters that change during the treatment program, should pave the way for defining mechanisms underlying tolerance in CMP allergy.

In our first aim, we will test over a four day induction (escalating) program, whether highly sensitive UM-reactive patients) can tolerate BM . Those successful will be randomized to a treated BM-OIT group (group A) and an observational control group (group B). In the second aim, the fraction of patients in Group A who successfully progress in BM-OIT (tolerate ≥ 360 mg BM) over a 6 month period will be determined and compared to the fraction of patients in Group B who can tolerate 360mg. The results will also be compared to the progression of highly sensitive IgE-CMA patients on UM-OIT (Group C, reactive to ≤21 mg of UM ). In aim-3, the fraction of BM-OIT patients able to tolerate minimally ≥ 12.5 mg of UM or higher than their initially eliciting dose. will be assessed.

Methods: Severe patients (\>4 years) with a positive clinical history, SPT and a positive DBPCFC to CMP will be first tested for their ability to tolerate BM. The treatment group will undergo three rounds of oral induction, each consisting of 4 days and performed every 4 weeks. On day #1, the patient will be rapidly desensitized up to their threshold. On days 2-3, the maximum tolerable dose and interval is determined. Day #4 mimics the home treatment. Home treatment will then continue until the next induction. After 6 months of treatment patients will be evaluated for reactivity to UM.

Eligibility Criteria:
Inclusion Criteria:

Patients with IgE-cow's milk allergy reacting to \<12.5 mg (any reaction) on oral food challenge to unheated milk

Exclusion Criteria:

Patients with unstable asthma\*\* or those with suspected compliance issues will be excluded. Patients with stable asthma are included.

* defined as active wheezing and/or use of oral steroids within one month prior to initiation of program and/or FEV1\<75% or a greater than 18% increase in FEV1 after bronchodilator treatment.
A Pilot Study of Sildenafil in COVID-19

Observe the efficacy and safety of G1(Sildenafil citrate tablets) in patients with COVID-19 under clinical actual diagnosis and treatment conditions


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed as COVID-19:

   1. mild patient: fever,respiratory and other symptoms, the manifestation of pneumonia can be seen on imaging.
   2. severe patients: meet the definition of severe pneumonia(comply with any of the followings): Shortness of breath,RR≥30 bpm;In a resting state:SPO2≤93%;PaO2/FiO2≤300mmHg.
2. Age≥18 years old,unlimited gender.
3. Patients who cannot stop the following drugs during the trial:erythromycin or strong inhibitors of CYP3A4 (such as saquinavir,ketoconazole,itraconazole),nonspecific inhibitors of CYP (such as cimetidine),HIV protease inhibitors (such as ritonavir).
4. Willing to participate in this study,signed Informed Consent and willing to participate in regular follow-up during the study.

Exclusion Criteria:

1. Suffer from severe cognitive impairment or mental illness.
2. Pregnant and lactating women.
3. Patients taking nitric oxide drugs and nitrates in any dosage form.
4. Patients with malignant tumors;AMI, stroke or life-threatening arrhythmias within 6 months;hereditary pigmented retinitis;heart failure or unstable angina pectoris of coronary heart disease;patients with severe hypotension and hypertension.
5. Patients who are allergic to the study drug or the researcher believes it is not appropriate.
6. Participate in other clinical studies at the same time.
A Multicenter, Double-blind, Parallel Phase III Study

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine) After Intramuscular Administration in Healthy Subjects

Eligibility Criteria:
Criteria: Inclusion Criteria:

* Given written informed consent
* Healthy Korean adults (age: over 19 )
* Korean adults who agree with 21 days follow up after vaccination and good compliance to study procedures
* Those who are able to comply with the requirements for the study

Exclusion Criteria:

* Inability in written/verbal communication
* Subjects who have participated in other interventional study within 30 days
* Alcohol or drug abuse within 6 months
* Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment
* Disorders in immune function
* History of Guillain-Barré syndrome
* Disease/medications which are likely to cause any severe bleeding
* Active infection or experience of fever (\>38.0 ℃) within 72 hours following vaccination
* Oral temperature \>38.0 ℃ at the vaccination day
* Erythema, tattoo, injury at shoulder (vaccination site)
* Hypersensitivity with egg, chicken, or any of the vaccine components, or Neomycin, Gentamicin
* Influenza vaccination within 6months
* Any vaccination within 30 days
* Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products, or anti-cancer chemotherapy or radiation therapy within3 months
* Pregnant or breast-feeding women
* Clinically significant underlying diseases or medical history at investigator's discretion
Chinese Occupational Population Cohort of Lifestyle and Physical Fitness (LiFitChina)

The incidence and prevalence of metabolic risk factors such as obesity, hypertension, diabetes, and dyslipidemia, as well as cardiovascular diseases (CVD), are continuously rising among the occupational population in China, primarily comprising the middle-aged and young adults. Unhealthy lifestyles and declining physical fitness are independent risk factors affecting cardiovascular health. Additionally, the level of physical fitness is influenced by postnatal lifestyles. Lifestyle factors related to cardiovascular health in the occupational population encompass various aspects, including smoking, physical activity, diet, sleep, psychological stress, etc. These factors may interact or have a synergistic effect, necessitating a comprehensive assessment.

This project proposes a prospective cohort study design to establish a monitoring cohort for lifestyle and physical fitness among the occupational population. The study will track and follow individuals with or without any CVD metabolic risk factors, collecting information on general status, lifestyle, physical fitness, and health examination data. Exposure factors such as lifestyle and physical fitness will be measured annually, and the occurrence of CVD-related health outcomes will be observed. The aim is to develop a comprehensive evaluation index for cardiovascular health lifestyle, analyze the direct and indirect impacts of lifestyle and physical fitness on the occurrence and development of CVD, and explore potential mediating and moderating effects of physical fitness in the association between lifestyle and cardiovascular health.


Eligibility Criteria:
Inclusion Criteria:

* adults between 18-59 years of age
* occupational staff
* willing to accept long-term follow-up

Exclusion Criteria:

* participants with previous CVD history such as myocardial infarction, stroke and severe aortic stenosis;
* with cancer;
* with congenital genetic diseases, or cannot cooperate with the investigation and follow-up due to acquired diseases, such as congenital heart disease, paralysis, deafness, dementia, mental abnormality, developmental retardation, etc.;
* with exercise contraindications;
* duration of pregnancy;
* refuse to sign the informed consent.
Effects of a Dexmedetomidine on Quality of Recovery 40 and Postoperative Nausea and Vomiting in Breast Cancer Surgery

Postoperative nausea and vomiting (PONV) is common following beast surgery. Dexmedetomidine was reported to a reduced PONV due to opioid-sparing effect. It is not clear if dexmedetomidine itself is useful on reducing PONV. The hypothesis of present study: intraoperative application of single dose dexmedetomidine (0.5 mcg/kg) is is effective than placebo for reducing of PONV and improve postoperative quality of recovery score within 48 postoperative hours.

This study was approved by the Institutional Review Board of Severance Hospital, Yonsei University Health System. After written informed consent was obtained from all patients, aged 20-75 years with ASA physical status class I-II who were scheduled breast cancer surgery under general anaesthesia were enrolled in this study All the patients were randomly assigned to receive dexmedetomidine or placebo during surgery. The primary outcome was quality of recovery determined by QOR-40 in the first 24h after surgery.The secondary outcome measure was PONV assessed by visual analogue scale every 6 hours within 48 postoperative hours.

Eligibility Criteria:
Inclusion Criteria:

* ASA I, II
* aged 20-70 years
* Undergoing breast cancer surgery

Exclusion Criteria:

* CAOD
* Bradycardia
* QT prolongation
Comparing KIDScore™ D5 and iDAScore®. The KiDA Study

A pilot study to gather information on clinical pregnancy rates for preparation of the planning of a larger randomized controlled trial comparing two decision support tools: the deep learning tool iDAScore® and the current annotation model, KIDScore™ D5.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing IVF/ICSI-treatment with controlled ovarian stimulation with gonadotrophins and the intention to treat by transfer of a single day 5 fresh blastocyst on day 5.
2. At least two good quality blastocysts (GQB) on day 5 (3BB or better on the Gardner scale), originating from normally fertilized oocytes (2PN).

Exclusion Criteria:

1. Previous participation in this RCT
2. Concurrent participation in another investigation
3. Intention to perform any form of preimplantation genetic testing
4. Fertility preservation
5. Planned transfer on day 2-4
6. Female age \>42 years
7. A reduced likelihood of obtaining two good quality blastocysts on day 5 as evidenced by an AFC \<5 (if available, AFC=antral follicle count)
Music for Insomnia

The aim of this study is to determine the effect of listening to music on sleep quality (subjective and objective), daytime dysfunction and neurophysiological arousal in patients with insomnia.

Sleep problems are highly prevalent in modern society and poor sleep is associated with impaired physical and mental health with large costs for both individuals and society. Pharmacological treatment is recommended only for short-term use, and there is a need to study promising drug-free aids to improve sleep. Furthermore, the mechanisms of insomnia are not well understood. In the present project we will investigate if listening to music can improve sleep quality in persons suffering from insomnia. We will use a randomized controlled trial design including both subjective and objective measures of sleep.

Eligibility Criteria:
Inclusion Criteria:

* Insomnia diagnosis

Exclusion Criteria:

* Use of hypnotic medications
* Alcohol or substance abuse
* Pregnant or breastfeeding women
* Sleep apnea with an apnea hypopnea index (AHI) \>15
* Clinically significant restless leg syndrome or periodic limp movement disorder (PLMS\>25)
Predictive Factors of Unpredicted Movement in Motor Evoked Potential

The purpose of this study was to identify the predictive factors of unpredicted movement in motor evoked potential (MEP) during intraoperative neurophysiologic monitoring in adult patients undergoing brain surgery.

Despite advances in neuroendovascular techniques, several complications can occur by brain urgery. Therefore, for neurosurgeons and anesthesiologists, it is a major concern to describe and monitor surgical lesion for maintaining structural and functional integrity as well as achieving maximal cytoreduction in lesion, and modifying the management of patients on the process of surgery. For example, microvascular Doppler sonography, indocyanine green aniography, intraoperative digital subtraction angiography, and intraoperative neurophysiologic monitoring (IONM) are used for this purpose.

The incidence of unpredictable and unacceptable movement is relative low. However, the results are so horrendous that they can cause injuries in site of rigid pin fixation of the head, cervical spine injuries, excessive surgical field movement, and deterioration of surgical outcome. However, risk factors associated with unpredictable and unacceptable movement remain unclear. Therefore, the aim of this retrospective study was to evaluate risk factors associated with unpredictable and unacceptable movement in the patients who underwent brain surgery with MEP monitoring under general anesthesia while using neuromuscular blocking agent.

The investigators recorded demographic data including age in years, sex, height in meters, weight in kilograms, body mass index (BMI in kg/m\^2), ASA physical status class, diagnosed disease, performed surgical procedure, duration of anesthesia in minutes, duration of surgery in minutes, underlying disease (e.g. hypertension, diabetes, neurologic disease, respiratory disease), medications. Laboratory data was also collected including arterial blood gas analysis, hematocrit, hemoglobin, sodium, potassium, ionized calcium, ionized magnesium, and lactate. Unpredictable and unacceptable movement was defined as either the dangerous gross movement requiring the increase the continuous infusion rate of rocuronium in view of the surgeon, anesthesiologist, and neurophysiologic specialist or the shake of the surgical field requiring the increase the continuous infusion rate of rocuronium.

Eligibility Criteria:
Inclusion Criteria:

* From June 2003 to August 2017, patients who underwent motor-evoked potential monitoring during brain surgery under partial neuromuscular relaxation at the Seoul National University Bundang Hospital.

Exclusion Criteria:

* Age : 18 or younger and 75 or older
* Anesthesiologists physical status classes III or more
* body mass index(BMI) \< 18.5 kg/m\^2 or BMI \> 25 kg/m\^2
* Patients who received medications that affect muscle relaxation recovery other than anticonvulsants
* OT/PT \> 40 IU/L, Cr \> 1.4 mg/dl
* Moderate to severe respiratory or heart disease
Viennese Prevalence Study of Anderson-Fabry Disease

The prevalence of Anderson - Fabry disease in patients with left ventricular hypertrophy is unclear. The investigators will examine urine - α - Galactosidase activity and globotriaosylceramide isoforms in these patients.

Anderson - Fabry disease (AFD) is a rare, X - linked hereditary systemic lysosomal storage disorder which usually affects the heart. The reported incidence of AFD is between 1 in 117000 and 1 in 240000 live births. Due to a deficiency of the enzyme α - galactosidase, glycosphingo-lipids, primarily globotriaosylceramide, are stored also in endothelial and myocardial cells, leading to morphologic and functional changes. AFD-cardiomyopathy progresses with age and with the course of the disease, leading to reduced life expectancy. The investigators hypothesize, that AFD could be underdiagnosed in patients with only mild or moderate left ventricular myocardial hypertrophy. Early diagnosis of AFD may be relevant since affected patients might benefit from enzyme replacement therapy at early stage of disease. The investigators will examine 4000 consecutive patients with an echocardiographically measured interventricular septum thickness of ≥ 12mm. Urine samples will be collected and Gb3-isoforms, creatinine and α - Galactosidase activity will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients with myocardial septum wall thickness ≥ 12mm

Exclusion Criteria:

* Patients \< 18 years
* Patients unable to provide urine sample
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE; subacute cutaneous lupus erythematosus \[SCLE\] and/or discoid lupus erythematosus \[DLE\]) participants in a randomized, double-blind, placebo-controlled, parallel, adaptive and dose-ranging setting. Study Duration: 33 weeks Visit Frequency: every 2 or 4 weeks Enpatoran is not available through an expanded access program.


Eligibility Criteria:
Inclusion Criteria:

* Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) \>= 8
* Active SLE with presence of: CLASI-A \>= 8 and BILAG 2004 1B, C, D (that is \[i.e.\], No BILAG 2004 A and No BILAG 2004 \>= 2B) or BILAG 2004 \>= 1A or 2B and 1 or 2 of the following: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI \>= 6 at Screening Visit and confirmed clinical hybrid SELENA-SLEDAI \>= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A \>= 8
* Receiving a stable dose of at least one of the following standards of care therapies for lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Autoimmune or rheumatic disease other than SLE or CLE
* Dermatological diseases other than cutaneous manifestations of SLE or CLE
* Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
* Ongoing or active clinically significant viral, bacterial, or fungal infection
* History of uncontrolled seizures or other neurological disorder
* History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
* History of malignancy
* Other protocol defined exclusion criteria could apply
The Canadian Triage and Acuity Scale for Children; A Prospective Multi-Center Evaluation.

The aim of this study is to evaluate the validity and the reproducibility of the canadian triage and acuity scale when applied by regular nurses for the triage of children in the Emergency Department.

The role of triage in the Emergency Department (ED) is to assign high priority to patients who need urgent care while identifying patients that may be able to wait safely. The Canadian Triage and Acuity Scale (CTAS) is a triage tool constructed from a consensus of experts that is universally used in Canada. Until now, there has been no evaluation of the validity of the tool for children in a clinical context. Also, its inter-rater reproducibility has not been evaluated. The expected implementation of a revised version of the Canadian triage tool in 2008 would be an ideal moment to evaluate its validity and reproducibility. Specific objective: 1. To evaluate the validity of the CTAS for children visiting a pediatric ED and 2. To measure the inter-rater agreement for nurses using the CTAS in these settings.

Eligibility Criteria:
Inclusion Criteria:

* Every patient younger than 18 years old that presents to the ED will be eligible except for those that need to go directly to the resuscitation room (triage level 1)

Exclusion Criteria:

* For ethical reasons, patients that need an immediate treatment will not be recruited in the study.
* Patients for whom an informed consent could not be obtained (example: insurmountable language barriers) will not be included.