cyrilzakka/clinical-trials huggingface dataset:
Results of Sleeve Gastrectomy Surgery in Relation With Eating Habits (After One Year)

Sleeve gastrectomy is one of the most common surgical procedures performed today for patients that undergo bariatric surgery. One of the primary reasons for morbid obesity is unhealthy eating habits and the belief that changes in those habits can ensure the success. Objectives: The investigators aimed to explore the effect of different eating habits prior to the bariatric surgery on the surgery success and on different aspect of quality of life. Design: The investigators conducted this study on patients that underwent sleeve gastrectomy as the first bariatric operation.

The investigators conducted this study on patients that underwent sleeve gastrectomy as the first bariatric operation. The investigators divided the patients into groups according to their pre-operation eating habits: binge, sweet, snack and high volume and compared different aspects of the surgery such as weight loss, BMI and distance from ideal weight. The investigators also examined the effect of the surgery on the quality of life, sexual life, physical activity, eating habits and satisfaction from the surgery by a telephonic survey that was conducted up to one year after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* morbid obesity
* approved for bariatric surgery by the hospital's committee
* Patients that underwent primary surgery

Exclusion Criteria:

* recurrent surgery
Quick ICD Study: Is Extensive Electrophysiological Testing Before, During and After ICD-Implantation Still Necessary ?

The purpose of this study is to evaluate the strategy of implanting an ICD with or without EPS before, during and after ICD-implantation in a randomised controlled trial, using a combined endpoint of major ICD-related adverse events as the primary outcome measure.

Usually, EPS before and during ICD-implantation is performed to allow risk stratification, to test serial antiarrhythmic drugs, to find suitable ablation sites in patients with hemo-dynamically stable monomorphic VTs, to exclude supraventricular tachycardias as a cause of cardiac arrest and to help programming detection rate and enhancement criteria in the ICD. However, routine EPS preceeding ICD-implantation exposes the patient to some risk and the health care system to considerable costs. So the question has been raised, whether such testing is still necessary and costseffective, if the indiaction for ICD-implantation is clear on a clinical ground.The purpose of this study is to evaluate the strategy of implanting an ICD with or without EPS before during and after ICD-implantation in a randomised controlled trial, using a combined endpoint of major ICD-related adverse events as the primary outcome measure (see details under "Endpoints"). The results will be viewed against the extra costs and patients´ quality of life both study arms.Secondary outcomes are considered as differences in decisions between the groups and difference of events in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* structural heart disease and survived cardiac arrest or hemodynamically unstable VT (bpm \> 200/min)

Exclusion Criteria:

* conditions, which make a secondary cause for cardiac arrest probable or are not compatible with a single chamber ICD; co-morbidity, prior ICD PM, or EPS
Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints

This study evaluates function, quality of life and development of hip- and knee osteoarthritis minimum 15 years after unilateral femoral lengthening on people with idiopathic or post-traumatic anisomelia.

This study has a cross-sectional design, where patients that completed femoral lengthening more than 15 years ago and fulfills the inclusion criteria's are invited to participate. Patients will undergo radiographic imaging to evaluate hip- and knee arthritis, axis deviaton and leg length discrepancy. To evaluate quality of life, function and pain, the participants will complete the forms EQ-5D-5L, Knee osteoarthritis outcome score (KOOS) and International physical activity questionnaire (IPAQ). Bilateral active hip and knee range of motion will be measured with hand held goniometer, and the functional tests 30 seconds sit to stand, hop tests and stair test will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic or post traumatic leg length discrepancy who are lengthened with the callutasis method minimum 15 years ago

Exclusion Criteria:

* Patients that are lenghtened with innate pathology resulting in shortening of the limb, angle deviation and less musculature, for example congenital femoral deficiency or fibula hemimelia.
* Patients with acquired leg length discrepancy who have had infection in knee or hip joint
Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass

The study evaluates the efficacy of intravenous levosimendan treatment started during a coronary artery bypass operation to wean patients from a heart lung machine.

Levosimendan or placebo infusion is started at the time of induction of anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Three vessel coronary artery disease.
* Indication for on-pump coronary artery bypass surgery.
* Ejection fraction below 50%

Exclusion Criteria:

* Indication for any cardiac valve surgery
* Previous coronary artery bypass surgery
Analysis of Clinical Features of Chronic Liver Disease Complicated With Hepatopulmonary Syndrome

Hepatopulmonary syndrome (HPS) has unknown pathogenesis, limited treatment and poor prognosis. The onset of HPS is insidious and easy to be ignored. Many liver diseases such as "cirrhosis and related complications" are the core characteristics of Beijing You 'an Hospital, but the clinical characteristics of HPS patients in the center are still unclear. The investigators plan to make the diagnosis of HPS among chronic liver disease patients in the hospital according to the diagnostic criteria of HPS proposed in the Practice Guidelines of the International Society of Liver Transplantation in 2016, collect clinical data of HPS participants, evaluate the severity, analyze and summarize clinical characteristics, and conduct management and follow-up. At the same time, The investigators collect blood samples for proteomics tests. In order to improve the diagnosis and treatment level of HPS.

At present, the mechanism of hepatopulmonary syndrome is not clear. The researchers plan to use the extracted plasma for detection, protein extraction and quality control, and then proteolytic hydrolysis, computer detection, and bioinformatics analysis.

Eligibility Criteria:
Inclusion Criteria:

* chronic hepatitis Agreed to venous blood collection

Exclusion Criteria:

* pneumonia, pulmonary vascular disease, interstitial pulmonary disease, COPD, bronchial asthma, lung cancer and other primary pulmonary diseases, acute upper gastrointestinal bleeding.
Minimum Effective Volume of Local Anesthetic for Peribulbar Block.Does it Differ With the Eyeball Axial Length?

The aim of this study is to calculate the minimum effective volume of local anesthetic for peribulbar block in patients undergoing cataract extraction surgery.

The main goal of this study is to estimate the minimum effective volume(MEV90) of local anesthetic and hyaluronic acid given for local anesthesia of the eye for 2 different axial length groups of patients undergoing eye surgery. Volume assignment was carried out using a biased coin design (BCD) up-and-down sequential method (UDM), where the volume given to each patient depends on the response of the previous one. The MEV90 was calculated using isotonic regression with bias-corrected 95% confidence interval (CI) derived by boots trapping. The mean value of the estimate was obtained from 3000 bootstrap samples.

Eligibility Criteria:
Inclusion Criteria:

* we allocated adult patients aged 40-70 years, of both gender, American Society of Anesthesiologists (ASA) II - III, listed for elective cataract extraction using phaco emulsification technique with intraocular lens implantation surgery.

Exclusion Criteria:

* Patients known to have any systemic contraindications (as severe hypertension) or allergy to the local anesthetic, those who refused local anesthesia, high myopes (axial length \> 26 mm), patients with a single eye, those with complicated vitreous hemorrhage, ocular infection, or associated glaucoma have been excluded.
Characterization of Professional COPD Related to Exposure to Organic Dust - Mean Follow up at 6 Years

The main objective of the BALISTIC research program is to characterize COPD related to organic particles (of which the model is agricultural COPD) in comparison with tobacco-related COPD, at the clinical, functional (at rest and exercise), inflammatory and physiopathological level.

The cross-sectional step BALISTIC 1 made it possible to include 400 patients between 2011 and 2015, and to identify approximately 100 dairy farmers COPD and 100 non-dairy farmers COPD (tobacco COPD). Preliminary results, as well as those of an ancillary study that included a group of subjects exposed to mineral dust and fumes, suggest that agricultural COPD is a predominantly non-emphysematous or essentially bronchial disease with IgE-mediated allergic mechanisms.

The current project BALISTIC 2 proposes to conduct a comparative study at + 6 years on average of the two groups of COPD subjects identified in BALISTIC 1 in order to specify the phenotype of COPD in dairy farmers by, in particular, the study of the rate of decline of resting and exercise respiratory function parameters, its computed tomography presentation and its genetic and epigenetic profile.

The prospects of this work are to improve the management of COPD in any cause by setting up preventive and curative therapeutic approaches in order to provide answers to the progression of a disease that makes part of the few major public health problems of the 21st century.


Eligibility Criteria:
Inclusion Criteria:

* Patients who participated to BALISTIC 1 and who had been diagnosed with COPD, belonging to either the "dairy farmers COPD" group or the "non farmers COPD" group.

Exclusion Criteria:

-
Effect of the Negative Pressure Therapy Dressing Compared With Hydrogel Dressing.

The objective of the study is to measure the efficacy of the use of single-use portable negative pressure therapy (PICO ®) in the prevention of surgical wound infections (SSI) from cardiac surgery under extracorporeal circulation compared to single-use hydrocolloid dressings "Aquacel Surgical".

Negative pressure therapy is a type of physical therapy for wound healing that is based on the application of a negative pressure (void) in the wound bed.

Negative pressure therapy is based on the application of a subatmospheric pressure in the wound bed to trigger a whole series of mechanisms, and that to a greater or lesser degree, and in a synergistic manner, act by creating or improving the conditions for the healing process to develop (negative pressure therapy).

All these mechanisms act by diminishing the possibility of creating an appropriate medium for the growth of pathogenic germs.

Today, negative pressure therapy is also used to create ideal conditions in surgical wounds to prevent or reduce the risk of local complications, is what we call incisional negative pressure therapy.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective or emergency cardiac surgery with extracorporeal circulation heart surgery who will have a median sternotomy.
* Who signs Informed Consent after agreeing to participate in the microbiological study.

Exclusion Criteria:

* Patients undergoing emergency cardiac surgery that does not time to randomization and/or coding.
* Patients with immunocompromised haematological diseases.
* Patients who are allergic or present some hypersensitivity to the dressing or excipient.
* Patients who are participating in another experimental study.
* Patients who, due to their fragility or comorbidity, the surgeon considers that they should not undergo randomization.
Phenylephrine in Septic Shock

The present study was conducted as a prospective, randomized, controlled study to compare:

* the effects of norepinephrine and phenylephrine on systemic and regional hemodynamics in patients with catecholamine-dependent septic shock
* to test the hypothesis that norepinephrine may likewise better preserve hepatosplanchnic perfusion versus phenylephrine in patients suffering from septic shock

Thirty two septic shock patients requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation will be enrolled in the study. Patients will be randomly allocated to be treated with either a) titrated phenylephrine, b) titrated norepinephrine (control; each n = 16), to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization, thermo-dye dilution catheter, gastric tonometry as well as data from organ function, will be obtained at baseline and after 12 hours.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Septic shock
* Vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)

Exclusion Criteria:

* Pregnancy
* Age \< 18 years
* Present cardiac dysfunction
* Present or suspected acute mesenteric ischemia
Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)

A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications.

This trial is designed to examine the effect of exenatide once weekly compared to exenatide twice daily on glucose control and safety in subjects for at least 30 weeks. The study is also designed to examine glucose control during the transition from exenatide twice daily for 30 weeks to exenatide once weekly. Long-term safety and efficacy will be monitored during the open-ended assessment periods. This study will be conducted in approximately 300 subjects with type 2 diabetes treated with diet modification and exercise alone or in combination with a stable regimen of metformin, SU, thiazolidinedione (TZD), a combination of metformin and SU, a combination of metformin and TZD, or a combination of SU and TZD.

Eligibility Criteria:
Inclusion Criteria:

* Has type 2 diabetes mellitus treated with diet modification and exercise alone or in combination with a stable regimen of a combination of metformin, sulphonylureas, and thiazolidinediones for a minimum of 2 months at screening.
* Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
* Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
* (For sub-study) Currently participating in open ended assessment period of main study 2993 LAR105

Exclusion Criteria:

* Has been previously exposed to exenatide (Byetta®), exenatide LAR, or any glucagon-like peptide-1 (GLP-1) analog.
* Received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening.
* Has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:

  * Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
  * Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
  * Regular use (\> 14 days) of drugs that directly affect gastrointestinal motility;
  * Regular use (\> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption;
  * Regular use (\> 14 days) of medications with addictive potential such as opiates and opioids;
  * Prescription or over-the-counter weight loss medications within 6 months of screening.
* (For sub-study) Subjects will be terminated from study who do not participate in the dual chamber pen substudy
Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.

To determine the objective tumor response and remission rate of AIDS-related Kaposi's sarcomas (KS) following a single dose of tin ethyl etiopurpurin (SnET2) followed by photodynamic therapy (PDT). To determine the systemic and local toxicity, and morbidity safety profile of SnET2-PDT.

All patients receive a single dose of SnET2 and are randomized to receive either PDT light treatment or no light treatment (control group). Patients are assessed prior to and at 4, 12 and 24 weeks following treatment, and are followed for 7 months.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documentation of at least one biopsy-confirmed KS lesion.
* A minimum of 4 and no more than 36 KS lesions.
* All eligible lesions must be bidimensionally measurable, treatable by surface (non-contact) light illumination, and \<= 40 mm in diameter of the longest bidimensional axis.
* ACTG disease state T(0) L(0) or (1) S(0) or (1).
* Life expectancy greater than 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active opportunistic infection or condition except thrush or herpes simplex virus infections.
* Advanced KS tumor stages including the presence of tumor associated edema or ulceration, extensive oral KS, or KS in other non-nodal viscera.
* Hematopoietic dysfunction.
* Coagulation dysfunction.
* Hepatic dysfunction.
* Renal dysfunction.
* Cardiovascular dysfunction - Presence of significant coronary artery disease requiring current treatment or myocardial infarction.
* Pulmonary dysfunction.
* Sepsis.
* Known disorder of lipoprotein metabolism or clearance.

Patients with the following prior conditions are excluded:

* History of allergic or hypersensitivity reactions to light, egg proteins or egg yolks, history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.

Excluded within 7 days of therapy:

* Hematopoietic dysfunction.
* Coagulation dysfunction.
* Hepatic dysfunction.
* Renal dysfunction.

Excluded within 3 months of therapy:

* Pulmonary dysfunction.

Excluded within 6 months of therapy:

* Myocardial infarction.

Prior Medication:

Excluded:

* Intralesional chemotherapy within the past 12 weeks.
* Systemic chemotherapy or investigational drugs within the past 4 weeks.

Prior Treatment:

Excluded within 3 months prior to therapy:

* Local cryotherapy or surgery to study lesions.
* Systemic or topical photodynamic therapy agents.
Serum 25-OH Vitamin D Modulation by Sunbed Use According to EU Guideline EN 60335-2-27

Our study aims to clarify the impact of the use of a standard sunbed according to new EU guideline EN 60335-2-27 and possibly discount the positive effects of tanning beds. We plan to investigate the serum elevation of 25(OH)D under sunbed use, respecting the new recommendations for the exposure plan for different skin types according to EN 60335-2-27.

The use of a sunbed will be compared to a control group not using a sunbed in the observation period.

* Trial with medical device

We will compare to baseline changes in serum vitamin D and health-related quality of life using a control group and an intervention group.

Eligibility Criteria:
Inclusion criteria: Probands intending to use a commercial sunbed :

1. Age 18 years or older
2. Regular use of commercial sunbeds
3. Oral and written informed consent

Exclusion criteria: 1. Skin type I according to Fitzpatrick according to EU guideline EN 60335-2-27 2. Sunbed use within the last three months 3. Use of vitamin D supplements or multivitamin supplements 4. Any medical condition which renders them unfit for sunbed use in the judgment of the investigator 5. Inability to provide oral and written consent to participate
A Study of IBI351 in Healthy Subjects

This is an open-label, two-cycle clinical study to evaluate the drug interaction between itraconazole or dextromethorphan and IBI351 in healthy subjects. A total of two cohorts of 12 healthy male subjects were planned to be enrolled in each cohort.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.
2. Healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
3. Body weight is not less than 50 kg, and body mass index (BMI) is in the range of 19 \~ 26 kg/m2 (including both ends).
4. Physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), thyroid function, 12-lead electrocardiogram, chest CT, abdominal ultrasound (hepatobiliary, pancreatic, spleen and kidney), echocardiography (only applicable to Cohort 1 subjects) showed no abnormalities; or abnormal test results but judged as normal or clinically insignificant by the investigator.

Exclusion Criteria:

1. have taken any products containing alcohol or have a positive alcohol breath test (≥ 20 mg/100 ml) within 24 hours before taking study medication.
2. hepatitis B surface antigen HBsAg positive.
3. hepatitis C virus antibody positive.
4. positive AIDS antigen/antibody or Treponema pallidum antibody.
Atopy Patch Test in Children With Atopic Dermatitis

Positive reactions in atopy patch test in children with atopic dermatitis.

The prevalence of food allergy seems to be increasing, which might explain the increased demand for reliable evaluation of patients with suspected food-related gastrointestinal symptoms. Little is known about the diagnostic accuracy of atopy patch tests(APT) in the clinical practice. APT seems to have a better specificity than the IgE methods and seems to reflect late-phase clinical reactions.The aims of this study were to evaluate:

(i) The prevalence of positive reaction of APTs for atopic dermatitis (ii)Positive reaction of APT compare with skin prick test. (iii)Positive reaction of APT using lyophilized food vs commercially available food extracts. (iv)Side effect or adverse

Eligibility Criteria:
Inclusion Criteria:

* Patients who had history of atopic dermatitis

Exclusion Criteria:

* Who have dermographism
* Who have chronic disease eg. autoimmune disease, immune deficiency, cancer or allergic disease
* Pregnant women
* Who receive antihistamine, topical steroid and systemic steroid \> 20 mg/day within 7 days prior study