cyrilzakka/clinical-trials huggingface dataset:
Glucose and Fructose Stimulated Brain Activity in Obese Subjects Before and After Bariatric Surgery

The objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI before and after bariatric surgery. Administration of glucose as well as fructose is followed by functional brain MRI, and findings are correlated with serum glucagon-like peptide 1 (GLP-1) levels as an endogenous satiety signal in obese humans.


Eligibility Criteria:
Inclusion Criteria:

* right-handed
* morbidly obese patients
* scheduled for bariatric surgery

Exclusion Criteria:

* Diabetes mellitus
* cardiovascular disease
* neurologic or psychiatric disorder
An Upgrading of the Resuscitative Patterns by Utilization of the Balanced Crystalloids and Synthetic Colloids and the Non-Invasive Hemodynamic Monitoring During Burn Shock

Fluid Therapy Lithium Dilution Cardiac Output (LIDCO) controlled trial in BURNS (FACT in BURNS) is a prospective randomized multicentric study.

Introduction: The goal of this trial is the verification, optional upgrading and optimizing of the resuscitative patterns in light of the new generation of balanced crystalloids and colloids and, by utilization the non-invasive hemodynamic monitoring LIDCO.

Methods: The extensively burnt patients (age range 18-75 years) with second and the third degree burns, with TBSA above 15%, with or without inhalation injury will be included to the study within 2009-2010. The patients meeting inclusion criteria but with an adverse critical prognosis from the beginning of the hospitalization, with surgically insoluble extent of burns or the dialyzed patients will be excluded.The patients will be routinely monitored. We will use the continuous real-time hemodynamic monitoring through transpulmonal lithium dilution additionally. The monitor Lithium Dilution Cardiac Output (LIDCO) Plus permits through analysis of the arterial blood pressure trace to acquire items about CO, SVR and DO2 . In fluid resuscitation, we will use a combination of the balanced crystalloids and synthetic colloids (of the middle molecular weight) in the ratio 2 ml/kg/% TBSA : 1 ml/kg/% TBSA. The control group will be composed of the patients supervised in a standard way, volume resuscitated according to the Brooke or Parkland formulas. MAP \> 65 torr, urine output 0,5 ml/kg/h, CI 2,5 - 4,0 l/min/m2, DO2I 500 - 600 ml/min/m2 are the goals.We will measure the levels of proANP (pro Natriuretic peptide) and Angiotensin Converting Enzyme (ACE) at artificial ventilated patients. The plasma ACE and proANP concentrations were measured by commercially available ELISA immunoassays.

Conclusions: We will evaluate the total fluid balance at day 1, 2 and cumulative fluid balance at day 7, reversal of organ dysfunction according to SOFA score at day 3 and 7 in both group. The days of invasive ventilatory support, length of ICU stay, ICU survival, total length of hospital stay and hospital survival are the additional endpoints.

Eligibility Criteria:
Inclusion Criteria:

* extensively burnt patients (age range 18-75 years) with second and third degree burns
* with TBSA above 15%
* with or without inhalation injury

Exclusion Criteria:

* patients meeting inclusion criteria but with an adverse critical prognosis from the beginning of hospitalization
* with surgically insoluble extent of burns
* dialyzed patients will be excluded
The Impact of Bariatric Surgery on Non-alcoholic Fatty Liver Disease

Up to 300 million people have a BMI over 30kg/m2. Obesity is the cause of many serious diseases, such as type 2 diabetes, hypertension and NAFLD. Bariatric surgery is the only effective method of achieving weight loss in patients with morbid obesity.

The aim of the study is to assess the impact of bariatric surgery on non-alcoholic fatty liver disease in patients operated on due to morbid obesity.

Investigators include 20 patients qualified for the bariatric procedure with BMI \> 40 kg/m2 or a BMI \> 35kg/m2 with the presence of comorbidities. The average body weight in the group was 143.85kg with an average BMI of 49.16kg/m2. Before the procedure, investigators evaluated the severity of the non-alcoholic fatty liver disease in each patient using the Sherif Saadeh ultrasound scale. Investigators also evaluated the levels of the liver enzymes. Follow up was performed twelve months after surgery.

Eligibility Criteria:
Inclusion Criteria:

Patients at the age of 18-60, meeting the criteria of qualification for the surgical treatment of obesity, i.e. BMI \> 40 kg/m2 or BMI \> 35 kg/m2 together with accompanying diseases.

Exclusion Criteria:

* chronic mental diseases
* addictions
* earlier bariatric procedures
Visual Feedback in Chronic Neck Pain

The objective of this study is to evaluate the impact of visual feedback of the posterior region of the cervical spine on pain intensity and range of motion.

60 patients with chronic idiopathic neck pain will be randomly assigned into one of two groups: a group receiving visual feedback when performing 10 repetitions of each of neck movements (flexion, extension, side-flexion and rotation) and a group performing the same task without visual feedback. Participants will be assessed for pain intensity, pain location, disability, range of motion, kinesiophobia, catastrophizing and anxiety both at baseline and after visual the intervention (i.e., neck movements with and without visual feedback).

Eligibility Criteria:
Inclusion Criteria:

* To have idiopathic neck pain defined as neck pain unrelated to any known pathology or lesion felt at least once a week in the last 3 months, located between the nuchal line and a horizontal line passing through T1 and pain intensity of at least 3 in the visual analogue scale.

Exclusion Criteria:

* History of cervical or facial trauma, radiculopathy, history of surgery in the vertebral segment in question, congenital anomalies involving the spine (cervical, thoracic and lumbar spine) or any neurological or rheumatic pathology, and, finally, evidence of significant visual changes, or of deficits not corrected by lenses or glasses.
Multiple Breath Washout as a Method for Diagnosing Lung Diseases

Comparison of the new multiple-breath washout method (ndd Medizintechnik Zürich, Trueflow™/Truecheck™) with established methods of lung function diagnostics in patients with idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease, asthma and cardiopulmonary healthy individuals.

This diagnostic, prospective, clinical study aims to investigate whether the lung function data measured with the EasyOnePro®LAB device correlates with the lung function data from established measurement methods used in routine clinical practice. It is to be investigated whether the EasyOnePro®LAB measurement leads to equivalent results even with a shorter measurement duration due to an improved evaluation. This is relevant for a broader clinical application in the future.

It will also be tested whether the fact that the EasyOnePro®LAB measurement can be carried out largely independently of the employee also leads to better reproducibility of the results. To this end, the intra-individual deviations in repeated measurements will be compared between the methods.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* existing consent
* confirmed diagnosis of one of the following diseases
* idiopathic pulmonary fibrosis (IPF), confirmed according to the guidelines
* chronic obstructive pulmonary disease (COPD) with/without emphysema
* bronchial asthma
* or patients who are admitted with suspected cardiopulmonary dysfunction (e.g. with unclear dyspnoea) and in whom there is no evidence of cardiopulmonary dysfunction during the diagnostic process (comparison group of "healthy" patients).
* Indication for routine performance of the following pulmonary function tests during the current inpatient stay: Whole Body Plethysmography \& Diffusion Capacity of the Lung (single-breath)

Exclusion Criteria:

* Age \< 18 years
* Simultaneous presence of at least two of the following diseases (IPF, COPD/emphysema, asthma, pulmonary arterial hypertension)
* any medical, psychological or other condition that restricts the patient's ability to give informed consent for voluntary participation in this trial
Stress and Musculoskeletal Health in Employees

This study aims to evaluate potential correlation of stress as estimated by certain biological markers, namely saliva cortisol, Heart rate variability (HRV), Electromyography (EMG) with musculoskeletal system health status, and assess the impact of a stress management intervention..The intervention group will be trained to apply two evidence based stress management techniques and they will be guided with tips and advice about musculoskeletal health.

Impact of the intervention upon measured stress related markers will be assessed.

The goal of this non-pharmacological randomized interventional study is to investigate work-related stress in relation to the musculoskeletal health of employees.

The primary purpose of this study is to investigate if stress management interventions in employees can improve self-reported musculoskeletal health problems or Medically Unexplained Symptoms (MUS), in relation with biomarkers of stress.

Secondary outcomes will include quality of life improvement and the number of absences from work, due to musculoskeletal conditions.

The main question aims to answer if specific stress management techniques can improve the self-reported musculoskeletal health of employees.

Researchers will compare the results between two groups (one participating in the the six (6) week program and the other not participating) to measure the effect size in the intervention group and between groups.

Participants from both groups will be measured twice (on week 1 and week 8) with the same self-report questionnaires and stress biomarkers, if possible. Especially for the intervention group a six-week stress management program will be applied. This will include the participation in one and a half hour consultation meetings about stress, musculoskeletal health, psychosocial work-related factors, and how to improve well-being and work/life satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Writing and reading greek.
* Consent to provide their medical history.
* Consent to be measured with electronic devices.

Exclusion Criteria:

* Employees who are close to retirement (at least 2 years before) and those for whom any known factor may prevent them from completing the intervention (eg travel, transfer).
* Pregnancy.
* Pacemaker, history of seizures.
* Diagnosed musculoskeletal injury.
* Diagnosed diseases such as: osteoarthritis, autoimmune diseases (rheumatoid arthritis, lupus, etc.), stroke, myocardial infarction, malignant neoplasms, psychiatric disease, disability.
* Systematic reception of cortisone and anti-inflammatory treatment, up to at least three months before the intervention.
* Drugs or substances.
* Participation in another interventional program of musculoskeletal rehabilitation, physical therapy, stress management or health promotion.
High Dose Versus Routine Dose Icotinib in Advanced Non-small Cell Lung Cancer Patients With Stable Disease

We hypothesize that higher dose icotinib is related with better efficacy. The primary objective is to compare the progression-free survival of higher dose and routine dose of icotinib in treating pretreated advanced non-small cell lung cancer patients with stable disease after 8-week routine dose icotinib treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology);
* Pretreated with at least 1 platinum-based chemotherapy;
* No previous targeted treatment such as gefitinib, erlotinib;
* With a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)and \>=20mm with conventional CT) according to RECIST Criteria;
* WHO performance status(PS)\<= 2;
* Adequate organ functions;
* Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

* Allergic to icotinib;
* Patients with metastatic brain tumors with symptoms;
* Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab;
* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Role of Interleukin-13 Pathways on Pain and Itch Sensitivity

Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the proteins interleukins are involved in inflammation and itch in atopic dermatitis. The medicinal product called Lebrikizumab, used for treatment of AD, has shown to block the interleukin called IL-13. The purpose of this experiment is to evaluate the role of IL-13 in itch in both healthy subjects and people with atopic dermatitis.

Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the interleukin-13 is involved in inflammation and itch in atopic dermatitis by increasing the neuronal sensitivity to pruritogens. However, the physiological mechanisms by which IL-13 increases the itch sensitivity are unclear. The aim of this project is to use, for the first time in humans, the monoclonal antibody Lebrikizumab that inhibits IL-13 with high affinity as a novel experimental tool to modulate the IL-13 pathway and evaluate its role in the transmission and processing of itch and pain.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids, or other drugs
* Previous or current history of neurological, dermatological (e.g., AD, psoriasis, etc.), immunological, musculoskeletal, cardiac disorder, or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.)
* Moles, wounds, scars, or tattoos in the area to be treated or tested
* Current use of medications that may affect the trial such as antihistamines and pain killers (use of antihistamines should be discontinued 72 hours before the experiment and all topical agents and emollients should be discontinued 24 hours before the experiment).
* Use of systemic and topical corticosteroids
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
* Lack of ability to cooperate
Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease

The study is a prospective, randomized, controlled, exploratory trail to evaluate the strategy of "one-stop" endovascular treatment for concomitant coronary artery disease and aortic atherosclerotic disease.

60 patients will be allocated randomly in a 1:1 ratio into one-stop strategy group or staging strategy group. In one-stop strategy group, percutaneous coronary intervention (PCI) will be performed on the same operating room immediately after the endovascular aortic repair (EVAR); In staging strategy group, PCI will be performed several days after EVAR. The safety and effectiveness will be assessed between two groups 1 year after the operation. The economic index will be evaluated as well as.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 years to 75years, male or female;
* Aortic atherosclerotic disease with indication of EVAR;
* Coronary heart disease with indication of PCI;
* Provided informed consent.

Exclusion Criteria:

* Acute aortic dissection
* Acute coronary syndrome
* Dysfunction of coagulation system
* Patients with gastrointestinal hemorrhage
* Known allergy to contrasts or antiplatelet drugs
* Renal dysfunction (GFR≤60ml/min)
* Patient with multi-branch coronary preferred CABG
A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy

This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r DLBCL who received CD19 CAR-T therapy.

This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection.

The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.

Eligibility Criteria:
Inclusion Criteria:

1. The patient volunteered to participate in the study, and signed the Informed Consent
2. Age 18-75 years old, male or female
3. Patients diagnosed with diffuse large B-cell lymphoma (DLBCL, De novo or transformed) histologically according to the 2016 WHO Classification, at least one measurable lesion(LDi≥1.5 cm)
4. r/r DLBCL patients who received prior CD19 CAR-T therapy, and positive for CD20
5. At least 2 weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
6. Adequate organ and bone marrow fuction
7. No contraindications of apheresis
8. Expected survival time \> 3 months
9. ECOG scores 0 - 1

Exclusion Criteria:

1. Have a history of allergy to cellular products
2. Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard
3. A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease
4. Patients with active CNS involvement
5. Patients with autoimmune disease, immunodeficiency, or other treatment requiring inhibitors
6. Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed
7. Live vaccination within 4 weeks before peripheral blood apheresis
8. HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers
9. Have a history of alcoholism, drug addiction and mental illness
10. Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception
11. Patients with severe fludarabine or cyclophosphamide hypersensitivity
12. The patient has a history of other primary cancers, except for the following:

    1. Non-melanoma such as skin basal cell carcinoma cured by resection
    2. Cured carcinoma in situ such as cervical, bladder or breast cancer
13. The investigators believe that there are other circumstances that are not suitable for the trial
Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial

For patients who are unable to receive surgery or having local advanced esophageal cancer stages, concurrent chemoradiotherapy is recommended. But radiotherapy is the main strategy for older patients because of their chemoradiotherapy intolerance. The whole world focused on targeted therapy which has strong specialties and mild toxicities. So combined targeted therapy and radiotherapy may be a novel strategy for older patients with esophageal cancer. Nimotuzumab is a EGFR monoclonal antibody. This clinical trial is to study the effect and safety of Nimotuzumab in combined with radiotherapy for older patients with esophageal cancer. All patients receive intensity modulated radiotherapy with conventional fraction. Nimotuzumab with 200mg is given weekly for all patients during radiotherapy.

Study Design Primary Purpose: To evaluate the response rate, progression-free survival, overall survival and complications.

Study Phase: Phase II Intervention Model: Targeted therapy combined with radiotherapy Number of Arms: One Masking: No Allocation: 30 patients for one single group Enrollment: 30 patients

Eligibility Criteria Inclusion Criteria: 1. ≥ 70 year-old, 2. Thoracic segment esophageal cancer with stage II to IV (supraclavicular lymph node metastasis only), 3. No previous surgery, radiotherapy or chemotherapy of cancer was allowed, 4. Estimated survival time ≥ 3 months, 5. KPS \> 60, 6. No serious diseases of important organs, 7. Signed consent forms voluntarily.

Exclusion Criteria: 1. Psychopath, 2. History of other malignant disease which has not been cured, 3. Joining other clinical trial prior this study.

Eligibility Criteria:
Inclusion Criteria:

1. patients aged 70 years or older;
2. treatment naive patients with histologically proven thoracic-segment EC that was inoperable and who could not tolerate CCRT;
3. stage II-IV disease (supraclavicular lymph node metastasis only), according to the 6th American Joint Committee on Cancer TNM staging system;
4. estimated survival time ≥3 months;
5. Karnofsky performance score ≥70;
6. adequate bone marrow, as well as hepatic and renal function;
7. voluntary written consent provided prior to treatment.

Exclusion Criteria:

1. esophagobronchial or esophagomediastinal fistula;
2. patients who had joined other clinical trials prior to this treatment;
3. serious heart, liver, and/or kidney insufficiency;
4. serious infectious disease;
5. relapse disease or distant metastasis;
6. recently diagnosed neoplastic diseases;
7. previous receipt of surgery, chemotherapy, or radiotherapy for EC.