cyrilzakka/clinical-trials huggingface dataset:
Multicentre Study to Record the Mental and Physical Effects of the COVID-19 Pandemic (COBESITY-Study)

Prospective, international multicenter study to investigate the physical and psychological effects of the COVID-19 pandemic in two obese patient cohorts (BMI ≥ 25 kg/m²) pre- and post-bariatric surgery. In addition, the investigation of country-specific differences will be performed.

The COVID-19 pandemic, first reported in November 2019, has led to a global health systems emergency. The number of confirmed COVID-19-associated deaths, according to WHO, is higher in countries with high obesity prevalence. However, whether obesity is an independent risk factor of the severity of COVID-19 remains unclear.

Obesity represents one of the major health problems worldwide and the COVID-19 pandemic is expected to further increase obesity prevalence rates. Initial research indicates that the pandemic has also led to an increased incidence and/or worsening of depression and eating disorders. Additional weight gain due to the COVID-19 pandemic may be suspected to increase the prevalence of psychological comorbidities in patients before weight-reducing surgery compared to patients who have already undergone weight-reducing surgery.

Therefore, the main aim of this international study is to gain a better understanding of the mental and physical effects of the coronavirus pandemic on obese patients before and after a weight-reducing surgery and use this to develop approaches for solutions. This study also aims to investigate the country-specific differences (Germany vs England) as well as the differences in the mental effects experienced by overweight patients who have or have not been infected with COVID-19.

To achieve these aims, obese patients aged 18 years and older, before and after weight-reducing surgery, will be recruited from the bariatric surgery clinic at King's College Hospital, NHS Trust Foundation as well as from the Medical University Hospital Hamburg-Eppendorf, Germany. Participants will be asked to complete a questionnaire about their health, socio-economic status, and the effects of the COVID-19 pandemic on their physical and mental health. The questionnaire will take 15 minutes to complete and can be done at home or during the patient's appointment at the bariatric surgery clinic to minimise unnecessary travel.

Eligibility Criteria:
Inclusion Criteria:

Overweight and obese patient cohort

* Age: 18 years and older
* BMI ≥ 25kg/m²

Overweight and obese patient cohort with bariatric surgery

* Age: 18 years and older
* BMI ≥ 25kg/m²
* Status post sleeve or gastric bypass surgery

Exclusion Criteria:

* Age under 18 years
* Cognitive, mental and/or linguistic limitations to complete the questionnaire independently
* Severe somatic illnesses, such as tumour diseases
* Pregnancy or breastfeeding
* Acute need for treatment due to comorbid mental disorders
Improvement to Perform Thoracocentesis After a Specific Training in Medical Students With the Supervised Use of an Augmented Reality Simulator

Monocentric study, aiming to assess the improvement of medical students to perform a first-time thoracentesis after training using a specific training using an augmented virtual reality simulator, versus standard training.

Study population: medical students from the department of Respirology (University hospital of Strasbourg), performing their first thoracocentesis in patients having an indication for a first-time thoracocentesis.

This is not an interventional study, no change in patient course being induced because of the study.

After the procedure: use of specific surveys for the patient and for medical students to assess the patient's pain, the patient and the medical student level of anxiety, and the student ability during the procedure.


Eligibility Criteria:
Medical students :

Inclusion criteria:

* Medical students between the 4th and 6th year of their medical course, working in the department of respirology at the University hospital of Strasbourg, France, without any prior experience of thoracocentesis.
* Older than 18 years old
* No opposition to participate to the study (signed consent form).

Exclusion criteria:

- Student with a prior experience of pleural procedure (chest tube, thoracocentesis).

Patients :

Inclusion criteria:

* Patients requiring a first-time thoracentesis in routine care.
* Older than 18 years old.
* Speaking and understanding French.
* Valid health insurance.
* No opposition to participate to the study (signed consent form).

Exclusion criteria:

* Patient with previous experience of pleural procedure (thoracocentesis, chest tube...).
* Patient having a high-volume pleural effusion according to radiological/ultrasound criteria.
* Patient with low-volume pleural effusion according to radiological/ultrasound criteria.
* Patient with poor clinical tolerance of the pleural effusion(respiratory instability, dependence on ventilation machine with positive expiratory pressure...).
* Patients with higher risk of complication during the procedure (BMI \> 35 kg/m², with increased risk of bleeding...).
* Contraindication to the use of Lidocaine.
* Local infection.
* Impossibility to provide detailed information to the patient.
* Subject under legal protection.
Clinical and Radiographic Evaluation of Bioceramic Putty MTA Versus MTA in Pulpotomy of Immature Permanent Molars

The present study aims to evaluate the clinical and radiographic success of bioceramics putty MTA versus MTA in the pulpotomy of immature permanent molars

The main question it aims to answer is:

Will the biocermaics putty MTA have higher clinical and radiographic success rates than MTA in pulpotomy of immature permanent molars?

limited clinical trials have reported the clinical and radiographic outcomes after pulpotomy with premixed putty bioceramic MTA and conventional MTA in young permanent molars.

MTA has various drawbacks, such as difficulty in handling, long setting time, discoloration of the tooth, and its form as a powder/liquid which raise the responsibility for major material waste. To conquer these issues, bioceramic materials have been developed premixed putty bioceramic MTA is a ready-to-use material for immediate placement with zero waste, saving cost and chair time. Thus, the present study aims to evaluate bioceramic putty MTA's clinical and radiographic success versus MTA in pulpotomy of immature permanent molars.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 6-8 years of both sexes have immature permanent molars
* with deep carious lesions indicated for pulpotomy.
* Restorable young permanent molars with no clinical symptoms of irreversible pulpitis.
* Permanent molars without any clinical sign of pulp necrosis including swelling, fistula, pain on percussion, and pathologic tooth mobility.
* Permanent molars without any adverse radiographic findings including thickening of the periodontal ligament space, radiolucency at the interradicular or periapical regions
* permanent molars without internal and external root resorption, or calcification in pulp tissue.

Exclusion Criteria:

* Medically compromised patients who have systemic disease.
* Uncooperative patients who refuse treatment.
* Permanent molars that were previously restored.
Hemodynamic Effects of Bolus of Ketamine Versus Fentanyl in Patients With Septic Shock

Ketamine is a commonly used drug for sedation and induction of anesthesia in patients with shock and/or cardiac dysfunction. Ketamine is characterized by its cardiovascular stimulatory effect due to increase release of endogenous catecholamines. On the other hand, laboratory data on the isolated human myofibers suggest that ketamine had a direct myocardial depressive effect; accordingly, many experts believe that ketamine might have a negative hemodynamic effect in catecholamine depleted patients such as critically ill patients. In critically ill patients, there are contradicting results for the effect of ketamine on the hemodynamic profile and there is paucity of clinical data about the effect of ketamine on cardiac contractility and cardiac output (CO). Cardiac output is the primary determinant of global oxygen delivery to organs and maintaining stable CO in critically ill patients is at most importance to avoid further organ damage in such patients.

Therefore, this study is designed to evaluate the effect a single bolus of ketamine on CO in patients with septic shock in comparison to fentanyl bolus.

Patients meeting the inclusion criteria will receive the study drug according to the randomization, if a bolus of sedation is required for resuming sedation after sedation vacation. All patients will be monitored by 5-lead electrocardiogram, pulse oximetry, and noninvasive blood pressure.

Hypotension defined as mean arterial pressure \< 65 mmHg and will be managed by increasing the norepinephrine infusion rate by 20%.

Bedside echocardiography will be used to measure the cardiac output by an experienced physician who is not aware of the nature of the study drug. The left ventricular outflow diameter (LVOT) will be measured in the parasternal long-axis view. Then velocity time integral (VTI) will be measured from the apical five-chamber view. The average of three VTI readings will be calculated.

The cardiac output will be calculated by the equation:

CO = π X (LVOT diameter/2) X VTI X heart rate Delta CO% will be calculated as percentage of change at each time point in relation to the baseline measurement the CO, heart rate, mean blood pressure will be measured before drug administration and at 3, 6, 10 and 15 min after drug administration

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years) patients.
* With septic shock on vasopressor therapy
* Mechanically ventilated
* Need for sedation

Exclusion Criteria:

* Hemodynamic instability (MAP \<65 mmHg) despite appropriate volume replacement and vasopressor therapy
* Noradrenaline infusion rate \<0.05 mcg/kg/min
* Poor cardiac window on the ultrasound.
* Known allergy to study drugs
* Neurocritical patients with signs of increased intracranial tension
Smart Integrated Health Promotion Program

health promotion behavior is important in older adults.The purpose of this study is to examine the efficacy of smart integrated health promotion intervention among middle age adults and older adults in community.

There very limited research focused on leisure activity, nutrition status, quality of life and subjective well-being. In addition, there is lack of research develop smart integrated health promotion intervention to enhance well-being for middle age adults older adults in community and examine the efficacy of the intervention. The purpose of this study is to examine the efficacy of smart integrated health promotion intervention among middle age adults and older adults in community .

Eligibility Criteria:
Inclusion Criteria:

(1) age over 50 years

Exclusion Criteria:

1. those who could not understanding protocol or communication with search nurses;
2. or with cognitive impairment or mental disorders;
3. or advance cancer;
4. or have been myocardial infarction;
5. or congestive heart failure was excluded.
A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia

The purposes of this study are:

* to determine if bilateral pallidal deep brain stimulation results in improvement in neck postures/movements;
* to determine if bilateral pallidal deep brain stimulation results in improvement in quality of life; and
* to document the adverse effects of surgery in patients with cervical dystonia.

Deep brain stimulation (DBS) of the globus pallidus has been proposed as a treatment for cervical dystonia. At present there are only anecdotal reports of benefit. The objective of this project is to prospectively assess the outcomes of DBS on cervical dystonia in a blinded manner. Our hypothesis is that in patients refractory to medical management, bilateral pallidal DBS will reduce the severity of cervical dystonia at 1 year follow up.

The research plan is that of a feasibility study, examining outcomes of 10 patients who would be referred for surgical management due to the severity of their disease. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) will be preformed by a blinded neurologist at the completion of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, male or female
* Diagnosed with cervical dystonia by a movement disorders neurologist
* Has cervical dystonia alone, not generalized or multifocal
* Has had adequate trials of medical therapy

Exclusion Criteria:

* Cognitive impairment
* Abnormalities on pre-operative magnetic resonance imaging (MRI)
* Medical conditions precluding general anaesthetic or surgery
* Unstable psychiatric disease
* Previous brain lesions to treat cervical dystonia
Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin

The purpose of this study is to explore the differences in efficacy and safety of sitagliptin,vildagliptin and saxagliptin and to find which one is more better in treating type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* signed the informed consent
* diagnosed with T2DM
* women of childbearing potential were required to have a negative urine; pregnancy test,and agreed to use adequate contraception throughout the; study and for up to 4 weeks after completion
* glycosylated hemoglobin ranged in 6.5-9.5%

Exclusion Criteria:

* patients in pregnancy or lactation period
* ever received any kind of oral Hypoglycemic drug in recent 3 months
* patients were currently receiving treatment with a cytochrome P450 3A4 inducer or depressor,a systemic corticosteroid,or a human immunodeficiency virus anti-viral medication
* gastrointestinal surgery that could affect drug absorption
* patients with haemoglobinopathy or rapidly progressing renal disease, or autoimmune skin disorder
* a recent history of alcohol or drug abuse within the past 12 months
* any contraindication listed in the package inserts of the study drugs
* a history of acute or chronic Pancreatitis or currently
* type 1 diabetes; a history of diabetic ketoacidosis or hyperosmolar nonketonic coma
* New York Heart Association class III or IV congestive heart failure; left ventricular ejection fraction ≤ 40%; a major cardiovascular event within the past 6 months
* significant abnormal liver function, defined as aspartate aminotransferase or alanine aminotransferase \> 2 times the upper limit of normal or total bilirubin \>34 µmol/L (\> 2 mg/dL); or a history of positive serologic evidence of infectious liver disease
* clinical signs or symptoms of active liver disease and/or significant abnormal liver function
* patients with any clinically significant abnormality identified on physical examination, electrocardiogram (ECG), or laboratory tests that, in the judgment of the investigator, would compromise the patients' safety or successful participation in the clinical study
* fasting plasma glucose level \> 13.3mmol/l
* creatinine clearance rate ≤ 90ml/min
International Lymphatic Disease and Lymphedema Registry

The purpose of the International Lymphatic Disease and Lymphedema Patient Registry and Biorepository is to collect health information in order to study the disease classification, natural history, and impact of Lymphatic Disease, Lymphedema and Related Disorders and its treatments and medical outcomes.

This project represents the inauguration of an International Patient Registry for Lymphatic Diseases. This project will be completed through an affiliation with the Lymphatic Education \& Research Network, a non-profit organization whose mission is to promote research and the development of new therapies for patients with lymphatic diseases, including lymphedema. The registry will provide researchers with much-needed clinical data to study the impact of diseases of the lymphatic system, in order to develop improved treatments and find a cure for lymphatic diseases, lymphedema, and related disorders. The establishment of this initiative is a major step forward in research for direct study of groups of patients with lymphatic disease. In the future, this project will be able to be linked with a biorepository, in which tissue and blood samples derived from patients will be made available for research into human disease states. An international patient registry and tissue/cell bank program paves the way for future clinical trials of experimental drugs and therapies designed to treat lymphatic disease in human subjects.

Eligibility Criteria:
Inclusion Criteria:

* Presence of lymphatic disease

Exclusion Criteria:

* None
Study to Investigate the Efficacy, Safety, and Tolerability of FBL-MTX in Patients With Rheumatoid Arthritis

The goal of this clinical trial is to evaluate the efficacy of FBL-MTX administered by subcutaneous route in Rheumatoid Arthritis patients.

Participants will be screened within 28 days prior to treatment period, to confirm that they meet the selection criteria for the study.

Treatment period: The treatment period will consist of eight sequential study visits, separated by a 2-week interval.

* DMARD-naïve Patients: Patients will be administered an initial dose of FBL-MTX of 1 mg, by SC route. Subsequent doses will be titrated according to clinical response at intervals of 4 weeks, for 12 weeks. Maximum dosage will be 2.5 mg, every 2 weeks.
* Patients with an Inadequate Response or Intolerance to Oral MTX: Patients will be administered an initial dose of FBL-MTX 2.5 mg, by SC route. Subsequent doses will be titrated according to clinical response at intervals of 4 weeks, for 12 weeks. Maximum dosage will be 2.5 mg, every two weeks.

The Sponsor is developing folate-based liposomes encapsulating methotrexate (FBL-MTX) as a putative therapy for RA, by intravenous (IV) or subcutaneous (SC) administration.

Considering the presented non-clinical and clinical data for FBL-MTX and that SC administration is the most adequate route for patient self-administration, the Sponsor intends to proceed the clinical development of FBL-MTX with the objective of providing a more patient-friendly product with at least the same efficacy.

This proof-of-concept study intends to demonstrate the plausibility of FBL-MTX SC administration in patients through the exploratory evaluation of SC FBL-MTX efficacy in patients with moderate-to-severe active RA, and collection data on its safety and tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female subjects with moderate-to-severe active RA, age ≥ 18 years, Body Mass Index \> 35 kg/m2.
* Diagnosis of RA according to the 2010 classification criteria of the American College of Rheumatology/ European Alliance of Associations for Rheumatology, formerly known as European League Against Rheumatism, (ACR/EULAR), with a Total Score ≥ 6/10.
* At least moderately active disease, as defined by DAS28-CRP \>3.2 at Screening and Baseline, including:
* Tender joint count (TJC) ≥ 4
* Swollen joint count (SJC) ≥ 4
* C Reactive protein (CRP) ≥ 5 mg/L
* Documented history of positive RA factor and/or cyclic citrullinated peptide antibody test.
* Chest X-ray performed in the previous 3 months not suggestive of tuberculosis.
* If under nonsteroidal anti-inflammatory drugs (NSAIDs), must be able to be on a stable regimen from at least 2 weeks before baseline up to end-of-study.
* If under an oral corticosteroid (≤ 10 mg per day of prednisone or equivalent), must be able to be on a stable regimen from at least 4 weeks before baseline up to EoS.
* Eligible to start treatment with an immunomodulator.
* No evidence of clinically significant active infection.

Exclusion Criteria:

* Positive Interferon-Gamma Release Assay (IGRA) test result.
* Creatinine clearance \< 60 mL/min.
Clinical Study of Intratumoral Injection of CAR-T Cells in the Treatment of Advanced Liver Tumors

Objective to study the safety and preliminary efficacy of intratumoral injection of CAR-T cells in the treatment of advanced liver tumors.


Eligibility Criteria:
Inclusion Criteria:

* GPC3 expression was positive by histological examination;
* 18-69 years old;
* The patients with advanced liver tumor who can not be operated and the effect of chemotherapy is poor;
* The patients who received traditional palliative therapy had an expected survival period of more than 4 months;
* Organ status allows clinical application.a. Creatinine \< 1.5mg/dl; b. Cardiac ejection index \> 55%; c. Heme \> 9g / dl, bilirubin \< 2.0mg/dl;
* No bleeding and coagulation disorders were found;
* There was no allergy to contrast medium;
* Contraception: contraceptive measures were taken during clinical application and within 3 months after the last cells transfusion;
* There is no other contraindication for lymphocyte collection;
* Sign informed consent.

Exclusion Criteria:

* Pregnant or lactating women;
* Patients need systemic steroids therapy;
* At present, the treatment conditions are as follows : a. Within 30 days before the collection of peripheral blood mononuclear cells,patiens were in other anti-tumor clinical observation period; b. Patients have not recovered from the acute side effects of previous treatment;
* Patients received radiotherapy within 4 weeks after enrollment;
* Patients received other cell modification therapy in the early stage;
* In the screening stage, patients with lymphocyte transfection rate less than 5%, or T cell culture can not expand (\< 5 times) patients;
* Uncontrolled symptoms or other diseases include, but are not limited to, infection, congestive heart failure, unstable angina pectoris, arrhythmia, psychosis, or limiting the social environment that meets the requirements, or the researchers believe that they may bring unpredictable risks;
* Patients with severe acute allergic reactions;
* Patients who participated in other clinical trials;
* Researchers believe that patients are not suitable to participate.