cyrilzakka/clinical-trials huggingface dataset:
A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease

This multi-center, double-blind, randomized, placebo-controlled study will evaluate the change in liver fat content, pharmacokinetics and safety of RO5093151 in patients with non-alcoholic fatty liver disease. Patients will be randomized to receive either daily oral doses of RO5093151 or matching placebo. The anticipated time on study treatment is 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 35-65 years of age
* Hepatic steatosis assessed by magnetic resonance spectroscopy (MRS) with liver fat \>5.56% at screening
* Body mass index (BMI) \>27 kg/m2 at screening
* Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR) \> 2.5 at screening
* Agreement to maintain prior diet and exercise habits during the full course of study

Exclusion Criteria:

* History of diabetes mellitus based on World Health Organization (WHO) criteria
* Known polycystic ovary syndrome
* Other liver disease e.g. chronic viral hepatitis, alcoholic liver disease, hemachromatosis, cirrhosis
* Known autoimmune disease or chronic inflammatory disease
* Myocardial infarction or stroke within 6 months prior to screening
* Patients taking any anti-diabetic and/or weight-lowering medication currently or within the previous 3 months before screening
Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19

The COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Based on reports of a hyperinflammatory state associated with COVID-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. JAK inhibitors have been shown to harness inflammation in a number of different pathologic conditions. The aim of the present study is to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized with SARS-CoV-2 pneumonia confirmed by RT-PCR or serology (IgA);
* PaO2/FiO2 \< 300 (not fully explained by heart failure or volume overload) or SpO2 \< 90% on room air.

Exclusion Criteria:

* Symptom onset \> 14 days;
* Neutrophil count \< 1,000/mm3;
* Platelets \< 50,000/mm3;
* ICU care at enrollment;
* On invasive mechanical ventilation at enrollment;
* Current use of experimental therapy for COVID-19 (except: azithromycin or corticosteroids)
* Uncontrolled arterial hypertension;
* Current or previous use of systemic immunosuppressive therapy in the last 30 days;
* Pregnancy or lactation;
* Estimated creatinine clearance \< 30 mL/min or receiving CRRT or intermittent hemodialysis;
* Allergy to ruxolitinib;
* Active tuberculosis;
* HIV seropositivity;
* Prior history of progressive multifocal leukoencephalopathy;
* Use of any JAK inhibitor in the last 30 days before study enrollment;
* Not qualifying according to investigators' perception.
Improvement of the Diagnosis and Medico-legal Management of Psychological Trauma in Patients Involved in the Terrorist Attack in Nice on the 14th July 2016

Psychological trauma is a major public health concern that affects numerous patients who have experienced traumatic events.

The objective of our research was to improve the diagnosis and management of persons experiencing such events.

We will seek to determine factors brought into play in the construction of psychological trauma and the best way to identify them so as to implement the optimal management of patients and ensure recognition of this condition.

In addition, in the context of our activity as expert witnesses, we will study the methods used to assess and quantify psychological trauma.

In this respect, a medical appointment will be made by a nurse of the Forensic Medicine Department of Dijon CHU. During this consultation, a self-report questionnaire will be completed by the patient alone to evaluate the level of acute stress followed by a psychiatric consultation and completion of the IES-R questionnaire with the doctor to identify symptoms of psychological trauma.


Eligibility Criteria:
Inclusion Criteria:

- Patients who have registered a complaint leading to the involvement of the Forensic Medicine Department of DIJON CHU to evaluate requests for temporary sick leave for psychological reasons following the event in NICE on the 14 July 2016.

Exclusion Criteria:

* Refusal of the patient to attend the consultation proposed by the Forensic Medicine Department of DIJON CHU,
* Refusal of the patient to take part in a clinical study.
* Verbal information about the clinical study when the appointment was made by the Forensic Medicine nurse,
* Reiteration of the verbal information during the consultation,
* A letter and an official information document given to each patient by the DIJON CHU research Unit stating the objectives and methods of the clinical study,
* Contact details of the Forensic Medicine Department given to patients if they have any questions about the study.
Neurologic Examination of Wide and Narrow Tourniquets

Nerve injury is a serious potential complication associated with the clinical use of exsanguinating tourniquets in surgery. Recently, a novel narrow tourniquet has been proposed, with the claim that it may cause less compression of the nerves. We performed an in vivo comparison of a standard wide tourniquet with the new, narrow tourniquet. Our study specifically looked at neurologic markers in the upper extremity.

The HemaClear ™ OHK Medical Device HemaClear™, approved by FDA, consists of a silicon ring wrapped in a stockinet sleeve and pull straps (Fig.1). It performs three functions - blood removal (exsanguinations), arterial flow occlusion, and placement of sterile stockinet 30. The ring is placed on the extremity and then straps are pulled proximally. The silicone ring rolls up the limb while the stockinet sleeve unfolds onto the limb. During the rolling up process, the ring exerts pressure and squeezes the blood away from the limb. Application of the device takes less than a minute.

The technique behind this device is fundamentally different from classic pneumatic tourniquets, as pressure is exercised by only a single silicon ring so that the profile is very small.

Zimmer A.T.S.®3000 The A.T.S.®3000 is an automatic broad tourniquet system with a Limb Occlusion Pressure (LOP) feature. It is the latest innovation in tourniquet technology and has FDA approval. It was invented by McEwen 4 and the basic function is described in several clinical trials and publications 28. The main difference to other pneumatic tourniquets is the LOP and the Recommended tissue pressure (RTP) feature. These parameters are suitable to optimize the pressure force on the tourniquet for each individual patient. The LOP is detected before inflating the tourniquet and the RTP is the LOP plus a safety margin to guarantee a blood free field (Operator \& Service Manual Zimmer A.T.S.® 3000 Automatic tourniquet system REF 60-3000-101-00).

Eligibility Criteria:
Inclusion Criteria:

* self defined Caucasian
* clinically healthy
* BMI of ≤ 30,
* a systolic arterial blood pressure ≤190 mmHg,
* no rash or dermatologic condition or tattoos which may interfere with the placement site
* no neurovascular impairment.
* all female participants received a pregnancy test at the initial screening visit.
* Study population was restricted to Caucasians to enable an assessment of device caused redness or skin lesions, not possible in a mixed study population.
Genetics and Heart Health After Cancer Therapy

The overall objective of this study is to use patient-centered in vitro and in vivo models to answer the fundamental question of whether or not pathogenic mutations in BRCA1/2 result in an increased risk of CV disease


Eligibility Criteria:
Inclusion Criteria

* ≥18 years of age
* Initial diagnosis of Breast Cancer in 2005 or later
* Documented BRCA testing (results from a local laboratory are acceptable) showing

  * confirmation of a germline mutation in BRCA1 or BRCA2 that is predicted or suspected to be deleterious OR
  * confirmation that no mutation was detected in BRCA1 or BRCA2
* Non-carriers will have been treated with an anthracycline-based chemotherapy regimen; carriers may or may not have been treated with an anthracycline-based chemotherapy regimen.
* Approximately at least 12 months from initiation of adjuvant treatment or neo-adjuvant chemotherapy
* Able to provide informed consent

Exclusion Criteria

* Stage IV Breast Cancer
* Genetic testing confirming a variant of unknown significance (VUS) or benign polymorphism in BRCA1 or BRCA2
* V02 Testing contraindicated for any reason, including:

  * Myocardial infarction (within past 3 months)
  * High-risk unstable angina;
  * High-risk or uncontrolled cardiac arrhythmias;
  * Symptomatic severe aortic stenosis;
  * Uncontrolled symptomatic heart failure;
  * Acute pulmonary embolus or pulmonary infarction;
  * Acute myocarditis or pericarditis;
  * Acute aortic dissection;
  * Coronary revascularization procedure within the past three months;
  * Uncontrolled hypertension, defined as systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 100mmHg;
  * Clinically significant valvular heart disease (severe stenosis or regurgitation);
  * Known aortic aneurysm; or
  * Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the V02 test
* Women who are pregnant
* Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Expression of Molecular Markers in Circulating Tumor Cells of Metastatic Castration-Resistant Prostate Cancer

As prostate cancer progresses into castration-resistant stage from initial hormone-sensitive status, the biological behavior of tumor cells that dissociated from primary lesions changed. Considered a "liquid biopsy," these circulating tumor cells (CTCs) can show how a patient's cancer responded to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of molecular markers in high volume circulating tumor cells in metastatic castration-resistant prostate cancer patients can predict the therapeutic effects and outcomes of these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male patients
2. 18 yrs and older, and 80 yrs and younger
3. Histologically or cytologically proven prostate adenocarcinoma;
4. Imaging examinations including Emission Computed Tomography (ECT), Positron Emission Tomography (PET) and so on revealed a high-volume disease of patients(A high-volume of disease was defined by the presence of visceral metastases or four or more bone lesions with at least one beyond the vertebral bodies and pelvis)
5. Have been received hormonal therapy and progressed into castration-resistant stage
6. Not yet receiving chemotherapy
7. Patients are willing to participate and can be followed up regularly

Exclusion Criteria:

1. Received the treatment of abiraterone acetate previously
2. Patients received chemotherapy previously
3. Combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years).
Memantine Versus Donepezil in Early Stages of Alzheimer's Disease

It is well known that in the brain of the patients with Alzheimer's disease there is a glutamatergic hyperstimulation leading to neuronal death. Memantine is a low affinity antagonist of NMDA glutamate receptors. The use of this drug in the early phases of the disease could provide neuroprotective effects and delay of progression. The effects of memantine should be compared to those of donepezil, which is the most prescribed anticholinesterase drug.

On the basis of the excess of glutamatergic stimulation, our objective is to demonstrate whether memantine could have a neuroprotective effect in Alzheimer's disease when administered in the early stages and in comparison to donepezil. The patients would be randomized to receive one of these drugs. At baseline we would evaluate the patients from a clinical standpoint with the ADAS-cog, the neuropsychiatric Inventory and a scale of daily living activities.We also would carry out Magnetic Resonance Spectroscopy in several areas of the brain (medial temporal lobe, prefrontal region, cingulate gyrus and occipital lobe) so as to measure the concentration of N-acetyl-aspartate which is a marker of neuronal density.Then we treat the patients with either memantine or denepezil and after 6 months we would repeat the same procedures as we did at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Clinical criteria of probable Alzheimer's disease in the stages mild-to-moderate with a Mini-Mental score higher than 15 points.

Exclusion Criteria:

* Previous treatment with anticholinesterase drugs or memantine.
* Advanced stages of the disease
* Lack of a reliable caregiver.
* Dementias other than Alzheimer's disease
Defining Circadian Metabolism in Non-alcoholic Fatty Liver Disease

The investigators will conduct an open label, experimental medicine study exploring the diurnal patterns of hepatic lipid metabolism in NAFLD and non-NAFLD participants (determined by Transient elastography (TE) with controlled attenuation parameter (CAP)). We will also determine whether the diurnal patterns of lipid metabolism in NAFLD participants can be modified using lifestyle and weight loss intervention. Fourteen participants without NAFLD will have morning and evening metabolic investigations (visit 1M \& 1E) to assess for changes in lipid flux pathways across the course of the day. After morning and evening investigations their involvement in the clinical study will then end. Seventeen NAFLD participants will also have identical baseline morning and evening investigation after which they will be enrolled into a 12-week lifestyle and weight loss programme. After 12-weeks, all 17 participants with NAFLD will have a follow up CAP, and morning and evening metabolic investigations (visit 2M \& 2E).


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* BMI 25-50 kg/m2
* Age 18-75 years

Exclusion Criteria:

* A diagnosis of type 1 diabetes
* Type 2 diabetes controlled with medications other than metformin (within last 3 months)
* Shift working patterns in last 3-months or if likely to work shifts during study period.
* Current or recent (\<3-months) use of weight loss medications
* Current or recent use of oral contraceptive pill or hormone replacement therapy (within last 3-months)
* Pregnancy
* A blood haemoglobin \<120mg/dL
* History of alcoholism or a greater than recommended alcohol intake (Recommendations \> 21 units on average per week for men and \> 14 units on average per week for women)
* Haemorrhagic disorders
* Treatment with anticoagulant agents
* Other co-morbidities that in the eyes of the investigators may affect data collection
* Any medical condition in the opinion of the investigator that might impact upon safety or validity of the results
* Transient elastography (TE) controlled attenuation parameter (CAP) of between 216-305 dB/m
Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary

The aim of this work is to compare the clinical outcomes of letrozole with laparoscopic ovarian drilling (LOD) in patients with clomiphene-citrate-resistant polycystic ovary syndrome (PCOS).


Eligibility Criteria:
Inclusion Criteria:

1. patients diagnosed as PCOS according to Roterdam (2003) criteria
2. patients with Clomiphene resistance, i.e. failure to ovulate following 100 mg CC for 5 days for at least three cycles.
3. patent fallopian tubes, confirmed by hysterosalpingography or hysteroscopic diagnosis.
4. normal semen analysis parameters of the patients' spouses according to the modified criteria of the World Health Organization.
5. normal serum prolactin, thyroid stimulating hormone and 17-OH progesterone.
6. no systemic disease; no gonadotropin or other hormonal drug treatment during the preceding 3 months.

Exclusion Criteria:

1- Infertility induced by reasons other than PCOS. 2- uterine cavity lesions or ovarian cyst. 3- \>40 years old. 4- body mass index (BMI) \>26 kg/m2. 5- contraindications to general anesthesia. 6- history of pelvic surgery. 7- other endocrine diseases. 8- a history of liver or kidney disease.

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Application of Radiomics in the Diagnosis and Treatment Prediction of Pituitary Adenoma

The images of patients with Pituitary adenoma were collected and analyzed based on the methods of radiomics.

Inclusion of pituitary adenoma patients diagnosed clinically or pathologically

1. Clinical data and pre-treatment imaging data of included patients (DICOM format)
2. Determine the subtype diagnosis of pituitary adenoma based on the patient's clinical and pathological data
3. Collect relevant data of patients before and after treatment
4. Using radiomics methods, extract radiomic features of patients and construct a radiomic model for predicting the diagnosis and treatment response of pituitary adenomas

Eligibility Criteria:
Inclusion Criteria:

1. Gender unlimited, 18-80 years old;
2. Clinical diagnosis of Pituitary Adenoma and receive surgical treatment;
3. Received brain imaging;
4. informed consent signed

Exclusion Criteria:

1. Pregnant / lactating women
2. Contraindications of imaging examination
3. Lack of effective clinical data
4. MRI data before treatment cannot be obtained
5. Postoperative pathology not revealed pituitary adenoma
A Study of Comparing Effects of Thulium Laser en Bloc Resection and Electrical Transurethral Resection of the Non-muscle Invasive Bladder Cancer

This study is to verify the short-term efficacy and long-term prognosis of thulium laser resection compared with conventional transurethral resection of non-muscular invasive bladder cancer. Half of participants will receive thulium laser resection of bladder cancer, while the other half will receive electrical transurethral resection of bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological or histological diagnosis of primary non-muscle invasive bladder urothelial carcinoma (TaTisT1);
2. Imaging examinations showed the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
3. Patients who agree to TURBT surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation;
4. Function of main organs (heart, liver, lung, kidney) should be normal, PS score 0-2;
5. Bladder capacity≥ 200ml.

Exclusion Criteria:

1. Find distant metastasis ,infiltration of the surrounding organs or relapse before operation.Metastatic bladder cancer or other cancers involve the bladder;
2. Received chemotherapy or BCG perfusion therapy in the nearly 3 months;
3. Patients who can not tolerate the serious side effects during the bladder perfusion treatment process (bladder irritation and other symptoms);
4. Patients during pregnancy ,critical care patients and patients who have other cases of surgical contraindications.Such as serious cardiovascular disease,coagulation abnormalities,non-transitional epithelial tumors( such as adenocarcinoma and squamous cell carcinoma),acute cystitis,can not be supine because of spinal deformity,untreated urethral stricture.
Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging

The aim of this study was to evaluate the feasibility and efficacy of a novel real-time navigation way for laparoscope liver resection, which was fused images comprising 3D imaging and indocyanine green Fluorescence imaging (fusion IGFI).

During liver resection, surgeons cannot completely view the intraparenchymal structure. Although a fluorescent imaging technique using indocyanine green has recently been developed for hepatobiliary surgery, limitations in its application for real-time navigation persist. A nove augmented reality surgery navigation system (ARSNS) can be combined with indocyanine green Fluorescence imaging to guide the surgery real-time.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years≤ Age ≤70 years
2. Compling with the diagnosis criteria of complex hepatic carcinoma.
3. Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled
4. Preoperative liver function is Child - Pugh grade A or B.
5. The patients are volunteered for the study.

Exclusion Criteria:

1. Patients with mental illness.
2. Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)
3. The patients refused to take part in the study.
4. There are other co-existed malignant tumors.
5. Benign liver diseases.
6. Indocyanine green allergy
Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort

This single blinded randomized pilot study was performed on 21 Caucasian females to determine if injections through follicular openings were less painful than traditional injections for cosmetic botulinum toxin type A injections.

Objective: To investigate whether injection of botulinum toxin type A is less painful if performed through follicular openings versus traditional non-specific approach.

Design: Prospective, randomized, single-blinded study.

Setting: Academic dermatology department.

Patients: A volunteer sample of twenty female patients aged 25-55 who had no prior history of botulinum toxin injection.

Intervention: Each patient received six randomized injections of botulinum toxin type A (Botox® Allergan). Two injections into the procerus muscle and two into each corrugator muscle. Three of the injections were performed through follicular openings and three were performed traditionally.

Main Outcome Measure: Patient discomfort on a 1-10 scale and direct comparison between the two injection techniques.

Eligibility Criteria:
Inclusion Criteria:

* Female
* No prior history of botulinum toxin
* Age 25-55

Exclusion Criteria:

* Male
* Prior history of botulinum toxin
* Neuromuscular disorders
* Aminoglycoside therapy