cyrilzakka/clinical-trials huggingface dataset:
Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain

Obtained 19 lead EEG data from 50 chronic pain patients along with their clinical history and self-reported pain scored. Machine learning was used to analyze the EEG data and derive a chronic pain biomarker.


Eligibility Criteria:
Inclusion Criteria:

* Male and female chronic pain patients
* Patients between the ages of 18-85 years
* Patients exhibiting the presence of symptoms in excess of 3 months duration
* Patients suffering from neuropathic (e.g., lower back pain), osteoarthritis, or muscular skeletal pain
* Patients with evidence of pathology related to the painful condition on which diagnosis was made (e.g., results of imaging or diagnostic pain code)
* Patients with NRS pain scores across the full range (1-10) at the time of testing

Exclusion Criteria:

* Patients with medically diagnosed psychotic illness
* Patients with medically diagnosed drug or alcohol dependence in the past 12 months
* Patients with a medical history of head injury with loss of consciousness and amnesia (within the last 2 years)
* Patients with skull abnormalities that preclude the proper placement of the electrodes for the EEG data acquisition
* Patients who have a spinal cord stimulator, or other implantable devices
* Patients for whom the source of pain at the time of the evaluation is associated with: neurological disorders (multiple sclerosis, Parkinson, dementia), diabetes, migraines, or those with reflex / sympathetic dystrophy disorder/complex regional pain syndrome, fibromyalgia, or visceral pain
* Patients with cancer
* Patients on workers compensation or disability
* Patient on anticonvulsant medication
* Patients who have a history of seizures
The ValenTx Endo Bypass System in Obese Subjects

The purpose of this study is to collect clinical data to support the use of the ValenTx Endo Bypass System to improve weight loss and the resolution of comorbidities in obese subjects.

* Single-arm, non-randomized, open-label, multi-center trial conducted in up to 70 subjects to assess the safety and efficacy of the ValenTx Endo Bypass System over implant duration of up to 36 months.
* Body weight, adverse events and device function in implanted subjects will be monitored at monthly visits for the first year after implant, at quarterly visits during the second year, and biannually during the third year.
* Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic assessments of the condition of the implanted device, and a quality of life questionnaire.
* All subjects will be followed for 12 months after device removal with scheduled visits at 1, 6 and 12 months after explant.
* Subject participation may last up to four years, but is expected to vary with implant duration, which will be determined on a case-by-case basis based on the condition of the implanted device.

Eligibility Criteria:
Inclusion Criteria

1. Between 18- 60 years old.
2. BMI of 40-50 kg/m2 with or without comorbidities, BMI of 35-40 kg/m2 with one or more obesity related comorbidities, or BMI of 30-35 with type 2 diabetes
3. Willing to give informed consent, and able to understand what this means.
4. Documented failure with non-surgical weight loss methods.
5. Willing to follow the study procedures and comply with the visits schedule.
6. Live within a reasonable distance of the research center and be able to attend routine follow up visits.

Exclusion Criteria

1. Pregnancy or intention to become pregnant during the course of the study.
2. Abnormal screening esophagogastroduodenoscopy findings
3. Prior esophageal, gastric or bariatric surgery.
4. Known allergies to any of the device materials.
5. Use of weight loss drugs, stimulants and/or herbal weight loss supplements.
6. Recent or ongoing health conditions that contraindicate undergoing an elective weight loss procedure involving a device implanted within the lumen of the esophagus, stomach and proximal small intestine.
7. Participation in another clinical trial within 60 days of the implant.
8. Presence of psychiatric conditions that would impair the ability to provide informed consent or to comply with study procedures.
Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y

Subjects who had not responded to previous hepatitis B vaccination were vaccinated with either the adjuvanted HBV-MPL vaccine or Engerix™-B vaccine according to a three-dose vaccination schedule (0, 1, 2 months) and boosted at Month 12 as per their group allocation. The immunogenicity and safety of the HBV-MPL vaccine were compared with the control vaccine, Engerix™-B.

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham.

Eligibility Criteria:
Inclusion Criteria:

At study entry:

* A male or female ≥ 15 years of age at the time of the first vaccination.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Written informed consent obtained from the subject.
* Documented non-response to previous hepatitis B vaccination within 6 months after having received a full vaccination course (i.e. ≥ 3 doses of a hepatitis B vaccine)
* If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.

Before booster dose at month 12:

* Additional written informed consent covering the booster administration and blood samples at months 12 and 13 must be obtained from the subject.
* If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to and up to two months after the administration of the booster dose

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
* Known exposure to hepatitis B within 6 weeks.
* History of hepatitis B infection.
* Confirmed human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease/reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrollment.
* Hepatomegaly, right upper quadrant abdominal pain or tenderness.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
* Pregnant or lactating female.
Clinical Study of CLL1 CAR-T Cells in the Treatment of Hematological Malignancies

Clinical Study on the Safety and Effectiveness of CLL1 CAR-T Cells in the Treatment of CLL1-positive Hematological Malignancies

Human C-type lectin-like molecule 1 (CLL1) is a type II transmembrane glycoprotein ，CLL1 expression is restricted to bone marrow cells and most AML blasts. In addition, CLL1 is expressed in leukemia stem cells (LSC) but not in hematopoietic stem cells (HSC), may provide a potential therapeutic target for the treatment of AML.The CAR-T cell injection uses immune cells from healthy donors, and is the final product obtained after CAR genetic modification, cell expansion, culture, screening, preparation, sub-packaging, and release inspection. The center intends to apply for a clinical trial of CLL1 CAR-T cells to treat CLL1-positive hematological malignancies on the basis of preliminary research.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients is histologically diagnosed with CLL1-positive AML according to the NCCN Clinical Practice Guidelines in Oncology：Acute Myeloid Leukemia（Version 2.2021） 2. The diagnosis is consistent with r/r CLL1 + AML, and includes any of the following conditions:

  1. No CR was obtained after 2 courses of standard chemotherapy
  2. The first induction was CR, but the duration of CR was less than 12 months
  3. No CR was obtained after the first or multiple remedial treatment;
  4. Relapse twice or more; 3. The number of blast cells in bone marrow was more than 5% (morphology) and / or \> 1% (flow cytometry).

     4. No active lung infection, inhaled air oxygen saturation ≥92% 5. The estimated survival time is more than 3 months 6. ECOG score was 0-2 7. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.

     Exclusion Criteria:
* 1. Patients with history of epilepsy or other central nervous system diseases; 2. Patients with prolonged QT or severe heart disease; 3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown); 4. The patients with uncontrolled active infection; 5. Active hepatitis B or hepatitis C virus infection; 6. Previous application of gene therapy; 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; 8. Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl; 9. Those who suffer from other uncontrolled diseases are not suitable to join the study; 10. HIV infection; 11. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Partial Heart Transplantation

The purpose of this study is to determine if a partial heart transplantation in patients with congenital heart disease is safe and feasible. Participants will have a partial heart transplant involving surgical replacement of the pulmonary valve with the heart valve and supporting blood vessels from an organ donor. The procedure, tests, medications, and follow-up visits will all be done per standard of care. Medical data will be collected to look at outcomes after surgery.

The purpose of this study is to determine if a partial heart transplantation in patients with congenital heart disease is safe and feasible. Potential participants are patients 12 and younger with congenital heart defects in need of pulmonary valve replacement.Participants will have a partial heart transplant involving surgical replacement of the pulmonary valve with the heart valve and supporting blood vessels from an organ donor. The study procedure, tests, medications, and follow-up visits will all be done per standard of care for heart transplant patients. Data will be collected from chart review, before, during and after surgery and at standard of care follow-up visits. Study data will be compared to historical data of patients who have undergone other types of pulmonary valve replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

* Congenital heart patient referred for a cardiac operation that involves valve replacement in pulmonary position
* Deemed acceptable for partial heart transplantation based on the standard evaluation process

Exclusion Criteria:

* Contraindication for heart transplantation
* Severe bliateral long segment pulmonary arterial hypoplasia
* Bilateral pulmonary vein stenosis
* Persistent acidosis with a pH \< 7.1
* Failure to pass psychosocial evaluation
* Parental (custodial) alcohol and/or substance abuse
* Documented parental (custodial) child abuse or neglect
* Parent (custodian) with cognitive/psychiatric impairment severe enough to limit comprehension of medical regimen
* Infection disease exclusion criteria
* Evidence of active sepsis
* Hepatitis B surface antigenemia
* HIV positivity
* Pregnancy
* Financial hardship or insurance non-approval
Mapping the Lumbar Spine Marrow Adiposity

The objective of this study is to describe the change in the percentage of fat in the lumbar spine.

The study of the distribution of bone marrow adiposity is little known in subjects who did not have pathology likely to alter the fat content of the vertebrae. Or that fat content is potentially a reflection of brittle bones (osteoporosis, for example), and deserves to be known because it can be used to normalize the lipid fraction values with respect to age or from the level (L1 , L2, L3, L4 or L5) of the vertebra being studied.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients who underwent MRI of the lumbar spine with Sagittal sequenceT1, T2 STIR and IDEAL, good quality, in a clinical setting type back pain, spondylitis research, radicular syndrome ...
* Examinations conducted between 2014 and 2015 on the same equipment
* Major patient
* Having formulated their non-opposition

Exclusion Criteria:

* Previous history of neoplastic disease
* Vertebral Fracture
* Pathology reaching the vertebral body detectable by MRI (disc lesion with rearrangements of the endplates (MODIC)
* Inflammation,
* Bone tumor,
* fracture
* Refusal of participation
Evaluation of Clinical Progression in Patients With Motor Predominant Parkinson Disease.

The objective of this study is the longitudinal prospective clinical evaluation in patients with motor predominant PD; it will assess the individual disease progression (change) of the clinical and imaging parameters measured at 6-month interval over a minimum of 12 months.

The absence of clear PD subtypes defining a common path and rate of disease progression, combined with the absence of validated biomarkers indicative of disease progression and a strong placebo effect, constitute a challenge for clinical trials assessing new potential disease-modifying therapies in PD.

The present cohort would constitute a well-defined population of patients, with individual progression assessment, suitable to evaluate new disease-modifying therapies in a subsequent Phase1/2 clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic Parkinson's Disease (According to British Brain Bank Criteria); genetic forms of PD are not excluded
2. Male or female adult, aged 70 or less
3. Modified Hoehn and Yahr stage 2 to 3 in OFF state
4. Disease duration, i.e. time from first motor symptoms between 2 to 8 (included) years ; first motor symptoms to be taken into consideration being the cardinal motor symptoms of PD (bradykinesia, tremor and rigidity)
5. Univoqual response to L-DOPA (of at least 50% in MDS-UPDRS Part III motor score)
6. Presence of fluctuations and/or dyskinesia
7. MDS-UPDRS total motor score ≥15 in OFF state
8. L-Dopa treatment stable for at least 4 weeks
9. Covered by healthcare insurance
10. Written informed consent form signed

Exclusion Criteria:

1. Scan Without Evidence of Dopamine Deficit (SWEDD) (DaTSCAN)
2. Atypical parkinsonism syndrome
3. Dementia as detected by a score \< 21/30 at the Montreal Cognitive Assessment Screening (MoCA)
4. Psychiatric disorders including major depression with suicidal thoughts as evaluated by a psychiatrist or a neurologist at the selection period
5. Any medical or psychological problems which may interfere with a smooth conduction of the study protocol (e.g. cancer with a limited life expectancy)
6. History of significant brain or vascular disease (tumor, epilepsy, stroke ...)
7. Any contraindication for undergoing MRI of the head
8. Prior brain surgical procedures with or without implementation of an intra-cerebral device
9. Drug or alcohol addiction
10. Pregnancy or breastfeeding
11. Patient with reproductive potential who do not agree to use an accepted effective method of contraception - investigator's judgment- during the study period
12. Illiteracy or insufficient language skills (French) to complete the questionnaires
13. Patient deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection (e.g. guardianship or curatorship).
14. Simultaneous participation in another clinical trial with the administration of investigational drug(s)
Retrospective Analysis for Patients With Metabolic Syndrome

The incidence of metabolic syndrome and related diseases is gradually increasing, and diet and medication are currently common outpatient treatment methods. This study retrospectively analyzes the clinical data of patients with metabolic syndrome and related diseases who have visited our outpatient department in the past 10 years, compares the therapeutic effects of different treatment methods on their blood glucose, blood lipids, blood pressure, uric acid, and body composition, and provides evidence support for clinical treatment.


Eligibility Criteria:
Inclusion Criteria:

• individuals who had at least a 2 follow up visits with a BMI of 24 or more with the pri-mary goal of losing weight.

Exclusion Criteria:

* patients did not follow-up on a monthly basis;
* patients followed-up less than 1 times within 3 months;
* patients having incomplete data;
* patients changing their interventions during fol-low-ups
Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma With Twin Cooled-wet Electrodes

To investigate the therapeutic effects and treatment results of radiofrequency ablation using combined bipolar and monopolar energy deliver with twin cooled-wet electrodes for recurrent tumor after locoregional treatment in patients with hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Child-Pugh Class A or B
* chronic hepatitis B or chronic hepatitis C or liver cirrhosis
* presence of recurrent hepatocellular carcinoma (HCC) after locoregional treatment confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018
* single lesion less than or equal to 5 cm, or up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment

Exclusion Criteria:

* number of recurrent HCCs, equal or more than 3
* largest recurrent HCC size over 3 cm
* presence of vascular invasion by HCC
* platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
* presence of extrahepatic metastasis
Aortic Valve Neocuspidization With Glutaraldehyde-Treated Autologous Pericardium (Ozaki Procedure)

The Ozaki aortic valve reconstruction procedure uses autologous or bovine pericardium as an aortic cusp replacement without the use of struts and with use of the patient's own native aortic root. In this technique one can replace individual aortic cusps, 1, 2, or all 3 cusps. Ideally the patient's autologous pericardium will be harvested and fixed in gluteraldehyde at the time and prepared for the patient's specific annular dimensions with the neoaortic root sizers. Based on the measured size, one then uses a leaflet template to independently replace the cusps resulting in more effective preservation of the natural motion of the aortic valve annulus in coordination of the left ventricle, aortic annulus, sinus of Valsalva, and aorta compared to stented bioprosthetic and/or mechanical aortic valve replacements. Professor Ozaki has now performed 1000 Ozaki neoaortic valve reconstructive operations and has better than 95% freedom from re-operation at late follow-up. The objective of this study is to collect a large collection of prospective data from patients undergoing aortic neocuspidalization surgery for aortic valve insufficiency or stenosis isolated or combined with other procedures


Eligibility Criteria:
Inclusion Criteria:

* severe aortic valve stenosis or insufficiency
* Written informed consent
* Willingness to carry out the follow-up visits

Exclusion Criteria:

* Other types of aortic valve surgery
Gonadal Hormone, Gonadotropin and Cardiovascular Events

Deficiency in gonadal hormone has been considered to play a role in ageing related increased incidence of cardiovascular events. But the mechanism has not been fully elucidated. On the other hand, the dramatic increase in gonadotropin level didn't drew much attention when talking about the increased risk of cardiovascular disease during menopausal transition. This study aim to investigate the association between gonadal hormone, gonadotropin and long-term cardiovascular events.


Eligibility Criteria:
Inclusion Criteria:

* Male or female with intact uterus and at least one ovary
* Aged of 18 to 75 years old;

Exclusion Criteria:

* Pregnancy or lactation women;
* Presence of pituitary/hypothalamic disorders, polycystic ovarian syndrome or other endocrinal and metabolic disorders that known to compromise hypothalamic-pituitary-gonadal function;
* Receiving psychotropic or hormonal medications including hormonal contraception and hormone therapies;
* Taking lipid-lowering agents or hypoglycemic agents and other drugs that known to influence cardiovascular health;
* Obviously poor compliance.
The Impact of Botulinum Toxin on Brow Height and Morphology: A Randomized Controlled Trial

The purpose of this study is to describe three safe and reproducible techniques for brow lifting using botulinum toxin. It will also describe the effect of 2 techniques on the eyebrow shape using quantitative, objective measurements and satisfaction scales.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive 30 female patients presenting to our clinic for brow lifting with botulinum toxin will be randomized to receive one of the two injection techniques

Exclusion Criteria:

* Patients with previous periorbital/forehead surgery
* Patients who plucked the upper eyebrow margin
* Patients with eyebrow tatoos
* Patients with upper face botulinum toxin injection in the past 12 months
* Patients with resorbable upper face fillers injection in the past 12 months
* Patients with previous permanent upper face fillers injection
* Pregnant patients
* Lactating patients
* Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome)
* Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics)
* Patients with sensitivity to botulinum toxin or human albumin
Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )

The aim of the Mashed Or Just Integral pill of TicagrelOr (MOJITO) study is to evaluate the superiority of Ticagrelor 180 mg LD mashed pill versus Ticagrelor 180 mg LD integral pill both orally administrated in decreasing residual platelet reactivity 1 hour after the administration among 70 patients with STEMI (ST segment elevation myocardial infarction) undergoing PPCI (primary percutaneous coronary intervention) with bivalirudin monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting within 12 hours from the onset of symptoms with STEMI
* Informed, written consent

Exclusion Criteria:

* Age \< 18 years or Age \> 75 years
* Active bleeding; bleeding diathesis; coagulopathy
* Increased risk of bradycardiac events
* History of gastrointestinal or genitourinary bleeding \<2 months
* Major surgery in the last 6 weeks
* History of intracranial bleeding or structural abnormalities
* Suspected aortic dissection
* Any other condition that may put the patient at risk or influence study results or investigator's opinion (severe hemodynamic instability, known malignancies or other comorbid conditions with life expectancy \<1 year)
* Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux .
* Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows
* Known relevant hematological deviations: Hb \<10 g/dl, Thrombi. \<100x10\^9/l
* Use of coumadin derivatives within the last 7 days
* Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine
* Known severe liver disease, severe renal failure
* Known allergy to the study medications
* Pregnancy