cyrilzakka/clinical-trials huggingface dataset:
Treatment of Insufficient Superficial and Perforatring Veins of the Lower Limb Using HIFU

This is a one-arm, open label, prospective, single center study to evaluate clinical standardization with Theraclion's Sonovein 2 HIFU device.

The original Sonovein device was tested in a clinical trial in 50 subjects and received CE Mark. That device has been updated yielding the current version of Sonovein 2. Based on the technical similarities between both devices in term of design, performance and principle of operation, the clinical data for Sonovein is sufficient to assure conformity of the Sonovein 2 with the respected essential requirements. At the same time, the compagny wishes to pursue the standardisation of the clinical practice with the second generation device and is, therefore, conducting this limited trial in 20 evaluable cases (from the planned 22 patients to be included). A "case" is defined as procedure conducted on a distinct vein.

The Sonovein 2 system provides high intensity focused ultrasound (HIFU) abaltion of soft tissue. The energy is delievered via an extra-corporeal treatment probe, which includes an imaging system. The high energy ultrasound waves propagate through the skin and are focused on a portion of the target tissue, generating intense heat and causing local cell apoptosis and progressive tissue volume reduction over the following months in the tissue within the focal area. The process is then repeated in a stepwize fashion to destroy the targeted tissues. The Sonovein 2 system is comprised of several components, including the console, treatment arm containing the visualization and treatment unit (VTU), a computer with touchscreen user interface. In addition, the Sonovein 2 system is intended to be used in conjunction with a disposable cooling and coupling system known as ePack.

Eligibility Criteria:
Inclusion Criteria:

1. Candidate for venous procedure involving lower limb superficial insufficiency involving reflux in the segment to be treated
2. Physical condition allowing ambulation after the procedure
3. Availability of the patient for all the follow-up visits
4. Targeted tissue reachable for treatment with the device-meaning between 5mm and 26mm below the skin surface
5. Age over 18 years of age at the time of enrollment
6. No acute venous thrombosis
7. No complete, or near complete deep vein thrombosis
8. Patient has signed a written informed consent
9. Targeted structure sonographically visible

Exclusion Criteria:

1. Patient is pregnant or nursing
2. Known allergic reaction to anesthetic to be used
3. Legally incapacitated or imprisoned patients
4. Patient's vein target not clearly visible on the ultrasound images (B mode) at the inclusion visit
5. Patient participating in another clinical trial involving an investigational drug, device or biologic
Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects

This is an open-label, non-randomized, clinical study to evaluate the drug interaction between itraconazole, rifampin or Cocktail and JMKX001899 in healthy subjects. A total of three cohorts of 72 healthy subjects were planned to be enrolled in each cohort.


Eligibility Criteria:
Inclusion Criteria:

1. voluntarily sign the informed consent, fully understand the content of the trial, and be able to complete the study according to the requirements of the trial protocol.
2. subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
3. male body weight is not less than 50 kg, female body weight is not less than 50 kg, and body mass index (BMI) is within the range of 19 \~ 27 kg/m2 (including cut-off value).

Exclusion Criteria:

1. hepatitis B surface antigen HBsAg positive, hepatitis C virus antibody positive, positive AIDS antigen/antibody or Treponema pallidum antibody.
2. Patients with a history of clinically significant diseases including, but not limited to, gastrointestinal, renal, liver, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric, or cardiovascular and cerebrovascular diseases, epilepsy, bipolar disorder/mania, intraocular hypertension, or acute angle-closure glaucoma.
3. have taken any products containing caffeine, alcohol, grapefruit, and xanthine-rich within 24 hours before taking study medication.
Evaluation of Autonomic Function in Individuals With Cornelia de Lange Syndrome (CdLS)

Based on survey data, individuals with Cornelia de Lange Syndrome (CdLS) often experience symptoms of autonomic dysfunction however there are no reported studies in which these patients have had objective testing of the autonomic nervous system. This is a pilot study in which patients with CdLS will undergo the standard clinical testing for autonomic dysfunction with a autonomic reflex screen and thermoregulatory sweat test.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (aged 8-17 years of age) with Cornelia de Lange syndrome.
* Consent obtained from responsible guardian.

Exclusion Criteria:

* Patients less than age 8 or 18 and older
* Female patients known to be pregnant
* Individuals not thought to be able to tolerate the testing.
* Concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. Patients may participate if the potentially interfering medication is held for five half-lives prior to the study
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

The purpose of this study is to demonstrate the efficacy of CJ-12420, once daily (QD), compared to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA) classification grades A to D at Week 8

This is a double blind, randomized, active controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (CJ-12420 100 mg or esomeprazole 40 mg).

All subjects will be asked to take two tablets at the same time each day throughout the study, and also all subjects will be asked to record daytime and nighttime symptom in a subject diary on a daily basis.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between 20 and 70 years
2. Subjects who had experienced heartburn and regurgitation within 7 days before visit 1. Entry into study also required that patients had experienced at least mild upper gastrointestinal symptoms on at least 2 days/week or at least moderate upper gastrointestinal symptoms on at least 1 day/week
3. Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization
4. Subjects who is able to understand and follow the instructions and is willing to participate throughout the entire study
5. Subjects who voluntarily signed written informed consent form
6. Subjects who agreed to use medically acceptable contraceptives during the period of study.

Exclusion Criteria:

1. Subjects who cannot undergo EGD
2. Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by EGD
3. Subjects who have warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool
4. Subjects with eosinophilic esophagitis
5. Subjects diagnosed with primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the last 3 months
6. Subjects who have a history of gastric acid suppression surgery or upper gastrointestinal, esophageal surgery
7. Pregnant or lactating women
8. Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder
9. Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc.
10. Subjects who participated in the other clinical trial within 4 weeks prior to randomization
Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in Subjects with Spinal Cord Injury

Established gait assessments for subjects with spinal cord injury (SCI) (6MWT, 10MWT, TUG, SCIM III and WISCI II) are widely used in the clinical and research setting. So far, no valid measurement exists that assesses the patients' perspective of walking ability in SCI. As there is the 12-item Multiple Sclerosis Walking Scale (12-WS) to assess the patients' perspective on gait ability in patients with multiple sclerosis, it is hypothesized that the 12-WS would also be a valid instrument for subjects with incomplete SCI. The main goal of this study is to collect data from clinical gait assessments in subjects with spinal lesions and to demonstrate that the 12-WS is a valid and reliable patient-reported outcome measurement for individuals with incomplete spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Diagnosis of chronic spinal cord injury (\>6 months; cervical or thoracic motor incomplete traumatic or non-traumatic (AIS C, D) above T12
* Must have impaired walking function as demonstrated by neurological examination.

Exclusion Criteria:

* Women who are pregnant or breast feeding
* Current orthopaedic problems of lower limbs
* History of major cardiac condition (e.g., infarction, insufficiency (NYHA II-IV))
* History of major pulmonary condition (e.g., chronic obstructive pulmonary disease GOLD II-IV
* Current major depression or psychosis
* Participation in another interventional study (except specTra-study) that may have an impact on walking function.
Automated Robotic Maneuvering System (RMS) vs Manual Reposition Maneuver in Treatment of Benign Paroxysmal Positional Vertigo (BPPV)

Comparison of treatment efficacy of an automated robotic maneuvering system (RMS) repositioning chair versus manual positioning maneuvers in Benign Paroxysmal Positional Vertigo.

The standard treatments for Benign Paroxysmal Positional Vertigo (BPPV) are manual positioning maneuvers. This method, beyond being costly and requiring extensive training, is a significant burden on healthcare resources. We developed an automated robotic maneuvering system, hereby known as RMS, to tackle this problem. Our Clinical Investigation is two-fold; (1) test the safety of RMS and, (2) understand the viability of RMS for treating BPPV when compared to manual positioning maneuvers.

Eligibility Criteria:
Inclusion Criteria:

* Characteristic positional nystagmus (for BPPV)
* Positive Dix-Hallpike
* Positive supine roll test
* Positive Deep Head Hanging
* Vertigo-Dizziness Imbalance symptom scores compatible with BPPV

Exclusion Criteria:

* Pregnant patients
* Patients who have taken vertigo suppressing agents (Dimenhydrinate) in the last 48 hours
* Patients taller than 200 cm (2.0 m)
* Patients who have had a cardiovascular or neurosurgical operation in the last month
* Patients with retinal detachment and/or glaucoma
* Lack of treatment cooperation
Effect of Cytoreductive Chemotherapy and a CCR5 Coreceptor Antagonist on HIV-1 Eradication

Effect on HIV-1 cell reservoirs of the concomitant administration of intensive chemotherapy and the pharmacological blockade of CCR5 coreceptors: a pilot, open, randomized, and controlled clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients who give written consent to participate in the study
* Age between 18 and 65 years old, included.
* Chronic HIV-1 Demonstration of R5 viral tropism (use of CCR5 coreceptors) by genotyping in plasma samples stored
* Patients that are to be treated with intensive chemotherapy for non Hodgkin lymphoma With or without stable antiretroviral therapy
* Patients that are able to understand the purpose of the study and be available for scheduled appointments.
* Both in the case of female and male patients, the patient agrees to use a double barrier method of contraception from the moment of signing the informed consent until 3 months after the end of their participation in the study.

Exclusion Criteria:

* To have planned antiretroviral treatment interruption during the participation in the study
* Hypersensitivity to products used in this study
* To be involved in another clinical trial or received an investigational drug within 3 months prior to the study initiation
* To have contraindications or limitations to perform leukapheresis
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis

The primary purpose of this study is to compare the efficacy of bimekizumab administered subcutaneously (sc) for 16 weeks versus placebo in the treatment of study participants with moderate to severe plaque psoriasis (PSO).


Eligibility Criteria:
Inclusion Criteria:

* Study participant is Chinese male or female ≥18 years of age
* Study participant has plaque psoriasis (PSO) for ≥6 months prior to the Screening Visit
* Study participant has Psoriasis Area and Severity Index (PASI) ≥12 and body surface area (BSA) affected by PSO ≥10% and Investigator's Global Assessment (IGA) score ≥3 on a 5-point scale.
* Study participant is a candidate for systemic PSO therapy and/or phototherapy
* Female study participants must be postmenopausal or permanently sterilized or if childbearing potential must be willing to use protocol defined highly effective method of contraception throughout the duration of the study until 17 weeks after last administration of investigational medicinal product (IMP) and have a negative pregnancy test at Screening and prior to first dose

Exclusion Criteria:

* Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 17 weeks following the final dose of IMP
* Study participant has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic, guttate, or drug-induced PSO)
* Study participant has an active infection or history of infection(s) as defined in the protocol
* Study participant has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.Study participant has a past history of active TB involving any organ system unless adequately treated and is proven to be fully recovered upon consult with a TB specialist
* Study participant has a diagnosis of inflammatory conditions other than PSO vulgaris or psoriatic arthritis (PsA)
* Study participant has presence of significant uncontrolled neuropsychiatric disorder. Study participants with history of suicide attempt within the 5 years prior to the Screening Visit must be excluded. Study participants with history of suicide attempt more than 5 years prior to the Screening Visit must be evaluated by a mental health care practitioner before enrollment.
Early FETO for Severe Congenital Diaphragmatic Hernia

Congenital diaphragmatic hernia (CDH) is associated high mortality and morbidity, mainly in those cases with severe forms where there are extremely reduced lung volumes, liver herniation and decreased abnormal pulmonary vascularization. Fetal endoscopic tracheal occlusion performed between 26 and 30 weeks (standard FETO) has been shown to increase fetal pulmonary size and vascularity, and to improve infant survival in isolated severe CDH. Fetal pulmonary response followed FETO can be used to predict outcome and is dependent on the size of the fetal lung prior to the procedure.

We hypothesize that performing an earlier FETO, between 22-24 weeks, fetuses with severe form of CDH will have a better fetal pulmonary response and higher chance of surviving.

We pretend to investigate if "early FETO" will improve the survival rate and the fetal pulmonary response, by conducting a randomized controlled trial comparing the results with those fetuses that undergo to "standard FETO" (between 26-28 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Fetuses with isolated congenital diaphragmatic hernia (normal fetal karyotype and absence of any associated structural anomaly);
* Gestational age established by last menstruation and/or first trimester ultrasonography;
* Prenatal diagnosis of congenital diaphragmatic hernia before 24 weeks of gestation
* Severe congenital diaphragmatic hernia (at 24 weeks, lung-to-head ratio \<1.0 and at least 1/3 of the liver herniated into the fetal thorax)
* written informed consent (by the patient)

Exclusion Criteria:

* Preterm premature rupture of the membranes before randomization
* Preterm labor before randomization
Study of Zonisamide in Early Parkinson Disease

The aim of this study is investigation of neuroprotective effect of zonisamide in early Parkinson disease. A total of 60 patients with early Parkinson disease who meet the study criteria will be enrolled and randomized into two groups alternately based on their visit date. Demographic data, Unified Parkinson's Disease Rating Scale (UPDRS), modified Hoehn\&Yahr and modified Schwab\&England activities of daily living scale will be determined and registered for each patient. Patients of group A will be treated by zonisamide 50mg/d for 12 months and the other group will be treated by placebo for the same time. Primary endpoint is occurrence of parkinsonian symptoms which interfere with patients' daily activity or cause psychosocial embarrassment. The mentioned scores will be registered every 2 months for both groups by blinded neurologist and also regular blood test will be performed to prevent drug adverse events.


Eligibility Criteria:
Inclusion Criteria:

1. Age 45-85 years
2. Symptoms and signs of idiopathic Parkinson disease for less than a month that do not lead to physical or psychosocial disability.

Exclusion Criteria:

1. Past history of treatment with antiparkinson drugs.
2. Past history of treatment with zonisamide
3. Hepatic insufficiency (ALT\>2ULN)
4. Renal insufficiency (Cr\>2mg/dl)
5. Self or family history of nephrolithiasis
6. Active psychosis
7. Epilepsy
8. Suicidal attempt in last 3 years
9. Hypersensitivity to sulfonamides
10. Pregnancy and breastfeeding
A Post Market Study to Assess the Spinal Modulation Neurostimulator System for Chronic Intractable Pain

04-SMI-2012 is post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic, intractable pain.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Chronic, intractable pain in the thoracic, lumbar and/or sacral distribution(s) for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
6. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
7. Subject is able to provide written informed consent
8. Subject speaks Dutch or English

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Patient has pain only or primarily within a cervical dermatomal distribution
7. Subject is unable to operate the device
8. Subjects with indwelling devices that may pose an increased risk of infection
9. Subjects currently has an active infection
10. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
11. Subject has participated in another clinical investigation within 30 days
12. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
13. Subject has been diagnosed with cancer in the past 2 years
Closed-loop Control of Glucose Levels in the Context of Exercise in Adults With Type-1 Diabetes

Recent developments of continuous glucose sensors and insulin infusion pumps have motivated the research toward closed-loop strategies to regulate glucose levels in patients with type 1 diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based on a computer-generated recommendation that relies on continuous glucose sensor readings. In this study, we aim to compare the effectiveness of dual-hormone (insulin+glucagon) closed-loop strategy to open-loop conventional continuous subcutaneous insulin infusion pump (CSII) therapy in regulating glucose levels during an evening exercise and on a night following an exercise in adults with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 1 diabetes for at least one year.
* On insulin pump therapy for at least 3 months.
* HbA1c ≤ 10%.

Exclusion Criteria:

* Clinically significant nephropathy, neuropathy or retinopathy.
* Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
* A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
* Pregnancy.
* Severe hypoglycemic episode within two weeks of screening.
* Current use of glucocorticoid medication (by any route of administration except low dose stable inhaled).
* Known or suspected allergy to the trial products or meal contents.
* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
* Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
* Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).