cyrilzakka/clinical-trials huggingface dataset:
Aortic Remodeling After Endovascular Management of Type B Aortic Dissection.

Assess the clinical outcome, morphological changes and behaviour of type B aortic dissection after endovascular repair.

Aortic dissection (AD) is considered the most common catastrophic event of the aorta, and its incidence has been reported to be ≈3/100000 per year, exceeding that of ruptured abdominal aortic aneurysm.

AD is a dynamic process and can occur anywhere along the course of the aorta, with the pathognomonic lesion being an intimal tear followed by blood surging either antegrade (typically) or retrograde, cleaving the the intima and medial layers of the aortic wall longitudinally for a variable distance, thus creating a true and false lumens.

Aortic dissections are classified by chronicity, anatomic location of false lumen, generally the entry tear and longitudinal extent, and the presence or absence of complicating features.

Temporally, AD is categorized as acute phase {\<14 days}, subacute {15-90 days}, and chronic {\>90 days}.

Thoracic Endovascular Aortic Repair (TEVAR) has emerged as the first-line therapy for the treatment of AD, with better short-term results than open repair due to a significant decrease in perioperative morbidity and mortality.

By covering the primary entry tear with stent-grafts, the blood flow is redirected into the true lumen, resolving malperfusion and/or preventing rupture of the false lumen, followed by its regression and re-expansion of the true lumen, which is known as "Aortic remodeling"

Eligibility Criteria:
Inclusion Criteria:

1. Complicated Stanford type B dissections:

   * Rupture.
   * malperfusion (visceral, extremities or spinal cord ischemia).
2. High-risk aortic dissections:

   * Refractory pain, refractory hypertension or bloody pleural effusion.
   * High-risk radiographic features (max. aortic diameter \>40mm, false lumen diameter \>22mm, 1ry entry tear \>1cm, entry tear location on the lesser curve and radiographic only malperfusin).
3. Aortic anatomy suitable for stent graft therapy:

   * Proximal landing zone (diameters between 15 and 42mm, measured form outer wall to outer wall) isn't aneurysmal, dissected or significantly thrombosed.
   * Proximal landing zone length ≥20mm.
   * Radius of curvature ≥20mm for aortic arch landing zones.
   * Arch or distal aortic angulation 45≤ degrees.
4. Compatible Iliac and/or femoral access vessel morphology (diameter and tortousity) that allows endovascular access to the dissection site with the delivery system of the appropriately sized device, with or without the use of either surigcal or endovascular conduit.
5. Age ≥18yrs.
6. Life expectancy \>2yrs

Exclusion Criteria:

1. Known hypersensitivity to device component or contraindication to anticoagulation or contrast media.
2. Systemic or local infection that may increase the risk of endovascular graft infection.
3. Subjects with past descending or abdominal aortic interventions.
4. Un-correctable coagulopathy
5. Active vasculitis
6. Inability or refusal to give informed consent by subject or legal representative
7. Subject is unwilling to comply with the follow-up schedule.
Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later

The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. Previous studies have shown that pregnancy and childbirth are risk factors for developing prolapse. There is a lack of studies that follow women several years after delivery aiming to find whether symptoms of prolapse are linked to delivery method, ie vacuum, forceps, normal vaginal delivery and cesarean section. The investigators plan this study is to get more knowledge about pathology of prolapse and incontinence, to enable development of preventive strategies for these conditions.

Aim of the study is to determine whether the prevalence of symptoms and performed surgery for urogenital prolapse differs among women delivered by vacuum, forceps, normal vaginal delivery and cesarean section 15-20 years after their first delivery.

The investigators identify women that delivered their first child at St. Olavs Hospital, Trondheim, Norway between 1990-1997. Questionnaires will be sent to 2500 women (PFIQ-7, PFDI-20, PISQ-12), 600 of whom will get a clinical examination, where pelvic floor musculature is examined by palpation and 4D ultrasound, and a POP-Q quantification of prolapse performed.


Eligibility Criteria:
Inclusion Criteria:

* first delivery in time period 1990-1997
* vaginal birth, spontaneous, forceps or vacuum extraction, or cesarean section
* residency in Klæbu, Malvik, Melhus, Midtre Gauldal, Rissa, Selbu, Trondheim, Tydal, Åfjord at the time of first delivery

Exclusion Criteria:

* stillbirth
* breech birth
* congenital Abnormalities
* residency outside the 9 selected communities
* forceps delivery following previous vacuum extraction delivery or spontaneous vaginal birth
* vacuum extraction delivery following previous forceps delivery or spontaneous vaginal birth
* Vaginal birth following previous cesarean section
Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial

The aim of the study is to evaluate renal and digestive tolerance of a food supplement, phytalgic, on elderly volunteers.


Eligibility Criteria:
Inclusion Criteria:

* 70 years old minimum
* Satisfying general health judged by principal investigator
* Pain and /or stifness associated with arthritis
* Regular used of analgesics and/or non-steroidal anti-inflammatory drugs (NSAIDs)
* Digestive tolerance biomarkers

  1. ASAT : Men \< 150 UI/L - Women \< 100 UI/L
  2. ALAT : Men \< 180 UI/l - Women \< 130 UI:l
  3. Gamma GT Men \< 180 UI/l - Gamma GT Women \< 100 UI/l
  4. Amylase \< 250 UI/l
  5. Lipase \< 750 UI/l
* Renal tolerance biomarker: Glomerular filtration rate (GFR)superior or equal to 60 mL /min / 1.73m3 - calculated with the "Modification of the Diet in Renal Diseases" formula

Exclusion Criteria:

* Inflammatory arthritis
* Allergy to any constituents of the study drug
* Types 2 diabetes
* Not legally fit to participate
* Any treatment able to modify determined biological parameters
Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure

This is a multicenter, prospective, randomized clinical trial (pilot study). 20 participants with diastolic heart failure will be assigned to ventilation therapy (AutoSet CS ™ ASV device; therapy group). The trial will run for 6 months, after which change in echocardiographic parameters of diastolic left ventricular function, sleep and quality of life parameters will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Clinical signs and symptoms of heart failure according to the ESC guidelines
* Echocardiographic evidence of a preserved systolic left ventricular function (echocardiographic left ventricular ejection fraction \> 50%)
* Polysomnographic evidence of at least moderate sleep-disordered breathing: apnea-hypopnea index (AHI) \> 15 / h with ≥ 50% central events and with with a central AHI of ≥ 10/h (AHI based on total sleeping time, TST)
* BNP or NT-pro BNP ≥ 300 pg / ml
* NYHA class II or III
* Patient tolerates the ventilation treatment (1h sample ventilation)
* Stable drug therapy in the last 4 weeks prior to randomization (no iv diuretic therapy or increasing the dose of diuretics to ≥ 100%)
* Minimum age of patients of 18 years
* patient willing to undergo study procedures
* signed informed consent

Exclusion Criteria:

* Oxygen saturation (sO2) \<92% of the days in peace without O2 therapy, measured baseline (start time) in the pulse oximetry or polysomnography in a cape. BGA (the measurement must be max. Lie back 1 week)
* Patients, who have a risk professional with symptomatic sleep apnea
* Known COPD with FEV1 \<70%
* patients with NYHA stadium IV
* Advanced congenital heart defects
* pericardial diseases
* Existing PAP or bi-level therapy (including adaptive servo-ventilation) in the last 3 months
* Acute cardiac event in the last 3 months
* BMI ≥ 35kg / m²
* Pregnant or lactating women
Comparison of 133Xe Scintigraphy With 19F MRI

The central hypothesis and current observation is that PFx gases used as contrast agents readily provide functional images of the lung airways including important regional ventilation information such as ventilation defect severity and gas trapping. This is a pilot proof of concept study to demonstrate the non-inferiority of 19F MRI gas Ventilation imaging compared to 133Xe ventilation Scintigraphy in subjects with lung disease. The secondary goal of the study is to develop sufficient information to adequately power a pivotal trial of 19F MRI gas Ventilation imaging compared to 133Xe Ventilation Scintigraphy

Aim 1: Compare measures of lung ventilation performance obtained using 133Xe Scintigraphy with performance using 19F Perfluorinated gas MRI using two independent readers.

133Xe Scintigraphy will be scored using the methods described in the statistics section and 19F images will be scored using the methods described in the statistics section. Scores for each subject will be earluated for consistency between readers and modalities. 60% concordance will be considered equivalent.

The outcomes of the work proposed is expected to show the non-inferiority of 19F Perfluorinated gas MRI to 133Xenon Scintigraphy

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial

1. Outpatients of either gender, age \> 18.
2. Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)
3. Women of childbearing potential must have a negative urine pregnancy test. This will be confirmed before participation in this investigational protocol.
4. Completion of 133Xe ventilation scintigraphy after referral for ventilation imaging for any reason in Pro00081987 A Comparison of Technegas® and Xenon 133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy. The MRI will be accomplished in a timely fashion after the Scintigraphy study based on scheduling availability in the Center for Advanced Magnetic Resonance Development (CAMRD).

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the trial:

1. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
Electroacupuncture for Mild-to-moderate Dry Eye

To determine if electroacupuncture acts as an dry eye treatment rather than a placebo, and identify if benefits are linked to corneal subbasal nerve changes and neuroimmunomodulatory indicators.

Acupuncture is an important method in the treatment of diseases in Chinese medicine and plays an important role in the treatment of many diseases. Electroacupuncture (EA), as a combination of acupuncture and electric stimulation, is now widely used in research and clinical treatment. Our preliminary study found that compared with 0.1% sodium hyaluronate eye drops, EA exerted more beneficial and durable effects after four weeks of treatment. However, the placebo effect of EA cannot be ruled out yet. The aim of this study is to determine if EA acts as an dry eye treatment rather than a placebo, and identify if benefits are linked to corneal subbasal nerve changes.

This is a multicenter, randomized, subject-blinded, sham-controlled trial. A total of 168 participants with mild-to-moderate dry eye will be randomly assigned (1:1) to verum EA or non-penetrating non-acupoint sham EA (3 times weekly for 4 weeks), followed by a 24-week follow-up. The primary efficacy outcome is the change from baseline to week 4 in the Noninvasive Tear Breakup Time (NIBUT). Secondary efficacy outcomes include tear meniscus height (TMH), Schirmer I test (SⅠT), corneal topography, corneal and conjunctival sensation, scores of Ocular Surface Disease Index (OSDI), corneal fluorescein staining (CFS), Numerical rating scale (NRS), and Chinese Dry Eye Related Quality of Life Scale (CDERQOL) . Additionally, we will apply the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder (GAD-7) to understand the mental health conditions of patients. IVCM will be performed to observe the morphological changes of the corneal basal nerve. The changes of NGF, CGRP, NPY, 8-OHDG, 4-HNE, MDA and other neuroimmunomodulatory indicators in tears and conjunctival cells will be detected by immunofluorescence, ELISA, or other techniques.

Eligibility Criteria:
Inclusion Criteria:

* Patients meeting the diagnostic criteria for dry eye according to the TFOS DEWS Ⅱ
* Ages 18-65 years, no gender limit

Exclusion Criteria:

* Diagnosed with severe dry eye
* Combined with other eye diseases (e.g. severe blepharitis, blepharospasm, conjunctival laxity, strabismus, amblyopia, glaucoma, cataract, fundus disease, ocular trauma)
* With active eye diseases or a history of eye surgery within 3 months
* Received acupuncture treatment or other dry eye treatment measures within 1 month that may influence the assessment of efficacy
* Previously experienced electroacupuncture intervention
* Pregnant or breastfeeding females
* Serious systemic diseases such as cardiovascular, cerebrovascular, hepatic, renal, and hematopoietic system and psychiatric disorders
* With autoimmune diseases such as Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, or ankylosing spondylitis
* With damaged, ulcerated, infected, or scarred skin at the selected acupoints
* Allergic to metal or tape
The Safety of a High-Dose, Rapid Infusion of Iron Sucrose

Iron sucrose infusion is an iron replacement used to treat iron deficiency anemia (not enough iron in the body to make hemoglobin). Iron is a mineral that the body needs to produce hemoglobin, which carries oxygen in the blood. When the body does not get enough iron, it cannot produce enough hemoglobin and you become anemic.

The research study is looking at the side effects of using a higher dose and faster rate of iron sucrose infusion than what is used in standard of care. The purpose of this study is to see if infusion with 500 mg of iron sucrose over a one hour time period can be done safely. If this can be done safely, it may reduce the total number of infusions required and the time for each infusion. This may be less costly and less burdensome to patients.


Eligibility Criteria:
Inclusion Criteria:

* Any patient requiring iron infusion

Exclusion Criteria:

* Patients will be excluded from enrollment if they are under the age of 18, unable to give signed consent, are pregnant, have end-stage renal disease, are on hemodialysis (HD), or have a history of clinically significant adverse reactions to iron sucrose.
Escitalopram (Lexapro) for Depression MS or ALS

The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.

This eight-week study aims to assess the effectiveness and tolerability of escitalopram in improving symptoms of Major Depression in patients with Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) as measured by the HAM-D. In addition, the study will assess improvement in the quality of life in patients with Major Depression and ALS or MS.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 70 years of age with documented ALS or MS,
* DSM-IV episode of non-psychotic Major Depression,
* ≥14 score on the 17-item HAM-D,
* Ability to give informed consent.

Exclusion Criteria:

* History of psychotic disorders,
* Psychotic depression,
* Bipolar depression,
* Suicide risk,
* History of substance abuse in the previous 6 months,
* History of unstable medical disorders,
* Pregnancy or planning for pregnancy,
* Severity of ALS or MS that limits participating in the study protocol.
Simultaneously Using Traditional Chinese Medicine (Si-Ni-Tang) to Treat Septic Shock Patients

The purpose of this study is to determine whether simultaneously using the traditional Chinese medicine, Si-Ni-Tang, is more effective in the treatment of septic shock patients.

Those with hemodynamic instability were the main population of the ICU patients, whether the exact etiology leading to the diseases. However, how to maintain adequate hemodynamic status in order to keep the patients with well organs perfusion is the main issue of the intensive care physicians. The choices of vasoactive drugs in the guidelines or experts' suggestions nowadays used are still limited in the western medicine. Si-Ni-Tang, a remedy previously used in ancient China and now widely prescribed in Taiwan and China, is used for treating patients diagnosed as shock or heart failure. The investigators are eager to know if there existed any benefit via adding this drug to treat the septic shock patients. Therefore, the investigators designed a prospectively randomized double blind control trial to determine whether simultaneously using the traditional Chinese medicine, Si-Ni-Tang, is more effective in the treatment of septic shock patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to our intensive care units are enrolled if their disease diagnosis meets the definition of septic shock
* Using vasopressor now and the duration from initiation of vasopressor use to the entrance of the study is within 24 hours
* Nasogastric tube feeding

Exclusion Criteria:

* More than one kind of vasopressor is administrated
* Patients with extremely poor gastrointestinal function and can not tolerate diet feeding
* Acute myocardial infarction
* Patients with evidence of major bleeding
* Expected surgical intervention or scheduled surgery in the subsequent one week
* Patients who received digoxin for arrhythmia in the past one week
Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.

The goal of this clinical trial is to test Epitel's™ Remote EEG Monitoring System's (REMI™) ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for extended periods (14 - 28 days) in patients presenting with questionable seizure characterization. The main questions it aims to answer are: • Can more seizure events be recorded in fourteen (14) days than can be recorded in three (3) days? • Do treating clinicians find clinical value in extended fourteen (14) - twenty-eight (28) days of EEG? Participants will wear a portable EEG device (REMI) for fourteen (14) to twenty-eight (28) days in their home/community setting.

This is a prospective study to quantify Epitel's™ Remote EEG Monitoring System's (REMI™) ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for extended periods (14 - 28 days). Patients presenting with questionable seizure characterization that are scheduling a conventional at home ambulatory EEG (Amb EEG) and who meet the study inclusion and exclusion criteria will be prescribed a REMI system.

The purpose of this study is to demonstrate that the REMI system is able to record EEG data that clinicians can use to identify ictal events over extended periods, and that extended clinical EEG data is valuable in the diagnosis and treatment of seizure related symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Patients have a reported history of seizures (epileptic, non-epileptic, or unknown),
* Have a minimum reported seizure rate of one every two weeks,
* Are prescribed an ambulatory EEG study as part of routine care,
* Is Male or Female between the ages of 18 and 70,
* Can understand and sign written informed consent, or have a legal guardian provide consent,
* The Patient (or Primary Caregiver) must be competent to follow all study procedures,
* The Patient must be willing to use the System for a prolonged period (up to 30 days), for a minimum of 20 hours/day.

Exclusion Criteria:

* Is sensitive or allergic to medical acrylics, silicones, or hydrogels,
* Is enrolled in another investigational drug or device trial,
* Is homeless or in a home without a power supply, or
* Cannot read, speak, or understand English (and does not have a translator).
Oral Chemotherapy And Platinum With Radiotherapy Followed Or Not By Consolidation With The Same Chemotherapy In Locally Advanced Non Small Cell Lung Cancer

This is a multicenter, open-label, randomised, phase III study of 2 cycles of oral vinorelbine in combination with cisplatin concurrently with radiotherapy randomised to either two more cycles of consolidation therapy with oral vinorelbine and cisplatin plus Best Supportive Care (BSC) or BSC alone in patients with unresectable locally advanced non small cell lung cancer (NSCLC).

The primary objective is to compare progression-free survival in both arms, the secondary is to evaluate the response rate, overall survival in both arms, to evaluate the safety profile in both arms and to assess quality of life by the LCSS questionnaire.


Eligibility Criteria:
Main Inclusion Criteria:

* Presence of at least one measurable lesion (RECIST criteria)
* Patients with a Karnofsky Performance Status = or \> 80%
* Adequate pulmonary function, bone marrow, hepatic and renal functions

Main Exclusion Criteria:

* Patients with NSCLC stage IV, with NSCLC stages I, II, IIIA (except N2), with NSCLC stage IIIB with tumour extent or pleural effusion
* Symptomatic neuropathy \> Grade 1
* Hearing impairment = or \> Grade 2
* Concomitant/uncontrolled medical disorder
* Pregnant women
Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy

The aim of the study is to prove the feasibility and safety of transcutaneous, electrical stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent
* Patients of both gender, aged from 18-75 years
* Diagnosis of epilepsy according to the diagnosis criteria of the DSM IV/ ICD 10 (especially G 40.1 /G 40.2/ G 40.3)
* Insufficient response to at least one attempt of treatment in medical history with anticonvulsive medication, dosed sufficiently long and high
* Antiepileptic Drugs (AED) therapy must be stable at a level that promises long-term continuity for at least 10 before study start and has to be continued for at least 3 months during treatment phase

Exclusion Criteria:

* Absence of Informed Consent
* Pregnancy
* Psychiatric diseases, especially post-traumatic stress disorder, obsessive-compulsive disorders, schizophrenia, Borderline personality disorders (BPD), character disorders as well as major depressive disorders, anxiety disorders and eating disorders as comorbidity.
* Abuse of drugs and alcohol until 12 weeks before study start
* Cerebrovascular diseases
* Dementia
* Severe traumatic brain injury in medical history including invasive and non-invasive methods of therapy (tumor surgery, "Gamma Knife Surgery")
* Indications of structural impairment of the basal ganglia or the brain stem
* active implants (e.g. cochlea implants, VNS, pacemaker)
* Severe neurological diseases (e.g. Morbus Parkinson, systemic neurologic diseases
* severe internistic diseases (e.g. arterial hypertension, respiratory failure)
* Bronchial asthma
* malignant diseases of any kind, within five years before study start
* Severe active infectious diseases (e.g. HIV, hepatitis)
* Bone diseases (e.g. Morbus Paget, recent fractures)
* Diseases of the ENT body system: Hearing loss of the left ear which is treated with a hearing instrument, all dermatologic and infectious diseases which affect the area around the pinna and the ear canal, severe malformation of the pinna
* Vagotomy
* Concurrent participation in other studies
* Other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject