cyrilzakka/clinical-trials huggingface dataset:
Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

The purpose of this study is to see if mental functions take place during different levels of anesthesia. The researchers expect to gain a deeper understanding of mental function during different levels of anesthesia, and to evaluate if the use of ultrasonic brain stimulation accelerates return to consciousness.

The decision was made in 2023 to focus on the Central Thalmus arm only for this trial. Participants were only randomized to this arm.

Eligibility Criteria:
Inclusion Criteria:

* The participants will be right-handed adults
* Body mass index (BMI) less than 30.
* All subjects will be English speakers.

Exclusion Criteria:

* Participants will be excluded if they have any medical contraindication to MRI scanning
* Unable to undergo MRI scanning because of possible pregnancy or currently breastfeeding,
* BMI\>30
* Metallic substances in the body, claustrophobia, anxiety, or cardiopulmonary disease;
* Intracranial structural abnormality on T1-weighted MRI scans.
* Potential subjects will be excluded if they have a history of allergy to propofol, eggs or egg products, soybean or soybean products,
* Neurological, cardiovascular, or pulmonary illness;
* Head injury with loss of consciousness;
* Learning disability or other developmental disorder; sleep apnea or any severe snoring history;
* Gastroesophageal reflux disease (GERD) or heartburn;
* Pancreatitis or a history of pancreatitis, or sensory/motor loss sufficient to interfere with performance of the study. Participants with tattoos in the head or neck region will be excluded from study; other tattoos are subject to determination by investigators based on their assessment regarding participant safety. To eliminate aspiration risk subjects will also be excluded if they have had recent food or liquid intake (within 8 hours). Subjects will be excluded if they have a history of drug use, have a positive drug screen, are unwilling to abstain from alcohol for 24 hours prior to dosing, or have a current history of nicotine use. Women will be required to take a pregnancy test prior to participation to ensure a negative result. The pre-scan drug screen and pregnancy test will be paid for by the study.
Manual Therapy and Exercise in Patients With Cervicogenic Headache

Hypothesis: The group of cervicogenic headache patients receiving upper cervical and upper thoracic thrust manipulation will demonstrate significant and clinically important changes in outcomes when compared to the mobilization and exercise group.

Patients with cervicogenic headache will be randomized to receive 6-8 sessions over 2-4 weeks of either: (1) upper cervical and upper thoracic thrust manipulation, or (2) upper cervical and upper thoracic non-thrust mobilization and range of motion, strength and postural exercises.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria
* Headache frequency of at least one per week for a minimum of 3 months
* Minimum pain score (NPRS) of 2/10 and minimum disability score (NDI) of 10/50

Exclusion Criteria:

* Bilateral headaches
* Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia
* Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
* History of whiplash injury within the last 6 weeks
* Diagnosis of cervical spinal stenosis
* Bilateral upper extremity symptoms
* Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes)
* Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

  * Muscle weakness involving a major muscle group of the upper extremity.
  * Diminished upper extremity deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
  * Diminished or absent sensation to pinprick in any upper extremity dermatome
* Prior surgery to the neck or thoracic spine.
* Involvement in litigation or worker's compensation regarding their neck pain and/or headaches.
* Physical therapy or chiropractic treatment for neck pain or headache in the 3 months before baseline examination.
* Any condition that might contraindicate spinal manipulative therapy
Observational Study on the Variation of Ascorbic Acid in Patients Undergoing Solid Organ Transplantation

The objective of this observational clinical study is to evaluate the variations in ascorbic acid during the transplantation phases and how these variations influence the oxidative status and patient outcome.

The main questions it aims to answer are:

* how many patients arrive at the transplant in a state of hypovitaminosis C?
* how does hypovitaminosis C affect the patient's oxidative status?
* how does hypovitaminosis C affect the length of stay in intensive care and post-transplant complications?

Researches will compared:

Differences between Hypovitaminosis Group and Normal Range Group Changes in oxidative stress markers before and after solid organ transplantation Incidence of allograft dysfunction between groups Incidence of acute kidney injury and other complications between groups

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing solid organ transplantation (liver or kidney or lung)

Exclusion Criteria:

* Minor patients
* Multi-organ transplantation
Cold Water Exposure's Effects on Physical and Mental Health

An interest in cold-water immersion (CWI) to elicit diverse physiological effects has been prevalent for centuries. CWI typically consists of bodily exposure to water at temperatures ranging from 5-10º C for various durations. CWI has profound cultural significance in different areas of the world, such as in Scandinavian countries, and has emerged as a popular modality for its purported health-promoting effects. Individuals on social media have repeatedly advocated for CWI as a method to improve muscular recovery, enhance sleep, and increase immune and cognitive function. Because of this, companies that specialize in cold tub production have become popularized; however, individuals who are seeking a more cost-effective option are drawn toward cold showers for their preferred method of cold exposure. Despite the scarcity of rigorous research investigating the difference in effects of cold tub versus cold shower CWI, individuals on social media promoting CWI via a shower continue to praise its comparable benefits to that of a tub. Therefore, investigations of chronic CWI (utilizing both a cold tub and a cold shower) is vital.

Thus, the purpose of the proposed study is to explore the varying effects of chronic CWI on neural and cognitive function using a cold tub and a cold shower. Further, the study aims to investigate performance measures and immune measures to create a comprehensive understanding of CWI's implications on human physiology over time. The investigators hypothesize measures relating to mental performance and health will improve after 4-weeks of CWI, and there will be no difference between tub and shower immersion groups.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Aged 18-45

Exclusion Criteria:

* Current holds a cold water exposure routine (≥3 sessions in the last month, consisting of ≥4 minutes per immersion)
* Currently pregnant of planning to become pregnant
* Chronic use of anti-inflammatory medication
* Prior history of chronic disease conditions: Cardiovascular Disease, Diabetes, Cancer, Raynaud's Disease, or severe/untreated anxiety or depression
A Study to Assess Safety, Tolerability and Pharmacokinetics of Ceftaroline in Healthy Subjects

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose regimens of Ceftaroline

A Phase I, Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ceftaroline after Different Intravenous Dose Regimens of Ceftaroline Fosamil to Healthy Subjects

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures including the optional safety biomarker analysis
* Healthy male and female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture
* Women of childbearing potential must have a negative pregnancy test, be non-lactating, and be using a highly effective form of birth control for 1 month prior to enrollment, during the study, and for 3 months after completion of all study-related proceed
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

* Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of investigational drug
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV)
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any clinically significant abnormalities in the physical examination, 12-lead ECG, or vital signs, as judged by the Investigator
D-dimer to Predict Recurrence in Patients With Multiple Episodes of Venous Thromboembolism

Optimal duration of oral anticoagulant therapy in patients with recurrent episodes of venous thromboembolism (VTE) is a matter of debate and recommendations are based on inadequate evidence. More than 12 months of treatment are currently recommended, and the grade of recommendation is low.

The PROLONG study has recently evaluated the predictive role of D-dimer measurement after withholding oral anticoagulant treatment in patients with a first episode of VTE. Patients with a positive D-dimer had a significantly higher incidence of VTE recurrences than patients with a negative D-dimer and required resumption of the antithrombotic treatment. Based on the results of this and of previous cohort studies, it appears safe to withhold treatment in patients with negative D-dimer values and to continue treatment in patients with altered D-dimer levels.

Aim of this study is therefore to assess the negative predictive value of D-dimer also in patients with recurrent VTE and to evaluate the clinical utility of this approach in this patient setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients with at least two episodes of objectively documented venous thromboembolism (at least one proximal deep vein thrombosis or pulmonary embolism)
* Ongoing treatment with oral anticoagulants for at least a) 12 months in case idiopathic DVT was the last event; b) 6 months in all other cases
* Age \> 18 years
* Informed consent provided

Exclusion Criteria:

* Pregnancy/puerperium
* One or more episodes of massive pulmonary embolism
* Last event isolated idiopathic pulmonary embolism
* Two or more idiopathic VTE events
* First degree relatives with recurrent VTE
* Right ventricular disfunction or pulmonary hypertension
* Active cancer
* Antiphospholipid antibodies syndrome
* Antithrombin deficiency
* Homozygous Factor V Leiden or G20210A prothrombin mutation
* Heterozygous Factor V Leiden and G20210A prothrombin mutation
* Concomitant congenital thrombophilic mutations
* Concomitant indications to long term oral anticoagulant treatment
* Severe cardiorespiratory insufficiency
* Severe liver or renal disease (creatinine clearance \> 2 mg/dL)
* Limited life expectancy
* Geographic inaccessibility
High Intensity Intervallic Training in Children With Bronchiolitis Obliterans

Post-Infectious Bronchiolitis Obliterans (PIBO) is an irreversible obstructive lung disease characterized by subepithelial inflammation and fibrotic narrowing of the bronchioles after lower respiratory tract infection. This disease is diagnosed mainly in children, more frequently before the age of 2 years. Due to symptoms such as dry cough and dyspnea sensation, most of these patients have low levels of physical activity compared to healthy individuals. Physical activity can positively influence oxygen consumption, muscle strength, and quality of life. High levels of oxygen consumption are associated with a lower risk of respiratory disease and hospitalization. High-intensity interval training (HIIT) may be an effective way to improve oxygen consumption, muscle strength, and quality of life in patients with chronic diseases. HIIT has been shown to produce less dyspnea sensation and to be more entertaining in children and adolescents with respiratory disease compared to continuous training. Thus, the investigators propose to perform telematically real-time guided training to reduce travel times and additional costs to patients.

Objective: To analyze the effects of a telematically supervised high-intensity intervallic training program on aerobic fitness, as well as functional/clinical outcomes in patients with PIBO.

Methods: Randomized controlled trial with two groups. Exercise group: 16-week HIIT training conducted telematically; Control group: will follow the routine physician's recommendations. Patients will be recruited at Vall D'Hebrón University Hospital (Barcelona), Niño Jesús University Hospital (Madrid), and Donostia Universitary Hospital (San Sebastián). Criteria for participation: (I) Diagnosis of PIBO; (II) Clinically stable at the time of the assessments; (III) Age between 6 to 20 years old.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Postinfectious bronchiolitis obliterans;
* Clinical stability at the time of the assessments;
* Age between 6 and 20 years old.

Exclusion Criteria:

* Symptoms of pulmonary exacerbation during the last four weeks;
* Diagnosis of other cardiorespiratory diseases leading to symptoms of persistent respiratory dysfunction;
* Difficulty in comprehension or musculoskeletal alterations that may influence the assessments;
* Pregnancy;
* Transplant list inclusion.
PremiCron Suture for Cardiac Valve Repair

The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an elective primary open or minimal invasive surgery for a single or multiple cardiac valve reconstruction or / and replacement.
* Age ≥18 years
* Written informed consent

Exclusion Criteria:

* Patients undergoing an elective primary cardiac valve reconstruction or / and replacement in combination with a coronary arterial bypass graft surgery.
* Emergency surgery
* Pregnancy
* Infective endocarditis
* Previous cardiac surgical intervention
* Known immunodeficiency or immunosuppression
* Participation or planned participation in another cardiovascular study before study follow-up is completed.
* Inability to give informed consent due to mental condition, mental retardation, or language barrier.
Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery

Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine surgery.

This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for spine surgery.

After spine surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anaesthesia is essential due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.

There is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use have been compared in adults. However, there is a massive lack of research regarding spine surgery and the Erector Spinae Plane Block.

In this study, investigators compare perineural Dexamethasone and Dexmedetomidine.

The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing primary posterior lumbar decompression and stabilization with instrumentation involving multi-levels in the lumbar region,
* aged \>18 years and \<100 years
* ASA physical status 1, 2 or 3.

Exclusion Criteria:

* refuse to participate,
* history of opioid abuse,
* infection of the puncture site,
* aged \<18 years and \>100 years
* ASA 4 and 5
Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age and older
* Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but \< 180 mm Hg and mean seated diastolic blood pressure ≥ 95 mm Hg and \<110 mm Hg

Exclusion Criteria:

* - Patients with sever hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
* Diabetes with fasting glucose \> 126 mg/dl or on existing anti-diabetic medication
* History of stroke, transient ischemic attack, or myocardial infarction within the last 6 months, or diagnosed with congestive heart failure.

Other protocol-defined inclusion/exclusion criteria may apply.
Trial of Subretinal Injection of (rAAV2-VMD2-hMERTK)

This study was to assess the safety of gene transfer via subretinal administration of rAAV2-VMD2-hMERTK in subjects with MERTK-associated retinitis pigmentosa (RP).

In this phase I open-label, dose-escalation trial, one eye of each patient (the worse-seeing eye in five subjects) will receive a submacular injection of the subretinal rAAV2-VMD2-hMERTK. Patients will be followed daily for 10 days and then at 30, 60, 90, 180, 270, 365, 540, and 730 days post-injection. Data will be collected on (1) full ophthalmologic examination including best-corrected VA, intraocular pressure, color fundus photographs, macular spectral-domain optical coherence tomography, and full-field stimulus threshold test (FST) in both the study and fellow eyes; (2) systemic safety data including CBC, liver, and kidney function tests, coagulation profiles, urine analysis, AAV antibody titers, peripheral blood PCR and ASR measurement; and (3) listing of ophthalmological or systemic adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* MERTK-associated retinal disease;
* VA: 20/100 or less in worse eye
* Ability to perform tests of visual and retinal function;
* Good general health based on a complete physical examination and hematology and chemistry studies performed at a pre-treatment evaluation;
* Ability to comply with research procedures;

Exclusion Criteria:

* Pre-existing eye conditions that would preclude the planned surgery or interfere with the interpretation of study endpoints or surgical complications (for example, glaucoma, corneal or lenticular opacities);
* Complicating systemic diseases (such as medical conditions causing immunosuppression) that would preclude the gene transfer, ocular surgery or known sensitivity or allergy to medications planned for use in the peri-operative period;
* Use of anti-platelet agents that may alter coagulation within 7 days prior to study agent administration;
* Use of immunosuppressive medications;
* Pregnancy or breastfeeding;
* Individuals (males and females) of childbearing potential who are unwilling to use effective contraception for 1 year following agent administration and barrier contraception for 3 months following agent administration;
* Any other condition that would prevent a subject from completing follow-up examinations during the course of the study and that, in the opinion of the investigator, makes the subject unsuitable for the study.
* Current, or recent (within the past 30 days, or 10 half lives of the drug) participation, in any other research protocol involving investigational agents or therapies.
* Recent (within past 6 months) receipt of an investigational biologic therapeutic agent.Subjects will not be excluded based on their gender, race or ethnicity.
Standardized Long Term Follow-up of Patients After Endovascular Embolization of a Brain Aneurysm

The time-frame and the follow-up elements after embolization of brain aneurysm are not standardized. Therefore, few reliable follow-up data are available for these patients.

This study aims at collecting standardized long term data for these patients, in order to assess the occurence of aneurysm recanalization and particularly those requiring another intervention on the aneurysm.

An intracranial aneurysm is a localised dilatation in the wall of an intracranial artery, creating a zone of fragility where the main risk is rupture (meningeal haemorrhage). Intracranial aneurysms are the 1st vascular pathology treated in the NRI department at the Rothschild Foundation (FOR). Since 2002, between 150 and 250 patients have been treated each year using the embolisation technique (filling the aneurysm sac with coils). Over the last thirteen years, this represents the largest cohort in France, with more than 2,000 patients selectively treated for one or more intracranial aneurysms, i.e. more than 2,500 aneurysms. Treatment consists of excluding the aneurysmal cavity from the bloodstream, usually by "plugging" it with platinum metal coils.

After treatment by embolisation of the aneurysm, recanalisation (recirculation of blood in the aneurysm, exposing the patient to a new risk of haemorrhage due to aneurysmal rupture) of the cavity may occur after a few months or years (approximately in 7% of cases). In addition, new aneurysms may develop during the patient's lifetime, often several years later.

Another type of aneurysm treatment is also possible: surgical treatment, which consists of clipping the neck of the aneurysm. Whichever type of treatment is used, patients are monitored according to a protocol for the first year following treatment, with visits at 6 months and 1 year: an MRI is performed 6 months after embolisation. An arteriogram was performed at one year, and a consultation was held for clinical evaluation. A retrospective assessment of follow-up data (study of 2009-2013 files) showed that the date of this consultation varied considerably and that the schedule of follow-up visits over the first 10 years was not standardised, which means that reliable follow-up data are not available for these patients. The occurrence of recanalisation led us to propose standardised longer-term follow-up, with imaging (MRI and/or arteriography) 3 years after the operation. In our clinical experience, this follow-up schedule (at 3-6 months, 1 year and then 3 years) makes it possible to detect recanalisation requiring re-treatment. The aim of this research is to obtain standardised, longer-term follow-up data for a large series of patients who have undergone embolisation or surgical treatment of an intracranial aneurysm.

Eligibility Criteria:
Inclusion Criteria:

* curative embolization of a brain aneurysm
* age \>18 years old

Exclusion Criteria:

* none