cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Guided Versus Landmark Guided Arterial Line Placement by Emergency Medicine Interns

Critically ill patients in the emergency department commonly require arterial line placement for continuous direct blood pressure monitoring, frequent arterial blood gas sampling, and frequent blood sampling. Trans-radial catheterization has been shown to reduce access site complications and increase patient comfort compared to trans-femoral access. Radial artery access on the first attempt is optimal; attempts at reentry delay care and increase the risk of vascular spasm, hematoma, infection, neurovascular injury, and pain. The traditional pulse palpation method of radial artery cannulation can be challenging, especially in patients with weak pulses (i.e. morbidly obese or hypotensive individuals).

A review of literature suggests that ultrasound guided trans-radial catheterization compared to standard pulse palpation reduces access time and increases rate of first-entry success when performed by physicians trained in ultrasound. Thus, complications ascribed to reentry are prevented and timely care is provided.

To the investigator's knowledge, only one other prospective study has been conducted to assess the utility of ultrasound guided radial artery cannulation in the emergency department. Due to the paucity of literature to support the use of ultrasound guided trans-radial catheterization in critically ill patients, the study will aim to provide further data on the topic. Both techniques are considered standard of care.

Patients presenting to the Emergency Department 18 years old or greater, who do not belong to a vulnerable group, requiring arterial line placement will be included in this trial. The investigators will randomize each patient into LM vs US. Data collected will include number of attempts, success rate, and time for procedure to be completed. PGY-1 residents will perform the arterial line placement.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring arterial line placement.

Exclusion Criteria:

* Adults Unable to Consent
* Members of Vulnerable Populations
Triamcinolone Versus Methylprednisolone in Transversus Abdominis Plane Block

In the current Study we will compare between triamcinolone and methylprednisolone as an additive to bupivacaine drug in ultrasound guided TAP block in major open abdominal surgery .

Postoperative pain is one of the main causes of respiratory function derangement after abdominal surgery .Transversus abdominis plane (TAP) block is widely used in abdominal surgery for postoperative analgesia The transversus abdominis plane (TAP) block is aperipheral nerve block that involves the injection of alocal anesthetic (LA) in the plane between the internaloblique and transversus abdominis muscle layers, with the aim of anesthetizing the intercostal nerves supplyingthe abdominal wall (from T6 to L1) By blocking intercostal nerves T6 to L1, TAPblock efficiently blocks somatic pain after abdominalwall surgery

. It providesadequate postoperative pain relief following various abdominal surgeries TAP block can reduce pain scores, opioid consumption, and the incidence of opioid-related complications after abdominal surgery.

The duration of the TAP block is limited to theeffect of the administered LAs. Various adjuvantmedications have been added to the LA to prolong theduration of TAP block and magnify its effects .

Perineural injection of steroids is reported to influence postoperative analgesia.

As a synthetic glucocorticoid, triamcinolone acetonide binds to and activates the glucocorticoid receptor to produce anti-inflammatory responses,such as down-regulating pro-inflammatory cytokine expression , preventing prostaglandin and leukotriene synthesis and release of arachidonic acid, and activating anti-inflammatory transcription factors such as lipocortins

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for major open abdominal surgery
* American Society Anesthesiologists (ASA) physical status I to II

Exclusion Criteria:

* Patient refusal.
* Morbidly obese patients.
* Patients with uncontrolled diabetes.
* Severe or uncontrolled renal, hepatic or endocrinal diseases.
* Pregnancy, post-partum or lactating females
* Allergy to one of the agents used.
* Recent (less than six months) use of glucocorticoids for at least two weeks
Two Intensities of Transcranial Direct Current Stimulation to Improve Consciousness in Severely Brain Injured Patients

Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some minimally conscious state (MCS) patients, and in some vegetative state (VS) patients. However the optimal intensity of electrical current stimulation remains unknown.

This study will test the effects of two intensities of tDCS stimulation (either 0.2mA or 2mA) applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the Coma Recovery Scale-Revised (CRS-R) scores -, as well as quantified EEG recorded during resting state (using algorithms previously designed and published by the investigators) and event-related potentials (using auditory paradigms we previously published) in severely brain damaged patients with disorders of consciousness (MCS, VS, and conscious but cognitively disabled patients) of various etiologies.

This study will use a cross-over double-blind design with each patient receiving both current intensities in a randomized order during 4 weeks (2 weeks for each tDCS intensity, totalizing a number of 10X2 stimulation sessions of 20 minutes each).

Eligibility Criteria:
Inclusion Criteria:

* Non communicative patients (including conscious patients but presenting with major fluctuations of vigilance and/or of cognitive abilities)
* Patients with stable clinical examination
* Age between 18 and 80 years
* Brain injury confirmed by cerebral imaging (MRI or TDM)
* Disorder of consciousness diagnosed by CRS-R (VS, MCS, exitMCS)

Exclusion Criteria:

* Status epilepticus
* Severely neurodegenerative illnesses (Alzheimer disease, Lewy Body Dementia)
* Pregnancy
* Patients underage
Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See

The goal of this non-randomized prospective study is to test whether 6-weeks antibiotic treatment can cure an cardiac implantable electronic device (CIED) infection in patients where device extraction is not feasible.

The main question it aims to answer:

• Is 6-weeks medical therapy effective in curing definite CIED infection with device retention?

Participants will discontinue the antibiotic treatment after at least 10 days iv antibiotic therapy and then per oral treatment to at least 6 weeks total. After discontinuation of antibiotics, patients are closely observed for bacterial relapse.

For patients who are not interested in participation and who do not have exclusion criteria, we will ask for consent into a registry as we wish to compare patients undergoing discontinuation of antibiotics with patients undergoing standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* Definite CIED infection by the EHRA criteria
* Deemed non-eligible for CIED extraction

Exclusion Criteria:

* Unavailable for follow-up (e.g., tourist)
A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 8-week screening period, a 60-week double-blind treatment period, and a 4-week follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Must be willing to participate in the study and provide written informed consent.
* Male or female, age 18 years or older at the time of signing informed consent
* Body mass Index (BMI) ≥25 kg/m²
* Diagnosis of Metabolic dysfunction-associated steatohepatitis (MASH) (Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) ≥ 4, with at least 1 point in steatosis, inflammation and ballooning each) and fibrosis stage F2 or F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 3 months prior to screening

Exclusion Criteria:

1. Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
2. HbA1c\>10%
3. History or current other forms of chronic liver disease other than MASH
4. Patients with positive Hepatitis B surface antigen (HBsAg). Patients with positive HBcAb will be eligible only when HBV DNA test negative at screening
5. patients with HCV antibody positive.
6. Patients with HIV antibody positive or syphilis specific antibodies positive (patients with non-specific antibody turned negative will be eligible)
7. Model for End-stage Liver Disease(MELD) \>12 or Child-Turcotte-Pugh(CTP) \>6
Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With COVID-19

The SARS-CoV-2 coronavirus pandemic is responsible for more than 180,000 deaths worldwide and 20,000 deaths in France. To date, no treatment or vaccine has been successful. Povidone-iodine is an antiseptic suitable for use on the skin and mucosa with potent virucidal activity, particularly against coronaviruses. It is marketed for oro-nasopharyngeal decolonization.

24 patients with positive nasopharyngeal SARS-CoV-2 carriage will be randomized (1:1) in an experimental group (benefiting from povidone iodine decolonization) or a control group. Patients in the experimental group will be asked to gargle with a 1% povidone-iodine solution, spray their nose with the same antiseptic solution, and finally applied 10% povidone-iodine cream in each nostril, all four times a day for five days. Patients will be followed for 7 days to evaluate the efficacy and safety of povidone iodine decolonization.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age over 18 yrs) of both sexes
* With positive SARS-CoV-2 carriage by RT-PCR
* Having given their written consent after having been informed

Exclusion Criteria

* Patient with low viral load (threshold cycle \[Ct\] \> 25 per RT-PCR),
* Patient unable to perform oro-nasopharyngeal decolonization
* Known hypersensitivity to one of the constituents, particularly to povidone-iodine,
* History of dysthyroidism,
* Known coagulopathy,
* Participation in another clinical trial aimed at reducing viral load in patients with SARS-CoV-2,
* Pregnant or breastfeeding women, or women of childbearing age without effective contraception
* Patients not covered by a social security scheme
* Patients with enhanced protection
Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation

The purpose of this clinical trial is to assess if the addition of DFDBA fibers to DBBM results in greater vital bone formation than the addition of DFDBA particles to DBBM.

The study team will examine the effects of the addition of DFDBA fibers to DBBM on vital bone formation. Specifically, we will assess histologically the percent vital bone formation with each of the groups during implant placement, six months after the sinus augmentation procedure. We will also evaluate the radiographic volume achieved with both groups of materials.

This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing maxillary sinus augmentation will be enrolled. There will be two subject groups in this study both of which will randomized to one of two standard care procedures. No risk or benefit is expected from being assigned to either group as both procedures are both standard care. In both groups a bone sample (core) will be obtained as a by-product of implant placement. Bone will not be extracted solely for research purposes, the bone sample attained for research will only be from bone left over after the SOC implant placement.

Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.

Eligibility Criteria:
Inclusion Criteria:

* Patients between age 18 and 89
* Patients needing sinus augmentation to support implant placement in the posterior maxilla
* Patients must be nonsmokers, former smokers, or current smokers who smoke \<10 cigarettes per day, by self-report
* Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential.

Exclusion Criteria:

* Patients who disclose that they will not be able to cooperate with the follow-up schedule.
* Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
* Pregnant women or women intending to become pregnant during study period
* Smokers who smoke \> 10 cigarettes per day
Automated Telehealth Diagnostics for Remote Parkinson Monitoring

The objective is to clinically assess the Kinesia HomeView system for automated and remote monitoring of Parkinson's disease (PD) motor symptoms.

Currently, there is limited access to movement disorder specialist centers for a significant portion of the PD population. Treatment effectiveness is judged during office visits by improvement of patient motor symptoms and quality of life. Clinicians evaluate patients by having them perform specific motor tasks and rating the severity on a 0-4 scale. A major limitation is that a single evaluation in a clinical setting may not accurately reflect motor symptom fluctuations experienced over the course of a day, week, or month. Clinicians currently lack effective, affordable medical devices that can be easily delivered to a patient's home for monitoring symptoms on a more continuous basis as motor symptoms typically change throughout the day. Kinesia HomeView provides a repeatable, automated system clinicians can use to remotely monitor PD motor symptoms on a more continuous basis in a patient's home. The investigators hypothesize use of the Kinesia HomeView system will improve outcomes and decrease costs especially for patient populations in areas not in close proximity to movement disorder specialists.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with self-reported clinically-confirmed diagnosis of idiopathic Parkinson disease.
* Be fluent in English
* Willing and able to provide informed consent

Exclusion Criteria:

* Inability to carry out study activities
* Subjects with cognitive deficits that would prevent following instructions and serious medical conditions that would compromise a subject's safety
* Subjects who have dementia, exhibited by those with a score less than 22 on the Montreal Cognitive Assessment (MoCA)
* Subjects with deep brain stimulation (DBS)
Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder

This single-center, observational study is being conducted to identify a well-characterized subgroup within the ASD patient population, based on clinical symptoms and biosample analysis.


Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed with ASD (based on DSM-5 criteria and supported by either ADI-R or ADOS-2 scores)
* At least two well documented head circumference values recorded within the first 2 years of life
* Participants must have a parent or reliable caregiver who agrees to provide information about the participant as required by the protocol and should be fluent in English

Exclusion Criteria:

* Genetically identified ASD (syndromic form of autism, e.g. fragile X)
* Episode of fever (i.e. ≥100.5 °F) or clinically significant illness without fever (as judged by the Investigator), within 10 days before the study visit
The Change in Vaginal Axis on MRI After Uterus Preserving Laparoscopic Lateral Mesh Suspension

Laparoscopic lateral mesh suspension is emerged as a practical, safe and feasible alternative to sacropexy to treat female genital apical prolapse. Investigators hypothesized that uterus-preserving lateral suspension provides a better anatomical positioning.

Suspending the cervix to the bilateral abdominal wall through subperitoneal tunnels may properly mimic cardinal ligament and restore the normal vaginal axis. To prove the null hypothesis, it is planned to compare the vaginal axis on Magnetic Resonans Imaging taken preoperatively and postoperatively in patients who are scheduled for lateral mesh suspension for apical prolapse.

Eligibility Criteria:
Inclusion Criteria:

* Female genital prolapse

Exclusion Criteria:

* Patients who had pouch of Douglas obliteration
* Patients with enterocele
* Patients who have any congenital or acquired anatomic and reproductive anomaly
The Role of Secretin on the Energy Homeostasis

As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal discontinuation. The mechanisms behind these regulatory effect of secretin on energy homeostasis are unclear,

Secretin was - as the first hormone - identified in 19021, but was not isolated until the 1960s. Secretin is produced in and secreted form small intestinal S cells. In the 1970s, the primary endocrine effects of secretin were unequivocally confirmed, namely potentiation of bicarbonate and pepsin secretion from the pancreas as well as stimulation of bile production in the liver. In the 1990s, the biosynthesis of secretin was delineated and its receptor was discovered. In the 2000s the pancreatic regulation of intestinal pH was shown to be secretin-mediated. As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal discontinuation.

The primary aim of this study is to evaluate the effect of a 5-hour intravenous infusion with the naturally occurring hormone secretin on ad libitum food intake (primary endpoint) compared to a double-blinded placebo (isotonic saline) infusion in 25 healthy young males.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* Body mass index between 18.5 and 27.5 kg/m2
* Informed consent
* Body weight above 50 kg

Exclusion Criteria:

* Anaemia (blood haemoglobin below normal range)
* Known liver disease and/or alanine aminotransferase and/or aspartate transaminase \> 2 times upper normal values
* Nephropathy (serum creatinine above normal range and/or albuminuria)
* Clinically significant kidney function impairment or other laboratory findings leading to the diagnosis of clinically relevant disorders (thyroid dysfunction, anaemia etc)
* Any physical or psychological condition that the investigators feel would interfere with trial participation
Peripheral Nerve Stimulation Registry for Intractable Migraine Headache

The purpose of this study is to evaluate the long-term safety and performance of neurostimulation for the treatment of intractable chronic migraine as well as to detect infrequent complications or problems only apparent in "real-world" practice


Eligibility Criteria:
* Patient is 18 years of age or older.
* Patient has signed and received a copy of the Informed Consent form;
* Patient has been implanted with a St. Jude Medical CE approved implantable neurostimulation system for the treatment of intractable chronic migraine:

  * Patient diagnosed with chronic migraine (15 or more days per month with headache lasting at least 4 hours per day)
  * Patient has failed three or more preventative drugs for treatment of their migraine
  * Patient has at least moderate disability determined using a validated migraine disability instrument \[e.g., MIDAS \>11 or HIT-6 \>56\]

Exclusion Criteria:

* NA
Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons

This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on spasticity in spinal cord injured persons.The study will be a phase 2, randomized, placebo-controlled crossover study. Each eligible subject will participate for 26 weeks.Subjects will be randomized to receive either nabilone or placebo during phase 1 of the study. Study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over the first 11-week phase. Following a 4-week washout period, subjects will be crossed-over to the opposite arm for another 11 week treatment period (phase 2).


Eligibility Criteria:
Inclusion Criteria:

* Spinal Cord Injury
* 12 months post -injury
* C2-T12, ASIA A-D, stable level of injury
* moderate to severe spasticity or moderate to severe neuropathic pain
* no cognitive impairment
* spasticity medications unchanged for at least 30 days or inadequate pain control at a stabilized dose of either gabapentin or pregabalin for at least 30 days
* no botulinum toxin injections x 6 months

Exclusion Criteria:

* significant cardiovascular disease
* major illness in another body area
* history of psychological disorders or predisposition to psychosis
* sensitivity to cannabinoids
* severe liver disfunction
* history of drug dependancy
* fixed tendon contractures
* used cannabis in the past 30 days
* unwilling to refrain from smoking cannabis during the study
* pregnant or nursing mother
DNA Methylation Combined With Artificial Intelligence Imaging to Identify Lung Nodules

Lung cancer is the leading cause of cancer deaths,and the key to reducing mortality in lung cancer patients is early diagnosis and treatment.Currently,peripheral blood DNA methylation is a novel in vitro molecular marker for tumors.Meanwhile artificial intelligence diagnostic system can further improve the diagnostic ability.The purpose of this study is to apply the overall DNA methylation level (i.e.,methylation profile) and the altered methylation degree of specific genes as tumor diagnostic indexes,and combined with the artificial intelligence imaging technology for the early and accurate diagnosis of lung cancer,to achieve the early detection,diagnosis,and treatment of lung cancer,and to effectively reduce the mortality rate of lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* (1) Patients with pulmonary nodules diagnosed by imaging;
* (2) No contraindications to blood collection;
* (3) Voluntary completed DNA methylation testing;
* (4) Signed informed consent and performed all the study mandated procedures.

Exclusion Criteria:

* (1) Pregnant or lactating(6 months) women;
* (2) History of malignancy or known malignancy or precancerous lesions or known tuberculosis within 3 years;
* (3) Autoimmune system disorders;
* (4) Undergoing any diagnostic puncture therapy, such as percutaneous lung biopsy, transbronchial, pre-enrollment biopsy, or surgical procedures (within 6 months); (5) Recipients of organ transplants or prior non-autologous (allogeneic) bone marrow transplants or stem cell transplants; (6) Received antibiotic therapy within 14 days or applied a drug that elevates white blood cells within 45 days prior to the blood draw.