cyrilzakka/clinical-trials huggingface dataset:
Remimazolam Versus Propofol for Painless Abortion

The goal of this clinical trial is to compare the efficacy and safety of propofol vs. remimazolam in combine use of esketamine in women with early pregnancy undergoing painless abortion. The main questions it aims to answer are:

* whether remimazolam plus esketamine (R+E) has a better sedative and analgesic effectiveness than propofol plus esketamine (P+E).
* whether R+E has less adverse events than P+E.

Participants will be randomly allocated to two groups: R+E and P+E group.

* For those in group R+E: they will be administered with 0.3mg/kg remimazolam and 0.3mg/kg esketamine before the abortion surgery.
* For those in group P+E: they will be administered with 2mg/kg propofol and 0.3mg/kg esketamine before the abortion surgery.

We will compare R+E with P+E to see if the time to loss of conscious and time to recover from the sedation will be shorter and if there will be less severe adverse events in R+E.


Eligibility Criteria:
Inclusion Criteria:

* early intrauterine pregnancy less than 12 weeks confirmed by transabdominal ultrasound and blood HCG
* the American Society of Anesthesiologists (ASA) physical status ranked I-II
* competent to provide informed consent

Exclusion Criteria:

* chronic pain
* psychiatric disorders
* liver or kidney failure
* severe metabolic disorders
* poor respiratory functions
* cardiovascular diseases
Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome

Evaluation of miRNA contained in exosomes in obese and OSA patients with endothelial dysfunction evaluated by digital plethysmography (ENDOPAT) compared to obese and OSA patients without endothelial dysfunction.

The aim of the study is to compare the content of exosomes between two goups of 20 patients, with and without endothelial dysfucntion.

the endothelial function will be evaluated after polysomnography, on obese patients with OSA (AHI \>15).

Eligibility Criteria:
Inclusion Criteria:

* adult subject
* Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent
* Subject with OSA (defined by AHI \>15/h)

Exclusion Criteria:

* cardiac or vascular desease
Prospective Cohort Study of Intracerebral Hemorrhage

The investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with intracerebral hemorrhage.

Intracerebral hemorrhage (ICH) remains a devastating disease with high mortality, yet few therapeutic managements have been proved effective. Large quantities of work needs to be done to fully delineate the prevalence and prognosis of ICH. Hence, the investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective, treatments and prognosis of Chinese hospitalised adult patients with ICH.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients over 18 years old of primary intracerebral hemorrhage.

Exclusion Criteria:

1. patients of secondary intracerebral hemorrhage，such as hemorrhagic transformation of ischemic stroke, aneurysmal, cavernomas, arterio- venous malformations, central venous thrombosis, trauma-related, or tumor.
2. isolated intraventricular hemorrhage or subarachnoid hemorrhage pregnant patients；
3. surgical evacuation of hematoma；
4. unavailability to get complete blood cell samples and presenting contraindications or refusal to MRI
5. patients cannot be followed up for any reasons.
6. patients death in 24 hours
7. pregnant patients
Comparison of Intraocular Pressure Measurement With the Novel TonoVera Device With Other Commonly Used Devices

We are testing the accuracy of Reichert's Tono-Vera tonometer by comparing measurements of IOP with this device and measurements with other commonly-used tonometers, including Goldmann Applanation and iCare.

This is a comparative study between the TonoVera, the gold standard Goldmann Applanation Tonometry (GAT) and an established rebound tonometry device, iCare. IOP measurements will be obtained using the following devices: Reichert's prototype Tono-Vera Rebound tonometer (a rebound tonometer in development), iCare's iC100 rebound tonometer (a device commonly used in clinical practice), GAT (a device commonly used in clinical practice). Reichert's iPac Handheld Pachymeter (a device commonly used in clinical practice) will be used to measure the test subject's Central Corneal Thickness (CCT), measured in µm if CCT is not already on file. An Autorefractor Keratometer (ARK) (a device commonly used in clinical practice) will be used to measure necessary vision correction and corneal curvature. The Ocular Response Analyzer (a device commonly used in clinical practice) will be used to measure corneal hysteresis. Multiple IOP measurements will be taken with each device on each eye for all subjects: 3 along the central cornea, 3 along the peripheral cornea, and 3 along the sclera.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide signed and dated informed consent form. Patients willing to comply with all study procedures and be available for the duration of the study.

Male or female patients aged 18 to 99 Patients in good general health as evidenced by ability to come to their appointment on day of study.

Exclusion Criteria:

* Patients age less than 18 years Patients unable or unwilling to provide informed consent to participate in the study Patients for which an accurate tonometry reading cannot be performed. This may include those with blepharospasm (lid squeezers), nystagmus, extensive corneal pathology, or contact lens wearers who cannot remove their contact lens.Patients with significant scleral thinning Patients with a known allergy to proparacaine or fluorescein as these are used to anesthetize and allow measurement respectively of the eye when used with the Goldmann tonometer.
Biology of Cerebral Arteriovenous Malformations and Prognosis of Cerebral Arteriovenous Malformations

The cerebral arteriovenous malformations correspond to the formation of an entanglement of morphologically abnormal vessels called nidus, which shunt the blood circulation directly from the arterial circulation to the venous circulation.

The cerebral arteriovenous malformations are an important cause of hemorrhagic stroke.

The hypothesis is that cerebral haemorrhage associated with a cerebral arteriovenous malformations would come from peri-nidal micro-vessels, in connection with infiltration of leucocytes and / or defective maintenance of microvascular integrity by platelets.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient with a cerebral AVM for which an intervention (endovascular treatment or surgery) or only clinical monitoring
* Express consent to participate in the study

And

* children
* Free informed and express consent of both holders of the minor patient's parental authority, or, by way of derogation and only if the other holder of parental authority cannot give his or her consent within a time limit compatible with the methodological requirements specific to the conduct of the research with regard to its purposes, of one of the two holders of parental authority

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant or breast feeding woman
Respiratory Exacerbation Plans for Action and Care Transitions for Children With Severe CP

This study will pilot test a just-in-time (JIT) adaptive intervention to reduce severe respiratory illness, for children with severe cerebral palsy (CP). The intervention program, called RE-PACT, delivers timely, customized action planning and health coaching when mobile text messaging with families predicts hospitalization risk is elevated. A total of n=90 caregivers of children with severe CP will be enrolled from the University of Wisconsin-Madison (UW) and the University of California, Los Angeles (UCLA) and can expect to be on study for up to 6 months.

The two-site study takes place at clinical programs at US children's hospitals: the UW and UCLA Pediatric Complex Care Pro-grams were each established to deliver care to children with medical complexity. Each program is comprised of primary care providers, care coordinators, and extended visit lengths, deliver comprehensive care to children with cerebral palsy. These sites have existing collaborative relationships through their participation in the CYSHCNet national research network (http://cyshcnet.org) and other federally funded initiatives, and a track record of successful productive scientific collaboration.

The study period will be divided into three waves: after each wave, feasibility, acceptability, and fidelity data will be reviewed against pre-defined measures of success to adjust the protocol and overcome implementation barriers.

This study will be conducted through a six-month randomized pilot trial. Briefly, after recruitment and baseline assessments, eligible caregiver/child dyads are randomized to intervention (I) or active control (AC). Intervention subjects receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted. AC subjects will receive usual comprehensive medical care and coordination. Assessments of feasibility, acceptability and fidelity, as well as clinical outcomes, will be conducted at baseline and monthly intervals for 6 months. Intervention outcomes will be evaluated at baseline (i.e., randomization) and 6 months post-enrollment, and will also include the primary clinical outcome (i.e., hospitalization for respiratory diagnosis).

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Primary caregiver to an eligible child (child criteria below)
* Speak English or Spanish well enough to be interviewed
* Have a phone capable of sending/receiving text messages
* Has a child

  * age 0-17 years
  * with Gross Motor Function Classification System level IV or V Cerebral Palsy
  * Cared for by respiratory specialist or receive daily respiratory treatments (oxygen, ventilation, airway clearance device, medications)

Exclusion Criteria:

* Lack of interest in text messaging or coaching interactions during the study
Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure

The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event. The study will use a non-experimental device that is inserted just under the skin of the chest, which continuously monitors the heart rhythm in combination with an experimental web-based heart failure risk status. Patients with atrial fibrillation and heart failure will be evaluated to collect data about the potential of this risk status to help improve patient outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older
* Patient (or patient's legally authorized representative) is willing and able to provide written informed consent
* Patient is willing and able to comply with the protocol, including follow-up visits
* Documented paroxysmal or persistent atrial fibrillation or strong suspicion of atrial fibrillation (i.e, palpitations)
* Patient is indicated for the Reveal XT insertable cardiac monitor or other commercially-available and substantially equivalent Medtronic insertable cardiac monitor
* Recent HF event within prior 120 days (HF event defined as meeting any one of the following two criteria: 1. Admission with primary diagnosis of HF 2. Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: admission with secondary/tertiary diagnosis of HF, emergency department, ambulance, observation unit, urgent care, HF/cardiology clinic, patient's home
* Willing and able to transmit data via CareLink

Exclusion Criteria:

* Patient is pregnant
* Patient has been participating in another study that may interfere with the IDENTIFY-HF protocol required procedures
* Endstage (Stage D or New York Heart Association class IV) heart failure
* Asymptomatic (Stage B or New York Heart Association class I) heart failure
* Severe aortic stenosis or insufficiency
* Existing insertable cardiac monitor implanted for more than 1 year
* Existing implantable pulse generator, implantable cardioverter defibrillator, cardiac resynchronization therapy device
* Severe renal impairment (estimated glomerular filtration rate \<25mL/min)
* Myocardial infarction within prior 30 days
Tele-health Enabled Clinical Trial for COVID-19

To determine the efficacy of high dose Vitamin D (an over-the-counter nutritional supplement) in preventing immune-related complications in outpatients with confirmed SARS-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Laboratory confirmed SARS-CoV-2 infection \< 4 days before randomization
3. Report of symptoms consistent with SARS-CoV-2 infection (including but not limited to fever, cough, muscle aches, joint pain, change in taste, change in smell, or shortness of breath) \<4 days before admission
4. Asymptomatic or mild symptoms (not requiring hospital admission)
5. Access to and ability to use a mobile phone with telehealth capability

Exclusion Criteria:

1. Unable to provide informed consent or comply with study directions
2. Admitted to an acute care bed
3. Baseline serum calcium \< 8.8 mg/dL or \> 10.2 mg/dl (as evaluated by labs taken in the ER/urgent care)
4. Women who are currently breastfeeding
5. History of kidney stone in the past year or h/o multiple (\>1) previous kidney stones
6. Does not have a smart phone that can download apps from Google Play or App Store.
7. No way to keep the phone charged consistently
8. The smartphone is shared with another individual.
9. Required laboratory data is unavailable (eg calcium levels)
10. No new oxygen requirement (see remote monitoring document)
11. Pregnant and lactating mothers.
12. Vitamin D level of 80ng/ml and above
13. No lab work for calcium or vitamin D completed in ED
The e-BILD Study: Effects of E-cigarettes on Lung Health in Teenagers.

Electronic nicotine delivery systems (ENDS/e-cigarettes/vaping) are increasingly popular among teenagers around the world. The safety and potential adverse effects of ENDS in this population are largely unknown. While the aerosol, that users inhale, appears safe under laboratory conditions, there are still open questions, which have not yet been assessed. These cover (a) differences in exposure to chemicals (such as metabolites of Volatile Organic Compounds (VOCs) and metabolites of Polycyclic Aromatic Hydrocarbons (PAHs)) between healthy teenagers using ENDS and healthy teenagers not vaping, (b) effects of exposure to such chemicals on the body (measured by lung health indicators: airway symptoms such as coughing; lung function and lung structure tests; immune response of airway cells exposed to vapor; markers of oxidative stress), and (c) the role of nicotine metabolism. It is unknown which lung health indicator/s is/are most relevant to assess the effect of ENDS on lung health in teenagers.

The primary hypothesis of this study is that there will be differences in exposure to chemicals, resulting in more or more severe airway symptoms in vaping teenagers compared to their non-vaping peers. While there might not yet exist any differences regarding lung function or structure, we expect already visible effects of vaping on the local immune response of primary cells isolated from airways in vaping teenagers as compared to non-vaping peers.

In this study, participants of the Bern Basel Infant Lung Development (BILD) cohort, a birth cohort of healthy term-born infants and their follow-up, will serve as healthy, non-vaping controls.1 Vaping teenagers will be recruited independently from the BILD study through advertisements and visits to Bernese schools. Both populations combined represent the study population of the e-BILD study. All e-BILD study participants will undergo the same investigations. While these are currently planned for once in a time (so-called cross-sectional design) to compare results from non-vaping BILD study participants to otherwise healthy but vaping teenagers, repeated measures might follow, depending on the findings of the first phase.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* BILD study participants: see inclusion criteria of BILD study (NCT04286464), non-vaping
* e-BILD: healthy, term-born, vaping at least weekly (might include healthy, vaping participants from BILD)

Exclusion Criteria:

• None, except for general exclusion criteria of BILD study (NCT04286464)
Effect of Indomethacin on the Progression of Alzheimer's Disease

The purpose of this study is determine whether indomethacin is able to retard disease progression in patients with mild to moderate Alzheimer's disease.

Previous research indicates that inflammation plays a role in the pathogenesis of Alzheimer's disease (AD), and nonsteroidal anti-inflammatory drugs (NSAIDs) may retard the progression of the disease.

Comparison(s): Cognitive decline of patients with mild to moderate AD receiving the NSAID indomethacin, compared to cognitive decline of patients with mild to moderate AD receiving placebo, during a one-year period.

Eligibility Criteria:
Inclusion Criteria:

* The patient will satisfy the DSM-IV criteria for dementia of the Alzheimer's type.
* The patient will satisfy the NINCDS/ADRDA criteria for the clinical diagnosis of probable Alzheimer's disease (Appendix I).
* The severity of dementia for each patient will be quantified by a Mini-Mental State Examination (MMSE) score between 10 and 26 (both inclusive).
* The patient is living at home or in a home for the elderly.
* The patient has a responsible caregiver who is able to provide information about the patient's functional status.
* Written informed consent is obtained from the patient or the legally accepted representative.

Exclusion Criteria:

* The patient satisfies the NINDS-AIREN criteria for probable vascular dementia.
* A known exaggerated pharmacological sensitivity or allergy to NSAID's.
* History of peptic ulceration, gastric surgery or gastrointestinal bleeding.
* Current diagnosis of active peptic ulceration.
* Current diagnosis of severe and unstable cardiovascular disease.
* Current diagnosis of renal failure.
* Advanced, severe and unstable disease of any type, other than Alzheimer's disease, that may interfere with primary and secondary variable evaluations, including a medical condition which should be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the patient to a significant degree or put the patient at special risk.
* Intake of any of the following concomitant medications: salicylates, coumarin derivatives, ACE-inhibitors, loop diuretics.
* Intake of any of the following concomitant medications more than two months immediately prior or during the study: NSAID's, systemic corticosteroids.
* Intake of any of the following concomitant medications with a possible effect on cognition: estrogen, deprenyl, vitamin E, neuroleptics, anticholinergics. Patients using stable doses of cholinesterase inhibitors were eligible, with the provision that the dose should not be changed during the study. Cholinesterase inhibitors could not be initiated during the study.
* Excessive use of alcohol (more than 5 units per day)
* The patient is, either alone or with the aid of a caregiver, not able to reliably take the medication.
Study of ALXN1820 in Healthy Adult Participants

This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1820 administered subcutaneously (SC) (ALXN1820 SC) and intravenously (IV) (ALXN1820 IV).

This study will include up to 10 different dosing cohorts, with each cohort consisting of 2 groups (ALXN1820 group, placebo group). Participants will be randomly assigned in a 3:1 ratio to each of these 2 groups, respectively, within all 10 cohorts, to receive either a single or multiple doses of ALXN1820 SC, a single dose of ALXN1820 IV, or a single or multiple doses of placebo.

The study will be conducted in healthy adult participants and will also include a multiple SC dose cohort in healthy participants of Japanese descent.

Eligibility Criteria:
Inclusion Criteria:

* Body weight 50 to 100 kilograms (kg); body mass index 17 to 32 kg/meter squared.
* Cohort 9 only: Japanese participants (defined as those participants whose parents and grandparents are both Japanese and who have spent less than 5 years outside of Japan).
* Satisfactory medical assessment.
* Must follow protocol-specified contraception guidance while on treatment and for up to 6 months after last dose.
* Vaccination requirement:

  * Vaccination with tetravalent meningococcal conjugate vaccine at least 56 days and not more than 2 years, 6 months prior to dosing;
  * Vaccination with serogroup B meningococcal vaccine at least 56 days prior to dosing, with a booster at least 28 days prior to dosing, with at least 28 days between the first and second injections.

Exclusion Criteria:

* Current/recurrent diseases or relevant medical history.
* History of any Neisseria infection.
* Hepatitis B/C, human immunodeficiency virus.
* History of latent or active tuberculosis (TB), or positive TB test.
* Active systemic infection within 14 days of dosing.
* Risk of meningococcal infections due to living/working conditions.
* History of complement deficiency or complement activity below the reference range.
* Participation in a clinical study within 90 days or 5 half lives of the investigational agent (whichever is longer) before initiation of dosing on Day 1.
* Participation in more than 1 clinical study of a monoclonal antibody (mAb), or participation in a clinical study of a mAb within the 6 months or 5 half lives of the mAb (whichever is longer) prior to screening.
* Acquired complement deficiencies (for example, those receiving eculizumab).