cyrilzakka/clinical-trials huggingface dataset:
Optimizing the Prehospital Use of Stroke Systems of Care-Reacting to Changing Paradigms-Implementation (OPUS-i)

This interventional trial will compare a novel prehospital stroke transport algorithm (OPUS-i) to a traditional prehospital stroke transport algorithm to improve outcomes in rural stroke patients by determining the effect of implementing a data-driven prehospital stroke algorithm on time to and endovascular therapy. The study consists of a multicenter cohort and will last 24 months but individual subject study duration is 90 days.

Stroke is the fifth leading cause of death in the United States (U.S.) and causes one in six deaths from cardiovascular disease. Intravenous thrombolysis (IVT), unless contraindicated, is the standard of care for acute ischemic strokes (AIS) presenting within 4.5 hours of last known well. IVT plus endovascular therapy (EVT) is standard of care for the typically debilitating large vessel occlusion strokes (LVOS), which represent 30% of AIS. However, only a limited number of stroke centers provide EVT. Currently only 12% of all stroke patients are treated with IVT and only 8% of patients are treated with EVT. Therefore, optimizing prehospital systems of care to provide timely IVT and EVT to all patients.

Most stroke patients arrive at the hospital by Emergency Medical Services (EMS). EMS clinicians use various stroke assessment tools to triage patients to the appropriate level of stroke center. Unfortunately, these prehospital stroke screen tools are imprecise and can delay care for LVOS patients. The choice of transport destination may vary by geography. In an urban area, where several stroke centers of varying capability may be concentrated in a small geographical area, there is negligible impact to the healthcare system if an ambulance bypasses the closest hospital for an ESC. In a more rural area, the decision regarding hospital transport destinations has greater implications. Transporting a patient to a farther ESC will result in a longer transport time and take an ambulance out of its primary coverage for a prolonged time. However, transporting rural stroke patients to their local non-ESC may worsen their clinical outcomes by delaying the time to EVT.

Therefore, we propose to implement the novel OPUS-i prehospital stroke transport algorithm to improve outcomes for stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical impression of stroke/TIA by EMS clinicians

Exclusion Criteria:

* Age \< 18 years
* Prisoner
Immunogenicity of Heterologous Versus Homologous Prime Boost Schedule With mRNA and Inactivated COVID-19 Vaccines

This study is a randomized, simple-blinded comparative phase III clinical trial comparing the immunogenicity of two doses Coronovac to that of a first dose of Coronovac (Sinovac, Beijing, China) followed by a booster shot with the mRNA-based BNT162b2 SARS-CoV-2 vaccine (Comirnaty, Pfizer-BioNTech).

The purpose of this study is to evaluate the superiority, safety and immunogenicity of the heterologous prime-boost CoronaVac/BNT162b2 vaccination to the homologous CoronaVac/CoronaVac regimen.

This study is a randomized simple-blinded comparative phase III clinical trial in COVID-19 vaccine naïve volunteers adults aged between 18 and 60 years. The purpose of this study is to evaluate the superiority, safety and immunogenicity of the heterologous prime-boost CoronaVac/BNT162b2 vaccination to the homologous CoronaVac/CoronaVac regimen. The study is conducted in four different sites located in the North of Tunisia.

A total of 240 eligible participants were included. Among them, the primary end point data were available for 100 participants randomly allocated to heterologous boost group versus 99 participants randomly allocated to homologous boost dose group.

Participants are assigned to receive either two injections of the CoronaVac vaccine (1st and 2nd vaccine), or CoronaVac as 1st dose and Pfizer as 2nd dose in 3 to 4 weeks interval.

A blood sample (5ml of the whole blood) is collected for each participant at the vaccination center before the first dose injection. After verifying the absence of a SARS-CoV-2 infection during the interrogation (a follow-up survey), a 2nd blood sample (5ml of whole blood) is taken for each participant at the vaccination center before the second dose injection. After the two injections, a 3rd blood sample (5ml of whole blood) will be taken for each participant between day 21 and day 35 after the second dose. Data collection and all samples are treated at Institute Pasteur of Tunis.

Eligibility Criteria:
Inclusion Criteria:

* Acceptance to participate in the study.
* Age: 18-60 years old.

Non-inclusion criteria:

* Presence of disability (mainly mental disability).
* Pregnancy.
* Patients under immunosuppressive treatment or immunocompromised individuals.
* Prior Covid-19 infection.

Exclusion Criteria:

* Occurrence of a serious adverse event (death, anaphylactic shock, ...).
* Subjects wishing to withdraw from the study.
* Occurrence of a SARS-CoV-2 symptomatic infection during the follow-up period.
Preliminary Study of Safety and Efficacy of Policosanol

Lay Language Summary: High cholesterol levels are common in persons with HIV infection. However, conventional cholesterol-lowering medications may have harmful side effects when given to HIV-infected persons. Therefore, we plan to evaluate the safety and effectiveness of policosanol, a dietary supplement derived from sugar cane that has cholesterol-lowering properties, to lower cholesterol levels in persons with HIV infection. We hypothesize that policosanol will lower levels of LDL cholesterol ("bad" cholesterol) and raise levels of HDL cholesterol ("good" cholesterol).

As per Brief Summary

Eligibility Criteria:
Inclusion Criteria:

CD4 count \> 250 Plasma HIV RNA \< 50,000 Currently receiving HAART age 18-60 total cholesterol between 200-240 or triglycerides between 150-400 or LDL cholesterol \> 160

Exclusion Criteria:

kidney or liver disease current use of lipid-lowering drugs pregnancy lactation

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The Effect of Amiloride and Spironolactone in Healthy Persons

This study will investigate whether retaining potassium in the body will lead to changes in blood pressure and changes in blood and urine samples.

The purpose is to measure the effect of amiloride and spironolactone on:

1. Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),
2. Pulsbewave velocity, augmentation index and central blood pressure,
3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and
4. Ambulatory blood pressure

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-smokers

Exclusion Criteria:

* Smoking
* Under medical treatment
Antimicrobial Stewardship Program (ASP) in Patients With a Sore Throat

The investigators have developed an antibiotic stewardship program (ASP) to increase adherence to the Swedish guidelines for managing patients with a sore throat. This is a randomized controlled trial where primary health care centers are randomised to get the ASP or not. The adherence to the Swedish guidelines are measured in all participating centers.

The investigators have developed an antibiotic stewardship program (ASP) to increase adherence to the Swedish guidelines for managing patients with a sore throat. This is a randomized controlled trial where primary health care centers are randomised to get the ASP or not. The adherence to the Swedish guidelines are measured in all participating centers 6 months before and after implementation of the ASP. The ASP consists of educational meetings at the clinic for medical practitioners and nurses being informed about current guidelines, seeing their clinics adherence to the guidelines as well as discussing cases.

Eligibility Criteria:
Inclusion Criteria:

* Being a primary health care center in the Vastra Gotaland region, Sweden accepting participation

Exclusion Criteria:

* None
One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning

This randomized trial will investigate important clinical outcomes of patients with acute carbon monoxide poisoning randomized to receive either one or three hyperbaric oxygen treatments.

All patients presenting with acute carbon monoxide poisoning will receive one hyperbaric oxygen treatment (barring contraindications for hyperbaric oxygen therapy). After this treatment, eligible patients who provide consent will be randomly allocated to receive two sham sessions, or two additional hyperbaric oxygen sessions administered in a double-blind fashion.

Outcome measures will be administered at 6 weeks and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic CO poisoning (headache, nausea, vomiting, dizziness, fatigue, muscle aches, slowed mentation, confusion, or loss of consciousness).
* Carboxyhemoglobin (COHb) levels \> 10% or confirmation of poisoning with ambient levels \> 50 ppm in a patient with symptoms compatible with CO poisoning and no other reasonable explanation for their signs and symptoms.
* Less than 24 hours from removal from the source of CO exposure and study enrollment.
* Accidental poisoning

Exclusion Criteria:

* Pregnancy
* Age \< 18 years or \> 79 years
* Complication during first hyperbaric oxygen session precluding subsequent hyperbaric oxygen.
* Intentional CO poisoning
* Unable to obtain informed consent
* Moribund patient
* Concomitant smoke inhalation with cyanide poisoning
* Bleomycin use within two weeks of study enrollment
* Intracardiac defibrillator that cannot be deactivated
* Non-English speaking
* Unlikely to return at 6 weeks
* History of central nervous system (CNS) disease (i.e., Alzheimer's, Parkinson's, dementia, demyelinating disease (MS), etc.)
* History of prior brain injury (i.e., stroke, traumatic brain injury)
* Presence of chronic debilitating disease likely to result in death within 12 months (i.e., kidney failure on dialysis, heart failure)
* Subject has a significant medical condition or conditions that would interfere with the treatment, safety, or compliance with the protocol.
* Intubated subjects
* Subjects requiring greater than 50% oxygen by non-rebreather facemask or exhibiting evidence of respiratory compromise or heart failure
* Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason. The investigator and the Sponsor, prior to enrolling the subject on a case-by-case basis, must approve and document any waiver of these inclusion and exclusion criteria.
Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype

HARMONIA is an international, multicenter, randomized, open-label and phase III study. The primary objective of this study is to demonstrate that the combination of ribociclib with endocrine therapy (letrozole or fulvestrant) is superior to palbociclib with endocrine therapy (letrozole or fulvestrant) in prolonging progression-free survival in patients with advanced HR+/HER2- and HER2-E breast cancer. The study will enroll approximately 456 patients with HER2-E disease from approximately 95 sites worldwide.

In addition, the HARMONIA trial will include an exploratory cohort of patients with HR+/HER2- and Basal-like disease treated with paclitaxel +/- Tislelizumab. This cohort does not have a predefined sample size and the objective is only exploratory, given the suggested lack of efficacy of the combinations of hormone therapy and CDK4/6 inhibitors in this subgroup of patients. Enrolment into the basal-like cohort will stop once the HER2-E disease cohort is fully enrolled.


Eligibility Criteria:
Main Inclusion Criteria:

* Histologically documented HR-positive and HER2-negative breast cancer by local testing
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer.
* Availability of FFPE tumor block for biomarker analysis, obtained during metastatic period.
* HER2-E or Basal-like subtype as per central PAM50 analysis.
* Measurable disease or non-measurable disease, as defined by RECIST v1.1
* Adequate hematologic and end-organ function
* Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.
* Women of childbearing potential must have confirmed negative serum pregnancy test within 7 days prior to randomization.
* Women of CBP must be willing to use highly effective methods of contraception.
* Patient must have a 6-lead or 12-lead ECG with ALL of the following parameters at screening:

  * QTcF interval (QT interval using Fridericia's correction) at screening \< 450 msec.
  * Resting heart rate 50-90 beats per minute (determined from the ECG).

Main Exclusion Criteria:

* Prior therapy with any CDK4/6 inhibitors.
* Patient has received prior treatment with chemotherapy for advanced/metastatic breast cancer
Adjunctive Bright Light Therapy for Opioid Use Disorder

Investigators propose to conduct a pilot single-blind, parallel arm, randomized placebo-controlled trial evaluating the feasibility, acceptability, and preliminary efficacy of bright light therapy on reward system functioning among patients undergoing medication-assisted treatment for opioid use disorder.

Bright light therapy (BLT) is a simple, safe, and accessible intervention that can effectively ameliorates sleep disruptions, as well as circadian misalignment and depressive symptoms, and could potentially improve reward system function among patients with OUD. Beyond seasonal affective disorder, BLT has shown efficacy as an intervention for non-seasonal depression, and post-traumatic stress disorder, which all exhibit significant impairment of the dopaminergic reward system and poor sleep quality as key symptoms. Investigators propose to conduct a pilot single-blind, parallel arm, randomized placebo-controlled trial evaluating the feasibility, acceptability, and preliminary efficacy of BLT on reward system functioning among patients undergoing medication-assisted treatment for OUD. The present study will establish feasibility for a larger randomized-clinical trial proposal.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65
* ability to speak, write, and read in English
* past 2 weeks of insomnia as evidenced by Insomnia Severity Index (ISI) total score of ≥10
* enrolled in outpatient medication-assisted treatment for OUD (i.e., either methadone or buprenorphine treatment)
* been in medication-assisted treatment for at least 3 months
* at least one month of stable methadone or buprenorphine dose
* have a smartphone

Exclusion Criteria:

* lifetime history of bipolar disorder or mania
* current narcolepsy, sleep paralysis, or restless leg syndrome as assessed by medical history
* history of seizure disorders/epilepsy
* the STOP-Bang score for obstructive sleep apnea ≥ 5
* retinal pathology, history of eye surgery or taking photosensitizing medications (e.g., lithium, L-tryptophan)
* current regular use of melatonin
* have circumstances that would interfere with study participation (e.g., impending jail sentence)
* previous experience with bright light therapy
* working a night shift or traveling outside the Arizona time zone in the past month
* pregnant, trying to get pregnant, or breastfeeding
* currently wearing prescription glasses with blue-light protection
The Life and Care of Patients With Colorectal Cancer Before Age 65 and Their Kindred

In a context the respect of the autonomy of the patients is important, it is necessary to pay a sustained attention to the experiences and the lived experience as well of the patients suffering or in remission of cancer as of their family. It is therefore, for the family, to deepen the synthesis carried out by the Societal Cancer Observatory which is a societal observatory of cancer


Eligibility Criteria:
Inclusion Criteria:

Patients will be

* over 18 years old
* with a diagnosis of CRC before 65 years.
* able to give their non-opposition and to nominate at least 2 family members who would be willing to participate in the study

The spouse and / or children and / or parents will be eligible:

if they are at least 18 years old, if they can be considered a caregiver or are first-degree relatives of the index patient for whom a diagnosis of CRC has been made. .

Exclusion Criteria:

* Patients under 18 years of age or with a diagnosis of CRC after 65 years.
* Near a deceased patient or under 18 years old.
Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive

The purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before received treatment.

Compare the efficacy and safety of viramidine 600 mg twice a day (BID) versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2a to treatment-naive patients with chronic hepatitis C (CHC)

Eligibility Criteria:
Inclusion Criteria:

* Treatment-naive patients with compensated chronic hepatitis C.
* HCV RNA \>2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL).

Exclusion Criteria:

* Severe neuropsychiatric disorders
* History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease
* Pregnant or breast-feeding patients
Macular Pigment Optical Density in Healthy Subjects

The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin, which are contained in vegetables and fruits. The highest concentrations of lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the MP before reaching the photo receptors it absorbs a significant portion of short-wavelength light. There is evidence that these absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina.

Measurement of macular pigment is difficult and the investigators have recently proposed a way of measuring macular pigment optical density (MPOD) based on optical reflectometry. There is increased interest in these measurements in the recent years, because a number of studies has provided evidence that low fruit and vegetable consumption increases the risk of age related macular degeneration (AMD). The present study investigates MP optical density (OD) in healthy volunteers and is used to form a database.

Furthermore the nutritional habits and the influence on MP density will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without any signs of AMD
* Age between 18 and 90 years, (20 subjects aged between 18 and 40, 20 subjects aged between 41 and 50, 20 subjects aged between 51 and 60, 20 subjects aged between 61 and 70, 20 subjects aged between 71 and 80, 20 subjects aged between 81 and 90)
* Clear non-lenticular ocular media
* Visual acuity \> 0.6

Exclusion Criteria:

* Any sign of AMD, or another retinal or optic nerve head disease
* Ocular surgery within the last 6 months
* Treatment with photosensitizing drugs
Cerebrospinal Fluid (CSF) Drainage Study

When patients suffer a subarachnoid hemorrhage (bleeding around the brain), they often develop hydrocephalus. This is an enlargement of the fluid-filled spaces (ventricles) in the brain. Standard-of-care treatment includes placing an external ventricular drain (EVD) to drain off fluid. Eventually the EVD is weaned with the goal of removing it. Occasionally a patient does not tolerate this and a permanent surgery needs to be done to internalize a shunt.

Though this is done commonly and routinely throughout the world, there are no good studies to address how to optimally set the EVD level and how fast to wean it. Most set the EVD to a level of around 15 mmHg. The investigators hypothesize that setting the EVD lower (which will allow higher volume Cerebrospinal Fluid (CSF) drainage through the EVD) will improve perfusion at the level of the microcirculation in the brain, and result in improved neurologic outcomes.


Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18 years
* Diagnosis of acute subarachnoid hemorrhage (SAH), confirmed with noncontrast head CT
* SAH is suspected to be aneurysmal in source
* Clinical management requires placement of EVD within 2 days of suspected time of hemorrhage

Exclusion Criteria

* Age \< 18 years
* SAH of traumatic or non-aneurysmal etiology
* Patients treated with lumbar drains
* EVD placement ≥ 3 days after suspected time of hemorrhage
* Known contraindication to induction of relative intracranial hypotension (e.g. acute subdural hematoma)
* Pre-morbid mRS ≥ 3
* EVD that is suboptimally placed by CT obtained after EVD placement (i.e. EVD not in the ventricular system)
Deep Learning Models for Prediction of Intraoperative Hypotension Using Non-invasive Parameters

The investigators aimed to investigate the deep learning model to predict intraoperative hypotension using non-invasive monitoring parameters.

Intraoperative hypotension is associated with various postoperative complications such as acute kidney injury. Therefore, precise prediction and prompt treatment of intraoperative hypotension are important. However, it is difficult to accurately predict intraoperative hypotension based on the anesthesiologists' experience and intuition. Recently, deep learning algorithms using invasive arterial pressure monitoring showed the good predictive ability of intraoperative hypotension. It can help the clinician's decisions. However, most patients undergoing general surgery are monitored by non-invasive parameters. Therefore, the investigators investigate the prediction model for intraoperative hypotension using non-invasive monitoring.

Eligibility Criteria:
Inclusion Criteria:

* The patients who are included in the open database, VtialDB.
* The patients who underwent inhaled general anesthesia for non-cardiac surgery.
* The patients who have non-invasive monitoring data including blood pressure, electrocardiography, pulse oximetry, bispectral index, and capnography.

Exclusion Criteria:

* The patient with missing data.
Intravenous Lidocaine to Reduce ED50 for Propofol Administered Using Target Controlled Infusion (TCI) During Gastroscopy

The goal of this prospective, interventionnal clinical trial is to assess if intravenous administration of linisol reduce the ED50 of propofol when administered using Target Controlled Infusion (TCI) during gastroscopy in healthy patients (ASA 1 and 2 patients).

Prior to propofol sedation, participants will receive either an intravenous bolus of linisol (1.5 mg/kg) = treated group or placebo = control group.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for gastroscopy under narcosis and who have signed the consent.
* ASA score: 1 and 2
* BMI between 18 and 30 kg/m2

Exclusion Criteria:

* Lidocaine allergy
* Anesthesia within the last 7 days
* Use of local anesthesia in the last 24 hours
* Rhythm disorder or HR \<50
* Pregnant women and breastfeeding
* Participation in another clinical study in the last months
* Cannot understand VAS score or French
* Severe central nervous disease and mental illness.
* Obstructive sleep apnea (known or STOP BANG score \>5)
* Upper lung infection.
* Liver or kidney function disorder