cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic/Pharmacodynamic Model of Propofol in Children

By measuring plasmatic concentration of propofol at different intervals during surgery of children aged 1 to 12 years old and measuring Bispectral Index (BIS) as a surrogate for cerebral activity, the investigators aim to create a pharmacokinetic/pharmacodynamic model of propofol for children.

Propofol is an intravenous anesthetic capable of providing a safe general anesthesia, free from many of the adverse effects associated with inhalation anesthetics (postoperative nausea and vomiting, agitation on awakening, seizures and trigger malignant hyperthermia crisis) and widely used in adults, but even less so in children. This is due to the fact that its pharmacological characteristics have not been clarified at all in the pediatric population.

The physiological maturation of different systems in children, as well as changes in body composition and metabolism may determine significant changes in the pharmacokinetics (distribution volumes and clearance) of children. Moreover, within the same age group, variations across different individuals may make even less predictable the pharmacokinetic models currently in use. Indeed, previous work in our group based on these models have shown that propofol dosage required by children to induce general anesthesia is inversely proportional to the age, which could be explained by biases in these models, different sensitivity to propofol at different ages and sizes, etc.

The effect of propofol in the brain is described by its pharmacodynamics, but in children this is still in debate. Using a brain activity monitor (BIS), the effect of propofol at the central nervous system can be analyzed under a model of nonlinear mixed effects (NONMEM) and establish the time to peak effect to characterize in detail the pharmacodynamics of this drug.

Integrating pharmacokinetic and pharmacodynamic data, a pharmacokinetic/pharmacodynamic (PK/PD) model for the pediatric population can be derived.

The aim of this paper is to describe the first PK / PD model of propofol in children, valid for different ages and to analyze them in the context of different body composition parameters.

The importance of this study is that its results will publish the missing link in the pediatric pharmacology of propofol, which will encourage more research and more widespread use of this technique in the pediatric population.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 year through 11 years 11 months and 29 days old.
* American Society of Anesthesiology (ASA) score 1 or 2.
* Elective surgery of more than 1 hour of expected duration.
* Written informed consent signed by parents or legal guardians.
* Oral and written consent in children aged over 7 years old.

Exclusion Criteria:

* Known allergies to study drugs.
* Use of any medication acting on central nervous system in the last 24 hours previous to surgery.
* Chronic cardiac, renal, hepatic or neurologic disease that determines abnormal function.
* Difficult airway (predicted or known).
* Use of neuraxial anesthesia.
Investigating the Effects of Cannabidiol on Social Anxiety Disorder

The purpose of this study is to test whether a single-dose of Epidiolex (cannabidiol) is associated with reduced psychological, physiological, and neuroimaging measures of anxiety in people diagnosed with social anxiety disorder (SAD).

Using a randomized, double-blind, placebo-controlled, parallel-group study design, this scientific investigation will examine the effect of 3 milliliters (mL) of Epidiolex (100mg cannabidiol/mL) on behavioral, physiological, and neuroimaging measures of anxiety in subjects diagnosed with SAD. The study will enroll 50 subjects with SAD who will be randomized in a double-blind manner to receive either Epidiolex or placebo before experiencing the Trier Social Stress Test (TSST), the gold-standard for ethically inducing stress in a controlled laboratory setting. Following the TSST, neuroimaging measures of emotional processing and self-referential processing will be acquired using functional magnetic resonance imaging (fMRI).

This study will be conducted primarily at Massachusetts Institute of Technology with research and clinical support from Massachusetts General Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to provide written informed consent.
* Sufficiently fluent in English to participate in the trial.
* Between 18-55 years of age (inclusive).
* Right-hand dominant.
* Current medications are stable for past 30 days (no changes to dose or frequency).
* Negative result on pregnancy test (if female).
* Negative result on urine drug screening.
* Current diagnosis of social anxiety disorder (QuickSCID-5).
* Liebowitz Social Anxiety Scale (LSAS ≥ 60).

Exclusion Criteria:

* History of bipolar disorder, schizophrenia, psychosis, delusional disorders.
* History of eating disorder within past 6 months.
* History of any traumatic brain injury.
* Currently diagnosed with diabetes mellitus.
* Presence of severe medical illness that would prevent completion of study procedures.
* Presence of significant neurological illness or cognitive dysfunction (e.g.; seizures, dementia).
* History of substance use disorder within past 6 months (other than nicotine and caffeine).
* Use of any cannabis-containing products in past 30 days (CBD or THC).
* Use of beta-blockers or benzodiazepines in past 2 weeks.
* History of claustrophobia.
* Contraindications for MRI (e.g.; shrapnel).
* Presence of any other medical condition that, in the investigator's opinion, may interfere with the study procedures.
* Use of concomitant medication that has a strong interaction with CYP3A4 or CYP2C19 (as assessed through Lexicomp).
* History of liver disease.
* History of hypersensitivity to cannabinoids.
* History of hypersensitivity to sesame seed oil.
* Currently breastfeeding (if female).
Efficacy and Safety of Low Dose Ticagrelor in Patients With Unstable Angina Pectoris After Coronary Stent Implantation

The study is to evaluate efficacy and safety of low dose of ticagrelor therapy for Chinese unstable angina patients treated with non-urgent coronary stent implantation, to examine whether lower dose ticagrelor (45 mg twice-daily) is not inferior to standard dose (90 mg twice-daily) for the prevention of major adverse cardiovascular and cerebrovascular events, as well as will reduce the incidence of bleeding during long-term treatment.

This is a prospective, single center, randomized, parallel-group trial designed to evaluate the efficacy and safety of low dose ticagrelor on a background of aspirin for patients treated with non-urgent coronary stent implantation. 2036 subjects will be enrolled. All patients will receive treatment with aspirin and a P2Y12 inhibitor for 3 months after the index procedure. At 3 months, eligible patients were then randomly assigned in a 1:1 ratio to receive a standard dose ticagrelor 90 mg bid or a lower dose ticagrelor 45 mg bid in addition to aspirin 100mg. The primary efficacy end points are the event rate of the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke at 24 months. The primary safety end point is the incidence of PLATO major bleeding at 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients admission for coronary artery disease treatment with non-emergency percutaneous intervention with stent deployment
* 18 years≤age≤80 years
* Patients understands the study requirements and the treatment procedures and provided informed consent before the procedure

Exclusion Criteria:

* Allergy or intolerance to ticagrelor or aspirin
* Need for oral anticoagulation therapy
* Concomitant oral or intravenous therapy with strong inhibitors of Cytochrome P450, family 3, subfamily A (CYP3A), Substrates of CYP3A with narrow therapeutic indices or strong inducers of CYP3A
* Active bleeding, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days
* High risk of bradyarrhythmias
* Severe liver dysfunction and abnormal renal function
* Patient is a woman who is pregnant or nursing
* Unable or unwilling to give written informed consent
The Efficacy of Lingual Aligners in Adults.

The goal of this clinical trial is to test the effectiveness of lingual aligners in adults.

The main question to answer is:

- Are lingual aligners effective in achieving desired and predicted tooth movements?

The aim of this pilot study is to assess the effectiveness and the accuracy of lingual aligners by evaluating the discrepancy between the predicted and the achieved amounts of tooth movements.

Also:

* Patient discomfort and pain
* Appliance defects
* Patient compliance
* Chair and treatment time

Key inclusion criteria:

* Adults older than 18 years old
* About to undergo orthodontic treatment

Key exclusion criteria:

* Patients with tooth extractions or tooth agenesis with space closure
* Patients with surface enamel defects
* Pregnant patients
* Syndromic patients or those with cleft lip and/or palate
* Patients with metabolic diseases

Eligibility Criteria:
Inclusion Criteria:

* Adults older than 18 years old
* About to undergo orthodontic treatment

Exclusion Criteria:

* Patients with tooth extractions or tooth agenesis with space closure
* Patients with surface enamel defects
* Pregnant patients
* Syndromic patients or those with cleft lip and/or palate
* Patients with metabolic diseases
Adductor Canal Block Versus Lumbar Plexus Block for Post Operative Pain Management After Total Knee Replacement

Adductor canal block (ACB), Saphenous nerve block, which is a block of a purely sensory nerve which shares in nerve supply of knee joint has a hypothetical advantage of better pain management with less motor affection. Also, it has a clear anatomical landmark that will increase the success rate (femoral artery) (\*).On the other hand, being a branch of the femoral nerve and far distal from the plexus, this can decrease the blocking effectiveness. Likewise, the great variation of the knee nerve supply.

This prospective double-blinded randomized controlled trial is comparing ultrasound guided adductor canal block (ACB) versus ultrasound-guided lumbar plexus block (LPB) in patients undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early mobilization and better physiotherapy.

This study hypothesizes that ACB, compared with LPB, will exhibit less motor, weakness, fewer opioids consumption with the same or better pain score.

This prospective double-blinded randomized controlled trial is comparing ultrasound guided adductor canal block (ACB) versus ultrasound-guided lumbar plexus block (LPB) in patients undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early mobilization and better physiotherapy.

This study hypothesizes that ACB, compared with LPB, will exhibit less motor, weakness, fewer opioids consumption with the same or better pain score.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Age more than 25 and less than 80 were included

Exclusion Criteria:

* Patients with known allergy to the medications to be given
* ASA III, IV
* Age less than 25 or more than 80
* Dementia
* Deafness
* Psychological disease
* Difficult to communicate
* Cannot lay flat
* INR more than 1.5
* Low platelets (less than 100000/ml3) or with significant coagulopathy
Vancomycin-Associated Acute Kidney Injury: A Cross-Sectional Study From a Multi- Center in China

The objective of this study was to investigate the current situation of vancomycin (VAN)-associated acute kidney injury (VA-AKI) in China and identify the risk factors for VA-AKI, as well as to comprehensively examine the risk related to concurrent drug use. Further, the investigators assessed the outcomes of patients who developed VA-AKI and the risk factors for these outcomes. Finally, the investigators aimed to provide suggestions for improving the prevention and treatment of VA-AKI in China.


Eligibility Criteria:
Inclusion Criteria:

* Using Vancomycin
* ≥18 years old

Exclusion Criteria:

* Medical records were incomplete
* Had been diagnosed with stage 5 CKD or were regularly receiving dialysis
* SCr were not being adequately monitored to detect the development of AKI
* Had undergone nephrectomy
Promoting Safe Use of Children's Cough/Cold Medicines

This study seeks to identify ways to help parents safely use cough/cold medications with their children. The study focuses on 3 key tasks that have been found to be difficult for parents: 1) decision-making about whether medicines should be given based on a child's age, 2) use of active ingredient information to determine which medications are safe to give together, and 3) medication dosing.

Specific ways that labels and dosing tools can be changed to improve parent understanding and ability to use pediatric cough and cold medications will be tested. This includes looking at whether including age restriction information on the front panel helps parents make better decisions about whether a medication should be given to a child, as well as whether presence of a specific warning or pictogram can help improve this understanding. In addition, the role of font size, including a box around ingredients, and use of a specific warning to look at and compare active ingredients, will be examined to see if these can help parents decide if two medications can be given together safely. Finally, dosing charts with pictograms of dosing tools, and provision of certain dosing tools, can lead to fewer parent dosing errors.

A label/dosing tool combination that incorporates what is learned from the first part of the study will be developed based on findings from the first part of the study, and then tested to see whether this improves parent understanding and use of pediatric cough and cold medicines.

Hypotheses include: 1) changes in labels and dosing tools, such as including explicit warnings, and pictographic warnings/instructions can improve parent understanding and ability to act on of medication instructions, 2) parents with low health literacy and/or LEP will especially benefit from strategies such as explicit wording, warnings, and pictogram, and 3) parents receiving the comprehensive labeling and dosing strategy will have a better understanding of appropriate use of cough/cold medications, including fewer dosing errors, compared to standard labels.

A multi-part experiment will be conducted. Findings will be merged with known evidence around health literacy best practices to develop a comprehensive, consumer-centered strategy for English and Spanish-speaking parents. Pilot testing of the comprehensive strategy in comparison to existing labels will then take place.

See Brief summary.

Eligibility Criteria:
Inclusion Criteria:

* Parent/Legal guardian 18 years or older
* Parent/Legal guardian with children \<6 years old
* English or Spanish speaking

Exclusion Criteria:

* Visual acuity worse than 20/50 (Rosenbaum Pocket Screener)
* Uncorrectable hearing impairment
* Parents/ children too ill to participate will also be excluded
Radiation Free Study

This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable.

Primary objective is to demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR)


Eligibility Criteria:
Inclusion Criteria:

* Subject will be undergoing a primary Fenestrated Endovascular Aortic Repair (FEVAR) procedure (including subjects with prior infrarenal EVAR or open repair) that includes the incorporation of visceral arteries into the repair.
* Subject is able to give informed consent and is 18 years of age or older, or of legal age to give informed consent per state or national law.
* Subject has a life expectancy of at least 2 years
* Target vessels to be included are the Celiac Trunk, Superior Mesenteric Artery and Renal Arteries

Exclusion Criteria:

* Subjects undergoing an endovascular procedure that include branches or iliac branched devices (IBD) in the repair
* Subject treated for re-intervention / staged procedure post-primary FEVAR procedure
* Subjects intended to be treated for more than 4 target vessels (not counting the contralateral gate)
* Subject treated for an emergent (\<24hrs after emergence) procedure
* Subject with connective tissue disorder eg, Marfan's or Ehlers Danlos Syndrome
* Subject with contrast allergies
* Subject participates in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials may be allowed provided that pre-approval is obtained from Philips.
* All vulnerable subjects such as immuno-compromised subjects, subjects lacking the capacity to provide consent, patients in emergency situations, pregnant or breast-feeding women, or any other subject who meets an exclusion criteria, according to applicable national laws, if any.
* Subject unwilling or unable to comply with the protocol unable to understand verbal and/or written informed consent
Robot Assisted Gait Training in Patients With Infratentorial Stroke

The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke

The hypothesis is to determine the robotic gait training would be better than conventional therapy regarding the postural balance.

Eligibility Criteria:
Inclusion Criteria:

* Patients with infratentorial stroke
* Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

* chronic neurological pathology
* orthopedic injuries
* femur lengths of less than 34cm
* severely limited range of lower extremity joint motion
* medical instability
Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis

The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity index (CAI) score and other evaluation indicators in pediatric patients with moderate to severe ulcerative colitis after TA-650 administration of at a dose of 5 mg/kg at weeks 0, 2, and 6, and then every 8 weeks at weeks 14 and 22. The safety and pharmacokinetics are also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed as ulcerative colitis at least 3 months prior to screening.
* Have active ulcerative colitis despite adequate conventional therapy.

Exclusion Criteria:

* Patients who have severe pancolitis.
* Patients who have undergone surgery for ulcerative colitis within 8 weeks before enrollment or who were judged to require surgery for ulcerative colitis at enrollment.
* Patients who have a history of treatment with infliximab or other biologic products (anti-TNFα agents, anti-IL-6 agents, etc.).
DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients

The purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (TKa) in HR+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved CDK4/6 inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Pre- or post-menopausal HR+ metastatic breast cancer patients who are:

  * Group 1: scheduled to initiate 1st line combination therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ metastatic breast cancer (mBC).
  * Group 2: scheduled to initiate second or later lines of therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.
  * Group 3: currently receiving 1st line therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.
  * Group 4: scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an FDA approved endocrine therapy (single agent) for pre- or post-menopausal HR+ mBC.

NOTE: Patients that meet eligibility criteria for any of the above groups that are already enrolled in an ongoing clinical trial are eligible for co-enrollment to this observational study.

Exclusion Criteria:

* Treatment including investigational agent or therapies
* Early breast cancer diagnosis
* Male breast cancer
* Currently receiving treatment for other active malignancy at time of registration

  * EXCEPTIONS: Nonmelanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate)
* Inability to give written informed consent
Introducing Rapid Diagnostic Tests Into the Private Health Sector

Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor access to health facilities, home management of malaria (HMM) can improve the timeliness of treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and impact, artemisinin combination therapies (ACTs) should be deployed in HMM programmes, as well as in formal health facilities. Up to 80% of malaria cases are treated outside the formal health sector and shops are frequently visited as the first (and in some cases only) source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role of shops in home management and to ensure that drugs sold are appropriate. The current practice of presumptive treatment of any febrile illness as malaria (both at health facilities and in the context of HMM) based solely on clinical symptoms without routine laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT being a more costly regimen, it is important to be more restrictive in its administration and rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in remote locations lacking electricity and qualified health staff.

This study therefore proposes to evaluate the feasibility, acceptability, and cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by ocal drug shops in an area with high malaria transmission.


Eligibility Criteria:
Inclusion Criteria:

* Patients with fever
* uncomplicted malaria

Exclusion Criteria:

* Complicated malaria
* known allergic reactions to Lumartem