cyrilzakka/clinical-trials huggingface dataset:
Correlation Between Dorsalis Pedis and Radial Arterial Invasive Blood Pressures During Anesthesia Induction in Neurosurgical Patients

Anesthesiologists need to understand the specific difference between dorsalis pedis arterial(DPA) pressure and the more commonly used radial arterial(RA) pressure When blood pressure monitoring at DPA. Generally, the systolic blood pressure measured in DPA is significantly higher than that in RA, with little difference of diastolic blood pressure and mean artery pressure in two sites. However, there is no specific study on the difference between them, and it is not clear how the diagnosis and treatment threshold should be adjusted when relying on DPA blood pressure measurement to guide treatment. The intraoperative blood pressure of patients is in the normal range in most cases. The purpose of this study is to analyze the correlation of different blood pressure stratification (RASBP90-109mmHg,110-129mmHg,130-149mmHg) of DPA-RA in the normal range to understand the correlation of DPA-RA in different blood pressure ranges, to provide a reference for clinical decision-making and hemodynamic management.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent neurosurgery,American Society of Anesthesiologists' physical status 1-3, BMI 18-24 kg/m², a clinical need for invasive arterial pressure monitoring in the supine position.

Exclusion Criteria:

* Arterial puncture site injury or infection,heart failure, severe arrhythmia, congenital heart disease, hypertension, diabetes,preoperative use of dehydration, and intracranial hypertension drugs such as mannitol, peripheral and macrovascular diseases, chronic lung disease, history of heart or lung surgery, The Allens test was positive.
A Human Trial to Assess the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Soy

This study is being conducted to test the hypothesis that daily consumption of a baked food product containing whole soy for 6 weeks will significantly reduce plasma Low Density Lipoprotein Cholesterol (LDL-C) in individuals with hypercholesterolemia. As such the overall goals of this study are to determine whether daily consumption of muffins made from whole soy flour for 6 weeks can lower plasma LDL-Cholesterol, and if so, establish whether the effect is dose-dependent. To do this, study collaborators will: (1) conduct a detailed chemical and physical characterization of certified defatted whole soy flour that will be incorporated into a muffin; (2) formulate and produce a palatable whole soy flour muffin along with a control muffin containing wheat flour; (3) conduct a parallel controlled trial in which soy muffins will be fed randomly to persons with elevated LDL-cholesterol in a human clinical trial. All participants will be randomized into one of three groups and asked to eat two muffins daily for 6 weeks in the following combination: high dose soy; control group or low dose soy. Before, after, and mid-way during the feeding period, blood samples will be obtained for measurements of lipids, glucose, insulin, inflammation, and soy phytochemicals. The effect of soy consumption on waist circumference, body mass index (BMI) and blood pressure will also be examined.


Eligibility Criteria:
Inclusion Criteria:

* Males and females (not pregnant or lactating) aged 30-70 year
* Body mass index (BMI) ≤40kg/m² and ≥18.5kg/m²
* Fasting plasma total cholesterol ≥5.0
* Fasting plasma LDL cholesterol ≥3.0 and \<5.0 mmol/L.

Exclusion Criteria:

* Fasting plasma triglycerides ≥4.0 mmol/L
* Abnormal liver and kidney function
* Unstable body weight(\>3kg change in 3 months) or intention to lose or gain weight;
* Diabetes mellitus (fasting plasma glucose ≥7.0 mmol/L or use of insulin or any hypoglycemic or anti-hyperglycemic medication);
* Use of any prescription or non-prescription drug, prebiotics or probiotics, herbal or nutritional supplement known to affect blood lipids, except for stable doses (no change in 3 months) of thyroxine, oral contraceptive agents, hormone replacement therapy, and medications for controlling blood pressure);
* Major surgical or medical events within the past 3 months;
* Presence of a gastrointestinal disorder or medication that alters the digestion and absorption of nutrients; including antibiotic use within the past 6 weeks.
* Consumption of a diet containing ≥15% of energy from saturated fat;
* Any food allergy or aversion or unwillingness to eat wheat, soy or milk;
* Consumption of ≥5 servings per week of soy based food products;
* Consumption of an average of \>2 alcoholic beverages per day;
* Regular smokers (smoking ≥1 cigarette per day) of cigarettes or cigars
Enhanced Screening for Early Treatment Targets After MTBI

The study will examine whether enhancing screening-informed follow-up letters will improve (i) family physician compliance with best practice guidelines for managing persistent symptoms following concussion, and (ii) clinical outcomes from concussion.

Family physicians are well positioned to proactively manage symptoms in the weeks following MTBI, which could prevent chronicity and reduce the need for specialist treatment. Clinical practice guidelines are now available for MTBI management in primary care, such as those developed by the Ontario Neurotrauma Foundation (ONF). However, awareness and use of these guidelines may be low. Distilling the guidelines into a small number of actionable messages that are tailored to an individual patient may facilitate family physician implementation.

The ONF guidelines for MTBI propose that early intervention should prioritize the most readily treatable symptoms - mood (depression and anxiety), insomnia, and headaches. The present cluster randomized trial will evaluate whether screening for these conditions and sending family physicians treatment algorithms for positive screening test results will result in earlier evidence-based treatment.

Patients will be recruited from two concussion clinics that provide group education sessions. Following the education session, eligible participants will complete self-reported screening measures for depression, anxiety, insomnia, and headaches. Family physicians will be randomized to receive these screening test results with associated treatment algorithms from the ONF guidelines or a letter providing generic MTBI management recommendations from the ONF guidelines (currently done as usual care).

Patients will be assessed by telephone one month and three months after the intervention. The primary outcome will be patient-reported treatment utilization that is congruent with the ONF guidelines for depression, anxiety, insomnia, and headaches after MTBI.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 60 years.
* Has a family physician.
* Physician diagnosed MTBI less than 3 months ago.
* English reading comprehension sufficient for the consent form and standardized questionnaires.

Exclusion Criteria:

* English reading comprehension not sufficient for the consent form and standardized questionnaires.
Singapore's Health Outcomes After Critical Illness in Kids

What is the problem? Every year about 2.5 million children are affected by critical illness and require admission to the pediatric intensive care unit (PICU). However, both children and their parents may encounter difficulties after critical illness. Children affected physically may have difficulties in breathing, eating, and drinking. Parents have reported feeling symptoms of stress such as nightmares and excessive worries after PICU discharge. Currently, the investigators do not know when and how the problems unfold and what harm does it cause. Without this information, healthcare professionals are not equipped to support these families after PICU discharge.

Research Plan? To understand how critical illness could affect the physical, emotional, and social experiences of children age 1 month to 18 years of age and their parents in the first 6 months after a PICU admission.

144 children and their parents will be followed from the time of PICU admission to 6 months after discharge. Children and their parents will complete surveys to measure physical, social, emotional and function outcomes. A total of 12 families will be interviewed at 1 and 3 months after PICU discharge. Using the data provided to map out any trend or changes in this information over time.

Why is this study important? To better understand the experience and health consequences of children and their parents in the first six months after PICU admission. This information would help to identify potential areas to improve the negative consequence of children and their families after a severe illness. Results will be shared to the PICU survivors and their families, national organizations, international pediatric intensive care community to improve the experiences and health outcomes following a PICU admission.


Eligibility Criteria:
Child inclusion criteria:

* Aged 1 month to 18 years at the point of PICU admission
* PICU total length of stay (LOS) ≥ 48 hours at the point of PICU discharge

Parents inclusion criteria:

* (a) Parent or legal guardian; (b) cohabits with the child
* For the family home to be the planned location following hospital discharge.

Exclusion Criteria:

* Opted for a "Do Not Resuscitate" status for their child and/or
* Had participated in the current study in a previous PICU admission within the recruitment period.
Virtual Reality in Teachers' Vocal Motor Behavior Acquisition (VirtuVox)

Scientific literature supports that teachers are at greater risk for voice disorders than the general population. In the classroom, the teacher's voice represents the main communication tool. Optimal voice use is indispensable to ensure effective teaching and preserve the teacher's vocal health.

This project investigates how virtual reality (VR) facilitates the learning of effective vocal skills and their application in real-world contexts. Based on acoustic analyses and self-assessment scales, the investigators compare 100 future teachers randomly assigned in two groups. The experimental group (n=50) receives a voice training by VR simulations and voice information. The control group (n=50) only receives voice information.

Experimental group participants receive direct method (three 1-hour sessions of voice training by virtual reality simulations over a course of 3 weeks) and indirect method (one 1-hour session of information on voice function and voice hygiene). Control group participants receive indirect method (one 1-hour session of information on voice function and voice hygiene).

Eligibility Criteria:
Inclusion Criteria:

* future teacher having completed at least one internship as a schoolteacher
* speaking French fluently

Exclusion Criteria:

* hearing impairment
* voice pathology at the time of the study
SB-681323-Methotrexate Interaction Study

SB-681323 is a p38 MAP-kinase inhibitor that has potential uses in inflammatory conditions such as RA. Previous p38 MAP-kinase inhibitors have been hindered in development by liver toxicity. Methotrexate (common treatment for RA patients) also has potential liver toxicity. This study was an enabling study to determine the safety of co-administration of the two compounds with respect to liver function


Eligibility Criteria:
Inclusion Criteria:

* Male or female. Females must be of non-child-bearing capacity
* BMI 19 - 30 kg/m2 (inclusive)
* Diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology (ACR)
* Negative urine drugs of abuse screen, breath alcohol tests, hepatitis B and C, and HIV tests.
* Liver function tests within normal limits
* Must be on a stable dose of methotrexate (2.5 - 25 mg/week) for \>8 weeks prior to enrolment and which will not be changed during the course of this study.
* Must be on stable folate supplements for \>8 weeks prior to enrolment with normal red cell folate levels at enrollment.

Exclusion Criteria:

* History of alcohol \&/or drug abuse
* Abnormal ECGs at screening
* Liver disease, uncontrolled hypertension, diabetes mellitus, psoriasis, history of peptic ulcer disease
* The patient is using glucocorticoid at doses \>10mg/day.
* The patient is using sulphasalazine at a dose \>3g/day.
* The patient is using hydroxychloroquine at a dose \>400mg/day.
* The patient is on treatment regimen of DMARDs other than MTX plus one or both of sulphasalazine and hydrochloroquine (e.g. leflunomide)
* The patient dose of NSAIDs, COX-2 inhibitors or glucocorticoids change at any time during 2 weeks prior to enrolment until the end of the clinical phase of the study
To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers

This is a single centre, open label, randomized, two-treatment, two-period, two-sequence, single dose crossover food effect study in 18 subjects. The subjects will receive the study medication under either fed or fast during each treatment period.

The present study will be conducted in healthy male volunteers. A single oral dose will be administered to the subject in each treatment period (under either fasting or fed state). Each treatment period will be separated by at least 7 calendar days. Post dose PK blood samples will be collected in each treatment period to evaluate the food effect on bioavailability of RP6530. The safety and tolerability of single dose will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers; aged 18 to 45 years;
* Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥ 50 kg;
* Non- smokers or ex-smokers;
* Able to give informed consent.

Exclusion Criteria:

* Subjects with evidence or history of clinically significant disease;
* Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests;
* Subjects who have received any investigational drug in the previous 28 days;
* Subjects participated in a study with PI3k inhibitors at least once in past year;
* Subjects who have received drugs metabolised by CYP3A4 enzyme in the previous 28 days.
Ascertainment of Saliva or Blood Samples For Genetic Epidemiology Studies of Cancer and Aging

The purpose of this study is to help us learn more about the roles of genes in cancers. Genes are short pieces of DNA which determine the inherited characteristics that distinguish one individual from another. This study will look at how some genes might raise or lower the chance some people may develop cancer. The sample collection will help generate the materials needed for this study.

This is a protocol to obtain saliva or blood samples from non-cancer affected volunteers aged 60 years or older, without a history of cancer other than non-melanoma skin cancer. These samples will be used in a genomic approach to elucidate novel pathways of cancer predisposition.

Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects must be non-cancer affected volunteers of either gender who are 60 years of age or older at the time of saliva/blood donation.
* Subjects will self-identify religion and country of origin of grandparents.
* Volunteers will have (by self report) no history of cancer other than nonmelanoma skin cancer. It is recognized that there may be some errors in self report, however, the literature reports a very low error rate for self reported disease reporting for cancer as assessed by interview.

Exclusion Criteria:

* Subjects with mental impairment will be excluded from this study.
Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment

Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment.

The main objective is to evaluate the safety and clinical response of intralesional injection of Autologous peripheral blood differentiated adult dendritic cells expanded tolerogenic in patients with refractory Crohn's disease treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of Crohn's disease ( Lennard -Jones criteria )
2. Active Crohn's disease in the last six months to the inclusion defined as : CDAI? 220 and endoscopic or radiological criteria of activity
3. Refractory or intolerance to conventional therapy including corticosteroids , immunomodulators and anti-tumor necrosis factor-alpha
4. Presence of visible lesions by endoscopy
5. Acceptance to participate in the study and written informed consent

Exclusion Criteria:

1. No injuries in pre-screening resonance
2. Pregnancy, lactation or women of childbearing age not taking appropriate contraceptive measures
3. Patients HIV + and Hepatitis C Virus + Hepatitis B Virus +
4. Serious concomitant disease:

   * Renal failure with creatinine clearance \< 40ml / min
   * Heart disease: congestive heart failure with ejection fraction \< 45 % , atrial fibrillation treated with oral anticoagulants, uncontrolled ventricular arrhythmias , pericarditis , pleural effusion with hemodynamic
   * Neoplasms or myelodysplasia
   * Psychiatric disorders including alcohol and drugs
5. Symptoms attributable to fibrotic strictures in Crohn's disease at the discretion of the investigators
6. Diarrhea attributable to " short bowel syndrome"
7. Active infection , including tuberculosis
8. Participation in research studies of new drugs in the 3 months prior to inclusion.
9. Vaccination with live/attenuated germs in the previous 3 months
10. Personal history of cancer (active or complete remission) or known family history of hereditary cancer.
11. Patients in whom , after observation of the state of their veins , these are considered inaccessible and impossible to perform apheresis
Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.


Eligibility Criteria:
Inclusion Criteria:

* Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent.
* Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC.

Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.

* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
* Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).
* Participants must be able to have SC injections administered in the abdomen (and/or thigh).
* Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.

Exclusion Criteria:

* Participants that have received prior DLL3 targeted therapy.
* Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids.
* Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment).
* Participants with leptomeningeal disease.
* Participants with baseline oxygen requirement.
Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients

* Assessment of pharmacokinetic parameters of once daily subcutaneously administered methylnaltrexone in 10 evaluable neurointensive care patients.
* Quantification of methylnaltrexone passage through the blood-brain-barrier in critically ill patients with severe cerebral affections.
* Observation of laxation response after methylnaltrexone application and relation to plasma concentrations of methylnaltrexone.
* Assessing the safety of once daily administered methylnaltrexone in neurointensive care patients.
* Trial with medicinal product

After administration of methylnaltrexone s.c. multiple peripheral blood samples and additionally two liquor samples are drawn during a dose interval on day 1, 3, and 5 of drug administration.

Eligibility Criteria:
Inclusion criteria:

* hospitalisation in the neurointensive care unit
* deep sedation with sufentanil doses of = 40 mcg/h
* male or female aged 18 years or older
* females: negative pregnancy test
* Ventricular drainage as part of needed therapeutic measures

Exclusion criteria:

* History of hypersensitivity to methylnaltrexone (Relistor®)
* confirmed or suspected obstructive ileus or factors possibly leading to intestinal obstruction (e.g. an intestinal tumor)
* increased risk for patients with localized or diffused reduction in structural integrity of the gastrointestinal tract (e.g. peptic ulcer, acute diverticulitis)
* severe hepatic insufficiency (Child-Pugh Class C)
* renal impairment (glomerular filtration rate \< 90 ml/min) with or without renal replacement therapy
* severe diarrhea despite high opioid dosing
* participation in another study with an investigational drug within the 30 days preceding and during the present study
A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).

The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC).

Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female participant aged ≥18 years old.
* Has definitive histologically confirmed adenocarcinoma of the colon or rectum.
* Has metastatic lesion(s).
* Has received at least 2 prior regimens of standard chemotherapies (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients) for mCRC and is refractory or intolerant to those chemotherapies or is not candidate for those chemotherapies.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during the screening period.
* Is able to take medications orally (i.e., no feeding tube).
* Has adequate organ function.
* Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to first day of test drug administration. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication. Women and female partners using hormonal contraceptive must also use a barrier method.

Exclusion Criteria:

* Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
* Eligible for enrolment into another available ongoing clinical study of trifluridine / tipiracil.
* Has previously received trifluridine / tipiracil or hypersensitivity to the active substances or to any of the excipients of trifluridine / tipiracil.
* Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
* Has certain serious illness or medical condition(s) described in the protocol.
* Has had certain other recent treatment e.g. major surgery, anticancer therapy, radiation therapy, participation in another interventional study, within the specified time frames prior to first day of study drug administration.
* Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).