Kornimate/medical-research-clean huggingface dataset:
tricaprilin liquid formulation pk study

Conditions: Alzheimer Disease

Summary: the purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of new liquid formulations of tricaprilin, with the aim of finding a suitable formulation to advance in development. this is a three-part, part-randomised study that include single-dose, food effect, and titration tolerability in up to 80 healthy participants.


Eligibility criteria:
inclusion criteria: * participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent. * participants who are overtly healthy (in the opinion of the investigator) as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring * body weight ≥45 kg and body mass index (bmi) within the range 18.0 - 32.0 kg/m2 (inclusive). * male and female * agrees to comply with study procedures including blood draws, confinement to clinic, meal requirements * continuous non-smoker or infrequent smoker (no more than 10 cigarettes per week for at least 3 months prior to screening) exclusion criteria: * history of, or current gastrointestinal (gi) conditions constituting a risk when taking the study treatment; or interfering with the interpretation of data, based on the investigator's judgement * past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing (paracetamol/acetaminophen \[up to 2 g per day\], hormone replacement therapy and hormonal contraception are permitted). * participants on a ketogenic diet, low-fat diet or actively using medium chain triglycerides, ketone esters, or other ketogenic products.
ap metabolism transcriptomics

Conditions: Neurodevelopmental Disorders; Irritability

Summary: it is known from the literature that treatment with antipsychotic drugs (ap) induces, even before changes in blood chemistry parameters, changes in gene transcription that are evident at the level of peripheral blood mononuclear cells. in this pilot study we intend to evaluate the transcriptomic profile of children and adolescents who are undergoing treatment with antipsychotics and show metabolic disorders, in order to compare it to the profile of similar patients who do not use antipsychotics, but show metabolic disorders, or who use antipsychotics, but do not show metabolic disorders. the hypothesis is that a different transcriptomic profile can be identified between the three populations under study, such as to allow to hypothesize that a series of transcripts can be used as early biomarkers of whether treatment with antipsychotics can induce metabolic disorders in the individual patient or not. this information could be used to improve the management of antipsychotic therapies in the direction of personalized medicine, reducing metabolic risks.


Eligibility criteria:
inclusion criteria: * age 5-17 years; * group 1: antipsychotic users with metabolic disorders; * group 2: antipsychotic users without metabolic disorders; * group 3: non-antipsychotic users with metabolic disorders. the definition of antipsychotic use includes daily use for at least 3 months prior to enrollment. the definition of metabolic disorders includes: bmi-z for age, sex and height \> +1 waist circumference \> 90th percentile for age, sex and height diastolic or systolic blood pressure \> 90th percentile for age, sex and height fasting blood glucose \> 99 mg/dl fasting triglycerides \> 149 mg/dl fasting cholesterol \< 41 mg/dl. patients with metabolic disorders are defined as those who meet at least one of the above criteria. patients without metabolic disorders are defined as those who do not present any of the above criteria. exclusion criteria: * presence of diagnosed genetic conditions known to alter energy metabolism and/or nutrition; * presence of diagnosed eating disorders; * habitual use of supplements known to alter energy metabolism and/or nutrition; * concomitant use of drugs known to alter energy metabolism and/or nutrition.

Keywords: antipsychotic drugs dyslipidemia pre-diabetes obesity transcriptomics
clinical study to investigate a new mouthwash in reducing plaque and helping prevent gum problems on dental implants over a 6-month period of product use

Conditions: Gingivitis

Summary: the objective of this six-month clinical research study is to evaluate the clinical efficacy of a new mouthwash on helping prevent gum problems (gingival index scores ) in adults as compared to a control mouthwash.


Eligibility criteria:
inclusion criteria: * availability for the six-month duration of the clinical research study. * good general health. * minimum of two dental implants (2 different quadrants ), each implant must have a restoration. * initial mucositis index of at least 1 .0 as determined by the use of the mombelli modified gingival index. * initial plaque index of at least 1 .5 as determined by the use of the mombelli modified plaque index. * signed informed consent form. exclusion criteria: * presence of orthodontic bands. * tumor (s ) of the soft or hard tissues of the oral cavity. * advanced periodontal disease (purulent exudate, tooth mobility, and /or extensive loss of periodontal attachment or alveolar bone ) or peri-implantitis. * five or more carious lesions requiring immediate restorative treatment. * antibiotic use any time during the one-month period prior to entry into the study. * participation in any other clinical study or test panel within the one month prior to entry into the study. * dental prophylaxis during the past two weeks prior to baseline examinations. * history of allergies to oral care /personal care consumer products or their ingredients. * on any prescription medicines that might interfere with the study outcome. * an existing medical condition that prohibits eating or drinking for periods up to 4 hours. * history of alcohol or drug abuse. * self-reported pregnant or lactating subjects
psychomotor therapy effects in adaptive behavior and motor proficiency in intellectual disability

Conditions: Intellectual Disability

Summary: people with intellectual and developmental disabilities (idd) usually present limitations at adaptive behavior and motor skills, which lead to limitations/barriers in the daily independent functioning of this population. the main goal of this research is to analyze the efficacy of a psychomotor intervention program on adults with and without idd, through an assessment of their progress both in adaptive behavior competences and motor proficiency skills.

this study sample comprised 15 participants divided by three groups of 5 individuals each: one group with idd (with different ethiology), another one with down syndrome and the third with typical development. ages range from 22 to 31 years-old (average=26,5; st. deviation=3,76), 6 were females and 9 males. all adults with idd were all institutionalized at an occupation activities centre of an institution and adults without id were selected by convenience, with ages comprised within the selected range. all groups were compared through both evaluation instruments: the portuguese version of adaptive behavior scale (pabs) and bruininks-oseretsky motor proficiency test (bot-2). both tests were applied according to original protocols. ethics requisites were fulfilled. after the initial assessment, a psychomotor intervention program was designed specifically for participants with idd. this program integrated individual and group sessions during 3 months, and the main goals of the program were related to motor coordination (balance, manual dexterity and coordination, global and fine praxis), economic and professional activities, academic and verbal skills.

Eligibility criteria:
inclusion criteria: * ages above 18 years * diagnosis of intellectual disability * institution in castelo branco exclusion criteria: * other co-morbilities associated * not institutionalised

Keywords: adaptive behavior motor proficiency psychomotor therapy intellectual disability
target bp i clinical trial

Conditions: Hypertension

Summary: the target bp i trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the peregrine system kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.

the target bp i trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the peregrine system kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization. the target bp i clinical trial uses a percutaneous catheter to deliver very small amounts of alcohol (neurolytic agent). the patient population for this trial is comparable to those used in other renal denervation studies, but also incorporates lessons learned from recent trials of renal denervation. this is to enable the study of an optimized patient population who stands to benefit from the intervention, in a manner that reduces possible study bias. this trial is intended to evaluate the safety and efficacy of the peregrine catheter when used to deliver a 0.6 ml volume of alcohol to the perivascular area of the respective renal arteries while patients are adequately managed with oral antihypertensive medications.

Eligibility criteria:
inclusion criteria: 1. has 3 office blood pressure measurements with a mean office systolic blood pressure (sbp) of ≥150 mmhg and ≤180 mmhg, and a mean office diastolic blood pressure (dbp) of ≥90 mmhg when receiving 2 to 5 antihypertensive medications. 2. has a mean 24-hour ambulatory sbp of ≥135 mmhg and ≤170 mmhg with ≥70% valid readings exclusion criteria: 1. subject has renal artery anatomy abnormalities. 2. subject has an estimated glomerular filtration rate (egfr) of ≤45 ml/min/1.73 m2, based on the chronic kidney disease epidemiology collaboration (ckd-epi) equation; or is on chronic renal replacement therapy. 3. subject has documented sleep apnea. 4. subject has any of the following conditions: severe cardiac valve stenosis, heart failure (new york heart association \[nyha\] class iii or iv), chronic atrial fibrillation, and known primary pulmonary hypertension (\>60 mmhg pulmonary artery or right ventricular systolic pressure). 5. subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only). 6. subject is being treated chronically (e.g. daily use) with nsaids, immunosuppressive medications, or immunosuppressive doses of steroids. aspirin therapy and nasal pulmonary inhalants are allowed. 7. subject has a history of myocardial infarction, unstable angina pectoris, or stroke/tia within 6 months prior to the planned procedure.

Keywords: renal denervation alcohol
bed rest for threatened preterm labor. pilot study

Conditions: Bedrest; Premature Labor

Summary: the aim of the pilot trial is to assess at what extend women with arrested threatened preterm labor change their activity patterns at home in response to bed rest prescription. an area of concern for the design of a trial is the strength of health provider's recommendation to change women's behaviors, and their compliance with bed rest recommendations. the study was a randomized parallel design. the intervention group consisted of total bed rest for four days (with allowance to go to the toilet). the control group consisted in the restriction of activities during four days.


Eligibility criteria:
inclusion criteria: * every woman admitted to hospital during the antenatal period because of an episode of tpl. if the attending physician decides that the woman is ready for hospital discharge the woman will be eligible for the study. exclusion criteria: * multiple pregnancy * premature rupture of membranes * cervical cerclage and whenever the attendant physician considers that the woman is not eligible to be randomized to bed rest or activity restriction.
young houston emergency opioid engagement system

Conditions: Opioid-use Disorder; Opioid Dependence; Opioid Overdose; Opioid Use; Substance Use Disorders

Summary: the houston emergency response opioid engagement system for youths and adolescents (young heroes) is a community-based research program integrating assertive outreach, medication for opioid use disorder (moud), behavioral counseling, and peer recovery support. the objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder. the investigators also intend to understand the prevalence of opioid overdoses and oud among youth in houston.

the houston emergency response opioid engagement system for youths and adolescents (young heroes) is a non-randomized cohort study based at the university of texas health science center of houston. this study recruits participants through three avenues: assertive community outreach with a peer coach and paramedic following and opioid overdose, community referrals, and emergency department referrals. the study explores the effect of the combination of assertive outreach, same-day induction into medication for opioid use disorder, ongoing maintenance treatment, behavioral counseling, peer recovery support, and paramedic follow-up on patient outcomes. the primary outcome is engagement and retention in outpatient treatment. secondary outcomes include quality of life assessment as well as subsequent relapses and overdoses. the hypothesis is that patients with earlier induction into moud treatment who receive routine follow-up, are more likely to engage and remain in treatment long-term.

Eligibility criteria:
inclusion criteria: * in otherwise good health based on physician assessment and medical history * drug screen positive for opioids * patients express a willingness to stop opioid use * meet diagnostic and statistical manual of mental disorders - text revision (dsm-iv-tr) criteria for opioid dependence * patients must be able to speak english * be agreeable to and capable of signing the informed consent and assent (parent or guardian must consent, minor must assent) exclusion criteria: * non-english-speaking patients * have a known sensitivity to buprenorphine or naloxone * be physiologically dependent on alcohol, benzodiazepines, or other drugs of abuse that require immediate medical attention. other substance use diagnoses are not exclusionary. * have a medical condition that would, in the opinion of the study physician, make participation medically hazardous, including unstable cardiovascular disease, neurological deficits, trauma, acute hepatitis, stroke, and liver or renal disease) * be acutely psychotic, severely depressed, and in need of inpatient treatment, or is an immediate suicide risk * be a nursing or pregnant female
high resolution imaging of retinal vessels as a biomarker of cardiovascular disease in patients with renal insufficiency - ri

Conditions: Retinal Imaging; Cardiovascular Biomarker; Renal Insufficiency

Summary: the objectives are to better understand, in the dialysis patient, the relationships between microvascular morphometry and cardiovascular events, survival, arterial hypertension, the pathology responsible for renal failure, the age of dialysis and metabolic parameters. the investigator team also want to better understand the relationship between the diameter of small arteries and parameters such as hypertension, the pathology that causes kidney failure, the age of dialysis, the use of vka or epo, metabolic parameters (hba1c, nfs, reticulocytes, bnp, lipid balance, phosphocalcic balance).

the cardiovascular morbidity of a dialysis patient is 10 times higher than that of a subject in the general population. the patient with renal insufficiency is therefore at high cardiovascular risk. an increase in the wall-to-lumen ratio (wlr) is an early sign of microvascular damage, predictive of the risk of a cardiovascular event. the benefits of wlr measurement are therefore at the level of both the diagnosis and prognosis of vascular disease. recently, a fundus camera coupled with an adaptive optics system has been able to measure for the first time in vivo non-invasively and reproducibly the wall thickness of the small arteries of the retina, and therefore the wlr, among other biomarkers relating to microvascular remodelling. studies in hypertension have confirmed that the rtx1 camera allows reliable and reproducible measurements of the wlr. the main aim of our study is to evaluate the value of the wlr as a biomarker of the risk of cardiovascular morbidity and mortality in patients with renal insufficiency. the objectives are to better understand, in the dialysis patient, the relationships between microvascular morphometry and cardiovascular events, survival, arterial hypertension, the pathology responsible for renal failure, the age of dialysis and metabolic parameters. the investigator team also want to better understand the relationship between the diameter of small arteries and parameters such as hypertension, the pathology that causes kidney failure, the age of dialysis, the use of vka or epo, metabolic parameters (hba1c, nfs, reticulocytes, bnp, lipid balance, phosphocalcic balance).

Eligibility criteria:
inclusion criteria: * adult * patients with renal insufficiency: waiting for management (dialysis or transplant), during dialysis or after a kidney transplant followed in the nephrology department of the saint martin clinic. * first examination in adaptive optics giving a usable result (possibility of measuring the wlr) * affiliate or beneficiary of a social security scheme * patient having given their free and informed consent exclusion criteria: * protected patients: adults under guardianship, trusteeship or other legal protection, deprived of liberty by judicial or administrative decision, hospitalised without consent. * pregnant, lactating or parturient women.
a skin stretching wound closure system

Conditions: Wounds; Injuries

Summary: a skin stretching device has been designed to stretch tissue prior to surgery, during surgery and in order to secure wounds following surgery. the device may be used in non-invasive and invasive applications.


Eligibility criteria:
inclusion criteria: * hard to close wounds exclusion criteria: * non-cooperative patients

Keywords: equipment and supplies
a novel scoring system for predicting the success of pci in patients with cto

Conditions: Chronic Total Occlusion (CTO)

Summary: the investigators conducted a retrospective, single-center observational registry upon which one novel scoring system was formed and evaluated for their accuracy in predicting technical success. the investigators reviewed the clinical and angiographic records of 432 patients with 459 cto lesions who underwent percutaneous recanalization attempts recruited between january 2012 and november 2023. the investigators aims to develop and validate a novel scoring system for predicting cto-pci success.

chronic total occlusions (cto) accounting for about 15-20% of coronary artery lesions can be challenging and only 10-15% of patients undergo successful percutaneous coronary intervention (pci) .thanks to the technological and device advances, the marked improvement of pci success rates could be seen. however, in contrast to non-cto lesions, these procedures are accompanied by longer procedure time, contrast and radiation burden, and higher complication rates. the possibility to predict which ctos are more likely to be treated successfully is still of utmost importance for patient selection. several scores have been proposed to predict the procedural success rate, such as j-cto, cl-score, progress-score et al , j-cto is widely accepted. but karatasakis et al.showed that these scores performed moderately in predicting technical outcome, while ignoring many factors such as stumpless lesion which may exert an influence on the procedural success. the investigators aims to develop and validate a novel scoring system for predicting cto-pci success.

Eligibility criteria:
inclusion criteria: 1. complete occlusion of the coronary artery, confirmed by coronary angiography with timi flow grade 0, and occlusion for ≥3 months; 2. presence of angina or angina-equivalent symptoms ; undergo coronary intervention; exclusion criteria: -

Keywords: chronic total occlusion (cto) a novel scoring system the success of percutaneous coronary interventions
effects of deep stripping versus kneading on pain, range of motion and functional activity among individuals with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this is a randomized controlled trial, 44 participants selected based on inclusion criteria from physical therapy department of surriya azeem surgical hospital, pattoki. participants randomly recruited into two groups, 22 in deep stripping group receiving deep stripping with conventional physical therapy and 22 in kneading group receiving kneading with conventional physical therapy. pain, range of motion and functional mobility are the primary outcomes measured by numeric pain rating scale, universal goniometer and lower extremity functional scale. data collected at the baseline, at the 6th session, and the 12th session.

in this randomized controlled trial, 44 individuals with knee osteoarthritis (ii-iii grade of kellgren-lawrence scale) pre-diagnosed by an orthopedic, were assessed for eligibility from the physical therapy department of surriya azeem surgical hospital, pattoki. participants with any other musculoskeletal disorder, cognitive problem and receiving any treatment within the past three months were excluded from the study. the participants were randomly recruited into two groups with 22 participants in each group. group a received deep stripping along with conventional physiotherapy and group b received kneading along with conventional physiotherapy. both the deep stripping and kneading technique applied on the quadriceps muscle group, hamstring muscle group and around the knee joint. data collected by a blinded assessor at the baseline, at the 6th session, and the 12th session. outcome measures were pain (measured by numeric pain rating scale), range of motion (measured by universal goniometer), and functional mobility (assessed by lower extremity functional scale). after collecting the data, normality of the data will be entered and analyzed in statistical package for the social sciences and than the statistical test will be applied to compare the within group analysis and between group analysis.

Eligibility criteria:
inclusion criteria: * chronic osteoarthritis (more than 3 months) with pain in one knee joint (unilateral) * a prior medical diagnosis having radiographic evidence of grade 2 and 3 of kellgren and lawrence criteria for knee osteoarthritis by an orthopedic. * pain intensity level more than 3 points of the numeric pain rating scale. exclusion criteria: * any acute inflammation, contracture, or surgery affecting the knee joint. * any cognitive problem. * participants taking non-steroid anti-inflammatory drugs, intra-articular injection, or physical therapy within the last three months for the knee joint. * participants having a lumbar spine and/or any other lower limb impairment and/or surgery affecting knee joint.

Keywords: non-inflammatory disease degenerative joint disease osteoarthritis knee joint soft tissue mobilization deep longitudinal stripping kneading