Kornimate/medical-research-clean huggingface dataset:
importance of multidimensional assessments in accompanying schooling of children with mild to moderate intellectual disability.

Conditions: Disability, Intellectual

Summary: the eval'id study aims to demonstrate the value of a multidimensional assessment in accompanying schooling of children with intellectual disability. the study will be performed in the rhône department (france) in children aged from 5 to 13 years with mild to moderate intellectual disability , and attending school either at ulis (unités localisées pour l'inclusion scolaire, which enables disabled children to attend regular schools), or ime (instituts médico-educatifs, which are special schools mandated to accommodate children and young people with intellectual disability at any level of disability). a multidimensional assessment encompasses the assessment of academic, cognitive, behavioral and adaptive skills of the children, with validated and reliable neuropsychological batteries, called id kit (intellectual deficiency assessment kit), which includes the following scales : the wechsler intelligence scale for children 4th edition (wisc-iv), the vineland adaptive behavioral scale ii, the gecen rating form (grille d'evaluation comportementale pour enfants nisonger, which is the french translation of the nisonger child behavior rating form), and an academic skills rating form (geva-sco). a comparison of the children neuropsychological profiles according to the type of school they attend, will be perform. the project consists of three phases: * stage 1: collection of information from each child records at mdph (departmental administration for disabled persons), ime, ulis schools, including the assessments that were performed, and from a survey of both caregivers and parents regarding their respective perception and knowledge of the child's disability * stage 2: all the children who were not previously assessed with the id kit will be further evaluated using these tests. the results of these assessments will be shared with parents and caregivers. * stage 3: a survey regarding the perception and knowledge of the child's disability will be carried out again among caregivers and parents.


Eligibility criteria:
inclusion criteria: * age : \> 5 and \<13 years * with mild to moderate intellectual deficiency * attending school either at ulis or ime in the rhône department. exclusion criteria: * no insurance coverage * no parents agreement

Keywords: intellectual deficiency cognitive, adaptive behavioral and academic profile regular and special schools
effect of robot rehabilitation exercise training on motor control after stroke

Conditions: Stroke

Summary: stroke is a leading cause of neurological disability worldwide, often causing significant weakening and paresis of the affected arm. national spending on post-stroke rehabilitation is project to expand 20% to 35% through 2010. as a new tool for therapists, robotic stroke therapy devices have the potential to be a cost-effective device aid to physical therapy and enable novel modes of exercise not currently available. while recent studies have shown chronic patients benefit from repetitive practice, it is not clear whether they improved via a reduction in impairment or increased functional compensation because there is a lack of standard treatment and scales to assess rehabilitation efficacy in chronic stroke patients. this study aims to reconcile difference performance measurements in robotic rehabilitation to assess the outcome of robotic rehabilitation training.


Eligibility criteria:
inclusion criteria: 1. hemiparesis of the upper extremity 2. diagnosis of a first clinically apparent ischemic stroke at least 6 months prior to study entry 3. age 18 years or older 4. ability to sit and be active for an hour on a chair (or wheelchair) without cardiac, respiratory disturbances and/or pain. exclusion criteria: 1. inability to understand and/or follow instructions 2. pain in shoulder or arm 3. other neurological or musculoskeletal target organ disorder 4. inability to give informed consent personally 5. previous or current contracture of the upper extremity
the relation between periodontal disease and metabolic syndrome

Conditions: Periodontal Disease; Metabolic Syndrome

Summary: periodontal disease is associated with the components of metabolic syndrome, such as obesity, diabetes, hypertension and hyperlipidemia. therefore, strong relation with periodontal disease and metabolic syndrome is suggested. the overall goal of this study is to define the relation between periodontal disease and metabolic syndrome, including atherosclerosis.


Eligibility criteria:
inclusion criteria: * patients with periodontal disease exclusion criteria: * patients with malignant disease * pregnant women

Keywords: periodontal disease metabolic syndrome
fat based enteral nutrition for blood glucose control in icu

Conditions: Hyperglycemia

Summary: in this randomized, double-blind clinical trial, eligible hospitalized icu patients with en will be included. patients will be divided into two groups. the control group with the standard en and intervention group with high fat en. 50% of the total fat will be provided by olive oil. nutritional intake record form will be completed and daily calorie intake will be calculated. high fat en feeding will be offered for 15 consecutive days maximally. at the end of the study mean blood glucose, duration of hospitalization and rate of infection will be compared in two groups.

in this randomized, double-blind clinical trial, 88 eligible hospitalized icu patients with en will be included. written consent form will be completed. physical examination will be done by specialist and nutritional care process will be offered by an rd. demographic, laboratory and nutritional data will be extracted and entered in prepared form. venous blood samples will be taken and laboratory values will be measured and recorded at specified times. patients will be divided into two groups. the control group with the standard en (protein; 20% carbohydrate; 50% and fat; 30% from total calories) and intervention group with high fat en (protein; 20% carbohydrate; 35% and fat; 45% from total calories). 50% of the total fat will be provided by olive oil. any feeding rout such as naso - gastric , percutaneous endoscopic gastrostomy (peg ) or percutaneous endoscopic jejunostomy (pej) with intermittent feeding protocol will be accepted feeding method . nutritional intake record form will be completed and daily calorie intake will be calculated. high fat en feeding will be offered for 15 consecutive days maximally

Eligibility criteria:
inclusion criteria: * being on enteral nutrition * bs≥ 200mg/dl * without renal and liver failure * without hyperlipidemia and nephrotic syndrome * without infection * without obesity exclusion criteria: * death or discharge before day 7

Keywords: critically ill diet blood glucose
safety, tolerability and antidepressant effects of dmt in patients with depression

Conditions: Depressive Disorder; Depression, Unipolar

Summary: this study aims to evaluate the acute and subacute effects of an inhaled n, n-dimethyltryptamine (dmt) in patients with partial response in depression.

this is a phase ii open-label, single-ascending, fixed-order study to assess the feasibility and efficacy of inhaled n, n-dimethyltryptamine (dmt) in patients with partial response in depression.

Eligibility criteria:
inclusion criteria: * patients in current treatment for depression with a partial response. exclusion criteria: * heart failure * liver failure * kidney failure * uncontrolled high blood pressure * history of heart rhythm disorders * history of valvular heart disease * history of chronic obstructive pulmonary disease (copd) * active or in treatment for bronchial asthma * severe obesity * coagulation disorders * clinical evidence or history of increased intracranial * clinical evidence or history of cerebrospinal pressure * history or reports of epilepsy * severe neurological disease * pregnancy * reported or clinically recognized thyroid disorders * diagnosis or family suspicion of genetic monoamine deficiency oxidase * previous adverse response to psychedelic substances * symptoms or family members with a present or past psychotic disorder * dissociative identity disorder * bipolar affective disorder * prodromal symptoms of schizophrenia * problematic use or abuse of alcohol or other psychoactive substances (except tobacco) * acute or subacute risk of suicide * acute flu symptoms * symptoms of airway infection * contact with a confirmed case of covid-19 (sars-cov-2) in the last 7 days
a study in adults with ulcerative colitis (uc) or crohn's disease (cd) receiving vedolizumab in real-world practice in switzerland

Conditions: Inflammatory Bowel Diseases; Crohns Disease; Colitis, Ulcerative

Summary: vedolizumab is a medicine that helps to reduce sensitivity and pain in the digestive system for participants with uc or cd. in this study, adults with uc or cd will be treated with vedolizumab according to their clinic's standard practice. participants will receive vedolizumab as either an infusion or an injection just under the skin (subcutaneous). the main aim of the study is to observe real-world treatment patterns in participants treated with vedolizumab. the study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

this is a non-interventional, prospective study of participants with moderately to severely active ibd (uc or cd) who are initiating or currently ongoing induction or maintenance treatment with vedolizumab in the real world setting. the study will enroll approximately 100 participants. the data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-crfs). all the participants will be assigned to a single observational cohort: * participants with ibd this multi-center study will be conducted in switzerland at specialized gastroenterology centers. the overall duration of the study will be 24 months (104 weeks). data will be collected at baseline, at 3 months (12 weeks) after induction, and every 6 months (24 weeks) after that, and at the time of switch, discontinuation and/or at routine follow-up visits up to 12 months (48 weeks).

Eligibility criteria:
inclusion criteria: 1. has moderately to severely active ibd (uc or cd), initiating or ongoing iv induction treatment with vedolizumab in accordance with the current smpc at baseline or ibd participants receiving ongoing/maintenance iv vedolizumab treatment, with the option to switch to sc vedolizumab maintenance treatment. exclusion criteria: 1. prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy) to vedolizumab therapy as defined in the current smpc. 2. current or planned participation in an interventional clinical trial for cd or uc. 3. cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Keywords: drug therapy
a clinical study to evaluate the tolerability and pharmacokinetics of tqb3617 capsule in patients with advanced malignant tumors

Conditions: Advanced Malignant Tumors

Summary: tqb3617 is a bromodomain and extra-terminal (bet) inhibitor that can competitively bind to bromodomains (brds) with acetylated lysine(kac) and block or partially block the role of kac in subsequent gene transcription and regulation of chromatin structure, thereby playing an anti-tumor role.


Eligibility criteria:
inclusion criteria: * aged: ≥18 years old. * eastern cooperative oncology group (ecog) performance status of 0 to 2. * life expectancy ≥ 3 months. * patients with advanced malignancy tumor who have failed standard treatment or are unable to receive standard treatment or have no effective treatment. * female and male subjects should agree to use an adequate method of contraception starting with signing informed consent form (icf) through 180 days after the last dose of study. the women of reproductive age who blood/urine results were positivetherapy before the first study drug is administered within less than 7 days. exclusion criteria: * patients has had or is currently having other malignant tumors within 3 years. * patients have multiple factors that affect their oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction). * the patient had unmitigated toxic reactions due to any prior treatment. * patients underwent major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to the start of study treatment. * patients have long - term unhealed wounds or fractures. * patients were taking cytochrome p450 3a4, cytochrome p450 3a5, cytochrome p450 2a6, cytochrome p450 2d6 (cyp3a4, cyp3a5, cyp2a6,cyp2d6) inhibitors or inducers before oral medication. * patients who, in the investigator's judgment, have a comorbidity that seriously endangers patient safety or interferes with study completion, or who are considered unsuitable for inclusion for other reasons.
effects of urocortins on forearm arterial blood flow in healthy volunteers - protocol 4

Conditions: Cardiovascular Disease; Heart Failure

Summary: impairment of the heart's pumping capacity (heart failure) remains a major clinical problem with a poor prognosis and the search for novel treatments remains an important area of research. urocortins are proteins that appear to increase blood flow and heart pumping activity. there has been particular interest in the role of urocortins 2 \& 3 (subtypes of urocortins) in heart failure. in this study, we will examine the pharmacokinetics and pharmacodynamics (in particular the onset-offset of action and reproducibility of vasodilator effects) of urocortins 2 \& 3 on forearm arterial blood flow healthy volunteers. utilising the well-established technique of 'forearm venous occlusion plethysmography', we will be able to focus on the local effects of urocortins on arterial blood flow in forearm vessels, without affecting this system in the body as a whole.


Eligibility criteria:
inclusion criteria: * healthy male volunteers between 18 - 65 years (inclusive) exclusion criteria: * lack of informed consent- age \ 65 years * current involvement in a clinical trial * severe or significant co-morbidity including bleeding diathesis, renal or hepatic failure * smoker * history of anaemia * recent infective/inflammatory condition * recent blood donation (prior 3 months) * positive baseline urine test for drugs of abuse (including cannabinoids, benzodiazepines, opiates, cocaine and amphetamines)

Keywords: pharmacodynamics pharmacokinetics urocortin 2 urocortin 3 reproducibility onset/ offset forearm blood flow plethysmography heart failure
a study to evaluate the efficacy and safety of ad-224

Conditions: Hypertension,Essential

Summary: the purpose of this study is to evaluate the efficacy and safety of ad-224

condition or disease : essential hypertension

Eligibility criteria:
inclusion criteria: * signed informed consent * patients with essential hypertension * other inclusions applied exclusion criteria: * patient with secondary hypertension * other exclusions applied
efficacy of genicular nerve radiofrequency

Conditions: Chronic Pain

Summary: in patients with knee pain, local anesthetics and radiofrequency applications to superolateral, superomedial and inferomedial genicular nerves that innervate the knee joint are also preferred methods besides analgesic and physical therapy. when necessary, total knee replacement is the preferred method for primary knee arthrosis. however, continuing knee pain is reported in approximately 20% of patients after total knee replacement. in similar cases; in the painful knees, the blockages of the genicular nerves are successfully applied. in this study; the efficacy of imaging-guided radiofrequency application will be investigated in patients presenting with knee pain after total knee replacement.

although simple analgesic and physical therapy methods are applied, some patients suffer from pain. genicular nerve blocks and radiofrequency methods are performed usually for this reason. this procedure is performed with ultrasound and / or fluoroscopy, sterile staining and covering of painful knee to the middle of thigh and leg, localization of superomedial, superolateral, inferomedial genicular nerves are tested and then conventional radiofrequency is applied to all 3 nerve regions.fifty patients who had total knee prosthesis for gonarthrosis in the orthopedics and traumatology clinic at least 3 months postoperatively had knee pain (infection, mechanical causes and radicular pain) were included in the study.the vas and womac values recorded at the time of application and the vas and womac values recorded at the 1st week, 1st month and 3rd month after the procedure will be used to evaluate the effectiveness of the method.

Eligibility criteria:
inclusion criteria: * knee pain exclusion criteria: * with communication problems (vas and womac scores could not be evaluated) * infectious-mechanical pain-related conditions, * with radicular pain

Keywords: genicular nerve knee pain ultrasound
could algometric assessment be effective to adjust postoperative analgesic requirement?

Conditions: Pain

Summary: the purpose of this study is to determine the correlation between preoperative algometer score and the amount of postoperative analgesic consumption. the algometer score of the patients will be recorded in the preoperative period. in postoperative period, the analgesic consumption rate will record and compare with the algometer score.

the aim of this study is to define the correlation between preoperative algometer score and the analgesic consumption rate. a total of 80 patients whose undergo septoplasty or septorhinoplasty will be included in this study. after preoperative examination, a positive pressure using algometer device will be performed until minimal pain is felt. in postoperative period, the amount of analgesic consumption of the patient will record and compare with the algometer score.

Eligibility criteria:
inclusion criteria: * patients those undergo septoplasty or septorhinoplasty exclusion criteria: * hypertension * diabetes mellitus type 1 or 2 * continuous use of analgesics * patients whose do not accept to participate in the study * patients those reoperated for bleeding

Keywords: pain management
grape extract and exercise effects on blood pressure

Conditions: Exercise Response; Blood Pressure Monitoring, Ambulatory; Polyphenol

Summary: exercise and grape extract intake (i.e., polyphenol-rich product) can independently improve blood pressure and endothelial function in prehypertensive individuals. nevertheless, their combined effects remain unexplored. furthermore, since the biological pathways targeted by both interventions are similar, they could overlap and be amplified by one another, promoting additive or synergistic effects. animal model studies have reported that a grape seed extract intake prevents exercise-induced oxidative stress, which could improve vascular dysfunction. furthermore, as previously reported, a single dose of grape seed extract reduces blood pressure, peripheral vasoconstriction, and heart stress, enhancing o2 delivery during exercise in prehypertensive males. these effects may be partly due to endothelium-dependent vasodilation enhancement. therefore, it is necessary to understand the potential impact of exercise and grape extract on blood pressure and vascular function in prehypertensive individuals.


Eligibility criteria:
inclusion criteria: * sedentary individuals (\<120 min·wk-1 of moderate-intensity activity assessed by 7-d ipaq). * aged 25-65 years and bmi 18-35 kg/m2. * elevated bp (i.e., prehypertensive; systolic and diastolic bp between 120-139 and/or 80-89 mmhg, respectively) exclusion criteria: * weight instability (\>5kg change in body mass over last 6 months) * pregnant or lactating * changes in physical activity over the last 3 months and planning on physical activity, or diet throughout the intervention. * untreated cardiovascular or renal disease, peripheral vascular disease, hypertension (≥140 mmhg systolic, or ≥90 mmhg diastolic bp), and any disease associated with exercise intolerance. * under pharmacological treatment for any cardiometabolic disease (i.e., hypertension, dyslipidemia or hyperglycemia) * currently taking dietary supplements that influence the cardiovascular response (e.g., polyphenols, omega-3 fatty acids, magnesium, nitrates, l-arginine, red ginseng, natto, ginkgo, coq10) or used in the last month. * current or recent use (within the past 6 months) of tobacco or nicotine-containing products, or illicit drugs. * any medical condition or medication that could introduce bias into the study (e.g. neurological disorders)

Keywords: grape extract exercise vascular function blood pressure polyphenol
a study to evaluate the safety, tolerability, and activity of intravenous mldl1278a in patients on standard-of-care therapy for stable atherosclerotic cardiovascular disease (glacier)

Conditions: Atherosclerosis

Summary: this is a phase ii (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of mldl1278a (also known as bi-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as quantified by fdg-pet/ct.


Eligibility criteria:
inclusion criteria: * evidence of qualifying vessel (carotid or aortic) plaque inflammation * documented atherosclerotic vascular disease clinically stable for at least 3 months prior to screening or type 2 diabetes mellitus with elevated cardiovascular risk * use of a stable dose of statin therapy for at least 6 weeks prior to screening. patients must be capable of maintaining statin therapy at a current dose level from screening until the last follow-up visit. * for patients taking angiotensin-converting enzyme (ace) inhibitors (ace-i) or angiotensin-receptor blockers (arbs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents, use of a stable dose for at least 6 weeks prior to screening and capable of continuing with that dose for the duration of the study exclusion criteria: * occurrence of a cardiovascular event \< 6 months prior to screening * pregnant, planning to become pregnant during the study, or breastfeeding * clinically significant abnormal laboratory values or abnormal ecg or vital signs * history of anaphylactic reactions * newly discovered type 2 diabetes mellitus (t2dm) (prior to study entry) or medical treatment for t2dm started \< 3 months prior to study entry * use of insulin, corticosteroids (oral, rectal, or injectable), or other immunosuppressive medications * current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including hiv, hepatitis b or c * impaired renal function * history of malignancy within 2 years prior to screening * current life-threatening condition other than vascular disease that may prevent a patient from completing the study * use of an investigational drug or biologic within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study medication * exposure to substantial radiation within 12 months prior to screening

Keywords: bi-204