Kornimate/medical-research-clean huggingface dataset:
phase 1 rct of tdcs in adults with asd and/or adhd without intellectual disability

Conditions: Autism Spectrum Disorder; Attention Deficit Disorder With Hyperactivity

Summary: the goal of this clinical trial is to learn about the safety and tolerability of transcranial direct current stimulation (tdcs) combined with cognitive training in adults with autism spectrum disorder (asd) and/or attention-deficit/hyperactivity disorder (adhd). the main question it aims to answer is: is tdcs safe and well-tolerated in adults with asd and/or adhd? researchers will compare active tdcs to a sham (placebo-like) stimulation to evaluate safety and tolerability. participants will: receive either active or sham tdcs for 20 minutes daily over 10 consecutive workdays undergo stimulation with the anode placed at f3 and the cathode at fp2 complete daily cognitive training exercises using the neuronup platform during stimulation attend baseline and follow-up assessments to monitor for any side effects or discomfort related to the intervention


Eligibility criteria:
inclusion criteria: adults aged 18 to 55 years clinical diagnosis of autism spectrum disorder (asd) and/or attention-deficit/hyperactivity disorder (adhd) confirmed via medical records or structured clinical interview able to provide informed consent fluent in the language used for assessments and cognitive training tasks stable medication regimen (if applicable) for at least 4 weeks prior to enrollment willing and able to attend 10 consecutive weekday sessions and follow-up assessment exclusion criteria: history of epilepsy, seizures, or significant neurological disorder (e.g., traumatic brain injury, stroke) current diagnosis of psychotic disorder or bipolar disorder presence of metal implants in the head (excluding dental work), pacemaker, or other contraindications to tdcs current substance use disorder (within past 6 months) pregnant or planning to become pregnant during the study period participation in another intervention study within the last 30 days any condition that, in the opinion of the investigators, may make participation unsafe or interfere with study procedures

Keywords: tdcs autism adhd
pride iii prison interventions and hiv prevention collaboration

Conditions: Hiv; Opioid Use

Summary: the primary objective of this research project is to identify barriers to scale-up of opioid agonist therapy (oat) in the justice systems (prisons and probation) in tajikistan, kyrgyzstan, moldova, and georgia, and establish a niatx learning collaborative to scale-up oat, and analyze scale-up utilizing latent class growth analyses in people who inject drugs (pwid).

aim 1 consists of the development of niatx learning collaboratives with prison oat providers (addiction care specialists or primary care doctors). this aim is an implementation science aim involving the collection of oat scale-up data from each country's national oat database, as well as administration of survey to prison narcologists every 6 months. aim 2 consists of the development of niatx learning collaboratives with probation and prison officers in kyrgyzstan, tajikistan, moldova, and georgia. investigators will collect oat scale-up data from each member country's national oat database, and administer a survey to probation officers every 6 months. investigators will also observe and interview probation clients and staff using ethnographic methods.

Eligibility criteria:
inclusion criteria: aim 1: 1. quantitative surveys for prison oat providers * being 18 years or older * being currently assigned and working as a probation oat provider for a probation site 2. echo procedures aim 2: 1. quantitative surveys for people in probation * being 18 years or older * screen yes to opioid injection on the online screener questionnaire * currently in probation 2. quantitative surveys for probation and prison officers * being 18 years or older * being currently assigned and working as a probation or prison officer at a probation site 3. focus groups (people in probation) * being 18 years or older * screen yes to opioid injection criteria on the online screener * currently in probation 4. focus groups (probation and prison officers) * being 18 years or older * being currently assigned and working as a probation or prison officer at a probation * has more than 3 months of field experience * works at a probation site within 25 kilometers of an oat site exclusion criteria: -
study to define optimal igf-1 monitoring in children treated with nutropinaq

Conditions: Turner Syndrome; Renal Insufficiency, Chronic; Pituitary Diseases; Dwarfism

Summary: the main purpose of this study is to establish an optimal monitoring regimen in nutropinaq treated children, using newly developed capillary blood spot igf-1 measurement technology.


Eligibility criteria:
inclusion criteria: * children under 18 with growth failure associated with inadequate growth hormone secretion, or turner syndrome or chronic renal insufficiency. exclusion criteria: * children with closed epiphyses * children with active neoplasm * children with acute critical illness

Keywords: growth child development growth hormone inadequate growth hormone secretion growth failure
study on aspirin versus placebo in resected colon cancer with pi3k mutation stage iii or ii high risk

Conditions: Colorectal Cancer

Summary: four retrospective studies were recently published on efficacy of aspirin in patients with surgically resected colon cancer. two of these studies strongly suggested that aspirin used in low doses (100 mg/d) after surgical resection of colorectal cancer with pi3k mutation could act as a targeted therapy with a major protective effect on the risk of recurrence. the other two studies did not confirm the benefit of aspirin in this situation. these four retrospective studies provide an insufficient level of evidence to demonstrate the benefit of low-dose aspirin as adjuvant to surgery for colorectal cancer. therefore, it is necessary as recommended in the conclusion of these studies and meta-analyses to perform a randomised prospective study to validate these data.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * colonic adenocarcinoma stage iii * colonic adenocarcinoma stage ii high risk mss: * t4bn0 or t4an0 tumour penetrating the surface of the visceral peritoneum * or less than 12 nodes evaluated; * or with at least two of the following criteria:lymphatic involvement, perineural invasion, venous invasion * or diagnosis of bowel obstruction or perforation; or poor differentiated tumour. * pi3k mutation, exon 9 or 20 (tumour) * resection r0 * who performance status 0-2 * chest and abdominal ct scan ≤ 8 weeks * life expectancy ≥ 3 years * written consent signed exclusion criteria: * anticoagulant and/or antiaggregating treatment including clopidogrel * regular aspirin use (\> 3 doses per week during more than 3 months the last year) * contraindication to aspirin : allergy to aspirin, active or antecedent peptic ulcer * severe renal or hepatic insufficiency * pregnancy or nursing ongoing * rectal cancer * hereditary forms (i.e. lynch syndrome patients) * follow-up of the patient not feasible

Keywords: pi3k mutation aspirin
effect of covid-19 pandemic in non covid-19 patients at the emergency surgical department

Conditions: Covid19; Emergencies; Appendicitis; Surgical Procedure, Unspecified

Summary: introduction most countries imposed mandatory lockdowns that were rapidly lifted, however argentina holds the record for one of the longest quarantines in the world. general surgery emergency conditions and trauma cases still require immediate evaluation and timely resolution. the primary objective of this study was to analyze the variations in the consults, surgical outcomes and severity of disease in admissions at our department of general surgery and to study the consequences of the lockdown effect in our community. materials and methods an observational, ambispective study was carried out on a prospective cohort of patients who consulted with on-call surgical pathology and required hospitalization in the period from march 13th, 2020 until july 31, 2020 (pg) were included, analyzed and compared with the same period of 2019 (cg).

participation in the study does not represent any additional risk for the included participants since participation in the protocol does not include any experimental intervention and the medical care and treatment of all participants that require it will be carried out according to the current guidelines. the protocol does not contemplate any procedure or study additional to the usual care of the patient.

Eligibility criteria:
inclusion criteria: * all non-covid-19 patients over 18 years who consulted at the emergency surgical department of hospital italiano de buenos aires and required hospitalization in the period from march 13th, 2020 until july 31, 2020 (pandemic group-pg) and compared with the same period of 2019 (control group-cg). exclusion criteria: * none
k-ras and egfr in lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: retrospective analysis where patients with histologically confirmed non-small cell lung cancer (nsclc) were centrally evaluated for the presence of kras and egfr mutations.

a retrospective analysis, performed by the hellenic co-operative oncology group (hecog), in samples from patients with histologically confirmed nsclc, who had been treated within hecog-affiliated centres from march 2000 through december 2012, were centrally evaluated for the presence of kras and egfr mutations. all patients had available clinicopathological data at diagnosis. formalin-fixed, paraffin-embedded tissue blocks were retrospectively retrieved from the hecog tumor repository. cytologic material was prospectively submitted for genotyping in more recent years (2010-2012).

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed nsclc * signed and dated written informed consent * age 18 years * available cytological material exclusion criteria: -
a study of glucocorticoid use to evaluate systematic methylprednisolone reduction in patients with rheumatoid arthritis on background roactemra/actemra (tocilizumab) (act-alone)

Conditions: Rheumatoid Arthritis

Summary: this open-label, single-arm study will assess the use of glucocorticoids (gc) in daily clinical practice and will evaluate the dose reduction of glucocorticoids once low disease activity is achieved in patients with rheumatoid arthritis tre ated with gc and background roactemra/actemra (tocilizumab) 8mg/kg intravenously every 4 weeks. in the non-interventional phase, the use of gc in daily clinical belgian practice will be evaluated and described. this period of maximum 6 mont hs will allow those patients to obtain the inclusion criteria for the secondary interventional phase. in the interventional phase, a systematic gc dose reductio n schedule will be evaluated in patients having achieved low disease activity wh ile receiving the same background therapy with roactemra/actemra 8 mg/kg. methyl prednisolone will be given from a starting dose of \>/= 1 mg to \</=20 mg orally d aily and will be tapered down. the anticipated study duration is up to 13 months


Eligibility criteria:
inclusion criteria: non-interventional phase * adult patients, \>/=18 years of age * moderate to severe active rheumatoid arthritis defined as disease activity score using 28-joint count (das28) \>/=5.1 * patients with inadequate clinical response to a current treatment with 2 or more non-biologic disease-modifying anti-rheumatic drugs (dmards), one of them being methotrexate (mtx) optimally administered during a period of more than 3 months or inadequate response to a current anti-tnf therapy * current use of oral glucocorticoids started at least 4 weeks prior to enrolment interventional phase * patients enrolled in the non-interventional phase * patients with low disease activity defined as das28 \</=3.2 at visit 2 * use of oral glucocorticoids with methylprednisolone equivalent dose of \>/=1mg and \</=20mg/day at visit 2 exclusion criteria: non-interventional \& interventional phase * rheumatic autoimmune disease other than rheumatoid arthritis, or significant systemic involvement secondary to rheumatoid arthritis * functional class iv as defined by the american college of rheumatology (acr) classification of functional status in rheumatoid arthritis * prior history or current inflammatory joint disease other than rheumatoid arthritis (e.g. gout)
oxidative stress and apoptosis of energy metabolism by deferiprone from the circulating lymphocytes

Conditions: Parkinson's Disease; Amyotrophic Lateral Sclerosis; Oxidative Stress; Iron Overload

Summary: peripheral blood mononuclear cells (pbmc) and platelets could be interesting ex vivo models to study brain diseases. indeed, there is no access to neurons from patients. however, pbmc can exhibit different physiopathological mechanisms that are ubiquitous (i.e. oxidative stress, mitochondriopathy with energy metabolism, inflammation, protein folding, iron metabolism and programmed cell death ...). the platelets are pivotal in the healing system with large range of growth factors. a new therapeutic concept of conservative iron chelation with deferiprone for neuroprotection is under development. the action of deferiprone on the different mechanisms and notably the oxidative stress are to obtain from a collection of pbmc and platelets from patient having parkinson's disease and amyotrophic lateral sclerosis and healthy controls to study ex vivo. pbmc and platelets will be stored for future analyses.

the study collection of pbmc and platelets from 30 patient having parkinson's disease 30 patients having amyotrophic lateral sclerosis and 30 healthy controls. the collection will be performed either by cytapheresis for half of the patient and by collecting the whole blood for the other half. pbmc and platelets will be stored at minus 80°c. pbmc of patients and controls are exposed ex vivo to different pathological condition (mainly hydrogen peroxide, menadione, hypoxia...) with and without deferiprone to analyse whether the level of oxidative stress (reactive oxygen species and notably hydroxyl radical with hydroxypethidine probe with flow cytometry) is reduced under deferiprone (primary criterion. secondary analyses will concern the level of iron, the energy metabolism (aerobic versus anaerobic and the level of adenosine triphosphate production), the type of cell death (apoptosis, autophagy and new programmed cell death: ferroptosis) and inflammation. finally, the level of growth factors and their effectiveness will be studied from platelets.

Eligibility criteria:
inclusion criteria: * parkinson's disease according to movement disorders society criteria * amyotrophic lateral sclerosis according to el escorial criteria * age and sex matched healthy controls exclusion criteria: * severe comorbidities (cancer, other degenerative diseases, hemopathy, inflammatory diseases)

Keywords: parkinson's disease amyotrophic lateral sclerosis peripheral blood mononuclear cells ex vivo model for oxidative stress iron metabolism and chelation
angelman syndrome (as) biomarker study

Conditions: Angelman Syndrome; Chromosome 15q Duplication (dup15q) Syndrome

Summary: the primary objective of this study is to measure ubiquitin-protein ligase e3a (ube3a) protein levels in cerebrospinal fluid (csf) and to evaluate its utility as a biomarker in support of the development of therapies for as.


Eligibility criteria:
key inclusion criteria: * ability of the participant's legally authorized representative (lar) to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local privacy regulations * must have genetically confirmed diagnosis of as (ube3a deletion, ube3a mutation, paternal uniparental disomy, or imprinting center defect) or dup15q syndrome (with number and size of duplications of 15q specified) provided by the investigator * must be scheduled for a procedure unrelated to the study that will involve administration of general anesthesia or conscious sedation. key exclusion criteria: * lumbar puncture (lp) procedure less than 30 days before the sampling visit * any contraindications to having an lp * the blood and csf collection will, in the opinion of the investigator, inhibit, in some way, the prescheduled procedure that requires anesthesia or sedation * current enrollment or past enrollment in an interventional clinical study in which an investigational gene therapy or antisense oligonucleotide (aso) is/was administered * enrollment in an interventional clinical study in which an investigational small molecule/antibody treatment or approved small molecule/antibody therapy is administered within 1 month (or 5 half-lives of study agent, whichever is longer) prior to the sampling visit which, under the judgement of the investigator and/or sponsor would affect ube3a and other csf biomarker levels. use of approved or investigational small molecule therapies which would not impact the biomarkers above will be eligible with sponsor approval prior to enrollment (e.g., anti-epileptic drugs being studied in alternative formulation, other derivatives of benzodiazepines, or other same class drugs as those already permitted as part of the study). note: other protocol defined inclusion/exclusion criteria may apply.
idea-033 open label study

Conditions: Joint Pain; Musculoskeletal Pain; Stiffness; Soft Tissue Inflammation in Designated Target Area(s)

Summary: the main aim of the study is to evaluate safety, efficacy, compliance, and usage of epicutaneously applied idea-033 in joint / musculoskeletal pain or soft tissue inflammation.

multi-centre, one arm, multiple dose, open-label, at home usage study. adult volunteers experiencing joint pain, musculoskeletal pain, stiffness, or soft tissue inflammation will be screened for study participation.

Eligibility criteria:
inclusion criteria: * at least 18 years or older * agree to refrain from chronic usage of nsaids or any other analgesics or anti-inflammatory drugs other than those provided during the course of the study or documented sporadic concomitant analgesics * joint pain, musculoskeletal pain, stiffness, or soft tissue inflammation in designated target area(s) that are appropriate for self-treatment with a topical analgesic or where availability of a second person can be guaranteed in case self-treatment is not possible * healthy skin in the target area(s) exclusion criteria: * known hypersensitivity to idea-033 or other nsaids * history of coagulation disorders * history of peptic ulcers or gastric intolerance with nsaids * urinary tract infection * clinically significant renal, hepatic, or gastric disease * acute or chronic coexisting illness qualifying for exclusion according to clinical judgement of the investigator * clinical laboratory values outside normal range deemed clinically significant by the investigator * narcotics-containing products within 7 days of administering imp * malignancy within the past 2 years

Keywords: musculoskeletal pain; soft tissue inflammation; idea-033
joint effort 2.0: a mobile application with university students

Conditions: Cannabis Use; Cannabis; Cannabis Dependence; Cannabis Smoking; Cannabis Use, Unspecified

Summary: the purpose of this study is to evaluate quantitatively and qualitatively a mobile application, joint effort, targeting safe cannabis use among consumers. this randomized controlled trial is currently conducted on the joint effort mobile application.

this online randomized controlled trial with parallel groups is conducted in quebec (canada). interested participants are invited to visit the study's website at www.etudejointeeffort.ca the study's website contains text explaining the study. after accepting the conditions and consenting, participants will enroll in the study by providing an email address and a pseudonym. each participant will be validated through an email address check. after their enrolment, participants will receive a hyperlink via email to invite them to complete a baseline questionnaire. after completing the baseline questionnaire, participants will be randomly assigned by the computer system either to an experimental group (joint effort mobile application) or to a control group (brief normative feedback and standard information). four weeks and eight weeks after the baseline questionnaire, participants will complete the online questionnaires again.

Eligibility criteria:
inclusion criteria: * aged between 18-35 years old * be a non-medical cannabis user and have used in the last month * understand, read and write french * own a smartphone (iphone) exclusion criteria: * none
non-invasive sacral nerve stimulation in children and adolescents with chronic constipation

Conditions: Chronic Constipation With Overflow; Encopresis With Constipation and Overflow Incontinence; Hirschprung's Disease; Anorectal Malformations

Summary: the purpose of this study is to assess the efficacy of additional neuromodulation for treatment of chronic constipation in pediatric patients

patients are selected according to the eligibility requirements. after being informed about the study and potential risks of neuromodulation, all included patients and next of kin give written informed consent to the study. at baseline, patients are classified to one of the two predefined subgroups: either medical and behavioral therapy is extended and optimized or neuromodulatory treatment is started with non-invasive sacral nerve stimulation via single current and two external adhesive electrodes. within 12 weeks, treatment success is evaluated in routine clinical check-ups (week 4/8/12) and via specialized questionnaires and bowel movement diaries. quality of life is evaluated at baseline and after 12 weeks of treatment.

Eligibility criteria:
inclusion criteria: * age between 2-17 years * informed consent * chronic constipation according to the rome iv criteria for more than 3 months with or without encopresis/soiling * refractory to conventional treatment in a sufficient application (training for bowel movements, lifestyle changes, pelvic floor training) * exclusion of metabolic, inflammatory and hormonal causes for chronic constipation (such as e.g., celiac disease, cystic fibrosis, hypothyroidism) * in cases of underlying hirschsprung's disease: confirmation of diagnosis via rectal biopsies * in cases of anorectal malformation: post-surgical status exclusion criteria: * metabolic, inflammatory and hormonal causes for chronic constipation with further therapeutic options * toxic megacolon or further emergencies, which must be treated surgically * fractures or substantial differences in the sacral anatomy * inflammatory bowel disorders * rectal prolapse * neuronal malignancies under medical and radiation therapy * seizures

Keywords: sacral nerve stimulation neuromodulation