Kornimate/medical-research-clean huggingface dataset:
sleep extension and behavior of young children

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this pseudo-randomized intervention study examined change in inhibitory control following a sleep manipulation in which children with and without adhd were instructed to advance their bedtime by 90 minutes for five days.

objective: to evaluate the efficacy of a sleep extension intervention in young children with adhd and determine whether sleep extension improves inhibitory control, a primary deficit in adhd. design: children with and without adhd completed two 5-day assessments: a baseline condition in which children followed their normal bedtime routine and a sleep extension condition in which children were instructed to go to bed 90 minutes earlier than their habitual bedtime. sleep was assessed with actigraphy and, on the final night, polysomnography. a go/no-go task was used to assess inhibitory control. setting: participants slept in their home on nights 1-4 and in the sleep laboratory on night 5 of each condition. main outcomes and measures: of interest is actigraph measurement of total sleep time for the baseline compared to the sleep extension condition. polysomnography will be used to compared changes in sleep physiology. the primary behavioral outcome is inhibitory control, indexed by accuracy on no-go trials in the go/no-go task.

Eligibility criteria:
inclusion criteria: * a subset of children were required to have an adhd diagnosis exclusion criteria: * diagnosis of intellectual disabilities or developmental delay * current diagnosis of history of sleep disorder * uncorrected hearing or visual impairments
topical ethanol extract (piper crocatum) for anogenital warts

Conditions: Anogenital Wart

Summary: this clinical trial aims to assess the efficacy of topical piper crocatum in treating anogenital warts. it aims to answer * the clinical efficacy of treating anogenital warts * the expression of foxp3+ regulatory t (treg), tgf/tumor growth factor -β1, and ifn/interferon -γ of anogenital wart lesion participants will be allocated into two topical treatments, intervention and active comparator trichloroacetic acid (tca) 90%. the researchers assume that intervention is superior compared to tca 90%

study design : a randomized controlled trial population: diagnosed with condyloma acuminata (international classification of disease 10 code a.63.0) intervention period : 8 weeks of daily topical intervention with follow-up at week 12 detailed formulation 1. extraction of piper crocatum with ethanol assisted in a microwave-assisted extraction (mae) 2. the dissolution and active substances are separated by evaporation using a rotary evaporator to obtain the extract in the form of a thick solution 3. freeze-drying is performed to obtain a stable thick extract 4. preparation of ointment by adding formulation of ethanol extract of red betel leaves with 50 mg of white vaseline to achieve 30% concentration settings: outpatient care at the designated hospital participants: consecutive recruitment sample size estimation: following the formula of two different means, with the indicator, as follows: 1. type 1 error 5% 2. power of study 80% 3. assuming the effect size of cohen d (in reducing the size of warts) is 0.5 4. equal allocation between two arms total sample: 100 participants proposed analysis: intention to treat (itt) with sensitivity and subgroup analysis

Eligibility criteria:
inclusion criteria: 1. men and women diagnosed with external anogenital warts 2. clinical lesions of anogenital wart at least 3 lesions with a size of 1-5 cm 3. in patients with hiv, cluster of differentiation 4 (cd4)cell count \>350 cells/mm and have been taking antiretroviral (arv) drugs regularly for 3 months, exclusion criteria: 1. pregnant or lactating women 2. lesions located in the external urethral orifice and vagina 3. using systemic immunomodulators/immunosuppressants the protocol treatment will be discontinued if patients a. withdraw their consent based on the patient's demand d. severe adverse events occurred or allergies to the components of the test product b. after undergoing clinical trials, the patient experienced things that caused him/her to no longer meet the criteria set out in this protocol. c. subjects do not comply the established study protocol

Keywords: anogenital wart trichloroacetic piper crocatum clinical efficacy inflammatory marker
personalized nutrition prediction for metabolic syndrome patients, an open single-center study

Conditions: Metabolic Syndrome

Summary: this clinical study is designed to evaluate the providing of a computational prediction engine for optimization of personalized nutrition personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions will be provided on a bi-weekly basis, all lab tests and dietician control will be performed twice a month.

pre-diabetic and pre-metabolic syndrome patients will be recruited to the study for a period of one year. after measurement of individual's parameters changes as blood tests, gut microbiome, urine tests, blood pressure, heart performance, body circumferences, mood and mental status as well as monitoring each individual's food intake - a model to predict individual's body reaction according to lifestyle, eating and activity habits will be built. personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions will be provided on a bi-weekly basis, all lab tests and dietician control will be performed twice a month.

Eligibility criteria:
inclusion criteria: 1. adults age 18-65 2. hba1c between 5.5 and 7%. 3. altered lipid metabolism 4. bmi \> 25 5. signed informed consent exclusion criteria: 1. pregnancy 2. usage of antibiotics within three months prior to participation 3. chronically active inflammatory or neoplastic disease in the three years prior to enrollment 4. chronic gastrointestinal disorder, including inflammatory bowel disease and celiac disease 5. skin disease, including contact dermatitis, precluding proper attachment of the continuous glucose monitor 6. active psychiatric disorder 7. myocardial infarction or cerebrovascular accident in the 6 months prior to participation 8. chronic immunosuppressive medication usage 9. clinical depression
use of direct oral anticoagulants (doacs) in patients with ph-negative myeloproliferative neoplasms

Conditions: Myeloproliferative Neoplasm

Summary: patients with myeloproliferative neoplasms (mpn) are predisposed to have an increased thrombotic and hemorrhagic risk and, in this context, the use of newly approved direct oral anticoagulants (doacs) may have improved bleeding risk compared to warfarin use. however, the published experience is very limited and does not allow any conclusion. in the cohort of patients with mpn and venous thromboembolism (vte) of european leukemia-net, only 3.3% of patients had been treated with doacs. similarly, in a recent publication of a series of 760 patients with single-center mpn, only 25 (3.3%) were treated with a doac (13 for atrial fibrillation and 12 for thrombotic events). while it is known that the risk of thrombotic recurrence and haemorrhagic event during warfarin treatment is about 30% at 5 years from the first event, the actual risk of such events in mpn patients is not known. the aim of the present study is therefore to obtain information on patients with mpn treated with doac for atrial fibrillation (af) and vte. this is an international multi-center retrospective survey aimed at describing the efficacy / safety of doac in the prevention of: * cardioembolic stroke in patients with mpn with af * recurrent thrombosis in patients with mpn with vte * major bleeding in all patients with mpn. the results will allow to design future prospective studies that evaluate the benefit / risk profile of doac compared to warfarin in these pathologies characterized by high risk of thrombosis and, in some subgroups, of bleeding.


Eligibility criteria:
inclusion criteria: * diagnosis of philadelphia-negative mpn according to world health organization (who) 2008 and/or 2016 criteria until 31/12/2018; * diagnosis of atrial fibrillation (af) and/or diagnosis of venous thromboembolism (vte) including thrombosis of deep veins of the limbs and the abdomen, cerebral and splanchnic veins (hepatic, portal, mesenteric, and splenic veins) and pulmonary embolism; * treatment with doacs. exclusion criteria: • administration of doac for any medical reason other than af and/or vte (excluding superficial vein thrombosis)

Keywords: efficacy and safety profile direct oral anticoagulants real world data
executive training and brain in children

Conditions: Healthy Children; Preterm Birth

Summary: the purpose of this study is to determine whether a daily executive training to cognitive inhibition, working memory or mindfulness as compared to an active control condition has a near- and far-transfer impact on brain and behavioral measures as collected in children aged 9-10 years, either born preterm or full-term.


Eligibility criteria:
inclusion criteria for all children: * male or female * aged 9-10 years at inclusion * french school curriculum (since 1st grade) * fully informed through the dedicated booklet * both parents gave their written consent * normal medical, neurological and brain imaging assessment inclusion criterion for non preterm children only: - full term pregnancy with no abnormal event (\>= 37 weeks of amenorrhea) inclusion criterion for preterm children only: - delivery before 33 weeks of amenorrhea exclusion criteria for all participants: * age over or under 9-10 years old at inclusion * monozygotic twins * restrictions to a magnetic resonance brain imaging exam: claustrophobia, metallic elements (cardiac implants, cochlear implants, metallic elements in the brain or the eyes and being close to the nervous system, metallic prothesis, braces), restless participants. * sudden cognitive impairments due to a stroke, head injury associated with loss of consciousness for more than one hour or encephalitis. * chronic neurological, psychiatric, infectious or liver condition, endocrine disruption. * past or current medical condition: cancer, diabetes, chronic lung condition, cardiac, metabolic, hematological, endocrine or immunological disorder. * medication assumed to interfere with brain imaging measures (psychotropics, hypnotics, anxiolytics, neuroleptics, benzodiazepine, steroidal anti-inflammatory, anti-epileptics, painkillers, muscle relaxants). * left-sided handedness * colour blindness or non-corrected visual disturbances * diagnosed developmental disorders * diagnosed cerebral palsy * diagnosed fine motor disturbances * parents not affiliated to the social security * parents not able to join at each time of the study

Keywords: learning executive functions cognitive control prefrontal cortex typically developing children genotype functional magnetic resonance imaging structural magnetic resonance imaging inhibition working memory metacognition mindfulness preterm children developmental psychology developmental cognitive neuroscience touch screen tablet adaptive training
mesalamine pellet formulation to maintain remission of mild to moderate ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.

this is a phase 3, multicenter, double-blind, randomized, placebo controlled study evaluating the effectiveness and safety of emg 1.5 g given once daily (qd) compared with placebo in approximately 300 subjects with demonstrated remission from uc. eligible subjects are randomized in a 2:1 ratio (active:placebo) to receive 1 of 2 treatments: 1.5g emg qd (four capsules total) or matching placebo capsules qd for 6 months. the study consists of a screening phase (completed within 7 days prior to randomization), a treatment phase (6 months), and a follow-up visit (2 weeks after end-of-study \[eos\] visit). the treatment phase consists of 4 scheduled study visits: visit 1 (baseline)/randomization (day 1), visit 2 (month 1), visit 3 (month 3), visit 4/eos (month 6). primary objective: to compare the maintenance of remission from mild to moderate ulcerative colitis (uc) as measured by rectal bleeding and endoscopic mucosal appearance after 6 months of treatment with encapsulated mesalamine granules (emg) at 1.5 g qd, as compared with placebo. secondary objective: to compare the safety and tolerability of long-term dosing with emg at 1.5 g qd as compared with placebo in the maintenance of remission from mild to moderate uc.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ulcerative colitis and in remission for at least 1 month. * greater than 18 years of age. exclusion criteria: * allergy/intolerance to aspirin, mesalamine or other salicylates. * prior bowel surgery other than appendectomy. * pregnancy, at risk of pregnancy or lactating. * hiv or hepatitis b or c.

Keywords: uc ulcerative colitis ibd inflammatory bowel disease
phase 1 study of l-nmma in patients with liver cirrhosis

Conditions: Liver Cirrhosis

Summary: phase 1 study of the effects of nitric oxide inhibition with l-nmma in patients with liver cirrhosis and healthy controls. it is hypothesized that nitric oxide availability is increased in liver cirrhosis.

in a randomized, placebo controlled design the acute effects of ng-monomethyl-l-arginine are studied on: * renal hemodynamics (gfr and rpf) * blood pressure and heart rate * lithium clearance * plasma levels of vasoactive hormones

Eligibility criteria:
inclusion criteria: healthy controls * age 20 to 60 years * both men and women * weight below 100 kg * normal clinical examination and laboratory screening * fertile women only if using contraception * informed consent according to the regulations of the local ethics committee liver cirrhosis * biopsy verified liver cirrhosis or clinical and laboratory signs of liver cirrhosis including hypoalbuminaemia, increased prothrombin time in combination with esophagusvarices or ascites * p-creatinine \< 250 µmol/l * age 20-60 years * both men and women * fertile women only if using contraception * body weight below 100 kg * informed consent according to the regulations of the local ethics committee exclusion criteria: healthy controls * history or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening * current medication * drugs or alcohol abuse * pregnancy * previously within one year received more than 0.2 msv radioactive treatment or diagnostic substances * donation of blood less than 1 month before the experiments liver cirrhosis * apart from liver cirrhosis no history of diseases of the heart and blood vessels, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease. * drugs or alcohol abuse * pregnancy * previously within one year received more than 0.2 msv radioactive treatment or diagnostic substances

Keywords: renal hemodynamics nitric oxide
a urine sample collection study in apparently healthy adults and adults with chronic, stable morbidities

Conditions: Healthy; Chronic Disease

Summary: the objective of this study is collect urine samples from healthy adult subjects and subjects with stable chronic morbidities for future testing to serve as controls and establish reference ranges in the development of new invitro diagnostic devices.


Eligibility criteria:
cohort a inclusion criteria: 1. apparently healthy adults (age \> 21 years); 2. provide written informed consent for study participation. exclusion criteria: 1. any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days; 2. any known or suspected significant new onset or chronic morbid medical condition such as those listed in the inclusion criteria for cohort b; 3. trauma-related surgery within the last 6 months; 4. any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months; 5. received any blood product transfusion within the previous 2 months; 6. pregnant women or children; 7. prisoners or institutionalized individuals; 8. already provided a urine sample for this study. cohort b inclusion criteria: 1. adults (age \> 21 years); 2. one or more of the following chronic, stable morbid conditions: i. active cancer ii. arrhythmia (atrial fibrillation, heart block, ventricular tachycardia) iii. chronic coagulation abnormality iv. chronic obstructive pulmonary disease (including emphysema, chronic bronchitis, and asthma) v. chronic pancreatitis vi. chronic renal insufficiency vii. congestive heart failure viii. coronary artery disease ix. diabetes mellitus (type 1 or type 2) x. gout xi. hyper- or hypothyroidism xii. hyperlipidemia (includes hypercholesterolemia) xiii. hypertension xiv. immunocompromised xv. inflammatory bowel disease (including crohn's disease and ulcerative colitis) xvi. liver cirrhosis xvii. neuromuscular disease xviii. peripheral vascular disease (a.k.a. peripheral artery disease) xix. polycystic kidney disease xx. rheumatoid arthritis xxi. systemic lupus erythematosus c. provide written informed consent for study participation. exclusion criteria: 1. any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days; 2. any new onset or unstable morbidities; 3. trauma-related surgery within the last 6 months; 4. any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months; 5. received any blood product transfusion within the previous 2 months; 6. pregnant women or children; 7. prisoners or institutionalized individuals; 8. already provided a urine sample for this study.
efficacy of new silver-coated prosthesis in reducing the incidence of periprosthetic infections

Conditions: Hip Infection

Summary: the aim of the present clinical study, of prospective observational nature with biological study, is to conduct a clinical investigation on the the efficacy of a device coated with bacteriostatic silver coating, with the overall objective of understand whether the device is indeed able to reduce the number of peri-operative and post-operative infections, both early and late.

among the various complications that can arise in orthopaedics following implant surgery, peri-prosthetic joint infections (periprosthetic joint infection -pji) represent one of the most feared complications and the main cause of revision surgeries (15% and 25% of hip and knee revision surgeries, respectively). in this complex context, prevention therefore plays a fundamental role and is a key objective considering the increasing number of patients considered to be at high risk such as the elderly, patients with recurrent infections (urinary, pulmonary, etc.), those suffering from diabetes mellitus or obese, the immunocompromised, or patients who have already undergone prosthetic surgery. in order to reduce the risk of infection, it is therefore essential to adopt and implement preventive strategies that also involve the medical devices themselves, such as the development of passive surfaces capable of counteracting bacterial adhesion or active surfaces capable of exerting a direct action on micro-organisms. to achieve this second type of action, antibacterial agents, such as silver, known for its antimicrobial and bactericidal properties, are used.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years; * immunocompromised patients and/or diabetic patients. * patients who have given consent exclusion criteria: * patients aged \< 18 years; * pregnant women;

Keywords: silver coating primary prosthesis second stage surgery
natural history study and establishment of a biorepository-tango2-related disorder

Conditions: TANGO2-related Disorder

Summary: the study aims to establish a biorepository of individuals with tango2 deficiency to support scientific research and establish a comprehensive clinical database of affected individuals to understand the disease course.

tango2-related disorder is a rare autosomal recessive genetic disorder that can cause recurrent rhabdomyolysis and life-threatening cardiac arrhythmias. metabolic crises can be triggered by prolonged fasting and dehydration. intellectual disability, seizures, hypothyroidism, and gait abnormalities are observed frequently. the function of tango2 is unknown and the pathogenesis of this disease is poorly understood. understanding disease mechanism requires studying disease cells/samples and thus establishing a biobank of tissues (blood and fibroblasts) of individuals affected with tango2 deficiency is paramount. natural history study of tango2-related disorder will allow investigators to understand the course of the disease and develop new therapies in the future to decrease morbidity associated with this genetic condition.

Eligibility criteria:
inclusion criteria: all patients with pathogenic tango2 variants will be included. exclusion criteria: patients who do not have tango2-related disease will be excluded.
the prognostic value of anion gap in predicting mortality among patients with acute pulmonary embolism

Conditions: Acute Pulmonary Embolism (PE)

Summary: this study aims to evaluate the prognostic value of the anion gap in predicting mortality among patients with acute pulmonary embolism. researchers will collect information based on hospital registry as secondary data of in patient who had diagnosed as acute pulmonary embolism by using computed tomography scan (ct scan). the data consist of demographic data, clinical presentation, laboratory, and ct scan were collected from hospital registry by reviewing medical record. then, the data was analyzed by using ibm spss statistics v26.


Eligibility criteria:
inclusion criteria: * age: 18 - 70 years old * patient with acute pulmonary embolism exclusion criteria -- patient with history of: * heart failure * valvular heart disease * chronic obstructive pulmonary disease * congenital heart disease * sepsis * chronic kidney disease

Keywords: anion gap acute pulmonary embolism mortality
treatment of great saphenous vein varicosities

Conditions: Varicose Veins

Summary: venous insufficiency at lower extremities may result in clinical problems from cosmetic issues to ulcerations. when the frequency of venous insufficiency and its related problems are considered besides their diversity, it is encountered as a public health issue. this pathology is reported to affect 40% of women and 20% of men.1 patients with varicose veins may complain of unsightly appearance, aching, heaviness, pruritus, and early fatigue of the affected leg. these symptoms worsen with prolonged standing and sitting and are relieved by elevation of the leg above the level of the heart. also, mild edema is often present. more severe signs include thrombophlebitis, hyperpigmentation, lipodermatosclerosis, ulceration, and bleeding


Eligibility criteria:
inclusion criteria: * patients presented by primary vv of the ll complaining of leg pain cosmetic disfigurement, leg ulcer, itching, or pigmentation at ll * the incompetence of the saphenofemoral junction (sfj) and or saphenopopliteal junction (spj). exclusion criteria: * lower limb involvement by any of the following conditions; secondary vv, recurrent vv, lymphedema, acute superficial thrombophlebitis, arterio-venous fistula (congenital or acquired), congenital anomalies of the venous system, general comorbidities, skin infection or ischemia