Kornimate/medical-research-clean huggingface dataset:
a deep brain stimulation system in epilepsy: tracking neural excitability

Conditions: Epilepsy; Nodular Heterotopia

Summary: the main purpose of this research project is to evaluate the safety and effectiveness of a surgically implanted device called the medtronic activa pc+s system in patients with medically refractory epilepsy (people who have seizures that are not completely controlled by medical therapy). the system sends small electrical pulses into a part of the brain called the thalamus to help control seizures. it sends this signal in regularly, regardless of if a seizure is occurring. a different version of this device is already approved for the treatment of epilepsy in australia. this study aims to use the brain's responses to single pulse electrical stimulation to measure the level of seizure susceptibility. the investigators would like to show that this measure can be used to provide more effective deep brain stimulation therapies, to stop seizures.


Eligibility criteria:
inclusion criteria: patients with epilepsy with non-resectable pathologies, or clearly defined focal seizures without a defined structural pathology. patients will be required to have a seizure diary (of up to 3 months) recording at least five seizures per month that are well separated in time (at least 8 hours apart). exclusion criteria: previous diagnosis of psychogenic/non-epileptic seizures
study of liposomal annamycin in patients with refractory or relapsed acute lymphocytic leukemia

Conditions: Acute Lymphocytic Leukemia

Summary: this is a phase i/ii multi-center, open label, dose escalation study to identify the maximum tolerated dose (mtd) of liposomal annamycin and to evaluate the safety of liposomal annamycin in patients with refractory or relapsed acute lymphocytic leukemia.

this is a phase i/ii, multi-center, open-label, dose escalation, mtd study of liposomal annamycin in refractory or relapsed all patients. enrollment will occur in cohorts of approximately 3 patients with 10 additional patients enrolled at the mtd. the liposomal annamycin doses will be escalated in sequential cohorts. four dose levels of liposomal annamycin are planned: 190, 230, 280, and 310 mg/m2/day.

Eligibility criteria:
inclusion criteria: * diagnosis of refractory or relapsed all (acute lymphocytic leukemia) * age greater than or equal to 15 years * no chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of study drug and recovered from toxic side effects of that therapy, unless treatment is indicated due to progressive disease. * no investigational therapy within 4 weeks of first dose of study drug * ecog performance status (ps) 0 to 2. * adequate liver function * adequate renal function * signed informed consent exclusion criteria: * concommitant therapy that includes other chemotherapy that is or may be active against all (except central nervous system \[cns\] therapy) * any condition which in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study. * cardiac ejection fraction less than 40% * clinically relevant serious co-morbid medical conditions. * pregnant, lactating or not using adequate contraception. * known allergy to doxorubicin or anthracyclines.

Keywords: refractory or relapsed acute lymphocytic leukemia
physical activity in fontan patients

Conditions: Heart Defects, Congenital

Summary: the purpose of this study is to determine which is the most effective intervention for increasing lifestyle physical activity in fontan patients: an education (stage of change) intervention or a physical activity (mastery experience) intervention.

over 100,000 canadian children are living with congenital heart defects and approximately 1.5% of them have a univentricular heart. the fontan procedure allows children with functionally univentricular hearts to live relatively normal lives. however, the cardiopulmonary physiology remains abnormal and chronic complications, including myocardial dysfunction, arrhythmias, pathway abnormalities, hepatic dysfunction, obstruction of the ventricular outflow tract or pulmonary veins, and pulmonary arteriovenous malformations may significantly reduce maximal exercise capacity and quality of life. quality of life and life-long heart health are, therefore, critically important for fontan patients as their survival depends on the continued functioning of an already sub-normal cardiopulmonary physiology.

Eligibility criteria:
inclusion criteria: * have undergone a successful fontan procedure prior to 5 years of age * 6 to 10 years of age at the start of the study * sufficient cardiopulmonary function (based on pulmonary function tests prior to the standardized cardiorespiratory exercise test) for safe participation in moderate to vigorous physical activity exclusion criteria: * disabilities or medical conditions that may influence physical activity participation.

Keywords: pediatrics fontan procedure physical activity physical fitness congenital heart defects exercise rehabilitation
prevention and treatment of digital ulcers in systemic sclerosis

Conditions: Systemic Sclerosis; Ulcer

Summary: systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs. digital ulcers are frequent and have a major impact on the quality of life in patients with systemic sclerosis. the etiology of digital ulcers is complex and multifactorial and the principal mechanisms underlying the digital ulcers formation are ischemic, mechanic and inflammatory, alone or in combination, on the basis of the systemic sclerosis vasculopathy. consequently, there are at least three types of du: (i) those localized at the tips of the fingers and toes, mainly resulting from an ischemic process, (ii) those localized on the dorsal aspect of the fingers where the skin retraction due to fibrosis over bony prominences seems to be the main cause, and (iii) those evolving on a pitting scar or subcutaneous calcinosis due to a combined irritative-inflammatory mechanism. an early therapy to prevent or rapidly heal digital ulcers is today considered a mandatory approach to maintain quality of life and spare the enormous costs due to conventional digital ulcer management. this observational trial is part of the collaborative project "desscipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. aim of this observational trial is: 1. to identify the best treatment combination for prevention of digital ulcers in patients with fulfilment of the new acr/eular ssc criteria or the preliminary vedoss criteria for very early diagnosis of systemic sclerosis 2. to identify the best treatment associated with improved healing of digital ulcers in patients with fulfilment of the new acr/eular ssc criteria thus, the observational trial consist of a prevention arm and a healing arm.


Eligibility criteria:
inclusion criteria: * juvenile and adult patients with diagnosis of systemic sclerosis according to the acr/eular ssc criteria or the pres/acr/eular juvenile ssc criteria for enrollment into the prevention and healing arm * patients with fulfilment of the preliminary criteria for very eary diagnosis of systemic sclerosis (vedoss criteria) for enrollment into the prevention arm patients with active digital ulcers will be allocated into the healing arm. patients without previous or history of digital ulcers (but currently without active digital ulcers) will be allocated into the prevention arm. definition of digital ulcers (du): du are 1) loss of tissue, 2) du derived from digital pitting scars and 3) du derived from calcinosis. in this study we consider only du (1) loss of tissue. the other du (2) and du (3) are registered in the data base if they are present, but are excluded from evaluation.
extension study of ns-089/ncnp-02 in dmd

Conditions: Duchenne Muscular Dystrophy (DMD)

Summary: this is the extension study of ns-089/ncnp-02 (study ncnp/dmt02), which is designed to assess the safety, tolerability and efficacy of ns-089/ncnp-02 in patients with duchenne muscular dystrophy (dmd).


Eligibility criteria:
inclusion criteria: 1. patient completed study ncnp/dmt02 exclusion criteria: 1. patient had any serious adverse events in study ncnp/dmt02 that, in the opinion of the investigator and/or sponsor, was probably or definitely related to ns-089/ncnp-02 use and precludes safe use of ns-089/ncnp-02 for the patient in this study. 2. patient had a treatment which was made for the purpose of dystrophin or dystrophin-related protein induction after completion of study ncnp/dmt02. 3. patient took any other investigational drugs after completion of study ncnp/dmt02. 4. patient was judged by the investigator and/or the sponsor that it was not appropriate to participate in the extension study for other reasons.
role of gtr on healing outcome & quality of life in combined endo perio lesions with communication

Conditions: Periapical Diseases; Endodontic Disease

Summary: the recovery of periapical defects linked to periodontal communication frequently yields less satisfactory results. numerous studies and case reports have highlighted the notable success achieved through the application of guided tissue regeneration techniques. more recently, autologous platelet concentrate plug \& placental membrane have emerged as a treatment option for addressing such lesions. nevertheless, there has been no study using prf-medium with acm membrane on the healing of aforesaid lesion \& quality of life assessment.

research question (pico) does the combined application of prf-medium plug and acm membrane lead to superior healing outcomes compared to conventional technique in treating apico-marginal defects with interproximal involvement? aim \&objectives: - aim to assess whether the combined application of prf-medium and acm membrane leads to improved healing outcomes and enhanced quality of life compared to conventional techniques in patients of apico-marinal defects with interproximal involvement. primary objective 1. to evaluate the impact of combined application of prf-medium and acm membrane on healing outcomes in cases of apico-marginal defects with interproximal involvement with 2d periapical radiographs \& 3d cbct imaging. secondary objective 2. to evaluate and compare differences in quality of life of patients after periapical surgery with use of prf-medium and acm membrane in cases of apico-marginal defects with interproximal involvement. pico p(population)- patients with non-vital teeth and persistant chronic suppurative apical periodontitis with apico-marginal defects and interproximal involvement. i(intervention)-endodontic surgery followed by placement of prf-medium plug and acm membrane. c(comparison)-endodontic surgery without using any plug and membrane. o(outcome)- periapical healing after surgery in both groups.

Eligibility criteria:
inclusion criteria: 1. patients of age 16yrs and above. 2. patients with apico-marginal defects and deep pocket upto apex of tooth. 3. failed primary root canal treatment. 4. presence of interproximal bone loss. 5. negative response to vitality test. 6. asa-1 or asa- 2 according to the classification of the american society of anesthesiologists) exclusion criteria: 1. presence of vertical root fracture 2. presence of root perforations 3. asa-3 or asa-4 according to the classification of the american society of anesthesiologists) 4. presence of root resorption 5. combined endodontic-periodontic lesions. 6. pregnancy

Keywords: guided tissue regeneration healing endo-perio lesions endodontic surgery
model-based versus traditional warfarin dosing in children

Conditions: Congenital Heart Defects

Summary: this study compares the clinical effectiveness of a new algorithm (model-based warfarin dosing) with standard practice (doctor's own judgement and intuition) designed to determine the most appropriate anticoagulant dose of warfarin in children after congenital heart surgery.

warfarin is widely used in children after heart surgery in order to prevent complications that may arise due to blood clots forming in unwanted places - for example in the brain causing a stroke. if too little warfarin is given, there is a risk that clots may form. if the dose is too high, bleeding will result. traditionally, the approach to dosing warfarin in children has been to select a starting dose according to standard guidelines and to then adjust the doses for each child by monitoring the inr (which measures how quickly blood clots). however, a person's make up as well as external factors, such as age, weight, diet and genetics can affect warfarin dosing and this makes controlling the dose and hence controlling the inr, more difficult. recently however, a more sophisticated dosing model has been developed by researchers which takes into account some of these factors. the model is designed to help doctors select the best dose of warfarin for children by individualising prescriptions. the aim of the proposed research is, therefore, to compare the model based warfarin dosing with the traditional approach to warfarin dosing in children who have undergone congenital heart surgery. the research will involve children who are started on warfarin for the first time and also children who are already receiving ongoing warfarin therapy.

Eligibility criteria:
inclusion criteria: -children from birth up to 18 years with congenital heart disease who have been treated or to be treated with warfarin after undergoing reconstructive heart surgery at glenfield hospital, leicester, united kingdom. exclusion criteria: 1. patients aged over 18 years who are treated as 'adults'. 2. children who refuse assent, parents who refuse consent. 3. any significant disease or disorder which, in the opinion of the direct care team, may either put the participant at risk because of study participation or adversely affect the participants' ability to participate in the study.
the impact of covid-19 pandemic on the smoking behaviour of young smokers and the youth quitline service in hong kong

Conditions: Smoking Cessation

Summary: the aims of the present study are: 1. to explore the impact of covid-19 pandemic on the smoking behavior of youth smokers 2. to explore the impact of covid-19 pandemic on the youth quitline service in hong kong

the coronavirus disease 2019 (covid-19) pandemic has spread rapidly across the globe. according to world health organization (who), due to the harmful effects on the lungs and the possible viral transmission from fingers to mouth during smoking, tobacco use is considered a major risk factor for developing covid-19. both tobacco use and covid-19 can cause damage to the cardiovascular and respiratory systems. smokers infected with covid-19 are at higher risk of developing severe covid-19 symptoms or death than non-smokers. the hong kong sar (hksar) government has announced different regulations to combat the spread of covid-19 since late january 2020, which significantly affect the working patterns and everyday lives of people. it remains unknown how smoking habits and smoking cessation services are being affected during the pandemic.

Eligibility criteria:
inclusion criteria: * hong kong resident aged 25 or below * able to communicate in chinese (cantonese) * smoked in the past 30 days exclusion criteria: * have difficulty to communicate via telephone

Keywords: youth smokers covid-19 smoking behaviors
evaluation of the efficacy and safety of fecal microbiota transplantation for constipation in parkinson's disease

Conditions: Parkinson Disease

Summary: participants will be allocated to fmt group or placebo group at a 1:1 ratio. for interventional group, patients will be given six fmt capsules twice a week for 24 weeks. placebo capsules are identical in appearance and smell but contain milk powder. at each follow-up visits, participants complete specific scales to assess improvement in constipation, emotion and quality of life. besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa.

this prospective, double-blind, randomised, placebo-controlled study aims to evaluate efficacy and safety of fecal microbiota transplantation for constipation in parkinson's disease. participants will be given either fmt capsules or placebo capsules at a ratio of 1:1. for experimental group, patients will be given six fmt capsules twice a week for 24 weeks. placebo capsules are identical in appearance and smell but contain milk powder. after 24-week treatment, participants complete specific scales to assess improvement in constipation, other pd symptoms, emotion and quality of life. besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa.

Eligibility criteria:
inclusion criteria: 1. participants who fulfill chinese diagnostic criteria for pd (2016 edition), aged 40-75 years; 2. pd hoehn-yahr stage 1-3 3. participants who have at least 2 of the following symptoms in the past 3 months and the symptoms have been present for at least 6 months: ① more than 25% of defecations are laborious; ② more than 25% of defecations consist of hard or lumpy stools; ③ more than 25% of defecations are accompanied by a sensation of incomplete evacuation; ④ more than 25% of defecations are accompanied by a sensation of anorectal obstruction; ⑤ more than 25% of defecations require manual assistance; ⑥ less than 3 spontaneous bowel movements per week. 4. have taken a stable dose of anti-parkinson drugs, antidepressants and antipsychotics for at least 1 month; 5. absence of red flags such as weight loss, hematochezia and exclusion of other diagnosis; 6. have signed the informed consent and agree to participate in this study; exclusion criteria: 1. parkinsonism-plus syndrome; 2. stroke, brain trauma or epilepsy; 3. have undergone surgery intervention due to pd; 4. pregnant, planning pregnancy or lactating; 5. psychiatric disorder or unable to cooperate with treatment and follow-up visit; 6. immunodeficiency or treatment with immune-modulating medication; 7. have undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy; 8. presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease; 9. use of probiotics or antibiotics within 1 month prior to study entry; 10. presence of severe diseases related to heart, brain, kidney and lung or concomitant malignancies;
a study to learn more about the relationship between the development of a gap in the upper lip (cleft lip) or in the roof of the mouth (cleft palate) in newborns and the use of glucocorticoids by the mother during pregnancy: a meta-analysis

Conditions: Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development

Summary: glucocorticoids are drugs that have many effects on body metabolism, raise sugar level in the blood, and reduce inflammation. by applying a statistical technique for combining the findings from a systematic literature review (meta analysis), researchers want to learn more about the relationship of the risk to develop a separation in the roof of the mouth (cleft palate) in newborns and contact with glucocorticoids during pregnancy.


Eligibility criteria:
inclusion criteria: * population: pregnant women * intervention: any glucocorticoid or corticosteroid or steroids use irrespective of mode of administration * comparator: any/none * outcomes: incidence/ risk of cleft lip/palate in infants * study design: * meta-analysis and systematic literature reviews * observational studies (such as cohort study, case-control study, registries data) * clinical trials - phase iib, iii, and iv * conference abstracts/posters * time period: no time period restriction * geography: no geography restriction exclusion criteria: * population: nonpregnant women * intervention: drugs other than glucocorticoid or corticosteroid or steroid * outcomes: incidence/ risk of cleft lip/palate in infants * study design: * animal study * in vitro studies * editorial, letters, comment * clinical trials - phase i or preclinical * case reports, case series * reviews * studies focusing on: * diagnosis and surgical procedure for cleft repair * impact of increased internal corticosteroids due to stress * the relationship between genetic mutations and cleft patients * adverse events for other drugs * safety profiles of glucocorticoid or corticosteroid
male lichen sclerosus - risk factors, treatment, and impact on quality of life

Conditions: Lichen Sclerosus

Summary: this observational study aims to evaluate routine treatment outcomes in men with lichen sclerosus (ls), including a long-term follow-up to assess disease progression and histopathological changes. the study also investigates potential risk factors for ls and the disease's impact on quality of life and sexual health.

lichen sclerosus (ls) is a chronic inflammatory and scarring dermatosis with a predilection for the anogenital area. while both sexes can be affected, this study focuses on men, in whom ls can cause phimosis and may require circumcision. topical corticosteroids are first-line treatment, but there is a lack of long-term studies evaluating the efficacy of circumcision in male ls. in addition, risk factors and the impact of ls on quality of life and sexual health are insufficiently studied. this observational cohort study aims to follow male patients with ls over time to assess treatment outcomes, disease progression, and the potential development of epithelial atypia. patients aged 18 years or older, swedish-speaking, and diagnosed with ls will be recruited from both the urology and dermatology departments in västerbotten county, sweden. at the urology department, patients undergoing circumcision for phimosis will be included; at the dermatology department, all men diagnosed with ls will be invited to participate. all participants will provide written informed consent and will receive treatment according to standard clinical routines and national or international guidelines. participants will complete a standardized questionnaire regarding symptoms, quality of life, and sexual health. a control group of age-matched, swedish-speaking men without genital symptoms will also complete the same questionnaire once but will not be followed longitudinally. for exploratory analyses, patients recruited from the urology department will also provide biological samples (e.g. foreskin, urine, feces) at baseline to facilitate future investigations of microbiome composition and metabolic profiles.

Eligibility criteria:
inclusion criteria for patients with ls (ls urology and ls dermatology): * biologically male * ≥18 years old * referred to the dermatology department or the urology department in västerbotten and diagnosed with ls. * must be able to read and write swedish to fill in questionnaire and informed consent. inclusion criteria for control group "controls - urology": * biologically male * ≥18 years old * phimosis without ls, treated with circumcision at the urology department in västerbotten * must be able to read and write swedish to fill in questionnaire and informed consent. inclusion criteria for control group "controls - general population": * biologically male with male genitalia * ≥18 years old * no genital symptoms * must be able to read and write swedish to fill in questionnaire and informed consent. exclusion criteria for all groups: * age under 18 years old * not able to read and write in swedish. * unable to leave an informed consent to participate.

Keywords: lichen sclerosus