Kornimate/medical-research-clean huggingface dataset:
first evaluation of comet-y

Conditions: Self Esteem; Quality of Life

Summary: the goal of this pilot study is to evaluate comet-y in 22 adolescents (11-18 years) with various mental health problems and low self-esteem. the main questions is: does comet-y, parallel to care as usual (cau), improve self-esteem? before and after the training participants fill in questionnaires to measure self-esteem, mental health problems, resilience, quality of life, emotions and individual goals. some of the outcomes are measured through diary methods. youth and therapists will be assessed to evaluate feasibility and acceptability of the comet-y training.

low self-esteem plays an important role in various mental health problems, and targeted treatment of self-esteem could potentially enhance the efficacy of existing treatments. research in adults shows that self-esteem training improves self-esteem and mental health problems, but in adolescents this is still unknown. comet-y is a personalized self-esteem training, specifically developed for adolescents. in this pilot study, 22 adolescents (11-18 years) with various mental health problems and low self-esteem will be included. participants receive comet-y parallel to care as usual (cau). before and after the training participants fill in questionnaires to measure self-esteem, mental health problems, resilience, quality of life, emotions and individual goals. some of the outcomes are measured through diary methods. feasibility and acceptability of the comet-y training will be evaluated with youth and therapists.

Eligibility criteria:
inclusion criteria: * sufficient mastery of dutch to complete the measurements * age between 11 - 18 years * having self-esteem below average (based on a score =\<15 on the rosenberg self-esteem scale; rses) * currently receiving care for a mental disorder, for example (but not limited to) anxiety disorder, depression, eating disorder, attention-deficit/hyperactivity disorder, oppositional defiant disorder, or autism spectrum disorder. * willingness to participate in weekly sessions exclusion criteria: • as intensive treatment can restrain the feasibility of attending the 7 weekly sessions of comet-y and engage in homework assignments, participants who need acute care are excluded (e.g. crisis, acute suicidality, or psychotic episode).

Keywords: adolescents self esteem mental health problems quality of life ecological momentary assesment
3d hd versus 2d hd in laparoscopic inguinal hernia repair: a randomized controlled trial

Conditions: Hernia, Inguinal; Hernia

Summary: the aim of this study is to compare 3d-laparoscopy versus 2d-laparoscopy with the use of hd resolution in inguinal hernia repair in terms of error rating, performance time and subjective assessment.

experimental studies have shown that even experienced surgeons gain from stereoscopy when solving both easy and complex tasks. inguinal hernia repair is a specialist operation and the large flow makes this type of operation suitable for exploring any advantage of three-dimensional laparoscopy for the experienced surgeon.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective inguinal hernia repair (out-patient treatment) exclusion criteria: * previous lower abdominal surgery * asa-score 3 or above

Keywords: 3d three-dimensional laparoscopy inguinal hernia repair
dental device for treatment of sleep apnea

Conditions: Sleep Apnea Syndromes

Summary: this study is being done to see if treatment of obstructive sleep apnea (osa) with a mandibular advancement device (mad) shows an increase in the quality of life. many patients prefer to call them mandibular advancers, jaw advancers, jaw advancement splints, jaw advancement devices, anti-snoring mouthpieces, or oral appliances for the treatment of snoring and mild to moderate obstructive sleep apnea. the investigators will also see how helpful the mandibular advancement device is on insulin resistance.

patients with obstructive sleep apnea (osa) will be included in this prospective controlled trial. osa patients who are unable to tolerate cpap or refuse cpap(continuous positive airway pressure) (and who are deemed appropriate by their attending physician for dental device treatment of osa will be randomized to a control group (no mad treatment) or to active mad therapy. epidemiologic studies suggest that osa is associated with insulin resistance independent of other known risk factors such as obesity. the cyclic intermittent hypoxia in osa is the primary stimulus that leads to insulin resistance, a primary risk factor for the development of type 2 diabetes. there is an association between the level of hypoxic stress in osa and insulin resistance. the overall hypothesis to be tested is that treatment of osa with mad will improve insulin sensitivity, increase levels of hmw (high-molecular- weight) adiponectin, and improve psychological adjustment.

Eligibility criteria:
inclusion criteria: * apnea-hypopnea index (ahi) of at least 20 events/hr based on overnight polysomnography * \> 18 years of age * unable to tolerate or refuse cpap treatment exclusion criteria: * known diabetes mellitus * body mass index (bmi) \> 45 kg/m2 * uncontrolled hypertension * known congestive heart failure * use of illicit drugs * excessive alcohol consumption, defined as: * more than 3 glasses of wine a day * more than 3 beers a day * more than 60 ml of hard liquor a day * room air oxyhemoglobin saturation \< 90% * use of home oxygen * use of corticosteroids * unable to give voluntary consent

Keywords: sleep apnea syndromes insulin resistance mandibular advancement device
eight weeks of elbasvir/grazoprevir in the treatment of hcv genotype 4

Conditions: Hepatitis C, Chronic

Summary: to evaluate the safety and efficacy of a daily, fixed-dose, 8-week course combination of elbasvir/grazoprevir in treatment-naïve, non-cirrhotic patients who are mono-infected with hepatitis c, genotype 4.

the treatment of hepatitis c has gone through significant advances in the last few years with the development of direct-acting antivirals "daas." since 2013, many daas have been approved for the treatment of hcv with excellent efficacy and safety profiles. the major hurdle in treating patients on a large scale is the high cost of the current treatment regimens. multiple approaches have been proposed, among them, a shortened treatment regimen of 6 to 8 weeks rather than the standard 12-week-regimen. the strategy of shortening the treatment will help in reducing the cost by 33% to 50%. thus, it will increase the availability of the treatment to more patients. zepatier is a combination drug of elbasvir (ebr), an ns5a inhibitor, and grazoprevir (gzr), a potent ns3/4a inhibitor. this study is being proposed to address two main issues. first, collecting information on the safety and efficacy of a shortened course of zepatier (8 weeks instead of the standard 12 weeks) in patients who are treatment-naïve, non-cirrhotic and mono-infected with hcv. second, to investigate whether this course provides similar clinical outcomes to the standard regimen in hcv-genotype 4, which is the most common genotype in saudi arabia.

Eligibility criteria:
inclusion criteria: 1. age above 18 years. 2. chronically infected with hcv genotype 4. 3. treatment naïve. 4. no advanced fibrosis. defined by the absence of clinical, radiological and laboratory signs of cirrhosis, and fibrosis assessment consistent with fibrosis stage (metavir f2) or less by liver biopsy or transient elastography. 5. not expected to leave the country for six months after the end of the intervention. exclusion criteria: 1. incapability of providing an informed consent to participate in the study. 2. advanced fibrosis (metavir f3) or cirrhosis (metavir f4). 3. hiv or hbv co-infection 4. organ transplant recipients. 5. type 2 or 3 cryoglobulinemia with end-organ manifestations. 6. proteinuria, nephrotic syndrome, or membranoproliferative glomerulonephritis 7. patients with a higher risk of transmitting the disease (dialysis patients, incarcerated individuals, and intravenous drug abusers). 8. the use of any medication that has major interactions with elbasvir or grazoprevir as defined by the university of liverpool drug interaction database, and cannot be discontinued or replaced with other alternatives. 9. pregnancy. 10. history of hepatocellular carcinoma.

Keywords: hepatitis c virus chronic hepatitis c genotype 4 treatment-naive non-cirrhotic
cognitive rehabilitation in sickle cell disease

Conditions: Sickle Cell Disease; Cognitive Impairment

Summary: the majority of school-age children with sickle cell disease (scd) experience neurocognitive deficits, even in the absence of stroke. in particular, deficits in attention and working memory have emerged as two of the most common neurocognitive sequelae of scd. thus, the goal of the present proposal is to address feasibility and compliance of a novel computerized cognitive training program, cogmed. pilot data will also be collected to establish preliminary efficacy. twenty-four children meeting initial age and diagnostic criteria will be identified and approached about participation by their attending physician during regularly-scheduled scd clinic visits. baseline assessments will include a brief measure of intellectual functioning, a brief cognitive testing battery evaluating processing speed and working memory, in addition to questionnaires regarding behavior and quality of life. children will then be randomized to the computerized ct program cogmed (n=12) or a waitlist control (n=12). participants enrolled in the computerized ct program will be asked to complete 25-sessions of cogmed over a five to eight week period (3 to 5 sessions per week). following completion of the program, children and their parents will be asked to return to clinic for a follow-up visit. after a five to eight-week waiting period, children in the waitlist condition will also be asked to return to clinic for a second visit. following this assessment, participants initially enrolled in the waitlist will be offered an opportunity to participant in the intervention. if interested, they will follow the same intervention protocol described above. these children will return to clinic for a third visit following completion of the intervention. compliance rate and its confidence interval will be calculated for the overall study population. a t-test for binomial proportion with continuity correction will be used to examine whether the compliance rate is lower than the target. participants' change in criterion outcomes will be evaluated (i.e., those neurocognitive measures such as attention, executive functioning and working memory, that are most closely related to the trained tasks).


Eligibility criteria:
inclusion criteria: * 1) children with a diagnosis of scd (all genotypes) * 2) a t-score ≥75th percentile on either the metacognition or executive composite of the brief; and/or * 3) a standard score ≥1 standard deviation below the mean (\<90) on the tasks of executive function or wm from the cogstate (mean=100; sd=10) exclusion criteria: * 1) estimated iq ≤ 75), or motor, visual, or auditory handicap that prevents computer use; * 2) a diagnosis of depression or a pervasive developmental disorder (by history); * 3) clinical stroke (via record medical history); or * 4) non-english fluency.

Keywords: sickle cell disease pediatric learning disability cognitive impairment memory attention children with sickle cell disease
new validated recipes for double-blind placebo-controlled low dose food challenges

Conditions: Allergy

Summary: this study aimed to validate new recipes for cow's milk, hen's egg, soy, cod and wheat, to be used in blinded low-dose food challenges.


Eligibility criteria:
inclusion criteria: * children belonging to one of two age groups: 7-8 years or 14-15 years * no previous hypersensitivity reaction to the food to be tested * capacity to understand the test instructions and to participate in the test sessions exclusion criteria: * children not belonging to one of the two age groups: 7-8 years or 14-15 years * one or more previous hypersensitivity reaction to the food to be tested * unability to understand the test instructions and to participate in the test sessions

Keywords: double-blind placebo-controlled food challenges food allergy food hypersensitivity triangle test validated recipes
newborn sequencing screening in china

Conditions: Newborns

Summary: the project will carry out the genetic testing of 10000 neonates. the aim of the project is to assess the application of targeted sequencing technology in the screening of neonatal diseases.

neonatal screening (nbs) is the last step of birth defects prevention. currently, biochemical and mass spectrometry are commonly used for nbs, but there are limited diseases and certain false positive/negative. high-throughput sequencing (ngs) has been widely used in prenatal diagnosis, tumor-targeted biomarkers detection and pathogen detection. although the application of ngs in new screening has a broad prospect and many countries around the world have begun to explore it, there are still challenges in the selection of screening diseases, gene clinical phenotypes, genetic counseling and clinical pathway. since 2019, our team began to explore the appllication of ngs technologies in the clinical application of tertiary prevention, combined with clinva, hgmd, omim database, on the basis of screening specific disease-causing genes and mutation sites as the target, a ngs panel for newborns in china (neoexome) was designed, covering 542 single-gene diseases with 601 genes. the rationality and validity of the ngs panel was preliminarily verified in 3423 neonatal blood samples collected from 5 new screening centers in china. in order to further optimize the gene screening spectrum of neonatal diseases in the chinese population, evaluate the efficacy of targeted sequencing technology in the screening and diagnosis of neonatal diseases, standardize the clinical pathway, and lay a foundation for the formulation of china's new screening ngs guidelines, the investigators further optimized the targeted sequencing package (neoexome-v2) on the basis of the first phase. 491 genes covering 485 single-gene genetic diseases were designed to launch the "budding action". the project plans to collect 10000 samples nationwide and carry out the multi-center clinical research on the application of targeted sequencing technology in the screening of neonatal diseases.

Eligibility criteria:
inclusion criteria: * -- subjects: all newborns (from birth to 28 days); * -- after fully understanding the program, the guardian signs the informed consent and agrees to participate in the program. exclusion criteria: * other similar clinical research projects are under way for the examined neonates; * neonates have received transfusion of allogeneic blood products; * newborns whose guardians explicitly refuse to participate in the program after receiving the mission. elimination criteria * samples that are not properly collected or stored for testing; * samples with non-standard data records; * samples without clinical follow-up results; * the project recalls newborns who are required to withdraw by their guardians during the follow-up.
modified atkins diet treatment for adults with drug-resistant epilepsy

Conditions: Epilepsy; Focal Epilepsy; Generalized Epilepsy

Summary: in oslo university hospital, department of complex epilepsy, offer ketogenic diet to treat children with medically intractable epilepsy. from 2009 we added modified atkins diet as a treatment option for children up to 18 years. we now initiate an open, prospective, randomized and controlled study with the aim to test the efficacy of treatment with modified atkins diet in adults with focal and generalized epilepsy diagnoses, in order to evaluate whether this treatment should be offered to patients on a permanent basis.

poorly controlled epilepsy in adults affects health and quality of life in many ways. within this heterogenous population there are individuals who are motivated for a very strict diet in order to reduce seizures. among adults with epilepsy 75 - 80 % are diagnosed with focal epilepsy, while 20 - 25 % have generalized onset of seizures. we plan to include 92 patients with focal epilepsy diagnosis. those are randomized into diet and control groups. during the inclusion period we also treat patients with generalized epilepsy that qualify for participation, but these are not to be randomized, rather they will follow the diet group course. we assume 18 - 23 patients with generalized epilepsy will be included in the project.

Eligibility criteria:
inclusion criteria: * focal or generalized epilepsy diagnosis * more than 3 recordable seizures per month * bmi \> 18,5 * not responded to at least three 3 aeds * 16 years or older * motivated to complete the diet after thorough information * capable of recording seizures * capable of preparing the diet exclusion criteria: * hypercholesterolemia, cardiovascular disease or kidney disease * been on modified atkins diet for more than one week during the last year * status epilepticus last six months * epilepsy surgery or vns implant last year * 4 weeks continuous seizure freedom last 2 months * pnes seizures * other disease where dietary treatment is contraindicated * usage of drugs or supplements that may interfere with diet or aed * being pregnant or planning pregnancy

Keywords: rct modified atkins diet epilepsy adults ketogenic diet
strategy for cardiovascular disease prevention through tailored health management in individuals with elevated risk

Conditions: Cardiovascular Diseases; Risk Reduction; Primary Prevention

Summary: the china peace smarter trial is a cluster ramdomized trial aiming to assess the effectiveness of village doctor-led tailored health management on risk reduction of high-risk individuals for cardiovascular disease.

in this study, investigators aim to develop a series of intervention strategies for cardiovascular disease (cvd) prevention through village doctor-led tailored health management in individuals with elevated risk, then assess their effectiveness through a cluster randomized trial. investigators hypothesize that the village doctor-led tailored health management can reduce the cvd risk and improve risk factor control of the high-risk subjects through 12 months of follow-up. around 4200 subjects from 120 villages in mainland china who are considered to be eligible according to inclusion and exclusion criteria will be enrolled to the study. the eligibility criteria is: individuals aged 35 or above who are in high risk for cvd (10-year ascvd risk ≥10%), able to use smart phone, and contracted with the local family doctor. patients with history of cvd or severe illnesses, pregnancy, cognition or communication problems are excluded from the study. the selected villages will be assigned (1:1) to either control group (usual care) or intervention group (village doctor-led tailored health management). the primary outcome is the change in 10-year ascvd risk from baseline to 12 months. follow up visits will be conducted every 3 months.

Eligibility criteria:
inclusion criteria: * aged 35 or above; * high cvd risk which defined as 10-year ascvd risk ≥10% based on china-par prediction model; * ownership of a smart phone and being able to use apps; * being contracted with the local family doctor (village doctor); * willing to participate and able to sign informed consent. exclusion criteria: * cvd history, including myocardial infarction (mi), stroke, heart failure, severe arrhythmia, or peripheral artery disease, or having received percutaneous coronary intervention (pci) or coronary artery by-pass grafting operation (cabg); * severe illnesses, such as cancer, or severe hepatic and renal dysfunction; * women during pregnancy, lactation, or plan to have children in the next year; * having problems in cognition or communication, or limited daily activities.
application of standardized cleaning and disinfection mode of hft surface in hospital infection prevention and control

Conditions: Hospital Infection

Summary: the scientific, feasible and effective mode of standardized cleaning and disinfection of icu high-frequency contact surfaces is discussed and verified.

this study is a multi-center unified interventional study, using the front and rear control method, it is proposed to improve the icu traditional cleaning and disinfection method on the basis of the icu high-frequency contact surface status survey, explore the best frequency and disinfection method of icu high-frequency contact surface cleaning and disinfection, establish a multi-center unified icu high-frequency contact surface standardized cleaning and disinfection mode, in order to achieve the ideal cleaning and disinfection effect, effective prevention and control of icu hospital infection occurrence and transmission.

Eligibility criteria:
inclusion criteria: * high-frequency contact with the surface of an object by icu patients and their surroundings; informed consent. exclusion criteria: * admission \< 24 hours; \< 18 years old; hospital infection prior to admission to the icu.
probiotic supplementation in children affected by upper respiratory infections

Conditions: Upper Respiratory Tract Infection

Summary: the goal of this randomized non-pharmacological intervention study is to evaluate the effects of probiotic supplements (bifidobacterium breve m-16v, bifidobacterium lactis hn019, lactobacillus rhamnosus hn001) on children affected by upper respiratory tract infections. the main questions it aims to answer are: * probiotic formulation can reduce intensity and duration of fever in children affected by upper respiratory tract infections * probiotic formulation can influence the gut microbiota composition in children affected by upper respiratory tract infections participants will be asked to take probiotic supplements or placebo for 14 days and to collect three fecal samples: before probiotic supplementation (t0), 14 days after probiotic supplementation (t1), and 12 months after the enrollment (t2).


Eligibility criteria:
inclusion criteria: * access to the emergency room with fever and upper respiratory tract infection * age \> 28 days and ≤ 4 years * signature of informed consent by parents or guardian exclusion criteria: * presence of pathologies associated with immunosuppression or ongoing immunosuppressant treatments * hospitalisation/hospitalisation * diarrhea at enrollment * no signed informed consent

Keywords: probiotic children respiratory infection
an efficacy and safety study of gevokizumab in treating active ulcers of pyoderma gangrenosum

Conditions: Pyoderma Gangrenosum

Summary: the study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (pg).


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of classic pyoderma gangrenosum * an active pyoderma gangrenosum ulcer * contraceptive measures adequate to prevent pregnancy during the study exclusion criteria: * clinical evidence of acutely infected pyoderma gangrenosum * history of allergic or anaphylactic reactions to monoclonal antibodies * history of recurrent or chronic systemic infections * female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding other protocol-defined inclusion/exclusion criteria may apply

Keywords: pyoderma gangrenosum classic pyoderma gangrenosum