Kornimate/medical-research-clean huggingface dataset:
validation of a salivary mirna diagnostic test for asd

Conditions: Autism Spectrum Disorder; Developmental Delay

Summary: this study involves sample collection to identify biomarkers relating to autism spectrum disorder(asd) in the saliva of children who are between the ages of 18 months to 6 years and 11 months. participants will at each timepoint have a non-invasive saliva swab collected and complete a brief demographic and medical history questionnaire as well. children in the pediatric/provider setting who will receive a referral for an asd diagnosis because they were determined to have a suspicion of developing asd will be enrolled in the study. children will also be enrolled in the specialist evaluation setting where they will receive a dsm-5 diagnosis. a subset of both enrollment cohorts will also be followed up with at a third time point in which their diagnosis will be confirmed, and information about any ongoing treatment will be gathered.


Eligibility criteria:
inclusion criteria: * 18 through 83 months old * the study will include children "at risk" for asd as defined by meeting one or more of the following criteria: * flagged positive on a developmental screening tool (see below for assessment cut off scores) * the child has a biological sibling with asd * significant provider concern based on parent report noted in the child's medical chart at the time of the appointment. * significant parental concern exclusion criteria: * feeding tube dependence * active periodontal disease * confounding neurological condition (i.e. cerebral palsy, epilepsy) * sensory impairments (i.e. blindness or deafness) * acute illnesses (i.e. upper respiratory infection) * currently on antibiotics * had taken antibiotics within the previous 30 days * wards of the state

Keywords: autism spectrum disorder asd saliva biomarkers
how can rehospitalisations of patients with schizophrenia be avoided? a comparison between different compliance programs

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: participation in one of the three interventions psychoeducation by professionals, psychoeducation by peer-moderators, or video-education can reduce the rehospitalisation rate of patients with schizophrenia compared to a control group.


Eligibility criteria:
inclusion criteria: * schizophrenia or schizoaffective disorder (icd-10) * age 18 to 67 years * hospitalised or treated in day care clinic exclusion criteria: * more than 12 months of hospitalisation within the last two years * substance-dependency (principal diagnosis) * mental retardation icd-10 chapter f70-79 * fluency of german language not given
a phase ii study of gsk1363089 (formerly xl880) for papillary renal-cell carcinoma (prc)

Conditions: Carcinoma, Renal Cell

Summary: this clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of gsk1363089 treatment in papillary renal cell carcinoma. papillary renal cell carcinoma may be classified into hereditary and sporadic forms; subjects with either classification will be accepted into this study.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of prc with metastatic disease or bilateral multifocal renal tumors localized to kidneys. measurable disease, ecog performance status of \</= 2. * adequate bone marrow reserve, hepatic, renal, and cardiovascular function. exclusion criteria: * radiation to \>/=25% of bone marrow within 14 days of gsk1363089, more than 1 prior anti-cancer therapy, received prior treatment with a c-met inhibitor, brain metastases, * any uncontrolled intercurrent illness, * pregnant or breastfeeding, * hiv positive

Keywords: c-met papillary renal cell carcinoma(prc) sporadic papillary renal cell carcinoma, clear cell renal carcinoma hereditary papillary renal cell carcinoma,
pregnancy-related obesity prevention through education & communication technology in africa:the protect-africa study

Conditions: Obesity

Summary: the purpose of this study is to investigate whether overweight but not obese pregnant african women having unlimited access to a health education-information technology (it) based intervention package gain weight within the acceptable range of 8-12 kg during the pregnancy period. therefore, we hypothesize that unlimited access to health education via an it-based intervention package has the potential to reduce the onset of obesity in african pregnant women. to date (aug 2015), 95% of patients have been recruited, 1320 potential subjects have been screened and 150 enrolled into the study


Eligibility criteria:
inclusion criteria: * body-mass index (bmi) range of 25.1-29.9 kg/m2 * weeks of pregnancy: 16-20 * singleton pregnancy exclusion criteria: * evidence of pre-existing cardiovascular disease or a metabolic disorder (i.e. gestational diabetes)

Keywords: pregnancy maternal health newborn health information technology health education cellphone touch screen technology pregnancy outcome low-middle income nurse-led nutrition exercise
bupivacaine versus bupivacaine plus lidocaine in infraclavicular block

Conditions: Pain, Acute; Postoperative Pain; Analgesia

Summary: in this study, the investigators will compare two different anesthetic solutions in the infraclavicular block in patients having forearm, wrist, and hand surgery. the solutions will be bupivacaine 0.5% versus bupivacaine 0.25% plus lidocaine 1%, both associated with epinephrine 5 mcg/ml and dexamethasone 4 mg. the main objective of this investigation is to demonstrate that using higher concentrations of bupivacaine alone results in a significant block duration increase compared with the mixture of bupivacaine and lidocaine.


Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * american society of anesthesiologists classification 1-3 * surgery of the forearm, wrist, and hand * weight ≥ 80 kilograms exclusion criteria: * adults who are unable to give their consent * infection in the injection site (infraclavicular region) * pre-existing neuropathy (assessed by history and physical examination) * coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work, i.e., platelets ≤ 100, international normalized ratio ≥ 1.4) * renal failure (assessed by history and physical examination and if deemed clinically necessary, by blood work, i.e., creatinine ≥ 1.2) * hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work, i.e., transaminases ≥ 100) * allergy to local anesthetics (las) * pregnancy or breastfeeding * prior surgery in the infraclavicular region * chronic pain syndromes requiring opioid intake at home

Keywords: bupivacaine lidocaine nerve block infraclavicular block upper extremity surgery
evaluation of the safety, tolerability, pharmacokinetics (pk) and effects on liver iron concentration of icl670 relative to deferoxamine(dfo).

Conditions: Sickle Cell Disease

Summary: the safety, tolerability, effects on liver iron concentration and pharmacokinetics of icl670 is studied in sickle cell disease patients with transfusional hemosiderosis.

the treatment period started once the patient completed the core study and signed informed consent. it is continued for up to 4 years. safety parameters were assessed every 4 weeks. eye and ear examinations were performed on a yearly basis. to further investigate the extent of iron overload, serum ferritin, iron, and transferrin were monitored every four weeks. the program safety board monitored the safety of icl670 during the study to evaluate and categorize any serious case reported in association with icl670.

Eligibility criteria:
inclusion criteria: patients were included who met the following criteria: * completion of the core \[study 0109\] * serum ferritin greater than or equal to 500 µg/l * ability to comply with all study-related procedures, medications, and evaluations * sexually active post-menarche female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months. * written informed consent and assent by the patient and or their parents or legal guardian. additional inclusion criteria for pediatric patients the definition of the term 'pediatric' for enrollment and study conduct was in accordance with local law. parents or the legal guardians were fully informed by the investigator as to the requirements of the study. the pediatric patients themselves were informed according to their capabilities in a language and terms that they were able to understand. written informed consent was obtained from their legal guardian on the patient's behalf in accordance with national legislation. if capable, all patients had to also personally sign their written informed consent. exclusion criteria: patients who met the following criteria were to be excluded: * history of non-compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative * serum creatinine above the age-appropriate upper limit of normal within one week prior to entry * patients with alt ≥ 500 u/l within one week prior to entry * evidence of chelation-related cataracts or hearing loss within 4 weeks prior to baseline * pregnancy (as indicated by serum β-hcg pregnancy test for all female patients with the potential to become pregnant) and patients who are breastfeeding * patients treated with systemic investigational drug within 4 weeks prior to or with topical investigational drug within 7 days prior to the baseline visit other protocol-defined inclusion/exclusion criteria may apply

Keywords: deferasirox icl670a iron chelators sickle cell disease transfusional hemosiderosis
internet-delivered psychological interventions for tinnitus

Conditions: Tinnitus; Distress, Emotional; Depression, Anxiety; Sleep

Summary: tinnitus can be very distressing for some individuals who experience it. the most studied intervention that works well for tinnitus distress is cognitive behavioral therapy (cbt). there is enough evidence to claim that internet-delivered guided cbt for tinnitus is as effective as cbt delivered face-to-face. the goal of this randomized controlled trial is to test the effectiveness of an internet-delivered cognitive behavioral therapy (cbt) for tinnitus and an internet-delivered mindfulness-based tinnitus stress reduction intervention by comparing them one against each other and a waiting list control group in the adult population experiencing tinnitus. the main questions this study aims to answer are: * feasibility of delivering interventions for tinnitus distress over the internet. * is any of the two interventions more effective in reducing tinnitus-related stress than the waiting list control? * is the effectiveness of mindfulness intervention non-inferior to cbt intervention for tinnitus? * is participant engagement and dropout different in mindfulness and cbt interventions? participants will be randomly assigned to a cbt, mindfulness, or control group and will be asked to engage with the materials prescribed to that group for eight weeks.


Eligibility criteria:
inclusion criteria: * experience tinnitus for at least three months; * scores 28 or more on thi; * has the ability to use a computer (or smartphone or tablet) with a connection to the internet for the duration of the study; * comprehension and ability to write and speak in the lithuanian language. exclusion criteria: * inability to allocate sufficient time for participation in an 8-week intervention; * significant medical or psychiatric conditions which would prevent participation; * participation in other tinnitus interventions during the study.

Keywords: cbt tinnitus mindfulness-based stress reduction internet-delivered cognitive behavioral therapy mindfulness
a single center prospective randomized controlled clinical study of janus stent in patients with coronary artery disease

Conditions: Coronary Heart Disease

Summary: janus stent is the only marketed drug-eluting stent (des) without polymer coating as yet in china. the goal of this study is to evaluate the efficacy of janus (tacrolimus eluted stent) in inhibiting of restenosis in percutaneous coronary intervention (pci) real world and to observe the safety and efficacy of 4 months'clopidogrel treatment after implantation of janus stent. patients were enrolled and randomized to be treated by janus or srncro (bare metal stent with the same platform as janus). all enrolled patients received daily clopidogrel for 4 months and aspirin for life long for post-pci period(in ami group, patients received daily clopidogrel 150mg for 2 weeks at first). the primary endpoints included death of heart, myocardial infarction, revascularization of the target lesson, sub-acute and late stent thrombosis one year after pci, the secondary endpoints included mace at 30 days, 6 months and restenosis by follow-up angiogram at 6 to 12 months.


Eligibility criteria:
inclusion criteria: * patients who were eligible for coronary stenting * all patients enrolled were implanted only one kind of stent * stent number ≤ 8 per patient and ≤3 per vessel (stents overlapping part for 3～5mm and being fully post-dilated; total stent length ≤ 85mm in same vessel) * willing and able to sign informed consent. exclusion criteria: * patients with multi-vessel disease could not be implanted the same kind of stent * in-stent restenosis target lesion * patients not eligible for des implantation (e.g. intolerance to anti-platelet therapy or undergoing heart or non-heart surgery recently
clinical and mri evaluation of acl reconstruction results in adolescents with follow-up at least 3 years.

Conditions: ACL Injuries; Knee Instability

Summary: in this retrospective research results of acl reconstruction in adolescent will be evaluated. as we know acl ruptures become more frequent and more often operated these days. according to literature the results in patients younger than 20 years old are worse. therefore clinical and mri evaluation will be performed. the aim of the study is to assess subjective and objective functional outcome of acl reconstruction with follow-up at least 3 years. mri scans will be evaluated to highlight any early signs of osteoarthritis and describe graft morphology. ikdc, koos scales will be utilised for subjective evaluation. clinical tests such as lachman's, pivot shift, appley's along with anterior tibial shift measurement with digital arthrometer for objective assessment will be also performed. additionally isokinetic tests will be performed in two speeds of 60 and 180 deg/s. most of important isokinetic parameters such as peak torque, torque in 30 deg, time to peak torque, peak torque to body weight both for quadriceps and hamstrings will be measured . preliminary group of patients consists of 150 cases with follow-up at least 3 years, operated in age 12-17 years. all cases available for the study will be assessed with methodology above. dedicated statistical test will be utilised to evaluate the results.


Eligibility criteria:
inclusion criteria: * age between 10-17 years at time of surgery * acl full thickness lesion * meniscal lesions repaired simultaneously * completed research protocol exclusion criteria: * age \ 17 yo. * pcl concomitant injury * polytrauma * other same knee surgeries performed before intervention

Keywords: anterior cruciate ligament acl knee injuries adolescents acl injuries
healthful diets and risk of hearing loss

Conditions: Hearing Loss

Summary: to prospectively examine the relations between adherence scores for three healthful dietary patterns, the alternate mediterranean diet (amed), the dietary approaches to stop hypertension (dash), and the alternative healthy eating index (ahei-2010), and risk of hearing loss in the nurses' health study ii.


Eligibility criteria:
inclusion criteria: * the investigators limited the study to women who provided information on their hearing on the 2009 or 2013 questionnaire. exclusion criteria: * the investigators excluded those who did not provide responses to the hearing questions on either questionnaire, reported a hearing problem that began before baseline for the current analysis (1991) or did not report date of onset, or reported cancer other than non-melanoma skin cancer. the investigators also excluded women who did not complete the baseline diet questionnaire and who had missing diet information for each subsequent time period.
aspirin or rivaroxaban thromboprophylaxis for patients with multiple myeloma

Conditions: Multiple Myeloma; Venous Thromboembolism

Summary: the aim of this study is to evaluate the efficacy and safety of aspirin and rivaroxaban in thromboprophylaxis in chinese mm patients at high risk for mm-associated vte.

venous thromboembolism (vte) is one of the most common and dangerous complications of multiple myeloma (mm). the occurrence of vte can disrupt treatment plans, compromise patients' quality of life, and even threaten their lives, presenting significant challenges in clinical management. although several guidelines recommend risk-stratified thromboprophylaxis, there is a deficiency in prospective validation, and most initial studies were conducted in western cohorts. this prospective, multicenter, open-label, randomized study aims to compare the efficacy and safety of aspirin or rivaroxaban in preventing vte in chinese mm patients who are at high risk for vte.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed multiple myeloma (according to guidelines for the diagnosis and management of multiple myeloma in china (2022 revision)) 2. high risk of vte (according to expert consensus on the prevention and treatment of multiple myeloma related venous thromboembolism in china (2022)) 3. life expectancy exceeding 12 months 4. gender: not specified, age: 18-90 years 5. serum hiv antigen or antibody negative 6. hcv antibody negative, or hcv antibody positive with hcv rna negative 7. echocardiogram shows a left ventricular ejection fraction of ≥50% 8. ability to sign an informed consent form exclusion criteria: 1. pregnant women or women who are breastfeeding 2. active gastrointestinal ulceration 3. active bleeding 4. when initiating treatment, platelet count below 50 g/l, or with pt prolonged by more than 3 seconds, and aptt prolonged by more than 10 seconds. 5. abnormal liver function (alt or ast greater than 3 times the upper limit of normal, or total bilirubin greater than 2 times the upper limit of normal) 6. abnormal renal function (creatinine clearance \< 30 ml/min) 7. unable to cooperate in completing the clinical trial 8. already enrolled in other clinical studies 9. diagnosed with smoldering multiple myeloma or plasma cell leukemia 10. patients already on antiplatelet therapy for other cardiovascular or cerebrovascular diseases.

Keywords: multiple myeloma venous thromboembolism aspirin rivaroxaban thromboprophylaxis
a behavior intervention study on cardiovascular health among chinese obese schoolchildren

Conditions: Cardiovascular Diseases

Summary: the aim of this study is to evaluate the effects of comprehensive behavior on cardiovascular health among obese schoolchildren. the intervention methods include dietary instruction and exercise intervention. the main outcomes are weight, body mass index, blood pressure, lipids and glucose.

two public primary schools of a similar size were selected. they were allocated either to the intervention or control group. children in grade 4th and 5th in each school were invited to participate in the physical examination (height and weight measures).obese children based on chinese bmi cut-off points were included in this study.children in the intervention group were encouraged to take healthy diet habits and increased their physical activity.after eight months healthy behavior intervention, children's height, weight, waist, hip, blood pressure, cardiorespiratory fitness will be measured. fasting blood will be taken to measure lipids and glucose levels.

Eligibility criteria:
inclusion criteria: * obese children; aged 8-12 years old. exclusion criteria: * history of cardiovascular diseases and diabetes; disability.

Keywords: obesity children cardiovascular health intervention study
clinical study on the treatment of breast hyperplasia with kou sha therapy based on real world

Conditions: Breast Hyperplasia

Summary: in this study, epidemiological prospective real-world cohort study design was adopted. the third affiliated hospital of beijing university of chinese medicine and the first hospital of handan city, hebei province were selected. from the same time appointed before the study, all breast hyperplasia participants who met the admission criteria choosing kou sha therapy or routine treatment of western medicine were selected in the sample hospitals.the first 30 participants were included in the planned kou sha therapy group while the first 30 participants were included in the control group.taking the change of the total score of breast pain (mcgill pain questionnaire short form score+breast pain score) as the main curative effect index, and taking mcgill pain questionnaire score, breast color ultrasound score, palpation lump score, quality of life, anxiety and depression symptoms, sleep and so on as the secondary curative effect indexes to observe the clinical effect of the method of kou sha therapy on breast hyperplasia. the research period is from march 2024 to may 2024.

investigators adopte a real-world prospective cohort study design to investigate the efficacy and safety of the kou sha therapy in the treatment of breast hyperplasia.kou sha on the key points of breast diseases can dredge the mammary veins, and scraping on the back of the liver, gall bladder, spleen, and stomach can loosen the liver and diarrhea, dredge the internal organs and meridians, regulate emotions, and facilitate the recovery of breast hyperplasia.

Eligibility criteria:
inclusion criteria: * it meets the diagnostic criteria of breast hyperplasia, and the course of disease is more than 3 months; * female, aged between 18 and 50, with regular menstrual cycle and period, with menstrual cycle of (28±7) d; * mild and moderate breast pain, with bi-rads grade below 4; * informed consent, voluntary subjects and signed informed consent. exclusion criteria: with one of the following circumstances cannot be included in this experimental study: * patients with breast malignant tumor, inflammatory disease and other breast diseases; * patients with serious primary diseases such as cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system are psychotics; * prepare for women during pregnancy, pregnancy, lactation, menopause, severe menstrual cycle disorder or functional uterine bleeding; * severe diabetes, skin trauma or obvious inflammation, redness and ulceration of the skin; * diseases with severe bleeding tendency, such as thrombocytopenia, leukemia and allergic purpura; * those who are using chinese and western medicines (including topical medicines, acupuncture, etc.) for the treatment of breast hyperplasia within one month before this treatment or now, and have not used hormonal drugs within half a year; * participants in other clinical trials within 3 months.