Kornimate/medical-research-clean huggingface dataset:
german sld-registry (deutsches sld-register)

Conditions: Steatotic Liver Disease

Summary: characterization of patients with steatotic liver disease (sld) the german sld-registry (deutsches sld-register) a project of the german liver foundation (deutsche leberstiftung), managed by leberstiftungs-gmbh deutschland. the german nafld-registry is financially supported by: advanz pharma specialty medicine deutschland gmbh und gilead sciences gmbh (grant to german livber foundation) sowie novo nordisk pharma gmbh (directly via leberstiftungs-gmbh).

the following data can be documented: * physical examination and vital parameters (e.g. age, weight) * comorbidities (e.g. diabetes mellitus, cardiovascular disease) * comedication (treatment of comorbidities related to sld) * laboratory values (e.g. liver function tests, creatinine) * genetic variants (e.g. pnpla3) * liver diagnostics (e.g. histological findings, sonographic findings) * lifestyle (alcohol consumption, physical activity) * health related quality of life (sf-36 questionnaire)

Eligibility criteria:
inclusion criteria: * diagnosed sld based on the following criteria: 1. typical finding of hepatic steatosis (abdominal ultrasound and/or pathological cap value (latter is optional) 2. evaluation of sld degree by nafld fibrosis score and/or fib-4-index and/or transient elastography 3. evaluation of metabolic syndrome * credible assessment of alcohol consumption * written informed consent exclusion criteria: * patients with other hepatologic diseases (chronically viral, metabolic, autoimmune origin * patients receiving hepatotoxic medications over a longer period (e.g. methotrexate, amiodarone, longterm nsar intake) * malignant disease with a life expectancy \<12 months * participation in clinical interventional/pivotal studies * inability to provide written informed consent
the effect of asthma education given by taking health literacy into account

Conditions: Asthma in Children; Health Literacy; Child Health; Asthma Management; Nursing

Summary: the aim of this randomized controlled trial was to examine the effect of education given to asthmatic children and their parents by taking health literacy into account on disease self-management. the study was conducted with 88 children and their parents between october 2018 and july 2019. while education and booklets were given to both children and parents in intervention group 1, only the children were given the education and the booklets in intervention group 2. there was no intervention applied for the control group. post-test was performed 3 weeks after the education and then follow-ups were carried out in the next three months over the phone.


Eligibility criteria:
inclusion criteria: * having asthma children with a physician diagnosis, * studying in one of the public primary schools in the district where the study was conducted, * using asthma medication, * having parents without any reading difficulties. exclusion criteria: * being in the 1st grade in their school, * not using any medication for asthma, * having parents with reading difficulties.
multiple dose study of mpc-6827 in subjects with refractory brain metastases

Conditions: Brain Neoplasms

Summary: phase 1, multiple dose study of mpc-6827 in subjects with refractory brain metastases.


Eligibility criteria:
inclusion criteria: * refractory brain metastases * at least 1 measurable intracranial lesion as defined by recist * ecog less than or equal to 1 * adequate hematology/organ function * no baseline peripheral or central neuropathy above grade 1 exclusion criteria: * hypersensitivity to cremophor el * pregnant or lactating * spinal cord compression * pre-existing dementia/cognitive disfunction * require neupogen or neulasta to maintain neutrophil count * have primary brain cancer * have history of ischemic heart disease * have diabetes

Keywords: metastases refractory brain
evaluation of dyslipidemia management after statin and ezetimibe complex treatment

Conditions: Dyslipidemias

Summary: this study is a large-scale, prospective, multi-site, and non-interventional observational study to observe the change and safety of dyslipidemia management status when administering statin+etimib complex drugs in patients with dyslipidemia.

all treatments, including drug administration and laboratory tests performed after administration of statin+etimib complex, are performed by the researcher's medical judgment regardless of the subject's participation in the study, and the information to be confirmed in this observational study is collected up to 24 weeks. data collection will begin after the date of signing the research contract, and the follow-up period for each study subject is from the registration date (visit 1) to the 24th week (visit 3). to evaluate subjects' clinical performance in real world, we collect demographic information and medical treatment based on patient's medical records, previous dyslipidemia drug administration information, blood lipid tests and liver function tests conducted at the start date of statin+etimib compound administration and subsequent 24 weeks (± 8 weeks). in the case of safety-related information, such as abnormal cases, data shall be collected at any time during the 24-week follow-up period if there is a visit by the study subject according to daily treatment.

Eligibility criteria:
inclusion criteria: 1. adult men and women aged 19 or older as of the time of the registered visit (visit 1) 2. patients with dyslipidemia who are planning to administer statin+ezetimib complex or who are administering dyslipidemia complex according to the researcher's medical judgment based on the permission of statin+ezetimib complex 3. a person who can understand the information provided to him or her and voluntarily sign a written consent form exclusion criteria: 1. patients who overreact to the main ingredients or components of the drug in the study 2. patients with active liver disease or patients with continuously high serum aminotransferase levels with unknown cause 3. patients with muscle disease. 4. pregnant women or pregnant women and nursing mothers 5. patients with genetic problems such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabortion 6. a person who is not permitted by administration of statin+etimib complex or who falls under prohibition of administration 7. in addition to the above, a person who has determined that the researcher is not suitable for participation in this observation study
visual acuity and optical coherence tomography one year after ilm-flap transposition

Conditions: Macular Hole

Summary: ilm-flap (internal limiting membrane-flap) transposition is a new surgical option in repair of macular holes, therefore one year outcomes are needed to better evaluate that method.

patients that have been scheduled for vitrectomy with ilm-flap transposition, a new surgical option in repair of macular holes, are invited to a follow-up one year after surgery, including optical coherence tomography and visual acuity testing.

Eligibility criteria:
inclusion criteria: * history of ilm-flap transposition exclusion criteria: * none
effect of standard nutrition therapy on nutritional status and prognosis in locoregionally advanced nasopharyngeal carcinoma patients with malnutrition

Conditions: Nasopharyngeal Carcinoma; Nutrition Therapy

Summary: this is a multicenter, randomized controlled, phase iii clinical trial. the purpose of this study is to evaluate the efficacy of standard nutrition treatment versus conventional nutrition treatment in local advanced nasopharyngeal carcinoma patients.


Eligibility criteria:
inclusion criteria: * newly histologic diagnosis of nasopharyngeal carcinoma(who ii/iii); * all genders，range from 18～65 years old; * karnofsky performance status(kps) ≥ 80; * clinical stage iii\~iva(ajcc/uicc 8th); * without significant digestive system disease，nutritional and metabolic diseases or endocrine disease * without significant cardiac，respiratory，kidney or liver disease; * not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy); * white blood cell(wbc) count ≥ 4×109/l, neutrophile granulocyte(ne) count ≥ 1.5×109/l, hemoglobin(hgb) ≥ 9g/l, platelet(plt) count ≥ 100×109/l * total bilirubin(tbil)、alanine aminotransferase (alt) or aspartate aminotransferase(ast) \< 2.5×upper limit of normal(uln); * adequate renal function: bun/cre ≤ 1.5×uln or endogenous creatinine clearance ≥ 60ml/min (cockcroft-gault formula); * no contraindications to chemotherapy or radiotherapy; * inform consent form; exclusion criteria: * have some peg/pej contraindications, such as coagulopathy, recent anticoagulant medications and aspirin, gastric ulcer or history of gastric bleeding, portal hypertension combined with abdominal and esophageal fundal varices, pyloric obstruction due to residual stomach under the costal arch after various major gastrectomy or various reasons; * distance metastases; * have or are suffering from other malignant tumors; * participating in other clinical trials; * drug or alcohol addition; * do not have full capacity for civil acts; * mental disorder; * pregnancy or lactation; * severe complication, eg, uncontrolled hypertension;
computer aided gap balancing improves sagittal stability and outcomes for cruciate-retaining total knee arthroplasty

Conditions: Osteoarthritis of the Knee

Summary: computer aided surgery in total knee arthroplasty improves knee stability and functional outcomes more than conventional total knee arthroplasty.

the success of total knee arthroplasty depends on restoration of limb alignment, precise implant positioning and optimal gap balancing. the advent of computer aided surgery (cas) has improved limb alignment and implant positioning. the objective of this study was to evaluate the functional outcome of computer aided soft tissue gap balancing in total knee arthroplasty.

Eligibility criteria:
inclusion criteria: * primary osteoarthritis of the knee exclusion criteria: * rheumatoid arthritis, previous knee surgery, infection and those who could not be treated with unconstrained cruciate retaining tka and a short stem tibial implant

Keywords: knee computer gap soft tissue balancing replacement arthroplasty
open label extension study evaluating safety and biological activity of c2l-oct-01 pr in acromegalic patients

Conditions: Acromegaly

Summary: the purpose of this study is to assess the safety profile of c2l-oct-01 pr for up to an additional 96-week period in acromegalic patients who completed the c2l-oct-01 pr-301 study.


Eligibility criteria:
inclusion criteria: •subjects who have completed the 24-week c2l-oct-01 pr-301 study exclusion criteria: * women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating * subjects who have experienced any clinically significant adverse event related to study medication in c2l-oct-01 pr-301 study * subjects with uncontrolled diabetes type ii * subjects with signs or symptoms related to a tumor compression of the optical chiasm * subjects with symptomatic cholelithiasis

Keywords: acromegaly
biop system's safety and performance

Conditions: Cervical Cancer

Summary: biop system's safety and performance in increased detection of high-grade lesions of the cervical epithelium in women scheduled for colposcopy

biop system's safety and performance in increased detection of high-grade lesions of the cervical epithelium in women scheduled for colposcopy. this is a multi-center, prospective, open label, non-randomized study to train the biop system's algorithm and evaluate the safety and performance of the biop system in women undergoing cervical colposcopy.

Eligibility criteria:
inclusion criteria: * female age ≥ 22 years and ≤ 65. * referred for colposcopy, following abnormal cervical cytology; * participant provides signed informed consent exclusion criteria: * currently pregnant (through six weeks postpartum) or nursing * currently menstruating * previous hysterectomy * currently has intrauterine device (iud) * cervical biopsy or therapeutic procedure since the referral cervical cytology, * diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis, polycythemia vera. * known human immunodeficiency virus (hiv) infection or acquired immune deficiency syndrome (aids) (applicable to training stage only) * a known latex allergy * psychological instability, inappropriate attitude or motivation * cervical cytology tests within the prior seven days * use of vaginal medications within the last 48 h or photosensitizing agents within 72 h * history of photosensitivity or other diseases affected by uv radiation, * an observable and untreated gynecological infection. * previous history of cin therapy
study of cm310 injection in adolescent subjects with atopic dermatis

Conditions: Atopic Dermatitis

Summary: this is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, pk, pd and immunogenicity of cm310 in children patients with moderate-to-severe atopic dermatitis.


Eligibility criteria:
inclusion criteria: * have the ability to understand the study and voluntarily sign a written informed consent form (icf). * with atopic dermatitis. exclusion criteria: * not enough washing-out period for previous therapies. * any major surgery planned during the research period. * with intestinal parasitic infection within the 6 months before screening. * with any circumstance that is not suitable to participate in this study. * major surgeries are planned during the study period.
effects of exercise training at different timeline on shoulder dysfunction after breast cancer modified radical mastectomy

Conditions: Shoulder Dysfunction; Breast Cancer; Modified Radical Mastectomy

Summary: patients who underwent modified radical mastectomy were enrolled in the study. 200 subjects were randomly divided into 4 groups: 7 days postoperative shoulder isotonic training + 4 weeks postoperative progressive resistance training group, postoperative 7 isometric training for the shoulder joint + progressive resistance training for 3 weeks after surgery group, 3 days postoperative isotope training + 4 weeks postoperative progressive resistance training group, 3 days postoperative shoulder isotonic training + postoperative 3 weekly progressive resistance training group. the effects of interventional rehabilitation at different time points on the recovery of shoulder function after breast cancer operation were observed. the results of the study will provide evidence-based evidence for the time point of intervention in early functional exercise after modified radical mastectomy for breast cancer.


Eligibility criteria:
inclusion criteria: 1. between the ages of 25 and 75 years; 2. diagnosed with breast cancer by pathological diagnosis, the time of diagnosis and the time of inclusion are less than 6 weeks; 3. patients undergoing modified radical mastectomy: mastectomy includes unilateral total breast or breast-conserving surgery, as well as dissection of the affected axillary lymph nodes, but does not include sentinel lymph node biopsy; 4. postoperative chemotherapy or radiation therapy according to the condition; 5. no other malignant tumors within 5 years; 6. no physical therapy related contraindications; 7. signing informed consent. exclusion criteria: 1. the result of slnb is negative who did not receive alnd; 2. received breast reconstruction surgery (prosthesis, latissimus dorsi, etc.); 3. combined tumor metastasis with other tissues and organs (liver, kidney, lung, brain, etc.); 4. combined severe heart disease, cerebrovascular disease, and mental illness; 5. patients with shoulder joint dysfunction before surgery; 6. unable to understand the rehabilitation training program provided by doctors or physiotherapists.

Keywords: breast cancer modified radical mastectomy shoulder dysfunction rehabilitation training
safety and effectiveness of a multifocal intraocular lens (iol)

Conditions: Cataract

Summary: to evaluate the safety and effectiveness of the zm900 tecnis multifocal lens. results from two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol diol-101-tcns, and an expansion study with 222 additional multifocal subjects, protocol diol-104-tcns) are combined to evaluate the zm900 tecnis multifocal lens vs. a monofocal control. the original study was conducted in 2004-2006; the expansion study was conducted in 2007-2008. results from both studies were analyzed together for fda approval.

the original study was protocol diol-101-tcns; the expansion study was protocol diol-104-tcns. the study protocols were almost identical with the exception that no control subjects were enrolled in the expansion study; only additional multifocal subjects. all eligibility criteria and testing conducted in the expansion study was the same as that in the original study. the hypotheses were that best corrected distance visual acuity of the zm900 lens would meet or exceed the fda grid values, complication and adverse event rates of the zm900 would be similar to the fda grid rates for posterior chamber iols, and near visual acuity of the zm900 lens would be improved compared to that of the monofocal control lens.

Eligibility criteria:
inclusion criteria: * visual potential of 20/30 or better in each study eye * preoperative bcdva worse than snellen 20/40 or worse than 20/30 in the presence of glare (as measured using a snellen chart with bat at medium) * naturally dilated pupil size (in dim light) \> 4.0 mm (with no dilation medications) for each study eye * preoperative corneal astigmatism of 1.0 d or less exclusion criteria: * use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated) * acute or chronic disease or illness that would increase the operative risk or confound the study outcome(s),(e.g., diabetes mellitus, immunocompromised, connective tissue disease, etc.) * uncontrolled systemic or ocular disease * history of ocular trauma or prior ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention * presence of ocular pathology other than cataract such as: * amblyopia or strabismus * corneal abnormalities * pupil abnormalities * capsule or zonule abnormalities * intraocular inflammation * known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 or worse (e.g. macular degeneration) * requiring an intraocular lens outside the study diopter range * contact lens usage prior to study procedure (time interval dependent upon contact lens type)

Keywords: cataract, tecnis, multifocal, intraocular lens
articaine efficacy and safety for children below age of 4-years

Conditions: Behaviour Assessment; Pain

Summary: pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. one of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. therefore, this study intends to get the benefits of articaine efficiency and apply it in children.


Eligibility criteria:
inclusion criteria: * children aged 36-47 months. asa i, ii. mentally capable of communication. having a mandibular primary molar tooth that required extraction or pulpotomy. exclusion criteria: * the presence of infection, which may compromise the efficiency of local anesthetic agent significant behaviour problems medical or mental unfitness

Keywords: articaine, local anaesthesia, child, pain
prospective study of the use of a mesh to prevent parastomal hernia after laparoscopic abdominoperineal resection

Conditions: Parastomal Hernia

Summary: introduction: parastomal hernia (ph) is a frequent complication after an ostomy, despite the many prevention and treatment techniques that have been described. since the introduction of laparoscopy, the frequency of ph is even higher than in open surgery. this type of hernia remains a surgical problem of considerable importance, requiring significant consumption of public health and economic resources, and representing a major alteration of the quality of life of these patients. objective: to evaluate the effectiveness of the insertion of a prosthesis to prevent ph in elective surgery for laparoscopic abdominoperineal resection. methodology: prospective, multidisciplinary, multi-center randomized controlled study. control group: rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal resection. study group: rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25). sample size was calculated based on a proportion of parastomal hernia of 65% in the control group and 15% in the study group. with an α risk =0.05 and 1- β= 0.8, 28 patients are required, 14 per group. estimating a drop-out rate of 10%, the final number will be 32 patients. the efficacy will be evaluated clinically at six months and abdominal ct will be performed at 12 months along with another clinical evaluation.


Eligibility criteria:
inclusion criteria: * patients of either sex intervened electively for colorectal surgery (rectal cancer) in whom definitive colostomy is indicated after laparoscopic abdominoperineal amputation. * life expectancy above 12 months exclusion criteria: * - patients with allergy or intolerance of the compounds in the mesh * carriers of prosthetic meshes in the area of the ostomy * patients electively intervened for colorectal surgery (neo de reco) in whom definitive colostomy is indicated after abdominoperineal amputation but not via a laparoscopic approach. * cirrhotic patients * patients with life expectancy below 12 months due to underlying disease

Keywords: parastomal hernias tolerance of lightweight meshes laparoscopic abdominoperineal resection