Kornimate/medical-research-clean huggingface dataset:
the children's wear trial(phase 1&2)

Conditions: Myopia

Summary: phase i: focus groups on different designs of adjustable glasses and standard glasses (august-september 2012) phase ii: two-month randomized trial comparing four groups: (september 2012 - august 2013)

phase i: focus groups on different designs of adjustable glasses and standard glasses (august-september 2012) phase ii: two-month randomized trial comparing four groups: self-refraction with adjustable glasses, receiving custom standard glasses; subjective refraction by an expert refractionist after cycloplegic automated refraction and receiving custom standard glasses; subjective refraction by a rural refractionist after cycloplegic automated refraction, receiving custom standard glasses; and subjective refraction by an expert refractionist after cycloplegic automated refraction receiving ready made glasses (september 2012 - august 2013)

Eligibility criteria:
inclusion criteria: phase1: - aged 12-17 years * with \<= -1.00d of myopic refractive error in each eye phase2: - 12-15 years old children from two locations in guangdong province * with uncorrected vision \</= 6/12 in at least one eye thought to be due to refractive error (that is, correctable to at least 6/7.5 with cycloplegic subjective refraction by an optometrist) exclusion criteria: * those corrected va can not up to 6/7.5 with cycloplegic subjective refraction by an optometrist * those with significant strabismus or vision abnormality (keratopathy, cataract, vitreous macular diseases ), or with vision deficiency ( amblyopia ) children are to be excluded. * children developing acquired vision problems other than myopia

Keywords: myopia focus groups refraction glasses spectacles
metabolic risk following gestational diabetes mellitus

Conditions: Gestational Diabetes

Summary: gestational diabetes (gdm) is defined by abnormal glucose tolerance during gestation. this complication occurs in 4-10% and is associated with fetal complications and macrosomia. in addition, women with gdm have an increased risk to develop type 2 diabetes after delivery. despite recommendations, it is difficult to follow-up all women with gdm during the postpartum period due to high numbers of subjects that exceed usual healthcare resources. it is therefore necessary to focus clinical attention toward women at high risk of type 2 diabetes in order to set adequate preventive strategies.


Eligibility criteria:
inclusion criteria: * women aged over 18years old * women with the criteria of gdm during pregnancy at 21-35 weeks of gestation (one situation): * after a 75g oral glucose tolerance test (ogtt - who criteria) with blood glucose (bg) values at t60≥180mg/dl and/or t120≥153mg/dl * an o. sullivan test following a 100g oral glucose load with at least two pathological values (t60 ≥ 180mg/dl and/or t120 ≥ 155mg/dl and/or t180 ≥ 140mg/dl) * with a fasting bg value ≥92mg/dl * women with signed informed consent exclusion criteria: * women aged less than 18years old * women with pregestational type 2 diabetes * women without signed informed consent * women who does not read and/or understand french language * women not affiliated to the health care system * women with recent infection (\<1month) and/or on steroids or anti-inflammatory drugs. * women with chronic diseases * women with a disable state * women with normal glucose tolerance * women already incorporated in another clinical study that could interfere with the present study
mk0431a comparative study in patients with type 2 diabetes (0431a-079)(completed)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * patient has type 2 diabetes mellitus * patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent * patient has hb1ac greater than or equal to 7.5% and is appropriate for oral therapy * patient has not been on any antihyperglycemic agent (aha) in the last 4 months * patient is a male, or a female who is unlikely to conceive exclusion criteria: * patient has type 1 diabetes mellitus or history of ketoacidosis
idelalisib in combination with rituximab for previously untreated follicular lymphoma and small lymphocytic lymphoma

Conditions: Follicular Lymphoma; Small Lymphocytic Lymphoma

Summary: the primary objective of this study is to evaluate the overall response rate (orr) and complete response (cr) rate to treatment with idelalisib in combination with rituximab in previously untreated adults with follicular lymphoma (fl) or small lymphocytic lymphoma (sll). an increased rate of deaths and serious adverse events (saes) among participants with front-line chronic lymphocytic leukemia (cll) and early-line indolent non-hodgkin lymphoma (inhl) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (dmc) during regular review of 3 gilead phase 3 studies. gilead reviewed the unblinded data and terminated those studies in agreement with the dmc recommendation and in consultation with the us food and drug administration (fda). all front-line studies of idelalisib, including this study, were also terminated.


Eligibility criteria:
key inclusion criteria: * histologically confirmed diagnosis of b-cell lymphoma * no previous systemic treatment for lymphoma * subject demonstrates need for treatment for lymphoma * ann-arbor stage 2 (noncontiguous), 3, or 4 disease * radiographically measurable lymphadenopathy or extranodal lymphoid malignancy * adequate performance status * required baseline laboratory data within protocol-specified parameters key exclusion criteria: * known history of transformed lymphoma or diffuse large cell lymphoid malignancy * known history of, or clinically apparent, central nervous system (cns) lymphoma or leptomeningeal lymphoma * evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment * known history of drug-induced liver injury, chronic active hepatitis b (hbv), chronic active hepatitis c (hcv), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis * ongoing inflammatory bowel disease * known human immunodeficiency virus (hiv) infection * history of prior allogeneic bone marrow progenitor cell or solid organ transplantation * ongoing immunosuppressive therapy, including systemic corticosteroids (\> 10 mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for autoimmune anemia and/or thrombocytopenia note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: cancer indolent non-hodgkin lymphoma fl sll
effect of interceptive strategies on the clinical outcome of impacted maxillary permanent canines

Conditions: Tooth Impaction; Canine Teeth

Summary: canine impaction is a sign of abnormal dental development with potentially far-reaching consequences (such as significant root resorption and loss of lateral incisors. this compromises both aesthetics and function of the teeth, making the prediction of canine tooth impaction increasingly important. interceptive orthodontic measures, such as extraction of deciduous canines or molars or maxillary expansion aim to create extra space in the dental arch, allowing the canines to position themselves better and normalizing their eruption pattern. this study corresponds to the second phase of an rct, based on the results of the first phase, published in july 2023 (s59030) (willems g, butaye c, raes m, zong c, begnoni g, cadenas de llano-pérula m. early prevention of maxillary canine impaction: a randomized clinical trial. eur j orthod. 31;45(4):359-369). the first phase compared the effect of 3 interceptive strategies (expansion, extraction and no intervention) on the position of impacted maxillary canines, finding that maxillary expansion provides the most improvement on impacted canine position. in second phase, 8-year-old patients without posterior crossbite and lack of space in the dental arch are randomized to treatment with 'slow maxillary expansion with removable plates' or 'no treatment'. these groups are additionally compared with patients with a crossbite and lack of space, which always receive expansion treatment. all selected patients will be followed up for at least 18 months. the primary endpoint is to investigate the effect of maxillary expansion with removable plates on the position of maxillary canines prone to impaction during early mixed dentition, assessed on panoramic x-rays. the secondary endpoint is the assessment of the need for additional orthodontic treatment.


Eligibility criteria:
inclusion criteria: general inclusion criteria: * female or male patients between 7.5 and 9.5 years-old coming to the department of orthodontics of uz leuven (or one of the participating centres) seeking for orthodontic advice. * presenting with one or two impacted maxillary permanent canines, defined by 3¨ml between 15 and 45 degrees (if bilateral impaction occurs, categorization into the different protocol groups will be based on the canine showing the worst position). * presenting with one or two maxillary permanent canines showing no more than ¾ root formation, persisting deciduous canines and molars and lack of space in the maxillary arch, defined by ald\>0 mm * any race inclusion criteria group a: posterior crossbite inclusion criteria groups b and c: no posterior crossbite exclusion criteria: * fully erupted permanent canines * previous orthodontic treatment. * canines with completed root formation * evidence of root resorption of adjacent teeth or root malformation of the canines that would obligate to extract any adjacent teeth or the canine(s). * craniofacial syndromes * systemic disease that would impede orthodontic treatment/surgery * recent exposure to radiotherapy.
dmso-pdt of bcc - a 6 year follow up

Conditions: Carcinoma, Basal Cell

Summary: the purpose of this study is to registrate long time clinical and histological treatment response of basal cell carcinoma (bcc) lesions treated with one or two procedures of dimethylsulfoxide supported 5-aminolaevulinic acid photodynamic therapy (dmso-pdt).


Eligibility criteria:
inclusion criteria: * histological verified bcc. * one or two pdt treatments with treatment interval no longer than two weeks. * lesion complete response three months after therapy. exclusion criteria: * pregnant. * gorlin's syndrome. * morpheaform or pigmented bcc. * histology older than one year. * tumour infiltration more than four mm. * previous pdt treated lesions.

Keywords: photodynamic treatment basal cell carcinoma dmso
study of scb01a in patient with head and neck cancer

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: to evaluate the safety and efficacy of scb01a in head and neck cancer.

the study is designed to evaluate the safety and efficacy of scb01a in patients with recurrent or metastatic squamous cell carcinoma in head and neck.

Eligibility criteria:
inclusion criteria: 1. confirmed squamous cell carcinoma of head and neck 2. patients with nonresectable, unfeasible radiotherapy, recurrent or metastatic carcinoma, after previous treatment with platinum agent. 3. at least one measurable tumor lesion according to recist 4. suitable eastern cooperative oncology group (ecog) performance status 5. all eligible patients of childbearing potential have to use effective contraception 6. signed informed consent before enrolment exclusion criteria: 1. receiving chemotherapy, radiation therapy, major surgery or investigational agents 2. severe pulmonary obstructive or restrictive disease 3. uncontrolled inflammatory disease 4. clinically significant cardiac disease 5. results of laboratory tests 6. pregnancy or nursing status 7. known hypersensitivity to any component of scb01a 8. history of exposure to scb01a or its analogues 9. history of malignancy other than head and neck cancer 10. history of active or significant neurological disorder or psychiatric disorder 11. any other reason the investigator deems the patient to be unsuitable for the study

Keywords: head and neck squamous cell carcinoma
18f-av-1451 pet imaging in tbi

Conditions: Traumatic Brain Injury

Summary: this study will evaluate imaging characteristics of 18f-av-1451 in subjects with subacute traumatic brain injury.


Eligibility criteria:
tbi subjects inclusion criteria: tbi subjects * subjects that have consented and are currently enrolled in either transforming research and clinical knowledge in traumatic brain injury (track-tbi), evaluation, pathogenesis, and outcome of subjects with or suspected traumatic brain injury protocol number: cns: 10-n-n122, or evaluation and diagnosis of potential research subjects with traumatic brain injury (tbi): protocol number: 11-n-0084 * history of having sustained a tbi \< 6 weeks prior to enrollment * can tolerate pet and mri scan procedures control subjects * mmse ≥ 28 * no significant history of cognitive impairment * no prior history of tbi * can tolerate pet and mri scan procedures exclusion criteria: * have behavior dysfunction that is likely to interfere with imaging * are claustrophobic or otherwise unable to tolerate the imaging procedure * have current clinically significant cardiovascular disease, or clinically significant abnormalities on screening ecg * a history of additional risk factors for torsades de pointes (tdp) or are taking drugs that are known to cause qt-prolongation * have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer * are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception * have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the 18f-av-1451 imaging session * have current alcohol dependence or alcohol dependence within the past 1 year * are currently participating in another interventional clinical trial * have evidence of a penetrating brain injury * have participated in contact sports in college or after high school age
focus on experienced anxiety related to an emergency department visit

Conditions: Fear

Summary: the aim of the present study is to determine the prevalence of anxiety in adult patients attending the ed of the medical centre leeuwarden.

determination of the prevalence of anxiety in adult patients attending the ed of the medical centre leeuwarden. secondarily, the common causes of anxiety and the effect of anxiety on the time of presentation to the ed and perceived pain will be investigated. in addition to gaining more insight into the relationship between the ed and anxiety, the study aims to raise awareness of anxiety among patients in the ed.

Eligibility criteria:
inclusion criteria: * age 18 years and older * competent to decide on study participation * written informed consent obtained exclusion criteria: * patients from who a dutch questionnaire cannot be obtained (e.g. delirious, comatose, confused and non-dutch speaking patients) * if the reason for ed presentation is: suicide, intoxication or reporting from a sexual violence center * patients with an active eating disorder * patient already included in this study * objection to the use of patient data registered in the epd

Keywords: fear, anxiety
the main content of this study is to use virtual reality technology combined with local anesthesia with lidocaine injection at different times to reduce the pain of picc in school-age children

Conditions: Catheterization, Peripheral

Summary: we try to through the use of virtual reality technology in combination with lidocaine in different injection time to reduce the pain of picc catheter school-age children. using the convenience sampling method, the selection in may 2020, 2021 - may need to picc placement of children as the research object, is divided into three groups a, b, c, group a in ultrasound guided by picc placement; group b and group c adopt vr intervention, and 5 min before the beginning of the next surgery using vr equipment. group b was anesthetized after the needle was placed into the guide wire, and group c was anesthetized before the needle was placed into the guide wire.

this study investigated the effect of vr combined with lidocaine local infiltration anesthesia in peripherally inserted central catheter (picc) insertion, aiming to improve one-needle puncture success rate, reduce pain, reduce fear, improve compliance and catheterization time. from may 2020 to may 2021, children requiring picc were recruited by convenience sampling and divided into three groups: a, b and c. group a was implanted with picc under ultrasound guidance. group b and group c all used vr intervention and used vr equipment 5 minutes before the operation began. group b was anesthetized after the puncture needle was sent into the guide wire, and group c was anesthetized before the puncture needle was sent into the guide wire.the success rate of one puncture, pain, fear, compliance and catheterization time were compared among the three groups. a sample size and power analysis were conducted to determine the sample size required.the investigators assumed a medium effect size (f2 = 0.25) of the active vr. using 2 tails and alpha = .05, a fixed-effect linear regression model would offer power greater than 0.80 with a total sample size of 159 children. to ensure adequate power, the investigators planned to recruit 56 participants for each group. three groups were all operated by picc specialist nurses, and the standard operation procedure of picc catheterization was implemented in accordance with the infusion therapy nursing practice guidelines and implementation rules and the 2016 ins guidelines.

Eligibility criteria:
inclusion criteria: * participants aged between 6 and 12 years. * undergoing their inaugural ultrasound-guided picc insertion in an up. * voluntarper limby participation and informed consent by parents or guardians. exclusion criteria: * children with severe cardiocerebral conditionsor critical coagulopathies. * known lidocaine allergies. * severe mental illness or cognitive impairment in patients.

Keywords: catheterization pain,virtual reality technology ,picc
safety and efficacy of nab001 in the treatment of mild to moderate onychomycosis of the toenails

Conditions: Onychomycosis

Summary: the objectives of this study are to assess the safety of nab001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of nab001 to vehicle alone at the end of the study (week 56) after treating for 52 weeks.


Eligibility criteria:
inclusion criteria: * mild to moderate fungal infection of the toenail as assessed by study doctor * koh positive \& dermatophyte culture positive at visit 1 * general good health as assessed by study doctor exclusion criteria: * severe fungal toenail infection * prior use of antifungal drugs (wash-out allowed, duration varies on class) * significant confounding conditions as assessed by study doctor * pregnancy/lactation * must forego nail salon procedures during study for at least \~60 weeks

Keywords: toenail fungus onychomycosis nail infection
international ledless pacemaker registry

Conditions: Block Complete Heart; Atrial Fibrillation

Summary: the micra mc1vr01 or micra avmc1avr1 transcatheter pacing system (medtronic, inc., minneapolis, mn, usa) has become a major breakthrough as an alternative to standard transvenous pacemakers. the aim of this multi-center study is to assess the clinical outcomes of patients implanted with micra llpm in real life, in different clinical scenarios.

the study includes consecutive patients implanted with a pacemaker leadless device (micra transcatheter pacing system; medtronic, inc., minneapolis, mn, usa). baselines characteristics, procedural and clinical outcomes will be collected and analyzed.

Eligibility criteria:
inclusion criteria: all patients implanted with the micra leadless pacing system * at least 1 month of follow up * at least 1 post-implantation assessment, in accordance to the routine clinical practice of every center exclusion criteria: * none

Keywords: leadless pacing
study of mk0677 for the treatment of alzheimer's disease (0677-030)(completed)

Conditions: Alzheimer's Disease

Summary: an investigational drug (mk0677) will be studied to determine whether it helps the memory and cognition of patients with alzheimer's disease.


Eligibility criteria:
* patients must have probable alzheimer's disease of mild or moderate severity. * a brain scan and laboratory results must be consistent with alzheimer's disease. * the patient must be otherwise medically healthy.
endovascular treatment of primary common femoral artery atherosclerotic disease with intravascular litothripsy

Conditions: Peripheral Arterial Disease; Common Femoral Artery Stenosis; Common Femoral Artery Occlusion; Critical Limb-Threatening Ischemia

Summary: prospective, nonrandomized, multicenter, national, multidisciplinary, real-world data collection with the aim to evaluate the short-term safety and efficacy of intravascular lithotripsy in the treatment of steno-obstructive disease of the common femoral artery


Eligibility criteria:
inclusion criteria: 1. patients with peripheral arterial disease (rutherford class 3-6) 2. presence of a steno-obstructive lesion of the common femoral artery (azema classification 1-3) 3. possible endovascular treatment of both the iliac axis and/or femoro-distal vessels 4. possible post-dilatation with plain or drug-coated balloon angioplasty exclusion criteria: 1. concomitant open surgery (ilio-femoral or femoro-distal bypass) 2. presence of a steno-obstructive lesion of the common femoral artery in previous open surgery (azema classification 4) 3. presence of a steno-obstructive lesion of the common femoral artery after a previous endovascular procedure
genetics of alpha thalassemia in israeli ethnic groups

Conditions: Alpha Thalassemia

Summary: alpha thalassemia causes mild anemia and is found in many ethnic groups. usually it is found in regions where malaria is endemic. we have found that alpha thalassemia is common in ashkenazim, whose countries of origin are in temperate climates. we are analyzing the alpha globin genes of individuals of many ethnic groups and will compare to try to define the origin of thalassemia in these individuals of european extraction.

alpha thalassemia causes mild anemia and is found in many ethnic groups. usually it is found in regions where malaria is endemic. we have found that alpha thalassemia is common in ashkenazim, whose countries of origin are in temperate climates. we are analyzing the alpha globin polymorphisms to determine the haplotypes of individuals of many ethnic groups and will compare to try to define the origin of thalassemia in these individuals of european extraction.

Eligibility criteria:
inclusion criteria: * diagnosis of deletional alpha thalassemia exclusion criteria: * under age 18