Kornimate/medical-research-clean huggingface dataset:
single arm trial of preoperative stereotactic body radiation therapy (sbrt) for t3a or gleason grade group 4 prostate cancer

Conditions: Prostate Cancer

Summary: this study involves stereotactic body radiation therapy (sbrt) followed by prostatectomy (removal of the prostate). sbrt is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. it has been used effectively in other cancers like lung and liver. the radiation will be given for only 5 days. the purpose of this study is to compare the effects, good and/or bad, of different doses of sbrt given before prostatectomy.


Eligibility criteria:
* histologically proven prostate adenocarcinoma. * clinical stage ≤t3a based on digital rectal exam (dre) and ≤t3a based on mri (within 3 months); n0-nx; m0-mx, or gleason score 4 + 4. no more than 1 lymph node \>1 cm. * psa ≤ 50 ng/ml, obtained within 3 months * prostate volume: ≤60 cc. * ipss score ≤15. * no previous radiotherapy to the prostate or lower pelvis. * lymph node risk of \<35% using https://www.mskcc.org/nomograms/prostate/pre_op. * no prior radical prostatectomy or cryotherapy of the prostate (prior transurethral resection or laser ablation are permitted). * no implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion. * no history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last 3 years. * no androgen deprivation therapy (adt) can be prescribed prior to or during radiation therapy. * participant must be able to have gold fiducial markers placed in the prostate. note: patients can be enrolled after fiducial markers have been placed, as long as the procedure was done in accordance with the protocol (section 4.2.2). * eastern cooperative oncology group (ecog) performance status ≤2 * ability to understand and the willingness to sign a written informed consent document. * willing to fill out quality of life questionnaires.

Keywords: high risk prostate cancer prostate radiation therapy
arresting active dental caries in preschool children by topical fluorides

Conditions: Dental Caries

Summary: this randomized clinical trial aims to compare the effectiveness of three topical fluoride application protocols, namely three applications of a 30% sdf solution at yearly or weekly interval and three applications of a 5% naf varnish at weekly interval, in arresting dental caries in the primary teeth of preschool children over 30 months.

this randomized clinical trial aims to compare the effectiveness of three topical fluoride application protocols, namely three applications of a 30% sdf solution at yearly or weekly interval and three applications of a 5% naf varnish at weekly interval, in arresting dental caries in the primary teeth of preschool children over 30 months. preschool children attending the first year of the kindergartens will be invited to join this study. an invitation letter will be sent to the parents explaining the purpose and procedures of this study. parental consent will be sought. generally healthy children who have at least one tooth with untreated caries into dentine will be invited to participate and they will be followed for 30 months. dental clinical examination of the children will be conducted by a calibrated dentist in the kindergarten. tooth and oral hygiene condition will be recorded. a parental questionnaire will be administered at baseline and at the 30-month follow-up visits regarding their children's socio-economic background and oral health related behaviours. the questionnaire will also assess parental satisfaction with their child's oral health and dental aesthetics. all active dental caries lesions of the participant children will be treated if possible. the children will be categorized as having a high or a low caries rate. they will then be allocated by a stratified randomization method to one of the three study groups: group a - 3 applications of a 30% sdf solution at yearly interval group b - 3 applications of a 30% sdf solution at weekly interval group c - 3 applications of a 5% naf varnish at weekly interval a dental operator who is not involved in the examination of the child will apply the fluoride agents. follow-up oral examinations will be conducted every 6 months in the kindergartens for 30 months. the status of the treated teeth and any possible side/adverse effects will be recorded in the follow-up examinations.

Eligibility criteria:
inclusion criteria: * generally healthy children who have at least one tooth with untreated caries into dentine exclusion criteria: * children who have major systemic diseases or on long-term medication, are uncooperative or refuse the treatment will be excluded.
observational study on safety of self-titration of once daily levemir®

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the main objective of the study is to assess the safety of self-titration in type 2 diabetic patients on antidiabetic tablets who are receiving insulin for the first time. the study will also look at the blood glucose control, frequency of dose adjustment, clinic visits, and time spent training patients to self-titrate. the objective of diabetes management is to achieve blood glucose levels as close as possible to normal in order to avoid late stage diabetic complications. self-titration (where patients adjust insulin dosage themselves) offers the potential for better blood glucose control than titration only at clinic visits. in recent years treatment of type 2 diabetes in the united kingdom has moved from hospitals to gp surgeries or local clinics. patients with type 2 diabetes, in general, have not been trained in self-titration to the same degree as patients with type 1 diabetes. less experience in self-titration could impact the level of blood glucose control and outcome for these patients. data from this study will be pooled with data from nn304-3714 (nct00825643) and will be reported in the final study report for nn304-3714.


Eligibility criteria:
inclusion criteria: * after the participating physician/nurse's decision has been made to initiate once daily levemir® therapy (within the license of the product), any patient with type 2 diabetes of 18 years or older who is currently treated with diet, exercise and one or more oads can be offered to participate exclusion criteria: * patients unable to give written informed consent * current treatment with insulin * patient deemed unable or unwilling to self-titrate * known or suspected allergy to study product or related products * pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months
to evaluate the efficacy of zometa® in treatment of bone metastases in patients with stage iv nasopharyngeal cancer

Conditions: Nasopharyngeal Cancer

Summary: the purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy variable of sres (skeletal related events) and to assess the safety in nasopharyngeal patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic treatment alone.


Eligibility criteria:
inclusion criteria: * age \>18, either sex * histologically confirmed stage iv nasopharyngeal cancer * one bone metastasis at least confirmed by imaging * without chemotherapy or radiotherapy after bone metastasis * life expectancy \> 6 m * ecog \<= 2 * adequate bone marrow reserve (wbc \> 3.5 x 109/l, neutrophile \> 1.5 x 109/l, platelet 100 x 109/l, hb \> 90 g/l) * serum creatinine\< 2.0 mg/dl (\< 1.5 times the upper limit of the normal range for the laboratory of the study center) * signed icf exclusion criteria: * women who are pregnant or in lactation * patients with hyperostosis * systemic treatment for another cancer within the year prior to study entry * previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy * initial serum creatinine \>265 micromol/l and/or progressive renal disease * known hypersensitivity to any of the study drugs or to drugs with similar chemical structures * use of investigational agents within 28 days of the baseline visit, or participating simultaneously in any other clinical studies * severe co-morbidity of any type that may interfere with assessment of the patient for the study
effect of prp on the therapy for hair growth

Conditions: Hair Loss/Baldness

Summary: the purpose of study is to examine the advantage of prp on hair loss and male pattern baldness. the investigators will inject prp into the scalp regions where with little or no hair, and evaluate the effect and efficiency of prp on human hair growth.

hair loss is a disorder in which the hair undergoes aberration growth cycles and falls out from scalp. a number of factors like hormones, genetic factors, diet, endocrine abnormalities, systemic illnesses, drug intake, and hair shaft abnormalities may cause hair loss. androgen alopecia or male pattern baldness is the most common cause of hair loss caused by progressive shortening of the anagen and increased number of hair follicles in telogen, which has a significant influence on psychological distress. except medical treatment and baldness surgery, a new interest in treating hair loss and baldness has been stimulated by using platelet plasma growth factors obtained from the patient's own platelet-rich plasma (prp). prp is a portion of plasma fraction of autologous blood having a high concentration of thrombocytes, and can be activated by thrombin to release multiple growth factors, including platelet-derived growth factor (pdgf), vascular endothelial growth factor (vegf), epidermal growth factor (egf), insulin-like growth factor (igf), and transforming growth factor beta (tgf-β). prp is known for the capacity to stimulate cell proliferation and differentiation. the action of platelet plasma growth factors on the development of hair follicles has already been established. prp has also been shown to increase the yield of implanted follicular units during male baldness surgery. our study will focus on the advantage of prp for the treatment of hair loss and male pattern baldness. prp from autologous blood can be mixed with thrombin in appropriate ratio and inject into the regions on scalp which is interested. we will track and evaluate regularly the effect and efficiency of prp on human hair growth.

Eligibility criteria:
inclusion criteria: * patient with hair loss/baldness * age of 20-70 years old exclusion criteria: * patient with systemic disorder * phyco * patient with coagulation abnormality * patient with inflammation
omnibond vs dermabond

Conditions: Osteoarthritis

Summary: this prospective, randomized, controlled, blinded clinical trial is designed to assess the incidence of all time and all types of wound-related complications following total joint arthroplasty (tja) when two different types of topical skin adhesives are used to close the incision.

the aim of this study is to assess the incidence of incision healing complications in patients undergoing primary total knee replacement and total hip replacement treated with either omnibond or dermabond advanced topical skin adhesive. all patients undergoing a primary, elective tka and tha at participating centers that sign a consent form will be followed up for a period of up to 30 days to determine if there are any incision healing complications. secondary outcomes will include dry time of the topical skin adhesive, user satisfaction, patient satisfaction, and incidence of adverse events.

Eligibility criteria:
inclusion criteria: 1. patient ≥18 years old 2. male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females 3. subjects scheduled to undergo primary, elective total knee arthroplasty or total hip arthroplasty 4. subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the investigator, sub-investigator or other designated study staff member has explained the study procedures, risks, and contact information 5. subjects deemed able to understand and comply with study visit schedule and procedures exclusion criteria: 1. local skin conditions such as dermatitis, eczema, psoriasis that, in the opinion of the investigator, will make it difficult to assess wound complications or local skin reactions following surgery 2. pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception 3. active or previous infection in the skin or the knee or hip to be operated, evidence of gangrene 4. subjects who have participated in this trial previously and who were withdrawn 5. subjects with known allergies to product components including cyanoacrylate, formaldehyde, benzalkonium chloride or have known allergies or skin sensitivity to the convatec aquacel dressing. 6. inability or refusal to provide informed consent or follow study and wound care instructions
efficacy of the earpopper device in children with recurrent otitis media

Conditions: Recurrent Acute Otitis Media; Acute Otitis Media

Summary: this is a randomized controlled clinical trial evaluating the efficacy of the earpopper device (ep) in the reduction of episodes of acute otitis media (aom) in children with recurrent otitis media. the control arm will be observational. the intervention arm will have the ep used.

the hypothesis of this randomized controlled trial is that the ep device will be able to prophylactically decrease incidence of aom in children with recurrent aom. the secondary hypothesis is that the ep device will be able to decrease morbidity of aom and severity of aom in children with recurrent aom (by measuring quality of life and associated endpoints). the ep device is 510(k) regulated (510(k) number k073401) as a non-surgical, non-drug related treatment for middle ear pressure problems such as: middle ear fluid (otitis media with effusion), eustachian tube dysfunction, temporary hearing loss, ear pain and pressure caused by air travel, ear fullness caused by colds, allergies and sinusitis. this is a randomized, controlled, double blinded study. this is a randomized controlled clinical trial evaluating the efficacy of the earpopper device (ep) in the reduction of episodes of acute otitis media (aom) in children with recurrent otitis media. the control arm will be observational. patients will be followed up for a period of one year, and monthly telephone call interviews will be conducted. all patients will receive the earpopper device for participation in this trial (for the control arm, they will receive the device at the end of their study follow up).

Eligibility criteria:
inclusion criteria in order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. provision of signed and dated informed consent form from parent, plus assent form (if age appropriate) 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 4-11 4. diagnosed with recurrent aom, defined as: least 2 episodes of aom within the preceding year of date of screening 5. must be able to follow directions to use earpopper, or have a caregiver able to administer the device. 6. patient must be currently free of middle ear effusion or current acute om. this will be determined on physical examination during screening visit exclusion criteria an individual who meets any of the following criteria will be excluded from participation in this study: 1. patient with chronic middle ear effusion. 2. patients with potential complications or confounding conditions: asthma, chronic sinusitis, immunodeficiency, diabetes mellitus 3. patient with cleft palate.

Keywords: earpopper prophylaxis randomized controlled trial
drug-eluting balloon angioplasty versus bypass surgery as first-line strategies in infrageniculate arterial disease for critical limb ischemia in type 2 diabetic pacients: a randomised controlled clinical trial

Conditions: Critical Limb Ischemia

Summary: the aim of this study is to evaluate the outcomes of drug-eluting balloon angioplasty and vein bypass surgery in diabetic patients with critical limb ischemia due to infrapopliteal arterial disease.

objective: to consider the clinical outcomes of drug-coated ballon angioplasty and vein bypass surgery in terms of amputation-free survival, overall survival, relief of symptoms, quality of life and to determine if limb revascularization contributes to diabetic peripheral neuropathy (dpn). all patients with type 2 diabetes mellitus and severe limb ischemia reffered to multidisciplinary diabetic foot team or endocrinology or vascular units can be considered. to be eligible for randomization, peripheral arterial occlusive disease must be located infra-popliteally; patients must have adequate inflow and outflow to support infrapopliteal interventions; have a good superficial vein for bypass surgery. if the patient is suitable for both treatment arms, they will be invited to enter the trial. if patient is suitable for both revascularization techniques randomization will be performed after diagnostic angiogram submission patient will be randomised to one of the following groups: a. vein bypass surgery first strategy b. endovascular treatment first (drug coated balloon angioplasty) strategy outcomes will be recorded at 1, 3, 6, 9, 12, 18, 24 month after revascularisation procedure. information collected will include further interventions (vascular, non-vascular), hospitalisations (for whatever reason), other health problems, clinical and haemodinamic status of limbs, funcional status, quality of life, neuropathy.

Eligibility criteria:
inclusion criteria: * patient with type 2 diabetes mellitus * severe limb ischemia (rutherford class \>=4) due to infrapopliteal, +/- popliteal disease \[ a.tibialis anterior, tr.tibioperonealis, a.peronea, a.tibialis posterior, a.dorsalis pedis stenosis or occlusion (50%-100%; \>40mm in length); leasion may involve a.poplitea p1-p3 segment; have adequate inflow and outflow to support infrapopliteal intervention (diagnostic imaging); suitable for both vein bypass and best endovascular treatment following; angiography diagnostic imaging and ultrasound examination of vein conduit.\] exclusion criteria: * requires primary limb amputation * acute limb ischemia * anticipated life expectancy of \<2 years * unsuitable for either revascularisation strategy * severe concomitant disease (acute coronary ischemic event, brain ischemic event, cognitive disorder, active oncology process)
assessment of pain management in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis patients who are about to be treated with adalimumab

Conditions: Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Summary: the purpose of this study is to assess whether or not adalimumab (humira®) can influence pain medication in participants with rheumatoid arthritis (ra), psoriatic arthritis (psa) and ankylosing spondylitis (as) with or without comorbidities, which do not constitute a contraindication for adalimumab as stated in the released summary of product characteristics. therefore it shall be evaluated if pain medication which is used in these participants is changed, reduced or stopped due to adalimumab treatment.

this is a non-interventional, observational study in which humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. the assignment of the patient to a humira-containing regimen has to be decided in advance and has to be current practice. the prescription of humira is clearly separated from the decision to include the participant in this study.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis * patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (chest x-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). in addition one of the following criteria must be fulfilled: * unsatisfactory disease modifying antirheumatic drug response defined as failure to treatment with at least two disease modifying antirheumatic drugs including methotrexate in patients with rheumatoid arthritis or psoriatic arthritis * unsatisfactory non steroidal antiinflammatory drug response in patients with ankylosing spondylitis or unsatisfactory response to prior biological disease modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis or ankylosing spondylitis exclusion criteria: * patients who meet contraindications as outlined in the latest version of the humira syringe® summary of product characteristics and humira pen® summary of product characteristics * patients participating in another study program or clinical trial * patients who have been treated with humira before

Keywords: ankylosing rheumatoid antibodies arthritis pain antirheumatic agents psoriatic spondylitis monoclonals
biodistribution&pharmacokinetic of position emission tomography(pet) radiopharmaceutical 18f c snat4

Conditions: Cancer; Lung Cancer

Summary: primary objectives * determine the biodistribution of \[18f\]-c-snat4 in 5 healthy volunteers. secondary objectives * determine the dosimetry of \[18f\]-c-snat4 pet in healthy volunteers and patients with lung cancer. * determine the acute toxicity of \[18f\]-c-snat4 pet in healthy volunteers and patients with lung cancer. * determine whether uptake in \[18f\]-c-snat4 pet imaging is significantly different in tumor and corresponding contralateral noncancer tissue in patients with lung cancer (tested by wilcoxon test) before the therapy. * determine/verify the safety profile of the \[18f\]-c-snat4 radiotracer, as an imaging agent in patients with lung cancer. * determine the time of maximal \[18f\]-c-snat4 radiotracer uptake post injection.


Eligibility criteria:
inclusion criteria: * anc ≥ 1.5 x 109/l without myeloid growth factor support for 7 days preceding lab assessment * hgb ≥ 9 g/dl (90 g/l); \< 9 g/dl (\< 90 g/l) is acceptable if hgb corrected to ≥ 9 g/dl (90 g/l) as by growth factor or transfusion prior to pet scan * platelet count ≥ 100 x 109/l w/o blood transfusions for 7 days preceding lab assessment * bilirubin ≤ 1.5 x upper limit of normal (uln) except for pts with documented history of gilbert's disease * alt ≤ 2.5 x uln * ast ≤ 2.5 x uln * alkaline phosphatase (ap) ≤ 3 x uln * if a women of childbearing potential (wcbp): negative early pregnancy test (ept) * karnofsky performance status (kps) ≥ 60 * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * has already begun non-surgical therapy for any recurrence, prior to the first \[18f\]-c-snat4 pet/ct scan * severe/uncontrolled inter-current illness within the previous 28 days prior to pet scan. * any other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation. * history of allergic reactions to iv contrasts or reactions attributed to compounds of similar chemical or biological composition to \[18f\]-c-snat4 used in study. * pregnant or nursing * patients who exceed the safe weight limit of the pet/ct bed (204.5 kg) or who cannot fit through the pet/ct bore (diameter 70 cm).