Kornimate/medical-research-clean huggingface dataset:
study of tetrathiomolybdate in patients with wilson disease

Conditions: Wilson Disease

Summary: objectives: evaluate the safety and efficacy of ammonium tetrathiomolybdate alone and compared with trientine therapy as initial treatment in patients with wilson disease presenting neurologically.

protocol outline: this a double blind, randomized study. patients are randomized into one of two treatment arms. arm i: patients receive tetrathiomolybdate (tm) 3 times a day with meals and 3 times a day between meals for 8 weeks in the absence of neurologic deterioration or unacceptable toxicity. arm ii: patients receive trientine therapy for 8 weeks in the absence of neurologic deterioration and unacceptable toxicity. additional therapy (off study): patients in the tm group may receive maintenance zinc, while those in the trientine group may continue on trientine or switch to zinc.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * wilson disease presenting with neurologic or psychiatric symptoms * no concurrent seizure activity * no white matter lesions on brain magnetic resonance imaging --prior/concurrent therapy-- * no more than 2 weeks of prior therapy * no penicillamine or trientine for longer than 2 weeks --patient characteristics-- * hepatic: no severe hepatic failure * other: no psychiatric or medical contraindication to protocol therapy * not pregnant

Keywords: wilson disease inborn errors of metabolism rare disease
early feasibility study of the cardiaq™ tmvi system (transfemoral and transapical ds)

Conditions: Mitral Insufficiency; Heart Valve Disease; Cardiovascular Disease; Heart Disease

Summary: the purpose of the study is to generate early us feasibility data of the cardiaq™ transcatheter mitral valve implant system. the study will enroll patients with moderate to severe mitral valve regurgitation who are considered high risk for mortality and morbidity from conventional open-heart surgery.

early feasibility study - multi-center, prospective, single-arm, and non-randomized study without concurrent or historical controls. the primary objective of the study is to generate early feasibility data for the cardiaq™ transcatheter mitral valve implant system with the transfemoral and transapical delivery systems for the treatment of moderate to severe mitral valve regurgitation in patients who are considered high risk for mortality and morbidity from conventional open-heart surgery. the secondary objectives of the study are to evaluate the long-term safety of the device and the effects of the device on performance, functional, quality of life parameters, and technical, device, procedural, and individual patient successes. the study is to be performed at a maximum of 5 investigational sites in the us.

Eligibility criteria:
key inclusion criteria: * nyha classification ≥ iii * left ventricular ejection fraction ≥ 30% * mitral regurgitation ≥ grade 3+ * subject meets anatomical and eligibility criteria for the investigational device exclusion criteria: * see protocol

Keywords: transcatheter mitral valve replacement mitral regurgitation mitral insufficiency transapical transfemoral
evaluating the effectiveness of multifaceted implementation strategies for implementing a guideline for the prevention of common mental disorders at the workplace in schools

Conditions: Common Mental Disorders

Summary: given today's high prevalence of common mental disorders and related sick leave among teachers an urgent need exists for a more sustainable working life for this professional group. one way of doing this is by improving schools' social and organizational risk management. recent reports have shown that many schools in sweden however lack a structured approach to the management of social and organizational risks. in 2015, we launched the first swedish occupational health guideline to support a structured prevention of social and organizational risks at the workplace with the aim of preventing common mental disorders. the long-term goal of this study is to support the implementation of this guideline within schools in order to improve social and organizational risk management and in doing so reduce risk factors for mental ill-health and related sick days. the objective of the study is to fill the current research-to-practice gap by conducting a cluster-randomized controlled trial that compares the effectiveness of two implementation strategies for implementing the guideline in schools. the strategies that will be compared are training (arm 1) versus training in combination with implementation teams and workshops (arm 2). our hypothesis for the study is that schools that receive support in implementing the guideline through combined strategies are more responsive to working in a structured and systematic manner with the management of social and organizational risks than schools that only receive training. the trial will be conducted in 20 primary schools in two municipalities in sweden. all schools have agreed to participate. the primary outcomes are adherence to the guideline (implementation effectiveness) and self-reported exhaustion among schools personnel (intervention effectiveness); the secondary outcomes are risk factors for mental ill-health and absenteeism. data will be collected at baseline, 6, 12 and 24 months by mixed methods (i.e. survey, focus-group interviews, observation, and register-data).


Eligibility criteria:
inclusion criteria: * all individuals who are employed by the participating schools exclusion criteria: * individuals employed by the participating municipalities and not by the participating schools, for example cleaning personal. individuals on sick-leave

Keywords: guideline-adherence implementation implementation-strategies randomized-controlled-trial organisational risk-factors schools social risk-factors
probe-based volumetric laser endomicroscopy (pvle) of endoscopic mucosal resection (emr) tissue in patients with barrett's dysplasia

Conditions: Barrett's Esophagus With High Grade Dsyplasia; Early Esophageal Cancer

Summary: this study is to assess the diagnostic accuracy and precision of the probe-based volumetric laser endomicroscopy (pvle) imaging system in detecting dysplasia in be in both in vivo and ex vivo imaging of endoscopic mucosal resection (emr) tissue, as compared to standard histopathology

to assess the ability of pvle to visualize subsurface architecture of emr tissue, as compared to histology in both in vivo and ex vivo imaging.

Eligibility criteria:
inclusion criteria: 1. males and females over the age of 18 years. 2. patients with either suspected or confirmed barrett's-associated high grade dysplasia (hgd) or intramucosal cancer (imc) presenting for endoscopy possibly requiring emr. 3. ability to provide written, informed consent. 4. females must be willing to take a pregnancy test if still capable of bearing a child. exclusion criteria: 1. patients on anticoagulation undergoing high risk procedures in accordance to asge guideline for the management of antithrombotic agents for endoscopic procedures (2009)\*. 2. patients with esophageal varices that preclude biopsies. 3. presence of an esophageal mass/cancer that precludes full distention of the balloon from the nvision balloon guide sheath. 4. patients with esophageal strictures that would prevent adequate expansion of the balloon from the nvision guide sheath. 5. patients with known inflammatory disease, esophageal tears or ulcers, which prohibit full distention of the balloon from the nvision balloon guide sheath. 6. patients with known eosinophilic esophagitis. 7. patients who are pregnant. 8. patients with a history of hemostasis disorders\*. * patients on anticoagulation undergoing low risk procedures are not excluded. \*\* hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (\<100,000 plt/ul) and individuals with von willebrand's disease or other known platelet malfunction disorders.
as-oct study of cornea and tear film parameters in sle patients

Conditions: Systemic Lupus Erythematosus

Summary: the aim of thie study to assess tear film parameters such as tear meniscus height (tmh), tear meniscus area (tma), and tear meniscus depth (tmd). in addition, corneal pachymetry and epithelial thickness maps in sle patients and compared to healthy subjects of similar age and gender.

systemic lupus erythematous (sle) is a relapsing and remitting autoimmune connective tissue disorder that can affect many organs such as skin, joints, kidneys, eye, and brain (1) . sle has a global prevalence of 0.3 to 23.2 cases per 100,000. women are more likely than men to develop the disease. four out of the following 11 diagnostic criteria are sufficient for the diagnosis of sle, malar rash, discoid rash, oral ulcers, non-erosive arthritis, serositis, photosensitivity, renal disorder, neurological disorder, hematological disorder, immunological disorder, and presence of antinuclear antibodies. (2,3) ocular manifestations occur in about one third of sle patients with keratoconjunctivitis sicca being the most common manifestation which is characterized by decreased tear film aqueous layer. scleritis, retinal vasculitis (which is often associated with cns lupus), and papillitis are considered as the most serious ocular manifestations. (4) corneal involvement in sle affects the superficial epithelium, resulting in superficial punctate keratitis, which is believed to be caused by sjögren\&#39;s syndrome (ss). however, some cases of non-infiltrative and infiltrative peripheral ulcerative keratitis have been identified (5) . schirmer\&#39;s test and fluorescein breakup time test (fbut) are two common clinical tests used to analyze tear film. (6,7) using an in vivo, non- contact technique, anterior segment optical coherence tomography (as- oct) is now used to image the tear film, measure the lower tear film height and area, measure corneal thickness (pachymetry), and measure surface epithelial thickness. (8,9)

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old.. 2. patients with sle diagnosed by a rheumatologist with no ocular involvement upon clinical examination exclusion criteria: * 1. patients with history of intraocular surgery as cataract surgery ,retinal detachment surgery, anti-glucoma surgery. 2. patients with history of any corneal refractive surgery as lasik, prk. 3. patients with significant media opacity as corneal opacity, cataract. 4. patients with ocular diseases as glaucoma, uveitis. 5. patients with any retinal affection as pathological myopia, macular hole, age related macular degeneration and retinal vascular occlusion. 6. patients with systemic diseases as diabetes mellitus, hypertension, abnormal kidney function.

Keywords: anterior segment optical coherence tomography tear film dry eye systemic lupus erythematous
single photon emission computed tomography (spect) imaging study of professional american football players

Conditions: Traumatic Brain Injury

Summary: the investigators primary objective is to acquire preliminary data on one-hundred former nfl veterans with at least one full year of professional service using brain spect imaging in order to assess the degree to which nfl football puts players at risk for traumatic brain injury (tbi). tbi severity shall be gauged via visual inspection by a clinician trained in neuroanatomy, and also by a statistical comparison of subjects' brains to an in-house proprietary database comprised of the brains of healthy subjects. the investigators secondary objective is to acquire additional data on these players such that investigators may establish causative factors and risks associated with said tbi. the investigators tertiary objective is to acquire data on subjects using various mental health metrics in order to determine the effects of tbi.


Eligibility criteria:
inclusion criteria: * subjects must be at least 18 years of age * each subject must have been on an active nfl roster for a minimum of one year exclusion criteria: * any subjects who could not cease taking psychoactive medications (recreational or otherwise) for an appropriate washout period prior to scanning were excluded from the study

Keywords: spect imaging football traumatic brain injury regional cerebral blood flow
safety and efficacy of oral versus intravenous amiodarone in the treatment of af

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) remains a significant contributor to cardiovascular morbidity. amiodarone is a potent antiarrhythmic drug; however, patients receiving iv amiodarone are at high risk for phlebitis. phlebitis may lead to infection, additional medical intervention, delay in treatment, and prolonged hospitalization. therefore, examining new therapy approach, aimed to reduce the incidence of phlebitis is a valuable clinical and research goal. aim: to evaluate the safety and efficacy of oral versus intravenous (iv) amiodarone in the treatment of af of recent onset (duration \< 48 h).

atrial fibrillation (af) is the most common heart rhythm abnormality worldwide. three therapeutic goals should be considered for each patient: rate control, maintenance of sinus rhythm and prevention of thromboembolism. in managing af, numerous antiarrhythmic drugs have been used. intravenous amiodarone is a class iii antiarrhythmic agent which has been reported to be safe and most effective in various clinical settings, without an associated increase in mortality rate. in most of the cases, the method of administration is via peripheral infusion. phlebitis is the most common complication with peripheral infusion of amiodarone. phlebitis adversely affects patient care; it may interfere with the continued infusion of amiodarone, necessitate insertion of another peripheral intravenous or central catheter, and extend hospitalization. furthermore, patients who develop phlebitis, experience pain, swelling, and inflammation. phlebitis can be prevented by oral administration. the goal of the proposed study is to evaluate the incidence rate of phlebitis following iv administration of amiodarone and to investigate whether the oral administration of amiodarone in patients with recent onset af (duration \< 48 h), is safer than, and as efficient as, the iv administration of the same drug in the iccu and icu setting.

Eligibility criteria:
inclusion criteria: * over 18 years of age, * patients who will be admitted to the iccu / icu wards * patients with recent onset of atrial fibrillation (duration \< 48h). exclusion criteria: * age \< 18 years * baseline systolic blood pressure \< 100 mm/hg * known thyroid disease * serum potassium \< 3.5 mmol/l * pretreatment with amiodarone * pregnant or lactating women. * participation in other clinical trial.

Keywords: oral amiodarone iv amiodarone phlebitis thrombophlebitis adverse events
adjuvant hypofractionated intensity-modulated radiation therapy with incorporated boost in treating patients with early-stage breast cancer

Conditions: Breast Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. hypofractionated (fewer treatments than in standard radiation therapy) intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may kill more tumor cells. purpose: this phase ii trial is studying how well adjuvant hypofractionated intensity-modulated radiation therapy with incorporated boost works in treating patients with early-stage breast cancer.

objectives: primary * determine the toxicity associated with adjuvant hypofractionated intensity-modulated radiotherapy using an incorporated boost in patients with early-stage breast cancer. secondary * determine the long-term cosmetic result and quality of life of patients treated with this regimen. * determine the long-term local control in patients treated with this regimen. outline: patients undergo adjuvant hypofractionated intensity-modulated radiotherapy with incorporated boost once daily 5 days a week for 4 weeks. quality of life is assessed within 1 month of starting radiotherapy, at 6 weeks after completion of radiotherapy, and then every 6 months for 5 years. patients are followed at 6 weeks and then every six months for 5 years. projected accrual: a total of 37-74 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed carcinoma of the breast * invasive or in-situ disease * stage tis, t1, or t2 (ajcc stage 0, i, or ii) disease * treated with breast-conserving surgery within the past 8 weeks * hormone receptor status: * not specified patient characteristics: age * 18 and over sex * not specified menopausal status * not specified performance status * ecog 0-2 life expectancy * not specified hematopoietic * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 75,000/mm\^3 hepatic * not specified renal * not specified other * no other malignancy within the past 2 years except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer * no active systemic lupus * no history of scleroderma * no other medical or psychiatric condition that would preclude study participation * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy * not specified chemotherapy * no more than 6 weeks since prior adjuvant systemic chemotherapy * no concurrent chemotherapy endocrine therapy * not specified radiotherapy * no prior radiotherapy to the breast surgery * see disease characteristics

Keywords: stage i breast cancer stage ii breast cancer breast cancer in situ
the impact of addiction management model on digital addiction and psychological resilience in second school students

Conditions: Technology Addiction, Psychological Resilience, Risky Technology Use in Adolescent

Summary: digital addiction has become a prevalent concern among adolescents, particularly middle school students. this study aims to develop and evaluate an addiction management model for 6th-grade students at risk of digital addiction. the model will combine standardized psychological resilience training with emotional freedom techniques to address both the behavioral and emotional aspects of digital addiction.


Eligibility criteria:
inclusion criteria: high risk of digital addiction as a result of the screening, secondary school 6th grade students, volunteering of the student and parent to participate in the research, the student must be able to speak, read and understand turkish, the student does not have an auditory or mental disability that would affect his/her participation in the research. exclusion criteria: -

Keywords: adolescent health, technology addiction, internet addiction health education, psychological resilience, emotional freedom tecnique.
cut off for the diagnosis of cytomegalovirus (cmv) disease in serum-positive kidney transplant recipients

Conditions: Cytomegalovirus Disease

Summary: cmv disease is a challenge to the success of renal transplantation. recently, the investigators analyzed data from 792 renal transplant recipients performed at our hospital between 1999 and 2005. after the usual exclusions, 663 patients were analyzed. this population showed that the incidence of cmv disease is stable and occurs in approximately 20-22% of all patients and invasive disease in approximately 5% every year. in seronegative patients and those receiving anti-lymphocyte (al), cmv prophylaxis, done with ganciclovir for 90 days is our routine and in the majority of transplant centers. in seropositive patients without associated risk factors (such as the use of al) universal prophylaxis is not done. rather, in this group, early diagnosis, by detection of antigenemia or viremia by quantitative pcr, is performed in patients who show symptoms compatible with cmv disease. in the investigators analysis the incidence of cmv disease in seropositive patients is around 16%. these patients are usually hospitalized and treated with gcv iv for 14-21 days. this leads to an additional costs of admissions, biopsies for the diagnosis of disease invasion, etc. besides these costs, the survival of the grafts in the long run is lower in patients with cmv disease than in those without cmv, particularly when associated with acute rejection. in recent years, monitoring of viremia (pcr / antigenemia) and preemptive treatment when it reaches substantial values, have increasingly been suggested. patients in whom the detection of viremia in progressive values is detected would be treated as outpatients before the disease develops. to turn this hypothesis into reality, there is an urgent need to define cutoff values for cmv-pcr in the detection of developing cmv disease.


Eligibility criteria:
inclusion criteria: * patients over 14 years and younger than 75 years * seropositive for cmv (igg) * kidney transplant recipients exclusion criteria: * patients who received anti-lymphocyte induction * patients with organ transplants double

Keywords: kidney transplantation pcr quantitative cytomegalovirus antigenemia