Kornimate/medical-research-clean huggingface dataset:
resolve-af: clinical evaluation of the ablacath™ mapping catheter and ablamap® system utilizing electrographic flow (egf) mapping to resolve extra-pv sources of atrial fibrillation and guide ablation therapy.

Conditions: Atrial Fibrillation; Atrial Fibrillation, Persistent; Atrial Fibrillation Paroxysmal; Arrhythmia; Arrhythmias, Cardiac; Atrial Flutter; Atrial Fibrillation, Paroxysmal or Persistent; Atrial Arrhythmia; Atrial Tachycardia

Summary: demonstrate the safety and effectiveness of the ablacath™ mapping catheter and ablamap® system in patients with all types of atrial fibrillation (af) including paroxysmal or persistent or long-standing persistent, undergoing and de novo or redo procedures. phenotype patients and demonstrate the prognostication power of electrographic flow (egf®) maps among all subjects using 12-month follow-up outcomes following egf-guided mapping and ablation.

subjects with all types of af who are candidates for catheter ablation of their af. the study will enroll up to 400 subjects in 25 centers globally.

Eligibility criteria:
inclusion criteria: 1. suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias including atrial fibrillation, atrial flutter and/or atrial tachycardia 2. above eighteen (18) years of age or of legal age to give informed consent specific to state and national law 3. left atrial (la) diameter ≤ 5.5 cm or la volume index ≤ 50 ml/m2 (use whichever measure is available or if both available, use the lesser of the two to qualify) exclusion criteria: 1. de novo paroxysmal af 2. af from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.) 3. cardiac surgery or intervention within the past 90 days (e.g. percutaneous coronary intervention, ablation for ventricular arrhythmias, left atrial appendage occlusion devices, atrial septal defect closure devices, transcatheter aortic valve replacement) 4. presence of transvenous pacing or defibrillator leads or an atrial leadless pacemaker 5. myocardial infarction within the past 90 days 6. severe valvular disease or prosthetic valve(s) 7. contraindication to therapeutic anticoagulation 8. decompensated heart failure or new york heart association (nyha) functional class iv 9. positive pregnancy test 10. any other contraindication to an intracardiac mapping and ablation of atrial arrhythmias 11. enrollment in another investigational study evaluating another device, biologic or drug
assessment of dental caries among a group of institutionalized orphan children compared to parented school children

Conditions: Dental Caries in Children

Summary: children from two orphanages will be examined for dental caries experience, in comparison to parented school children.

a total of 156 children were included in this study, they were, residing in governmental orphanage, non-governmental orphanage and parented children attending primary school. written informed consent was obtained prior to the start of the study, form legal guardians or child's parent. dental examination was carried out on an ordinary chair beside a window on day light. dmf and def indices were used to assess dental caries for primary and permanent teeth. also, unmet treatment need index, care index and significant caries index were calculated.

Eligibility criteria:
inclusion criteria: * apparently healthy children aged from six to12 years old exclusion criteria: -
hypothermia after in-hospital cardiac arrest

Conditions: Cardiac Arrest

Summary: ilcor recommendations "on the basis of the published evidence to date, the advanced life support (als) task force of the international liaison committee on resuscitation (ilcor) made the following recommendations in october 2002: unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32°c to 34°c for 12 to 24 hours when the initial rhythm was ventricular fibrillation (vf).such cooling may also be beneficial for other rhythms or in-hospital cardiac arrest" (circulation. 2003;108:118-121). this study ist to investigate the efficacy of mild therapeutic hypothermia on mortality and neurological outcome in patients after in-hospital cardiac arrest.

this is a randomized controlled multicenter trial. patients after in-hospital cardiac arrest are randomized either to standard therapy or to standard therapy in addition to mild therapeutic hypothermia. mild therapeutic hypothermia is performed for 24 hours with a target temperature of 32-34°c. inclusion criteria are: adult patients which have been resuscitated after cardiac arrest in-hospital and who remain unconscious after restoration of spontanous circulation. exclusion criteria are: severe cardiogenic shock, severe rhythm disorders, major surgery within the last 10 days, planned surgery within the next 24 hours afer resuscitation, active bleeding, suspicion od intracranial bleeding, severe infection, such as pneumonia or sepsis, a severe neurological deficit before cardiac arrest, an aquired immun deficency, pregnacy. the primary endpoint is mortality for all causes after six months. secondary endpoints are neurological outcome after six months measured by the glasgow-pittsburgh cerebral performance scale, and in-hospital-mortality.

Eligibility criteria:
inclusion criteria: * in-hospital cardiac arrest * restoration of spontanous circulation * unconsciousness * age over 18 * initiation of mild therapeutic hypothermia is possible within 4h after resuscitation exclusion criteria: * active bleeding * suspicion of intra cranial bleeding * severe infection * aquired immun deficency * severe rhythm disorders * suspicion of cerebral insult * known severe cognotive deficit before the index event * pregnancy * pre existing disease which makes 6 months survival unlikely

Keywords: in-hospital cardiac arrest resuscitation mild therapeutic hypothermia
identification and semi -quantification of er/pr proteins expression

Conditions: Breast Cancer

Summary: the purpose of the study is the identification and quantification of proteins expression level in breast cancer tissues. the imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying er/pr ihc stained samples.

the anti er/pr kit is a semi-quantitative immunohistochemical (ihc) assay to identify the progesterone (pr) and estrogen (er) expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. results from the er/pr test is indicated as an aid in the assessment of the hormones status of breast cancer patients. while the er/pr kit provides the antibodies that offer direct visualization and semi-quantification of the protein expression through a brightfield microscope, the genasis gopath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides.

Eligibility criteria:
inclusion criteria: * women having breast cancer exclusion criteria: * others

Keywords: immunohistochemical (ihc) er/pr breast cancer
erlotinib (tarceva (trademark), osi-774) in treating patients with advanced non-small cell lung cancer

Conditions: Advanced Non Small Cell Lung Cancer; Failed Prior Chemotherapy

Summary: the purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced non-small cell lung cancer.

only patients with 0 to 1 performance status on the ecog scale are eligible.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of stage iiib or iv non-small cell lung cancer (histological or cytological). * received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer. * measurable disease per recist criteria. * adequate bone marrow, hepatic and renal function. exclusion criteria: * breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years. * brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days. * known hypersensitivity to minocycline. * history of serious cardiac disease that is not controlled. * serious eye conditions. * prior treatment with inhibitors of egfr of any kind.

Keywords: tarceva erlotinib nsclc non-small cell lung cancer egfr osi-774
efficacy and safety of lenalidomide for treatment of autistic spectrum disorders

Conditions: Autism

Summary: the purpose of this study is to determine if lenalidomide (revlimid®)reduces proinflammatory cytokines including tnf-alpha and may actually alter the clinical course of autism for some children.

autism currently affects 1:142 births and has no definite cause. recent research has shown possible identifying markers in neuroglial inflammation with elevated cytokines il-1, il-6, and mcp-1 and elevated ratios of csf/serum levels of tnf-alpha in patients with regressive autism. lenalidomide (revlimid®) is an analogue of thalidomide. based on the improved clinical efficacy predicted for revlimid® in its effects on tnf-alpha and other immunomodulatory cytokines, this oral compound may prove efficacious with less toxicity compared with thalidomide. the study will evaluate the efficacy of lenalidomide by measurement of changes in eeg, clinical global impression, childhood autism rating scale, and serum and csf (if available) tnf-alpha at the end of the study compared with the same measurements at baseline.

Eligibility criteria:
inclusion criteria: * diagnosis of autistic spectrum disorder as defined by dsm-iv criteria. * inflammatory csf and serum markers with elevated level of tnf-alfa (\> 50pg/ml) or other cytokine markers such as il-1, il-6 or mecp-1, or serum levels of such cytokines greater than 2x normal levels even in absence of csf markers. or * patients with interictal epiliptiform eeg changes in the absences of clinical seizures, if csf inflammatory markers are identified. * patients will maintain any other baseline medications for autistic problems or eeg treatment as long as on these for prior 6-8 weeks with no dosage changes. mentally impaired minors require a parent or legal guardian to sign the informed consent. exclusion criteria: * -diagnosis of ppd-nos and other autism spectrum disorders. * any serious medical condition, laboratory abnormality, genetic, brain, structural, or psychiatric illness that would prevent the subject from participating. * history of neutropenia, thrombocytopenia or other types of myelosuppression or risk factors for myelosuppression. * history or risk factors for thromboembolic events. * any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * use of any other experimental drug or therapy within 28 days of baseline. * current use of steroids (e.g. dexamethasone, prednisone), anthracyclines (doxil, adriamycin). * known hypersensitivity to thalidomide. * the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. * any prior use of lenalidomide. * known positive for hiv or infectious hepatitis, type a, b or c or tuberculosis.

Keywords: autistic spectrum disorder lenalidomide
fetal growth restriction a case control study

Conditions: Idiopathic Fetal Growth Restriction

Summary: the study aims to investigate the responsible factors that leads to idiopathic fetal growth restriction.

the study aims to investigate the relationship between maternal serum level of progesterone, immune-expression of hmox-1 a placental angiogenesis marker with idiopathic fetal growth restriction.

Eligibility criteria:
inclusion criteria: * singleton * dated pregnancy exclusion criteria: * fetus with structural or chromosomal anomaly * receive treatments such as aspirin, progestogen, low molecular weight heparin * has pre-existing medical disorders such as autoimmune disease, hypertension, diabetes * smoking * suspected intrauterine infection

Keywords: progesterone heme oxygenase-1 idiopathic fetal growth restriction
srebp1 as a potential biomarker promotes cell proliferation and invasion in thyroid cancer

Conditions: Thyroid Cancer

Summary: in this study, the investigators detected the expression of srebp1 in thyroid cancer tissues, explored the biological functions of srebp1 in thyroid cancer cells.

qrt-pcr and immunohistochemistry were used to detect the expression of srebp1 in 96 pairs thyroid cancer tissues and the adjacent normal tissues. the following methods, including the mts, colony-forming assay, flow cytometry and hoechst staining were used to detect the biological function of thyroid cancer cells based on srebp1 interference or not.

Eligibility criteria:
inclusion criteria: clinical diagnosis of thyroid cancer reciving thyroidectomy surgery no experience of radiation therapy nice treatment compliance and follow-up regularly exclusion criteria: prior history of malignancy ; radiotherapy history, chemotherapy history; serious concomitant diseases ; chronic renal insufficiency and liver dysfunction

Keywords: thyroid cancer srebp1
quality of life with bone conduction hearing device

Conditions: Conductive Hearing Loss

Summary: the aim of this study is to compare the audiological and quality of life performance patients have with an adhear (adhesive bone conduction device) compared to no hearing device.

patients will be recruited at the outpatient's department of the medical university of vienna - otorhinolaryngology department. patient will be asked to participate in the study when inclusion and exclusion criteria are met. mostly patients scheduled for a surgery improving conductive hearing loss or scheduled for implantation of an implantable bone conduction hearing aid will be included in the study. patients who do not use a hearing aid and who are not planning on using a hearing aid meeting the inclusion and exclusion criteria will also be asked to participate in the study. after inclusion in the study patients will be asked to fill out two questionnaires (quality of life and hearing specific questionnaire). they will then be fitted with an adhear device and undergo unaided and aided soundfield audiometry. randomization will be carried out (randomization ratio 1.4:1) and patients in the intervention group will keep the device for the following 4 months with one visit after the first probation time of one month. at the one month mark patients in the control group will be asked to fill out the two questionnaires. patients in the control group will be asked to return to the department and fill out the three questionnaires (ssq-12 (speech spatial and hearing questionnaire), aqol(assessment of quality of life) and in-house questionnaire). further audiologic assessment will be carried out. at this appointment patients will be able to talk about their experiences in the probation period und easily terminate the study in case of insufficient improvement, pain, skin irritations or other issues. at the four month mark patients in both groups will be asked to return for audiologic assessment and for filling out the questionnaires.

Eligibility criteria:
inclusion criteria: * unilateral and/or bilateral conductive hearing loss (chl) * conductive hearing loss \>10 decibel on average * subjective benefit from the device * subjects aged 13 years or older * capable of the german language * willingness and ability to perform all tests required for the study * signed, and dated informed consent before the start of any study specific procedure exclusion criteria: * pregnancy or breastfeeding * patient uses a hearing aid or plans to acquire a hearing aid * patient is intolerant of the materials as described by manufacturer * patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter. * patient cannot perform the audiological tests or is unable to fill out the questionnaires. * patient presents with retrocochlear, or central auditory disorder. * any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures
vaginal or laparoscopic hysterectomy, persistent postsurgical pain

Conditions: Chronic Postsurgical Pain

Summary: previous studies have shown that chronic pain after hysterectomy is common. the aim of this study is to investigate the incidence of chronic pain after vaginal or laparoscopic hysterectomy for benign reasons. the aim of this prospective study is also to study the role of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.


Eligibility criteria:
inclusion criteria: * patients who undergo vaginal or laparoscopic hysterectomy for benign conditions * age 18-69 years * gender: female * asa status 1-3 exclusion criteria: * body mass index over 35 * diabetes mellitus * liver disease * preoperative use of opioids
study evaluating the efficacy of dvs-233 in fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to determine if dvs-233 is safe and effective in the treatment of pain and other symptoms of fibromyalgia syndrome.


Eligibility criteria:
inclusion criteria: * fibromyalgia according to 1990 american college of rheumatology (acr) criteria exclusion criteria: * other painful conditions that may make results difficult to interpret. * treatment with other drugs for fibromyalgia with 14 days of study start or during the study.

Keywords: fibromyalgia adults outpatients adult double-blind method
surgical treatment of peri-implantitis with and without an initial non-surgical approach

Conditions: Peri-Implantitis

Summary: randomized, surgeon and outcome assessor blinded, multi-centric, superiority trial with two parallel groups and a 1:1 allocation ratio with the aim of comparing the surgical treatment of severe peri-implantitis with or without an initial non surgical approach.


Eligibility criteria:
inclusion criteria: any patient having at least one implant affected by severe peri-implantitis, being at least 18 years old and able to sign an informed consent form will be potentially eligible for this trial. severe peri-implantitis will be defined as peri-implant probing pocket depth \[ppd\] ≥6 mm in at least 1 site of the implant, together with bleeding and/or suppuration on probing \[bop and/or sop, respectively\] and radiographically documented marginal bone loss/level ≥3 mm (carcuac et al. 2016) on implants in function by at least 1 year. in case of absence of baseline radiographs, the reference point for baseline bone levels will be considered where bone was likely to be at implant placement. exclusion criteria: patients fitting to all the inclusion criteria as above will be not included in the study if they appear to be unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria are found in the enrolment phase. systemic primary exclusion criteria: * compromised general health which contraindicates the study procedures (asa iv-vi patients); * systemic diseases which could influence the outcome of the therapy (uncontrolled diabetes mellitus); * pregnant or nursing women; * chronic use of corticosteroids or nsaid or immune-modulator drugs (any type and any dose); * patients who need use of medications affecting bone metabolism or peri-implant mucosa (bisphosphonates, any type and any dose). local primary exclusion criteria: * history of peri-implantitis treatment on implants to be included in the study (included topical antibiotics); * hopeless implants (e.g. mobility) to be included in the study. secondary exclusion criteria: - uncompliant patients (poor oral hygiene 2 weeks after ohi).
deep brain stimulation for treatment-refractory major depression

Conditions: Depression

Summary: this study will investigate the use of deep brain stimulation (dbs) to reduce symptom severity and enhance the quality of life for patients with treatment-refractory major depression.

despite advances in pharmacotherapy and psychotherapy for major depression, a substantial number of patients fail to improve significantly even after years of conventional and experimental interventions. bilateral deep brain stimulation (dbs) to the region of the anterior capsule/ventral striatum is an adjustable and reversible procedure that may be a more effective treatment for patients with major depression. this study will determine the effectiveness, safety, and tolerability of dbs in patients with treatment-refractory major depression.

Eligibility criteria:
inclusion criteria: * major depression (md), severe, unipolar type * german mother tongue * hamilton depression rating scale (hdrs24) score of \> 20 * global assessment of function (gaf) score of \< 45 * at least 4 episodes of md or chronic episode \> 2 years * \> 5 years after first episode of md * failure to respond to \*adequate trials (\>5 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes; * adequate trials (\>3 weeks at the usually recommended or maximum tolerated dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, t3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant); \*an adequate trial of electroconvulsive therapy \[ect\] (\>6 bilateral treatments) and; \*an adequate trial of individual psychotherapy (\>20 sessions with an experienced psychotherapist). * able to give written informed consent * no medical comorbidity * drug free or on stable drug regimen at least 6 weeks before study entry exclusion criteria: * current or past nonaffective psychotic disorder * any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or gilles de la tourette syndrome * any clinically significant abnormality on preoperative magnetic resonance imaging (mri) * any surgical contraindications to undergoing dbs * current or unstably remitted substance abuse (aside from nicotine) * pregnancy and women of childbearing age not using effective contraception * history of severe personality disorder

Keywords: major depression treatment refractory major depression