Kornimate/medical-research-clean huggingface dataset:
ablation strategies for repeat procedures in patients with atrial fibrillation recurrences

Conditions: Atrial Fibrillation

Summary: the aim of the study is to evaluate different ablation strategies in patients with af recurrences despite chronic pvi after prior catheter ablation. the present study is a multi-centre prospective randomized study enrolling 256 patients with drug-refractory af despite previous af ablation. after pv remapping confirming durable pvi patients will be assigned to 2 different groups: group a: substrate modification. after obtaining a voltage map of the la, substrate modification will be performed aiming at low-voltage areas (lva) \< 0.5mv. group b: laa isolation. patients will undergo laa-isolation using the cryoballoon (cb). catheter ablation procedures will be performed with commercially available devices including 3d mapping systems (carto, ensite) and irrigated radiofrequency current (rfc) ablation or cryothermal balloon ablation (arctic front advance). the primary endpoint is freedom from documented recurrence of af or any atrial tachyarrhythmia lasting \> 30 seconds between day 91 and 365 after the index procedure.


Eligibility criteria:
inclusion criteria: * • symptomatic non-valvular atrial fibrillation despite prior ablation with an indication for re-ablation according to current guidelines. * permanent pulmonary vein isolation according to mapping with a spiral mapping catheter * age 18-85 years. * left atrial size \< 55mm. * left ventricular ejection fraction ≥ 45%. * patient is able to provide informed consent and is willing to comply with the study protocol. exclusion criteria: * contraindications for repeat ablation * reconnected pulmonary veins according to mapping results with a spiral mapping catheter * minimal diameter of laa neck ≥25mm * history of mitral valve surgery * severe mitral valve regurgitation * inability to be treated with oral anticoagulation * presence of intracardiac thrombi * chronic obstructive pulmonary disease treated with long acting bronchodilatators * asthma * obstructive sleep apnea syndrome * pregnancy * participation in other clinical studies * unwilling to follow the study protocol and to attend follow-up visits

Keywords: catheter ablation
cv004-007 thrombosis chamber study

Conditions: Thrombosis

Summary: the purpose of this study is to determine whether bms-986120, aspirin, or aspirin and clopidogrel decrease blood clotting.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs and clinical laboratory determinations * body mass index (bmi) of 18 to 32 kg/m2 inclusive. bmi = weight (kg)/ \[height (m)\]2 * females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 65, inclusive * azoospermic males and women who are not of child-bearing potential (i.e. are postmenopausal or surgically sterile; see section 3.3.3 for the definition of wocbp) are exempt from contraceptive requirements. however, women must still undergo pregnancy testing as described in this section exclusion criteria: * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations beyond what is consistent with the target population * any condition that could affect drug absorption * other protocol-defined exclusion criteria could apply
safety and efficacy of adult adipose-derived stem cell injection into partial thickness rotator cuff tears

Conditions: Rotator Cuff Tears

Summary: extension study of protocol rc-001- safety and efficacy of adult adipose-derived stem cell injection into partial thickness rotator cuff tears. purpose is to investigate the long- term safety and efficacy of autologous stem cells in patients with partial thickness rotator cuff tears versus a steroid treatment.

the purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (ptrcts) after the administration of a single injection of adipose-derived regenerative cells (adrcs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space. the adrc mixture is generated from the transpose® rt system, a point-of-care solution for extraction of an autologous regenerative cell mixture from the adipose tissue after a same-day limited liposuction procedure. a pilot clinical study was recently completed using an injection of adrc compared to a corticosteroid injection for treatment of ptrcts. results support the initiation of a pivotal study to study the same.

Eligibility criteria:
inclusion criteria: * patient completed participation in rc-001 (nct02918136) study * must have the ability to understand and sign a written informed consent form (icf), which must be obtained prior to initiation of study procedures associated with this trial. exclusion criteria: * none
comparison of repaglinide and metformin administered alone or in combination in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this trial is to compare repaglinide and metformin administered alone or in combination in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * previously treated with oral hypoglycaemic agents (oha) as monotherapy (if metformin, less than 1500 mg daily) * body mass index (bmi) of 21-35 kg/m\^2 * hba1c (glycosylated haemoglobin a1c) between 7.0-10% exclusion criteria: * treatment with insulin within the last 3 months preceding the trial * uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm hg, and/or diastolic blood pressure above 105 mm hg) * participation in any other clinical trial within 30 days of screening
the effects of obesity and protein intake on the kidney

Conditions: Kidney Diseases

Summary: the purpose of this study is to determine if being overweight and eating lots of protein causes separate changes in the kidney that lead to kidney disease over time. these questions are important because the number of people who have kidney disease is quickly growing. if being overweight and eating lots of protein is found to cause kidney disease, then doctors may be able to limit the number of people with kidney disease by recommending weight loss and eating less protein

the purpose of this study is to test the hypothesis that being obese leads to changes in kidney function that are independent of, and enhanced by, high dietary protein intake. kidney function will be measured by the kidney's ability to filter blood and by the amount of protein in the urine. the hypothesis will be tested in the following manner: the first part of the study will involve a crossover design comparing kidney function in obese people with stable weights on a low and high protein diet ("low/high protein study"). the second part of the study will compare kidney function in obese people before and after weight reduction surgery ("before/after surgery study"). since certain changes in kidney function may lead to kidney disease over time, it is important to confirm the effects of obesity and dietary protein intake on the kidney, especially with the current rise in obese people and the popularity of high protein diets.

Eligibility criteria:
inclusion criteria: * greater than 18 years of age * ability to give informed consent * not pregnant and using appropriate contraceptive methods, or not of childbearing potential * bmi of 30 or higher exclusion criteria: * iodine or shellfish allergy * history of adverse reaction to intravenous contrast * dialysis dependence * diagnosis of diabetes mellitus or taking medicine for diabetes mellitus

Keywords: glomerular hyperfiltration proteinuria
prophylactic antibiotics for prevention of wound complications following vulvectomy

Conditions: Wound Infection

Summary: this randomized prospective study will specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely cefazolin - in preventing wound infection and wound breakdown following vulvectomy.

infectious morbidity in gynecologic oncology has not been thoroughly investigated to date. included in the literature are several studies that highlight substantial numbers of post-surgical infectious complications. specifically among patients undergoing radical vulvectomy, the incidence of post-operative wound complication is as high as 58%. surgery is the treatment of choice for vulvar cancer, but few studies establish protocols or management strategies to prevent the complications of post-operative wound infection and breakdown. this proposed randomized prospective study would specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely cefazolin - in preventing wound infection and wound breakdown following vulvectomy. this same regimen has been described by a leader in the field of gynecology in his text - telinde's operative gynecology. this study will utilize two arms - one as the treatment arm utilizing 24 hours of prophylactic antibiotics and the other as control.

Eligibility criteria:
inclusion criteria: * all female patients 18 years of age or older undergoing surgery for vulvar carcinoma (this includes female patients undergoing any form of vulvectomy - radical, vulvectomy without groin node dissection, and partial vulvectomy) * disease state will not affect inclusion in the study. women with previous surgery for vulvar carcinoma will be included as will those undergoing initial operation. * number of subjects: 160 exclusion criteria: * women simultaneously undergoing treatment for other forms of cancer * women under the age of 18 * pregnant patients

Keywords: vulvectomy wound infection wound complication prophylactic antibiotic post-operative wound complications following vulvectomy
safety and tolerability of oxymetazoline and energy-based therapy in participants with rosacea

Conditions: Rosacea

Summary: this study will evaluate the safety and tolerability of oxymetazoline hcl cream 1.0% when used as an adjunctive treatment to energy-based therapy for participants with moderate to severe persistent facial erythema associated with rosacea.


Eligibility criteria:
inclusion criteria: -documented clinical diagnosis of rosacea. exclusion criteria: * history of any of the following conditions: raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, cerebral or coronary insufficiency, thromboangiitis obliterans, scleroderma, sjögren's syndrome, severe or unstable or uncontrolled cardiovascular disease, or any other current uncontrolled systemic disease * diagnosis or presence of any of the following conditions: rosaceaconglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or chronic recurring facial acne * current treatment with monoamine oxidase (mao) inhibitors * current treatment with niacin ≥ 500 mg/day * greater than 3 inflammatory lesions on the face * history or current evidence of drug or alcohol abuse within 12 months prior to the screening visit.
comparison of transdermal fentanyl and morphine for oral mucositis pain in nasopharyngeal cancer patients

Conditions: Pain; Nasopharyngeal Carcinoma; Head and Neck Cancer; Radiation Induced Oral Mucositis

Summary: the primary purpose of this study is to explore the significance of analgesic treatment for radiation-induced oral mucositis pain in patients with nasopharyngeal carcinoma during radiotherapy, and to compare the analgesic effect of morphine controlled-release tablets with that of fentanyl transdermal patch. half of participants will receive morphine controlled-release tablets,while the other half will receive fentanyl transdermal patch.

morphine controlled-release tablets and fentanyl transdermal patch each relieve radiation-induced oral mucositis pain in patients with nasopharyngeal carcinoma. but they do so by different mechanisms and in different effects. morphine is a classic strong analgesic, which has been widely used in patients with advanced cancer pain. it has achieved satisfactory results in pain control, sleep improvement and quality of life. oral morphine has been regarded as the standard treatment for moderate and severe cancer pain. fentanyl transdermal patch is a system device for transdermal delivery of drugs. it is compressed on a film containing fentanyl memory. the film can continuously release fentanyl into the blood circulation and maintain stable for more than 72 hours. it is not affected by gastrointestinal ph or food, and it has no hepatic frst-pass effect, with a bioavailability of up to 92%. this study will test the efficacy and safety of morphine controlled-release tablets compared to fentanyl transdermal patch in the treatment of pain in patients with radiation-induced oral mucositis.

Eligibility criteria:
inclusion criteria: * patients were pathologically newly diagnosed with nasopharyngeal carcinoma and had no previous history of other tumors * according to the treatment strategies of doctors, patients need to receive radiotherapy with or without chemotherapy (for example, neoadjuvant chemotherapy, concurrent chemotherapy, adjuvant chemotherapy) or targeted therapy * never use a opioid before treatment * hematology: wbc≥4.0×109/l, anc≥1.5×109/l, plt≥100×109/l,hb≥90g/l. * participants with the ability to assess the pain level * willingness to return to enrolling institution for follow-up exclusion criteria: * patients do not conform to the inclusion criteria * known allergy to fentanyl, morphine, or any known component of the drug formulation * refuse to use of opioid drugs * nasopharyngeal patients with mental illness * current untreated or unresolved oral candidiasis or oral hsv infection * co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * pregnant or nursing women * men or women of childbearing potential who are unwilling to employ adequate contraception * other contraindications or unsuitable conditions for radiotherapy
anti-pd-1 antibody combined with pegaspargase in the treatment of advanced stage nk/t-cell lymphoma

Conditions: Nasal Type Extranodal NK/T-Cell Lymphoma

Summary: this open-label, single arm study will evaluate the efficacy and safety of anti-pd-1 antibody in combination with pegaspargase in treatment of newly diagnosed advanced stage nk/t-cell lymphoma.

extranodal natural killer (nk)/t-cell lymphoma (enktl), nasal type, is a distinct and heterogeneous histopathologic subtype of non-hodgkin lymphoma (nhl), accounting for 5%\~10%. the frequency of enktl among nhl patients is significantly higher in asia than in western countries, with poor prognosis. l-asparaginase-based chemotherapy has improved the survival for these patients with advanced stage. however, there is no standard of care for those patients with advanced stage. anti-pd-1 antibody has been proven its efficacy in relapsed or refractory nk/t cell lymphoma. this open-label, single arm study will evaluate the efficacy and safety of pd-1 antibody in combination with pegaspargase in treatment of newly diagnosed advanced stage nk/t-cell lymphoma.

Eligibility criteria:
inclusion criteria: * pathologically confirmed nk/t cell lymphoma based on 2016 who classification * treatment naive * age \> 18 years * advanced stage * must has measurable lesion in ct or pet-ct prior to treatment * ecog 0,1,2 * informed consented exclusion criteria: * aggressive nk/t-cell leukemia * has accepted pd-1,pd-l1 or pd-l2 antibody before * has accepted autologous stem cell transplantation before * history of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3 years prior to study treatment * uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease * primary cns lymphoma * lab at enrollment (unless caused by lymphoma): neutrophile\ 3\*uln; creatinine\>2\*uln * other uncontrollable medical condition that may that may interfere the participation of the study * not able to comply to the protocol for mental or other unknown reasons pregnant or lactation * hiv infection * hbv-dna or hcv-rna positive * diagnosed immunodeficiency or received systemic corticoid therapy 2 weeks prior to first dose. * received attenuated live vaccine 4 weeks prior to first dose.

Keywords: anti-pd-1 antibody nasal type extranodal nk/t-cell lymphoma complete response rate safety
ehealth for the elderly

Conditions: Multiple Myeloma

Summary: since internet usage as a complementing element in cancer care is becoming more and more important in oncological routine we launched my-esteps (ehealth strategy for elderly patients with multiple myeloma) to investigate how specifically elderly patients and their healthcare professionals (hcps) adopt electronic health (ehealth) support during outpatient treatment. the purpose of this project is to explore how ehealth support influences patients' interaction with their hcps and how both can benefit from this.


Eligibility criteria:
inclusion criteria: * multiple myeloma patients * treated by oral imids exclusion criteria: -
patterns of neurodevelopmental disorders

Conditions: Neurodevelopmental Disorders; Autism Spectrum Disorder; Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcal Infection; Pediatric Acute-Onset Neuropsychiatric Syndrome; Down Syndrome; Epilepsy; Mitochondrial Encephalomyopathies; Cerebral Folate Deficiency

Summary: the purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.

although neurodevelopmental disorders are very prevalent (for example autism affects 1 out of every 36 children and dyslexia affects up to 15% of the population), the etiology of such disorders is not known. the purpose of this investigation is to identify common etiologies of neurodevelopmental disorders (i.e., speech delay, global developmental delay, autism) and determine if it is possible to find early indicators of the diagnosis and foster the potential for a better prognosis of these disorders. at this time the investigators examine patients with neurodevelopment disorders with various medical investigations, but the results of these investigations are not systematically evaluated. one of the goals of this research is to systematically examine this information in order to identify patterns of test abnormalities that have not been previously described. another goal of this research is to identify the common etiologies typically identified by the medical evaluation, so we can further refine our approach. in addition, the investigators now have the ability to evaluate biological samples for biomarkers that have potential to be diagnostically useful.

Eligibility criteria:
inclusion criteria: neurodevelopmental delays clinical visit at an rossignol medical center exclusion criteria: -
study of xl999 in patients with previously treated ovarian cancer

Conditions: Ovarian Cancer

Summary: this clinical trial is being conducted at multiple sites to evaluate the activity, safety, and tolerability of xl999 when given weekly to patients with ovarian cancer that has previously been treated with platinum-based chemotherapy. xl999 is a small molecule inhibitor of multiple kinases including vegfr, pdgfr, fgfr, flt-3, and src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.


Eligibility criteria:
inclusion criteria: * female patients with a histologically confirmed diagnosis of metastatic ovarian cancer * measurable disease according to response criteria for solid tumors (recist) * prior treatment with platinum-based therapy * platinum-sensitive or platinum-resistant disease * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy of ≥3 months * adequate organ and marrow function * signed informed consent * no other malignancies within 5 years exclusion criteria: * radiation to ≥25% of bone marrow within 30 days of xl999 treatment * use of an investigational drug or cytotoxic chemotherapy within 30 days of xl999 treatment * prior anticancer therapy targeting vegf (eg, bevacizumab, sorafenib, or sunitinib) * more than two prior systemic non-platinum cytotoxic chemotherapy regimens * subject has not recovered to grade ≤1 or to within 10% of baseline from adverse events due to other medications administered \>30 days prior to study enrollment * history of or known brain metastases, current spinal cord compression, or carcinomatous meningitis * uncontrolled and/or intercurrent illness * patients who are pregnant or breastfeeding * known human immunodeficiency virus (hiv)

Keywords: cancer recurrent platinum-resistant platinum-sensitive
effects of ozone therapy on clinical parameters and inflammatory cytokines in chronic periodontitis patients

Conditions: Chronic Periodontitis

Summary: the objective of this study is to evaluate of ozone therapy on both clinical and biochemical effects in periodontally patients.

this study is evaluated clinical and biochemical effect of ozone therapy at 8 weeks in periodontitis patients.

Eligibility criteria:
inclusion criteria: * systemically healthy * non-smokers * chronic periodontitis participants exclusion criteria: * smokers * pregnancy or lactation * individiuals with any systemic disease