Kornimate/medical-research-clean huggingface dataset:
half-normal saline in atrial fibrillation ablation

Conditions: Atrial Fibrillation

Summary: the study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during atrial fibrillation ablation. by increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes.


Eligibility criteria:
inclusion criteria * male or female between 18 and 75 years of age at the time of enrollment * undergoing first-time radiofrequency ablation for atrial fibrillation * written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study exclusion criteria * robotic-guided atrial fibrillation ablation * baseline hyponatremia (serum sodium level \< 135 meq/l) * pregnant, breastfeeding, or unwilling to practice birth control during participation in the study * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
study to assess the long-term safety of oral lacosamide in subjects with partial-onset seizures

Conditions: Partial Epilepsies; Partial Onset Seizures

Summary: the purpose of this study is to allow eligible subjects from the parent study, sp925 \[nct00655551\] to continue lacosamide and to obtain additional long-term safety data

a multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the sp925 study \[nct00655551\] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).

Eligibility criteria:
inclusion criteria: * eligible subjects who participated in sp925 \[nct00655551\] for treatment of partial-onset seizures exclusion criteria: * receiving any study drug or experimental device other than lacosamide * meets withdrawal criteria for parent study sp925 \[nct00655551\] * experiencing ongoing serious adverse event

Keywords: epilepsy seizures antiepileptic lacosamide vimpat safety adjunctive
sintilimab plus chidamide in the treatment of relapsed and refractory cutaneous t-cell lymphoma: a multicenter phase ii study

Conditions: Cutaneous T-cell Lymphoma

Summary: this is a multicenter prospective single arm phase ii study. the purpose of this study is to evaluate the safety and efficiency of sintilimab combined with chidamide in the treatment of relapsed/refractory cutaneous t-cell lymphoma.

this is a single-arm phase 2 study with fixed does of combined sintilimab and chidamide regimen. this regimen is repeated every 21 days. sintilimab (200mg) is administered intravenously on day 1 of every cycle. chidamide is used 20mg twice per week continuously. from the beginning of the trial, sindilimab will be used for 96 weeks, until disease progress, intolerable toxicity or patient/investigator discretion. patients will continue to receive chidamide treatment until disease progression, unacceptable toxicity, or patient/investigator discretion. the response will be evaluated every 2 cycles in the first 36 weeks and every 4 cycles from week 36 till the end of treatment. the patients who achieve complete remission (cr), partial remission (pr), and stable disease (sd) will receive further treatment. the patients with progressed disease (pd) will be continue on the treatment and reassess after 4-8 weeks to rule out false progression. on confirmation of pd , patients will be withdrawn from the trial and receive salvage regimens.

Eligibility criteria:
inclusion criteria: * pathologically confirmed cutaneous t-cell lymphoma according world health organization (who) classification. * ecog≤2 * patients with measurable lesions, with or without extra-dermal lesions, clinical stage of iib-ivb. * patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment. * absolute neutrophil count (anc）≥0.75×109/l，platelet (plt) ≥ 50×109/l，hemoglobin (hgb）≥ 80 g/l * thyroid stimulating hormone (tsh) within normal range exclusion criteria: * pre-existing uncontrolled active infection * alanine aminotransferase (alt) \>3 times upper limit of normal (uln), total bilirubin (tbil) \>1.5 times uln, serum creatinine \>1.5 times uln * patients with clinically significant qt interval prolongation (male \> 450ms, female \> 470ms), ventricular tachycardia (vt), atrial fibrillation (af), acute coronary syndrome (acs) within 1 year, congestive heart failure (chf), and symptomatic coronary heart disease. * patients who have received organ transplantation or hematopoietic stem cell transplantation. * active bleeding or recent thrombotic disease * patients with known interstitial lung disease * patients with active autoimmune disease or history of autoimmune disease in the past 2 years * patients with cns involvement * pregnant or lactating women * history of mental illness

Keywords: chidamide sintilimab cutaneous t-cell lymphoma
study to evaluate the safety and efficacy of emtricitabine and tenofovir alafenamide (f/taf) fixed-dose combination once daily for pre-exposure prophylaxis in men and transgender women who have sex with men and are at risk of hiv-1 infection

Conditions: Pre-Exposure Prophylaxis of HIV-1 Infection

Summary: the primary objective of this study is to assess the rates of hiv-1 infection in men (msm) and transgender women (tgw) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (f/taf) or emtricitabine/tenofovir disoproxil fumarate (f/tdf) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.


Eligibility criteria:
key inclusion criteria: * must be at high risk of sexual acquisition of hiv * hiv-1 negative status * msm and tgw (male at birth) who have at least one of the following: * condomless anal intercourse with at least two unique male partners in the past 12 weeks (partners must be either hiv-infected or of unknown hiv status) * documented history of syphilis in the past 24 weeks * documented history of rectal gonorrhea or chlamydia in the past 24 weeks * adequate renal function: estimated glomerular filtration rate ≥ 60 ml/min according to the cockcroft-gault formula * adequate liver and hematologic function: * aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 × upper limit of normal (uln) and total bilirubin ≤ 1.5 mg/dl, or normal direct bilirubin * absolute neutrophil count ≥ 1000/mm\^3; platelets ≥ 75,000/mm\^3; hemoglobin ≥ 10 g/dl key exclusion criteria * grade 3 or grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable. note: other protocol defined inclusion/ exclusion criteria may apply.
radiation induced alterations in resting state brain networks in pediatric brain tumor patients

Conditions: Brain Tumor, Primary

Summary: with modern therapy, the survival rate for pediatric brain tumor patients has significantly improved, with over 70% of patients surviving their disease. however, this progress often comes at the cost of substantial morbidity, with cognitive deficits being the primary obstacle to independent living. robust predictors of cognitive decline and a comprehensive understanding of the underlying mechanisms of cognitive injury remain elusive. this study will prospectively investigate alterations in brain resting state networks following radiation therapy using functional imaging. the hypothesis is that radiation therapy leads to dose-dependent alterations in functional connectivity in the networks associated with higher level cognition, ultimately leading to cognitive decline.


Eligibility criteria:
inclusion criteria: * between 8 and 21 years of age, inclusive * newly diagnosed primary brain tumor of any location and any histology that will be treated with proton radiation therapy * life expectancy of at least one year * able to understand and willing to consent or assent to the research proposed (or that of a legally authorized representative, if applicable), along with consent of legal guardian(s) if applicable exclusion criteria: * presence of visual impairment to an extent that the patient is unable to complete the computer testing * contraindication to mri scan (i.e. due to cardiac pacemaker) * presence of programmable shunt or dental braces * requires sedation for mri scans

Keywords: proton therapy radiation brain tumor
comparison of preincisional infiltrated dexmedetomidine and lidocaine plus adrenaline for nasal sephoplasty surgery.

Conditions: Surgery; Pain

Summary: it is very important to decrease the bleeding during nasal septoplasty in order to increase the visibility of the surgical site. our primary goal was to investigate the effects of dexmedetomidine and lidocaine plus adrenaline on visibility of surgical site and postoperative analgesic consumption.

nasal septoplasty is a surgery procedure which needs to have decrease the bleeding during the surgery for the visibility of surgical site.and postoperative pain is very usual after the surgery, so an effective postoperative analgesia procedure reduces the complications and helps to be discharged earlier from the hospital. an alpha 2 agonist dexmedetomidine has an analgesic effect and vasoconstructive effect on the periferal blood vessels. our hypothesis was dexmedetomidine makes a better surgecal conditions during the surgery and reduce the postoperative analgesic consumption. we administered the infiltrated dexmedetomidine or lidocaine plus adrenaline to the both side of the nasal septum 10 minutes before the surgery. bleeding scores (fromm and boezaart bleeding scores) were recorded during the surgery. and postoperative analgesic consumptions were recorded in first 24 hours after the surgery.

Eligibility criteria:
inclusion criteria: * scheduled for the nasal septoplasty surgery * asa 1-2 patients * 18-60 yo patients exclusion criteria: * pregnant patients * asa 3-4 patients * under 18 yo childrens

Keywords: septoplasty, dexmedetomidine, surgical conditions
phase ia/ib multicenter trial of mogamulizumab for advanced or recurrent cancer.

Conditions: Solid Tumor

Summary: the purpose of this study is to investigate safety, pharmacokinetics, effect of regulatory t cell depletion with mogamulizumab for advanced or recurrent cancer patients.

this study consists of phase ia and ib portions for patients with solid tumors. phase ia portion is the standard 3+3 dose-escalation design with 0.1mg/kg, 0.5mg/kg and 1.0mg/kg of mogamulizumab. phase ib portion is the randomized study comparing 0.1mg/kg and tolerated dose of mogamulizumab based on the phase ia portion to pursue safer and immunologically more efficient dose.

Eligibility criteria:
inclusion criteria: 1. patients with histologically confirmed, ccr4 negative lung, stomach, esophageal, ovarian or skin cancer. 2. patients with therapy-resistant cancer. patients with recurrent cancer or advanced cancer who refused standard therapies. 3. eastern cooperative oncology group (ecog) performance status is 0, 1 or 2. 4. patients should be 20 years or older at the time of informed consent. 5. no serious dysfunction of major organs (bone marrow, heart, lung, liver and kidney) and meet the following conditions ; 1) wbc count : \>=1,500/mm3 2) hemoglobin : \>=8.0g/dl 3) platelet count : \>=75,000/mm3 4) serum total bilirubin : \ =93 % 8) ecg : no abnormal findings. 9) ef : \>=50 % 6. agree to use birth control including condom etc. from the time of obtaining the first consent to 24 weeks after the final administration of the study drug (except female after menopause (1 year or more after the last menstruation) and female/male after the operation for sterilization). 7. given written informed consent. 8. patients who can be hospitalized from the day of first administration to the next day. 9. patients who have target lesions measurable by recist ver.1.1. 10. life expectancy \>= 3 months. exclusion criteria: 1. patients with hiv antibody positive. 2. patients with hcv antibody positive. 3. patients with autoimmune disease. 4. patients with hbs antigen or hbv-dna positive. 5. history of serious anaphylaxis induced by antibody preparation. 6. patients with double cancer. 7. within 4 weeks after treatment with anticancer agent, immune suppressant, immune enhancer, cytokine therapy, radiotherapy or surgery for the primary disease. 8. pregnant or breast-feeding females and females who have a possibility of pregnancy. 9. patients with active infection. 10. patients with psychosis or dementia. 11. patients who need continuous systemic administration of adrenocorticosteroid. 12. patients who have received hematopoietic stem cell transplantation. 13. patients who have presence or suspicion of cns involvement. 14. patients who are administered the other investigational product within 4 weeks of the entry. 15. patients treated with immunotherapy for cancer (e.g. cancer vaccine therapy) within 12 weeks of the entry. 16. any other inadequacy for this study.
the natural history of danon disease

Conditions: Danon Disease

Summary: danon disease (dd) is a rare, x-linked disorder associated with severe cardiomyopathy, and in many cases, skeletal myopathy, and cognitive impairment caused by mutations in the lamp2 gene. there is still uncertainty regarding the natural history of dd because of its rarity. this study aims to determine the natural history of dd through the collection and analysis of retrospective and prospective data. to achieve this, the investigators will perform surveys and obtain medical records from dd patients. the same cohort of patients will also be assessed by a multidisciplinary team with expertise in dd (cardiologist, neurologist, ophthalmologist, psychologist, geneticist) at the university of california, san diego. all patients with dd are eligible, including those who underwent a heart transplant. additionally, data and records from deceased patients will provide valuable retrospective data for this study.

the study design will include: 1. collection of information for all patients from: * survey of patient or caregiver (if the patient has deceased) * medical charts 2. collection of information from living patients assessed by the multidisciplinary team at the university of california, san diego including: * a complete medical history and physical examination * cardiac testing (electrocardiography; echocardiography; cardiac magnetic resonance imaging with gadolinium contrast agent-gadolinium contrast is optional-; cardiopulmonary test) * pulmonary function testing (pft) * neuromuscular assessment * cognitive tests * vision exam including retinal evaluation * laboratory tests * questionnaires on quality of life * needle skeletal muscle biopsy (only for patients over 18 years old) * abdominal ultrasound for assessment of the liver structure

Eligibility criteria:
inclusion criteria: • living or deceased patients with a diagnosis of danon disease(including patients who may or may not have undergone heart transplantation) based on a genetic test positive for the lamp2 mutation exclusion criteria: • patients without a genetic test positive for a lamp2 mutation
role of circulating pyrophosphate as a biomarker of mediacalcinosis in type 2 diabetic patients

Conditions: Type 2 Diabetes; Type 2 Diabetes Patients

Summary: type 2 diabetes currently affects around 4 million people in france, with the number of cases rising steadily. complications of t2dm are essentially cardiovascular. in particular, t2dm is associated with calcification of peripheral vessel walls (mediacalcosis), responsible for increased vascular stiffness. this calcium deposition is known to be a cardiovascular risk factor, but the mechanism of its deposition in relation to diabetes is not clearly established. an important blood compound, inorganic pyrophosphate (ppi), which is the body's natural anti-calcifier is impacted in some way in t2dm. ppi is degraded by alkaline phosphatase (alp), and is produced by an enzyme called enpp1. enpp1 activity is decreased and apl activity increased in insulin-resistant subjects, which could contribute to a decrease in tissue and circulating ppi, and thus favor a tissue pro-calcifying balance. we propose to test this hypothesis in a pilot study characterizing plasma ppi levels, in relation to enpp1 activity, in type 2 diabetic patients. the aim of the study is also to determine if there is a link between blood ppi levels and the progression of calcifications in arteries.


Eligibility criteria:
inclusion criteria: 1. adult men (between 40 and 70 years of age). 2. t2dm defined according to ada or has criteria, evolving for more than 6 months, may be : - not complicated * complicated by diabetic retinopathy and/or diabetic nephropathy (creatinine clearance \> 60 ml/min) and/or peripheral arterial disease and/or ischemic heart disease and/or stroke. - with dyslipidemia (ldlc \> 1.90) and/or a history of past or active smoking. * balanced with hba1c \ 9%. * treated with insulin therapy (single or multi-injections) or not. - whose treatment includes at least one isglt2. 3. member of 'sécurité sociale" exclusion criteria: 1. patient already included in another study. 2. patient in a particular situation judged incompatible with the study by the investigator. 3. patient living in a department other than alpes-maritimes or var. 4. patient refusing to give consent. 5. patient deprived of liberty by administrative or judicial decision, under guardianship or curatorship. 6. patient with decompensated hepatic cirrhosis (child c and above, score 10 to 15 points). 7. patients with chronic kidney disease (from stage 3, i.e. gfr \< 59 ml/min/1.73 m2). 8. patient with a recent fracture (within the last 3 months). 9. patient treated with avk or biphosphonates. 10. patient with known, treated osteoporosis. 11. patient with unsupplemented vitamin d deficiency. 12. patient with active cancer. 13. patient with an active inflammatory pathology.

Keywords: type 2 diabetes
safety and efficacy study of ultrasonic coagulation device and bipolar energy sealing system

Conditions: Thyroid Cancer

Summary: the aim of the study is to evaluate differences between use of ultrasonic coagulation device (new harmonic ace™, ethicon endo-surgery) and bipolar energy sealing system (ligasure precise™, covidien) in surgery for thyroid cancer. abbreviations: ultrasonic coagulation device (uc), bipolar energy sealing system (bes), recurrence-free survival (rfs), overall survival (os)

background: thyroid is an organ that has abundant vessels. in thyroid surgery, it should be cautious to avoid injury of the recurrent laryngeal nerve and parathyroid, thus careful hemostasis during surgery is crucial for surgeons who perform thyroid surgery. recently, there have been significant advances in vessel sealing systems for the occlusion of vessels during surgery as endoscopic surgery has been developed. uc and bes are now commonly used in thyroid surgery. however, only a few studies have compared the two surgical devices to determine which technique is superior in terms of operative time and complication rate. thus, this single-blind prospective randomized trial is conducted to determine if there was a difference in operative time, complication rate, postoperative drainage volume, admission time, cost, and, furthermore, oncologic outcomes (rfs and os) between the two surgical devices in surgery for thyroid cancer.

Eligibility criteria:
inclusion criteria: 1. an age between 20 and 80 years old who are diagnosed as thyroid cancer or suspicious papillary thyroid cancer in fine needle aspiration biopsy 2. patients who are agree with the study enrollment exclusion criteria: 1. an age under 20 or over 80 years 2. severe co-morbidities that were contraindications for thyroid surgery (e.g., severe liver, heart, kidney, or pulmonary problems) 3. a lack of consent to participate in the study 4. the inability to include a patient in clinical trials according to the regulations or laws in korea 5. the inability to complete regular follow-up visits (e.g., immigration) 6. the use of modified radical neck dissection due to lateral neck node metastasis 7. prior thyroid surgery or cervical irradiation 8. active enrollment in another clinical trial 9. the intention of the patient to undergo an additional operation at the time of the thyroid surgery (e.g., mastectomy and thyroidectomy at the same time) 10. the desire to undergo endoscopic or robot-assisted thyroidectomy

Keywords: operation time complication rate costs admission time rfs os
clinical evaluation of laser therapy used as an adjunct to non-surgical treatment of gum disease

Conditions: Periodontitis Chronic Generalized Moderate; Periodontitis Chronic Generalized Severe

Summary: the use of lasers to treat various problems in dentistry is growing as it has in medicine. one application is the use of lasers to treat periodontal disease. it has been suggested that the laser may reduce the need for surgical treatment by reducing pockets. the goal of this study is to evaluate the effectiveness of laser treatment for periodontal disease. laser therapy will be used in addition to traditional non-surgical scaling and root planing (deep cleaning). the information obtained from this study will provide an objective assessment of adjunctive laser therapy compared to conventional periodontal therapy and will attempt to show the benefits, if any, lasers can provide in the treatment of chronic periodontal disease.


Eligibility criteria:
inclusion criteria: * age 18 years old or older (male or female) * healthy without systemic diseases that may adversely effect healing * not pregnant and no current plans to become pregnant * no periodontal treatment in the previous 12 months * no systemic antibiotic therapy in the previous 6 months * at least two quadrants with periodontitis (ideally opposite side same jaw) * each quadrant must have two or more sites with probing pocket depths ≥ 5mm * each quadrant should include interproximal intrabony defect(s) exclusion criteria: * any systemic disease, medication, or habit known to adversely influence bone metabolism and/or wound healing: * poorly controlled diabetes (hba1c \> 7%) * history of bisphosphonate medications * history of radiation therapy affecting the proposed treatment site(s) * history of immunosuppressive medications (e.g. corticosteroids) * history of tobacco use (current or past tobacco use within the past 1 year) * immune compromise caused by disease, treatment or other condition * recent history of periodontal surgery (within the previous 2 years) * recent history of scaling and root planing (within the previous 12 months) * any condition that contraindicates periodontal therapy including surgery

Keywords: laser therapy non-surgical periodontal therapy scaling and root planing