Kornimate/medical-research-clean huggingface dataset:
effect of mouthrinsing on inflammation of the gums.

Conditions: Gingivitis

Summary: the purpose of this study is to determine whether rinsing with an amine fluoride/stannous flouride mouthrinse in addition to daily tooth brushing is more effective than tooth brushing alone.

gingivitis prevalence is 100% among the population. this is mostly due to an inadequate mechanical cleaning of the teeth. however, remaining dental biofilm can be approached by antibacterial mouthrinses. as a consequence of regular use of these mouthrinses, gingivitis can be reduced. amine fluoride/stannous flouride mouthrinse (asf)has proved its efficacy in several studies. in the previous years, a new formulation that does not contain ethanol anymore was introduced in the market. therefore, it is the aim of the study to proof whether rinsing with asf adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone. in addition, effects on dental plaque, discoloration of teeth and bacterial colonization should be studied.

Eligibility criteria:
inclusion criteria: * healthy male and female adults aged ≥18 years. * participants who have gingivitis/mild chronic periodontitis (approximal probing depth ≤ 3.5 mm at ≥ 80 % of the sites and at ≤ 20 % of the sites \> 3.5 mm and \< 5 mm). * participants must have read, understood and signed the informed consent form. * participants who have a gi ≥ 1.3 at baseline. * participants who have at least 20 own teeth excluding the wisdom teeth (incl. 16 natural crowns). * participants who have an acceptable compliance according to the investigators' assessment. exclusion criteria: * participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e. g. phenytoin, nifedipine, cyclosporine, antibiotics, steroids, antiphlogistics). * participants who require antibiotic treatments for dental appointments (endocarditis prophylaxis). * participants who were treated with antibiotics 8 weeks before recruitment and during the course of the study. * participants who were treated with any antibacterial mouthrinse 6 weeks before recruitment. * participants who use other than the recommended mouthrinse or toothpaste during the study period. * participants who have moderate and severe chronic or aggressive periodontitis. * participants who have irregularities of the gingival tissues, e. g. hyperplastic gingiva, mucosal diseases. * participants who have rampant caries. * participants under guardianship or without freedom by administrative or legal award. * known hypersensitivity or allergy to the study product and standard toothpaste ingredients used in the present study. * known pregnancy or breast feeding during the course of the study. * participation in another clinical trial or receipt of an investigational compound/treatment at the same time and 4 weeks prior to inclusion.

Keywords: gingivitis index plaque index discoloration index mouth rinse amine fluoride/stannous fluoride clinical trial
a study of ast-120 for evaluating prevention of progression in chronic kidney disease including assessment of quality of life (eppic-2)

Conditions: Chronic Kidney Disease

Summary: 1) to evaluate the effectiveness of ast-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe chronic kidney disease (ckd), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (scr) when compared with placebo; 2) to evaluate the safety and tolerability of long-term ast-120 therapy in patients with ckd; 3) to evaluate the effects of ast-120 versus placebo, on other measures of renal function and quality of life.


Eligibility criteria:
inclusion criteria: * age 18 years or older * moderate to severe ckd, not anticipated to require dialysis or renal transplant within the next 6 months * patient survival expected to be no less than one year * serum creatinine in men \>= 2.0 mg/dl (\>= 177 µmol/l) and \ = 1.5 mg/dl (\>= 133 µmol/l) and \<= 5.0 mg/dl (\<= 442 µmol/l) at screening * urinary total protein to urinary total creatinine ratio must be \>= 0.5 on a spot void obtained at screening * blood pressure \ 160/90 mmhg * in patients being treated for hypertension, they should be on a stable anti-hypertensive regimen exclusion criteria: * obstructive or reversible cause of kidney disease * nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine of \> 6.0 as measured on a spot void * adult polycystic kidney disease * history of previous kidney transplant * history of recent (within the past 6 months) accelerated or malignant hypertension * uncontrolled arrhythmia or severe cardiac disease within the past 6 months * history of malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, or severe gi dysmotility, not attributable to the use of a phosphate binder * received any investigational agent or participated in a clinical study within the previous 3 months * presence of any significant medical condition that might create an undue risk with study participation, or significantly confound the collection of safety and efficacy data in this study

Keywords: kidney diseases
comparison of microcirculation indexes and hemodynamic indexes to guide resuscitation in patients with septic shock

Conditions: Sepsis

Summary: comparison of microcirculation indexes and hemodynamic indexes to guide resuscitation in patients with septic shock

objectives: comparison of microcirculation indexes and hemodynamic indexes to guide resuscitation in patients with septic shock. intervention: 1. microcirculation-oriented resuscitation group: when the system hemodynamics meets the standard of edgt, the microcirculation-oriented resuscitation group will evaluate the organ perfusion level and adjust the hemodynamic therapy according to the sublingual microcirculation parameters (ppv \> 68%). 2. control group: the standard treatment group will adjust the shock management scheme through systemic hemodynamic parameters. primary outcome: (1)change in sofa score at 72h (2)30-day mortality

Eligibility criteria:
inclusion criteria: * patients fulfilled the diagnostic criteria of septic shock. exclusion criteria: * declined to participate * pregnant * patients who were younger than 18 years old * active bleeding * septic shock is diagnosed for more than 4 hours * patients are expected to be die within 24hours

Keywords: septic shock; sublingual microcirculation
direct carotid sinus nerve stimulation in anesthetized human subjects

Conditions: HTN-Hypertension; Blood Pressure Management

Summary: uncontrolled hypertension (htn) is growing in incidence globally creating a critical need for alternative therapeutic strategies. directly stimulating the carotid sinus nerve (csn) is known to potentially reduce blood pressure (bp) but its clinical efficacy has not been consistently demonstrated with existing electrode technologies in humans. we investigated the effect of acute direct csn stimulation on bp and hr in anesthetized humans using an application-specific multi-contact electrode.


Eligibility criteria:
inclusion criteria: * . eligible patients were those scheduled to undergo elective surgical procedure that therapeutically indicated exposure of the carotid bifurcation and vascular sheath (e.g. carotid endarterectomy, neck dissection, or carotid tumor resection) regardless of a htn diagnosis. exclusion criteria: * history of stroke * prior ipsilateral neck surgery or radiation treatment * cardiovascular disease that precluded enrollment were diagnoses which independently increased surgical and anesthetic risk (american society for anesthesia classification system).

Keywords: neuromodulation hypertension autonomic electrode implant
the efficacy and safety of pulp regeneration induced by shed polymerization

Conditions: Pulp Necroses

Summary: dental pulp necrosis is one of the most common pathological conditions that results in tooth loss. however, regeneration of functional dental pulp has proved difficult. therefore, the investigators conduct a single-arm study to evaluate the efficacy and safety of pulp regeneration induced by shed mixed with hyaluronic acid polymerization in patients with pulp necrosis of permanent teeth.

this study is a single-center, prospective, single-arm study to evaluate the efficacy and safety of pulp regeneration induced by shed mixed with hyaluronic acid polymerization in patients with pulp necrosis of permanent teeth. this study plans to include 30 subjects from the department of stomatology of the fifth affiliated hospital of guangzhou medical university. all participants in this study will receive stem cells from human exfoliated deciduous teeth (shed) mixed with hyaluronic acid polymers after the preparation and disinfection of the root canal of the affected teeth. all participants will undergo screening and baseline visits. after surgery, the participants will be followed up for 2 years.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 45 years * patients with pulp necrosis of a single canal permanent tooth due to trauma or caries * patients who have signed informed consent exclusion criteria: * patients with pulp necrosis caused by severe trauma to the tooth, such as crown root fracture, tooth root fracture, tooth displacement, etc * patients with calcification of the apical foramen at the root of the tooth * history of hereditary disorders of abnormal tooth development * dental occlusal trauma, bruxism, malocclusion * bad oral habits (sticking out the tongue, biting lips, biting nails, sucking fingers, etc.) * presence of uncontrollable pathological processes in the oral cavity (presence of acute advanced diseases in the oral cavity) * malnutrition (serum albumin concentration\<2 g/dl) * patients with history of other systemic, communicable or hereditary diseases have been diagnosed * pregnant, nursing, planning to become pregnant * the investigators determined that the patient was not suitable for the study

Keywords: pulp necrosis pulp regeneration
quantification of silicone oil emulsification after pars plana vitrectomy

Conditions: PArs Plana Vitrectomy; Retinal Detachment; Silicone Oil Droplets on Intraocular Lens

Summary: silicone oil tamponade removal after previous injection of complicated retinal detachment can be achieved with active suction followed by triple air-fluid exchange or prolonged lavage of the vitreous chamber to remove emulsification. purpose of the study is to compare the amount of silicone oil emulsification droplets within the lavage fluid in case of air exchange and simple lavage to compare which technique removed the highest percentage of emulsion. this is achieved by comparing consecutive samples of lavage fluid

silicone oil tamponade removal after previous injection of complicated retinal detachment can be achieved with active suction followed by triple air-fluid exchange or prolonged lavage of the vitreous chamber to remove emulsification. purpose of the study is to compare the amount of silicone oil emulsification droplets within the lavage fluid in case of air exchange and simple lavage to compare which technique removed the highest percentage of emulsion. this is achieved by comparing consecutive samples of lavage fluid. therefore consecutive patients scheduled to sio removal with triple air exchange or vitreous chamber lavage are enrolled and 3 samples of intraocular fluid aspirated during the fluid exchange procedure sent to the lab for sio emulsion count and quantification.

Eligibility criteria:
inclusion criteria: * previous silicone oil tamponade after pars plana vitrectomy * age \>18 years * attached retina exclusion criteria: * unwilling or unable to participate, * previous multiple eye surgery * history of trauma
impact of intraventricular electrical activation in resynchronization therapy

Conditions: Heart Failure; Cardiomyopathy, Dilated; Coronary Disease

Summary: impact of intraventricular electrical activation in resynchronization therapy. we seek to evaluate the impact of cardiac resynchronization therapy (crt) on electrical activation of the left ventricle (lv). the first goal of the study is to evaluate if crt is able to decrease the heterogeneity of lv activation in heart failure patients. a second goal is to evaluate the electrical determinant of clinical response to crt using invasive and non-invasive mapping technology.

comprehensive study, prospective, monocentric and cohort study. biventricular pacing is an effective therapy to improve end stage heart failure patients, however up to 30% of patients are unresponsive to this therapy. among others, optimization of left ventricle (lv) pacing site location is critical to optimize response to cardiac resynchronization therapy (crt). whether a better comprehension of baseline lv electrical activation can help to determine optimal lv lead location remains to be investigated. after informed consent patients are included in the sudy. day 1: crt device is implanted under general anesthesia in a conventional fashion. the coronary sinus leads will be implanted guided by the acute hemodynamic response (+(dp/dt)max) using a radi guide wire. after device implantation, a steerable mapping catheter will be inserted in the lv cavity to build a tridimensional activation map of the lv. this map will be obtained with and without crt. from these maps different parameters describing lv activation will be measured and compared between patients with and without crt. quantitative parameters: global lv activation time (lvatg) (primary outcome); septal activation time (lvtas); global intra-lv dispersion time and qualitative parameters: presence of intralv line of block, area of late activation. day 5±2: a non-invasive map of the lv will be recorded with the cardioinsight ® system with and without crt. the same parameters will be measured and compared with those obtained with invasive mapping. a 3 and 6 months follow-up visit including clinical, biological evaluation (nyha status, 6-min walking test, bnp) of the patients will be performed with an additional transthoracic echocardiography at 6 months.

Eligibility criteria:
inclusion criteria: * adult (aged 18 or above) * sinus rhythm * patient must have signed informed consent * cardiac insufficiency of whatever cause (ischemic or non-ischemic) * patient eligible for implantation of a ventricular resynchronization device or patient with a ventricular resynchronization device having a procedure of ventricular tachycardia ablation * left ventricular ejection fraction \<35% * nyha class ii to iv with optimal medical treatment * patient covered by national healthcare insurance exclusion criteria: * pregnant woman * sequel of transmural myocardial infarction

Keywords: cardiac insufficiency invasive procedure heart failure noninvasive procedure congestive heart failure mapping cardiac resynchronisation therapy open study cardiac pacings, artificial hemodynamics
t-cell depleted allogeneic stem cell transplantation for patients with hematologic malignancies

Conditions: Acute Myelogenous Leukemia; Lymphoid Leukemia; Chronic Myelogenous Leukemia; Malignant Lymphoma; Hodgkin's Disease; Chronic Lymphocytic Leukemia; Myeloproliferative Disorder; Anemia, Aplastic; Myelodysplastic Syndromes

Summary: objectives: 1. to evaluate disease free survival after campath 1h-based in vivo t-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies. 2. to evaluate the incidence and severity of acute and chronic gvhd after campath 1h-based in vivo t-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation. 3. to evaluate engraftment and chimerism after campath 1h-based in vivo t-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.


Eligibility criteria:
inclusion criteria: * zubrod performance status 2 (see appendix b). * life expectancy is not severely limited by concomitant illness. * adequate cardiac and pulmonary function. patients with decreased lvef or pfts will be evaluated by cardiology or pulmonary prior to enrollment on this protocol. * serum creatinine \ 50 ml/min . * serum bilirubin 2.0 mg/dl, sgpt \<3 x upper limit of normal * no evidence of chronic active hepatitis or cirrhosis. * hiv-negative * patient is not pregnant * patient or guardian able to sign informed consent. exclusion criteria: * n/a

Keywords: relapsed or refractory acute myelogenous or lymphoid leukemia. acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.chronic myelogenous leukemia in accelerated phase or blast-crisis. chronic myelogenous leukemia in chronic phase chronic myelogenous leukemia in accelerated phase or blast-crisis recurrent or refractory malignant lymphoma or hodgkin's disease. chronic lymphocytic leukemia, relapsed or with poor prognostic features. myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features. severe aplastic anemia after failure of immunosuppressive therapy. myelodysplastic syndromes (including pnh) multiple myeloma at high risk for disease recurrence.
fimasartan-based bp targets after drug switching

Conditions: Essential Hypertension

Summary: the recent hypertension clinical practice guidelines published by american college of cardiology (acc) and american heart association (aha) reduced the target bp to 130/80 mmhg, indicating the needs for more aggressive efforts in hypertension treatment. however, studies in koreans must be preceded before applying such new overseas guidelines; thus, this study has been designed to establish clinical materials reflecting treatment setting in korea. in this study, patients with uncontrolled hypertension whose antihypertensive regimens are changed to arb-based therapy (arb monotherapy or arb-containing combination therapy) will be followed to assess the treatment trend, treatment effect, and risk of cardiovascular disease.

this study will be performed in patients with blood pressure (bp) uncontrolled by existing antihypertensive drugs (including arb) among hypertensive patients visiting outpatient clinic of medical institutions in korea. the study enrollment number will be assigned to the subjects who provide a written consent to the use of personal information and meet the inclusion/exclusion criteria. follow-up will be conducted for 12 weeks in total and prespecified study related data will be collected in the case report form.

Eligibility criteria:
inclusion criteria: * provided written consent to the use of personal information after receiving the explanation of the objective, methodology, etc. of this clinical study * male or female adults ≥ 19 years who are diagnosed with essential hypertension * receiving outpatient treatment at the time of study enrollment * patients with hypertension uncontrolled by existing antihypertensive drugs (including arb) whose antihypertensive regimens decided and scheduled to be changed to arb monotherapy or arb-containing combination therapy (the result of the arm with a higher mean bp \[systolic bp preferred\] when measured twice with at least a 2-minute interval in both arms at the medical office on the study enrollment date, will become the reference) * definition of uncontrolled hypertension: target bp (sbp \<140 mmhg and dbp \<90 mmhg) not achieved even after the treatment using the existing antihypertensive drugs for 4 weeks or longer exclusion criteria: * patients who were hospitalized or are scheduled to be hospitalized 4 weeks before or after the study enrollment date * patients with suspected or confirmed secondary hypertension * pregnant or breast-feeding women * patients who received investigational product within 12 weeks or are scheduled to participate in another clinical study while participating in this study * patients who are determined inappropriate for participating in the study by investigators for other reasons

Keywords: hypertension fimasartan
safety and efficacy evaluation of γ-globin reactivated autologous hematopoietic stem cells

Conditions: Thalassemia Major

Summary: this is a single arm, open label, single-dose, phase 1/2 study in up to 5 participants with β-thalassemia major.the study will evaluate the safety and efficacy of the treatment with γ-globin reactivated autologous hematopoietic stem cells in subjects with β-thalassemia major.

γ-globin reactivated autologous hematopoietic stem cells will be manufactured using glycosylase base editors. subject participation for this study will be 2 year. subjects who enroll in this study will be asked to participate in a subsequent long-term follow up study that will monitor the safety and efficacy of the treatment they receive for up to 15 years post-transplant.

Eligibility criteria:
key inclusion criteria: * fully understand and voluntarily sign informed consent. 3-35years old. at least one legal guardian and/or subjects to sign informed consent. * clinically diagnosed as β-thalassemia major, phenotypes including β0β0, β+β+、β +β0, βeβ0 genotype. * subjects with no affection with ebv, hiv, cmv, tp, hav, hbv and hcv. * subjects body condition eligible for autologous stem cell transplant. key exclusion criteria: * subjects acceptable for allogeneic hematopoietic stem cell transplantation and have an available fully matched related donor. * active bacterial, viral, or fungal infection. * treated with erythropoietin prior 3 months. * immediate family member with any known hematological tumor. * subjects with severe psychiatric disorders to be unable to cooperate. * recently diagnosed as malaria. * history of complex autoimmune disease. * persistent aspartate transaminase (ast), alanine transaminase (alt), or total bilirubin value \>3 x the upper limit of normal (uln). * subjects with severe heart, lung and kidney diseases. * with serious iron overload, serum ferritin\>5000mg/ml. * any other condition that would render the subject ineligible for hsct, as determined by the attending transplant physician or investigator. * subjects who are receiving treatment from another clinical study, or have received another gene therapy. * subjects or guardians had resisted the guidance of the attending doctor. * subjects whom the investigators do not consider appropriate for participating in this clinical study