Kornimate/medical-research-clean huggingface dataset:
impact of non-surgical periodontal therapy on oral and gut microbiome

Conditions: Microbial Colonization; Periodontal Diseases; Periodontal Inflammation

Summary: periodontitis is an inflammatory disease characterized by a dysbiotic microbiome which can lead to bone destruction and tooth loss. several studies had been reported the association to periodontal disease with systemic conditions and this relation suggests and axis that links oral and gut microbiome. in order to clarify the impact of periodontal condition on gut microbiome, we aim to evaluate the clinical, immunological parameters and the microbiological condition by sequencing of subgingival biofilm and stool samples both before and after non-surgical periodontal treatment with and without antibiotics as adjunct.


Eligibility criteria:
inclusion criteria: * diagnosis of stage iii/iv and grade c periodontitis * presence of at least 20 teeth * good general health exclusion criteria: * pregnant or lactating * were suffering from any other systemic diseases (e.g., cardiovascular, diabetes) * received antimicrobials in the previous 6 months * received a course of periodontal treatment within the last 6 months * were taking long-term anti-inflammatory drugs * smoking habits
a study of cytomegalovirus (cmv) infection after kidney transplant in adults in the united kingdom

Conditions: Cytomegalovirus (CMV)

Summary: this observational study intends to retrospectively gather information on cytomegalovirus (cmv) infection management in the united kingdom (uk) over a period of 7 years (2017-2024). the main aims of this study are the following: * to estimate the overall prevalence and annual rate of adults with refractory cmv infection after a kidney transplant and describe how such cmv infections are treated * to describe how effective and well-tolerated the treatment was. * to describe the demographic and clinical characteristics of adult participants with cmv infection (refractory and non-refractory). in this study, already existing data will be reviewed and analysed from a uk database called the registry of rare kidney diseases (radar) (nct06065852). the study will only review data collected as part of routine clinical practice. the study will not impact the standard medical care and treatment of participants.


Eligibility criteria:
inclusion criteria: refractory cmv group: 1. participants aged greater than or equal to (\>=) 18 years at index date 2. kidney transplant recipients on or subsequent to june 2016. 3. cmv viraemia or disease identified as requiring treatment and which was refractory to previous cmv management (at least one course of therapy), with or without confirmed resistance. 4. at least six months follow up time (except for participants who have died earlier). reference cohort of non-refractory cmv group: 1. participants aged \>=18 years. 2. kidney transplant recipients. 3. received initial cmv management (at least one course of therapy). 4. at least six months follow up time (except for participants who have died earlier). exclusion criteria: refractory cmv group: 1. multi-organ transplant recipients. 2. participation recorded in an anti-cmv prophylaxis or treatment clinical trial from 2010 onward. participants with non-refractory cmv are to be included as a reference to indicate impact of refractory cmv not responding to initial therapy on resource use and other outcomes. reference cohort of non-refractory cmv group: 1. multi-organ transplant recipients. 2. participation recorded in an anti-cmv prophylaxis or treatment clinical trial from 2010. 3. cmv viremia or disease refractory to any previous anti-cmv therapy. 4. treatment for cmv viremia or disease refractory to initial therapy during the follow up period.

Keywords: drug therapy
mucin levels in dry eye and normal populations

Conditions: Dry Eye

Summary: the purpose of this study is to evaluate changes in ocular mucin levels in response to a drying environment in subjects with dry eye disease as well as patients who report no history of dry eye disease. it is expected that exposure to the dry environment will alter mucin levels in different ways when comparing the two groups.

this is a single-center, two visit, pilot, drying environment study (cae). there will be two different groups of subjects enrolled into this study: dry eye subjects and subjects with no prior diagnosis of dry eye. all subjects will undergo safety and dry eye assessments as well as tear collection prior to and after being exposed to a dry environment. they will also return the following day to undergo dry eye assessments, tear collection, and safety procedures again.

Eligibility criteria:
inclusion criteria: * be male or female of any race, at least 18 years of age at visit 1. * have provided verbal and written informed consent. * have a best corrected visual acuity of +0.70 logmar or better in both eyes at visit 1, as assessed by early treatment of diabetic retinopathy study (etdrs) chart. * if a woman of childbearing potential, have a negative urine pregnancy test at visit 1 and agree to use a medically acceptable form of birth control throughout the study duration . \[females are considered of childbearing potential unless they are surgically sterilized (bilateral tubal ligation, hysterectomy or bilateral oophorectomy) or post-menopausal (at least 12 months since last menses).\] * have previously completed a recent trial or not completed a recent trial and report no symptoms of dry eye disease. exclusion criteria: * have planned surgery during trial period * female currently pregnant, planning a pregnancy or lactating * use of disallowed medications * have ocular infections, or ocular conditions that could affect study parameters * have used an investigational drug or device within 30 days of start of study * female that is currently pregnant, planning a pregnancy or lactating
a phase 2 study to evaluate abt-126 for the treatment of cognitive deficits in schizophrenia

Conditions: Schizophrenia

Summary: this is an efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.

safety and efficacy study for cognitive deficits in adult subjects with schizophrenia.

Eligibility criteria:
inclusion criteria: * has a current diagnostic and statistical manual of mental disorders-, 4th edition, text revision (dsm-iv-tr) diagnosis of schizophrenia confirmed by the mini-international neuropsychiatric interview (m.i.n.i.). * is clinically stable while receiving a regimen of one or two allowable antipsychotic medications; lack of hospitalizations in 4 months prior to initial screening visit; taking the same antipsychotic medication(s) for at least 8 weeks prior to baseline visit; core positive symptoms of positive and negative syndrome scale (panss) no worse than moderate in severity throughout screening period of at least 4 weeks. * has been diagnosed with or treated for schizophrenia for at least 2 years prior to initial screening visit. * has had continuity in psychiatric care (e.g., mental health system, clinic or physician) for at least 6 months prior to initial screening visit. * has an identified contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject to ensure compliance with protocol requirements. exclusion criteria: * in the investigator's judgment, has a current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder, or obsessive-compulsive disorder, or the subject has a current major depressive episode. * has a positive urine drug screen for cocaine, phencyclidine (pcp), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines during the screening period. * has a current or past history of seizures, with the exception of a single febrile seizure occurring prior to 6 years of age. * has a clinically significant abnormal electrocardiogram (ecg) at screening visit 1 as determined by the investigator. * has any risk factors for torsades de pointes (tdp)

Keywords: schizophrenia
long-term follow-up of bivalent human papillomavirus (hpv) vaccine study in women

Conditions: Cervical Cancer; Vulvar Cancer; Vaginal Cancer; CIN - Cervical Intraepithelial Neoplasia; Human Papillomavirus Infection

Summary: this extension study aims to evaluate the long-term protection and immune response of the bivalent hpv vaccine in women aged 18-30 who participated in a previous efficacy study (311-hpv-1003). participants will be monitored over two years, with two visits at 96 and 120 months after their initial vaccination. no additional vaccine doses will be given. cervical samples will be obtained for thinprep cytologic testing (tct) and hpv dna typing. if applicable, participants meeting referral criteria for colposcopy will undergo the procedure during these visits, and tissue samples will be collected from those requiring a biopsy. blood samples will be drawn from an immunology subset for antibody testing.the study includes data collection from multiple sites across china to assess the vaccine's long-term efficacy in preventing hpv-related cervical diseases and its durability over time.


Eligibility criteria:
inclusion criteria: * have the ability to understand and provide informed consent by signing the informed consent form (non-illiterate). * have the ability to comply with protocol requirements, such as attending scheduled visits and responding to follow-up phone calls. * prior enrollment in the 311-hpv-1003 study, with at least one dose of the study vaccine administered. * at least one documented gynecological visit between 6 and 48 months during the previous 311-hpv-1003 study. * refrain from vaginal intercourse for 48 hours and avoid behaviors such as vaginal douching or using vaginal medications that could interfere with gynecological examinations or sample collection for 72 hours prior to each gynecological visit. exclusion criteria: * participants who received another hpv vaccine during the prior 311-hpv-1003 study or between the end of that study and enrollment in this extension study. * participants diagnosed with hpv 16- or 18-related cin2+ by an independent pathology expert panel during the prior 311-hpv-1003 study, or who were definitively diagnosed with hpv 16- or 18-related cin2+ through external testing after the prior study ended. * participants who, at baseline in the 311-hpv-1003 study, tested positive for both hpv 16 and 18 antibodies, or were positive for both hpv 16 and 18 (by cobas 4800), or whose cytology was not normal or of low-grade changes. * participants who are pregnant at the time of gynecological visits or within three months prior to the visit. * participants with any other factors deemed unsuitable for participation in the clinical trial, as determined by the investigator.

Keywords: bivalent hpv vaccine long-term protective efficacy
telotristat with lutathera in neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: this trial will test the hypothesis that telotristat treatment increases the antitumor efficacy of lutetium lu 177 dotatate therapy in neuroendocrine tumors (nets).

neuroendocrine tumors (nets) are a very heterogeneous group of tumors that develop predominantly in the gastrointestinal and pulmonary systems. clinical detection and diagnosis are more reliable at late stages when metastatic spread has occurred. patients with advanced disease may suffer from complications of uncontrolled hormone secretion and usually succumb due to tumor progression. this trial tests the hypothesis that inhibition of serotonin production with telotristat will lead to cytostatic effects on neuroendocrine tumors and will complement the anti-tumor activity of lutetium 177 dotatate. the proposed combination may result in improved treatment efficacy as reflected by improved 20-month progression-free survival (pfs) as compared to historical control.

Eligibility criteria:
inclusion criteria: * metastatic, or unresectable, histologically confirmed well-differentiated grade 1 and 2 neuroendocrine tumor with a positive gallium 68 dotatate scan within 6 months prior to study enrollment * baseline ct scan or mri with measurable progressive disease based on recist criteria * failure of at least one prior systemic cancer treatment for this diagnosis * recovered from adverse events of previously administered therapeutic agents to grade 2 or less toxicity according to ctcae version 5.0 * eastern cooperative oncology group (ecog) performance status ≤2 * normal organ and marrow function exclusion criteria: * prior exposure to lutetium lu 177 dotatate * history of allergic reactions attributed to compounds of similar chemical or biologic composition to telotristat or lutetium lu 177 dotatate. * presence of unstable angina or myocardial infarction * new york heart association (nyha) class iii or iv heart failure * uncontrolled angina * history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or grade 3 conduction system abnormalities * pregnant or lactating women * women of childbearing potential or male patients of reproductive potential * any other significant medical or psychiatric condition, currently uncontrolled by treatment, which may interfere with completion of the study

Keywords: net
compositional shift of gut microbiome according to the complications in patients with liver cirrhosis

Conditions: Liver Cirrhosis

Summary: change in gut microbiome is closely associated with liver cirrhosis diseases initiation, progression, establishment, and severity. nevertheless, compositional alterations in gut microbiome during cirrhosis development still not been evaluated, comprehensively. here, investigators compared the gut microbial composition in cirrhosis patients to encompassing the gut microbial role in whole spectrum of disease.

stool samples were collected prospectively from 240 participants (healthy control (hc=52) + alcoholic control (hc=46) + cirrhosis patients (n=142)). 16s rrna (ribosomal ribonucleic acid) gene sequencing were performed using the miseq sequencer on the illumine platform and based on the phylogenetic relationship,16s-based microbiome taxonomic profiling was performed to discovery gut microbial compositional shift along with cirrhosis severity progression.

Eligibility criteria:
inclusion criteria: 1. registered in the hallym university hospital 2. presented initially sign of liver cirrhosis 3. patients must have the following laboratory parameters at screening: 1. alanine aminotransferase (alt) ≤10 × upper limit of normal (uln) 2. aspartate aminotransferase (ast) ≤10 × uln 3. hemoglobin ≥12 g/dl for male, ≥11 g/dl for female patients 4. platelets ≥ 50,000/mm3 5. international normalized ratio (inr) ≤1.5 × uln unless patient has known haemophilia or is stable on an anticoagulant regimen affecting inr. 6. albumin ≥3g/dl. 7. direct bilirubin ≤1.5 × uln h) hba1c ≤10.0% i) creatinine clearance (clcr) ≥60 ml/min, as calculated by the cockcroft-gault equation. - exclusion criteria: * pregnant female
potential beneficial effects of resveratrol

Conditions: Metabolic Syndrome; Obesity

Summary: we want to investigate whether the food supplement resveratrol is able to counteract the detrimental effects of obesity.

the aim of this study is to investigate potential metabolic effects of resveratrol in healthy but obese men. we hypothesize that resveratrol will counteract some of the detrimental effects of obesity, and as an imitator of calorie restriction will give new insight into the basic biochemical pathways underpinning human metabolism. of special interest is the potential connection between resveratrol, calorie restriction, sirt1, stat5b and the gh/igf-i axis.

Eligibility criteria:
inclusion criteria: * bmi \> 30 kg/m2 * otherwise healthy * written informed consent exclusion criteria: * any disease * alcohol dependency * allergy to trial medication * present or previous malignancy * participation in other clinical trials within three months before randomization

Keywords: resveratrol diabetes sirt1 stat5 igf-i growth hormone nafld longevity substrate metabolism calorie restriction
long-term safety and efficacy of imsidolimab (anb019) in subjects with generalized pustular psoriasis

Conditions: Generalized Pustular Psoriasis

Summary: this is a phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (gpp).

this study will also evaluate the pharmacokinetic (pk) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with gpp

Eligibility criteria:
inclusion criteria: * subject participated in the preceding placebo-controlled phase 3 study anb019-301 and completed at least the week 1 visit of the anb019-301 study without the use of rescue/prohibited medication for gpp * subject must be a candidate for prolonged gpp treatment according to the investigator's judgment exclusion criteria: * use of prohibited medications between the last visit of the anb019-301 study and the day 1 visit of the anb019-302 study.

Keywords: il-36 receptor interluekin 36 imsidolimab
short-term efficacy of intravitreal afilibercept depending on subtypes of polypoidal choroidal vasculopathy: polypoidal choroidal neovascularization or idiopathic choroidal vasculopathy

Conditions: Polypoidal Choroidal Vasculopathy

Summary: to compare the short-term effect of intravitreal aflibercept injection between two subtypes of polypoidal choroidal vasculopathy

the subjects were classified into two subtypes (type 1 and type 2 polypoidal choroidal vasculopathy) based on the presence or the absence of both of a feeder and a draining vessels on indocyanine green angiography. all received intravitreal injection of aflibercept (2.0 mg) at baseline and months 1, 2 and 4.

Eligibility criteria:
inclusion criteria: 1. symptomatic typical pcv accompanying branch vascular network involving subfoveal area 2. signed informed consent; and 3. over 6 months follow-up period after enrollment. exclusion criteria: 1. retinal diseases other than pcv 2. extrafoveal pcv not involving subfoveal area 3. massive subretinal hemorrhage blocking polypoidal lesion on icga 4. severe media opacity such as senile cataract 5. previous history of intravitreal injection 6. previous intraocular surgery history except cataract surgery which was done more than 3 months.
santeon-cap; dexamethasone in community-acquired pneumonia

Conditions: Community-acquired Pneumonia

Summary: the present study is designed to investigate the beneficial effects of adjunctive dexamethasone therapy in patients admitted with community-acquired pneumonia, additionally aiming at assessing what patients benefit from dexamethasone treatment mostly. a large multicenter study will be conducted comparing a 4 days dexamethasone 6 mg per os course with placebo in 600 patients and with predefined subgroup analyses planned.

community-acquired pneumonia (cap) is a common infection. approximately 20 percent of all episodes of pneumonia result in hospitalization. it is the leading cause of community-acquired infection requiring intensive care unit (icu) admission. in pulmonary infections, the release of cytokines and other inflammatory mediators from alveolar macrophages serves as a mechanism by which invading pathogens are eliminated. however, this reaction of the innate immune system can be potentially harmful when excessive release of circulating inflammatory cytokines causes damage to the patient, particularly the lung. interest in the role of corticosteroids in the pathophysiology of critical illness has existed since the early part of the 20th century. on icu, early treatment with corticosteroids to attenuate systemic inflammation is widespread. at the same time, outside the icu little evidence is available on the effect of treatment with corticosteroids in patients diagnosed with cap. theoretically, early initiated administration of corticosteroids in the course of a cap can lower systemic and pulmonary inflammation. this may lead to earlier resolution of pneumonia and a reduction of complications (sepsis, mortality).

Eligibility criteria:
inclusion criteria: * 18 years or older * chest radiograph showing new opacities. in combination with two of the following findings: * cough * production of sputum * temp \>38,0 °c or \<36,0 °c * audible abnormalities by chest examination compatible with pneumonia * leukocytosis (\>10.000 cells/mm3), leftward shift (\>10%) or leucopenia (\<4000 cells/mm3) * c-reactive protein \> 15 mg/l (three fold higher than the upper limit of normal) exclusion criteria: * immunocompromised patients: * patients with a known congenital or acquired immunodeficiency. * patients who received chemotherapy less than 6 weeks ago. * patients who received corticosteroids in the last 6 weeks. * patients who received immunosuppressive medication in the last 6 weeks (e.g. cyclosporin, cyclophosphamide, azathioprine). * patients with chronic obstructive pulmonary disease who are on systemic corticosteroids. * patients who require intensive care unit treatment. * patients with tropical worm infection. * patients with dexamethasone intolerance. * pregnant and breastfeeding women.

Keywords: community-acquired pneumonia dexamethasone corticosteroid
autologous adipose tissue derived mesenchymal stem cells transplantation in patient with avascular necrosis of the femoral head

Conditions: Avascular Necrosis of the Femoral Head

Summary: the purpose of this study is to investigate the efficacy and safety of autologous transplantation of adipose tissue derived mesenchymal stem cells (mscs) in patient with avascular necrosis of the femoral head.


Eligibility criteria:
inclusion criteria: * age :18-70, males and females. * subjects who understand and sign the consent form for this study. * clinical diagnosis of nontraumatic avascular necrosis of the femoral head * steinberg stage i, ii, ⅲa * patients whose lesion is more than 30% (by kim's method) exclusion criteria: * patients who have collapsed femoral head * patient has had a core decompression or multiple drilling in the affected hip * patients who received osteoporosis medicines and parathyroid hormone drugs * taking medications that use the immunosuppressive drugs and cytotoxic agents or unable to discontinue their use for the duration of the study * taking medications that use the adrenocortical hormone drugs or unable to discontinue their use for the duration of the study * subject unable to undergo mri (i.e. patients with pace-maker, metallic hip prosthetic implants) * women who are pregnant or breast feeding or planning to become pregnant during the study. * positive serology for hiv and hepatitis * serious pre-existing medical conditions like cardiovascular diseases, cancer, renal diseases, endocrine diseases and autoimmune diseases * participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study. * other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.