Kornimate/medical-research-clean huggingface dataset:
huaiqihuang granule in the treatment of primary glomerulonephritis of stage ckd3

Conditions: Renal Insufficiency, Chronic

Summary: this is a multicentre prospective, randomized, double-blind and imitation, positive-drug parallel controlled clinical trail. the objective of this study is to evaluate the efficacy and safety of huaiqihuang granule in patients with ckd stage 3 primary glomerulonephritis.

chronic kidney disease is a common disease that affects health seriously. in some regions of china, the morbidity of this kind of disease is as high as 10.8%. primary glomerulopathy is one of the pathogenesis of chronic kidney disease, which occupied 50%-60%. however, at present, there is still a lack of effective means for the treatment of primary glomerulonephritis in ckd stage 3. huaiqihuang granule is a kind of chinese herbal medicine compound preparation, previous researches showed that huaiqihuang has a comprehensive effect on primary glomerulonephritis. in this study, there were about 40 first-class hospitals participating in. we planned to enroll 466 participants, who will be randomly divided into the huaiqihuang granule group (experimental group) and the valsartan group (control group). all participants will take medication for 48 weeks, and investigators will follow up participates at weeks 0, 8,16, 24, 32, 40, 48.

Eligibility criteria:
inclusion criteria: 1. diagnosed as primary glomerulonephritis by renal biopsy 2. male or female, 18≤age≤65 3. blood pressure can be effectively controlled at or below 140/90mmhg 4. 30ml/（min.1.73m2）≤ egfr\<60ml/（min.1.73m2） 5. 24-hour urine protein ration ≤ 2.0g/24h 6. the participants must be capable of understanding and comply with the protocol and sign a written informed consent document exclusion criteria: 1. diagnosed as secondary glomerulonephritis 2. exposure to corticosteroids, immunosuppressors, tripterygium glycosides, arbs or aceis, without a two weeks washout period 3. blood pressure \< 90/60 mmhg 4. serum potassium \> 5.5 mmol/l 5. serum albumin \< 30g/l 6. unilateral or bilateral renal artery stenosis 7. pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period 8. having comorbidities that affect the progression of primary glomerulonephritis (including but not limited to malignant tumors, systemic autoimmune diseases, liver cirrhosis, diabetes, and gout) 9. allergic to the huaiqihuang granule or valsartan 10. participating in another clinical trial 11. investigators do not think it suitable for a participant to join this study

Keywords: primary glomerulonephritis huaiqihuang granule ckd3
the influence of endurance sports activity on the oral microbiota of young adults.

Conditions: Microbial Colonization

Summary: the oral cavity is an easily accessible anatomical site that accurately reflects the health of the individual. the mouth is considered an early indicator of biological aging, leading to the identification of oral biomarkers predictive of future alterations. current data show that the oral health of high level athletes is globally altered with an increase in cariogenic indexes, an increased incidence of periodontitis, dental trauma and dry mouth syndromes. few studies have focused on the oral microbiota compared to mouthguards used in rugby or boxing which seem to induce dysbiosis, a recent study shows an effect of ketogenic diet on bacterial changes in the mouth of endurance athletes. this project focuses on the impact of intensive sport practice on oral health and the identification of oral biomarkers associated with physical activity. the objective of this study is to investigate the impact of the amount of endurance sport practice on oral microbiota and oral health in young adults. the hypothesis is that a sedentary lifestyle and high-level sport induce depletion and/or changes in the oral microbiota compared to regular physical activity.


Eligibility criteria:
inclusion criteria: * be between 18 and 30 years old * if practicing sports, it must be an endurance sport as main activity (cycling or running) exclusion criteria: * practice more than 3 hours of swimming per week * have taken anti-inflammatory drugs, less than 48 hours before the study * have taken antibiotics and/or probiotics, less than 3 weeks before the study
intense pulsed light therapy for hidrosadenitis suppurativa

Conditions: Hidradenitis Suppurativa; Acne Inversa

Summary: 6 monthly treatments with ipl laser in patients with hidradenitis suppurativa. the effect in measured on several severity scores.

patient suffering from bilateral hs in the axilla or groin area are threated with ipl laser monthly for 6 months. patients are randomized to treatment in either left or right side, the other side works as control. no sham treatment, but observers are blinded.

Eligibility criteria:
inclusion criteria: * bilateral hs in the axilla or groin area * fitzpatrick skin type i-ii exclusion criteria: * pregnant * unable to understand or communicate with study personnel
supplemental benefit of angiotensin receptor blocker in hypertensive patients with stable heart failure using olmesartan

Conditions: Chronic Heart Failure

Summary: the purpose of this study is to investigate whether an angiotensin ii receptor blocker (olmesartan), in addition to conventional treatment, will reduce the mortality and morbidity in hypertensive patients with stable chronic heart failure.


Eligibility criteria:
inclusion criteria: patients who meet all of the following criteria. * patients with nyha class ii through iv chronic heart failure. * patients who have a history of hypertension or those who have antihypertensive medications. * patients who are aged 20 years or older and less than 80 years at the entry. * stable patients who have angiotensin converting enzyme inhibitor and/or beta-blocker. * patients who do not have angiotensin ii receptor blocker. exclusion criteria: * patients who have renal dysfunction (serum creatinine \>=3.0mg/dl) or those who are receiving chronic hemodialysis. * history of drug hypersensitivity to olmesartan. * patients who have severe liver dysfunction. * history of angioedema. * history of malignant tumor or life-threatening illness of poor prognosis. * pregnant or possibly pregnant patients. * cardiovascular surgery within 6months prior to the date of the entry. * acute myocardial infarction within 6 months prior to the date of the entry. * percutaneous coronary intervention or stent implantation within 6 months prior to the date of the entry. * other patients deemed unsuitable as subjects of the study by the treating physician.
nab-paclitaxel plus gemcitabine in chinese patients with advanced pancreatic cancer

Conditions: Advanced Pancreatic Cancer

Summary: the purpose of this study is to determine the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus gemcitabine as first-line treatment in chinese patients with advanced pancreatic ductal adenocarcinoma.

advanced pancreatic ductal adenocarcinoma is a fatal disease with about 6 months of median overall survival (os). gemcitabine is the only approved single agent. gemcitabine-based chemotherapy did not show benefit in os during the past decade. the recent phase iii trial mpact (metastatic pancreatic adenocarcinoma clinical trial) demonstrated an improvement in overall response rate (orr), progression free survival (pfs) and os, with nab-paclitaxel (125 mg/m2 on day 1, 8 and 15 every 28 days) plus gemcitabine (1000 mg/m2 on day 1, 8 and 15 every 28 days) compared to gemcitabine alone. accordingly the combination of nab-paclitaxel with gemcitabine became one of standard treatments in metastatic pancreatic cancer. a chinese phase ii trial showed the modified dosage of nab-paclitaxel (120 mg/m2 on day 1 and 8 every 21 days) plus gemcitabine (1000 mg/m2 on day 1 and 8 every 21 days) is more suitable for chinese patients. this study aims to explore the efficacy and safety of the tentative dosage of nab-paclitaxel (125 mg/m2 on day 1 and 8, every 21 days) and gemcitabine (1000 mg/m2 on day 1 and 8, every 21 days) for chinese patients.

Eligibility criteria:
inclusion criteria: 1. signed informed-consent form. 2. age no less than 18 years. 3. histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with recist measurable lesions. 4. eastern cooperative oncology group (ecog) 0-1 with life expectation of no less than 12 weeks. 5. patients must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. prior treatment with 5-fluorouracil or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. 6. adequate liver/bone marrow function. 7. human chorionic gonadotropin (hcg) test negative for female with contraception measure until 3 months after study end. 8. compliant, and can be followed up regularly. exclusion criteria: 1. pregnant or breast-feeding female, or not willing to take contraception measures during study. 2. serious infection requiring antibiotics intervention during recruitment. 3. allergic to study drug. 4. more than grade 1 neuropathy. 5. uncontrolled brain metastasis or mental illness. 6. congestive heart failure, uncontrolled cardiac arrhythmia, etc. 7. other malignancy within 5 years. 8. can't be followed up or obey protocol. 9. ineligible by the discretion of the investigator.

Keywords: nanoparticle albumin-bound paclitaxel gemcitabine advanced pancreatic cancer
a randomized, multicenter, phase iii trial comparing treatment with r-mini-chop with r-mini-chp + polatuzumab vedotin in patients with diffuse large cell b cell lymphoma

Conditions: DLBCL; Diffuse Large B Cell Lymphoma

Summary: this is a phase iii, randomized, open-label, multicenter trial, conducted in sweden, norway, finland, denmark, italy, australia and new zealand, in elderly patients with untreated diffuse large b-cell lymphoma. elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified comprehensive geriatric assessment. patients will be randomized 1:1 to either the standard treatment for this population, r-minichop, or an experimental regimen, r-pola-minichp, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. the duration of the screening period is up to 4 weeks. the duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. start of enrollment is planned in q1 2020, and the last visit of the last patient included (end of trial) is estimated in q1 2027.


Eligibility criteria:
inclusion criteria: * age ≥80 years or frail ≥75 years, according to simplified comprehensive geriatric assessment * histologically confirmed lymphoma belonging to one of the following subtypes: 1. diffuse large b-cell lymphoma, including transformation from an indolent lymphoma 2. follicular lymphoma grade 3b 3. t-cell/histiocyte-rich lbcl 4. primary cutaneous dlbcl, leg type 5. ebv-positive dlbcl, nos 6. primary mediastinal lbcl 7. high grade b-cell lymphoma with myc/bcl2 rearrangement * stage ii-iv disease * at least 1 measurable site of disease (\>1.5 cm long axis) * no previous treatment for lymphoma * who performance status 0 - 3 (grade 3 if related to dlbcl) * written informed consent exclusion criteria: * severe cardiac disease: nyha grade 3-4 * cns involvement at diagnosis * uncontrolled serious infection * impaired liver (transaminases \> 3x normal upper limit or bilirubin \> 1.5 x normal upper limit, unless due to gilbert´s syndrome) , renal (gfr\<30ml/min) or other organ function not caused by lymphoma, which will interfere with the treatment. * absolute neutrophil count (anc) \<1000 cells/µl or platelets \<100,000 cells/µl, unless due to lymphoma * any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma, unless treated with curative intent, and without relapse since 2 years, or low grade prostate cancer, not in need of treatment * psychiatric illness or condition which could interfere with their ability to understand the requirements of the study * known hypersensitivity to rituximab, polatuzumab vedotin, cyclophosphamide, vincristine or doxorubicin, or haca against rituximab * peripheral neuropathy grade ≥ 2

Keywords: dlbcl diffuse large b cell lymphoma
the impact of triptan and doxycycline on neuroinflammatory biomarkers in acute migraine

Conditions: Migraine Disorders; Headache, Migraine; Migraine; Migraine Headache; Migraine With Aura; Migraine Without Aura; Headache Disorders, Primary

Summary: the purpose of this study is to determine the effects of triptans and doxycycline on neuroinflammatory markers in acute migraine.

increased inflammatory cytokines and matrix metalloproteinases (mmps) have been recently implicated in migraine. inflammation may be a key player in the pathophysiology of migraine by altering blood-brain barrier (bbb) function. as an inflammation induced mmp, mmp-9 is involved in both bbb disruption and neuropathic pain, and is largely derived by neutrophil degranulation during neutrophil-bbb interaction. the tetracycline group of antibiotics may suppress mmp production and neutrophil degranulation. this study aims to investigate known neuroinflammatory biomarkers with a focus on bbb breakdown during acute migraine attacks and assess marker responses to conventional treatment (triptans) and novel mmp targeted therapy (doxycycline). this pilot project data will supplement future projects investigating novel therapeutic strategies such as mmp inhibitors in both migraine acute treatment and prevention.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of migraine with or without aura that fulfill the 2nd edition of the international headache classification (ichd-ii) criteria * active prescription for an oral triptan medication to abort acute migraines exclusion criteria: * tetracycline group or other anti-inflammatory medication use in the preceding three months * pregnant
efficacy of omija (schisandra chinensis) extract in subjects with knee osteoarthritis

Conditions: Mild Knee Osteoarthritis

Summary: knee osteoarthritis (ko) is a common arthropathy and a leading cause of disability in elderly adults. schizandra chinensis(omija) has been known to have five predominant tastes: salty, sweet, sour, astringent, and bitter. it has also been shown to have various effects on the anti-inflammatory, cardiovascular system, gastrointestinal system, central nervous system, endocrine system, and stress protect. therefore, this study is designed to evaluate the efficacy and safety on ko of omija extract.

in the present study, the investigators will assess the efficacy and safety of the formulation of omija extract(1,200 mg administered twice a day) on the symptoms of knee osteoarthritis (ko) during a 12-week treatment course. in a randomized, double-blind placebo-controlled trial, subjects will be randomly assign to receive oral omija treatment group(n=30) or placebo group(n=30). the primary efficacy outcome measure will be score change in the womac(western ontario and mcmaster university osteoarthritis index) after 12-weeks. secondary parameters will be included the lysholm index score, hs-crp, osteocalcin(osc), and deoxypyridinoline(dpyr).

Eligibility criteria:
inclusion criteria: * males and females 30-70 years old * mild to moderate ko(knee osteoarthritis) as indicated by womac(western ontario and mcmaster university osteoarthritis index) score ≥ 38 * able to walk * subject agrees not to start any new therapies for oa during the course of the study * able to give informed consent exclusion criteria: * history of underlying inflammatory arthropathy; septic arthritis; inflammatory joint disease; gout; pseudogout; paget's disease; joint fracture; acromegaly; fibromyalgia; wilson's disease; ochronosis; haemochromatosis; heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis * expectation of surgery in the next 4 months * recent injury in the area affected by oa of the knee, i.e. meniscal tear (past 4 months) * cartilage reconstruction procedure in the target knee * intra-articular corticosteroid injections in the target knee within the last 3 months * viscous injections in the target knee within the last 6 months * abnormal liver or kidney function tests (alt or ast \> 2 times the upper limit of normal; elevated creatinine, males\>125 umol/l, females\>110 umol/l)

Keywords: omija knee osteoarthritis
effect of atorvastatin as a renal protection in patients with systemic inflammatory response syndrome using renal arterial resistive index

Conditions: Renal Protection

Summary: offering renal protection in systemic inflammatory response syndrome by atorvastatin


Eligibility criteria:
inclusion criteria: * patients ( male and female) with systemic inflammatory response ( total leucocytic count \>12,000 mm3'. temperature \>38 c, heart rate \>90 b/min and respiratory rate\>20 cycle). exclusion criteria: * hemodynamic instability * pre-admission chronic kidney disease. * intra-vascular coagulopathy * patients with myopathy.
circadian rhythmicity in cold-induced thermogenesis

Conditions: Healthy; Obese; Glucose Intolerance

Summary: this study aims to investigate whether maximum cold-induced non-shivering thermogenesis (e.g. thermogenesis as a consequence of bat activity) differs between morning and evening.

brown adipose tissue (bat) recently emerged as a novel player in energy expenditure (ee) in humans as it combusts fatty acids and glucose towards heat. human bat can be activated by sympathetic stimulation resulting from cold exposure or treatment with sympathomimetic drugs. short-term acclimation to mild cold was shown to reduce fat mass in obese subjects and decrease peripheral insulin resistance of patients with t2dm. recently, in preclinical studies the investigators showed that bat has a circadian rhythm. it is currently unknown whether this is also the case in humans. the investigators postulate that bat activity should display a circadian rhythm that adapts to changes in circadian behavior, and may determine glucose/lipid levels throughout the day.

Eligibility criteria:
inclusion criteria: * dutch white caucasian males or females * age: 18-35 years * lean group: bmi ≥ 18 and ≤ 25 kg/m2 * obese glucose tolerant group: bmi ≥ 30 and ≤ 42 kg/m2 and fasted plasma glucose levels \< 5.5 and/or 2 h after ogtt ≤ 7.8 mm * obese impaired glucose tolerant group: bmi ≥ 30 and ≤ 42 kg/m2 and fasted plasma glucose levels ≥ 5.5 and/or 2 h after ogtt between 7.8 and 11.1 mm exclusion criteria: * diabetes mellitus (determined on basis of fasting or ogtt defined by ada criteria (30) * any other active endocrine disease (thyroid disease, any signs of cushing's syndrome, adrenal disease and lipid-associated disorders such as familial hypercholesterolemia) * any chronic renal or hepatic disease * use of medication known to influence glucose and/or lipid metabolism or brown fat activity (e.g. beta blockers, antidepressants) * smoking * abuse of alcohol or other substances * pregnancy * participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study * current participation in another research projects that may influence the current research project * clinically relevant abnormalities in clinical chemistry at screening (to be judged by the study physician)

Keywords: lean young healthy overweight obese
technological devices in circumcision

Conditions: Circumcision Adult; Circumcision, Male; Circumcision

Summary: it aims to investigate the effect of circumcision on the pain and anxiety level of children who are circumcised by watching videos/playing games during the procedure. previous studies have been conducted to explain the procedure with informative videos and games before circumcision, and reductions in anxiety and pain levels have been detected. the research will start with hospitalization and end with a check-up after discharge.


Eligibility criteria:
inclusion criteria: * circumcision for medical or religious reasons. exclusion criteria: * children with chronic diseases. * children with genital medical problems. * children with mental and communication disabilities and their parents.

Keywords: circumcision
resection of metastatic pancreatic neuroendocrine tumors after induction system treatment

Conditions: Neuroendocrine Tumors; Metastases; Surgery

Summary: this study is to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment. the willing of participants decide who receive surgery and who will continue to receive standard systemic treatment.

system treatments of metastatic pannet include ssa, sunitinib, mtor inhibitor and chemotherapy. for patients achieved pr/sd after system treatment, resection of primary tumor and metastasis maybe a better way to decline tumor burden and get longer survival. this real world study is focused on this group of patients with metastatic pannet, and to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment.

Eligibility criteria:
inclusion criteria: 1. biopsy-proven neuroendocrine tumor 2. primary site in pancreas 3. advanced disease with lymph node or distant metastases (n1, m1) cannot undergoing cytoreduction by surgery/local ablative therapy at the diagnosis 4. curative intent of all therapies possible 5. ecog 0-2 exclusion criteria: 1. undifferentiated neuroendocrine carcinoma or mixed neuroendocrine carcinoma secondary tumor 2. functioning net or advanced carcinoid heart disease 3. part of hereditary syndrome, such as men1, vhl 4. do not willing to receive systemic treatment 5. diagnosed with other cancer within 5 years
the alvision™ interventional cardiology diagnostic catheter post market clinical follow-up (pmcf) study.

Conditions: Coronary Artery Disease; Coronary Disease; Vascular Diseases

Summary: the objective of this prospective observational study is to collect clinical data on the medical device alvision™ interventional cardiology diagnostic catheter in an unselected population in the current clinical practice

within the scope of this observational medical device trial, brand/model of the catheter that will be used during the pci will be decided by the physician and decision of the physician won't be interfered. pci will be performed according to the standard clinical procedures. data of the patients to whom alvision™ interventional cardiology diagnostic catheter is applied will be gathered for the purpose of this study.

Eligibility criteria:
inclusion criteria: * turkish citizen, * ≥18 years of age, * has indication for a diagnostic coronarography according to alvision™ instruction for use, * has signed and dated the informed consent. exclusion criteria: * having a known allergic reaction to any of the composition of alvision™ interventional cardiology diagnostic catheter. * has synthetic vascular grafts through which the alvision™ interventional cardiology diagnostic catheter should pass * participating in another medical device or pharmaceutical clinical trial