Kornimate/medical-research-clean huggingface dataset:
allogeneic microbiota-reconstitution (amr) in diarrhea-predominant irritable bowel syndrome (ibs-d)

Conditions: Diarrhea-predominant Irritable Bowel Syndrome

Summary: the investigators will perform a multicenter, 2:1 randomized, double-blinded, placebo-controlled trial of amr in patients with diarrhea predominant-ibs (ibs-d) diagnosed according to rome iii criteria and the ibs-qol questionnaire. central supply and quality control of donor material will be used to control bias. primary endpoint is improvement of ibs-sss (severity score system) compared to baseline. secondary endpoints include changes in ibs-qol, short term safety and one year follow up to control long term effects, safety and changes in and acceptance of donor microbiome after amr using16s rdna sequencing and quantitative diversity analysis.

this study assesses allogeneic microbiota reconstitution (amr) as novel treatment to improve symptoms and quality of life of patients with diarrhea-predominant irritable bowel syndrome (ibs-d). the investigators will perform a prospective multicenter, 2:1 randomized, double-blinded, placebo-controlled trial of amr in patients with ibs-d diagnosed according to rome iii criteria and the ibs-qol questionnaire. the experimental intervention is an infusion of donor feces via gastroscopy. the placebo intervention is an infusion of sterile saline via gastroscopy. planned number of patients included in the study: 42 patients planned per-protocol group: 33 patients

Eligibility criteria:
inclusion criteria: * written informed consent * irritable bowel syndrome of diarrhea-predominant type according to rome iii criteria * symptoms for \> 1 year before study inclusion * persisting symptoms \> 1 year before study inclusion * relevant symptoms with reduced quality of life (ibs-qol \< 60 points) * no specific findings in gastroscopy and colonoscopy with biopsies in the last 2 years exclusion criteria: * chronic inflammatory diseases * gastrointestinal infectious diseases * microscopic colitis * celiac disease * diarrhea caused by fructose- or lactose intolerance * gastrointestinal malignancies or intestinal polyps * irritable bowel syndrome of other type than ibs-d * bile acid diarrhea * constipation * symptoms caused by other diseases than ibs-d * dementia * abdominal surgery in the last months * antibiotic therapy in the last 3 months * pregnancy * linguistic barrier for informed consent

Keywords: allogeneic microbiota reconstitution diarrhea-predominant irritable bowel syndrome microbiome
an open-label study to compare the lipid effects of niacin er and simvastatin (ns) to atorvastatin in subjects with hyperlipidemia or mixed dyslipidemia (supreme)

Conditions: Hyperlipidemia; Mixed Dyslipidemia

Summary: to demonstrate that niacin er and simvastatin (ns) tablets, when compared to atorvastatin (lipitor®; pfizer, inc.), has superior high-density lipoprotein cholesterol (hdl-c) elevating effects at week 12 in subjects with type ii hyperlipidemia or mixed dyslipidemia who are currently off lipid-modifying therapy. this was a prospective, randomized, open-label, blinded endpoint (probe) study.


Eligibility criteria:
inclusion criteria: * subjects must meet all of the following laboratory criteria: * hdl-c \<40 mg/dl for men and \<50 mg/dl for women. * ldl-c ≥130 mg/dl but \<250 mg/dl. * tg \<350 mg/dl. * creatine phosphokinase (cpk) \< 3 x upper limit of normal (uln). * alanine aminotransferase (alt); serum glutamic pyruvic transaminase \[sgpt\] and aspartate aminotransferase (ast); serum glutamic oxaloacetic transaminase \[sgot\] \< 1.3 x uln. * subjects must also be reasonably compliant with the therapeutic lifestyle changes (tlc) diet during the 4 to 5 week screening period prior to randomization (and be willing to comply for the duration of the study). exclusion criteria: * subjects who have a history of any important medical conditions or abnormalities (as specified in the protocol) that would preclude study inclusion
cardiorenal and metabolic effects of nighttime eating

Conditions: Night Eating Syndrome; Metabolic Syndrome; Cardiorenal Syndrome; Sleep Disorder

Summary: in this study, the investigators are trying to find out of the effect of nighttime eating on metabolism, cardiorenal, hormonal and circadian rhythm, and a study was conducted to examine the effects of diseases that are quite common in internal medicine practice, such as type 2 diabetes mellitus, chronic kidney disease, hypertension, metabolic syndrome and sleep disorders.

the coronavirus disease (covid)-19 pandemic, which emerged in recent years, has deeply affected living conditions and has had an impact on societies on eating habits. as shown by some studies, it has been shown that night sleep habits have changed and night nutrition and calorie intake have increased due to reasons related to staying at home, working remotely, and isolation during the pandemic period. however, some recent studies have shown a relationship between nighttime eating and conditions that predispose to metabolic syndrome, such as obesity and hyperglycemia. at the same time, prospective studies on the details of the cardiorenal and metabolic effects of night feeding behavior, which is one of the important predisposing factors for metabolic syndrome, are quite insufficient. although the importance of nighttime eating habits has begun to be emphasized in recent years with recent randomized cross-controlled studies on this subject, there are not yet enough prospective studies on this subject. in this respect, studies on nighttime eating behavior, which is common in society, are important.in this study, a cross-over design study was conducted on the effectiveness of nighttime eating on metabolism, cardiorenal, hormonal and circadian rhythm, and a study was conducted to examine the effects of diseases that are quite common in internal medicine practice, such as type 2 diabetes mellitus, chronic kidney disease, hypertension, metabolic syndrome and sleep disorders. the investigators aim to create a new and additional perspective on the management, treatment and follow-up of common diseases and to contribute to raising awareness about night nutrition.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65 * being willing to adapt to the desired feeding time and calories * body mass index (bmi) is between 18-30 * not having any systemic disease, not using chronic medication exclusion criteria: * -\ 65 years old * failure to comply with the regulated nutrition program * bmi between \ 30 * presence of systemic disease: e.g. diabetes mellitus, chronic kidney disease, coronary artery disease, hypertension etc. * inability to have polygraphy * chronic drug use

Keywords: night eating syndrome nutrition metabolic syndrome
novel blood-based colorectal cancer screening method using natural killer cell activity and gene panel expression

Conditions: Colorectal Adenoma; Colorectal Cancer

Summary: natural killer cells (nk cells) are cytotoxic lymphocytes that play an important role in the innate immune system. in particular, it plays a very important defense function against host cells or cancer cells infected with a specific virus. recent studies have shown that the activity of nk cells is decreased in patients with various carcinomas compared with normal controls, suggesting that the measurement of activity of nk cells in the blood may be helpful in the early diagnosis of cancer. in a recent study analyzing nk cell activity in 762 patients undergoing colonoscopy, nk cell activity showed performance in diagnosing advanced colorectal adenoma and colorectal cancer with sensitivities 42.2% and 85.7%, and specificity 58.3% and 59.5%, respectively. this finding suggests that nk cell activity may be useful as a screening method for colorectal neoplasms. however, as a single test, this diagnostic power is relatively low. on the other hands, another blood-based colorectal cancer screening test that using 29 gene panels algorithm has recently been reported. according to this study, 29 gene panel algorithms (colox®) showed performance in diagnosing advanced colorectal adenoma and colorectal cancer with sensitivity of 55.4% and 79.5% and specificity of both 90.0%, respectively. for diagnosis of advanced adenoma and colorectal cancer, respectively. although the colox® test seems to be useful for the colorectal cancer screening using blood test, this diagnostic power is relatively low. in order to overcome low diagnostic performance of aforementioned tests (nk activity and colox®) as a single use, combination of individual biomarkers can be a promising alternative. in this regards, the aim of this study was to evaluate the diagnostic value for predicting advanced colorectal neoplasms by combining colox® and nk cell activity indicators.


Eligibility criteria:
inclusion criteria: * adults population over 40 years of age * patients who understood this study process and agreed to participation of this study * colon cancer patients who have been confirmed as colorectal cancer by endoscopic biopsy within 1 month * colon cancer patients who received no anticancer treatment such as surgery, chemotherapy, radiation therapy after cancer diagnosis. * colorectal adenoma and normal control group: patients undergoing colonoscopy for diagnostic purposes or colorectal cancer screening. exclusion criteria: * patients who did not agree to participate in the study and did not write their informed consent * vulnerable subjects with mental retardation or severe psychiatric illness. * patients who are not appropriate enrollment of this study by researchers judgement. * patients who have had an immunosuppressive drug within 6 months.
prevalence of oral findings in chronic kidney disease

Conditions: Oral Disease; Chronic Kidney Diseases

Summary: there are severe deficiency of database concerning the oral health status in both pre-dialysis and end stage renal disease in egyptian population. our aim in the present study is to assess the oral health of the chronic kidney disease patients to increase their awareness and minimize all the possible risk factors, to achieve a proper management for all oral problems.

the study will be held in the nephrology units at the kasr al-ainy cairo university hospital. the data collected through the questionnaire will be obtained through an interview between the investigator and the patient. clinical examination will be performed for both oral (soft tissue) and dental (hard) tissue. for patients undergoing dialysis, examination will be performed before dialysis therapy. selection bias: will be minimized by enrolling the participants in the study in a consecutive order of the entering the clinic. non-respondent bias: will be minimized by explaining to the participants the aim of the study and their importance and role in the study. incomplete records: will be excluded from statistical analysis with reporting the cause of not completing the record. sample size estimation: using a precision of 5, a design effect set at 1 with 90% ci (confidence interval), a total sample size of 250 pre-dialysis patients and 200 end stage renal disease patients will be sufficient. the sample size was calculated by epi info software. the sample will be divided between two researchers; each researcher will have 50% of the whole sample to collect.

Eligibility criteria:
inclusion criteria: 1. adult patients \>18 years old with a diagnosis of non-dialysis chronic kidney disease at stage 2, 3 and 4. 2. adult patients \>18 years old with a diagnosis of end stage renal disease "stage 5". 3. recorded data of glomerular filtration rate for every patient. 4. recorded data for dialysis patients (hcv, platelets count, creatinine, blood urea nitrogen, urea level and partial thromboplastin time). exclusion criteria: 1. adult patients \<18 years. 2. end stage renal disease undergoing peritoneal dialysis. 3. patients not physically able to participate in oral examination. 4. patients with kidney transplantation. 5. patients undergoing renal dialysis for reasons other than chronic kidney disease, such as acute renal failure, accidents, trauma, snake poisoning.

Keywords: oral findings or oral manifestation pre-dialysis stage or end stage renal disease
2% chlorhexidine (chx) vs caoh2 (ch) calcium hydroxide paste as an intracanal medicament

Conditions: Apical Periodontitis

Summary: this is a pilot phase iii single-blind randomized controlled clinical trial in patients, aged 18 years and older, presenting with symptoms of apical periodontitis. the overall goal is to assess whether 2% chlorhexidine (chx) is superior to calcium hydroxide in reducing interappointment pain.

this is a pilot phase iii single-blind randomized controlled clinical trial in patients, aged 18 years and older, presenting with symptoms of apical periodontitis. patients will be treated with one of two current clinically-used medications, 2% chlorohexidine (intervention) vs. calcium hydroxide (standard-of-care). one week following treatment (+/- 2 days), patients will return for reevaltuion of apical periodontitis symptoms, via patient's pain perception after a bite test. the primary objective of the proposed study is to determine if there is a difference in 7-day (+/- 2) post-procedure apical periodontitis following randomization to either 2% chlorohexidine vs. calcium hydroxide paste among patients presenting with symptoms of apical periodontitis. additionally, the investigators will assess the number of adverse events that occur in each treatment group to determine if there appears to be a difference across groups, descriptively.

Eligibility criteria:
inclusion criteria: * 18 years and older * symptomatic apical periodontitis (positive to the bite test) * restorable tooth * requires root canal therapy * able to undergo informed consent process * must be english or spanish speaker exclusion criteria: * cracked tooth * non-restorable tooth * no pain medication or antibiotic taken in the past 3 days
obinutuzumab in primary fsgs

Conditions: Primary Focal Segmental Glomerulosclerosis

Summary: the purpose of this study is to evaluate the safety and efficacy of obinutuzumab in inducing complete or partial remission of proteinuria.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age. * biopsy proven focal segmental glomerulosclerosis (fsgs) lesion * foot process effacement ≥ 80% on electron microscopy. * presence of nephrotic syndrome (proteinuria \> 3.5g/24hrs and serum albumin \< 3.5 g/dl) prior to initiation of immunosuppressive therapy. * resistant or dependent on therapy, including corticosteroids or calcineurin inhibitors or who have failed rituximab. patient who have contraindication to or refuse to take high dose corticosteroids are allowed. exclusion criteria: * genetic or secondary forms of fsgs. * hepatitis b, c or hiv positive. * pregnant or breast-feeding. * active infection. * kidney transplant. * anemia with hgb \< 8.0 g/dl. * thrombocytopenia with platelet count \< 100'000. * any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication. * patients who have received cyclophosphamide in the last 6 months. * patients who received rituximab previously with cd20 count of \< 5 cells/microliter at the time of enrollment. * for women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (\<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug. * for men: agreement to remain abstinent or use two adequate methods for contraception, including at least one method with failure rate of less than 1% per year during the treatment period and for at least 6 months (180 days) after the last dose of drug.
efficacy and safety of head acupuncture after mechanical thrombectomy for acute ischemic stroke

Conditions: Acupuncture; Acute Ischemic Stroke; Mechanical Thrombectomy

Summary: to evaluate the efficacy and safety of head acupuncture combined with endovascular therapy for cerebral infarction compared with endovascular therapy alone

control group: mechanical thrombectomy followed by the guideline recommended treatment for acute ischemic stroke; experimental group: after mechanical thrombectomy, head acupuncture and the treatment regimen recommended by the guideline for acute ischemic stroke were administered

Eligibility criteria:
inclusion criteria: * age ≥18 years; * patients with acute ischemic stroke who received endovascular treatment within 24 hours of onset; * 6 \< nihss ≤25; * aspect score ≥6 points; * signed informed consent. exclusion criteria: * ct or brain mri confirmed intracranial tumor and intracranial hemorrhage; * contraindications of contrast media; * dementia or mental illness，unable to cooperate with treatment and follow-up; * the expected survival time was less than 3 months; * women who are pregnant, planning to become pregnant or breastfeeding; * currently participating in other clinical trials.
sarizotan in parkinson patients with l-dopa-induced dyskinesia

Conditions: Parkinson's Disease; Dyskinesia

Summary: the primary purpose of the study is to investigate the anti-dyskinetic effect of several doses of sarizotan in parkinson patients in order to generate information on the dose-response relationship (dose-finding).


Eligibility criteria:
inclusion criteria: * male or female * the subject is an out-patient * age 30 years or above * dyskinesias present during more than 25% of the waking day * dyskinesias at least moderately disabling * written informed consent exclusion criteria: * pregnancy and/or lactation * participation in another study within the last 30 days * dementia or other psychiatric illness that prevents provision of informed consent * history of allergic disorders such as asthma * known hypersensitivity to the study treatment(s) * known hypersensitivity to acth

Keywords: parkinson's disease dyskinesia l-dopa-induced dyskinesia
a study of ethizia versus surgicel original in controlling soft tissue bleeding during open surgery

Conditions: Hemostasis; Hemostatic Techniques

Summary: the objective of this clinical investigation is to evaluate the safety and efficacy of ethizia to control minimal, mild, or moderate soft tissue bleeding during open surgery when compared to surgicel original in the percentage of cases achieving hemostasis at 3 minutes after product application, and without re-bleeding up to 10 minutes after application.


Eligibility criteria:
inclusion criteria: pre-operative * participant is scheduled to undergo an elective open, abdominal, retroperitoneal, pelvic, thoracic (non-cardiac) or extremity surgical procedure * participant is willing and able to give written informed consent for the clinical investigation participation intra-operative * participant in whom the investigator can identify and visualize a target bleeding site for which any applicable conventional means for hemostasis (e.g., suture, ligature, or cautery) are ineffective or impractical * target bleeding site is identified to originate from soft tissue, defined as organ bed, loose areolar tissue, fat, lymphatic tissue/lymph node beds, and muscle * the choice is made to use a hemostatic agent to stop the bleeding, and there is the ability to apply pressure on the surface of the hemostatic agent to achieve hemostasis * participant has a target bleeding site with a sbss score of 1, 2, or 3 (e.g., reflecting minimal, mild, or moderate bleeding severities) exclusion criteria: pre-operative * participant is scheduled for another planned surgery within the follow-up period and the subsequent surgery would jeopardize the ethizia or surgicel original application * participant is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, but allowing exclusive use of acetylsalicylic acid * participant has an active or suspected infection at the bleeding site * participant is pregnant, planning on becoming pregnant, or actively breastfeeding during the 28-day follow-up period intra-operative * target bleeding site is identified to originate from parenchymal organ tissue, cardiovascular (anastomotic or cardiovascular repair sites) tissue, or is in proximity to a foramina in bone, or areas of bony confine * target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency
the effects of isotonic and hypertonic saline infusion on renal biomarkers in healthy young subjects

Conditions: Nephropathy

Summary: the kidneys have numerous salt and water channels and play a major role in the regulation of sodium and water. we do not know how these channels work in certain water and sodium accumulating medical conditions. the purpose of this study is to identify and measure the activity in the water and sodium channels by measuring urine biomarkers/proteins in young healthy subjects.

25 healthy subjects from age 18-45 are recruited. subjects will be examined on three examination days. four days prior to the examination days the subjects will consume a standard diet based on the amount of sodium and calories. on the examination day subjects are randomised to an infusion with either isotonic saline 23 ml/kg, hypertonic saline 7 ml/kg or glucose 23 ml/kg for a period of 50 minutes. renal function is measured by renal clearance of 51cr-edta, urinary sodium, potassium and creatinine. urinary ncc, nkcc and enac will be measured to evaluate the activity of sodium channels in the nephron.

Eligibility criteria:
inclusion criteria: * healthy males and females * age 18-45 * bmi range 18,5-30,0 kg/m2 exclusion criteria: * hypertension (ie ambulatory bp \>130 mmhg systolic or/and \>80 mmhg diastolic) * history or clinical significant signs of heart, lung, liver, kidney, endocrine, brain or neoplastic disease. * alcohol abuse * drug abuse * smoking * pregnancy or nursing * blood donation within a month prior to examination * medical treatment apart from oral contraception

Keywords: nephrology enac ncc nkcc sodium channels renal biomarkers
follow-up study of safety of pneumostem® in premature infants with intraventricular hemorrhage

Conditions: Intracranial Hemorrhages; Mesenchymal Stem Cells; Newborn Infant

Summary: this is a follow-up study of the open label, single-center, phase i clinical trial to evaluate the safety of pneumostem® in premature infants with intraventricular hemorrhage.


Eligibility criteria:
inclusion criteria: * patients who enrolled in the previous phase 1 clinical trial of pneumostem transplantation for ivh. exclusion criteria: * patients who did not enrolled in the previous phase 1 clinical trial of pneumostem transplantation for ivh.