Kornimate/medical-research-clean huggingface dataset:
the effect of laparoscopic sleeve gastrectomy on insulin secretion pattern in morbidly obese patients with acanthosis nigricans

Conditions: Morbid Obesity; Acanthosis Nigricans; Insulin Resistance; Insulin Sensitivity; Bariatric Surgery Candidate

Summary: acanthosis nigricans (an) is increasing in its prevalence and is the most prevalent cutaneous manifestation in individuals with obesity. insulin resistance or hyperinsulinemia is the main pathophysiological mechanism of obesity-related an. however, the effect of laparoscopic sleeve gastrectomy (lsg) on insulin secretion pattern in chinese morbidly obese patients with an is unknown. in these study, the investigators aimed to explore the insulin secretion patterns in chinese morbidly obese patients with acanthosis nigricans (an) and their alterations after lsg.


Eligibility criteria:
inclusion criteria: * aged 18 to 65 years * bmi equal or greater than 35 kg/m2 * completed a 75-g ogtt and insulin release assay * eligible for the 12-month follow-up. exclusion criteria: * severe liver and renal dysfunction, preexisting heart disease, malignancy, or endocrine diseases such as pituitary adenoma and hypogonadism * mental illness * genetic disease * current or previous treatment that might affect the sex hormones and insulin secretion * gestation or lactation * loss to follow-up, or withdrawal from the study * unable to understand and comply with the study protocol.

Keywords: acanthosis nigricans morbid obesity insulin secretion pattern prolactin sleeve gastrectomy
dbrct on the effect of wheat polysaccharides on common cold infections in elderly

Conditions: Upper Respiratory Infections; Common Cold

Summary: the aim of the study is to measure the effect of wheat polysaccharides on the occurence of common cold (cc) in elderly during a 12-week consumption period.

the study is conducted in the frame of the collaborative project 'fibebiotics' (no. 289517) (fibers as support of the gut and immune function of elderly - from polysaccharide compound to health claim) within the seventh framework programme (fp7) for research and technological development of the european union (eu).

Eligibility criteria:
inclusion criteria: * men and postmenopausal women aged ≥ 50 * willingness to abstain as far as possible from food and supplements containing probiotics, prebiotic supplements, other fermented products, supplements containing vitamins and minerals as well as willingness to sustain a low dietary fibre diet for 14 weeks * written informed consent exclusion criteria: * subjects currently enrolled in another clinical study * subjects having finished another clinical study within the last 4 weeks before inclusion * surgery or intervention requiring general anaesthesia within 2 months before the study * current symptoms of common infectious diseases (cid) of the airways or other organ systems e.g. gastrointestinal tract * history of allergic rhinitis, allergic asthma, anaphylactic shock, quincke edema, food allergy (type i allergy) * allergy or hypersensitivity to any component of the test product (e. g. wheat, corn) * known congenital, acquired or iatrogenic immunodeficiency (e.g. hiv, chemotherapy, immunosuppression) * active autoimmune diseases * severe chronic disease (copd, respiratory insufficiency, cancer, ibd, malabsorption, malnutrition, chronic inflammatory diseases, severe renal, hepatic or cardiac diseases) * known coeliac disease (gluten enteropathy) * chronic systemic or chronic topical treatment likely to interfere with evaluation of the study parameters: antiallergic drugs, antibiotics, intestinal or respiratory antiseptics, anti-rheumatics, antiphlogistics (except aspirin or equivalent products preventing from aggregation of platelets or blood clotting) and steroids prescribed in chronic inflammatory diseases (in the last 4 weeks before inclusion) * diabetes mellitus * other chronic treatments likely to interfere with study outcome: e.g. laxatives, body weight management and/or medication * chronic abdominal pain * bowel movement less than 3 times per week * subjects, who meet 2 or more rome iii criteria for constipation or who take laxatives on a regular basis * vegetarian, vegan diet * eating disorders (e.g. anorexia, bulimia) * alcohol and drug abuse * severe neurological, cognitive or psychiatric diseases * subjects not understanding or speaking fluently german * legal incapacity
thrombocytopenia and bleeding in wiskott-aldrich syndrome (was) patients

Conditions: Wiskott-Aldrich Syndrome; Thrombocytopenia; Bleeding

Summary: the purpose of this project is to describe the pathophysiology of thrombocytopenia and bleeding in patients with wiskott-aldrich syndrome (was) and determine the response to thrombopoietic agents in vitro and in vivo.

wiskott aldrich syndrome is an x-linked disease characterized by immunodeficiency, eczema and thrombocytopenia; a milder form of the disease known as x-linked thrombocytopenia also exists. the thrombocytopenia in both was and xlt is characterized by: severe thrombocytopenia with platelet counts frequently less than 10-30,000/ul; small platelets which may be dysfunctional; and, as a result, a high rate of serious bleeding including intracranial hemorrhage. because eltrombopag has been shown to be remarkably efficacious in substantially increasing platelet counts in a high percentage of itp patients, this study seeks to effectively treat patients who exhibit similar pathologies, as well as evaluate the state of platelets in patients with was and relate it to clinical bleeding. it also aims to demonstrate whether eltrombopag administered daily will enhance stem cell function, increase platelet production and platelet count, and reduce bleeding in patients with was.

Eligibility criteria:
inclusion criteria: in order to be eligible for study entry, subjects must comply with the following: * males from 3 months old to 80 years old * signed written informed consent obtained prior to study entry * clinical diagnosis of was or xlt * platelet levels less than 100 x 109/l * adequate renal and hepatic function (creatinine and bilirubin less than or equal to 1.5 x iuln, ast and alt less than or equal to 2.5 x iuln) exclusion criteria: any patient is ineligible for study entry if he/she: * over the age of 80 * women (only males are eligible) * fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study or until at least 6 months after treatment * aspirin, aspirin-containing compounds, salicylates, non-steroidal anti-inflammatory medications (nsaids), clopidogrel or ticlopidine, warfarin or other vitamin k antagonists, unfractionated or low molecular heparin within 7 days of first infusion * red blood cell transfusion in the past four weeks * elevated (\> 1.5 x uln) prothrombin time (pt) or partial thromboplastin time (ptt) * new york heart classification iii or iv heart disease. other severe cardiovascular or cardiopulmonary disease, including copd. * known hiv infection, hepatitis b or c infection * any infection requiring antibiotic treatment within 3 days * other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations. * prior malignancy with less than a 5-year disease-free interval, excluding nonmelanoma skin cancers and carcinoma in situ of the cervix
a first-in-human study of d-0502 alone and in combination with palbociclib in women with advanced or metastatic er-positive and her2-negative breast cancer

Conditions: Breast Cancer

Summary: this is a phase i, open-label study of d-0502 single agent and d-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an mtd, and/or rp2d, evaluate the pk properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic er-positive, her2-negative breast cancer.


Eligibility criteria:
inclusion criteria: 1. histologically-proven, er-positive, her2-negative locally advanced, inoperable, and/or metastatic breast cancer. 2. female patients with menopausal status: i. postmenopausal status defined as meeting at least one of the following criteria: 1. have undergone a bilateral oophorectomy any time in life; 2. age ≥60 years, or 3. age \ 40 milli-international units per milliliter (miu/ml) and an estradiol value \<40 picograms per milliliter (pg/ml) (140 picomoles per liter \[pmol/l\]). ii. premenopausal or perimenopausal concurrently given a luteinizing hormone-releasing hormone (lhrh) agonist starting at least 4 weeks before the start of trial therapy and is planned to continue lhrh agonist during the study. 3. patients meeting all the following criteria: 1. has had at least 6 months of endocrine therapy for metastatic er+ breast cancer prior to disease progression; 2. limited number of prior chemotherapy, endocrine therapy, and targeted therapy for advanced or metastatic disease 3. radiological or objective evidence of disease progression on or after the last systemic therapy prior to starting current study treatment. 4. for phase ia: not eligible for standard therapy that would confer clinical benefit to the patient. exclusion criteria: 1. patients with prior anticancer or investigational drug treatment within the following windows are excluded: 2. participants with prior anticancer or investigational drug treatment within the following windows are excluded: 1. any anti-cancer therapy (including endocrine therapy, chemotherapy, targeted therapy, etc.) less than 30 days before first dose of study treatment. 2. any investigational drug therapy less than 28 days or 4 half-lives (whichever is shorter) prior to first dose of study treatment. 3. patients with untreated or symptomatic or progressive central nervous system (cns) metastases. * other protocol defined inclusion/exclusion criteria could apply
study to assess the use of lanreotide autogel® 120 mg in patients with locally advanced or metastatic gastroenteropancreatic neuroendocrine tumours (gep-nets) in routine clinical practice

Conditions: Neuroendocrine Tumors

Summary: the main aim of this study is to assess the progression-free survival (pfs) at 12 months of lanreotide autogel 120 mg use when administered as part of routine gep-net treatment and to follow patient treatment pathways, identify prognostic factors of pfs, evaluate patient's qol, and patient's and clinician's satisfaction with treatment in routine long-term care setting. the study will provide real-world evidence on the use of lanreotide autogel 120 mg and will provide information on topics such as optimization of product usage and identification of best practices and will provide evidence on product effectiveness in a realistic setting.


Eligibility criteria:
inclusion criteria: * functioning or non-functioning histopathologically confirmed, locally advanced or metastatic (grade 1 or grade 2 according to the world health organisation (who) 2017 classification and european neuroendocrine tumour society (enets) grading system) gep-net g1,g2 (ki67≤10%, based on recent ki67). * measurable disease, as defined by recist 1.0, on a ct scan/mri obtained up to 6 weeks prior to initiation of treatment with lanreotide autogel 120 mg. * subject eligible for treatment with lanreotide autogel 120 mg or subject currently being treated with lanreotide autogel 120 mg administered every 28 days for a period no longer than 5 months prior to inclusion * treatment with lanreotide autogel 120 mg alone, according to local summary of product characteristics (smpc). exclusion criteria: * lanreotide autogel treatment for more than 5 months prior to inclusion into the study * concomitant anti-proliferative medication/therapies for gep net at initiation of lanreotide autogel treatment (e.g. peptide receptor radionuclide therapy (prrt), cytotoxic chemotherapy, targeted therapy everolimus, sunitinib, interferon, loperamide). * has been treated with prrt, chemotherapy, everolimus, sunitinib or interferon within 3 months prior to initiation of lanreotide autogel treatment * parallel participation in an interventional study
the value of diffusion-weighted imaging in evaluating the early efficacy of liver metastasis in colorectal cancer

Conditions: DWI-MRI

Summary: the study is designed to evaluate the value of dwi-mri (diffusion weighted magnetic resonance imaging) in predicting the efficacy of liver metastases after chemotherapy in colorectal cancer.


Eligibility criteria:
inclusion criteria: * aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma * eastern cooperative oncology group performance status of 0 to 2 * life expectancy of ≥ 3 months * at least one measurable liver metastatic lesion in mri (≥10mm) * have adequate bone marrow, hepatic, and renal function * previously received no palliative chemotherapy exclusion criteria: * patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction * patients with symptomatic brain metastases * active clinical severe infection * have contraindication of mri screening
a study to evaluate the effect of spinal cord stimulation (scs) on painful diabetic peripheral neuropathy (pdpn)

Conditions: Chronic Pain

Summary: the purpose of the study is to evaluate the effects of stimulation parameters on clinical outcomes of spinal cord stimulation (scs) in the treatment of chronic, intractable limb pain resulting from painful diabetic peripheral neuropathy (pdpn).


Eligibility criteria:
key inclusion criteria: * clinical diagnosis of diabetes mellitus, according to international diabetes guidelines. * willing and able to comply with all protocol-required procedures and assessments/evaluations. * eligible candidate for scs from a surgical, cognitive, psychological and psychiatric standpoint per site's routine screening process and based on investigator judgement. * subject signed a valid, ec-approved informed consent form (icf) provided in local language. key exclusion criteria: * primary etiology for lower limb neuropathic pain not due to diabetic peripheral neuropathy (dpn). * participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study. * currently implanted with an active implantable device(s) (e.g., pacemaker, drug pump). * a female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.

Keywords: spinal cord stimulation chronic pain
does hirschsprung disease increase the risk of febrile urinary tract infection in children

Conditions: Hirschsprung Disease; Febrile Urinary Tract Infection (Disorder)

Summary: febrile urinary tract infection (futis) are the most common bacterial infections in children under the age of 2 years. they represent 7% of children presenting with fever without a source. in case of recurrent or undertreated futis there is a risk for kidney function with the threat of chronic renal failure \[7\]. they are more often isolated but some futis may reveal an underlying and facilitating condition. beside the well-known congenital anomalies of the kidneys and urinary tract such as reflux or obstructions, others risk factors for futi are reported. age less than 1 year, uncircumcised males, poor fluid intake, bladder bowel dysfunction (bbd) including dysfunctional voiding pattern and constipation increase the risk of futi. the prevalence of bbd in children with futis is far higher than in the general population. recommendations emphasize on an efficient treatment of bbd in the first-line management of recurring futis and it has been proven to be efficient (ref). one of the bbd may include hirschsprung's disease (hd). hd is the first congenital malformation of the enteric nervous system with a reported prevalence of 1 in 5000 live birth. it's characterized by an aganglionosis and subsequent dysmotility affect by always the anal canal, most commonly there is a rectosigmoid form (74-80%), and less commonly involves a long segment of colon (12-22%) or a total colonic aganglionosis with ileal involvement upto 50 cm proximal to ileocecal junction (4-13%). the treatment is based on the resection of dysfunctional segment of colon with an anastomosis between the normally innervated bowel to the anus, while preserving normal sphincter function. but significant bowel dysfunction may persist postoperatively. 20% of the children present a fecal incontinence, and 14% a constipation in long-term studies. bladder dysfunction and associated urological anomalies are also reported in these patients. all of that may facilitate the occurrence of febrile urinary tract infections (futi) in patients with hd. unfortunately, few studies focused on this specific population. the objective of this study was to find out whether children with hd are more prone to develop futis than controls and which patient with hd are more at risk to develop utis.


Eligibility criteria:
inclusion criteria: patients : - surgical treatment of an hd confirmed on histopathologic exam. controls : - appendicetomy for acute appendicitis without history of hd, ano rectal malformation or any other colic disease exclusion criteria: * patients with hd but not yet operated * patient with a stoma at the time of the study * patient with chronic intestinal pseudo obstruction without hd

Keywords: pediatric surgery case control study
assessment of quality of life in hemophiliac patients

Conditions: Improvement of Quality of Life of Hemophiliac Patients

Summary: hemophilia is an x-linked congenital bleeding disorder caused by deficiency of coagulation factor viii (in hemophilia a) or factor ix (in hemophilia b). the deficiency is the result of mutations of the respective clotting factor genes.

hemophilia is rare, with only about 1 instance in every 10,000 births (or 1 in 5,000 male births) for hemophilia a and 1 in 50,000 births for hemophilia b. according to the world federation of hemophilia, 400 000 people worldwide \& 5,307 people in egypt are suffering from hemophilia. hemophilia a is more common than hemophilia b, representing 80-85 % of the total hemophilia population. signs and symptoms of hemophilia vary according to the level of clotting factors, mild, moderate and sever. * unexplained excessive bleeding from cuts or injuries * epistaxis without a known cause * many large or deep bruises * hamoarthritis * hematuria and melena. * intracranial hemorrhage and death * in infants, unexplained irritability it is subjective representation of health, including not only physical,mental and social, but also emotional and everyday life dimensions in terms of well-being. several definitions of qol have been provided, the definition of the who viewing qol as 'individuals perceptions of their position in life in the context of culture and value systems in which they live and in relation to their goals, expectation standards and concerns'

Eligibility criteria:
inclusion criteria: * - hemophilia a \& b * different age groups (pediatric - adolescence - adult ) * home or hospitalized treatment * complications such as joint swelling , spontaneous bleeding, etc.... exclusion criteria: - 1- other causes of bleeding tendency such as liver failure, dic, anticoagulant drugs, etc.. 2- diseases that affect joints such as osteoarthritis, sle , etc.. 3- mentally retarded patients.
patency and safety of the drug eluting covered biliary stent comparing to the common covered biliary stent

Conditions: Biliary Stricture; Malignant Neoplasms

Summary: paclitaxel covered metal biliary stent extents their patency rate comparing to the common covered metallic biliary stent.

paclitaxel covered metal biliary stent(mira-cover biliary stent) extents their patency rate comparing to the common covered metallic biliary stent(niti-s biliary stent.

Eligibility criteria:
inclusion criteria: * patient who is inoperable and/or unresectable cases of pancreatic cancer and/or biliary cancer with mid or distal cbd invasion * among patient of a.,patient who previously had surgical biliary drainage of plastic stent have eligibility exclusion criteria: * patient who have life expectancy under 3 months * patient who have severe metastasis of liver or whole body * patient who previously had surgical biliary drainage

Keywords: paclitaxel drug eluting stent
study to evaluate persistence of antibodies after vaccination with meningococcal vaccine gsk 134612

Conditions: Infections, Meningococcal

Summary: subjects were previously vaccinated at 11 to 17 years of age. this extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. no new subjects will be enrolled.

subjects were previously vaccinated at 11 to 17 months of age with gsk biologicals' meningococcal vaccine 134612 or with mencevax™. this extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. no new studies will be enrolled. the subjects will have 4 blood samples taken: at 24, 36, 48 and 60 months after vaccination.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female having been vaccinated with a meningococcal vaccine in the primary study 109069. * written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject's first visit. * history of meningococcal disease; such cases will be documented. * administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history. * administration of immunoglobulins and/or any blood products within the three months preceding the subject's first visit. * bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy * subjects who withdrew consent to be contacted for follow-up studies.

Keywords: meningococcal vaccine gsk 134612