Kornimate/medical-research-clean huggingface dataset:
sitagliptin in cystic fibrosis-related diabetes

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to determine whether the dipeptidyl peptidase iv (dppiv) inhibitor sitagliptin is effective in the treatment of cystic fibrosis-related diabetes (cfrd). we hypothesize that sitagliptin will improve meal-stimulated insulin secretion.

to date, no clinical trials have been conducted using the dppiv inhibitor sitagliptin in cystic fibrosis-related diabetes. cystic fibrosis-related diabetes is characterized initially by post-prandial hyperglycemia, with normal fasting sugars. as the disease progresses, fasting hyperglycemia develops. as sitagliptin augments post-prandial insulin release, while avoiding fasting hypoglycemia, it may be an alternative therapy for cystic fibrosis-related diabetes in individuals who do not yet require basal insulin therapy.

Eligibility criteria:
inclusion criteria: * 19 years of age or older * cystic fibrosis-related diabetes with or without fasting hyperglycemia either untreated or using only pre-prandial repaglinide or pre-prandial bolus insulin therapy exclusion criteria: * age under 19 years * use of basal insulin therapy * creatinine clearance \< 50 ml/min * active cystic fibrosis exacerbation * pregnancy * women of child-bearing age not using effective contraception * current or prior use of dppiv inhibitor

Keywords: cfrd sitagliptin cystic fibrosis-related diabetes incretins hyperglycemia gip glp-1
imaging characteristics of a follow-up 18f-av-1451 scan

Conditions: Alzheimer's Disease

Summary: this study will evaluate the imaging characteristics of flortaucipir in subjects with a previous flortaucipir scan in order to assess the rate of change of tau deposition over time.


Eligibility criteria:
inclusion criteria: * have a previous 18f-av-1451 brain scan * can tolerate up to two positron emission tomography (pet) imaging sessions and a magnetic resonance imaging (mri) scan * ability to provide informed consent exclusion criteria: * current clinically significant psychiatric disease * are claustrophobic * current clinically significant cardiovascular disease or ecg abnormalities, or additional risk factors for torsades de pointes * current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer * females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception * have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
rct of stent versus standard therapy in oesophageal variceal haemorrhage

Conditions: Acute Bleeding Esophageal Varices

Summary: the mortality rates from acute variceal haemorrhage remain significant and first line therapy may fail in 15-25% of patients. the self-expandable metal stent has been described in case series as having a very high efficacy at control of haemorrhage from oesophageal varices when used as rescue therapy. this randomised controlled trial aims to assess for any potential superiority of the stent over 'standard' endoscopic techniques as primary or rescue therapy for bleeding oesophageal varices.

despite improvements in recent years, mortality from variceal bleeding remains significant. the routine use of banding ligation, vasoactive drugs, and antibiotics has had an impact on survival rates such that survival rates of patients with childs-pugh a and b class cirrhosis may be as high as 90% at 30 days. however, the successful outcome of variceal bleeding is compromised in some patients because of initial failure to control bleeding or early re-bleeding, both of which have a significant impact on mortality. the sx-ella danis stent (ella-cs, hradec kralove, czech republic) is a removable, covered, self-expanding mesh-metal stent (sems) that can be deployed in the lower oesophagus over an endoscopically placed guidewire without radiological screening. the stent controls bleeding by tamponade of varices in the lower oesophagus. the series reported to date suggest that the self-expandable covered stents can provide 100% haemostasis rates when applied for refractory oesophageal variceal bleeding. given the potentially lower risks of re-bleeding and safe, easy insertion techniques the self-expandable covered stents may offer a superior alternative to standard endoscopic therapy.

Eligibility criteria:
inclusion criteria: * arm 1: participants with child-pugh grade b or c cirrhosis with variceal haemorrhage, where the bleeding is from a site which would ordinarily be treated with band ligation . the diagnosis of cirrhosis may be proven by previous histology or suspected using clinical, radiological and biochemical data. * arm 2: participants with child-pugh grade a, b or c cirrhosis who present with failure to control bleeding within 5 days of an initial attempt at standard endoscopic therapy of acute haemorrhage from a site which would ordinarily be treated with band ligation. exclusion criteria: * \< 18 years of age * child-pugh grade a cirrhosis (for arm 1 only) * varices which would not be treated with band ligation as standard therapy * non-cirrhotic portal hypertension * malignancy of the oesophagus, stomach or upper respiratory tract * oesophageal stenosis which prohibits endoscopy * recent oesophageal surgery * a large hiatus hernia which prevents stent placement * known hepatocellular carcinoma considered to be incurable (according to milan criteria) * patients in the terminal phases of hepatological or other disease * pregnancy

Keywords: gastrointestinal haemorrhage varices liver cirrhosis stent
association of hepatitis c virus with breast cancer

Conditions: Breast Cancer; Hepatitis C

Summary: hepatitis c viral infection is a major health problem in egypt. the management of breast cancer patients is often complicated by the presence of associated hcv infection. this study aims at investigating the epidemiological association of the two conditions. it will also investigate the possible correlation with treatment outcome.

breast cancer is the most common cancer in adult egyptian females. the world's highest prevalence of hepatitis c virus is found in egypt. several investigators examined the epidemiological association of hcv with breast cancer. published literature reports conflicting results regarding the hcv association with breast cancer incidence. population-based studies from hcv-endemic area demonstrated increased breast cancer incidence in hcv-positive women younger than 50 years. on the other hand, population studies from hcv-low prevalence regions failed to detect an association of the virus with breast cancer. hcv seropositive patients constitute a large sector of oncology patients treated in egyptian practice. hcv infection with or without clinically-significant liver disease impose several therapeutic, social and logistic problems. recently, investigators from mansoura university reported their findings among breast cancerpatients. according to these data, hcv-positive breast cancer patients had several markers of disease aggression such as large tumor size, high tumor grade and nodal infiltration. moreover, hcv-ns4 (non-structural protein-4) blood levels positively correlated with the level of the known breast cancer marker ca15-3. in the current study, the investigators will investigate the incidence of hcv seropositivity in breast cancer patients and an age-matched control group. the study also examines the association of hcv status on the patients' baseline characteristics such as tumor stage and grade and with patients' treatment plan and treatment outcome. specifically, the aims of the study are the following: 1. to test if hcv seropositivity is associated with breast cancer diagnosis in egyptian population. 2. to test if hcv-positive patients harbour more aggressive breast tumors. 3. to test if hcv-positivity affects management decision in breast cancer patients. 4. to test if hcv-positive patients suffer more frequent adverse effects to breast cancer treatment. 5. to compare disease-free survival of hcv seropositive breast cancer patients vs. seronegative patients.

Eligibility criteria:
inclusion criteria: * biopsy-proven invasive breast cancer. exclusion criteria: * patients with unknown viral marker status. * patients who did not complete their management at ocmu. * patients with multiple cancer diagnoses. * patients with virus-unrelated hepatic pathology.

Keywords: breast cancer hepatitis c virus prognosis epidemiology
amyloid imaging and safety study of acc-001 in subjects with early alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this study in individuals with early alzheimer's disease is designed to assess:(1) safety and tolerability (2) the capacity of acc-001 and qs-21 adjuvant to reduce brain amyloid load as measured by positron emission tomography (pet) scans.


Eligibility criteria:
inclusion criteria: * concern about a change in cognition expressed by the subject or by an informant that knows the subject well * mini-mental state examination (mmse) score ≥ 25 * global clinical dementia rating = 0.5. * general cognition and functional performance sufficiently preserved such that a diagnosis of alzheimer's dementia cannot not be made by the site physician at the time of screening. * amyloid burden detected on screening brain pet scan. * other inclusion criteria apply. exclusion criteria: * significant neurological disease other than early alzheimer's disease * major psychiatric disorder or symptom * contraindication to undergo brain mri * unstable medical conditions * other exclusion criteria apply

Keywords: early alzheimer's disease active immunization amyloid imaging
mechanisms of immune tolerance and inflammation in patients with cystic fibrosis with abpa

Conditions: Cystic Fibrosis; Allergic Bronchopulmonary Aspergillosis

Summary: the goal of this study is to identify the immunological factors that influence a patient's response to the presence of the fungus aspergillus fumigatus (a. fumigatus) in the lungs. in patients with cystic fibrosis (cf), this fungus is not known to cause damage to the lungs, but some patients respond with an allergic reaction that may cause wheeze, cough, or difficulty breathing. approximately 230 patients will be enrolled with an additional 60 people who do not have cf and who do not have a history of asthma to serve as a comparison group.

in this cohort the investigators will study blood t-cell responses to aspergillus antigens to determine if patients with abpa have greater type 2 responses as measured by il-13 compared to cf or non-cf controls.

Eligibility criteria:
inclusion criteria: (cf) * diagnosis of cf * age 6 years or older * presence of a. fumigatus in culture of airway flora, or the presence of one or more of the diagnostic criteria for abpa (control) * age and sex matched to cf population exclusion criteria: (cf) * uncontrolled cf-related diabetes mellitus * use of oral steroids at a dose ≥ 0.5 mg/kg/day * history of lung transplantation * pulmonary exacerbation as defined by requirement for use of intravenous antibiotics or need for hospitalization within the preceding 14 days. * patients who have a diagnosis of hiv and have a cd4+ tcell count below 500 cells/ml will be excluded (control) * asthma

Keywords: allergic bronchopulmonary aspergillosis aspergillus fumigatus cytokine expression
the effect of hyaluronic acid injection on tnf-alpha and il-1β in knee osteoarthritis

Conditions: Knee Osteoarthritis; Hyaluronic Acid

Summary: in this study, the effect of intra-articular ha injection therapy on pre- and post-treatment tnf-alpha and il-1beta levels and methylation changes in blood and synovial fluid in patients with knee osteoarthritis will be determined and compared with the placebo group. in addition, the effects of ha injection on pain, functional status and quality of life will be evaluated and these effects will be related to changes in tnf-alpha and il-1-beta.


Eligibility criteria:
inclusion criteria: * diagnosis of knee osteoarthritis according to acr (american college of rheumatology) criteria * knee pain for more than 3 months * presence of knee pain resistant to conservative treatment for at least 3 months * to be between the ages of 45-75 * kellgren-lawrence stage 2-3 gonarthrosis detected in the available knee direct radiographs of the patients exclusion criteria: * patients with kl stage 1 and 4 oa * systematic diseases (severe cardiovascular disease, severe renal failure, severe hepatic failure, uncontrolled diabetes, cancer, immunosuppression, haematological diseases, systemic bone diseases) * bleeding tendency (acquired or inherited) \[lnr\>2 in a patient on coumadin\], * infection (systemic or local) * secondary knee osteoarthritis (inflammatory joint disease, post-traumatic, post-infectious, etc.) * major knee trauma within the last 1 year * bmi \>40 * history of total knee or hip arthroplasty within 1 year * pregnancy * history of intra-articular injection within the last 6 months * patients with hb less than 11 g/dl and plt less than 150.000 * presence of allergy to hyaluronic acid products
effect of thiamine on serum glucagon and reactive oxygen species (ros)

Conditions: Sepsis; Thiamine Deficiency

Summary: this research is a clinical trial with a randomized controlled trial (rct) design. the purpose is to identify the effect of intravenous thiamine administration compared to normal saline placebo on glucagon levels and ros levels in patients undergoing general anesthesia surgery

surgery may increase postoperative cortisol and blood glucose levels. changes in normal metabolic patterns due to surgery stimulate gluconeogenesis, glycogenolysis, proteolysis, lipolysis, and cytogenesis. these result in hyperglycemia and ketosis conditions. surgery and anesthesia lead to an immunosuppressive effect. increased secretion of proinflammatory cytokines may also occur after the surgery. besides an increase in cortisol levels, surgery can also increase cytokine response and ros production in patients who have undergone surgery under general anesthesia after 72 hours. ros production can also be a useful indicator in assessing the severity of surgical trauma. in surgical procedures, there is an acute increase in reactive oxidative stress (ros). this occurs when ischemia is followed by reperfusion. ros can trigger tissue injury seen in transplantation (liver and heart), the release of aortic clamps during abdominal and thoracic aortic surgery, the release of limb tourniquets during orthopedic surgery, and reperfusion during and after cardiopulmonary bypass. there is a thiamine deficiency in 20% of patients treated in the intensive care unit (icu). thiamine deficiency is a source of lactic acidosis that does not seem in severe sepsis and septic shock. an imbalance between the formation and removal of free radicals causes a pathological condition called oxidative stress. however, the human body uses antioxidants to suppress these free radicals. one of the antioxidants that can reduce oxidative stress is thiamine. previous studies proved this finding. thiamine has also been able to significantly prevent the expression of inflammatory cytokines and chemokines, depending on nf-b induced by thromboxane and pgi2 synthase.

Eligibility criteria:
inclusion criteria: * patients aged 18-65 years who undergo surgery under general anesthesia * asa physical statuses 1 and 2 * sepsis exclusion criteria: * refuse to participate * diabetes mellitus, experience shock sepsis or lactic acidosis * have a history of hypersensitivity (allergy) to thiamine * thiamine deficiency * take immunomodulatory drugs, antiplatelet or anticoagulants surgery duration \> 6 hours, and thiamin regularly * they experience massive bleeding and receive blood transfusions preoperatively, intraoperatively, or postoperatively

Keywords: thiamine sepsis glucagon ros perioperative stress response
the impact of point-of-care ultrasound

Conditions: Ultrasound; Shock

Summary: point-of-care ultrasound (pocus) has been found to be useful for aiding in the prediction of fluid responsiveness. it is unknown if trainees can effectively utilize this tool to improve their assessment of fluid responsiveness. in this prospective, observational study, pulmonary and critical care fellows are asked to make 2 assessments of fluid responsiveness in adults with shock: (1) based on clinical exam alone (clinical) and (2) after performing a pocus (clinical + us). the accuracy of their pre- and post-ultrasound assessments are compared using a bioreactance monitor and passive leg raise test as the gold standard of fluid responsiveness in this study.


Eligibility criteria:
inclusion criteria: * adults age 18 or older admitted to the micu with a diagnosis of shock while a fellow was on duty. exclusion criteria: * none
telerehabilitation & telecoaching of parents of cochlear implanted children at sohag university hospital

Conditions: Cochlear Implantation; Hearing Loss

Summary: design online program for language sessions for cochlear implanted children in arabic and monitor its validity and reliability to improve language outcome

design online program for teletherapy and coach parents to improve language of their children with cochlear implant and evaluate language outcome before and after teletherapy and compare it with control group who will take classical face to face sessions

Eligibility criteria:
inclusion criteria: * cochlear implanted children with non verbal intelligence quotient 80 or above * parents are compliant to the sessions exclusion criteria: * cochlear implanted children who have non verbal intelligence quotient less than 80 using the arabic version of stanford binet intelligence scale 5th edition * parents are non compliant to sessions

Keywords: cochlear implant telerehabilitation telecoaching
leptin biology in adipose tissue

Conditions: Obesity

Summary: leptin is a fat hormone which acts in maintaining energy balance. however, leptin levels are high in obese subjects indicating resistance to the actions of leptin. high leptin levels have been associated with increased cardiovascular and metabolic risks, but it is not clear if increased leptin or leptin resistance contributes to the increased cardiovascular risk. further, even though leptin receptors are present in fat tissue, leptin's role in fat tissue functions are not completely investigated in humans. based on preliminary data the investigators hypothesize that resistance to leptin action in obese adipose tissue is responsible for altering the expression of adipose tissue proteins which contribute to the development of cardiovascular and metabolic dysfunction. to test this hypothesis the investigators propose a novel study directed at investigating the leptin dependent changes in adipose tissue protein expression using adipose tissue obtained from lean and obese human subjects


Eligibility criteria:
inclusion criteria: 1. age 18-75 years 2. bmi bmi ≤25 (lean) or \>30 kg/m2 (obese) 3. going to undergo a surgical procedure where omental and subcutaneous adipose tissue may be biopsied. exclusion criteria: inability to provide written informed consent. -
the efficacy of salvage bgd with autosct consolidation in advanced classical hl patients not responding to abvd

Conditions: Hodgkin's Lymphoma

Summary: the objective of the study is evaluation of efficacy of bendamustine, gemcytabine, dexamethasone (bgd) salvage therapy with autologus stem cell transplantation (asct) consolidation in advanced classical hodgkin lymphoma patients not responding to abvd therapy.

treatment regimen: bendamustine (b) 90 mg/m2 iv day 1, 2 gemcytabine (g) 800 mg/m2 iv day 1, 4 dexamethasone (d) 40 mg iv/po day 1,2,3,4 course of treatment every 21-28 days, 4 courses of treatment max; next round of treatment may be given if anc\>1000/μl and plt\>75000/μl. up to 7-day delay is permitted.

Eligibility criteria:
inclusion criteria: * histologically confirmed classical hodgkin's lymphoma treated with abvd regimen with pet scan/ct performed before, during and after treatment, and also one of the following: * positive result (deauville 4 and 5) of early pet scan after 2 abvd courses * disease progression or relapse after first-line abvd treatment or abvd and radiotherapy combination treatment * no contraindications for salvage chemotherapy and asct * at least one measurable malignancy * ecog performance status ≤ 3 * written signed and dated informed consent prior to any study procedures being performed exclusion criteria: * non-classical hodgkin's lymphoma * other than abvd first-line treatment, preceding patient's inclusion * lack of pet scans performed in accordance with inclusin criteria during abvd treatment * transformation of hodgkin's lymphoma * central nervous system (cns) metastases * contraindications for asct or lack of patient's consens for the procedure * second malignancy - active or cured less than 5 years prior * uncontrolled diabetes * hepatic impairment (bilirubin concentration ≥ 1.5 x uln, sgot \> 5 x uln), if non-realted to the lymphoma or gilbert's syndrome * hiv infection * active hbv or hcv infection. subjects who have had hepatitis b and are abhbc positive, need to undergo hbv dna test using a polymerase chain reaction (pcr) technique and be applied appropriate preventive treatment. * pregnancy or lactation * hypersensitivity to any of the drugs * lack of written informed consent

Keywords: lymphoma immunochemotherapy salvage therapy bendamustine gemcitabine dexamethasone hodgkin's lymphoma asct
a trial assessing changes in blood sugar and the number of periods where supplementation of carbohydrate is needed to treat low blood sugar, during two different treatment regimens of nn1250 in type 1 diabetics

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim is to compare changes in blood sugar and the number of periods where carbohydrate supplementation is needed to treat low blood sugar, during two different treatments with nn1250 (insulin degludec), a soluble insulin basal analogue (siba) in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus for at least 12 months * glycosylated haemoglobin (hba1c) between 7.5 and 9% (both inclusive) exclusion criteria: * donation or loss of more than 500 ml blood or plasma within three months prior to this trial * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) or not able or willing to refrain from smoking and the use of nicotine gum or transdermal nicotine patches during the in-house periods * prior or current treatment with metformin or thiazolidinediones