Kornimate/medical-research-clean huggingface dataset:
a study of cellcept (mycophenolate mofetil) in patients with lupus nephritis.

Conditions: Lupus Nephritis

Summary: this 2 arm study will compare the efficacy and safety of cellcept plus corticosteroids, versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine in the maintenance phase, in maintaining remission and renal function in patients with lupus nephritis. patients will be randomized to receive cellcept 1g bid po plus corticosteroids for 24 weeks, followed by cellcept 0.75g bid po plus corticosteroids for the following 24 weeks, or cyclophosphamide 0.5-1.0g/m2 monthly plus corticosteroids for 24 weeks, followed by azathioprine 2mg/kg/day po plus corticosteroids for the following 24 weeks. response rate will be assessed at the end of the induction phase, and at the end of study. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * systemic lupus erythematosus; * histological diagnosis of lupus nephritis. exclusion criteria: * not in need of immunosuppressive treatment (in addition to corticosteroids); * continuous dialysis starting \>2 weeks before randomization, with an anticipated duration of \>8 weeks; * previous or planned kidney transplant.
a study in participants with obesity or overweight with at least one weight-related comorbidity

Conditions: Obesity or Overweight

Summary: a phase iib randomised, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of azd6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index \[bmi\] ≥ 30 kg/m2), or overweight (bmi ≥ 27 kg/m2) and at least one weight-related comorbidity

the study will comprise of: a screening period of maximum 28 days a treatment period of 36 weeks a follow up period after last dose of study drug this study will consist of 4 cohorts. approximately 231 eligible participants will be randomized to azd6234 or placebo

Eligibility criteria:
inclusion criteria: * adults ≥ 18 years of age * bmi of (a) ≥ 30 kg/m2, or (b) ≥ 27kg/m2 and have a current diagnosis of at least 1 weight-related comorbidities (treated or untreated) * a stable body weight for 3 months prior to screening (±5% body weight change) exclusion criteria: * have obesity induced by other endocrine disorders, such as cushing's syndrome or prader-willi syndrome * has received prescription or non-prescription medication for weight loss within the last 3 months prior to screening * previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier) * history of type 1 diabetes mellitus or t2dm

Keywords: obesity overweight
towards simple and non-invasive assessment of residual beta-cell function in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: type 1 diabetes is condition in which progressive autoimmune destruction of insulin-producing beta-cells leads to absolute insulin deficiency. at the time of clinical presentation, it is estimated that 50-80% of beta-cell function has been lost. good glycaemic control from diagnosis has been shown to preserve beta-cell function. the recent identification of immuno-interventions able to reduce autoimmune destruction and preserve beta-cell function has lead to an increased urgency to develop such tools. with mixed-meal stimulated serum c-peptide being a gold standard, there are currently no tests that are suited for use in clinical practice to detect and monitor residual beta cell function. there is a therefore a need for a test that is sufficiently sensitive to assess beta cell function reserve in type 1 diabetes for clinical practice purposes, which will be simple, reproducible and suitable for use even in the non-observed setting. using mixed meal stimulation of plasma c-peptide (stable by-product in insulin secretion that reliably reflects insulin production) response as a reference, we propose to compare mixed meal stimulated urinary c-peptide as potential candidate for this application. this is a pilot investigation in which a sample of 30 participants will be recruited. it is anticipated that the current project will identify a simple method for analysing beta cell reserve in type 1 diabetes. this will then be applied to screening clinic populations of recently diagnosed patients with type 1 diabetes. the aim will be to identify subjects who may be suitable for early intensified insulin regimes (e.g. insulin pump therapy) and novel immuno-intervention strategies designed to preserve residual beta cell function and improve long-term outcomes. currently such immunointervention has been reserved for subjects within 3 months of diagnosis only, excluding a significant number of subjects who may potentially benefit.


Eligibility criteria:
inclusion criteria:1. 1. type 1 diabetes diagnosed in the last 5 years 2. age 18-45 years 3. bmi between 18.5 and 29.9 4. insulin requirement less than 0.8 units/kg - exclusion criteria: 1. hba1c higher than 10% 2. ongoing steroid treatment or chemotherapy 3. pregnancy and breast feeding 4. egfr less than 50ml/min/1.73m2 -

Keywords: beta cell reserve, urinary c peptide
improving obstructive sleep apnea management via wireless telemonitoring

Conditions: Sleep Apnea Syndromes

Summary: obstructive sleep apnea (osa) is a major chronic condition affecting the quality of life of up to one-fifth of all veterans. because of disappointingly low adherence to the gold-standard treatment (continuous positive airway pressure therapy - cpap), the institute of medicine has stated that new adherence strategies are needed that improve the quality of care, reduce social and economic costs, and help osa patients live happier, healthier, and more productive lives through improved clinical management. the combination of a self-management approach along with emerging wireless technologies has strong potential to increase treatment adherence and improve outcomes.

the sleep apnea self-management program (sasmp) was evaluated by conducting a randomized, controlled trial of the program compared to usual care in patients diagnosed with osa and prescribed cpap therapy. participants randomized to the sasmp group attended 4 weekly educational sessions of approximately two hours each. a trained leader facilitated the program from a scripted manual. key topics covered in this program included: (1) management of osa symptoms, cpap side effects, and weight loss; (2) maintaining social contacts and family relationships; and (3) dealing with symptoms of depression and worries about the future. the primary aim of this study was to examine the effect of the sasmp, compared to usual care, on cpap adherence. it is hypothesized that sasmp participants will have higher levels of cpap adherence compared to those in the usual care group. a second aim of the study was to examine the effect of the sasmp, compared to usual care, on proposed mediating variables derived from social cognitive theory (perceived self-efficacy, outcome expectations). it is hypothesized that sasmp participants would have higher levels of self-efficacy and outcome expectations compared to the usual care group. and the third aim of the study was to measure the short- and long-term effects of the sasmp, compared to usual care, on health outcomes (e.g., osa symptoms and osa-specific hrqol). it is hypothesized that improvements in osa symptoms and osa-specific hrqol will be seen both initially and as maintained 6 months and 1 year after the start of the sasmp.

Eligibility criteria:
inclusion criteria were: 1. diagnosis of osa 2. prescription for cpap treatment by a sleep physician 3. being cpap naïve (ie, no previous use of cpap). exclusion criteria were: 1. residence in a geographical area outside of san diego county 2. fatal comorbidity (life expectancy less than 6 months as indicated by treating physician) 3. significant documented substance/chemical abuse

Keywords: treatment compliance self-management telemedicine
3d printed models for liver surgery

Conditions: Liver Cancer

Summary: comprehensive preoperative planning and real-time intraoperative guidance are essential prerequisites for achieving precise liver resection. in pursuit of this goal, the investigators have developed innovative 3d printed liver models utilizing a physically crosslinked self-healing elastomer created through the copolymerization of 4-acryloylmorpholine (acmo) and methoxy poly (ethylene glycol) acrylate (mpega). these printed models exhibit exceptional healing capabilities, efficiently restoring their structure within minutes at room temperature, and rapidly recovering within moments after being incised. herein, the investigators aim to assess the viability of employing these 3d printed liver models as instrumental tools in designing the optimal surgical approach through an iterative trial-and-error methodology. concurrently, the investigators aim to determine whether the integration of these 3d printed models into conventional methods (contrast-enhanced ct or mri) can enhance the safety, ease, and efficiency of hepatic resection procedures.


Eligibility criteria:
inclusion criteria: 1. 18-80 years old; 2. patients with a resectable tumor in the liver; 3. eastern cooperative oncology group performance status score: 0; 4. child-pugh classification: a; 5. the laboratory test results meet the following criteria and patients can tolerate surgery: haemoglobin≥90g/l, neutrophil count≥1.5×10⁹/l, platelet count≥100×10⁹/l, aspartate or alanine aminotransferase≤5 upper limits of normal(uln）, alkaline phosphatase≤2.5 uln, serum albumin≥30g/l, serum creatinine\<1.5 uln, international normalized ratios（inr）≤2 or prothrombin time（pt）exceed uln≤6s, creatinine clearance≥60 ml/min. exclusion criteria: 1. patients with extra-hepatic metastasis; 2. anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation in 28 days prior to the surgery; 3. clinically significant bleeding or bleeding tendencies within 3 months prior to enrollment or on thrombolytic or anticoagulant therapy; 4. severe lung disease (eg, acute lung disease, pulmonary fibrosis that affects lung function, interstitial lung disease), uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/l); 5. there are other unsuitable candidates for clinical trials, such as mental illness or alcohol dependence.
endoscopic treatment for zenker's diverticulum

Conditions: Zenker Diverticulum

Summary: zenker's diverticulum (zd) is a rare benign condition, due to an acquired sac-like outpouching of the mucosa and submucosa layers originating from the pharyngoesophageal junction. endoscopic techniques like flexible endoscopic septum division (fesd) or per-oral endoscopic septotomy (poes), represent a minimally invasive alternative to surgery or to rigid endoscopic procedure to treat zd. the goal of the research will be to evaluate the safety of the procedures and to measure zenker-symptom severity in all patients treated by endoscopic procedures.


Eligibility criteria:
inclusion criteria: * patients with symptomatic zd treated by endoscopic procedures exclusion criteria: * pregnancy and breastfeeding
pk study of dapagliflozin in pediatric subjects with t2dm

Conditions: Type 2 Diabetes Mellitus

Summary: the primary purpose of this study is to evaluate the pharmacokinetics (pk) of dapagliflozin in pediatric subjects with type 2 diabetes mellitus (t2dm)

primary purpose: the primary purpose is to assess the pharmacokinetics of a single dose of dapagliflozin in the range of 2.5 to 10 mg in pediatric subjects aged 10 to 17 years with t2dm

Eligibility criteria:
inclusion criteria: * clinical diagnosis of t2dm * male and female subjects ages 10-17 * glycosylated hemoglobin a1c (hba1c) ≥6 to 10% * body weight ≥30 kg exclusion criteria: * fasting plasma glucose (fpg) \>240 mg/dl at screening * abnormal renal function * active liver disease and/or significant abnormal liver function
safety and efficacy of zp-glucagon to injectable glucagon for hypoglycemia

Conditions: Hypoglycemia

Summary: the purpose of this study is to determine whether glucagon administered by microneedle patch is comparable to glucagon administered by injection pen in the treatment of insulin-induced hypoglycemia.

the purpose of this study is to compare zp-glucagon transdermal patch system at doses of 0.5 mg and 1 mg to glucagon by injection at doses of 0.5 mg and 1 mg by means of a 4 way crossover open label design. eligible subjects giving informed consent will be randomised to a treatment sequence of each of the four treatments in one week intervals. at each treatment visit, subjects will undergo an insulin induction procedure designed to safely induce hypoglycemia, and then have a treatment applied, either by injection or by patch, and then monitored for return to normoglycemia.

Eligibility criteria:
inclusion criteria: * women or men 18 to 60 years with type-1 diabetes on daily insulin treatment (basal-bolus injection regimen or insulin pump) for at least two years, on a total daily dose that has been stable for the last 3 months preceding enrollment (no more than 20% variation), and with a current level of glycated hemoglobin between 6.5% and 10% exclusion criteria: * any history of hypoglycemic coma or hypoglycemic seizures. * any episode of severe hypoglycemia (requiring treatment) within one month prior to study start. * any history of pheochromocytoma or insulinoma
effects of dexmedetomidine/lidocaine/intrathecal morphine on cancer metastasis biomarker after colorectal surgery

Conditions: Colorectal Cancer; Anesthesia; Cancer Metastatic; Inflammation

Summary: this is a prospective randomized controlled trial. investigators aimed to compare the effect of three different anesthetic adjuvants (continuous infusion of lidocaine or dexmedetomidine, intrathecal morphine injection) on the biomarker for cancer recurrence and metastasis. patients undergoing elective colorectal cancer surgery will be randomly allocated to three parallel arms and the biomarkers for cancer recurrence and metastasis, inflammation, and immune response will be compared. and we will compare the clinical outcomes in the three method.

perioperative period is critical in determining the risk of postoperative metastatic disease. surgical damage and related stress response could suppress cell-mediated immunity and facilitate malignant cell survival, motility, invasion and proliferation. increasing evidence supported that the continuous infusion of lidocaine or dexmedetomidine, or intrathecal morphine were associated with the reduction of postoperative pain and opioid consumption and improved the quality of recovery. also, they were reported to decrease perioperative inflammatory responses and preserve immune response which is known to be critical in anti-metastatic process during perioperative period. however, no comparison was conducted among these anesthetic adjuvants. thus, investigators try to evaluate the effect on the biomarkers and clinical outcomes in the three methods.

Eligibility criteria:
inclusion criteria: * patients who were scheduled for elective colorectal cancer surgery american society of anesthesiologists physical status of i-iii exclusion criteria: * atrioventricular conduction disorder * having bradycardia (\<50 bpm) * severe pulmonary dysfunction in pulmonary function test * high risk for cardiovascular complications(expected postoperative event \>5%) * allergy or hypersensitivity reaction to each adjuvant. * history or risk factors for malignant hyperthermia * body mass index \>40 kg/m2
comparing bronchodilation of symbicort with and without valved holding chamber (aerochamber plus)

Conditions: Asthma

Summary: this study will compare the amount of bronchial tube relaxation from the formoterol medicine contained in the symbicort pressure metered dose inhaler(pmdi)(a combination of budesonide, a steroid, and formoterol, a drug which relaxes the bronchial smooth muscle. the comparison will be using the pmdi in the usual fashion to the pmdis and a spacer which allows more time for breathing in the medication. breathing tests will be measured over a 12 hour period for the comparison.

sixteen subjects will receive treatment in a cross-over design. they will inhale symbicort 160/4.5 two inhalations in the manner prescribed in the approved package insert. the second intervention will be the inhalation of symbicort 160/4.5 two inhalations through a valved holding chamber (aero chamber plus). breathing tests including spirometry will be measured at various time periods over a 12-hour time frame in each intervention. comparison will be made of the two periods to demonstrate that the use of the valved holding chamber does not adversely affect the bronchodilation of the formoterol component of the combination drug.

Eligibility criteria:
inclusion criteria: * asthma with 15% or more increase in forced expiratory volume at 1 second (fev-1) after 180-360 mcg of albuterol pmdi exclusion criteria: * any illness or condition which might place subject at risk in the study;e.g. some cardiovascular disorders inability to understand and sign informed consent

Keywords: asthma formoterol long acting beta adrenergic bronchodilator symbicort aerochamber
global strain and mechanical dispersion may predict death and ventricular arrhythmias better than ejection fraction

Conditions: Left Ventricular Function Systolic Dysfunction

Summary: the aim of the study is to investigate if global strain and mechanical dispersion may predict death and ventricular arrhythmias better than ejection fraction(ef) in patients with myocardial infarction and heart failure regardless of cause.

1. the main aim of this study is to investigate if global strain and mechanical dispersion may predict death and ventricular arrhythmias better than left ventricular ejection fraction in patients with myocardial infarction and heart failure. 2. in patients who receive internal cardioverter defibrillator(icd) the main aim is to investigate if mechanical dispersion may predict ventricular arrhythmias better than ef. 3) no interventions,only evaluation of the measurements obtained with transthoracic echocardiography. 4) follow up for 3 years, extended from 3 to 5 years.

Eligibility criteria:
inclusion criteria: * all patients with 1. myocardial infarction 2. heart failure( defined as heart failure symptoms: reduced left ventricular function/ and or heart failure signs on chest x ray. 3. planned for primary prophylactic icd * over 18 years of age * informed consent exclusion criteria: -

Keywords: ejection fraction, global strain, mechanical dispersion
restricting blood flow in improving muscle strength in patients with hemophilic arthropathy

Conditions: Hemophilia

Summary: background. the main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). this sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy. objective. to assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in the perception of muscle activation and strength, functionality, joint pain, joint status and the perception of quality of life in patients with hemophilic arthropathy. knee and ankle. study design. randomized, multicenter, single-blind clinical study. method. 20patients with hemophilia a and b will be recruited in this study. patients will be recruited in 3 regions of spain. the dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale), joint status (hemophilia joint health score scale), strength (dynamometer) and range of motion (goniometer). three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks. expected results. observe the safety of blood flow restriction in hemophilia patients. to analyze the efficacy of blood flow restriction in improving muscle strength, joint pain, range of motion, and joint damage in patients with hemophilic knee and ankle arthropathy.


Eligibility criteria:
inclusion criteria: * patients diagnosed with hemophilia a and b * patients with a medical diagnosis of hemophilic ankle and knee arthropathy * people over 18 years of age * patients on prophylactic or on-demand treatment regimen with fviii / fix concentrates exclusion criteria: * patients with neurological or cognitive disorders that impede understanding of the test. * pain free patients * amputees, epileptics or patients with severe vision problems * patients who are receiving physiotherapy treatment at the time of the study * patients who have not signed the informed consent document

Keywords: hemophilic arthropathy blood flow restriction physiotherapy muscular strength muscle activation chronic pain functionality quality of life
inhaled tpi-1020 versus inhaled budesonide in smokers with mild reversible asthma

Conditions: Asthma

Summary: the investigators will look at tpi-1020 safety and tolerability in mild to moderate asthmatic smoker subjects.

this study will assess and compare the safety and tolerability of inhaled tpi 1020 versus budesonide. pharmacokinetic (pk) and pharmacodynamic (pd) parameters will also be studied in a sub-group of subjects.

Eligibility criteria:
inclusion criteria: * males or females 18 through 65 years of age. * smoking history of more than 5 pack/years but less than 25 pack/years and who have no desire to quit smoking despite physician's advice and who currently smoke at least 5 cigarettes per day. * mild to moderate, stable, allergic asthma as defined by american thoracic society (ats) criteria 1 * history of episodic wheeze and shortness of breath * subjects currently and only receiving inhaled short-acting bronchodilator treatment for asthma. exclusion criteria: * history or symptoms of significant autoimmune, hematological, or neurological disease, including transient ischemic attack (tia), stroke, seizure disorder, or behavioural disturbances that are judged clinically significant by the investigator * history of serious adverse reaction or hypersensitivity to corticosteroids * abnormal chest x-ray that is judged clinically significant * pregnant or lactating or have positive plasma pregnancy test * use of oral/parenteral/inhaled corticosteroids within the last 28 days or injectable depot corticosteroids within the last 6 weeks. * use of any other asthma-related medications within 1 month of screening

Keywords: smokers adults inflammatory markers