Kornimate/medical-research-clean huggingface dataset:
study on impact of lifestyle change and weight loss before bariatric surgery

Conditions: Severe Obesity; Bariatric Surgery

Summary: the purpose of the trial is to determine whether a preoperative lifestyle intervention (targeting diet, exercise, and preparation for surgery) will favorably impact obesity-related parameters prior to bariatric surgery and improve short-term postoperative outcomes.

this is a randomized, controlled trial to evaluate the impact of a preoperative lifestyle intervention that targets diet, exercise, and preparation for surgery as an adjunct to the surgical treatment of obesity. patients will be randomized to a 6-month lifestyle intervention (n = 100) or to usual care (n = 100) prior to undergoing bariatric surgery. we aim to evaluate the effect of the intervention on select pre- and postoperative outcomes. we hypothesize that patients who participate in the preoperative intervention will exhibit greater improvements in weight and related outcomes and better preparation for surgery than those who receive usual care. after operation, we hypothesize that patients who participate in the intervention will exhibit better compliance and fewer behavior-related eating problems, as well as a lower rate of complications and fewer outpatient visits with surgery-related conditions than those who received usual preoperative care. our secondary aim is to determine whether the intervention affects weight/bmi trajectory through 24 months after operation.

Eligibility criteria:
inclusion criteria: * any candidate for weight loss surgery who is at least 18 years old \[at the university of pittsburgh medical center, bariatric surgery is recommended as a treatment for individuals with class iii obesity (bmi \> 40), or class ii obesity (bmi 35- 40) and serious obesity-related health problems\] exclusion criteria: * mental retardation or psychosis * previously diagnosed genetic obesity syndrome * participation in a structured weight management program in the 6 months prior to study enrollment * uncontrolled psychiatric symptomatology sufficiently severe to require immediate treatment * pregnant or lactating in the previous 6 months * taking a medication known to affect body weight such as oral steroids in the previous 6 months * any previous surgery for weight loss * deemed high risk surgical candidate.

Keywords: morbid obesity diet therapy bariatric surgery gastric bypass behavior therapy randomized controlled trial weight loss
genetic variants and phenotypic characteristics of patients with t2dm

Conditions: Type 2 Diabetes Mellitus

Summary: background: genetic risk-markers associated with t2dm are thoroughly studied. so far, only a few genetic variants, also termed single nucleotide polymorphisms (snp's), have been replicated in several studies and each of them gives only limited explanation for the growing incidence of t2dm. the hypothesis of the present study is that determination of combinations of genetic variants by snp-chip technology may improve the prediction of t2dm, complications and efficacy of treatment compared to the methods previously used including genome wide association (gwa) studies. the snp-chip/ dna microarray makes it possible to study several snp's association with t2dm, one by one but also in combination. aims: to study whether specific genetic variants, and combinations of these, 1) are present with higher prevalence in patients with t2dm than in the normal population, 2) are associated with specific diabetes-related complications and 3) the effect of the anti-diabetic treatment. methods: during the next three years 1000 patients with t2dm and 1000 healthy, non-diabetic persons will be included in the study, and examined by blood samples, a questionnaire and clinical evaluation, all in one visit. initially, we will perform dna analyses on blood samples from 372 patients included in another clinical study from our department. description of genetics will be done by a dna-chip with approximately 70 snp's, which have previously been reported to be associated with t2dm. results and conclusions: it is expected that the result of this project can help us predicting t2dm, diabetes-related complications and individualizing treatment to the individual patient with t2dm.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * \> 18 years and

Keywords: type 2 diabetes mellitus genetic variants snp dna microarray
phase 1b study of omega duros® in patients with chronic hepatitis c who relapsed after prior treatment

Conditions: Chronic Hepatitis C

Summary: omega duros® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days. this study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the omega duros® device in combination with ribavirin in subjects with chronic hepatitis c genotype 1.


Eligibility criteria:
inclusion criteria: * chronic hepatitis c with hcv genotype 1 infection * relapse following an end of treatment response after treatment with a pegylated interferon and ribavirin. exclusion criteria: * presence or history of non-hcv chronic liver disease * treatment with any interferon subsequent to the relapse with pegylated interferon-alpha and ribavirin * decompensated liver disease

Keywords: relapse hcv hepatitis c interferon ribavirin
clinical study of venetoclax combined with cacag regimen in the treatment of newly diagnosed acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to evaluate the efficacy and safety of venetoclax combined with cacag regimen in the treatment of newly diagnosed acute myeloid leukemia.

despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor. in order to improve the outcome of patients with de novo aml, participants developed a venetoclax combined with cacag regimen in the treatment of de novo aml. in this study, participants intent to evaluate the efficacy and safety of venetoclax combined with cacag regimen in the treatment of newly diagnosed aml.

Eligibility criteria:
inclusion criteria: * patients who are able to understand and willing to sign the informed consent form (icf). * all patients should aged 14 to75 years,no gender limitation. * patients who are newly diagnosed with aml. * liver function: alt and ast≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal; * renal function: creatinine ≤the upper limit of normal; * patients without any uncontrolled infections , without organ dysfunction or without severe mental illness; * the score of eastern cooperative oncology group (ecog) is 0-3,and the predicted survival ≥ 4 months. * patients without severe allergic constitution. exclusion criteria: * patients with allergy or contraindication to the study drug; * female patients who are pregnant or breast-feeding. * patients with active infection * patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment; * patients with mental illness or other states unable to comply with the protocol; * less than 6 weeks after surgical operation of important organs. * liver function: alt and ast\>2.5 times the upper limit of normal ,bilirubin\>2 times the upper limit of normal;renal function: creatinine \>the upper limit of normal; * the patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)

Keywords: venetoclax cacag aml
ultrasound assessment of residual gastric content in critically ill patients

Conditions: Critically Ill Patients

Summary: this prospective observational study aims to assess whether ultrasound assessment of gastric content may be useful for the monitoring of the gastric residual content in critically ill patients


Eligibility criteria:
inclusion criteria: * critically ill patients under mechanical ventilation and enteral feeding through a gastric tube since \>48 h exclusion criteria: * digestive hemorrhage contra-indication to prokinetic drugs enteral feeding through jejunostomy or gastrostomy pregnancy
comparing super high-flux and high-flux dialyzer performance among hemodialysis patient with sepsis : a randomized control trial

Conditions: The Efficacy and Safety for Super High-flux Dialyzer in Case of Sepsis in ESKD; End Stage Kidney Disease (ESRD); Sepsis

Summary: comparing the efficacy of superhigh-flux dialyzer with high-flux dialyzer in eskd patient who have sepsis to improve mortality and sepsis outcome, an open label randomized control trial.

sepsis in people who have eskd is the risk of developing poor outcome. cytokines play a role in the process of sepsis and cause the worsening clinical outcome despite definitive antibiotic treatment. superhigh-flux dialyzer has a larger molecular weight cut off (mwco) clearance, include cytokine, could contribute to improved sepsis management in individuals with eskd. this study is conducted to prove the efficacy of super high-flux dialyzer comparing with high-flux dialyzer in case of mortality reduction for regular hemodialysis eskd patients. method this study is an open label single center randomized control trial. we randomized eskd patients who have sepsis condition with high interleukin-6 (il-6 \> 50 pg/ml). the participants were allocated to super high-flux dialyzer group and high flux dialyzer group, stratified with diabetes, vascular access, and septic shock. we excluded; patient who needed dialysis with continuous kidney replacement therapy, vulnerable patient, include pregnant woman, patient who closed and patient who expected to pass away within the 24 hours. we aim to enroll total 202 participants; divided equally in each arm. according to our protocol, non reused super high-flux dialyzer and high-flux dialyzer are used in the same assigned patient in first week without crossing over. the standard of care of sepsis and antibiotic are provided in both groups without intervening of researcher and our protocol. the primary endpoint is 28 days of mortality. the secondary outcome include cardiovascular death, rate reduction of il-6 after dialysis, days of hospitalization, ventilator free days and complication of dialysis are also monitored.

Eligibility criteria:
inclusion criteria: * eskd patients who have sepsis condition with high interleukin-6 (il-6 \> 50 pg/ml) exclusion criteria: * patients who needed dialysis with continuous kidney replacement therapy, vulnerable patient, include pregnant woman, patient who expected to pass away within the 24 hours. * patients who have the history of allergic dialyzer reaction to dialyzer which used in this trial.

Keywords: superhighflux hemodialysis end stage kidney disease sepsis
a first-in-human, phase 1 dose-escalation and cohort expansion study to evaluate the safety, tolerability, and pharmacokinetics of bj-005 in patients with advanced solid tumor or lymphoma

Conditions: Advanced Solid Tumor or Lymphoma

Summary: this is a first-in-human, phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of bj-005 in patients with advanced solid tumor or lymphoma. bj-005 is a recombinant bifunctional molecule, composed of a humanized anti-pd-l1 igg1 monoclonal antibody (mab) fused with a portion of the extracellular domain of human tgf-β receptor ii (tgf-βrii).


Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years. 2. willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures. 3. histologically or cytologically confirmed advanced solid tumors or lymphoma 4. measurable or evaluable disease per recist v1.1 5. ecog performance status 0 or 1 6. life expectancy ≥3 months 7. adequate hepatic function 8. calculated creatinine clearance (crcl) \> 50 ml/min (cockroft-gault equation) 9. adequate hematological function 10. prothrombin time, international normalized ratio or activated partial thromboplastin time \< 1.5 × uln 11. recovery, to grade 0-1, from adverse events related to prior anticancer therapy exclusion criteria: 1. prior therapy with anti pd-l1/tgfβrⅱ targeting treatment. 2. symptomatic primary central nervous system (cns) tumor of cns metastases. 3. uncontrolled hypertension. 4. significant thrombotic or hemorrhagic events. 5. prior car-t therapy 6. severe cardiovascular disease. 7. active infection requiring therapy 8. active hiv, hepatitis b or hepatitis c virus 9. active tuberculosis 10. anticancer therapy or radiation therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to study entry 11. pregnant or breast-feeding females 12. active or history of autoimmune disease or inflammatory disorders
preoperative single-dose steroid application for the treatment of nausea and vomiting after thyroid surgery

Conditions: Thyroidectomy; Thyroid Diseases

Summary: the study is to compare the postoperative recovery, as determined by postoperative nausea and vomiting (ponv) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy.


Eligibility criteria:
inclusion criteria: * age \> 18 * planned partial or total thyroidectomy exclusion criteria: * history of adverse effects to dexamethasone or propyleneglycol or di-natrium-edta * patients with chronic pain * necessity for opioids-application in the postoperative course * not possible administration of a cervical block (0.5% bupivacaine at a dose of 20ml) * patients with diabetes mellitus * pregnancy (test in young women) * glaucoma * patients who received antiemetic therapy within 48h before surgery * patients with acute pain requiring painkillers others than paracetamol or more than single dose nsar treatment within 48h before surgery * use of psychotropic drugs * incompliant patients * preoperatively high suspicion of malignancy * re-operations

Keywords: postoperative nausea and vomitus ponv thyroid surgery
physician focused intervention to improve adherence with hiv antiretrovirals

Conditions: HIV Infection; HIV Infections

Summary: we hypothesized that providing physicians treating with hiv disease, at the time of a routine outpatient visit, with a detailed report describing patients' adherence with hiv antiretroviral medications, would improve the quality of the physician-patient interaction, and also patients' subsequent adherence.


Eligibility criteria:
inclusion criteria: * on art * willing to use mems cap * speaks and reads english * detectable viral loads exclusion criteria: * uses a pill box

Keywords: hiv antiretroviral therapy medication adherence treatment experienced
an alternative treatment for cervical intraepithelial neoplasia using the focal loop electrosurgical excision procedure

Conditions: High-grade Cervical Intraepithelial Neoplasia

Summary: this is a pilot study to test the short-term effectiveness of an alternative treatment approach for precancerous cells of the cervix. the study will also explore whether this new treatment is feasible to perform and if it is acceptable to patients.

standard treatment for precancerous cells of the cervix is called electrosurgical excision procedure (leep). standard leep involves treating the entire cervix using fda-approved equipment. focal leep utilizes the same surgery and the same equipment but only treats the visually unhealthy part of the cervix and not the entire cervix. side effects and unusual symptoms will be monitored as well as the patient's thoughts and recommendations of the procedure. the total amount of time of study participation is six months.

Eligibility criteria:
inclusion criteria: * age 21-45 years old * histologically confirmed high-grade cervical intraepithelial neoplasia (cin2, cin3, or cin2/3). a copy of the pathology report is required at the time of enrollment. we will only include patients that had their biopsy performed at the uab colposcopy clinic because those that return for treatment represent a select group that is more reliable for follow-up given the standard no-show rate of 50% at the clinic. * focal lesion visualized in its entirety colposcopically and involving less than or equal to 2 quadrants of the cervix. * satisfactory (adequate) colposcopy. * lives within 100 miles of the university of alabama at birmingham. exclusion criteria: * any suspicion for invasive cancer. * glandular abnormalities on cytology or histology. * cervical lesion incompletely visualized (e.g. extending into the endocervical canal). * endocervical curettage positive for high-grade cervical intraepithelial neoplasia. * unreliable for follow-up (drug use, planning to move out of region, etc.). any patient that lives \>100 miles away will be excluded due to concern for possible loss to follow-up. * immunosuppression (hiv positive, history of transplantation, lupus on immunosuppressive medication, etc.). * pregnancy. * mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

Keywords: cervical neoplasia cervix high-grade dysplasia leep (loop electrosurgical excision procedure) precancerous cells colposcopy
closurefast vs. laser ablation for the treatment of gsv disease: a multicenter, single-blinded, randomized study.

Conditions: Venous Reflux

Summary: the objective of this post-market study is to compare the post-procedure recovery between two types of minimally invasive catheter treatments for venous disease in the great saphenous vein.

comparison of the post-procedure recovery of radiofrequency (rfa) treatment vs. laser treatment.

Eligibility criteria:
inclusion criteria: * all subjects must provide written informed consent. * must be a candidate for either treatment with radiofrequency ablation (rfa) or endovenous laser. exclusion criteria: * subjects who require additional treatments in either leg within 30 days before or after the study procedure. * subjects who are participating in another investigational study.

Keywords: varicose veins, venous reflux, gsv disease
bay1003803 single and multiple dose escalation, safety, tolerability and pharmacokinetics study

Conditions: Psoriasis

Summary: systemic safety following single and multiple dermal administration of bay1003803


Eligibility criteria:
inclusion criteria: * healthy male subject * age: 18 to 64 years (inclusive) at the first screening visit * body mass index (bmi): above or equal 18 and below or equal 30 kg / m² at the first screening visit * non-smoker at least 3 months prior to study start and during the study * healthy skin on which reddening can be easily recognized exclusion criteria: * a history of relevant diseases, especially incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, excretion and effect of the study drugs will not be normal, dermal diseases, diseases which present a risk for subjects to be treated with glucocorticoid receptor agonists (e.g. gastric ulcers, cornea ulcer, colitis ulcerosa, severe infections, glaucoma, diabetes, myocardial infarction, thromboembolic disease, hypertension, thyroid disease, tuberculosis, myasthenia gravis, osteoporosis, psychiatric diseases) * infections and febrile illness within 4 week before the first study drug administration * use of systemic or topical medicines or substances which oppose the study objectives or which might influence them * inoculations with live vaccine within 8 weeks before the first study drug administration * signs of irritation or folliculitis or any other dermatological conditions in the test areas that would interfere with the planned assessments as judged by the investigators * human leukocyte antigen-dr (hla-dr) \< 15000 ab/monocyte

Keywords: phase i healthy volunteers
agnes - aging nephropathy study, a prospective observational cohort of chronic kidney disease in elderly patients

Conditions: Chronic Kidney Diseases; Elderly; Mortality; Renal Replacement Therapy

Summary: with the aging population, a high prevalence of obesity, systemic arterial hypertension and diabetes mellitus, we are facing an increased incidence of elderly patients with chronic kidney disease (ckd) initiating renal replacement therapy. the correct diagnosis of ckd, the prognosis of the elderly patient with ckd, mainly comparing initiated dialysis vs. remaining in conservative treatment, the nutritional prognostic markers (sarcopenia), cardiovascular, mineral and bone metabolism, geriatric syndromes and sleep disorders are still debatable. elderly patients are usually excluded from clinical trials and the scientific evidence is either scarce or based on retrospective data. thus, the present study is a prospective cohort to evaluate the long-term evolution of patients ≥ 70 years with stage 4 or 5 ckd. the main outcomes are mortality and dialysis as a combined event. these endpoints will be correlated with independent parameters: klotho, fgf23, nutrition and sleep quality. confounders variables are cognition, depression, demographic, clinical and laboratory parameters, and daytime somnolence. patients will be followed at the nephrology outpatient clinic of the hospital das clinicas, universidade de sao paulo. the sample size was calculated to be 200 subjects. the summary methodology will include a broad geriatric assessment, cognition test, fragility, charlson comorbidity scores, biochemical measurements of urea, creatinine, alkaline phosphatase, parathyroid hormone, calcium, phosphorus, vitamin d, vitamin b12, folic acid, thyroid hormones, hepatitis virus, serum albumin, albumin/creatinine ratio, protein/creatinine ratio, 24-h urinary protein, epworth sleepiness scale, pittsburgh questionnaire, segmental electric bioimpedance, and nutritional evaluation by 24h dietary interview.

main outcome: combined event mortality-dialysis independent variables: nutrition status, sleep quality, klotho and fgf-23 confounders: clinical and demographic variables, charlson comorbidity index, laboratory parameters, depression, functionality, cognition.

Eligibility criteria:
* clinical diagnosis of chronic kidney disease stage 4 or 5 * minimal age of 70 years * must be able to understand and sign the consent form exclusion criteria: * patients who did not accept and sign the consent form * patients with cancer and life expectance lower than 6 months * moderate to advanced dementia