Kornimate/medical-research-clean huggingface dataset:
different effects of delayed clamping on neonatal bilirubin levels between pregnant women with intrahepatic cholestasis of pregnancy and normal pregnant women

Conditions: Intrahepatic Cholestasis of Pregnancy

Summary: objective:the aim of this study was to investigate the relationship between delayed cord clamping and neonatal bilirubin levels in pregnant women with intrahepatic cholestasis of pregnancy. method:this observational prospective cohort study included a total of 200 pregnant women at 37-40 gestational weeks. among them, 100 pregnant women with intrahepatic cholestasis of pregnancy were divided into 50 cases of immediate cord clamping group （icc in pregnant women with icp）and 50 cases of delayed cord clamping group（dcc in pregnant women with icp）, and 100 normal pregnant women were also divided into 50 cases of immediate cord clamping group （icc in normal pregnant women）and 50 cases of delayed cord clamping group（dcc in normal pregnant women）. the bilirubin levels of neonates in each group were compared.


Eligibility criteria:
inclusion criteria: 1. the pregnant woman is born at a gestational age of 37-40 weeks; 2. the pregnant woman has a single child; 3. regular obstetric examination durinv pregnancy with complete obstetric examination data was diagnosed as intrahepatic cholestasis of pregnancy(icp). exclusion criteria: 1. pregnancy complicated with medical and surgical diseases, such as thyroiddysfunction and chronic hypertension; 2. insufficiency of vital organ function or complicated tumor; 3. pregnant women with other pregnancy complications besides icp, such as preeclampsia, etc.

Keywords: intrahepatic cholestasis during pregnancy neonatal bilirubin bilirubin icp neonatal jaundice
a study of retatrutide (ly3437943) on renal function in participants with overweight or obesity and chronic kidney disease with or without type 2 diabetes

Conditions: Overweight or Obesity; CKD; Type 2 Diabetes

Summary: the main purpose of this study is to investigate the effect of retatrutide on renal function in participants with overweight or obesity and chronic kidney disease (ckd), with or without type 2 diabetes (t2d). the study will last around 31 weeks.


Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) ≥27 kilogram/square meter (kg/m²) * have either * no t2d with an hba1c \< 6.5% or * have t2d with an hba1c ≤ 9.5% and treated with diet and exercise only or with stable doses of up to 3 oral antihyperglycemic medications, with or without basal insulin for at least 90 days before screening. * have been diagnosed with chronic kidney disease (ckd). exclusion criteria: * have a self-reported change in body weight \>5 kilogram (kg) (11 pounds) within 90 days before screening. * have used in 90 days before the screening any of the following antihyperglycemic class: dipeptidyl peptidase iv (dpp4) inhibitors, amylin analogs, glucagon-like peptide-ra (glp-ra), gastric inhibitory polypeptide (gip)/gip-1 ra, and short acting or rapid acting insulins or u500 insulin * have a prior or planned surgical treatment for obesity * have type 1 diabetes (t1d) * have acute or chronic hepatitis * have a history of malignant disease within 5 years before screening.
safety and efficacy of ketogenic diet for promoting weight loss in obese individuals with compensated nash cirrhosis

Conditions: NASH - Nonalcoholic Steatohepatitis; Cirrhosis, Liver

Summary: this is an open-label, randomized study comparing a monitored ketogenic diet intervention using standard ketogenic diet (skd) and standard of care (soc) dietary recommendations for 16 weeks. subjects enrolled in the standard of care group will receive a voucher to weight watchers after study completion.

the primary aim is to assess the safety of ketogenic diet as compared to standard of care approach for weight loss in patients with compensated cirrhosis due to nash. the safety endpoints captured in the study include liver decompensation events, measured through several questionnaires, fasting blood glucose, serum creatinine, fasting lipid profile and other adverse events. the tolerability of the ketogenic diet will be assessed by study compliance and by administering a questionnaire. secondary aims include weight loss, changes in body composition via serial use of bioelectrical impedance via an inbody machine, changes in liver fat and liver stiffness using mri and proton density fat fraction (mri-pdff), liver biochemistries, changes in child-turcotte-pugh and meld scores measured via labs and changes in liver steatosis and stiffness via serial measures of vcte by fibroscan®.

Eligibility criteria:
inclusion criteria: 1. nash cirrhosis (criteria in appendix 1) with obesity (bmi \>30 kg/m2). 2. age 18 and greater exclusion criteria: 1. actively participation in investigational drug treatment for non-alcoholic fatty liver disease 2. currently taking medications for weight loss or have joined a supervised weight loss program prior to enrollment 3. have hepatocellular carcinoma and are undergoing therapy 4. women who become pregnant or plan to become pregnant prior to the study date; female subjects who become pregnant during the study will be withdrawn from the study 5. pacemaker or implantable cardioverter devices 6. history of hepatic surgery 7. current significant alcohol consumption, defined as more than 20 grams per day in females or 30 grams per day in males 8. presence of ascites or hepatic encephalopathy 9. symptomatic gastroparesis 10. uncontrolled diabetes, as defined by a hgba1c \>11% 11. uncontrolled congestive heart failure 12. active infections 13. child turcotte pugh score \> 6 14. meld score \>12 15. unwilling to undergo an mri or have contraindications to an mri
cognitive training for post traumatic stress disorder: effects on cognitive, emotional, and brain function

Conditions: Posttraumatic Stress Disorders

Summary: the purpose of this pilot study is to determine the effects of computer-based training in executive functioning compared to word games on cognitive and emotional aspects of combat-related ptsd.

many posttraumatic stress disorder (ptsd) patients either choose not to complete or do not achieve optimal response to current first-line behavioral and pharmacologic treatments. neurocognitive research points to the potential of novel treatments targeting dorsal prefrontal function and inhibition, attention, and working memory processes. this study investigates effects of computer-based training in executive functions compared to word games on cognitive and emotional aspects of combat-related ptsd. paper-and-pencil questionnaires, interviews, computer-administered testing, and magnetic resonance imaging will be complete before and after the intervention. results from this pilot study will provide information concerning feasibility and treatment potential of cognitive training for ptsd.

Eligibility criteria:
inclusion criteria: * combat veterans who served in operation iraqi freedom, operation enduring freedom, or operation new dawn exclusion criteria: * enrolled in other active treatment protocols * current substance abuse or dependence * current suicidal ideation * diagnosis of a neurological disorder * history of moderate to severe traumatic brain injury

Keywords: veterans neuropsychology neuroimaging attention working memory inhibition magnetic resonance imaging, functional trauma stress anxiety emotion prefrontal cortex
structured treatment interruption for hiv patients with virologic failure

Conditions: HIV

Summary: the purpose of this study is to assess the virologic impact of switching treatment-experienced hiv-infected patients with virologic failure to a salvage regimen with or without a 12 week sti prior to the switch. hypothesis: a sti prior to starting a salvage regimen will result in an improved virologic response.

to prospectively determine the virologic impact of switching treatment-experienced hiv-infected patients with virologic failure to a salvage regimen with or without a 12 week sti prior to the switch. hypothesis: by withdrawing arv drug pressure, resistant hiv virus will revert to wild-type. in treatment-experienced hiv patients who experience virologic failure, a sti prior to starting a salvage regimen will result in an improved virologic response and more prolonged vral suppression compared to immediate switching to a new regime. interventions: immediate switch to salvage therapy: patients randomized to the control arm will be switched immediately to a salvage regimen using the information from the treatment history and genotype results. structured treatment interruption: patients randomized to the sti arm will have their present regimen stopped for 12 weeks and will have a genotype repeated in the 12th week. a salvage regimen will be started at week 12 using the information from the treatment history and baseline genotype results.

Eligibility criteria:
inclusion criteria: * age \> 18 years. * on therapy with a triple arv that includes a protease inhibitor and/or non-nucleoside reverse transcriptase inhibitor for the past 3 months with no changes in any agent of the combination in the past 14 days. * virologic failure while on the combination as defined by a plasma hiv rna \> 1000 copies/ml measured on 2 occasions at least 4 weeks apart. * hiv rna \<500,000 copies/ml. * cd4 cell count must be \> 50/mm3 * patients must not have a present history of opportunistic infections or acute illness requiring treatment within the preceding 30 days. * the patient has at least two new arv available based on history, and at least two of these new agents will be included in the new salvage regimen. exclusion criteria: * active substance abuse which would interfere with the patient's ability to participate in this trial, or declared non-compliance. * pregnancy or breast feeding. * patients with any of the following abnormal laboratory test results at screening:· hemoglobin\ 5x upper limit of normal (uln)· creatinine \> 250 umol/l * end stage organ disease * patient with malignancy receiving systemic chemotherapy * patient has need for immune modulators (interleukin, interferon, gmcsf etc) or prednisone. this excludes a short course of inhaled or oral steroids for asthma exacerbation)

Keywords: hiv salvage regimen virologic failure treatment interruption arv experienced
dna array analysis of patients with cervical cancer

Conditions: Cervical Cancer

Summary: the goal of this clinical research study is to find out if the expression of certain genes is linked with the response of cervical cancer to radiation. researchers will study a large number of genes located in tumor material to learn this information.

patients in this study are already scheduled to begin radiation therapy. researchers will get tumor cells by taking two biopsies of the cervix. the first biopsy of the cervical tumor will be done before any treatment is given. the second biopsy will be performed about 48 hours after the radiation treatment has begun. they will then study the cells in the lab with a new technique for studying gene expression called dna array, as well as human papillomavirus (hpv) analysis, quantification of apoptosis levels, hematoxylin and eosin staining, and storage of tissue for future research. the patterns of gene expression in the biopsies will be compared with the success of radiation treatments. some of the material will also be stored and used in the future for other research projects. this is an investigational study. a total of 18 patients will take part in this study. all will be enrolled at utmdacc.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed cervical cancer: clinical stage ib -iiib 2. invasive pure squamous cell carcinoma 3. planned treatment with concurrent cisplatinum/5-fluorouracil chemotherapy and pelvic radiation exclusion criteria: 1. previous cervical cancer treatment including but not limited to transvaginal cone irradiation

Keywords: cervical cancer dna array analysis gene expression dna
assessment of vitamin d supplementation and immune function

Conditions: Vitamin D Deficiency

Summary: hypothesis: volunteers with vitamin d insufficiency (serum 25(oh)d 25-50 nmol/l) given intermediate or high dose vitamin d supplements (2,000 or 5,000 iu per day) will have increased production of anti-bacterial peptides and interleukin-1, decreased production of other pro-inflammatory cytokines, increased production of regulatory cytokines and an enhanced t- and b-cell response to a tetanus vaccine compared to vitamin d insufficient subjects given low dose vitamin d supplements (400 iu per day).

specific aim 1: determine if high dose vitamin d supplements decrease the production of proinflammatory and increase the production of regulatory cytokines and chemokines by innate immune cells stimulated ex vivo. specific aim 2: determine if high dose vitamin d supplements decrease serum markers of inflammation and increase serum and cellular levels of defensive molecules (e.g., cathelicidin). specific aim 3: determine if high dose vitamin d supplements decrease blood levels of proinflammatory t-helper type 1 (th1) and th17 cells and increase levels of anti-inflammatory t-regulatory (treg) and th2 cells. specific aim 4: determine if high dose vitamin d supplements increase antigen specific t cell and b cell responses after tetanus vaccination.

Eligibility criteria:
inclusion criteria: * age 20-49 (men) and 20-45 (women) * bmi 18.5-30 * serum 25oh vitamin d 25-50 nmol/l exclusion criteria: * pregnant or nursing women * daily smoker * anemia (hgb\<12 mg/dl for women and \<13 mg/dl for men) determined at initial visit * any report or diagnosis of disease or chronic condition that may affect vitamin d absorption such as cystic fibrosis, celiac disease, surgical removal of part of the stomach or intestines, and some forms of liver disease * diagnosis of hyper parathyroidism and chronic granulomatous disease, which increases risk of hypercalcemia. * planned to travel to a location at which either altitude or latitude would result in significant vitamin d synthesis during the study period. * not previously vaccinated with tt, or vaccinated within five years * use of steroids or antibiotics within the past 4 weeks * current use of nutritional supplements that may alter immune function such as omega 3 fatty acid supplements * current use of anti-inflammatory or anti-convulsion medications * self reported history of significant adverse response to previous vaccinations

Keywords: vitamin d immune function
snare-assisted poem for treatment of esophageal achalasia

Conditions: Esophageal Achalasia

Summary: poem is a new intervention for the treatment of achalasia and has been reported to relieve the dysphagia symptom effectively. although the cost of poem method is less than the method of laparoscopic heller myotomy and fundoplication, it is still of an economic burden for the patients with achalasia. in this trial, investigators plan to use snare to assist poem procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared with other knifes-assisted procedure.


Eligibility criteria:
inclusion criteria: * age between 18-70 years * diagnosed as achalasia base on high resolution manometry, barium esophagram and upper endoscopy * signed written informed consent exclusion criteria: * asa class \> ⅲ * previous endoscopic or surgical treatment for achalasia * esophageal malignancy * pregnant

Keywords: peroral endoscopic myotomy snare endoscopic knife esophageal achalasia
a phase ii study for nab-paclitaxel plus cisplatin vs gemcitabine plus cispatin as first line chemotherapy in advanced biliary tract cancer

Conditions: Biliary Tract Cancer

Summary: it is a trial to compare the efficacy and safety of nab-paclitaxel plus cisplatin vs gemcitabine plus cispatin as first line chemotherapy in advanced biliary tract cancer.


Eligibility criteria:
inclusion criteria: 1. aged 18 to 70 years; 2. diagnosis of unresectable or recurrent or metastatic biliary tract cancer (ampulla of vater, gallbladder, intra or extra-hepatic biliary ducts); 3. adequate bone marrow, liver and kidney function: absdute neutrophil count (anc) ≥ 1.5 x 10\^9/l, platelet count (plt) ≥75 x 10\^9/l, hemoglobin (hb) ≥ 75 g/l, white blood cell(wbc) ≥ 3.0 x 10\^9/l, no bleeding symptoms or bleeding tendency; total bilirubin (tbil) ≤ 3 x upper limit of normal range (uln), alanine glutamate transaminase (alt) and glutamate transaminase (ast) ≤ 5 x upper limit of normal range (uln); creatinine(cr) ≤ 1.5 x upper limit of normal range(uln) or creatinine clearance rate（ccr）≥ 45ml/min; 4. at least one measurable lesion; 5. karnofsky performance status(kps) ≥ 70; 6. estimated life expectancy of at least 3 months; 7. resolution of all acute clinical toxic effects of any prior treatment to grade ≤ 1, with the exception of alopecia; 8. be able to understand and willingness to sign irb-approved informed consent; (if the patient cannot sign the informed consent due to consciousness disorder, upper limbs paralysis or inability to write, the legal representative shall sign the informed consent on behalf of the patient). exclusion criteria: 1. ongoing uncontrolled infections, or have received systemic antibiotic therapy within 72 hours prior to registration; 2. myeloproliferative disorder or any other hematopoietic function disorder; 3. have an untreated second malignancy or brain metastasis; 4. allergic to the chemotherapy drugs of this protocol; 5. unable to cooperate due to neurologic diseases or psychiatric illness; 6. pregnant or lactating female patients; women of child-bearing age who refuse to accept contraceptive measures; 7. have other significant medical illness, for example,active tuberculosis, active pneumonia, uncorrected electrolyte disturbance, uncontrolled tumor associated pain, uncontrolled hydrothorax or seroperitoneum and so on; 8. patients need to receive other antitumor therapy at the same time; 9. have received any other experimental treatment or participated in another interventional clinical trial within 30 days prior to registration; 10. any other situation that the researcher considered patients are unsuitable for the trial.

Keywords: nab-paclitaxel + cisplatin
autologous bone marrow derived stem cells for acute myocardial infarction

Conditions: Myocardial Infarction

Summary: one of the important reasons for human dying is ischemic heart disease (ihd). the most reason is coronary artery disease. beside morbidity, ihd induce myocardial infarction and necrosis which due to congestive heart failure. one therapeutic method is cellular cardiomyoplasty, which is to produce and substitute the cardiac cells with stem cell transplantation. cell therapy is a potential therapeutic method to prevent ventricular remodeling after acute myocardial infarction. human and animal studies have shown that stem cell trans plantation to myocardial infarcted zone can improve heart contractile function. the aim of this study is to comparison the effects of bm-derived ac133 and mnc implantation in patients with myocardial infarction.


Eligibility criteria:
inclusion criteria: * cabg candidate * at least 4 akinetic segments * first anterior heart attack within in 10 days to 3 month. * st elevation mi defined by: post acute mi lvef less than 45% as assessed by echocardiography. * the target lesion had to be located in the left anterior descending (lad) section. exclusion criteria: * history of prior anterior myocardial infarction: * history of prior cabg * poor echocardiography window. * active infection or history of recurrent infection or positive test for syphilis (rpr), hepatitis b and c (hbsag/ anti hbc anti - hcv) hiv and htlv-l * documental terminal illness or malignancy. * previous bone marrow transplant * autoimmune disease (e. g lupus, multiple sclerosis) * any contraindication for bone - marrow aspiration. * positive pregnancy test (in women with child bearing potential)

Keywords: myocardial infarction bone marrow stem cells ac133
growth hormone study in adults with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: the overall objective of this study is to measure the effect of growth hormone (gh) treatment on physical and psychosocial health in adults with prader-willi syndrome. adults with pws who have not been treated with gh during the past three years and who will start with gh treatment as part of regular patient care will be asked for informed consent to participate in this open-label prospective cohort study. we hypothesize that growth hormone treatment will improve the physical and psychosocial health.

objectives: to measure the effect of ght on physical and psychosocial health in adults with pws. the primary endpoint is change in lean body mass (lbm (kg)) as assessed by dual energy x-ray absorptiometry (dexa) scan. secondary endpoints are total fat mass, bone density, physical health and psychosocial health. also the occurrence of side-effects will be assessed. only data that are collected as part of regular patient care will be used. study design: open-label prospective cohort study. study population: adults with pws who have not been treated with gh during the past three years and who will start with ght as part of regular patient care.

Eligibility criteria:
inclusion criteria: * the patient is diagnosed with prader-willi syndrome (genetically confirmed) exclusion criteria: * non cooperative behaviour * pregnancy * known malignancies * poorly controlled diabetes (hba1c \> 64 mmol/mol (8%)) * untreated obstructive sleep apnea (apnea-hypopnea index \> 5) * body mass index above 40 kg/m2 * upper-airway obstruction of any cause

Keywords: prader-willi syndrome growth hormone body composition cardiovascular disease
post-marketing surveillance of donepezil hydrochloride investigation of the safety and effectiveness of combination therapy of donepezil hydrochloride and memantine hydrochloride in patients with alzheimer's disease

Conditions: Alzheimer's Desease

Summary: to investigate the safety and effectiveness about administration of both donepezil hydrochloride and menatine hydrochloride in patients with alzheimer's disease in clinical practice.


Eligibility criteria:
inclusion criteria: patients diagnosed with alzheimer's disease who are to be administered both donepezil hydrochloride and memantine hydrochloride in clinical practice. exclusion criteria: patients with a history of hypersensitivity to any ingredients of aricept or piperidine derivatives.

Keywords: alzheimer's disease donepezil hydrochloride