Kornimate/medical-research-clean huggingface dataset:
comparison of three confirmatory tests in the diagnosis of primary aldosteronism

Conditions: Primary Aldosteronism

Summary: to compare the diagnostic value of three confirmatory tests for primary aldosteronism.

this is a prospective study involving 240 hypertensive patients who underwent primary aldosteronism screening. every patient will undertake four confirmatory tests to compare the diagnostic accuracy of the oral sodium loading test with captopril challenge testing (cct) and seated saline infusion test(ssst)using the fludrocortisone suppression testing (fst) as the reference standard, and to investigate the optimal cutoff of oral sodium loading test

Eligibility criteria:
inclusion criteria: 1. hypertensive patients with arr≥10(pg/ml)(uiu/ml) 2. hypertensive patients with arr\<10(pg/ml)(uiu/ml) but suspicious of pa clinically exclusion criteria: 1. pregnancy or lactation; 2. child-bearing women refuse to take effective contraceptive measures; 3. history of malignant tumor; 4. patients with cardiovascular and cerebrovascular diseases (eg. myocardial infarction, acute heart failure, stroke), in the past 3 months 5. nyha iii (new york heart association)and above 6. hypohepatia 7. chronic kidney disease with an estimated glomerular filtration rate \<30ml/min/1.73 m² 8. severe arrhythmia by ecg or severe heart disease by cardiac ultrasound 9. patients who are unwilling to participate in and complete this study and refuses to sign the informed consent form for this study

Keywords: primary aldosteronism, oral sodium loading test captopril challenge test, saline infusion test
keloid tissue bank

Conditions: Keloid

Summary: much progress in treatment of various tumors has been made in the laboratory and the results have been brought back to the patients, i.e. from bench to bedside. this trial intends to collect samples of keloid tissue from patients and study them in laboratory. such a research may help us with finding better treatments for keloid.

to aims of this trial are: 1. to prospectively collect keloid and normal skin tissue samples from patients with keloid by performing keloid tissue biopsy and biopsy of uninvolved skin. 2. to collect blood and/or saliva for genomics, proteomics, tissue culture, flow cytometery and other keloid investigational studies. 3. to collect any keloid tissue that has been previously removed from the patient (unrelated to enrollment on this study). 4. to prospectively collect keloid tissue from patients who are undergoing a planned surgical removal of their keloids. 5. to evaluate keloid histology, genomics, proteomics, molecular markers, cytokines, growth factors receptors, ligands and signal transduction pathways within keloid tissue in order to find druggable targets. 6. to prospectively follow the patients and correlate patient demographics and natural history of the disease, response to the past and future treatments with the genomic and molecular maker profiles. 7. to culture nucleated blood cells from keloid patients in order to determine the genomics of this disease as well as learning about potential presence of keloid stem cell in peripheral blood. to use flow cytometry as well as other technology to search for circulating keloid stem cells in peripheral blood. 8. to test in vitro: a- the effect of small molecule kinase inhibitors on the activation of wild-type and mutant kinases. b- the effects of various drugs that inhibit ligands, receptors or pathways.

Eligibility criteria:
inclusion criteria: 1. patients must have clinically confirmed diagnosis of keloid 2. signed consent form; parent or a legal guardian should consent for children and those under age of 18. 3. have at least one paraffin block of excess keloid tissue that has been removed in the past; or is planned to be removed in future. 4. able and willing to undergo a keloid biopsy (optional) 5. able and willing to undergo biopsy of their normal appearing skin (optional, minimum age 18). exclusion criteria: 1. individuals who are mentally challenged, who cannot consent to participate in this study. 2. psychological illness that may result in non-compliance with the procedure and the required follow up. 3. known allergy to lidocaine or other local anesthetics.

Keywords: keloid
personal therapy comfort settings pilot clinical study

Conditions: Obstructive Sleep Apnea

Summary: 350 participants will be enrolled in this study. the target population are patients newly diagnosed with osa and starting cpap treatment. user accessible customizable comfort settings (response setting, expiratory pressure relief (epr) on/off and epr level, and ramp) will be set to either default (control group), or personalized for that participant (active treatment group). usage will be recorded for the first 1 month of cpap treatment, to determine if customizing comfort settings can improve cpap compliance


Eligibility criteria:
inclusion criteria: * patients willing to give written informed consent * patients who can read and comprehend english * patients who are ≥ 18 years of age * patients newly diagnosed with osa and indicated for cpap therapy. exclusion criteria: * patients who have previously used pap therapy * patients who require a bilevel device * patients who are or may be pregnant \* patients who are unable to attend follow up appointments * patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: copd, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury * patients believed to be unsuitable for inclusion by the researcher

Keywords: continuous positive airway pressure
dietary protein and insulin sensitivity study

Conditions: Insulin Resistance; Type 2 Diabetes; Metabolic Syndrome; Cardiovascular Disease; Dyslipidemia

Summary: the overall objective of the dietary protein and insulin sensitivity study is to test the hypothesis that increased protein in a diet with reduced carbohydrate (35% energy) can ameliorate insulin resistance in the absence of weight loss, and that this effect is independent of saturated fat content. moreover, we will test whether such diets result in beneficial changes in total ldl cholesterol, small, dense ldl, and hdl cholesterol that are also independent of saturated fat intake.

insulin resistance is a major metabolic disturbance associated with excess adiposity that contributes to atherogenic dyslipidemia and predisposes to both cardiovascular disease and type 2 diabetes mellitus. the effects on insulin resistance of changes in dietary macronutrient composition in the absence of weight loss are poorly understood. to better understand these effects, we will study men and women with insulin resistance after 4 weeks on a basal diet (15% protein, 55% carbohydrate, 30% fat) and 4 weeks after random assignment to the basal diet or one of 4 diets with 35% carbohydrate and either 20% or 30% protein, and either 7% or 15% saturated fat. at the end of each dietary period (4 weeks and 8 weeks), we will draw a blood sample for detailed metabolic measurements and measure insulin sensitivity by the frequently sampled intravenous glucose tolerance test (fsigt) method. in addition to insulin resistance, we will assess the effect of dietary composition on parameters of atherogenic dyslipidemia.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥ 27 and ≤ 40 kg/m2 * homa-ir ≥ 2.5 * non-smoking * total cholesterol and ldl cholesterol \<95th percentile for sex and age * fasting triglycerides \< 500mg/dl * fasting blood sugar \< 126 * urinary microalbumin \< 30 mg/l * normal thyroid stimulating hormone levels * hematocrit ≥ 36% * blood pressure \< 150/90 * at least 3 months of a weight-stable state (± 5 lbs) prior to the study. during the study, subjects will be required to maintain their body weight within ± 3% (up to a maximum change of 5 lbs) of their initial weight over the course of any consecutive two weeks after the second week of baseline diet or during the last week of each diet phase exclusion criteria: * history of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, hiv, or cancer (other than skin cancer) in the last 5 years * use of drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent, warfarin * use of alcohol or dietary supplements during the study * pregnancy

Keywords: diet protein glucose insulin cholesterol triglycerides ldl subclasses
mirna223 and hmgb1 as apredictos for drug resistant epilepsy

Conditions: Drug Resistant Epilepsy

Summary: evaluation of the role of estimation of serum level of mirnas223 and hmgb1in detection of patient with drug resistant epilepsy. early detection of the prognosis might help in guiding patients for proper management and treatment strategy. this may open the door for new drug trials.

epilepsy is the most prevalent neurological disorders (1). drug-resistant epilepsy (dre) represent approximately 30% of epilepsy..dre is defined as failure to achieve sustained seizure freedom after adequate and well tolerated trials of two antiseizure medications( asms).the identification of circulating biomarkers for dre could give an early idea about the prognosis and improve the choice of correct treatment. mirnas are small noncoding rnas that span between 19 and 24 nucleotide bases((2).they gain biological activity through base pairing in the 30-untranslated regions of target messenger rna (mrna) , thereby guiding a protein complex termed the rna-induced silencing complex (risc) that bind to the mrna sequence and results in either the inhibition of translational processes or the degradation of the mrna (3). dysregulated mirna expression has been associated with inflammatory pathways, cell death, neuronal excitability, and synaptic reorganization, which underlie epileptogenesis (4). high- mobility group box 1(hmgb1) is a chromatin component that is physiologically attached to nuclei. however, following cns insult, it can promptly be migrated towards cytoplasm and is discharged extracellularly. hmgb1mediates sterile neuro-inflammation evoked by epileptogenic injury and recurrent seizures(5) .hmgb1 increases in neurons, glia, and endothelial cells of the blood brain barrier (bbb) in dre. the hmgb1 contributes to the overexpression of p-glycoprotein, a bbb protein, which is induced in dre foci and extrudes various asms from the brain(6) .

Eligibility criteria:
inclusion criteria: * patients diagnosed as drug resistant epilepsy . * control group: patients diagnosed as medically controlled epilepsy exclusion criteria: * symptomatic epilepsy (vascular, tumor, post encephalitic, syndromic and febrile seizures). * alzheimers disease * parkinsons disease * amyotrophic lateral sclerosis * major depression disorder * non neurological criteria: tumors and cardiovascular
study of epratuzumab in systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: epratuzumab is an investigational antibody designed to help treat sle. the purpose is to evaluate safety and long term efficacy in concert with standard sle treatments


Eligibility criteria:
inclusion criteria: * must have completed sl0003 alleviate a through 48 weeks exclusion criteria: * development of toxicity to epratuzumab * significant protocol deviations from sl0003 study.

Keywords: lupus, antibody, b-cell immunotherapy
evaluating cvd medication adherence program in low ses

Conditions: Cardiovascular Disease; Hypertension; Diabetes

Summary: the investigators propose to evaluate the implementation of an efficacious medication adherence program in a group at high risk for cvd. the program involves patients receiving/responding to e-reminders to take cvd medications via patient-selected technology \[mobile/web-based applications, short message service (sms; text messaging), interactive voice response (ivr), or e-mail\] supported by a tailored, monthly, self-management program administered by either research staff or a case manager staff member from the duke outpatient clinic via the telephone. this is a hybrid type ii implementation science study.

the investigators propose to evaluate the implementation of a medication adherence program among patients who attend duke outpatient clinic (doc). it is anticipated that, among the providers' patient panels, at least 100 and up to 300 with cvd risk and poor cvd medication adherence (\<0.08 medication possession ratio) will consent to the program. using procedures from the investigators previous studies, the investigators will identify potential patients from the ehr, and will identify a pool of potential patients using electronic health records, with the goal of administering the program to at least 100 patients. patients will be mailed letters, signed by their own provider or medical director of doc, requesting their participation in the programs. the ra will contact patients via telephone to explain the study, screen for eligibility, and determine what mode of administration individuals prefer to receive the program (sms, ivr, or email). the primary outcome will be that the effectiveness/impact of the proposed adherence program will be a 10% improvement in mpr and cvd outcomes (anticipate reducing sbp by 5 mmhg, hgb a1c by 0.5%, ldl-c by 20 mg/dl).

Eligibility criteria:
inclusion criteria: 1. medicaid recipient (preferred); however the investigators will include those patients with other types of insurance or those who are uninsured 2. enrolled in duke outpatient clinic for at least one year 3. outpatient diagnostic code for hypertension and/or hypercholesterolemia and/or diabetes 4. poorly controlled bp levels (\>140/90) and/or ldl-c (\>130mg/dl) and/or hba1c of \>8 within last 6 months exclusion criteria: 1. no access to cell phone 2. not proficient in english 3. nursing home/long-term care facility resident or receiving home health care 4. impaired hearing/ speech/ vision 5. participating in another trial (pharmaceutical or behavioral) 6. planning to leave the area in the next 12 months 7. pregnancy (or planning) 8. diagnosis of life-threatening disease with death probable within 1 year 9. active diagnosis of psychosis or dementia (has been hospitalized in the last 30 days) 10. diagnosis of esrd
immune profiles and circulating tumor cell status following prostate cryotherapy

Conditions: Prostate Cancer; Immune Profile; Circulating Cancer Cells; Clinical Corelation

Summary: the change of immune profiles and existence of circulating tumor cells following prostate cryotherapy may be correlated with the clinical outcome.


Eligibility criteria:
inclusion criteria: * age\>20 years * histopathology-proven prostate adenocarcinoma * non-metastatic localized disease * subjects have chosen their curative, definitive treatments for prostate cancer prior to enrolling for the study * subjects are willing to sign the informed consent and agree to comply with the study procedures exclusion criteria: * chronic use (\> 2 weeks) of \> 10 mg/day of prednisone or prednisolone within 2 months of the screening (topical or inhalational corticosteroids are permitted) * concurrent use of immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry * other conditions the investigators think may affect subjects' compliance
proof of concept human study: dietary intervention to modify intestinal inflammation in ibd

Conditions: Reduction of Intestinal Inflammatory Activity

Summary: the objective of this clinical study is to demonstrate efficacy and feasibility of a long-term dietary intervention to modify intestinal inflammation in high-risk patient cohorts. to this end a 78 weeks wheat protein-free diet will be administered in patients with inflammatory bowel disease (ibd) with and without associated primary sclerosing cholangitis (psc-ibd).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of uc, cd or psc-ibd * willingness, to follow a gluten-free diet for 78 weeks * stable therapeutic treatment for more 8 weeks * for cd: harvey bradshaw index (hbi) of more 5 points, corresponding to a minimum of mild intestinal inflammation in cd * for uc: mayo score of more 2 points, corresponding to a minimum of mild intestinal inflammation in uc * patient signed informed consent exclusion criteria: * antibiotics during last 4 weeks * intake of probiotics * gluten-free diet is already practiced * concomitant diagnosis of celiac disease * positive serology for transglutaminase iga / igg antibody or deamidated gliadin iga / igg * breast feeding * pregnancy

Keywords: ibd psc
a virtual cardiometabolic health program for african immigrants: the afro-dpp program

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 2; PreDiabetes; Hypertension; High Blood Pressure; High Blood Sugar; Obesity; Overweight; Overweight and Obesity; Overweight or Obesity

Summary: a pilot study titled "a virtual cardiometabolic health program for african immigrants (the afro-dpp program) will be conducted to address the cardiometabolic of community-dwelling african immigrants who have multiple cardiometabolic risk factors including hypertension, type 2 diabetes, high cholesterol, and overweight/obesity. the proposed study will recruit a total of 60 participants and will use a non-equivalent control group design to test the effectiveness of the intervention at two african churches in the baltimore, washington, d.c. area. the two churches will be randomly assigned to the intervention or delayed intervention group. at the end of a 6-month follow-up period, the control church will receive the intervention (delayed control group). all participants will receive a bluetooth-enabled digital scale (omron model: bcm-500) that measures body composition including body weight, body fat percentage, visceral fat, skeletal muscle percentage, resting metabolism and body mass index. a bluetooth-enabled blood pressure monitor (omron model: bp7250) will also be distributed to all participants. all participants will download the omron connect app which will allow the participants to sync participants' blood pressure readings and body composition readings into the app. the research team will access these readings to monitor study outcomes and participants progress during the follow-up period.


Eligibility criteria:
inclusion criteria: * african immigrants who are aged 25-75 years * participants who report being uninsured or have no access to a healthcare provider * have at least two of the following chronic conditions: * body-mass index ≥ 25 kg/m2 * self-reported fasting plasma glucose of 95 to 125 mg/d or hba1c of 5.7-6.5% in the past 6 months * systolic blood pressure ≥140 mmhg or diastolic blood pressure ≥ 90 mmhg exclusion criteria: * participants who cannot communicate in english * participants who have cognitive challenges that would restrict them from participation * participants who have any serious illness that would interfere with participation * participants who are not members of the churches that are involved in this study

Keywords: african immigrant prediabetes national diabetes prevention program
the effects of stress reduction on surgical wound healing

Conditions: Wound Healing; Stress; Surgery

Summary: the purpose of this study is to investigate whether a stress reduction intervention prior to surgery can improve wound healing and recovery.the investigators hypothesise that patients who receive a psychological stress reduction intervention prior to surgery will report lower stress and higher perceived control, have lower stress hormones, better wound healing and better self-reported recovery than patients who receive standard care alone.

in previous prospective research, psychological stress has been shown to slow the healing of small superficial wounds and impair surgical healing. we will investigate whether a psychological intervention to reduce stress can improve surgical healing. ninety patients undergoing elective laparoscopic cholecystectomy will be randomised to receive either standard care or a brief pre-surgical psychological intervention plus standard care. patients will complete a pre-surgical questionnaire to assess stress, anxiety, depression, illness perceptions and current health, at least 3 days prior to surgery. then the intervention will be delivered. a second questionnaire on the morning of surgery will reassess stress, anxiety and illness perceptions to see whether the intervention has reduced stress and increased control perceptions. plasma catecholamines and salivary cortisol will be tested to assess the effectiveness of the intervention in reducing stress-related hormones and to investigate their role in wound healing. during surgery 2 small expanded polytetrafluroethylene tubes will be inserted in the wound, which will be removed after 7 days. wound healing will be assessed by hydroxyproline and total protein deposition in the tubes, as well as by the presence of wound infection. patients' post-surgical recovery, including pain and fatigue, will also be assessed. if this brief psychological intervention can improve wound healing and aid recovery, it would provide a simple strategy to improve outcomes in surgery.

Eligibility criteria:
inclusion criteria: * planned elective laparoscopic cholecystectomy at manukau surgical centre * able to understand english

Keywords: psychology laparoscopy cholecystectomy psychoneuroimmunology wound healing preparation for surgery stress reduction stress relaxation
radiation therapy plus topotecan in treating patients with non-small cell lung cancer

Conditions: Lung Cancer

Summary: phase i trial to study the effectiveness of radiation therapy plus topotecan in treating patients who have non-small cell lung cancer. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining chemotherapy and radiation therapy may kill more tumor cells.

objectives: i. determine the maximum tolerated dose of topotecan and chest irradiation in patients with non-small cell lung cancer. ii. determine the qualitative and quantitative toxic effects of this regimen in these patients. iii. determine the degree of antitumor activity of this regimen in these patients. outline: this is a dose escalation study of topotecan and thoracic radiotherapy. beginning on day 1, patients receive topotecan iv continuously for 3-6 weeks and thoracic radiotherapy 5 days a week for 2, 3, or 6 weeks. cohorts of 4-6 patients receive escalating doses of topotecan and thoracic radiotherapy until the maximum tolerated dose (mtd) of each therapy is determined. the mtd is defined as the dose preceding that at which 2 of 4 or 6 patients experience dose-limiting toxicity. six additional patients are treated at the mtd. patients who fail to achieve complete remission (cr) and continue to have measurable disease at 4-6 weeks after completion of radiotherapy receive topotecan iv continuously on days 1-21 at 1 dose level preceding the mtd as determined by the ongoing protocol nyu-9123. treatment continues every 4 weeks in the absence of unacceptable toxicity.

Eligibility criteria:
disease characteristics: * histologically proven non-small cell lung cancer * eligible for chest irradiation with 3,000 to 6,000 cgy (based upon standard radiotherapy indications) * measurable or evaluable disease * measurable disease defined as bidimensionally measurable lesion on physical exam or radiograph (ct or mri acceptable) patient characteristics: * age: 18 and over * performance status: 0-2 * life expectancy: at least 12 weeks * wbc at least 4,000/mm3 * platelet count at least 100,000/mm3 * bilirubin no greater than 1.5 mg/dl * ast less than 3 times normal * alkaline phosphatase less than 3 times normal * creatinine no greater than 1.5 mg/dl * not pregnant or nursing prior concurrent therapy: * no more than 1 prior chemotherapy regimen allowed * at least 4 weeks since prior chemotherapy and recovered * no prior radiotherapy * recovered from toxic effects of any prior therapy

Keywords: recurrent non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer