Kornimate/medical-research-clean huggingface dataset:
studying dna and outcome in patients with advanced colorectal cancer treated with fluorouracil and oxaliplatin with or without bevacizumab on clinial trial e-3200

Conditions: Colorectal Cancer

Summary: rationale: studying samples of blood, urine, and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients respond to treatment. purpose: this laboratory study is analyzing the dna in tissue samples from patients with advanced colorectal cancer treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial e-3200.

objectives: * determine the cpg island methylation pathway markers that are adverse for survival after treatment with fluorouracil in patients with advanced colorectal adenocarcinoma treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial e-3200. * compare the methylation results to clinicopathologic and molecular findings and survival. outline: this is a multicenter study. tissue, blood, and urine samples and genomic dna samples from tumor tissue blocks are examined by pyrosequencing assay for methylation. genes examined include mint1, mint31, p14, and p16. microsatellite instability and loss of heterozygosity (loh) on chromosome 18 (18q loh) are also assessed. microsatellites examined include bat loci, tgfβrii, d2s123, d55346, and d17s250. projected accrual: a total of 350 specimens will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of adenocarcinoma of the colon or rectum * advanced disease * enrolled on clinical trial e-3200 and received fluorouracil and oxaliplatin * tumor tissue blocks available * routine pathology specimens (i.e., blood, urine) available patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: recurrent colon cancer recurrent rectal cancer stage iii colon cancer stage iii rectal cancer stage iv colon cancer stage iv rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum
transgender in transition

Conditions: Gender Incongruence

Summary: prospective trial in gender dysphoric patients who undergo gender-affirming hormone therapy, aiming to investigate psychological, biological and behavioural consequences of hormonal therapy.

gender-affirming hormone treatment impacts myriads of body functions, from which it has to be assumed that only a minority has already been elucidated so far. this project aims to investigate the consequences and health-related outcomes of various hormone therapies in the treatment of gender dysphoric patients. the main scientific interest lies in the research of the effects of sex hormones on psychological, metabolic and behavioural parameters. for this purpose, various investigations are aimed at, including a clinical-diagnostic interview (external rating) and psychometric measurements in self-rating, behavioral experiments (e.g. in a virtual reality elevated plus maze and the computer-based ultimatum game) and genetic investigation of the body's own materials (blood samples, stool samples, hair samples and saliva samples). the results of this study should form the basis to better understand consequences of the long-term administration of sex hormones.

Eligibility criteria:
inclusion criteria: * diagnosis of gender incongruence (icd-11) or gender dysphoria (dsm-5) * written informed consent following adequate oral and written information * before gender-affirming hormonal treatment exclusion criteria: * pregnancy or breast-feeding
a study to evaluate the safety and efficacy(immunogenicity) of gc3114 in elderly healthy subjects

Conditions: Influenza, Human

Summary: elderly healthy subjects will be once administered gc3114a(high-dose quadrivalent influenza vaccine) or gcflu quadrivalent pre-filled syringe inj..

elderly healthy subjects will be once administered gc3114a(high-dose quadrivalent influenza vaccine) or gcflu quadrivalent pre-filled syringe inj.. safety and immunological efficacy will be evaluated.

Eligibility criteria:
inclusion criteria: * healthy adults aged over 65 years old * informed consent form has been signed and dated exclusion criteria: * known systemic hypersensitive to eggs, chicken proteins, or any of the vaccine components * personal history of guillain-barre syndrome(gbs) * subjects with severe chronic disease who are considered by investigator to be ineligible for the study * subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study * immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
acupuncture for postoperative urinary retention after hemorrhoidectomy: a randomized controlled trial

Conditions: Postoperative Complications; Postoperative Urinary Retention

Summary: the goal of this study is to examine the efficacy of acupuncture in the management of acute postoperative urinary retention. clinical question: is acupuncture efficacious for postoperative urinary retention after hemorrhoidectomy compared with sham acupuncture and neostigmine. study design: the participants who undergo hemorrhoidectomy and report postoperative urinary retention will receive one session of acupuncture or sham acupuncture or one injection of 1-mg neostigmine. the primary outcome was the time to first urination after surgery.


Eligibility criteria:
inclusion criteria: * aged between 18 and 65 years * meets the diagnostic criteria of postoperative urinary retention * received milligan-morgan hemorrhoidectomy and general anesthesia exclusion criteria: * received diuretic drugs * organic diseases that cause urinary retention * severe infection in the urinary tract * has a history of adverse reaction to neostigmine * cognitive dysfunction that affects outcome assessment * being pregnant
validity and reliability of the turkish form of the knowledge assessment scales for dementia and urinary incontinence

Conditions: Urinary Incontinence in Old Age; Dementia

Summary: the primary aim of the study was to determine the turkish version of the "validity and reliability of the knowledge assessment scales for dementia and urinary incontinence in community older people". the secondary aim of the study was to measure the knowledge level of dementia and urinary incontinence in the community-living elderly population.


Eligibility criteria:
inclusion criteria: 1. being 55 years of age or older 2. knowing how to read and write 3. being willing to participate in the study exclusion criteria: 1. having any chronic illness that would prevent urinary retention and dementia level

Keywords: urinary incontinence dementia validity reliability
left septal or deep septal pacing to prevent pacing-induced cardiomyopathy

Conditions: Complete Heart Block; Second Degree Atrioventricular Block Möbitz Type II

Summary: multicenter randomized controlled trial which will include patients with left ventricular ejection fraction \>50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages. patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. the primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.


Eligibility criteria:
inclusion criteria: * first implant of a single-chamber or dual chamber pacemaker due to persistent bradycardia associated with high degree atrio-ventricular (av) block (complete av block or second degree type ii av block), with second-degree type i av block (symptomatic or associated with intra-hisian or infra-hisian block), or with atrial fibrillation with symptomatic slow ventricular rate (\<45lpm). * lvef\>50% at echocardiography performed maximum 7 days before pacemaker implant. * informed consent signature. exclusion criteria: * life expectancy \<12 months * severe cardiac valvular abnormality requiring intervention * unstable angina, acute myocardial infarction, coronary revascularization, valvular surgery or valvular percutaneous intervention in the 90 days prior to pacemaker implant. * inclusion in another trial which may influence the results of this study.
long-term non-interventional study (nis) to investigate the safety and effectiveness of macugen in patients with neovascular age-related macular degeneration under conditions of routine clinical practice

Conditions: Age-related Macular Degeneration

Summary: to define what procedures were used for the diagnosis and monitoring of the treatment age-related macular degeneration (amd). what is the effect of the macugen, compliance with macugen treatment, safety profile of macugen, final physician assessment of treatment with macugen.

no sampling

Eligibility criteria:
inclusion criteria: * age over 18 years old * patients with neovascular age-related macular degeneration * enrollment to study is fully on physician decision in compliance with current spc exclusion criteria: * patient who did not meet indication according to spc macugen.

Keywords: ophthalmology age-related macular degeneration outpatients
effect of n-acetylcysteine on prevention of acute kidney injury in high risk patients undergoing off-pump coronary artery bypass graft

Conditions: Postoperative Acute Kidney Injury After Off-pump Coronary Artery Bypass Graft

Summary: n-acetylcysteine may prevent acute kidney injury in high risk patients undergoing off-pump coronary artery bypass graft.


Eligibility criteria:
inclusion criteria: * patients undergoing off-pump coronary artery bypass surgery and meets more than one of the following criteria; * preoperative serum creatinine \> 1.4 mg/dl * age \> 70 years * diabetes mellitus * left ventricular ejection fraction \< 35 % or congestive heart failure (nyha iii or iv) * emergency surgery or re-operation exclusion criteria: * preoperative acute renal failure, patients on dialysis, use of n-acetylcystein within 5 days of surgery, history of hypersensitivity to n-acetylcystein
tablet-based mobile health ultrasound for point-of-care breast cancer diagnosis in nigeria

Conditions: Breast Cancer

Summary: the purpose of this study is to train nigerian radiologists to perform ultrasound-guided breast biopsies on women that present to the hospital with a suspicious breast mass. before performing biopsies on patients, the nigerian radiologists will have already successfully completed a competency-based mobile health ultrasound-guided breast biopsy-training program. this program, developed by experts in nigeria and the united states of america, certifies that they have the skills required to safely perform these biopsies on patients.


Eligibility criteria:
inclusion criteria: * age 18 and older female * breast ultrasound demonstrating a solid mass that is suspicious for cancer, which would typically undergo either a blind biopsy or surgical excision at the nigerian hospital where the patient is seeking diagnosis. exclusion criteria: * participants unwilling to sign consent * participants under the age of 18.
expression of steap-1 and p40 in prostatic carcinoma and its mimickers

Conditions: Prostatic Carcinoma

Summary: prostatic carcinoma is the second most common cancer in men with high incidence of morbidity and mortality. it is a common health problem. most cases occur at the age of 50 years, reaching its peak at 60-70 years of age. diagnosis of prostatic carcinoma is still a problematic issue as accurate diagnosis can be very challenging due to the presence of either a small focus of cancer or the presence of many benign mimickers of malignancy. six transmembrane epithelial antigen of the prostate 1 (steap-1) is primarily localized at the cell membrane, mostly at cell-cell junctions, but it may also be found dispersed in the cytoplasm. in prostate, the expression of steap-1 is higher in neoplastic tissues compared to its restricted expression in normal prostatic samples. the antibody designated as p40 recognizes exclusively δnp63 and not tap63. in prostate tissues, it has been shown that p40, the δnp63 isoform of p63, stains prostatic basal cells as reliable as p63 in most cases. furthermore, aberrant staining of tumor cells was seen more rarely with p40 than with p63. in this study, the investigators hope to solve some problematic issues in diagnosis of prostatic carcinoma and reach the better way to distinguish prostatic carcinoma from mimicking lesions by using both steap-1 and p 40. also, the way to detect cancer at early stage of development and its progression which is extremely important as it allows establishing the most effective treatment and predicting patient's outcome.


Eligibility criteria:
inclusion criteria: * trans-rectal ultrasound guided biopsy (trus) procedure, transurethral resection prostatectomy (turp) and radical prostatectomy. * prostatic adenocarcinoma and prostatic lesions that mimic prostatic adenocarcinoma exclusion criteria: * patients with recurrence of the primary tumor. * patients with a history of preoperative chemotherapy and/or radiotherapy. * insufficient or tiny tissue biopsies
hydroxyurea in treating patients with recurrent and/or unresectable meningioma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of hydroxyurea in treating patients who have recurrent and/or unresectable meningioma.

objectives: * determine complete, partial, or stable response to hydroxyurea in patients with recurrent and/or nonresectable meningioma. * determine response at 2 years to this regimen in these patients. * determine overall and disease free survival of these patients after this regimen. * determine quality of life of these patients. * determine the toxicities of this regimen in these patients. outline: this is a multicenter study. patients are stratified according to grade of disease (i vs ii or iii). patients receive oral hydroxyurea daily for 2 years. quality of life is assessed before treatment, then every 3 months for 2 years. projected accrual: a total of 60 patients (30 per stratum) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically proven progressive meningioma that is not curable by surgery patient characteristics: age: * 16 and over performance status: * karnofsky 70-100% life expectancy: * over 3 months hematopoietic: * wbc at least 3,000/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 2 times upper limit of normal (uln) * ast and alt no greater than 2 times uln * alkaline phosphatase no greater than 2 times uln renal: * creatinine no greater than 2 times uln other: * not pregnant or nursing * fertile patients must use effective contraception during and for 6 months after study * no other malignancy prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy * no other concurrent chemotherapy endocrine therapy: * concurrent corticosteroids allowed for control of intracranial pressure radiotherapy: * prior radiotherapy allowed * no concurrent radiotherapy surgery: * see disease characteristics other: * at least 1 year since prior experimental therapy

Keywords: recurrent adult brain tumor adult grade iii meningioma adult grade i meningioma adult grade ii meningioma
the effect of glycemic control and of glp-1 receptor agonism on islet glp-1 in people with type 1 and type 2 diabetes

Conditions: Type 1 Diabetes; Type 2 Diabetes

Summary: the investigators recently demonstrated that blockade of glucagon-like peptide-1's (glp-1) receptor (glp1r) results in changes in islet function without changes in circulating glp-1. these effects are more pronounced in people with early type 2 diabetes (t2dm) in keeping with increased expression of pc-1/3 and glp-1 that is observed in diabetic islets. however, its regulation is at present unknown. there is evidence that α-cell proglucagon processing is subject to paracrine regulation by the β-cell3. it is unclear if the effects of glp1r agonism on islet glp-1 differ in type 1 diabetes (t1dm) compared to t2dm. this experiment will examine the effect of glycemic control ± a glp1r agonist on islet glp-1 in people with (t2dm) and without (t1dm) β-cells.

the investigators recently demonstrated that blockade of glucagon-like peptide-1's (glp-1) receptor (glp1r) results in changes in islet function without changes in circulating glp-1. this supports other evidence (rodents and humans) that through the (inducible) expression of a prohormone convertase (pc-1/3), the α-cell can process proglucagon to intact glp-15,6. 'islet' or 'pancreatic' glp-1 acts in a paracrine fashion to regulate insulin (basal and 1st phase) and glucagon secretion. these effects are more pronounced in people with early type 2 diabetes (t2dm) in keeping with increased expression of pc-1/3 and glp-1 that is observed in diabetic islets. there is evidence that α-cell proglucagon processing is subject to paracrine regulation by the β-cell. β-cell secretion of the signaling peptide 14-3-3-zeta is decreased by glp1r agonism (fig.1), stimulating α-cell production of glp-1. this is a testable hypothesis in humans; people with type 1 diabetes (t1dm) have dysregulated glucagon secretion and evidence of islet glp-1. it is unclear if the effects of glp1r agonism on islet glp-1 differ compared to t2dm. this experiment will examine the effect of glycemic control ± a glp1r agonist on islet glp-1 in people with (t2dm) and without (t1dm) β-cells.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes treated with insulin exclusion criteria: 1. age \ 70 years. 2. hba1c \> 10.0% 3. for female subjects: positive pregnancy test at the time of enrollment or study 4. history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. 5. prior use of glp-1 receptor agonists in the previous year. 6. active systemic illness or malignancy. 7. symptomatic macrovascular or microvascular disease.

Keywords: islet function glucose toxicity
research on probiotics in improving obesity

Conditions: Obesity

Summary: assess the effects of akkermansia muciniphila akk11 heat - killed bacteria capsules compared to a placebo on body composition indicators (weight, bmi, body fat rate, waist - hip ratio (wc), wrist circumference, visceral fat area, basal metabolic rate) and blood lipid concentrations (total cholesterol (tc), low - density lipoprotein (ldl), high - density lipoprotein (hdl), triglycerides (tg)) in overweight/obese adults.


Eligibility criteria:
inclusion criteria: 1. a body mass index (bmi) of ≥25 kg/m²; 2. willingness to provide written informed consent to participate in the study; 3. agreement to adhere to the study protocol and restrictions, including a low-carbohydrate, energy-restricted diet; 4. no plans for conception from 14 days before screening until 6 months after the trial, with a commitment to using effective contraception. exclusion criteria: 1. use of products similar to the test product in the near term that may affect the results; 2. presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergies; 3. pregnant, breastfeeding, or planning pregnancy; 4. irritable bowel syndrome (ibs), ulcerative colitis, hepatic cirrhosis, or diabetes mellitus; 5. antibiotic use within the past three months; 6. failure to consume the test product as required or attend follow-ups on time, making efficacy assessment impossible; 7. smoking more than 10 cigarettes a day; 8. allergy to probiotic products; 9. other participants deemed unsuitable for the study by the investigator.
developing an hiv disclosure intervention for men in uganda

Conditions: HIV Infections; Sexually Transmitted Infections (Not HIV or Hepatitis)

Summary: the goal of this clinical trial is to test an hiv disclosure intervention that the investigators are developing focused on men living with hiv in uganda. the main questions the investigators are trying to answer is whether the hiv disclosure intervention the investigators develop will help men who receive this intervention to disclose their hiv status to a greater extent than men who receive standard care. participants assigned to the intervention group will likely participate in the following: * sexual health education * cognitive behavioral therapy strategies * problem-solving skills building * motivational interviewing * developing a personalized hiv disclosure plan * communication skills building * role-playing disclosure strategies


Eligibility criteria:
for all 3 aims, "index participants" inclusion criteria will include: * men living with hiv * with sexually transmitted infection symptoms (e.g., urethral discharge, genital lesions) * either not accessing antiretroviral therapy (per self-report109 and/or clinic documentation) or accessing antiretroviral therapy without hiv viral suppression * age ≥18 years, * with at least one sexual partner in the past three months aims 2 and 3 have the additional inclusion criteria: * men living with hiv without hiv disclosure to at least one partner. in aims 2 and 3, male participants will be encouraged to invite sexual partners for enrollment. these "partner participants" will have the following inclusion criteria: * age ≥18 years * partnered with an enrolled man who reports hiv disclosure or plans for hiv disclosure with study support * referred by the male participant. exclusion criteria: * an inability to speak the local language (runyankole) or english * an inability to provide informed consent
familial hyperlipidemia family registry

Conditions: Familial Hyperlipidemia

Summary: the aim of the study is to identify children and families that are at risk for cardiovascular disease because of a condition known as familial hyperlipidemia. this condition may increase the risk of cardiac events such as hardening of the arteries anywhere in the body which can result in heart attacks, strokes, and death over ten fold. children have already been assessed in the healthy hearts screening program and identified as having elevated cholesterol. a buccal smear will identify whether the familial hyperlipidemia condition exist in your child. if the child's test shows that they have the specific gene for familial hyperlipidemia and shows a genetic tendency towards premature heart disease, we would encourage genetic testing for as many blood family members as possible. the study plan is to determine whether the healthy hearts screening program is a more effective way of identifying students at risk since it is estimated that less than 10% of those individuals with the problem have been identified. if it is effective, then it will be incorporated as part of the standard screening process in the healthy hearts program. aim 1: is a school screening program a more effective method to identifying those at risk for familial hyperlipidemia? aim 2: what percent of children with elevated cholesterol ≥ 200 mg/dl have familial hyperlipidemia?


Eligibility criteria:
inclusion criteria: \* primary family member of child from school screening program with documented fh variant exclusion criteria: * none

Keywords: cholesterol school based biometric screening genetic healthy hearts children