Kornimate/medical-research-clean huggingface dataset:
integrating hepatitis c screening with dried blood spot testing into colorectal cancer screening

Conditions: Hepatitis C Virus Infection

Summary: the main purpose of the study is to compare the acceptance and viability of three strategies aimed to screen hepatitis c virus (hcv) infection in a birth cohort by: a) invitation letter offering hcv screening with dried blood spot (dbs) testing at the primary care center, b) invitation letter offering both hcv and colorectal cancer (ccr) screening with faecal occult test (fot) at the primary care center, and c) invitation letter offering self-collected screening at home for hcv and ccr.

this is a prospective, randomized, study in which subjects of four different health areas will be invited to participate in three different screening strategies for hcv. hepatologists from a tertiary care hospital and general practitioners from four health areas will participate coordinating the study, to first select potential candidates for the study (subjects between 50 and 70 years old of the four areas) and secondly, randomize and include 150 subjects of each area into the three strategies (50 subjects each). the strategies include offering by letter screening at the local primary care center for hcv by using dried blood spot (dbs) testing, screening for hcv and colorectal cancer (ccr) using faecal occult test (fot) at the primary care center, and self-testing at home-collection with dbs and fot to be performed by the subject and sent by postal office. subjects will receive an invitation and informative letter and will be ask to sign the informed consent to participate. in all the planned strategies subjects will be asked to complete a questionnaire that includes demographic variables. after two months of sending the letters without response, researchers will contact subjects by phone to complete a survey to confirm they received the letter and asking for factors of non-participation. the hypothesis of the study is that subjects in the risk of having hcv are willing to be screened for hcv infection if offered and that the acceptance will be improved if attached to ccr screening and even higher if the tests are offered to be self-screened. for the present study, a 15% improvement in the participation (acceptance of the screening strategy) was hypothesized in the group of patients receiving the strategy 2 (and 3) compared to the strategy 1. taking into account a power of 80%, alpha error of 5% and losses of 20% will require 200 patients per group.

Eligibility criteria:
inclusion criteria: * age 50-70 years * subjects attending selected primary care centers * willing to participate (informed consent signed) exclusion criteria: -
tamoxifen therapy for myotubular myopathy

Conditions: X Linked Myotubular Myopathy

Summary: this is a phase 1 / 2, randomized, double-blinded, single cross-over study, with a washout period between treatment regimens, to test the efficacy and safety of tamoxifen therapy to improve motor and respiratory function in males with xlmtm.

pre-clinical studies in mtm1 knockout mice (a model of xlmtm) demonstrated prolonged survival, increased motor function (including muscle strength), and improved muscle histopathology with tamoxifen treatment. based on these data, and the known safety profile of the drug in humans, we hypothesize that tamoxifen treatment will be safe and will improve motor and respiratory function in xlmtm patients. this is a randomized, double-blinded, single crossover clinical trial to test this hypothesis and determine the safety and efficacy of tamoxifen in improving motor and respiratory function in mtm patients. each subject will serve as his own control during the placebo phase of the study. as treatments for xlmtm are current not available, this study addresses a critical unmet need by testing a therapy that, if effective, may serve as a primary treatment, or in the future as an adjunct to other therapies in development.

Eligibility criteria:
inclusion criteria 1. male 2. patients ages 6 months and older may participate. 3. xlmtm resulting from a confirmed mutation in the myotubularin 1 (mtm1) gene 4. patients over 18 years of age and parent(s)/legal guardian(s) of patients \<18 years of age must provide written informed consent prior to participating in the study and informed assent will be obtained from minors, or at least 7 years of age when required by regulation. 5. willing and able to comply with all protocol requirements and procedures. exclusion criteria 1. other disease which may significantly interfere with the assessment of myotubular myopathy (mtm) and is clearly not related to the disease, at the discretion of the qualified investigator. 2. has undergone surgery or hospitalization \< 3 months before starting tam4mtm (at t = -3 months), or has surgery scheduled during the 18 months of participation in tam4mtm, which will impede motor assessments in the opinion of the investigator. 3. has a history of thromboembolic events 4. currently enrolled in a treatment study for xlmtm or receiving treatment with an experimental therapy other than pyridostigmine. 5. treatment with pyridostigmine for \< 6 weeks duration (must be greater than 6 weeks to be included in tam4mtm). 6. use of concomitant medication known to inhibit cyp2d6 and/or cyp3a4, including clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal and grapefruit, paroxetine, troleandomycin, rifampin, phenobarbital, aminoglutethimide, medroxyprogesterone, amiodarone, haloperidol, indinavir, ritonavir, quinidine, rifampicin, or any selective serotonin reuptake inhibitor (ssri). 7. subject has a contraindication to tamoxifen or its ingredients

Keywords: tamoxifen x-linked myotubular myopathy
visual performance of the vivity iol in post-myopic lasik and prk patients

Conditions: Cataract

Summary: the objective is to evaluate visual outcomes and patient satisfaction in patients with a history of myopic lasik or prk who will have completed cataract surgery with the vivity iol.

this study prospective, non-interventional, single-center, single-surgeon, single-arm observational study of visual outcomes and patient satisfaction in patients with a history of myopic lasik or prk who will have completed cataract surgery with the vivity iol. subjects will be assessed at least 3 months postoperatively. clinical evaluations will include administration of a satisfaction questionnaire (iolsat), as well as measurement of binocular and monocular visual acuities, defocus curve, and manifest refraction.

Eligibility criteria:
inclusion criteria: subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in both eyes. * adult (at least 40 years) patients with a history of successful myopic lasik/prk and underwent bilateral uncomplicated cataract surgery with non-toric alcon vivity iol at least 3 months before enrollment. * monocular bcdva 20/25 or better. * patients may be \>2 weeks post-yag capsulotomy for visually significant pco. * post-operative sphere ≤0.50d, astigmatism ≤0.50d, and mrse \< 0.75d. exclusion criteria: if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * patients with corneal refractive surgery complications, significant ocular pathology, including moderate and severe dry eye, retina, optic nerve (including glaucoma) and corneal pathologies (e.g. corneal dystrophy, edema, significant scarring), limiting or affecting visual potential, in the opinion of the surgeon. * patients undergoing cataract removal with migs procedure. * patients with h/o ocular surgery, other than corneal refractive surgery, that may limit or affect visual potential in the opinion of the surgeon. the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
cold induced activation of brown adipose tissue in winter swimmers

Conditions: Adipose Tissue; Brown Adipose Tissue; Brown Fat; Uncoupling Protein 1; Adipokines; Proteomics; Infra-red Thermography; BAT; Winter Swimmers; Type2 Diabetes; Proteins

Summary: this study investigates cold-induced brown fat activation in winter swimmers and not-winter swimmers by skin temperature measures assessed with infra red thermography imaging and skin temperatures. winter swimmers and not-winter swimmers will participate in an acute cooling intervention and thermoneutral intervention for comparison of energy expenditure and skin temperatures at the supraclavicular area.

the field of human brown adipose tissue (bat) research is focused on activation of bat as a means of manipulating energy expenditure and potentially anti-obesity and anti-diabetic properties of the tissue. this is well established in rodent studies and explained as due to the specific brown fat uncoupling protein 1 (ucp1). despite increasing evidence that indicates a metabolic regulatory role of bat in humans, bat activation/recruitment is not fully understood. cold induced brown fat activity will be measured by skin temperature measures by means of infra-red thermography imaging and skin temperature. 15 healthy male winter swimmers and 8 healthy male non-winter swimmers (controls) will be included in the study.

Eligibility criteria:
inclusion criteria: age 18-35 years. men caucasian white body mass index 19-25 kg/m2. moderate physical activity level (not more than 8-10 hours of training pr. week) ability to give informed consent. ability to follow verbal and written instructions in danish. body fat percent under 21% measured at the pre-examination day. winter swimmers: min. 2 swim/ week. swimming in winter-season in open water outdoor in denmark from september/october until study start in march. not-winter swimmers: not winter-swimmers or taken cold showers on a regular basis. exclusion criteria: * chronic diseases: hormonal: metabolic diseases mb. graves, hypothyroidism, myxedema and goiter. diabetes melitus, coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure), cancer treated within last 3 years. tobacco, marijuana or intravenous drug use within 1 year of screening. dieting, recent weight loss (\>3 kg within 3 month) or a history of an eating disorder. dietary supplements. history of depression, psychosis, or other psychiatric illness requiring hospitalization. alcohol consumption \>14 units/week. history of alcohol abuse within the past 3 years. known liver disease or elevated liver biomarkers more than 2 times upper normal levels in the preliminary investigation. known kidney disease or elevated kidney biomarkers, in the preliminary investigation. use of daily medications, except for seasonal use of antihistamines. diagnosed sleep disturbances.
an exploratory trial to evaluate efficacy and safety for combination treatment of adenovirus double suicide gene therapy

Conditions: Pancreas Cancer

Summary: replication-competent adenovirus-mediated double suicide gene therapy (theragene®,ad5-ycd/muttksr39rep-adp) showed safety and anti-cancer effect in patients with pancreatic cancer in phase i study. from the experience of phase i study, the safety and efficacy of combination with standard chemotherapy and radiation therapy with theragene treatment will be assessed in this study.

phase iia study of replication-competent adenovirus-mediated double suicide gene therapy (theragene®,ad5-ycd/muttksr39rep-adp) with radiation therapy

Eligibility criteria:
inclusion criteria: * patients with borderline resectable or locally advanced pancreatic cancer * patients with histologically confirmed pancreatic adenocarcinoma * patients with no evidence of peritoneal or hematogenous metastasis * patients with ecog performance status 0-1 * patients with renal function (serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 ml/min/m²) * patients with bone marrow function (wbc \> 4,000/ul or absolute neutrophil count ≥ 1500/ul, plt ≥ 100,000/ul, and hemoglobin \> 10 g/dl) * patients with liver function (bilirubin \< 2.0 mg/dl and sgot and sgpt \< 3 times upper limit of normal (uln)) * patients with agreement with informed consent exclusion criteria: * patients with a history of other cancer * patients with recurred pancreatic cancer * patients with a history of radiation on more than 25% of bone marrow * patients with a history of major surgery except laparoscopic examination, endoscopic intervention, or gastrojejunostomy * patients who have contraindication of radiation therapy * patients with hiv infection, chronic hepatitis b, chronic hepatitis c, or liver cirrhosis * female patients with childbearing age or pregnancy or breast feeding * patients who are considered as inappropriate candidate by investigators

Keywords: pancreatic cancer radiation therapy adenovirus gene therapy
study of ono-7475 in combination with osimertinib in egfr gene mutation-positive non-small cell lung cancer

Conditions: Stage IIIB Non-small Cell Lung Cancer; Stage IIIC Non-Small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Recurrent Non-Small Cell Lung Cancer; EGFR Mutation-Related Tumors

Summary: this study is to evaluate the tolerability and safety of ono-7475 in combination with osimertinib in the first-line treatment of patients with egfr-mutated, stage iiib/iiic/iv or recurrent non-small cell lung cancer (nsclc), which is unsuitable for radical irradiation.


Eligibility criteria:
inclusion criteria: 1. patients with stage iiib/iiic/iv or recurrent nsclc, which is unsuitable for radical irradiation 2. patients with confirmed egfr gene exon 19 deletion or egfr gene exon 21 mutation(l858r)and who are scheduled to receive osimertinib 3. patient has an ecog performance status of 0-1 exclusion criteria: 1. patients with severe complication 2. patients with multiple primary cancers
impact of palliative catheter placement on the quality of life of patients with refractory ascites

Conditions: Ascites

Summary: the purpose of this study is look at how treatments for ascites affect quality of life. your quality of life is the ability for you to enjoy the normal things you do. ascites (pronounced as-ī-tees) is the presence of extra fluid in the abdomen. sometimes ascites is caused by cancer, also called malignancy. all people who participate in this study have ascites associated with cancer. ascites can cause symptoms that make it difficult for the patient to do simple things. patients with ascites often report: abdominal swelling difficulty walking. difficulty breathing. feeling full when eating. clothes not fitting due to a swollen abdomen. swelling in the legs. it is hoped that this catheter will relieve the symptoms of the ascites. the goal of the investigators study is to understand the quality of life before the procedure and after the procedure. since the patient is having this procedure to make their symptoms better, the investigators want to hear from the patient of how the procedure has affected their quality of life.


Eligibility criteria:
inclusion criteria: * patients diagnosed with a stage iv malignancy or end-stage disease documented in patient's chart. * patients referred to interventional radiology for treatment of refractory ascites with the placement of a permanent catheter including, but not limited to, a tenckhoff catheter, a pleurx catheter, or a denver shunt. * fluency in english to enable instrument and interview completion. * patients must be at least 18 years of age. * patients must be physically capable of completing instruments and/or interview. * patients must be able to comprehend and execute informed consent. exclusion criteria: * unable to complete questionnaire due to a significant physical or mental deficits as assessed by the consenting professional. * proxy completion is not accepted * medical or psychiatric condition that, in the judgment of the investigator, prevents appropriate comprehension and execution of either the informed consent or the study instrument

Keywords: catheter palliative quality of life 10-059
study of irinotecan administered as a continuous infusion and radiation therapy for upper gastrointestinal cancers

Conditions: Pancreatic Cancer; Gastric Cancer; Duodenum Cancer; Bile Duct Cancer

Summary: this study is for people with advanced cancer of the digestive tract and cancer that cannot be completely removed by surgery. radiation therapy is commonly used in the treatment of these types of cancer in combination with a chemotherapy drug, called 5-fluorouracil (5-fu). in this study, doctors will administer the standard dose of radiation therapy in combination with an investigational chemotherapy drug, called irinotecan. irinotecan can decrease the size of tumors and also appears to increase the effectiveness of radiation. the purpose of this study is to determine the highest dose of irinotecan that can be given safely in combination with radiation therapy, and to determine the side effects when these two treatments are given together. irinotecan is approved by the food and drug administration (fda) for the treatment of colon cancer, but is not approved for cancers of the digestive tract. however, the fda is allowing its use in this research study.


Eligibility criteria:
inclusion criteria: * histologically confirmed neoplasm of the upper gastrointestinal tract (pancreas, stomach, duodenum, common bile duct, ampulla of vater) or metastatic tumor to the upper abdomen. * eligible patients include patients with locally advanced unresectable tumors, positive surgical margins, local recurrence and resected stage ii-iii pancreatic, gastric, duodenum, bile duct or ampulla of vater carcinoma. * performance status swog 0-2 * fully recovered from prior surgery or chemotherapy (greater than or equal to 4 weeks). patients previously treated with 5-fu or gemcitabine may start therapy 2 weeks after the last dose of 5-fu or gemcitabine. * absolute granulocyte count (agc) \> 1500; platelets \> 100,000; serum creatinine \< 2.0 mg/dl; total bilirubin \< 2.0 mg/dl; ast or alt and alkaline phosphatase \< 3 times the upper limit of normal. * prior chemotherapy is allowed. exclusion criteria: * prior radiation therapy to the upper abdomen * tumors of the gastroesophageal junction. * other medical, psychological or social circumstances that, in the opinion of the investigator, would prevent participation in the clinical trial * pregnancy.

Keywords: pancreas stomach common bile duct cancer ampulla of vater cancer
efficacy and safety of combination therapy of vildagliptin/metformin in patients in type 2 diabetes mellitus (t2dm)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will assess the efficacy and safety of combination therapy of vildagliptin/metformin in patients with t2dm inadequately controlled with metformin 1,000 mg/day.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months * the patient is required to have hba1c 6.5-11.0% * bmi in the range of 22-48 kg/m2 exclusion criteria: * severe or uncontrolled type 2 diabetes mellitus (hba1c\> 11.0%) * acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months * congestive heart failure requiring pharmacologic treatment * any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention * liver disease such as cirrhosis or chronic active hepatitis

Keywords: type 2 diabetes mellitus vildagliptin metformin
prediction of neoadjuvant chemotherapy efficacy in locally advanced gastric cancer

Conditions: Gastric Cancer

Summary: this study intends to explore the value of 68ga-fapi-04 and 18f-fdg pet/ct in the evaluation of treatment response to neoadjuvant chemotherapy(nac) for patients with locally advanced gastric cancer(lagc).

before the start of nac, baseline 68ga-fapi-04 pet/ct and 18f-fdg pet/ct scans will be scheduled in all enrolled patients. next, the patients with resectable lagc will receive nac treatment, surgery will follow 3\~6 weeks after finishing nac. abdomen 68ga-fapi-04 pet/ct and 18f-fdg pet/ct will be scheduled after one cycle of nac treatment or before surgery. imaging response measurements will be compared with the histopathological tumor regression grade (trg) of the resection specimen as gold standard.

Eligibility criteria:
inclusion criteria 1. age between 18-75 years. 2. histologically confirmed gastric adenocarcinoma through gastroscopy. 3. resectable gastric cancer. 4. ecog performance status 0-1. 5. white blood count \>4x109/l, absolute neutrophil count (anc) \>2x109/l, hemoglobin (hb)\>90g/l, platelets \>100x109/l. 6. ejection fraction\>50%. 7. serum bilirubin \<1.5x uln; alt and ast \<1.5x uln. 8. serum creatinine ≤1.5x uln, or gfr\> 60ml/min. 9. agreement to participate in this study with informed consent form. 10. willingness and ability to comply with the protocol for the duration of the study. 11. no children bearing petential in the next six months before enrollment. exclusion criteria 1. with second primary malignant diseases in past five years, exceptions include basal cell and squamous cell carcinoma of the skin that have been cured. 2. known hypersensitivity reaction to chemotherapy drugs or with contraindications. 3. with severe disease or other unsuitable conditions determined by investigators. inadequate organ function. 4. with uncontrollable diabetic or fasting blood glucose level ≥11 mmol/l on the test-day. 5. with severe mental symptoms, unconscious or unable to complete the examination. 6. pregnancy or possibly pregnant woman, breastfeeding woman. 7. lack of compliance.