Kornimate/medical-research-clean huggingface dataset:
comparison between internal and external preoperative biliary drainage in periampullary cancers

Conditions: Periampullary Cancers With Obstructive Jaundice; Pancreas Head Cancer; Bile Duct Cancer; Ampulla of Vater Cancer

Summary: preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (ptbd), endoscopic nasobiliary drainage (enbd), and endoscopic retrograde biliary drainage (erbd). endoscopic biliary drainages often induce peritumoral inflammation and it increase difficulties in determining a proper resection margin. the purpose of this study is to compare the clinicopathological outcomes according to the methods of preoperative biliary drainage in periampullary cancers causing obstructive jaundice, and to find out a proper biliary drainage method.


Eligibility criteria:
inclusion criteria: * patient who have periampullary tumors causing obstructive jaundice * patient age: ≥20 and ≤85 * resectable state of disease * no history of previous chemotherapy or radiotherapy * patients without uncontrollable severe cardiovascular, respiratory disease * karnofsky performance scale ≥70 * informed consent exclusion criteria: * patients with distant metastasis or locally advanced disease with major vascular invasion * duodenal cancer * biliary drainage before randomization * previous chemotherapy or radiotherapy * uncontrollable active infection except cholangitis * severe comorbid disease (cardiac, pulmonary, cerebrovascular)
oxygen concentration and recovery after carotid endarterectomy

Conditions: Hypoxia-Ischemia, Brain; Ischemia, Vertebral Artery; Artery Stenosis, Carotid

Summary: this study evaluates effects of high inspiratory oxygen on cerebral tissue oxygenation and patient recovery after carotid endarterectomy. two group of patient undergoing to carotid with total intravenous anaesthesia will receive either 35% inspired oxygen or 100% oxygen.

high inspired oxygen concentration may reduce brain hypoxia in the patients undergoing carotid endarterectomy with total intravenous anaesthesia. however, there are some studies suggesting that high inspired oxygen concentration may induce cerebral vasoconstriction. this study was performed to measure the influence of fraction of inspired oxygen (fio2) on the regional tissue oxygenation in the patients undergoing carotid endarterectomy with total intravenous anaesthesia. the invos 5100b monitor was used for regional cerebral oxygen saturation (rso2) measurement from operative and nonoperative side, and invos analytics tool (covidien) for area under curve (auc) calculations. a bispectral index and invasive blood pressure monitoring were used in all patients.

Eligibility criteria:
inclusion criteria: * patient undergoing surgery (carotid endarterectomy) exclusion criteria: * decompensated and uncontrolled respiratory and cardiac disease, myocardial infarction suffered in the last 6 months, cerebrovascular infarction, coagulopathy, anaphylaxis to drugs

Keywords: normobaric hyperoxia cerebral oxygenation near-infrared spectroscopy carotid endarterectomy tiva
the effect of tdcs on subcortical brain functioning

Conditions: Brain Damage, Chronic

Summary: this research is being done to determine whether transcranial direct current stimulation (tdcs) can improve certain abilities related to cognition, emotion and/or physical functioning in individuals with subcortical brain damage.

while cortical brain structures are thought to be responsible for higher level cognitive functioning (i.e., perception, thoughts, language, memory, attention, and processing), subcortical brain regions (i.e., amygdala, midbrain, hippocampus, and thalamus) are generally believed to be responsible for more fundamental bases of such functions. a significant fraction of the population suffer from disabling disorders and diseases (i.e., parkinson's disease, subcortical dementia, hypoxic brain damage) that affect subcortical areas. despite their prevalence, very little success has been achieved in treating such impairments effectively. this study has two main goals. one is to examine the effect of stimulation on a variety of subcortical functions (i.e., level of alertness, mood, cognition, and motor responding). a second goal is to examine the effects of varying some of the stimulus parameters of tdcs, notably the placement of the electrodes and the duration and frequency of application of current. adult participants with a confirmed diagnosis of subcortical brain damage, as well as healthy adults will be randomly assigned to anodal and cathodal stimulation in a counterbalanced order, and both will engage in simple behavioral tasks and/or physiological monitoring. these tasks will be specific to the deficit of interest.

Eligibility criteria:
inclusion criteria: * fluent in the english language * history of subcortical brain damage (patient group only) * no known neurological or cognitive impairment (control group only) exclusion criteria: * appreciable deficits in hearing * schizophrenia, bipolar disorder, or major depression (normal controls only) * any neurological disorder associated with cognitive impairment or neuroanatomic abnormality (normal controls only) * language-based learning disorder (normal controls only) * dementia or mini-mental state exam \<24 for normal control participants * any implanted metal device (precludes use of tdcs) * any implanted cardiac pacemaker

Keywords: parkinson's disease lewy body dementia korsakoff's syndrome subcortical dementia huntington's disease
study of igpro20 to prevent infection in people with multiple myeloma and hypogammaglobulinemia

Conditions: Multiple Myeloma; Hypogammaglobulinemia; Hypogammaglobulinemia, Acquired

Summary: the main purpose of this study is to see if igpro20 can prevent infection in people with multiple myeloma (mm) who have hypogammaglobulinemia from receiving bispecific monoclonal antibodies (bsabs).


Eligibility criteria:
inclusion criteria: * diagnosis of rrmm receiving a commercially available bispecific antibody * received at least 1 but no more than 4 cycles of bsab * received 2 or more lines of therapy for mm igg ≤ 4 g/l excluding paraprotein. for igg kappa mm, hypogammaglobulinemia will be determined by subtracting the m spike from igg * males or females greater than or equal to 18 years old at the time of consent * ecog ≤ 3 * life expectancy \> 12 months exclusion criteria: * hsct within 3 months before enrollment * planned car-t therapy in the next 6 months * \>1 major (deep-seated) infection within the preceding 3 months * hiv infection, active hcv, or active hbv infection * pregnancy * neutrophils \< 500 x 10\^9 per ml, platelets \< 30 x 10\^9 per ml * history of cancer other than mm in the last 3 years requiring active chemotherapy or radiation * known reaction/allergy to igg products * intracranial hemorrhage or embolic cva in the last 6 months * hyperproteinemia * protein-losing enteropathy * creatinine cl \<30 ml/min * documented progression on bsab * known history of hyperprolinemia * on current or previous ivig (in the last 3 months)

Keywords: multiple myeloma hypogammaglobulinemia igpro20 memorial sloan kettering cancer center 24-137
the ohio state university dermatology biorepository

Conditions: Hidradenitis Suppurativa

Summary: this study will create and extend a source of clinical specimens for the future study of inflammatory skin disorders.

a variety of molecular techniques can be used to investigate diseases by analyzing protein, dna, and rna. flow cytometry, polymerase chain reaction (pcr), histology and immunohistochemistry are assays which can identify specific cell populations and provide valuable information regarding the pathologic characteristics of those populations. flow cytometry analyzes the surface markers of cells. histology and immunohistochemistry further characterize surface and cellular molecules and aid in the diagnosis of certain skin diseases. gene expression profiling allows investigators to examine the genes detectable to determine the function of the cells involved, and pcr techniques are useful for the diagnosis of certain conditions and for dna analysis. by procuring blood, skin tissue, and swab samples from patients with and without neoplastic and inflammatory skin disorders at the time of their appointments, the hypothesize that future translational research can be conducted on such specimens using the aforementioned techniques to further understand disease mechanisms in cutaneous disorders, and to potentially discover defective function and genetic mutations within cells from patients with neoplastic and inflammatory skin disorders. by establishing a tissue bank, we aim to lay the foundation for future work that will improve our understanding of the biology and natural history of neoplastic and inflammatory cutaneous diseases.

Eligibility criteria:
inclusion criteria: * seen by an ohio state university (osu) dermatology provider on the main university hospital campus, including the james cancer hospital, osu dermatology east, osu dermatology at the ohio state eye and ear institute, martha morehouse medical pavilion, and osu dermatology at upper arlington after the date of approval of this protocol * ability to provide informed consent, or parent or legal guardian capable of providing consent for child or mentally handicapped individuals * willingness to participate in a research study. exclusion criteria: * inability to provide informed consent
feasibility of reducing cardiovascular disease risk factors in hispanics through a family-based community intervention

Conditions: Cardiovascular Diseases; Metabolic Syndrome

Summary: the purpose of this study is to evaluate the feasibility of a 6-month family-based community intervention to mitigate cardiovascular disease risk factors in hispanic families in northern colorado as measured through biometric screenings, body composition, physical activity, and health knowledge.

the current project aims to leverage the uchealth healthy hearts family program to provide a free, non-insurance-based 1-year cardiovascular disease (cvd) prevention and wellness program to hispanic colorado families. this program includes an interactive educational class series, baseline and quarterly biometric screenings, and optional consultations with an exercise physiologist and a dietitian. this program takes a novel approach to preventative care by incorporating the family unit with the intention of having the child be the agent of change. the long-term goals of this project are to significantly improve cvd risk factors among participating families and to disseminate study findings to inform developing and current outreach programs to offer effective cvd prevention programs for hispanic citizens. this work may ultimately lead to more hispanics being served through new or existing programs, therefore expanding important preventative community health interventions into this underserved population.

Eligibility criteria:
inclusion criteria: * at least one member of the family unit self-identifies as hispanic * at least 13 years of age exclusion criteria: * unwilling to wear fitbit devices daily for 6 months except when charging and sleeping * cannot read or understand either english or spanish * cannot return to screening location to perform the minimum of the baseline, 3-month and 6-month follow-up screenings * children or adolescents will be excluded from this project without a minimum of one accompanying parent or guardian

Keywords: metabolic syndrome cardiovascular disease risk factors community intervention
a study to evaluate the safety, tolerability, pk, and pd effects of azd2389 in participants with liver fibrosis and compensated cirrhosis.

Conditions: Liver Fibrosis; Hepatic Cirrhosis

Summary: the purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises azd2389 as compared to placebo in participants with liver fibrosis and compensated cirrhosis. the study will also examine how the drug acts on the body

study details include: the study duration will be up to 63 days (9 weeks). * 1 or 2 screening visits (up to 28 days before treatment) * 28 days of treatment including 5 clinic visits * week 1: 24-hour in-clinic stay (day 1) * week 2: outpatient clinic visit (day 7) * week 3: outpatient clinic visit (day 14) * week 4: telephone visit (day 21) * week 5: 24 to 48-hour in-clinic stay (day 28) * week 6: follow-up visit (day 35) disclosure statement: the study consists of two cohorts, each with a parallel-group design and two arms, with participants blinded to treatment allocation. number of participants: the study will randomise approximately 36 participants in total. cohort a: approximately 75 participants with presumed mash/nash with fibrosis will be screened such that approximately 18 participants will be randomised. twelve participants will be randomised to receive azd2389 and 6 participants will receive placebo. cohort b: approximately 75 participants with sld with advanced fibrosis including compensated cirrhosis will be screened such that approximately 18 participants will be randomised. twelve participants will be randomised to receive azd2389 and 6 participants will receive placebo

Eligibility criteria:
key inclusions: * males/females aged ≥ 18 years * indications: presumed mash (cohort a) or other steatotic liver disease (cohort b) with fibrosis * no significant change in weight over the last 6 months * barrier contraceptives use by males * capable of informed consent * judged to be suitable for study by investigator key exclusions: * a condition that could put the participant at risk, influence the participant's ability to participate in the trial, interfere with evaluation of the study intervention or affect the interpretation of the results * other causes of liver disease which are not the principal inclusion criteria for each cohort * significant elevations in liver blood tests or platelets \<140 x10\^9/l * decompensated liver disease, hepatobiliary cancer or listing for liver transplantation * bleeding disorders or major bleeding risk * hiv infection or hepatitis b infection * clinically significant cardiovascular (e.g. severe ischaemic heart disease, severe heart failure or cardiac dysrhythmia) or cerebrovascular disease within the past 3 months * stage 2 hypertension * egfr \<60ml/min/1.73m2 * clinically significant gastrointestinal disease which can affect the interpretation of pharmacokinetic, safety, and tolerability data * skin disorders or ongoing wound healing * psychiatric disorders which may negatively affect participation in the trial. * females of childbearing potential

Keywords: liver fibrosis hepatic cirrhosis
extracellular vesicle cargo in obesity and type 2 diabetes

Conditions: Glucose Intolerance; Insulin Resistance; Diabetes

Summary: the purpose of this research is to obtain blood samples before and after a bariatric procedure to better understand the reasons for glucose intolerance and insulin resistance (diabetes) in the obesity, and the reasons for improvement of diabetes after bariatric surgery


Eligibility criteria:
inclusion criteria: * enrolled in the bariatric surgery program. * patients with a1c of 6.5 or higher within the last 6 months. or * patients with a1c less than 6.5; have diagnosis of stable type 2 diabetes for \> 6 months. exclusion criteria: * disqualified for bariatric surgery. * bmi \< 35 kg/m\^2.

Keywords: bariatric surgical procedure
engaging newly diagnosed men about cancer treatment options

Conditions: Prostatic Neoplasms

Summary: this research is being done to better understand how a new lab test called the oncotype dx prostate cancer assay may impact what treatment men decide to get and how they feel and think about their choice of treatment. the study will compare men who receive this new lab test with men who receive the usual counseling given to men after they get a new diagnosis of prostate cancer. prostate cancer is sometimes slow-growing and sometimes fast-growing. healthcare providers are searching for better ways to predict how each tumor will behave so that each man can make a better decision about when to receive treatment. the oncotype dx lab test uses leftover prostate biopsy tissue to generate a genomic prostate score (gps). the gps is related to the risk of a fast-growing cancer being discovered if surgery is performed to remove a man's prostate. the goal of this study is to find out if this test helps men when they are deciding how their prostate cancer will be treated. treatment options include surgery to remove the prostate, radiation therapy, or an approach called "active surveillance" in which there is no immediate therapy and the tumor is watched using prostate specific antigen (psa) tests and repeat biopsies.


Eligibility criteria:
inclusion criteria: * men with newly diagnosed prostate cancer who are categorized as very low, low, or intermediate risk by nccn criteria; * are age 76 or younger exclusion criteria: * men who are categorized as high or very high risk by nccn criteria; * men who have already received counseling from their urologist about their treatment options and have decided to undergo treatment, active surveillance, or watchful waiting; * men age 77 or older

Keywords: prostatic neoplasms oncotype dx treatment decisions
bio|concept.amvia study

Conditions: Bradycardia; Heart Failure

Summary: the goal of this exploratory study is to test the preliminary safety and product performance of the new amvia/solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (crt-p) implantation. the study will be conducted at sites in australia and new zealand. it is planned to include 50 subjects in the study. participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. at the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. programming of the pacemakers will be done according to the participant´s therapeutical needs.


Eligibility criteria:
inclusion criteria: * standard indication for pacemaker or cardiac resynchronization therapy pacemaker (crt-p) implantation, including de novo, upgrade or replacement implantations * ability to understand the nature of the study * willingness to provide written informed consent * ability and willingness to perform all follow-up visits at the study site * ability and willingness to use the cardiomessenger and acceptance of the biotronik home monitoring concept exclusion criteria: * planned for conduction system pacing * planned for activation of atrial anti-tachycardia pacing (aatp) without known history of atrial arrhythmia, or with permanent atrial fibrillation (af) * planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months * pregnant or breast feeding * age less than 18 years * participation in another interventional clinical investigation according to the definition given in the study protocol * life-expectancy less than 12 months

Keywords: cardiac pacemaker crt-p
precision medicine for combined hepatocellular-cholangiocarcinoma

Conditions: Liver Cancer

Summary: our project is a large-scale characterisation of chcc-cca will allow us to determine which subsets harbor actionable gene alterations. we will also aim to improve diagnosis of this tumor type by the use of immunohistochemical biomarkers and the development of deep-learning based models able to help chcc-cca diagnosis. this will represent an important step towards precision medicine for the patients with this highly aggressive malignancy.

* scientific background combined hepatocellular-cholangiocarcinoma (chcc-cca) is a rare liver cancer characterized by a dual hepatocytic and biliary differentiation. it is resistant to conventional anti-cancer treatments and there is currently no effective systemic therapy available. inter-observer agreement for diagnosis of chcc-cca is low, even among expert pathologists, and the development of clinical trials remain thus challenging. the molecular mechanisms that drive its progression also remain under-investigated. * project objectives and brief description of the methods which will be used to achieve them we aim to perform an integrative molecular, immune and phenotypical study of chcc-cca that will allow the distinction of different tumor subgroups linked to particular actionable genetic/immune alterations. the development of immunohistochemical markers and artificial intelligence-based approaches is also likely to improve the diagnosis of chcc-cca. a overall multicentric series of 357 chcc-cca samples, already available in our biobanks, will be investigated by means of gene and rna sequencing, digital pathology and immunohistochemistry in order to build a morphomolecular classification of this tumor. spatial transcriptomics and in situ proteomics will be performed to decipher the intra-tumor heterogeneity and identify biomarkers of the different subclasses. finally, deep-learning based models will be developed in order to 1) improve the diagnosis of chcc-cca and 2) identify the morphological features linked to prognosis. • expected results this large-scale characterisation of chcc-cca will allow us to determine which subsets harbor actionable gene alterations. we will also aim to improve diagnosis of this tumor type by the use of immunohistochemical biomarkers and the development of deep-learning based models able to help chcc-cca diagnosis. this will represent an important step towards precision medicine for the patients with this highly aggressive malignancy.

Eligibility criteria:
inclusion criteria: histological diagnosis of combined tumor biological sample available exclusion criteria: unequivocal histological features

Keywords: liver cancer precision medicine
corticosteroids and / or arthrographic distention in the treatment of adhesive capsulitis

Conditions: Adhesive Capsulitis; Frozen Shoulder

Summary: arthrographic distention of the shoulder joint is an increasingly popular treatment option in the management of patients with frozen shoulder. most have included the intra-articular injection of a corticosteroid as part of the procedure, but it is not known if this is necessary. it is also not known whether arthrographic distention using steroid and saline is better than intra-articular steroid injection alone. the purpose of this study is to determine whether there is an additional benefit in the combination of arthrographic distention plus intra-articular corticosteroid injection compared to arthrographic distention or intra-articular corticosteroid injection alone.


Eligibility criteria:
inclusion criteria: * pain and stiffness in predominantly 1 shoulder for 4 weeks or longer * restriction of passive motion of greater than 30° in 2 or more planes of movement (measured to onset of pain with goniometer) exclusion criteria: * previous arthrographic distention and/or corticosteroid injection * systemic inflammatory joint disease * radiological evidence of osteoarthritis of the shoulder or fracture * signs of a complete rotator cuff tear * contraindications to arthrogram and/or distention * lack of written informed consent

Keywords: arthrographic distention hydrodilatation intra-articular corticosteroid injection
spc3649 multiple dose study in healthy volunteers

Conditions: Hepatitis C

Summary: the purpose of this study is to investigate the safety and tolerability of spc3649 given in multiple doses to healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy volunteers: males and postmenopausal females aged ≥ 18 to 60 years

Keywords: antisense mir-122 antagonist safety in healthy volunteers hepatitis c