Kornimate/medical-research-clean huggingface dataset:
dbs tat in peer-assisted telemedicine for hepatitis c

Conditions: Hepatitis C

Summary: the purpose of this study is to compare the rate of treatment initiation achieved by peer-assisted telemedicine contingent on phlebotomy (usual care) versus that achieved with a new protocol, called dried blood spot test and treat (dbs tat). dbs tat includes dbs testing to diagnose hepatitis c (hcv), utilizes a novel clinical decision aid that identifies patients who are low risk for hepatic (liver) fibrosis, and directs those patients to hcv treatment initiation prior to routine hepatic fibrosis assessment. the investigators hypothesize that dbs tat will increase the rate of hcv treatment initiation compared to peer-assisted telemedicine contingent on phlebotomy (usual care).

oregon has the fourth highest prevalence of hepatitis c (hcv) and third highest hcv-related mortality in the nation and it predominantly effects people who use drugs (pwud). to respond to this, peer assisted telemedicine for hepatitis c (paths), a substance abuse and mental health services administration supported telemedicine-based hcv treatment program that serve pwud in predominantly rural areas of oregon was created. paths partners with "peers," people with lived experience of substance use, who work for community-based organizations serving pwud in high-needs rural counties. patients are referred to paths from opiate treatment programs and community-based organizations throughout the state, which are paths' "sites." the leading barrier to hcv treatment initiation within paths is the requirement for participants to complete phlebotomy prior to treatment. to address this problem, paths is piloting the use of commercially available, laboratory-validated dried blood spot (dbs) tests to confirm active hcv, but patients who complete dbs must still undergo either phlebotomy or transient elastography (teg) to complete guideline-recommended hepatic fibrosis staging before hcv treatment. transient elastography is a validated, non-invasive, clinical standard of hepatic fibrosis assessment covered by oregon medicaid, but it is inconvenient to access in rural areas. this study aims to determine the impact of dried blood spot test and treat (dbs tat) compared to phlebotomy-contingent treatment (usual care) in a cluster randomized controlled trial performed within peer assisted telemedicine for hepatitis c (paths). the primary outcome is the rate of treatment initiation in paths sites utilizing dbs tat versus paths sites utilizing usual care. 18 paths sites are randomized to dbs tat implementation or ongoing usual care. within dbs tat, participants with low risk for hepatic fibrosis will be offered hcv treatment without phlebotomy but will still undergo imaging-based hepatic fibrosis assessment to ensure safety.

Eligibility criteria:
inclusion criteria: * active hepatitis c infection * willing to engaged with the paths program for clinical care exclusion criteria: • currently pregnant

Keywords: hepatitis c substance use
evaluation of patient reported outcome instruments in celiac disease patients

Conditions: Celiac Disease

Summary: this is an evaluation of celiac-specific patient reported outcome instruments in celiac disease patients.


Eligibility criteria:
inclusion criteria: * history of biopsy proven celiac disease * adherence to a gluten-free diet (established patients only) * tg2 negative (established patients only) * tg2 positive (newly diagnosed patients only) * signed informed consent exclusion criteria: * history of ige-mediated reactions to gluten * significant laboratory abnormalities * history of untreated or gi disease * positive pregnancy test * any medical condition which could adversely affect study participation

Keywords: celiac disease coeliac disease celiac sprue keilakia disease
cardiovascular outcomes in orthotopic liver transplanted patients (colt study)

Conditions: Liver Transplant; Complications; Cardiovascular Complication; Cardiovascular; Attack; Cardiovascular Stroke; Death

Summary: all patients with orthotopic liver transplantation who are evaluated and followed at each participating centers will be recorded in this study. within this register a characterization of patients and therapy will be done. prognostic factors of defined clinical relevant endpoints will be evaluated.


Eligibility criteria:
inclusion criteria: * all patients with ortothopic liver transplantation and at least 2 year follow-up at the referral center exclusion criteria: * missing informed consent form * missing contact informations for follow up
virtual reality therapy on dysphagia in wallenberg syndrome

Conditions: Wallenberg Syndrome

Summary: the goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. the main questions it aims to answer are: the efficacy of virtual reality therapy in the rehabilitation of patients with dysphagia in wallenberg syndrome. participants received conventional dysphagia treatment and virtual reality therapy once a day for 14 days. researchers compared the control group to see the effect and mechanism of virtual reality therapy.

virtual reality technology has revolutionized various fields, and its application in rehabilitation medicine is particularly noteworthy. virtual reality provides immersive environments that simulate real-life situations, making it an invaluable tool in the rehabilitation process. the goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. the main questions it aims to answer are: the efficacy of virtual reality therapy in the rehabilitation of patients with dysphagia in wallenberg syndrome. participants received conventional dysphagia treatment and virtual reality therapy once a day for 14 days. researchers compared the control group to see the effect and mechanism of virtual reality therapy.

Eligibility criteria:
inclusion criteria: * age more than 18, and right-handed; * first onset, vital signs stable and conscious; * the dysphagia confirmed by videofluoroscopic swallowing study; * no cognitive impairment, the mini-mental state examination score: \>17 for those with an illiterate education, \>20 for those with an elementary education, and \>24 for those with a secondary education and above; * cranial integrity without craniotomy and/or craniectomy; * patient and/or his/her relative agrees and signs written informed consent. exclusion criteria: * combined ischemic foci at other sites; * presence of organic swallowing dysfunction or pre-existing dysphagia due to parkinson's disease, dementia, and others; * severe cardiac, pulmonary, hepatic, and renal insufficiency and vital organ failure; * infected or broken skin on the head; * poorly controlled epilepsy; * poor patient compliance.
impact of perioperative treatment with intravenous glutamine on myocardial protection in cardiac surgery patients with aortic stenosis

Conditions: Aortic Valve Stenois

Summary: the purpose of this study is to confirm if myocardial protection effect can be obtained by intravenous administration of glutamine in patients undergoing aortic valve replacement with severe aortic stenosis (who are at high risk for ischemia-reperfusion injury). as a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the degree of myocardial damage(with ck-mb and troponin t) and myocardial protection (through hsp 70 expression in atrial tissue), cardiovascular index, inflammatory reaction, and clinical manifestation.


Eligibility criteria:
inclusion criteria: * adult patients with between 20 and 80 years scheduled for aortic valve replacement alone or combined surgery including aortic valve replacement due to severe aortic valve stenosis exclusion criteria: * patients with renal insufficiency (egfr 60 ml / min / 1.73 m 2 or less) * patients who are considering surgery for coronary artery disease or who have a stenosis\> 70% * hemodynamically unstable patients undergoing emergency surgery or patients with intra-aortic balloon pump insertion * patients unable to make their own decisions, illiterate, foreigners * epilepsy * severe metabolic acidosis * pulmonary edema * history of myocardial infarction * elevation of total bilirubin or ast / alt * patients higher than normal, weighing more than 80 kg * with evidence of infection * pregnant and lactating women
a feasibility study on the use of f-18-fdg-pet and optical imaging in evaluation of radiation-induced oral mucositis

Conditions: Squamous Cell Carcinoma of the Oral Cavity; Oropharynx Metastases; Lymph Metastases

Summary: in this study, the feasibility of optical imaging and fdg-pet in the evaluation of radiation-induced mucositis will be evaluated.


Eligibility criteria:
inclusion criteria: * non-operated histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx (except the posterior wall) and lymph node metastases from the unknown primary tumor (cup) * stage t1-4; tx n+ for the cup * multidisciplinary group of head and neck tumors at ghent university hospital decision of radical radiotherapy (±concurrent chemotherapy) * informed consent obtained, signed and dated before specific protocol procedures. exclusion criteria: * age \< 18 years * pregnant or lactating women * active infection or fistula in the oral/oropharyngeal mucosa * previous cancer of the oral cavity and the oropharynx * prior head-and-neck radiotherapy * expectation of non-compliance with the study protocol * known allergy for topical anesthetics (xylocaïne)

Keywords: oropharynx and lymph node metastases from an unknown primary tumor
perillyl alcohol followed by surgery in treating patients with stage ii or stage iii pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. purpose: phase ii trial to study the effectiveness of perillyl alcohol followed by surgery in treating patients who have stage ii or stage iii pancreatic cancer.

objectives: i. assess the biologic activity of perillyl alcohol in patients with potentially resectable, stage ii or stage iii pancreatic adenocarcinoma. ii. characterize the acute toxicity of this drug in these patients. iii. evaluate the antitumor activity of this drug in these patients. iv. monitor and quantitate the plasma levels of perillyl alcohol after oral administration in this patient population. outline: patients receive oral perillyl alcohol 4 times daily on days 1-14. patients undergo surgical resection on day 15. there is no continuation of perillyl alcohol postoperatively. patients are followed at a minimum of 2 and 4 months following surgery. projected accrual: a total of 10 patients will be accrued for this study within 12-18 months.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed stage ii or stage iii pancreatic adenocarcinoma that is considered resectable lesions should be amenable to surgery with curative intent bidimensionally measurable or evaluable disease no evidence of metastatic disease no clinically detectable third space fluid collections (e.g., ascites or effusions) patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: not specified hematopoietic: wbc at least 3,500/mm3 platelet count at least 100,000/mm3 hemoglobin at least 9.5 g/dl hepatic: bilirubin no greater than 4 times upper limit of normal (uln) ptt no greater than 1.5 times control (unless on anticoagulants) renal: creatinine no greater than 1.5 times uln other: not pregnant or nursing fertile patients must use effective contraception no concurrent serious systemic disorders incompatible with study no active infection no second primary malignancy, previously untreated with curative intent or presently active, that would preclude curative resection of the pancreas prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy for pancreatic carcinoma endocrine therapy: not specified radiotherapy: no prior radiotherapy for pancreatic carcinoma surgery: see disease characteristics other: at least 1 month since prior investigational agents at least 72 hours since prior anticoagulant therapy, cholesterol-lowering agents (e.g., lovastatin), high dosage vitamins, or antioxidants no concurrent anticoagulants except for the sole purpose of central line patency maintenance no other concurrent investigational agents

Keywords: stage ii pancreatic cancer stage iii pancreatic cancer adenocarcinoma of the pancreas
randomised study comparing the effects of inhaled fluticasone furoate (ff)/vilanterol (vi; gw642444m) combination and ff on an allergen induced asthmatic response

Conditions: Asthma

Summary: we propose to use an inhaled allergen challenge model to explore the individual contributions of the components of a novel long-acting beta agonist (laba)/ inhaled corticosteroid (ics) combination product on protection from allergic triggers in asthma.


Eligibility criteria:
inclusion criteria: * body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2). * females of non-child bearing potential. * documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation * pre-bronchodilator fev1 \>70% of predicted at screening * subjects who are current non-smokers * methacholine challenge pc20 \< 8 mg/ml at screening * screening allergen challenge demonstrates that the subject experiences an early asthmatic response exclusion criteria: * current or chronic history of liver disease, or known hepatic or biliary abnormalities * subject is hypertensive at screening * respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication. * history of life-threatening asthma * symptomatic with hay fever at screening or predicted to have symptomatic hayfever * unable to abstain from short acting beta agonists * unable to abstain from antihistamines * unable to abstain from other medications including non-steroidal anti-inflammatory drugs (nsaids), anti-depressant drugs, anti-asthma anti-rhinitis or hay fever medication * the subject has participated in a study with a new molecular entity during the previous 3 months or has participated in 4 or more clinical studies in the previous 12 months * undergoing allergen desensitisation therapy

Keywords: mild asthma allergen challenge early asthmatic response
interventistic clinical investigation on the use of medical device in subjects with mild-moderate osteoarticular pain

Conditions: Osteoarthritis, Knee

Summary: evaluation of the performance and safety of artofill in subjects with mild to moderate osteoarticular pain

monocenter, prospective, open label, interventional clinical investigation evaluating the performance and safety of 3 intra-articular injections of artofill for the treatment of mild-moderate osteoarticular pain.

Eligibility criteria:
inclusion criteria: * patient (males and females) aged between 18 and 84 years (limits included); * patient able to understand the nature and purpose of the study, including possible risks and side effects; * patient able to provide written informed consent, in accordance with good clinical practice and current legislation; * pain ≥ 40 mm on the vas score in the target knee for at least 2 months; * patient with knee osteoarthritis assessed radiographically, grade 1 to 3 according to the kellgren-lawrence scale (k-l); * body mass index (bmi) ≤ 35; * patient who will benefit from this treatment; * patient available for the entire study period; * patient able to cooperate and meet the requirements of the clinical investigation plan. exclusion criteria: * patient with knee osteoarthritis, assessed radiographically, grade 4 by the k-l scale; * patient presenting ongoing inflammation/infection at the level of the joint being investigated; * patient with abundant intra-articular effusion; * patient with symptoms of viral or bacterial infections or similar; * patient with insertion point of the joint infected or in the presence of a skin disease; * simultaneous treatment with disinfectants containing quaternary ammonium salts or chlorhexidine; * patient with known or potential allergy or hypersensitivity and/or history of allergic reactions to one of the components of the medical device; * concomitant treatments with thrombolytic or anticoagulant therapies, for less than 2 weeks prior to the screening visit; * intra-articular treatments carried out in the last 3 months (9 months if with products containing hyaluronic acid) of the target joint; * topical treatments of the target joint in progress or performed within 1 week of the screening visit; * taking nsaids and/or paracetamol as rescue treatment for more than two consecutive days; * surgical interventions of prosthetic replacement in the target joint; * physiotherapy and instrumental physical therapy treatments for the target joint performed in the last 2 weeks prior to the screening visit, and during the study period; * participation in another clinical trial within 60 days prior to the screening visit; * evidence of severe or uncontrolled systemic disease or any other significant disorder (e.g. haemophilia, bleeding disorders etc.); which do not allow participation in the study or could compromise the results. * patients who are pregnant or breastfeeding; * subject unable to follow clinical investigation procedures and follow-up visits; * any other medical condition which could influence participation in the clinical investigation or compromise its results.
assessment of aliskiren/amlodipine and amlodipine on ankle foot volume (afv) in patients with hypertension

Conditions: Hypertension; Ankle Edema

Summary: the purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.


Eligibility criteria:
inclusion criteria: * patients (male or female) with hypertension aged between 18-75 yrs. * patients not treated with amlodipine or no amlodipine in previous 1 year. * post-menopausal females exclusion criteria: * patients unable to switch from prior hypertensive medication. * severe hypertension. * pregnant or nursing females. * patients with type 1 or type 2 diabetes mellitus * history of immunodeficiency diseases, including a positive human immunodeficiency virus (hiv) (enzyme-linked immunosorbent assay \[elisa\] and western blot) test result. * a positive hepatitis b surface antigen (hbsag) or hepatitis c test result. other protocol-defined inclusion/exclusion criteria are applied

Keywords: pedal edema hypertension aliskiren amlodipine
a study of pimitespib in combination with imatinib in patients with gist (chapter-gist-101)

Conditions: Gastrointestinal Stromal Tumors

Summary: this study consists of dose escalation part and expansion part. in dose escalation part, the maximum tolerated dose of combination of pimitespib and imatinib in patients with gastrointestinal stromal tumors (gist) who are judged to be refractory to imatinib, estimate the recommended dose, evaluate safety and pharmacokinetics, and observe the antitumor effect. expansion part consists of 3 arms. in arm a, the efficacy and safety will be evaluated, which of the combination of pimitespib and imatinib in patients with gist who have failed imatinib at doses below the mtd determined in dose escalation part. in arm b, the efficacy and safety of pimitespib monotherapy will be evaluated and the therapeutic effect of imatinib administration after pimitespib will be evaluated in an exploratory manner. in arm c, the efficacy and safety of sunitinib monotherapy will be evaluated as reference data.


Eligibility criteria:
inclusion criteria: * provided written informed consent * histologically confirmed gist * has radiographic progression based on recist 1.1 during or within 6 months of the last imatinib administration at enrollment. if surgery/radiotherapy has been performed, radiographic progression based on recist 1.1 with imatinib must have been observed after the last surgery /radiotherapy * has at least one measurable lesion based on the recist version 1.1, except lymph nodes (not dependent on size), which should be chosen as nontarget lesions; * eastern cooperative oncology group (ecog) performance status of 0 to 1 exclusion criteria: * corrected visual acuity \< 0.5 (using the international visual acuity measurement standard) for both eyes * received treatment with any other line of therapy besides imatinib for advanced gist * history of total gastrectomy and/or whole resection of the small intestine * a serious illness or medical condition * previous or concurrent cancer that is distinct in primary disease or histology from cancer that is being evaluated in this study. however, any previous cancer curatively treated \> 5 years before the enrollment can be eligible * pregnancy or lactation (including lactation interruption)
safety and efficacy of baclofen for treatment of muscle spasms in patients with cirrhosis: a pilot study

Conditions: Muscle Cramps; Cirrhosis

Summary: the purpose of this study is to determine the safety and efficacy of the medication baclofen for treatment of muscle cramps in patients with cirrhosis.


Eligibility criteria:
inclusion criteria: * cirrhosis * presence of muscle cramps on a regular basis exclusion criteria: * allergy or hypersensitivity to baclofen * active or untreated portosystemic encephalopathy * active alcohol or substance abuse * age less than 18 * pregnancy * concomitant use of narcotic pain medication, other muscle relaxer, or other anti-spastic agent * concomitant use of tricyclic antidepressant due to drug interaction * history of chronic kidney disease defined by gfr \< 30 (using mdrd equation) * subject is institutionalized or a prisoner * inability or unwillingness to give informed consent * expected lifespan less than 3 months * severe or poorly controlled coexisting medical conditions or other significant issues as determined by the principal investigator to hinder the ability to adhere to study protocols
evaluation of pandemic influenza a (h1n1)candidate vaccines

Conditions: Influenza

Summary: this is a prospective phase i study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza a (h1n1) virus.

the candidate vaccines are produced by butantan institute - sao paulo, brazil

Eligibility criteria:
inclusion criteria: * health adults of both genders * age ≥ 18 ≤ 50 years * able to understand every required study procedure * female volunteers should agree to take an acceptable contraceptive method menopause is characterized by absence of menstrual flux for two consective years * normal values for pre-stablished laboratory assays * accpetance to participate and sign the consent form exclusion criteria: * any chronic condition * be on immunossupressive or stimulant therapy * have egg alergy * have past history of alergy to sazonal influenza vaccine * have received another inactivated vaccine within the prior 2 weeks or a live vaccine in the past four weeks to his/her participation in the study * acute infectious disease during seven days prior vaccination * female on breasthfeeding * confirmed prior infection by pandemic influenza a * participation in another clinical trial in the last 6 months * any other condition identified by the principal investigator which is considered not safe for enrollment of the volunteer

Keywords: vaccine pandemic influenza a adjuvant safety