Kornimate/medical-research-clean huggingface dataset:
outcomes for one-stage and two-stage brachial basilic arteriovenous fistulas

Conditions: End Stage Renal Failure; Hemodialysis Access Failure; Arterio-venous Fistula

Summary: an arteriovenous (av) fistula is essential for patients with kidney failure on dialysis. there is no clear data on the best method to create a new brachial basilic av fistula (bbavf), so the choice between a single procedure and two separate procedures is left to the surgeon. both approaches are standard care. this study aims to compare patient-centered outcomes and quality of life by randomly assigning patients needing a bbavf to either a one-stage or two-stage procedure.

the aim of the pilot trial is to compare the outcomes of patients with end stage kidney failure (eskd) who are candidates for a new brachial basilic arteriovenous fistula (bbavf). patients will be randomized to either one-stage or two-stage bbavf procedure, both standard of care for creating bbavf. the main outcome will be primary clinical functional patency, defined as successful use of bbavf over a continuous 4-week period without any need for additional procedure on the bbavf. the secondary outcomes are fistula-related complications, duration of central venous catheter (cvc) for those on dialysis, and quality of life (qol) measures. the study hypothesizes that the primary patency will be superior following the two-stage bbavf procedure compare to one-stage procedure. however, cvc-related complications are expected to be higher following the two-stage procedure compared to the one-stage procedure. patient will be followed for a minimum duration of 12-months per subject.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. esrd receiving hemodialysis in need for new hemodialysis access; 3. candidate for one-stage and two-stage bvt procedure as judged by the enrolling investigator; 4. greater than 3 mm diameter of upper arm basilic vein on venous duplex scan; 5. life expectancy ≥ 12 months; exclusion criteria: 1. life expectancy \< 12 months; 2. brachial artery stenosis or occlusion; 3. a documented hypercoagulable state (defined as a known blood disorder associated with venous or arterial thrombosis); 4. current immunosuppressive medication, chemotherapy or radiation therapy; 5. pregnancy or lactation

Keywords: renal failure upper extremity arteriovenous fistula brachial basilic arteriovenous fistula
double blind phase iii trial of effects of low dose 13-cisretinoic acid on prevention of second primaries in stages i-ii head and neck cancer

Conditions: Stage I-II Head and Neck Cancer

Summary: in this trial the investigators propose to utilize 13-cra to prevent dysplastic changes and second malignancies in patients with squamous cell carcinoma of the head and neck regions who have a high probability of cure from their primary cancer. comparisons between patients treated by 13-cra and patients receiving placebo will include: 1. the time to diagnosis of second primary for the treatment versus control groups. 2. survival time for the treatment versus control groups. 3. secondarily, the cost-benefit ratio for 13-cra will be analyzed by assessing the toxicities of 13-cis retinoic acid treated patients in comparison to those experienced by placebo treated patients.


Eligibility criteria:
inclusion criteria: * informed consent i obtained, the approved form is signed, and on file at the institution. * histologically confirmed squamous cell carcinoma. * all chest x-rays and cervical spine x-rays done after definitive treatment within 35 days prior to randomization and all hematology andchemistries done within 2 weeks prior to randomization. * the following sites and stages of cancers will be eligible. oral cavity 1. t1 no 2. t2 no 3.142 oropharynx 1. t1 no 2. t2 no 3.143 hypopharynx 1. t1 no 3.144 larynx 1. t1 no 2. t2 no * age greater than 18 years. * ecog performance status 0 or 1. * patients must have adequate bone marrow, hepatic and renal function defined as follows: wbc \>3,500/mm, platelets \> 125,000/mm.3 total bilirubin \< 2 mg%, serum creatinine \< 2.5 mg%. serum sgot \< 2x normal, alkaline phosphatase \< 2x normal. fasting serum triglyceride levels \< 210 mg %. fasting cholesterol \< 350 mg %. patient may not be under systemic therapy for hyperlipidemia or have symptomatic arteriosclerotic coronary artery disease or have undergone coronary bypass surgery. * the patient must have completed primary treatment of their cancer with surgery and/or radiation therapy within 730 days prior to randomization. * the patient has had surgery and/or radiation therapy as outlined in sections 5.0 and 6.0, and has been rendered disease-free. * if currently receiving, patient must discontinue mega vitamin doses exclusion criteria: * women of child bearing potential. * patient with severe coronary artery disease (class iii-iv new york heart association.) * histology other than squamous cell carcinoma. * distant metastases. * completion of previous treatment for their primary cancer with radiation, or surgery (except for biopsy) more than 730 days ago. * prior, synchronous, or concurrent malignancy except basal cell skin cancer. * failure to be rendered disease-free of primary tumor (includes positive surgical margins). * the patient has had prior therapy other than that outlined in sections 5.0 and 6.0 of the protocol.
couple and spouse caregiver in huntington's disease

Conditions: Huntington Disease

Summary: the objectives are to better document the psychosocial status and needs of caregiver of hd patients and understand the dyad functioning, facing the disease at various stages.


Eligibility criteria:
inclusion criteria: for patient : * hd, cag \> 36, motor uhdrs \> 5 * being able to communicate with the investigator for both spouses : * living together since at least 5 years * 30 to 60 years old exclusion criteria: for patient : - other chronic neurologic disorder for both spouses : * psychiatric disease * unable to participate, incl read, understand and sign the informed consent

Keywords: huntington's disease spouse caregiver quality of life
central pain syndrome in survivors of head and neck cancer

Conditions: Head and Neck Cancer

Summary: this is a cross-sectional pilot study of head and neck cancer survivors who have completed multi-modal treatment to assess and characterize the presence of distinct pain syndromes.

primary objectives: * to correlate structural and functional mri signature with one of three pain phenotypes in head and neck cancer survivors: 1) no pain, 2) central pain, and 3) nociceptive pain. * to correlate the presence of chronic systemic symptoms with pain phenotype exploratory objectives: - dna, rna, and plasma will be collected for genomic, transcriptomic, and proteomic studies. results will be vertically integrated along with the results of clinical studies described within this protocol to identify targets for future correlative studies.

Eligibility criteria:
inclusion criteria: * patients with histologically proven head and neck cancer * patients without a diagnosis of head and neck cancer (up to 10 patients, see below) * we anticipate enrolling a total of 75 patients with a history of head and neck cancer who will complete all questionnaires and mri scanning. we will also recruit up to 10 patients without a diagnosis of head and neck cancer to facilitate optimization of the mri scanning processes. this will allow us to address logistical issues, such as pressure stimulator setup and timing of each scan to be performed. * completed multi-modality therapy a minimum of 6 weeks prior to study entry. * willing and able to provide informed consent * all participants must be at least 21 years of age * able to speak english exclusion criteria: * patients who are pregnant * patients who are unable to lie still * patients who are unable tolerate pressure stimulator * non-mri compatible devices such as aneurysm clips, cardiac pacemakers or defibrillators, cochlear implants, hardware, or any other implants * iron-based tattoos, pieces of metal (bullet, bb, shrapnel) close to or in an important organ (such as the eye), or other non-mri compatible metal in the body
exogenous glucose oxidation breath test

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine if oxidation of 13c glucose to 13co2 is changed in type 2 diabetic patients.

recruitment - non diabetic participants will be recruited from within the national university of ireland, galway student and staff community. diabetic patients will be recruited from university college hospital, galway in collaboration with their hospital consultant. test- day - they will undergo two separate, identical and simultaneous oral glucose tolerance test and 13c-glucose breath tests on two separate occasions after an overnight fast of 12 hours starting at 8pm. on arrival their heart rate, blood pressure, height and weight will be recorded. following a resting period of 10 minutes, samples will be obtained for fasting glucose and breath enrichment values (at t = -20 and -10mins). at t = 0 min, participants will consume a standard glucose solution. this glucose solution will consist of 150mg of 13c-glucose, 74.85g of glucose and 200ml of water and 25ml of orange flavoring. breath samples will be obtained immediately after consumption of test solution and repeated every 15 min over a 4-h interval. blood glucose concentrations will be taken every 15 min starting at t = 15 min, over a 2-h interval and every 30 min for another 2-h interval. participants will remain at rest throughout the study. sample size assessment - target recruitment is 40 non-diabetics and 40 diabetic participants. this study will use a student's t-test to determine difference, or otherwise, in glucose oxidation in breath 13co2, in 2 different groups of individuals. with power arbitrarily set at 0.8, effect size of 1.21 reduction in breath, and alpha set at 0.01 a final number of 35 participants is required for each group. the n=40 for each group is set to allow a 5 participant drop out in each group dillon et al (2009).

Eligibility criteria:
inclusion criteria: * all research participants must be between 18 and 65 years * non-diabetic participants must not be taking any medication for diabetes * participants must speak english or irish proficiently * all participants must be males * all participants must live within galway city * type 2 diabetic participants must have been diagnosed within the last five years * type 2 diabetic participants must be treated by metformin alone for their diabetes * all participants must provide written informed consent to comply with every aspect of the study exclusion criteria: * females

Keywords: 13co2 breath test glucose oxidation diabetes mellitus
optical coherence tomography in the diagnosis of scleritis and episcleritis

Conditions: Scleritis and Episcleritis

Summary: the main purpose of this study is to describe the optical coherence tomography (oct) findings in eyes with scleral inflammation and to differentiate cases with anterior scleritis from those with episcleritis and normal controls.

a total of 40 eyes will be included. 20 eyes with scleral inflammation and 20 eyes from healthy subjects as controls. each patient will undergo complete ophthalmic and medical examination. laboratory studies will performed whenever indicated. optical coherence tomography b-scans of the sclera in the perilimbal area will done for all cases.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 years any gender * patients with clinical signs of scleritis or episcleritis * signed informed consent exclusion criteria: * infectious keratitis or conjunctivitis * patients 18 years or younger * inability to open the eye

Keywords: scleritis episcleritis optical coherence tomography
balance in people with frozen shoulder

Conditions: Frozen Shoulder

Summary: the aim of this study was to investigate the balance characteristics of patients with frozen shoulder.


Eligibility criteria:
inclusion criteria: * volunteers aged 40-65 years, * diagnosed with unilateral frozen shoulder, frozen shoulder stage 2-3, * pain lasting more than 3 months, * no mental or cognitive impairment * at least 25% movement limitation in at least 2 movement planes and * able to cooperate. exclusion criteria: * who had a neurological, rheumatic, cardiac and active malignant diseases * who had a history of surgery, trauma, and fracture * who had comorbid conditions that would affect balance the control group consisted of healthy subjects who were not diagnosed with frozen shoulder and did not have a chronic disease that would affect balance between the ages of 40-65.

Keywords: adhesive capsulitis balance pain
can magnetic brain stimulation improve language function in primary progressive aphasia

Conditions: Logopenic Progressive Aphasia

Summary: the purpose of this study is to investigate the feasibility of using repetitive transcranial magnetic stimulation (rtms) - a form of non-invasive brain stimulation - to improve language functioning in individuals who have the logopenic variant of primary progressive aphasia (ppa-l) - a slowly progressive impairment of language, characterized by difficulties with word-finding, sentence repetition and sentence comprehension.

this study is an open label pilot study that aims to recruit 10 individuals with diagnosed logopenic primary progressive aphasia (ppa-l) to investigate the tolerability and efficacy of using repetitive transcranial magnetic stimulation (rtms) to improve language functioning in this disorder. rtms is a non-invasive method of brain stimulation that uses rapid magnetic pulses applied over the scalp to activate neurons in a specified target location of the brain. a variety of language tests will be administered to participants prior to rtms treatment as well as following 30 sessions of daily rtms. additionally, language testing will be performed during the first session of rtms treatment in order to assess the effect of simultaneous rtms administration on language function. performance on the pre- and post-treatment tests will be compared to determine the effect of rtms treatment on language abilities. treatment will consist of daily sessions of high frequency (10 hz) rtms applied over the left temporal gyrus. patients will receive one session of rtms per day for 30 consecutive weekdays. each session will take approximately 45 minutes to complete. as a pilot study, this research will be used to evaluate the effect size and the feasibility of a more definitive project in the future. both patient response and tolerability to rtms will be analyzed.

Eligibility criteria:
inclusion criteria: * diagnosis of ppa-l (confirmed by a neurologist or neuropsychiatrist who has observed the patient for at least one year); * mild to moderate language impairment as assessed by the druks and masterson naming task; * native english speaker. exclusion criteria: * cerebrovascular disorders, hydrocephalus or intra-cranial mass, documented by mri; * history of traumatic brain injury, seizures, or another neurological disease; * significant medical problems (e.g. poorly controlled diabetes or hypertension or cancer within the past 5 years); * major depressive disorder, bipolar disorder, schizophrenia, substance use disorder or mental retardation according to the criteria of the dsm-iv; * any contraindication for rtms (e.g., implanted metal devices; cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps, metal in the body \[rods, plates, screws, shrapnel, dentures, iud\] or metallic particles in the body, surgical clips in the head, previous neurosurgery, cochlear implants, prosthetic heart valves); * currently pregnant or breastfeeding.

Keywords: primary progressive aphasia brain stimulation
drug persistence/adherence in patients treated with dabigatran or vka for stroke prevention in non valvular atrial fibrillation (spaf)

Conditions: Atrial Fibrillation

Summary: 1600 af patients receiving pradaxa or vka for stroke prevention will be followed up for 12 months in quarterly visits. prescriptions, adverse events and (if applicable) reasons for definitive treatment discontinuation will be collected. at 6 months, patient adherence will be assessed, using the morisky score.


Eligibility criteria:
inclusion criteria: * newly prescribed treatment with pradaxa® (dabigatran etexilate)/vka in the indication "stroke prevention in non-valvular atrial fibrillation" (af) respecting the indication and contraindications as described in the respective summary of product characteristics for pradaxa® 110 mg or 150 mg hard capsules or the appropriate vka (patients are eligible for both pradaxa® and vka therapy). * treatment with dabigatran etexilate or vka is given in accordance with the respective summaries of product characteristics. the routine diagnostic procedures and treatment that would be undertaken irrespective of the study are unaffected. * only patients who are eligible both for therapy with pradaxa® and for therapy with vka in accordance with the respective summaries of product characteristics will be documented (patients eligible for vka and pradaxa®) * patients must have signed the patient consent form prior to inclusion in the non-interventional study (nis). exclusion criteria: * patients with the general and special contraindications mentioned in the packaging leaflet or summary of product characteristics must not be included. * patients participating at the same time or within the last 30 days in another non-interventional study (nis) or an interventional clinical trial must not be included. * patients treated with anticoagulants for a condition other than non-valvular atrial fibrillation must not be included. * pradaxa® and vka should not be used during pregnancy and lactation. pregnant or breastfeeding women must therefore not be included in the nis.
efficacy and safety of ricovir® in maintaining durability of viral response in chronic hepatitis b patients who have been treated with viread® and have undetectable hbv dna in serum

Conditions: Chronic Hepatitis B Infection

Summary: this is a phase iv, open label, historical controlled comparative study to evaluate the efficacy and safety of ricovir® in maintaining durability of viral response in chb patients who have been treated with viread® and have undetectable hbv dna in serum by real-time polymerase chain reaction (pcr) assay.


Eligibility criteria:
ricovir® group inclusion criteria: * male or female aged more than 20 years old; * chb patients who have been treated with viread® for more than 1 year; * serum hbv dna level is undetectable (not detected or \<20 iu/ml) at screening; * informed consent must be obtained before the commencement of any screening procedures or study drugs exclusion criteria: * patients with active hcc or other types of malignancy; * patients with impaired renal function (defined as egfr ≦ 30 ml/min/1.73m2); * patients with hepatitis a (hav), hepatitis c (hcv), hepatitis d (hdv) or human immunodeficiency virus (hiv) coinfection; * patients with alcohol dependence or addiction; * patients with autoimmune hepatitis; * patients with primary biliary cholangitis (pbc); * pregnancy, planning on getting pregnant, or breast-feeding; * history of allergy, hypersensitivity, intolerance, or experiencing severe adverse reactions to tenofovir or any ingredient of the study drug; * not suitable for participating in this trial at the investigator's discretion. historical control group eligible individuals will be obtained from the tcvgh historical database based on matching (1:1) in terms of age (±5 years) and gender. to be eligible for the study, subjects must meet all of the following criteria: * male or female aged more than 20 years old; * chb patients who had been treated with viread® for more than 1 year; * patients who had discontinued viread® therapy for at least 24 weeks during the period from january 2014 to december 2021 and had undetectable hbv dna (not detected or \<20 iu/ml) in serum at the time of discontinuation; * patients who have the data of hbv dna level 24 weeks after the time of discontinuation, with a time window of +4 weeks is allowed; * the informed consent requirement will be waived based on the approval of irb.
matrix metalloproteinases in patients with critical limb ischemia undergoing surgical revascularization

Conditions: Critical Limb Ischemia; Extracellular Matrix Alteration; Peripheral Revascularisation

Summary: in the present study the investigators will evaluate mmps. serum levels variations in patients affected by critical limb ischemia, before and after lower limb surgical revascularization through venous or prosthetic bypass.

recent clinical studies showed an association between peripheral artery disease (pad) and circulating levels of matrix metalloproteinases (mmps), especially mmp-2, mmp-9, mmp-8 and mmp-10, compared with healthy controls. a recent study showed the association between mmp-10 serum levels and severity and poor outcome in patients affected by critical limb ischemia (cli). also, mmps seems to be involved in intimal hyperplasia and constrictive remodeling, both responsible of restenosis after surgical treatment of atherosclerotic lesions. intimal hyperplasia is a thickening of the tunica intima resulting in narrowing of the vessel lumen. elevated tissue levels of mmp-2 and mmp-9 have been identified in pig models of vein bypass grafts, temporally coinciding with the period of smooth muscle cells (smc) migration and neointimal formation. in the present study the investigators want to evaluate mmp-1; mmp-2, mmp-9, mmp-8 and mmp-10 serum levels variations in patients affected cli, before and after lower limb surgical revascularization through venous or prosthetic bypass in order to assess their role in predicting the surgical outcome of these procedures. patients with cli will be randomized to receive lower limb surgical revascularization through autogenous venous (group i) or prosthetic bypass (using synthetic polytetrafluoroethylene - ptfe- ) (group ii). patients enrolled in the present study will be followed through clinical and ultrasonographic examination at 1, 3, 6, 12 and 24 months. at the same time points mmps plasma levels (by means of blood sampling through venipuncture) will be evaluated. clinical, instrumental and laboratory data then will be matched.

Eligibility criteria:
inclusion criteria: * patients with cli stage iii-iv according to the fontaine's classification exclusion criteria: * patients with evidence of systemic sepsis, known neoplastic disease or any established generalized inflammatory disease