Kornimate/medical-research-clean huggingface dataset:
study of itraconazole in patients with advanced hiv infection

Conditions: HIV Infections

Summary: to demonstrate a dosage regimen for intravenous itraconazole that produces a plasma concentration range comparable to that obtained after currently used oral dosages of itraconazole oral solution; and to obtain preliminary safety data in patients with advanced hiv disease.

patients will receive intravenous itraconazole solution twice daily for 2 days and then once daily for five additional days. patients then randomized to receive twice-daily or once-daily itraconazole oral solution for an additional 28 days.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: antiretroviral therapy providing patient has already been on a stable, unchanged regimen for 8 weeks prior to study entry. patients must have: * documented hiv infection. * cd4 lymphocyte count \< 300 cells/mm3. * no clinically significant abnormalities, elicited by history and physical examination. * no clinically significant abnormalities in blood count, biochemical profile, or urinalysis within 2 weeks of study entry. * negative urine screening. * no clinically significant abnormalities of electrocardiogram. prior medication: allowed: antiretroviral therapy providing patient has been on a stable, unchanged regimen for 8 weeks prior to study entry. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * acute opportunistic infection or other significant concurrent illness that would preclude participation for the required 36 days. * unable to swallow oral solution. * obesity greater than 25% of ideal body weight. concurrent medication: excluded: * rifampin. * rifabutin. * phenobarbital. * phenytoin. * carbamazepine. * digoxin. * warfarin. * midazolam. * triazolam. * terfenadine. * astemizole. * cisapride. * h2 blockers. * omeprazole. * continual antacids. * didanosine. * any medication known to affect absorption, metabolism or excretion of imidazole or azole compounds. patients with the following prior symptoms and conditions are excluded: * previous hypersensitivity to azole antifungals. * history of surgical procedure that may interfere with absorption of itraconazole. * history of significant blood loss in the previous 30 days. prior medication: excluded: excluded within 15 days prior to study entry: * rifampin. * rifabutin. * phenobarbital. * phenytoin. * carbamazepine. * digoxin. * warfarin. * midazolam. * triazolam. excluded within 8 weeks prior to study entry: * change in antiretroviral therapy. risk behavior: excluded: patients who chew tobacco or regularly smoke more than 10 cigarettes per day.

Keywords: itraconazole administration, oral antifungal agents acquired immunodeficiency syndrome drug administration schedule
magnesium alloy scaffold for coronary artery disease (magic)

Conditions: Coronary Artery Disease; Myocardial Infarction

Summary: the retrospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world setting including high volume pci centers in italy

coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (pci) according to existing guidelines. however, thrombosis and restenosis are still the main limitations of current permanent metallic stents. in contrast to bare metal stents (bmss), drug eluting stents (dess) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. however, late and very late stent thrombosis remains the limitation of des in spite of prolonged dual antiplatelet therapy. bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents. the aim of this observational retrospective study is to investigate the clinical performance and long-term safety of scaffold in a real world setting. institution involved in the present registry are high volume pci centers. operators have experience in pci with bioresorbable scaffolds technology the study organization is based on: data safety monitoring board (dsmb) all adverse events will be reported to the dsmb and reviewed on an on-going basis throughout the subject enrolment and follow-up period to ensure the safety of subjects enrolled in this study. in case of clinical events, coronary artery angiographies and percutaneous coronary interventions was reviewed by an independent core-lab.

Eligibility criteria:
inclusion criteria: * subjects \>18 years * able to provide an informed consent * implantation of at least one scaffold exclusion criteria: * inability to provide at least one year follow-up

Keywords: bioresorbable scaffolds magnesium made bioresorbable scaffolds magmaris coronary artery disease percutaneous coronary intervention myocardia infarction multivessel coronary disease
a study of tirzepatide in participants with impaired liver function

Conditions: Hepatic Insufficiency

Summary: the purpose of this study is to assess how fast tirzepatide gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants. the study will last about two months and will include five visits to the study center.


Eligibility criteria:
inclusion criteria: all participants: * women of childbearing potential are excluded from the study. * women not of childbearing potential may participate and include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or postmenopausal * are between the body mass index (bmi) of 19.0 and 40.0 kilograms per meter squared (kg/m²), inclusive, at screening healthy participants: - healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function participants with impaired liver function: * males or females with chronic mild, moderate and severe liver impairment, assessed by child-pugh scoring * have type 2 diabetes mellitus (t2dm) controlled with diet or exercise alone or on stable doses of metformin for at least 8 weeks * have a hemoglobin a1c (hba1c) ≥6.0% and ≤11.0% at screening exclusion criteria: all participants: * have known allergies to tirzepatide or related compounds * have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2 * have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gi disorder (eg, relevant esophageal reflux or gall bladder disease) or any gi disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (glp-1) analogs or dipeptidyl peptidase iv (dpp-iv) inhibitors participants with impaired liver function: * have hemoglobin \<8.5 grams per deciliter (g/dl) * have kidney function that is significantly impaired at screening * have taken any glucose-lowering medications other than metformin, including insulin, in the past 3 months before screening * have brain function impaired significantly due to liver condition
a study to learn about the study medicine called pf-07868489 in healthy adult people and in people with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: the purpose of the study is to learn how the study medicine called pf-07868489 is tolerated and acts in healthy adult people and people with pulmonary arterial hypertension (pah). part a: an investigator- and participant-blind, sponsor-open, placebo-controlled, single ascending dose study to assess the safety, tolerability, and pharmacokinetics (pk) of pf-07868489 in healthy adult participants. part b: a 24-week, randomized, double blind, placebo-controlled study to assess the safety, tolerability, pk, and pharmacodynamics (pd) of pf-07868489 in adult participants with pah.


Eligibility criteria:
key inclusion criteria part a: * overtly healthy * body mass index (bmi) of 16 to 32 kg/m2; and a total body weight \>50 kg. key exclusion criteria part a: * clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, infections or allergic disease. * smoking more than 10 cigarettes (or equivalent) per day or smoking history ≥10 pack-years. key inclusion criteria part b: * diagnosis of pulmonary arterial hypertension (pah) * stable dose of standard of care pah vasodilators * bmi 16 to 32 kg/m2; and a total body weight \>45 kg. * 6mwd ≥ 150 and ≤ 450. * pre-randomization rhc documenting a minimum of pvr ≥ 400 dyn ∙sec/cm5. key exclusion criteria part b: * any medical or psychiatric condition or laboratory abnormality. * stopped receiving pulmonary hypertension chronic general supportive therapy 90 days prior to day 1. * pulmonary capillary wedge pressure \> 15 mmhg on right heart catheterization (rhc) conducted during screening. * history of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product. * major surgery within 8 weeks prior to randomization. * participants who smoke more than 10 cigarettes (or equivalent) per day or has a smoking history ≥10 pack-years.

Keywords: pulmonary high lung artery pressure
two year follow up of cadence total ankle replacement

Conditions: Ankle Arthritis

Summary: over the last decades, total ankle replacement (tar) emerged as a reliable treatment option in end-stage ankle osteoarthritis (oa) while preserving motion and physiological load. the cadence™ is a fourth-generation, two-component, fixed-bearing implant with minimal tibial and talar resection. it has been in clinical use since july 2016, the purpose of this study was to compare the clinical outcome and radiological outcomes of total ankle arthroplasty with use of the cadence™ prosthesis at st. michael's hospital.

over the last decades, total ankle replacement (tar) emerged as a reliable treatment option in end-stage ankle osteoarthritis (oa) while preserving motion and physiological load. the cadence™ is a fourth-generation, two-component, fixed-bearing implant with minimal tibial and talar resection. it has been in clinical use since july 2016, the purpose of this study was to compare the clinical outcome and radiological outcomes of total ankle arthroplasty with use of the cadence™ prosthesis at st. michael's hospital.

Eligibility criteria:
inclusion criteria: * ankle arthritis treated with cadence total ankle replacement system exclusion criteria: * under 18 years of age
cold plasma therapy for acceleration of wound healing in diabetic foot

Conditions: Diabetic Foot

Summary: diabetic foot is a common complication of diabetes mellitus and requires specialized treatment. wounds are characterized by persistent infection and chronic inflammatory processes, impeding well directed matrix remodelling and wound closure. cold plasma applications have demonstrated beneficial effects on wound healing in several case reports. the investigator-initiated "kaltplasma wund (kpw)-trial" was performed to prove beneficial effects of cold plasma in wound healing in a prospective, placebo-controlled, randomized bi-center study.

diabetic foot (df) is a major complication in patients with diabetes leading to increased risk of hospitalization, lower limb amputation, and death, as well as a significant decrease in quality of life. during lifetime the risk for developing df is assumed to be 25%; with 30% of df resulting in lower limb amputation. if compared to general population people with diabetes have a 20-fold higher risk for amputation. diabetes mellitus is the leading cause of lower limb amputation. ulceration and impaired wound healing are commonly associated with common co-morbidities; the increased risk of infection amongst patients with diabetes is driving chronification and accounts for lack of wound healing. non-thermal atmospheric pressure plasma has been proposed as a tool for various biological and medical applications relying on its capacity to reduce bacterial load in the wound and to initiate wound healing. biological plasma effects are largely dependent on plasma-generated reactive species in the gas phase, which subsequently diffuse or react with proteins and lipids in cells or tissues. thus, the objective of this placebo-controlled patient-blinded study was to show that application of cold plasma in addition to standard care treatment compared to placebo could accelerate wound healing in terms of more rapid and clinical meaningful wound surface regression. wound closure progression and microbiological analysis were monitored time dependently to prove the effects. patient's well-being and subjective perceptions were evaluated during treatment.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus * hba1c ≤ 10% * at least one chronic wound persisting for at least three weeks without healing tendency following standard care wound therapy (armstrong wagner grade ib or iib) exclusion criteria: * concomitant wound treatment with local vacuum therapy or maggot therapy * dialysis * use of topical active antibiotics, * concomitant treatment with platelet rich fibrin, * presence of critical limb ischemia defined as ankle brachial index below 0.5 or transcutaneous oxygen pressure below 15 mmhg. * participation in another clinical trial * women of child bearing potential without effective contraception or active breastfeeding
immune response to high-dose vs. standard dose influenza vaccine

Conditions: Elderly Immune System

Summary: this 5-year proposal is a randomized study of split-virus influenza vaccine (svv) in a high-dose (hd) vs. standard-dose (sd) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a newly approved high-dose influenza vaccine in older people


Eligibility criteria:
inclusion criteria: 1. written informed consent provided by the participant 2. age 20-40 years old with no underlying chronic diseases or age ≥65 years old 3. willing to receive influenza vaccination 4. older cohort has received their influenza vaccine for the previous influenza season - exclusion criteria: 1. immunosuppressive disorders or medications (including oral prednisone in doses \>10 mg daily) 2. have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination 3. participant has received a community available influenza vaccine for the approaching influenza season 4. females who are pregnant at visit 1 (a pregnancy test will be administered for all females of child-bearing potential) -

Keywords: influenza vaccine
the effects of compensatory auditory stimulation and transcranial direct current stimulation on tinnitus perception

Conditions: Tinnitus

Summary: this study evaluates the ability of compensatory auditory stimulation (cas) and transcranial direct current stimulation (tdcs) to help alleviate tinnitus. subjects will receive cas, tdcs, and the combination of the two to assess the effectiveness of the treatment.

tinnitus refers to persistent "ringing in the ears" in absence of external sound. for some individuals tinnitus can be disabling. most tinnitus is of idiopathic origin and currently there are no reliable treatment options available. existing approaches, such as hearing aids, counseling, and noise masking typically provide only partial relief and only for a minority of patients. newer exploratory methods include tailored auditory stimulation and various brain stimulation techniques. while these techniques show great promise in a subset of subjects (maybe about 1/3), it is hard to anticipate which, if any, will benefit a given patient. transcranial direct current stimulation (tdcs) has been explored for a number of neurological conditions, and it is most effective when paired with some form of training (e.g. motor rehab after stroke). for tinnitus however this treatment modality has only been tested in isolation. the purpose of this pilot study is to explore the benefits of combining tailored compensatory auditory stimulation with tdcs. there is widespread consensus in the research community that tinnitus originates with some peripheral hearing deficit, and that maladaptive central plastic mechanisms subsequently lead to the tinnitus percept. most individuals with tinnitus have audiometric evidence of hearing loss. our hypothesis is that reduced input to the auditory pathway leads to increased sensitivity (auditory gain) and finally aberrant activity in the frequency band with hearing loss. in this view, auditory stimulation that compensates for the reduced input can potentially revert the maladaptive plasticity.this is consistent with the reported benefits of hearing aids and tailored auditory stimulation. our hypothesis is that tdcs can boost adaptation induced by compensatory auditory stimulation to reduce the strength of the phantom percept.

Eligibility criteria:
inclusion criteria: * between 18-80 years of age * no history of otological disease * subjects with hearing loss, hyperacusis and/or tinnitus are eligible to participate exclusion criteria: * hearing loss greater than 50 db hl * shows signs of depression or anxiety (zung self-rating depression scale \> 50; beck anxiety inventory \> 36)
social cognition training in schizophrenia

Conditions: Schizophrenia; Social Cognition

Summary: people with schizophrenia show deficits in social cognition, the ability to process information about other people such as identifying their emotional expressions. social cognition is associated with everyday life functioning and could therefore be an important treatment target. several social cognitive training programs have been developed during the last years. results indicate that social cognitive performance can be ameliorated through commonly used intervention techniques. however, it is less clear whether this improvement generalizes to everyday life. the purpose of this study is to investigate if a social cognitive training program (training in affect recognition) improves performance on social cognitive and neuropsychological tests and leads to improved everyday life functioning in persons with schizophrenia. the study also aims at examining if an improvement is present three months after completion of the training intervention.


Eligibility criteria:
inclusion criteria: * age 18-55 * diagnosis of schizophrenia or schizoaffective disorder * iq \> 69 * sufficient mastery of norwegian to undergo assessments exclusion criteria: * history of head trauma * neurological/medical condition known to interfere with central nervous system * receiving outpatient care at time of recruitment

Keywords: functional capacity training neurocognition
increasing colorectal cancer screening in urban african american communities via churches

Conditions: Colorectal Cancer

Summary: this is an intervention study to increase colorectal cancer screening and physical activity in members of african-american churches who are 50 years old and older. the control arm receives the body \& soul program, a program to increase fruit and vegetable intake. the investigators hypothesize that those receiving the intervention, which includes four tailored newsletters and peer counseling, will be more likely to be screened if not up-to-date, and more likely to increase physical activity if screening was up-to-date at baseline, than controls.


Eligibility criteria:
inclusion criteria: * members of african-american churches who are at least 50 years old. exclusion criteria: * non-members of african-american churches; members who are under 50 years of age.

Keywords: crc screening status physical activity level fruit and vegetable consumption early detection of cancer colorectal cancer (crc) screening status
routine versus symptomatic protein pump inhibitor therapy for prevention of gastroesophageal reflux after per oral endoscopic myotomy for esophageal achalasia

Conditions: Esophageal Achalasia

Summary: per oral endoscopic myotomy (poem) is a treatment of choice for achalasia with an excellent safety and efficacy profile. there is a high rate of esophagitis related to gastroesophageal reflux following this procedure. there is no recommendation on the prescription of protein pump inhibitors (ppi) after the procedure and no study has studied the benefit of systematic prescription of ppi after poem for achalasia. the study authors hypothesize that routine ppi prescribing post-poem for 12 months would reduce the rate of esophageal acid exposure compared to a symptom-based prescribing strategy.


Eligibility criteria:
inclusion criteria: * patient with an indication for esophageal poem for achalasia * patient with all types of achalasia with eckardt score \> 3 * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan exclusion criteria: * patient with contraindications to ppis * patient with mediastinal and esophageal neoplasia * patient with a history of heller myotomy surgery * patients requiring any type of anti-reflux valve surgery * the subject is in a period of exclusion determined by a previous study * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * patient is pregnant, parturient or breastfeeding