Kornimate/medical-research-clean huggingface dataset:
a safety and efficacy of drm02 in subjects with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to determine whether drm02 is safe and effective in the treatment of atopic dermatitis when applied twice daily for 6 weeks.

this is a double-blind, randomized, within-subject control, study enrolling 20 subjects with atopic dermatitis and designed to assess the safety, tolerability, and preliminary efficacy of drm02. safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs. preliminary efficacy will be assessed through the physician's lesion assessment (pla) and the eczema area and severity index (easi) from only the two lesions identified at the baseline visit.

Eligibility criteria:
inclusion criteria: * male or female 18 to 70 years of age. * clinical diagnosis of stable atopic dermatitis (ad) and with two lesions of similar size and have an identical score of at least 5 but no more than 9 on the sum of the individual components of the eczema area and severity index (easi) at the target lesion scale. * male or non-pregnant, non-lactating females. * signed informed consent. exclusion criteria: * subjects who have unstable atopic dermatitis (ad). * significant infection at the target lesion site. * prior or concomitant use of systemic therapies for ad within the past 4 weeks. - prior or concomitant use of topical treatments for ad, to within 10 cm of the target lesion within the past 4 weeks. * prior or concomitant use of oral retinoids for ad within the last 6 months. * use of biologics for ad within the past 3 months, or 5 half-lives (whichever is longer). * subjects who have poor skin condition within 5 cm of the target lesion. * subjects who are current drug or alcohol abusers; have a history of immunodeficiency disease; or are a poor medical risk because of other systemic diseases or active uncontrolled infections. * subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy. * subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days. * subjects who have a clinically significant laboratory value at screening.
a randomized placebo-controlled trial of manuka honey for oral mucositis due to radiation therapy for cancer

Conditions: Radiotherapy Induced Mucositis; Head and Neck Cancer

Summary: the primary hypothesis of this study is that regular topical oral application of manuka honey will reduce the severity and duration of oral mucositis in patients who are undergoing mucotoxic radiation therapy for cancer treatment.

oral mucositis is a common side-effect of radiation therapy for many head and neck cancers, and can have a very severe impact on quality of life and nutritional status. at least42% of patients treated for head and neck cancers will develop grade 3 or 4 oral mucositis. although there have been positive trials, no study has had overwhelming data to strongly support any one agent in the prevention or treatment of oral mucositis. a comprehensive review of the literature done in 2004 found only benzydamine (a topical nonsteroidal anti-inflammatory agent) to be beneficial as a palliative treatment for established mucositis. management essentially consists of pain management, with topical and oral analgesics/anaesthetics and anti-inflammatory agents, and nutritional support, once mucositis is established. despite the use of these agents, many patients still have severe mucositis, and there is great need for new treatments to reduce this distressing complication of cancer therapy. currently, the only standard "treatment" consists of an oral rinse of warm water, salt, and baking soda 4 times a day. this is only to maintain oral hygiene and does not have any impact on the severity or duration of the mucositis itself. topical fluoride is applied at bedtime to reduce the caries risk. basic oral care (brushing and flossing as tolerated) is recommended to maintain general mucosal health and to reduce the impact of oral microbial flora. study objectives the primary objective of this study is to see if topical oral manuka honey reduces the severity of mucositis in patients receiving radiation treatment for head and neck cancer. secondary objectives are to assess the impact of any demonstrated improvement in mucositis on nutrition, symptom burden, quality of life, and radiotherapy treatment interruptions.

Eligibility criteria:
inclusion criteria: * patients commencing radiation therapy of 50 gy or higher with the dosage field affecting the oral mucosa unilaterally or bilaterally (minimum 3 observable sites affected). * patients willing and able to attend weekly assessments throughout their treatment, plus one week after completion of treatment. exclusion criteria: * patients unable to understand the consent process (translators will be used if necessary so being english-speaking is not required). * patients unable to attend the follow-up visits * patients participating in other clinical trials which might affect the severity of mucositis * patients allergic to honey, multiple pollens, or to celery

Keywords: mucositis radiation honey
hemoglobin kinetics in response to mircera® in patients with acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: hypothesis: based on available pharmacokinetic data from healthy volunteers we hypothesize that the administration of a cumulative dose of 210μg of the continuous erythropoietin receptor activator, mircera® (roche), during 3 months post percutaneous coronary intervention (pci) does not result in hemoglobin (hb) levels \>15 g/dl in patients with st-segment elevation myocardial infarction (stemi) design: prospective, open label single center pilot study

this pilot trial will include 8 patients. the inclusion of 8 patients will allow to perform representative statistics of expected hb kinetics in response to mircera®.

Eligibility criteria:
inclusion criteria: * patients (age 18 - 80 years) with acute stemi undergoing pci main exclusion criteria: * hemoglobin levels \>15g/dl * history of a myeloproliferative syndrome * thrombolysis for index infarction * anticipated additional revascularization within 3 months * cardiogenic shock

Keywords: acute myocardial infarction continuous erythropoetin receptor activator mircera hemoglobin kinetics
clad phenotype specific risk factors and mechanisms

Conditions: Lung Transplant; Post Lung Transplantation

Summary: while many patients experience benefits from transplant, complications such as infections and lung rejection may affect long term survival and quality of life. in this study doctors are looking at a complication called chronic lung allograft dysfunction (clad). clad is thought to be chronic rejection of the lung by the immune system and is the leading cause of death after lung transplantation. the purpose of this study is to help doctors determine: * why some people get clad and others do not * how patients who get clad do after clad is diagnosed * how clad may affect quality of life

this is an observational, prospective, multicenter study of newly transplanted adult, first lung transplant recipients that will collect longitudinal clinical data, patient reported quality of life (qol) data, and serial biological samples to determine the risk factors, pathophysiology, and manifestations of restrictive chronic lung allograft dysfunction (rclad) and bronchiolitis obliterans syndrome (bos). anticipated participant accrual is within three years of study start-up. the total study duration is four years. participants will be followed a minimum of 1 and a maximum of 4 years.

Eligibility criteria:
inclusion criteria: individuals who meet all of the following criteria are eligible for enrollment as study participants: 1. subject must be able to understand and provide written informed consent and -must be ≥18 years of age at the time of written informed consent. 2. anticipated listing for lung transplantation or within 45 days of having received a single or bilateral cadaveric donor lung transplant. - enrollment must occur prior to the start of bronchoscopies eligible for research bronchoalveolar lavage (bal) sampling. 3. undergoing first lung transplant operation. 4. transplant surgery to be performed or performed at enrolling center. * note: concurrent participation in immune monitoring studies or interventional device trials are permitted. exclusion criteria: individuals who meet any of the following criteria are not eligible for enrollment as study participants: 1. multi-organ recipient. 2. prior recipients of any solid organ transplant, including prior lung transplant. 3. prior or concurrent recipient of bone marrow transplant. 4. hiv infection. 5. any condition which the investigators feel would make it unlikely for the recipient to complete follow up procedures or complete the study. 6. participation in an investigational drug trial at the time of enrollment visit.

Keywords: chronic lung allograft dysfunction (clad) restrictive chronic lung allograft dysfunction (rclad) bronchiolitis obliterans syndrome (bos) clad risk factors observational study
incidence and morbidity of cardiac rhythm disorders in patients assisted by ecmo-va for refractory cardiogenic shock

Conditions: Cardiac Rhythm Disorder

Summary: brief summary : rhythm disorders are a frequent and potentially serious complication of critical patients in the icu and postoperative cardiac surgery. in particular, atrial fibrillation (af) is the most common rhythm disorder in patients admitted to the icu and is associated with excess mortality during acute circulatory failure. in postoperative cardiac surgery, af affects 15 to 45% of patients. in addition to hemodynamic effects, af increases the risk of stroke, bleeding, respiratory or renal failure, and doubles mortality at 30 days and 6 months. in the longer term, the recurrence rate of af within 1 year after hospital discharge is about 50%. similarly, other rhythm disorders, supraventricular or ventricular, can be life-threatening in icu patients. while the incidence and complications of rhythm disorders are well documented during sepsis, cardiogenic shock or after cardiac surgery, there are to our knowledge no data on the frequency and complications of rhythm disorders in patients assisted by va ecmo. the primary objective is to describe the incidence of supraventricular rhythm disorders in patients assisted by va ecmo.

this study is an observational study to describe the conditions of occurrence of arrhythmias, particularly atrial fibrillation, in patients supported by va ecmo, as well as their short-term and long-term prognosis. patients will be recruited from the intensive care units and crfs will be completed by the investigators at each of the participating centers. data will be collected directly from the medical records, except for vital status at 1 year, which may be collected by telephone from the patient by the investigator at the center in the absence of data in the medical record. atrial fibrillation episodes will be recorded on a 12-lead electrocardiogram and securely transmitted to the coordinating center. in addition, investigators will send weekly data to the principal investigator for incidence calculation. patients or their relatives will be informed about the study by an information sheet presented and explained by the investigator or another person authorized to conduct the research. the investigator will record the patient's consent in the patient's medical record.

Eligibility criteria:
inclusion criteria: * patient 18 years of age or older * assistance with va ecmo exclusion criteria: * opposition to the use of data. * persons under legal protection (curators, guardianship), judicially safeguarded. * va ecmo for refractory cardiac arrest.

Keywords: arrhythmia veno-arterial extra corporeal membrane oxygenation (va ecmo) cardiogenic shock.
effect of celliant materials on pain and blood oxygenation in subjects with chronic elbow and wrist pain

Conditions: Chronic Wrist Pain; Chronic Elbow Pain

Summary: the purpose of this research is to determine whether a new type of fabric, celliant, can reduce elbow and wrist pain associated with chronic medical conditions such as carpel tunnel syndrome, arthritis or tennis elbow and whether it can increase blood flow and oxygenation levels in the arms and hands after wearing the material.

a new type of fabric, celliant, is made from polymer yarns containing optically active particles (1-1.2 micron diameter titanium dioxide, quarts and aluminum oxide particles) with modify absorption, reflection and transmission of light in the visible and near infrared portion of the spectrum. it is believed that the celliant particles increase skin illumination such taht cytochrome pigments and other enzymes are activated, leading to increased blood flow and oxygenation of the skin and neighboring soft tissues. in addition, numerous anecdotal reports from patients with chronic foot and arm pain indicate that wearing celliant garments for even a few days leads to dramatic improvement in many different painful conditions. this is a single center, stratified, randomized, prospective, double-blind study. questionnaires that subjects will be asked complete are 1) visual analog scale, 2) brief pain inventory, 3) mcgill short form pain survey and 4) sf-36 quality of life inventory.

Eligibility criteria:
inclusion criteria: * chronic pain for a minimum of 6 months * a score of equal to or greater than 3 on question iii of mcgill short form pain questionnaire exclusion criteria: * open wounds on the involved limb * threatened limb loss from ischemia * changes in pain or inflammatory medication within the last 30 days * psychiatric or other conditions that would affect compliance * inability to comply with use of the study articles or to fill out questionnaires

Keywords: arthritis carpel tunnel syndrome epicondylitis
vis opti-k vision improvement for presbyopes

Conditions: Presbyopia Correction

Summary: the vis opti-k device and procedure were used to provide vision improvement to patients with presbyopia.

the vis opti-k device was used to irradiate the cornea with light that changed corneal shape.

Eligibility criteria:
inclusion criteria: female or male any race 40 years of age or older presbyopia exclusion criteria: none -
predictive value of spirometric pif to produce pif rate needed for the use of current dpi's.

Conditions: Severe Asthma; COPD

Summary: the main aim is to study correlations between peak inspiratory flow measured during a spirometry (pifspiro) and peak inspiratory flow measured over a pre-set resistance (pifresist) in copd patients and severe asthma patients. pifresist will be measured using 5 different resistances, representing all dpi's relevant for the treatment of obstructive lung diseases. if this shows a distinct relationship between pifspiro and pifresist, pifspiro cut-off points will be sought in an attempt to predict which patients are likely to be able to produce optimal flows for dpi use. if successful, this will make the actual measurement of pifresist redundant in clinical practice. also the relationship between pifresist and device internal resistance in addition to pifspiro (which corresponds to a very low resistance) will be examined.

the correct use of dry powder inhalers (dpi) crucially depends on the peak inspiratory flow (pif) that the patient can generate when overcoming internal resistance of the inhaler device. it has been shown that some patients cannot achieve sufficient peak inspiratory flows with some dpi's, especially in the elderly population. the in-check dial device (clement clarke international ltd, harlow, uk) allows to measure these inspiratory flows for different pre-set resistances, representing different dpi's. study design: interventional, single center, single visit study 30 severe asthmatics and 70 copd patients will be recruited in the uz brussel respiratory outpatient clinic. all participants will provide written informed consent. patients will perform: * pre-bronchodilator spirometry for the measurement of pifspiro as per european respiratory society/american thoracic society (ers/ats) guidelines for standard lung function5 (part of routine clinical follow-up). * 5 forced inspiratory manoeuvres using the in-check dial device g16, set at 5 different resistances (performed in order of increasing resistance), yielding the pifresist values for the different dpi's

Eligibility criteria:
inclusion criteria: * severe asthmatics (m/f; \> 20 y) entering the belgian severe asthma registry (bsar) * copd patients (gold stage ii-iv; m/f; \> 40 y) exclusion criteria: * inability to perform spirometry
comparative efficacy of bifonazole cream vs placebo after nail ablation with urea paste

Conditions: Onychomycosis

Summary: the study is focused to prove that the efficacy of a 1% bifonazole cream is superior to a placebo cream after non-surgical nail ablation with a 40% urea paste.


Eligibility criteria:
inclusion criteria: * age of at least 18 years; * positive clinical findings of onychomycosis according to the judgement of the investigator (e.g. thickening, discoloration, structural changes, misshaped nails); * positive mycological findings (positive microscopy and positive culture with identification of pathogen) in material taken from affected nail sites before the start of treatment; * nail mycosis with an affected nail area between 20% and 50% in the target nail, * nail mycosis in not more than 3 nails (each nail not more than 50% infected area) exclusion criteria: * doubtful or negative mycological findings; * proximal subungual onychomycosis (pso); * topical antimycotic treatment of feet or hands within 4 weeks prior to screening, topical treatment of onychomycosis of feet or hands within 12 weeks prior to screening; * systemic antimycotic treatment within 12 weeks prior to screening; * failure to treat tinea pedis/manus (diagnosed at screening) successfully with topical treatment between screening visit and visit 1 (baseline); * tinea pedis/manus at visit 1 (baseline); * uncontrolled diabetes mellitus * psoriasis * peripheral arterial disease * chronic venous insufficiency; * diabetic neuropathy; * history of hypersensitivity to bifonazole, or any other similar pharmacological agents or components of the products; * known sensitivity to plasters.

Keywords: bifonazole placebo urea nail fungus
triple negative breast cancer: study of molecular and genetic factors

Conditions: Breast Cancer

Summary: breast cancer triples negatives (tn; 15 % of the cases) are characterized by a high histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse prognosis than the other forms of breast cancer. it is however a heterogenous group for histological and molecular level, but also for evolution. most of the tn is part of the basal breast cancer subcategory. until now, the medical treatment is based on chemotherapy. breast cancers by constitutional mutation of brca1 / brca2 (5 % of breast cancers) are mostly of basal type and their prognostic seems better that what could be expected from high grade tumours and without hormonal receptors. they would be much more frequent in the tn group. however, at this day, no prospective study was led to estimate this incidence, or to study the intervention of other genes of predisposition, as well to analyse the links between this phenotype and their consequences at the germinal or somatic level, in terms of associated molecular changes and prognosis. the purpose of this study is, on a prospective study, to lead a joined analysis at the germinal level, in search of mutations of the main genes of breast cancer predisposition (brca1/2, palb2, pten, palb2), and at the tumour level (tissue micro-array and transcriptome), by correlating these results to the main clinical parameters. the 5 years relapse-free survival will also be estimated.


Eligibility criteria:
inclusion criteria: * women \> 18 * non metastatic breast cancer * triple negative * 5 years follow-up * signed informed consent exclusion criteria: * other cancer (except in situ) * metastases at diagnosis * impossibility of follow-up

Keywords: triple negative breast cancer
cpg 7909 in patients with cutaneous t-cell lymphoma

Conditions: Lymphoma, T-Cell, Cutaneous

Summary: to assess the effect of cpg 7909 injection on cutaneous t-cell lymphoma and the safety of cpg 7909 injection in patients with this cancer.


Eligibility criteria:
inclusion criteria: patients 18 years or older with biopsy (histopathologically) confirmed cutaneous t-cell lymphoma (limited to mycosis fungoides (mf)) who have had prior therapy with at least one and no more than 3 systemic treatments. exclusion criteria: patients with visceral involvement, serious infection or illness including human immunodeficiency virus infection, or a karnofsky performance status (kps) \< 60 will be excluded.

Keywords: immunotherapy, lymphoma
project team: teaching hiv prevention in the hiv clinic

Conditions: HIV

Summary: the purpose of this study is to determine if the team prevention intervention delivered by a physician and an hiv-positive counselor is effective. it is hypothesized that those who receive the intervention will report a higher reduction in risky sex than those who were in the standard-care condition.


Eligibility criteria:
inclusion criteria: * 1) 18 years or older, 2) hiv-infected, 3) sexually active, 3)receiving hiv primary care at participating clinic, 4) can communicate in english or spanish, 5) no previous enrollment in the team study or intervention. exclusion criteria: * 1) participation in a similar study run by the team pi.