Kornimate/medical-research-clean huggingface dataset:
the role of calcipotriol as radioprotector of skin

Conditions: Radiodermatitis

Summary: examining the hypothesis that protecting keratinocytes by calcipotriol can prevent in-vivo cutaneous side effect in patients receiving radiotherapy to the breast. to check the connection between the skin effect of radiotherapy and different parameters including diseases such as diabetes and lupus, use of medications, allergies, weight, habits, size of the irradiated breast, previous chemotherapy treatment and exposure to sunlight.

study protocol fifty women diagnosed with breast cancer planned to receive adjuvant radiotherapy, will participate in the study. about 15 minutes after receiving the daily radiation dose fraction, a cream containing an active vitamin d analogue will be applied to half of the breast with inspection of a nurse. the other half of the breast will have a standard cream applied . during the days that radiotherapy is not administered the standard cream will be applied to both halves of the breast in a case of strong reaction to radiotherapy (e.g. strong erythema, painful tenderness etc.)the adverse skin effects will be assessed according to the following criteria: 1. . an assessment by a physician and a nurse according to the rtog score (6). as follows: grade 0 - no reaction. grade 1 - light erythema dry peeling, decrease in sweat production. grade 3 - extensive moist peeling, pitting edema. grade 4 - ulcers, bleeding and necrosis. 2. . a questionnaire to each patient regarding the efficacy and safety of the cream. 3. . number of interruption of radiotherapy treatment. the assessment will be done each week during radiotherapy treatment and weekly for three weeks following the completion of radiotherapy treatment. safety report will be sent to the local independent ethics committee after the examination of the first ten patients. the protective effect of the cream containing calcipotriol will be compared to the standard treatment and analyzed statistically using the parameters mention above. the relation between the background disease, medications, allergies, weight, habits, size of the irradiated breast, sun exposure, previous chemotherapy treatment and exposure to sunlight and the skin reaction will be evaluated. inclusion criteria 1. . age ranging from 18 to 75. 2. . confirmed histological diagnosis of breast cancer. 3. . radiotherapy treatment to the breast following lumpectomy. exclusion criteria 1. . scleroderma. 2. . an extremely large breast. interfiled above 25 cm. 3. . prior radiotherapy to the same breast, radiotherapy to the contra lateral breast is not a contraindication. 4. . mastectomy.

Eligibility criteria:
inclusion criteria: 1. age ranging from 18 to 75. 2. confirmed histological diagnosis of breast cancer. 3. radiotherapy treatment to the breast following lumpectomy. exclusion criteria: 1. scleroderma. 2. an extremely large breast. interfiled above 25 cm. 3. prior radiotherapy to the same breast, radiotherapy to the contra lateral breast is not a contraindication. 4. mastectomy.

Keywords: calcipotriol breast cancer radiotherapy radiodermatitis in breast cancer
levosimendan to improve exercise limitation in patients with ph-hfpef

Conditions: Pulmonary Hypertension

Summary: this study will evaluate the efficacy of tnx-103 (oral levosimendan) compared with placebo in subjects with ph-hfpef as measured by the change in 6-minute walk distance (6 mwd; day 1 to week 12).

this is a phase 3, double-blind, randomized, placebo-controlled study of oral levosimendan in patients with ph-hfpef. there will be a screening period of up to 30 days. subjects will provide written informed consent prior to completing any study procedures. upon meeting all eligibility criteria, patients will continue to the 12-week randomized, double-blind treatment phase. approximately 230 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan or placebo all randomized subjects will have the option to enter the 92-week ole following the completion of all study events at week 12.

Eligibility criteria:
inclusion criteria: 1. men or women, greater than or equal to18 to 85 years of age. 2. nyha class ii or iii or nyha class iv symptoms. 3. a diagnosis of world health organization (who) group 2 ph-hfpef with qualifying hemodynamics 4. qualifying baseline rhc. 5. qualifying echocardiogram 6. qualifying 6-mwd 7. a 48-hour ambulatory cardiac rhythm monitor during the screening period. 8. requirements related to child bearing potential, contraception, and egg/sperm donation exclusion criteria: 1. a diagnosis of ph who groups 1, 3, 4, or 5. 2. echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy 3. structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous). or, planned valve intervention. or, the presence of significant valve disease 4. a diagnosis of pre-existing lung disease 5. history of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product. 6. major surgery within 60 days. 7. prior heart, lung, or heart-lung transplants or life expectancy of \<12 months 8. history of clinically significant other diseases that may limit or complicate participation in the study.

Keywords: hfpef pulmonary hypertension group 2 ph-hfpef heart failure
panitumumab regimen evaluation in colorectal cancer to estimate primary response to treatment

Conditions: Colon Cancer; Colorectal Cancer; Rectal Cancer; Cancer; Metastatic Cancer; Metastatic Colorectal Cancer; Oncology

Summary: the primary objective is to estimate the effect of the human homolog of the kirsten rat sarcoma-2 virus oncogene (kras) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mcrc) receiving second-line chemotherapy with panitumumab after failing first-line treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of metastatic adenocarcinoma of the colon or rectum * available paraffin-embedded tumor tissue * failure of first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab for mcrc * measurable disease * adequate hematologic, renal, hepatic and metabolic function exclusion criteria: * radiotherapy ≤ 2 weeks prior to day 1 of cycle 1 * unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the investigator, precludes the subject from study enrollment * prior irinotecan therapy, anti epidermal growth factor receptor (egfr) therapy, or vaccine for the treatment of mcrc * cyp3a4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and st. john's wort) ≤ 2 weeks prior to day 1 of cycle 1 * infection requiring systemic anti infectives completed ≤ 2 weeks prior to day 1 of cycle 1 * clinically significant cardiovascular disease * history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) * pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤ 8 weeks prior to day 1 of cycle 1 * any significant bleeding ≤ 6 weeks prior to day 1 of cycle 1, per the investigator's judgement * gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 4 weeks prior to day1 of cycle 1 * any co-morbid disease or condition that could increase the risk of toxicity (eg, dihydropyrimidine deficiency, significant ascites, or pleural effusion) * major surgery (requiring general anesthesia), open biopsy, or significant traumatic injury ≤ 4 weeks prior to day1 of cycle 1. subjects must have recovered from surgery and have no significant complications

Keywords: k-ras biomarker colorectal colon rectal folfox folfiri
effects of mouthrinse on the microbiome of the oral cavity and gi tract

Conditions: Oral Bacterial Infection; Oral Infection; Microbial Colonization; Viral Infection

Summary: the purpose of this research study is to identify the effects of 2 over-the-counter mouthwashes on bacteria and 3 viruses in the participant's mouth and gut. the participant will be randomly allocated to rinse their mouth twice daily either with listerine mouthwash, lumineux oral essentials mouthwash, or water. the overall duration of the study will be approximately 180 days and will include approximately 5 visits and 15-30 minutes for each visit with a total of approximately 2.5 hours of your time. additionally, fecal matter will also be collected in some subjects using a commercial collection kit.

goal of this pilot study is to identify the effects of 2 over-the-counter mouthrinses on the microbiome of the oral cavity and the gi tract. we will investigate 2 mouthwashes, plus an additional non-treatment group (water rinse only). one mouthwash has antimicrobial activity (listeriner, johnson \& johnson consumer healthcare products, skillman, new jersey); the other targets microbial products only (lumineux oral essentials clean and fresh mouthwashr, los angeles, ca). oral plaque will be collected with a sterile swab using a commercial collection kit on day 0, day 30, day 60, day 90, and day 180 of the study. additionally, fecal matter will also be collected in some subjects using a commercial collection kit. subjects will rinse 2x daily for approximately 180 days using either mouthwash or water.

Eligibility criteria:
inclusion criteria: * eligible men and non-pregnant and non-lactating women of all races age 18-25. * volunteers must consent to participate in all scheduled exam visits and procedures. * volunteers must be available for follow up on the telephone. * healthy gums or gums that bleed when you brush them. exclusion criteria: * volunteers unable or unwilling to sign the informed consent form. * less than 20 teeth (excluding third molars). * individuals who have taken antibiotics in the previous 3 months. * presence of any condition, abnormality, or situation at baseline that in the opinion of the principal investigator may preclude the volunteer's ability to comply with study requirements, including completion of the study or the quality of the data.

Keywords: oral microbiome fecal microbiome
do ccr5 antagonists improve the overall survival of patients with aids-related progressive multifocal leucoencephalopathy?

Conditions: AIDS; Progressive Multifocal Leucoencephalopathy (PML)

Summary: progressive multifocal leucoencephalopathy (pml) is a demyelinating disease caused by john cunningham virus (jcv) reactivation. numerous molecules have been overstated because there were inaccurately tested in non-rigorous clinical trial. the objective is to draw lessons from repeatedly false hopes of unconfirmed pml treatments that might contribute to prescribing ineffective drugs on claimed efficacy in case reports or small series and by failing to respect the need for clinical trial evaluation before authorizing their widespread use.


Eligibility criteria:
inclusion criteria: * patients with ar-pml * diagnosed between january 2008 and december 2015 * followed in one of the four university hospitals' infectious diseases departments exclusion criteria:

Keywords: maraviroc john cunningham virus (jcv) immune reconstitution inflammatory syndrome (iris) combined antiretroviral treatment (cart) overall survival (os)
education for osteoporosis in persons with existing fractures

Conditions: Osteoporosis

Summary: we wish to investigate whether a weekly, 2½ hour group-based osteoporosis education intervention (the osteoporosis prevention and self-management course), is different to one session course (1x 2½ hours) on osteoporosis knowledge, confidence to eat calcium-containing foods, confidence to exercise, and amount of exercise undertaken after three and nine months of follow-up in people aged over 50 years who have already had a bone fracture.

instruments used to determine change after 3 and 9 months: osteoporosis knowledge: osteoporosis knowledge assessment test (winzenberg et al. bmc musculoskelet disord 2003) calcium intake: food frequency questionnaire (angus et al. j am diet assoc 1989) calcium and exercise self-efficacy: osteoporosis self-efficacy scale (horan et al res nurs health 1998) physical activity: champs ii (stewart et al. j gerontol a biol sci med sci 2001)

Eligibility criteria:
inclusion criteria: * presented to modbury hospital's accident and emergency department with a new bone fracture exclusion criteria: * residence in nursing home * fracture sustained in motor bike, push bike or motor vehicle accident * fracture sustained due to high trauma, such as fall from roof or ladder * dementia * inability to participate in group settings * inability to understand spoken english * inability to provide informed consent * pathological fracture * usual place of residence outside south australia

Keywords: osteoporosis/prevention & control osteoporosis prevention and self-management course patient education/*trends//questionnaires adult//aged//middle aged life style//
symphony il-6 cutoff establishment study for patients at risk of severe sepsis due to covid-19

Conditions: Severe Sepsis

Summary: symphony il-6 is a device that quantitates human il-6 by fluorescence enzyme immunoassay (feia) from whole-blood specimens. use of symphony il- 6 removes the need for plasma separation before testing. symphony il-6 comprises two components, the symphony fluorescence immunoanalyzer and the symphony il-6 cartridge. whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. after 20 minutes a readout and printout are given with a quantitative il-6 concentration. the used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. given the nature of this device and its portability, there is potential for future deployment as a point-of-care (poc) device. this study is to establish an interleukin-6 (il-6) cutoff value using the symphony il-6 test for patients at high risk of severe sepsis caused by a covid-19 infection.


Eligibility criteria:
inclusion criteria: * whole-blood specimen collected in k2 edta anticoagulant tubes * subject is considered to have severe or critical illness per below: severe illness 1. spo2 \< 94% on room air at sea level; 2. ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) \< 300 mmhg; 3. respiratory frequency \> 30 breaths/min; 4. or lung infiltrates \>50% critical illness a) respiratory failure; b) septic shock; c) and/or multiple organ dysfunction d) at least one criterion of severe illness * subject confirmed to be covid-19 positive by an eua rt-pcr test * subject is 18+ years of age * minimum volume of 100µl for symphony il-6 testing * specimen is available for testing within 12 hours from collection exclusion criteria: * subject is receiving an anti-il-6 treatment * subject is receiving corticosteroids * hemolyzed specimens
implantation of peripheral stem cells in patient with ischemic cardiomyopathy

Conditions: Heart Failure

Summary: this is a randomized study of efficiency and safety of intramyocardial implantation of peripheral mononuclear cells with high concentration of cd34+ stem cells in patients with myocardial ischemia after preparatory course of shock - wave therapy.


Eligibility criteria:
inclusion criteria: * patients with ischemic cardiomyopaty and hf ii-iv nyha class * mi more than 6 months before the study * lvef less than 35% * absence effect of coronary revascularization during 6 months * optimal pharmacological therapy no less than 8 weeks * heart transplantation is contraindicated * patients with implantable cardioverter-defibrillator (icd) or cardiac resynchronization therapy defibrillator (crt-d) * patients giving informed consent exclusion criteria: * acute coronary syndrome * coronary revascularization less than 6 months * patients requiring surgical correction of post-mi aneurism * lv wall thickness less than 5 mm in site of possible injection * patients with crt implanted within 3 month before cells injection * clinically significant associated diseases * active oncology desiase * pregnancy
to evaluate adenosine monophosphate and allergen challenge in allergic rhinitis

Conditions: Allergic Rhinitis

Summary: allergic rhinitis is a common condition characterize by inflammation of the upper airways. third generation antihistamines have been demonstrated effective in the treatment of this condition. allergen challenge can be use to assess the effects of drugs in allergic rhinitis, adenosine monophosphate may also be used as a means to investigate these effects but as yet its effects have yet to be compared to allergen challenge. we intend to compare the effects of levocetirizine at a single dose of 5mg on allergen and amp challenge compared to placebo in a double blind cross-over study. the study will include 20 patients with allergic rhinitis. each patient will have allergen and amp challenge on placebo and active treatment. the primary outcome variable will be the change in concentration of amp/allergen required to produce a 20% drop in nasal flow as manifest by peak nasal inspiratory flow. a 1 doubling dose change in concentration of challenge medium to cause a 20% drop in nasal flow will be deemed significant. we will also measure time to recovery after both challenges. amp challenge is a safe alternative to allergen challenge and does not have the risk of anaphylaxis.


Eligibility criteria:
inclusion criteria: * male or female 16-75 * patients with persistent rhinitis must be skin prick positive to house dust mite with perennial symptoms * patients with seasonal rhinitis should be skin prick positive to grass/tree pollen with seasonal symptoms * concomitant asthma is permitted in those with rhinitis if fev1 \>60% * no recent exacerbations of asthma or chest infections if asthmatic * able to perform all of the techniques necessary to carry out challenge testing * must be compliant to study medication * must give informed consent exclusion criteria: * male or female outwith the above age range * negative skin prick testing * patients with concomitant asthma with fev1 less than 60% predicted * patients with asthma with recent chest infection or exacerbation * pregnant females, those at risk of becoming pregnant or breast feeding. females must be on adequate contraception for the whole study period

Keywords: allergic rhinitis levocetirizine nasal provocation testing nasal allergen challenge nasal adenosine monophosphate challenge
assessment of self-collected sample compared to clinician collected sample in covid-19 and influenza program

Conditions: Subjects Possibly Exposed to COVID-19

Summary: we are trying to see whether a self-collected saliva swab in the home setting is as good as or better than a study clinician-collected anterior nose swab in evaluating whether you are positive for covid-19 or influenza a/influenza b. you may have no symptoms, so you may be positive and capable of spreading the infection to others and you don't know it. knowing whether you are positive is important because you would have to quarantine and not go out to prevent spreading the infection to others.

in some research studies, saliva has been shown to be as good as or even better than an anterior nares or nasopharyngeal specimen in detecting sars-cov-2; we are interested in making sure that is the case. being able to collect a specimen at home and mail it in would help with patient compliance and would reduce the need for clinicians (nurses or other health care professionals) to use personal protective equipment (ppe), which is in short supply. also, people would not have to go to a healthcare facility or other testing site to have the covid-19 or the influenza a/influenza b testing done. we are using a sensitive method (rt-pcr) to look for the three viruses. once you have had the anterior nose swab collected by the study clinician, your participation would last only as long as it takes to complete the self-collected saliva collection and return the sample to the researchers. the self-collection of the saliva specimen should be collected as soon as possible after the collection of anterior nares and saliva samples by the clinician you will mail in the saliva swab in a prepaid mailer no later than 10 days after sample collection and the result will be available within one day of our lab receiving the swab. once our lab receives your specimen, the gift card which you received will be activated and your participation will be complete. biocerna, llc (fulton, maryland), is the commercial laboratory to which the research subjects' samples will be shipped and tested. we anticipate approximately 500 subjects will be enrolled. you qualify because you live in a location which is reporting an increased number of covid-19 positive cases. incidence of influenza a/influenza b is also useful to track to find out whether social distancing and/or wearing masks decreases the number of influenza a/influenza b cases during the winter months.

Eligibility criteria:
inclusion criteria: patients will qualify because they live in a location which is reporting an increased number of covid-19 positive cases. incidence of influenza a/influenza b is also useful to track to find out whether social distancing and/or wearing masks decreases the number of influenza a/influenza b cases during the winter months. - exclusion criteria: -
dynamics of insulin absorption in subclinical lipohypertrophy using the euglycemic clamp technique

Conditions: Diabetes Mellitus; Lipohypertrophy

Summary: this study will use the euglycemic clamp technique to evaluate insulin absorption when insulin is administered subcutaneously in an area of subclinical lipohypertrophy vs an area of normal tissue.

the use of insulin to manage diabetes can cause changes to the skin at sites where insulin is administered. these changes may be felt as lumps under the skin. insulin injected into these areas may not work as well leading to needing increasing doses of insulin to control blood glucose levels. hypoglycemia can occur when insulin is injected into normal areas. previous studies have found that these lipohypertrophic areas can be seen on ultrasound before they can be felt. the investigators will be using the euglycemic clamp techique to evaluate insulin absorption to see whether tissue with lumps that cannot be felt but are seen on ultrasound affect how insulin is absorbed.

Eligibility criteria:
inclusion criteria: * participated in glycemic variability study * type 2 diabetes for at least 2 years * currently using insulin to manage diabetes * have used insulin to manage diabetes for at least 2 years * age 19 or older * bmi \< 30 kg/m2 * confirmed areas of subclinical lipohypertrophic adipose tissue lesions via ultrasound exclusion criteria: * taking other injectable medications (eg liraglutide/victoza * taking systemic steroids (ie prednisone) * severe renal insufficiency (egfr \< 30 ml/min/1.73 m2 * hypoglycemic unawareness * current pregnancy * not fluent in speaking and writing english (unless accompanied by a translator)

Keywords: diabetes insulin lipohypertrophy euglycemic clamp
safety and efficacy of ranibizumab in diabetic macular edema with center involvement

Conditions: Diabetic Macular Edema

Summary: this study evaluated the safety and efficacy of ranibizumab on retinal edema and visual acuity in patients with diabetic macular edema with center involvement.


Eligibility criteria:
inclusion criteria: * diabetic macular edema with center involvement in at least one eye * type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening * laser photocoagulation in the study eye can be withheld for at least 3 months after randomization exclusion criteria: * patients with uncontrolled systemic or ocular diseases * have any history of any intraocular surgery in the study eye within the past 6 months preceding screening * conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: dme diabetic macular edema ranibizumab diabetic macular edema with center involvement