Kornimate/medical-research-clean huggingface dataset:
transgender education for affirmative and competent hiv and healthcare

Conditions: Stigma, Social; HIV/AIDS; Health Care Acceptability

Summary: educational workshops are an efficacious strategy to increase healthcare providers' ability to provide gender-affirming care for transgender (trans) people. this strategy may also reduce healthcare providers' stigma towards trans people and people living with hiv. there is less evidence, however, of educational workshops that address hiv prevention and care among trans women. this protocol details the development and pilot testing of the teachh: transgender education for affirmative and competent hiv and healthcare intervention that aims to increase gender-affirming hiv care competency among healthcare providers.this community-based research (cbr) project involves intervention development and implementation of a non-randomized multi-site pilot study with pre- post-test design. first, the investigators will conduct a qualitative formative phase involving focus groups with 30 trans women and individual interviews with 12 providers to understand hiv care access barriers for trans women and elicit feedback on a proposed workshop. second, the investigators will pilot test the intervention with 90-150 providers (n=30-50x3 in-person settings). primary outcomes include feasibility (e.g., completion rate), workshop satisfaction, and willingness to attend another workshop. secondary pre- and post-intervention outcomes, assessed directly preceding and following the workshop, include perceived competency, intention to provide gender-affirming hiv care, and attitudes/biases towards trans women with hiv. primary outcomes will be summarized as frequencies and proportions (categorical variables) and means and standard deviations (continuous variables). the investigators will conduct paired-sample t tests to assess pre- and post-intervention differences for secondary outcomes.


Eligibility criteria:
inclusion criteria: * workshop participants must be 18 years or older and identify as working at a location that provides health or social services to trans women or being in-training to work in health or social services (e.g., medical student, social work student). workshop participants may include a mix of hiv- and non-hiv service providers. exclusion criteria: * not fitting the above criteria.
effectiveness of fractionated laser resurfacing to protect geriatric skin from actinic neoplasia

Conditions: Actinic Keratoses; Aging; Non-Melanoma Skin Cancer

Summary: this study is following up on previous studies that have demonstrated that geriatric subjects respond different to ultraviolet b (uvb) light than young subjects. the treatment of geriatric skin with dermal rejuvenation therapies (dermabrasion, fractionated laser resurfacing) restores the appropriate uvb response. ongoing studies have tested the ability of fractionated laser resurfacing (flr) to assess how long this wounding effect lasts-and have found that this appears to be a durable response which lasts for at least two years. the findings that flr protects geriatric skin at two years is the impetus for this study. this study is an interventional study to assess if flr treatment of one forearm of geriatric subjects with multiple actinic keratosis will result in the short-term removal of actinic keratosis, and the long-term decrease in levels of future actinic keratosis and other non-melanoma skin cancers in comparison to the untreated arm. study length and visit: the first part of the study is completed in 1 day then there are follow up visits at 90 days and every 6 months for 5 years.


Eligibility criteria:
inclusion criteria: * diagnosed with actinic keratosis within the past 6 months * at least 60 years of age, or older * ability to comprehend procedures and risks versus benefits * able to provide informed consent * fair skin (fitzpatrick type i or ii) * possess both right and left forearms exclusion criteria: * uncontrolled diabetes mellitus * not able to comprehend procedures or risks versus benefits * pregnant or nursing * large tattoos on forearms * history of abnormal healing or scarring (i.e., keloids) * any disease that gets worse while in the sun * use of topical or oral anti-inflammatory medication or steroids * allergy to lidocaine * current use of photosensitizing medication
bariatric surgery and pharmacokinetics of dexamphetamine

Conditions: Obesity, Morbid

Summary: changes to gastric ph, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. these factors are potentially influenced by bariatric surgery. little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. in this study the pharmacokinetic effects of bariatric surgery on dexamphetamine are investigated.


Eligibility criteria:
inclusion criteria: * preparing to undergo gastric bypass or sleeve gastrectomy in central norway * being a norwegian citizen exclusion criteria: * having previously undergone resections in the gi-tract

Keywords: bariatric surgery gastrointestinal tract biological availability pharmacokinetics dextroamphetamine
phase 3 study of the biologic lung volume reduction (blvr) system in advanced upper lobe predominant (ulp) emphysema

Conditions: Advanced Upper Lobe Predominant Emphysema

Summary: the purpose of the study is to evaluate the efficacy and safety of the 20 ml blvr system in treating patients with advanced upper lobe predominant emphysema.

patients with emphysema currently have limited treatment choices. many patients are treated with steroids and inhaled medications,which often provide little or no benefit. in recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. lung volume reduction surgery involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. this procedure, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk. aeris therapeutics has developed the biologic lung volume reduction (blvr) system to achieve lung volume reduction without surgery and its attendant risks. with blvr, a physician uses a bronchoscope to direct treatment to the most damaged areas of the patient's lungs. the treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a bioabsorbable gel. the gel is comprised of clotting proteins that deliver the treatment, an antibiotic to prevent infection and drugs designed to remodel damaged areas of the lungs-actually using the body's natural scar formation response to permanently collapse the diseased areas. this reduction in lung volume creates more space for adjacent healthier parts of the lungs to function more effectively.

Eligibility criteria:

Keywords: emphysema chronic obstructive pulmonary disease copd lung volume reduction lvrs blvr aeris
golimumab versus pamidronate for the treatment of axial spondyloarthropathy: a 48-week trial

Conditions: Spondyloarthropathy

Summary: to compare the efficacy of golimumab with pamidronate in the treatment of axial spondyloarthropathy

to compare the efficacy of golimumab with pamidronate in the treatment of non-radiological axial spondyloarthropathy

Eligibility criteria:
inclusion criteria: 1. subjects greater than 18 years of age 2. fulfilling the latest classification criteria for axial spondyloarthropathy 3. active spondylitis as defined by a bath ankylosing spondylitis disease activity index (basdai) score of more than 4 despite treatment with non-steroid anti-inflammatory drugs for more than 3 months exclusion criteria: 1. major surgery (including joint surgery) within 8 weeks prior to study entry 2. history of treatment with anti-tumor necrosis factor agents or any investigational therapies within 12 months of study entry 3. immunization with a live/attenuated vaccine within 4 weeks prior to study entry 4. active current bacterial, viral, fungal, mycobacterial or other infections at study entry 5. chronic hepatitis b or hepatitis c carriers 6. history of malignancies, including solid tumors and hemic malignancies 7. history of congestive heart failure 8. history of demyelinating disorders 9. history of peripheral neuropathy 10. pregnant women or lactating mothers 11. baseline liver parenchymal enzymes elevated to more than 2 times normal 12. absolute lymphocyte count less than 500/mm3 13. serum creatinine level of more than 200umol/l

Keywords: spondyloarthropathy ankylosing spondylitis
study of inhaled iloprost in pediatric pulmonary hypertension (ph) after surgery

Conditions: Pulmonary Hypertension

Summary: the aim of this study is to determine whether inhaled iloprost can be used to prevent and treat ph and phc while in children after operation of chd

pulmonary hypertension (ph) is a significant contributor to the postoperative morbidity and mortality of congenital heart disease. inhaled iloprost has been approved for the treatment of adults with ph, but little is known about the effects in children with ph. iloprost is a prostacyclin analogue. when applied by inhalation, it selectively dilates pulmonary vessels without side affecting the systemic circulation. there is no rcts of iloprost have previously been performed in this indication.

Eligibility criteria:
inclusion criteria: before corrective procedure for chd, two of bellow ten criteria should be met 1. pulse sao2 smaller than 93% in left-right shunt chd case (in room air) 2. ekg: right ventricular hypertrophy, right atrial dilatation 3. chest x-ray: enhanced vascular signs in trans-hilar, loss of blood vessal in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement 4. cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt 5. under-filling of pulmonary capillary, 'pruning' of the peripheral blood vessels 6. pp/ps greater than 0.75 7. qp/qs smaller than 1.5 8. pvr grater than 9 wood unit/m2 9. rp/rs graeter than 0.5 exclusion criteria: after corrective procedure for chd: 1. deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation 2. severe arrhythmia led to low cardiac output 3. plt smaller than 50,000\*109/l and obvious bleeding
dna methylation and the increased risk of cervical cancer development

Conditions: Cervical Cancer; Papillomavirus Infections

Summary: this study aims to investigate the correlation between reproductive tract microbiota and dna methylation in cervical epithelial cells, as well as its impact on the development of cervical cancer, through a paired case-control clinical study

this study is a multicenter matched case-control study. the inclusion and exclusion criteria are verified by collecting hpv test results, tct examination results, and for the case group, participants' histopathological results are also collected. participants who meet the inclusion and exclusion criteria have their hpv dna test original secretion samples and tct examination original cervical scrape cell samples (preserved in rna preservative solution) collected. enrollment involves dividing the samples into a discovery cohort of 800 cases and a validation cohort of 1200 cases. the discovery cohort undergoes multi-target dna methylation testing, stds pathogen testing, hpv e6/e7 testing, and metagenomic sequencing; the validation cohort undergoes pcr validation of dna methylation sites related to cervical cancer, stds pathogen testing, hpv e6/e7 testing, and metagenomic sequencing

Eligibility criteria:
inclusion criteria: 1. aged 18-50 years old, with a history of sexual activity 2. hpv and tct tests are performed concurrently in the gynecology clinic 3. those with abnormal hpv and tct test results undergo tissue pathological testing exclusion criteria: 1. pregnant or breastfeeding 2. patients with immunological disorders or severe autoimmune diseases, such as aids, sle 3. those who have had organ transplants or are currently using immunosuppressive agents 4. use of vaginal douching within 48 hours before sample collection 5. use of vaginal probiotics within one month before sample collection 6. use of vaginal antibiotics or antifungal treatments within one month before sample collection 7. history of surgery related to cervical intraepithelial neoplasia (cin), including but not limited to conization of the cervix, leep procedures, etc. 8. blood samples (avoid sampling during menstruation), insufficient remaining sample volume to support subsequent analysis needs, and samples not stored as required.
topical local anaesthesia and cooling during capsaicin 8% patch application

Conditions: Pain

Summary: aim of the study is to demonstrate superiority of a continuous cooling of the skin over topical emla or placebo in reducing the burning pain during the application of capsaicin 8% patch ("qutenza"). secondary it will be tested, if the 2 different pre-treatments have an effect on the application pain within the first 24 hours, and if different pre-treatments have an effect on the reduction of the epidermal nerve fiber density (enfd) 1 week after qutenza application.

according to literature, one of the most common adverse events of capsaicin 8% patch is a burning pain and a reversible erythema at the application site. in general it is recommended to apply a topical anesthetic one hour before capsaicin 8% patch application, or to treat the pain with cooling, nsaids or even opioids. nevertheless, there is still only limited data available on the effects and side-effects. in this study it shall be tested if cooling the skin down for about 5-10 celsius, immediately before qutenza is applied, and continuing the cooling during the whole application time, results in a reliable prevention of the burning pain compared to pretreatment with topical anesthesia applied one hour in advance. this would lead to the assumption that the application pain is predominantly caused by a decrease of the threshold for heat pain beyond skin temperature and can therefore be prevented by a lowering of the skin temperature. by ascertaining pain 24 hours after capsaicin 8% patch application and epidermal nerve fiber density (enfd) 1 week after capsaicin 8% patch application it shall be proved if the different pretreatment methods do not change the secondary effects of capsaicin application. if results turn out to be positive, it would be a massive relief with regard to time management and rescue medication.

Eligibility criteria:
inclusion criteria: * healthy volunteers 18 ore more years old exclusion criteria: * dermatologic or neurologic injuries on both thighs

Keywords: topical local anaesthesia cooling capsaicin 8% epidermal nerve fiber density treatment pain
preload-tavi trial

Conditions: TAVI

Summary: the aim is to assess the response of cardiac output and stroke volume to volume preload optimization in patients with severe aortic stenosis treated with aortic prosthesis implantation.

patients with severe aortic stenosis present a maintained overload pressure of the left ventricle that can lead to a progressive hypertrophy. this results in elevated left-sided filling pressures and impaired diastolic function.in this context, paradoxical changes in left ventricular function after aortic valve replacement have been described, with acute decrease of the afterload condition that can result in the development of a dynamic intraventricular gradient, especially in the presence of small ventricles with severe hypertrophy, resulting in hemodynamic collapse. in this setting, it is particularly important to ensure accurate left ventricular preload to optimize myocardial contractility and guarantee an adequate hemodynamic response to valve implantation. patients with severe aortic stenosis submitted for transfemoral tavi on spontaneous breathing will be randomly assigned 1:1 to standard care vs volume preload optimization. non-invasive continuous monitoring (clear sight system, edwards lifesciences) will be used to evaluate the cardiac output and the stroke volume in both groups, comparing the hemodynamics before and after valve implant.

Eligibility criteria:
inclusion criteria: * aortic valve stenosis with echocardiographic derived criteria: mean gradient \>40 mmhg or jet velocity greater than 4.0 m/s or an initial aortic valve area of \< 0.8 cm2 exclusion criteria: * cardiogenic shock. * life expectancy \< 1 year. * need of mechanic ventilation.
a randomised,multi-center study of docetaxol plus capecitabine or cisplatin in anthracycline-pretreated patients with advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: docetaxol plus capecitabine regimen is the standard treatment for the anthracycline-pretreated patients with advanced breast cancer. cisplatin is an important drug for advanced breast cancer and potential effective drug for triple negative breast cancer.the study primary objective:assess orr,ttp,ttf and 2 year pfs rate between docetaxol+capecitabine and docetaxol+cisplatin. the second objective:assess the safety and qol.

the study main inclusion criteria are:1.age≥18,kps\>70.2.anthracycline-pretreated patients with advanced breast cancer.3.at least 1 measurable lesion as defined by modified recist criteria.4.screening laboratory values within the following parameters:anc ≥1.5×109/l,hemoglobin≥10.0 g/dl，platelet≥100×109/l. 5. signed icf the patients will be randomised two group: docetaxol+capecitabine and docetaxol+cisplatin. according to ae, the dose will be adjusted.

Eligibility criteria:
inclusion criteria: * age≥18y * kps≥ 70 * pathologic diagnosis of breast cancer * at least 1 measurable lesion as defined by modified recist criteria * screening laboratory values with the following parameters: hemoglobin:≥10.0 g/dl absolute neutrophils count:≥1.5×109/l platelet:≥100×109/l creatinine clearance rate: ≥60ml/min total bilirubin: ≤1.5 ×upper limits of normal alkaline phosphatase,aspartate aminotransferase and alanine aminotransferase:≤ 2.5×upper limits of normal（≤5×upper limits of normal if liver metastasis are present) * signed icf * for women of child bearing potential,a negative serum or urine pregnancy test result before study entry. exclusion criteria: * more than 2 cytotoxic chemotherapy treatment regimens for metastatic disease. * prior exposure to 5-fluorouracil continuous infusion. * prior exposure docetaxol for metastatic disease * any other cancer within 5 years prior to screening with the exception of contralateral breast cancer,adequately treated cervical carcinoma in situ,or adequately treated basal or squamous cell carcinoma of skin

Keywords: advanced breast cancer docetaxol capecitabine cisplatin
phase 1 placebo-controlled,dose-escalation study to evaluate the safety and pharmacokinetics of medi8852 in adults

Conditions: Influenza

Summary: the purpose of this study is to evaluate the safety and pharmacokinetics of medi8852 compared to placebo when administered to healthy adult subjects.

this is a phase 1, single-dose, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and pharmacokinetics of medi8852 compared to placebo when administered to healthy adult subjects. approximately 40 subjects will be entered to receive treatment across 4 fixed dose cohorts at 1 site. investigational product will be delivered intravenously (iv). a total of 4 different dose levels of investigational product will be evaluated across the cohorts. subjects will be followed for approximately 100 days.

Eligibility criteria:
inclusion criteria: 1. age 18 through 65 years at the time of screening 2. weight ≥ 45 kg and ≤ 110 kg at screening 3. healthy by medical history, physical examination, and baseline safety laboratory studies. 4. systolic blood pressure (bp) \< 140 mm hg and diastolic bp \< 90 mm hg at screening 5. electrocardiogram without clinically significant abnormalities at screening 6. able to complete the follow-up period through day 101 as required by the protocol 7. females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for at least 28 days prior to the first dose of investigational product and must agree to continue using such precautions through day 101 of the study exclusion criteria: 1. acute illness, including fever \> 99.5°f, on day prior to or day of planned dosing 2. any drug therapy within 7 days prior to day 1 (except contraceptives or a single use of acetaminophen, aspirin, antihistamine. and other nutritional supplements that have not been taken for at least 30 days prior to enrollment, are not exclusionary. 3. blood drawn in excess of a total of 450 ml (1 unit) for any reason within 2 months prior to screening 4. receipt of immunoglobulin or blood products within 6 months prior to screening 5. receipt of any vaccine within 14 days prior to investigational product dosing or planned receipt of any influenza vaccine within 100 days after investigational product dosing 6. either history of active infection with hepatitis b or c or positive test for hepatitis c or for hepatitis b surface antigen at screening 7. aspartate aminotransferase (ast), alanine aminotransferase (alt), or serum creatinine above the upper limit of normal or hemoglobin, white blood cell count, or platelet count below the lower limit of normal at screening 8. history of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years 9. pregnant or nursing mother 10. history of alcohol or drug abuse within the past 2 years tha or positive class a drug screen for amphetamines, barbiturates, opiates, or cocaine at screening.

Keywords: influenza, flu, flu a, influenza a