Kornimate/medical-research-clean huggingface dataset:
identification of biomarkers predictive of worse prognosis in henoch schonlein purpura

Conditions: Purpura, Schoenlein-Henoch

Summary: henoch schonlein purpura (hsp), vasculitis of small vessels with deposits of iga, is considered by many authors as the systemic form of berger's disease (iga-n). iga-n is characterized by iga1 deposits in mesangial areas associated with mesangial proliferation. these two diseases remain the leading cause of esrd by primitive glomerulopathy in western countries. in recent years, considerable progress has been made in understanding the pathophysiological mechanisms of iga-n. however, only a high rate of proteinuria at one year or the presence of severe glomerular inflammation on renal biopsy remain predictors of long term renal function. moreover, the high variability of hsp clinical expression, from few purpura skin lesions that evolve favourably spontaneously, to rapidly progressive renal failure, remains so far unexplained but suggests the existence of individual genetic susceptibility. in the first part of the study, we will study key factors based on physiopathological data obtained by our laboratory as well as by other groups. the second part of the study concerns genetic factors. although the candidate genes that may confer a particular susceptibility to the disease, to progress to esrd or respond to treatment are many, the genes involved in inflammation or controlling renin-angiotensin system are of particular interest. we will apply these results by studying patients with hsp showing three distinct phenotypes (hsp with isolated cutaneous purpura or associated with minimal or severe renal disease) at diagnosis and after clinical remission. the purpose of this study is to assess whether the phenotype at diagnosis is associated with the physiological markers and if one of them predicts a pejorative evolution of renal disease at 1 year. meanwhile, study of polymorphism of selected genes of interest could allow identification of patients with specific genetic susceptibility or with bad prognosis factors who would be thus eligible for specific treatment.


Eligibility criteria:
inclusion criteria: * patients with hsp whose diagnosis was confirmed by histology of an active skin lesion, who signed the informed consent form or for minors, signature of the holders of parental authority. exclusion criteria: * patients who do not have skin lesions; patients receiving immunosuppressive drugs or steroids for more than 2 weeks; patients with another diagnosis (platelets\<100,000/mm3, bacterial purpura, other systemic disease); * patients unable to understand the protocol, refusing to sign the information form or unable to comply with regular follow-up consultation.

Keywords: purpura, schoenlein-henoch adults children pronostic factors
pharmacokinetics of hydrocortisone after subcutaneous administration in chronic adrenal insufficiency

Conditions: Primary Adrenal Insufficiency

Summary: patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. in cases of more severe impairment or unsecure gastrointestinal absorption (e.g. gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone dose is crucial. the study is conducted to offer patients the possibility to perform hydrocortisone self administration in emergency situations in a way of administration which is easy to perform and accepted by the patient. therefore, pharmacokinetics and safety of subcutaneous hydrocortisone administration will be studied and compared to intramuscular administration.


Eligibility criteria:
inclusion criteria: * primary adrenal insufficiency under standard glucocorticoid replacement therapy due to autoimmune adrenalitis or bilateral adrenalectomy (disease duration at least 12 months), * age ≥ 18 years, * patient´s written informed consent, * ability to comply with the protocol procedures exclusion criteria * diabetes mellitus, * infectious disease with fever at time of investigation, * known intolerance to the study drug or constituents oft he study drug, * oral contraception, * known pregnancy or breast feeding, * renal failure (creatinine \> 2.5 uln)

Keywords: adrenal insufficiency addison's disease
trust-ace - anticancer-treatment cardiotoxicity identification by echocardiography

Conditions: Breast Neoplasm Malignant Primary

Summary: trust-ace will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomised design in follow-up of breast-cancer patients with respect to identification of cancer treatment related cardiac dysfunction (ctrcd). secondly, the study will evaluate whether novel tools used to improve standardization of recordings as well as automated measurements of central measurements, e.g. ejection fraction (ef) and global longitudinal strain (gls) can improve the precision of echocardiography in daily clinical practice.

cancer treatment related cardiac dysfunction (ctrcd) is a well-known complication to cancer treatment with implication both with respect to treatment and prognosis of the cancer as well as heart. ctrcd, often named cardiotoxicity, usually refers to myocardial dysfunction and heart failure developing after administration of potentially cardiotoxic therapy. by precise diagnostics, adequate treatment can be started early to prevent heart failure and unnecessary discontinuation of the potential life-saving cancer treatment may be avoided. however, guideline advocated analyses of cardiac function (ef and gls) by echocardiography are time consuming and many operators base their semi-quantitative estimates on visual assessment. furthermore, test-retest variability for both ef and gls are significant and may exceed the guideline recommended cut-offs for identification of cancer therapy-related cardiovascular toxicity. the study will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomized design. the study will also evaluate if novel tools for improved standardization of recordings and automated measurements of relevant measurements as ejection fraction (ef) and global longitudinal strain (gls) can improve the diagnostic precision. breast cancer patients referred for follow-up at the echocardiography will be included. patients will be randomized 1:1 to a) examinations with two- and three-dimensional echocardiography including all central measures of cardiac size and function measured by sonographers as recommended by the european guidelines and as clinical practice or b) echocardiographic examinations focusing on the ventricles. subpopulations will undergo additional testing with serial echocardiographic examinations by four operators on the same day with and without use of novel tools for improved standardization of recordings and automated measurements.

Eligibility criteria:
inclusion criteria: * breast cancer and referral for follow-up to identify potential ctrcd exclusion criteria: * not willing or able to consent

Keywords: echocardiography breast cancer artificial intelligence cardiotoxicity
the incidence of subclinical high-altitude pulmonary oedema at high altitude

Conditions: Acute Mountain Sickness; Subclinical High Altitude Pulmonary Edema

Summary: the aim of this investigation is to determine the incidence of silent interstitial pulmonary edema by chest ultrasound at moderate altitude (3905m). secondary endpoints are to detect a suspected association with acute mountain sickness (ams), co-morbidities and endothelial dysfunction (marker of hypoxia responses, endothelial damage and inflammation).

the high-altitude pulmonary edema (hape) is the leading cause of death from high altitude sickness. at moderate altitude (2500-4500m) the incidence (0.2-6%) may be underestimated because only clinical hape leads to symptoms and motivates the patient to seek medical advice. cremona et al. \[cremona et al. pulmonary extravascular fluid accumulation in recreational climbers: a prospective study. lancet 2002;359:303-09\] suggested that a silent interstitial pulmonary edema arises in most recreational climbers at moderate altitude. recently, chest sonography has been shown to effectively detect pulmonary edema and quantify extravascular lung water through the sign of "ultrasound lung comets" (ulcs) originating from water-thickened interlobular septa \[lichtenstein d et al. the comet-tail artifact. an ultrasound sign of alveolar-interstitial syndrome. am j respir crit care med;156:1640-46\]. the technique requires only basic twodimensional technology and has been applied in extreme, out-of-hospital setting, showing in recreational climbers a high prevalence of clinically silent interstitial pulmonary edema at high-altitude \[pratali l et al. frequent subclinical high-altitude pulmonary edema detected by chest sonography as ultrasound lung comets in recreational climbers. crit care med 2010;38:1818-23\]. however, data for moderate altitude remain scarce, despite that mountaineers are increasing in age and comorbidities and could be more prone to high altitude emergencies. prospective, non-randomised, observational study. study participants are recruited from a scientific research group lead by the ohio state university during a glaciology study on the ortles glacier in south tyrol (3905m). patients are tested for a baseline measure, during a permanent stay on the glacier camp (3h, 9h, 24h, 48h, 72h, 7d ). parameters include chest ultrasound, lake louise score, cerebral sensitive score, non-invasive haemodynamic parameters (i.e. us) and markers of hypoxia responses, endothelial damage and inflammation.

Eligibility criteria:
inclusion criteria: * healthy of age \>18y exclusion criteria: * cardiac failure * chronic kidney disease * chronic pulmonary disease * acute lung/heart/kidney/brain conditions * neoplastic disease * lack of consent
impact evaluation of the wise guys program

Conditions: Sexual Behavior; Sexually Transmitted Infections

Summary: the purpose of this study is to evaluate the impact of the wise guys program on the delaying sexual initiation on adolescent males in eastern iowa.

this study uses a randomized controlled design to compare the impacts of the wise guys program to the "business-as-usual" school curriculum. the wise guys multi-session curriculum is delivered in different formats that range in length from 5 to 12 weeks and topics covered include communication and masculinity, dating violence, abstinence and contraception, and sexually transmitted infections. study participants are 7th grade boys attending a participating school in either the davenport iowa or north scott community school districts. this study is being conducted as part of the national personal responsibility education program evaluation funded by administration for children and families within the u.s. department of health and human services.

Eligibility criteria:
inclusion criteria: * 7th grade student in participating schools * male
safety and tolerability study of macitentan in patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the music ol study is an open-label extension study, in which all eligible patients having completed the double-blind ac-055b201/music study as scheduled receive macitentan 10 mg once daily. the study objective is to assess the long-term safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis (ipf).


Eligibility criteria:
inclusion criteria: * signed informed consent prior to initiation of any study-related procedure. * patients with ipf and having completed the double-blind ac-055b201/music study as scheduled, i.e., having remained in the study until the sponsor-declared end-of-study (eos), whether or not study treatment was prematurely discontinued. * women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination. exclusion criteria: * any major violation of protocol ac-055b201/music. * premature discontinuation of study treatment during the ac-055b201/music study due to an adverse event (ae) assessed as related to the use of macitentan, excluding events of ipf worsening. * pregnancy or breast-feeding. * ast and/or alt \> 3 times the upper limit of the normal range. * any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease. * known hypersensitivity to drugs of the same class as macitentan, or any of the excipients.

Keywords: idiopathic pulmonary fibrosis ipf pulmonary fibrosis
study of azeliragon in patients with mild alzheimer's disease and impaired glucose tolerance

Conditions: Alzheimer Disease

Summary: this is a study to evaluate the efficacy and safety of azeliragon in patients with mild alzheimer's disease and impaired glucose tolerance. patients will receive either azeliragon or placebo with a patient's participation lasting approximately 9 months (in part 1) or 21 months (in part 2).


Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer disease (ad) with documented evidence of progression of disease * mini mental state examination (mmse) score of 21-26, inclusive * clinical dementia rating global score of 0.5 or 1 * alzheimer's disease assessment scale - cognitive subscale (adas-cog14) of 10 or more * brain magnetic resonance imaging (mri) consistent with the diagnosis of probable ad * concurrent use of cholinesterase inhibitor or memantine with stable dose for at least 2 months prior to screening * hemoglobin a1c (hba1c) 6.5% - 9.5%, inclusive * caregiver willing to participate and be able to attend clinic visits with patient * ability to ingest oral medications exclusion criteria: * significant neurological or psychiatric disease other than alzheimer's disease * previous clinical trial participation within 90 days of screening * previous exposure to putative disease modifying therapy for alzheimer's disease within 1 year of screening * history of cancer within the last 5 years except adequately treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate cancer not requiring current treatment * women of childbearing potential * uncontrolled blood pressure and/or blood pressure above 140/90 * participants receiving medications that may negatively impact cognitive function * history of diabetic ketoacidosis within the past year * history of chronic pancreatitis * stage 4 kidney disease * use of insulin therapy

Keywords: receptor for advanced glycation endproducts (rage) adas-cog cdr-sb
enb guided rfa for early-stage peripheral lung cancer

Conditions: Lung Cancer

Summary: the objective of the study was to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy (enb) guided radiofrequency ablation (rfa) for the treatment of early-stage peripheral lung cancer.

the study is aimed to evaluate the efficacy and safety of enb guided rfa for the treatment of patients with early-stage non-small cell lung cancer (nsclc). the study is designed as a single-center prospective trial with one arm. the participating centers are department of pulmonary medicine and endoscopy, shanghai chest hospital affiliated to shanghai jiao tong university, china. patients diagnosed with early-stage nsclc will be enrolled into the study. fifty patients are expected to be enrolled totally.

Eligibility criteria:
inclusion criteria: 1. patients discovered with peripheral lung nodules that have demonstrated to be non-small cell lung cancer by pathology with the clinical stage of ia. 2. the tumors are solid or part-solid peripheral lung nodules and the length-diameter of the nodules are more than 10 mm and no more than 30 mm. 3. patients are unsuitable for surgery assessed by multi-modality treatment and agree to the primary treatment of ablation. 4. patients have good compliance and sign the informed consent. exclusion criteria: 1. patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications. 2. patients have contraindications of general anesthesia. 3. chest ct suggests that navigation bronchoscopy technology cannot guide treatment equipment to reach the peripheral lung lesion. 4. chest ct or bronchoscopy shows that the bronchial lumen occlusion or deformation leading to the guided and treatment equipment cannot reach the peripheral lung lesion. 5. there are large blood vessels or important structures adjacent to peripheral lung lesion. 6. researchers consider the patient do not fit for the study.

Keywords: electromagnetic navigation bronchoscopy(enb) radiofrequency ablation(rfa) peripheral lung cancer
fluoxetine versus fluoxetine plus du125530 in major depressive disorder

Conditions: Major Depression

Summary: the purpose of this study is to examine whether the speed of the clinical antidepressant action of fluoxetine can be accelerated by administering du125530 a full 5-ht1a antagonist.

ssri acts by blocking the serotonin transporter (5-ht), increasing the availability of serotonin at the synaptic cleft averting its reuptake. the increment of serotonin activates 5-ht1a presynaptic autoreceptors, resulting in a modulation in the release of serotonin by the presynaptic neuron. it is proposed that 5-ht1a receptor antagonism could accelerate the clinical effect of antidepressants by preventing this negative feedback.preclinical data obtained with selective 5-ht1a antagonists, such as pindolol, and with mice lacking 5-ht1a receptors supports this hypothesis. results on partial antagonists (pindolol) are conclusive in accelerating ssri. it is reasonable to call into question whether a total antagonism of 5-ht1a receptors could imply a more rapid antidepressant response. to test this hypothesis we conducted a double blind, randomised, controlled trial with du 123550 added to fluoxetine 20 mg/day

Eligibility criteria:
inclusion criteria: * consecutive eligible patients aged 18 to 70 * diagnosis of unipolar major depression using dsm-iv criteria with moderate to severe symptoms (score e 18 on the hamilton depression rating scale-hdrs- of 17 items). * there was a wash-out of 1 week of any antidepressant drug (specifically 28 days for fluoxetine) prior entering the study. * written informed consent was obtained from all participants. exclusion criteria: * concurrent psychiatric disorders (dsm iv axis i, ii cluster a or b) * failure to respond to drug treatment in current depressive episode * previous resistance to ssris or other antidepressant drug * suicide risk score e 3 on the hdrs. * participation in other drug trials within the previous month * presence of delusions or hallucinations * history of substance abuse (including alcohol) in the past three months * pregnancy or lactation * organic brain disease or history of seizures * serious organic illnesses such as hypo or hyperthyroidism,cardiac arrhythmias, asthma, diabetes mellitus. * myocardial infarction in the past 6 month * frequent or severe allergic reactions * concomitant use of other psychotropic drugs (benzodiazepines were allowed), lockers or catecholamine-depleting agents * current structured psychotherapy.

Keywords: major depression du 125530 treatment depression latency antidepressant
immunerecov contributes to improvement of respiratory and immunological response in post-covid-19 patients.

Conditions: Long Covid19; Dietary Supplements; Respiratory Tract Infections; Inflammation

Summary: background: covid-19 left consequences in different organs from months to years requiring different types of rehabilitation. in fact, a severe loss in the lung function, and in the respiratory and peripheral muscle strength is commonly observed in post-covid-19 patients. objectives: thus, the present study investigated whether 30 days of supplementation with a nutritional blend (immunerecov®; composition: whey protein concentrate, astaxanthin, creatine, selenium, vitamin c, glutamic acid, tryptophan, magnesium) would help to minimize the respiratory (lung function) and muscular (respiratory and peripheral muscles) sequelae in post-covid-19 patients.

background: covid-19 left consequences in different organs from months to years requiring different types of rehabilitation. in fact, a severe loss in the lung function, and in the respiratory and peripheral muscle strength is commonly observed in post-covid-19 patients. objectives: thus, the present study investigated whether 30 days of supplementation with a nutritional blend (immunerecov®; composition: whey protein concentrate, astaxanthin, creatine, selenium, vitamin c, glutamic acid, tryptophan, magnesium) would help to minimize the respiratory (lung function) and muscular (respiratory and peripheral muscles) sequelae in post-covid-19 patients. design: this is a non-controlled open label prospective clinical study. methods: fifty-eight post-covid-19 patients were recruited and twenty-four accepted to take the nutritional blend, while twenty-four did not accept but required to participate in the evaluations and 10 refused to participate. so, the patients were evaluated before the 14th day after hospital discharge and after 30 days of use of the nutritional blend or control (no supplementation).

Eligibility criteria:
inclusion criteria: the inclusion criteria encompassed post-covid-19 patients with a confirmed covid-19 diagnosis through a positive rt-pcr test, who also required hospitalization, meeting the criteria for moderate severity classification as defined by the world health organization (who). in summary, according to the who, moderate illness is characterized by individuals who exhibit signs of lower respiratory disease during clinical assessment or imaging and maintain an oxygen saturation level (spo2) of ≥94% while breathing room air at sea level. exclusion criteria: exclusion criteria included individuals discharged from the hospital for more than 14 days and those who initiated physical activity or began taking any dietary supplements or vitamins.

Keywords: covid-19 dietary supplementation inflammation lung function muscle strength sars-cov-2