Kornimate/medical-research-clean huggingface dataset:
efficacy of face mask in reducing respiratory allergic symptoms in birch-allergic subjects in alyatec exposure chamber

Conditions: Allergic Asthma; Allergic Rhinitis

Summary: there is no clinical evidence that face masks are efficient in birch pollen-induced asthma. as the use of face masks has become widespread worldwide to limit the spread of sars-cov-2, this study aims to demonstrate the clinical efficacy of medical masks in patients allergic to birch in the same way that clinical trial with drugs.

all patients should have positive skin prick tests and specific ige to birch at screening visit. 24 patients with asthma response during 1-hour baseline exposure to airborne bet v 1 in alyatec environmental exposure chamber.will be randomized into 2 groups: with (n=12) and without (n=12) a kolmi® surgical face mask (op-air), for a 6-hour exposure to birch allergen. allergic symptoms will be observed during the 6-hour exposure and compared between the 2 different groups (with and without face mask) to evaluate the efficacy of the face mask.

Eligibility criteria:
main inclusion criteria: * subjects who signed the written informed consent, * subjects covered by health social identification number, * subjects able to understand and complete study-related procedures, * subjects reported history of symptomatic birch pollen allergen-triggered asthma (gina1) with associated allergic rhinitis, * positive skin prick test (spt) with cat hair extract with mean wheal diameter ≥ 5 mm compared to negative control (nacl reaction \< 2 mm), * positive sige tests for birch tree pollen and bet v 1 (≥0.7 kua/l), * subjects with fev1 ≥ 70% predicted at screening and before allergen exposure, * subjects with at least one drop in fev1 ≥20% during the 1-hour baseline exposure * act≥ 20, * women of childbearing potential with a negative pregnancy test throughout the study period and a highly effective contraception: oral contraceptives, condom with spermicide, intrauterine device, bilateral tubal ligation, vasectomized partner. main exclusion criteria: * allergen immunotherapy to birch pollen allergen for more than 1 month in the 3 years prior to the screening visit, * ongoing allergen immunotherapy to another allergen, * history of anaphylactic reactions to birch allergen exposure or birch allergen immunotherapy, * history of anaphylactic reactions to another allergen in the last 6 weeks before inclusion, * nasal polyposis, deviation of nasal septum or diagnosis of uncontrolled non-allergic rhinitis, * subjects allergic to indoor environmental allergens (molds, house dust mite allergens) with obvious exposure to these allergens causing allergic symptoms,
use of non-invasive positive pressure ventilation in patients with severe obesity undergoing upper endoscopy procedures

Conditions: Severe Obesity; Hypoxia

Summary: the study evaluated the effect of non-invasive positive pressure ventilation (nippv) to decrease the incidence of desaturation events in patients with severe obesity undergoing upper endoscopy.

patients being evaluated for bariatric surgery often undergo preoperative upper endoscopy. patients with obesity are at increased risk for sedation related adverse events during endoscopy. the study evaluated the effect of non-invasive positive pressure ventilation (nippv) to decrease the incidence of desaturation in patients with severe obesity undergoing upper endoscopy. the study was a randomized controlled trial that assessed the effectiveness of nippv in patients undergoing upper endoscopy. patients were randomized into experimental group nippv or control group. primary endpoints were desaturation events (spo2 \<=94%) and desaturation events requiring intervention (spo2\<=90%). a secondary endpoint was the use of nippv to rescue patients who developed a clinically significant desaturation event.

Eligibility criteria:
inclusion criteria: * weight loss surgery patients undergoing preoperative upper endoscopy * bmi 40-60 exclusion criteria: * pregnant patients * previous weight loss surgery or stomach surgery * bmi \> 60 and bmi \< 40 * active smokers * patients with a history of recent urti (upper respiratory tract infection) within the preceding 2 weeks * lung disease, copd asthma, cystic fibrosis, sarcoidosis * baseline o2 saturation less than or equal to 94% * exclude substance abusers (active alcohol abuse, benzodiazepine abuse, and active illicit drug use)

Keywords: severe obesity non-invasive positive pressure ventilation endoscopy hypoxia bariatric surgery sedation adverse events bmi anesthesia complications
non-invasive neurally adjusted ventilatory assist

Conditions: Respiratory Failure

Summary: neurally adjusted ventilatory assist (nava) is a new concept of mechanical ventilation. nava delivers assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. the investigators will study the effects of non-invasive nava on respiratory muscle unloading critically ill patients.

to assess the effects of non-invasive nava on respiratory muscle unloading in critically ill patients

Eligibility criteria:
inclusion criteria: * age 18 - 85 years * history of chronic obstructive lung disease * invasive mechanical ventilation for more than 12 hours * planned extubation according to the weaning protocol of our clinic * informed consent obtained from a next of kin * enrollment approval from a neutral physician neither participating in the study nor in the clinical treatment of the patient exclusion criteria: * tracheostomy * facial or cranial trauma or surgery * oral, esophageal, diaphragmatic or gastric trauma or surgery * contraindication to insertion of a nasogastric tube (e. g. malformation, esophageal varices, esophageal perforation or rupture, zenkers diverticulum, severe bleeding disorder) * uncooperative state and combativeness not responding to low levels of sedatives * neurological disease possibly influencing the brainstem respiratory centre, such as but not limited to: intracerebral, subarachnoidal or subdural hemorrhage, cerebral infarction, possible hypoxic encephalopathy * next of kin refuses informed consent * pregnancy. in female patients between 18 and 60 years of age, a pregnancy test will be performed.

Keywords: non-invasive ventilation diaphragm electrical activity neurally adjusted ventilatory assist critically ill patients
study evaluating the safety, efficacy and tolerability of bio89-100 in subjects with biopsy-confirmed nonalcoholic steatohepatitis (nash)

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: this is a randomized, double-blind, placebo-controlled study that will evaluate the safety, efficacy, tolerability of bio89-100 in patients with biopsy-confirmed fibrosis stages f2-f3 nash.


Eligibility criteria:
key inclusion criteria: * age 21 to 75 * biopsy-confirmed nash with fibrosis stage f2 or f3 per nash crn system and nas ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation. * qualifying biopsy must be either within 6 months of screening visit or obtained during screening period key exclusion criteria: * have poorly controlled high blood pressure * have type 1 diabetes or poorly controlled type 2 diabetes. * history of cirrhosis or evidence of cirrhosis by clinical, imaging or liver biopsy evaluation * are planning to try to lose weight during the conduct of the study. * have a bmi \<25 kg/m2 other inclusion and exclusion criteria may apply.

Keywords: liver diseases fatty liver digestive system diseases non-alcoholic fatty liver disease metabolic diseases nash nafld
genetic testing to improve management of patients undergoing breast biopsy

Conditions: Breast Carcinoma

Summary: this study evaluates genetic testing to improve risk assessment and advance efforts to develop precision management for breast cancer by studying saliva samples for genotyping and evaluate associations with pathologic diagnoses and detailed pathologic and radiologic features.

primary objectives: i. to collect saliva from 500 consenting women undergoing a clinically indicated breast biopsy, perform genotyping, and then assess the associations of polygenic risk score (prs) (and related single nucleotide polymorphisms \[snps\]) to final diagnosis of ductal carcinoma in situ (dcis), invasive breast cancer or benign breast disease (bbd); bbd severity; specific bbd lesions; and features of background benign lobules from which these lesions arise. ii. to relate prs (and related snps) to radiologic features, including breast density and sentinel lesions, such as masses, densities, calcifications, and asymmetries. iii. to relate prs (and related snps) to molecular markers in pathologic lesions and background tissues, including associations with breast cancer (bc) molecular subtypes (e.g., luminal, triple-negative (basal) and human epidermal growth factor receptor 2 \[her2\] overexpressing) and biomarkers in bbd and lobules. outline: this is an observational study. patients undergo saliva sample collection and complete questionnaires on study. patients' medical records are reviewed.

Eligibility criteria:
inclusion criteria: * \* women over the age of 18 years * able to provide informed consent * referred for a radiologically guided breast biopsy exclusion criteria: * \* men * women under the age of 18 years * unable to provide informed consent
effect of eszopiclone on sleep disturbance and pain in cancer

Conditions: Sleep Initiation and Maintenance Disorders

Summary: to assess the effectiveness of lunesta on cancer patients who have received chemotherapy and who require patient controlled analgesia (pca), specifically to assess whether lunesta will: * improve sleep thereby decreasing need for opiates via pca * improve sleep thereby decreasing pain by self report * improve sleep thereby decreasing fatigue by self report

pain and fatigue are the most common symptom complaints of cancer patients. although dramatic improvements have come about in recognizing and treating cancer related pain, less progress has been made in treating fatigue. interventions to improve sleep may offer benefit in terms of pain and fatigue. one of the less commonly recognized side effects of opiate use is sleep disruption. experimentally-induced sleep disruption lowers the threshold for detection of painful stimuli. thus, although opiates are obviously helpful for pain, they do so at certain "costs": they increase next day fatigue, constipation, and have other side effects; they disrupt sleep which further increases next day fatigue; and finally, by virtue of their sleep disruptive properties, they lower the threshold for pain stimuli. cancer patients requiring chemotherapy commonly require pca because of oral mucositis. the objective of this study is to assess whether opiate usage may be reduced and complaints of fatigue and pain be lessened if patients had better sleep.

Eligibility criteria:
inclusion criteria: 1. male or female patients hospitalized for chemotherapy or blood/bone marrow transplant. 2. age 20 - 75 3. not currently regularly taking any prescribed sleeping pill more often than 4x/week. 4. can tolerate oral medication. exclusion criteria: 1. patients with a current history of substance abuse 2. patients with a history of allergic response to lunesta. 3. patient who require additional oral or parenteral opioids after starting pca opioid treatment.

Keywords: pain fatigue sleep bone marrow transplant cancer
grape and pomegranate polyphenols in postprandial glucose and related parameters

Conditions: Subjects With Abdominal Obesity

Summary: the aim of this is study is to evaluate the acute effect of grape and pomegranate polyphenols in the modulation of markers of metabolic syndrome. most of the previous works about polyphenols have only considered a fraction of polyphenols, i.e., extractable polyphenols. as a consequence, an important amount of dietary polyphenols, the so-called non-extractable polyphenols are ignored. in contrast, the effect of both extractable and non-extractable polyphenols will be considered in this study. furthermore, the effect of both polyphenols as present in the food matrix and metabolites derived from microbial fermentation will be evaluated.


Eligibility criteria:
inclusion criteria: * abdominal perimeter ≥102 cm. for male participants and ≥88 cm for female participants. * subjects presenting some or several of these characteristics will be prioritized: fasting glucose values between 110-128 mg/dl. triglycerides = 150-195 mg/dl. hdl-cholesterol: \ 130 mm hg; diastolic \> 85 mm hg. exclusion criteria: * subjects taking drugs for hyperglycaemia, hypertension or hypercholesterolaemia. * volunteers participating in other studies or weight loss plans. * pregnant or breastfeeding women.

Keywords: polyphenols grape pomegranate metabolic syndrome abdominal obesity postprandial glucose insulin resistance
opioid-induced bowel dysfunction: long-term assessment of lubiprostone

Conditions: Opioid-Induced Bowel Dysfunction

Summary: the purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.


Eligibility criteria:
inclusion criteria: * has completed 12 weeks of blinded treatment in nct00595946 or nct00597428 * will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study * willing to continue to abstain from use of disallowed medications as defined per protocol exclusion criteria: * has newly diagnosed impaired renal function identified at the screening visit \[i.e., serum creatinine concentration \> 1.8 milligrams per deciliter (mg/dl)\] * has experienced an unexplained and/or clinically significant weight loss defined as \> 5% within 90 days prior to screening visit. * has plans to participate in another trial with an investigational drug or device during the course of the extension study
a comparative confirmatory study of stn1012600 in subjects with primary open angle glaucoma or ocular hypertension

Conditions: Primary Open Angle Glaucoma, Ocular Hypertension

Summary: to investigate whether the iop lowering efficacy of stn1012600 ophthalmic solution 0.002% is non-inferior to that of latanoprost 0.005% in subjects with poag or oht after treatment for 4 weeks.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * diagnosis of poag or oht in both eyes, or one eye with poag and the other with oht. * corrected visual acuity of +0.60 logmar (decimal visual acuity 0.3) or better in each eye. exclusion criteria: * presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids in either eye. * history of severe ocular trauma in either eye. * any condition that prevents clear visualization of the fundus in either eye. * known allergy, hypersensitivity or contraindications to any components of the study medications or other study related procedures/medications. * history of ocular surgery specifically intended to lower iop in either eye. * history of keratorefractive surgery in either eye. * females who are pregnant, nursing, or planning a pregnancy. * subjects with known or suspected drug or alcohol abuse. * participation in other investigational drugs or device clinical trials within 30 days prior to screening. * any decision by the investigator to terminate a subject in screening or declare any subject ineligible for any sound medical reason.
effect of lipikar baume ap+m on quality of life and pain of adults with dryness or severe xerosis

Conditions: Atopic Dermatitis; Skin Diseases

Summary: this study aims at evaluating the effect of a topical product on the improvement of quality of life and pain of patients suffering from atopic dermatitis or other skin diseases with dryness or severe xerosis. patients aged 16 years and over are asked to apply the product once or twice a day for 2 months. they may be prescribed a corticosteroid upon decision of the dermatologist.

the general approach of the statistical methodology is the following: * the qualitative variables are described with number and percent of each level. * the quantitative variables are described with mean and standard deviation. * all statistical hypotheses are performed at the 5% significance level using 2-sided tests. * given the large sample size, no normality assessment will be done. * mean reduction rate for quantitative variables is calculated as (mean v0 - mean v1)/mean v0)\*100. * due to the high number of zeros at inclusion in the self-assessment quantitative criteria, analyses will concern only patient with an intensity above 0 at inclusion or at final visit. * response rate for qualitative variables is calculated as the percent of patients with at least on level decrease between the two visits. * response rate for satisfaction is the percent of patients declaring being satisfied or very satisfied. * response rate for tolerance is the percent of patients declaring the tolerance high or excellent.

Eligibility criteria:
inclusion criteria: • atopic dermatitis or other skin disease with dryness or severe xerosis exclusion criteria: • patients not suffering from atopic dermatitis or other skin disease with dryness or severe xerosis

Keywords: atopic dermatitis severe xerosis quality of life dryness
early assisted discharge for copd exacerbations with telemonitoring.

Conditions: COPD Exacerbation

Summary: to determine if an early assisted discharge program for acute exacerbations of copd (aecopd), with telemonitoring and telephone control, is equally effective and more efficient in terms of use of health care resources, that a home care provided by hospital respiratory nurses and pulmonologists.

this study seeks to improve the health of patients with aecopd by home care after discharge from the hospital using the technology of the information and the communication. the investigators want evaluate the efficiency, satisfaction (patients, keepers) and effectiveness of a program of early discharge with home care in patients with aecopd with telemonitoring and telephone control, in relation to the traditional protocol of home care based on nurse and pulmonologist visits.

Eligibility criteria:
inclusion criteria: * patients admitted to the hospital with copd exacerbation * no concomitant serious unstable diseases * without fever in 48 hours * aerosol treatment at the most every 6 hours * treatment with glucocorticoid intravenous \< 40 mg twice a day * a thoracic radiograph without new disease * subjective improvement of the patient * familiar suitable environment exclusion criteria: * neoplasias and other chronic diseases in terminal situation * alcoholism * intravenous medication * disability to understand and take part in the program * admitted to intensive care unit (icu) or non invasive mechanical ventilation during the exacerbation * unstability hemodynamic * to be an institutionalized patient.

Keywords: telemonitoring copd home care
study to assess clinical activity of zelenectide pevedotin in participants with advanced breast cancer

Conditions: Breast Cancer

Summary: this is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with nectin4-amplified recurrent, unresectable, or metastatic breast cancer who have received prior therapy (see inclusion criteria below). the study will comprise of 2 cohorts. cohort a will include participants with hormone receptor positive/ human epidermal growth factor receptor 2 negative \[hr+/her2-\] breast cancer, whereas cohort b will include participants with triple-negative breast cancer (tnbc).


Eligibility criteria:
inclusion criteria * archival or fresh tumor tissue comprised of recurrent unresectable or metastatic tnbc or hr+/her2-negative breast cancer available for nectin4 gene amplification testing. * confirmed nectin4 gene amplification by an analytically validated clinical trial assay. * measurable disease as defined by recist v1.1. * life expectancy ≥ 12 weeks. * eastern cooperative oncology group performance status of ≤ 2. * cohort a specific inclusion criteria: histologically or cytologically confirmed hr+/her2-negative endocrine resistant/refractory breast cancer according to asco-cap guidelines and received up to 3 prior lines of non-endocrine therapy for advanced disease. * cohort b specific inclusion criteria: histologically or cytologically confirmed tnbc, including er-low positive breast cancers (1-10% of cells expressing hormonal receptors by ihc), according to asco-cap guidelines and have received at least 1 but no more than 3 prior lines of systemic therapy for advanced disease. exclusion criteria * prior treatment with any antibody drug conjugate containing an monomethyl auristatin e (mmae) (vedotin) payload or other mmae-based therapy. * known hypersensitivity or allergy to any of the ingredients of any of the study interventions or mmae. * previously tested her2-positive (ihc 3+ or ish+) on prior pathology testing (per asco-cap guidelines). * active keratitis or corneal ulcerations. * active or untreated cns metastases. * uncontrolled diabetes or hypertension. * uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent draining procedures (monthly or more frequently). * active interstitial lung disease or penumonitis requiring ongoing treatment with steriods (\>10mg/day of prednisone or equivalent) or other immunosupressive medications. * requirement, while on study, for treatment with strong inhiitors or strong inducers of human cytochrome p450 3a (cyp3a) or inhibitors of p-glycoprotein (p-gp) including herbal- or food-based inhibitors. * prior treatment with any systemic anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to first dose of study treatment note: additional protocol defined inclusion/exclusion criteria apply

Keywords: nectin4 zelenectide pevedotin hr+/her2-negative tnbc chemotherapy