Kornimate/medical-research-clean huggingface dataset:
endomicroscopy in patients with food allergy: a new diagnostic option

Conditions: Food Allergy

Summary: the purpose of this study is to evaluate the endoscopic diagnostic options of the endomicroscopy in patients with food intolerance.

food allergy is with a prevalence of 2-4% a seldom disease. the endoscopy of the gastrointestinal tract and the histological analysis of taken biopsies of the intestinal mucosa are basic instruments in the diagnostic of food allergy. with modern high-resolution video endoscopy the intestinal mucosa can be investigated on inflamed areas and can evaluate several of differential diagnosis. with the implementation of a fluorescein based confocal laser endoscope the intestinal mucosa can be magnified 1000 fold, so that even next to the macroscopic investigation the cellular patterns can be analyzed. the laser endoscope offers for the first time an in vivo presentation of cellular structures. our study group could utilise for the first time the laser endoscope in patients with colitis ulcerosa for cancer prevention. hereby, the cancer prediction could be enhanced obviously. furthermore, we conducted these investigations in more than 1500 patients und could present that this method is a safety method. based on these investigations we want to implement now the laser endoscope in the diagnostic field of food allergy. patient wit food allergy generates through the intestinal mediators and histamine secretion an oedema, an increase of inflammatory cells, vasodilatation and expansion of lymph nodes. in comparison of patients with food allergy to healthy subjects, the degree of oedema formation, the amount of cell infiltration and the expansion of lymph nodes will be evaluated. the aim of the present study is to detect these cellular structures in patients with food allergy and to open with that a new diagnostic option in patient with an allergy disease.

Eligibility criteria:
inclusion criteria: * new diagnosed and not treated patients with food allergy exclusion criteria: * decreased clotting (quick \< 50%, platelet \< 50.000/µl) * not given consent * known allergy against fluorescein * pregnant and breastfeeding woman

Keywords: food allergy confocal laser endoscope diagnosis diagnosis of food allergy
remote ischemic conditioning and atrial fibrillation after coronary artery bypass grafting (cabg)

Conditions: Atrial Fibrillation

Summary: recent studies indicate that remote ischemic conditioning can protect the heart and other organs during cardiac surgery. the investigators aim to investigate whether such a stimulus can reduce the incidence of atrial fibrillation or other complications following coronary artery bypass surgery.


Eligibility criteria:
inclusion criteria: * elective on-pump cabg surgery * informed consent exclusion criteria: * prior cardiac surgery (re-operations) * prior atrial fibrillation * use of class 1 or 3 anti arrhythmic medication or digoxin use of intermittent aortic cross clamping during surgery * age \<18 years * left ventricular ejection fraction ≤30% * serious pulmonary disease (resting po2 \<90% at room air) * renal failure (clearance \<30 ml/min as calculated using the modification of diet in renal disease formula) * liver failure * use of the sulfonylurea derivative glibenclamide (this drug is known to block any preconditioning stimulus

Keywords: remote ischemic conditioning cabg surgery atrial fibrillation coronary artery bypass ischemic preconditioning
carbon dioxide rebreathing during exercise assisted by non-invasive ventilation

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study was to evaluate whether co2 rebreathing occurs in healthy subjects or patients with copd ventilated during exercise assisted by the single-limb circuit with a plateau exhalation valve at a given inspiratory positive airway pressure and a minimal level of expiratory positive airway pressure (epap) and whether there is a potential threshold for predicting co2 rebreathing.

non-invasive ventilation circuit consists of single-limb tubing for inspiration and expiration, including a plateau exhalation valve. as exhaled gases was vented out the plateau exhalation valve at a constant rate, during exercise, with the increase of exhalation flow, single-limb circuit with a plateau exhalation valve might cause carbon dioxide(co2) rebreathing. therefore, our aim in the present study was to evaluate whether co2 rebreathing occurs in copd patients ventilated during exercise assisted by the single-limb circuit with a plateau exhalation valve and estimate a potential threshold for predicting co2 rebreathing.

Eligibility criteria:
inclusion criteria: * presented clinically stable (no exacerbation in the 4 weeks prior to study participation or with no change in medications); * physician diagnosed copd, forced expiratory volume in 1s (fev1) \< 50% predicted; * dyspnea as a main symptom that limited daily activities. exclusion criteria: * subjects with obvious pulmonary bullae demonstrated by chest ct scan or x-ray; * examination or facial trauma/malformation, recent facial, upper airway or upper gastrointestinal tract surgery, that would preclude receiving niv therapy; * a history of coronary artery disease or cardiac arrhythmias or potential electrocardiographic alterations; * a history of uncontrolled hypertension, or other respiratory diseases; * oxygen saturation(spo2) \< 88% at rest with a fraction of inspired oxygen (fio2) ≥ 0.5; * patients with musculoskeletal or neurological disorders; * or failure to comply with the research protocol.

Keywords: copd noninvasive ventilation exercise co2 rebreathing
assessment of the therapeutic utility of hmg-hp

Conditions: Sterility

Summary: to assess the effectiveness of a protocol of ovarian hyperstimulation with urinary gonadotrophins, to achieve clinical pregnancy in females undergoing ivf. study hypothesis: to assess the effectiveness of a protocol of urinary gonadotrophins


Eligibility criteria:
inclusion criteria: * women aged 18-38 years * body mass index (bmi) between 18 and 30 * women classified as normogonadotrophin patients. not more than 3 previous cycles of art (assisted reproductive technology) * testosterona, fsh (follicle-stimulating hormone) lh (luteinizing hormone) and prolactin serum levels during the early folicular phase (days 2-4 of the cycle) within the laboratory normal range * no administration of clomiphen citrate or gonadotropins during the month prior to the start of the study exclusion criteria: * failure in previous cycles of assisted reproduction ivf/icsi (in-vitro fertilisation/intracytoplasmic sperm injection) * seminal samples not apt for ivf-icsi (according to the criteria of each center). evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months * data suggestive of possible ovarian failure * antecedents of severe ovarian hyperstimulation syndrome (ohss) * important systemic disease * pregnancy or contraindication to pregnancy
guanfacine to improve substance use outcomes in women

Conditions: Substance Use Disorders

Summary: hypothesis: guanfacine (gua) (3mg/day) will reduce drug craving, improve cognitive flexibility and result in associated lower drug use in women with substance use disorder (sud) in an outpatient clinical setting.

this study proposes to extend previous phase i experimental work to address the following specific aims: (1) assess gua's target engagement of drug craving and cognitive flexibility in a laboratory challenge session and in a 10-week outpatient clinical study, (2) demonstrate target validation by showing that reduced drug craving and improved cognitive flexibility will predict lower drug use outcomes during the 10-week clinical trial in sud women, and finally, (3) evaluate data replication and scalability of gua target effects across two clinical sites (yale and suny-stony brook).

Eligibility criteria:
inclusion criteria: * 100 treatment seeking women * ages 18-70 years * body mass index (bmi) of 18-35 * meet current dsm-v criteria for co-occurring suds, with primary dsm-v cocaine or primary dsm-v opioid use disorder and co-occurring cannabis or alcohol or nicotine use disorders; * positive drug urine toxicology screens for primary addictive disorder during a 2-week intake assessment period * good health as verified by screening examination * able to read english and complete study evaluations * able to provide informed written and verbal consent exclusion criteria: * meet criteria for physiological dependence on alcohol requiring medical detoxification * regular use of anti-hypertensives, anti-arrythmics, antiretroviral medications, and medications that would interact with guanfacine and be contraindicated as per study physician; * psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania) * significant underlying medical conditions which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study; specifically hepatic and renal impairment as per liver enzymes at 3x the normal limit, or bun\>50mg or bun:cr \> 10:1. * hypotensive women with sitting blood pressure below 100/50 mmhg * women who are pregnant, nursing or refuse to use a reliable form of birth control * ekg evidence at baseline screening of any clinically significant conduction abnormalities, including a bazlett's qt c\>470 msec for women.
study of cad-1883 for spinocerebellar ataxia

Conditions: Spinocerebellar Ataxias; Spinocerebellar Ataxia Type 1; Spinocerebellar Ataxia Type 2; Spinocerebellar Ataxia Type 3; Spinocerebellar Ataxia Type 6; Spinocerebellar Ataxia Type 7; Spinocerebellar Ataxia Type 8; Spinocerebellar Ataxia Type 10; Spinocerebellar Ataxia Type 17; ARCA1 - Autosomal Recessive Cerebellar Ataxia Type 1

Summary: this is a randomized, double-blind, placebo-controlled phase 2 study evaluating oral administration of cad-1883 in the treatment of adults with a genotypic diagnosis of spinocerebellar ataxia (sca). this study offers the opportunity to understand the safety, tolerability, and efficacy of cad-1883 in the sca patient population.

this is a randomized, double-blind, placebo-controlled phase 2 study evaluating oral administration of cad-1883 in the treatment of adults with a genotypic diagnosis of sca using multiple dose levels. the study will include multiple cohorts of 16 patients each where 12 patients will be randomized to cad-1883 and 4 to matching placebo. potential subjects will undergo a screening period (14 to 28 days), a baseline (day 1) visit, and a 12-week treatment period. a follow-up visit will occur 4 weeks after the end of the treatment period. the total duration of individual subject participation may be up to 20 weeks, depending on the duration of the screening period. the study will assess safety by adverse events, vital signs, laboratory parameters (including chemistry, hematology and urinalysis); pharmacokinetics of cad-1883; and efficacy measures by scale for the assessment and rating of ataxia (sara), clinician/patient rating of ataxia and symptoms, patient quality of life measures and wearable sensors to capture falls and gait measurements. for planning purposes, the anticipated study completion date assumes evaluation of 3 cohorts.

Eligibility criteria:
key inclusion criteria: * prior spinocerebellar ataxia (sca) diagnosis of the following sca genotypes: sca1, 2, 3, 6, 7, 8, 10, 17, or autosomal recessive cerebellar ataxia type 1 (arca1). * scale for the assessment and rating of ataxia (sara) total score ≥8 and \<30 at screening * sara item #1 (gait) score of ≥2 at screening * ability to ambulate 8 meters at screening without assistance from another person key exclusion criteria: * neurological condition other than sca that could predominantly explain or contribute significantly to the subjects' symptoms of ataxia or that could confound the assessment of ataxia symptoms (e.g., chronic alcoholism, vitamin deficiencies, multiple sclerosis, parkinson's disease, friedreich's ataxia, vascular disease, tumors, paraneoplastic disease, head injury, idiopathic late onset ataxia, multisystem atrophy, stroke, arthritis, cerebral palsy, spasticity of unknown origin). * moderate or severe scores on the following inventory of non-ataxia signs (inas) items at screening: dystonia: at least 3 of 5 items; spasticity: at least 2 of 3 items; rigidity: at least 2 of 3 items

Keywords: ataxia sca
transarterial chemoembolization (tace) therapy of hepatocellular carcinoma (hcc) with blocking tumor blood temporarily and enhancing perfusion

Conditions: Hepatocellular Carcinoma

Summary: according to radiology imaging, the patients of hcc are divided into two groups(hypovascular tumor group and moderately vascular tumor group). every group is divided into tace therapy with balloon catheter subgroup and regular tace therapy subgroup. patients take the tace therapy each 45 days, and have mri diffusion examine or ct one week before next therapy. all objects are observed until the end event happening or in the group for 6 months.


Eligibility criteria:
inclusion criteria: * sign the written informed consent form provided. * diagnosed clinically as hcc,need to take tace. exclusion criteria: * have had an allergic reaction following iodine. * have been in any tace or radiotherapy or biotherapy within 30 days before the study. * hcc of diffuse type,failure of hepatic function, chronic illness or disease including failure of heart function, uncontrolled high blood pressure, heart disorders, serious infection, uncontrolled diabetes mellitus.

Keywords: hepatocellular carcinoma transcatheter arterial chemoembolization overall survival
ctdna-mrd in stage iiib-c nsclc patients treated with induction chemoimmunotherapy

Conditions: Non-small Cell Lung Cancer

Summary: the goal of this observational study is to explore whether ctdna-mrd dynamic monitoring can more effectively predict the therapeutic effect of induction chemoimmunotherapy followed by surgery or non-surgical treatment for stage iiib-c driver-negative nsclc in the mdt model, so as to accurately guide clinical diagnosis and treatment.

this study is a single-center, observational, non-interventional, prospective study. 50 patients diagnosed with stage iiib-c driver-negative nsclc receiving induction chemoimmunotherapy will be planned to be enrolled in the study. pre-treatment biopsy tissues of enrolled patients will be collected for next-generation sequencing (ngs) of institutionally-developed 1021-gene panel, and personalized detection panel will be customized based on ngs testing results. patients will be received induction chemoimmunotherapy followed by surgery or non-surgical treatment in the mdt model and ctdna-mrd testing will be performed at prespecified time points. for patients who received surgery following induction therapy, peripheral blood will be collected in baseline, 1 day before the third cycle of neoadjuvant therapy, 1 day before surgery, 3 days after surgery and landmark time and pulmonary venous blood will be collected intraoperatively. for patients who received non-surgical treatment following induction therapy, peripheral blood will be collected in baseline, 1 day before the third cycle of neoadjuvant therapy, 1 day before non-surgical therapy and landmark time. all included patients will be regularly followed up for at least 5 years.

Eligibility criteria:
inclusion criteria: * histopathology or cytology confirmed the non-small cell lung cancer * age ranging from 18 to 75 * agree to participate in this study and sign an informed consent form * treatment-naive tumor * driver gene negativity * according to the american joint committee on cancer (ajcc) eighth edition of the lung cancer staging manual, the clinical stage is stage iiib-c potentially resectable tumor * the eastern cooperative oncology group (ecog) performance status (ps) score is 0-1 exclusion criteria: * patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form * small cell lung cancer * driver gene positivity * tumor directly invades esophagus, heart, aorta, diaphragm, trachea, or carina, or is considered unresectable even following induction therapy * patients with solid organ or blood system transplantation * previous use of recombinant cytotoxic t-lymphocyte associated antigen 4 (ctla-4), programmed cell death 1 (pd-1), or programmed cell death ligand 1 (pd-l1) immune checkpoint inhibitors * patients with interstitial lung disease * patients with acute or chronic infectious disease * pregnant and lactating women * patients who have undergone other clinical drug trials
comparison of corneal grafts cultured in serum-free versus corneal grafts cultured in serum supplemented culture media

Conditions: Fuch's Endothelial Dystrophy; Pseudophakic Bullous Keratopathy

Summary: the goal of this clinical trial is to compare the quality of corneal grafts cultured in a serum-free culture medium with a defined composition versus corneal grafts cultured in a standard serum supplemented culture medium transplanted in patients with decompensated corneal dystrophy

the primary objective of this clinical trial is to test the equivalence of the quality of the corneal grafts cultured under serum free conditions to corneal grafts cultured in the minimal essential medium supplemented with 2% fetal calf serum, based on a parallel comparison of the endothelial cell density of paired corneal grafts deriving from single donors at different time points before and after the grafting procedure. in addition, the safety of the clinical use of corneal grafts cultured in both media will be determined. the graft survival rate during the follow-up period will be quantified in regard to immune mediated graft rejection and non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation.

Eligibility criteria:
inclusion criteria: * male and female patients between 50 and 85 years of age * clinically proven fuchs corneal dystrophy or secondary decompensation the corneal endothelium (e. g. after surgical intervention in the anterior segment of the eye) * patient informed consent exclusion criteria: * previous penetrating keratoplasty * corneal neovascularisation * pathologic changes in the anterior segment of the eye (anterior / posterior synechiae, uveitis) * glaucoma * aphakia * infectious diseases of the cornea * neurodermitis * participation of the patient in another clinical trial within the last four weeks that precede the recruitment * the patient is unlikely to comply with the requirements of the protocol * previous or current abuse of medications, narcotics or alcohol * pregnancy

Keywords: penetrating keratoplasty corneal transplantation corneal grafting corneal grafts culture media corneal culturing in vitro culturing
the collection and transmission of electrocardiogram using a wearable device

Conditions: Arrhythmia

Summary: a multi-center clinical trial to explore the status of collection and transmission of electrocardiogram using a wearable device

the collection and transmission of electrocardiograms to a central data server using a wearable device were evaluated.

Eligibility criteria:
inclusion criteria: * healthy adult male volunteers who can use an android smartphone. * the subjects who voluntarily agree to participate and give written informed consent. exclusion criteria: * the subjects who have hypersensitivity to adhesives, such as medical bandages, or have clinically significant skin lesions. * the subjects who are judged to be inappropriate for the clinical trials to participate.
pharmacokinetics, dialysability and safety of p03277 in healthy volunteers and in patients with impaired renal function

Conditions: Renal Insufficiency; Healthy Volunteers

Summary: this is an open-label, non-randomized, successive cohorts design, multicenter, single dose phase i study. the primary objectives are: * to evaluate the pharmacokinetics (plasma and urine) profile of p03277 following single intravenous injection (0.1 mmol/kg body weight) in patients with mild to severe renal impairment and in healthy volunteers with normal renal function used as reference. * to assess dialysability of p03277 following a single intravenous injection (0.1 mmol/kg body weight) in patients with end stage renal disease requiring hemodialysis.

a full range design including the different degrees of renal impairment and healthy volunteers used as reference has been chosen. enrolment will be successive starting with both healthy volunteers (cohort 1) and patients with mild renal impairment (cohort 2), then patients with moderate renal impairment (cohort 3), then patients with severe renal impairment (cohort 4) to end with patients with end stage renal disease (cohort 5). pharmacokinetics and safety profiles following the confinement period will be reviewed per each successive cohort by a data monitoring committee before starting recruitment of patients in the next cohort. cohorts 1 and 2 will be recruited in parallel and data monitoring committee review will start after the completion of these first two cohorts.

Eligibility criteria:
inclusion criteria: for all subjects: * subject being 18 years or older, able and willing to participate in the trial * subject in good enough health status as determined by investigator according to medical history, physical examination, vital signs, 12 lead ecg and laboratory tests at screening and inclusion for healthy volunteers / cohort 1: healthy volunteer with stable normal renal function defined with an absolute value of egfr ≥ 90 ml/min based on two egfr assessments done at screening and inclusion, with a maximum tolerance of 15% between the 2 measurements for patients with renal impairment / cohorts 2 to 5: * cohort 2: patient with stable mild renal impairment defined with an absolute value of egfr between 60 and 89 ml/min included based on two egfr assessments done at screening and inclusion, with a maximum tolerance of 15% between the 2 measurements * cohort 3: patient with stable moderate renal impairment defined with an absolute value of egfr between 30 and 59 ml/min included based on two egfr assessments done at screening and inclusion, with a maximum tolerance of 15% between the 2 measurements * cohort 4: patient with stable severe renal impairment defined with an absolute value of egfr between 15 and 29 ml/min included based on two egfr assessments done at screening and inclusion, with a maximum tolerance of 15% between the 2 measurements * cohort 5: patient with end-stage renal failure who requires 3 hemodialysis sessions per week
evaluation of vitrase as a spreading agent

Conditions: Pain

Summary: the purpose of this study is to determine whether vitrase (hyaluronidase for injection) is effective as a spreading agent for other injected drugs prior to ocular surgery


Eligibility criteria:
inclusion criteria: * scheduled for an ophthalmic surgical procedure exclusion criteria: * documented history of hypersensitivity to hyaluronidase or any other ingredient in vitrase * known history of hypersensitivity reaction to bee or wasp venom * needing enhanced absorption and dispersion of dopamine, alpha agonist drugs, furosemide, the benzodiazepines, or phenytoin * inflammation or apparent clinical signs of infection in the area where vitrase was to be injected

Keywords: adjuvants, anesthesia spreading factor