Kornimate/medical-research-clean huggingface dataset:
counterregulatory hormone production in adrenal insufficiency and diabetes type i

Conditions: Addison's Disease; Adrenal Insufficiency; Diabetes Mellitus Type I

Summary: patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction. furthermore, patients who suffer from both, adrenal insufficiency and type i diabetes more frequently report hypoglycemia, particularly after strenuous activities. the study investigates the counter regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without addison's disease, type i diabetes and healthy subjects.

as patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction and patients who suffer from both, adrenal insufficiency and type i diabetes more frequently report hypoglycemia, particularly after strenuous activities this study investigates the counter-regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without addison's disease, type i diabetes and healthy subjects. patients will perform ergometer training with an individualized intensity and fulfill cognitive function testing (stroop test and fatigue inventories) before and after strenuous activity.

Eligibility criteria:
inclusion criteria: * diagnosis of addison's disease and/or diabetes mellitus type i or healthy control with normal adrenal function and normal glucose regulation * age ≥ 18 years * ability to comply with the study protocol * capability to perform spiroergometry exclusion criteria: * any contraindication for performing spiroergometry according to the guidelines of the german cardiac society: * acute myocardial infarction * instable angina pectoris * symptomatic arrhythmia * severe and symptomatic stenosis of the aortic valve * decompensated heart failure * acute pulmonary embolism * acute myocarditis * acute pericarditis * acute aortic dissection * main coronary artery disease * valvulopathies * electrolyte disturbance * arterial hypertension (systolic blood pressure \> 200 mm hg, diastolic bp \> 110 mm hg) * tachyarrhythmia or bradyarrhythmia * hypertrophic cardiomyopathy and other forms of obstructive heart disease * second or third degree atrioventricular block * fever * diabetes mellitus type 2 * diseases or medication influencing the endogenous levels of plasma catecholamines(e. g. pheochromocytoma, paraganglioma, antidepressants, levodopa) * glucocorticoid-pharmacotherapy
my ms and my menstrual cycle

Conditions: Multiple Sclerosis; Menstrual Cycle

Summary: the goal of this observational study is to understand how ms symptoms change during different phases of the menstrual cycle in individuals who menstruate living with ms (multiple sclerosis). the main questions it aims to answer are: 1. does fatigue get worse during certain phases of the menstrual cycle? 2. how do symptoms like thinking skills, pain, and mobility change throughout the cycle? participants will: * use the my normative app to track their menstrual cycle and ms symptoms. * complete symptom check-ins at five points during their cycle for six months. * answer questions about fatigue, thinking skills, mood, sleep, and other ms symptoms at the start and end of the study. these findings may help researchers better understand ms symptom patterns and improve symptom management.


Eligibility criteria:
inclusion criteria: * female participants diagnosed with ms based on the 2024 mcdonald diagnostic criteria (biologically sex-based, any gender as long as not on hormonal gender-enhancing therapy) * aged 16 or older * experiencing menstruation with cycles ranging from 21 to 35 days * have entered menarche, still experiencing menstrual cycles, and have not yet entered menopause * may be using hormonal contraceptive methods (e.g., oral contraceptives or hormonal iuds) * able to speak english * willing to provide informed consent (mature minors will be assessed by their physician for consent eligibility) * able to complete questionnaires and operate the app exclusion criteria: * diagnosed with cns inflammation disorders other than ms, such as: nmosd (neuromyelitis optica spectrum disorder) or mogad (myelin oligodendrocyte glycoprotein antibody-associated disease) * male or intersex individuals, given the inclusion criteria of requiring a uterus * females under 15 years of age * females who have not started menstruation * females who have stopped menstruation due to menopause or hysterectomy * pregnant or postpartum individuals within one year of delivery, * individuals currently breastfeeding * unable to provide informed consent, or not deemed a mature minor * unable to complete questionnaires and operate the app

Keywords: multiple sclerosis menstrual cycle ms symptoms fatigue cognition
kisspeptin administration subcutaneously to patients with ihh

Conditions: Hypogonadotropic Hypogonadism

Summary: the goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (ihh). the investigators are also examining whether kisspeptin can help women release eggs from their ovaries. kisspeptin will be administered sc for two weeks in a pulsatile fashion. ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time. funding source: fda oopd

assignment: all study subjects will undergo the same interventions. delivery of interventions: * each subject will undergo a review of their medical history, physical exam, and screening laboratories. * a single sc injection of leuprolide acetate may be administered approximately six days before kisspeptin administration. * a pelvic ultrasound will be performed on women to assess baseline follicular size. * a pump will be placed to administer pulsatile sc kisspeptin for two weeks. * during the course of kisspeptin administration, subjects will * undergo q10 min blood sampling (approximately 10 sessions, 70 minutes each) * for women, undergo pelvic ultrasounds (approximately 3 sessions) * optional q10 min sampling up to 8 hours may take place before and after the course of kisspeptin

Eligibility criteria:
inclusion criteria: * congenital ihh o confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins * normal blood pressure (systolic bp \< 140 mm hg, diastolic \< 90 mm hg) * not using hormonal replacement or willing to complete an appropriate washout for that particular medication and method of administration * no current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and method of administration exclusion criteria: * any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol * excessive alcohol consumption (\>10 drinks/week) and/or active use of illicit drugs o any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation. * pregnant or trying to become pregnant * breast feeding * history of bilateral oophorectomy (ovaries were removed)

Keywords: hypogonadotropic hypogonadism kisspeptin idiopathic hypogonadotropic hypogonadism
esba1008 safety, tolerability and effects in wet age-related macular degeneration (amd) patients

Conditions: Exudative Age-Related Macular Degeneration

Summary: the purpose of this study was to assess the safety, tolerability, and the effects of treatment on ocular outcomes following a single intravitreal administration of esba1008 compared with lucentis® in patients with exudative age-related macular degeneration (amd).

this study was conducted in two parts. in part 1, patients were initially randomized (5:2) to receive either esba1008 at the lowest dose (dose a) or lucentis. after safety committee review, a second cohort was enrolled and randomized (5:2) to the next higher dose of esba1008 (dose b). safety review and enrollment of patients into the third cohort (dose c) and fourth cohort (dose d) was conducted in the same manner. part 2, the expansion period, consisted of 2 arms. in the first arm patients were randomized to receive esba1008 dose c or lucentis (43:44) . in the second arm, patients were randomized to esba1008 doses a:b:d:lucentis (5:30:35:9). all enrolled patients (part 1 and part 2) were evaluated for safety and efficacy across 13 study visits, including screening, randomization, and 11 post- treatment follow-up visits (day 1 through month 6).

Eligibility criteria:
inclusion criteria: * provide written informed consent. * primary subfoveal choroidal neovascularization (cnv) secondary to amd, including predominantly classic, minimally classic or occult lesions, in the study eye. * new diagnosis of wet amd or evidence of recent disease progression within the last 3 months in study eye. * evidence of subretinal fluid or retinal cystic changes with a csft of \> 340 μm using a spectralis sd-oct (heidelberg engineering) imaging system. * best-corrected visual acuity (bcva) of snellen equivalent 20/200 or better in the non-study eye. * other protocol-defined inclusion criteria may apply. exclusion criteria: * previously administered therapy, approved or investigational, for wet amd in the study eye. * any current or history of macular or retinal disease in the stuy eye other than wet amd. * lasik or cataract surgery within the last 3 months in the study eye or expected to have cataract removal surgery during the study. * uncontrolled or advanced glaucoma in the study eye. * use of systemic or topical ocular corticosteroids. * history of a medical condition that, in the opinion of the investigator, would preclude scheduled visits, completion of the study, or safe administration of study medication. * abnormal or unsuitable laboratory results at screening visit. * lactating or pregnant. women of childbearing potential must use adequate birth control for the duration of the study. * other protocol-defined exclusion criteria may apply.

Keywords: amd wet amd exudative cnv
crestal bone loss in mandibular telescopic overdentures. overdenture with milled titanium, milled poly-ether ketone ketones and 3d printed chrome cobalt secondary copings.

Conditions: Telescopic Overdentures; Dental Implants; Customized Abutments

Summary: the objective of this clinical trial is to evaluate crestal bone loss every three months at time of overdenture insertion, 3, 6, 9, 12 months from overdenture use. also, to evaluate prosthesis satisfaction. all participants will receive conventional complete dentures, followed by two intraforaminal implants. after healing time, fabrication of secondary copings in all cases according to randomized groups for final overdenture insertion.


Eligibility criteria:
inclusion criteria: 1. sufficient remaining bone in height, width and thickness in the interforaminal area to allow installation of at least 3.3 mm diameter and 8 mm length implants. 2. adequate amount of interarch space of at least 12mm. 3. age range from 55 to 75 years old age. exclusion criteria: 1. systemic and metabolic diseases that may affect osseointegration. 2. patients receiving bisphosphonates therapy. 3. patients under radiotherapy or chemotherapy.
retrospective collection of effectiveness and safety data from patients treated with liraglutide or dpp-4 inhibitor in primary care in europe

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this study is to demonstrate the clinical effectiveness and safety of liraglutide and dipeptidyl peptidase-4 (dpp-4) inhibitor therapy in routine primary care in europe.


Eligibility criteria:
inclusion criteria: * patients treated with liraglutide or dpp-4 inhibitors, according to license in respective participating country with data available for 12 (+/- 2) months exclusion criteria: * patients treated with liraglutide or dpp-4 inhibitors, outside of license in respective participating country
folatescan in autoimmune disease

Conditions: Rheumatoid Arthritis; Osteoarthritis; Multiple Sclerosis; Crohn's Disease; Systemic Lupus Erythematosus

Summary: this study will gather information on the safety of folatescan and the ability of folatescan to detect inflammation in the joints and other organs in people with arthritis (rheumatoid arthritis and osteoarthritis), systemic lupus erythematosus, multiple sclerosis, interstitial pneumonitis, crohn's disease as well as in healthy persons without these conditions.

the folate receptor is over-expressed on many types of cancer cells and in ra models, and new folate receptor targeted therapies are being developed to target cancer cells that over-express the folate receptor. as with other targeted therapies, it is important to develop diagnostic tests that will provide accurate information on folate receptor status and aid in selecting patients that may benefit from folate-targeted therapy. ec20 concentrates in the extremities and liver and spleen of rats with adjuvant induced arthritis. the increased uptake is mediated by overexpressed folate receptor on macrophages, and the intensity of the uptake is greatly reduced by addition of excess folate, supporting the specificity of the uptake. depletion of macrophages greatly reduced folate receptor and abolishes uptake of ec20. this suggests that ec20 may be useful in assessing macrophage involvement in the active inflammatory process of ra, and perhaps other systemic immune mediated disorders as well. folatescan may allow the clinician to get accurate real-time data on receptor binding, in a less invasive manner, at all actively inflamed sites throughout the treatment regimen. this kind of information may help the physician make better clinical decisions regarding therapy, including folate targeted therapies.

Eligibility criteria:
inclusion criteria: * study will include 40 subjects with rheumatoid arthritis (active or inactive disease, defined as no swollen joints) and 5 patients in each of the following diagnosis: osteoarthritis, multiple sclerosis, crohn's disease, systemic lupus erythematosus, interstitial lung disease and no autoimmune disease (healthy). * subjects must have disease duration of at least 6 months and creatinine level may not be greater than 1.5 mg/dl. exclusion criteria: * subjects will be excluded if they are pregnant, have an active infection, received an investigational therapy in the past month or previous malignancy within the past 5 years.
corneal cross linking and topography guided excimer laser treatment

Conditions: Keratoconus; Pellucid Marginal Degeneration

Summary: topography guided laser treatment enables the surgeon to correct higher order aberrations in corneas with irregular astigmatism. several case reports and small uncontrolled trials have been published on the combination of this treatment with corneal cross linking (ccl) in patients with ectatic corneal diseases. this randomized study will evaluate the safety and efficacy of a combined treatment of corneal cross linking with a partial topography guided excimer laser treatment in eyes with progressive ectatic corneal diseases.


Eligibility criteria:
inclusion criteria: * signed informed consent * patient age 18 - 40 years * documented progressive corneal ectatic disease except post lasik/lasek ectasia exclusion criteria: * allergy to one of the used substances * tendency towards excessive scar formation * pregnancy * rheumatic diseases * central corneal thickness below 450 µm * active infection of the study eye * previous corneal surgery of the study eye

Keywords: corneal cross linking topography guided excimer laser keratoconus pellucid marginal degeneration post excimer ectasia
the sir-poba bypass trial

Conditions: Peripheral Arterial Occlusive Disease; Bypass Complication; Femoropopliteal Artery Occlusion; Femoropopliteal Stenosis; Critical Limb-Threatening Ischemia; Claudication, Intermittent

Summary: the goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an infrainguinal venous bypass stenosis. the main question we aim to answer is, how patency is affected by each of the randomised treatment options.

this clinical trial will be conducted at our division of vascular surgery and endovascular surgery at the university hospital of salzburg. patients will be randomized into one of the two treatment options (plain old ballon angioplasty versus sirolimus coated balloon angioplasty). the recruitment phase is calculated for two years with a planned follow-up of 2 years. follow-up data will be collected to answer the endpoints and will include all available follow-ups to monitor the bypass up to 2 years after the procedure. typically, follow-up visits will be conducted at 6 weeks, 3 months, 6 months, 12 months, and 24 months after the procedure.

Eligibility criteria:
inclusion criteria * age at least 18 years * informed consent with signature * rutherford category 2 or 3 (in terms of lifestyle-limiting moderate or severe claudication symptomatology) or chronic critical ischemia (rutherford 4-6) * venous bypass stenosis requiring intervention * confirmed inflow * at least 1 crural outflow vessel exclusion criteria: * pregnant or lactating women * active infection or sepsis * patients currently participating in another clinical trial * unconfirmed inflow * intolerance to sirolimus * coagulopathy * radiotherapy * patients on immunosuppressive therapy * non-dialysis renal insufficiency (egfr \< 45 ml/min/1.73m2) * use of potent cyp3a4 and/or p-gp inhibitors (such as ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin) or strong cyp3a4 and/or p-gp inducers (such as rifampin or rifabutin).

Keywords: autologous vein bypass endovascular revascularization
clinical study of acupuncture in the treatment of diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: diabetic peripheral neuropathy (dpn) is the most common chronic complication of diabetes mellitus that has a considerable impact on quality of life, but there are few effective therapeutic strategies. the aim of this trial is to determine the efficacy and safety of manual acupuncture (ma) versus sham acupuncture (sa) for dpn.

a total of 118 patients with dpn will be recruited and randomly assigned in a 1:1 ratio to either the ma group or sa group. all patients will receive 24 sessions over 12 weeks. participants will complete the trial by visiting the research center at month 6 for a follow-up assessment. the primary outcome is peroneal motor nerve conduction velocity (peroneal mncv) at week 12 compared with baseline. secondary outcomes include peroneal motor nerve action potential amplitude (peroneal mnap) and latent period (peroneal mnlp), sural sensory nerve conduction velocity (sural sncv), action potential amplitude (sural snap) and latent period (sural snlp), fasting plasma glucose (fpg), 2-h postprandial blood glucose (2hpg), glycated hemoglobin (hbalc) at week 12 compared with baseline, michigan neuropathy screening instrument (mnsi) score and diabetes specific quality of life scale (dsql) at week 12 and month 6 compared with baseline. safety will be assessed during the whole trial. masking effectiveness will be assessed by patients.

Eligibility criteria:
inclusion criteria: * 1. aged 18-75 years (either sex) * patients who meet diagnosis of dpn defined by ada in 2005：a. dpn is defined as the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes, after the exclusion of other causes. b. np is defined as altered sensitivity to pressure and (1) altered sensitivity to pain or (2) altered sensitivity to vibration or (3) achilles reflex. * symmetric and predominantly sensory, starting from the lower limbs distally and gradually spreading proximally in a glove-and-stocking distribution. * ability to understand study procedures and willingness to comply with them for the entire period of study. * written informed consent exclusion criteria: * pn caused by conditions other than diabetes (e.g.,alcohol abuse, chemotherapy, hereditary causes, chronic inflammatory, or idiopathic pn) * psychiatric illnesses other than mild depression. * severe or unstable cardiovascular, liver, kidney, respiratory, or hematological disorders. * received acupuncture treatment in the last 3 months. * pregnant or lactating women. * research unit personnel directly related to the study and their immediate family members. * incapable of giving informed consent or following the study instructions due to language disturbances, serious cognitive deficits, or lack of time. * currently participating in other clinical trials.

Keywords: diabetic peripheral neuropathy acupuncture treatment
epidemiology of vascular inflammation & atherosclerosis

Conditions: Atherosclerosis; Cardiovascular Diseases; Heart Diseases; Coronary Arteriosclerosis; Coronary Disease; Cerebral Arteriosclerosis; Cerebrovascular Accident

Summary: to investigate the relationship of vascular cell phenotypes to atherosclerosis.

background: currently, the predominant hypothesis regarding atherosclerosis is that it is in major part driven by two independent pathways: hyperlipidemia (the "stimulation") and inflammation (the "response"). although vascular cells mediate the influence of inflammation on atherosclerosis, very little is known about vascular cell epidemiology and the relationship of vascular cell phenotypes to atherosclerosis. the main hypothesis tested in this study is that variation in vascular cell biology is related to the population variation in atherosclerosis. design narrative: the cross-sectional study will be nested within a large cohort study, the multiethnic study of atherosclerosis (mesa). a partial sample of 1,000 individuals who have undergone other special laboratory analyses will be identified and new measures collected as part of their upcoming site visit. a number of novel cellular phenotypes describing the innate immune response (monocyte activation, natural killer and t cell counts), the adaptive immune response (th1 and th2 helper cells, and memory t cells), and vessel integrity (circulating endothelial progenitor cells) will be measured in these participants. plasma constituents will also be measured that relate to the cellular phenotypes. the overall goal is to test the hypothesis that these novel phenotypes are associated with subclinical atherosclerosis in the coronary and carotid arteries assessed by quantification of coronary calcification (cac) and b-mode ultrasound (cimt), in addition to the other subclinical measures available from the mesa cohort.

Eligibility criteria:
no eligibility criteria
metformin to treat corticosteroids-induced hyperglycemia

Conditions: Pregnancy Preterm; Glycemic Control; Corticosteroids Induced Hyperglycemia

Summary: antenatal corticosteroids, particularly, betamethasone is routinely administered to pregnant women at risk for preterm delivery to improve neonatal outcomes. although antenatal betamethasone was shown to induce both maternal hyperglycemia and neonatal hypoglycemia, to date, there is insufficient data to establish whether treatment for maternal hyperglycemia, particularly, metformin, will decrease the risk for neonatal hypoglycemia, particularly of preterm neonates. in the present study the investigators will examine the effect of treatment with metformin on maternal glycemic control and hypoglycemia in preterm neonates following maternal betamethasone treatment.


Eligibility criteria:
inclusion criteria: * pregnant women receiving betamethasone from 24 to 36.5 gestational weeks * before or within 24 hours following the first dose of betamethasone * ≥18 years old exclusion criteria: * women with pre-gestational and gestational diabetes mellitus (gdm) * known allergic sensitivity to metformin * known chronic heart failure * known chronic renal failure * refuse to participate * refuse to perform glucose challenge test/glucose tolerance test later on