Kornimate/medical-research-clean huggingface dataset:
areds 2 ancillary spectral domain optical coherence tomography study

Conditions: Age Related Macular Degeneration

Summary: the purpose of this study is to identify whether changes in age-related macular degeneration (amd) over time as seen with spectral domain optical coherence tomography (sdoct) imaging, can be used to predict vision loss and the advancement of amd in people at moderate to high risk for progression.

the primary objective of this study is to identify whether sdoct patterns such as: drusen size, oct reflectivity within drusen, photoreceptor (pr)change over drusen, microfoci of subretinal fluid (srf), or retinal thickening are predictive of vision loss, progression of drusen, progression of photoreceptor loss over drusen, development of choroidal neovascularization (cnv), or development of geographic atrophy (ga). the secondary objectives of this study are: 1. to define the relationship between sdoct imaging, autofluorescence (af)imaging, and color photographic or other fundus imaging of areds 2 patients in both a cross-sectional study of baseline data and a longitudinal study in data collected over the 5 year areds 2 study. 2. to compare the extent of geographic atrophy on sdoct versus color photographs and autofluorescence. 3. to evaluate whether the sdoct outcome measures differ significantly between areds 2 patients randomized to different oral supplements in the areds2.

Eligibility criteria:
inclusion criteria: amd subjects and controls * men and women between the ages of 50 and 85 years amd subjects * enrollment in the areds 2 trial; * macular status ranges from large drusen in both eyes or large drusen in one eye and advanced amd (neovascular amd or geographic atrophy) in the fellow eye exclusion criteria: * ocular media not clear enough to allow good fundus photography.

Keywords: spectral domain optical coherence tomography optical coherence tomography areds2 amd age-related macular degeneration drusen
a safety study of galcanezumab in participants with migraine, with or without aura

Conditions: Migraine

Summary: the main purpose of this study is to evaluate the longer term safety of the study drug known as galcanezumab in participants with episodic or chronic migraine.


Eligibility criteria:
inclusion criteria: * have a diagnosis of episodic or chronic migraine as defined by international headache society (ihs) international classification of headache disorders (ichd)-3 beta guidelines (1.1, 1.2 or 1.3) (ichd-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50. * prior to baseline, a history of 4 or more migraine headache days per month on average for the past 3 months. exclusion criteria: * are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product. * current use or prior exposure to galcanezumab or another cgrp antibody. * known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab. * history of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by ihs ichd-3 beta.

Keywords: prevention prophylaxis headache
effects of edp-938 in hematopoietic cell transplant recipients infected with respiratory syncytial virus of the upper respiratory tract

Conditions: Respiratory Syncytial Virus Infections

Summary: this was a phase 2b, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of edp-938 in hct recipients with acute rsv infection and symptoms of urti.


Eligibility criteria:
inclusion criteria: * received an autologous hct (within 6 months of signing icf) or an allogeneic hct (any time) using any conditioning regimen * absolute lymphocyte count (alc) \<500 cells/ µl in allogeneic hct recipients. absolute lymphocyte count (alc) \<300 cells/ µl in autologous hct recipients. * laboratory confirmed rsv diagnosis from a respiratory sample obtained within 3 days before signing the icf. * new onset of at least one of the following respiratory symptoms within 3 days before signing the icf: nasopharyngeal discharge, nasopharyngeal congestion, sneezing, sinus congestion, sore throat, hoarseness, earache, cough, shortness of breath, respiratory wheeze, or worsening of one of these symptoms if present chronically (associated with a previously existing diagnosis \[eg, chronic rhinorrhea, chronic lung disease\]) in the 3 days before signing the icf or at screening. * no evidence of new abnormalities consistent with lrti on a chest imaging (chest x-ray and/or computed tomography) performed in the 2 days before signing the icf or at the screening visit if there is no chest x-ray and/or computed tomography available in the 2 days before signing the icf. * oxygen saturation \>95% on room air. * a woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of screening until 30 days after her last dose of study drug. * a male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of screening to 90 days after his last dose of study drug. exclusion criteria: * admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator. * known to be concurrently infected with other respiratory viruses (eg, severe acute respiratory syndrome coronavirus 2 \[sars-cov-2\] or other coronavirus, influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus) within 7 days before signing the icf, as determined by local testing. * clinically significant viremia, bacteremia, or fungemia, or bacterial or fungal pneumonia within 2 weeks before signing the icf that has not been adequately treated, as determined by the investigator. * known positive human immunodeficiency virus (hiv). * any clinical manifestation resulting in qt prolongation.
efficacy and safety of las41003 in the treatment of intertriginous candida infections

Conditions: Candidiasis

Summary: the aim of this study is to determine the efficacy and safety of once daily topical application of the combinational cream las41003 compared to the corresponding mono-substances in the treatment of candida infections in intertriginous areas at the trunk.


Eligibility criteria:
inclusion criteria: * presence of candida infections in one or more intertriginous areas (trunk), confirmed by positive mycological sample at baseline; * female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices \[iuds\], sexual abstinence or vasectomized partner; * written informed consent exclusion criteria: * receiving systemic therapy with cytotoxic or immunosuppressive drugs either concurrently or within 12 weeks before the baseline visit; * patients who have been treated with oral anti-fungal agents within the 12 weeks prior to study entry or treated with topical anti-fungal agents on the intertrigines within the previous 2 weeks; * evidence of drug or alcohol abuse; * pregnancy or nursing; * symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; * treatment with any other investigational drug in the four weeks preceding the study; * known allergic reactions to components of the study preparations, hypersensitivity against cetylstearyl alcohol; * treatment with systemic or locally acting medications which might counter or influence the study aim within two weeks before the beginning of the study (e.g. glucocorticosteroids); * in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable non-compliance or inability to

Keywords: candida infections in intertriginous areas
study of the immunogenicity and efficacy of hbsag vaccine in combination with standard antiviral therapy with hb110e

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to examine the immunogenicity and efficacy of hbsag vaccine in combination with entecavir in patients who have been treated with hb110e hbv dna vaccine.


Eligibility criteria:
inclusion criteria: * subjects who have been treated with hb110e 2mg or 4mg within 6 months prior to screening. * positive hbsag at screening * serum hbv dna level below 300copies/ml at screening * alt level within 2 x uln at screening * voluntarily provide the informed consent exclusion criteria: * participation in other study within 30 days of screening * subjects with severe allergic reaction or severe adverse event to hbsag vaccine, or not suitable for hbsag vaccine. * any other conditions that are considered inappropriate for the study by the investigator
study of hepalatide(l47) at phase ib in healthy volunteers

Conditions: Hepatitis B， Chronic

Summary: to evaluate the safety and tolerability of hepalatide(l47) and characterize the clinical pharmacokinetics in healthy volunteers.

this is a randomized, double-blinded, dose escalating, phase ib trial, which will be conducted in no. 302 hospital of china. there are three cohorts at dose of 4.2mg, 6.3mg and 8.4mg. all healthy volunteers will be randomized into hepalatide or placebo group at 4:1 rate, all healthy volunteers will be received treatment drug by abdominal subcutaneous injection once a day for seven days and will be observed for 3 days.

Eligibility criteria:
inclusion criteria: * ages between 18 and 45 years * bmi index between 19 and 25 (bmi=weight/height2) * normal previous history and physical exam * no drug and alcohol abuse * no illness in 4 weeks and no drug therapy in 2 weeks * no blood donation or subject not sampled in 3 months * consistent and correct use of recommended methods of birth control for men and women * good compliance with study protocol * understand and agree to sign a consent form exclusion criteria: * infection with hav, hbv, hcv, hev, hiv, ebv or cmv * abnormal and clinical significance test of physical examination, vital signs, blood routines, urine routines, liver and kidney functions, coagulation indicator, electrolyte, glucose, blood lipid, thyroid functions, chest x-ray, ecg, b ultrasound of gallbladder, spleen and kidney, afp ,and cea * positive for anti-pre-s1 antibody * women being pregnant or nursing, or with abnormal sex hormones, b ultrasound of ovaries/uterus proliferative diseases or breast mass * unable to quit smoking in trial * subject with little chance of enrollment (i.e. the weak) * subject not suitable to join the trial under other circumstances judged by investigator.
amazing prague (prague-12)

Conditions: Atrial Fibrillation; Restore of Sinus Rhythm; Post-Operative Complications

Summary: aim of the project is to assess the long-time clinical impact of surgical ablation (maze procedure) on patients who suffer from atrial fibrillation but are indicated to a cardiac surgery for other predominant cardiac diagnosis (heart valve surgery, coronary revascularization or combined surgery). in recent years, those patients are more and more frequently indicated to some type of maze procedure, without the real benefit of this procedure for patients has been assessed with an enough large, randomized study. even though it is well known, that maze procedures declines the early postoperative incidence of atrial fibrillation, convincing data about its mid-term and long-term impact on patients and about the appearance of recidives of atrial fibrillation in long-time horizon are still missing. our hypothesis assumes, that maze procedure will significantly decrease the appearance of atrial fibrillation one year after the operation, without increasing mortality or incidence of serious postoperative complications in thirty postoperative days.


Eligibility criteria:
inclusion criteria: * indication to a cardiac surgery (coronary bypass, valve repair, others or combination of those) * atrial fibrillation (paroxysmal, persistent or permanent) present or documented in last 6 month before the operation * signed informed consent exclusion criteria: * rejection of signing the informed consent with randomization * emergent surgery

Keywords: atrial fibrillation maze procedure mid-term results long-term results surgical ablation
hemodynamic changes during dry cupping therapy on low back pain

Conditions: Oxygen Metabolism; Muscle Spasticity

Summary: this study aims to investigate the hemodynamic changes during dry cupping therapy (dct) on low back pain. 50 patients with low back pain as experimental group and 50 healthy people as control group are treated by dct. they will receive four consecutive wct application in one month. optical sensors were used to monitor the hemodynamic changes including oxyhemoglobin (\[hbo2\]), deoxy-hemoglobin (\[hb\]) and the derived change in blood volume (\[thb\]) in/surround the cupping sites during treatment. the investigators hope to interpret the curative effect of dct from the perspective of modern hemodynamics.


Eligibility criteria:
inclusion criteria: * patients who have had non-specific low back pains at least 12 weeks now. * healthy people who are interested in dry cupping therapy exclusion criteria: * patients who have had non-specific low back pains at least 12 weeks now. * healthy people who are interested in dry cupping therapy exclusion criteria: * patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome). * patients who are inappropriate to the wet cupping treatment. * aids, active hepatitis, tuberculosis, syphilis * patients who regularly take anticoagulants, antiplatelet drugs * anemia, thrombocytopenia * hemorrhagic disease like hemophilia * diabetes * severe cardiovascular disease * kidney diseases (renal failure, chronic renal disease) * patients who have experiences of wet cupping treatment during last 3 months. * patients who have had treatment for low back pain during last 2 weeks. * patients who are in pregnancy or have plan to conception. * patients who have vertebra surgery or have plan of surgery. * patients who are inappropriate to join this trial judged by the radiologists or specialists.

Keywords: cupping therapy near infrared spectroscopy
evaluation of the contamination of ligatures

Conditions: Orthodontics

Summary: this crossover, in-vivo study was carried out with 10 patients who have been started to be treated at orthodontics department. 3 elastomeric ligatures were examined in terms of microbiological and surface roughness.

the development of dental plaque has been associated with several environmental and individual factors including diet composition, oral hygiene, the quality of saliva, the composition of the oral microflora and immune factors. orthodontic fixed appliances also impede the maintenance of oral hygiene. plaque accumulation surrounding orthodontic appliances leads to enamel demineralization caused by organic acids produced by bacteria in the dental plaque. in patients with fixed orthodontic treatment, common pathological changes are gingivitis, bleeding and gingival growth; thus, gingival index and plaque index parameters have been used as indicators of periodontal disease in many studies. enamel demineralization which results in white spot formation is observed due to the increase in the number and volume of acid-producing bacteria, and the decrease in ph level because of the glucose metabolized by these cariogenic bacteria . the most commonly investigated bacteria among those mentioned above is streptococcus mutans. in the literature, it has been the subject of many studies, including those investigating the correlation between the s. mutans count and the amount of adhesive left between brackets and the enamel, adhesion of s. mutans to nickel titanium and copper-nickel brackets, the difference in s. mutans colonization between self-ligation system and normal brackets, and the effect of elastomeric rings and ligature wires on s. mutans colonization. non-conventional elastomeric ligatures were produced in order to reduce the friction of orthodontic sliding mechanics. manufacturers claim that non-conventional elastomeric ligatures reduced ligation friction by 60% compared to conventional modules. it was reported in another study that brackets combined via non-conventional elastomeric ligatures resulted in a reduced friction force compared to conventional elastomeric ligatures in any wires from 14-inch niti to 19.25 ss. to our current knowledge, bacterial colonization on non-conventional elastomeric ligatures was investigated in one study only, using microbial culture technique. in light of this information, present study was aimed to compare s. mutans colonization among different commercial types of non-conventional ligatures and ligature wires. the surface structures of these ligature types also will be investigated by atomic force microscope (afm) and the results of this investigation will be associated with the results of bacterial colonization amount.

Eligibility criteria:
inclusion criteria: * permanent teeth in the mouth * patients with good oral hygiene * patients did not use antimicrobial drugs such as antibiotics and mouthwashes 3 weeks before the study period and within the 18-week period covering the study period. exclusion criteria: * smoker

Keywords: bacterial adhesion elastomeric ligatures
a real-world study to assess the use of siponimod in spain to treat patients with secondary progressive multiple sclerosis

Conditions: Secondary Progressive Multiple Sclerosis

Summary: resyze was a non-interventional/observational, retrospective, multi-center study conducted in 28 public and private hospitals in spain, assessing secondary progressive multiple sclerosis (spms) patients in a real-world setting. patients underwent clinical assessments and received their standard routine medical care, as determined by their treating physicians. the study used secondary data i.e., electronic medical records (emr) from hospitals. patients who met the eligibility criteria were selected from the emr of each of the sites, to include adult spms diagnosed patients who received at least one dose of siponimod during the start of treatment period between april 2021 and 01 september 2022, with a 12-month observation period, regardless of whether or not they continued the treatment. the study compiled data that was available in the hospital emr from each patient up to 24 months before the first siponimod dose, and 12 months after the first siponimod dose. data were collected for each patient at regular intervals of 6/12 months and within a window period of ±45 days, as available.


Eligibility criteria:
inclusion criteria: * patients with spms, as diagnosed by a physician, who started siponimod treatment at least 12 months before (during the start of the treatment period: from april 2021 to september 2022), regardless of whether they continued treatment or they did not. * patients who received at least 1 dose of siponimod treatment for spms with a 12-month observation period. * availability of the data for at least 12 months after siponimod initiation. exclusion criteria: * patients with any contraindication to siponimod, according to applicable summary of product characteristics (smpc). * patients included in any clinical trial at any moment of the study period.
clinical study to assess safety and effectiveness of the zenith® dissection endovascular system in patients with aortic dissection

Conditions: Aortic Dissection Involving the Descending Thoracic Aorta

Summary: the purpose of this study is to evaluate the safety and effectiveness performance of the zenith® dissection endovascular system in the treatment of aortic dissections involving the descending thoracic aorta.

the zenith® thoracic dissection study is a clinical trial to study the safety and effectiveness of the zenith® dissection endovascular system in the treatment of dissections (length-wise tear) of the descending thoracic aorta. the zenith® dissection endovascular system is comprised of the zenith tx2® taa endovascular graft and the zenith® dissection endovascular stent. instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.

Eligibility criteria:
inclusion criteria: * branch vessel obstruction/compromise * peri-aortic effusion/hematoma * resistant hypertension * persistent pain/symptoms * transaortic growth greater than or equal to 5 mm within 3 months (or transaortic diameter greater than or equal to 40 mm) exclusion criteria: * age less than 18 years * frank rupture * diagnosed or suspected congenital degenerative connective tissue disease * systemic infection * untreatable reaction to contrast * surgical/endovascular aaa repair within 30 days * previous placement of thoracic endovascular graft * prior repair of descending thoracic aorta * interventional/open procedures within 30 days * onset of symptoms \> 3 months

Keywords: thoracic dissection dissection endovascular
a novel iron-based supplement for athletes aged 14-17

Conditions: Iron Deficiencies

Summary: female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. this study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females.

current iron supplements on the market are commonly associated with side effects including gastrointestinal distress, nausea, vomiting, and constipation. as a solution, the investigators have developed a novel delivery system for iron supplementation that overcomes many of these limitations. the goal of this study is to assess the efficacy of a yeast-iron complex in improving iron status, gut microbiome, and exercise performance in endurance-trained adolescent females (aged 14-17) with sub-optimal iron status. participants will consume 40mg of elemental iron every second day for 8 weeks. before and after supplementation, participants will be assessed for exercise capacity (vo2max), iron status, and the current state of the gut microbiome. each week during supplementation, participants will complete a survey in which they will report feelings of stress and recovery as well as gastrointestinal symptoms.

Eligibility criteria:
inclusion criteria: * cis-gendered female 14-18 years old * sub-optimal iron status (ferritin ≤45mcg/ l) * at least 1 year past the age of menarche * engage in moderate to vigorous endurance activity for at least 3 hours a week exclusion criteria: * supplemented with iron iron (\>5mg/day), prebiotics, or probiotics in last 3 months * antibiotic use in last 3 months * - energy availability \>30 kcal/kg lean body mass

Keywords: iron microbiota exercise