Kornimate/medical-research-clean huggingface dataset:
normobaric hypoxic training and metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the patient numbers with metabolic syndrome and diabetes have doubled in the last decade. data that physical exercise ameliorates the metabolic syndrome are convincing, although the mechanisms of the effect in man are not clear. numerous endocrine or molecular mechanisms modified by physical exercise are known to be hypoxia-sensitive, i.e. by hypoxia-inducible factor-1 (hif-1) regulation. thus, relative hypoxia may link physical exercise and modification of endogenous metabolism. medical communities seem ill equipped to address the primary issues involved. the investigators have experience with normobaric "hypoxia chambers" and will now test a (physical exercise) training program, using state-of-the-art assessments available nowhere else in germany. the investigators will compare hypoxia chamber, to ambient training, to test the notion that specific exercise conditions could regulate specific molecular pathways involved in the pathogenesis of the metabolic syndrome. indeed, hypoxia chamber training could be superior to conventional training in terms of reducing cardiovascular risk factors or improving fitness. the investigators will test overall metabolism-related effects with a metabolic chamber. the investigators will test local metabolism with microdialysis during exercise routines, and the investigators will perform fat and muscle biopsies to investigate tissue-related effects. the investigators include experience from a broad-ranging spectrum. the investigators findings might improve understanding mechanisms linking physical exercise and endogenous metabolism. furthermore, they could influence decision-making regarding non-pharmacological interventions.


Eligibility criteria:
inclusion criteria: * body mass index 27-40 kg/m2 * abdominal obesity (waist circumference \>102 cm form men, \>88 cm for women) * two further diagnostic criteria of metabolic syndrome (atp iii definition): * hdl cholesterin \<40 mg/dl for men, \<50 mg/dl for men * triglyceride \>150 mg/dl * fasting glucose \>110 mg/dl * blood pressure \>135/80 mm hg * less than 2 hours of physical activity per week * sinus rhythm exclusion criteria: * other relevant metabolic or cardiovascular diseases

Keywords: tissue metabolism skeletal muscle adipose tissue hif
safety and efficacy of luliconazole solution, 10% in subjects with mild to moderate onychomycosis

Conditions: Distal and Lateral Subungual Onychomycosis

Summary: the purpose of this study is to determine the safety and efficacy of a topical antifungal formulation, luliconazole solution, 10%, in the treatment of adults with onychomycosis of the toenails.


Eligibility criteria:
inclusion criteria: * subjects of either gender, any race and between the ages of 18 and 70 inclusive * subjects with a clinical diagnosis with culture confirmation of distal subungual onychomycosis (dso) - subjects must be free of any disease that in the investigator's opinion might interfere with the study evaluations or jeopardize the subject's safety exclusion criteria: * subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the solution * subjects who are currently participating or have recently participated in another investigational medication or device study

Keywords: onychomycosis toenail fungus luliconazole antifungal topical
study to evaluate the safety and tolerability of treatment with atogepant 60 mg daily for the prevention of migraine in participants with episodic migraine

Conditions: Episodic Migraine

Summary: this study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.


Eligibility criteria:
inclusion criteria: * written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures. * participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral soc migraine prevention medications and the participant is willing to accept soc treatment. * participants must be using a medically acceptable and effective method of birth control during the course of the entire study, * at least a 1-year history of migraine with or without aura consistent with a diagnosis * age of the participant at the time of migraine onset \< 50 years * history of 4 to 14 migraine days per month on average in the 3 months prior to visit 1 exclusion criteria: * difficulty distinguishing migraine headaches from tension-type or other headaches * has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine * has a current diagnosis of chronic migraine (cm), new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy * ≥ 15 headache days per month on average across the 3 months prior to visit 1 * usage of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (nsaids), acetaminophen) ≥ 15 days/month in the 3 months prior to visit 1 per investigator's judgment, or during the baseline period. for all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. for participants randomized to atogepant, barbiturates are excluded through the duration of the study as well * female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. women of childbearing potential must have a negative urine pregnancy test * any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (gi), or neurologic disease * hypertension as defined by sitting systolic blood pressure (bp) \> 160 millimeter of mercury (mm hg) or sitting diastolic bp \> 100 mm hg at visits 1 or visit 2. vital sign measurements that exceed these limits may be repeated only once. * at visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence * history of any gi prior procedures or gi conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., lap band) which have been reversed are not excluded.
"mandometer®" study for managing childhood obesity

Conditions: Childhood Obesity

Summary: we run a successful clinic in bristol for children with severe obesity who already demonstrate many features to suggest they are at increased risk of early diabetes and heart disease. however, we have found that young children respond better to simple interventions than do adolescents. we have used a new treatment regimen "mandometer®" to help our most difficult adolescent cases lose weight. we would like to do a study to see if all adolescents might improve weight loss using this technology compared to what we routinely offer

childhood obesity is rapidly reaching epidemic proportions in the united kingdom. recent studies have indicated a prevalence level for obesity of 15% at 15 years of age. the implications for metabolic, cardiovascular and cancer risk in later life are enormous. the international obesity task force (iotf) and the european association for the study of obesity (easo) have identified childhood obesity as a matter for urgent attention. however, there are very few obesity clinics for children in the uk and effective treatment regimens are simply not available. we have developed an obesity clinic at the royal hospital for children in bristol and observed effective weight reduction in pre-pubertal children. our simple treatment framework has proved far less effective in adolescence. we have therefore collaborated with an eating disorder clinic from the karolinska institute in sweden to develop a novel therapy to treat obesity using modified equipment originally designed to treat adolescents with dsm-iv eating disorders. pilot data indicate that adolescents are better able to address the issue of weight reduction within this treatment modality. having established the software and treatment process we now wish to perform a randomised, control trial to test the efficacy of this new treatment against that currently provided.

Eligibility criteria:
inclusion criteria: * obese children and adolescents aged 10-18 exclusion criteria: children: * having associated learning difficulties * who have received medication for associated insulin resistance * refusal of parent/legal guardian to give informed consent.

Keywords: childhood obesity behavior modification insulin resistance
identifying patients with unrecognized treatable diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this trial will assess the incidence of new and/or undiagnosed diabetic macular edema (dme) in diabetic patients that undergo a dme screening exam. the screening exam will consist of medical history, electronic etdrs visual acuity assessment, sd-oct and color fundus photography


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age \> 18 years * patient related considerations * patients with diabetes mellitus * disease related considerations * diabetes mellitus exclusion criteria: * prior admission screening within twelve months. * inability to sit for evaluation
the italian transthyretin amyloidosis web-network

Conditions: ATTR Amyloidosis

Summary: the study aims, by generating a large registry of patients with attr amyloidosis, including data at diagnosis and during follow up, to describe the natural history of attr amyloidosis in a real-world setting and to define and validate prognostic models, response criteria applicable at any point of the disease. the registry will also be used for data sharing and to allow the possibility of a close collaboration amongst the amyloidosis experts of the artc and all the physicians around the country involved in the diagnosis and management of systemic amyloidosis. thanks to the online registry, the diagnostic facility of the artc will be made available to requesting physicians.


Eligibility criteria:
inclusion criteria: 1. suspected diagnosis of systemic and localized amyloidosis; 2. age .18 years; 3. ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted); 4. planned (or ongoing) follow-up at participating center. exclusion criteria: 1. diagnosis of light chain (al) amyloidosis

Keywords: amyloidosis systemic amyloidosis
comparison of rosuvastatin with atorvastatin in chronic periodontitis

Conditions: Chronic Periodontitis

Summary: the present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical and radiographic efficacy of two local drug delivery systems containing 1.2% rsv gel and 1.2% atv gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to srp.

background: rosuvastatin (rsv) and atorvastatin (atv) are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. the aim of the present study is to evaluate and compare the efficacy of 1.2% rsv and 1.2% atv gel as local drug delivery systems in adjunct to scaling and root planning (srp) for the treatment of intrabony defects in patients with chronic periodontitis (cp). methods: a total of 90 intrabony defects were treated with either 1.2% rsv, 1.2% atv or placebo gel ldd after srp. clinical parameters (plaque index, modified sulcus bleeding index, probing depth and clinical attachment level) were recorded at baseline and 6 months. radiographic intrabony defect depth change was calculated on standardized radiographs by using image analysis software at 6 months.

Eligibility criteria:
inclusion criteria: * systemically healthy patients with pd ≥5mm or ca loss ≥4mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included exclusion criteria: * patients with a known systemic disease; * known or suspected allergy to statin group; * on systemic statin therapy; * with aggressive periodontitis; * who used tobacco in any form; * alcoholics; * immunocompromised patients; * pregnant or lactating females were excluded from the study
an evidence based delivery model of care for newly implanted adult ci recipients

Conditions: Sensorineural Hearing Loss, Bilateral

Summary: the clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to ci surgery.


Eligibility criteria:
inclusion criteria: * patients who are receiving a nucleus® ci512, ci522, or ci532 electrodes * 18 years and older * postlingual onset of hearing loss (onset of hearing loss \>two years of age) * individuals who qualify for cochlear implantation using the clinics current ci candidacy criteria * individuals who have recently been implanted but not yet had their external device activated * willingness to participate in a study and comply with all study requirements * fluent in spoken english exclusion criteria: * ossification or any other cochlear anomaly that might prevent insertion of less than 10 electrodes of the electrode array * diagnosis of retro-cochlear pathology * diagnosis of auditory neuropathy * subject considering an acoustic component in the implanted ear * unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device * unwillingness or inability to comply with all investigational requirements * severe-profound sensorineural hearing loss \>30 years * previous cochlear implant in the contralateral ear. additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the investigator
hyaluronic acid for hypofractionated prostate radiotherapy

Conditions: Prostate Cancer

Summary: the present phase ii study aims to assess the rates of late rectal toxicities of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 gy in 20 fractions of 3.1 gy with an injection of hyaluronic acid (ha) in the space between the rectum and the prostate. thirty-six patients with a low- to intermediate-risk prostate cancer according to the d'amico classification are included in the present protocol. the main characteristics of the study are that the patients benefit of a reduction of the treatment duration from 40 to 20 fractions, due to the hypofractionated irradiation, and of an injection of 3 to 10 cc of hyaluronic acid in the perirectal fat between the rectum and the prostate.


Eligibility criteria:
inclusion criteria: * age superior or equal to 18 years and inferior to 80 years. * patient with a low- to intermediate-risk prostate cancer, according to d'amico classification, for an exclusive irradiation. * prostate cancer histologically proven. * life expectancy superior to 10 years. * karnofsky performance status ≥ 60% (performance status ecog 0-2). * the patient has to be the beneficiary of a social security system or other insurance (order n° 2006-477 from april 26th 2006). * the signed consent form. exclusion criteria: * age inferior to 18 years and ≥ 80 years; * history of rectal surgery; * patient who can't cooperate during the treatment; * history of pelvic irradiation; * history of inflammatory bowel disorder such as ulcerative colitis or the crohn's disease; * other current neoplasia or history of neoplasia dating from less than 5 months, excepting basal-cell carcinomas; * patients treated with anti-neoplastic or anti-angiogenic or with other treatments used in rheumatology and which may include methotrexate (in order not to have a radiosensitizing effect); * patients receiving anticoagulant treatment or plavix; * other undergoing study that may interfere with the present study; * patient under legal protection measure.

Keywords: prostate hypofractionated radiotherapy hyaluronic acid spacer rectum toxicity rectal toxicities after hypofractionated irradiation and injection of hyaluronic acid in patients with low- to intermediate-risk prostate cancer
safety & initial efficacy of the lunguard pft sys. on enteral-fed, sedated and mechanically ventilated patients peristaltic feeding tube

Conditions: Gastro-esophageal Reflux

Summary: this study is designated to test the safety and initial efficacy of the lunguard's pft device for reduction of ger. enterally-fed, sedated and mechanically ventilated critically ill patients in the icu will have the pft positioned in them and used for feeding of a nutritional formula.samples will be taken by suction on predetermined intervals and analysed for pepsin a concentration. the pft will be removed upon completion of the study's scheduled routine. patients in the control group will have a standard polyurethane nasogastric device inserted according to standard procedure, which is considered the gold standard.


Eligibility criteria:
inclusion criteria: * informed consent. * patients who are expected for at least 12 hours to be: * mechanically ventilated and sedated. * requiring a nasogastric tube. * included are: * patients who have undergone tracheostomy. * patients who require use of pro-kinetic drugs and proton pump inhibitors. * all levels of gastric residual volume (grv) exclusion criteria: * • patients with a contraindication for insertion of a nasogastric tube. * patients with a known esophageal obstruction, preventing passage of the device. * esophageal disease including: achalasia, hiatal hernia or any other anatomical anomaly and/or esophageal pathology, esophagitis, zenkers diverticulum, para-esophageal hernia, esophageal varices. (not excluded are minor gerd patients) * acute and severe coagulation disorders * (inr\> 2 or platelets below 30,000) * diabetic patients with documented gastrointestinal neuropathy * pregnancy or lactation * allergy to silicon * patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
netarsudil use after descemtorhexis without endothelial keratoplasty

Conditions: Fuchs' Endothelial Dystrophy

Summary: this will be a prospective assessment of whether adjuvant netarsudil use in patients undergoing descemetorhexis without endothelial keratoplasty improves time to corneal clearance and post-operative central endothelial cell counts. the anticipated enrollment is 25 patients.

subjects meeting inclusion criteria will be identified by massachusetts eye and ear cornea surgeons during their pre-operative assessment and invited to participate in the study. written informed consent will be obtained from the patient. the patients will then be added to a shared epic patient list with a shared to-do column (outside of the patient record) indicating their subject id and date of recruitment. all subjects will be asked to provide their best contact phone number which will be updated in the chart. upon obtaining informed consent, subjects will receive a bottle of netarsudil from the massachusetts eye and ear research pharmacy with post-operative instructions to use the drop once a day at bedtime starting on post-operative day 1 . each patient will then receive regular, scheduled post-operative monitoring with a post-operative day 1 visit, post-operative week 1 visit, post-operative month 1 visit, and then every 2 month follow up for twelve months. clinical examination, including best corrected visual acuity and intraocular pressure, will be recorded during every visit. corneal topography and specular microscopy will be performed during the pre-operative assessment and during each bi-monthly visit in order to monitor for post-operative outcomes. a retrospective chart review will be performed prior to new patient enrollment for patients who had previously had dwek and did not receive a rho-kinase inhibitor. these patients will be included for pre-operative and post-operative vision, pachymetry, corneal topography results, and specular microscopy results with minimization of data acquisition as no informed consent can be obtained from these patients.

Eligibility criteria:
inclusion criteria: * fuchs corneal dystrophy exclusion criteria: * women of childbearing potential * other corneal eye diseases * non-compliance with netarsudil * intolerance of netarsudil

Keywords: descemetorhexis without endothelial keratoplasty
enoblituzumab plus mga012 or mgd013 in squamous cell carcinoma of the head and neck

Conditions: Head and Neck Cancer; Squamous Cell Carcinoma of Head and Neck

Summary: this is an open-label study designed to evaluate safety and efficacy of enoblituzumab in combination with mga012 or mgd013 in first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (scchn).

the study will initially be conducted in 2 modules, module x (enoblituzumab plus mga012) and module y (enoblituzumab plus mgd013). enrollment into modules x and y, with approximately 30 patients each, will occur independently in a non-randomized fashion. data from these modules will determine if further evaluation will occur in randomized module a (phase 2) and randomized module b (phase 3).

Eligibility criteria:
inclusion criteria: * histologically proven, recurrent or metastatic scchn not curable by local therapy * no prior systemic therapy for scchn in the recurrent or metastatic setting (with the exception of systemic therapy completed \> 6 months prior of given as part of multimodal treatment for locally advanced disease) * primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx * at least one radiographically measurable lesion * hpv test results available (positive and negative eligible) * ecog performance status of 0 or 1 * adequate end organ function * positive pd-l1 expression level (cps ≥ 1%) exclusion criteria: * disease suitable for local therapy administered with curative intent * progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced scchn * radiation or other non-systemic therapy within 2 weeks of first dose of study drug * diagnosis of immunodeficiency, or use of immunosuppresive therapy within 14 days of first dose of study drug

Keywords: scchn head and neck oropharyngeal oral cavity hypopharyngeal laryngeal cancer immunotherapy pd-1 b7-h3 lag-3
tms and body image treatment for anorexia nervosa

Conditions: Anorexia Nervosa

Summary: to evaluate if tms together with a body image intervention is an efficacious treatment for anorexia nervosa compared to treatment as usual.


Eligibility criteria:
inclusion criteria: * being enrolled as a patient at the eating disorder unit of the child and adolescent psychiatric clinic and psychiatric clinic in linköping * having a dsm-5 diagnosis of anorexia nervosa, atypical anorexia (restrictive type) * being at least 18 years of age * having a bmi of 20 or under. * being free of psychotropic medications or on stable (at least three months on the same dose) medication. exclusion criteria: * clinical diagnosis of schizophrenia or psychotic disorder * clinical diagnosis of bipolar disorder * alcohol/drug dependence * ongoing treatment with antipsychotics or tricyclic antidepressants * previous severe head injury * birth before 33 weeks of gestation * hearing impairment * earlier epilepsy or seizures of other causes * having severe claustrophobia * being pregnant * having a cognitive disability