Kornimate/medical-research-clean huggingface dataset:
a research study looking at the effect of food intake on how the medicine nn0385-0434 behaves in the body of healthy participants

Conditions: Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk; Elevated Cholesterol; Healthy Volunteers

Summary: in this study participants will receive nnc0385-0434. nnc0385-0434 is being developed for the treatment of hypercholesterolemia, a fat metabolism disorder characterized by high levels of cholesterol in the blood. the dose to be tested in this study is 40 mg nnc0385-0434. nnc0385-0434 is a new potential medicine that is currently being tested for intake as a tablet. it is not yet approved and cannot be prescribed yet. besides 40 mg of nnc0385-0434, each tablet also contains 500 mg of the absorption enhancing agent snac, which helps to move nnc0385-0434 from the stomach into the blood. the aim of this study is to investigate the effect of food intake on the amount of nnc0385-0434 in the blood after multiple tablet intake. for this purpose, nnc0385-0434 is given either after a high-fat breakfast or on an empty stomach. after dosing, participants must either fast for another 4 hours or receive a meal 30 minutes after dosing, depending on the group participants are assigned to. after taking the nnc0385-0434 tablets, the amount of nnc0385-0434 (and of snac) in the blood will be measured. the effect of food intake on the uptake of nnc0385-0434 into the body will be investigated so that correct and safe intake recommendations and medicine labels can be given. the study can last for up to approximately 14 weeks for each participant, with a total of 7 clinic visits. this includes a screening period (up to 4 weeks) and one in-house treatment period (together a total of 13 consecutive days). it also includes a follow-up period with 5 ambulatory visits at the clinic (for approximately 7 weeks \[total of 50 days\] after the last dosing). participants will have blood tests at every clinic visit. participants must be healthy and have a body mass index (bmi) between 20.0 and 34.9 kg/m2 (both inclusive). only men can participate in this clinical study.


Eligibility criteria:
inclusion criteria: * male. * aged 18 to 55 (both inclusive). * considered to be generally healthy based on medical history, physical examination, and the results of vital signs, ecg and clinical laboratory tests performed during the screening visit, as judged by the investigator. * body weight minimum 54 kg. * body mass index (bmi) between 20.0 and 34.9 kg/m\^2 (both inclusive). exclusion criteria: * any disorder, which in the investigator's opinion might jeopardise participant safety or compliance with the protocol. * meal habits and diet requirements which are contradictory to the meals provided or unwillingness to eat the food provided in the study. * presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
intestinal metagenome of undernourished in patients

Conditions: Undernourished; Anorexia Nervosa

Summary: the objective of this trial is to evaluate gut microbiota changes in undernourished patients with anorexia nervosa under enteral nutrition.

this is a prospective, comparative, non-interventional study involving one clinical nutrition unit in france. gut microbial will be evaluated with feces between patients and healthy volunteers. main investigations: * presence of gut microbial deviation compared to healthy volunteers; * presence of a significant statistical association between this deviation and metabolic disorders. for each patient under the routine care a clinical examination and a blood sample will be done for standard biology report and nutrition. the age, gender, weight, height (for calculation of bmi), type of anorexia nervosa will be also collected with the pathological behavior associated (physical and intellectual hyperactivity, potomania, ongoing supplements drug taking including vitamins and trace elements). eating and psychological disorders will be evaluated with edi (eating disorder inventory) questionnaire. only the age, gender, height, weight (bmi), medical antecedents and ongoing treatment taking will be collected.

Eligibility criteria:
inclusion criteria: patients: 1. anorexia nervosa as defined by dsm-5 (diagnostic and statistics manual of mental disorders 2. undernutrition defined by bmi under 15 3. age superior to 18 4. patient hospitalised for undernutrition or seen in hospital day 5. affiliation to the french social security regime or a similar regime 6. patient signed informed consent healthy volunteers: 1. age superior to 18 2. normal weight (bmi 18.5 - 25) 3. affiliation to the french social security regime or a similar regime 4. patient signed informed consent exclusion criteria: patients: 1. taking antibiotics two month before hospitalization 2. purge line with laxative abuse one month before hospitalization 3. another disease may be associated to microbiota profile modification (diabetes, mici or digestive organ pathology, metabolic disease) 4. obesity prior to anorexia nervosa 5. safeguard justice procedure healthy volunteers: 1. metabolic anomaly 2. recent weight change

Keywords: microbiota anorexia nervosa under nutrition inpatients enteral nutrition
evaluation of a new daily disposable multifocal contact lens design

Conditions: Presbyopia; Hyperopia; Refractive Error

Summary: the purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available air optix® aqua multifocal (aoamf) lens in high contrast/high illumination (hc/hi) near visual acuity (va).


Eligibility criteria:
inclusion criteria: * subjects with normal eyes who are not using any ocular medication. * must sign the informed consent document. * habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(d)). * manifest cylinder less than or equal to 0.75d. * best corrected distance va greater than or equal to 20/25 in each eye. * existing soft contact lens (cl) wearers who wear contact lenses in both eyes at least 5 days per week. * presbyopic with a spectacle addition (add) \>0.50d and \<2.75d. * other protocol-defined inclusion criteria may apply. exclusion criteria: * any ocular disease, inflammation, or abnormality that contraindicates cl wear. * any use of systemic or ocular medications for which cl wear could be contraindicated. * history of herpetic keratitis. * history of refractive surgery or irregular cornea. * a clinically significant dry eye that precludes cl wear. * participation of the subject in a clinical study (including cl or cl care product) within the previous 30 days. * monocular (only 1 eye with functional vision). * history of intolerance or hypersensitivity to any component of the test articles. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses multifocal daily disposable silicone hydrogel presbyopia
cosentyx (secukinumab) for the treatment of adult onset pityriasis rubra pilaris

Conditions: PITYRIASIS RUBRA PILARIS

Summary: the primary objective of this study is to assess the potential effectiveness of cosentyx in the treatment of adult-onset pityriasis rubra pilaris or prp.


Eligibility criteria:
inclusion criteria informed subject consent will be obtained from those patients meeting the following inclusion criteria: * male and female patients 18 years or older. * clinical and/or histopathological diagnosis of prp * candidate for systemic therapy (pasi ≥ 10) * body surface area of involvement ≥ 10% * good general health as confirmed by medical history * patients who are willing and capable of cooperating to the extent and degree required by the protocol; and * patients who read and sign an approved informed consent for this study exclusion criteria patients are to be excluded based on the following criteria: * vulnerable study population * pregnant or nursing women * women planning a pregnancy within the study period * human immunodeficiency virus (hiv) positivity * known history of adverse reaction to cosentyx * known history of hepatitis b, hepatitis c, or tuberculosis * personal or family history of inflammatory bowel disease
deferred stent trial in stemi

Conditions: ST-Elevation Myocardial Infarction

Summary: during primary pci, stent deployment and post-dilatation are associated with no-reflow. the mechanisms for no reflow include distal embolization of thrombus, enhanced thrombus formation and vascular spasm. no reflow is associated with risk factors such as prolonged duration of ischaemia, heavy thrombus burden, persistent st elevation and long stent length. active hypothesis: once normal antegrade flow has been re-established with initial aspiration thrombectomy and/or balloon angioplasty at the beginning of primary pci, compared with usual care with direct stenting, a strategy of deferred stenting for 4 -16 hours to permit the beneficial effects of normalized coronary blood flow and anti-thrombotic therapies will reduce the incidence of no reflow in at-risk stemi patients. design: in consecutive stemi patients with risk factors for no reflow and who have given informed consent, when normal flow has been established (timi 3) by initial aspiration thrombectomy and/or balloon angioplasty, participants will be randomized to deferred stenting or usual care with direct stenting. all patients will receive dual anti-platelet therapy. patients who are randomized to deferred stenting will receive intravenous glycoprotein iibiiia inhibitor and anti-coagulation with low molecular weight heparin. patients who are screened and not eligible to be randomized will be prospectively entered into a registry. study assessments for feasibility, safety and efficacy will be prospectively performed. an independent clinical event committee will review all serious adverse events. study endpoints will be subject to core laboratory analyses. the study is intended to inform the design of a larger multicentre clinical trial.


Eligibility criteria:
inclusion criteria: * rescue pci * prolonged ischaemic time (\> 12hours) * previous mi * age \> 65 * occluded artery (timi 0/1) at initial angiography * thrombus burden (timi grade 2+) * long plaque/ stent length (\> 24 mm) * severe coronary artery disease (e.g calcified artery) * small reference vessel diameter (\< 2.5 mm) * persistent st-elevation (\> 50%) following reperfusion * index of microvascular resistance (imr) \> 40 exclusion criteria: * absence of normal coronary flow (timi 3)

Keywords: stemi no-reflow primary percutaneous intervention deferred stenting
dexamethasone and block duration in upper extremity

Conditions: Duration of Pain Relief

Summary: effect of dexamethasone on prolonging upper extremity block is well known. but it not known if the effect comes from its local effect on the nerves or from its general analgesic effect. in this study we will compare the systemic effect to its local effect to find out if there is a difference or not.


Eligibility criteria:
inclusion criteria: * age 18-75, no contraindication to regional anesthesia, exclusion criteria: * opioid user, chronic pain conditions, peripheral neuropathy

Keywords: block duration analgesia
immersive room for visual attention in children with autism spectrum disorders

Conditions: Autism Spectrum Disorder; Autism

Summary: autism spectrum disorder (asd) is a common neurodevelopmental disorder characterized by language delay, impaired social interactions, and repetitive behaviors. its manifestation varies among individuals due to genetic and environmental factors. technology-based interventions, such as robots, serious games, virtual reality and immersive room, have shown better results in the cognitive-behavioral treatment of asd. visual attention, which is often deficient in individuals with asd, is a focus in these interventions, as it can aid stimulus processing. virtual reality offers a more ecological environment for such interventions. in this study, it has been demonstrated the effectiveness of virtual reality training by comparing the performance of an asd group delivering treatment through the immersive room with a control group delivering traditional treatment. fifteen children with asd between the ages of 5 and 10 years, with iqs between 55 and 85 will be included in the trial and, following an assessment related to visual attention processes, will be randomly assigned to the control group and the experimental group. the trial participants will, first, undergo structured sessions to foster or increase the receptive area related to the stimuli to which they will be subjected during the training.


Eligibility criteria:
inclusion criteria: * child with diagnosis of autism exclusion criteria: * presence of other medical disorders

Keywords: autism children applied behavior analysis
mastiha treatment for obese with nafld diagnosis

Conditions: Non Alcoholic Fatty Liver Disease

Summary: nafld/nash is one of the most common complications of obesity and diabetes mellitus in western populations affecting approximately 50% of diabetics and 76% of obese patients. due to the lack of specialized treatment, many new efforts focus on exploring alternative, non-pharmacologic means for managing the disease, including bioactive substances in fruits, vegetables and plants or their products. mastiha, a natural product of greece, consists of a great variety of bioactive phytochemical compounds and demonstrates antioxidant, antiinflammatory, antimicrobial and lipid lowering properties. taking into account the contribution of oxidative stress and inflammation to nafld/nash pathogenesis, the hypothesis that mastiha could improve disease aspects is investigated. thus, design of a multicenter (4 centers across europe), randomized, double-blind, placebo controlled (parallel arm) clinical trial to assess the effect of mastiha on clinical course of nafld/nash patients has been conducted. the effectiveness of the proposed intervention will be evaluated via clinical and laboratory markers. mast4health aims also at exploring gene-diet interactions and at correlating genetic and epigenetic markers with metabolomic and intestinal microbiota profiles pre- and post- intervention. to this end, patients with confirmed nafld/nash will be allocated to either verum or placebo group. duration of the intervention will be 6 months and the dosage applied will be 2.1 g daily. nafld/nash diagnosis will be confirmed by ms scanning and the sensitive livermultiscan technique. anthropometric, demographic data, body composition, dietary habits, physical activity, family history and smoking status will be assessed pre- and post- intervention. biochemical profile, oxidative stress and inflammation, as well as epigenetic and metabolomic profiles will be assessed in blood samples, while the metagenome profile will be examined in stools. both groups will receive counselling to allow for body weight regulation up to 5%. compliance will be assessed monthly and side effects will be reported.


Eligibility criteria:
inclusion criteria: * confirmed nafld/nash * 18 years \< age \< 67 years * bmi \> 30 kg/ m2 exclusion criteria: * hepatotoxic medication, concomitant liver disease * decompensated diabetes mellitus * dysthyroidism, hypopituitarism, cushing syndrome / disease * alcohol abuse or drug addiction * clinically or biochemically recognized systemic diseases * pregnancy test, lactation * vegan or lacto- and ovo-lacto- vegetarianism * psychiatric or mental disorder * recent loss in body weight or current diet * any use of antioxidant-phytochemical rich supplement, anti-, pre- or pro-biotics within 3 months pre-intervention * changes in drug treatment for e.g. hypertension, diabetes mellitus, 3 months prior or during the 6month intervention * antibiotic treatment during and 2 months prior to screening
pharmacogenetic testing in an outpatient population of patients with depression

Conditions: Depression

Summary: this is a randomized, control group design of pharmacogenetic implementation in a mental health population of subjects taking anti-depressants and/or anti-psychotics with a new or current primary or secondary diagnosis of major depressive disorder (mdd) or depressive disorder not otherwise specified (ddnos).

this is a randomized, control group design of pharmacogenetic implementation in a mental health population of subjects taking anti-depressants and/or anti-psychotics with a new or current primary or secondary diagnosis of major depressive disorder (mdd) or depressive disorder not otherwise specified (ddnos). prospective data will be collected on all subjects until study completion at 24-25 weeks post enrollment. claims data may be reviewed per pay, if such data are readily available in a timely manner.

Eligibility criteria:
inclusion criteria: * current primary or secondary diagnosis of major depressive disorder or depressive disorder not otherwise specified * have moderate to severe depression as identified by phq-9 scoring of 10 or greater * taking or be newly prescribed an anti-depressant or anti-psychotic medication * able to provide informed consent * prescribing physician practices at the avera medical group university psychiatry associates clinic in sioux falls, sd exclusion criteria: * pregnant or breastfeeding * active and/or unstable diagnosis of substance abuse, excluding nicotine * primary diagnosis of dementia, bipolar disorder (any type), schizophrenia, schizoaffective disorder, or personality disorder

Keywords: pharmacogenetic, pharmacogenomic, depressive, mental health
a randomized control trial examining two treatments for problem gambling

Conditions: Gambling, Pathological; Anger

Summary: despite evidence of high rates of concurrent substance use and anger problems among problem gamblers, until recently there have been no empirically evaluated treatments for these co-morbid problems. a recent study (korman, collins, mcmain, \& skinner, 2005) found that an emotion and behaviour regulation treatment (ebrt) was more effective than a gambling-only treatment-as-usual in engaging clients in treatment and in reducing gambling, anger, and substance use. this study is a replication of korman et al's study and will compare an emotion and behaviour regulation treatment (ebrt) for problem gambling, anger and substance use to a manualized cognitive behavioural treatment (cbt) for problem gambling.

80 participants will be randomly assigned to either an emotion and behaviour regulation treatment (ebrt) or to a cognitive behavioural treatment (cbt). randomization will be stratified by the presence of substance dependence disorder. both treatment conditions will consist of 12 one-hour weekly outpatient individual sessions. participants will be assessed at baseline, end of treatment, and 3-months, 6-months and 12-months follow-up.

Eligibility criteria:
inclusion criteria: * problem gambling (pgsi \> 7; c.f., ferris \& wynne, 2001) * clinically significant anger (staxi-ii anger expression/trait subscale score \>75th percentile and/or anger control subscale score \< 25th percentile; c.f., spielberger, 1999) exclusion criteria: * major thought disorders * acute manic episode * high psychopathy * severe developmental/cognitive disability * outstanding legal charges/sentencing

Keywords: problem gambling clinically significant anger
non invasive blood test to diagnose acute rejection after kidney transplantation

Conditions: Kidney Transplant Recipients

Summary: this is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfdna and other future research purposes, will be drawn after transplant

this is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfdna and other future research purposes, will be drawn after transplant periodically and also after the treatment of acute rejection up to 8 weeks post treatment. the blood samples and all relevant clinical data will be provided to caredx scientists for laboratory assay of dd-cfdna levels and correlation of dd-cfdna levels with the clinical features of the subjects. the primary objective of the study is to correlate circulating dd-cfdna to clinical and sub-clinical acute rejection in renal allograft recipients. the secondary objective of the study is to correlate circulating dd-cfdna to renal function, both serum creatinine and estimated glomerular filtration rate \[egfr\]).

Eligibility criteria:
inclusion criteria 1. adult recipients (age \> 18 years ) 2. both genders and all racial and ethnic groups 3. kidney transplant alone 4. both living and deceased donor transplants 5. primary and re-transplants. a total of 30 re-transplant recipients across all study sites will be eligible for enrollment. caredx will notify all centers when this subset of enrollment has been met. thereafter, all enrolled patients should be primary transplant recipients. 6. ability to come for follow-up and undergo biopsy (performed in accordance to soc) 7. ability to give written informed consent prior to study enrollment patients can be enrolled at any time; before or after transplantation and/or at time of outpatient or inpatient visits for workup of medical problems; e.g. at the time of a renal biopsy (regardless of elapsed time since post transplant) as specified in this study protocol. exclusion criteria 1. pediatric recipients (age \< 18 years) 2. pregnant women 3. patients undergoing multi-organ transplants (e.g. kidney with pancreas or liver) 4. patients receiving donor organ from an identical twin
clinical applications of advanced ophthalmic imaging

Conditions: Multiple Sclerosis; Dry Eye Syndromes; Diabetic Retinopathy; Presbyopia; Myopia; Dementia

Summary: the purpose of this study is to determine the clinical application of advanced ophthalmic imaging devices such as optical coherence tomography (oct), retinal function imager (rfi), slit-lamp biomicroscopy (slb), perg in diseased eyes and normal controls. there are two phases in this study. the first phase is an observational phase which studies the eye in various conditions. the second phase is an interventional phase which studies the changes in the eyes after taking an over-the-counter medical food (ocufolin) for 6 months.


Eligibility criteria:
observational phase 1 group inclusion criteria: 1. self-reported normal healthy subjects; 2. clinical diagnosis of alzheimer's disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetics and stroke; 3. who can keep the eye open for imaging. exclusion criteria: 1. who can not read and sign the icf; 2. who can not receiving ophthalmic imaging; 3. who cannot tolerate bright light during imaging. interventional phase 2 group: inclusion criteria the participant will be eligible for entry in the study if s/he: 1. is at least 18 years old and has full legal capacity to volunteer; 2. has read and signed the irb informed consent document; 3. is willing and able to follow participant instructions; 4. has clear corneas and crystalline lens; 5. initial visual acuities were 20/80 or better; 6. mthfr c677tt homozygous, or mthfr c677t/a1298c compound heterozygous with mild to moderate micro-aneurismal vascular retinopathy disease; 7. hemoglobin a1c is 10 or less; 8. normotensive with or without medications; 9. without retinal capillary dropout or macular edema; 10. blood homocysteine \> 9. exclusion criteria the subjects will be ineligible for entry into the study if s/he: 1. has an active ocular disease; 2. has had surgery or an eye injury within 6 months.