Kornimate/medical-research-clean huggingface dataset:
ivermectina colombia (ivercol)

Conditions: COVID-19 Pneumonia

Summary: a parallel, prospective, double-blind, placebo-controlled clinical trial will be conducted in the population affiliated to eps suramericana s.a. with positive test for antigen and pcr for sars-cov-2. participants will be randomly assigned in a 1: 1 ratio to the intervention group or the control group using a sequence of random numbers. the patients included will be those with less than 7 days from the onset of symptoms, and without evidence of serious disease. one group will be assigned oral ivermectin therapy at a dose of 600 mcg/kg every 12 hours for 5 consecutive days, and the other group will received placebo. a minimum sample size of 483 patients for each arm was calculated to observe differences. all randomized patients will be included in the analysis according to the randomization arm (intention-to-treat analysis). the primary objective is to evaluate the efficacy of ivermectin in the prevention of severe disease, reduction in the rate of hospitalization, reduction of icu stay, and mortality. this evaluation will be carried out up to 28 days after the intervention begins. given the public health emergency, the study is expected to be completed in a period of 6 months from the invima approval.


Eligibility criteria:
inclusion criteria: * age equal to or greater than 18 years. * patients with positive antigen test or rt-pcr for sars-cov-2. * patients with less than 7 days from symptoms onset. * patients with indication for outpatient management. * patients with mild disease according to the official guide "pneumonia diagnosis and treatment scheme for novel coronavirus infection (trial version 8)": subjects with mild symptoms, with or without radiological signs of pneumonia, with oxygen saturation\>90% . - able to provided consent to participate. exclusion criteria: * patients who at the time of admission require hospitalization and / or supplemental oxygen. * known history of allergy to ivermectin. * known medical history of liver disease. * belong to another clinical trial evaluating the efficacy of an investigational drug against covid-19. * the following comorbidities: * immunosuppression or hiv. * acute or chronic kidney failure. * current neoplasia. * currently use of warfarin, erdafitinib, or quinidine. * have received vaccination for sars-cov-2. * ivermectin consumption prior to inclusion in the research protocol. * the patient does not accept the conditions of home care and monitoring. * the patient desists from participating in the study. * women in pregnancy or breastfeeding.

Keywords: ivermectin covid-19 ambulatory
short-term outcome of covid-19 surgical patients: case-series of a high-risk area community hospital

Conditions: General Surgery; Disease Outbreaks

Summary: the investigators retrospectively evaluated all the patients operated in a high-risk community hospital from the first italian case of covid-19 (february 21st) to the april 10th (in order to have at least a 30-days follow-up). the investigators selected those patients who had a preoperative or post-operative positive real time - polymerase chain reaction (rt-pcr) for sars-cov-2 and the clinical outcome of the participants was evaluated in term of need of intensive care unit (icu) post-operative recovery, medical and surgical complications, length of hospital stay and death.


Eligibility criteria:
inclusion criteria: * preoperative or post-operative positive real time - polymerase chain reaction (rt-pcr) for sars-cov-2 * surgical procedure in elective or acute care surgery performed under general anesthesia exclusion criteria: * patients operated without general anesthesia * patients preoperatively intubated for covid-19

Keywords: surgery covid-19 sars-cov-2 surgical outcome
gameplay as a source of intrinsic motivation in a randomized controlled trial of auditory training for tinnitus

Conditions: Tinnitus

Summary: tinnitus refers to a the perception of a ringing, hissing or buzzing sound despite there being no such sound in the external world. it is prevalent and for many individual is a distressing condition. recent advances in the understanding of changes in the hearing brain and their relation to tinnitus perception has led to a focus on forms of active auditory training which might provide effective techniques for tinnitus management. our recent trial of auditory training provided evidence that training using sounds where there is no hearing loss has benefit in terms of reduced tinnitus intrusiveness, above training at where there is some level of hearing loss. our next challenge is to build on this finding in ways that might maximize the benefits we observe. the training software we used previously was developed for use with children. past participants have given mixed reviews of this software. while some enjoyed the training or found it soporific, others reported that they found it too monotonous and un-motivating. we therefore wish to explore the impact of different game mechanics in the delivery of auditory training and have designed two different interactive games in the context of training for tinnitus benefit. these games will deliver the same type of auditory training as the software we currently use, but should be intrinsically motivating, i.e. be a game that the people are motivated to play irrespective of any potential benefit for tinnitus. the game we previously used is reactive, i.e. the sounds play and the player selects what they think is the correct answer (odd one out). the two new games we wish to test can be described as interactive, i.e. players control the sound delivery and actively seek the correct answer: this may have additional benefit for tinnitus.


Eligibility criteria:
inclusion criteria: (i) chronic subjective tinnitus (experienced for over 6 months) (ii) aged 18 + years old (iii) not currently receiving treatment for tinnitus from the national health service or other sources exclusion criteria: (i) significant distress (beck anxiety score \>25, beck depression score \>13) (ii) hyperacusis (khalfa hyperacusis questionnaire score \>27) (iii) significant bilateral hearing loss (\>39 decibel at all tested frequencies)
ct lucia 601 iol implantation in the sulcus

Conditions: Cataract; Complicata; Posterior Capsule Tear; Lens Dislocation

Summary: to perform a retrospective investigation of the ct lucia 601 iol implantation in the sulcus

the purpose of the study is to collect data that are parameters of post-iol implantation safety: * questionnaire on subjective quality of vision * centration and anteroposterior position of the iol (using biometry) * presence and quantification of any inflammation or pigment present in the anterior chamber (flare meter) * refractive outcome, with calculation of customized a-constant of the ct lucia 601 iol in-the-sulcus and quantification of higher-order aberrations (hoa) * general safety-parameters: * visual acuity * intra-ocular pressure * presence of macular edema or retinal nerve fiber layer (rnfl) thinning (sd-oct) * any adverse ophthalmic events

Eligibility criteria:
inclusion criteria: * patients with an implantation of a ct lucia 601 lens for different reasons: * during vitrectomy to treat a complicated cataract surgery and had the implantation of a ct lucia 601 iol in the sulcus or patients * during phaco surgery with a posterior capsule tear that necessitated the implantation of the implant lens in the sulcus * explantation of an in-the-bag lens and implantation of a ct lucia 601 as replacement lens (e.g. to treat opacification of the implant lens or intolerance of the implant lens). * age : \> 18 years * signed informed consent * preoperative myopia less than 10 diopters * implantation of the ct lucia iol at least six months earlier exclusion criteria: * history of uveitis * ocular pathology or history that could influence the biometry of the effective lens position, such as ocular trauma with zonulolysis, congenital iris- or lens defects etc. * any eye condition influencing the lens position (to be specified) according to the investigator

Keywords: ct lucia 601 lens
the french national nafld cohort (french patients with metabolic steatosis)

Conditions: NAFLD; NASH; NASH - Nonalcoholic Steatohepatitis; Fibrosis; Cirrhosis

Summary: the main objective of this cohort study is to determine genetic, clinical biologic and metabolic factors associated with patient heterogeneity in regards to severity of nafld at diagnosis as well as during the clinical course. * at diagnosis, with the aim to better characterize patients of different severity and improve our understanding of clinical and histological heterogeneity at diagnosis * during the clinical course to better understand and predict disease progression in terms notably of fibrosis progression and progression to cirrhosis

non-alcoholic fatty liver disease (nafld) is considered the hepatic manifestation of metabolic syndrome and is currently the most common cause of liver disease in many developed countries worldwide. the aim of the study is to improve the scientific knowledge on markers associated with disease severity and progression in nafld. the study is a multicentre french nafld cohort of well-characterized patients with biological samples covering the entire spectrum of nafld severity (steatosis, nash, significant fibrosis, cirrhosis, hepatocellular carcinoma).

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. patients with a confirmed diagnosis of nafld 3. patients affiliated to french social security 4. written informed consent signed by the patient exclusion criteria: 1. refusal or inability (lack of capacity) to give informed consent. 2. average alcohol ingestion greater than 21/14 units/week (males/females) in the preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years. 3. history or presence of type 1 diabetes mellitus. 4. presence of any other form of chronic liver disease except nafld 5. recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \[\>10 days\], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid). 6. any contra-indication to liver biopsy. 7. recent (within 3 months) change in dose/regimen or introduction of vitamin e (at a dose ≥400 iu/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline. 8. non-french speaking/unable to access an interpreter. 9. patients judged by the investigator to be unsuitable for inclusion in the study (e.g. judged by the physician as unlikely to be compliant with the study protocol). 10. pregnant or breastfeeding women 11. patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom

Keywords: cohort
comparison of repaglinide and gliclazide in chinese subjects with type 2 diabetes never received oral antidiabetic drug treatment

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this clinical trial is to investigate the blood glucose lowering effect and the safety profile of repaglinide given alone compared to gliclazide given alone in chinese subjects with type 2 diabetes who never have been treated with oral anti-diabetic drugs (oads). this study also investigates the augment effect of repaglinide on the phases of insulin secretion as a subgroup study.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * oral anti-diabetic drug (oad) naïve (unsystematic oad treatment 6 months prior to this trial is allowed) * insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed) * lipid-lowing agent naïve * hba1c: 6.5-8.5% * fasting glucose: 6.1-13.0 mmol/l (110-234 mg/dl) * body mass index (bmi): 20-35 kg/m\^2 * be able and willing to perform self-monitored plasma glucose (smpg) * be able and willing to eat 3 main meals per day * only applicable to subjects who will participate in the subgroup study: be able and willing to perform and complete ivgtt (intravenous glucose tolerance test) at additional visits exclusion criteria: * known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (sus)), or any of the excipients in the study drugs * previous participation in this study * participation in a study of another investigational drug within 1 month prior to study start
impact of consuming a plant-based enriched meal on the adult gut microbiome

Conditions: Healthy

Summary: the aim of this study is to evaluate the impact of a diversified plant-based meal on the gut microbiome and its composition.


Eligibility criteria:
inclusion criteria: * age 18-55 years, * healthy participants, both male and female, * bmi in the normal and overweight range 18.5 ≤ bmi ≤ 29.9 kg/m2, * able to understand and to sign a written informed consent prior to study enrolment. exclusion criteria: * known chronic diseases or conditions for which the investigators/investigation team deem as not suitable for study participation, * known food allergy and intolerance e.g. lactose intolerance, nuts allergy, * habitually, have \< 5 spontaneous bowel movements on average per week, * chronic or recurrent diarrhoea with spontaneous bowel movements \> 2 per day * prior gastrointestinal surgery (apart from appendectomy or herniotomy), * received systemic antiviral/antibacterial/antifungal therapy during the 3 months prior to study enrolment, * medications or supplements that are known to alter gut function or microflora i.e. acid antisecretory drugs, pre-/probiotics, laxative during the 4 weeks prior to study enrolment, * anti-hyperlipidaemic, antihypertensive medications and/or anticoagulant agents, * currently participating in another interventional clinical trial or research project, * alcohol intake \> 2 servings per day; specifically, a serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. or other chronic substance abuse, * changing diet patterns due to travelling and staying abroad for more than two weeks (asia, africa, or latin america) during the two months prior to study enrolment, * food restrictions such as vegan, vegetarian, ketogenic, low carb, paleo, raw diets, caloric restrictive diets, * artificially sweetened beverage intake \>1000 ml/ per day, * female participants will be excluded if they are pregnant, have given birth in the last 6 months, or are lactating, * subject having a hierarchical or family link with the research team members, * occurrence of fever episodes, infection, or vaccination during 14 days before the start of the study.
atac - pharmacokinetics (pk) sub-protocol

Conditions: Breast Cancer

Summary: to assess the effect of arimidex on the pharmacokinetics of tamoxifen and the effects of tamoxifen on the pharmacokinetics of arimidex..


Eligibility criteria:
inclusion criteria: * eligible for entry into the main atac trial 1033il/0029 * patients must have been taking atac trial medication for at least 3 months (i.e. patients must have reached at least visit 2 of the main atac study) * patients should be taking their medication in the mornings for at least 3 months * patients must be 100% compliant over the preceding fourteen days exclusion criteria: * excluded from entry into the main atac trial (1033il/0029) * patients whose concurrent treatment includes diazepam or drugs which might affect tamoxifen steady state levels or steroid hormone status. these include ketoconazole (antifungal) or related compounds
preconception nutrition education intervention for prospective brides

Conditions: Health Education

Summary: this research focuses on the importance of preconception health care. in this research, an intervention was carried out providing health education regarding preconception nutritional preparation. research methods used is a quasi experiment with the non equivalent control group method. example used in this research were 100 prospective brides and grooms in indonesia. the intervention group will be provided with education through a preconception nutrition education module and the brides health card, and the control group was given education using the brides health leaflet.


Eligibility criteria:
inclusion criteria : * women aged 20 to 35 years old * have no history of disease that weakens anemia and nutritional intake * examination maximum 3 months before the wedding * prospective bridal couples do not delay the pregnancy program exclusion criteria : * not complete premarital reproductive health examination
study of fyu-981 in hyperuricemia with or without gout

Conditions: Hyperuricemia

Summary: the purpose of this study is exploratory investigation of safety and efficacy (dose response and optimal dose according to the percent reduction from baseline in serum urate level at the final visit) of fyu-981 administered orally to hyperuricemic patients with and without gout for 8 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 4 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.


Eligibility criteria:
inclusion criteria: * hyperuricemic or gout patients * serum urate level: \>= 7.0mg/dl in patients with history of gout, or \>= 8.0mg/dl in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dl exclusion criteria: * gouty arthritis within two weeks before start of study treatment * secondary hyperuricemia * hba1c: \>= 8.4% * uric acid-overproduction type in the classification of hyperuricemia * history of, clinically significant cardiac, hematologic and hepatic disease * kidney calculi or clinically significant urinary calculi * egfr: \< 60ml/min/1.73m\^2 * systolic blood pressure: \>= 180 mmhg * diastolic blood pressure: \>= 110 mmhg
a clinical trial comparing efficacy and safety of insulin degludec/liraglutide (ideglira) versus basal-bolus therapy in subjects with type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally. the aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (ideglira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * male or female, age at least 18 years at the time of signing informed consent * type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening * hba1c (glycosylated haemoglobin) 7.0-10.0% \[53mmol/mol-86mmol/mol\] (both inclusive) by central laboratory analysis * current treatment with iglar (insulin glargine) for at least 90 calendar days prior to screening * stable daily dose of iglar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive * stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening * body mass index (bmi) below or equal to 40 kg/m\^2 exclusion criteria: * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening * anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids) * impaired liver function, defined as alanine aminotransferase (alt) at least 2.5 times upper limit of normal * renal impairment egfr (electronic case report form) below 60 ml/min/1.73 m\^2 as per ckd-epi (chronic kidney disease epidemiology collaboration) * screening calcitonin at least 50 ng/l * history of pancreatitis (acute or chronic) * personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
take steps: motivational interviewing to prevent stis

Conditions: Self Efficacy; HIV Prevention; STI Prevention

Summary: this study will consist of a randomized controlled trial of a motivational interviewing intervention for adolescents with diagnosed sexually transmitted infections (stis). the sessions will provide hiv/sti prevention education, use motivational interviewing (mi) to enhance goal setting, and providing skill building and referral to evidence based sti and hiv prevention strategies pre-exposure prophylaxis (prep), condom use, and partner notification.

pilot phase: pilot testing will occur over a 3-month period to prime intervention for implementation, with the aim of recruiting n=10 pilot participants. pilot phase participants will follow the same study procedure timeline as participants randomized to the mi intervention arm of the randomized control trial (rct), excluding the 6-month follow-up visit. pilot participants will not be followed in the rct or contribute outcome data. at the end of every intervention visit in the pilot phase (the baseline, 1-week, 1-month and 3-month visits), participants will complete a brief feedback interview to ensure face validity and identify areas needing refinement. feedback will be incorporated into the study design, with amendments submitted to the institutional review board (irb) as needed. data from pilot participants will not be included in analysis of the rct. intervention phase:the rct will randomize youth with recent sti 2:1 to the take steps intervention vs a standard of care (soc) control. both arms (intervention and soc) will have data collection visits at the baseline, the 3-month, and the 6-month-follow-up time points. in addition, the intervention group will have intervention sessions at baseline, 1 week, 1 month and 3 months. the study treatment phase for the rct will consist of data collection and motivational interviewing sessions over a 6-month period. intervention sessions will consist of hiv and sti prevention education, motivational interviewing, skill building, and referral to therapy. all visits can occur in-person or remotely.

Eligibility criteria:
inclusion criteria: * males or females aged 13 to 19 years. * history of ≥1 sti in the 30 days prior to recruitment * confirmed treatment for a laboratory confirmed diagnosis of trichomonas vaginalis (via microscopy or nucleic acid amplification test \[naat\]), neisseria gonorrhea (naat), chlamydia trachomatis (naat), treponema pallidum \[via new positive rapid plasmin reagin (rpr) assay\] within the prior 30 days * self-reported hiv negative status. * able to speak and understand written english exclusion criteria: * unable to provide informed consent due to intoxication or severe psychological distress.
ifh depression registry 2013

Conditions: Depression

Summary: this is an observational registry intended to track depression scores of patients over time in treatment.


Eligibility criteria:
inclusion criteria: * patients with phq-9 score greater than or equal to 10, have a depression diagnosis active on the problem list, or have had a depression encounter diagnosis used in the past year, and are in behavioral health treatment at the institute. exclusion criteria: * patients under the age of 18

Keywords: depression phq9 phq-9 standard treatment