Kornimate/medical-research-clean huggingface dataset:
drug utilization study for pirinase hayfever relief

Conditions: Rhinitis, Allergic, Seasonal

Summary: the purpose is to obtain real-world information on how consumers are complying with the product labelling this study will coincide with the launch of pirinase hayfever relief for adults 0.05% nasal spray in the united kingdom (uk).


Eligibility criteria:
inclusion criteria: * participants will be required to review, and electronically sign a participation agreement prior to completing the online survey. * participants of any age may participate. * participants who have purchased and used pirinase hayfever relief for adults 0.05% nasal spray for at least 7 days and are willing to participate in the online survey. * participants of either gender may participate exclusion criteria: * anyone who is directly involved with medicines such as doctors, nurses, and pharmacists. * participants who decline participation in the online survey
optimal encephalitis/meningitis roadmap via precise diagnosis and treatment

Conditions: Encephalitis; Meningitis; Meningoencephalitis; Next-Generation Sequencing; Polymerase Chain Reaction

Summary: encephalitis and meningitis are serious central nervous system diseases. there is currently a lack of comprehensive and accurate diagnosis and treatment pathways. therefore, we conducted this multicenter, prospective, and randomized controlled study. it was designed to evaluate the diagnostic performance and its impact on the outcomes of the patients enrolled. as such, we came to the results of the optimal process of diagnosis and treatment strategy of encephalitis/meningeal syndromes with improved effective treatments.


Eligibility criteria:
inclusion criteria: * patients with suspected meningitis : the patient has a new fever (\>38.5℃), accompanied by ≥1 of the following manifestations： 1. stiff neck 2. change in state of consciousness 3. other signs of meningitis: such as meningeal irritation. * patients with suspected encephalitis: unexplained changes in the state of consciousness for more than 24 hours (including lethargy, agitation, personality changes, etc.) or accompanied by recent memory impairment, with the following ≥1 manifestations: 1. fever during the course of the disease (≥ 38℃); (oral temperature) 2. convulsions or focal neurological symptoms; 3. increase in the number of cerebrospinal fluid cells (\>4\*10\^6/l); 4. abnormal eeg that meets the manifestations of encephalitis and cannot be attributed to other reasons 5. imaging suggests encephalitis (ct or mri) * have not received effective anti-infective treatment yet * have an identifiable address and live in the area during treatment. * suspected encephalitis/meningitis patients who are willing to participate in trial treatment and follow-up and can give informed consent (if the subject is illiterate, sign or hearing consent is required). * willing to comply with follow-up research procedures. exclusion criteria: * known breastfeeding or pregnancy * failure to comply with treatment or follow-up time; * the researcher believes that there are any conditions (social or medical) that allow subjects to participate in unsafe; * participating in other clinical studies * insufficient cerebrospinal fluid or blood samples * clinically diagnosed infections, tumors or other neurological diseases
application and effectiveness analysis of internet-based diabetes prevention program

Conditions: Type 2 Diabetes

Summary: this study was conducted to test the possibility of preventing or delaying the development of type 2 diabetes in individuals with impaired glucose tolerance and elevated fasting plasma glucose concentrations by internet-based diabetes prevention program.

diabetes is common and rapidly increasing, because of obesity, unhealthy eating habits, and physical inactivity in korea. many studies reported that lifestyle modification related in the primary prevention of diabetes in multiethnic populations. the aim of this study is to determine whether internet-based interventions in those at high risk may delay the development of type 2 diabetes mellitus, and thereby reduce the incidence of cardiovascular diseases and strokes in korean populations. in january 2008, participant recruitment began in chung-ju city, a rural area in korea. the subjects with impaired glucose tolerance or elevated fasting plasma glucose concentrations were selected from initial screening and then randomized to either a control or intensive lifestyle group to carry out intervention over 4 years. the primary outcome of this study is the development of diabetes by ada criteria. to confirm the onset of diabetes, all subjects have an ogtt at the interim 6-month and each annual visit. also, systematic evaluation examination will be done at the same time. the proportion of subjects developing diabetes in each group and the factors relating the progression will be estimated using statistical analysis.

Eligibility criteria:
inclusion criteria: * age of 30-69 years * bmi ≥ 20 kg/m2 * impaired glucose tolerance : 2h postprandial glucose (75 g ogtt) 140-199 mg/dl or impaired fasting glucose : fasting plasma glucose 110-125 mg/dl exclusion criteria: * diabetes at baseline * cardiovascular disease, cancer requiring treatment in the past 5 years, renal disease * unable to communicate with clinic staff, pregnancy and childbearing

Keywords: diabetes prevention lifestyle modification obesity impaired glucose tolerance diet physical activity
tolerability of the immersive virtual reality system grail in subjects affected by rett syndrome

Conditions: Rett Syndrome

Summary: the main goal of this study is to investigate the tolerability to the use of the grail system in subjects affected by rett syndrome, particularly referred to: 1. grail environment (training in dark conditions, interaction with wide and surrounding screen, positioning over the treadmill); 2. time to prepare a set of body marker in order to execute a gait analysis; 3. walking activity over treadmill, with immersive virtual reality; 4. proprioceptive stimulatione provided by the grail platform; 5. cognitive-attentive span time to the activity proposed. the secondary goal is to understand if a training that avail of treadmill and virtual reality would be useful in the future in improving gait characteristics in subjects affected by rett syndrome


Eligibility criteria:
inclusion criteria: * subjects affected by rett syndrome that are able to walk with hands support (corresponding to a score ranging from 1 to 3 in item 8 of rett syndrome gross motor scale) exclusion criteria: * subjects unable to walk and with a complete incapacity to undestand verbal directions

Keywords: virtual reality rett syndrome walk
trial of vitamin d supplementation in cape town primary schoolchildren

Conditions: Latent Tuberculosis

Summary: the investigators will conduct a n=5,400 phase 3, double-blind, individually randomised placebo-controlled clinical trial of 5 years' duration in primary schools in city of cape town metropolitan municipality, western cape province, republic of south africa. the primary objective of the trial is to determine whether a weekly oral dose of 0.25 mg (10,000 iu) vitamin d3, administered for three years, reduces risk of acquisition of latent tuberculosis infection (ltbi) in cape town primary schoolchildren. statistical analysis will be performed on an intention-to-treat basis to compare acquisition of ltbi in intervention vs. control arms during three-year follow-up. the primary analysis will be logistic regression with presence/absence of ltbi at follow-up as the outcome, adjusted for a random effect of school of attendance.


Eligibility criteria:
inclusion criteria: * pupil enrolled in grades 1-4 of participating primary schools * age 6-11 years at enrolment * pupil gives written informed assent to participate in main trial * pupil's parent / legal guardian gives informed consent for pupil to participate in main trial exclusion criteria: * age ≤5 years or ≥12 years at enrolment * previous positive interferon-gamma release assay (igra) or mantoux test * previous treatment for ltbi or active tb * clinical signs of rickets * history of myalgia on walking * inability to rise unaided from squatting position * taking supplemental vitamin d at a dose \>400 iu daily or equivalent in the previous month * diagnosis of any chronic illness other than asthma * suspected hiv infection in child with parent or legal guardian declining to have child hiv-tested * use of any regular medication other than asthma medication * plans to move away from study area within 3 years of enrolment * unable to swallow one placebo softgel with ease * positive quantiferon-tb gold plus test at screening
clinical study to evaluate the effect of ph on pain upon local anesthetic administration.

Conditions: Local Anesthetics

Summary: when one receives a local anesthetic, such as novocaine for a dental procedure, there is a burning painful sensation experienced upon injection of the local anesthetic. we are trying to understand the role of ph (how acidic a solution is) in the production of pain during local anesthetic administration. we hypothesize that less acidic solutions produce less burning. we also want to determine whether or not the ph of the solution affects the rate of onset of the local anesthesia. we will recruit subjects from patients who have a clinical indication for lumbar medial branch (lmb) nerve blocks, procedures frequently performed at the massachusetts general hospital center for pain medicine. for each patient, three nerve blocks are administered at adjacent spinal levels, typically using either lidocaine or bicarbonate-buffered lidocaine as the local anesthetic. we will add a saline control as part of the research procedure and then provide lidocaine at the control location before continuing with the nerve blocks. this clinical procedure offers an ideal opportunity to compare the effects of the three solutions. there will be almost no deviation from the standard clinical procedure. after the injection of each solution, the pain score on administration of the medication will be recorded immediately. we will also provide a continuous stimulation (pin taps) after the local anesthetic injection and record when the patient experiences hypoesthesia (reduced sensation) and anesthesia (absent sensation). finally, we will record the pain score upon reinsertion of a needle to mark the precise location (part of the clinical procedure) one minute after the local anesthetic injection. all data will be collected during the a single clinical visit. the study will conclude when 60 subjects have successfully been tested. data will be reviewed annually.


Eligibility criteria:
inclusion criteria: * patients at mgh center for pain medicine who have clinical indication for undergoing diagnostic medial branch block of nerves to facet joints. exclusion criteria: * contraindication to the clinical procedure * do not speak english

Keywords: pain ph local anesthetics
clinical evaluation of investigational multifocal toric contact lenses

Conditions: Presbyopia; Astigmatism

Summary: this non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

this non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

Eligibility criteria:
inclusion criteria: * has had a self-reported oculo-visual examination in the last two years. * is aged 40-75 years, inclusive and has full legal capacity to volunteer. * has read and understood the participant information sheet. * is willing and able to follow instructions and maintain the appointment schedule. * is able to participate in parts a and b related to this work. * has a contact lens spherical prescription between +10.00 to -10.00d (inclusive). * has an add component to their spectacle refraction (between +0.75 and +2.50ds). * has astigmatism between -0.75 and -5.75dc (based on the vertexed ocular refraction in each eye. * can be satisfactorily fitted with the study lenses. * is correctable to a visual acuity of 20/40 (0.30 logmar) or better (in each eye) with their habitual vision correction or 20/25 (0.10 logmar) best-corrected. * they have successfully worn soft contact lenses in the last six months * has clear corneas and no active ocular disease. * has not worn lenses for at least 12 hours before the examination. * has an up-to-date pair of spectacles. exclusion criteria: * has never worn contact lenses before. * has any systemic disease affecting ocular health. * is using any systemic or topical medications that will affect ocular health. * has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would, in the opinion of the investigator, affect the wearing of contact lenses. * has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye that would, in the opinion of the investigator, be problematic for their participation in the study. * has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * is aphakic. * has undergone corneal refractive surgery. * has a history of anaphylaxis or severe allergic reaction. * has diabetes or an infectious or immunosuppressive disease which could contraindicate contact lens wear or pose a risk to the investigator. * they are pregnant or breast-feeding. * is participating in any other type of eye-related clinical or research study.
a prospective study for the treatment of severe pulmonary embolism with pharmacodynamic thrombectomy

Conditions: Pulmonary Embolism

Summary: the mortality of severe pulmonary embolisms admitted to the resuscitation department for circulatory failure remains in the range of 30-40% at the acute phase. hemodynamic failure is the leading cause of death. these patients frequently have a contraindication to thrombolysis. surgical pulmonary arterial desobstruction still leads to significant hospital mortality and can't be implemented in all hospitals. concerning advanced hemodynamic support techniques, they can't always reduce mortality on themselves. there is therefore a need for developing alternative approaches for less invasive pulmonary arterial desobstruction. data on the efficacy and safety of percutaneous methods of desobstruction are still too limited to implement them in current practice. angiojet ™ pe is a device ce marked for intra-arterial desobstruction of pulmonary arteries. it has been successfully tested in more than 25 patients with pulmonary embolism in france. before considering a request for reimbursement from the has it is necessary to have propective data of sufficient quality. this phase 2a prospective study is proposed to evaluate the efficacy and safety of the angiojet ™ pe catheter use. the resulting data will allow us to submit a phase 3 controlled study to an upcoming phrc-type project call.


Eligibility criteria:
inclusion criteria: * pulmonary embolism objectively confirmed by thoracic angiotdm * date of onset of pulmonary embolism 14 days prior to inclusion * state of shock * presence of at least 6 mm thrombus in a main or lobar pulmonary artery * contraindication (absolute or relative) or systemic fibrinolysis treatment failure defined by persistence of shock, as defined above, more than 6 hours exclusion criteria: * known cardiac pathologies with right-left cardiac shunt * target pulmonary artery 6 mm in diameter * known heparin allergy or thrombocytopenia * known severe hypersensitivity to iodine contrast products * severe renal failure defined by creatinine clearance 30 ml/min pregnant or lactating patient * patient not affiliated to social security * patient with unhealed lesion due to recent mechanical intervention on the vessel to be treated

Keywords: pulmonary embolism pharmacodynamic thrombectomy endovascular embolectomy
change of fructose to fat in south asians

Conditions: Elevated Triglycerides; Diabetes; Cardiovascular Disease; Dyslipidemia

Summary: the purpose of this study is to determine whether hepatic de novo lipogenesis (dnl) in response to the ingestion of a mixture of glucose and fructose is greater in south asians compared to controls (caucasians).

south asians, who originate from the indian subcontinent and make up one-fifth of the world's population, are among the highest number who suffer from heart disease and diabetes. the results of many research studies suggest that genes play a role in developing heart disease and diabetes that is made worse by the diet in the united states. fructose is a sugar widely used in the american diet, and when consumed, it is taken up by the liver and changed into fats through a process called de novo lipogenesis (dnl). the current study will compare this change into fats in the liver between south asians and caucasians. the participants will be screened on the initial visit, and on the second visit, the dnl response will be measured in the blood over four hours after drinking one sweetened beverage, containing half glucose, half fructose, similar to a soft drink. we expect that dnl in response to fructose intake is higher in south asians when compared to caucasians and may partially explain why south asians have earlier heart disease and diabetes.

Eligibility criteria:
inclusion criteria: * males and females, 18-35 years of age. * south asian or caucasian descent through self-identification (south asians are to have both biological parents with ancestry from india, pakistan, sri lanka, nepal and bangladesh and no known non-south asian ancestry in parents; caucasians are to have both biological parents who self-identify as caucasian and no known non-caucasian ancestry in parents). * body mass index (bmi) 18.0-24.9 kg/m2 with no history of obesity. * fasting glucose \<100 mg/dl, 2h glucose oral glucose tolerance test (ogtt) \< 140 mg/dl. * triglycerides (tg) \ 30 mg/dl, ldl cholesterol (ldl-c) \<160 mg/dl. * willing and able to stop fish oil, fiber supplement, other non-prescribed vitamins/supplements for 1 week prior to visit #2 until completion of study. * willing to not drink alcohol for 24-hours before visit #2. * willing and able to provide informed consent. exclusion criteria: * history of diabetes or other endocrine disorder, hepatitis or other liver disorder, hiv, or autoimmune disease. * medication(s) known to affect lipids, including hormonal contraceptives. * recent acute illness * gastrointestinal disease resulting in significant gastrointestinal dysfunction or malabsorption. * cigarette smoking * history of ethanol abuse (current intake \>2 drinks/day) or illicit drugs. * history of severe psychiatric illness * if female, pregnant or breastfeeding * participation in an investigational drug study within one month of screening. * unusual diet or extreme level of physical activity * have any other condition, which in the opinion of the investigator, should prohibit the participation in the study

Keywords: elevated triglycerides diabetes mellitus dyslipidemia lipid metabolic disorders body weight
study of heart disease and immunity after covid-19 in ireland

Conditions: SARS-CoV Infection; Covid19; Cardiomyopathies

Summary: setanta study will investigate the incidence of cardiac abnormalities as assessed by cardiac magnetic resonance imaging in unselected patients after acute sars-cov-2 infection and correlation with immunological response and biomarkers of coagulation.

approximately 100 participants from primary care will be enrolled via general practitioner (gp) or primary care centers in dublin. a patient information sheet (pis) will be made accessible to participants recovering from covid-19 via their gp practice inviting the participants to contact cardiovascular research institute dublin. the participants, subject to suitability, will be invited for a site visit over two days, where upon explicit consent being granted, the investigators will proceed with data collection. the study population includes participants who are recovering from covid-19 in the community. primary objective to investigate the incidence of cardiac abnormalities as assessed by cardiac magnetic resonance imaging in unselected participants after acute sars-cov-2 infection and correlation with immunological response and biomarkers of coagulation. secondary objectives * to investigate the incidence of sars-cov-2 immunity and * to investigate the extent of coagulopathy persistent after acute sars-cov-2 infection. follow-up data collection points will be at 1, 6- and 12-months including assessment of major adverse cardiovascular events (mace) such as myocardial infarction (mi), revascularization, pulmonary embolism (pe), deep venous thromboembolism (dvt), incident heart failure and stroke. 'patient reported outcome measures' via two quality of life (qol) questionnaires will be administered at baseline and at 6 and 12 months.

Eligibility criteria:
inclusion criteria: 1. patients 18 years or older 2. written informed consent 3. recent covid-19 infection ≥ 6 weeks and ≤ 12 months before enrolment, as evidenced by positive reverse-transcriptase polymerase chain reaction (rt-pcr) sars-cov-2 swab exclusion criteria: 1. prior history of myocarditis or ischemic heart disease 2. general contraindications for magnetic resonance imaging e.g. magnetic resonance unsafe pacemaker, devices, implants etc. 3. contraindication to gadolinium (estimated glomerular filtration rate \<30 ml/min) 4. contraindication to regadenoson, including cardiac conduction disease, asthma, seizures, pregnancy or breast-feeding 5. inability to provide written informed consent, to fill out the safety questionnaire, or to fully cooperate with the scan and breath holds 6. insufficient cardiac magnetic resonance image quality

Keywords: cardiac magnetic resonance imaging covid19 cardiomyopathy
a commercial available tooth positioner for the treatment of simple orthodontic relapse

Conditions: Orthodontics; Orthodontic Appliance

Summary: orthodontic relapse occurs in almost 80% of orthodontic treatment. the only prevention to phenomenon is the use of fixed retainers or life time active retention. unfortunately, patients do not comply and after a year of treatment, many stop wearing their retainers and orthodontic relapse occurs. the aim of this project is to prospectively analyze the treatment result of consecutive treated patients who have had active orthodontic relapse. 20 patients will be recruited through advertisement to the department of orthodontics at the university of alabama at birmingham (uab). the sample will comprise of 20 patients with class i malocclusions. the records to be collected will comprise of clinical pictures and pre and post study casts. the 3d study casts will be evaluated using the little's index. the results will be analyzed with the paired t-test and anova, using the statistical analysis system (sas/stat®) software.


Eligibility criteria:
inclusion criteria: 1. permanent dentition 2. class i malocclusion with crowding or spacing of less than 6 mm for mandibular or maxillary incisors, lower number 1's through 3's 3. predicted compliance with device use, as determined by the investigator orthodontist 4. good oral hygiene, as determined by the investigator orthodontist 5. at least average intelligence, as determined by investigator orthodontist exclusion criteria: 1. any medical or dental condition that in the opinion of the investigator could impact study results during the expected length of the study 2. patient is currently using any investigational drug or any other investigational device 3. patient plans to relocate or move within six months of enrollment 4. allergic to acetaminophen (use of aspirin or non-steroidal anti-inflammatory drugs is excluded for patients while on the study) 5. use of bisphosphonates, such as osteoporosis drugs, during the study 6. pregnancy