Kornimate/medical-research-clean huggingface dataset:
comparison of metformin, repaglinide or the combination of both in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to compare the efficacy of metformin and repaglinide used alone or combined administered as initial treatment in subjects with type 2 diabetes in which diet and exercise have failed.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes * treated by diet for at least 3 months * never treated with hypoglycaemic drugs * hba1c (glycaemic haemoglobin a1c) on inclusion time superior to 6.5% exclusion criteria: * very symptomatic diabetes * advanced vascular complications * manifest renal failure * manifest hepatic disease * pregnancy, breast feeding or intention to become pregnant or if it is considered that the patient is not using adequate contraceptive measures. adequate contraceptive measures are considered to be an intrauterine device, oral contraceptives and barrier methods
a study of ibuprofen (ibu) 250mg/apap 500mg in the treatment of post-surgical dental pain

Conditions: Pain

Summary: this study is being conducted to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in subjects who are experiencing post operative pain following surgical extraction of 3 or more third molar teeth. a review of any reported adverse events will also be completed.


Eligibility criteria:
inclusion criteria 1. males and females 18 years to 40 years of age (inclusive). 2. outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction. 3. subject must have at least moderate pain on the 4 point categorical scale, confirmed by at least 50 mm on the 100 mm vas psr scale within approximately 5 hours (ie, less than or equal to 5 hours, 15 minutes) after surgery is completed. 4. in general good health and have no contraindications to the study or rescue medication. exclusion criteria 1. presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder determined by the investigator to place the subject at increased risk, including the presence or history within 2 years of screening of the following medical conditions/disorders: * gastrointestinal ulcer or gastrointestinal bleeding; * paralytic ileus or other gastrointestinal obstructive disorders; * bleeding disorder. 2. hypersensitivity to ibuprofen, naproxen, aspirin, or any other nsaid; or to apap, tramadol, other opioids, or to their combinations. 3. prior use of any type of analgesic or nsaid within five half lives of that drug or less before taking the first dose of investigational product, except for pre anesthetic medication and anesthesia for the procedure. .

Keywords: ibuprofen, acetaminophen, pain, molar extraction
mitochondrial diseases - long-read genome and transcriptome sequencing in cases unresolved after short-read genomics

Conditions: Rare Diseases; Genetic Predisposition

Summary: the midiseq project will enroll 20 unresolved index patients with suspected mitochondrial disease prioritized for genomic analysis.

in the midiseq (monocentric, prospective, open-label diagnostic) project, patients with suspected mitochondrial disease prioritized for i) high a priori probability for a genetic basis (e.g. positive family history) as well as availability of (ii) fibroblast cell lines with a biochemically defined phenotype, (iii) parental samples, (iv) short read whole genome and transcriptome datasets and (v) optional additional metabolomics and proteomics data. the following questions will be leading the project: i) to systematically benchmark different sequencing technologies to detect genetic and epigenetic variation and their impact on gene regulation. (ii) to further develop algorithms for integrative analyses of different 'omics datasets. (iii) to expand the analysis from coding single-nucleotide variants (snvs) and regulatory mutations to structural variants (svs), repeat expansions and contractions, low complexity regions and epigenetic signatures. (iv) to identify novel alterations and disease mechanisms. (v) to gain fundamental new insights into disease mechanisms and cellular biology. (vi) to improve genetic diagnostics of future rare disease patients and to evaluate personalized therapeutic options.

Eligibility criteria:
inclusion criteria: unclear diagnosis suspected genetic cause of the disease exclusion criteria: missing informed consent of the patient/ legal guardian

Keywords: rare diseases genetic predisposition epigenetic variation omics genetic variation mitochondrial disease next generation sequencing (ngs)
real-life effectiveness and cost-effectiveness of qvar versus fp and bdp in the management of copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the objective of this study is to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing chronic obstructive pulmonary disease (copd) in primary care patients with evidence of copd who either initiate inhaled corticosteroid (ics) therapy, or have an increase in their ics dose, as hydrofluoroalkane (hfa) beclometasone dipropionate (bdp) (hereafter qvar®), cfc-bdp (hereafter bdp) and fluticasone propionate (fp) via pressurised metered-dose inhalers.

current asthma guidelines in the uk are underpinned by evidence derived from randomised controlled trials (rcts). although rct data are considered the gold standard, patients recruited to asthma rcts are estimated to represent less than 10% of the uk's asthma population. the poor representation of the asthma population is due to a number of factors, such as tightly-controlled inclusion criteria for rcts. there is, therefore, a need for more representative rcts and real-life observational studies to inform existing guidelines and help optimise asthma outcomes. short randomised trials have shown that qvar is at least as effective as fp pmdi and as bdp pmdi at half the prescribed dose in patients with asthma. there is also evidence to suggest that, in adults, hfa formulation as used by qvar (featuring bdp in solution rather than suspension) may achieve 10-fold higher deposition compared with cfc-bdp.4 furthermore, deposition in the peripheral regions is higher compared with cfc-bdp and the fine-particle formulation also offers greater tolerance of poor co-ordination of breathing and inhaler actuation, resulting in lower oro-pharyngeal deposition compared with cfc-bdp. evidence of the efficacy of ics monotherapy in copd remains mixed at this time. while qvar and ics monotherapy use in the treatment of copd is currently off-label, it occurs in clinical practice in two common scenarios: 1. before a diagnosis of copd is made 2. unlicensed use as monotherapy, or in combination with long-acting bronchodilators the study hypothesis, therefore, is that qvar treatment in copd may be associated with improved disease management and control (as assessed by effectiveness, cost-effectiveness and direct healthcare costs of managing copd) compared with other commonly used ics therapies, namely bpd and fp, by virtue of its improved deposition throughout the lungs and the small airways.

Eligibility criteria:
inclusion criteria: * aged ≥40 years at index prescription date * copd diagnosis: * diagnostic code, and * ≥2 prescriptions for copd therapy in baseline year (at different points in time) * for the ics increase cohort (i.e. ipda) ≥1 of these prescriptions must be for ics therapy. * commence ics therapy at any time (even if before copd diagnosis is made) exclusion criteria: - a diagnostic read code for any other chronic respiratory disease (except asthma)

Keywords: chronic obstructive pulmonary disease inhaled corticosteroid increase initiate exacerbations treatment success
bioequivalency study of letrozole 2.5 mg tablets under fasted conditions

Conditions: Breast Cancer

Summary: the objective of this study was to prove the bioequivalence of letrozole tablet under fasted conditions.


Eligibility criteria:
inclusion criteria: - no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to letrozole or any comparable or similar product.
durvalumab long-term safety and efficacy study

Conditions: Solid Tumor

Summary: the aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (os) information.

this is a multicenter, open-label, global study that will enroll patients who are currently receiving durvalumab monotherapy, or have previously received durvalumab as monotherapy or in combination with any other approved or investigational anticancer agents, in an eligible astrazeneca/medimmune-sponsored clinical study.

Eligibility criteria:
inclusion criteria: 1. patient must be 18 years or older, at the time of signing the icf. for subjects aged \< 20 years and enrolled in japan, a written icf should be obtained from the subject and his or her legally acceptable representative. 2. patient received durvalumab monotherapy and/or durvalumab containing combination in an astrazeneca/medimmune-sponsored parent clinical study that is approved for enrollment into this study. 3. patients who received durvalumab in combination with any other approved or investigational anticancer agents in the parent clinical study must have completed or discontinued all other anticancer therapy (beyond durvalumab regimen). 4. patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures. exclusion criteria: the following exclusion criteria apply only to patients receiving treatment or retreatment: 1. currently receiving treatment in another interventional study other than the parent clinical study or, for retreatment patients, received treatment during the follow up period with an agent other than durvalumab 2. any concurrent chemotherapy, ip, biologic or hormonal therapy for cancer treatment 3. experienced an immune-mediated or non-immune-mediated toxicity that led to permanent discontinuation of durvalumab in parent clinical study 4. diagnosis of a new primary malignancy since enrollment into the parent clinical study

Keywords: non-small cell lung cancer (nsclc) urothelial cancer durvalumab long-term safety, efficacy overall survival immunotherapy checkpoint inhibitor pd-l1 retreatment gastric adenocarcinoma
baker gordon syndrome natural history study

Conditions: Rare Diseases; Autism or Autistic Traits; Development Delay; SYT-SSX Fusion Protein Expression; Sleep Disorder; Epilepsy, Generalized; Motor Delay

Summary: the goal of this study is to conduct a prospective, longitudinal assessment of the natural clinical progression of children and adults with synaptotagmin1-associated neurodevelopmental disorder also known as baker gordon syndrome (bagos). this will be performed by acquiring baseline measurements and developing effective outcome measures and diagnostic tools for the disorder, to prepare the healthcare system for future clinical trials.

the current natural history study is being conducted in anticipation of future treatments for patients with confirmed bagos. the study is an important avenue of investigation that will increase the understanding of the disorder and lead to important diagnostic and therapeutic advances. its purpose is to identify demographic, genetic, environmental, and treatment modalities and concomitant medications that correlate with the disease's development and outcomes. this study will use standard scales and questionnaires for the assessment of global development, language, memory, and motor function, and by collecting sleep and seizure diaries. a small blood sample will be collected for whole genome sequencing and proteomic analysis. brain imaging (mri) and electroencephalography (eeg) recordings will be collected to identify disease biomarkers. the investigators will also be asking participants to provide a small skin sample for the development of patient specific stem cells which will be used to further understand the impact of synaptotagmin1 mutations on neurodevelopment and as a potential screen for future therapies.

Eligibility criteria:
inclusion criteria: * genetically confirmed diagnosis of baker gordon syndrome. * 0-99 years * ability to send medical records and diagnostic test results. * ability to complete tests and questionnaires. exclusion criteria: • the presence of another condition or co-morbidity unrelated to baker gordon syndrome, that affects neurodevelopment. in this study, the primary caregivers/lar for each participant diagnosed baker gordon syndrome will be also considered participants. caregivers/lar will have to meet the following inclusion criteria: * \>18 years. * legal caregiver of the patient diagnosed with a baker gordon syndrome. * willingness to follow study procedures, as assessed by the research team. * willingness to sign the consent form. * ability to understand all the information regarding the study, as assessed by the research team. caregivers/lar exclusion criteria: • less than 18 years old.

Keywords: baker gordon syndrome bagos synaptotagmin 1-associated neurodevelopmental disorder
study to show that the combined hepatitis a and b vaccine is non-inferior to monovalent vaccines in adults

Conditions: Hepatitis B; Hepatitis A

Summary: this protocol posting describes the booster phase of the study. the objectives \& outcome measures of the primary phase are presented in a separate protocol posting (nct number = nct00289731).

all subjects will receive a dose of the vaccine that they received in the primary study (100382), approximately 4 years after the first dose. blood samples will be taken before and after the administration of the vaccine dose to evaluate the anti-hav and anti-hbs antibody response.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol. * a male or female who completed the primary vaccination phase of the study. * written informed consent obtained from the subject. * if the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. exclusion criteria: * use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * history of any hepatitis a or hepatitis b vaccination or infection, since the primary vaccination study. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrolment. * pregnant or lactating female.

Keywords: combined hepatitis a and b vaccine risk factors
a randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of nnc0114-0006 in subjects with active crohn's disease

Conditions: Inflammation; Crohn's Disease

Summary: this trial is conducted in europe and the united states of america (usa). the aim of the trial is to assess clinical efficacy and safety of nnc0114-0006 in subjects with active crohn's disease.


Eligibility criteria:
inclusion criteria: * moderately to severely active crohn's disease, defined as a crohn's disease activity index (cdai) of 220-450 (both inclusive) at visit 2 (day 0, dosing), with evidence of inflammation confirmed by a c-reactive protein (crp) above or equal to 10 mg/l or endoscopic verification (according to endoscopy imaging manual) performed at visit 1 (day -28 to -7, screening) * biologic-naïve subjects or biologic-experienced for the treatment of crohn's disease. biologic-experienced subjects are eligible if they have not failed more than one marketed biologic therapy for the treatment of crohn's disease due to lack of efficacy (primary or secondary efficacy failures) exclusion criteria: * body mass index (bmi) equal to or above 38.0 kg/m\^2 * any of the following: symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation, total colectomy or subtotal colectomy with less than 20 cm colon remaining, any abscesses not adequately treated * history of dysplasia in the colon * any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy * any history of serious recurrent infections requiring hospitalisation
study of inv-102 ophthalmic solution in adults with moderate symptomatic dry eye disease

Conditions: Dry Eye Disease

Summary: phase 1/2, first-in-human, 2-part study to assess topically administered eyedrops of inv-102 during 2-week repeat dosing in subjects with moderate symptomatic dry eye disease. part 1 will be a dose escalation phase across 4 cohorts of subjects to assess safety and tolerability of inv-102, and part 2 will be an optional dose expansion phase in a fifth cohort of subjects, pending the outcome of part 1, to assess efficacy of inv-102 in the treatment of moderate symptomatic dry eye disease.


Eligibility criteria:
key inclusion criteria: * healthy male or female subject ≥18 years of age * presence of moderate ded in at least one eye key exclusion criteria: * presently using prescription eyedrops, except those used for ded, which must be discontinued 2 weeks prior * use of otc eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing * external eye disease except primary ded * systemic disease associated with ded * history or evidence of ocular infection within the previous 30 days * history or evidence of ocular herpes simplex or ocular herpes zoster * blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months

Keywords: dry eye keratoconjunctivitis sicca
age-related macular degeneration (amd) in the vitamin d and omega-3 trial (vital)

Conditions: Age-related Macular Degeneration

Summary: the vitamin d and omega-3 trial (vital; nct 01169259) is a randomized clinical trial in 25,875 u.s. men and women investigating whether taking daily dietary supplements of vitamin d3 (2000 iu) or omega-3 fatty acids (omacor fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. this ancillary study is being conducted among participants in vital and will examine whether vitamin d or omega-3 fatty acids, compared to placebo, reduce the incidence and/or progression of age-related macular degeneration (amd).

this ancillary study to the vitamin d and omega-3 trial (vital) will examine whether vitamin d3 and omega-3 fatty acids can help prevent the onset or progression of age-related macular degeneration (amd). the study will also examine whether vitamin d3 and omega-3 fatty acids interact with each other, or with specific genes associated with amd or vitamin d3 or omega-3 fatty acid metabolic activity, to affect the risk of developing amd.

Eligibility criteria:
inclusion criteria: * all participants in vital (nct 01169259) are eligible to participate in this ancillary study. exclusion criteria: * none

Keywords: age-related macular degeneration incidence progression
applying num vapocoolant spray to cervix before paracervical block to decrease pain during gynecology procedures

Conditions: Pain With Paracervical Block; Pain With Gynecology Procedure; Pain

Summary: the purpose of this study is to assess if num vapocoolant spray decreases pain associated with paracervical block in gynecology procedures.

after patients seen in our clinic have decided to proceed with a gynecology procedure that requires a paracervical block, the doctor will evaluate if the patient meets eligibility criteria for this study. if the patient does meet eligibility criteria, the doctor will inform the patient about the study and the potential risks. all patients will be given written informed consent. if the patient decides to participate in the study, they will be randomized (patient blinded) to receive either num vapocoolant spray or placebo (normal saline spray), which the patient will receive during their gynecologic procedure just before the paracervical block. the purpose of this study is to see if the num vapocoolant spray decreases patients pain with the paracervical block.

Eligibility criteria:
inclusion criteria: * age 18 years of age or older undergoing a procedure requiring paracervical block english-speaking able and willing to sign the informed consent form and agree to terms of the study exclusion criteria: * required or requested narcotics, anxiolytics, iv sedation, or general anesthesia for the procedure declines or has a contraindication/allergy to ibuprofen previously received vapocoolant spray in a medical setting contraindications or allergies to lidocaine for paracervical block or vapocoolant spray components (1,1,3,3-pentafluoropropaine or 1,1,1,2-tetrafluroethane)

Keywords: pain with paracervical block pain with gynecology procedure num vapocoolant spray vapocoolant spray vapocoolant
validation of claritydx prostate as a reflex test to refine the prediction of clinically-significant prostate cancer

Conditions: Prostate Cancer

Summary: this study is designed to determine the accuracy of blood test claritydx prostate to predict the results of prostate biopsies in men who have psa (prostate specific antigen) greater or equal to 3 ng/ml.

the main objective of this study is to validate claritydx prostate as a reflex test to psa to refine the prediction of clinically-significant prostate cancer in a prospective cohort of men to be recruited in north america when they are scheduled for a biopsy as a result of on an elevated psa or other suspicion of prostate cancer and in retrospective databases from selected sites in the united states of america and the world. this prospective training and validation cohort study will consist of up to 2,800 consenting men from alberta in addition to up to 5,000 men from external institutions, between ages 40-75 (inclusive) years old, without prior diagnosis of prostate cancer, who have been selected to undergo a prostate biopsy to rule out prostate cancer.

Eligibility criteria:
inclusion criteria: 1. males between 40-75 (inclusive) years of age; 2. with and without family history of prostate cancer; 3. no prior prostate cancer diagnosis and who are referred to have a prostate biopsy; 4. total psa results \>/= 3ng/ml collected within 6m of enrollment; 5. willing to permit provincial agencies (e.g. alberta health services, alberta health, netcare, service alberta or other based on recruitment jurisdiction) to disclose health-related information to study; 6. undergoing a diagnostic prostate biopsy; and 7. provided informed consent to participate in the study. exclusion criteria: 1. unwilling to participate in the study; 2. unavailable for biopsy procedure in recruitment areas; 3. not undergoing a prostate biopsy; 4. prior diagnosis of cancer excluding non-melanoma skin cancer; and/or 5. under the age of 40 years of age or over the age of 75 years of age.

Keywords: claritydx prostate diagnosis reflex test