Kornimate/medical-research-clean huggingface dataset:
"true incidence of hip dislocation after primary tha - a nationwide population study"

Conditions: Hip Dislocation

Summary: the primary objective is to report the true incidence of hip dislocations in primary tha patients within 2 years of index surgery. secondary, patient and component characteristics (age, sex, comorbidity, cemented/uncemented, approach, head diameter) are analyzed as potential risk factors for dislocation. specific components may be analyzed based on number.

based on published literature and personal experience, most hip surgeons have an assumption of the degree of hip dislocation. this will be the first study to reveal the actual extent of this specific complication in a large population. it will give surgeons knowledge of the current standards -both on a national and hospital level. depending on the results and comparisons to relevant countries, the investigators will be able to either substantiate or forced to rethink current procedures. this applies to both surgical access and use of specific components. since the vast majority of dislocations appear within 1-2 years after primary surgery (29), the follow-up period will be 2 years. by applying the national patient registry the investigators are able to identify any type of patient contact with the hospital system throughout denmark in these 2 years. patients assigned with correct diagnostic and procedural codes for dislocation and reduction are identified. however, the investigators will also find the cases of dislocation that are incorrectly coded in the registry. therefore, the investigators will manually look in all the patient files from orthopedic contacts regardless of assigned diagnostic and procedural codes. additionally, emergency room and internal medicine contacts are scanned with a broad and comprehensive range of relevant hip- and dislocation-related codes to identify episodes of hip dislocation, which are incorrectly coded. these patient files will also be manually reviewed. if a patient is revised within the first 2 years, the follow-up period ends on the revision date. revisions are also registered in the danish hip arthroplasty registry. however, the completeness is 93-95% and therefore lower than for primary operations. in order to have the complete set of revisions, the investigators will enrich our data with an extraction from the national patient registry by applying all approved hip revision codes

Eligibility criteria:
inclusion criteria: * patients with the diagnosis "primary/idiopathic hip oa and inserted tha from 01.01.2010 - 31.12.2014. exclusion criteria: * patients receiving a resurfacing hip arthroplasty and hip revisions * patients with incomplete registry data * patients with previous hip surgery
vaccination with comirnaty in subjects with a vaxzevria first dose

Conditions: Covid19

Summary: combivacs is a phase 2 randomized, adaptive trial developed to evaluate the immunogenicity of a dose of comirnaty after a previous single dose of vaxzevria. a stratification will be made based on the following factors: study site, sex and age. this protocol allows to test the immunogenicity and safety of a heterologous vaccination strategy after a previous single dose of vaxzevria.

this is a randomized, non-blinded, controlled, adaptive, multicenter, phase ii study in subjects aged ≥18 years and in good health or stable clinical situation that have received a previous single dose of vaxzevria. subjects will be randomized to immediately receive or not a dose of comirnaty in a ratio of 2:1. if primary analysis at day 14th confirms the starting hypothesis, subjects randomized to no vaccination will be considered for administration of one dose of cominarty at day 28th according to public health department of the ministry of health recommendations on heterologous vaccination. in case the primary analysis does not confirm the starting hypothesis, subjects will be followed at the time points defined in the flow-chart without administration of comirnaty. other heterologous vaccination strategies could be incorporated if deemed necessary for public health reasons. this could include the use of different vaccination strategies including those already marketed vaccines for comparative assessment of their safety and efficacy on sars-cov-2 and its variants.

Eligibility criteria:
inclusion criteria: * adult subjects (18 years old) having received a prime vaxzevria vaccination between 8 and 12 weeks before the screening visit * participants must provide consent indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study. * subjects in good health or stable clinical situation. * participant is willing and able to adhere to the procedures specified in this protocol. exclusion criteria: * participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºc within 24 hours prior to the planned dose of study vaccine. * participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to comirnaty excipients. * subjects with any contraindication to the administration of comirnaty, included pregnancy. * subjects with prior documented covid19 since vaxzevria vaccination. * subjects have symptoms or signs compatible with covid19. * subjects participating in a clinical trial in the last three months. * any condition or situation precluding or interfering the compliance with the protocol.

Keywords: heterologous vaccination
validation of a boindicator as monitoring tool for oyster norovirus outbreak

Conditions: Gastroenteritis Norovirus

Summary: noroviruses are responsible for 700m of annual cases of gastroenteritis, of which 15m are directly related to the consumption of contaminated food, including oysters. current regulations do not require control of human noroviruses in shellfish. however, an iso standard recommended to detect their genome in high-risk foodstuffs. however, presence of viral genome doesn't testify to the presence of infectious particles. routine application of this standard would therefore wrongly lead to the withdrawal of shellfish from market, since norovirus genomes are widely found in the environment and in food without indicating a viral risk. given the difficulty of cultivating human noroviruses in vitro and thus of discriminating infectious particles from non-infectious particles only based on genome detection, it is necessary to identify an indicator of the infectious nature of these pathogenic viruses. to be suitable, the indicator must first be associated with the presence of norovirus genome in the environment. this is the case of fecal bacteriophage f-specific rna. since bacteriophages are cultivable in the laboratory, it is easy to estimate the proportion of genomes of these bacteriophages corresponding to infectious particles. to confirm this indicator, it is necessary to demonstrate a relationship between the presence of infectious bacteriophages with that of infectious norovirus. this is only estimable by the occurrence of a gastroenteritis after consumption of a contaminated food by humans. we propose this randomized controlled clinical trial to evaluate the incidence of norovirus infection after consumption of oysters free from or containing infectious f-specific rna bacteriophages. the purpose of this study is to evaluate if norovirus infections incidence is significantly weak after the consumption of oysters free of f-specific infectious rna bacteriophages, compared to the consumption of oysters containing these same infectious bacteriophages.


Eligibility criteria:
inclusion criteria: * informed consent signed * health status * no seafood allergy * nancy city residents exclusion criteria: * recent gastroenteritis (\<6 months) * fragile health person proximity * oysters consumption during the study * pregnancy or breastfeeding * "nonsecretor" phenotype
canakinumab in patients with active hyper-igd syndrome

Conditions: Mevalonate Kinase Deficiency

Summary: this pilot study is designed to evaluate the efficacy, the safety, and the pharmacokinetics (pk) / pharmacodynamics (pd) of canakinumab treatment in patients with hids.


Eligibility criteria:
inclusion criteria: 1. patients with a diagnosis of hids proven by dna analysis and/or enzymatic studies. 2. at time of start of drug treatment: active hids as evidenced by a physician global assessment of hids flare severity ≥ 2 and crp values \>10 mg/l (normal crp \< or = 10 mg/l). 3. patients who have a history of \> or = 3 febrile acute hids flares in a 6-month period when not receiving prophylaxis treatment (e.g. anakinra daily treatment) with a duration of each flare lasting \> or = 4 days and limiting the normal daily activities. exclusion criteria: 1. pregnant or nursing (lactating) women. 2. history of being immunocompromised, including a positive hiv at screening (elisa and western blot) test result. 3. positive hepatitis b or hepatitis c. 4. live vaccinations within 3 months prior to the start of the trial 5. positive tuberculosis screening test. other protocol-defined inclusion/exclusion criteria may apply

Keywords: hyper igd syndrome canakinumab hids mevalonate kinase deficiency mkd
korean registry of target organ damages in hypertension

Conditions: Hypertension

Summary: the objective of this study is to know prevalence of clinical or subclinical target organ damages in korea hypertensives by constructing nationwide hypertension registry. we will register 5000 consecutive patients with incident hypertension at 20 major university hospitals in south korea. we will investigate clinical/subclinical target organ damages, renin/aldosterone level and cardiovascular events in each patient.

background: the exact prevalence of target organ damages in korean hypertensives are unknown. study objective: to investigate the prevalence of target organ damages in korean patients with incident hypertension. study design: prospective, multi-center and observational study study populaton: approximately 5000 consecutive patients with incident hypertension, who visited outpatients clinics and agreed to participate in the registry primary outcome * subclinical organ damages 1. left ventricular hypertrophy on electrocardiogram or echocardiography 2. increased intima media thickness of carotid artery (\> 0.9 mm) or plaque 3. increased pulse wave velocity (\> 12 m/s) 4. low estimated glomerular filtration rate (\< 60 ml/min/1.73 m2) or creatinine clearance (\<60 ml/min) * established cv or renal disease 1. cerebrovascular disease: ischemic stroke; cerebral stroke; transient ischemic attack 2. heart disease: myocardial infarction; angina; coronary revascularization; heart failure 3. renal disease: diabetic retinopathy; serum creatinine m \> 133, w \> 124 mmol/l; proteinuria \> 300 mg/24 hr 4. peripheral artery disease 5. advanced retinopathy: hemorrhage or exudates, papilledema

Eligibility criteria:
inclusion criteria: * age≧30years * primary incident hypertension * singed informed consent exclusion criteria: * participated in other clinical trials

Keywords: target organ damage incident hypertension cohort
epidemiologic study of kras mutation in brazilian patients with advanced or metastatic non small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to characterize the demographic and clinical aspects, and describe the frequency and type of kras mutation in a brazilian population sample with advanced non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of locally advanced or metastatic non small cell lung cancer (iiib-iv) * tumour sample (block of slides) available for kras analysis exclusion criteria: * confirmation of locally advanced or metastatic nsclc (iiib-iv) exclusively by cytology, with no tumour sample access. * previous treatment using a mek inhibitor or any other regimen containing docetaxel (previous treatment with paclitaxel is accepted)

Keywords: the frequency and type of kras mutation in a sample of the brazilian population with advanced nsclc kras mutation in population with advanced nsclc
evaluation of the effect of virtual reality glasses

Conditions: Anxiety; Cancer; Chemotherapy; Virtual Reality; Treatment Compliance

Summary: the study was planned as a randomized controlled study to evaluate the effect of virtual reality glasses used on anxiety and treatment compliance in outpatient cancer patients receiving chemotherapy. the sample of the study consisted of a total of 30 patients, including 15 experimental and 15 control groups, who received intravenous chemotherapy treatment every 21 days between april 1 and september 31, 2023, in the outpatient chemotherapy unit of a research hospital. research data will be collected using the patient information form, beck anxiety scale (bai) and chronic disease adaptation scale (ccds). in evaluating the data, it was planned to analyze the differences between the rates of categorical variables in independent groups with chi-square tests. it was planned to use t tests to compare quantitative continuous data between two independent groups. dependent groups t-test will be used to compare measurements within groups. after being informed about the research, patients in both groups will be given a pre-test. patients in the experimental group will be shown 3 different videos with virtual reality glasses during 3 cycles of chemotherapy treatment, and a final test will be administered to both groups at the end of the 3rd cycle..


Eligibility criteria:
inclusion criteria: * being over 18 years old * knowing turkish, agreeing to participate in the research * being diagnosed with cancer, regardless of the type of cancer * starting an intravenous chemotherapy treatment regimen after diagnosis * those who receive their treatment in 21-day periods to ensure equality in application frequencies. * able to use virtual reality glasses * people without hearing or visual impairment are included exclusion criteria: * anyone with any visual or hearing impairment * the patient does not know the diagnosis of cancer, has been diagnosed with cancer but has not received treatment or has completed the cure. * those with brain tumor or brain metastasis are not included.
effect of insulin detemir and insulin glargine on blood glucose control in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia, south america and the united states of america (usa). the aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (oad).


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes for at least 6 months * stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other oad (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (dpp-4) inhibitors) for at least 3 months * subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed) * hba1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed) * body mass index (bmi) less than or equal to 35.0 kg/m\^2 exclusion criteria: * any contraindication to insulin detemir or insulin glargine according to the local labelling * receipt of any investigational product within 4 weeks * anticipated change of dose of any systemic treatment with products, which in the investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids) * clinically significant diseases which, in the investigator's opinion may confound the results of the trial or pose additional risk in administering trial product * any other condition that the investigator feels would interfere with trial participation or evaluation of results
effect of a pre-operative internet-based educational video on post operative opioid consumption

Conditions: Patient Empowerment

Summary: one of the most challenging issues in modern medicine is the current opioid epidemic. given the association between opioid use after surgery and the development of opioid addiction, an essential goal of the medical community should be to develop strategies aimed at instructing the safe use of opioids. in addition, instructions on how to use non-opioid painkillers and exercises and techniques to better cope with pain can be used to reduce the patients opioid requirements after surgery. this study aims to evaluate the effect of providing an online educational video presentation to patients prior to surgery. this will be a 30 minute video which will provide the study participants with instructions on how best to use their opioid and non-opioid medication for pain and also teach the study participants exercises and techniques to better cope with their pain. this intervention will be used with a view to reduce the amount of opioids used by patients following hip or knee replacement surgery. participants will be followed during their immediate phase after surgery to determine how much pain killers the participants have used and at six weeks the participants will be asked to return their unused opioids to see how much the participants have used in total.


Eligibility criteria:
inclusion criteria: * patients must be adults (\> 18 years of age) undergoing knee or hip arthroplasty. * patients will be asa 1-3 undergoing elective surgery. * english speaking patients with internet and computer access at home will be included. * patients with pre-existing psychological conditions who receive either pharmaceutical or talk-based therapy will be included. * patients must meet a minimum cognitive capacity to understand the instructions for the opioid counseling and pain coping skills presentation. this will be assessed by the administration of the montreal cognitive assessment during screening (moca), whereby a minimum score of 18 will be required to meet inclusion into the study. exclusion criteria: * significant cognitive impairment. * chronic pain, long-term opioid therapy * renal replacement therapy * standing opioid requirements * neuropathic pain * fractures requiring emergency surgery * end stage cardiac or respiratory disease * severe hepatic dysfunction, * patients with severe psychiatric disorders * vision loss * allergy to local anesthesia. * patients who refuse to consent to neuraxial anesthesia and/or peripheral nerve blocks will also be excluded.
aromatherapy using a nasal clip after surgery

Conditions: Post-operative Nausea

Summary: the purpose of this follow up study is to determine the duration of action regarding aromatherapy to treat nausea occurring postoperatively.

the primary hypothesis of the study is that post-operative patients who meet eligibility criteria and report nausea and receive a blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils while using a nasal clip to facilitate inhalation will have more relief from nausea than those who receive normal saline inhalation using the same delivery system. the secondary purposes of the study is to determine the duration of effectiveness of the essential oil blend as compared to the saline in the relief of post-operative nausea and to investigate the degree of comfort participants report using the nasal clip delivery system for aromatherapy.

Eligibility criteria:
inclusion criteria: * 18 years or over * cognitively able to give consent based on nurse's assessment, * having gynecological or other abdominal surgery * not allergic to peppermint, spearmint, cardamom or ginger * not receiving blood thinning medications exclusion criteria: * less than 18 years old * unable to cognitively give consent * allergic to ginger, peppermint, cardamom or spearmint. * receiving warfarin (coumadin) or any antiplatelet drug (heparin, 325 mg aspirin, clopidogrel (plavix) or other) or a diagnosis of bleeding diatheses (predisposition to abnormal blood clotting/hemorrhage) will not be included in this study. * all surgeries other than gynecological or abdominal surgery

Keywords: nausea post-operative
long-term follow-up of transplanted human central nervous system stem cells (hucns-sc) in spinal cord trauma subjects

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to determine the long term safety and preliminary efficacy of intramedullary transplantation of hucns-sc cells in subjects with thoracic spinal cord trauma.

the investigation is a multi-year observational study following the completion of the open-label, single dose phase i/ii study involving transplantation of allogeneic hucns-sc cells into 12 subjects with thoracic spinal cord injury. subjects will be monitored at routine intervals for safety and preliminary efficacy for four years. the ltfu study will commence following the one year post-transplantation termination visit of the phase i/ii investigation.

Eligibility criteria:
inclusion criteria: * must have undergone hucns-sc transplantation as a subject in the phase i/ii trial * must agree to comply in good faith with all conditions of the study and to attend all required study visits exclusion criteria: * subjects have received or are receiving off-protocol immunosuppressive medications * subjects who, after completion of phase i/ii trial (protocol # cl-n02-sc), have entered or are about to enter any other investigational study.

Keywords: spinal cord injury hucns-sc cells human neural stem cells neural stem cells stem cells
measurement of the free fraction of 25-hydroxyvitamin d in serum

Conditions: Impaired Glucose Tolerance

Summary: in the circulation 25-hydroxyvitamind (25(oh)d) is bound to the vitamin d binding protein (dbp) and albumin. according to the free hormone hypothesis, it is, however, the free fraction that is biologically active. polymorphisms in dbp are related to the serum level of 25(oh)d. as these polymorphisms may also affect the binding affinities for 25(oh)d, the total serum 25(oh)d may not necessary reflect the free fraction. to test this hypothesis, we will calculate the free fraction of 25(oh)d by correction for dbp and albumin content, and also measure free 25(oh)d from equilibrium dialysis and ultra filtration. furthermore, we will relate total serum 25(oh)d as well as the free and biologically active (free- albumin-bound) 25(oh)d to the well established vitamin d effect marker serum parathyroid hormone as well as to the rna expression in peripheral blood to evaluate the biological importance of the free versus the total fraction of 25(oh)d. we will invite 300 subjects from an ongoing vitamin d supplementation study to participate in the study which will be one visit only and include collection of blood samples.


Eligibility criteria:
inclusion criteria: * impaired glucose tolerance * living in the tromsø area exclusion criteria * pregnancy * serious illness