Kornimate/medical-research-clean huggingface dataset:
a trial to assess safety and efficacy of ado09 versus insulin aspart in subjects with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: this is a randomized, double-blind, active-controlled, 2 period cross-over clinical trial in subjects with type 1 diabetes mellitus using a multiple daily injection (mdi) regimen.

after a screening visit, eligible subjects will enter a run-in period. subjects will receive a continuous glucose monitoring (cgm) system for glucose monitoring and control at the beginning of the run-in and for the whole duration of the study. each eligible subject will then be randomly allocated to a sequence of the 2 treatments, i.e. multiple daily injections of ado09 and insulin aspart during 2 dosing periods. at day 1 a mixed meal test (mmt) will be conducted at breakfast and subjects will remain at the clinical site until day 3. at day 3 subjects will leave the clinical site and continue the treatment with imp for the next 3 weeks. on day 23 subjects will come back for a mmt on day 24. this study is constituted of 2 parts. in the first part (part a), only subjects with daily prandial insulin dose ≤ 40 u/day will be enrolled. following the completion of the part a, an extension part (part b) will be conducted to particularly assess the safety and tolerability of higher daily doses of ado09 in patients with insulin requirements ≥ 40 u/day. the clinical conduct and procedures will not change for the extension part of the study.

Eligibility criteria:
inclusion criteria: * signed and dated informed consent obtained before any trial-related activities. * type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months. * treated with insulin ≥ 12 months. * using a multiple dosing insulin therapy (mdi) with basal and bolus insulin. * hba1c ≤ 9.0%. * fasting negative c-peptide (≤ 0.30 nmol/l). * total daily prandial dose: ≤ 40u in the part a and ≥ 40 u in the part b exclusion criteria: * known or suspected hypersensitivity to products used in the clinical trial * type 2 diabetes mellitus * previous participation in this trial. participation is defined as randomized. * receipt of any medicinal product in clinical development within 3 months before randomization in this trial. * known slowing of gastric emptying, including gastroparesis, and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption. * presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the investigator. * intake of medication known to affect gastrointestinal motility, including but not limited to erythromycin, metoclopramide, cisapride, cholestyramine or colestipol within 4 weeks before screening.
multimodal magnetic resonance imaging study on the neural mechanisms of remission in children with adhd

Conditions: ADHD

Summary: attention-deficit/hyperactivity disorder(adhd) is highly prevalent among children and adolescents and often associated with poor long-term outcomes in adulthood. it is thus a serious public health problem. methylphenidate(mph) and atomoxetine(atx) are most frequently used for treating adhd in many countries but the individual treatment response varies. some patients present good response to either mph or atx with minimal or no symptoms left and optimal functioning(remission) after treatment, while others are poor responders to one of the two or even both. the underlying mechanism for the heterogenous responsiveness remains unknown. thus we proposed to use multimodule magnetic resonance imaging(mri) technology to explore the neural mechanisms of remission in children with adhd treated with mph or atx.

the main aim of the current study is to explore the mechanism of remission in children with adhd treated by mph or atx. baseline information including demographic information, clinical features including adhd symptoms, cognitive assessments such as executive function, mri scans including resting state functional mri, structural mri, and dti would be acquired in each participant. after 8-12 weeks of treating with mph or atx, patients would be classified into subgroups of remitted and unremitted groups. all baseline tests would be acquired again at the end of the study. comparisons would be done to explore the remission mechanism induced by mph or atx

Eligibility criteria:
inclusion criteria: - clinical diagnosis of adhd, based on k-sads-pl medication naive aged 6-16 exclusion criteria: - history of severe head injury (with coma) other severe physical problem or disease in nervous system intelligence quotient (iq) \< 80

Keywords: multimodule mri, remission, mph, atx, adhd
cpr decision aid for patients with advanced gynecologic malignancies

Conditions: Advance Care Planning

Summary: the purpose of this research is to assess the effect of a cardiopulmonary resuscitation (cpr) decision aid video on cpr knowledge and end-of-life preferences in women with advanced gynecologic malignancy. we will assess the baseline cpr knowledge in our research population, gauge the improvement after viewing a decision aid video, and evaluate its effects on patient preferences regarding cpr.


Eligibility criteria:
inclusion criteria: * patients with stage iii or greater cervical, ovarian, or uterine malignancies * receiving chemotherapy at uab gynecologic oncology infusion center exclusion criteria: * early stage gynecologic cancer * receiving chemotherapy at a different location * non-english speaking * deafness * blindness

Keywords: ovarian cancer cardiopulmonary resuscitation end of life care endometrial cancer cervical cancer
double-masked study of photrex (rostaporfin) photodynamic therapy in the treatment of age-related macular degeneration

Conditions: Macular Degeneration

Summary: the purpose of this study is to confirm the efficacy and safety of rostaporfin (photrex) photodynamic therapy (pdt) in the treatment of classic and occult subfoveal choroidal neovascularization (cnv) associated with age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: patients with age greater than or equal to 50 years with at least one subfoveal cnv membrane secondary to amd that can be demonstrated by fluorescein angiography.

Keywords: macular degeneration amd visual acuity
seroepidemiology of viral hepatitis in hong kong

Conditions: Viral Hepatitis

Summary: immunisation policies have strong influences on the epidemiology of hepatitis a and b infection. in hong kong, vaccines against both viruses have been available through different channels and programmes in the past 3 decades. to evaluate the changes in the prevalence of hepatitis a and b in the general population, a seroepidemiology study is conducted involving a prospective cross-sectional survey followed for serology testing. eligible members of 1327 spatially random households would be invited to join the study by completing a questionnaire and providing blood samples, either by dried blood spots or venesection, for determining the presence of antigen and/or antibody against hepatitis b, as well as antibody against hepatitis a. the main measures comprise a set of metrics on the prevalence of hepatitis a and b. analysis would be conducted to examine the association of risk factors with the tested markers and describe the attitudes towards viral hepatitis vaccination. the results would allow us to understand the transmission potential of hepatitis a and b in the community would be influenced by the changing disease epidemiology and coverage of vaccination, which inform the development of new vaccination strategies in hong kong


Eligibility criteria:
inclusion criteria: * residents normally living in hong kong * living in domestic households randomly selected from building groups * any age, while subjects below the age of 18 would require informed consent of their guardians for participation * any gender exclusion criteria: * unable to understand written chinese or english, * failure to give consent for participation * living in institution or non-domestic housing, * foreign domestic helpers, * normally living in hong kong

Keywords: hepatitis a hepatitis b epidemiology
endometrial lesions predictions

Conditions: Endometrial Neoplasms

Summary: to explore the risk factors of endometrial lesions in patients with abnormal uterine bleeding and establish prediction models which can discriminate between different endometrial etiologies of abnormal uterine bleeding(aub).


Eligibility criteria:
inclusion criteria: * 1) non-pregnancy related abnormal uttering bleeding（aub） in women of 18-60 years old; 2)women who had indications for hysteroscopy and endometrial histology in the study period exclusion criteria: * 1) postmenopausal women, 2) aub due to other causes such as hormones or medications, coagulation disorders, and vascular malformation of the uterus; 3) final diagnosis outside the scope of this study.
safety, tolerability, and pharmacokinetic characteristics of sss11 in patients with gout and hyperuricemia

Conditions: Gout; Hyperuricemia

Summary: this is a safety, tolerability, pharmacokinetics, and preliminary pharmacological study of multiple administration, dose escalation, randomized double-blind, placebo-controlled.the main purpose of this experiment is to evaluate the safety and tolerability of multiple injections of pegylated recombinant candida urate oxidase (test drug code: sss11) in patients with gout and hyperuricemia.the experimental period includes a screening period of 4 weeks, a treatment period of 4 or 8 weeks, and an observation period of 4 weeks。


Eligibility criteria:
inclusion criteria: * a patient with clinical diagnosis of gout (according to the 2015 acr/eular gout classification criteria), non acute attack phase, and hyperuricemia {under normal purine diet, blood uric acid\>420 µ mol/l (7 mg/dl) not tested twice on an empty stomach on the same day}。 * screening period blood uric acid\>420 µ mol/l (7mg/dl)。 exclusion criteria: * within 14 days prior to enrollment (or within 5 half lives of the drug, whichever is longer), medication that lowers uric acid levels or affects uric acid levels and related drugs (allopurinol, febuxostat, benzbromarone, probenecid, benzenesulfonazolone, tongyifengning tablets, etc.) must be taken, or during the study period, other drugs that lower uric acid levels or affect uric acid levels and related drugs other than experimental drugs must not be discontinued。 * patients with acute gout attacks within 14 days prior to enrollment。 * previously received uric acid oxidase or treated with similar drugs such as pegolase or rabulidase。 * individuals with a history of glucose-6-phosphate dehydrogenase (g6pd) deficiency or g6pd enzyme activity levels below the lower limit of normal。 * individuals with a history of catalase deficiency or evidence that meets the diagnostic criteria for catalase deficiency。 * malignant tumor patients (whether treated or not)。
bladder instillations versus onabotulinumtoxin a for treatment of interstitial cystitis/bladder pain syndrome

Conditions: Interstitial Cystitis; Bladder Pain Syndrome

Summary: recognition of interstitial cystitis (ic)/bladder pain syndrome (bps) is increasing. there is a dire need to develop effective treatment options for these patients as it manifests as more than a physical disease, affecting general and psychological health as well. existing trials comparing varying bladder instillation formulations have not identified an optimal bladder instillation therapy, however existing studies support combined heparin and alkalinized lidocaine bladder instillation as an affordable and effective treatment for ic/bps. additionally, intradetrusor onabotulinumtoxina injection has been well established for the treatment of overactive bladder (oab), a constellation of symptoms similar to that of ic/bps. onabotulinumtoxina has now come into the forefront for treatment of oab due to its efficacy, safety profile, and absence of cognitive effects related to the previous mainstay anticholinergic treatment. while both bladder instillation and onabotulinumtoxina therapy have been shown to be effective for treatment of ic/bps, a direct comparison of these treatments has not been performed. we therefore designed a randomized controlled trial to compare the efficacy of heparin with alkalized local anesthetic bladder instillation versus intradetrusor onabotulinumtoxina injection in treating ic/bps symptoms.


Eligibility criteria:
inclusion criteria: * females ≥ 18 years of age * o'leary-sant questionnaire score ≥ 6 * ability to follow study instructions and complete all required follow-up exclusion criteria: * contraindications and/or allergies to medications used * known alternative diagnosis explaining bladder pain symptoms * bladder instillation within the past 3 months * intradetrusor onabotulinumtoxina injection within the past 6 months * use of ≥ 400 units of onabotulinumtoxina in the last 3 months * inability or unwillingness to self-catheterize * post-void residual \> 200ml * concurrent procedural treatment (including hydrodistension, sacral neuromodulation) * current use of vaginal pessary/devices * untreated symptomatic prolapse \> pelvic organ prolapse quantification system (pop-q) stage 2 * females who are pregnant or planning a pregnancy during the study or who think that they may be pregnant at the start of the study and who are unwilling or unable to use a reliable form of contraception during the study * inability to speak/read english
assessment of safety and satisfaction toward covid-19 vaccines.

Conditions: COVID-19 Vaccine Adverse Reaction

Summary: this is a cross-sectional, web-based online survey done with the use of a google form-questionnaire to gather information from the general public regarding their knowledge, satisfaction, and tolerability about the covid-19 vaccine.

* a cross-sectional study was conducted. the subjects participating in the study are residents in egypt. * an online questionnaire, designed on google forms, was written in arabic language and delivered to participants via social media (primarily facebook, whatsapp and linkedin). * the questionnaire comprised two categories of inquiries. the first is demographic data of the subject. the second is questions about covid-19 vaccine-related data, such as whether had taken the vaccine or not, the type of vaccine administered, side effects encountered from the vaccine , if got enough information regarding the vaccine and where obtain the vaccine information from and if reluctant to taking the vaccine and the reasons for hesitancy. all participants were permitted to terminate the survey at any time of the study.

Eligibility criteria:
inclusion criteria: * all adults (age ≥ 18 years) complete the questionnaire were considered eligible to participate in the survey. exclusion criteria: * incomplete questionnaires were excluded from the final analysis.
a study investigating treatment factor x in people with factor x deficiency

Conditions: Factor X Deficiency

Summary: the main objective of the study is to assess the pharmacokinetics of factor x after a single dose of 25iu/kg. the secondary objectives of the study are to assess efficacy and safety of factor x in the treatment of bleeding episodes over at least 6 months.


Eligibility criteria:
inclusion criteria: * written informed consent given, or for subjects aged 12-17 years, have given written assent and whose parent/guardian has given written informed consent * at least 12 years of age at dtae of written informed consent * have hereditary severe or moderate fx deficiency * currently treated with fresh frozen plasma ffp, prothrombin complex concentrate pcc or factor ix/x concentrate * must have a minimum of one spontaneous or menorrhagic bleed in the last 12 months which required treatment of ffp, pcc or factor ix/x concentrate. newly diagnosed subjects who present at the hospital with a bleed may be included * must have had at least 7 days, and ideally 10-14 days, since an infusion of either ffp, pcc or factor ix/x concentrate at baseline visit * females of child bearing potential must have a negative result on a hcg based pregnancy test. if they are or become sexually active, they must practise contraception by using a method of proven reliability for the duration of the study exclusion criteria: * have a history of inhibitor development to fx or a positive result at the screening visit * bleeding at the appointment for the pk assessment * subjects who have thrombocytopenia * have clinically significant liver disease * known to have other coagulopathy or thrombophilia * have known or suspected hypersensitivity to the investigational medicinal product or its excipients * have abused chemicals or drugs within the past 12 months * have a history of unreliability or non-cooperation * participating or have taken part in another trial within the last 30 days, with the exception of bpl fx surgery study - protocol ten03. in such cases, subjects should have completed their end of study visit either before or on the day of screening visit for this study * female subjects who are pregnant or lactating * subjects planning greater than 4 weeks absence from the locality of the investigational site, between the screening visit and the repeat pk assessment
non-interventional study with ectoin containing and/or decongesting nasal spray in patients with rhinosinusitis

Conditions: Acute Rhinosinusitis

Summary: the goal of this non-interventional study is to investigate the efficacy and tolerability of an ectoin containing rhinosinusitis nasal spray (sns01). within the study, sns01 will be used either alone as monotherapy or as concomitant therapy in addition to the use of a xylometazoline-containing decongestant nasal spray. a control group will use a xylometazoline-containing decongestant nasal spray as monotherapy. it will be investigated if the dose of the used decongestant nasal spray might be reduced, the development of the disease might be positively influenced and/or the potentially occurring side effects (e.g. dryness of the nasal mucosa, sneezing) might be alleviated by using the ectoin containing rhinosinusitis nasal spray as concomitant therapy.

the current non-interventional study aims to investigate the efficacy and tolerability of ectoin containing rhinosinusitis nasal spray (sns01) in patients with acute rhinosinusitis. patients can chose one of three treatment options: a) ectoin containing rhinosinusitis nasal spray (sns01), b) decongestant xylometazoline-containing nasal spray or c) ectoin containing rhinosinusitis nasal spray (sns01) and a decongestant xylometazoline-containing nasal spray. efficacy will be studied by documentation of the following symptoms: * oedema, redness (assessed by rhinoscopy) * nasal obstruction, nasal secretion, headache/face pain, loss of sense of smell/taste * sore throat, cough in parallel, participating patients will document their symptoms and the their quality of life over the entire study duration in patient diaries. patients of both genders aged 6 years and above can take part in the study if diagnosed with acute viral rhinosinusitis. the assignment of a patient to a particular treatment is not decided in advance but falls within current practice, and is clearly separated from the decision to include the patient into the study. study therapy will be applied in accordance with the respective instructions for use. study duration is 7-14 days, depending on the improvement of symptoms. at the end of the study, both the investigators and the patients are asked to judge the efficacy and tolerability of the treatments.

Eligibility criteria:
inclusion criteria: * patients with acute viral rhinosinusitis * presence of common cold symptoms exclusion criteria: * contraindications in accordance with instructions for use * acute bacterial rhinosinusitis * chronic rhinosinusitis
suprachoroidal visco-buckling for the treatment of rhegmatogenous retinal detachment

Conditions: Retinal Detachment With Break

Summary: the study compares standard surgery for retinal detachment (rd) (vitrectomy, cryotherapy and gas) with a surgical variation that replaces the intraocular gas tamponade with suprachoroidal injection of viscoelastic underneath the break that caused the retinal detachment.

after being informed about the study and the potential risks, the eligible patients who have given written consent to the treatment will be randomized into treatment (vitrectomy, cryo and gas) or control (viscobuckle vitrectomy) group.

Eligibility criteria:
inclusion criteria: patients requiring pars plana vitrectomy for the treatment of primary rhegmatogenous retinal detachment (rd) caused by a single break, or multiple breaks within one clock hour. the final determination of qualifying breaks is made at the time of surgery following 360-degree, internal, indented search using a wide-angle viewing system. exclusion criteria: * hypersensitivity to hyaluronate or. healon5® pro ovd * participation in another interventional study within 8 weeks of enrolment or planned to occur during this study. * bleeding disorders or the use of anticoagulants (such as warfarin, rivaroxaban) or dual anti-platelet drugs such as aspirin with clopidogrel. monotherapy with low dose (≤100 mg) aspirin is permitted, and if clinically appropriate this should be stopped prior to surgery and recommenced only after satisfactory day 1 post-operative review. * unwilling, unable, or unlikely to return for scheduled follow-up for the duration of the trial. * any other condition that, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol, such as dementia, mental illness, or serious systemic medical disease. study eye: * presence of proliferative vitreoretinopathy (pvr) or any tractional rd * previous vitreoretinal surgery, open-globe injury or endophthalmitis * aphakia * previous or current congenital cataract * previous or current suprachoroidal haemorrhage * congenital or acquired ocular, orbital or periocular abnormality that, in the opinion of the attending vitreoretinal surgeon, would preclude the safe delivery of healon 5 into the suprachoroidal space (detail the specific reason for exclusion in the source documents) * presence of other ocular co-morbidity that, in the opinion of the investigator, is likely to prevent an accurate assessment of retinal attachment * current intraocular inflammation other than mild cellular activity thought to be secondary to rd * current ocular or periocular infection other than blepharitis

Keywords: retinal detachment vitrectomy gas tamponnade suprachoroidal buckle viscobuckle postoperative recovery
inflammation, polyphenols, and genetics

Conditions: Overweight; Obese

Summary: pilot study to determine whether daily consumption of blackraspberry powder (high in polyphenols) can reduce markers of inflammation and to determine whether genetics influence baseline levels of inflammatory markers as well as individual's response to polyphenols. a total of 10 males participated in this cross-over study.

a high-fat, high-calorie challenge meal is administered to induce an inflammatory response in overweight and obese adult males. serum levels of crp, tnf-alpha, and il-6 are measured prior to the challenge meal and at various times (1,2,4,8, and 12 hours) after the challenge meal. the challenge meal is given once without intervention and once after 5 daily doses of concentrated black-raspberry powder mixed in water.

Eligibility criteria:
inclusion criteria: * adult males over 55 years of age * overweight or obese exclusion criteria: * history of adverse reaction to berries or berry products * history of adverse reaction to high-fat, high-calorie challenge meal * significant liver or renal insufficiency * significant cognitive impairment