Kornimate/medical-research-clean huggingface dataset:
clinical performance of a new daily disposable contact lens worn in a neophyte population.

Conditions: Refractive Error; Myopia

Summary: this study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.


Eligibility criteria:
inclusion criteria: 1. they are of legal age (18 years) and capacity to volunteer. 2. they understand their rights as a research subject and are willing to sign a statement of informed consent. 3. they are willing and able to follow the protocol. 4. they would be expected to attain at least 6/9 (20/30) in each eye with the study lenses. 5. they are able to wear contact lenses with a back vertex power of -1.00 to -6.00ds. 6. they have a maximum of 1.00d of refractive astigmatism (i.e. ≤ 1.00 dc). 7. they have successfully worn contact lenses within six months of starting the study. exclusion criteria: 1. they have an ocular disorder which would normally contra-indicate contact lens wear. 2. they have a systemic disorder which would normally contra-indicate contact lens wear. 3. they are using any topical medication such as eye drops or ointment. 4. they are aphakic. 5. they have had corneal refractive surgery. 6. they have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus. 7. they are pregnant or lactating. 8. they have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear. 9. they have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. hiv). 10. they have diabetes. 11. they have taken part in any other clinical trial or research, within two weeks prior to starting this study.
study evaluating bazedoxifene/conjugated estrogen combinations in vasomotor symptoms associated with menopause

Conditions: Vaginal Atrophy

Summary: the purpose of this study is to determine whether bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.


Eligibility criteria:
inclusion criteria: * generally healthy, postmenopausal women, aged 40 to 65 years * intact uterus * at least 1 moderate to severe vulvar/vaginal symptom that is most bothersome exclusion criteria: * hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia * thrombophlebitis, thrombosis or thromboembolic disorders * neuro-ocular disease

Keywords: vaginal atrophy postmenopause
leap-ct for treatment of covid-19 patients (master protocol)

Conditions: 2019 Novel Coronavirus Disease; 2019 Novel Coronavirus Infection; 2019-nCoV Disease; 2019-nCoV Infection; COVID-19 Pandemic; COVID-19 Virus Disease; COVID-19 Virus Infection; Covid19; Coronavirus Disease 2019; SARS-CoV-2 Infection; SARS-CoV-2 Acute Respiratory Disease; COVID-19

Summary: this master protocol serves as a common reference for the inpatient and outpatient clinical studies that share common elements.

there are currently two addenda to this master protocol: addendum 1, study ldos-21-001-01, is a phase 2, randomized, single-blind, placebo-controlled study to evaluate the safety and efficacy of the combination of famotidine and celecoxib as a treatment in moderate-to-severe patients hospitalized for covid-19. addendum 2, study ldos-21-001-02, is a phase 2 randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of the combination of famotidine and celecoxib as a post-exposure prophylaxis (pep) for newly infected covid-19 patients.

Eligibility criteria:
* for eligibility criteria specific to the protocol, see: * addendum #1 (ldos-21-001-01) or * addendum #2 (ldos-21-001-02)

Keywords: covid-19 covid covid19 sars-cov-2
body fat distribution and its associated factors in chinese women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome (PCOS)

Summary: to investigate the body fat distribution in chinese women with polycystic ovary syndrome (pcos) and the association of those distribution with metabolic parameters, microeconomics, hormone profiles and psychological state.

the polycystic ovary syndrome (pcos) is one of the most common endocrine and metabolic disorders in women of reproductive age. it is also one of the leading causes of anovulatory infertility and secondary amenorrhea, which represent major stress factors in the female life. in the previous studies, the investigators found that pcos patients showed decreased quality-of-life and increased psychological disturbances compared with healthy controls. body mass index (bmi) was associated with emotional disorders and physical aspects of quality-of-life and negative emotions were negatively correlated with bmi in pcos patients.these results prompted that pcos could be separated into at least two subtypes by the fat content. so the investigators expand the epidemiological investigation for comparing the body composition between the pcos and the normal women, and finding specific biological indicators in different subtypes.

Eligibility criteria:
inclusion criteria: * age 18 to 45 years * for the pcos group, pcos diagnosis according to rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 ml exclusion criteria: * exclusion of other endocrine disorders such as androgen secreting tumors, suspected cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone \< 3nmol/l) thyroid dysfunction and hyperprolactinemia. * type i diabetes or not well controlled type ii diabetes * stage 2 hypertension (resting blood pressure ≥160/100mmhg) * psychiatric diagnoses or using psychiatric medications including antidepressants * pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. depo provera or similar within 6 months. the control group are non- pcos normal women (age 18-45) and meet the same exclusion criteria.

Keywords: fat distribution insulin resistance negative emotion polycystic ovary syndrome (pcos)
an observational study of alogliptin benzoate in participants with diabetes mellitus type 2

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the effect of alogliptin benzoate (vipidia®) on glycosylated hemoglobin (hba1c) level dynamics in participants with diabetes mellitus type 2 (t2dm) at month 6.

the drug being studied in this study is called alogliptin benzoate. alogliptin benzoate is being researched to treat people who have t2dm. this study will look at the hba1c level dynamics in participants with t2dm. the study enrolled 1409 patients. alogliptin benzoate will be prescribed by their physician in accordance with the russian summary of product characteristics (smpc). this multi-center study will be conducted in the russian federation. the overall duration of study for observation will be approximately 6 months. participants will make multiple visits to the clinic as assigned by each physician according to their routine practice, in every 3 months.

Eligibility criteria:
inclusion criteria: 1. male and female participants ≥ 18 years of age; 2. has a diagnosis of type 2 diabetes mellitus (t2dm) 3. participants with: * newly diagnosed diabetes mellitus (dm) type 2 (drug naïve) or * inadequate glycemic control on previously prescribed any oral antidiabetic drug. 4. vipidia® is prescribed according to the approved label for the russian federation. 5. the participant's physician decides to prescribe vipidia®: * as monotherapy or * as a part of combination therapy. 6. the participant (or, when applicable, the participant's legally acceptable representative) signs and dates a written, informed consent form prior to the start of data collection. participant is capable of understanding the written informed consent, provides signed and written informed consent, and agrees to comply with protocol requirements. in case the participant is blind or unable to read, informed consent will also be witnessed. exclusion criteria: 1. contraindications of respective approved russian summary of product characteristics (smpc); 2. in the opinion of the physician, the participant has any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study; 3. had used dipeptidyl peptidase-4 inhibitors (dpp-iv inhibitors) or glucagon like peptide-1 agonists (aglp-1) within the 3 months prior to the start of vipidia® treatment. 4. is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.

Keywords: drug therapy
study of ivacaftor in cystic fibrosis subjects aged 12 years and older with the g551d mutation

Conditions: Cystic Fibrosis

Summary: the purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the g551d mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene. ivacaftor is a potent and selective cftr potentiator of wild-type, g551d, f508del, and r117h forms of human cftr protein. potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic amp-dependent protein kinase a (pka) activation.

this was a phase 3 study in subjects with cystic fibrosis (cf) age 12 years and older who have a g551d-cftr mutation and percent predicted forced expiratory volumn in 1 second (fev1) between 40% and 90%. based on in vitro studies and pharmacologic, pharmacokinetic (pk), and safety profiles, ivacaftor was selected for clinical development as a possible treatment for patients with cf. patients with the g551d mutation were the targeted population for this study because ivacaftor is a potentiator of the gating function of the cftr protein, and the most prevalent mutation with a gating defect in cf is the g551d mutation. this study was designed to further evaluate the efficacy of ivacaftor in subjects with cf who have a g551d-cftr gene mutation and to evaluate safety in this population over a longer period than previously studied.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cystic fibrosis (cf) and g551d mutation in at least 1 allele * forced expiratory volume in 1 second (fev1) of 40% to 90% (inclusive) of predicted normal for age, gender, and height at screening. * no clinically significant abnormalities that would have interfered with the study assessments, as judged by the investigator * willing to use highly effective birth control methods during the study exclusion criteria: * history of any illness or condition that might confound the results of the study or pose an additional risk in administering study drug to the subject * acute respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks of day 1 of the study * history of alcohol, medication or illicit drug abuse within one year prior to day 1 * abnormal liver function ≥ 3x the upper limit of normal * abnormal renal function at screening * history of solid organ or hematological transplantation * pregnant, planning a pregnancy, breast-feeding, or unwilling to follow contraception requirements * ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days prior to screening * use of inhaled hypertonic saline treatment * concomitant use of any inhibitors or inducers of cytochrome p450 3a4 (cyp 3a4)

Keywords: fibrosis pancreatic diseases lung diseases respiratory tract diseases genetic diseases, inborn infant, newborn, diseases pathologic processes
telehealth could mitigate disease progression compared to standard of care in copd - a randomized controlled trial

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the objective of this randomised controlled trial is to test, whether telehealthcare can improve hrqol and reduce emergency admissions and hospitalisations due to aecopd. different outcome parameters as described in the endpoints section will be analysed.


Eligibility criteria:
inclusion criteria: * copd gold b-d and age ≥ 40 years exclusion criteria: * inability to provide informed consent or to follow trial procedures
xience xpedition everolimus-eluting coronary stent japan post marketing surveillance (xience xpedition sv japan pms)

Conditions: Ischemic Heart Disease; Angina Pectoris; Coronary Artery Disease; Myocardial Ischemia

Summary: the objective of the study is to evaluate the safety and efficacy of xience xpedition everolimus-eluting 2.25mm stent in real world practice in japanese hospitals.

based on good post-marketing study practice (gpsp) regulation, general patient population with ischemic heart disease who are eligible for treatment with xience xpedition everolimus-eluting 2.25mm stent will be registered, with no particular inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and clinical follow-up at one year. the xience xpedition 2.25 mm stent is composed of the stent identical to the stent of the xience prime sv stent.therefore, the data collected from the pms will be pooled with data collected from the ongoing xience prime sv pms for analysis.

Eligibility criteria:
1. inclusion criteria 1. patient informed consent is required for registration of this pms. in cases where patient informed consent (or providing some type of information) is required for pms per the participating site policy, the sponsor will cooperate as needed. 2. patients who are treated by xience xpedition 2.25mm stent will be registered. * the observations will be compiled on a per-patient basis even if multiple xience xpedition 2.25mm stents are implanted during the index procedure. * a patient whose side-branch is treated by xience xpedition 2.25mm stent can be registered. in such a case, main vessel should be treated by xience xpedition. * the observations will not be compiled on a per-patient basis if a patient is treated by xience xpedition 2.25mm stent overlapped with other stents for bail-out purpose. * additional revascularization procedures as a part of adverse event treatment and planned staged procedures will not be considered as another registration, or adverse events. * a patient who is treated, but failed to be implanted by xience xpedition 2.25mm stent and finally treated by other devices only (no xience xpedition 2.25mm stent are implanted) must also be registered. in such a case, only the stent information, device deficiency information and reportable adverse events related to the xpedition stent, if any, are required to be captured. follow-up of the patient who does not receive any xience xpedition 2.25mm stent is not required. 2. exclusion criteria 1. if it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the pms. 2. patients who are attending or will attend other pms with invasive medical procedure will not be registered. 3. a patient may have another lesion(s) that may be treated by larger diameter (≥ 2.5mm) stent(s). in such a case, treatment by xience xpedition is preferable. lesion(s) treated by other than xience xpedition 2.25mm stent is not considered as the target lesion.

Keywords: drug eluting stent coronary stent everolimus stent thrombosis
systemic vascular endothelial growth factor (vegf) protein dynamics following intravitreal injections of ranibizumab versus aflibercept in patients with neovascular age-related macular degeneration

Conditions: Wet Age-Related Macular Degeneration

Summary: the purpose of the study was to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic vegf protein levels in treatment naïve wet neovascular age-related macular degeneration (wamd) patients in a detailed time course.

a planned study visit schedule was established at the time of baseline visit (day 1) for all patients. study assessments for patients were performed at screening visit, baseline (day 1), day 2, day 8 (± 1 day to allow for flexibility in scheduling) and as of day 15 through to day 169 at biweekly visits.

Eligibility criteria:
inclusion criteria: * visual impairment predominantly due to neovascular amd. * active, newly diagnosed, untreated, angiographically documented, cnv lesion (i.e. leakage on fluorescein angiography plus intraretinal, subretinal or sub-rpe fluid on oct) secondary to neovascular amd in line with smpc of ranibizumab and aflibercept exclusion criteria: * stroke or myocardial infarction less than 3 months prior to screening. * presence of uncontrolled systolic blood pressure or diastolic blood pressure * type 1 or type 2 diabetes mellitus * use of any systemic anti-vegf drugs * use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening. * women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant\* and not practicing a medically approved method of contraception for either eye: * any active periocular or ocular infection or inflammation * uncontrolled glaucoma * neovascularization of the iris or neovascular glaucoma * history of treatment with any anti-angiogenic drugs for study eye: * atrophy or fibrosis involving the center of the fovea at the time of screening or baseline. * cataract (if causing significant visual impairment), planned cataract surgery during the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wamd * irreversible structural damage within 0.5 disc diameter of the center of the macula * any intraocular procedure (including cataract surgery, yttrium-aluminum-garnet capsulotomy) within 3 months prior to baseline or anticipated within the next 6 months following baseline. * use of intravitreal or topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening. for fellow eye - retinal or choroidal neovascularization or macula edema of any cause other protocol-defined inclusion/exclusion criteria may apply.
a study of changes in hepatic function during radiation therapy using hepatobiliary single photon emission tomography (spect)

Conditions: Hepatocellular Carcinoma

Summary: radiation-induced liver disease (rild) is a syndrome characterized by the development of anicteric ascites approximately 2 weeks to 4 months after hepatic irradiation. previous studies have shown that both the volume of liver irradiated and the dose of radiation delivered are prominent factors for development of rild. while use of a population-based normal tissue complication probability model allows investigators to limit the risk of rild to a clinically acceptable level, a test that permits investigators to determine an individual's risk of rild during the course of treatment may allow for individualized treatment modifications, either to prevent toxicity or increase efficacy.

early, but subclinical physiologic changes in the liver may be associated with the future development of rild. there are currently limited data on how a local change in hepatic function associates with regional radiation dose, and how the change of hepatic function during and after radiation therapy (rt) associates with rild. in the present study, a radiological methodology that is minimally invasive will be used to measure volumetric hepatic functions in patients with intrahepatic malignancies before, during, and after a course of fractioned radiation therapy.

Eligibility criteria:
inclusion criteria: * cancer patients undergoing radiation of the liver * women and men who agree to avoid pregnancy * life expectancy of at least 6 months exclusion criteria: * pregnant women * breatsfeeding women * prisoners

Keywords: hepatocellular carcinoma
analysis of glycemic control in type 1 diabetes patients using hybrid closed loop insulin pump therapy (medtronic 670g)

Conditions: Biomedical Technology; Type 1 Diabetes

Summary: observational study of patients at boston childrens hospital with type 1 diabetes (t1d) who elected to treat their diabetes with the medtronic 670 g hybrid closed loop insulin pump.

outcome study of 90-100 patients with type 1 diabetes who elected to use the medtronic 670g. major outcome measure was to assess the percent of patients who were able to successfully continue to use the 670g technology over time. additional outcome variables included hemoglobin a1c pre and post treatment with the 670g, time in desired glucose range 70-180.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of t1d * patient of boston childrens hospital diabetes program * deemed to be adequate candidates for hybrid closed loop technology by their diabetes health care team * patient received medtronic 670g training at boston childrens hospital * patient received follow up diabetes care at boston childrens hospital for at least 3 months after starting on the 670g exclusion criteria: * patients not trained at boston childrens hospital or self started

Keywords: medtronic 670g
coagulopathy in covid19 - a multi-centre observational study in uk

Conditions: COVID; Thrombosis; Bleeding; Anticoagulation

Summary: a novel coronavirus (covid-19) infection leading to pneumonia and severe acute respiratory failure \[acute respiratory distress syndrome (ards)\] and death is a global threat. on 11/03/2020, who declared the covid-19 outbreak a global pandemic. as of 18th of march, there are 202,309 confirmed cases with 8,013 deaths. patients with severe illness may develop dyspnoea and hypoxemia within 1week after onset, which may quickly progress to ards or end-organ failure 1. based on chinese data abnormal coagulation parameters (prolonged prothrombin time \[pt\] and raised d dimer) are reported to predict a poor prognosis and may therefore be important therapeutic targets. the number of patients with infected with covid- 19 in uk is rapidly rising as with many other european countries. eventually \>50% of people will have become infected and covid-19 will remain a public health threat in the long term. it is therefore very important to understand every aspect of this disease, including the associated coagulopathy leading bleeding, blood clots (thrombosis) and death. emerging data from europe and some centres in uk, indicates that venous thromboembolism (vte), mainly pulmonary embolism (pe), is major problem in covid patients. in this retrospective-prospective: multicentre study, investigators will document the patient characteristics, presenting haematological parameters and associated comorbidities and their association with bleeding, thrombosis and mortality in patients admitted for hospital treatment. determining the predictive value of patient characteristics and presenting laboratory measurements for clinical outcomes in these patients will allow us to optimise management of these patients in the future. furthermore, by comparing these data with data from patients without covid-19, investigators will be able to modify existing protocols and tailor them to the management of covid -19.


Eligibility criteria:
inclusion criteria: * adult patients (\>18 years) admitted hospitals with covid 19 infection (covid rna+ +/- radiological change +/- clinical suspicion in absence of rna) exclusion criteria: * no exclusions