Kornimate/medical-research-clean huggingface dataset:
study of safety and efficacy of doxercalciferol in patients with chronic kidney disease, stage 3 or 4, and secondary hyperparathyroidism

Conditions: Secondary Hyperparathyroidism; Renal Failure; Chronic Renal Insufficiency

Summary: the purpose of this study is to demonstrate the safety and effectiveness of hectorol® (doxercalciferol) capsules in treating patients with stage 3 or stage 4 chronic kidney disease (ckd) with secondary hyperparathyroidism who have vitamin d levels in the normal range. previous studies with doxercalciferol were conducted in patients who had low levels of vitamin d.


Eligibility criteria:
inclusion criteria: * plasma ipth value above 110 pg/ml for ckd stage 3 subjects or above 150 pg/ml for ckd stage 4 * serum 25-hydroxyvitamin d level greater than or equal to 30 ng/ml * ckd stage 3 evidenced by a glomerular filtration rate (gfr) from the abbreviated mdrd equation between 30-59 ml/min or ckd stage 4 evidenced by a glomerular filtration rate (gfr) from the abbreviated mdrd equation between 15-29 ml/min exclusion criteria: * serum cca \> 9.5 mg/dl * serum p \> 4.6 mg/dl * abnormal liver functions * anticipated requirement for maintenance hemodialysis * use of active vitamin d sterol therapy
clinical validation of a predictive model for the presence of cervical lymph node metastasis in papillary thyroid cancer

Conditions: Papillary Thyroid Cancer

Summary: this research study is performed to compare the accuracy of two methods of lymph node evaluation: research method versus standard method. standard method is what is usually performed as standard of care where the radiologist evaluates the images overall and decides whether each node seen should or should not be biopsied. in the research method, a second radiologist will evaluate the ultrasound images of the lymph nodes separately, and use a small specific checklist of ultrasound appearance to determine whether each node should or should not be biopsied. results of both the standard and research method will be used to decide which node(s), if any should be biopsied. neck ultrasound examination, lymph node evaluation by standard method and subsequent lymph node biopsy are part of the standard clinical care. it is less likely but possible that the research method may identify additional lymph nodes for biopsy to check if that lymph node contains thyroid cancer.


Eligibility criteria:
inclusion criteria: * diagnosis of ptc and at least one sonographic examination of the cervical lymph nodes. * patients can only be included in the study once. thus, if they have two sonographic examinations, only one can be included in the study results. * all patients who fit the study criteria after the start of the study will be included, using the first sonographic exam as the study exam. exclusion criteria: * lymph node with oval shape, hypoechoic cortex, smooth border, hyperechoic hilum and hilar doppler flow by ultrasound are considered to be normal and be excluded from fnab per standard clinical practice. * lymph node less than 5 mm in short axis on ultrasound.
atrial fibrillation ablation registry

Conditions: Atrial Fibrillation

Summary: the atrial fibrillation ablation registry (afib ablation registry™) is designed to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous catheter ablation procedures to treat atrial fibrillation (af).

the atrial fibrillation ablation registry (afib ablation registry™) is designed to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous catheter ablation procedures to treat atrial fibrillation (af). patient-level data will be submitted by participating hospitals on a quarterly basis to the american college of cardiology foundation's national cardiovascular data registry (ncdr™). the primary aims of the afib ablation registry are to optimize the outcomes and management of patients through the implementation of evidence-based guideline recommendations in clinical practice, facilitate efforts to improve the quality and safety for patients undergoing percutaneous catheter ablation procedures, investigate novel quality improvement methods and provide risk-adjusted assessment of patients for comparison with nationwide ncdr data. the secondary purpose of the afib ablation registry is to serve as a rich source of clinical data to support assessments of short- and long-term safety, comparative and cost effectiveness research, and as a scalable data infrastructure for post market studies.

Eligibility criteria:
inclusion criteria: 1. adult patients 2. 18 years and older 3. undergoing percutaneous catheter ablation procedures to treat atrial fibrillation exclusion criteria: 1. none
a pd/safety study of rdea3170 in combination with febuxostat for treating gout or asymptomatic hyperuricemia patients

Conditions: Gout and Asymptomatic Hyperuricemia

Summary: the purpose of this study is to explore the pharmacodynamics (pd), pharmacokinetics (pk), safety, and tolerability of multiple doses of rdea3170 administered in combination with febuxostat compared to rdea3170 administered alone and febuxostat administered alone in japanese adult male subjects with gout or asymptomatic hyperuricemia.


Eligibility criteria:
inclusion criteria: * screening serum uric acid level ≥ 8 mg/dl; * body weight ≥ 50 kg and a body mass index (bmi) ≥ 18 and ≤ 40 kg/m2; * free of any clinically significant disease or medical condition, per the investigator's judgment. exclusion criteria: * history or suspicion of kidney stones; * diagnosis of benign prostatic hypertrophy (bph) or neurogenic bladder or evidence of bph/neurogenic bladder such as thin urinary stream or difficulty in urination; * an estimated creatinine clearance \< 60 ml/min calculated by the cockcroft-gault formula; * qtcf interval (qt interval corrected for heart rate using fridericia's formula) \> 450 msec at screening; * receiving strong or moderate cytochrome p450 (cyp) 3a inhibitors or p-glycoprotein inhibitors, or digoxin
operative vs. conservative treatment of distal radius fractures

Conditions: Radius Distal Fracture; Distal Radius Fracture; Radius Fracture Distal

Summary: even though broken wrists are of frequent occurrence, the investigators see a lack of extensive and well executed international studies to clarify which is the best treatment for elderly participants at 65+ years. the danish health and medicines authority recommend that broken wrists are treated with surgery by using plates and screws when certain radiological criteria are met. recent studies show that, apparently, there are no advantages by operating rather than treating with plaster when comparing the functional results after one year. however, there is a 30 % risk of serious complications occurring after surgery. this study will examine the pros and cons that participants at 65+ years with broken wrists experience after, by lot, having been treated with either surgery (using plates and screws) or without surgery (using plaster for 5 weeks). the purpose of this study is to compare the complications and level of functioning between participants treated with surgery and without surgery.


Eligibility criteria:
inclusion criteria: * danish national guidelines for operative treatment of distal radius fractures exclusion criteria: * patients treated with plaster in arm1/control group who unexpectedly requires surgery
efficacy of collagen-elastin dermal substitute in the treatment of loss of cutaneous substances with skin grafts

Conditions: Skin Graft; Collagen -Elastin Matrix

Summary: in reconstructive surgery , most losses of cutaneous substance require the use of a thin skin graft . this technique allows epidermization of the defect by applying a thin layer of autologous epidermis. it does not reconstitute the injured skin. transplants cause retractile scars, adherent to the deep plan, that may require revision surgery . since a decade , dermal matrices are mainly used in burned skin centers . the collagen -elastin matrix has the advantage to set up in the same operation that the skin graft and contain elastic fibers , two assets which improve the results of skin grafting. objective: evaluation of the clinical efficacy of the addition of a dermal matrix to skin graft on skin foldability, at day 360. methodology: this is a multicenter randomized study (chu caen , amiens, rouen and lille) conduct of the study : the transplant will be performed according to the protocol defined between inter -region surgeons. the implementation of the dermal matrix will be in the same surgical technique as thin skin graft ( group 1 ) or the thin skin graft will be performed alone ( group 2) time . evaluation criteria main : skin foldability ( uf ) assessed grafted site will be compared to the opposite side ungrafted evaluated at day 360 . quantitative data will be measured by a cutometer skin elasticity meter 580 (courage and khazaba electronic gmbh). to achieve the main objective, it is planned to compare the ratio between uf graft site and the opposite healthy site between two groups: skin + matrix graft , or skin graft only. thus, the wilcoxon test for independent samples will be used to settle bilateral formulation between the null hypothesis ( there is no difference between the two groups ) and the alternative hypothesis ( there is a difference between the two groups ) . in determining the overall risk of first species to 5% and the power of this test to detect the 90% expected under the alternative hypothesis difference should be the main criterion for evaluating at least 59 patients in each group so 118 patients total. prospect if the contribution of a dermal matrix in loss of skin substances improves skin pliability and reduces pain , functional and aesthetic sequelae grafts thin skin , the dermal matrix may be proposed as a complementary treatment in these indications.


Eligibility criteria:
inclusion criteria: * aged over 18 * signed informed consent * patients with loss of cutaneous substance of at least 15 cm2 * patient without bone exposure, vascular, joint or tendon * eligibility for surgical treatment by skin graft * loss of substance trauma (avulsion, burns) or surgery (skin excision) exclusion criteria: * patient with a chronic wound * wound superinfected * patient unable for local or general skin graft * patient with an old or a recent skin injury strictly contralateral to the graft site. * patient unable to consent

Keywords: collagen -elastin matrix skin graft loss of cutaneous substance
double-blind study in paediatric epileptic to compare the subject preference for esl suspension formulation with alternative flavours

Conditions: Epilepsy

Summary: the purpose of this study is to investigate the taste preference in children of 3 different flavours of the esl oral suspension.

children between the age of 5 and \<8 years who are patients of the participating investigators will be screened for participation in the study. this may be at a regularly planned visit or the investigators may invite children who would be suitable candidates. children who agree to participate will be invited to come back to the clinic on a single study day and will be randomised to a particular sequence of flavours. on the study day, all children will be given 3 different flavoured samples of eslicarbazepine acetate (esl) oral suspension for tasting, in the sequence to which they were randomised, in a double-blind, standardized setting. each sample will consist of 2.5 ml and is to be given with a spoon in a double-blind manner, and is not to be swallowed. after tasting and spitting out each sample the child will be asked to rate the taste on a 10 cm visual analogue scale incorporating a facial hedonic scale. at the end of the session, the child will also be asked which flavour they thought tasted the best and which tasted the worst, to assess overall taste. a follow-up telephone contact interview will be performed between 1 and 4 days after the study day to collect adverse event (ae) data.

Eligibility criteria:
inclusion criteria: * a written informed consent form signed by the subject's parent(s) or guardian(s) and an assent form for any 7-year-old subjects signed by subjects. * male or female, between the age of 5 to \<8 years. * diagnosed with partial-onset epilepsy. * is considered, in the opinion of the investigator, to be able to make the required taste assessment. exclusion criteria: * uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological, or oncology disorder. * known hypersensitivity to carboxamide derivatives or tricyclic antidepressants. * strong congestion, flu, or any other acute illness that could influence the child's sense of taste. * a known swallowing or taste perception problem. * currently or previously treated with esl. * concomitant participation in another drug clinical trial. * any other condition or circumstance that, in the opinion of the investigator, could compromise the subject's ability to comply with the study protocol.
dexcom g6 continuous glucose monitoring in hemodialysis

Conditions: Diabetes; Hemodialysis; Glucose Measurement

Summary: this is a pilot study enrolling adult hemodialysis patients with diabetes recruited from the university of california irvine medical center (ucimc) who will undergo simultaneous measurement of glucose levels using 1) continuous glucose monitor (cgm) measured by a dexcom g6 device vs. 2) "gold-standard" blood glucose levels using capillary fingerstick or venous blood glucose measurements obtained on a point of care (poc) blood glucose meter. the study will assess dexcom g6 accuracy by comparing glucose levels on the cgm device vs. blood glucose measurements in the study population.


Eligibility criteria:
inclusion criteria: * adult hemodialysis patients age 18 years or older * have a comorbidity of diabetes * receipt of care from the inpatient university of california irvine medical center nephrology consult service * expected hospital stay ≥48 hours * have the ability to directly provide informed consent for participation in the study exclusion criteria: * critically-ill patients receiving care in the intensive care unit (icu) or cardiac care unit (ccu) * moribund patients expected to die within 48 hours * presence of any condition deemed by pi's judgment that would seriously limit life expectancy (i.e., poor survival) * pregnant * unwilling or unable to provide informed consent
ubx-303061 in subjects with relapsed/refractory b-cell malignancies

Conditions: Relapsed/refractory B-cell Malignancies

Summary: this is a first-in-human phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of ubx-303061 in patients with relapsed/refractory b-cell malignancies.


Eligibility criteria:
key inclusion criteria * capable of giving signed informed consent * age ≥18 years * ecog performance status ≤2. * phase ia (dose-escalation part only): subjects with relapsed and/or refractory b-cell malignancies (cll/sll, dlbcl, fl, mcl, wm or mzl) who have received at least 2 prior therapies and for subjects with no available treatment options as per the investigator's discretion. * phase ib (dose-expansion only): subjects with relapsed and/or refractory b-cell malignancies who have received at least 2 prior therapies and for subjects with no available treatment options as per the investigator's discretion, and fit into one of the following groups: cll/sll or dlbcl or mcl or fl, wm, mzl * all subjects must have evaluable or measurable disease based on the appropriate tumor type criteria * adequate organ and bone marrow function key exclusion criteria * for subjects with lymphoma: * systemic antineoplastic therapy or any experimental therapy within 3 weeks or 5 half-lives, whichever is shorter, before the first dose of study treatment. * therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment. * unconjugated monoclonal antibody therapies \<6 weeks before the first dose of study treatment. * subjects that have undergone autologous stem cell rescue within 100 days prior to the first dose of study treatment. * subjects that have undergone allogeneic stem cell transplant within 6 months prior to the first dose of study treatment. * subjects with active graft-versus-host disease (gvhd) or on anti-gvhd treatment or prophylaxis. * history of chimeric antigen receptor t cell (car-t) therapy within 100 days prior to start of study drug. * any immunotherapy within 4 weeks of first dose of study drug. * the time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drug is \<5 times the t1/2 of the previously administered agent(s). * previously exposed to btk degradation therapy * malignant disease, other than that being treated in this study. * radiotherapy within 2 weeks of the first dose of study treatment * known hypersensitivity to btk degraders or any of the ingredients. * impaired cardiac function or clinically significant cardiac disease * subjects with history of severe bleeding disorders and known/suspected other autoimmune disease * major surgery within 4 weeks of the first dose of study treatment
hbv reactivation in anti cd20 treatment

Conditions: Hepatitis B

Summary: the goal of this observational study is to test and describe the frequency of hepatitis b virus reactivation in patients who received anti-cd20 drugs for a wide variety of autoimmune and hemato-oncological diseases in order to find out whether a group of patients from a certain field was more sensitive to treatment in this respect than patients from other fields.

hepatitis b virus(hbv) is the most common chronic virus worldwide. it causes an infection of the liver (hepatitis b) and it is transmitted from person to person through contact with virus-contaminated blood, through sexual intercourse, and vertically from mother to fetus. anti cd20 drug or rituximab is an anti-cd20 monoclonal antibody on the surface of b lymphocytes, which induces cell death (apoptosis) and thus causes depletion. the main side effects of rituximab are infectious and hypersensitivity reactions. it can also increase the chance of hepatitis b reactivation to the point of acute hepatitis. the information for this retrospective study will be collected from clalit health care's databases. the patients will be sorted according to the indications for which the treatment with anti-cd20 drugs was given in order to see the differences in the response to the drug in different groups of patient

Eligibility criteria:
inclusion criteria: * subjects (men and women) of age 18 and above, who received anti-cd20 (rituximab) drugs as a treatment for a variety of diseases . exclusion criteria: * healthy subjects. * subjects under the age 18. * subjects who did not receive anti cd20

Keywords: anti cd20 rituximab hbv- hepatitis b virus
the cost in oxygen of surgical trauma

Conditions: Oxygen Consumption (V̇O2); Oxygen Delivery (DO2); Post-operative Complications

Summary: the investigators will examine the relationship between post-operative oxygen consumption (using non-invasive measurement technology ) and complications in patients having contemporary major abdominal surgery. the investigators hypothesis is that major surgery may trigger a physiological stress response that results in an increase in post-operative metabolic demand and oxygen consumption (v̇o2) which must be met by an increased oxygen delivery (do2). 1. to determine the feasibility of non-invasive measurement of oxygen consumption (v̇o2) using indirect calorimetry in a cohort of patients 2. to determine the feasibility of non-invasive measurement of oxygen delivery (do2) in the same cohort using non-invasive measures of cardiac output, oxygen saturation and haemoglobin (pulse wave transit time and co-oximetry techniques)

prospective observational study of non-invasive measurements of v̇o2 and do2 pre-operatively and at 8 time points in the 48 hours postoperatively in a cohort of 40 patients undergoing elective major abdominal surgery (both open and laparoscopic) with a pre-operative cardiopulmonary exercise testing (cpet). as pilot work examining the relationship between post-operative oxygen consumption and complications in patients having contemporary major abdominal surgery , the investigators need to define and grade the severity of complications. the post-operative morbidity survey (poms) is a simple outcome scale designed to record the incidence of clinically important complications - specifically complications likely to keep a patient in hospital. a poms score performed on day 5 is likely to be discriminative between patients who are recovering well, and those who are developing complications. poms is easily performed, has good internal validity and is predictive of a prolonged length of stay. poms is not a simple additive scale; however patients with poms score of 1 or greater are highly likely to remain in hospital, whereas those with a score of 0 are likely to be able to go home.

Eligibility criteria:
inclusion criteria: * male and female patients aged 18 or over. * undergoing elective major open or laparoscopic abdominal surgery. exclusion criteria: * refusal to participate * requirement for post-operative ventilation * requirement of inspired oxygen concentrations (fio2) \> 28% to maintain oxygen saturations ≥ 90%.

Keywords: non-invasive measurement of oxygen consumption delivery post-operative complications
giotrif rpms in korean patients with nsclc

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: to monitor the safety profile and efficacy of giotrif® (afatinib dimaleate, q.d) in korean patients with locally advanced or metastatic non-small cell lung cancer (nsclc)


Eligibility criteria:
inclusion criteria: 1. patients who have been started on giotrif® in accordance with the approved label in korea 2. age = 19 years at enrolment 3. patients who have signed on the data release consent form exclusion criteria: 1. known hypersensitivity to afatinib or any of its excipients 2. patients with rare hereditary conditions of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption 3. patients for whom giotrif® is contraindicated according to the local label
liftactiv b3 in post inflammatory hyperpigmentation (pihp)

Conditions: Acne; Post Inflammatory Hyperpigmentation

Summary: the purpose of this research study is to measure the depigmenting effect of a serum product called liftactiv b3 in patients with mild to moderate facial pihp (post inflammatory hyper pigmentation)


Eligibility criteria:
inclusion criteria: * multiethnic subjects * 18 to 50 yo * phototype iii-vi * all skin types * 50% with sensitive skin (declarative) * symmetrical mild to moderate facial post-acne pihp lesions with iga scale * mild active acne (less than 10 retention and 5 inflammatory lesions) * agreeing not to change their lifestyle during the study period. * capable of reading the documents presented to them, of adhering to the study regulations and accepting the limitations. * available to follow the study * agreeing to participate and having signed the informed consent exclusion criteria: * moderate to severe active acne * patients under topical or systemic retinoids * patients under systemic immunosuppressants * patients under active treatment of pihp (including topicals or procedures) within the last 3 months * patients treated with facial procedures within the last 3 months * pregnancy * patient with a recent change in contraception (since less than 6 months) * known allergy to any component of tested product * not presenting with the conditions needed to comply with the protocol. * unable to give their informed consent * not available to follow the study in its entirety