Kornimate/medical-research-clean huggingface dataset:
study of elastographic properties of the clot by technical swire (shear wave induced resonance elastography)

Conditions: Deep Vein Thrombosis

Summary: deep vein thrombosis (dvt) is a vascular disease characterized by the formation of a thrombus within the venous system, mainly the lower limbs. the clot structure directly influences both its location, but also its progressive profile expansion material or regression and embolic migration. few data are available regarding the evolution of structural properties of thrombus after an acute episode of dvt. thrombus formation is due to the polymerization of fibrinogen into fibrin. fibrin is a viscoelastic polymer. its mechanical properties directly determine how the thrombus responds to forces which it is subjected. determining the mechanical properties of the thrombus in vivo and ex vivo is expected to study its evolutionary properties.

the main objective of the study is to characterize the in vivo properties of elastographic thrombus in patients with proximal deep vein thrombosis (dvt), for quantitative elastography performed at d0, d7, d30. the ability to analyze the structural properties of the thrombus should allow us to then correlate these properties to the evolving nature of the thrombus (embolic migration or not, recanalization or not), and the effect of different treatment on the evolution of the thrombus

Eligibility criteria:
inclusion criteria: * patient with proximal dvt, provoked or not, the symptomatology is less than 3d, with or without pulmonary embolism treated with heparin or oral anticoagulant * signed informed consent * patient affiliated to a social security scheme, exclusion criteria: * pregnant or lactating * life expectancy \<1 month * patient with distal dvt or asymptomatic dvt accidental discovery * patient who underwent venous unclogging in acute phase * exclusion period in another study, * under administrative or judicial oversight, under guardianship

Keywords: blood coagulation endogenous thrombin potential rotational thromboelastometry
estrogen receptors and her2 levels' expression in luminal metastatic breast cancer

Conditions: Advanced Breast Carcinoma

Summary: cyclher is a retrospective observational multicentric italian study aimed to evaluate the correlation between hormone receptors (hr) and her2 immunohistochemistry (ihc) levels and treatment'response in patients affected by advanced breast cancer treated with first line cdk4/6 inhibitor plus endocrine therapy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 yo * histological diagnosis of hr+/her2- advanced breast cancer * immunohistochemical her2 negative evaluation (0, 1+ or 2+ fish-) * immunohistochemical expression levels of estrogen and progesterone receptors * first line cdk4/6 inhibitor plus endocrine therapy stared up to 12/31/2020 * signing of informed consent approved by local ethic committee exclusion criteria: * absence of clinical and pathological data that would compromise the definition of the study endpoints * her2 positive (ich 2+ and fish positive or her2 3 +) or triple negative disease * previous chemotherapy for treatment of metastatic disease
p3 study in acne comparing once daily sb204 and vehicle

Conditions: Acne Vulgaris

Summary: this is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the us.

this is a double-blind, placebo controlled study in subjects with moderate to severe acne. subjects who satisfy the entry criteria will be randomized to sb204 4% qd or vehicle gel qd in a 1:1 ratio. efficacy assessments will include investigator global assessments (iga) and inflammatory and non-inflammatory lesion counts. subjects will return for post-baseline evaluation at weeks 2, 4, 8, and 12/early termination (et).

Eligibility criteria:
inclusion criteria: * moderate to severe acne * minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face * minimum of 20 and no more than 40 inflammatory lesions (papules and pustules) exclusion criteria: * women of child-bearing potential who are pregnant, nursing, considering becoming pregnant * any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic acne
a multicenter observational cohort of degenerative spine diseases in china（dsdc）

Conditions: Degenerative Spine Diseases

Summary: study type: the objectives of this observational study were to understand, analyze, and compare the treatment and prognosis of patients with degenerative spine diseases and to construct a risk warning model and an assisted decision-making system the main questions it aims to answer are: * \[question 1\] to construct a database of patients with degenerative spinal diseases and to study their associated prognosis, complications, and other risks * \[question 2\] use big data to build a risk early warning model and assisted decision making system the study will not intervene with patients


Eligibility criteria:
inclusion criteria: * patients with degenerative spine disease admitted to the units participating in the study from january 2015 to mid-january 2022; * complete patient data with no more than 5% missing; exclusion criteria: * patients with oncology;
a study of galcanezumab (ly2951742) in participants with episodic migraine

Conditions: Episodic Migraine

Summary: the reason for this study is to see if the drug galcanezumab is safe and effective in participants with episodic migraine. the study will last about 53 weeks and may include up to 12 visits.


Eligibility criteria:
inclusion criteria: * participants must have a diagnosis of migraine as defined by international headache society (ihs) international classification of headache disorders (ichd)-3 (1.1 or 1.2) (ichd-3 2018) with a history of migraine of at least 1 year prior to screening and migraine onset prior to age 50 * prior to screening, participants must have a history of 4-14 migraine headache days and at least 2 migraine attacks per month on average within the past 3 months exclusion criteria: * are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study * current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (cgrp) antibody, including those who have previously completed or withdrawn from this study or any other study investigating a cgrp antibody * participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (for example, adalimumab, infliximab, trastuzumab, bevacizumab, etc.) * known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab * women who are pregnant or nursing * history of chronic migraine, daily persistent headache, cluster headache, medication overuse headache, migraine with brainstem aura, or hemiplegic migraine

Keywords: prevention prophylactic
taste and smell impairment in critically ill covid-19 patients

Conditions: Smell Disorder; Taste Disorders; Coronavirus Infection

Summary: evaluating the smell and taste perceptions of patients hospitalized in the intensive care unit with suspicion of coronavirus disease-19 diagnosis with a survey study

patients who were treated in the intensive care unit of şişli hamidiye etfal training and research hospital with the diagnosis of coronavirus disease-19 will be determined by scanning the hospital registry system. it was planned that patients discharged from the intensive care unit would be called by phone and their complaints about smell and taste disorders were evaluated with a questionnaire.

Eligibility criteria:
inclusion criteria: * adults between the ages of 18-80 * agree to participate in the study * patients treated in the intensive care unit with the diagnosis of coronavirus disease-19 exclusion criteria: * pre-existing smell and taste impairment * the patients have no enough cooperation to answer the questionnaire * having additional diseases such as dementia and alzheimer

Keywords: coronavirus disease-19 anosmia hyposmia dysgeusia
a 6-month extension study of vmdn-003-2 to assess engensis in participants with painful diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: to evaluate the durability of efficacy and long-term safety of intramuscular administration of engensis or placebo that was administered in the double-blind, randomized, vmdn-003-2 placebo-controlled phase 3 study.

the purpose of this 6-month extension study (vmdn-003-2b) is to evaluate the durability of efficacy and long-term safety of intramuscular administration of engensis or placebo that was administered in the double-blind, randomized, vmdn-003-2 placebo-controlled phase 3 study. no treatments will be administered in this vmdn-003-2b extension study. the combined overall duration of the vmdn-003-2 and vmdn-003-2b studies will be 12 months. participants will be enrolled in the vmdn-003-2b study at completion of the day 180 visit of study vmdn-003-2. participants will continue to be identified by the same participant number and the same treatment group (engensis or placebo) assigned by randomization in study vmdn-003-2. no study drug or treatment will be administered in this vmdn-003-2b extension study. the double-blind treatment assignment from the prior study will be maintained for investigators and participants during this extension study. this extension study will assess the durability of efficacy and long-term safety of engensis compared to placebo as measured by changes in average daily pain score of the full brief pain inventory for diabetic peripheral neuropathy, bedside sensory testing, physical examinations, laboratory assessments, vital signs, treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest.

Eligibility criteria:
inclusion criteria: * completed study vmdn-003-2 and consent to enroll in study vmdn-003-2b exclusion criteria: * none
assess the effect of erythromycin on the rate of success in placement of a self-propelled feeding tube

Conditions: Pancreatitis

Summary: the purpose of this study is to assess the effect of erythromycin on the rate of success in placement of a self-propelled feeding tube.


Eligibility criteria:
inclusion criteria: * aged 18-80 years * having pancreatitis * require jejunal enteral nutrition exclusion criteria: * known impaired peristalsis (critically ill patients, postoperative patients, history of surgery of the stomach/duodenum) * pregnancy * hypersensibility to erythromycin * cardiac arrhythmias with a prolonged qt-time * simultaneous usage of drugs impairing peristalsis

Keywords: erythromycin prokinetics nasojejunal tubes bengmark feeding tube post-pyloric feeding pancreatitis non-critically ill patients having pancreatitis who require jejunal enteral nutrition
intrapartum glucose management among women with gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus

Summary: gestational diabetes mellitus (gdm) is one of the most common medical complications of pregnancy. neonatal hypoglycemia is a common and well described complication for infants born to mothers with gdm and diabetes mellitus (dm) and studies have linked intrapartum maternal glucose levels with neonatal hypoglycemia. while guidelines exist to guide practitioners in how to best manage intrapartum maternal glucose levels among type i and and type ii dm, there is a paucity of data guiding practitioners in the intrapartum management of blood glucose levels for women with gdm, particularly those treated with insulin antepartum. the goal of this project is to compare two protocols of intrapartum glucose management in women with gdm and investigate the impact on neonatal blood glucose levels.

research objective- to compare "tight" vs. "less tight" intrapartum glucose management hypothesis: neonates born to mothers managed via the "less tight" intrapartum glucose management protocol will have lower mean glucose levels in the first 24 hours of life when compared to mean glucose levels among infants born to mothers managed via the "tight" intrapartum glucose management protocol. study design: randomized trial population: english or spanish speaking women with a diagnosis of gdm managed at the diabetes in pregnancy program at women \& infants hospital, with a plan to deliver at women \& infants hospital once enrolled, patients will then be randomized to "tight" or "less tight" intrapartum glucose control. once admitted to the labor floor for intrapartum management the appropriate power plan for glucose control will be initiated. the specifics of labor management will be left to the discretion of the provider.

Eligibility criteria:
inclusion criteria: * english or spanish speaking women with a diagnosis of gdm managed at the diabetes in pregnancy program at women \& infants hospital, with a plan to deliver at women \& infants hospital exclusion criteria: * pre-existing dm, multiple gestations, major fetal anomalies anticipated to require nicu admission, planned cesarean delivery, medications known to effect glucose metabolism other than insulin (i.e. metformin)

Keywords: intrapartum
intraoperative body core temperature monitoring: oesophageal probe vs heated controlled servo sensor

Conditions: Surgery; Temperature Change, Body

Summary: monitoring of intraoperative core temperature is essential for patient safety, reducing the risk of perioperative hypothermia. a recently developed measuring system, spoton® (3m, st. paul, mn), measures the core temperature in a non-invasive manner. its accuracy in patients undergoing general surgery has not been investigated yet. the study was aimed at comparing the accuracy of the spoton® in comparison with the oesophageal probe which is considered the current standard in our care units.

monitoring of intraoperative core temperature is essential for patient safety, reducing the risk of perioperative hypothermia. a recently developed measuring system, spoton® (3m, st. paul, mn), measures the core temperature in a non-invasive manner. its accuracy in patients undergoing general surgery has not been investigated yet. the study was aimed at comparing the accuracy of the spoton® in comparison with the oesophageal probe which is considered the current standard in our care units. in this study, patients who were candidates for major or urological surgery will be considered eligible for enrollment. the core body temperature will be thus measured with both a single-use oesophageal probe and a spoton® heated controlled servo sensor.

Eligibility criteria:
inclusion criteria: * age\>18 years * patients scheduled for major abdominal surgery * patients scheduled for general anesthesia * expected surgery duration longer than 30 minutes exclusion criteria: * skin infection in the forehead * upper airway anatomy alterations * pre-existing oesophageal disease

Keywords: intraoperative, hypothermia
a study of women with an early diagnosis of breast cancer, taking celecoxib between the biopsy and lumpectomy/mastectomy

Conditions: Breast Cancer

Summary: to assess the effects of short term administration of celecoxib 400 mg bid between biopsy and reexcision.

a double blind randomized study of celecoxib 400 mg bid versus placebo in newly diagnosed breast cancer. assessment of modulation of tissue markers (ki-67, er, vegf, pr, etc.) and serum markers (estradiol, estrone, shbg, etc.).

Eligibility criteria:
inclusion criteria: * women with a recent diagnosis of t1 or t2 non-invasive breast cancer by large core needle or excisional biopsy * confirmation that tissue was processed in methods acceptable to protocol and sufficient tissue remains post-diagnostic analyses to perform research assessments * reexcision planned within 10 days to 6 weeks from study start * if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision exclusion criteria: * no hormone replacement therapy within the 90 days prior to biopsy * if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision * no evidence of metastatic malignancy of any kind * no history of asthma, allergy asa, nsaids, celecoxib or other cox-2 inhibitors for a chronic non-oncological condition with the excision of low dose asa (160 mg daily) during 4 weeks prior to biopsy and for the duration of the study. * no celecoxib or rofecoxib use within one month of biopsy * no history of gastrointestinal ulcer or ulcerative colitis requiring treatment * no current anticoagulants * no neoadjuvant antihormone or chemotherapy as treatment following biopsy prior to study entry or concurrently with participation on study * no aromatase inhibitor in the six months prior to participation * no concomitant lithium * no known significant bleeding disorder

Keywords: early breast cancer double-blind randomized placebo-controlled rct pre-surgical model dcis model cox-2 inhibitor celecoxib ki-67 placebo
specific language impairment (sli) in children may caused by epileptic brain activity

Conditions: Specific Language Impairment

Summary: the objective of this study was to find if there is a possible association and the impact of epilepsy and epileptiform activity in children with sli.

this study concentrates on the impact of epileptiform activity for childhood epilepsy on the speech and language disturbances in addition to the associated social, cognitive and intellectual dysfunctions.

Eligibility criteria:
inclusion criteria: * 80 children were suffering from specific language impairment * 80 healthy children with age and sex match control group. exclusion criteria: * previous history of perinatal hypoxic-ischemic damage * meningitis or encephalitis * motor weakness * hearing disorders * iq below seventy * cp, social deprivation * autism and * psychiatric disorders .
postprandial response to different jams

Conditions: Postprandial; Hyperglycemia, Postprandial; Feeding Behaviors; Antioxidant; Lipid Profile

Summary: the aim of this study is to investigate the effects of an acute intake of three different types of strawberry jam, differing in the carbohydrates and antioxidants content, on postprandial glucose metabolism, lipid profile, antioxidant status and satiety indices, in healthy adults.

study design: randomized, postprandial, crossover, double-blind intervention with three arms. subjects: sixteen healthy adults product studied: at each arm, participants consume 60g of strawberry jam: * high-sugar jam (traditional; hs), * low-sugar jam (without added-sugar; ls), * low-sugar jam including antioxidant extract from strawberry pulp (lsa).

Eligibility criteria:
inclusion criteria: * adult men and women * normal weight or overweight (bmi between 18.5 and 29.9 kg/m2) * age between 20 and 50 years old. exclusion criteria: * to suffer from any chronic disease related to metabolism, * to follow concomitant medications, * to follow slimming treatments or hormone replacement therapy, * to have any inability to perform the follow-up, * smoking, * known food allergies, * pregnancy, lactation or menopause

Keywords: antioxidant glucose metabolism jam polyphenols postprandial strawberry
a study to evaluate the effect of mk-5684 in male participants with severe renal impairment (ri) and with end-stage renal disease (esrd) (mk-5684-010)

Conditions: Kidney Failure, Chronic; End-Stage Kidney Disease; Renal Failure, Chronic; Renal Failure, End-Stage; Healthy Participants

Summary: the goal of the study is to learn what happens to levels of mk-5684 in people with severe renal impairment and end-stage renal disease versus a healthy person's body over time. researchers will compare what happens to mk-5684 after hemodialysis in people with severe renal impairment and end-stage renal disease versus healthy people.


Eligibility criteria:
inclusion criteria: inclusion criteria include, but are not limited to: all participants * is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to the first dosing * has a body mass index (bmi) ≥ 18.0 and ≤ 42.0 kg/m\^2 at the screening visit participants with severe renal impairment (ri) (group 1): * has severely impaired renal function as determined by estimated glomerular filtration rate (egfr) using the 2021 chronic kidney disease epidemiology collaboration (ckd-epi) creatinine equation participants with end-stage renal disease (esrd) (group 2): * has esrd maintained on stable outpatient regimen of intermittent high-flux hemodialysis (hd) (at least 3 times per week) for a minimum of 3 hours per dialysis session, using a complication free well-maintained arteriovenous fistula or arteriovenous graft, for at least 3 months prior to first dosing and is expected and planning to continue hd during the study and at least up to the follow-up visit healthy control participants (group 3): * has normal renal function exclusion criteria: exclusion criteria include, but are not limited to: all participants: * has a history or presence of any of the following: adrenal insufficiency; hepatic impairment; clinically significant hypotension; cardiac arrhythmia; cardiac conduction abnormalities or recurrent unexplained syncopal events; second- or third-degree atrioventricular (av) heart block (except in participants with a functional artificial pacemaker); clinically significant sick sinus syndrome; any systemic fungal infection; hypothyroidism; chronic infection * has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including brugada syndrome) * has a history of cancer (malignancy) * is positive for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c virus (hcv) participants with severe ri (group 1): * has a history or presence of renal artery stenosis * has had a renal transplant * has esrd requiring hd participants with esrd (group 2): * has required frequent emergent hd (≥ 3) within a year prior to the first dosing * has a history or presence of renal artery stenosis. * has had a functioning renal transplant within the past 2 years
evaluate the efficacy and safety of combination treatment with dw1501-r1+dw1501-r2 versus dw1501-r1 or dw1501-r2+dw1501-r3 in patients with hypertension and dyslipidemia

Conditions: Hypertension; Dyslipidemia

Summary: a multicenter, randomized, double-blinded, double-dummy, phase 3 clinical trial to evaluate the efficacy and safety of combination treatment with dw1501-r1+dw1501-r2 versus dw1501-r1 or dw1501-r2+dw1501-r3 in patients with hypertension and dyslipidemia


Eligibility criteria:
inclusion criteria: * adults both male and female who are ≥19,\<80 years old * at screening, 140mmhg≤ sbp\<180mmhg \& 90mmhg≤ dbp\<110mmhg \& ldl-c≤250mg/dl \& triglyceride\<400mg/dl exclusion criteria: * at screening, the difference bp of one-side arm is sbp ≥ 20mmhg and dbp ≥ 10mmhg * secondary hypertension or secondary dyslipidemia * patients who have uncontrolled diabetes melitus, hyper/hypothyroidism or cardiac disease * women who are pregnant or lactating