Kornimate/medical-research-clean huggingface dataset:
study to evaluate the pharmacodynamic and pharmacokinetic effects of lx4211 in subjects with type 2 diabetes and renal impairment

Conditions: Type 2 Diabetes Mellitus; Renal Impairment

Summary: this phase 1 study is intended to assess the pharmacodynamics (pd), pharmacokinetics (pk), safety and tolerability of lx4211 following once daily oral administration in subjects with type 2 diabetes mellitus (t2dm) and moderate to severe renal impairment.


Eligibility criteria:
inclusion criteria: * adults ≥18 to ≤80 years of age * history of t2dm for at least 6 months prior to screening * moderate to severe renal impairment and not actively on dialysis * willing and able to perform self-monitoring of blood glucose * willing and able to provide written informed consent exclusion criteria: * history of type 1 diabetes mellitus, diabetic ketoacidosis (within the previous 6 months), or diabetes resulting from pancreatic disorder or secondary diabetes (from acromegaly and/or cushing's disease) * subjects who have received a renal allograft * subjects expecting to require dialysis or to undergo kidney transplantation within 3 months of study dosing * presence of active hepatic disease or clinically significant abnormal liver function tests at screening or planned study day -1 * subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study day -2 * history of clinically significant cardiac arrhythmias within 1 year prior to study day -2 * subjects with congestive heart failure * subjects with uncontrolled stage iii hypertension * history of 2 or more emergency room visits, doctors' visits, or hospitalizations due to hypoglycemia within the 6 months prior to planned study day -2 * history of alcohol or illicit drug abuse within 1 year prior to screening * history of human immunodeficiency virus (hiv), hepatitis b, or hepatitis c * major surgery within 6 months prior to planned study day -2 * history of any malignancy within the last 5 years * triglycerides \>1000 mg/dl at screening or planned study day -1 * history of any serious adverse reaction or hypersensitivity to an sglt inhibitor * use of corticosteroids within 2 weeks prior to study day 1 * use of any investigational drug within 30 days prior to study day 1, or investigational protein or antibodies within 60 days of day 1 * positive urine pregnancy test at screening * positive urine screen for illicit drug abuse at screening * prior exposure to lx4211
uc-mscs in the treatment of severe and critical covid-19 patients with refractory hypoxia

Conditions: Mesenchymal Stem Cell; COVID-19 Pneumonia

Summary: the goal of this randomized, controlled, open-labeled interventional clinical trial is to test the efficacy and safety of umbilical cord mesenchymal stem cells (uc- mscs) in the treatment of severe and critical covid-19 patients with refractory hypoxia even after sufficient standard treatment according to the tenth edition of chinese guidelines for covid-19 infection. the main questions it aims to answer are: 1. the efficacy of uc-mscs in the treatment of severe and critical covid-19 patients with refractory hypoxia. 2. the safety of uc-mscs in the treatment of severe and critical covid-19 patients. 3. the potential immune mechanisms of uc- mscs in the treatment of severe and critical covid-19 patients. participants will receive standard therapy, or the uc-mscs treatment. for the standard treatment, it will be conducted according the 10th edition of chinese guidelines for severe or critical covid-19 infection. for uc-mscs treatment, participants will be given uc-mscs instillation at the first and fourth day after assignment. blood examples will be taken at indicated time for arterial blood gas analysis and other tests. and participants should also objectively report their symptoms change and other information related to the treatment as listed the research protocol.


Eligibility criteria:
inclusion criteria: * the age ranges from 18 to85 (inclusive), regardless of gender. * patients who still have refractory hypoxia after sufficient standard treatment for severe and critical covid-19 pneumonia following the suggestion of the chinese diagnostic criteria for covid-19 pneumonia in the diagnosis and treatment plan for covid-19 pneumonia (tentative tenth edition). * 20kg/m2≤body mass index(bmi)≤30 kg/m2. * volunteer to participate in this clinical study and sign the written informed consent exclusion criteria: * those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation. * t lymphocyte abnormality (allogeneic may be considered, depending on clinical opinion), hiv positive. * highly allergic or have a history of severe allergy, especially interleukin-2 allergy. * pregnant and lactating women. * patients with severe autoimmune disease history; allergies to all biological reagents in this treatment, such as interleukin-2. * patients with serious complications, including chronic cardiac insufficiency (nyha cardiac function grading assessment of cardiac function grade iii - iv), chronic renal insufficiency (ckd stage 3 and above); chronic liver insufficiency (child-pugh score\>7); patients with malignant tumors. * patients with pulmonary embolism or acute coronary syndrome. * patients with severe organ dysfunction caused by other diseases. * there are other situations that the researcher thinks are not suitable to participate in this clinical study

Keywords: umbilical cord mesenchymal stem cells covid-19 pneumonia refractory hypoxia
bolus administration of intravenous lidocaine at the time of abdominal hysterectomy

Conditions: Abdominal Hysterectomy

Summary: the objective of the study to evaluate whether a bolus administration of intravenous lidocaine decreases postoperative pain and represents an opioid-minimizing strategy after abdominal hysterectomy compared with placebo.

total abdominal hysterectomy (tah) is the most common gynecological operation worldwide. some studies noticed about abused of opioids in postoperative care, led to a more adverse effect of opioids, slow recovery, prolong the length of hospitalized stay and consequently increase the unnecessary cost of treatment. guidelines have considered using preoperative analgesics for reducing post-operative opioids consumption, including lidocaine infusion. with its anti-inflammatory, anti-hyperalgesia and analgesic properties, intravenous perioperative lidocaine infusion (ivli) has been used for optimal postoperative care in different surgeries and in various procedures involving hysterectomy. therefore, the aim of this study is to assess the efficacy of bolus administration of intravenous lidocaine at the time of abdominal hysterectomy to decrease postoperative pain and reducing morphine requirements, after tah.

Eligibility criteria:
inclusion criteria: * women ranging age between 35-60 years a who undergoing elective total abdominal hysterectomy exclusion criteria: * participants had known sensitivity to lidocaine * participants had difficulty in intubation * participants were on chronic pain medication or already on long-term opioids * participants smokers * participants with disabilities who were unable to communicate pain levels * refuse to consent

Keywords: lidocaine postoperative pain hysterectomy
pilot study of aspirin versus warfarin for cervicocephalic arterial dissection

Conditions: Ischemic Stroke

Summary: pilot study of aspirin versus warfarin for cervicocephalic arterial dissection.

20 patients with cervicocephalic arterial dissection will be randomized to open-label aspirin or warfarin, rate of stroke and adverse events will be endpoints.

Eligibility criteria:
inclusion criteria: * clinical and imaging diagnosis of cervicocephalic arterial dissection within 3 months. exclusion criteria: * any contraindication to aspirin or warfarin.

Keywords: cervicocephalic arterial dissection
university of wisconsin solution versus new parathyroid transport solution for parathyroid allotransplantation

Conditions: Parathyroid Allotransplantation

Summary: compare the functionality of new parathyroid transport solution (npts) with university of wisconsin solution (uw) on parathyroid glands. also assess its effects on cell viability, parathormone (pth) secretion, calcium-sensing receptor (casr) and vitamin d receptor (vdr) levels during cold ischemia.

parathormone (pth) and vitamin d are two critical hormonal regulators of calcium homeostasis. there is an important relationship between the pth release and vitamin d receptor for controlling hormonal systems. also calcium-sensing receptor plays a crucial role in regulating parathormone secretion which means controlling the calcium-dependent systemic ion homeostasis. cold ischemia protects organs and tissues by slowing their metabolism. the cold ischemia of the transplant tissue is a very important process. the university of wisconsin (uw) solution substantially improves graft preservation and consequently increases patient survival. the researchers newly developed npts for transportation of parathyroid glands. for the comparision the researchers measured the parathyroid cell viability and the calcium sensing and vitamin d receptor density of the parathyroid cells at the 0, 6, 12 and 24 hours of cold ischemia.

Eligibility criteria:
inclusion criteria: * patients who have parathyroid hyperplasia due to chronic renal failure. exclusion criteria: * patients who refused to join the study * patients younger than 18 years and older than 80 years. * patients who have hepatitis b, * patients who have hepatitis c, * patients who have human immunodeficiency virus (hiv).

Keywords: parathyroid cell viability ischemia parathyroid allotransplantation vitamin d receptor calcium sensing receptor
a trial to evaluate the efficacy of magnetic resonant therapy in autism

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study is to show that a magnetic field applied to the front part of the brain of children suffering from autism spectrum disorder(asd) can improve function and ameliorate symptoms.


Eligibility criteria:
inclusion criteria: * primary diagnosis of autism spectrum disorder by diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) rendered by the examination and sufficient childhood autism rating scale 2nd edition (cars-2) score to qualify as autism. * cars-2 score between 36 and 47 inclusively * age between 4 and 12 years (at day of informed consent) * child must suffer disrupted sleep patterns defined as a minimum of 3 nights per week of delayed onset of sleep or night-time awakenings. if these are medicated with mild sedatives or melatonin and corrected, the requirement for medication or melatonin will qualify as evidence of a sleep disorder. exclusion criteria: * diagnosis of asperger's disorder, pervasive developmental disorder not otherwise specified * history of clinically significant traumatic brain injury * any condition associated with increased intracranial pressure * cerebral aneurysm * down's syndrome or other chromosomal abnormality * eeg abnormalities that indicate seizure risk * intracranial implant * unstable medical condition not otherwise specified * clinically significant organic disease unrelated to autism
manipulating the microbiome in ibd by antibiotics and fmt

Conditions: Exacerbation of Ulcerative Colitis; Ulcerative Colitis, Active Severe; Crohn's Colitis

Summary: the etiology of inflammatory bowel diseases (ibd) is closely associated with the gut microbiome. the results of previous studies on the effectiveness of antibiotics and fecal macrobiota transplantation (fmt) are contradicting. aims: to evaluate the effectiveness of wide-spectrum antibiotic regimens in acute severe colitis in an addition to standard corticosteroid therapy (uc and isolated "uc-like" crohn's colitis). the secondary aim is to assess the outcome of fmt in those not responding to five days of therapy (in either arm). as an exploratory aim, any ibd patient with a resistant disease to at least two immunosuppressive medications, may be treated with either interventions.


Eligibility criteria:
inclusion criteria: * children over the age the 2 years and adults of all ages with established diagnosis of uc using standard criteria (26, 27). * admission for iv steroid therapy * pucai of at least 65 points at admission (i.e. severe attack) * pucai\>45 at enrollment * ability to swallow antibiotics (pills or syrup) exclusion criteria: * change in dose or intervals of anti-tnf within the past 2 months prior to admission. * disease confined to the rectum (proctitis). * antibiotic use in the past 4 weeks. * any known erosive inflammation anywhere in the small bowel or esophagus. * any proven infection such as positive stool culture, parasite or c. difficile, urinary tract infection, cellulitis, abscess, pneumonia, line-infections etc. * fever \>38.5, or \>38.0c thought to be unrelated to the inflammatory process of active uc. * the probable need for second line medical therapy (infliximab, cyclosporine, tacrolimus) or colectomy within 5 days of enrollment, as judged by the caring physician. * known allergy to more than one antibiotic regimen from the list below. * pregnancy.

Keywords: ibd: inflammatory bowel diseases cd: crohn's disease uc: ulcerative colitis asc: acute severe colitis fmt: fecal microbiota transplantation pucai: pediatric ulcerative colitis activity index ciprofloxacin, doxycycline, gentamycin, amoxicillin, vancomycin, metronidazole,ciprofloxacin
cannabinoids, learning, and memory

Conditions: Cannabis; Psychotic Disorders

Summary: the overarching goal of this study is to characterize the effects of cannabinoids on working and episodic memory.

this study will be achieved by studying the acute effects of delta-9-tetrahydrocannabinol (thc), the main psychoactive component of cannabis and a cannabinoid-1 receptor (cb1r) agonist, on a wide range of memory tasks in healthy human subjects.

Eligibility criteria:
inclusion criteria: * men and women aged 18 and 55 years (extremes included) on day of first dosing * exposed to cannabis at least once in their lifetime exclusion criteria: * cannabis naive * positive pregnancy screen during screening * hearing deficits
evaluation of dexpanthenol and hyaluronic acid eye drops on corneal epithelialization after trans epithelial prk

Conditions: Corneal Epithelial Wound Healing

Summary: the aim of this prospective, contralateral, randomized, double-blind, placebo-controlled study is the evaluation of the performance of a fixed combination of dexpanthenol and hyaluronic acid preservative-free eye artificial tears eye drops, in corneal wound healing after trans epithelial photorefractive keratectomy. one eye of each patient, randomly determined, will be assigned to receive artificial tears containing a combination of dexpanthenol-hyaluronic acid (study group) while the fellow eye will receive placebo / identical combination containing the same ingredients and hyaluronic acid without dexpanthenol (control group). the drops will be applied hourly postoperatively, starting one hour after the surgery. all subjects will be treated until the day of complete reepithelialization or a maximum of 7 days postoperatively. researchers will compare the epithelialization between the two eyes. the primary endpoint is the time to reepithelialization.the secondary endpoints are the intra-individual differences measured in each eye in terms of epithelial defect size in each visit, subjective evaluation of pain (discomfort) and subjective evaluation of vision.


Eligibility criteria:
inclusion criteria: * male and female subjects aged ≥ 18 * bilateral trans prk for the correction of myopia using the schwind amaris 1050rs laser at the same treatment zone (6.5mm) * signed written informed consent ability and willingness to participate in all examinations exclusion criteria: * known hypersensitivity or intolerance to any component of the product * previous refractive surgery * myopic refractive error higher than 8.00 diopters (d) * anisometropia higher than 2.00 d * ocular or systemic disease that could affect epithelial healing

Keywords: epithelial defect re-epithelialization reepithelialization dexpanthenol trans - prk contrallateral study double-blinded study prospective study corneal healing corneal epithelium healing
dietary and dialysate sodium reduction on body fluid volume and inflammatory state in hemodialysis patients

Conditions: Chronic Kidney Diseases Stage 5

Summary: objective: to evaluate the influence of dietary sodium reduction on body fluid volume and inflammatory state in hemodialysis (hd) patients. design: prospective controlled randomized study. setting: dialysis unit of botucatu medical school hospital, sao paulo state university, brazil. patients: adult patients on hd for at least 30 days and c-reactive protein (crp) ≥ 0.7 mg/dl were randomly allocated into two groups: group a: 21 patients treated with a 2g sodium restriction in their habitual diet, and group b: 18 controls. inflammatory, biochemical, hematological and nutritional markers, as well as dialysis dosage were assessed at baseline and after 8 and 16 weeks.

the prognosis of chronic kidney diseases (ckd) patients is strongly compromised by cardiovascular (cv) complications. inflammation is established as a major risk factor for cv complications in these patients, occurring in approximately one third of them. recently, growing evidences have suggested the body water volume expansion is a cause of inflammation in ckd. in a previous study rodrigues telini showed that dietary sodium restriction reduced the inflammatory markers levels in hemodialysis (hd) patients. similar results were observed in patients treated by reduction of hd dialysate sodium concentration. however in both studies no significant reduction in body volume markers was observed. these results could be due to small number of patients or low sensibility of volume markers; on the other hand they could suggest a direct role of sodium as an inflammatory inducer independently of volume. with a larger number of patients and using a more sensitive volume marker as the b-type natriuretic peptide (bnp), this study intends to confirm the hypothesis that sodium mobilization can reduce the body water volume and attenuate the inflammatory in hd patients. a hundred thirty-five patients will be enrolled and divided in three groups with 35 patients: a, treated by reduction of 2 grams in daily sodium intake; b, exposed to reduction of sodium dialysate from 138 to 135 meq/l and c, control group. the patients will be followed up by 16 weeks and inflammatory markers (crp, interleukin-6, and tumor necrosis factor) as well as volume markers (watson formula, electrical bioimpedance measurements and bnp concentration) will be determine each 8 weeks.

Eligibility criteria:
inclusion criteria: * included patients aged ≥ 18 years who had been on hemodialysis for at least 90 days, and were diagnosed with inflammation. inflammation was defined as c reactive protein ≥ 0.7 mg/dl exclusion criteria: * acute inflammatory processes confirmed by clinical criteria and/or complementary tests * acute inflammatory diseases * tuberculosis * use of antibiotics within the past two months * chronic inflammatory diseases * neoplasias * chronic obstructive pulmonary disease * use of central venous catheter and positive hiv serology

Keywords: salt inflammation hypervolemia diet
genicular artery embolization (gae) for the treatment of chronic post knee arthroplasty pain

Conditions: Knee Pain Chronic; Knee Swelling Pain; Arterial Occlusion

Summary: this study seeks to evaluate the safety and efficacy of genicular artery embolization (gae) as a treatment for patients with chronic pain following primary total knee arthroplasty (tka) or revision tka at 6 months as measured by the knee injury and osteoarthritis outcome score (koos).

this is a single center, single arm, prospective pilot study evaluating the safety and efficacy of genicular artery embolization (gae) for treatment of chronic pain following primary total knee arthroplasty (tka) or revision tka. following screening, eligible participants will be offered enrollment. patients who demonstrate baseline imaging findings of knee synovitis either on us, mri, or both modalities will be offered gae. genicular artery embolization will be performed using a sequre® microcatheter (guerbet llc, villepinte, france) using embozene microspheres (varian medical systems, palo alto, ca).

Eligibility criteria:
inclusion criteria: 1. ambulatory 2. history of total knee arthroplasty or revision arthroplasty in the symptomatic knee 3. moderate to severe knee pain: pain vas ≥50 mm 4. knee pain resistant to at least 3 months of conservative therapy including pharmacologic therapy or intra-articular injection. 5. absence of pregnancy at time of screening as determined by urine hcg 6. provision of signed and dated informed consent form 7. willing, able, and mentally competent to provide informed consent and to tolerate angiography, us, and mri. exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in this study: 1. history of severe peripheral arterial disease symptoms including claudication, diminished or absent lower extremity pulses, leg numbness or weakness or known arterial atherosclerosis or occlusion that would limit selective angiography 2. history of inflammatory arthropathy such as rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus 3. presence of non-mri compatible devices (e.g., cardiac pacemaker). 4. known history of anaphylaxis to iodinated or gadolinium-based contrast agents 5. bmi greater than 50 6. renal dysfunction as defined by serum creatinine \>1.6 dl/mg or egfr \<60 obtained within 30 days of procedure. 7. uncorrectable coagulopathy (platelet count \ 1.5 within 30 days of procedure 8. active systemic or local knee infection 9. pregnant or intent to become pregnant during the study