Kornimate/medical-research-clean huggingface dataset:
safety, tolerability & pharmacokinetics study of cntx-6016 in healthy subjects and subjects with pdn

Conditions: Painful Diabetic Neuropathy

Summary: a phase 1b study to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of cntx-6016 in healthy subjects and a single cohort to evaluate painful diabetic neuropathy.


Eligibility criteria:
key inclusion criteria: * is in good general health as determined by investigator's review. * has a body mass index (bmi) between 18 and 35 kg/m2. * non- or ex-smoker (\> 1 year) and has not used any nicotine containing products within 12 months prior to screening. * for females, is not currently pregnant and is either of non-childbearing potential or willing to use an adequate method of birth control. * for males, must agree to use barrier contraception and not to donate sperm key exclusion criteria: * is pregnant, lactating, or planning a pregnancy during the study. * tests positive for covid-19 after screening is complete and subject is confirmed to enroll * history of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia. * has any history or currently active type of cancer except excised or cured basal cell carcinoma. * has an immunological disorder such as, but not limited to, human immunodeficiency virus (hiv), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection. * positive urine screen for alcohol, cotinine, thc and/or drugs of abuse * has positive screening test for hepatitis b virus (hbv) or hepatitis c virus (hcv). key inclusion criteria- pdn cohort * a diagnosis/history of type 2 diabetes mellitus * the pain is present in both feet/legs with symmetrical onset * the pain is characterized as burning, painful, cold or electrical shocks in nature * the pain is associated with tingling, numbness, itching or pins and needles type sensations * the pain has been present and consistent for ≥ 6 months key exclusion criteria- pdn cohort * diagnosis of type 1 diabetes * has serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness * has a history or currently active type of cancer except excised or cured basal cell carcinoma. * has a history of psychological conditions or neurological disorders * has a history of lower back pain with radiculopathy * has received non-pharmacological treatment for pain within 14 days * has a history of frequent and/or severe allergic reactions with multiple medications

Keywords: painful diabetic neuropathy
thrombolysis outcome in ischemic stroke

Conditions: Stroke, Acute; Thrombolytic Therapy; Alteplase; Mortality

Summary: consecutive patients with diagnosis of acute ischemic stroke and candidate of thrombolytic therapy during jan 2017-mar 2019 in buali sina hospital ,sari, iran, enrolled to this cohort study. the demographic data, stroke characteristis, lab data and ... recorded. then patients evaluate every 3 month until 12 month for fallow up.

the variables of the study, including demographic characteristics, risk factors, complete drug history, nosocomial infection and other in-hospital events, hemorrhagic complications, duration of hospitalization,door to needle time, symptom to needle time, clinical and imaging characteristics of resent stroke, laboratory data including fasting blood glucose, lipid profile (total cholesterol, triglyceride, ldl, hdl), hematology markers (cbc diff, hgb, platelet), coagulation markers (pt, ptt, inr), liver function test (alt, ast, alp, bill) and renal function test (bun, cr, cr cl) were collected. all patients underwent a brain computed tomography scan early on the admission and after 24 hours. cardiological evaluation including electrocardiogram and echocardiography performed for all patients. carotid and vertebrobasillar assessed by doppler ultrasound or magnetic resonance angiography (mra). stroke severity estimated by using modified rankin scale (mrs) and national institutes of health stroke scale(nihss) scores on the first day of admission and at discharge by a neurology resident. then patient evaluate every 3 months until 12 m for fallow up and in each visit vital sign, patient clinical status, any event, barthel index was recorded. safety endpoints of this study were any adverse events clinically relevant to alteplase, specially hemorrhagic complications. all patients who met all inclusion and exclusion criteria treated with 0.9 mg/kg recombinant tissue plasminogen activator (actilyse, boehringer industry, germany) up to maximum of 90 mg, 10% of which was injected as a blous dose and remainder infused over an hour. primary outcome of this study was alteplase effect in reduce morbidity rate defined by nihss and mrs score reduction and rate of functional independence at 3,6 and 12 months barthel index in fallow up. minimal clinically important difference defined as reduce nihss score at least 25% or mrs score 2 point at discharge day in comparison to admission day. in fallow up evaluations barthel index 85-100 was considered favorable outcome. binary outcomes included independence compared with disability or death. secondary outcome was rtpa therapy safety that assessed by fatal intra cranial hemorrhage. also, mortality rate, intracranial hemorrhage rate, any hemorrhagic event rate and any adverse event rate assessed.

Eligibility criteria:
inclusion criteria: 1. writen inform consent 2. diagnosis of acute ischemic stroke by neurologist 3. met all criteria of thrombolytic therapy 4. resived full dose of alteplase exclusion criteria: 1. any contraindication of thrombolytic therapy 2. resived lower than 0.9 mg/kg alteplase
post market study for an adhesion barrier following laparoscopic myomectomy

Conditions: Fibroid; Myoma; Leiomyoma

Summary: this study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of sprayshield™ adhesion barrier plus good surgical technique, versus good surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (sll) following laparoscopic myomectomy.


Eligibility criteria:
inclusion criteria: * females, 18 years of age or older, of child-bearing potential. * subject has at least one myoma \>= 3 cm. exclusion criteria: * pregnant or lactating females. * females undergoing prior open or closed myomectomy for treatment of myomas. * evidence of current active endometriosis or infection * history of or active inflammatory bowel disease or pelvic inflammatory disease. * presence of a frozen pelvis, or hydrosalpinges.

Keywords: adhesion fibroid myoma leiomyoma myomectomy
study of roxadustat conversion in participants receiving stable esa or as initial anemia treatment in hemodialysis participants

Conditions: Anemia Associated With End Stage Renal Disease

Summary: the purpose of this study is to assess the safety and effectiveness of roxadustat dosing regimens among hemodialysis participants converted from erythropoiesis stimulating agent (esa) therapy or who are esa-naïve.


Eligibility criteria:
key inclusion criteria: * receiving chronic dialysis for end stage renal disease (esrd) * vascular access must be a functioning native arteriovenous fistula or graft with adequate flow in the opinion of the investigator, or permanent tunnelled catheter * screening hb criteria: participants converting from an esa: between 9.0 to 12.0 grams (g)/deciliter (dl); participants initiating anemia treatment: \< 10.0 g/dl * ferritin ≥ 50 nanograms (ng)/mililiter (ml), transferrin saturation (tsat) ≥ 10% at screening * participant's alanine aminotransferase (alt) and aspartate aminotransferase (ast) are ≤ 3 x upper limit of normal (uln), and total bilirubin (tbl) is ≤ 1.5 x uln at screening and prior to initiating roxadustat treatment. * body weight between 45.0 to 160.0 kg key exclusion criteria: * red blood cell (rbc) transfusion within 4 weeks prior to enrollment * known history of myelodysplastic syndrome or multiple myeloma * known hereditary hematologic disease or other known causes for anemia other than chronic kidney disease (ckd) * known chronic inflammatory disease that is determined by the investigator to be the primary cause of anemia * active or chronic gastrointestinal bleeding * treated with iron-chelating agents within 4 weeks prior to enrollment * history of new york heart association (nyha) class iii or iv congestive heart failure * history of myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (excluding vascular dialysis access stenosis/thrombosis) within 12 weeks prior to enrollment * uncontrolled hypertension, in the opinion of the investigator * participant has a diagnosis or suspicion (for example, complex kidney cyst of bosniak category ii or higher) of renal cell carcinoma (principal investigator's discretion) * history of malignancy, except for cancers determined to be cured or in remission for ≥ 2 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
continued access of focal mr-guided focused ultrasound for localized intermediate risk prostate lesions

Conditions: Prostate Cancer

Summary: this extended clinical investigation is a multicenter, prospective, single arm study intended to provide continued access of the exablate model 2100 device (exablate prostate) to patients for treatment of prostate lesions and collect additional safety and effectiveness data during the 510(k) preparation and review period.


Eligibility criteria:
inclusion criteria: * biopsy proven adenocarcinoma of the prostate * intermediate risk, organ-confined prostate cancer (t1a up to t2b) and voluntarily chooses exablate, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy * up to 2 mri visible gleason 7 confirmed on mapping prostate biopsy that investigator deems treatable within a single treatment session; may have secondary gleason 6 on ipsilateral or contralateral side confirmed with biopsy and/or mri * psa less than or equal to 20ng/ml exclusion criteria: * evidence of distant prostate cancer including lymph node involvement and/or metastasis of cancer * subject undergoing androgen deprivation therapy, initiating any new medication that can affect psa, or history of bilateral orchiectomy * active bladder cancer, active uti, or untreated prostatitis * untreated urethral stricture/bladder neck contracture * prostate-specific chemotherapy, brachytherapy, cryotherapy, photodynamic therapy, radical prostatectomy, or focal therapy (excluding fus); or any prior radiation therapy to the pelvis for prostate cancer or any other malignancy * subjects with pathology or implants that may adversely impact treatment due to acoustics, imaging, or safe probe insertion * subject not able or willing to tolerate the required prolonged stationary supine position during treatment * contraindications to mri
residual gastric volume measured by ultrasound in diabetic surgical population versus non-diabetic surgical population.

Conditions: Diabetes Mellitus

Summary: comparison of residual gastric volume measure by ultrasounds between diabetic and non-diabetic patients scheduled for elective surgery

the presence of gastric content increases the risk of aspiration during general anesthesia. delayed gastric emptying has been described in diabetic patients; for that reason, diabetic patients could have a high risk of aspiration despite adequate fasting. this study aimed to compare ultrasound-guided measurement of residual gastric volume between diabetic and non-diabetic patients scheduled for elective surgery.

Eligibility criteria:
inclusion criteria: * bmi\<40 kg.m-2; * age over 18 years; * american society of anesthesiologists' physical status status i-iii * who were to undergo elective surgery and had the ability to understand the rationale of the study and provide informed consent exclusion criteria: * pregnancy * recent upper gastrointestinal bleed (\< 1 month) * abnormal anatomy of the upper gastrointestinal tract (such as hiatal hernias and gastric tumors) * previous surgical procedures on the esophagus, stomach, or upper abdomen * gastroesophageal reflux disease * previous use of prokinetics or high doses of opiates.

Keywords: diabetes mellitus gastric ultrasound full stomach surgery
the effect of the anticholinergic burden following elective coronary artery surgery

Conditions: Mortality; Postoperative Complications

Summary: many drugs have anticholinergic activity. this means that it blocks the muscarinic binding of the neurotransmitter acetylcholine. in this study, the anticholinergic burden of the patients in the perioperative period will be calculated with the anticholinergic cognitive burden scale (acbs) and patients with a score of 1 or above will be included in the study. anticholinergic load of drugs used in the intraoperative period; its effect on postoperative hospital stay, morbidity and mortality following elective heart surgery will be investigated.


Eligibility criteria:
inclusion criteria: * patients undergoing elective coronary artery bypass surgery * patients with high anticholinergic burden exclusion criteria: * all other procedures except isolated coronary bypass surgery * patients with low anticholinergic burden * patients whose records cannot be accessed through the data system

Keywords: cardiac surgery anticholinergic burden
impacts of stoppa and total extraperitoneal inguinal hernia repair on the lower extremity muscular functions

Conditions: Hernia, Inguinal

Summary: comparison of physical activity parameters of the lower extremity muscles in patients who received total extraperitoneal repair (tep) and stoppa repair.

the patients were evaluated during the preoperative period and in the postoperative day 3, to achieve an isometric and isokinetic, objective assessment of the pain-related lower extremity muscular function changes.

Eligibility criteria:
inclusion criteria: * unilateral inguinal hernia exclusion criteria: * contralateral hernia repair history * recurrent inguinal hernia * incarceration or strangulation * bilateral inguinal hernia * severe congestive heart failure * severe hypertension * rheumatoid arthritis * systemic or neurologic diseases altering lower extremity functions
(ymp) young moms program

Conditions: Chronic Toxic Stress; Developmental/ Behavioral Regression in Young Children

Summary: young moms program (ymp) is designed to address systemic barriers to the health and stability of young moms and their children such as the lack of coordination of service delivery or logistical barriers within the health system. the ymp also streamlines the referral pipeline, connecting moms to evidence-based resources, and ensuring children complete all recommended assessments prior to kindergarten.

this application is a community-engaged research collaboration between the non-profit imprints cares, the wake forest baptist medical center (wfbmc) birth center, and wake forest school of medicine (wfsom). this project addresses the myriad risks associated with young moms ≤ 21 years old. because ymp is a tiered program model, services meet parents where they are through a "warm hand-off" approach that uses one-on-one consultation and assessment-based interventions.

Eligibility criteria:
inclusion criteria: * subject must be an immediately post-partum mother * subject will reside with her newborn * subject must be referred from either the birth center at wake forest baptist health or from one of the wake forest baptist health patient priorities care (ppc) partner practices * participants must speak english or spanish exclusion criteria: * newborn of participating mothers must be \>= 35 weeks of gestation and not have an extended neonatal intensive care unit (nicu) stay

Keywords: young moms child health teen births child maltreatment food insecurity
pain management with virtual reality hypnosis

Conditions: Hypnosis; Labor Pain; Virtual Reality; Labor Induction; Latent Period

Summary: the latency phase corresponds to the first phase of the first stage of labour, during which the parturient feels regular, rhythmic uterine contractions that are often painful, with or without changes of the cervix. this phase lasts an average of 8 hours for primiparous women, compared with 5 hours for multiparous women, and can last up to twenty hours in total. cervical ripening corresponds to the medical induction of regular, painful uterine contractions in order to obtain a favourable cervix for the induction of labour. cervical ripening is carried out either medically (oral or local prostaglandins) or mechanically (double balloon dilatation) and accounts for 69.2% of labour inductions, which in turn account for 25.8% of births. at amiens-picardie university hospital, this maturation stage can last from a few hours to 2 days, depending on the service protocol. what these two stages of childbirth have in common is that they are both painful, with very few analgesic drugs available that can be used without side-effects on the foetus during pregnancy. in recent years, there has also been a growing demand from parturients for the use of non-medicinal therapies. it therefore seems essential to provide parturients with as many effective non-drug methods as possible to manage their pain properly. if virtual reality hypnosis sessions prove to be effective, they will provide better pain management for women in labour, reduce the use of morphine derivatives (with their attendant side-effects, particularly on the foetus), and above all meet the growing demand from women in labour for the most physiological possible support during childbirth.


Eligibility criteria:
inclusion criteria: * parturient over 18 * parturient who speaks and understands french * parturient hospitalised prior to labour * membranes intact or ruptured * spontaneous or induced labour * parturient in latency phase * term ≥ 37sa * end \> 3 * parturient requiring active pain management (medicinal or non-medicinal) * low-risk pregnancy exclusion criteria: * parturient under legal protection * parturient with a hearing impairment * parturient with visual impairment * parturient with epilepsy * parturient with psychiatric problems * pathological pregnancy * parturient with chronic pain * parturient with addiction-related disorders * parturient allergic to paracetamol * parturient allergic to phloroglucinol * parturient allergic to codeine * parturient allergic to nalbuphine * parturient allergic to orozamudol

Keywords: hypnosis labor pain virtual reality labor induction latent period
engaging hiv patients in primary care by promoting acceptance

Conditions: HIV

Summary: engagement in primary care for people living with hiv/aids (plwha) is a significant public health concern because reduced commitment to care puts plwha at risk for illness progression, death, and transmission of hiv to others. this project will develop a novel treatment, brief acceptance-based behavior therapy (abbt), to promote self-acceptance of hiv status as a pathway to reducing engagement barriers. the clinical and public health impact of this project will be the development of a simple, low-cost, disseminable intervention that enhances longitudinal commitment to care so plwha can obtain effective medical treatments that will prolong survival and improve quality of life. we hypothesize that individuals randomized to brief abbt will showed increased longitudinal attendance of primary care appointments.


Eligibility criteria:
inclusion criteria: * new to the primary care clinic * hiv+ * between 18 and 60 years old * entering hiv care for the first time * able to speak and read english sufficiently to be able to complete the study procedures * have access to a telephone exclusion criteria: * psychiatrically or cognitively impaired

Keywords: hiv primary care engagement acceptance disclosure stigma
prediction of lymph node invasion for prostate adenocarcinoma

Conditions: Adenocarcinoma of the Prostate

Summary: despite lymph node involvement (lni) being one of the main prognostic factors in patients with prostate cancer (pca), pelvic lymph node irradiation remains debated, possibly due to an insufficient selection of patients. significant advances in lni risk modelling have been achieved with the addition of visual interpretation of magnetic resonance imaging (mri) data, but it is likely that quantitative analysis could further improve prediction models. in this study, the investigators aimed to develop and internally validate a novel lni risk prediction model based on radiomic features extracted from pre-operative multimodal mri.


Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of the prostate treated by prostatectomy with extensive lymph node dissection * available pre-operative +/- pet choline exclusion criteria: * unanalyzable pre-operative mri

Keywords: mri lymph node
evaluation of the drug plerixafor in combination with chemotherapy and g-csf for stem cell collection

Conditions: Myeloma; Lymphoma

Summary: the purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and g-csf can better activate your bone marrow stem cells to improve the chances of transplant. the study will look for the activation of a certain type of blood cell, called cd34+ cells in patients who receive plerixafor, chemotherapy and g-csf. the investigators will follow the number of patients that achieve the target numbers of cd34+ cells. the number of patients achieving the target level of cd34+ cells, and the total number of cd34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and g-csf, without plerixafor. the investigators will also test the safety of the combination of plerixafor with chemotherapy and g-csf and look at the success of the transplantation after 12 months.


Eligibility criteria:
inclusion criteria: 1. age 18-70 years 2. multiple myeloma (mm) or non-hodgkin's lymphoma (nhl) patients in first or second complete or partial remission 3. eastern cooperative oncology group (ecog) performance status of 0 or 1 4. up to 3 prior treatment regimens 5. meet all eligibility requirements for autologous transplant 6. adequate marrow function defined as white blood cells (wbc) \>3,000; anc \>1,500/mm3; platelets \>75,000/mm3 7. adequate renal function defined as creatinine clearance \> 30 ml/min by cockcroft-gault 8. adequate liver function defined as aspartate aminotransferase (ast)/alanine aminotransferase (alt)/bilirubin \< 2 times upper limit of normal 9. able to provide informed consent 10. women not pregnant and agree to use contraception exclusion criteria: 1. high risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease) 2. brain metastases or carcinomatous meningitis 3. previous treatment with high dose chemotherapy and autologous transplant 4. previous attempt to collect b-hematopoietic progenitor cells (hpcs) following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors 5. acute infection or unexplained fever \>38°c 6. weight \> 175% of ideal body weight as defined by the devine equation 7. experimental therapy within 4 weeks 8. cytokine administration in the previous 14 days

Keywords: myeloma lymphoma stem cell transplantation