Kornimate/medical-research-clean huggingface dataset:
safety and pharmacokinetics of sm04755 in subjects with advanced colorectal, gastric, hepatic, or pancreatic cancer

Conditions: Colorectal Cancer; Gastric Cancer; Hepatic Cancer; Pancreatic Cancer

Summary: this is an open-label, multi-center, dose escalation study in adult subjects with advanced colorectal, gastric, hepatic or pancreatic cancer. the study will evaluate the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of sm04755 administered orally. upon determination of the maximum tolerated dose (mtd), expansion cohorts may be enrolled.


Eligibility criteria:
inclusion criteria: * subjects with advanced colorectal, gastric, hepatic or pancreatic cancer * subjects must have recovered from all toxicity associated with previous chemotherapy, targeted therapy, or radiotherapy * subjects must meet certain laboratory criteria * expected survival \> 3months * subjects must have no uncontrolled intercurrent illness exclusion criteria: * women who are pregnant or lactating, or who are of childbearing potential , and men who do not use a barrier method * subjects with significant cardiac issues * subjects using certain medications * subjects with certain medical conditions * subjects with brain metastasis * subjects who have recently been enrolled in other experimental clinical trials of investigational agents
safety and efficacy of an anticancer medication combined with immune cells in subjects with gastrointestinal cancer

Conditions: Gastrointestinal Cancer

Summary: this is an open-label study to evaluate the safety and efficacy of an anticancer medication (a01) combined with immune cells (ic01) in subjects with advanced gastrointestinal cancer.


Eligibility criteria:
inclusion criteria: 1. signed informed consent form must be obtained prior to any research procedures; 2. age: 18 years to 70 years; 3. the patient's biological parent or child whose age ≥18 years voluntarily donates peripheral blood (200 ml) for the treatment, and who signs the informed consent form independently; 4. histologically confirmed diagnosis of gastrointestinal cancer; 5. patients who have received at least one standard treatment (surgery, chemotherapy, radiotherapy, or targeted therapy) or refuse to receive standard treatments; 6. karnofsky performance status (kps) score ≥ 70 7. expected survival ≥ 3 months 8. adequate organ function defined as: anc≥3.5×10\^9/l, plt≥50×10\^9/l, alb≥25g/l, ast≤2.5×uln, alt≤2.5×uln, tbil≤1.5×uln 9. if a subject is a female of childbearing potential, she must have a negative urine pregnancy test result. exclusion criteria: 1. patients who received chemotherapy, large-field radiotherapy or participated in other studies of anti-tumor therapy within 2 weeks before enrollment; 2. patients who have not recovered from adverse reactions related to above-mentioned procedures; 3. patients with two types of primary solid tumors; 4. patients with brain metastases or bone metastases; 5. patients with poorly controlled hypertension (systolic blood pressure \> 160 mmhg and/or diastolic blood pressure \> 90 mmhg), or cardiovascular and cerebrovascular diseases with clinical significance, such as cerebrovascular accident (within 6 months before signing informed consent), myocardial infarction (within 6 months before signing informed consent), unstable angina, congestive heart failure (new york heart association class ii or above), or severe arrhythmia which can't be controlled with drugs or have potential impact on treatment; 6. patients with other serious organic diseases or mental disorders; 7. patients with systemic or active infection; 8. patients with positive hiv test result; 9. patients who have received an organ transplant; 10. patients who are breastfeeding or pregnant.
sacubitril-valsartan versus usual anti-hypertensives in lvad

Conditions: Congestive Heart Failure; Hypertension

Summary: this pilot, feasibility study evaluates the efficacy of sacubitril-valsartan (entresto) versus usual anti-hypertensive medications in patients with left ventricular assist devices (lvad). it also measures diurnal blood pressure variations in the context of continuous flow physiology.

left ventricular assist devices (lvad) have become a life-saving therapy for patients with acc/aha stage d congestive heart failure (chf). despite longevity and improved quality of life, lvad-supported patients are plagued with adverse events, the most debilitating of all is stroke. ischemic and hemorrhagic strokes have been associated with hypertension (mean arterial pressure, or map \> 90 mmhg) in addition to out-of-range inr and aspirin doses. strict blood pressure control has been shown in a recent randomized trial to confer a significant decline in stroke rates of patients implanted with the heartware lvad. patients with poorly controlled hypertension are also at risk for inadequate left-ventricular unloading and worsening chf due to the exquisite sensitivity to afterload of the continuous flow lvad. there are no guidelines for the use of anti-hypertensives in lvad patients. most are started on standard chf therapies, though this practice varies greatly across lvad centers. the angiotensin receptor blocker-neprilysin inhibitor sacubitril-valsartan (entresto) is a potent anti-hypertensive mediation that was recently approved by the food and drug administration for the treatment of patients with heart failure and low ejection fraction. we aim to randomly assign patients to receive entresto or usual anti-hypertensive therapy for blood pressure control, then crossover to the other arm after 30 days. daily blood pressure measurements will be performed and correlated with lvad pump flows and waveform analysis.

Eligibility criteria:
inclusion criteria: * more than 30 days after lvad implant * ambulatory * map \> 85 mmhg requiring initiation of anti-hypertensive medications exclusion criteria: * allergy to acei or arb * egfr \< 30 ml/min/1.73m2 * k \> 5.4 mmol/l * map \< 60 * inability to check blood pressure at home * lack of prescription coverage * frequent hospitalizations (monthly)
project uplift: substance use and mental health treatment for young sexual and gender minorities

Conditions: Substance Use; Mental Health

Summary: this study provides substance use and mental health treatment for young sexual and gender minority adults in durham and charlotte, nc and seeks to provide intensive wraparound services that address factors that influence substance use and mental health among this population such as minority stressors and lack of social support, housing instability, lack of access to affirmative health care, and limited job opportunities.

project uplift provides evidenced-based substance use and mental health treatment, intensive case management, and peer support services for sexual and gender minorities, ages 18-35. the program is based in two metropolitan areas in north carolina, durham and charlotte, and will offer services for approximately 80 sexual and gender minority young adults. survey data collected from participants at baseline and at the end of the 6-month program will be used to evaluate the effectiveness the comprehensive care program.

Eligibility criteria:
inclusion criteria: 1) age 18-35; 2) substance use in the last 90 days; 3) self-identify as a sexual and/or gender minority; 4) reside in the durham or charlotte geographic areas including neighboring counties exclusion criteria: 1) inability to speak and read english

Keywords: sexual and gender minorities substance use and mental health treatment mental health substance use minority stress young adults intensive case management peer support
t cell memory fuels the innate response in chronic cf lung disease

Conditions: Cystic Fibrosis

Summary: this study seeks to define the role of cd4+ and cd8+ t cell memory responses in the immunologic failure of patients with cystic fibrosis (cf) to clear infections. in a normal host, the immune system clears pathogens upon re-infection more swiftly and efficiently than during an initial infection, in great part due to the recall and effector functions of memory t cells. in cf, far less is understood regarding the response of t cell memory when hosts reencounter antigens, otherwise known as pulmonary exacerbations. pulmonary exacerbations are pivotal events that lead to a decline in health status among cf patients, with many never recovering to baseline health. cf patients will be recruited from patients followed by the adult cf program at national jewish health. following enrollment at the time of antibiotic initiation, blood will be collected at two different time points. the first samples will be collected within 24 hours of starting iv antibiotic therapy. the second blood specimen will be collected at the end of hospitalization, after a minimum of 5 days. at the time of each blood draw, complete blood counts, a sputum sample, and simple spirometry will be measured as part of the standard care of a cf exacerbation. isolated pbmcs will be stained with antibodies to designate cell surface phenotype. they will then be sorted to identify the t cell population. these cells will be tested on their ability to clear pathogens. the relationship between cellular immune responses and clinical indicators of pulmonary status will be examined by fitting linear mixed models.


Eligibility criteria:
inclusion criteria: * documented diagnosis of cf. * age 18 years old or greater. * hospitalization with planned iv antibiotic treatment for a pulmonary exacerbation of cf. * ability to perform reproducible pulmonary function tests and produce sputum. * willingness to comply with study procedure and willingness to provide written consent. exclusion criteria: * presence of a condition or abnormality that, in the opinion of the principal investigator (pi), would compromise the safety of the patient or the quality of the data. * use of systemic steroids at the start of iv treatment for a pulmonary exacerbation
an epidemiological registry study to evaluate clinical practice treatment in patients with bipolar disorder

Conditions: Bipolar Disorder

Summary: the aim of this study is to describe the treatment pattern and patient characteristics in real life setting in patients with bipolar disorder treated with seroquel xr and/or seroquel ir in sweden.

an epidemiological registry study to evaluate clinical practice treatment in patients with bipolar disorder treated with quetiapine xr and/or quetiapine ir

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of bd. exclusion criteria: * patients with a diagnosis of any schizophrenia spectrum disorder after the diagnosis of bipolar disorder.

Keywords: real life setting bipolar disorder registry based data base audit
determination of target of adequate partial neuromuscular blockade for electrophysiologic monitoring during microvascular decompression surgery

Conditions: Hemifacial Spasm; Microvascular Decompression; Lateral Spread Response Monitoring

Summary: there have been reports of monitoring lsr during mvd surgery helps predicting the clinical outcome of mvd.however, there have been no evidence of which degree of partial neuromuscular blockade should be performed or no neuromuscular blockade could be performed during lsr monitoring. therefore, we performed a randomized controlled trial to evaluate the effect of different degree of partial neuromuscular blockade, including no neuromuscular blockade on the lsr monitoring for mvd surgery.

hemifacial spasm develops by vascular compression of facial nerve at the root exit zone from brain stem. microvascular decompression (mvd) is known for its curative treatment. lateral spread response (lsr) is a kind of pathologic electromyographic (emg) wave form which develops when facial nerve is compressed by vessel. there have been reports of monitoring lsr during mvd surgery helps predicting the clinical outcome of mvd. as neuromuscular blockade during lsr monitoring decreases the amplitude of emg, partial neuromuscular blockade is usually maintained during general anesthesia for mvd. however, there have been no evidence of which degree of partial neuromuscular blockade should be performed or no neuromuscular blockade could be performed during lsr monitoring. therefore, we performed a randomized controlled trial to evaluate the effect of different degree of partial neuromuscular blockade, including no neuromuscular blockade on the lsr monitoring for mvd surgery.

Eligibility criteria:
inclusion criteria: * those who undergo microvascular decompression by diagnosis of hemifacial spasm in our institution exclusion criteria: * patients were excluded from the study if they had any of following: severe cardiopulmonary disorder with hemodynamic unstability (pulmonary hypertension, cardiomyopathy, mechanical ventilation, american society of anesthesiologists physical status iii or more), severe hepatic or renal disease. * those who can not undergo mep monitoring due to central or peripheral neuromuscular disease, e.g. cerebral palsy, myasthenia gravis, acute spinal injury, neurologic shock
laryngeal disorders after childhood cardiac surgery

Conditions: Laryngeal Injury; Swallowing Disorder; Voice Disorders in Children; Surgery--Complications

Summary: laryngeal disorders after childhood cardiac surgery is a complication well described in the literature. however, the long term progression of the affected children has never been studied (all the studies stopped before 2 years of follow up).


Eligibility criteria:
inclusion criteria: * no opposition from children and parents * patient or parents able to understand the ins and outs of the study exclusion criteria: * none

Keywords: laryngeal dysfunction cardiac surgery
a single-dose study evaluating romosozumab (amg 785) in healthy postmenopausal japanese and non-japanese women

Conditions: Osteopenia

Summary: the main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (sc; injection under the skin) dose administration in healthy postmenopausal japanese and non-japanese women.


Eligibility criteria:
inclusion criteria: * japanese subjects must be first (4 grandparents, biologic parents and subject born in japan), second (4 grandparents and biological parents born in japan) or third (4 grandparents born in japan) generation japanese * body mass index ≤ 25 kg/m², inclusive at screening * postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (fsh) result \> 40 miu/ml, or 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) as documented in medical history (verified with an operative note, if available) exclusion criteria: * osteoporosis, as defined by bone mineral density (bmd) t-scores of the lumbar spine (l1-l4) or total evaluable vertebrae (if fewer than l1-l4); or femoral neck ≤ -2.5 * history of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis; * diagnosed with any condition that will affect bone metabolism

Keywords: amgen phase 1 postmenopausal japanese
prospective randomized study comparing ex-press to trabeculectomy

Conditions: Glaucoma

Summary: prospective randomized study comparing guarded ex-press to trabeculectomy. primary outcome: iop and success (complete success defined as iop between 5-18 mmhg and 20% reduction from baseline without medication or additional glaucoma surgery and qualified success defined as iop between 5-18 mmhg and 20% reduction from baseline with or without glaucoma medication but no additional glaucoma surgery). secondary outcomes: number of glaucoma medications, visual acuity, number of complications, corneal pachymetry and corneal endothelial cell counts.

complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. in addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). as an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.

Eligibility criteria:
inclusion criteria: * age 18 to 85 * open-angle glaucoma uncontrolled medically * intraocular pressure ≥ 18 mmhg * trabeculectomy as the planned surgical procedure exclusion criteria: * any previous ocular incisional surgery with the exception of previous clear * cornea cataract surgery * uveitis * vitreous present in anterior chamber * patient unwilling or unable to accept randomization or to give consent or to attend the follow up visits

Keywords: glaucoma filtration surgery trabeculectomy express shunt
postoperative follow-up of asymptomatic papillary microcarcinomas on patient survival

Conditions: Papillary Carcinoma

Summary: this is a study assessing the interest of post-operative follow-up of asymptomatic papillary microcarcinomas. today, this post-operative follow-up represents an economic cost and is a source of anxiety for patients. the aim of this study is to determine the global survival of patients with asymptomatic papillary microcarcinoma to assess the interest of a post-operative ultrasound and/or biological follow-up.


Eligibility criteria:
inclusion criteria: * patients with uni or multifocal papillary microcarcinoma (cumulative size of foci \<10mm) asymptomatic or not and who underwent partial or total thyroidectomy from 2012 to 2017. * non opposition patient * affiliation to a social security scheme exclusion criteria: * lesion crossing the thyroid capsule, or cervical lymph node involvement clinical or histological cervical lymph node involvement. * patient under guardianship, curators or safeguard of justice

Keywords: papillary carcinoma postoperative follow-up
thrombolysis using tenecteplase (metalyse®) in cardiac arrest - the troica trial

Conditions: Heart Arrest

Summary: the general aim of this study is to compare the efficacy and safety of tenecteplase to standard treatment during cardiopulmonary resuscitation in patients suffering from out-of-hospital cardiac arrest.

the trial is a prospective, international, multi-centre, randomised (1:1), double-blind, parallel group comparison conducted for investigating the efficacy and safety of tenecteplase and placebo in patients with cardiac arrest of presumed cardiac origin. approximately 1300 patients (two groups of 650 patients; tenecteplase or matching placebo) suffering from witnessed (by eye or ear) out-of-hospital cardiac arrest of presumed cardiac origin, who are treated with als-cpr will be randomised at approximately 40 study centres. randomisation is done immediately after insertion of an iv line is established. study drug application, as a single iv bolus over 5-10 seconds, should be done immediately after the first vasopressor application during the als-cpr procedure. pci facilities will be required at all participating sites, i.e. hospitals receiving patients. study hypothesis: the primary aim of the trial is to demonstrate superiority in the intent-to-treat analysis of tenecteplase over placebo with regard to primary endpoint as the incidence of 30-day survival (30daysurv). comparison(s): group a (experimental; fibrinolytic treatment) tenecteplase, as a single iv bolus over 5-10 seconds, immediately after first vasopressor dosage during standardised als-cpr procedures according to the international cpr guidelines. group b (reference) placebo, as a single iv bolus over 5-10 seconds, immediately after first vasopressor dosage during standardised als-cpr procedures according to the international cpr guidelines.

Eligibility criteria:
patients, indicated for pre-hospital als-cpr procedures\* must fulfil the following inclusion criteria: * age at least 18 years (known or estimated; no upper limit) * out-of-hospital cardiac arrest of presumed cardiac origin (including recurrent cardiac arrest(s) after initial rosc) * witnessed (by eye and/or ear) cardiac arrest * bls-cpr started within 10 min of onset (known or estimated time) and may be performed for up to 10 min, followed by als-cpr - or als-cpr started within 10 min of onset (known or estimated time) subjects who meet any of the following criteria will be excluded from randomisation into the study: * in-hospital cardiac arrest * cardiac arrest of presumed non-cardiac origin (e.g., drug overdose, carbon monoxide poisoning, drowning, hypothermia, exsanguination, electrocution, asphyxia, hypoxia, trauma, cerebrovascular accident) * obvious significant internal bleeding * known neurological impairment * known coagulation disorder * known pregnancy * known current participation in any other clinical study * known hypersensitivity to study medication * institutionalised subjects (e.g., prisoner) * any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
predicting acute kidney injury after coronary artery bypass graft

Conditions: Coronary Artery Bypass Surgery; Acute Kidney Injury; Creatinine; Mortality

Summary: acute kidney injury after cardiac surgery is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. there have been many studies reporting risk factor of acute kidney injury after cardiac surgery, but the influence of perioperative variables related to anesthesia and perioperative medication has not been evaluated fully. the investigators attempt to evaluate the influence of perioperative clinical variables including preoperative medication, preoperative albumin level, uric acid concentration, anesthesia technique, use of hydroxyethyl starch, blood glucose level, intraoperative medication, perioperative cardiac function (systolic and diastolic function) and hemodynamic variables during surgery on the incidence of acute kidney injury after coronary artery bypass graft.

acute kidney injury (aki) after cardiac surgery is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. there have been many studies reporting risk factor of acute kidney injury after cardiac surgery, but the influence of perioperative variables related to anesthesia and perioperative medication has not been evaluated fully. the investigators attempt to evaluate the influence of preoperative medication, preoperative albumin level, uric acid concentration, nl ratio, anesthesia technique, use of hydroxyethyl starch, blood glucose level, intraoperative medication, perioperative cardiac function (systolic and diastolic) and hemodynamic variables during surgery on the incidence of acute kidney injury after coronary artery bypass graft. preoperative and postoperative diastolic dysfunction may be associated with postoperative aki. in addition, preoperative neutrophil-lymphocyte ratio (nlr) which has been reported to be a marked for systemic inflammation and was associated with prognosis in cardiac patients undergoing coronary artery bypass graft or percutaneous coronary intervention. this preoperative or immediate postoperative nlr might be able to predict aki after coronary artery bypass surgery.

Eligibility criteria:
inclusion criteria: * patients who underwent coronary artery bypass surgery during between 2010 and 2012 in samsung medical center exclusion criteria: * lack of postoperative creatinine or urine output data * patients who expired within 24hours after surgery

Keywords: coronary artery bypass surgery acute kidney injury creatinine mortality