Kornimate/medical-research-clean huggingface dataset:
a study of vemurafenib in participants with braf v600 mutation-positive cancers

Conditions: Multiple Myeloma, Neoplasms

Summary: this open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with braf v600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. the safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0-2 * must have recovered from all side effects of their most recent systemic or local treatment * adequate hematological, renal and liver function for solid tumors only: * histologically confirmed cancers (excluding melanoma and papillary thyroid cancer) with a braf v600 mutation and that are resistant to standard therapy or for which standard or curative therapy does not exist * measurable disease according to response evaluation criteria in solid tumors (recist) for multiple myeloma only: * confirmed diagnosis of multiple myeloma with a braf v600 mutation * must have received at least one prior systemic therapy for the treatment of multiple myeloma * treated with local radiotherapy * must have relapsed and/or refractory multiple myeloma with measurable disease exclusion criteria: * melanoma, papillary thyroid cancer or hematological malignancies (with the exception of multiple myeloma) * uncontrolled concurrent malignancy * multiple myeloma: solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia * active or untreated central nervous system (cns) metastases * history of or known carcinomatous meningitis * concurrent administration of any anti-cancer therapies other than those administered in this study * other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that would, in the investigator's opinion, contraindicate participation in this study
musk myasthenia 1000 study

Conditions: Myasthenia Gravis; MuSK MG; MuSK Myasthenia Gravis

Summary: the musk myasthenia gravis 1000 study seeks to collect saliva samples from 1000 subjects with laboratory confirmed diagnosis of musk myasthenia to identify genetic variations associated with musk mg. the data collected may be used by researchers to gain a better understanding of the cause of musk mg and to identify biomarkers and targeted therapy for musk mg.

myasthenia gravis is a rare, neuromuscular (disease of the muscle and nerves) autoimmune disease characterized by weakness of the muscles. mg has a prevalence of approximately 14-40 per 100,000 people in the united states. there is no cure for mg, however understanding the disease is crucial to pave the way for development of new therapies. important to note, the most common subtype of mg associated with acetylcholine receptor antibodies (achr) are found in more than 80% of patients with generalized myasthenia gravis, whereas muscle-specific kinase (musk) antibodies are found in only 8% of mg patients. these are found in patients with the achr antibodies. since the discovery of musk antibodies in patients, much has been learned. it has become clear that musk antibody mg differs in many ways from achr antibody mg. there is some information that specific genetic factors play a role in development of musk mg. our objective is to collect saliva samples from 1000 subjects with laboratory confirmed diagnosis of musk myasthenia. these saliva samples will be then sent to the laboratory of bryan traynor who directs the neurogenetics laboratory at nih. dr. traynor will conduct a genome-wide association study (gwas). this study will provide important information of genetic factors leading to musk mg. gwas, also known as genome-wide association study, is a study performed to identify genetic characteristics associated with a particular disease. gwas is currently used across various disciplines in medicine to better understand complex conditions where genetic risk factors contribute to the development of diseases. presently, this study has not been done in patients with musk mg. researchers can use information from this study to develop quality treatment and ultimately, move toward targeted therapy approach for patients. we hope to find unique results and further enhance myasthenia research.

Eligibility criteria:
inclusion criteria: * lab test confirming diagnosis of musk myasthenia gravis * willingness to provide saliva sample via mail or in person exclusion criteria: * inability to provide informed consent * unwillingness to provide lab results of elevated muscle specific kinase antibody * unwillingness to provide saliva sample
urinary retention rates in clinical practice after treatment with onabotulinumtoxina for idiopathic overactive bladder

Conditions: Urinary Bladder, Overactive

Summary: this study is a retrospective chart review of patients treated with botox® for idiopathic overactive bladder (oab) as standard of care in clinical practice. the study will determine the rate of post procedural urinary retention requiring catheterization and identify factors that may predict urinary retention.


Eligibility criteria:
inclusion criteria: -patients treated with botox® for overactive bladder. exclusion criteria: * received botulinum toxin formulations other than botox® in the bladder. * had symptoms of oab associated with a neurological condition. * had a history of chronic urinary retention treated with clean intermittent catheterization (cic) or indwelling catheter.
assessment of the therapeutic utility of r-fsh in association with hmg-hp

Conditions: Sterility

Summary: to assess the effectiveness of a protocol of ovarian hyperstimulation combining urinary gonadotrophins + recombinant gonadotrophins, to achieve clinical pregnancy in females undergoing ivf. study hypothesis: to assess the effectiveness of protocols combining urinary gonadotrophins + recombinant gonadotrophins


Eligibility criteria:
inclusion criteria: * women aged 18-38 years * body mass index (bmi) between 18 and 30 * women classified as normogonadotrophin patients. not more than 3 previous cycles of art (assisted reproductive technology) * testosterona, fsh (follicle-stimulating hormone), lh (luteinizing hormone) and prolactin serum levels during the early folicular phase (days 2-4 of the cycle) within the laboratory normal range * no administration of clomiphen citrate or gonadotropins during the month prior to the start of the study exclusion criteria: * failure in previous cycles of assisted reproduction ivf/icsi (in-vitro fertilisation/intracytoplasmic sperm injection) * seminal samples not apt for ivf-icsi (according to the criteria of each center). evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months * data suggestive of possible ovarian failure * antecedents of severe ovarian hyperstimulation syndrome (ohss) * important systemic disease * pregnancy or contraindication to pregnancy
central line study

Conditions: Shock

Summary: two different techniques for placing a central venous catheter will be compared. the studyu team hypothesizes that clinicians randomized to the peripheral catheter technique will have higher first attempt success rates, fewer procedural complications, and a shorter mean time to procedure completion than physicians assigned to wire through hollow bore needle.

central venous catheterization (cvc) is a lifesaving procedure carried out by emergency and acute care physicians to access proximal blood vessels in order to deliver medications, blood products and other resuscitative agents. typically, this access is achieved by threading a wire through a hollow bore needle and then placing the central venous catheter over the wire. this procedure, called the seldinger technique, results in the cannulation of the femoral or internal jugular veins. nowadays, physicians use concurrent ultrasound guidance rather than an anatomic landmark-based approach to increase the success rate of central venous catheterization. the wire through hollow bore needle approach requires the use of two hands to hold the needle in the vessel in order to pass a guidewire. when done under ultrasound guidance, this requires dropping the ultrasound probe in order to have both hands available to achieve vessel cannulation. recent research has demonstrated that cannulation of central veins can be obtained by first using a peripheral intravenous catheter rather than a hollow bore needle. this technique requires just one hand, thereby allowing the physician to continue use of the ultrasound. furthermore, the peripheral intravenous catheter is more stable within the vein than the hollow bore needle and less likely than the needle to damage the vessel wall when the catheter is jiggled. this is the same technique used to place mid-lines, a hybrid technique that incorporates the seldinger technique and a peripheral intravenous catheter.

Eligibility criteria:
inclusion criteria: adult patients in the emergency department who require ultrasound guided central line placement are eligible for participation and will be referred for participation in the study by the clinical team. exclusion criteria: * inherited, acquired, or medication related coagulopathy or thrombocytopenia (platelets \< 100,000). patients will not be excluded for use of aspirin or other anti-platelet medication. * previous central venous access at the same anatomical site. * any indwelling catheter or wire that could potentially interfere with central line placement * anterior border of the target vein deeper than 3.5cm or for any clinical feature that would interfere with obtaining informed consent including dementia, delirium, or encephalopathy, as determined by the clinical attending physician.
function preserving gastrectomy for t1/2 gastric cancer patients

Conditions: Gastric Cancer; Gastrostomy

Summary: the real world based multi-cohorts study aims to evaluate the safety and effectiveness of function preserving gastrectomy including pylorus-preserving distal gastrectomy, proximal gastrectomy and wedge gastrectomy for t1 and t2 gastric cancer patients.

gastric cancer patients with clinical stage t1/2 will be screened for the study. for the patients enrolled, a multidisciplinary discussion will be performed to evaluate the proper gastrectomy for the patients and functional preserving gastrectomy will be considered for the indicated patients. for patients not proper for functional preserving gastrectomy, standard gastrectomies will be suggested. after surgery, a close follow up will be performed. during the study, a thorough data collection will be performed to evaluate the safety and effectiveness of functional preserving gastrectomy and recovery and postoperative function of remnant stomach.

Eligibility criteria:
inclusion criteria: * karnofsky performance over 70% * histologically proven gastric or gastroesophageal joint adenocarcinoma with clinical stage t1-2n0-3m0 * no severe comorbidity with estimated survival less than 5 years exclusion criteria: * pregnancy * signs of distant metastases * received chemotherapy, radiotherapy, immune therapy * received gastrectomy * other malignant tumors within 5 years except for cured skin cancer and cervical caner in situ. * uncontrolled epilepsy, central nervus system disease or mental disease that affect the compliance of treatment and follow-up * severe heart disease * organ transplantation that needs immunosuppressor * emergency surgery due to hemorrhage, perforation and ileus of gastric cancer

Keywords: gastric cancer function preserving gastrectomy
pharmacokinetic and pharmacodynamic effects of mtr107 in end-stage renal disease (esrd) patients

Conditions: Hypotension; End Stage Renal Disease; Intra Dialytic Hypotension

Summary: mtr107 effect on blood pressure throught the dialysis procedure and its ability to prevent intra dialytic hypotension

the present clinical trial aims to investigate and provide a more precise characterization of the pharmacokinetic and pharmacodynamic profile of mtr107 in a population of esrd patients predisposed to developing intradialytic hypotension. the study is also designed as a dose esclating study aiming to assess mtr107 safety.

Eligibility criteria:
inclusion criteria: 1. age 20-75 years, inclusive. 2. presence of frequent bouts of hypotension defined as 3 or more intradialytic hypotensive events per month for the last six months prior to baseline, despite standard adjustments in dry weight. 3. ecg performed up to one month before study start. 4. well-preserved hepatic function (within normal laboratory ranges) at study entry as judged by: * serum bilirubin (total bilirubin (direct and indirect) 0.3-1.0 mg/dl, and direct bilirubin 0.1-0.5 mg/dl) * serum albumin (\>3.6 g/dl), * serum aminotransferases (ast (0-37 u/l) and alt (0-40 u/l)), * ggt (gamma glutamine trans peptidase) 5. normal coagulation status at study entry as judged by pt-inr, ptt, fibrinogen and platelet count. 6. willingness to participate in the study and adhere to the study design. 7. willingness to sign an informed consent form. exclusion criteria: 1. uncontrolled hypertension \>140/90 mmhg. 2. unstable angina. 3. abnormal ecg which may indicate acute disease 4. variable weight gains. 5. mental retardation. 6. pregnancy. 7. malignancy or other concomitant serious diseases. 8. current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days.

Keywords: hypotension end stage renal disease intra dialytic hypotension esrd blood pressure dialysis
phase 2 study to evaluate the efficacy, safety and pk of intravenous single injection lc28-0126 immediately before pci in stemi patients

Conditions: ST-segment Elevation Myocardial Infarction

Summary: evaluate the efficacy, safety and pharmacokinetics of intravenous single injection lc28-0126 immediately before pci (percutaneous coronary intervention) in patients with stemi (st-segment elevation myocardial infarction)


Eligibility criteria:
inclusion criteria: * age between 20 and 75 * within 12 hours after the onset of chest pain * st-segment elevation of more than 0.1 mv in two contiguous leads or new lbbb(left bundle-branch block) patients * signed for written informed consent exclusion criteria: * left main disease * multi-vessel disease
chemo-genomics based treatment of acute myeloid leukemia

Conditions: Leukemia, Myeloid, Acute

Summary: adult acute myeloid leukemia (aml) is a heterogeneous hematologic malignancy associated with poor prognosis, especially after relapse. high-throughput genomic studies have highlighted the importance of molecular alteration in the pathophysiology, clinical evolution and treatment response of aml. in addition, identification of specific gene mutation can be targeted by specific inhibitors, opening the way to personalized treatments. however, only a limited number of gene mutations are druggable or actionable, highlighting the need for additional information to guide treatment choices. among them, new drug screening tests (dst) allow for the screening of library of hundreds of drugs to ex-vivo patient-derived aml cells. combination of genomic and pharmacologic approaches might therefore improve prediction of drug effects. there is an urgent need to bring these approaches into the clinic but feasibility trials are necessary before incorporating them into treatments strategies.the proposed study is a prospective multicentre feasibility study of a combined "chemo-genomic" approach in patients with advanced aml.


Eligibility criteria:
inclusion criteria: * age \>18 years * diagnosis of acute myeloid leukemia according to who classification * refractory or relapsed disease * ecog performance status of \<3 * life expectancy \>3 months * written informed consent * affiliation to the french social security system. exclusion criteria: * diagnosis of acute promyelocytic leukemia. * patients deprived of liberty or placed under the authority of a tutor.

Keywords: acute myeloid leukemia- refractory aml- relapsed aml- precision medecine-
the use of propranolol to block memory reconsolidation in ptsd

Conditions: Posttraumatic Stress Disorders

Summary: the purpose of this investigation is to see if propranolol will reduce the psychophysiological hyperactivation associated with memories of combat stress in veterans with posttraumatic stress disorder.

the goal of this translational research project is to generate a pilot sample of data from an investigation of a novel therapeutic approach to post traumatic stress disorder (ptsd). current treatments for ptsd include exposure and other aspects of cognitive therapy as well as drug therapies based on serotonin-reuptake inhibiting antidepressant agents. however, these treatments are often unsuccessful, and symptoms in affected individuals may persist for decades. the central hypothesis guiding this research project posits that acquired fear responses, such as those in ptsd, when reactivated by recall become sensitive to noradrenergic modulation and thus may be permanently attenuated by blocking noradrenergic transmission. further, we predict that this attenuation will facilitate subsequent therapy. in the current study, we will be investigating this model in three groups of veterans of either operation iraqi freedom or operation enduring freedom (oif/oef) with ptsd: 1) individuals who receive propranolol following recall of a traumatic memory (propranolol-trauma); 2) individuals who receive a placebo following recall of a traumatic memory (placebo-trauma), and; 3) individuals who receive propranolol following recall of an affective neutral memory (propranolol-neutral). in addition, traumatic memory recall will be psychophysiologically assessed by measuring veterans' facial corrugator electromyography (emg), skin conductance, blood pressure and cardiovascular inter-beat interval responses pre- and one month post-medication administration.

Eligibility criteria:
inclusion criteria: * participants will meet the clinical criteria of ptsd (dsm ivtr) secondary to combat exposure. exclusion criteria: * current illicit substance use or alcohol consumption, as determined by urine toxicology and alcohol breath test. * any diagnosis of current comorbid psychotic disorders, bipolar disorder, or illicit substance or alcohol abuse or dependence. * any current prescription medication usage or supplement (dietary or herbal) usage that is contraindicated with propranolol. * active enrollment into any psychiatric or psychological treatment. * any condition that contraindicates the use of propranolol, such as: * history of bronchial asthma. * heart block. * sinus bradycardia. * congestive heart failure. * insulin-dependent diabetes. * initial systolic blood pressure \< 100 mmhg. * hyperthyroidism. * thyroid disease. * renal or liver impairment.
vitamin d receptor, interleukin-1a and interleukin-1b gene polymorphisms in periodontitis

Conditions: Periodontitis; Polymorphism, Restriction Fragment Length

Summary: background: the aim of the study is to find out the prevelance of vdr (rs731236), il1b (rs1143634) and il1a (rs1800587)gene polymorphisms in turkish population and their association with stage iii grade b / c periodontitis. methods: individuals who were found to be systemically and periodontally healthy (n = 100) after clinical and radiographic examination and who were diagnosed with stage iii grade b / c periodontitis (n = 100) were included in the study. gingival index, plaque index, bleeding on probing, clinical attachment level and pocket depths of the patients were recorded. subjects genotyped for rs731236, rs1143634 and rs1800587 gene polymorphisms with real time polymerase chain reaction.

in this study we recruited 200 participants from the periodontology clinics. periodontal clinical parameters such as plaque index, gingival index, probing depth and clinical attachment level were assessed. genotyping rs731236, rs1800587 and rs1143634 gene polymorphisms was performed by real time polymerase chain reaction.statistical analysis was done by the statistical software package spss v16. snpassoc.

Eligibility criteria:
inclusion criteria: systemically healthy, previously untreated periodontitis patients exclusion criteria: presence of systemic disease such as diabetes, rheumatic fever, liver or kidney diseases, neurologic deficiencies, immunologic diseases; pregnancy; smoking; receive of any medication which may affect periodontal tissues; used antibiotics for any purpose within 6 months.

Keywords: vitamin d receptor polymorphism periodontitis, interleukin-1b interleukin-1a
cmr features in patients with suspected myocarditis

Conditions: Outcome, Fatal

Summary: presentation of myocarditis is heterogeneous, often ranges from being asymptomatic, to chest pain, dyspnoea, palpitations, and even sudden cardiac death. diagnosing myocarditis is challenging with no current uniform clinical gold-standard. cmr is a key investigative tool, however the predictive value of cmr features is unknown. in this study we assess 670 consecutive patients with suspected myocarditis who were referred for cmr between 2002 and 2015 at the bwh. cmr features such as late gadolinium sizing, t1 mapping, extracellular volume fraction assessment, strain analysis (feature tracking), clinical data, labortory tetsings and electrocardiogramm are linked to the outcome in order to assess its predictive value.


Eligibility criteria:
inclusion criteria: * patients referred by their treating physician to undergo cmr for "suspected myocarditis" as the primary clinical question exclusion criteria * evidence of coronary artery disease * hypertrophic cardiomyopathy * arrhythmogenic right ventricular cardiomyopathy * cardiac sarcoidosis * cardiac amyloidosis * takotsubo cardiomyopathy * constrictive pericarditis * loeffler endocarditis * ventricular non-compaction * cardiac tumor * pulmonary embolism * severe valve disease
a study of mk-6213 co-administered with atorvastatin in participants with hypercholesterolemia (mk-6213-006)

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to test the safety and effectiveness of mk-6213 as compared to mk-6213/atorvastatin in participants 18 to 75 years) with high cholesterol.


Eligibility criteria:
inclusion criteria: * 18 to 75 years of age at the time of the study with high cholesterol * can have diabetes mellitus but is not currently on lipid lowering therapy * have a stable weight for \>6 weeks exclusion criteria: * has significant cardiovascular (heart), renal (kidney), neurologic (nervous system), respiratory (lung), hepatic (liver) or metabolic disease * history of mental instability or drug/alcohol abuse within the past 5 years * pregnant or nursing; human immunodeficiency virus (hiv) positive; history of cancer within the past 5 years or participation in an investigational trial within the last 30 days