Kornimate/medical-research-clean huggingface dataset:
stimulating the brain to improve self-awareness

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this study investigates whether introspective accuracy (ia) can be improved in individuals with schizophrenia by stimulating the brain via transcranial direct current stimulation (tdcs).

self-awareness is markedly impaired in severe mental illness including schizophrenia and schizoaffective disorder. this impairment spans awareness of symptoms as well as deficits in the estimation of abilities and capabilities, which we refer to as introspective accuracy (ia). recent work has provided evidence of ia deficits in schizophrenia spectrum disorders, specifically in the abilities to retrospectively judge everyday functioning and neurocognitive impairment, as well as the ability to make correct real-time judgments of performance on neurocognitive tests. transcranial direct current stimulation (tdcs) is a form of noninvasive neurostimulation which has been proposed as a therapeutic procedure in numerous psychiatric disorders. tdcs in healthy adults has been demonstrated to improve cognitive and memory performance, and in schizophrenia, tdcs has been found to improve emotion recognition ability. tdcs thus appears to be a promising therapeutic technique that may be useful for improving ia. this study will compare ia performance in individuals with schizophrenia across two conditions: active anodal tdcs and sham tdcs.

Eligibility criteria:
inclusion criteria: * age: 18-55 * dsm-iv-tr or dsm-5 diagnosis of schizophrenia or schizoaffective disorder and clinically stable (i.e., no hospitalizations) for at least 8 weeks and on a stable medication regimen for at least 6 weeks with no dose changes for a minimum of 2 weeks exclusion criteria: * presence or history of pervasive developmental disorder (e.g., autism) or mental retardation (defined as iq \<70) by dsm-iv criteria * presence or history of medical, cardiac, or neurological disorders that may affect brain function (e.g., cardiac disease, endocrine disorders, renal disease, pulmonary disease, history of seizures or head trauma with unconsciousness for a period of 15 minutes or greater or cns tumors) * presence of sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments that interfere with assessment * not proficient in english * presence of substance abuse in the past one month * presence of substance dependence not in remission for the past six months * contraindications for tdcs (e.g., pregnancy or implanted devices such as pace maker)
quantification of contrast enhanced ultrasound (ceus) in the detection of prostate cancer

Conditions: Prostate Cancer

Summary: with contrast enhanced ultrasound (ceus) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. the past years numerous studies have been performed with ceus, all basing their results on subjective judgement of the investigator. ceus image interpretation is difficult and requires a well-trained expert. to overcome these difficulties ceus quantification techniques can be of use. the techniques used in this protocol have been developed in cooperation with the technical university in eindhoven (tu/e) and bracco, geneva. the investigators hypothesize improvement of the pca detection rate with quantification, compared with subjective ceus interpretation and known numbers in literature. also a comparison between quantification results and tumour differentiation grade (gleason score) will be made, the investigators hypothesize a positive correlation.


Eligibility criteria:
population: all patients already scheduled for biopsy because of a raised prostate-specific antigen (psa) and/ or abnormal digital rectal examination (dre) in the academic medical centre (amc), excluding patients who do meet the exclusion criteria. inclusion criteria: * age ≥ 18 years * signed informed consent exclusion criteria: * has documented acute prostatitis or urinary tract infections. * history of any clinically unstable cardiac condition including class iii/iv cardiac failure or right-to-left shunts. * has had severe cardiac rhythm disorders within the last 7 days. * has severe pulmonary hypertension (pulmonary artery pressure \>90 mmhg) or uncontrolled systemic hypertension or respiratory distress syndrome * has received a biopsy procedure within 30 days before admission into this study * has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study. * is incapable of understanding the language in which the information for the patient is given.

Keywords: contrast enhanced ultrasound (ceus) prostate cancer quantification prostate biopsies transrectal ultrasound (trus) microbubbles
phase ib/ii study of efficacy and safety of mek162 and panitumumab, in adult mcrc patients with mutant or wild-type ras tumors

Conditions: Metastatic Colorectal Cancer

Summary: the primary purpose of the phase ib is to estimate the mtd/rpd2 and of the phase ii is to assess the anti-tumor activity of mek162 in combination with panitumumab.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * metastatic colorectal cancer * progression on or following standard therapy, or no standard therapy (phase ib). progression on or following at least 2-prior fluoropyrimidine-containing chemotherapy regimens (phase ii) * written documentation of mutant or wild-type ras * life expectancy ≥ 3 months * ecog performance status ≤ 2 exclusion criteria: phase ii arms 1 and 4 only: previous treatment with cetuximab, panitumumab, and/or other egfr inhibitors * previous treatment with mek-inhibitors * history of severe infusion reactions to monoclonal antibodies. * symptomatic or untreated leptomeningeal disease * symptomatic brain metastasis * current evidence of retinal disease; history of csr, rvo or ophthalmopathy as assessed by ophthalmologic examination at baseline that would be considered a risk factor for csr/rvo and history of keratitis. * acute or chronic pancreatitis * clinically significant cardiac disease * not adequate hematologic, renal and hepatic function

Keywords: mek162, panitumumab, mutant ras, wild-type ras, metastatic colorectal cancer, adult mcrc patient
medical versus surgical management of moderate mitral regurgitation following percutaneous coronary intervention

Conditions: Myocardial Infarction; Mitral Regurgitation

Summary: the pilot prospective randomized trial is designed to determine the safety and feasibility of enrolling patients to surgically correct residual mitral regurgitation (mr) following percutaneous coronary intervention (pci) for myocardial infarction (mi) verses ongoing medical management of mr. the investigators hypothesize that if moderate mr is corrected in this patient subset, the patients will have improved outcomes as measured by decreased number of major adverse cardiac events, including death, congestive heart failure requiring hospitalization, atrial fibrillation, deterioration of new york heart association (nyha) functional status and improved quality of life.

mitral regurgitation (mr) is a frequent complication of myocardial infarction. ischemic mr portends a poor prognosis on long term follow up. this pilot prospective randomized trial is a safety and feasibility trial to evaluate mitral valve repair versus surgical management in patients with residual mr after primary percutaneous coronary intervention (pci). patients will be screened for possible inclusion to identify those that have first mi treated with primary pci. patients with moderate mr at 6 or more weeks following first primary pci will be randomized to continued medical management versus surgical mitral valve repair. patients with previous or subsequent coronary artery bypass surgery and patients with severe ventricular dysfunction will be excluded. patients will be followed for one year from the time of randomization. the safety and feasibility data will be used to design a large trial powered to detect a difference in mortality between treatment arms. results of this study could lead to a radical change in the treatment paradigm for patients with ischemic mr following pci for acute mi. in addition, insight gained from this study could advance our understanding of the interrelationship between lv remodeling and mr and shed some light into the mechanism of ventricular function deterioration following mi. moreover, it may provide a framework for the development of further recommendations with respect to the indications for surgical intervention in this patient population.

Eligibility criteria:
inclusion criteria: * patients who have undergone pci for first acute mi (index mi) since 7/1/09 at mmc and stj * documented moderate mitral regurgitation on follow up echocardiography six or more weeks after pci procedure * english speaking exclusion criteria: * cabg after pci for acute mi * history of previous mi prior to index mi * history of previous pci or cabg prior to index pci * ef \<30 % on the echocardiogram at 6 weeks after pci for mi

Keywords: myocardial infarction mitral regurgitation percutaneous coronary intervention
continued access to the recell® device for treatment of acute burn injuries

Conditions: Burns

Summary: the overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the recell® autologous cell harvesting device is under fda review. this is a prospective, multicenter, single-arm observational study to evaluate the safety and clinical performance of the recell® device when used as an adjunct to meshed autografts in patients with acute thermal burn injuries requiring skin grafting for closure.

patients 5 years or older with a total body surface area (tbsa) thermal burn injury between 5 and 50% (inclusive) who require autografting will be considered for participation in this study. res (regenerative epithelial suspension) derived from the use of the recell® device will be applied over skin grafts meshed more widely than conventional autografting. healing, scar outcomes, pain and treatment-related adverse events will be evaluated at follow-up visits. data concerning the clinical performance and safety of the recell device will be collected. safety will be evaluated in terms of treatment and serious related adverse events. each subject will participate in up to 7 total visits (treatment visit and 6 follow-up study visits) over a period of 24 weeks. up to 60 subjects will be enrolled and treated within this study at up to 15 institutions. it is anticipated that enrollment will continue until pma approval. subject follow-up will continue until the last enrolled subject completes the 24-week visit.

Eligibility criteria:
inclusion criteria: 1. the subject requires skin grafting as a result of an acute thermal burn injury (i.e., injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water). 2. the area of total burn injury is 5-50% tbsa inclusive. 3. area(s) requiring skin grafting at least 320 square centimeters. 4. the subject is at least 5 years of age. 5. the subject (or family, for those under 18 years of age) is willing and able to complete all follow-up evaluations required by the study protocol. 6. the subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary. 7. the subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study. 8. the subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent. exclusion criteria: 1. the subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances. 2. the subject is unable to follow the protocol. 3. the subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives. 4. the subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (hartmann's) solution. 5. pregnant or lactating women.
pharmacokinetics of levofloxacin and capreomycin in multidrug-resistant tuberculosis patients

Conditions: Tuberculosis

Summary: this is an open label observational pharmacokinetic drug study to evaluate levofloxacine and capreomycin in patients with multidrug-resistant tuberculosis (mdr-tb).

patients receive mdr-tb treatment with o.a. levofloxacin and capreomycin. at least one week after start of treatment, the pk samples samples will be obtained via an intravenous catheter at 0, 1, 2, 3, 4, 7, and 12 hours after intake.

Eligibility criteria:
inclusion criteria: * age\> 18yrs * culture positive * diagnosis of mdr-tb exclusion criteria: * dm2 * pregnancy * allergy to iv canula material * insertion of iv canula not possibele

Keywords: pharmacokinetics pharmacodynamics mdr-tb levofloxacin capreomycin
a study to assess efficacy and safety of ser-287 in adults with active mild-to-moderate ulcerative colitis

Conditions: Ulcerative Colitis

Summary: a randomized, double-blind, placebo-controlled, multiple dose, multicenter study to assess efficacy and safety of ser-287 in adults with active mild-to-moderate ulcerative colitis

this is a phase 2b randomized, double-blind, placebo-controlled, multiple dose, multicenter study designed to evaluate the efficacy, safety and microbiome alterations associated with two dose levels of ser-287, after pre-treatment with vancomycin, in adult subjects, age 18-80, with active mild-to-moderate ulcerative colitis (uc).

Eligibility criteria:
inclusion criteria: * documented diagnosis of uc at least three months prior to screening, and with a minimum disease extent of 15 cm from the anal verge * active mild-to-moderate uc * inadequate response to, loss of response to, or intolerance of, at least one of the following conventional therapies: 5-asa compounds, corticosteroids, 6-mercaptopurine (6-mp) or azathioprine (aza), anti-tnfα, anti-integrin or tofacitinib exclusion criteria: * known history of crohn's disease * no previous history of treatment for uc (treatment-naïve) * subjects on steroid medication who are unable to have steroids tapered and be completely off steroids at least two weeks prior to screening * unable to stop steroid enemas or suppositories, or 5-asa enemas or suppositories, at least two weeks prior to screening * subjects who have received any investigational or approved biologic therapy within eight weeks or five half-lives prior to screening (whichever is longer) * subjects who have received any investigational or approved non-biologic therapy, except for those specifically listed in the permitted concomitant medications, for the treatment of underlying disease, within 30 days or five half-lives prior to screening (whichever is longer) * major gastrointestinal surgery (not including appendectomy or cholecystectomy) within two months before screening, or any history of total colectomy

Keywords: microbiome
antimicrobial photodynamic therapy on teeth with molar incisor hypomineralization

Conditions: Molar Incisor Hypomineralization

Summary: molar incisor hypomineralization (mih) is a change in the formation of dental enamel of systemic origin that affects at least one of the first four permanent molars and usually affects incisors. during the eruption, the affected surfaces tend to fracture, exposing the dentin, which causes excessive sensitivity in addition to making the region very susceptible to the appearance of carious lesions. the objective of this research will be to evaluate the clinical effect of antimicrobial photodynamic therapy (apdt) in permanent teeth with severe and sensitive mih. the methodology will be based on the selection of patients from 6 to 12 years of age with permanent molar teeth, randomly divided in two groups. the selected teeth should have mih on the occlusal surface, indicated for clinical restorative treatment. in group 1, apdt will be applied for the treatment of infected dentin. afterwards, the teeth will be restored with high viscosity glass ionomer cement. in group 2, the removal of the softened dentin around the side walls of the cavity with sharp dentine curettes and posterior restoration with high viscosity glass ionomer cement will be carried out. all patients will have clinical and radiographic follow-up with a time interval of 6 and 12 months. the data obtained will be submitted to descriptive statistical analysis to evaluate the association of categorical variables. chi-square test and fisher's exact test will be used, and to analyze the correlation between the continuous variables, pearson correlation test will be applied. for the analysis of dentin density in the scanned radiographic images and the microbiological results for colony forming units, anova and kruskal-wallis will be applied.


Eligibility criteria:
inclusion criteria: * healthy children, without systemic alterations; * collaborative children; * present at least one permanent molar with active and acute caries lesion in dentin, not exceeding 2/3 and involving only the occlusal, with direct vision and access, without clinical and radiographic signs and symptoms of pulp involvement. exclusion criteria: * child with systemic impairment; * non-cooperative behavior; * carious lesion of class ii, iii, iv or v type of black; * clinically: carious lesion involving enamel, deficient restorations, small carious lesions in dentin (without access to hand excavators), occult caries lesions, clinical sign and/or symptom of pulp involvement, clinical impossibility of restoration; * radiographically: evidence of pulpal involvement, carious lesion extending beyond 2/3 of the dentin.
effects of soft ball tissue release exercises on low back pain secondary to tight hip muscles.

Conditions: Low Back Pain; Tight Hip Muscles

Summary: it is also suggested that low back pain patients tend to have trigger point or tight muscles, i.e. gluteus maximus, gluteus medius, iliopsoas and quardatus lumborum, on at least one side.after approval from the university ethical committee, 23 (male, female) were enrolled in this study. all patients who presented nonspecific low back pain were included on the basis of inclusion and exclusion criteria. demographic data of the patients were collected. oswestry low back disability index was used to evaluate the disability level of low back. piriformis muscle tightness was diagnosed among low back pain patients using fair (flexion, abduction, internal rotation) and freiberg's test. the fair test was performed on the patient in, side lying position, with the hip flexed at 60º and the knee flexed at 90º. with the hip being stabilized, a single examiner will internally rotate and adduct the hip by applying downward pressure onto the knee. freiberg's test was performed on the patient in the supine position with the thigh extended. the leg and thigh are passively internally rotated by the examiner. if pain is registered, the test is positive. the effects of soft ball tissue release exercises on low back pain secondary to tight hip muscles


Eligibility criteria:
inclusion criteria: * age: 35-50 years gender: male and female low back pain for at least 12 weeks. tight hip muscles (priformis (fair test), tfl (ober's test), iliopsoas (thomas test). exclusion criteria: * any anatomical or neurophysiological causes of disease (x-ray and examination by a medical doctor) of spine. abnormal past histories of the spine, i.e. spondylitis, fracture, etc. neurologic diseases. functional restrictions on the upper and lower limbs. disc prolapse lumber spinal stenosis l4-5 spondylolysthesis any abnormality at sacroilliac joint (faber,pattricks,thigh thurst, asis distraction, sacral compression test)

Keywords: low back pain,tight hip pain
ed-home pilot study

Conditions: Housing Problems; Drug Use; Alcohol; Use, Problem

Summary: this is a single-arm pilot study to test the feasibility of homelessness prevention and substance use interventions to be delivered to at-risk patients in the bellevue hospital emergency department (ed). ed patients (n=40) found eligible for the study will complete a baseline assessment and receive referrals to appropriate services, with a final six-month follow-up assessment.

ed patients found eligible for the study will complete a baseline survey and receive one-time, in person services at the time of the baseline/enrollment ed visit including referrals to homelessness prevention and substance use services, with a final six-month follow-up survey. interim contacts at 7-10 days, 3 months, and 5 months will be used to assure intervention components were received and to confirm participant contact information.

Eligibility criteria:
inclusion criteria: * be a patient in the bellevue hospital center ed. * be ≥18 years old. * screen positive for homelessness risk using a homelessness risk screening tool (hrst). * screen positive for unhealthy alcohol or drug use. * able to provide consent. exclusion criteria: * medically (e.g., critically ill) or psychiatrically unstable. * unable to provide informed consent for other reason (e.g., cognitive deficit, profound intoxication). * incarcerated or in police custody. * unable to understand and speak english. * lives outside nyc and/or cannot give a nyc zip code. * already homeless (residing in a shelter or on the streets). * does not have a telephone where can be reached for follow-up. * has already received specialized peer navigator/addiction social worker services during current ed visit. * has already participated in the study.