Kornimate/medical-research-clean huggingface dataset:
cognitive remediation therapy in schizophrenia: effects on bdnf levels

Conditions: Schizophrenia

Summary: the main objective of the study is to analyse the role of a neurotrophic factor (bdnf) as a putative biological marker of the cognitive recovery in schizophrenia following a cognitive remediation therapy (crt). additionally, the role as outcome predictors of bdnf serum levels and the val66met polymorphism and data from functional and structural neuroimaging will be studied.

forty patients with schizophrenia disorder and twenty healthy volunteers will be recruited. patients will be randomly allocated either the experimental group, undergoing an individual crt for 40 hours during 16 weeks, or the control group following a psycho-educational intervention without any neurocognitive work, both lasting the same amount of hours and period of time. blood samples will be obtained from participants in four moments: before treatment, at week 4, at week 16, and at 32 week follow-up. in addition, repeated measurements will be obtained with a neurocognitive battery based on the matrics consensus battery and the positive and negative syndromes scale (panss). assessments will be conducted by trained personnel who will remain blind to the group assignment. a factorial model will be performed conducting a repeated measures analysis of covariance (ancova) to study the effects of crt on the levels of bdnf, neurocognition, symptoms and social functioning, adding the necessary co-variants. finally, a linear regression model to determine the predictive role of serum levels of bdnf and data from functional and structural neuroimaging on the effects of crt will be performed.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia according to dsm-iv-tr and confirmed by the semi-structured interview (scid) for the axis 1. * presence of cognitive deficit confirmed by the neuropsychological battery * stable symptomatology at least during the last six months and the estimation of not modifying pharmacological antipsychotic treatment. exclusion criteria: * presence of organic-cerebral affectation due to neurological or traumatic conditions * abuse of psychotropic substances * presence of other psychiatric symptomatology

Keywords: schizophrenia cognitive remediation bdnf
18f-fes pet/ct in imaging patients with desmoid tumors

Conditions: Deep Fibromatosis/Desmoid Tumor; Familial Adenomatous Polyposis

Summary: this pilot clinical trial studies fluorine (f)-18 16 alpha-fluoroestradiol (18f-fes) positron emission tomography (pet)/computed tomography (ct) in imaging patients with desmoid tumors. 18f-fes binds to estrogen receptors, which are present on desmoid tumors, and gives off radiation that may be detected by pet and ct scans. the pet/ct scan forms an image that may show where tumor cells with estrogen receptors can be found in the body.

primary objectives: i. establish the avidity of desmoid tumors on 18f-fes pet/ct imaging. ii. correlate 18f-fes pet avidity with degree of estrogen receptor (er) expression by immunohistochemistry (ihc). outline: patients undergo 18f-fes pet/ct imaging over 30 minutes. after completion of study, patients are followed up for 30 days.

Eligibility criteria:
inclusion criteria: * patients with biopsy-proven extra-abdominal desmoid tumors * not currently on estrogen medication for birth control, menopause, or other reason * no anti-estrogen therapy for desmoid tumor within the past 6 months * both sporadic desmoid tumors and those associated with familial adenomatous polyposis (fap) syndromes will be included exclusion criteria: * pregnancy or nursing patients * patients who do not wish to participate

Keywords: desmoid fes-pet aggressive fibromatosis
safety and tolerability study of nivolumab and cabiralizumab for resectable biliary tract cancer

Conditions: Resectable Biliary Tract Cancer

Summary: the purposed of this research is to study the safety and clinical activity of the combination of nivolumab and cabiralizumab in people with resectable biliary tract cancers (btc).


Eligibility criteria:
inclusion criteria: * has confirmed biliary tract cancer * ability to understand and willingness to sign a written informed consent document. * age ≥18 years * have biopsiable disease * eastern cooperative oncology group (ecog) performance status 0 or 1 * patient must have adequate organ function defined by the study-specified laboratory tests. * must use acceptable form of birth control while on study. exclusion criteria: * has active autoimmune disease that requires systemic treatment. * has a known additional malignancy that is progressing or has required active treatment within the past 2 years or that is expected to require active treatment within two years. * prior treatment with immunotherapy agents (including, anti-pd-1, anti-pd-l1, anti-pd-l2, anti-ctla4, etc.). * has known central nervous system (cns) metastases and/or carcinomatous meningitis. * has evidence of interstitial lung disease or active, non-infectious pneumonitis. * has evidence of an uncontrolled, active infection requiring parenteral anti-bacterial, anti-viral or anti-fungal therapy ≤ 7 days prior to administration of study medication. * has received a blood transfusion within 72 hours prior to first dose of study drug administration * unwilling or unable to follow the study schedule for any reason. * major surgery within 4 weeks prior to initiation of study treatment. * patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant muscle disorders or psychiatric illness/social situations that would limit compliance with study requirements. * pregnant or breastfeeding women. * have known history of infection with hiv, hepatitis b, or hepatitis c. * received any prophylactic vaccine within 30 days of first dose of study drug treatment. * has a history of allergy to study treatments or any of its components of the study.

Keywords: nivolumab cabiralizumab immunotherapy anti-pd-1 anti-csf-1r biliary tract cancers (btc) neoadjuvant chemotherapy adjuvant chemotherapy tumor microenvironment
multiple sclerosis intimacy and sexuality questionnaire

Conditions: Multiple Sclerosis; Sexual Dysfunction; Questionnaires

Summary: aims: this study aimed to psychometrically evaluate the turkish version of the multiple sclerosis intimacy and sexuality questionnaire (msisq-15) in women with ms. methods: the study included 130 women with ms. the turkish linguistic validation process of the original english msisq-15 was performed according to standardized guidelines. reliability analysis was evaluated with test-retest analysis and intra-class correlation (icc). internal consistency between the items was analyzed using the cronbach's alpha coefficient. item analysis results were used to assess the contribution of the items to the scale. in evaluating the validity of the scale, the relationship between the msisq and the female sexual function index (fsfi), the multiple sclerosis quality of life questionnaire-54 (msqol-54), and the pelvic organ prolapse/urinary incontinence sexual questionnaire (psiq-12) was investigated. psychometric properties were analyzed using internal consistency, test-rest reliability, construct validity, and floor-ceiling effect.


Eligibility criteria:
inclusion criteria: * women over the age of 18 who were literate, * who did not have any mental problems preventing cooperation and understanding, * who were diagnosed with ms exclusion criteria: * having pelvic organ prolapse stage 2 or more; * having a history of relapse in the past 30 days; * experiencing loss of balance or gait disturbance caused by a condition other than ms; * being pregnant; having a history of gynecological, urological and/or neurological surgery; * having a history of cesarean or vaginal birth in the past six months; * being sexually inactive; and, having urinary tract infections

Keywords: multiple sclerosis questionnaires sexual dysfunction self-report
outcomes of biological therapy on rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: evaluate effect of biological therapy on activity of ra compared to usual dmards

comparison between ra activity in both groups who recieved biological and dmards therapy

Eligibility criteria:
inclusion criteria: * ra patients exclusion criteria: * any other connective tissue disease

Keywords: ra
effect of use of straw on tolerability and quality of split dose 4l-peg preparation

Conditions: Colon Cancer

Summary: the purpose of this study is to determine whether patients drinking their bowel preparation solution with a straw will have improved tolerability for ingestion of their bowel preparation solution and achieve a higher bowel preparation quality score than patients drinking their bowel preparation solution without a straw.


Eligibility criteria:
inclusion criteria: * patients over 18 y/o scheduled for elective outpatient colonoscopy exclusion criteria: * history of colonic surgery, contra-indication for preparation (peg solution), history of inflammatory bowel disease

Keywords: bowel preparation
upper extremity rehabilitation using smart glove system with transcranial direct current stimulation

Conditions: Stroke

Summary: the aim of this study to investigate the effect of combined bilateral tdcs and vr-based therapy on distal upper extremity training in patients with stroke. we hypothesized that experimental group (vr-based training with dual-tdcs) would improve distal upper extremity function rather than control group (vr-based training with dual sham tdcs).

this is a double-blind, randomized controlled study. patients were randomly assigned to 1 : 1 ratio to experimental group (vr-based training with dual-tdcs; vr-dual) or the control group (vr-based training with dual sham tdcs; vr-sham) . for both conditions, vr-dual and vr-sham group commenced at the same time (20 minutes). the therapist and patients were blinded as to whether the patients received real or sham tdcs. the study was approved by the ethics committee of the national rehabilitation center, korea, and all participants provided written informed consent before enrollment.

Eligibility criteria:
inclusion criteria: * first-time ischemic or hemorrhagic stroke * unilateral upper extremity functional deficits after stroke * presence of a score of at least 3 points on the medical research council (mrc) * a score ≥ 4 on the brunnstrom stage * a score ≥ 25 on the korean version of the mini-mental status exam (k-mmse) exclusion criteria: * age \< 20 years * wrist and finger spasticity with the modified ashworth scale (mas) score ≥ 2 * uncontrolled hypertension, heart problems, infection, or any history of seizure or epilepsy * neurological disorders that cause motor deficits * being unable to perform the task or to understand instructions * presence of pacemaker, pregnancy, cognitive impairment, or psychiatric disorders

Keywords: stroke rehabilitation
the effect of random vibrations on perception and balance

Conditions: Diabetic Neuropathy

Summary: the purpose of this study is to investigate the effects of vibrating insoles on vibration perception threshold (vpt) and balance of people with diabetic neuropathy.

rationale: people with diabetes mellitus often suffer from polyneuropathy. reduced somatosensation of the feet due to polyneuropathy is one of the major risk factors for ulceration at the plantar side of the feet and may often cause problems in balance. it has been shown that the application of a mechanical noise signal to the feet (a vibration with a random frequency) can reduce the sensation threshold and improve standing balance. however, techniques used in research so far have several problems that limit applicability in daily practice. new vibrating insoles have been developed that overcome these problems, but it is unknown if these insoles have the same effects. study population: two samples of 20 consecutive patients with diabetes mellitus will be included. patients will be included if their vpt is between 25 and 45v. patients with a history of ulceration on mtp, halllux or heel region will be included in the first sample group. in the second sample group patients with no history of ulceration will be included. patients with an ulceration or (a history of) amputation will be excluded in both groups. intervention: first, participants will be standing on vibrating insoles placed on a platform for the measurement of vpt. secondly, participants will be standing on a force platform while wearing standardized shoes in which vibrating insoles are placed. the insoles are either turned on (i.e. random vibrations applied) or off (i.e. no random vibrations applied). main study parameters: vibration perception threshold and centre of pressure displacements.

Eligibility criteria:
inclusion criteria: * diabetes mellitus, type i or type ii * aged 18 years or older * diagnosed with neuropathy * vpt between 25-45v * understand dutch or english * is able to detect the stimulus at full power exclusion criteria: * a history of neuropathic conditions other than diabetes mellitus * problems with the somatosensory or motor system that affect balance or plantar sensation, not related to dm (for example: cva) * severe visual problems * current ulcer * (a history of) amputation

Keywords: diabetic neuropathy foot ulcers random vibration vibration perception threshold mechanical noise
beta blockade in in traumatic brain injury

Conditions: Brain Injuries, Traumatic

Summary: the purpose of this study is test the effect of beta-adrenergic blockade on mortality in patients with traumatic brain injury with the hypothesis being that the addition of beta blockade to the treatment regime of this patient population will lower mortality and supress the catecholamine surge that accompanies traumatic brain injury as compared to those who do not receive beta blockade. half the patients will be randomized to receive propranolol and half will be randomized to receive no beta blocker.

the use of beta-adrenergic blockade is not currently the standard of care of patients with traumatic brain injury. traumatic brain injury is a common problem in our society with greater than 1.5 million cases occurring annually and over 50,000 deaths per year in the civilian population in the united states. medical therapy has long consisted of monitoring intracranial pressure and supportive measures designed to limit intracranial pressure. two retrospective observational studies completed at the university of tennessee demonstrate that the addition of beta-adrenergic blockage to the treatment of the traumatic brain injury lessens mortality. the basis for conducting this study was established by retrospective data showing no harm to patients receiving inderal and potential benefit. available data, including data from the university of tennessee, are retrospective and are limited to simple exposure to the drug. the proposed study will attempt to further quantify the effect by dosing with the drug to actual beta-blockade instead of simple exposure to the drug. the effect of propranolol at the dosing levels used in this research will be determined by measurement of urinary catecholamines in both study arms and comparison of the actual effect of the drug on the catecholamine surge that occurs following traumatic brain injury will be determined. additionally, the effect of healthcare disparities on outcomes in patients with traumatic brain injury will be measured. outcomes will be stratified by payer status and ethnicity to determine the effect each of these variables has on outcomes.

Eligibility criteria:
inclusion criteria: * subjects ages 18 and older with isolated traumatic brain injury as defined by glasgow coma scale score 12 or less with documented injury on head ct and limited injury to the rest of the body. (abbreviated injury scale (ais) must be \< or = 3 from other body areas.) exclusion criteria: * subjects \ 3). * subjects who cannot be enrolled within 48 hours of admission following acute resuscitation will not be enrolled into this study.
etna-ms device validation study

Conditions: Multiple Sclerosis

Summary: the overarching goal of this research protocol is to validate the effectiveness of innodem's etna-ms device in informing clinicians on the disability status of multiple sclerosis (ms) patients. effectiveness of the device will be assessed by the level of agreement between the edss estimated by the device and the actual scores measured by the neurologist in-person assessments.

this study will use a multi-site cross-sectional design in a single cohort of multiple sclerosis (ms) patients. eligible patients with ms will be selected and categorized based on their expanded disability status scale (edss) score. patients eye movements will be captured using the patented eye-tracking technology at one single time point. in addition to the eye-tracking tests, patient phenotypes will be further detailed via brief functional and cognitive assessments using the edss, brief international cognitive assessment for ms (bicams) and multiple sclerosis functional composite (msfc). all patients will be required to participate in a single session.

Eligibility criteria:
inclusion criteria: * able to provide informed consent * aged 18 years or older at the time of enrolment * able to read in either english, spanish or french * able to read the oculomotor task on-screen instructions at the testing distance (45 cm) with or without corrective lenses * confirmed diagnosis of ms as per the macdonald criteria, irrespective of ms subtype (relapsing-remitting (rrms), secondary-progressive (spms), primary-progressive (ppms), and progressive-relapsing (prms)) * neurologist-determined edss score between 1.0-4.5 exclusion criteria: * evidence or medical history of a neuropsychiatric disorder such as schizophrenia and autism, which are known to impair eye movements and oculomotor control. * presence of comorbid neurological conditions causing significant eye movement anomalies (such as strabismus, cranial nerve palsy, stroke-causing hemianopsia). * diagnosis of macular edema or other pre-existing ocular conditions that would prevent a participant from performing the eye movement assessments. * having started a new prescription medication or having changed the dose of a medication known to influence ocular motor visual function (e.g. benzodiazepines, antipsychotics, and anticonvulsants) within the past three months. * participants with non-disease related physical impairments to a leg, hand, or arm (e.g., broken bone or severe sprain) that would not allow completion of the assessments. * having an edss score for which the desired sample size has been reached.
optical coherence tomography guided transepithelial phototherapeutic keratectomy

Conditions: Corneal Opacity

Summary: optical coherence tomography (oct) machines are non-contact instruments that can measure the depth of scars and other causes of cloudiness in the front of the cornea. the purpose of this study is to determine whether oct-guided settings for the lasers used for removal of corneal scars and other partial-thickness corneal defects result in improved vision in patients receiving these procedures.

the long-term goal of this project is to utilize newly available very high-speed oct technology to guide surgical treatments of corneas with superficial opacities and irregularities. oct is well known for its exquisite resolution, but until recently it has not had sufficient speed to capture the shape of the cornea because of eye motion during oct scanning. the development of fourier-domain oct (fd-oct) technology has made the requisite speed possible. eyes with superficial opacities (corneal scars and stromal dystrophies) can be treated by phototherapeutic keratectomy (ptk). currently, many surgeons rely on subjective slit-lamp impression of opacity depth to guide ptk and repeat slit-lamp examinations during surgery to determine if the opacity has been sufficiently reduced. unpredictable hyperopic shifts can occur after ptk. the aim of this project is to develop methods for imaging the cornea with an fd-oct system that will precisely measure corneal shape and use this information to guide surgery. patients with irregularly shaped corneas could have their vision restored by reshaping the corneas with a procedure that combines the precision of oct and lasers.

Eligibility criteria:
inclusion criteria: * patients with vision primarily limited by superficial opacities and irregularities that could be removed by ptk while leaving at least 250 µm. exclusion criteria: * inability to give informed consent * inability to maintain stable fixation for oct imaging * inability to commit to required visits to complete the study * deep corneal opacities and irregularities * cataracts, retinal disease, glaucoma, or other eye conditions that may limit the visual outcome after surgery

Keywords: phototherapeutic keratectomy optical coherence tomography corneal opacity corneal dystrophy
gastric gluten-degradation activity of pvp001

Conditions: Digestive System Disease

Summary: this is a single blind, dose escalating, placebo-controlled, crossover study of gluten-degrading drug pvp001 administered to healthy volunteers (age 18-64 years). subjects will be randomized to one of three groups representing different levels of gluten exposure - low, medium, or high - in a single meal. within each gluten exposure group, increasing doses of pvp001 (or placebo) will be administered.


Eligibility criteria:
inclusion criteria: * healthy volunteers; * able to maintain a gluten-free diet (gfd) for 24 hours prior to each of visits 1-4; * able to abstain from alcohol consumption 72 hours before and 72 hours after each visit; * able to tolerate the placement, presence, and manipulation of an oro-gastro-duodenal (ogd) tube; * women of child-bearing potential and men whose partners are women of child-bearing potential must be willing to use acceptable birth control for the duration of the study; * able to read and understand english; * able to provide written informed consent exclusion criteria: * any condition or abnormality, current or past, that, in the opinion of the investigator, would compromise the safety of the subject, or would interfere with or complicate study procedures or assessments. * no current or recent (within 14 days prior to each study visit, clinical laboratory testing, and ecg) use of over-the-counter or prescription medications via any route of administration, except for oral contraceptives for birth control (provided they have been used regularly for at least the past 3 months). other medications used regularly at stable doses may be acceptable at the discretion of the study doctor. * current symptoms of congestion, upper respiratory tract infection, or acute illness * chronic viral infection or immunodeficiency condition * any female who is pregnant, planning to become pregnant during the study, or breast-feeding * history of intolerance, hypersensitivity, or reaction to wheat or other grains, gluten, or any other food or food ingredient (including an additive or preservative) in the study meal; * receipt of an investigational medication within four weeks prior to the screening visit or from the screening visit through the final visit; * alcohol consumption \>5 drinks/week or any alcohol consumption within the 72 hours prior to each study exposure visit or a positive breathalyzer test result at any study visit; * illicit or recreational drug use in the past 12 months or positive urine drug screen at the screening visit; * history of smoking, nicotine, or tobacco use in the past 12 months; * history or high risk of noncompliance with treatment or visits.