Kornimate/medical-research-clean huggingface dataset:
efficacy of ketamine infusion compared with traditional anti-epileptic agents in refractory status epilepticus

Conditions: Refractory Epilepsy

Summary: the study will investigate the efficacy of the n-methyl-d-aspartate receptor antagonist ketamine as a first line agent in refractory status epilepticus versus traditional general anesthetic agents used for burst suppression that target the gamma-aminobutyric acid adrenergic receptors.

the traditional treatment for refractory status epilepticus includes diazepam, midazolam, valproic acid, thiopental and propofol. these medications fail to control seizure activity in 20-40% of patients. this is attributed to decrease in activity of gamma-aminobutyric acid receptors along with reciprocal up regulation of n-methyl-d-aspartate receptors. glutamate activation of n-methyl-d-aspartate receptors promotes calcium influx and excitotoxicity. ketamine, an intravenous anesthetic agent which is a non-competitive antagonist of n-methyl-d-aspartate receptors can block the flow of ca and na and by combining with phencyclidine binding sites inside the ion channel of n-methyl-d-aspartate receptors, reduce the epileptiform burst discharges and after potential. therefore, targeting the n-methyl-d-aspartate receptors with ketamine may provide a novel approach to control refractory seizures. moreover, by blocking glutamate mediated n-methyl-d-aspartate receptor induced neurotoxicity, ketamine may render neuroprotection. ketamine also provides additional advantage of hemodynamic stability. currently, ketamine is used as a last resort drug in the treatment of refractory status epilepticus. the specific aim is to determine whether continuous infusion of ketamine as a first line agent for refractory status epilepticus is effective in controlling seizures. the central hypothesis of our proposal is that early treatment with ketamine will be much more efficacious in controlling refractory status compared to the traditional treatment.

Eligibility criteria:
inclusion criteria: * patients more than 18 years of age with a diagnosis of status epilepticus * considered for burst suppression therapy after failing 2 or 3 anti-epileptic medications exclusion criteria: * post anoxic status epilepticus * pregnant women, as confirmed by urine, or blood human chorionic gonadotropin, ultrasound or physical exam * prisoners * age less than 18 years * allergy or sensitivity to the drug in question

Keywords: seizure glutamate activation n-methyl d-aspartate gamma-aminobutyric acid receptor ketamine
radiotherapy alone versus concurrent chemoradiation in low risk nk/t-cell lymphoma

Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type

Summary: the purpose of this study is to prove the superiority of concurrent chemoradiation compared with radiotherapy alone in patients with low risk nk/t-cell lymphoma.

radiotherapy alone is commonly used in nk/t-cell lymphoma without adverse risk including lymph node involvement, local invasion, b symptoms and high ldh level. recently, methotrexate was prove to be a radiosensitizer in nk/t-cell lymphoma cells. therefore, the investigators aim to verify the superiority and safety of weekly methotrexate in combination with radiotherapy in a randomized phase ii study.

Eligibility criteria:
inclusion criteria: * age range 18-75 years old * histological confirmed, previously untreated stage ie nasal nk/t cell lymphoma without following risk factors including local invasion, b symptoms and high ldh level * ecog performance status 0-1 * life expectancy of more than 3 months * adequate bone marrow and organ functions exclusion criteria: * non-nasal nk/t-cell lymphoma * prior exposure of methotrexate * with third space effusion * pregnant or lactating women * serious uncontrolled diseases and intercurrent infection * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Keywords: nk/t-cell lymphoma methotrexate radiotherapy concurrent chemoradiation
resource-oriented music therapy for psychiatric patients with low therapy motivation

Conditions: Mental Disorders; Mood Disorders; Personality Disorders; Schizophrenia and Disorders With Psychotic Features

Summary: the aim of this study is to examine whether resource-oriented music therapy helps psychiatric patients with low therapy motivation to improve negative symptoms and other health-related outcomes.

background: previous research has shown positive effects of music therapy for people with schizophrenia and other mental disorders. in clinical practice, music therapy is often offered to psychiatric patients with low therapy motivation, but little research exists about this population. the aim of this study is to examine whether resource-oriented music therapy helps psychiatric patients with low therapy motivation to improve negative symptoms and other health-related outcomes. an additional aim of the study is to examine the mechanisms of change through music therapy. method: 144 adults with a non-organic mental disorder (icd-10: f1 to f6) who have low therapy motivation and a willingness to work with music will be randomly assigned to an experimental or a control condition. all participants will receive standard care, and the experimental group will in addition be offered biweekly sessions of music therapy over a period of three months. outcomes will be measured by a blind assessor before and 1, 3, and 9 months after randomisation. discussion: the findings to be expected from this study will fill an important gap in the knowledge of treatment effects for a patient group that does not easily benefit from treatment. the study's close link to clinical practice, as well as its size and comprehensiveness, will make its results well generalisable to clinical practice.

Eligibility criteria:
inclusion criteria: * non-organic mental disorder * low therapy motivation * willingness to work with music exclusion criteria: * severe mental retardation * life-threatening somatic illness

Keywords: motivation music therapy psychotherapy
transcranial direct current stimulation to treat major depressive disorder

Conditions: Major Depressive Disorder

Summary: the investigators purpose is to offer active transcranial direct current stimulation (tdcs) in patients of the investigators previous study who received either placebo or sertraline and have not responded.


Eligibility criteria:
inclusion criteria: patients from a previous study (id:usp-hu-001) who: * received sertraline and did not respond. * received placebo and did not respond. exclusion criteria: patients from a previous study who: * received active tdcs. * responded.
icare home2 clinical trial

Conditions: Intraocular Pressure; Glaucoma

Summary: the aim of this clinical study is to provide information about the variability of the intraocular pressure (iop) self-measurements with the icare home2 tonometer in comparison to the variability of the iop measurements with the reference tonometer (icare ic200), over a wide range of iop values.

the clinical study is planned to estimate the variability of the iop measurement of icare home2 and ic200. in the study, the subjects will learn to operate the icare home2 tonometer independently by using the labeling materials provided to them. once they learn to operate the tonometer, subjects will take three self-measurements on the selected eye both in sitting and supine position. the variability of the measurement results taken with icare home2 will be compared to the variability of the measurement results taken with icare ic200 by using the recorded results from the study subjects.

Eligibility criteria:
inclusion criteria: * glaucoma patients having confirmed optic nerve damage with visual field defects consistent with the glaucomatous optic neuropathy or * glaucoma-suspects being followed because of elevated iop, and/or because of other risk factors for developing glaucoma or optic nerve damage. exclusion criteria: * active ocular infection (e.g., pink eye or infectious conjunctivitis) * recent trauma to the eye including corneal laceration or corneal/scleral perforation * disabling arthritis or difficulty handling the tonometer * severe difficulty in opening the eyes including abnormal contractions or twitches of the eyelid (blepharospasm) * involuntary, rapid, and repetitive eye movements (nystagmus) * low uncorrected near visual acuity of 20/200 or below * significant glaucomatous central field loss * only one functional eye * poor or off-center visual fixation * poor hearing and/or communicates using sign language * keratoconus (or other corneal disorder) * congenitally small eye (microphthalmos) * enlarged eyeball from the childhood glaucoma (buphthalmos) * previous experience using or interacting with the home tonometer during usability tests or clinical trials * any affiliation with icare and its employees * high corneal astigmatism (\>3d) * history of prior invasive corneal surgery including corneal laser surgery less than six months ago (e.g., lasik, lasek, smile) * corneal scarring * very thick or very thin corneas (central corneal thickness greater than 600 μm or less than 500 μm) * cataract extraction within the last 2 months * wearing contact lenses during the study
resin infiltration treatment for mih

Conditions: Molar Incisor Hypomineralization; Enamel Hypoplasia; Enamel Caries; Anterior Teeth

Summary: the investigators aimed to evaluate changes in mineralisation degree, colour, and size of the lesion after icon® in permanent teeth with mih in 6 months.

a total of 116 permanent central teeth of 37 patients were included in the study. icon® was applied to teeth with mih, while the healthy teeth received no treatment (control). group i : icon® resin infiltration treatment was performed on 58 permanent central teeth with mih and evaluated before; immediately after; and 1, 3, and 6 months after the procedure. group ii (control group): no treatment was performed on healthy teeth. however, similar to the treated teeth, 58 healthy permanent central teeth of the same individuals were evaluated before; immediately after; and 1, 3, and 6 months after the procedure. lesions were evaluated before, immediately after, and 1, 3, and 6 months after treatment. mineralisation degree of mih lesions was evaluated using diagnodent pen, changes in the lesion colour and lesion size were evaluated using vita easyshade and the cross polarization technique, respectively.

Eligibility criteria:
inclusion criteria: * molar incisor hypomineralisation on the labial surface of permanent central teeth least one of the labial surface of the permanent anterior teeth were affected by mih. exclusion criteria: * dental caries and filling on anterior teeth. * dental anomaly on anterior teeth. * undergoing orthodontic treatment. * periodontal diseases. * cognitive and behavioural problems.

Keywords: molar incisor hypomineralisation resin infiltration discoloration enamel lesion
adoptive transfer of mart1/melan-a ctl for malignant melanoma

Conditions: Melanoma (Skin)

Summary: rationale: cytotoxic t lymphocytes (ctl) are cells of the immune system that can fight infections and cancer. these ctl can be manipulated in the laboratory so that they can target an individual's cancer. purpose: this early phase trial is studying the feasibility and side effects of intravenous infusions of ctl generated in the laboratory. to produce the ctl, the study participant's own immune cells are collected by a procedure called a leukapheresis. the cells then undergo laboratory processing for three weeks. part of this processing includes mixing the patients immune cells with a new kind of cell that has some extra genes added to it. these extra genes are to "teach" the participant's own immune cells to become anti-tumor ctl that can attack the melanoma.

detailed outline: this is an early phase pilot/feasibility trial. study subjects will be sequentially accrued to three cohorts. cohorts 1 and 2 will evaluate the safety and feasibility of infusing two different doses of ctl. * participants in all cohorts will undergo two ctl infusions 5 weeks apart. * procedures performed during the trial will include physical examinations, laboratory tests, delayed hypersensitivity testing, and skin biopsies. * between 5 and 8 days after the first ctl infusion, a biopsy or excision of a melanoma lesion may be performed. * three leukapheresis procedures will be performed: two to collect peripheral blood for ctl production and one for research purposes at the end of the clinical trial. * radiology tests (including ct scans) will be performed prior to infusion and about 4-5 weeks after the second ctl infusion.

Eligibility criteria:
inclusion criteria: * patients with metastatic melanoma: either unresectable stage iii or any stage iv * ecog of 0 or 1 * hla-a\*0201 haplotype * baseline tumor biopsy mart1/melan-a expression present (in \>10% of tumor cells) * patient provides consent for all required biopsies * adequate intravenous access for leukapheresis * absolute lymphocyte count \>500/ul at least once within 30 days of leukapheresis * life expectancy greater than 4 months in the opinion of the study clinician * negative pregnancy test exclusion criteria: * administration of systemic corticosteroids within 28 days of planned leukapheresis * administration of cytotoxic chemotherapy or anti-tumor immunotherapy within 28 days of planned leukapheresis * administration of radiotherapy within 28 days of planned leukapheresis with the exception of subjects accrued to cohort 3 * active autoimmunity requiring systemic immunosuppressive therapy * hiv infection * previous enrollment on this protocol and infusion of mart1/melan-a ctl

Keywords: ctl mart-1 melan-a artificial apc melanoma metastatic melanoma adoptive immunotherapy adoptive cell transfer immunotherapy
arsenic, disordered glucose homeostasis and atherosclerosis

Conditions: Atherosclerosis; Type 2 Diabetes (T2D)

Summary: investigators will recruit 250 subjects; group a will consist of 100 prediabetic patients with an a1c of 5.7%-6.4%. group b will consist of 100 patients with uncontrolled t2d defined as either a) an a1c of 6.5%-7.9% without diabetes medications or b) an a1c ≥ 8.0% with or without diabetes medications. group c will include 50 participants without t2d or known cardiovascular disease to serve as control comparisons.

patients with prediabetes have an elevated risk of cardiovascular disease (cvd). cardiovascular disease (cvd) is also the leading cause of morbidity and mortality in patients with type 2 diabetes. there remains an unmet clinical need to identify modifiable risk factors for cvd in patients with disordered glucose homeostasis, including prediabetes and t2d. exposure to inorganic arsenic and other environmental toxicants may be novel targets for cvd risk reduction for these patients. however, there have been no clinical studies of environmental exposures on vascular function and thrombotic risk among patients with prediabetes and growing understanding of environmental exposures as modifiable risk factors for cvd, and can have an impact by: (1) describing the role of environmental exposures for patients with or at risk for t2d; (2) identifying t2d patients at higher risk for the adverse biological effects of environmental exposures; and (3) informing health policies and treatment pathways to reduce the risk of these exposures. investigators will evaluate the association between inorganic arsenic exposure and measures of vascular function, estimate the association between inorganic arsenic exposure and measures of thrombotic risk and will explore the independent association between environmental exposures other than inorganic arsenic and measures of vascular function and thrombotic risk.

Eligibility criteria:
inclusion criteria: * no known cardiovascular, cerebrovascular or peripheral arterial disease * able and willing to provide written informed consent for the study exclusion criteria: * unable to speak spanish or english * active smoking (within the past year) * autoimmune, rheumatologic or inflammatory disease * known active cancer receiving treatment * pregnancy * anemia (hemoglobin \< 9 mg/dl) * chronic kidney disease (crcl \< 30ml/min) * known coronary artery disease (cad; prior stents or cabg) * congestive heart failure * known peripheral arterial disease (pad; lower extremity revascularization surgery or lower extremity stenting) * known prior stroke or transient ischemic attack (tia) (mini-stroke or temporary/transient stroke)

Keywords: arsenic
effect of acheta domesticus supplementation on post-exercise muscle recovery in recreationally active male

Conditions: Muscle Soreness

Summary: the goal of this clinical trial is to test the effect of house cricket (acheta domesticus) supplementation for strength recovery in recreationally active males. the main question\[s\] it aims to answer are: whether house cricket powder could improve strength recovery and whether house cricket powder could be an alternative to commonly used protein supplement. participants will do exercise (100 drop jumps) to induce fatigue and then they will consume either isocaloric carbohydrate, whey protein isolate or defatted house cricket powder for 4 days. their strength will be measured every 24 hours for 4 days in order to observe the recovery. researcher will compare house cricket powder with isocaloric carbohydrate to see if the strength recovery is faster in house cricket powder group researcher will compare house cricket powder with whey protein isolate to see if the strength recovery is comparable.

participants: recreationally active males study type: double-blind randomized controlled trial supplement dose is tailored to each participant daily protein consumption. it aims to reach 1.4 g/kg body weight protein, hence participant is required to provide dietary record 3 days before the experiment and during the experiment. subject will attend one familiarization 1 week before the experiment. during day one of the experiment, subject warmed up before the session. then their baseline strength and jumping measurement will be taken. afterwards, they will do 20 reps of drop jumps for 5 sets (each set separated by 2 minutes rest). immediately after the exercise, they will consume either whey, house cricket or maltodextrin. 10 minutes afterwards, they will undergo another strength and jumping measurement. 24, 48 and 72 hours after the exercise, subject will come for strength and jumping post-test after consuming the supplement. they are also required to fill in a visual analogue scale and 7-points likert scale form regarding their pain and soreness perception.

Eligibility criteria:
inclusion criteria: * 5-10 hours of exercise per week exclusion criteria: * smoking * drinking alcohol * history of surgical/medical procedure that could affect the study * food allergy * in medication * have participated in similar studies before
neuroimaging mechanisms by which memory and glucocorticoids promote risky drinking

Conditions: Alcohol Drinking; Drinking Behavior; Episodic Memory; Long-term Memory

Summary: the purpose of this study is to determine whether hydrocortisone biases formation of alcohol-related memories to potentiate drinking.

this study aims to 1) characterize the effect of elevated glucocorticoids during encoding on long-term memory for alcohol-related information; 2) identify the neural mechanisms by which glucocorticoids influence encoding of alcohol-related experiences; and 3) determine how glucocorticoid modulation of alcohol-related encoding relates to drinking after retrieving alcohol-related memories.

Eligibility criteria:
inclusion criteria: * able to read and write english * bmi 18-35 * beer drinking exclusion criteria: * meet current criteria for any substance use disorder, excluding caffeine * current significant medical conditions or psychiatric symptoms requiring medication * current use of medications/drugs that interfere with the hpa axis response * peri and post-menopausal women, pregnant or lactating women, and those with hysterectomies * metal in body (for mri safety) * systemic fungal infections (contraindication for hydrocortisone) * known hypersensitivity to components of hydrocortisone tablets (hydrocortisone, calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose)
do relaxation exercises decrease postoperative pain after arthroscopic rotator cuff repair?

Conditions: Rotator Cuff Injuries

Summary: the purpose of this study is to determine the effect of relaxation exercises on pain level and pain medication use after arthroscopic rotator cuff shoulder surgery


Eligibility criteria:
inclusion criteria: 1. males and nonpregnant females aged 18 years or older 2. full-thickness rotator cuff tear undergoing arthroscopic rotator cuff repair surgery exclusion criteria: 1. patients with an irreparable tear, revision shoulder surgery, multiple shoulder surgeries, concomitant severe glenohumeral arthritis, concomitant adhesive capsulitis 2. worker's compensation claim 3. diagnosed psychological disorder 4. history of alcohol or drug abuse 5. patients on preoperative narcotic therapy 6. patients who already practice relaxation techniques (i.e. mindful meditation, guided imagery, breathing exercises, yoga, etc.).
combined intravitreal bevacizumab with topical timolol-dorzolamide eye drops in diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this study is a double-blind randomized clinical trial in diabetic patients (type 2) over 18 years of age who have diabetic macular edema with involvement of the central 1 millimeter (central macular thickness is more than 300 μm) and bcva 20/30 or less who visit the retina clinic of labbafinejad hospital are studied. (in patients with bilateral macular edema, only one eye is included in the study.) complete ocular examinations (including best corrected visual acuity - anterior segment - intraocular pressure - dilated pupil funduscopy with severity of diabetic retinopathy), optical coherence tomography (oct), edi-oct( enhanced depth imaging optical coherence tomography ) - as well as optical coherence tomography angiography (octa ) are performed for all patients at baseline. blood tests are also taken from patients for fasting blood sugar and hba1c. patients are then randomly divided into two groups. the first group is treated with injections of 1.25 mg of intravitreal bevacizumab monthly for 3 months (months 0, 1 and 2) with topical drops of timolol twice a day and dorzolamide twice a day. for the second group (control group), 3 injections of 1.25 mg of intravitreal bevacizumab monthly with artificial tears (twice a day as a placebo) are prescribed. patients in both groups are visited 1 month after the third basic intravitreal bevacizumab (ivb) injection and complete ophthalmology examinations are performed and central thickness of macula is recorded based on the patient's oct as well as the need for ivb re-injection. edi (enhanced depth imaging)-oct and octa are performed again for all patients.


Eligibility criteria:
inclusion criteria: * patients with diabetic melitus type 2 * patients with center-involving diabetic macular edema (central macular edema \> 300 micrometer) * patients have diabetic retinopathy at the stage of nonproliferative diabetic retinopathy (npdr) or early pdr (proliferative diabetic retinopathy) or regressed pdr * in patients with bilateral macular edema, only one eye is included in the study. exclusion criteria: * uncomplicated cataract surgery * history of cataract surgery during last 4 months * history of panretinal photocoagulation (prp) during last 4 months * any retinochoroidal disease except diabetic retinopathy * optic disc pathology * patient with high-risk pdr or advanced pdr * one-eye patients * patient with glaucoma or uveitis * pregnant or lactating patients * patients whom topical timolol or dorzolamide are prohibited for any reason