Kornimate/medical-research-clean huggingface dataset:
human leukocyte antigen (hla) class i haplotype mismatched natural killer cell infusions

Conditions: Lymphoma; Myeloma; Leukemia

Summary: the purpose of this research study is to examine the safety of infusing escalated doses of allogeneic (from a relative of the patient), enriched natural killer (nk) cells after autologous (from the patient) stem cell transplantation. the hypothesis is that the infusion of these nk cells early after an autologous stem cell transplant will help to eliminate and eradicate any residual cancerous cells that remain in the body and may have survived the chemotherapy or radiation.

natural killer cells are blood cells that are responsible for eliminating cancer cells especially when there are only a few. it has been shown that nk cells coming from a "mismatched" person (a relative) have a better chance than the patient's own nk cells to recognize and kill cancer cells. these cells will be collected from the blood of a parent, child or sibling and after preparation in the laboratory, will be given to the patient early after an autologous stem cell transplantation like a blood or platelet transfusion. a person who has been diagnosed with a blood tumor and received an autologous stem cell transplant has the chance of his/her cancer coming back. this study uses nk cells obtained from a relative to prevent disease recurrence by potentially eliminating and eradicating any residual cancerous cells.

Eligibility criteria:
inclusion criteria: * patients who have undergone an autologous stem cell transplant for the following diseases: * acute myeloid leukemia * non-hodgkin's lymphoma * hodgkin's disease * multiple myeloma * age 13 - 70 years old * able to give informed consent * hepatic and renal function: bilirubin less than or equal to 2x normal limits, ast and alt less than or equal to 2x normal limits, serum creatinine less than or equal to 1.5x normal * ecog performance status less than or equal to 1 (at planned time of transplantation) * patients with no active infection exclusion criteria: * patients who have not recovered sufficiently from the side effects of the autologous transplant (i.e. have \> grade 2 toxicity in any organ system) * patients who have insufficient engraftment parameters according to the following criteria: wbc \< 2,500 /mm3 and platelets \< 50,000/mm3 * radiation therapy, chemotherapy, or immunotherapy beginning one week before nk-cell infusion and lasting 2 weeks after nk-cell infusion. * intrinsic impaired organ function (as stated above). * physical or psychiatric conditions that in the estimation of the pi or designee place the patient at high-risk of toxicity or non-compliance. * uncontrolled, life-threatening infections at the time of infusion. * concurrent treatment with corticosteroids and/or other immuno-suppressive drugs.

Keywords: natural killer cells autologous stem cell transplant immunotherapy
a study of flexible-dose brexpiprazole as adjunctive therapy in the treatment of adults with major depressive disorder, the delphinus trial

Conditions: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders

Summary: to compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (adt) in the proposed subject population with mdd.

this is a trial designed to assess the safety and efficacy of brexpiprazole (flexible dose) as adjunctive therapy to an assigned known anti-depressant in depressed subjects. the trial consists of a continuous 18-week double-blind treatment period with a 30-day follow-up. subjects who complete all trial visits through the week 18 visit may be offered entry into an optional open-label rollover trial.

Eligibility criteria:
inclusion criteria: * male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent. * subjects with both a diagnosis of mdd, and in a current major depressive episode, as defined by dsm-iv-tr criteria * subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period. exclusion criteria: * females who are breast-feeding and/or who have a positive pregnancy test result during screening prior to receiving trial medication * subject has a current axis i (dsm-iv-tr) diagnosis of: dementia, schizophrenia, bipolar, eating disorder , obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder * subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current major depressive episode. * subjects who have met dsm-iv-tr criteria for substance abuse or dependence within the past 180 days * subjects currently treated with insulin for diabetes. * subjects with uncontrolled hypertension * subjects with known ischemic heart disease or history of myocardial infarction, congestive heart failure, angioplasty, stenting, or coronary artery bypass surgery * subjects with a positive drug screen for cocaine, marijuana, or other illicit drugs * inability to swallow tablets or tolerate oral medication * abnormal laboratory test results, vital signs and ecg results * subjects who previously participated in any prior brexpiprazole clinical trial.

Keywords: opc-34712 brexpiprazole major depressive disorder adjunctive treatment
the efficacy of coenzyme q10 and curcumin in patients with myelodysplastic syndromes

Conditions: Myelodysplastic Syndrome

Summary: to determine the clinical effects of coenzyme q10 and curcumin in improving the cytopenias of patients with myelodysplastic syndromes. we propose to explore the efficacy of the natural compounds curcumin and coq10 in mds because these two agents possess many of the effects that are desirable in mds.


Eligibility criteria:
inclusion criteria: * mds patients with ra, rars or raeb will be eligible for treatment with coq10 as long as their ipss score ≤ 1.5. exclusion criteria: * pregnant women and nursing women will be excluded. * history of clinically significant liver or kidney disease. * ecog\>2 * ipss score \>1.5 * poorly controlled diabetes mellitus, hypertension, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.

Keywords: myelodysplasia curcumin coenzyme q10 cytopenia
purified anthocyanins supplementation and high-density lipoprotein (hdl) function

Conditions: Diabetes Mellitus，Type 2

Summary: hdl function is impaired in patients with type 2 diabetes mellitus. anthocyanin, a water-soluble compounds,is beneficial for vascular function by increasing nitric oxide (no) bioavailability and decreasing oxidative stress. this study was designed to evaluate whether anthocyanin supplementation might improve cardiovascular function in diabetic patients.

the study is designed as a randomized, double-blind label, interventional study on patients with t2dm. the eligible participants are randomly assigned to control and anthocyanins group. during the 24 weeks trial period, the participants are instructed to consume two anthocyanin capsules or placebo capsules twice daily (30 minutes after breakfast and supper).

Eligibility criteria:
inclusion criteria: * subject is diagnosed with type 2 diabetes mellitus according to the chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows: (1) diabetes symptoms（polydipsia、polyphagia, polyuria, weight loss、skin itching、blurred vision and other acute metabolic network disorder that caused by high blood sugar）combined with random blood sugar ≥11.1 or, (2) fasting plasma glucose (fpg) ≥7.0 or, (3) 2 h blood sugar after oral glucose tolerance test (ogtt) ≥11.1 * subject is between 40 and 60 years of age, inclusive * subject's bmi is \>18.5 kg/m2 and \<35 kg/m2. exclusion criteria: * subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type 2 * subject that is pregnant * subject that has coronary artery disease, mental disorder, cancer, cirrhosis, renal disease and hepatic disease * subject that has had operation less than six months prior to screening visit * subject that uses multivitamin supplement or other polyphenol supplement
tmc207-c202: study to evaluate bactericidal activity of multiple oral doses of tmc207 in subjects with sputum-smear positive tuberculosis

Conditions: Tuberculosis

Summary: the purpose of this study is to assess the effects of 3 different oral doses of tmc207 administered over a 7 day period on the organism that causes tuberculosis

this is a phase iia, open-label, randomized trial in treatment-naïve, sputum smear-positive, subjects with pulmonary tb to assess the extended early bactericidal activity (eeba) of tmc207. the study population will consist of 60 treatment-naive subjects with m. tuberculosis infection. subjects will receive orally 25 mg tmc207 po q.d. (treatment a), 100 mg tmc207 po q.d. (treatment b) or 400 mg tmc207 po q.d. (treatment c) daily for 7 days. subjects in treatment group d will receive 600 mg rifampin po q.d. daily for 7 days and subjects in treatment group e will receive 300 mg isoniazid po q.d. daily for 7 days. after 7 days, subjects in all treatment groups will receive appropriate anti-tb therapy according to national standards of country tb guidelines and culture and sensitivity results of the sputum specimens until clinical and microbiological cures have been achieved. three once-daily dose regimens of tmc207, for 7 days, will be studied versus 2 comparator treatments, rifampin and isoniazid in the present trial.tmc207 treatment groups: 25 mg tmc207 po q.d; 100 mg. tmc207 po q.d; 400 mg tmc207 po q.d.; tmc207 will be administered as a 10 or 40 mg/ml oral solution. comparator groups: 600 mg rifampin po q.d. administered as capsules containing 300 mg rifampin; 300 mg isoniazid po q.d. administered as tablets containing 300 mg isoniazid.

Eligibility criteria:
inclusion criteria: * treatment-naive subjects with pulmonary m. tuberculosis infection, willing to start anti-tb therapy * positive for acid-fast bacilli on direct smear exam of sputum specimen * must consent to hiv testing * must agree to hospital admission exclusion criteria: * history or presence of hepatic or gi disease that may interfere with the absorption of tmc207, isoniazid or rifampin * subjects who received previous anti-mycobacterial drugs for the treatment of a mycobacteria infection and subjects who have received more than 2 weeks of treatment with a fluoroquinolone * subjects who have received antiretroviral therapy and/or oral or i.v. anti-fungal medication w/in the last 90 days * subjects with sputum cultures of m. tuberculosis resistant to rifampin * impaired hepatic function

Keywords: tuberculosis
predictive value of sublingual microcirculation and peripheral tissue oxygen monitoring

Conditions: Sepsis

Summary: change and predictive value of sublingual microcirculation and peripheral tissue oxygen monitoring in sepsis patients with successful fluid resuscitation

fluid therapy for sepsis patients has always been a research hotspot. early studies suggest that early goal-directed therapy (egdt) can reduce mortality in patients with sepsis and septic shock, which is included in the guidelines. however, recent studies suggest that egdt does not reduce mortality. this may be related to the fact that egdt only pays attention to systemic circulation and neglects microcirculation. in the past few decades, arterial blood pressure, blood lactic acid and other circulatory indicators have been the target of septic shock treatment, but normal systemic circulation does not mean normal tissue perfusion. obstacles to tissue perfusion, oxygenation and microcirculation may still exist. at the same time, compared with systemic hemodynamic parameters, microcirculation parameters may play a stronger role in predicting the prognosis of sepsis patients. it is believed that the ideal goal of resuscitation therapy for sepsis should be based on whether microcirculation function has been restored or not. objective:to observe the success rate of microcirculation imaging and oxygen saturation of peripheral tissues in sepsis patients under the guidance of current guidelines and procedures. at the same time, we compared the predictive value of microcirculation indicators to the prognosis of septic shock patients.

Eligibility criteria:
inclusion criteria: * patients fullfilled the diagnostic criteria of sepsis 3.0 exclusion criteria: * patients who were younger than 18 years old， * pregnant women * patients who had been admitted to the intensive care unit(icu for\<24 h)

Keywords: sepsis, nirs, sublingual microcirculation
comparing different montages of tdcs combined with dual-task training on eeg microstates

Conditions: Stroke

Summary: this study investigates whether electroencephalographic (eeg) measures of functional connectivity of the target network are associated with the response to different sets of transcranial direct current stimulation combined with dual-task training in post-stroke patients.

the present study seeks to compare the effects of conventional anodic tdcs (m1) with double-site/dual-site anodic tdcs (m1 + dlpfc) and simulated tdcs on functional connectivity, as assessed by eeg, in patients after staged stroke. chronic. the study is a randomized, double-blind, placebo-controlled, crossover clinical trial. participants will be submitted to three sessions, each session consisting of a different condition, namely: anodic tdcs - participants who will receive real current over the primary motor area; dualsite tdcs - participants who will receive real current over the primary motor area and over the dorsolateral prefrontal area (dlpfc) and simulated tdcs - participants who will receive simulated stimulation. participants will receive 3 tdcs sessions, lasting 20 minutes, associated with a physical therapy protocol based on dual motor and cognitive tasks, on alternate days (3 times a week). on each intervention day, pre and post-intervention assessments will be carried out, the evaluated outcomes will be: functional connectivity (eeg), functional mobility (timed up and go) and executive functions (trail-making test a and b, the clock drawing test and phonemic verbal fluency test). statistical performance will be performed using spss software (version 20.0) and matlab 9.20 with a significance level of p\<0.05.

Eligibility criteria:
inclusion criteria: * post-stroke participants for more than 6 months * individuals over 18 years of age; * both sexes; * patients with mild to moderate degree of injury severity (nihhs \<17 points) exclusion criteria: * patients with other associated pathologies that can influence motor activity (example: traumatic brain injury, brain tumor); * habitual use of drugs or alcohol; * use of drugs that modulate the activity of the central nervous system; * gestation; * use of metallic / electronic implants and / or cardiac pacemakers; * participants unable to communicate verbally;

Keywords: transcranial direct current stimulation stroke dual-task training eeg
cicatricial upper eyelid entropion management

Conditions: Entropion

Summary: suture-less technique will be used in treatment for cicatricial upper eyelid entropion to detect its long-term efficacy


Eligibility criteria:
inclusion criteria: * upper eyelid cicatricial entropion with no history of previous surgery. * cooperative patients older then 16 years old. exclusion criteria: * previous lid surgery. * senile and mechanical entropion.
efficacy and safety study of abatacept subcutaneous plus methotrexate in inducing remission in adults with very early rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and to maintain remission following 6 months of drug withdrawal.


Eligibility criteria:
key inclusion criteria: * presence of active clinical synovitis in at least 2 joints, 1 of which must have been a small joint, for a minimum of 8 weeks prior to screening * onset of persistent symptoms ≤ 2 years prior to screening * positive test result for anticyclic citrullinated peptides 2 * methotrexate naive or with minimum exposure to methotrexate, defined as no more than 10 mg/week for ≤4 weeks and no methotrexate dose for 1 month prior to screening visit * biologic naive, including no treatment with an investigational biologic prior to screening * disease activity score 28 based on c-reactive protein score ≥3.2 at screening * withdrawal from any treatment with chloroquine, hydroxychloroquine, and/or sulfasalazine (wash-out) for a minimum of 28 days prior to randomization * if receiving oral corticosteroids, on a stable low dose (≤ 10 mg/day prednisone equivalent) for at least 4 weeks * able to undergo magnetic resonance imaging key exclusion criteria: * meeting diagnostic criteria for other rheumatic disease (eg, lupus erythematosus) * treatment with an intravenous, intramuscular, or intraarticular corticosteroid within 4 weeks prior to randomization * scheduled for or anticipating joint replacement surgery * presence of concomitant illness likely to require systemic glucocorticosteroid therapy during the study, in the opinion of the investigator * history of malignancy in the last 5 years * any serious bacterial infection within the last 3 months not treated or resolved with antibiotics, or any chronic or recurrent bacterial infection * at risk for tuberculosis * evidence of active or latent bacterial or viral infection at the time of potential enrollment, including human immunodeficiency or herpes zoster virus or cytomegalovirus that resolved less than 2 months prior to enrollment
a study to assess the pharmacologic equivalence of two orlistat dosage forms

Conditions: Overweight

Summary: the purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.


Eligibility criteria:
inclusion criteria: * age: 18-60 years * body mass index: 25-33 exclusion criteria: * gastrointestinal disease * organ transplant * hiv, hepatitis b or c * food allergies * alcohol or other substance abuse * smoking

Keywords: orlistat overweight bioequivalence
safety and efficacy of fibryga in congenital fibrinogen deficiency

Conditions: Congenital Fibrinogen Deficiency

Summary: open-label, uncontrolled, multicenter observational study on the safety and efficacy of fibryga in congenital fibrinogen deficiency

there is a need to increase the body of data on treatment effectiveness and safety in the ultra-rare setting of congenital fibrinogen deficiency. real-world evidence (rwe) derived from non-interventional studies can describe product utilization, demonstrate value, and facilitate benefit-risk assessments; rwe can only be fully assessed once a product is launched and used in a real-life setting. this post-marketing, observational study is designed to collect information concerning safety, efficacy, and outcomes of fibryga administration in routine clinical use in patients of any age with congenital afibrinogenemia or hypofibrinogenemia. documentation of the administration of fibryga in clinical practice for the treatment of both minor and major bleeding events (bes) will not only enhance the knowledge on the efficacy and safety profile of fibryga, but will also gather information that cannot be obtained in the same way in controlled clinical studies. these observational data will support the safety and efficacy data generated with fibryga in good clinical practice (gcp) clinical studies, providing benefit for both physicians and patients.

Eligibility criteria:
inclusion criteria: * patients of any age with a documented diagnosis of congenital afibrinogenemia or hypofibrinogenemia expected to require on-demand in-hospital treatment for bes with fibryga exclusion criteria: * bleeding disorder other than congenital fibrinogen deficiency * patients with acquired fibrinogen deficiency or dysfibrinogenemia * suspicion of an anti-fibrinogen inhibitor as indicated by previous in vivo recovery, if available, of \<0.5 (mg/dl)/(mg/kg); there is currently no standard test for inhibitors * participation in an interventional clinical study at the time of or within 4 weeks prior to enrolment
study evaluating benefix in previously treated patients with hemophilia b

Conditions: Hemophilia B

Summary: to assess efficacy and safety of benefix® for prophylaxis in "short-term" therapy and on demand therapy for all bleeding episodes of subjects with hemophilia b.

phase iv, open-label, non comparative, multicenter, previously treated patients (ptp) clinical trial. patients with severe or moderate hemophilia b with baseline levels of plasma factor ix \< 5% activity will participate in this study for both treatment regimens: "on demand" therapy for acute bleeding episodes and therapy for prophylaxis of bleeding episodes ( "short-term therapy")\*. \* short-term therapy: prophylactic therapy given before surgery, including dental procedures, prior to a event that would likely result in bleeding ( sports, exercise, or heavy work), as well as to prevent further bleeds into a target joint). this short-term therapy for intermittent secondary therapy.

Eligibility criteria:
inclusion criteria: 1. patients with moderate to severe hemophilia b ( \< 5% circulating factor ix activity) having acute hemorrhage or requiring "short-term therapy" for intermittent secondary prophylaxis regimens. 2. hiv seropositive ( asymptomatic) or seronegative subjects. 3. no history or detectable inhibitors.

Keywords: benefix hemophilia b