Kornimate/medical-research-clean huggingface dataset:
plasma dilution and infusion to improve cognition in mild cognitive impairment (mci)

Conditions: Alzheimer Disease

Summary: in the addition-mci project, patients with a diagnosis of mild cognitive impairment probably caused by alzheimer's disease will receive plasma exchange.

repeated plasma exchanges will be conducted, and cognitive outcomes will be measured before and after the intervention.

Eligibility criteria:
inclusion criteria: clinical diagnosis of alzheimer's disease moca score \ 17 able to give informed consent as judged by the doctor setting the ad diagnosis and study doctor. at least one biomarker of the at(n)-classification system supporting the diagnosis expected to live more than five years at inclusion by the study doctor. exclusion criteria: known iga deficiency known severe protein s depletion previous severe allergic reaction after transfusion of a blood product known heart failure known liver failure known kidney failure previous cancer \<10 years. not deemed able to participate by the study staff other severe chronic diseases, interfering with the tpe-procedure ongoing infections other unresolved medical conditions known coagulopathies fulfilling icd-10 criteria for dementia at baseline, as evaluated by the evaluating physician. peripheral veins not expected to be suitable for repeated venous access procedures.
chronic obstructive pulmonary disease (copd) and domestic endotoxin (code)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this project aims to characterize the independent effect of domestic endotoxin exposure on health status, as well as pulmonary and systemic inflammation, in former smokers with copd. positive findings from this study would be clinically relevant, as they would provide evidence to support aggressive reduction of ongoing endotoxin exposure in patients with copd. the investigators also hope to make a methodological advance in the field of endotoxin exposure assessment by elucidating whether settled dust and/or airborne endotoxin measurements are the more relevant exposure of interest in epidemiological studies of respiratory disease. to fulfill the specific aims, the investigators will conduct a longitudinal study, including 75 former smokers with copd. all subjects will have indoor air monitoring, in-home settled dust collections, home inspections as well as assessments of health status, quality of life (qol), lung function and pulmonary and systemic inflammation.


Eligibility criteria:
inclusion criteria: * patient reported physician diagnosis of copd/chronic bronchitis/emphysema * cigarette smoking \> 10 pack-years * age \> 40 years * has not smoked \> 1 year * post bd fev1/fvc ≤ 70% * post bd fev1 (% predicted) 30-80% * ability and willingness to provide consent exclusion criteria: * non- english speaking * planning to move or live away from the home during the study period * co-morbid illnesses such as: * current physician diagnosis of asthma * other pulmonary diseases * systemic disease requiring treatment with immunosuppressive agents * known alpha-1 antitrypsin deficiency * occupational exposure with high endotoxin exposure * within the last 6 months use of oral corticosteroids

Keywords: chronic obstructive pulmonary disease (copd)
dual hemisphere rtms for rehabilitation of post stroke aphasia

Conditions: Non Fluent Aphasia in Subacute Stroke

Summary: to investigate the therapeutic effect of dual hemisphere repetitive transcranial magnetic stimulation (rtms) on post-stroke non fluent aphasia.

thirty patients with subacute post-stroke non-fluent aphasia were randomly allocated with a ratio 2:1 to receive real (n = 20) or sham (n = 10) rtms of the affected motor cortex. each patient received 1000 rtms pulses (1 hertz at 110% of resting motor threshold) over the unaffected broca's area and 1000 pulses (20 hertz at 100% resting motor threshold) over affected left broca's area for 10 consecutive days. language section of hemispheric stroke scale, stroke aphasic depression questionnaire hospital version (sadq-h) and nih stroke scale were assessed before, post sessions, 1 and 2 months after the last session . motor threshold was assessed before and after the end of last session.

Eligibility criteria:
inclusion criteria: * acute hemiplegia with non-fluent aphasia, single thromboembolic non-haemorrhagic infarction documented by computerized tomography (ct) in the distribution of middle cerebral artery. exclusion criteria: * head injury or neurological disease other than stroke, * unstable cardiac dysrhythmia, * fever, * infection, * hyperglycaemia * prior administration of tranquilizer * patients with no motor evoked response recorded from first dorsal interosseus (fdi) muscle of the affected hand

Keywords: aphasia, stroke, repetitive transcranial magnetic stimulation.
changes in optical coherence tomography leakage mapping in diabetic macular edema after conbercept treatment

Conditions: Diabetic Macular Edema

Summary: eyes with diabetic macular edema requiring conbercept treatment will be followed up for one month. before treatment, one week after treatment and one month after treatment, the eyes will be examined by optical coherence tomography (oct) and optical coherence tomographic angiography (octa). the changes of macular edema will be observed and analyzed by oct leakage mapping software, and the relationship between the changes of macular edema and visual acuity will be analyzed.

1. research purpose: after one month follow-up, we will observe whether octleakage mapping can be used as a biomarker to predict the prognosis of dme eyes, and will observe the effect of conbercept on improving edema and visual acuity of dme eyes. 2. subjects number of subjects planned to be recruited: 35 inclusion criteria: 1. age ≥ 18 2. diabetic macular edema eyes treated with conbercept for the first time in 1 week 3. informed consent of patients and signing of informed consent exclusion criteria: 1. high myopia 2. macular diseases affecting vision 3. vitreous hemorrhage requiring surgery 4. patients with anterior segment neovascularization 5. eye or periocular infection 6. optic neuropathy and glaucoma 7. periphlebitis, ophthalmic ischemic syndrome, uveitis, coat's disease, fevr and other retinal diseases 8. ametropia and cataract surgery 9. in 3 months, in addition to this treatment of conbercept, other anti vegf treatment, laser treatment or vitreoretinal surgery were performed 10. other systemic diseases can not complete follow-up

Eligibility criteria:
inclusion criteria: 1）age ≥ 18 2) diabetic macular edema eyes treated with conbercept for the first time in 1 week 3) informed consent of patients and signing of informed consent exclusion criteria: 1）myopia ≥ 6.0d 2) macular diseases affecting vision 3) vitreous hemorrhage requiring surgery 4) patients with anterior segment neovascularization 5) eye or periocular infection 6) optic neuropathy and glaucoma 7) periphlebitis, ophthalmic ischemic syndrome, uveitis, coat's disease, fevr and other retinal diseases 8) ametropia and cataract surgery 9) in 3 months, in addition to this treatment of conbercept, other anti vegf treatment, laser treatment or vitreoretinal surgery were performed 10) other systemic diseases can not complete follow-up

Keywords: diebetic macular edema optical coherence tomography conbercept
a double blind randomized study using placenta derived decidual stromal cells for hemorrhagic cystitis

Conditions: Hemorrhagic Cystitis; Stem Cell Transplantation; Decidual Stromal Cells

Summary: a prospective double blind randomized study comparing placenta derived decidual stromal cells with placebo for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. it is hypothesized that the decidual stromal cell therapy will be superior to placebo.

patients with grade 2-4 hemorrhagic cystitis will be randomized to receive either decidual stromal cell therapy at approximately 1x106 cells/kg or placebo on two occasions at weekly intervals. patients not responsive within 2 weeks will receive decidual stromal cells at approximately 1x106 cells/kg openly.

Eligibility criteria:
inclusion criteria: * hemorrhagic cystitis grade 2-4 * receives misoprostol therapy exclusion criteria: * patients with urinary urge without macroscopic hematuria or clots
prostate-specific membrane antigen (psma) radionuclide therapy

Conditions: Prostate Cancer

Summary: this study is a single-center registry study collecting clinical data regarding the treatment of psma-positive metastatic castration-resistant prostate cancer treated with psma radionuclide therapy per the treating physician's discretion. clinical data from candidates for or who undergo the psma procedure at methodist dallas medical center from august 2022 to august 2027 will be collected after discharge and patients will undergo clinical follow-up per the treating physician's discretion.

this study is a single-center registry study collecting clinical data regarding the treatment of psma-positive metastatic castration-resistant prostate cancer treated with psma radionuclide therapy per the treating physician's discretion. clinical data from candidates for or who undergo the psma procedure at methodist dallas medical center from august 2022 to august 2027 will be collected after discharge and patients will undergo clinical follow-up per the treating physician's discretion. participants will be followed for two years following the first psma procedure. during these visits, participants will also be asked to report any change in their medications. participants will not need to visit the study doctor more often than their usual treatment unless they have other medical needs. however, if participants experience any significant change in their medical condition they may be asked to have additional tests such as computed tomography (ct) scans, blood tests, etc.

Eligibility criteria:
inclusion criteria: * 1. \>18 years of age * 2. diagnosed with psma-positive metastatic castration-resistant prostate cancer and - has consented to undergo psma nuclear therapy per the treating physician. specifically: * metastatic or locally advanced and inoperable * clear disease progression on psma-pet/ct * psma-pet/ct scan positive disease within 6 weeks * labs: * hemoglobin: \>8 g/dl * white blood cell count: \>2k cells/µl * platelet (thrombocyte) count: \>75 x 109/l * no prior therapy with radium-223 dichloride exclusion criteria: * patients who do not meet the inclusion criteria laid out in section 4.2 will be excluded from the study.
efficacy study of t cell vaccination in hiv infection

Conditions: HIV Infections

Summary: the hallmark of hiv infection and aids is the continuous attrition of cd4 t cells. one of the mechanisms that may account for the cd4 attrition , is autoimmunity against the cd4 t cells, caused by autologous immune cells. vaccination against autoimmune reactive t cells has been successfully tried in animal models of autoimmune diseases and is now being tried in patients with multiple sclerosis. the purpose of the present study is to test this hypothesis in hiv infection. we will vaccinate hiv infected patients in whom specific autoimmune reactivity against cd4 is present , with their own cd4 reactive t cells. following that, we shall study the patients and find out if the t cell vaccination caused a rise in cd4 t cell levels, and whether it influenced hiv viral load, as well as hiv and cd4 specific immunity.

the study will be based on forty hiv infected patients, receiving anti retroviral treatment (haart), with cd4 levels between 150-350 and hiv plasma viral load \< 5000, for at least 12 months and despite continuous anti-retroviral treatment. the patients will be randomly divided into two groups, one that will get the t cell vaccination, and the other that will serve as controls. the t cell vaccine will be prepared from autologous t cells that responded by specific proliferation to recombinant cd4, further expanded in vitro by il-2, and then fixed by glutaraldehyde. each vaccine portion will consist of 10,000 such cells suspended in saline and given subcutaneously every three months during the first year of the trial. the outcome measures will be cd4 levels, specific immunity to hiv antigens, immune activation profile and hiv plasma viral loads, determined sequentially during the 24 months of the trial. these outcome measures will be compared between the experimental and the control groups, to determine if this mode of treatment is effective in influencing cd4 levels as an additional mode of treatment during hiv infection.

Eligibility criteria:
inclusion criteria: 1. cd4 cell counts -from 150 to 450/mm3 and stable for at least 12 months, and treatment with haart for at least 6 months. 2. positive cell proliferation assay to cd4 molecule 3. low hiv viral load (\<400 - 5000 copies/ml) for at least 12 months 4. no change of antiretroviral treatment for at least 6 months 5. signed informed consent exclusion criteria: 1. concomitant immunosuppressive or antineoplastic treatment as well as chronic systemic glucocorticoid therapy. 2. pregnancy and women without any efficacious contraception. 3. clinically relevant liver disease (ast and/or alt \>2,5x upper limit of normal range, or total bilirubin \> 3,5 mg/dl). 4. serum creatinine \>1,8mg/dl or creatinine clearance \<30ml/min. 5. patients who cannot fully understand the treatment protocol or are unable to sign the informed consent.

Keywords: hiv cd4 t cell level cd4 autoimmunity viral load t cell vaccination hiv therapeutic vaccine
a phase ii study of m2951 in sle

Conditions: Systemic Lupus Erythematosus

Summary: m2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. the purpose of the study was to assess the safety and efficacy of m2951 in participants with systemic lupus erythematosus (sle).


Eligibility criteria:
inclusion criteria: * eligible male and female participants, aged 18 to 75 years * must have diagnosis of sle with either the systemic lupus international collaborating clinics (slicc) criteria for sle, or at least four of the 11 american college of rheumatology (acr) classification criteria for sle, of at least six months duration prior to screening * sledai-2k total score greater than or equal to (\>=) 6 (including clinical sledai greater than or equal to (\>=) 4) at screening visit * and be positive for anti-double-stranded deoxyribonucleic acid (dna) and/or anti-nuclear antibody (ana greater than or equal to (\>=) 1:80) and/or anti-smith (anti-sm) antibody at the time of screening * other protocol defined inclusion criteria could apply exclusion criteria: * participants are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension * proteinuria (urine protein to creatinine ratio \[upcr\] \> 4 mg/mg) * acutely worsened renal function * central nervous system sle * or within two weeks prior to screening or during screening: use of oral corticosteroids greater than (\>) 30 mg daily prednisone equivalent * use of injectable corticosteroids, or change in dose of corticosteroids. * other protocol defined exclusion criteria could apply

Keywords: systemic lupus erythematosus m2951 placebo dose response oral corticosteroids safety efficacy autoimmune and inflammatory disorders
dyslipidemia treatment in thailand and cardiovascular outcomes

Conditions: Dyslipidemia

Summary: the purpose of this study is to establish the proportion of patients on lipid-lowering pharmacological treatment (statin or combination) reaching the ldl-c goals according to the updated 2004 national cholesterol education program adult treatment panel iii (ncep atp iii) guidelines.

mc md

Eligibility criteria:
inclusion criteria: * provision of subject informed consent, female or male aged = 18 years * patients eligible for treatment of dyslipidemia with statins, according to the current guidelines ncep atpiii about dyslipidemias and atherosclerosis prevention receiving lipid-lowering drug treatment for at least 15 days. exclusion criteria: * involvement in the planning and conduct of the study (applies to either astrazeneca staff or staff at the study site). * previous enrolment or randomisation of treatment in the present study * participation in a clinical study during the last 90 days

Keywords: dyslipidemia treatment and cardiovascular outcomes
effect of kron (citicoline and nicotinamide oral solution) on patients with open-angle glaucoma

Conditions: Glaucoma

Summary: aim of this study is to investigate the administration effects of the combination of citicoline 40mg/ml and nicotinamide 15mg/ml oral solution (kron®) on short term improvement in inner retinal function, bioelectrical activity of the visual cortex and visual function.

prospective, masked, randomized placebo-controlled study to evalute the offect of the oral solution kron® (citicoline 40mg/ml and nicotinamide 15mg/ml) on patients with a diagnosis of open angle glaucoma and risk of glaucoma progression. glaucomatous patients with a diagnosis of open angle glaucoma and risk of glaucoma progression who meet the study criteria will be enrolled and randomly assign to the following two arms: 1. treatment group (tg): 20 patients will receive citicoline 40 mg/ml + nicotinamide 15 mg/ml oral solution for 3 months (10 ml/day) 2. control group (cg): 10 patients will be evaluated as control once recruited, a clinical evaluator will perform a comprehensive ophthalmologic evaluation at baseline, week 6 and week 12. the following examinations will be done in the following sequence: * visual acuity * slit lamp evaluation * perg * pev pattern * tonometry * visual field * optical coherence tomography * dilated fundus examination

Eligibility criteria:
inclusion criteria: * glaucomatous patients with moderate visual field loss, md ranging from -6 db and -12 db, and risk of progression * controlled intraocular pressure * at least 3 previous visual field examinations. exclusion criteria: * angle closure glaucoma and secondary open angle glaucoma * refractive error outside +2d and -6d * ophthalmic surgery 6 months before the recruitment * presence of cataract or other conditions that could affect results of perimetry or electroretinography * treatment with supplements in any form with a demonstrated or presumed neuroprotecting/neuroenhancing effect in the last six months * presence of other ocular or systemic diseases that could affect results of perimetry or electroretinography.
a thorough qtc study to assess the effect of cotadutide on cardiac repolarization in healthy participants

Conditions: Non-alcoholic Steatohepatitis

Summary: this study will investigate the effect of multiple doses of cotadutide on the cardiac activity (qtc interval) of healthy participants.

this study will be a randomized, double-blind, placebo-controlled 3-arm parallel study with a nested crossover design for positive control with moxifloxacin administration in healthy male and female participants. participants will be randomized to receive treatment with either cotadutide during the 13-week treatment period (arm 1) or cotadutide-placebo (arm 2). the cotadutide-placebo treatment arm will be further divided into 2 subgroups (arms 2a and 2b), in a nested crossover design for only the placebo-treated participants. participants will be randomized in a 2:1:1 ratio to arm 1, arm 2a, and arm 2b. approximately 80 participants will be randomized to have 64 evaluable participants in the study. each participant will be involved in the study for approximately 22 weeks.

Eligibility criteria:
inclusion criteria: * healthy male and female participants of age 18 to 55 years. * females must have a negative pregnancy test. * have a body mass index (bmi) of ≥ 18 and ≤ 29.9 kg/m\^2. exclusion criteria: * history or presence of any clinically significant disease or disorder. * history or presence of gastrointestinal, hepatic or renal disease, or any other condition (including gastrointestinal surgery) known to interfere with absorption, distribution, metabolism, or excretion of drugs. * history of acute or chronic pancreatitis. * family history of sudden cardiac death before the age of 50 of a first-degree relative. * history of additional risk factors for torsade de pointes (eg, heart failure, clinically important bradycardia and electrolyte disturbances eg, hypokalemia, hypocalcemia, hypomagnesemia or family history of long qt syndrome). * history of neoplastic disease * any clinically significant abnormalities in clinical chemistry, hematology, urinalysis results or vital signs. * any clinically significant abnormalities in rhythm, conduction, or morphology of the 12-lead resting electrocardiogram (ecg). * any positive result on screening for serum hepatitis b surface antigen or anti-hbc antibody, indicative of active hepatitis b (ie, participants with positive anti-hbc antibody result are acceptable if anti hbc igm antibodies are negative), hepatitis c antibody, and human immunodeficiency virus (hiv) antibody. * current smokers or those who have smoked or used nicotine products (including e-cigarettes). * known or suspected history of alcohol or drug abuse or excessive intake of alcohol. * use of drugs with enzyme-inducing properties such as st john's wort. * participant has a positive test result for sars-cov-2 rt-pcr during screening period or at baseline. * participant has clinical signs and symptoms consistent with covid-19 or a history of severe covid-19 (hospitalization, extracorporeal membrane oxygenation, mechanically ventilated).

Keywords: non-alcoholic fatty liver disease glucagon-like peptide-1 (glp-1) receptor
g-csf moblized peripheral harvest for poor engraftment after stem cell transplantation

Conditions: Poor Graft Function; Stem Cell Transplantation; Graft Versus Host Disease

Summary: poor graft function (pgf) is a common complication after allogeneic stem cell transplantation, which was associated with high mortality. the pathogenesis fo pgf was poorly understood. infusion of donor peripheral cell harvest was effective for some patients with pgf in our preliminary study. this present study aimed to explore the efficacy of peripheral cell harvest for poor graft function.

poor graft function (pgf) is a common complication after allogeneic stem cell transplantation, which was associated with high mortality. the pathogenesis fo pgf was poorly understood. infusion of donor peripheral cell harvest was effective for some patients with pgf in our preliminary study.the peripheral cell harvest was aphaeresis on the fourth or fifth day after mobilization with recombinant human granulocyte colony stimulating factor. hematogical response was assessed at 30 days after infusion. good response was defined as neutrophil \> 1.0×109/l without g-csf support for at least 3 consecutive days, and persistent platelet \>20×109/l without transfusion for at least 7 days. otherwise, poor response was defined.

Eligibility criteria:
inclusion criteria: * patients received allogeneic stem cell transplantation;diagnosis of pgf after hsct; without concurent gvhd,relapse of underlying disease. exclusion criteria: * age\<14 years;active gvhd;relapse of underlying disease