Kornimate/medical-research-clean huggingface dataset:
allogeneic stem cell therapy in heart failure

Conditions: Heart Failure

Summary: the present aim is to perform at clinical double-blind placebo-controlled cardiology stem cell centre - adipose stem cells (cscc_asc) study in heart failure patients to investigate the regenerative capacity of the cscc_asc treatment.

the primary objective is to investigate the regenerative capacity of direct intra-myocardial injection of 100 mio. allogeneic cscc_ascs in patients with reduced left ventricular ejection fraction (ef) (≤45%) and heart failure in a double-blind placebo-controlled design. a total of 81 patients with will be enrolled in the study and treated in a 2:1 randomization with either cscc_asc or placebo (saline). the primary endpoint is change in left ventricle end-systolic volume (lvesv) at 6 months follow-up.

Eligibility criteria:
inclusion criteria: 1. 30 to 80 years of age 2. signed informed consent 3. chronic stable ischemic heart disease 4. symptomatic heart failure - new york heart association (nyha) class ii-iii 5. ef ≤45% 6. plasma nt-pro-bnp \> 300 pg/ml (\> 35 pmol/l) in sinus rhythm and plasma nt-pro-bnp \> 422 pg/ml (\> 450 pmol/l) in patients with atrial fibrillation 7. maximal tolerable heart failure medication 8. medication unchanged two months prior to inclusion 9. no option for percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg) 10. patients who have had pci or cabg within six months of inclusion must have a new angiography less than one month before inclusion or at least four months after the intervention to rule out early restenosis 11. patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device exclusion criteria: 1. heart failure (nyha i or iv) 2. acute coronary syndrome with elevation of creatine kinase (ck) isoenzyme mb (ckmb) or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion 3. other revascularisation treatment within four months of treatment 4. if clinically indicated the patient should have a coronary angiography before inclusion 5. moderate to severe aortic stenosis (valve area \< 1.3 mm2) or valvular disease with option for surgery. 6. diminished functional capacity for other reasons such as: obstructive pulmonary disease (copd) with forced expiratory volume (fev) \<1 l/min, moderate to severe claudication or morbid obesity 7. clinical significant anaemia (haemoglobin \ 14 109/l) or thrombocytopenia (thrombocytes \< 50 109/l) 8. anticoagulation treatment that cannot be paused during cell injections 9. patients with reduced immune response 10. history with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma 11. pregnant women 12. other experimental treatment within four weeks of baseline tests 13. participation in another intervention trial
microparticles in peritoneal carcinomatosis of colorectal origin

Conditions: Colorectal Carcinoma

Summary: peritoneal carcinomatosis (pc), a tumoral tumor of the peritoneum, is a frequent metastatic localization of colorectal cancer (crc, 13%). long regarded as a palliative situation, its management has progressed significantly with a curative treatment based on a complete cytoreduction surgery coupled with intraperitoneal hyperthermic chemotherapy. however current screening tools, tumor markers (ace, ca19-9, ca125) and abdominopelvic ct scan are insufficient, to diagnose cp early. a non-invasive biomarker, more sensitive and more specific than currently available tumor markers, would be a major advance in oncology. microparticles (mps), vesicles from extracellular membrane budding in response to cell activation or apoptosis of different cell types, have been described as implicated in tumor progression, procoagulant activity associated with cancer, and initiation of metastatic niches. a specific microparticulate (microparticulosome) signature has been reported in patients with crc, particularly in the presence of a thromboembolic event. however, there is currently no data on pms and their involvement in cp. in addition, cp and surgery coupled with hyperthermic intraperitoneal chemotherapy are major risk factors for thromboembolic complications. the characterization of prothrombotic pms is therefore essential to predict such event. the main objective of this project is to characterize the microparticulate signature of cp of colorectal origin and to compare it with that of cp without cp. the secondary objectives are to compare the microparticulate signature obtained on peripheral venous samples and intraoperative tumor samples, evaluate the evolution of the microparticulate signature between the beginning and the end of the intervention, then correlate the peripheral signature to the oncological follow-up of the patients with cp and the occurrence of a thromboembolic event.


Eligibility criteria:
inclusion criteria: * patient presenting a peritoneal carcinomatosis from colorectal cancer origin exclusion criteria: * patient presenting a peritoneal carcinomatosis from other pathologies than colorectal cancer origin
caregiver burden of wet age-related macular degeneration (wamd) in japan

Conditions: Wet Macular Degeneration

Summary: this study aims at investigation of the caregiver burden of wet age-related macular degeneration (wamd) patients and at the assessment of how much of caregiver burden could be reduced in transitioning from pro re nata to proactive therapy especially in real-life rural settings where public transportations are not readily available.


Eligibility criteria:
inclusion criteria: * \[patients\] * female and male out-patients diagnosed with wamd. * patients who are accompanied by his/her caregiver(s). * patients who have been receiving anti-vegf therapy with proactive regimen for 12 months or more at the participating site. * providing informed consent for the participation in this study. * \[caregivers\] * providing informed consent for the participation in this study. * capable of understanding and completing the questionnaires without any help from others exclusion criteria: * \[patients\] * presence of a disease or a condition more disabling than wamd in term of caregiving. * presence of intractable neurologic disease, physical handicap, mental handicap, or any condition that rendered them unable to walk independently. * intraocular surgery for other eye diseases after the start of wamd therapy. * \[caregivers\] * professional carers

Keywords: age-related macular degeneration caregiver burden anti-vascular endothelial growth factor (vegf) therapy
multiparametric mri as a non-invasive biomarker of the tumor microenviroment

Conditions: Breast Cancer; Triple-negative Breast Cancer

Summary: this study is looking at how an imaging test could help doctors understand if a patient with early breast cancer will respond to drugs that use the patient's immune system to fight cancer.

primary objective: - to evaluate serial multiparametric mri as an early marker for tumor immune response to an immune checkpoint inhibitor agent secondary objective: * to assess the potential of early treatment imaging changes on mri to discern final tumor treatment response * to assess the prognostic potential of mri features correlative: * to correlate mri features with immunophenotypes (i.e. hot and cold tumors) * to evaluate the association of mri features with other known biomarkers of immune checkpoint inhibitor response

Eligibility criteria:
inclusion criteria: women and men at least 18 years of age. * have a new diagnosis of invasive breast cancer with clinical stage i - iii disease or regional stage iv with metastasis to the supraclavicular nodes only * hormone receptor negative (estrogen-receptor \< 5% and/or progesterone-receptor \< 5%) * human epidermal growth factor receptor 2 (her2) negative by immunohistochemistry or fluorescence in situ hybridization (fish) * enrollment in a neoadjuvant clinical trial that includes the evaluation of immunotherapy as a part of the regimen; patient must be randomized to a treatment arm (including the control arm) prior to enrolling in this study * planning to undergo surgical resection and subsequent adjuvant therapy as per the treatment clinical trial or the clinical provider * have tissue available for additional correlative studies or planned to undergo an additional pre-treatment biopsy for additional tissue acquisition as per provider or the treatment clinical trial * be a candidate for mri imaging. * be willing to comply with scheduled visits required for the trial. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: systemic or locoregional treatment for the current episode of breast cancer prior to baseline breast mri. * poor visualization of the tumor on the initial breast mri (investigator discretion) * pregnant or nursing.
distance savvy: testing tele-savvy, a distance dementia family caregiver education program

Conditions: Dementia; Alzheimer's Disease; Depression

Summary: the purpose of this study is to refine and test the web-based delivery of a well-established in-person group program that provides information and education to informal caregivers (family and friends) of persons with alzheimer's disease (or related illnesses).

the pilot project proposed will allow the investigators to use telehealth methods to deliver the savvy caregiver, an evidence-based dementia caregiver psychoeducation program, to family caregivers of community-dwelling persons with dementing illnesses (pwd) for whom attending in-person meetings poses difficulties. the program - named tele-savvy - uses ipad and pc technology and on-line conferencing capacity to deliver the program through daily asynchronous self-learning modules and weekly, hour-long synchronous group meetings with program facilitators. tele-savvy addresses all of the learning objectives of the current in-person savvy program (savvy entails in-person participation in six weekly two-hour group sessions).

Eligibility criteria:
inclusion criteria: * an informal caregiver for a person with a dementing disorder, such as alzheimer's disease * able to speak, read, and understand english * has access to a computer with internet connection * lives in the us exclusion criteria: * unwilling to participate in data gathering
the safety of intravenous lacosamide

Conditions: Epilepsy

Summary: to evaluate the safety of iv lacosamide in children with partial-onset epilepsy, ages 4-35 years old, inclusive, who are either unable to take oral medication or require intravenous administration of iv lacosamide.

lacosamide tablets and intravenous formulations were both approved in the united states in the fall of 2008. lacosamide is indicated for use as adjunctive therapy in the treatment of partial onset seizure disorder in patients' age seventeen years and older. a parenteral dosage form of lacosamide is desirable for patients who are temporarily unable to take medication orally. the objective of this study is to evaluate the safety of iv lacosamide in children with epilepsy, ages 4 to 35 years, who are either unable to take oral medication, or whom parenteral administration of iv lacosamide is desirable.

Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of epilepsy and have received anti-epileptic drug therapy prior to initiation of iv lacosamide * patients must have a medical condition in which the parenteral administration of lacosamide is desirable. * patients may be male or female. * patients must be 4 years of age or older, and less than age 35 years. * patient or his / her legally authorized representative must sign an informed consent form prior to any study specific procedures. exclusion criteria: * patients will be excluded from entry into the study if any of the following are true: * patient has previously participated in any other intravenous lacosamide study. * patient has status epilepticus within the last 3 months. * patient has a history of drug allergy to lacosamide. * patient is pregnant. * patient has taken experimental drug within last 30 days. * patient with significant hepatic or renal disease.

Keywords: partial onset epilepsy pediatric lacosamide partial onset epilepsy vimpat
exacerbation and training in patients with chronic obstructive pulmonary disease

Conditions: COPD

Summary: when patients with chronic obstructive lung disease (copd) are admitted to the hospital with a severe exacerbation they lose muscle strength. this muscle weakness predisposes these patients to further hospital admissions. resistance training is a potent countermeasure to prevent and treat muscle weakness. in the setting of an acute exacerbation this intervention however has not been validated. the present study aims at investigating the safety and efficacy of resistance training (3x8 quadriceps extensions per day) to prevent muscle weakness. end points are quadriceps muscle strength and hospital readmission and functional status at discharge. using the minimally invasive needle muscle biopsy technique described by bergström the effects of resistance training on the skeletal muscle will be analyzed in detail. after giving informed consent, patients will be randomized on admission into usual care or usual care plus resistance training. patients will be followed-up using the clinical pathway for copd (10 days). after one month patients will attend the outpatient clinic for a follow-up visit. besides the measurement prescribed in the clinical path for copd (including arterial blood gas measures, lung function, functional investigation of the patients), patients will undergo muscle strength measures and venous blood will be drawn for the analysis of systemic inflammatory and growth factors. half of the patients will receive a resistance training program. at the end of the hospital admission, a needle biopsy of the vastus lateralis muscle will be obtained.


Eligibility criteria:
inclusion criteria: * copd exacerbation, admitted to the respiratory units * informed consent * age \< 80 * no critical comorbidity compromising outcome up to one month. * no suspect of malignancy exclusion criteria: * patient is involved in a rehabilitation program with a frequency \>1/wk during one month after inclusion in the study * nimv or icu on admission * patient scheduled for procedure (ltx/lvrs) within one month after discharge * readmission \<14 days after previous hospitalization * significant pathology that would hinder the participation in resistance training (gonarthrosis, arthritis to be judged by the investigator) * clinical signs of pulmonary hypertension

Keywords: exacerbation copd resistance training muscle force
pulmonary vascular hemodynamics before and after mitral valve procedures

Conditions: Pulmonary Hypertension

Summary: the objective of this proposal is to study circulating and echocardiographic markers of pulmonary vascular and right ventricular remodeling in patients with a who-2 diagnosis of pulmonary hypertension after mitral valve procedures. the investigators are proposing the study will be impactful for the early detection and prediction and of residual pulmonary hypertension (ph) that would otherwise be undetected and fatal with no curative treatment.

the investigators will enroll 3 groups: group 1: patients with established who-2 diagnosis of ph undergoing open and interventional mitral valve procedures. group 2: patients with no ph undergoing open and interventional mitral valve procedures. group 3: patients with established diagnosis of who-1-4 groups of ph undergoing right heart catheterization. groups 2 and 3 will serve as controls. all procedures will be performed at the main uab hospital cardiac surgical operating rooms and at the cardiac angiographic suites. the investigators will collect a total of 3 blood samples; the first sample will be obtained on arterial cannulation before the initiation of the intervention, the second sample will be collected upon the end of the procedure prior to leaving the procedure room, and the third sample will be collected on the day of discharge from the hospital. a comprehensive echocardiogram at the 3 corresponding time points of the blood samples obtained; before, and after the intervention and before discharge.

Eligibility criteria:
inclusion criteria: * \>= 18 years/old exclusion criteria: * patients with ejection fraction (ef) \< 35% * patients with severe tricuspid valve regurgitation * transplant patients * patients scheduled for ventricular assist devices * patients with a diagnosis of heart failure with preserved ejection fraction * any aortic valvular disease
efficacy and safety study of rhgm-csf gel to treat deep 2nd thickness burn

Conditions: Deep Partial Thickness Burn

Summary: this was a multicenter, randomized, phase ⅳ study, to investigate the extensive efficacy and safety of recombinant human granulocyte/macrophage colony-stimulating factor hydro-gel for topical application (rhgm-csf gel) on deep 2nd burn. there are two parts of the phase ⅳstudy, the first part was a multicenter, randomized, reference controlled study, all the subjects were randomized into two groups, test group (rhgm-csf gel) and control group (iodophor gauze), totally 358 deep 2nd burned patients were enrolled in first part of the study, 177 cases were enrolled in test group and 181 cases were enrolled in reference control group. in the test group, after the patients were enrolled in the group, clean the wound surface regularly and wash with normal saline, spread the test drug on the wound surface, bandaging with sterilized vaseline gauze, change the drug product every two or one day according to the effusion. in the reference control group, after the patients were enrolled in the group, clean the wound surface regularly and wash with normal saline, bandaging with iodophor gauze, change the drug product every two or one day according to the effusion. whole treatment were lasted till the wound surface was healing completely, if it is not recovered in 4 weeks, calculate and record the healing rate. the secondary part of the study was a multicenter, open study, to investigate the safety of rhgm-csf on deep 2nd burn patients. totally 2329 patients were enrolled in this part of the study.


Eligibility criteria:
inclusion criteria: * age is not less than 3 years old, any gender is ok. * the subject who is diagnosed as deep 2nd thickness burn * the subject who was not administrated with any other topical durg on wound surface before enrolled in the clinical study. * the subject who sign the \ exclusion criteria: * age is less than 3 years old * the subject who participated in any other clinical trial within 3 months * the subject who was administrated with any other topical drug on wound surface before enrolled in the clinical study * the female subject who is in lactation or pregnancy * the subject who are allergic to rhgm-csf, or has the allergic history to many drug products or has the allergic disease recently * the subject who has serious heart disease, unstable angina pectoris break out, cardiac functional insufficiency, myocardial infarction or serious general infection. * the subject who has serious renal inadequacy, creatinine(cr) is more than 2.5 times of the upper limit * aspartate aminotransferase or alanine transpeptidase is more than 2.5 times of the upper limit * the subject who use immunosuppressant
study of ixekizumab in participants with active ankylosing spondylitis (as)

Conditions: Spondylitis, Ankylosing

Summary: this study will assess the safety and efficacy of ixekizumab (ly2439821) compared to placebo in participants with active as.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe as with prior documented radiologic evidence (x-ray) fulfilling the modified new york criteria for as (1984) * have active as defined as bath ankylosing spondylitis disease activity index (basdai) ≥4 and the spinal pain (back pain) score ≥4 on a numeric rating scale (nrs) * participants should have been on nonsteroidal anti-inflammatory drugs (nsaids) with an inadequate response * participants who are regularly taking nsaids or cyclooxygenase-2 (cox-2) inhibitors as part of their as therapy are required to be on a stable dose * participants who have been on a tumor necrosis factor alpha (tnf) inhibitor (not more than one) must have experienced an inadequate response * total duration of prior therapy (nsaids and/or adequate physical therapy) should be at least 12 weeks * men must agree to use a reliable method of birth control or remain abstinent during the study * women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment exclusion criteria: * participants with a total ankylosis of the spine * prior or current treatment with adalimumab * participants previously treated with any biological or other immunomodulating agents except for those targeting tnf * evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than ankylosing spondylitis * have participated in any study with interleukin 17 (il-17) antagonists, including ixekizumab * serious disorder or illness other than ankylosing spondylitis * serious infection within the last 3 months * breastfeeding or nursing (lactating) women
a trial to evaluate the safety and efficacy of ncr300 in preventing recurrence of acute myeloid leukemia（aml) after transplantation

Conditions: Acute Myeloid Leukemia

Summary: a trial to evaluate the safety and efficacy of ink in the treatment of subjects for preventing recurrence of acute myeloid leukemia after allogeneic blood stem cell transplantation.

this is an open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of ncr300 injection.

Eligibility criteria:
inclusion criteria: 1.subjects who understand and voluntarily sign the informed consent form(icf); 2.18-65years; 3.clinical diagnosis of aml; 4.accepted allogeneic blood stem cell transplantation within 60 to 28 days prior before initial infusion; 5.complete donor chimerism and with high-risk recurrence factors prior to transplantation , or bone marrow examination shows positive mrd； 6.have already recovered from the adverse reactions of previous treatment； 7.having appropriate organ functions； 8.eastern cooperative oncology group(ecog)\<3; 9.subjects who are able to comply with contraceptives from the study period to 6 months after the end of this study; exclusion criteria: 1. bone marrow examination shows hematological recurrence; 2. have malignant tumors within 5 years before screening; 3. subjects with acute promyelocytic leukemia(apl); 4. subjects with severe respiratory diseases; 5. subjects with clear history of neurological or psychiatric disorders in the past; 6. active central nervous system involvement； 7. hiv(human immunodeficiency virus) antibody positive,treponema pallidum(tp) antibody positive.have active hepatitis b or hepatitis c; 8. allergies to ncr300 or its excipients; 9. subjects with active cardiovascular and cerebrovascular diseases; 10. received organ transplantation or planned transplantation； 11. received other treatment drugs after transplantation； 12. graft-versus-host disease (gvhd)\>ii grades; 13. subjects with active nervous system autoimmune or inflammatory diseases; 14. expected survival period within 3 months; 15. have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances; 16. having mental illness； 17. having uncontrollable active infections; 18. subjects whose state is not suitable for entering the study; 19. other situations determined by investigator that it is not suitable to enter the study.

Keywords: ink