Kornimate/medical-research-clean huggingface dataset:
car-t for children with relapsed and refractory acute lymphoblastic leukemia

Conditions: Childhood Acute Lymphoblastic Leukemia

Summary: in this study, car-t will be administered to children with acute lymphoblastic leukemia to explore the effect of car-t intervention time on the duration of complete remission and further verify the long-term safety and efficacy of car-t treatment.

after clinician evaluation, if the child meets the study criteria and after adequate communication, the parent or legal guardian voluntarily joins the clinical study, car-t technique can be used for related treatment, and the long-term therapeutic effect can be observed. in this trial, 50 children were publicly enrolled and treated with car-t. patients participating in the clinical trial will be tested and assessed in terms of treatment safety, efficacy, and duration of response.

Eligibility criteria:
inclusion criteria： 1. the treat history meeting the following criteria: recurrence of lymphoma patients with imaging (ct/mri/pet-ct) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the mrd recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation; can't get complete remission (including mrd positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients; one or twice chemotherapy cannot get remission again (including mrd positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients. 2. there is a measurable lesions before treatment at least; 3. ecog score≤2; 4. to be aged 1 to 18 years; 5. more than a month lifetime from the consent signing date exclusion criteria: 1. serious cardiac insufficiency, left ventricular ejection fraction\<50%; 2. has a history of severe pulmonary function damaging; 3. merging other progressing malignant tumor; 4. merging uncontrolled infection; 5. merging the metabolic diseases (except diabetes); 6. merging severe autoimmune diseases or immunodeficiency disease; 7. patients with active hepatitis b or hepatitis c; 8. patients with hiv infection; 9. has a history of serious allergies on biological products (including antibiotics); 10. has acute gvhd on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month; 11. any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
ptg-300 in subjects with hereditary hemochromatosis

Conditions: Hereditary Hemochromatosis

Summary: this study will be conducted at multiple sites and every patient will get treated with ptg-300. the objective of the study is to assess the effect of ptg-300 in treating adult hereditary hemochromatosis patients.

this study is a multicenter, open-label study. the objective of the study is to assess the effect of ptg-300 on transferrin saturation (tsat) and serum iron in adult hereditary hemochromatosis patients.

Eligibility criteria:
inclusion criteria: * men and women aged 18 and older * confirmed diagnosis of hfe-related hereditary hemochromatosis with prior genotype testing * documented stable phlebotomy for ≥ 6 months * screening hemoglobin \>11.5 g/dl * documented evidence of prior serum ferritin ≥500 ng/ml * serum ferritin \>50 ng/ml and \<300 ng/ml at screening exclusion criteria: * clinically meaningful laboratory abnormality * receiving iron chelation therapy * receiving erythrocytapheresis * pregnant or lactating females * infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 3 months of dosing; any infections requiring antimicrobial therapy within 4 weeks of dosing. * serious or unstable medical or psychiatric condition that would prevent subject providing informed consent * organ damage from iron overload * primary or secondary immunodeficiency * positive hepatitis b or hepatitis c or known human immunodeficiency virus infection * known history of autoimmune/inflammatory diseases * any surgical procedures requiring general anesthesia within 1 month prior to screening or planned surgery during study * history of invasive malignancies within last 2 years, except non-malignant skin cancer and local cured prostate cancer, cervical cancer, or ductal carcinoma in situ * receipt of an investigational agent within 30 days of screening
advancing the standard of care for pin site care

Conditions: Diabetes Mellitus; Open Reduction External Fixation

Summary: the purpose of this study is to prospectively evaluate the effect of active leptospermum honey utilizing the medihoney hcs dressing, on the occurrence of pin site infections, and also to see if the use of medihoney hcs reduces the frequency of dressing changes compared to published reports of routine standard pin site care.

up to 20 diabetic mellitus patients undergoing open reduction external fixation (oref) for foot and/or ankle fusions, fracture repair, or osteotomy will be enrolled to receive weekly medihoney pin site care until frame removal. standard size dressings and application technique will be used at each pin site with prefabricated materials. no procedures, tests or interventions will be performed exclusively for research purposes or more frequently than the standard of care. upon completion of the study, pin sites sepsis rates will be compared to published reports for standard pin site care.

Eligibility criteria:
inclusion criteria: * a signed and dated informed consent has been obtained from the subject. * subject is able and willing to comply with study procedures. * subject is 18 years of age or older. * type i or ii diabetes * albumin \>2.5 * a1c\<12 or average fasting levels \<200 * abi \> .6 or biphasic pedal vessels by doppler * charcot arthropathy of lower extremity * foot/ankle deformity * foot/ankle fracture * subject will undergo an open reduction with external fixation (oref). exclusion criteria: * a1c \> 12 * abi \< .6 or monophasic pedal pulses on doppler * recent (\<2 months) or ongoing bone infection based on radiograph or scan * cellulitis of lower extremity within the last 2 months based on clinical exam and/or laboratory markers * honey or honey based allergy

Keywords: diabetes surgical intervention honey
changes of keratometric value and ocular aberration after treatment of meibomian gland dysfunction

Conditions: Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)

Summary: ocular aberration may play a role in determining optical quality. recently performed study reported that ocular aberration of preocular tear film would be important factor in not only diagnosing the dry eye but also determining the efficacy of treatment. therefore, in this study, the investigators will aim to prove the improvement of quality of vision via ocular aberration changes indirectly after the proper treatment for moderate and severe meibomian gland dysfunction. also, the investigators will evaluate the changes of keratometric values after treatment for moderate and severe meibomian gland dysfunction, which could be demonstrated by autokeratometry, iolmaster, pentacam, and itrace.


Eligibility criteria:
inclusion criteria: (1) stage 3 or 4 meibomian gland dysfunction exclusion criteria: 1. history of previous ocular or intraocular surgery 2. ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease, 3. history of intolerance or hypersensitivity to any component of the study medications, 4. wearing contact lenses during the study period, presence of current punctal occlusion, 5. pregnancy, lactating women, and children. 6. additionally, patients were excluded if they were using any topical ocular or systemic medication that could be used for the treatment mgd or dry eye, including topical or oral antibiotics, topical cyclosporine a, topical or oral steroids, topical non-steroidal anti-inflammatory drugs, topical ocular allergy medications or artificial tears

Keywords: meibomian gland dysfunction keratometric value ocular aberration
the french multiple sclerosis registry

Conditions: Multiple Sclerosis; Neuromyelitis Optica Spectrum Disorders

Summary: ofsep is an observational cohort of multiple sclerosis (ms) and related disorders set up in france. it aims to provide a major epidemiological tool on ms for the scientific community in france and abroad. this tool must help to answer a large number of questions concerning the causes and mechanisms of ms, the prognostic factors of disease progression, the effectiveness and safety of therapeutic drugs, the impact of the disease on patients and society, etc. in december 2015, it has already included more than 54.000 patients. to achieve this goal, ofsep's objectives are * to maintain and develop the french cohort of patients suffering from ms or related diseases and syndromes. this means collecting standardized socio-demographic and clinical data as part of the routine medical follow-up of patients already in the cohort and recruitment of new patients. * to supplement the existing clinical data with standardized and quality biological samples and mri scans. * to improve the previous data with medical/administrative data from the health insurance fund databases in particular, in order to get more information on comorbidity, treatment protocols and the medico-economic aspects of this disease. * to use ofsep infrastructures to facilitate the implementation of specific studies requiring the collection of additional data or specific patient monitoring processes. * to ensure the availability of these data and samples to researchers, health care authorities and industrial players to enable analysis and thus provide answers to research questions or public health issues. this availability is only possible after scientific and regulatory evaluation of the request. * to provide regular descriptions of the patient population in the cohort to offer statistics, targets and up-to-date information on this disease and thus enable a better approach to the personal, professional and social impacts of the illness, the effects of basic treatments and the requirements related to the follow-up of this disease in france. * to conduct specific studies on the entire population of patients in the cohort (parent cohort) or on patient sub-groups with specific characteristics (nested cohorts). four nested cohorts have been defined: patients with radiologically isolated syndromes, patients with clinically isolated syndromes, patients with primary progressive courses of the disease and patients with neuromyelitis optica (devic's syndrome) spectrum disorders.


Eligibility criteria:
inclusion criteria: * ris * cis * ms according to mcdonald 2010 criteria * nmosd and others as per nomadmus criteria * no age limt * all clinical courses * domiciliated in france * signed ofsep informed consent exclusion criteria: none -

Keywords: multiple sclerosis pharmacoepidemiology disease modifying drugs neuro-myelitis optica
magnesium supplementation in the second trimester of pregnancy to overweight and obese individuals

Conditions: Gestational Diabetes; Obesity

Summary: this is a prospective, randomized, placebo controlled study with three parallel arms examining the effects of magnesium supplementation in the second trimester of pregnancy. recent research has shown that supplemental magnesium can have beneficial effects, especially in overweight individuals. not only do many people have a magnesium deficient diet, there is also evidence that magnesium can improve blood sugar levels. due to the growing concern of obesity with pregnancy and its associated complications, such as diabetes and abnormal fetal growth, magnesium therapy could have novel and beneficial effects on pregnancy outcomes. in this study, 60 overweight and obese pregnant patients in their first trimester will be enrolled and randomized. the first group (a) will receive oral magnesium citrate (300mg elemental magnesium), group b will receive dietary counseling about following a magnesium rich diet from a nutritionist, and group c will receive a placebo (control). blood and urine specimens will be collected at three time points during the pregnancy to analyze changes in levels of metabolic markers, inflammatory markers, and protein expression profiles. fetal and maternal complications of pregnancy will be noted, including maternal weight gain. at delivery, patients will have a placental cord blood specimen and placental biopsy collected for gene expression patterns and further analysis.


Eligibility criteria:
inclusion criteria: * between 18 and 40 years of age * pregnant in the first trimester * able to give informed consent * planning to deliver at ucla * bmi greater than or equal to 25 exclusion criteria: * on insulin therapy or other oral hypoglycemic agents * multiple gestation * baseline hgba1c \> 6.5% * prior history of clinically diagnosed t2d * multiple dietary restrictions/food allergies * heart, renal, or liver failure * clinical history of psychiatric illness or substance abuse * out of town travel planned at study visits

Keywords: weight gain in pregnancy metabolic and inflammatory markers
the safety and efficacy of fecal microbiota transplant (fmt) for steroid-refractory graft-versus-host disease

Conditions: GVHD

Summary: this clinical study evaluates the safety and efficacy of fecal microbiota transplantation (fmt) in patients with steroid-refractory graft-versus-host disease (gvhd).


Eligibility criteria:
inclusion criteria: 1. able and willing to sign the informed consent form and complete follow-up; 2. aged 18-65 years, regardless of gender; 3. patients with refractory gvhd. exclusion criteria: 1. life-threatening or associated with severe non-gvhd complications; 2. persistent malignant conditions; 3. patients who have undergone second or multiple hematopoietic stem cell transplants; 4. history of severe allergic reactions; 5. any condition that the investigator considers unsuitable for inclusion (such as any history, treatment history, or abnormal test data that may confound the study results, interfere with full participation in the study, or harm the patient's interests);

Keywords: gvhd
yoga chikitsa for neck pain caused by cervical spondylosis

Conditions: Cervical Spondylosis

Summary: neck pain caused by cervical spondylosis (cs) is one of the most common health complaints. despite its frequency as clinical problem worldwide, there are few evidence-based studies that document efficacy of therapies for neck pain. the aim of this study was to evaluate the effects of yoga chikitsa (yoga therapy) on pain and quality of life (qol) in cs patients compared to usual care.


Eligibility criteria:
inclusion criteria: * diagnosis of cs and confirmed by cervical radiographic examination * neck pain with cs * ready to consent exclusion criteria: * pregnancy * duration of neck pain \< 6 months * comorbid systematic condition (diabetes, cardiovascular) * history of cervical surgery, cervical injury, or disease of bones or joints.
blood flow restriction exercise in patients with pancreatic, biliary tract, and liver cancer (prev-ex)

Conditions: Pancreatic Cancer; Biliary Tract Cancer; Liver Cancer

Summary: in patients with cancer, resistance training appears to be a safe and effective exercise modality to increase both lean muscle mass and strength, as well as attenuates cancer-related fatigue. it may serve as a feasible intervention in these patients to mitigate cachexia, especially if implemented before the onset of cancer cachexia or in a pre-cachectic state. this study is a multicenter randomized controlled trial that will compare a blood flow restricted resistance training intervention during the pre- (prehabilitation) and post-operative (rehabilitation) phase in patients with pancreatic, biliary tract and liver cancer, versus usual care on skeletal muscle and other health-related outcomes.


Eligibility criteria:
inclusion criteria: * diagnosis of resectable pancreatic cancer * diagnosis of resectable biliary tract cancer (includes cholangiocarcinoma and ampullary cancer) * diagnosis of resectable liver cancer * ecog (eastern cooperative oncology group scale) performance status ≤ 2 exclusion criteria: * serious active infection * uncontrolled severe pain * severe neurologic or cardiac impairment according acsm criteria * uncontrolled severe respiratory insufficiency as determined by the treating clinician * any other contraindications for exercise as determined by the treating physician * poor swedish comprehension * pregnancy
gloria-af registry program (phase i)

Conditions: Atrial Fibrillation

Summary: this study constitutes phase i of the registry program. the main objective of this study is to characterize the newly diagnosed non-valvular af patient population at risk for stroke and the selection of antithrombotic treatment for stroke prevention in a real-world setting before dabigatran etexilate is approved for the prevention of strokes and systemic emboli in patients with non-valvular af in different regions of the world.

study design: cross-sectional

Eligibility criteria:
inclusion criteria: 1) patients newly diagnosed with non-valvular atrial fibrillation at risk for stroke. exclusion criteria: 1. presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention; 2. patients who have received more than 60 days of oral anticoagulant treatment (vitamin k antagonist) (vka) in their lifetime; 3. atrial fibrillation (af) with a generally reversible cause; 4. patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (vkas) is indicated
obesity prevention in african american school children

Conditions: Obesity

Summary: obesity is the second leading preventable cause of disease and death in the united states. low socioeconomic status (ses) and minorities are disproportionately affected. obesity prevention among children and adolescents is a public health priority. schools have been identified as key settings for obesity prevention; however, most health education interventions have had only a moderate effect on body weight. we propose a randomized intervention trial (pilot study) to test the feasibility and effectiveness of a school-based, environmental obesity prevention program in urban low-ses african american students. schools, students and their families, and local communities will be involved to promote healthy eating and physical activity (hepa) for prevention of childhood obesity. six chicago public schools will be randomly assigned as intervention (4 schools) and controls (2 schools). focus group studies will assess needs and barriers for promotion of hepa and guide the intervention. the intervention group will receive a school environment enrichment (see) program to modify the school physical and social environment, targeting food service, recess, physical education (pe) and school climate, and a community support \& environment modification (csem) program, involving local corner and chain grocery stores to promote healthy eating among students and their families. family involvement will be included for 5th and 6th graders, who will be followed for two years, to test ways to modify family environment. to assess the intervention effectiveness, multilevel data will be collected from schools (eg, food service, recess and pe), students (eg, body weight, eating and physical activity), parents (eg, family food purchasing practices) and communities (eg, available choices of snack foods in local stores). in addition, process evaluation data will be collected to assess the feasibility and acceptance (participation and satisfaction) of various intervention components by the target audience. the primary outcome variable is change in students' body weight status; secondary outcomes include changes in students' eating behavior and physical activity and changes in target environmental factors. in addition, cost-effectiveness of the intervention will be determined. if the intervention proves effective, a full-scale study will be developed. findings from this study will provide insights into the prevention of obesity among low-ses and minority students.


Eligibility criteria:
all 4-6th graders in the selected public schools in chicago and their parents/guardians

Keywords: obesity overweight children adolescents african american diet nutrition physical activity chicago
use of computers to prevent metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the objective of the proposed study is to design and evaluate a touch screen computer based multi-factorial intervention to educate individuals at risk of metabolic syndrome in diverse indian settings including urban, rural and slum in the state of bhubaneshwar. the study objective is to improve metabolic syndrome related knowledge, attitude and practices among individuals using the proposed interactive, bilingual computer based educational program.

the rising prevalence of overweight and obesity has a direct correlation with increasing prevalence of hypertension, dyslipidemia, type2 diabetes mellitus (t2dm), metabolic syndrome (mets), and cardiovascular diseases (cvd). most of the previous studies in india have been cross sectional nature and have looked at prevalence of metabolic syndrome (mets. despite the clinical and public health importance of this phenomenon, not enough work has been carried out so far to study and remedy this situation. a computer based interactive and bilingual system is proposed to improve metabolic syndrome related knowledge, attitudes and practices among individuals living in urban, rural and slum settings of bhubaneswar, india. we propose to enroll 750 individuals and the eligible study participants will be randomly assigned to either the intervention (computer based mets program cbmp) or control (printed educational material, pem) groups. the study participants will be followed at days 30, 60 and 90 days following the baseline visit. the primary outcomes include change in knowledge, attitudes and practices and secondary outcomes include improvement in quality of life and increase satisfaction to medical care.

Eligibility criteria:
inclusion criteria: * adults age 30 years and above, agreeing to participate in the study available for follow-up interview. exclusion criteria: * mental and physical challenge that makes it difficult to use the touch based computer program nonavailability for telephone follow-up involvement in other clinical trials or protocols related to metabolic syndrome.

Keywords: diabetes hypertension hypercholesterolemia obesity