Kornimate/medical-research-clean huggingface dataset:
evaluation of vitamin a and zinc supplementation on malarial morbidity

Conditions: Malaria; Malnutrition

Summary: the purpose of this study was to determine whether young children receiving vitamin a and zinc supplements will have a lower incidence of symptomatic malaria than similar children receiving vitamin a supplements alone.

the aim of our study was to determine the impact of the combination of vitamin a and zinc supplements on malaria morbidity in young children. the primary objective was to determine the effect of vitamin a alone vs. vitamin a and zinc supplements on the incidence of clinical malaria. the specific objectives were to determine the effect of vitamin a alone vs. vitamin a and zinc supplements on changes in anthropometric measurements specifically weight and length/height and to assess the effect of the study interventions on the incidence of anemia, diarrhea and pneumonia. it also assessed the tolerability of the supplements and determined the change in zinc status by measuring plasma zinc concentration using atomic absorption spectrometry before and at the end of the intervention. the study also determined the change in vitamin a status as assessed by the modified relative dose response (mrdr) test during and at the end of the intervention.

Eligibility criteria:
inclusion criteria: * children aged 6 - 24 months * child's guardian is willing to provide informed consent * child's family plans to remain resident in the study areas during the study period exclusion criteria: * clinical evidence of vitamin a deficiency * severe acute malnutrition * severe illness * child aged \ 24 months * receipt of vitamin a supplement within the last three months

Keywords: vitamin a zinc malaria morbidity mrdr
treatment of cd19 chimeric antigen receptor t cells for pediatric patients with cd19-positive b-cell acute lymphoblastic leukemia who are indicated for hematopoietic stem cell transplantation

Conditions: Very High Risk Acute Lymphoblastic Leukemia; CD19 CAR-T Therapy

Summary: this is a phase 2 clinical trial targeting pediatric and adolescent patients diagnosed with cd19-positive b-all, considered very high-risk group. the study aims to administer cd19 car-t therapy as an alternative to hematopoietic stem cell transplantation in patients eligible for such transplantation. the trial includes patients aged 25 or younger.


Eligibility criteria:
inclusion criteria: * subject eligibility criteria include individuals who are under the age of 25 at the time of snuh-cd19-car-t administration. confirmation of b-cell acute lymphoblastic leukemia diagnosed at the initial assessment by a treating physician for the first diagnosis is required. immunophenotypic analysis of cd19 expression on leukemia cells must be confirmed through immune profiling at the time of the initial diagnosis of b-cell acute lymphoblastic leukemia. in patients experiencing hematologic relapse of b-cell acute lymphoblastic leukemia, cd19 expression should also be confirmed at the time of relapse confirmation. patients must achieve hematologic complete remission defined as less than 5% blasts in the bone marrow after the first-line or second-line chemotherapy (first salvage therapy). eligible patients for hematopoietic stem cell transplantation, defined by indications for transplantation, include those meeting at least one of the following criteria: 1. philadelphia chromosome-positive due to t(9;22)(q34;q11) translocation. 2. hypodiploidy defined by fewer than 44 chromosomes. 3. e2a-hlf gene fusion due to t(17;19) translocation. 4. detection of minimal residual disease (mrd) positive at 0.01% or higher by next-generation sequencing confirmed after consolidation therapy and maintenance therapy. 5. failure of the first-line therapy. 6. cases not meeting any of the above criteria but deemed eligible for hematopoietic stem cell transplantation based on the investigator's judgment. exclusion criteria: * patients who have undergone hematopoietic stem cell transplantation. * individuals for whom an adequate or sufficient leukapheresis product suitable for the production of snuh-cd19-car-t cannot be obtained or is unavailable. * those known to be infected with the human immunodeficiency virus (hiv). * presence of uncontrolled active infections, determined by the investigator's assessment. if appropriate treatment has been administered for the infection, and there are no signs of progression at the time of enrollment, it is considered controlled. persistent fever without other symptoms is not interpreted as progressive infection. * women who are pregnant or breastfeeding. * individuals deemed clinically inappropriate for participation in the clinical trial based on the investigator's clinical judgment.
evaluation of tabalumab using auto-injector or prefilled syringe in participants with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the serum concentration of tabalumab after the administration using either prefilled syringe or auto-injector after the initial loading dose and after 12 weeks of treatment. treatment period is followed by 40 weeks optional safety extension.


Eligibility criteria:
inclusion criteria: * ambulatory males or females ≥18 years of age * diagnosis of adult-onset ra * active ra (at least 8/68 tender and at least 8/66 swollen joints) * screening c-reactive protein (crp) \>1.2 times the upper limit of normal (uln) or a screening erythrocyte sedimentation rate (esr) \>28 millimeters per hour (mm/hr) * documented history of, or current, positive rheumatoid factor (rf) and/or anti-cyclic citrullinated peptide antibody (anti-ccp ab) test * regular use of methotrexate (mtx) for at least 12 weeks and stable dose (10 to 25 mg/week) for at least 8 weeks prior to baseline * american college of rheumatology (acr) functional class i, ii, or iii * able and willing to inject tabalumab by themselves (or have an assistant who will inject tabalumab) and able and willing to complete all study procedures * able and willing to have blood drawn for pharmacokinetic (pk) sampling exclusion criteria: * use of oral corticosteroids at average daily doses of \>10 milligrams per day (mg/day) of prednisone or its equivalent within 6 weeks prior to baseline * injection of any parenteral (including intraarticular) corticosteroid within 6 weeks of baseline * have previously discontinued treatment with a biologic disease-modifying antirheumatic drug (dmard) or a novel drug that interrupts cytokine signaling \[for example, janus kinase (jak) inhibitors\] due to insufficient efficacy * participants who had discontinued biologic dmards for reasons other than efficacy will not be excluded but must have done so prior to baseline * participants who discontinued a jak inhibitor for lack of efficacy * participants who discontinued a jak inhibitor for reasons other than efficacy will not be excluded, but must have done so prior to baseline for 21 days * previous severe reaction to any biologic therapy that, in the opinion of the investigator, would pose an unacceptable risk to the participant if participating in the study * have had an inadequate response to treatment with 3 or more of the following dmards prescribed alone or in combination at approved doses for a minimum of 90 days: leflunomide, azathioprine, cyclosporine, and/or sulfasalazine * use of other dmards (for example, gold salts, cyclosporin, azathioprine, or any other immunosuppressives) other than mtx, hydroxychloroquine, chloroquine, or sulfasalazine, or the use of a jak inhibitor in the 8 weeks prior to baseline
subclinical atherosclerosis using dual-source ct coronary angiography in chinese adults with different glycaemic status

Conditions: Thromboembolism

Summary: part i: survey of coronary artery calcification and stenosis in participants with different glycaemic status aims: to evaluate coronary artery calcification and stenosis in community-dwelling adults with different glycaemic status, using dual-source ct angiography (cta) study subjects and methods: 200 adults with normal glucose regulation (ngr), 200 with impaired glucose regulation (igr) and 200 with type 2 diabetes were recruited from an urban community of shanghai, who then underwent a comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis and cta. part ii: follow-up of cardiovascular events and re-evaluation of coronary artery calcification and stenosis aims and methods: to investigate the development of cardiovascular diseases in subjects recruited in part i and re-evaluate coronary artery calcification and stenosis using cta after 3-year follow-up to identify the predictive value of coronary artery calcification and stenosis with future risks of cardiovascular diseases and the possible development of coronary artery disorders among participants with different glycaemic status


Eligibility criteria:
inclusion criteria: 1. age between 40 and 70 years old 2. gender: males and females 3. provide written informed consent 4. satisfactory compliance exclusion criteria: 1. history of cardiovascular diseases 2. allergy to iodine 3. exposure to radiation within last 3 months 4. alt more than 100iu/l, or serum creatine more than 133μmol/l \[1.5mg/dl\] or gfr less than 60ml/min 5. heart rate more than 100 bpm or severe arrhythmia 6. malignancy, myocardial infection, acute hepatitis or other major diseases
first in human study of uct-01-097 in participants with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of uct-01-097 in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * advanced solid tumor * measurable disease, per recist v1.1 * eastern cooperative oncology group (ecog) performance status 0-1 * adequate organ function exclusion criteria: * has not recovered \[recovery is defined as nci ctcae, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements * received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of uct-01-097 * progressive or symptomatic brain metastases * serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection * history of phosphate or calcium disorder * history of significant cardiac disease * history or current evidence/risk of retinopathy * history of myelodysplastic syndrome (mds) or aml * history of another cancer within 3 years before day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. a history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (dcis) of the breast and prostate cancer with a gleason score less than or equal to 6, are also not excluded * if female, is pregnant or breastfeeding
oral glucose tolerance testing after gestational diabetes

Conditions: Gestational Diabetes; Pregnancy; Obesity

Summary: this is an observation study of women with gestational diabetes. subjects recruited undergo immediate postpartum diabetic screening prior to discharge. post-partum screening for overt diabetes is repeated 6-12 weeks postpartum. the outcome of interest is the utility of an immediate post partum screen for overt diabetes compared to a traditional 6 week test.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * gestational diabetes exclusion criteria: * multiple gestations * pre-pregnancy diabetes
prospective cohort for early detection of liver cancer

Conditions: Cirrhosis; Hepatocellular Carcinoma

Summary: this study aims to recruit 3000 people with liver cirrhosis into a prospective cohort for early detection of liver cancer - the pearl cohort. the study team believe that using a combination of novel tests may improve the detection of early hepatocellular carcinoma (hcc).

during a four-year follow-up period, around 100 pearl patients are expected to be diagnosed with hcc. blood, urine, clinical and imaging data will be collected over the follow up period. the samples will be used to identify a range of tests (including genetic, protein and other biomarkers), which along with the clinical data will hopefully identify those most at risk of developing hcc, and to identify hcc at the earliest possible time points.

Eligibility criteria:
inclusion criteria: 1. patients of all genders, age \>18 years 2. participant is willing and able to give informed consent for participation in the study. 3. evidence of cirrhosis cp a or b (as defined below, cirrhosis ever diagnosed), with an underlying aetiology of at least one of the following: chronic hepatitis b virus (hbv) infection, chronic hepatitis c virus (hcv) infection, alcoholic liver disease, non-alcoholic fatty liver disease or haemochromatosis cirrhosis diagnosis definition 1. histological assessment (ishak stage 5 or 6) or 2. at least one of the following: i. validated non-invasive marker of fibrosis including fibroscan, ast to platelet ratio index (apri) score \>2 or enhanced liver fibrosis (elf) score \>10.48 or fibrotest score \>0.73. fibroscan readings should be assessed by aetiology as below: * hbv: \>=10 kpa * hcv: \>=14.5 kpa * alcoholic liver disease (ald): \>=19.5 kpa * non-alcoholic fatty liver disease (nafld): \>=15 kpa * haemochromatosis: \>=12kpa ii. evidence of varices at endoscopy or imaging in the context of a patent portal vein iii. definitive radiological evidence of cirrhosis (i.e. nodularity of liver and splenomegaly on ultrasound/ct) exclusion criteria: 1. diagnosis of current or historical hepatocellular carcinoma 2. liver transplant recipients or patients on active listing for liver transplantation 3. child-pugh c cirrhosis 4. in the view of the clinician, if the patient has a co-morbidity likely to lead to death within the following 12 months 5. in the view of the clinician, if the patient was not thought to be suitable for hcc surveillance
study of physiological signals during and after copd exacerbations

Conditions: COPD; COPD Exacerbation

Summary: background : acute exacerbations of copd (chronic obstructive pulmonary disease) are frequent events in the course of the disease and they can deteriorate the respiratory function of the patients, impact their quality of life and even potentially threaten their life. it is therefore crucial to prevent these exacerbations from occurring. aim of the study : investigate how cardiorespiratory parameters of copd patients differ between exacerbation phases and their nominal state in order to identify predictors of copd exacerbations. study design : patients admitted at one of the investigation centers on a suspicion of copd exacerbation will be enrolled on a voluntary basis. enrolled patients' cardiorespiratory parameters will be monitored with a connected wrist-worn pulse oximeter (bora band) during the hospitalisation phase and one month after they have been discharged. setting : 4 investigative centers across brittany patients : 50 patients will be enrolled in the study


Eligibility criteria:
inclusion criteria: * patient known or suspected to suffer from copd * patient admitted in pulmonology unit for copd exacerbation * patient accepting to use bora band during and after hospitalization * patient accepting to be followed by the partner health care provider for this study (air de bretagne) * patient able to understand french and express their informed consent * patient affiliated to social security exclusion criteria: * patient is intubated * patient already followed by a health care provider other than air de bretagne * investigator assesses that the patient will have difficulties following the protocol * patient already enrolled in another interventional study
a long term study of stn1012600 in subjects with open angle glaucoma or ocular hypertension

Conditions: Open Angle Glaucoma, Ocular Hypertension

Summary: to evaluate safety and the ocular hypotensive effect of stn1012600 ophthalmic solution 0.002% alone or in combination with timolol ophthalmic solution 0.5% for 52 weeks in subjects with open angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * diagnosis of oag or oht in both eyes, or one eye with oag and the other with oht. * corrected visual acuity of +0.60 logmar (decimal visual acuity 0.3) or better in each eye. exclusion criteria: * presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids in either eye. * history of severe ocular trauma in either eye. * any condition that prevents clear visualization of the fundus in either eye. * known allergy, hypersensitivity or contraindications to any components of the study medications or other study related procedures/medications. * history of ocular surgery specifically intended to lower iop in either eye. * history of keratorefractive surgery in either eye. * females who are pregnant, nursing, or planning a pregnancy. * subjects with known or suspected drug or alcohol abuse. * participation in other investigational drugs or device clinical trials within 30 days prior to screening. * any decision by the investigator to terminate a subject in screening or declare any subject ineligible for any sound medical reason.
efficacy of low level laser therapy in treating temporomandibular muscle disorders

Conditions: Temporomandibular Joint Dysfunction Syndrome

Summary: this study aimed to evaluate the sustainability of the efficacy of using low level laser therapy and cad/cam michigan splint in improving the range of mandibular movements, muscle activity and reducing the pain.

56 female patients were randomly divided into two groups, group a: patients received applications of low-level laser therapy using semiconductor ingaasp diode laser type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions. group b: patients received hard occlusal splints (michigan splints) of 2 mm thickness constructed on their upper teeth, the hard occlusal splint was 3d digitally printed. arcus digma facebow was used to evaluate the range of mandibular movements affected from tmj problems. the opening measurements of the patient were taken using a millimeter ruler. electromyogram (emg) was used to evaluate muscle activity. visual analogue scale (vas) was used to evaluate the pain intensity. all was done before the beginning of the treatment at three and six months follow up period.

Eligibility criteria:
inclusion criteria: tenderness in the tmj or muscles of mastication (e.g., temporalis and masseter) that might get worse in the morning or with eating, headache, periauricular pain, teeth wear that appears in the form of multiple smooth shinny facets, teeth mobility, and malocclusion exclusion criteria: * pregnant females, breast feeders, patients having pacemakers, heart disease, tumors, general connective tissue disease e.g., rheumatoid arthritis, psychiatric disorders, skeletal morphology as class ii or iii, tmj clicking sounds, local skin infection over the masseter or temporalis, symptoms that may be referred to other disorders of orofacial region (tooth ache, trigeminal neuralgia, migraine), or patients using medications such as muscle relaxant, steroids, dopamine precursors like l dopa and aminoglycoside * vulnerable groups (prisoners, mental disorders, patients not capable of decision making).

Keywords: low level laser therapy michigan splint electromyogram myofascial pain
snap: study nutrients in adult pku

Conditions: Phenylketonuria

Summary: phenylketonuria (pku) is a rare inherited metabolic disorder, where subjects are born with a genetic deficiency in the phenylalanine hydroxylase enzyme (pah), which leaves them unable to convert phenylalanine (phe) into tyrosine (tyr). pku patients have specific dietary needs and must follow a restrictive diet in the aim of preventing toxic levels of the amino acid phenylalanine (phe) accumulation.

the aim of this explorative cross-sectional study is to gain quantitative insights on blood nutrient levels of adult pku patients on a protein substitute.

Eligibility criteria:
- inclusion criteria: both pku and non-pku comparison subjects: 1. age ≥18 years 2. willing and able to provide signed informed consent pku specific inclusion criteria 3. pku patients identified by newborn screening and started low phe diet before 1 month age 4. usage of at least one phe-free protein substitute (i.e. an amino acid mixture including micronutrients) on a daily basis for at least 26 consecutive weeks up to visit 1 non-pku comparison subjects specific inclusion criteria: 5. same age- (±3 years) and sex as an included pku subject * exclusion criteria: both pku and non-pku comparison subjects: 1. for women: currently pregnant or lactating 2. current psychiatric disorders 3. current substance use disorders (as described in dsm v) 4. current use of psychotropic and/or inotropic medication 5. omega-3, antioxidant, (multi)vitamin and/or (multi)mineral supplement use within six weeks prior to entry in the study 6. severe hepatic, thyroid or renal dysfunction 7. no acute illnesses like flu, diarrhea, or vomiting (subjects should be symptom free for a week prior to v1) 8. participation in any other clinical intervention studies involving test products concomitantly or within six weeks prior to entry into the study 9. other family members taking part in this study pku subject specific exclusion criteria: 10. use of bh4, or drugs that may interfere with main outcomes non-pku comparison subjects specific exclusion criteria: 11. any condition or special diet (e.g. vegan or vegetarian diet) that effects the metabolism and/or normal dietary pattern/intake 12. a first or second degree relative with inborn errors of metabolism 13. living together with someone with inborn errors of metabolism (e.g. partner, spouse or roommate)