Kornimate/medical-research-clean huggingface dataset:
study of the safety, tolerability, pharmacokinetics and biomarker of donq52 in celiac disease patients

Conditions: Celiac Disease

Summary: this study is to characterize the safety and tolerability of an investigational drug called donq52 and consists of a single ascending dose part (part a) and a multiple ascending dose part (part b) in well-controlled celiac disease patients.


Eligibility criteria:
inclusion criteria: * history of medically diagnosed celiac disease based on biopsies and positive celiac serology. * be on a gfd for at least 12 months * hla-dq2.5 genotype * experienced at most mild symptoms of celiac disease exclusion criteria: * refractory celiac disease * positive for any of the 3 serology (-tissue transglutaminase-2,- deamidated gliadin peptide-iga, and deamidated gliadin peptide-igg)
efficiency and safety study of pegylated somatropin to treat growth hormone deficiency children

Conditions: Growth Hormone Deficiency

Summary: the purpose of the multicenter, randomized, open-label, controlled phase ii study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.


Eligibility criteria:
inclusion criteria: * have a height less than two standard deviations (sd) below the median height for individuals of the same age or height, a growth velocity (gv) ≤4 cm/yr, a gh peak concentration \<7 ng/ml in two different provocative tests, a bone age (ba; ≤9 years in girls and ≤10 years in boys) at least 2 years less than his/her chronological age (ca); * be in preadolescence (tanner stage 1) and have a ca \>3 years; * have a height value recorded 3 months before the start of gh treatment to calculate pre-treatment gv; * receive no prior gh treatment. * sign informed consent exclusion criteria: * patients with severe cardiopulmonary * patients with hematological diseases * a current or past history of malignant tumors * immunodeficiency diseases * mental diseases * patients positive for hepatitis b e-antibody (hbeab) * hepatitis b surface antigen (hbsag) * hepatitis b e antigen (hbeag) * patients with other growth disorders, such as turner syndrome * constitutional delay of growth and puberty, and laron syndrome

Keywords: pegylated somatropin peg-gh growth hormone peg-rhgh growth hormone deficiency (ghd) phase 2 study
treatment and prevention of anemia with ferrous sulfate plus folic acid in children in goiania - goias, brazil

Conditions: Anemia

Summary: iron deficiency anemia is the most common nutritional problem in the world. the objectives of this study are: * to evaluate the prevalence of anemia in children from 6 to 24 months of age and the therapeutic and prophylactic response to ferrous sulfate plus folic acid on hemoglobin levels. * to compare the effect of folic acid supplementation with ferrous sulfate on the linear and weight growth of anemic and non-anemic study hypothesis: * the ferrous sulfate plus folic acid can improve the response on hemoglobin levels. * the folic acid supplementation with ferrous sulfate have effect on the linear and weight growth of anemic and non-anemic.

purpose the objective of this study were: * to assess the prevalence of anemia and the therapeutic and prophylactic response to ferrous sulfate and folic acid. * to compare the effect of folic acid supplementation with ferrous sulfate on the linear and weight growth of anemic and non-anemic. a double-blind, randomized, controlled clinical trial was conducted with 196 children 6 to 24 months of age enrolled in municipal daycare centers in goiânia, goias state, brazil. the children were assigned to two treatment groups that received a daily dose (5 times a week) of either 4.2mg/kg/day of ferrous sulfate + folic acid (50μg) or 4.2mg/kg/day of ferrous sulfate + folic acid placebo. one of the prevention groups received 1.4mg/kg/day of ferrous sulfate + folic acid (50μg/day) and the other 1.4mg/kg/day of ferrous sulfate + folic acid placebo. supplementation lasted approximately three months.

Eligibility criteria:
inclusion criteria: * from 6 to 24 months * born at term * non-twins * with parental approval for participation in the study * attending municipal daycare centers with mor than four children each exclusion criteria: * children with special needs * low birth weight (\<2.500g) * with growth-impairing heart diseases * neurological syndromes * sickle-cell anemia * sickle-cell trait * under treatment for anemia at the time of the first interview or screening performed by the pediatrician * those no longer attending the daycare center * the clinical trial excluded children with hemoglobin \>=7 amd \<=8g/dl. * for the second objective: incomplete anthropometric surveys

Keywords: anemia iron deficiency anemia infants children clinical trials ferrous sulfate folic acid daycare centers anaemia in children born at term non-twins with parental approval for participation in the study growth
effects of rr and mt on patient with stroke

Conditions: Cerebrovascular Accident

Summary: the purpose of this proposal is 1) to compare the relative effects of the robotic rehabilitation (rr), mirror therapy (mt), and conventional intervention (ci), 2) to compare the effects of the combined therapy of the rr-functional electrical stimulation (fes) and the rr-placebo intervention (pi), and 3) to identify the clinical predictors that will potentially influence the functional outcomes after interventions.

motor deficit of upper extremity is one of the prominent problems in patients with stroke. looking for effective and efficient treatments to improve affected ue function is of great importance in the field of rehabilitation. two emerging movement therapies in stroke rehabilitation are robotic rehabilitation (rr) and mirror therapy (mt). scientific evidence for comparative effectiveness research of rr versus mt versus ci on functional outcomes (e.g., motor, muscle, sensory, and daily functions) in stroke patients is limited. in addition, studies showed fes induced some improvements in individual movements at the shoulder, elbow, wrist, and fingers or in muscle strength in patients with moderate-to-severe paresis. the combination therapy of the fes and training protocols may increase the benefits of standard rehabilitative treatments and may also facilitate motor learning. however, the combined training effects of the rr and fes on stroke patients have not been well studies in a larger sample yet. specific objectives of this proposed research are as follows: first, the investigators will compare the efficacy of the rr, mt, and conventional rehabilitation. secondly, the investigators will compare the efficacy of the rr-fes versus rr-pi on outcome measures. thirdly, the investigators will identify the clinical predictors that will potentially influence the functional outcomes after interventions.

Eligibility criteria:
inclusion criteria: * willing to provide the written informed consent * more than 6 months onset of unilateral stroke * an initial 25-56 or 18-50 scores on the ue subtest of the fma * sufficient cognitive ability (mini mental state examination ≧ 24 points) * without upper limb fracture within 3 months exclusion criteria: * recurrent of stroke or seizure episode during the intervention * occurence of serious or continuous pain on affected upper-extremity * history of other neurological disease or severe orthopaedic condition

Keywords: comparative effectiveness research robotic rehabilitation mirror therapy functional electrical therapy combined therapy stroke rehabilitation translational science
arterial spin labeling blood flow magnetic resonance imaging for the evaluation of response to therapy in metastatic renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: the purpose of this study is to assess magnetic resonance imaging (mri) as a tool to track tumor growth for renal cell carcinoma while participants are on clinical treatment therapy of sunitinib and amg386. an mri is a type of scan that uses powerful magnets to make clearer images or to focus on detailed medical information in the abdomen and pelvis. the imaging done for this study will use the arterial spin labeling (asl) mri technique that allows us to see blood flow changes which possibly may indicate changes in tumor growth. participants will be on a clinical trial for the treatment.

all participants must be enrolled on protocol, "collection of specimens and clinical data from patients with renal cell carcinoma treatment with targeted therapies", about to start a treatment course with sunitinib and amg386, and willing to come in for successive mris at the following times: baseline, 2 weeks upon initiation of therapy with sunitinib and amg386, after cycle 2 and/or cycle 4 of therapy, and at the end of your study therapy.

Eligibility criteria:
inclusion criteria: * age greater than 18 years * patients diagnosed with metastatic renal cell carcinoma and who will initiate therapy with the combination of sunitinib and amg386 as either their first anti-angiogenic therapy or after failure of prior cytokine therapy * enrolled on protocol 06-105, "collection of specimens and clinical data from patients with renal cell carcinoma treated with targeted therapies" * found to have tumors that are \>/=2.5 cm as determined by ct imaging * candidate lesions for asl mri should be \>/= 2.5cm. order of preference of lesion location will be as follows: abdominal lesions, bone lesions and chest lesions exclusion criteria: * subjects will be excluded from the study if they have a contraindication to mri which may include the following: pacemaker, mri incompatible metal implant, recently implanted vascular clip, history of claustrophobia, metal fragment within the eye

Keywords: metastatic renal cell carcinoma asl mri sunitinib amg386
an-art study: atrioventricular (av) node ablation in cardiac resynchronisation therapy

Conditions: Congestive Heart Failure

Summary: cardiac resynchronisation therapy (crt) is a highly effective treatment option for patients with symptomatic heart failure and electrical intraventricular dyssynchrony, who are unresponsive to medical therapy. crt has been shown to improve the quality of life in these patients and lately two studies had shown a mortality reduction with and without the adjunct of an implantable cardioverter defibrillator (icd). unfortunately, up to 25% of the crt recipients do not show a symptomatic improvement after device implantation ("non-responder"). because of possible intermittent tachycardiac intrinsic conduction, it remains difficult in numerous patients to assure a 100% biventricular stimulation as the prerequisite for a beneficial therapeutic effect. in a important study by knight et al it could be shown that in a population of 440 crt-patients, 36% did not have continuous biventricular stimulation. the main cause was the occurrence of atrial tachyarrhythmias, in particular atrial fibrillation. the medical control of rapid ventricular conduction remains a difficult problem in heart failure patients. furthermore it is unknown how many patients have good biventricular pacing under resting conditions but develop an improved av-conduction with exercise. this can cause inhibition of ventricular stimulation or in many cases fusion beats. conversely, an av-interval programmed too short may have detrimental effects on diastolic filling times. the safest method to control the ventricular rate and prevent ventricular fusion beats with a normal av time is the av node ablation using radiofrequency ablation. the an art study investigates whether patients with an implanted crt pacemaker or a crt defibrillator will benefit from an av-node-ablation using a combined symptomatic heart failure endpoint and duration of biventricular stimulation as compared to a crt control group.


Eligibility criteria:
inclusion criteria: * all patients who had a crt pacemaker or crt-icd implanted and who are under optimal medical therapy, can be included 3 months after implantation of the device. exclusion criteria: * the sole exclusion criterion is no consent of the patient.

Keywords: ventricular dyssynchrony
mechanism study of ventilator-induced lung injury in elderly people.

Conditions: Ventilator-Induced Lung Injury

Summary: 1. we collect lung tissues from patients with different ages and confirm that klk8 expression is positively correlated with age. 2. we collect peripheral blood from patients with different ages and duration of mechanical ventilation to explore the correlation between the degree of endothelial/epithelial damage, age and duration of mechanical ventilation.

1. we collect lung tissues from patients with different ages and confirm that klk8 expression is positively correlated with age. all clinical samples have been collected and tested uniformly. correlation analysis between klk8 and age will be performed by using statistical package for the social sciences (spss) 22.0 software, and p\<0.05 indicates a statistically significant difference. the obtained clinical data should be recorded on survey forms, and researchers should verify patient information by recording basic information such as age and gender. 2. we collect peripheral blood from patients with different ages and duration of mechanical ventilation to explore the correlation between the degree of endothelial/epithelial damage, age and duration of mechanical ventilation. all clinical samples have been collected and tested uniformly. correlation analysis between endothelial/epithelial damage index, age and duration of mechanical ventilation will be performed by using spss 22.0 software, and p\<0.05 indicates a statistically significant difference. the obtained clinical data should be recorded on survey forms, and researchers should verify patient information by recording basic information such as age and gender.

Eligibility criteria:
inclusion criteria: 1. lung tissues from patients with different ages: patients undergoing elective general anesthesia surgery; patients undergoing partial lung resection with mechanical ventilation; american society of anesthesiology (asa) grade 2-3; 2. peripheral blood from patients with different ages and duration of mechanical ventilation: patients undergoing elective general anesthesia surgery with mechanical ventilation; asa grade 2-3; exclusion criteria: 1. lung tissues from patients with different ages: patients with chronic lung diseases (asthma, chronic obstructive pulmonary disease (copd), pulmonary heart disease, etc.); patients with human immunodeficiency virus (hiv), hepatitis b virus (hbv), hepatitis c virus (hcv), hepatitis d virus (hdv), or receiving immunotherapy; patients who have recently suffered from pneumonia; recent history of mechanical ventilation; patients with thrombotic diseases; children and pregnant women. 2. peripheral blood from patients with different ages and duration of mechanical ventilation: patients with chronic lung diseases (asthma, copd, pulmonary heart disease, etc.); smoking patients; patients with hypertension/diabetes/coronary heart disease; patients with hiv, hbv, hcv, hdv, or receiving immunotherapy; patients who have recently suffered from pneumonia; recent history of mechanical ventilation; patients with thrombotic diseases; children and pregnant women.
chemotherapy-free regimen of venetoclax, azacitidine plus orebatinib (vao regimen) for newly diagnosed ph+all

Conditions: Ph-Positive Acute Lymphoblastic Leukemia

Summary: the purpose of this study is to evaluate the efficacy and safety of venetoclax, azacitidine plus orebatinib in newly diagnosed philadelphia chromosome-positive acute lymphoblastic leukemia.

this is a phase ⅱ, single-arm, open label, multicenter clinical study in newly diagnosed ph-positive acute lymphoblastic leukemia patients. the patients will receive venetoclax, azacitidine and orebatinib regimen in the induction treatment. the patients who respond to induction treatment will undergo consolidation treatment, and an optional allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment with induction therapy according to patient's wishes.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed ph-positive all without the history of chemotherapy or target therapy. 2. age ≥18. 3. eastern cooperative oncology group (ecog) score: 0-3. 4. total serum bilirubin ≤ 2 x upper limit of normal (uln), alanine aminotransferase (alt) ≤ 1.5 x uln, aspartate aminotransferase (ast) ≤ 1.5 x uln. 5. creatinine clearance ≥ 30 ml/min. 6. serum lipase ≤ 1.5 x uln, amylase =\< 1.5 x uln. 7. provide informed consent. exclusion criteria: 1. patients with another malignant disease. 2. patients with uncontrolled active infection. 3. patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade iii/iv cardiovascular dysfunction according to the new york heart association classification. 4. patients with hiv infection, active tuberculosis infection, or active hepatitis b or hepatitis c infection. 5. patients with uncontrolled active bleeding. 6. patients who has participated or participating in other clinical trials related to this disease. 7. patients with history of previous chemotherapy or target therapy (except for oral hydroxyurea and/or leukopheresis for lowering white blood cell counts). 8. pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period. 9. patients with other commodities that the investigators considered not suitable for the enrollment.

Keywords: ph-positive all venetoclax+azacitidine+orebatinib
efficacy of tofacitinib, methotrexate combination therapy versus upadacitinib, methotrexate combination therapy in moderate to severe rheumatoid arthritis

Conditions: Moderate to Severe Rheumatoid Arthritis

Summary: the aim of this study is to assess the efficacy of upadacitinib, methotrexate combination therapy in comparison to tofacitinib, methotrexate combination therapy in moderate to severe ra patients. this study will guide us to treat ra patients with inadequate response to methotrexate more effectively


Eligibility criteria:
inclusion criteria: - 1.patients of both gender (age ≥18 years). 2.patients fulfill the acr/eular 2010 classification criteria for rheumatoid arthritis. 3.patients with das-28 crp \>3.2 despite optimum dose and duration of methotrexate (20-25 mg/week for minimum one month). exclusion criteria: * 1.recent or concurrent infection 2.active or latent tuberculosis 3. hemoglobin (hb) \< 8 g/dl 4. white blood cell count \< 4000/ micro l, neutrophil count \< 1000/ micro l, platelet count \< 100000/mm3 5. live vaccines (rota virus, varicella, yellow fever) within 3 months prior to the first dose 6. child-pugh class -c 7. pregnant or planned for pregnancy and breastfeeding females of child-bearing potential 8. evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ 9. new york heart association class iii and iv congestive heart failure 10. previous history of thromboembolism, deep venous thrombosis, stroke, ihd
study of the impact of intermittent preventive treatment in schools on malaria, anaemia and education.

Conditions: Malaria, Falciparum

Summary: this study seeks to establish whether intermittent preventive treatment (ipt) can reduce malaria among school-going children and its consequent impact on school performance.

although the risk of malaria is greatest in early childhood, significant numbers of schoolchildren remain at risk from malaria-specific morbidity and mortality. each year between 20-50% of schoolchildren, aged 10-14 years, living in malaria-endemic areas will experience a clinical attack of malaria (clarke et al., 2004). malaria accounts for 3-8% of all-cause absenteeism from school, and up to 50% of preventable absenteeism (brooker et al., 2000). in addition, asymptomatic parasitaemia contributes to anaemia, reducing concentration and learning in the classroom (holding \& snow, 2001). intermittent preventive treatment (ipt) delivered through schools is a simple intervention, which can be readily integrated into broader school health programmes. this study seeks to examine whether ipt can reduce malaria and anaemia amongst school-going children, and its consequent impact on school performance, in order to assess its suitability for inclusion as a standard intervention in school health programmes. the efficacy of ipt is being evaluated in schoolchildren with a high-level of acquired immunity and ability to limit parasite growth, in whom most infections are asymptomatic and may go untreated. the intervention: intermittent preventive treatment of malaria administered each school term with the purpose to reduce asymptomatic parasitaemia and prevent clinical attacks, thereby reducing anaemia and school absenteeism, with consequences for improved attendance and concentration in class. schools are randomly allocated to one of two arms: * intervention schools: ipt given three times a year (once per term) + mass treatment with anthelminthics * control schools: mass treatment with anthelminthics only mass treatment with anthelminthics is carried out in all study schools twice annually in accordance with national policy.

Eligibility criteria:
inclusion criteria: * enrolled in primary school, and attending regularly * enrolled in nursery or classes 1-7 * informed consent from parent or guardian exclusion criteria: * enrolled in primary class 8 * haemoglobin level below 70g/l at baseline * history of reaction to sulfa drugs (e.g. fansidar, septrin) * history of severe skin reaction to any drug withdrawal criteria: * withdrawal of parental consent * haemoglobin level falling below 70g/l * severe adverse reaction to treatment

Keywords: malaria anaemia school performance education intermittent preventive treatment schools
to evaluate the efficacy of supplementation with l. reuteri + vit. d3 in asthmatic children

Conditions: Asthma

Summary: the purpose of this project is to evaluate in a randomized clinical trial, double-blind, controlled, the effects of a dietary supplement containing lactobacillus reuteri dsm 17938 and vitamin d3 in reducing bronchial inflammation and improve asthma control in patients in children with mild / moderate persistent asthma .

to evaluate if the supplementation for three months with lactobacillus reuteri dsm 17938 (108 cfu) + vitamin d3 (400 iu) result in a reduction of the degree of allergic bronchial inflammation, measured with the fractional exhaled nitric oxide (feno) and with a series of markers of bronchial inflammation (measured at 'beginning and at the end of the treatment on exhaled condensate): interleukin 2(il-2); interleukin 4 (il-4); interleukin 10(il-10); interferon γ (ifn-γ).

Eligibility criteria:
inclusion criteria: * patients aged between 6 and 14 years old, of both sexes * diagnosis of mild / moderate persistent asthma (gina step 2/3) * allergy mite (dermatophagoides farinae and pteronyssinus + + + / + + + +) * levels of vitamin 25 (oh) d \<30 ng / ml * signature of the informed consent of one parent or a legal representative exclusion criteria: * cardiovascular disease or systemic * anatomical abnormalities * other respiratory diseases * taking probiotics and / or prebiotics in the previous 2 weeks * taking vitamin d or systemic corticosteroids within 4 weeks * participation in other clinical trials

Keywords: bronchial inflammation asthma childhood asthma control test (c-act) asthma exacerbations