Kornimate/medical-research-clean huggingface dataset:
carbohydrate counting and dash intervention among children with diabetes and celiac disease.

Conditions: Diabetes Mellitus, Type 1; Celiac Disease in Children

Summary: study is an interventional clinical trial. children (aged 6-18 years) diagnosed with type 1 diabetes and celiac disease will be recruited conveniently from endocrinology pediatric clinic at prince hamzah hospital. amman, jordan. a sample of 45 diagnosed children, who will meet the inclusion criteria and will be agreed to participate will be centrally randomized to follow carbohydrate counting with gfd dietary intervention, carbohydrate counting with gfd and dash dietary intervention, and control dietary intervention.

the main objective of this study to compare the effects of three diets: carbohydrate count with gluten-free diet, dash and carbohydrate count with gluten-free diet, and gluten-free diet alone on glycemic control, growth rate, and the quality of life of 45 individual patients diagnosed with diabetes and celiac disease, who are receiving care in prince hamzah hospital, and aged between 6-18 years, will be enrolled in this study. the duration of the follow-up will be up to ( 9 months); starting from the first interview and enrollment till reaching 9 months from the intervention. all the biochemical tests that are routinely measured will be recorded for each patients during the follow-up duration. these biochemical tests will be, mainly hemoglobin a1c, serum glucose, tissue-trans glutamines iga( ttg iga), vitamin d, calcium, phosphorus, and acute intermittent porphyria ( aip) and will be recorded at baseline, after 6 months and at the end of the study (12 months). growth rate, and quality of life will be also assessed at based line, after 6 months and at the end of the study.

Eligibility criteria:
inclusion criteria: 1- jordanian children aged between 6 to 18 years old . 2- diagnosed with diabetes type 1 and celiac disease together. - exclusion criteria: 1- any children diagnosed with celiac disease alone. 2- any children diagnosed with type 1 diabetes alone. 3- any children with different disease. -
a study of reslizumab in patients 12 years of age and older with severe eosinophilic asthma

Conditions: Eosinophils, Asthma

Summary: this is a multicenter, open-label (ol) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who completed the treatment period of a placebo-controlled phase 3 trial of sc reslizumab. the study consists of a screening/baseline visit followed by a 36-week ol treatment period and a 15-week follow-up period.


Eligibility criteria:
inclusion criteria: • patient with eosinophilic asthma who completed the treatment period of a double-blind, placebo controlled sc reslizumab study (study c38072-as-30025 or c38072-as-30027) \~\~ additional criteria apply, please contact the investigator for more information exclusion criteria: * patient has received any reslizumab administration in any previous clinical trial other than studies c38072-as-30025 and c38072-as-30027. * the patient has any clinically significant, uncontrolled medical condition * the patient has another confounding underlying lung disorder * the patient has a known/diagnosed hypereosinophilic syndrome. * the patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers. * the patient is a pregnant or lactating woman * the patient is a current smoker (ie, has smoked within the last 6 months before screening) or has a smoking history ≥10 pack-years. * the patient is currently using any systemic immunosuppressive or immunomodulatory agents other than ocs * the patient has a history of allergic reaction or hypersensitivity to any component of the study drug. * the patient has a history of an immunodeficiency disorder including human immunodeficiency virus (hiv). * additional criteria apply, please contact the investigator for more information
managing diabetes during pregnancy in the wireless age

Conditions: Gestational Diabetes Mellitus; Type 2 Diabetes Mellitus

Summary: this randomized controlled trial (rct) will test the efficacy of a home blood glucose telemonitoring system against usual care in women with gestational diabetes mellitus (gdm) or type 2 diabetes mellitus (t2dm) during pregnancy. we hypothesize that the system can improve glycemic control in patients, assessed using the mean blood glucose during gestation as the primary outcome measure.

establishing good glycemic control is crucial for the treatment of patients with gestational diabetes mellitus (gdm) and type 2 diabetes mellitus (dm2). high levels of blood glucose in pregnancy may lead to complications during delivery and pose threat to the fetus. the self-monitoring of blood glucose (smbg) by patients at home is used to provide clinicians with information to make adjustments to treatment plans. patients record the values and present them at their next meeting with the physician. as such, smbg by the patients is an important part of disease management and a method for clinicians to follow a patient's day-to-day response to a treatment regime. the system is designed to send the blood glucose values from the patients' glucometers wirelessly to the server where they can be viewed by the patients' health care providers. the system generates automated adherence reminders to patients and alert messages to both patients and their care providers. the system will provide clinicians with better access to the patient data, so that they may better manage their case loads, make timely clinical decisions, and ultimately provide better patient care.

Eligibility criteria:
inclusion criteria: * patients must be pregnant * diagnosed with gestational diabetes or type 2 diabetes * must be comfortable with instructions in english and be able to express themselves using simple phrases in english. exclusion criteria: * unable to complete self monitoring of blood glucose (smbg) for any reason * uncomfortable with the use of the telemonitoring equipment * develop an acute illness requiring hospitalization, where they may deviate from the normal delivery of care * refusal to sign consent form or to carry out the demands made by the study
use of track health function of the myhealthevet personal health record

Conditions: Prediabetic State

Summary: this study was a pilot 3-month clinical trial that investigated the feasibility, effectiveness, and acceptability of using the track health function of the veterans health administration's patient health record for effecting a more positive physical activity (pa) and dietary intake lifestyle in a sample of 38 overweight and obese veterans with prediabetes. baseline and three-month post-intervention outcomes were measured in two main domains: objective (e.g., weight) and subjective (e.g., self-efficacy).

this was a pilot clinical trial that used a single-group design to test the feasibility, effectiveness, and acceptability of using the track health (th) function of my healthevet, the va's patient health record (phr), as a tool for effecting a more positive physical activity (pa) and dietary intake lifestyle in overweight and obese veterans with prediabetes. baseline and three-month post-intervention outcomes were measured in two main domains: objective (pa as measured by an accelerometer, diet, weight, abdominal circumference, bmi, and blood pressure) and subjective (self-efficacy, intent to adhere to lifestyle change, and patient activation). assessments, including screening on inclusion and exclusion criteria, physiological measurements, administration of questionnaires, and training on use of two critical features of the th function--the use of journals to enter dietary and pa data and the use of vitals + readings to enter weight and track physiological measures--took place place across four visits to the study site, which was the veterans administration medical center in miami. the investigators hypothesized that this phr-based intervention would demonstrate improvements and increases, respectively in the objective and subjective domain measures. the investigators also hypothesized that engagement by study participants with mhv would be demonstrated through meeting target criteria regarding making entries into this phr's th function, and that participants would be satisfied with the intervention.

Eligibility criteria:
inclusion criteria: * veterans with diagnosis of prediabetes (hba1c 5.7-6.4%, fasting plasma glucose 100-125 mg/dl or oral glucose tolerance test 140-199 mg/dl) * english speaking * access to the internet * body mass index (bmi) of 25-42 kg/m and a sedentary lifestyle (not being physically active three days per week for 20 minutes each time for the previous six months and not performing regular resistance exercise) * able to engage in a regular program of mild-to-moderate intensity physical activity but were not currently following a weight loss diet or participating in an intervention trial exclusion criteria: * cognitively impaired (mini-cog greater than or equal to 3) * depressed (phq-2 less than or equal to 3) * vision or hearing disorders * have been diagnosed with diabetes mellitus, uncontrolled hypertension, or cardiovascular disease * currently pregnant or nursing.

Keywords: lifestyle patient health record veterans prediabetes
a safety and tolerability study of vrdn-003 in participants with thyroid eye disease (ted)

Conditions: Thyroid Eye Disease (TED)

Summary: this is a clinical trial assessing the safety and tolerability of an investigational drug, vrdn-003, in participants with thyroid eye disease (ted).

this is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), controlled study that will include participants with ted of any duration. the key objectives of this study are to determine if vrdn-003 is safe and tolerable when administered as a series of subcutaneous (sc) injections every 4 weeks or every 8 weeks in participants with ted.

Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of ted with or without proptosis and with any cas (0-7) and in the opinion of the investigator may benefit from vrdn-003 * not require immediate ophthalmological or orbital surgery in the study eye for any reason. * must agree to use highly effective contraception as specified in the protocol * female ted participants must have a negative serum pregnancy test at screening exclusion criteria: * must not have received prior treatment with another anti-igf-1r therapy * must not have received systemic corticosteroids for any condition, including ted, or selenium within 2 weeks prior to first dose. * must not have received other immunosuppressive drugs for any condition, including ted, or any other therapy for ted within 8 weeks prior to first dose * must not have received an investigational agent for any condition, including ted, within 8 weeks prior to first dose * must not have received radioactive iodine (rai) treatment within 8 weeks prior to first dose * must not have had previous orbital irradiation or decompression surgery for ted to the study eye's orbit * must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results * must not have abnormal hearing test before first dose. must also not have a history of ear conditions considered significant by study doctor * must not have a history of inflammatory bowel disease * female ted participants must not be pregnant or breastfeeding

Keywords: graves thyroid eye disease thyroid-associated ophthalmopathy dysthyroid ophthalmopathy graves eye disease graves orbitopathy myopathic ophthalmopathy congestive ophthalmopathy edematous ophthalmopathy infiltrative ophthalmopathy
efficacy and safety of angelica gigas n. extract on improvement of blood triglyceride

Conditions: Hyperlipidemias

Summary: this study was conducted to investigate the effects of daily supplementation of angelica gigas n. extract on improvement of blood triglyceride.

this study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. twenty subjects were randomly divided into angelica gigas n. extract or a placebo group. fasting triglyceride profiles before and after the intervention.

Eligibility criteria:
inclusion criteria: * age 19-80 years with triglyceride 130-200 mg/dl exclusion criteria: * lipid lowering agent within past 6 months * severe cardiovascular disease(mvocardial infarction, stroke, etc) * renal disease(heredity hyperlipidemia, acute/chronic renal failure, nephrotic syndrome, etc) * cancer, respiratory organ disease(asthma, chronic obstructive pulmonary disease) * autoimmune disease * diabetes mellitus * allergic or hypersensitive to any of the ingredients in the test products * history of disease that could interfere with the test products or impede their absorption * under antipsychotic drugs therapy within past 2 months * history of alcohol or substance abuse * participation in any other clinical trials within past 2 months * laboratory test by show the following results * aspartate aminotransferase, alanine aminotransferase \> reference range upper limit treble * serum creatinine \> 2.0 mg/dl * pregnancy or breast feeding * not contraception(except: surgery for female infertility)

Keywords: angelica gigas n. extract hyperlipidemia clinical trial
clinical trial to evaluate the antihypertensive effect of agsct101 in patient with hypertension

Conditions: Essential Hypertension

Summary: the purpose of this study is to evaluate the antihypertensive effect of agsct101 tablet in patient with stage 1 to 2 essential hypertension.

this study is 2,8 weeks, multi-center, randomized, double-blind, active clinical trial to evaluate the efficacy and safety of agsct101 versus carvedilol in patient with stage 1 to 2 essential hypertension.

Eligibility criteria:
inclusion criteria: * male or female outpatients ≥ 19 years of age * mild to moderate essential hypertension: sdbp 90 \~ 109, ssbp 140 \~ 179 * subjects who agree to participate in this sudy and give written informed consent * subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study exclusion criteria: * the sitting dbp is more than 110mmhg or the sitting sbp over 180mmhg * patients with postural hypotension * patients with severe renal(creatinine more 1.5mg/dl), gastrointestinal, hematological or hepatic(ast, alt more 3 times more than upper limit of normal)disease * female of childbearing potential who does not undergo hysterectomy or is not post-menopausal * patients judged to have a history of alcohol or drug abuse by the investigator * patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months * patients with uncontrolled diabetes mellitus * patients participated other clinical trial 12 weeks before screening patients judged to be inappropriate for this study by the investigator with other reasons

Keywords: essential hypertension hypertension
the ctdna-recist trial part one

Conditions: Gastrointestinal Neoplasm

Summary: a study investigating if analysis of circulating tumor dna (ctdna) can guide palliative treatment in patients with gastrointestinal cancer.

background: circulating tumor dna, (ctdna) has the potential to better monitor treatment efficacy compared to imaging, possibly sparing the patient for ineffective treatment and their associated toxicity an allowing for an early change of the treatment approach. based on multiple dataset we have defined ctdna-recist - the ctdna response evaluation criteria. aim: this phase ii randomized trial evaluates the use of ctdna response evaluation criteria in solid tumors (ctdna-recist) versus standard imaging-based recist to guide treatment decisions in patients with metastatic gastrointestinal cancers. design: patients are randomized 1:1. patients in arm a are offered standard treatment with response evaluation according to the recist criteria based on imaging, and treatment pauses according to institutional guidelines. in arm b, treatment response is evaluated based on change in ctdna between the baseline sample and the evaluation and confirmation sample, according to ctdna-recist: * progressive disease: an increase of ctdna above the previous value with no overlap of the two ci's * stable disease: a value within ci of the previous value. the category also includes samples with both previous and present value being 0 (undetectable). * partial response: a decrease below the previous value with no overlap of the two ci's but the lower ci does not overlap 0. * complete response: decreasing value to an undetectable level * near complete response: a decrease below the previous value with no overlap of the two ci's and with the lower ci overlapping 0 complete and near complete response can be combined and classified as maximal response. the study is initiated as a feasibility study (part one)and will continue into the expansion trial after interim analysis.(part two)

Eligibility criteria:
inclusion criteria: * incurable metastatic gastrointestinal cancer * indication for first or second-line systemic treatment * measurable disease according to recist v.1.1 * ct of chest and abdomen less than 30 days old at time of treatment initiation * age at least 18 years * ecog performance status 0-2 * clinically eligible systemic palliative treatment at investigators decision. * adequate bone marrow, liver and renal function allowing systemic chemotherapy * anticonception for fertile women and for male patients with a fertile partner. intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable * written and verbally informed consent exclusion criteria: * incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy * other concurrent malignant tumor except non-melanoma skin cancer or carcinoma in situ cervicis uteri * pregnant (positive pregnancy test) or breast-feeding women

Keywords: circulating tumor dna liquid biopsy gastrointestinal neoplasm metastatic
exercise capacity before and after af ablation in patients with hfpef

Conditions: Heart Failure With Preserved Ejection Fraction; Atrial Fibrillation

Summary: in a prospective, observational pilot study of patients scheduled for an atrial fibrillation (af) ablation at the university of vermont medical center the investigators will compare exercise capacity before and four months after af ablation.

patients ≥ 18 years of age who are scheduled for an af ablation at the university of vermont medical center will be screened for the following inclusion criteria: h2fpef score of ≥ 6 (corresponding to ≥90% probability of hfpef (19)) and echocardiogram within the past 2 years that reported a lv ejection fraction ≥ 50% and at least one symptom of hf (dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea). exclusion criteria: (1) life expectancy \<12 months, (2) moderate or more valvular disease, (3) inability to walk on a treadmill. patients with early recurrent af (defined as af after a 12-week post-procedural blanking period accounting for post-ablation inflammation) will be withdrawn from the study and not proceed to the 4 month follow up visit.

Eligibility criteria:
inclusion criteria: * h2fpef score of ≥ 6 (corresponding to \>90% probability of hfpef (19)) * echocardiogram within the past 2 years that reported a lv ejection fraction ≥ 50% * at least one symptom of hf (dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea). * af ablation scheduled at uvmmc exclusion criteria: * life expectancy \<12 months * moderate or more valvular disease * inability to walk on a treadmill

Keywords: ablation hfpef atrial fibrillation exercise capacity peak oxygen consumption
dual task in duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: this study was planned to determine the effects of the dual-task performance of children with dmd with motor dysfunction and varying degrees of cognitive impairment compared to their healthy peers, to compare the dual-task performance of children with different functional levels, and to determine the relationship between parameters that may affect dual-task performance.

children who are at least 6 years old and who can walk 10 meters independently, whose duchenne's muscular dystrophy (dmd) diagnosis has been confirmed as a result of genetic testing, will be included in the study. to determine dual-task performance, the 10-meter walk test will be performed with additional motor and cognitive tasks. functional level (brooke lower extremity functional classification), ambulation level (north star ambulation rating), muscular performance and functions (6 minute walk test), balance (pediatric berg balance scale and four square step test), fear of falling (fear of falling questionnaire), gait (gait in dmd assessment scale, gait quality and independence classification scale in dmd, and functional evaluation scale for duchenne muscular dystrophy-gait domain (fes-dmd-gd)), cognitive level (modified mini-mental state test (mmdt)), independence and activity limitation (pediatric functional independence measure (weefim) and activlim), quality of life (the pediatric quality of life inventory (pedsql)-neuromuscular module turkish version pedsql-3.0 neuromuscular module) will be evaluated.

Eligibility criteria:
inclusion criteria: * having been diagnosed with dmd by a pediatric neurologist, * must be at least 6 years old and have the ability to walk 10 meters independently, * being able to cooperate with the instructions given by the physiotherapist, * not having undergone surgery in the last 6 months and not having any injuries, exclusion criteria: * failure to cooperate with the physiotherapist who made the evaluations, * have had any injury and/or surgery in the last 6 months, * children without consent will not be included.

Keywords: duchenne muscular dystrophy dual task balance gait