Kornimate/medical-research-clean huggingface dataset:
characteristic and modulation of gut microbiota on the consequences of pregnancy

Conditions: Gestational Diabetes Mellitus; Medical Nutrition Therapy; Overweight/Obese; Gut Microbiota; Adverse Pregnancy Outcomes

Summary: since the incidence of maternal obesity and gestational diabetes mellitus (gdm) is on the rise globally, how to improve the intrauterine environment of the offspring and prevent obesity and metabolic diseases from the early life has become a medical research. since 2012, journals such as nature and science have reported that intestinal micro-ecological environments composed of intestinal microbes and their interactions are involved in human body and energy metabolism, and a variety of metabolic diseases including obesity and type 2 diabetes mellitus (t2dm). the incidence is closely related. although intestinal microbes have an important impact on human health, the research on intestinal microecology during pregnancy is still in its infancy. the current research is still unclear about the relationship between intestinal microecology and pregnancy outcomes and whether it can be a potential target for regulating maternal metabolism and fetal intrauterine environment. therefore, this study aims to regulate overweight/obese pregnant women by using prebiotic-containing dairy products to explore the effects of interventions targeting intestinal microbes on glucose and lipid metabolism, insulin resistance and risk of gdm in overweight/obese pregnant women. in order to improve the intrauterine environment and reduce the risk of fetal diseases. it is of great significance and value to improve the quality of the birth population in china and to alleviate the medical economic burden caused by obesity and metabolic diseases.


Eligibility criteria:
inclusion criteria: * age 18 \~ 45 years * single pregnancy * enrollment week 8-12 + 6 weeks (based on the last menstrual period or b-ultrasound monitoring) * bmi ≥ 25 kg / m2 * living in beijing for at least 5 years exclusion criteria: * taking antibiotics, probiotics or prebiotics * smoking regularly * drinking alcohol * assisted fertility technology conception * mental illness who were unable to answer questions correctly or were unwilling to conduct questionnaire surveys * history of bariatric surgery * not following dietary recommendations * lactose intolerance * milk protein allergy * pre-pregnancy hypertension, diabetes, hyperlipidemia, hepatitis, nephritis, gastrointestinal diseases (chronic gastritis, enteritis, gastric ulcer and duodenal ulcer, etc.) and a history of infectious diseases (hepatitis, tuberculosis, etc.).
a study of bi 853520 in japanese and taiwanese patients with various types of advanced or metastatic cancer

Conditions: Neoplasms

Summary: the primary objective of this trial is to explore the safety and tolerability of bi 853520 monotherapy and determine the maximum tolerated dose (mtd) for japanese and taiwanese patients with advanced or metastatic solid tumours. secondary objective is collection of preliminary data on anti-tumour efficacy


Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of advanced, measurable or evaluable, non-resectable and/or metastatic non-hematologic malignancy, which has shown to be progressive in the last 6 months * patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options * recovery from reversible toxicities (alopecia excluded) of prior anti-cancer therapies (common terminology criteria for adverse events grade \<2) * age \>= 20 years * written informed consent in accordance with international conference on harmonisation/good clinical practice (ich/gcp) and local legislation * eastern cooperative oncology group (ecog), performance score 0-1 exclusion criteria: * serious concomitant non-oncological disease/illness * active/symptomatic brain metastases * second malignancy * pregnancy or breastfeeding * women or men who are sexually active and unwilling to use a medically acceptable method of contraception. * treatment with cytotoxic anti-cancer-therapies or investigational drugs within four weeks of the first treatment with the study medication
weight variations impacts on the ankle of the child

Conditions: Ankle Injuries; Risk of Falling; Stability

Summary: obesity is a global health problem. it changes the measurement of the human body and makes a big change to move the body. the increased weight and mass change the way the limbs and whole body generate and react to force excess fat also interferes with joint-muscle interactions that are important for functional capacity and postural balance the tendency to increase the thickness of the abdomen contributes to anterior movement of the com of the body. the purpose of the study is to investigate the biomechanical effect of weight on foot stability in children.


Eligibility criteria:
inclusion criteria: * their age will be ranging from 7 to 9 years. * all children have normal stature for age percentile according to cdc chart. * the sample will include both sex and will be divided in to 4 groups according to the cdc (centers for disease control and prevention) growth charts * all children are normal \&perform all activities of daily living * they were able to understand and follow verbal commands and instructions included in the testing procedures. exclusion criteria: * all of them could be part of recreational activities in their public schools but no competitive sports. children who participated in any regular sport activities involving the lower extremities will be excluded. * none of them had any surgical intervention in the lower extremities. * none of them had any history of musculoskeletal deformities or neuromuscular disorders. * they had neither visual, auditory defect.
an observational study to assess change in disease activity and adverse events of adalimumab in chinese pediatric participants with polyarticular juvenile idiopathic arthritis (pjia)

Conditions: Polyarticular Juvenile Idiopathic Arthritis

Summary: juvenile idiopathic arthritis (jia) is the most common rheumatic disease affecting children, characterized by chronic synovitis with systemic multi-organ damage. polyarticular juvenile idiopathic arthritis (pjia) is a subtype of jia defined as disease involving more than five joints in the first 6 months of disease. this study will assess how safe and effective adalimumab (humira®) is in treating pediatric participants with pjia in china real-world setting. adalimumab is an approved drug for the treatment of pjia. approximately 50 participants age 2 to 17 who are prescribed adalimumab for the treatment of pjia in routine clinical practice will be enrolled at multiple sites in china. participants will receive adalimumab per their physician's usual prescription. individual data will be collected for 52 weeks. no additional study-related tests will be conducted during the routine physician visits. only data which are routinely collected during a regular visit will be utilized for this study.


Eligibility criteria:
inclusion criteria: * male or female participants aged 2-17 years old with body weight ≥ 10kg. * diagnosis of polyarticular pjia by treating physician. * adalimumab (humira®) treatment is indicated as per chinese label and according to judgement of the physician to chinese clinical practice guidelines for the diagnosis and treatment of juvenile idiopathic arthritis. * participants or their parents/legal guardians are able and willing to give assent as well as informed consent approved by an institutional review board (irb)/independent ethics committee (iec) if applicable according to local law, and to comply with the requirements of this study protocol and adalimumab (humira ®) label. exclusion criteria: * participants who cannot be treated with adalimumab according to chinese humira® label and by judgement of treating physician. * participants who receive any biological disease-modifying anti-rheumatic drugs (bdmards) within 6 months prior to the screening visit or who are on concomitant use of any bdmard. * post menarche adolescent female subjects who are pregnant or breastfeeding or considering becoming pregnant during the study * participant is considered by the investigator or sub-investigator, for any reason, to be an unsuitable candidate for the study.

Keywords: polyarticular juvenile idiopathic arthritis pjia adalimumab humira
the dosage exploration study of peg-rhgh for treating short stature in prepubertal and pubertal children

Conditions: Short Stature

Summary: this study is dedicated to addressing the lack of research on the most effective dosage of long-acting growth hormone for children with short stature. by employing clinical trial design, we are committed to investigating the therapeutic benefits and safety profiles associated with varying doses of long-acting growth hormone. our ultimate goal is to offer clinicians more precise treatment guidance and assist patients in attaining optimal growth and developmental outcomes.


Eligibility criteria:
inclusion criteria: 1. patients with short stature or a genetic target height below 2 standard deviations; 2. individuals who are pre-pubertal (tanner stage i) and pubertal (tanner stages ii-iv). 3. legal guardians consenting to participate in the study and signing informed consent forms. exclusion criteria: 1. known or suspected hypersensitivity reactions to the investigational product or related products; 2. presence of severe systemic diseases; 3. patients with malignant tumors; 4. participation in any other clinical trial and receipt of drug or non-drug interventions within the 3 months prior to screening; 5. patients unable to adhere to follow-up or receive treatment as scheduled; 6. other circumstances in which the investigator deems the patient unsuitable for inclusion in this clinical trial.
cystic fibrosis transmembrane conductance regulator (cftr) and exocrine pancreatic dysfunction in type 1 diabetes

Conditions: Type 1 Diabetes; Exocrine Pancreatic Insufficiency

Summary: this study proposes to examine the contribution of cftr variants to exocrine pancreatic insufficiency and hypoglycemic risk. hypoglycemia is one the most frequent complications of type 1 diabetes management. despite recent innovations, hypoglycemic risk remains high for people living with type 1 diabetes (pwt1d). recent studies have shown that pancreatic insufficiency could affect hypoglycemic risk. up to now, there are limited data on the association between pancreatic insufficiency and glucose control (i.e. the frequency and severity of hypoglycemic episodes as well as hba1c levels). the main objective of this study is to determine the impact of pancreatic insufficiency on glucose control in pwt1d, and to address the role of cftr variants as potential contributors to pancreatic insufficiency.

in this a one year cross sectional study, we plan to enroll 100 adults living with type 1 diabetes. patient data will then be separated into two groups based the presence or absence of exocrine pancreatic insufficiency (epi). epi will be defined based on the levels of pancreatic enzymes (amylase; lipase; and trypsinogen). as the prevalence of epi in people living with type 1 diabetes (pwt1d) is \~50%, we expect roughly the same number of individuals into both groups (with or without epi). variables : subject data (age, gender, duration of diabetes, age at diagnostic, etc.) will be collected. glucose variation will be assessed with a continuous glucose monitoring system for 1 month. briefly we will collect the number and severity of hyperglycemic events, average glucose levels, glycemic variability, etc.. from collected peripheral blood mononuclear cells (pbmcs) we will quantify cftr function and level of expression, as well as identify cftr variants by next generation sequencing.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * living in montreal exclusion criteria: * pregnancy, * use of corticosteroid * use of medication known to have a relevant impact on glycemic control.

Keywords: cystic fibrosis transmembrane regulator type 1 diabetes hypoglycemia exocrine pancreas
long-term follow-up of participants from studies evaluating gsk hiv vaccine

Conditions: AIDS

Summary: the purpose of this long-term follow-up study is to assess the long-term health status of hiv-infected subjects who previously participated in gsk-sponsored trials evaluating the investigational hiv vaccine 732462. this study will provide additional data concerning the long-term benefits/risks associated with vaccination. no vaccine will be administered during the study period. vaccines were administered during the primary studies.

general information on the health of the subject and persistence of the cellular and humoral immune responses to study vaccination will be evaluated.

Eligibility criteria:
inclusion criteria: all subjects must satisfy all the following criteria at study entry: * hiv-infected subject. * previous participation in a study evaluating gsk hiv vaccine 732462. * written informed consent obtained from the subject. exclusion criteria: the following criteria should be checked at the time of study entry. if any exclusion criterion applies, the subject must not be included in the study: • subjects who did not receive a complete vaccination course in previous studies.

Keywords: long-term follow-up study hiv-infected subjects hiv therapeutic vaccine
does auricular acupuncture improve tolerance to electromyography (emg) testing?

Conditions: Pain

Summary: needle electromyography (emg) is an important test used to assess muscle and nerve function, but the test can be uncomfortable. it is currently not standard practice to provide any pain-relieving intervention for this procedure. the purpose of this research study is to determine whether auricular (ear) acupuncture will make emg testing less painful.


Eligibility criteria:
inclusion criteria: * gender: male or female * of any racial or ethnic group * adult between the ages 18 to 65 years * healthy * normal sensation and strength * pain approximately the same on each side of body with no major difference between right and left sides * can understand and are able to complete the outcomes questionnaires which will be explained before the study protocol begins exclusion criteria: * pregnant or actively trying to become pregnant * diabetes mellitus or other systemic disease which may affect nerve function * history of a neurologic disorder or other cause for abnormal sensation or weakness * have had recent trauma to an upper arm, hand or ear * have scars or burns on an upper arm, hand or ear that causes abnormal or decreased sensation * taking pain medications on a regular basis * have a bleeding or clotting disorder * taking blood thinners, such as aspirin, heparin, enoxaparin (lovenox), clopidogrel (plavix) or coumadin (warfarin) * have received chemotherapy or radiation * have a permanent pacemaker * have a serious psychiatric disorder (such as schizophrenia) * more sensitive to pain on one side of my body more than the other

Keywords: pain electromyography acupuncture randomized controlled trial rehabilitation
ckd-330 phase 3 trial in amlodipine non-responder

Conditions: Hypertension

Summary: trial to evaluate the efficacy and safety of a ckd-330 versus amlodipine monotherapy in hypertensive patients inadequately controlled by amlodipine monotherapy

a randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of a ckd-330 versus amlodipine monotherapy in hypertensive patients inadequately controlled by amlodipine monotherapy

Eligibility criteria:
inclusion criteria: * age of 19 or above * essential hypertension with 140mmhg ≤ mean sitsbp \< 180mmhg on target arm at visit 2 * ability to provide written informed consent exclusion criteria: * the difference between arms of sitsbp ≥ 20mmhg and/or sitdbp ≥ 10mmhg at visit 1 * mean sitsbp ≥ 200mmhg and/or mean sitdbp ≥ 120mmhg on target arm at visit 1 * mean sitsbp ≥ 180mmhg and/or mean sitdbp ≥ 120mmhg on target arm at visit 2 * known or suspected secondary hypertension * type i diabetes mellitus and type ii diabetes mellitus with hba1c \> 9% * patients with severe congestive heart failure(nyha class iii, iv) * patient with ischemic heart disease, ischemic cardiovascular disease, valvular heart disease, arrhythmia requiring treatment within 3 months * history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months * history of severe or malignant retinopathy * ast/alt ≥ unl\*3, serum creatinine ≥ unl\*1.5, k \> 5.5meq/l * patients with acute or chronic inflammatory status requiring treatment * patient who need to take antihypertensive drug besides investigational products * patient must be treated with medications prohibited for concomitant use during the study period * history of angioedema related to ace inhibitor or angiotensin ii receptor blockers * history of disability to drug adme, active inflammatory bowel syndrome within 12months, impaired pancreatic function, gi bleeding, obstructions of urinary tract * history of malignant tumor within 5 years * patient who are dependent on drugs or alcohol within 6 months * hypersensitive to candesartan/amlodipine * women with pregnant, breast-feeding * patients treated with other investigational product within 30 days at first time taking the investigational product * not eligible to participate for the study at the discretion of investigator
study of safety and efficacy of the percutaneous reduction of mitral valve regurgitation in heart failure patients

Conditions: Heart Failure; Mitral Regurgitation

Summary: improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.


Eligibility criteria:
inclusion criteria: * functional mr 2+ - 4+ * symptomatic heart failure, nyha class ii to iv * lvef \> 25% or \ 30mm exclusion criteria: * mr of organic origin * severe mitral leaflet tethering * history of mi or pci within 60 days of study procedure * inability to walk a minimum of 100 meters in 6 minutes * significant left main stenosis or proximal circumflex stent * indication of non-patent cso or discontinuous cs-gcv-aiv * bi-ventricular with leads in cs or other devices impeding device placement * severe aortic valvular disease * chronic corticosteroid use other than \< 20mg prednisone for arthritis * significant co-morbidities

Keywords: heart failure mitral regurgitation percutaneous coronary sinus
the efficacy and safety of hyeonggaeyeongyo-tang for chronic rhinitis according to pattern identification in korean medicine

Conditions: Respiratory Tract Diseases; Nose Diseases; Rhinitis

Summary: the purpose of this study is to evaluate the safety and effectiveness of hyeonggaeyeongyo-tang for chronic rhinitis according to pattern identification in korean medicine.


Eligibility criteria:
inclusion criteria: 1. patients who are diagnosed by moderate level of chronic rhinitis for more than 8 weeks * at least one of the following conditions: nasal congestion, rhinorrhea, sneeze, pruritus * at least one of the following moderate abnormality conditions: sleep disturbance; daily activity, physical exercise, leisure activity limitations; work/school work limitations; discomfort with several symptoms 2. age between 19 and 65 years 3. able to dialogue 4. agree with informed consent exclusion criteria: 1. patients who are taken one of the following drugs for treating rhinitis or acute upper respiratory infections etc * drugs which determined to have negative effect on symptoms of rhinitis or skin prick test (oral or nasal) * short acting anti-histamines / h1 blockers (drug use within lase 1 week) * long acting anti-histamines / h1 blockers (drug use within lase 2 week) * corticosteroids (drug use within lase 1 month) ④ anti-cholinergic drug (drug use within lase 1 week) * anti-leukotriene drug (drug use within lase 1 week) * decongestants (drug use within lase 1 week) ⑦ tricyclic antidepressants, phenothiazines (drug use within lase 2 week) ⑧ non-steroidal analgesics (drug use within lase 1 week) ⑨ drugs that is judged to be inappropriate for the trial by the researchers 2. used korean medicine for treating rhinitis within last 7 days 3. patients who has severe disease, such as malignant tumor, severe dyslipidemia, liver or kidney dysfunction, anemia, active pulmonary tuberculosis, infection or systemic disease etc 4. presence of internal nasal obstruction or nasal deformities or history of nasal surgery within 2 months 5. history of active respiratory disease(ex. asthma) 6. hypertension or diabetes 7. experienced immunotherapy or systemic steroid treatments within last 3 months 8. experienced drug allergic reactions 9. experienced anaphylactic reactions, during allergen test 10. female patients who are pregnant or lactating or have the chances of pregnancy 11. patients who are participated other clinical trials within last 1 month 12. patients who are unable to participate the trial (paralysis, severe mental or psychological illness, dementia, drug addiction, unable to make to participate in the trial, severe visual or auditory dysfunction, unable to visit hospital regularly, unable to communicate through spoken or written korean etc) 13. patients who are judged to be inappropriate for the clinical study by the researchers

Keywords: hyeonggaeyeongyo-tang chronic rhinitis pattern identification korean medicine
an open-label, multicenter evaluation of the use of topically administered fp1198 in subjects with pain associated with cyclic mastalgia

Conditions: Moderate to Severe Cyclic Mastalgia

Summary: the purpose of this study is to determine the safety of topical fp1198 for the treatment of moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity of fp1198.


Eligibility criteria:
inclusion criteria: * menstruating females at least 18 years of age * bmi less than 30 * moderate to severe breast pain associated with the menstrual cycle * in good general health exclusion criteria: * pregnant within the last 6 months * has taken in the last 3 months or currently taking hormonal contraception * history of malignancy or currently being treated for cancer of the breast or genital organs * has had breast implants or breast reduction surgery

Keywords: cyclic mastalgia cyclic breast pain fibrocystic breast disease