Kornimate/medical-research-clean huggingface dataset:
a double-blind, randomized control trial comparing botulinum toxin type a (botox) and placebo in the treatment of idiopathic clubfoot

Conditions: Idiopathic Clubfoot (Talipes Equinovarus)

Summary: the purpose of this study is to continue the work from the previous review study and determine the effectiveness of botox in treating patients with idiopathic clubfoot by comparing outcomes of subjects treated with manipulation and casting plus botox (treatment group) to those treated with manipulation and casting plus placebo (control group). the null hypothesis is that manipulation and casting plus botox is not an effective treatment for idiopathic clubfoot. the alternate hypothesis is that manipulation and casting plus botox is an effective treatment for idiopathic clubfoot.

the study timeline is divided into five phases which have been defined based on experiences with the previous review and with clubfoot treatment in general. these phases are as follows: 1) study treatment (botox injection versus placebo); 2) post-treatment manipulation and casting; 3) bracing and full-time maintenance; 4) intent-to-treat intervention for management of first-time non-responders (nr1) and first-time recurrences (rec1) post-study treatment; and 5) rescue intervention for management of second-time non-responders (nr2) and second-time recurrences (rec2) post intent-to-treat intervention. we will utilize a double-blind randomized control trial to assess the efficacy of botox in the treatment of idiopathic clubfoot. patients, parents, both participating surgeons, and members of their clinical and research teams (physiotherapist, occupational therapist, orthopaedic technologist, orthotist, research assistant) will be blinded to the study group (botox group versus control group) each subject belongs in. the pharmacist preparing the syringes for injection will not be blinded. subjects will be randomly assigned to receive either botox (treatment group) or placebo injection (control group). subjects in the treatment group will receive botox injections dosed at 10 iu/kg prepared by diluting 100 iu of botox in 1cc of unpreserved saline. if the child has bilateral clubfoot, the contents will be divided equally for injection into each gastrocnemius. placebo injections for the control group will contain unpreserved saline at 0.1cc/kg (such that a 4.5 kg subject will receive 0.45cc).

Eligibility criteria:
inclusion criteria: 1. children presenting with idiopathic clubfoot at bc children's hospital and hospital for sick children 2. children ranging in age from 1 day to 2 months old 3. children who have reached hindfoot stall 4. children with complete pre-study data \*from protocol, hindfoot stall is defined: "following initial manipulation and casting of clubfoot, when the forefoot can be abducted beyond 60 degrees but hindfoot equinus persists, requiring need for further intervention to correct the clubfoot deformity" exclusion criteria:
efficacy of functional magnetic stimulation in urinary incontinence

Conditions: Incontinence

Summary: functional magnetic stimulation (fms) appears to modulate autonomic and somatic nervous systems that innervate the lower urinary tract. stimulation of the pudendal afferent nerve near the third sacral root induces relaxation of the detrusor muscles and reinforcement of urethral sphincter. some preliminary studies had indicated the positive effect of fms on stress urinary incontinence. investigators aimed to evaluate the immediate and long-term effect of this method on stress urinary incontinent patients.

5 hz repetitive magnetic stimulation was applied over bilateral sacral roots for 20 minutes.

Eligibility criteria:
inclusion criteria: * urine incontinence refractory to traditional treatment exclusion criteria: * arrhythmia, pacemaker implantation

Keywords: fms urine incontinence
clopidogrel versus cilostazol on vessels

Conditions: Type 2 Diabetes; Atherosclerosis

Summary: diabetes is an increasing cause of atherosclerotic and cardiovascular illnesses in south korea. the clinical application of ultrasound for measuring carotid intima-media thickness, which helps in early detection and surveillance of atherosclerosis, is advancing. due to lifestyle changes and an aging population, koreans, especially diabetics, are developing more vascular diseases and are at higher risk for peripheral vascular disorders. diabetics with lower limb peripheral artery disease require effective therapy to avoid major complications and a reduced quality of life. although licensed for symptom control, clopidogrel and cilostazol have not yet been established for primary prevention of cardiovascular risks. these medications will be evaluated for their potential as primary preventive agents against cardiovascular disease in type 2 diabetes patients. the goal of this research is to investigate the efficacy of cilostazol and clopidogrel in inhibiting the progression of carotid atherosclerosis and to evaluate their influence on hemorheological changes in individuals with type 2 diabetes. the goal of this research is to investigate the efficacy of cilostazol and clopidogrel in inhibiting the progression of carotid atherosclerosis and evaluating their influence on alterations in blood flow among individuals with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * adults with diabetes aged 19 and older * individuals with a carotid ultrasound cimt (carotid intima-media thickness) of 1.0mm or more * those who have not changed their combination therapy medications (including oral hypoglycemics, antihypertensives, and lipid-lowering drugs) in the last three months * individuals with an hba1c level of 10% or less * those who have voluntarily signed the written consent form and agreed to participate in the study exclusion criteria: * individuals currently using antithrombotic or anticoagulant medications other than aspirin * individuals with bleeding or conditions that may increase the risk of bleeding, such as: * hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal bleeding, urinary bleeding, hemoptysis, vitreous hemorrhage, etc * active peptic ulcer, hemorrhagic stroke within the last 6 months, surgical operations within the last 3 months, proliferative diabetic retinopathy, uncontrolled hypertension * patients who have had cerebrovascular or cardiovascular complications within the past 6 months (including stroke, transient ischemic attacks, myocardial infarction, unstable angina, coronary artery bypass graft, or percutaneous coronary intervention) * patients with severe renal or hepatic diseases * patients with congestive heart failure * individuals with a history of hypersensitivity to the drug or its components * pregnant women or women who may be pregnant * women who are breastfeeding or plan to breastfeed during the study
pilot sleep intervention to improve diabetes management in school-aged children

Conditions: Type 1 Diabetes Mellitus

Summary: evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention for school-aged children with type 1 diabetes and their caregivers in a pilot randomized trial. the primary outcome is improvements in child sleep, and secondary outcomes include glycemic control (hba1c, % in range), improvements in parent sleep, parental distress, and child behavior problems.


Eligibility criteria:
inclusion criteria: * child between 5-9 years of age * child have been diagnosed with type 1 diabetes for at least 12 months * caregiver lives with child * caregiver can read/speak english exclusion criteria: * child has other major health problems or sleep disorders other than insufficient sleep or insomnia * participating in other intervention studies
a trial of paclitaxel (genexol®) and cisplatin versus paclitaxel loaded polymeric micelle (genexol-pm®) and cisplatin in advanced non small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this is a randomized clinical trial of paclitaxel (genexol®) and cisplatin versus paclitaxel loaded polymeric micelle (genexol-pm®) and cisplatin in advanced non small cell lung cancer.


Eligibility criteria:
inclusion criteria: * histological or cytological evidence of locally advanced, metastatic or recurrent nsclc (stage iiib or iv) * at least one measurable lesion(s) by recist criteria * no previous palliative chemotherapy * age 18 or higher. * ecog ps 0-2 * life expectancy of at least 3 months. * adequate hematologic, hepatic, renal function * adequate bone marrow function (≥ anc 1,500/ul, ≥ platelet 100,000/ul) * adequate liver function (≤ total bilirubin ≤ 1.5 upper normal limit, ≤ ast/alt x 2.5 upper normal limit, alkaline phosphatase ≤ 2.5 upper normal limit) * adequate renal function (≤ serum creatinine 1.5 mg/dl) * written informed consent exclusion criteria: * no prior chemotherapy for nsclc * patients with malignancies (other than nsclc), except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix. * peripheral neuropathy ≥ grade 2 (nci ctc, version 3.0) * clinically significant cardiac disease (medically uncontrollable heart disease) * active infection or other serious medical illness * contraindication to any drug contained in the chemotherapy regimen * pregnant or lactating women were excluded.

Keywords: nsclc
investigation of the detection rate of pathogenic viruses in the feces of individuals with non-gastrointestinal infections

Conditions: Virus Infections

Summary: this project is a cross-sectional study. investigators plan to search and collect 1600 publicly published fecal metagenomic and metatranscriptome data through the pubmed database, by summarizing and analyzing them to construct an enterovirus database. 200 apparently healthy individuals are planned to be enrolled. at the time of enrollment, fecal specimens of participants will be collected, and their demographic characteristics, disease and medication history, gastrointestinal status, dietary habits, lifestyle habits, and mental health information will be recorded. another 200 specimens will be collected from patients with parenteral virus infection. the demographic characteristics and pathogen test results of the parenteral virus infected patients will be reviewed and recorded. by virus metagenomic sequencing on fecal specimens, investigators will identify which viruses can be detected in the intestinal tract of apparently healthy people, and to explore whether parenteral infection viruses can be detected in feces.


Eligibility criteria:
inclusion criteria: 1. age ranged from 18 to 75 years; 2. no obvious symptoms and signs of the disease; 3. not taking a drug for a long time; 4. good psychological condition ; 5. no unhealthy lifestyle; 6. willing to participate in the study, sign the informed consent, fill out the questionnaire and provide fecal samples. exclusion criteria: 1. pregnant and lactating women; 2. suffering from certain diseases, such as cardiovascular disease, digestive system disease and nervous system disease.
a study of ly3209590 in chinese participants with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to evaluate the safety of a study drug known as ly3209590 in chinese participants with type 2 diabetes mellitus who are on a stable dose of basal insulin. side effects and tolerability will be documented. blood samples will be taken to assess how the body processes the study drug and the effect of the study drug on blood sugar levels. the study will last up to 18 weeks and may include 18 visits for each participant.


Eligibility criteria:
inclusion criteria: * have been diagnosed with type 2 diabetes mellitus (t2dm) and treated with basal insulin and up to one non-insulin anti-hyperglycemic medication. * body mass index (bmi) of 18.5 to 40.0 kilograms per meter squared (kg/m²) * have received a stable daily dose of basal insulin at screening * have hemoglobin a1c (hba1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening * native chinese participant who has both parents and all 4 grandparents of chinese origin. exclusion criteria: * have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes * have a history of ketoacidosis or hyperosmolar state/coma episode or severe hypoglycemia or hypoglycemia unawareness in the 6 months prior to screening * are receiving insulin other than once daily basal insulin * have any active infectious or serious disease or major organs insufficiency * women who are pregnant or lactating
megadose of hydroxocobalamin for the treatment of pernicious anemia

Conditions: Megaloblastic Anemia Nos; Pernicious Anemia

Summary: demonstrate the effectiveness of a single dose of a multivitamin complex for the treatment of megaloblastic anemia

the investigators will administrate a single intramuscular dose of hydroxocobalamin 10,000mcg, thiamin 100mg, pyridoxine 50mg. to assess response to treatment, a complete blood count (cbc) will be performed weekly during the first month of treatment, after the first month a cbc will be taken monthly for 6 months. also to confirm the diagnosis and assess response the investigators will measure levels of methylmalonic acid, homocysteine, and hydroxocobalamin at the beginning of the study, 3 and 6 months.

Eligibility criteria:
inclusion criteria: age \>18, all sex clinical suspicious of megaloblastic anemia ( cytopenias and macrocytosis (cbc), hypersegmented neutrophils and elevated lactate dehydrogenase) patients must sign an informed consent indicating that they are aware of the investigational nature of this study - exclusion criteria: administration of hydroxocobalamin in the three years before enrollment patients with active, uncontrolled psychiatric disorders severe neurologic deficit known hematologic malignancy known coagulation disorder that contraindicates intramuscular injection end-stage kidney disease (gfr \<15ml/min) chronic liver disease (child-pugh b or c) pregnant patients known infection of hepatitis b or c and hiv diagnosis of myelodysplastic syndrome -
a study of the efficacy and safety of efgartigimod in patients with primary sjögren's syndrome

Conditions: Primary Sjogrens Disease

Summary: the main purpose of the proposed study is to evaluate the efficacy of efgartigimod ph20 sc in patients with moderate-to-severe primary sjögren's disease (psjd). the study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. the maximum study duration for participants in both study parts is approximately 105 weeks.


Eligibility criteria:
inclusion criteria: * is at least 18 years of age and the local legal age of consent for clinical studies when signing the icf. * meets the following criteria at screening: acr/eular classification criteria 2016 psjd; clinessdai ≥ 6; anti-ro/ss-a positive at central laboratory; unstimulated residual salivary flow (≥ 0.01 ml/min) exclusion criteria: * secondary sjögren's disease where another confirmed autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and inflammatory bowel disease) is the primary diagnosis. * active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening. * any severe systemic psjd manifestation that is not adequately controlled at baseline that may put the participant at undue risk based on the investigator's opinion. * use of cyclophosphamide ≤ 24 weeks prior to screening * anti-cd20 or anti-cd19 antibody received \< 6 months before screening
safety and immune response of different pediatric combination vaccines.

Conditions: Diphtheria; Polio; Pertussis

Summary: the overall aim of the study is to corroborate that a schedule consisting of 3 doses of pentacel™ and a 4th dose of daptacel® and acthib® or 4 doses of pentacel™ or 4 doses of quadracel and acthib® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines daptacel®, vero cell derived inactivated poliovirus vaccine (ipol®), and acthib® and a 4th dose of daptacel® and acthib®.


Eligibility criteria:
inclusion criteria: * aged ≥ 42 days and ≤ 89 days on the day of inclusion * born at full term of pregnancy (≥ 36 weeks) * informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure * vaccination with a hepatitis b vaccine at least 30 days before inclusion * able to attend all scheduled visits and to comply with all trial procedures(i.e., access to a phone) * provide blood sample prior to dose 1 * parent or legal representative willing to take rectal temperatures after each vaccination. exclusion criteria: * participation in another clinical trial in the 4 weeks preceding the (first)trial vaccination * planned participation in another clinical trial during the present trial period * personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy * known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s) * chronic illness that could interfere with trial conduct or completion * received blood or blood-derived products since birth * any vaccination in the 2 weeks preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination. flu vaccine could be administered only 2 weeks after any trial vaccination * previous vaccination with any acellular pertussis- (dtap) or whole cell pertussis- (dtwp) based combination vaccines, haemophilus influenzae type b (hib)-conjugate, poliovirus, or pneumococcal conjugate vaccines * coagulation disorder contraindicating intramuscular (im) vaccination * clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion) * developmental delay or neurological disorder * any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.

Keywords: pertussis whooping cough filamentous haemagglutinin fimbriae types 2 and 3; pertactin diphtheria tetanus poliovirus types 1, 2, and 3.
an extended access program for bardoxolone methyl in patients with ckd (eagle)

Conditions: Chronic Kidney Diseases; Alport Syndrome; Autosomal Dominant Polycystic Kidney

Summary: this extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (ckd) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. patients will remain in the study until bardoxolone methyl is available through commercial channels or until patient withdrawal, whichever is sooner.


Eligibility criteria:
inclusion criteria: * patients who are participating (or who have participated) in qualifying studies and who have not been required to discontinue study treatment for protocol or safety reasons and who have completed required end-of-treatment and/or follow-up visits in a prior clinical study with bardoxolone methyl and who, according to the assessment of the investigator, have a potential positive benefit-risk assessment for participating in the trial. * meets the following eligibility criteria based on assessments from the prior qualifying study (last on-treatment visit) or from a screening visit, if applicable: 1. not expected to reach end stage kidney disease (eskd) or nephrotic syndrome within 12 weeks of study enrollment, in the investigator's judgement; subjects with egfr \ 1.0 ml/min/1.73m2 per month in the 3 months prior to eligibility assessment may not be eligible); 2. bnp \< 200 pg/ml at the last on-treatment visit in the prior qualifying study or at a new screening visit, if applicable; 3. no occurrence of a cardiovascular serious adverse event in the prior qualifying study or in the interval between the end of the qualifying study and the screening visit, if applicable. * willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * evidence of a personally signed and dated informed consent document (and assent form if necessary) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures. exclusion criteria: * participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication; * patients who have an ongoing sae from a clinical study that is assessed by the investigator as related to bardoxolone methyl; * unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while screening, taking study drug and 30 days after the last study drug dose; * women who are pregnant or breastfeeding; * patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason; * known hypersensitivity to any component of the study drug.

Keywords: bardoxolone methyl cddo-me rta 402 alport syndrome autosomal dominant polycystic kidney adpkd
choroidal thickness vitrectomy

Conditions: Epiretinal Membrane

Summary: the purpose of this study is to assess the influence of vitrectomy on changes in central choroidea and comparing the results in imaging of the choroidea with two different oct devices. this is a prospective, open, non-randomized, observational, mpg study this study will be performed at the department of ophthalmology, medical university of vienna. 40 patients who undergo vitrectomy will be included into this study. the investigation will help to gain new information about the effects of vitrectomy on the choroid.

since the development of new oct modalities, like enhanced depth or swept-source oct imaging, a better visualization and evaluation of retinal structures and the choroidea became possible. 23g vitrectomy and membrane peeling seem to have an influence on posterior segment structures of the eye but data show no clear evidence evaluating those changes after surgery. only little information is currently available on the influence or the changes resulting from vitreous surgery on the central choroidea. hence, the aim of this study is to evaluate those influences resulting on choroidea using two different oct devices. to assess the influence of vitrectomy on changes in central choroidea and comparing the results in imaging of the choroidea with two different oct devices. this is a prospective, open, non-randomized, observational, mpg study this study will be performed at the department of ophthalmology, medical university of vienna. 40 patients who undergo vitrectomy will be included into this study. the investigation will help to gain new information about the effects of vitrectomy on the choroid. the measuring procedures used in this study are well tolerated and used in routine clinical practice and are non-invasive.

Eligibility criteria:
inclusion criteria: * patients with epiretinal membrane scheduled to undergo vitrectomy without endotamponade * male or female, at least 18 years of age * written informed consent has been obtained * visual acuity ≥0.4 exclusion criteria: * any abnormalities preventing reliable measurements as judged by the investigator * participation in a clinical trial in the 3 weeks preceding the study