Kornimate/medical-research-clean huggingface dataset:
myocardial protection with adenosine preconditioning

Conditions: Heart Defects, Congenital; Cardiac Surgical Procedures; Myocardial Reperfusion Injury; Adenosine

Summary: adenosine has been proved to be an important mediator of myocardial protection induced by ischemic preconditioning. the hypothesis of this study is that adenosine preconditioning can provide additional myocardial protection in the setting of pediatric open heart surgery with cardioplegia and cardiopulmonary bypass.

adenosine has been used for diagnosis and treatment of cardiovascular diseases for many years. new progresses in myocardial protection in the settings of acute myocardial infarction treatment put forward the its clinical use to a broader field. but the safety and effectiveness of its use in myocardial protection in the setting of open heart surgery has not been investigated intensively. our primary results suggested that adenosine preconditioning could decrease the release of myocardial serum markers, such as ctni. this study will focus on the safety and effectiveness of adenosine in the field of pediatric myocardial protection during surgery repair of congenital heart defects with cpb and cardioplegia.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of congenital heart defects eligible for surgery treatment under cardiopulmonary bypass and cardioplegia * body weight less than or equals to 10kg exclusion criteria: * cardiac surgery is performed without cardiopulmonary or cardioplegia * body weight more than 10kg

Keywords: ischemic preconditioning, myocardial adenosine
pubertal induction in individuals with hypogonadism

Conditions: Primary Amenorrhoea; Hypothalamic Amenorrhoea; Hypogonadotrophic Hypogonadism; Hypopituitarism; Turner's Syndrome; Primary Ovarian Insufficiency

Summary: the investigators wish to explore the variability of uterine, breast and bone outcome markers as surrogates to assess the adequacy of exogenous oestrogen replacement in individuals with hypogonadism.

the investigators will invite individuals with hypogonadism who require pubertal induction to participate in the study. the participants will receive conventional routine oestrogen replacement in the form of transdermal patch. the participants will be reviewed every 2 months for a total of 8 months to document uterine, breast and bone assessment. this will be completed using a variety of tools. after 4 months, the participants will receive an incremental increase in oestrogen dose.

Eligibility criteria:
inclusion criteria: 1. have a diagnosis of hypogonadism (turner's syndrome, hypogonadotrophic hypogonadism, primary ovarian insufficiency, hypopituitarism, hypothalamic amenorrhoea, transgender) 2. ≥ 10 years of age 3. oestrogen naïve i.e. no prior commencement of oestrogen treatment 4. breast tanner stage ≤ than 2 exclusion criteria: 1. previous oncology treatment 2. primary amenorrhoea secondary to chronic medical comorbidity 3. pcos diagnosis
medical treatment for acute appendicitis

Conditions: Acute Appendicitis

Summary: medical treatment for acute appendicitis

patients with clinically and radiologically approved acute appendicitis will be treated medically. the main aim of the study is to define the long term results of medical treatment for acute appendicitis. patients will be followed by clinical visits and recurrences will be recorded.

Eligibility criteria:
inclusion criteria: * clinically and radiologically approved acute appendicitis * approved and signed the informed consent form exclusion criteria: * perforated cases * cases with peritonitis * patient wish for surgical treatment * allergy to drugs used in medical treatment of acute appendicitis
a multicenter study to evaluate the rox coupler in subjects with hypertension

Conditions: Hypertension; High Blood Pressure

Summary: to evaluate the safety and effectiveness of the rox coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.


Eligibility criteria:
inclusion criteria: * mean 24-hour ambulatory blood pressure monitoring (abpm) sbp ≥ 140 mmhg at screening. exclusion criteria: * any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.

Keywords: hypertension high blood pressure systolic blood pressure uncontrolled hypertension essential hypertension resistant hypertension vascular disease
hyperbaric oxygen therapy as adjunctive treatment of chronic diabetic foot ulcers

Conditions: Diabetes; Foot Ulcer; Healing

Summary: the purpose of this study is to evaluate if hyperbaric oxygen therapy heels more foot ulcers as compared to placebo in patients with diabetes mellitus and chronic foot ulcers.


Eligibility criteria:
inclusion criteria: * diabetes mellitus, * foot ulcer with duration \> 3 months, * treatment at diabetes foot clinic for \> 2 months, * vascular surgical intervention had not been recommended for the affected lower limb. exclusion criteria: * severe obstructive pulmonary disease, * malignancy and untreated thyrotoxicosis), * current drug or alcohol misuse, * vascular surgery in the lower limbs within the last two months, * participation in another study or suspected poor compliance.

Keywords: diabetes foot ulcer neuropathy ischemia
a study to observe vedolizumab and anti-tumour necrosis factors (anti-tnfs) outcomes in real-world biologic ulcerative colitis (uc) and crohn's disease (cd) participants

Conditions: Colitis, Ulcerative; Crohn Disease

Summary: the purpose of this study is to describe treatment patterns associated with first-line and second line biologic use (vedolizumab or other biologic) and to describe the real-world clinical effectiveness of the use (first-line and second line) vedolizumab versus other biologics at least 6 months post-treatment initiation.

this is a retrospective, non-interventional study of participants with cd or uc. the study will review the medical charts of participants who have initiated the first or second line treatment with vedolizumab or another biologic agent (infliximab, adalimumab, or golimumab \[uc only\]) (index event) during the eligibility period to evaluate the treatment effectiveness, treatment patterns, health care utilization and safety of vedolizumab, and to provide the real-world treatment landscape with anti-tnf alpha therapies. the study will enroll approximately 400 participants, with 200 participants in each treatment cohort. all participants will be enrolled into two observational groups: * cohort 1: vedolizumab * cohort 2: other biologics the data for participants will be collected in two main periods: * pre-index event period: from the data of diagnosis of uc/cd until one day prior to the date when vedolizumab or other biologic treatment was initiated during the eligibility period. * post-index event period: from the date when vedolizumab or other biologic treatment was initiated during the eligibility period until the earliest of 6 months (post-index treatment discontinuation, death of participants, lost-to-follow up, or date of chart abstraction initiation. this multi-center trial will be conducted in spain and portugal. the overall time for data collection in the study will be approximately 12 months and the overall duration of the study is approximately 24 months.

Eligibility criteria:
inclusion criteria: 1. has a diagnosis of moderate to severe uc or cd documented in the medical chart. 2. received at least one dose of vedolizumab or other biologic (infliximab, adalimumab, or golimumab \[uc only\]) during the eligibility period. 3. received the biologic treatment as first-line or second line biologic for uc or cd. 4. has a minimum of six months of follow-up between date of starting biologic therapy (index event) and the date of completion of the participant pre-selection registry. exclusion criteria: 1. received vedolizumab or another biologic as part of an interventional clinical trial ever in their lifetime (includes index treatment). 2. index treatment was another biologic therapy other than vedolizumab, infliximab, adalimumab, or golimumab (uc only). 3. initiated index treatment as combination therapy with two biologic agents. 4. the biologic was prescribed for treatment of perianal disease. 5. received biologic therapy before the index period for a disease other than inflammatory bowel disease. 6. medical chart is unavailable.

Keywords: drug therapy
adaptive dose-escalated multi-modality image-guided radiotherapy

Conditions: Head and Neck Cancer

Summary: patients with primary head and neck squamous cell carcinoma (hnscc) planned for treatment with radiotherapy with or without chemotherapy in curative setting will be treated with an adaptive radiotherapy scheme. an fdg-pet/ct scan for re-delineation and re-planning will be made at the end of the second and fourth of week of radiotherapy. the non-responding part of the tumor on fdg-pet will receive a mild dose-escalation. depending on the metabolic response, the entire tumor will receive 70 gy or the residual fdg-avid area will receive 74 or 78 gy.

if there is a complete metabolic response on the fdg-pet after 2 weeks, the entire tumor will receive 70 gy. if there is a complete metabolic response after 4 weeks of treatment, the residual fdg-avid area will receive 74 gy. if there also is no complete metabolic response after 4 weeks of treatment, the residual fdg-avid area will receive 78 gy.

Eligibility criteria:
inclusion criteria: * histologic biopsy confirmed squamous cell carcinoma of the oral cavity, hpv-negative oropharynx, hpv-positive oropharynx with a minimum of 10 pack-years, hypopharynx or larynx * t2-t4 * scheduled for radiotherapy or radiotherapy with cisplatin or cetuximab exclusion criteria: * gfr\<30 * other neoplasms with metastases in the previous 3 years

Keywords: adaptive image-guided radiotherapy head and neck cancer
phase 1 study of ht-102 administered subcustaneously in healthy participants and patients with chronic hepatitis b for safety, tolerability, pharmacokinetics (pk), and antiviral activity (only in participants with chronic hbv infection)

Conditions: Chronic Hepatitis B

Summary: safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of ht-102 (bm012) injection in healthy subjects and hepatitis b e antigen-negative patients with chronic hepatitis b virus infection: a randomized, double-blind, placebo-controlled, single and multiple subcutaneous injections, and dose escalation phase 1 clinical study


Eligibility criteria:
inclusion criteria: healthy participants sad: * male participants weighed ≥ 50.0 kg, female participants weighed ≥ 45.0 kg; * participants were healthy individuals; * participants promise to have no plans to have a child, donate sperm or eggs and voluntarily take effective non-drug contraception measures during the trial and within 3 months after the end of the trial; participants with chronic hbv infection, mad: * chronic hbv infection, and hbeag negative; * patients who had received antiviral therapy for at least one year before screening and stabilization therapy with nucleoside (nucleotide) reverse transcriptase inhibitors for ≥ 3 months before screening (nucleoside (nucleotide) reverse transcriptase inhibitors; exclusion criteria: * participants with a history of active pathological hemorrhage or those with bleeding tendency, or those with a history of neurological disease; * participants with major trauma or major surgery within 3 months before trial screening; * participants with a history of drug allergy; * participants who used any drugs before trial screening or are using any drugs, including vitamins and chinese herbal medicines; * participants with abnormal results of ecg examination, laboratory test in the screening period which were judged as clinically significant; * participants who cannot tolerate subcutaneous injection; * patients with a previous clinical diagnosis of liver cirrhosis, or a history of alcoholic liver disease, autoimmune liver disease, inherited metabolic liver disease, and other liver diseases; * participants with a clinically significant acute infection; * women who were pregnant or lactating or had a positive pregnancy test result;
a study of rslv-132 in subjects with primary sjogren's syndrome

Conditions: Sjogren's Syndrome

Summary: the present study will examine the role of circulating rna complexed with autoantibodies and immune complexes and its role in activation of inflammatory pathways in patients with primary sjogren's syndrome. the study will be conducted in a subset of sjogren's patients who have elevated levels of autoantibodies and a pattern of elevated interferon-stimulated gene expression in blood cells. a number of biochemical and clinical parameters will be analyzed to determine the potential therapeutic utility of nuclease therapy in sjogren's syndrome.

this is a multi-center, double-blind, placebo-controlled study to evaluate the impact of 8 intravenous infusions of rslv-132 in 28 patients with primary sjogren's syndrome. each of the subjects will be randomized 3:1 (active:placebo) and will receive 8 infusions of 10 mg/kg of rslv-132 or placebo as follows on days: • 1, 8, 15, 29, 43, 57, 71, and 85 potential subjects will be screened to assess their eligibility to enter the study within 60 days prior to study entry (i.e., prior to baseline visit). following baseline evaluations on day 1, subjects will receive their first infusion of rslv-132 or placebo. subjects will return to the research unit for follow-up visits as described in appendix a. dose selection rationale: the dose level was chosen based on safety and tolerability data from protocol 132-02 (multiple ascending dose study in sle patients). additionally, in a 6-month toxicology study in cynomolgus monkeys, 50 mg/kg of rslv-132 was administered by iv infusion weekly. no dose-limiting toxicity was noted, therefore the no observed adverse effect level is at least 50 mg/kg, providing at least a 5-fold safety margin for this study. rslv-132 shall be prepared for each subject from individual stock vials provided by sponsor. details of dilution, dose preparation, and administration instructions will be provided in the study drug reference guide. the dose for each individual shall be based on the subject's body weight.

Eligibility criteria:
inclusion criteria: 1. meet 4 of 6 criteria of 2002 american-european consensus group (aecg) criteria for primary sjogren's syndrome 2. presence of anti ro autoantibodies 3. presence of interferon signature exclusion criteria: 1. use fo hydroxychloroquine within 30 days of baseline 2. use of cyclophosphamide within 180 days of baseline 3. use of oral corticosteroids greater than 10 mg/day 4. known igg4-related disease
study for comparing the pharmacokinetics of a pregabalin controlled release tablet 300mg with immediate release formulation and to assess the effect of high fat diet in healthy male subjects

Conditions: Healthy

Summary: the purpose of this study is to: 1. compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg \* 2). 2. evaluate the effectiveness of food to pharmacokinetics profile of pregabalin sustained release tablet.


Eligibility criteria:
inclusion criteria: * 19\~44 aged healthy adult. * someone tho has at least 50kg body weight and ideal body weight ±20% exclusion criteria: * someone has acute symptom at screening phase * someone has any disease or symptoms which is clinically significant * someone had been determined during healthy examination in screening period * ast or alt \> 1.25 times than normal * total bilirubin \> 1.5 times than normal * someone who has a history of allergy, anaphylaxis, drug abuse or misuse. * someone who had enrolled to other clinical trial within the last 60 days. * someone who had donated blood within the last 60 days. * someone who can't take a meal derived from this trial. * someone who has taken abnormal meals like which can affect to drug adme * someone who has taken other etc drugs or oriental drugs within the last 14 days, or otc drugs within the last 7 days * someone who has taken caffein continuously (coffee or green tea more than 5 cups per a day) or took caffein since 24hours before. * someone who has taken alcohol more than 30g/day or smoked more than 10 piece of tobacco/day. * someone who has galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption.

Keywords: neuropathic pain pregabalin
chemotherapy in treating patients with recurrent malignant glioma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of topotecan plus carmustine in patients with recurrent primary malignant glioma.

objectives: * determine the maximum tolerated dose of topotecan administered in combination with a fixed dose of carmustine. * determine the toxic effects of topotecan and carmustine in patients with recurrent primary malignant glioma. outline: topotecan is administered by an ambulatory infusion pump for 72 hours each week. topotecan dose escalation is carried out in cohorts of three patients. dose escalation is continued until toxic effects or disease progression is observed in these patients. carmustine is administered over 1 hour every 6 weeks, on the same day as the first topotecan dose for that week. three patients will be treated at an initial dose level of topotecan, and if one of these patients experience dose limiting toxicity (dlt), an additional 3 patients must be treated at this dose level without further dlt in order for dose escalation to proceed. the mtd is the highest dose at which dlt occurs in no more than 1 of 6 patients. patients are evaluated after every 6 week cycle. projected accrual: an estimated 18-36 patients will be entered.

Eligibility criteria:
disease characteristics: * histologically proven recurrent primary malignant glioma * measurable recurrent or residual primary central nervous system neoplasm confirmed by mri patient characteristics: age: * 18 and over performance status: * karnofsky at least 60% hematopoietic: * hematocrit greater than 29% * anc greater than 1,500/mm\^3 * platelet count greater than 125,000/mm\^3 hepatic: * sgot less than 1.5 times upper limit of normal (uln) * bilirubin less than 1.5 times uln renal: * creatinine less than 1.5 mg/dl * bun less than 25 mg/dl other: * not pregnant * effective contraceptive method must be used for the duration of the study prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy within 6 weeks of study * no prior topotecan or carmustine treatment failure * no more than 1 prior chemotherapy regimen endocrine therapy: * patients taking corticosteroids must be on stable dose for at least 2 weeks prior to study and the dose should not escalate over entry level radiotherapy: * no prior radiotherapy within 6 weeks of study surgery: * no prior surgical resection within 3 weeks of study other: * no concurrent medication that may interfere with study results

Keywords: recurrent adult brain tumor
multicenter diagnostic clinical performance study for automated detection of diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: this study is a retrospective study to assess the efficacy and accuracy of the eyecheckup software in screening for diabetic retinopathy in healthcare settings.

this is a clinical diagnostic performance study for eyecheckup with data obtained consecutively at multiple geographically different sites within the us population. these sites include all healthcare settings with a trained ophthalmic camera operator using non-mydriatic cameras that are compatible with eyecheckup. moreover, primary endpoints are devised that will be used to validate eyecheckup to diagnose dr in the primary care and eye care settings. during this color fundus images representing either 4 wide field or 7 standard fields of view will be graded by a qualified professional for diabetic retinopathy according to etdrs on drss scale. the human grading output will be compared with diagnosis generated for diabetic retinopathy by ai software. a comparison of both these grades will be used to determine sensitivity and specificity for the eyecheckup software for screening for diabetic retinopathy.

Eligibility criteria:
inclusion criteria: * a diagnosis of either diabetes type 1 or diabetes type 2 * 22 years of age or older * patients fundus images must include at least 1 macula centered and 1 optic disc nerve centered image * all the subjects must be sequentially photographed meaning no omissions of data between a certain time frame by the sites providing images to ensure consecutive selection * no history of any other retinal vascular disease, glaucoma, or another disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed) subject with image taken by color fundus photography that meets the following requirements: * the resolution of image is 1024×1024 pixels or higher * the ability to provide a 7 standard or 4 wide field of view * must obtained from either topcon nw400 or cannon model cr-2 af or cr-2 plus af or optomed aurora cameras along with the following data: their age, ethnicity and gender, patient ocular history as evaluated of verified by the clinical sites where data is obtained exclusion criteria: * no diagnosis of either diabetes type 1 or diabetes type 2 * the macula, optic nerve, or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the certified ophthalmologist who is grading the images.

Keywords: diabetic retinopathy artificial intelligence deep learning retinal images diabetic macular edema diabetic eye problems