Kornimate/medical-research-clean huggingface dataset:
effects of work shop for children with developmental delays

Conditions: Developmental Delays

Summary: to identify the effects of family work shop for children with speech developmental delays.

to assess the improvement of functional performance of children with speech developmental delays by 2-3 hours per session, one session per week, a total of 6 weeks of family work shop

Eligibility criteria:
inclusion criteria: * 18 m/o to 36 m/o of children with speech development delay exclusion criteria: * less than 18 m/o older than 36 m/o

Keywords: family work shop speech developmental delays children
pharmacogenomics blood sampling protocol for irinotecan/fluorouracil/leucovorin(cpt-11/fu/lv).

Conditions: Colorectal Neoplasms

Summary: this protocol describes procedures for the collection of blood samples for the intent of determining genetic contribution to the safety and efficacy of cpt/fu/lv.


Eligibility criteria:
inclusion criteria: * participation in studies employing treatment with irinotecan and a signed informed consent. exclusion criteria: * none.
examination of low wattage and high wattage e-cigarettes

Conditions: Smoking, Cigarette; Smoking, Tobacco; Nicotine Dependence; Exposure to Toxic Agent

Summary: the overall aim of the proposed study is to evaluate the effect of switching from conventional cigarettes to either a lwe or hwe on smoking behavior, product use patterns and continued use, as well as biomarkers of toxicant exposure and effects.


Eligibility criteria:
inclusion criteria: 1. smoke ≥5 cigarettes per day for the past year; 2. no quit attempt in the prior 3 months and no plan to quit in the next 3 months; 3. read, write, and speak in english; 4. report at least minimal interest in switching to an alternative product (\> "not at all" on a likert scale); 5. never purchased or regularly used a tank system, mechanical mod, or advanced personal vaporizer ec, though previous use of cig-a-like devices will be allowed but not in the last 3 months; 6. plan to live in the local area for next year; and 7. have reliable means of transport. - exclusion criteria: 1. \<18 years old; 2. unstable or significant medical condition such as respiratory, kidney, or liver disease that could potentially affect biomarker data; 3. unstable or significant psychiatric conditions (past and stable conditions will be allowed); 4. history of cardiac event or distress within the past 3 months; and 5. currently pregnant, planning to become pregnant, or breastfeeding (n.b: pregnancy status will continue to be evaluated throughout the study at each visit). -
prospective global registry for the study of chronic total occlusion intervention

Conditions: Coronary Artery Disease

Summary: percutaneous coronary intervention (pci) of chronic total occlusions (ctos) is increasingly being performed in patients with advanced coronary artery disease, but there is limited information on the techniques utilized and the procedural outcomes. the goal of this multicenter, investigator initiated registry is to collect information on treatment strategies and outcomes of consecutive patients undergoing cto pci among various participating centers. the information collected will be used to determine the frequency of cto pci performed at the participating sites and examine the procedural strategies utilized, and the procedural (both immediate and during follow-up) outcomes.


Eligibility criteria:
inclusion criteria: * patients undergoing cto pci at each of the participating centers. exclusion criteria: * none

Keywords: chronic total occlusion, percutaneous coronary intervention
laparoscopic gastrectomy for advanced gastric cancer

Conditions: Advanced Gastric Cancer; Laparoscopic Gastrectomy

Summary: although laparoscopic gastrectomy (lg) is widely used for the treatment of early gastric cancer, there have been few reports of the efficacy of lag in the management of advanced gastric cancer(agc). the aim of this study is to evaluate the surgical outcomes and oncologic safety of laparoscopic gastrectomy for agc.

prospective phase ii clinical trial to evaluate technical and oncological safety of lg for agc lg procedure for agc: d2 lymphadenectomy total omentectomy for tumor with serosa exposure under laparoscopic exploration primary end point: 3 year disease free survival secondary end point: postoperative outcomes, morbidity and mortality, 3,5 and 7 year overall survival, quality of life, recurrence pattern study duration: 7 years(enrollment: 4year, follow-up: 3year)

Eligibility criteria:
inclusion criteria: * age 20-80 * informed consent * no other malignancies * ct2n0-ct3n2 according to jgca 2nd edition * asa score\<3 exclusion criteria: * distant metastasis(p1 or m1) under laparoscopic exploration * conglomerated n2 * early gastric cancer in permanent pathologic report
clinical and molecular description of pkd1 and pkd2 mutation negative carriers in adpkd

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Summary: the aim of this study is to identify families with adpkd , characterize the phenotype and screen for mutations in known genes (pkd1 and pkd2, and then hnf1b and umod in pkd1 pkd2 negative carriers). genome wide analysis will be performed in families without mutations identified.

* inclusion of adpkd patients in 20 different centers of nephrology in the western part of france * characterization of the phenotype * collect dna sample * analysis of pkd1 and pkd2 genes first * analysis of hnfib and umod for pkd1 and pkd2 negative patients * recruitment of affected and non-affected relatives of pkd1 and pkd2 negative adpkd patients * identify new genes involved in adpkd using exome sequencing in pkd1 and pkd2 negative pedigrees

Eligibility criteria:
inclusion criteria for the proband : * patients with a diagnosis of adpkd * written informed consent * affiliated or benefiting from a national insurance inclusion criteria of the relatives (affected or non affected) : * relatives with a diagnosis of adpkd (adpkd relatives) * and relatives over age 30 for whom the diagnosis of adpkd has been discarded (non adpkd relatives) with renal ultrasonography performed after age 30. * written informed consent * affiliated or benefiting from a national insurance exclusion criteria for the probands: * subjects unable to provide written informed consent * previous molecular analysis of pkd1 and pkd2 genes with identification of the pathogenic mutation exclusion criteria for the relatives: * subjects unable to provide written informed consent * age under 30 for the "non-affected" relatives

Keywords: autosomal dominant polycystic kidney disease (adpkd) renal cysts chronic kidney diseases genetic
a study of pegcetacoplan in pediatric patients with paroxysmal nocturnal hemoglobinuria (pnh)

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH); Paroxysmal Hemoglobinuria

Summary: the purpose of this study is to evaluate the safety, effectiveness, and biological activity (how the investigational medication is processed by the body) of pegcetacoplan in 12-17 year-olds (adolescents) who have paroxysmal nocturnal hemoglobinuria (pnh).

this is an open-label study to evaluate pegcetacoplan in people with pnh who are 12-17 years old. the study will consist of a 4-week screening period followed by a 16-week treatment period. participants switching from a c5 inhibitor will have an additional 4 week run-in period between the screening and treatment periods. at the completion of the study treatment period, participants will either enter a long-term extension period or a 2-month follow-up period. all eligible study participants will receive pegcetacoplan, administered via subcutaneous infusion twice a week at home. the subcutaneous infusion requires two small needles to be inserted into the fatty layer of tissue under the skin and the investigational medication will flow into the body. study participants and/or caregivers will be trained on home administration of pegcetacoplan.

Eligibility criteria:
inclusion criteria: * are 12-17 years old at the time of screening * weigh at least 20 kg (approx. 44 lbs) * have the diagnosis of pnh, confirmed by high-sensitivity flow cytometry (granulocyte or monocyte clone \>10%) * either: * not being treated with an approved complement inhibitor (eculizumab or ravulizumab) prior to start of pegcetacoplan dosing, and have hemolytic anemia. hemolytic anemia is defined as hemoglobin (hb) less than the lower limit of normal (hb \ 1.5 times the upper limit of normal (uln); or * currently receiving treatment with an approved complement inhibitor (eculizumab or ravulizumab) and have evidence of ongoing anemia. ongoing anemia is defined as hb \ uln * have a platelet count \>75,000/mm3 and an absolute neutrophil count \>1000/mm3 exclusion criteria: * are an adult, 18 years of age or older, with pnh * known or suspected hereditary fructose intolerance (hfi) * history of hereditary complement deficiency, bone marrow transplant, or meningococcal disease (meningitis, bacteremia or septicemia) * females who are pregnant or breastfeeding

Keywords: paroxysmal nocturnal hemoglobinuria pnh pediatric adolescent apellis anemia, hemolytic pegcetacoplan apl-2
safety and feasibility of autologous endothelial progenitor cells transplantation in patients with idiopathic pulmonary arterial hypertension

Conditions: Idiopathic Pulmonary Arterial Hypertension

Summary: recent researches indicate that impairment of vascular and endothelial homeostasis plays a major role in the initiation and development of ipah.we have recently reported the safety and feasibility data for autologous endothelial progenitor cells (epcs) injection in patients with ipah. yet many questions remain unanswered: what is the ideal quantity of epcs for therapy, the duration of the therapeutic effect, and moreover, the potential toxicity of such therapy. to help answer these questions, we designed the one year follow-up to investigate the safety and efficacy of autologous epcs injection in patients with ipah.


Eligibility criteria:
inclusion criteria: * the inclusion criteria included a base-line six minute walking distance between 100 and 450 m * a resting mean pulmonary-artery pressure greater than 30 mm hg * a pulmonarycapillary wedge pressure of less than 15 mm hg * pulmonary vascular resistance greater than 240 dyn•sec•cm-5 * 18-60 years old exclusion criteria: * the exclusion criteria included secondary pulmonary hypertension as a result of heart disease * pulmonary disease * sleep-associated disorders * chronic thromboembolic disease * autoimmune or collagen vascular disease * hiv infection * liver disease * new york heart association functional class iv * major bleeding requiring blood transfusion * diabetes * renal dysfunction * evidence for malignant diseases were excluded
pharmacokinetics of doxycycline in skin of healthy volunteers

Conditions: Rosacea

Summary: this study explored the impact of food on skin and plasma pharmacokinetics of doxycycline

sub-antimicrobial dose doxycycline is approved for the treatment of rosacea. this work investigated the pharmacokinetics of doxycycline in skin and plasma of fed and fasting healthy volunteers receiving a 14-day treatment course with once daily 40 mg doxycycline. dermal measurements were performed by means of in vivo microdialysis.

Eligibility criteria:
inclusion criteria: healthy males * healthy, according to the medical history, ecg, vital signs, laboratory results and physical examination as determined by the investigator/sub-investigator * signed written informed consent prior to inclusion in the study * 18-45 years old inclusive * bmi: 18.5 to 30 kg/m2 * sbp: 100-139 mmhg * dbp: 55-89 mmhg * pr: 55-100 bpm (measured after 5 min of rest, sitting position) * ability to comprehend the full nature and purpose of the study, including possible risks and side effects * ability to co-operate with the investigator and to comply with the requirements of the entire study * availability to volunteer for the entire study duration and willing to adhere to all protocol requirements exclusion criteria: any clinically relevant abnormalities in ecg (12 leads) * any clinically relevant abnormal physical findings * any clinically relevant abnormal laboratory values indicative of physical illness * ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drug or to tetracyclines in general * history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study * relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study * any psychiatric illnesses * presence of any skin condition that would interfere with the placement of microdialysis probes * any dermatological drug therapy on the surface of both thighs within 14 days before study day 1 of this study * use of any medication(including otc) within 1 week prior to study day 1 * use of any enzyme-modifying drugs, including strong inhibitors of cytochrome p450 (cyp) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and hiv antivirals) and strong inducers of cyp enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and st john's wort) within 1 month prior to study day 1 * participation in another clinical study investigating another imp within 1 month prior to study day 1 * blood donations within 1 month prior to study day 1 or planned within 1 month after the last study-related blood draw * history of drug or alcohol abuse (\>2 drinks/day, defined according to usda dietary guidelines 2005) * other objections to study participation in the opinion of the investigator

Keywords: pharmacokinetics microdialysis healthy volunteers
study to evaluate efficacy, safety and tolerability of hm15211(efocipegtrutide) in subjects

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: this study is a phase 2 study to evaluate efficacy, safety and tolerability of hm15211 treatment for 12 months in subjects with biopsy confirmed nash


Eligibility criteria:
inclusion criteria: * united states sites: adults ≥ 18 to ≤ 70 years. * korean sites: adults ≥ 19 to ≤ 70 years. * bmi ≥ 18 kg/m2, with stable body weight (defined as change \< 5%) by history for 3 months prior to screening or since baseline liver biopsy, whichever is earlier. * subjects have a diagnosis of noncirrhotic nash with liver fibrosis (fibrosis stage f1-f3) confirmed by liver biopsy within 6 months of day -7. * mri-pdff performed at screening with ≥ 8% steatosis. exclusion criteria: * subjects with a history of active or chronic liver disease, including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus (hiv). * any history of clinically significant chronic liver disease including esophageal varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for treatment of chronic liver disease; or model for end stage liver disease \>12. * recent (within 3 months of baseline biopsy) use of therapies associated with development of nafld (e.g., systemic corticosteroids, methotrexate, tamoxifen, aromatase inhibitors, amiodarone, or long-term use of tetracyclines). * type 1 diabetes subjects, or t2dm subjects on insulin and/or glp-1 receptor agonist therapy, or other therapies not allowed for this study
comparison of peg-intron and two different doses of ribavirin for the treatment of chronic hepatitis c in treatment naïve subjects

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to compare peg-interferon alfa-2b and two different doses of rivavirin for the treatment of chronic hepatitis c in previously untreated adult subjects

primary objective: this study will evaluate the safety and efficacy of two different peg-interferon and ribavirin regimens in patients who have not previously been treated for hepatitis c. patients have an equal chance to assignment to one of two treatment arms: treatment arm a: peg-interferon 1.5 mcg/kg2 qw + ribavirin 800 mg/day or treatment arm b: peg-interferon 1.5mcg/kg2 qw + ribavirin 800 to 1400 mg/day arm a \& arm b: duration of treatment will be 48 weeks for genotype 1 patients and 24 or 48 weeks for genotype 2 or 3 patients.

Eligibility criteria:
adult naive subjects with a diagnosis of compensated chronic hepatitis c (hcv rna+) who have not previously been treated with interferon, peg-interferon, ribavirin, or combination interferon + ribavirin are being selected for the study.

Keywords: hepatitis c chronic hepatitis c ribavirin win-r
a study evaluating the safety and efficacy of clevidipine for patients who with hypertensive emergency and sub-emergency

Conditions: Hypertensive Emergency

Summary: a multicentre, randomized, double-blind, parallel design phase iii study to evaluate the efficacy and safety of qlg2071 versus cleviprex® in the treatment of hypertensive emergency and sub-emergency

this is a multicenter, randomized, double-blind, active-compared phase iii clinical study to evaluate the efficacy and safety of clevidipine butyrate injectable emulsion in the treatment of hypertensive emergency and sub-emergency. the cleviprex® will be chosen as the positive controlled medicine with the same usage of the test drug

Eligibility criteria:
inclusion criteria: 1. age ≥18 years-old and ≤75 years-old, regardless of gender; 2. systolic blood pressure \>180 mmhg and/or diastolic blood pressure \>120 mmhg assessed on two successive occasions, 15 minutes apart at baseline； 3. able to understand informed consent, participate in the experiment voluntarily and sign informed consent. exclusion criteria: 1. patients with known severe lipid metabolism disorders; 2. patients with severe acute cardiovascular disease, such as confirmed or suspected severe aortic stenosis or aortic dissection, aortic syndrome, severe mitral stenosis, obstructive hypertrophic cardiomyopathy, acute myocardial infarction, and patients who have had an acute myocardial infarction within 1 month prior to signing the written informed consent; 3. patients with acute ischemic/hemorrhagic stroke or cerebral hemorrhage within 1 month before signing the written informed consent; 4. patients with known history of liver failure or cirrhosis and chronic kidney disease stage 5 requiring long-term regular dialysis treatment; 5. patients with clear history of secondary hypertension; 6. patients with other serious large organ damage or serious complications, it may threaten life; 7. known intolerance to test drugs or calcium channel blockers; or who are allergic to soy, soy products, eggs, and egg products, or to experimental drug excipients; 8. intravenous antihypertensive drugs have been used within 2 hours before the administration of test drugs; 9. patients who cannot tolerate intravenous infusion therapy for at least 6 hours; 10. pregnant and lactating women or patients who plan to have a family during the trial period; 11. patients who have participated in other interventional clinical trials within 3 months prior to screening;
comparing acular ls and pred forte in reducing post-selective laser trabeculoplasty anterior chamber flare and cells

Conditions: Open Angle Glaucoma

Summary: the investigators will compare, in a randomized, prospective, masked and controlled fashion the effect of a non-steroidal anti-inflammatory agent (acular ls), a corticosteroid (pred forte) and a placebo (refresh tears) on patient discomfort, degree of intraocular pressure (iop) lowering and degree of ocular inflammation following selective laser trabeculoplasty treatment for open angle glaucoma.

currently, many ophthalmologists use anti-inflammatory agents like corticosteroids and nonsteroidal anti-inflammatory agents (nsaids) as a preventative measure to control the post-selective laser trabeculoplasty (slt) anterior chamber inflammation. both classes of compounds reduce inflammation through the inhibition of the cyclooxygenase pathway, whereas the corticosteroid class also inhibits the lipoxygenase pathway of the arachidonic acid cascade. although effective, topical corticosteroids are associated with increase in intraocular pressure (iop), posterior subcapsular cataract formation, and reduced response to infection. these adverse side effects have not been reported to occur with topical nsaids, which are effective in controlling the pain after slt along with the prevention and suppression of the ocular inflammation. there are ophthalmologists who forgo using the anti-inflammatory agents post slt and prescribe refresh tears to their patients to comfort the treated eye. the significance of the study lies in assessing the efficacy of acular ls, compared to pred forte and to refresh tears in reducing discomfort, inflammation and maximizing iop lowering following slt procedure for open angle glaucoma with the hope of resolving the dispute over the effective post-operative care in slt patients.

Eligibility criteria:
inclusion criteria: * diagnosed with open angle glaucoma patients at the rocky mountain lions eye institute glaucoma clinic. * able to provide written informed consent to participate. * must be the age of 18 years of age or older. * patients in which further intraocular pressure lowering by selective laser trabeculoplasty is necessary in the opinion of the treating physician. exclusion criteria: * patients with eye surgery in the prior six months. * patients with prior or current use of topical or systemic corticosteroids or nsaids. * patients with pre-existing anterior chamber inflammation. * patients with known sensitivity to any of the study medications. * due to the age range and the disease entity, special patient populations such as children or pregnant women will not be enrolled in this study

Keywords: glaucoma selective laser trabeculoplasty anterior chamber flare
thinking zinc: a study of zinc supplements on the navajo nation

Conditions: DNA Damage; Immune System Disorder

Summary: this is a study to assess the effect of dietary zinc supplementation to mitigate biomarkers of metal toxicity in exposed tribal populations.

communities living in proximity to abandoned uranium mines have documented exposures to metals in drinking water, soil and dust. exposure to these metals, principally uranium and arsenic, and metal mixtures is associated with dysregulation of immune function and other health effects. the objective of this study is to conduct an intervention trial to assess the effect of dietary zinc supplementation to mitigate the toxicity of metal exposures. the current project is part of a larger research effort funded by the nih superfund program to study environmental metals exposures in tribal communities in new mexico.

Eligibility criteria:
inclusion criteria: * men or women between the ages of 21 and 64 years of age * lives in or near the participating communities of blue gap-tachee arizona or red water pond road community new mexico * willing to provide blood and urine samples * willing to attend study visits on scheduled dates * willing to take a daily zinc supplement exclusion criteria: * women who are pregnant or nursing or women who plan to become pregnant during the course of the study. * individuals who have self-reported diabetes, report that they are undergoing treatment for diabetes, or are currently taking medication for diabetes. * known or suspected allergy to zinc. * individuals previously diagnosed with syndromes of copper homeostasis (menkes disease or wilsons disease). * individuals consuming zinc supplements or multivitamins and are unwilling to stop for the duration of the study.