Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the effiacy and safety of hip0612 in patients with gastric ulcer

Conditions: Gastric Ulcer

Summary: a multicenter, randomized, double-blind, active-controlled, phase iii study to evaluate the efficacy and safety of hip0612 in patients with gastric ulcer.


Eligibility criteria:
inclusion criteria: * 19 years to 75 years * diagnosis of active gastric ulcers according to the sakita-miwa classification from upper gi endoscopy * patients understood the consents and purpose of this trial and signed consent form exclusion criteria: * patients who cannot perform endoscopy * finding of malignancy, duodenal ulcer, ulcer perforation, postoperative (eg, endoscopic mucosal resection, endoscopic submucosal dissection) ulcer(s), barrett's oesophagus measuring \>3cm, oesophageal dysplasia, oesophageal and/or gastric varices, bleeding disorder on upper gi endoscopy * history of definitive acid lowering surgery or pervious oesophageal or gastric surgery (except for benign tumor excisionn, simple close of perforations) * zollinger-ellison syndrome, pyloric stenosis, oesophageal motility disorder, esophageal stricture * severe hepatic disease * severe renal disease, ckd * bleeding disorder * history of malignancy or was treated for malignancy within 5 years before the start of the visit 1 * patients who have taken drugs containing following list within 2 weeks prior to upper gi endoscopy, or requirement of persistent use of drugs during the study period: acid suppressive drugs, antacids, anticholinergic drugs, gastroprotective agent * patients who have taken drugs containing following list within 1 weeks prior to upper gi endoscopy, or requirement of persistent use of drugs during the study period: antithrombotic agents, nsaids, aspirin * requirement of use of excluded medications during the study * history of allergic reaction to the medications used in this study * glucose-galactose malabsorption, fructose intolerance, sucrase-isomaltase deficiency * use of other investigational drugs within 30 days prior to the study * history of alcohol or drug abuse * positive to pregnancy test, nursing mother, intention on pregnancy * considered by investigator as not appropriate to participate in the clinical study with other reason
a study of the pharmacokinetics and safety of sm03 in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this was an open phase i trial to evaluate the pharmacokinetic, pharmacodynamic, safety and clinical activity profiles of anti-cd22 monoclonal antibody sm03 in patients with active ra.

this was an open phase i trial to evaluate the pk, pd, safety,tolerability, efficacy, and immunogenicity of sm03 in patients with ra. the total study duration was approximately 16 weeks for each participant, including a screening period of maximally 4 weeks, a multiple-dose period of 2 weeks (day 0 \~ day 14), and a post-treatment follow-up period of 10 weeks (day 15 \~ day 84).

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis (ra) for ≥ 6 months, diagnosed according to the revised 1987 american college of rheumatology (acr) criteria for the classification of rheumatoid arthritis. * moderate to severe active ra with swollen joint count (sjc) ≥ 6 (66 joint count), and tender joint count (tjc) ≥ 8 (68 joint count) at screening and baseline. * at screening, either c-reactive protein (crp) ≥ 0.6 mg/dl (6 mg/l), or erythrocyte sedimentation rate (esr) ≥ 28 mm/hour, or morning stiffness of joint for ≥ 45 minutes. * receiving methotrexate (mtx) 7.5 - 25mg/week (oral) for at least 12 weeks, at a stable dose over the past 4 weeks. exclusion criteria: * females who are pregnant, breastfeeding, or planning a pregnancy during the treatment period of and 12 months after the last infusion of study drug. * rheumatic autoimmune disease other than ra. * use of any biological dmards for ra within past 6 months. * active infection, or history of serious or chronic infection. * any significant cardiac disease, moderate to severe chronic obstructive pulmonary disease. * allergy or sensitivity to components of the drug vial or any of the materials used for infusion
ctace or deb-tace+haic combined with regorafenib ± anti-pd1 antibody for uhcc

Conditions: HCC; Transarterial Chemoembolization; Hepatic Arterial Infusion Chemotherapy; Regorafenib

Summary: explore the effectiveness and safety of conventional transarterial chemoembolization (ctace) or transarterial chemoembolization (deb-tace) plus hepatic arterial infusion chemotherapy (haic) combined with regorafenib and anti-pd-1 antibody or not for unresected hepatocellular carcinoma (uhcc)

this is a non-randomized, open, single-arm clinical study. patients receive ctace/deb-tace+haic treatment( 6-8 weeks as a cycle) and regorafenib and anti-pd1 antibody or not until the disease progresses, intolerable toxicity occurs, the patient is lost to follow-up or death, or situations other judged by researchers which treatment should be stopped.

Eligibility criteria:
inclusion criteria: 1. volunteer to participate and sign the informed consent in writing; 2. age: 18-75 years old; 3. no gender limit; 4. unresectable hepatocellular carcinoma with clear pathological diagnosis or clinical diagnosis; 5. unresectable hepatocellular carcinoma patients who failed first-line treatment (including but not limited to sorafenib, lenvatinib, atezolizumab combined with bevacizumab, etc.); 6. at least one measurable lesion (according to mrecist criteria) imaging diagnosis time ≤ 21 days from selection; 7. child-pugh grade a-b7 grade 8. the expected survival period is ≥3 months; 9. general physical condition (ecog) 0-2; 10. sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥9 g/dl, white blood cells ≥3.0×10\^9/l, neutrophils ≥1.5x 10\^9/l, platelets ≥80x 10\^9/l; liver and kidney functions are normal; (within 14 days): tbil≤1.5 times the upper limit of normal; alt and ast≤5 times the upper limit of normal; creatinine≤1.5 times the upper limit of normal; inr≤1.7 or prolonged pt≤4s. exclusion criteria: 1. those who are currently receiving other effective treatments; 2. patients who have received regorafenib in the past; 3. patients who have participated in other clinical trials within 4 weeks before enrollment; 4. unable to cooperate with ctace and haic treatment; 5. patients with primary malignant tumors other than hepatocellular carcinoma at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 6. clinically significant cardiovascular diseases, such as heart failure (nyha iii-iv), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or a history of myocardial infarction within the past 1 year; 7. neurological or mental abnormalities that affect cognitive ability, including central nervous system transfer; 8. there were active serious clinical infections (\>grade 2 nci-ctcae version 4.0), including active tuberculosis within 14 days before enrollment; 9. known or self-reported hiv infection; 10. uncontrolled systemic diseases, such as poorly controlled diabetes; 11. known to have hypersensitivity or allergic reactions to any component of the study drug; 12. pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding
digital dance for people with parkinson's disease during the covid-19 pandemic

Conditions: Parkinson Disease

Summary: dance as a treatment to support physical, cognitive and emotional functioning, has gained increased acceptance as a healthcare intervention for people with parkinson's disease (pd). the impact of the covid-19 pandemic has been far reaching with devastating effects for at-risk populations. to find alternative and safe treatment delivery options during the pandemic has been of outmost importance. this mixed-methods, feasibility study on digital for people with parkinson's disease aimed to investigate: (1) the feasibility and safety of a digital home-based dance intervention for people with pd; (2) change in self-reported quality of life, cognitive complaints, psychological health and fatigue; and (3) the experience of digital dance for people with pd. twenty-three participants partook in 10 weekly digital dance classes at home via zoom. feasibility outcomes measures were administered at post-test. pre-post changes in self-reported quality of life, cognitive complaints, psychological health and fatigue were measured, as well as the experience of digital dance via focus groups.


Eligibility criteria:
inclusion criteria: * self-reported diagnosis of parkinson's disease * participant in dance for pd at balettakademien, stockholm, sweden exclusion criteria: * none
mortality predictions with scorring indices in gastrointestinal tumours

Conditions: Gastrointestinal Tumours

Summary: the asa-ps, sort and sarcopenia scores of the patients who will undergo surgery for a gastrointestinal tumor will be recorded. thus, the correlation between preoperative indices and mortality/morbidity will be evaluated.

asa-ps values of patients who are planned to be operated due to gastrointestinal tumor will be recorded, then sort (the surgical outcome risk tool) values will be calculated from sortsurgery.com. sarcopenia measurements will be made by the radiologist from the abdomen ct at the l-3 level. the pathology results of the patients will be recorded. morbidity and mortality rates will be recorded in the short and long term.

Eligibility criteria:
inclusion criteria: * \>18 years of age * operation for gastrointestinal tumors exclusion criteria: * patient rejection

Keywords: asa-ps sort sarcopenia mortality morbidity
non-invasive differential diagnosis of noisy breathing infants and toddlers

Conditions: Noisy Breathing Infants; Noist Breathing Toddlers; Wheezing; Rattling

Summary: almost 50% of all children have at least 1 episode of noisy breathing before the age of 2 years and almost 25% of these children have more episodes of noisy breathing. the lack of an objective technique for diagnosing noisy breathing children often leads to overrated diagnosis of "wheezing", whereas there may be other noisy breathing phenotypes, like "rattling", that don't favor from the same therapeutic treatment. presumably, different underlying pathophysiological mechanisms are involved with different biomarker profiles characteristic for different phenotypes. the goal of this study is to optimize the diagnosis of noisy breathing infants and toddlers. children will be followed for a treatment period of 6 weeks and will visit the paediatrician 3 times (week 0, 3 and 6). during the consultations breath sound analysis will be performed and a breath sample and a nasal mucus will be collected to analyse biomarker profiles. both methods for diagnosing noisy breathing infants are non-invasive and will be compared to the standard procedure of the paediatrician which consists of auscultation and palpation of the chest. an objective and non-invasive method for diagnosing noisy breathing infants and toddler will pave the way for more cost-effective and personalized prescription of therapies which will increase the quality of life of children with noisy breathing.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of noisy breathing ("wheezing" or "rattling") exclusion criteria: * born before pregnancy week 37 * congenital or genetic conditions (down syndrome, klinefelter's syndrome, ...) * acquired chronic respiratory diseases (bronchopulmonary dysplasy, lung fibrosis, ...)
effect of fiber supplementation in children with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: high fiber foods are recommended as a preferential source of carbohydrate by the nutrition study group of the european association for the study of diabetes. dietary fibers may delay glucose absorption and reduce postprandial glycemic excursion. they also appear to have a beneficial effect on cholesterol levels. it has been shown, in few short term adult studies, that high fiber foods reduce postprandial blood glucose levels. the american diabetes association feels that there is little evidence confirming the positive effect of high fiber foods on blood glucose control. it is not clear whether a high fiber diet can improve glycemic control and/or reduce the risk of hypoglycemic events. our hypothesis is that children with type 1 diabetes will benefit from having added fibers in their diet. the investigators plan to study blood glucose values using a continuous blood glucose monitor before and after dietary fibers are introduced. this will help us determine whether a diet rich in fiber should be recommended in all children with type 1 diabetes mellitus


Eligibility criteria:
inclusion criteria: * the inclusion criteria are: diagnosis of type i diabetes for at least two years prior to enrollment, the ability tolerate wearing the continuous blood glucose monitoring device for a total of 6 days, and the ability to follow a prescribed meal plan. exclusion criteria: * the exclusion criteria are: medical conditions that could potentially affect the absorption of nutrients such as celiac disease of inflammatory bowel disease and the use of any fiber supplements at home.
study of hemostasis in case of severe covid-19

Conditions: COVID-19 Infection

Summary: the covid-19 outbreak has led to a significant increase in the number of patients admitted to intensive care for respiratory distress. early data indicate a particularly high risk of thrombotic risk to viral lung disease, particularly in the most severe patients, with a particularly high incidence of pulmonary embolism. catheter thrombosis and extra-renal purification filters are also abnormally common. these thrombotic complications could contribute to the mortality observed in this pathology. the introduction of early curative anticoagulation in the most severe patients has just been proposed by the perioperative hemostasis interest group biologically, a significant proportion of patients hospitalized in intensive care have a marked biological inflammatory syndrome, associated with signs of activation of clotting (a frank increase in d-dimers). the presence of circulating anticoagulants is common. interestingly, thrombocytosis, normally observed in such inflammatory syndromes, is absent. in this context, it seems legitimate to explore these patients from a hemostasis perspective to identify the factors that cause this thrombotic over-risk, in order to minimize the occurrence of these complications.


Eligibility criteria:
inclusion criteria: * adult patient (\<18y) * with a sars-cov-2 infection confirmed by rt-pcr * hospitalized in intensive care exclusion criteria: * patients under guardianship/curator * anemia at 7 g/dl at inclusion
study on incidence of diabetic ketoacidosis among participants with type 2 diabetes mellitus treated with sodium-glucose co-transporter 2 (sglt2) inhibitors or other antihyperglycemic agents

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to compare the incidence of diabetic ketoacidosis (dka) among participants diagnosed with type 2 diabetes mellitus (t2dm) and pair-matched on exposure propensity scores for new use of any sodium-glucose co-transporter 2 inhibitors (sglt2i) versus new use of various other antihyperglycemic agents (ahas), combined as one group.

this study will be an overall retrospective, observational, new-user cohort study using 4 large administrative claims databases in the us. participants diagnosed with t2dm and initiated on sglt2i or other ahas (metformin, sulfonylureas (su), thiazolidinediones (tzds), dpp-4 inhibitors (dpp4i), glp-1 agonists, insulin, and other ahas) between april 1, 2013 and the end of claims data availability will be included in the study and will be estimated for incidence rates of dka in the different aha new-user groups.

Eligibility criteria:
inclusion criteria: * at least 1 antihyperglycemic agents (aha) prescription (rx) during the study period, between 4/1/2013 and 9/30/2014. * diagnosed of type 2 diabetes mellitus * enrollment history of at least 12 months * having prescription drug coverage * having no prescription of the index drug during the 6 months prior exclusion criteria: - participants who receive diagnosis of type1 diabetes mellitus (t1dm) and/or secondary diabetes mellitus (sdm) any time after index date.

Keywords: sodium-glucose co-transporter 2 inhibitors diabetes mellitus, type 2
lay health worker expanded intervention in community oncology practices

Conditions: End of Life; Cancer

Summary: undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. previously a lay health worker (lhw)-led symptom screening intervention was developed for patients with cancer. in pilot work, the intervention was associated with improvements in patient symptom burden and reductions in healthcare use and costs of care at the end of life. this intervention will be expanded across several clinics to evaluate the impact of the lhw intervention on with cancer and the lhw will be trained to refer patients to palliative care. this randomized intervention will evaluate the effect on healthcare use, total costs, palliative care and hospice referral.

all patients with newly diagnosed cancer, over the age of 75 will be randomized into the caremore pilot 2 program with 200 randomized to the intervention grou and 200 randomized to the control group.

Eligibility criteria:
inclusion criteria: * newly diagnosed or relapsed cancer diagnosis. * 75 years or older * diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician. * must have capacity to verbally consent exclusion criteria: * inability to consent to the study due to lack of capacity as documented by the referring physician.

Keywords: cancer end of life patient-centered
anca ii - quality of life and functional outcome in patients with anal cancer

Conditions: Anal Cancer

Summary: anal cancer is a rare disease, but the incidence is rising. about 200 patients will get this type of cancer yearly in sweden. curative treatment includes chemotherapy and radiotherapy. the prognosis is good, but some patients will have recurrent or persistent disease after concluded chemo-radiotherapy and will then be offered salvage surgery. some patients develop distant metastases that can be treated with good results. the aim of this study is to identify and describe functional outcome in patients diagnosed with anal cancer. we will study patients from diagnosis, try to identify early toxicity to treatment and then identify long-term morbidity.


Eligibility criteria:
inclusion criteria: * age \> 18 years * anal squamous carcinoma diagnosed within the last 2 months exclusion criteria: -no informed consent
prognostic value of prothrombin fragments 1+2 for pulmonary embolism incidence

Conditions: Pulmonary Disease, Chronic Obstructive; Disease Exacerbation; Pulmonary Embolism; Prothrombin Fragments

Summary: to determine the possible association of prothrombin fragments 1+2 elevation with incidents of pulmonary embolism in patients with copd exacerbation.


Eligibility criteria:
inclusion criteria: * copd exacerbation * able to give informed consent * able to perform spirometry exclusion criteria: * known malignancy * known hypercoagulable state * receiving anticoagulant treatment * pregnancy * renal failure * allergy to iodine
treatment of pregnant women with oud

Conditions: Opioid-use Disorder

Summary: the investigators are testing two models of support for pregnant women with an opioid use disorder (oud)

the investigators are proposing a cluster randomized clinical trial to compare the effectiveness of two models of support for reproductive health clinicians to provide care for pregnant and postpartum women with an oud: 1) a collaborative care (cc) approach based upon the massachusetts office-based-opioid treatment (obot) model that would provide onsite training, and support to providers and participants through the use of care managers (cms) vs 2) a telesupport approach modeled on the project extension for community healthcare outcomes (echo), a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * females age 18 or older * documented pregnancy in the medical record at less than 34 weeks gestation * delivery date no later than july 1, 2024 * willingness to adhere to the study schedule * confirmed opioid use disorder by the dsm-5 opioid use disorder questionnaire * ability to communicate in english * no current plan to move out of the obstetrical provider treatment area within the study timeframe of approximately 44 weeks exclusion criteria: * experiencing cognitive or emotional impairment that precludes the participant from providing informed consent * current hospitalization, incarceration, or institutionalization (if women present for care after institutionalization, participation is possible * current court case pending that would make incarceration likely during the study treatment period (approximately 44 weeks)

Keywords: opioid pregnant
prescreening protocol to enroll in food allergy clinical studies at a single site

Conditions: Food Allergy

Summary: this is a protocol for prescreening of participants who would like to be in clinical studies in our center at stanford.


Eligibility criteria:
inclusion criteria: * any individual with possible food allergy (as per their clinical history) who is interested in performing the gold standard food challenge for diagnosis. exclusion criteria: * any individual who does not consent * any individual who is currently taking oral steroids * any individual with moderate to severe asthma (fev1\<80%)
egyptian hypertrophic cardiomyopathy program

Conditions: Hypertrophic Cardiomyopathy

Summary: egyptian hcm program aims at defining incidence, severity, phenotype, genotype and determinants of the disease in egypt, and providing state-of-the-art treatment strategies including medical, surgical and interventional procedures which are patient- and disease-specific.

this project aims to: * define incidence, severity, phenotype, genotype and determinants of the disease in egypt. * characterise the phenotype and genotype of several large cohorts with inherited muscle disease and their relatives. * provide state-of-the-art treatment strategies including medical, surgical and interventional procedures which are patient- and disease-specific. * study the basic mechanisms responsible for the different phenotypes at a molecular and cellular level including genotype-phenotype correlation. * provide a special focus for studying patients who are genotype positive and phenotype negative which we believe could yield critical data regarding the evolution of the disease. * develop sophisticated laboratory studies for single cell electrophysiology and immunocytochemistry and others focusing on the explanted human material from the surgical program. * define the role of microvascular coronary artery in the development and progression of the disease. * training egyptian cardiologists, cardiac surgeons and scientists on state-of-the-art diagnosis and management of heart muscle disease including the latest developments in imaging, novel surgical techniques, coronary physiology, next generation sequencing, bioinformatics and cellular electrophysiology.

Eligibility criteria:
inclusion criteria: * all patients diagnosed with hypertrophic cardiomyopathy (index patients) who are willing and consented to participate in the registry. * all family members of index patients who are willing and consented to participate in the registry. exclusion criteria: * refusal to consent to participate in the registry program.

Keywords: hcm hocm hypertrophic cardiomyopathy familial hypertrophic cardiomyopathy hypertrophic cardiomyopathy with genetic marker hypertrophic obstructive cardiomyopathy