Kornimate/medical-research-clean huggingface dataset:
comparing two doses of iv esomeprazole after successful endoscopic therapy

Conditions: Peptic Ulcer Bleeding

Summary: the investigators used two different doses of esomeprazole (40 mg iv q.d. and 40 mg iv q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement. the goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.

a bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients receiving intravenous proton pump inhibitor (ppi）and is now recommended as the first hemostatic modality for these patients. in the past few years, adjuvant use of a high-dose proton pump inhibitor (ppi) after endoscopic therapy has been endorsed in some studies, including two consensus statements and two meta-analysis. to sustain a high intragastric ph, a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding. however, in one recent published metaanalysis found that low dose ppi may be as effective as high dose ppi in preventing further bleeding in high-risk patients. therefore, one double blind study is needed clarify this puzzle. we used two different doses of esomeprazole (40 mg iv q.d. and 40 mg iv q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement. the goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.

Eligibility criteria:
inclusion criteria: * patients with peptic ulcer bleeding with active bleeding or nonbleeding visible (initial hb\<10, shock, or coffee grounds or blood in stomach) exclusion criteria: * age \>90y/o * pregnant woman * allergic to esomeprazole * unwilling to enter this study * bleeding tendency * severe co-morbid illness, including cancer, hepatic failure, renal failure,

Keywords: hemostasis heat probe hemoclip rebleeding
perception of intonation by bimodal and bilateral cochlear implant users

Conditions: Hearing Loss

Summary: the purpose of this study is to evaluate the benefit of bimodal hearing and bilateral cochlear implant hearing in comparison to unilateral cochlear implant hearing in the perception of speech intonation.

bilateral hearing which is a fundamental characteristic of normal auditory system provides significant advantages in adverse listening conditions. in cochlear implant users, binaural hearing can be achieved via bilateral cochlear implant (ci/ci) or binaural-bimodal stimulation, i.e. a cochlear implant in one ear and a hearing aid in the other (ci/ha). it is assumed that ci/ci hearing and ci/ha hearing differ with respect to their physiological sources and functional benefit. although both hearing prosthesis (ci/ci or ci/ha) lack several of the features needed to allow listeners to experience the full binaural advantage conferred by a normal-hearing auditory system it can, however, provide significant advantages over the use of a unilateral hearing prosthesis. most of the accepted assessment clinical materials are not sensitive enough to evaluate the contribution of binaural hearing rehabilitation via ci/ci or ci/ha hearing for the perception of intonation. in a previous study the perception of intonation was evaluated in 29 adults ci/ha users via a closed-set format design with the same target talker. the results of the study showed small bimodal benefit. the test paradigm was apparently an easy task for the adult listeners and not sensitive enough to show the expected ci/ha bimodal benefit over cochlear implant alone. the perception of correct intonation identification will be computed for each listener in each of the listening conditions. the amount of change in the fundamental frequency that was required in order to identify a question will be computed for each listener in each of the conditions. anova with repeated measures will be used to assess the differences among the conditions for each group as well as the differences among the groups.

Eligibility criteria:
inclusion criteria: * bilateral cochlear implant users * bilateral-bimodal users who use hearing aids for at least 75% of their waking hours. exclusion criteria: -
adherence/outcomes after use of constipation action plan

Conditions: Constipation - Functional

Summary: adherence to recommendations for treatment of chronic constipation in pediatric population is often poor. this study is attempting to improve adherence, and outcomes, by implementing a trial of a constipation action plan plus standard of care, compared to standard of care alone, in an outpatient pediatric population.

functional constipation is a common childhood problem. the goal of this study is to evaluate if a constipation action plan had any impact on improved adherence in management. children are eligible to participate in the study if they are otherwise healthy children whose primary language is english with no conditions that would predispose them to develop constipation, between the ages of 3 and 8 years of age and if they meet the rome iv criteria for functional constipation. the primary objective is to assess compliance in pediatric patients with functional constipation that have been provided a constipation action plan plus educational information. the secondary objectives are to assess improvement of constipation symptoms in pediatric patients with functional constipation that have been provided a constipation action plan and educational information and to assess the perceived effectiveness of the constipation action plan from the viewpoint of the family. the proposed study hypothesizes that patients diagnosed with functional constipation will have improved adherence to medication treatment plan, to fiber intake, and to toilet sit time and have improved constipation symptoms overall when provided with both a constipation action plan and educational information regarding dietary changes, toilet sit time, and medications as compared to education information alone.

Eligibility criteria:
inclusion criteria: * healthy * history of functional constipation * english as primary language exclusion criteria: * history of medical conditions pre-disposing to constipation * english as a second language * chronic gastrointestinal disease

Keywords: action plan adherence pediatrics
induction preoperative chemotherapy for patients with locally advanced triple negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: the purpose of this study is to increase survival of patients with locally advanced triple-negative breast cancer using two consequent induction preoperative chemotherapy regimens.

compared to other breast cancer subtypes, patients with triple-negative breast cancer have a lower recurrence-free and overall survival, regardless of disease stage at diagnosis. that's why new approaches to treatment of this aggressive breast cancer subtype are extremely anticipated. one of the ways to improve the results of treatment of locally advanced triple-negative breast cancer is intensification of induction preoperative chemotherapy regimens. elevation of the rate of pathological complete responses after completion of intensification induction preoperative chemotherapy enables to decrease the stage and increase survival of this aggressive breast cancer subtype. we hope to achieve more clinical and pathological treatment responses than with standard chemotherapy regimens and therefore to improve treatment outcomes of this extremely adverse group of patients.

Eligibility criteria:
inclusion criteria: * female patients, age ≥18 years≤75 * histologically confirmed invasive er-, pr-, and her2-negative (triple-negative) adenocarcinoma of the breast * stages т2-4 n 2-3 m0 * signed inform consent exclusion criteria: * previous treatment for this breast cancer * history of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease * pregnancy or breast-feeding * serious concurrent diseases or conditions that may alter chemotherapy conduction
multicenter myocardial viability trial

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to test the hypothesis of whether contrast enhanced magnetic resonance imaging can be used to predict improvement of the wall motion in regions of the heart with abnormal movement following bypass surgery or percutaneous angioplasty in various institutions across three continents.


Eligibility criteria:
inclusion criteria: * age: \> 21 years and \< 85 years * sinus rhythm * weight \< 120 kg * lvef \> 30% * wall motion abnormality on echo. or lv-gram * scheduled for revascularization - angioplasty/stent or cabg - within 30 days exclusion criteria: * resting heart rate \> 100 bpm * frequent atrial or ventricular ectopy * severe aortic stenosis or hocm * unstable angina * myocardial infarction within 14 days * active congestive heart failure * pregnancy * known allergy to gadolinium * contraindication to mri

Keywords: myocardial viability delayed enhancement magnetic resonance imaging functional recovery
more fresh fruit and vegetable prescription program for families with type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: rady children's hospital san diego (rchsd), ucsd division of child and community health and the center for community health, and northgate gonzalez (ng) markets will collaborate to create a produce prescription program (fruit and vegetable prescription program) to be implemented in the rchsd diabetes clinic. we will provide families on medi-cal who have a child with t2dm with a fruit and vegetable prescription (fvrx) which will enhance their ability to purchase gusnip-eligible fresh fruits and vegetables (fv). these prescriptions will be delivered in the form of an electronic voucher that can be filled at any ng markets throughout san diego and riverside counties. the goal of this program is to increase the purchase and consumption of fresh fruits and vegetables, decrease food insecurity, and improve metabolic outcomes for children with type 2 diabetes mellitus (t2dm).

participants upon enrollment will be randomized into two groups, either to immediately receive nutrition incentive vouchers for 12 months (intervention group) or to receive nutrition incentive vouchers for 12 months after a 6-month delay (delayed-intervention group). to evaluate the implementation and outcomes of this program, we will collect fruit and vegetable prescription (fvrx) voucher data in addition to standardized laboratory studies, (hemoglobin a1c (hba1c), total cholesterol, hdl cholesterol and liver function tests (lfts)) and physiologic assessments (height, weight) at the child's follow-up appointments through the diabetes clinic. these markers will be evaluated at baseline, 6-, 12- and 18-months. additionally, we will ask participants to complete online or phone surveys including the dietary screener questionnaire (dsq) for youth and parents and the 18-item us household food security survey module every 6 months.

Eligibility criteria:
inclusion criteria: * age \< 18 years old * diagnosis of type 2 diabetes mellitus * hemoglobin a1c greater than or equal to 6.5 * receiving care at the rady children's hospital diabetes clinic exclusion criteria: * another immediate family member living in the same household who is already recruited into the study
teledermatology versus usual care on delay before diagnosis and treatment of dermatologic conditions

Conditions: Dermatologic Conditions

Summary: in france, there is usually a long delay (approximately 6 weeks) before a general practitioner can obtain a specialized advice by dermatologists for diagnosis of "unusual" dermatologic conditions of their patients. previous studies have shown that teledermatology is a reliable way for diagnosis in dermatology. we hypothesize that a teledermatology advice could reduce delay before diagnosis and therefore treatment for patients.

in france, there is usually a long delay (approximately 6 weeks) before a general practitioner can obtain a specialized advice by dermatologists for diagnosis of "unusual" dermatologic conditions of their patients. previous studies have shown that teledermatology is a reliable way for diagnosis in dermatology. we hypothesize that a teledermatology advice could reduce delay before diagnosis and therefore treatment for patients.

Eligibility criteria:
inclusion criteria: * consultation with a general practitioner for any motive during which, the general practitioner deems necessary to obtain a dermatologic expertise for a skin lesion (for diagnosis or treatment) exclusion criteria: * emergency, assessed by the general practitioner (needs care or quick telephonic advice in the next 24 hours) * patients for which diagnosis and/or treatment are known by the general practitioner (the gp needs a dermatologic advice for a specific treatment (for example= laser, instrumental treatment...)) * patient cannot go the dermatologic consultation by himself (for example: dependant patients...) * cognitive or psychiatric impairment (cannot give informed consent)

Keywords: teledermatology dermatology general practice organization of care
lentiviral fviii gene therapy

Conditions: Hemophilia A

Summary: this study is a phase i trial using an advanced lentiviral vector to deliver a functional gene for human clotting factor viii into patients with hemophilia a, to evaluate the safety and efficacy of infusion of lentiviral gene modified autologous stem cells in patients.

hemophilia a is a genetic bleeding disorder caused by the lack of ability to produce blood-clotting factor viii (fviii). individuals with hemophilia a suffer repeated bleeding episodes, which can cause chronic joint disease and sometimes even death due to the inability for blood to clot efficiently. the current treatment is intravenous infusion of clotting factor concentrates, either prophylactically or in response to bleeding. the procedure is life time long and expensive while still cannot achieve a cure.gene therapy is a novel technology that has been successfully demonstrated in a number of clinical studies for diseases such as cancer and genetic diseases. in this study, an advanced lentiviral vector system nhp/tyf will be used to deliver a functional fviii gene to overcome human clotting fviii gene defect in patients with hemophilia a. this study is a phase i trial evaluating the safety and efficacy for infusion of gene modified autologous stem cells in patients with hemophilia a.

Eligibility criteria:
inclusion criteria: 1. able to provide informed consent and comply with requirements of the study. 2. males ≥2 years with confirmed diagnosis of hemophilia a (endogenous factor viii ≤2 iu/dl or ≤2% of normal). 3. a minimum average of 4 bleeding events per year requiring episodic treatment of factor viii infusions or prophylactic factor viii infusions. 4. no measurable factor viii inhibitor as assessed by the central laboratory and have no prior history of inhibitors to factor viii protein. 5. agree to use reliable barrier contraception until 3 consecutive samples are negative for vector sequences. exclusion criteria: 1. significant liver dysfunction as defined by abnormal alanine transaminase, bilirubin and alkaline phosphatase. 2. history of inhibitor against factor viii. 3. evidence of active hepatitis b or c and currently on antiviral therapy. 4. have serological evidence of hiv-1 or hiv-2 with cd4 counts ≤200/mm3 (subjects who are hiv+ and stable with cd4 count \>200/mm3 and undetectable viral load are eligible to enroll). 5. any evidence of active infection or any immunosuppressive disorder. 6. participated in a gene transfer trial within the last 6 months or in a clinical trial with an investigational drug within the last 12 weeks. 7. unable or unwilling to comply with study assessments.

Keywords: hemophilia a factor viii gene therapy lentiviral vector
in-tandem familial hypercholesterolemia pilot study

Conditions: Familial Hypercholesterolemia

Summary: the purpose of this study is to validate the use of the fh foundation find fh® algorithm as a clinical decision support tool. find fh (flag/identify/network/engage) is a national initiative that utilizes machine learning and data mining techniques to identify individuals whose profiles are consistent with fh patients. the algorithm will be tested in adults with at least one cardiovascular comorbidity. study subjects will be asked to provide either a saliva, buccal or venous blood sample for dna and biomarker analysis


Eligibility criteria:
inclusion criteria: * age 18 years or older * at least one cardiovascular co-morbidity or receiving treatment for a cardiovascular comorbidity * algorithm score 0-1 * most recent encounter with a provider within five years of query date exclusion criteria: * any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, or confound study data
novel prediction score for postoperative acute renal failure (arf) following liver resection

Conditions: Acute Renal Failure

Summary: arf is a frequent event after hepatic resection and therefore clinically highly relevant. there is limited evidence on the incidence of postoperative arf and its clinical relevance in patients undergoing liver resection. this study will evaluate the incidence of acute renal failure (arf) after liver resection and its impact on postoperative mortality.

arf is a frequent event after hepatic resection and therefore clinically highly relevant. there is limited evidence on the incidence of postoperative arf and its clinical relevance in patients undergoing liver resection. this study will evaluate the incidence of acute renal failure (arf) after liver resection and its impact on postoperative mortality.

Eligibility criteria:
inclusion criteria: * patient age \>/= 18 years * benign and malign liver diseases exclusion criteria: * trauma cases

Keywords: evaluation incidence liver surgery resection impact postoperative mortality
a phase ii study of codox-m/ ivac in relapsed/refractory all

Conditions: Acute Lymphoblastic Leukemia

Summary: a phase ii study of codox-m/ ivac in relapsed/refractory all

the feasibility will be evaluated in terms of complete remission rate, duration of complete remission, disease-free survival, overall survival, and toxicities.

Eligibility criteria:
inclusion criteria: * patients with relapsed/resistant acute lymphoblastic leukemia * patients must be between 15 and 65 years of age. * estimated life expectancy of more than 3 months * ecog performance status of 2 or lower, karnofsky scale \> 60 (see appendix i) * adequate cardiac function (ef\>45%) on echocardiogram or muga scan * adequate kidney function (estimated ccr \>50 ml/min) exclusion criteria: * patients with cns involvement of leukemic blasts will not be excluded. * patients with extramedullary relapse(s) only will be excluded.
laser treatment of bladder tumors in the outpatient department

Conditions: Bladder Tumors

Summary: * primary objective: to show that small pta bladder tumors can be removed with diode laser in an outpatient department. * secondary objective: to evaluate the patients' symptoms during and after the laser turbt. * tertiary objective: to evaluate the rate of remnant tumor tissue one month after the laser turbt.

the patients will have a pdd guided flexible cystoscopy performed and the bladder tumor will be removed by a diode laser (400μm fiber, 6-12w, laser pulse 1ms and intervals of1ms).the treatment will take place in the opd in awaken patients. one hour prior to the treatment the patient will have hexvix® (photodynamic substance) and lidocaine 20 ml (pain treatment) installed in the bladder. simultaneous pain treatment will be oral paracetamol 1 g and ibuprofen 600 mg. biopsy from the tumor will be taken to confirm the histological diagnosis. immediately after the procedure the pain assessed by the vas score will be recorded and the patients are given a qol questionnaire (eortc qlq-bls24) and a stamped envelope and are asked to return it one week later. the patients will be telephoned after 5 days to remind on the questionnaire and to ash, whether they has had a urinary infection after the procedure. one month after the laser turbt a flexible ppd and spies guided cystoscopy is performed in the opd to evaluate the laser efficacy. to confirm that all tumour tissue has been removed a biopsy will be taken from the previous tumor place. the biopsy will be send to the pathologist according to the normal procedure for biopsies. visual presentation of the laser treated area will be visualized using pdd and spies.

Eligibility criteria:
inclusion criteria: * recurrence of pta low grade urothelial bladder tumor * tumor \< 1.5 cm * \< 6 tumors exclusion criteria: * patients with porphyria * known hypersensitivity to hexvix® or porfhyrins * use of any anticoagulantia * macroscopic hematuria * pregnant or breast feeding women * expected poor compliance * patients \< 18 years * patients who do not read or understand danish
68ga-p16-093 and 68ga-psma-11 pet/ct imaging in the same group of primary prostate cancer patients

Conditions: Prostate Cancer

Summary: prostate-specific membrane antigen (psma)-targeted pet imaging with 68ga-labeled compounds is able to provide superior sensitivity and specificity to detect primary prostate tumor and its metastases, like the most widely studied 68ga-psma-11. this pilot study was evaluate the diagnostic performance of 68ga-p16-093, a novel radiopharmaceutical targeting psma, which was compared with 68ga-psma-11 in the same group of primary prostate cancer patients.

prostate cancer (pc) is one of the most common malignancies worldwide in men, with persistently high numbers dying from this disease. due to low levels of glycolysis in prostate cancer cell, the uses of 18f-fdg pet/ct to detect prostate cancer and its metastases are limited. prostate specific membrane antigen (psma), as known as folate hydrolase i or glutamate carboxypeptidase ii, is overexpressed on the cells of prostatic adenocarcinoma. various low molecular weight radiopharmaceuticals targeting psma such as psma-11, psma-617 for 68ga-labeling have been developed. 68ga-psma pet/ct has demonstrated desirable sensitivity and specificity in the detection of prostate cancer lesions, which can find many micro lesions that cannot be identified by ct, mri and bone scan. 68ga-p16-093, a novel radiopharmaceutical modified based on 68ga-psma-11, with the urea fragment of a conjugate that employs the hbed-cc chelator for labeling with 68ga(iii). the hbed-based chelating ligand binds the 68ga3+ ion with high affinity in a pseudo-octahedral n2o4 coordination sphere by its two phenolate o, two amino-acetate carboxylate o, and two amino n donor atoms. this pilot study was prospectively designed to evaluate the diagnostic performance of 68ga-p16-093 compared with 68ga-psma-11 in the same group of primary prostate cancer patients.

Eligibility criteria:
inclusion criteria: * histologically confirmed untreated primary prostate cancer patients; * 68ga-psma-11 and 68ga-p16-093 pet/ct within a week; * signed written consent. exclusion criteria: * known allergy against psma; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.