Kornimate/medical-research-clean huggingface dataset:
efficacy, safety study and benefit of alkali therapy in sickle cell disease

Conditions: Sickle Cell Anemia; Chronic Kidney Disease; Metabolic Acidosis

Summary: the objective of this study is to assess the effect of alkali administration on bicarbonate and potassium levels in patients with sickle cell disease (scd) and depressed serum bicarbonate levels. the study is a prospective non-blinded evaluation of tolerability and efficacy of alkali repletion with 4 weeks of observation and two sequential 4 week courses of escalating oral sodium bicarbonate treatment.

primary objective: to assess the effect of alkali administration on bicarbonate and potassium levels in patients with scd and depressed serum bicarbonate levels. secondary objectives: to assess the effect of alkali administration on improvement in hemolysis and on sequelae of impaired kidney function, ie, ldh, hgb, reticulocyte count, red cell half-life, and muscle strength, vitamin d levels, and markers of bone turnover, respectively. to assess the influence of alkali administrations on markers of kidney tubule inflammation. to evaluate intraparenchymal iron in patients with scd and renal dysfunction. safety and adverse events of alkali patients with sickle cell disease will be monitored. this research will supplement current knowledge about management of the clinically important subset of people with scd who have renal insufficiency and acid-base perturbation.

Eligibility criteria:
inclusion criteria: * sickle cell disease patients with hbss * egfr \ 30mg/g. * age ≥18 years exclusion criteria: * previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda) * bicarbonate level \>25 meq/l * decompensated heart failure * uncontrolled systolic blood pressure \>140 mm/hg (the cutoff for systolic hypertension in scd is lower than in non-scd) * moderate-to-severe lower extremity edema * projected progression to esrd within 6 months * kidney transplantation * treatment with immunosuppressives within the last 3 months * vasoocclusive (voc) within 1 week of study entry * active (open) leg ulcer * change in hydroxyurea dose within the last 3 months, unless a self-limited interruption of a stable dose * blood transfusion within 8 weeks, unless on chronic transfusions * pregnancy * inability to give informed consent

Keywords: sickle cell disease chronic kidney disease bicarbonate therapy
morbidity and mortality in patients with hypertrophic cardiomyopathy: a caliber study

Conditions: Hypertrophic Cardiomyopathy

Summary: the aim of this project is to study the association of a number of demographic and cardiovascular risk factors with death, health care utilisation and systemic embolisation by examining the clinical evolution of hypertrophic cardiomyopathy in a large, community based cohort identified from linked electronic health records.

most data on hypertrophic cardiomyopathy related morbidity and mortality are derived primarily from longitudinal, observational studies based at tertiary cardiac centres. it is unclear what the main causes of morbidity and death are in the general hypertropic cardiomyopathy population (outside tertiary referral centres) and it is likely that many patients have a benign clinical course and die from non-cardiac causes. linkage of the clinical practice research datalink (cprd) to the myocardial ischaemia national audit project (minap), hospital episode statistics (hes) and office of national statistics (ons), offers the opportunities to study the natural history of hypertrophic cardiomyopathy, from the time of diagnosis to the end of life, health care utilisation and to investigate the association between clinical characteristics and common clinical fatal and non-fatal outcomes.

Eligibility criteria:
inclusion criteria: * one year or more of follow-up in the practice prior to study entry * 18 years or older exclusion criteria: • unknown sex and age

Keywords: morbidity mortality health care utilization cohort epidemiology cardiovascular diseases
combination chemotherapy plus peripheral stem cell transplantation in treating patients with small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have small cell lung cancer.

objectives: i. determine the feasibility of the administration of intensive chemotherapy with ifosfamide, carboplatin, and etoposide followed by peripheral blood stem cell support in patients with small cell lung cancer. ii. determine the rate and duration of response in these patients after this treatment. iii. determine the progression free and overall survival of these patients. outline: this is an open label, multicenter study. patients receive 4 courses of intensive chemotherapy consisting of ifosfamide iv over 24 hours and carboplatin iv over 1 hour on day 1 and etoposide iv over 1 hour on days 1 and 2. filgrastim (g-csf) is administered subcutaneously beginning on day 2 and continuing until blood cell counts recover. courses repeat every 14 days. peripheral blood stem cells (pbsc) are collected after course 1. pbsc are reinfused on day 3 of courses 2 and 3. patients who experience a complete response receive prophylactic cerebral irradiation on day 71. patients are followed every 2 months for 5 years. projected accrual: a total of 36 patients will be accrued for this study within 18 months.

Eligibility criteria:
disease characteristics: histologically proven small cell lung cancer good prognosis on the manchester scale, with no more than 2 of the following high risk factors: karnofsky less than 60% hyponatremia (low sodium) alkaline phosphatase at least 1.5 times upper limit of normal (uln) ldh greater than uln no symptomatic cns metastases requiring corticosteroids patient characteristics: age: 18 to 60 performance status: see disease characteristics life expectancy: not specified hematopoietic: neutrophil count at least 2,000/mm3 platelet count at least 125,000/mm3 hepatic: see disease characteristics bilirubin less than 1.25 times upper limit of normal (uln) sgot/sgpt less than 1.25 times uln renal: creatinine less than uln cardiovascular: lvef at least 50% no myocardial infarction within 5 years no uncontrolled cardiac disease pulmonary: no severe chronic obstructive pulmonary disease other: no neurological symptoms greater than grade 2 no severe psychoses no other concurrent medical problems no active infection hiv negative no allergy to e. coli derived products no prior malignancy within 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or lung or respiratory cancer in remission not pregnant or nursing prior concurrent therapy: see disease characteristics no prior antineoplastic therapy

Keywords: extensive stage small cell lung cancer
interscalene block with low-dose iv vs. perineural dexamethasone for shoulder arthroscopy

Conditions: Pain; Shoulder Arthroscopy

Summary: many patients undergoing ambulatory shoulder arthroscopy experience moderate to severe pain after surgery. finding ways to minimize postoperative pain are ideal. dexamethasone is a corticosteroid that is commonly used to prevent and/or treat nausea and inflammation. the addition of higher doses of dexamethasone to nerve blocks, which are injections of local anesthetics into the upper shoulder area, has been shown to prolong block duration and reduce pain. however, it is unclear whether the advantage of longer pain relief outweighs patient dissatisfaction with the prolonged feeling of a numb arm. furthermore, recent studies have shown that systemic, intravenously administered dexamethasone may similarly reduce pain levels when compared with dexamethasone in the block. in our study, the investigators propose to examine the effect of low-dose iv versus block dexamethasone on interscalene block duration in patients undergoing shoulder arthroscopy. most studies have used 4 mg or more. one study suggests that 1 mg may have the same effect as larger doses. our aims are to determine whether the addition of low-dose dexamethasone to a local anesthetic in the block can prolong its duration, and whether there are differences in postoperative pain, consumption of painkillers, side effects, and satisfaction in patients who received iv or block dexamethasone. patients (128 total) will be randomly assigned to either receive iv or block dexamethasone, and postoperative assessments (pain, painkiller use, side effects, block duration, satisfaction, complications) will be made via phone at 2, 3, 4 (if needed), and 7-10 days after surgery. results from this study will reveal whether patients prefer the longer-duration analgesia that may be obtained with low-dose dexamethasone in the block.


Eligibility criteria:
inclusion criteria: * patients having ambulatory arthroscopic shoulder surgery under ultrasound-guided interscalene block (rotator cuffs, acromioplasties, stabilizations, labral repairs, etc.) * age 18-70 years exclusion criteria: * contraindication to interscalene block * known allergy/sensitivity to any study medications * having taken daily steroids for 10 days or longer anytime during the past year * body mass index \ 40 * history of uncontrolled nausea and vomiting with opioids or severe post-op nausea and vomiting (to prevent any need for higher doses of iv dexamethasone) * non-english speaking * revision procedures * additional procedures (e.g., removal of hardware, procedures involving other areas, etc.) * planned open procedures * history of diabetes * arthroscopic irrigation and debridement secondary to infection * peripheral neuropathies affecting the operative extremity * having taken opiates daily for 10 days or longer immediately preceding surgery, 3 times a week for greater than 3 months anytime in the past year, or currently taking for anything other than shoulder pain
radiation oncology mobile application

Conditions: Head and Neck Cancer; Radiation Toxicity

Summary: to develop a novel a mobile phone application (available on android and ios) for patients receiving radiation treatment for head and neck cancer. through this application, patients will get access to their treatment calender, through a system connected with mosiac database, which provides a timely and precise access to their treatments schedule. in addition, patients will be able to report their treatment related toxicity in real time fashion, these symptoms will be addressed daily instead of the weekly floor clinic checks. furthermore, the radiation oncologist will receive an instant notification through the application, if there is error in patient's treatment (missing field, wrong dose, etc..)


Eligibility criteria:
inclusion criteria: adult patients receiving definitive or adjuvant rt to head and neck site chemotherapy is allowed ps:0-1 has a smart phone exclusion criteria: poor performance early laryngeal cancer patient with metastatic disease, or palliative intent.
visual feedback therapy for treating individuals with hemiparesis following stroke

Conditions: Hemiparesis; Stroke

Summary: the purpose of the study is to determine whether an existing treatment for problems that participants have with making movements after a stroke can be performed at home.

this study will compare two forms of home-based treatment for post-stroke problems making movements with the arms and hands. after initial pre-treatment assessments, participants will complete 4 weeks of treatment, with assessments after each week of treatment and 3 months after the completion of treatment.

Eligibility criteria:
inclusion criteria: * 6 months or more post-stroke * upper extremity fugl-meyer score between 10 and 50 * no longer participating in upper-extremity physical or occupational therapy * sufficient comprehension ability to understand instructions exclusion criteria: * previous head trauma, psychiatric illness or chronic exposure to medications that might be expected to have lasting consequences for the central nervous system (e.g., haloperidol, dopaminergics) * dementia

Keywords: stroke hemiparesis arm movement sensory functioning
safety and tolerability of mrz-99030 eye drops in healthy volunteers and glaucoma patients

Conditions: Healthy Volunteers and Glaucoma Patients

Summary: * to assess the safety and tolerability of repeat dose topical administration of mrz-99030 ophthalmic solution with ascending doses in healthy subjects (stage 1) and glaucoma subjects (stage 2). * to assess plasma pharmacokinetics and urine concentration of mrz- 99030 and its metabolite mrz-9499 after single and repeat dose topical administration of mrz-99030 ophthalmic solution.


Eligibility criteria:
inclusion criteria: for stage 1: - healthy volunteers for stage 2: - glaucoma patients exclusion criteria: for stage 2: - any relevant eye disease other than glaucoma
the effect of face-to-face and online training on cancer screening on women's knowledge, attıtude and shyness

Conditions: Being Literate; Not Having Any Cognitive, Visual or Orthopedic Disabilities; Being Between the Ages of 50-65; Having a Smart Phone; The Effect of Education on Cancer Screening on the Knowledge Level of Women; The Effect of Education on Cancer Screening on Women&Amp;#39;s Attitudes; The Effect of Education on Cancer Screening on Women&Amp;#39;s Shyness Level

Summary: cancer is a large group of diseases that occur due to abnormal cell proliferation in almost all organs of the body. cancer is the second leading cause of death in the world after cardiovascular diseases. the fact that cancer is a preventable disease reveals the importance of cancer screenings. cancer screening aims to detect it in the early stages when the chance of treatment is high. screening programs for breast cancer, cervical cancer and colorectal cancer are recommended by who. in order for these screening programs to achieve their goals, people within the scope of screening must participate in screening. however, there are many factors involved in participating in these screening programs. even though health professionals direct people to screening programs, at this point people's knowledge, attitude and shyness levels affect their participation in screening programs. the research is planned to be experimentally pre-test-post-test, and the data will be collected before and after the training to be given face-to-face and online by the researcher. the results obtained as a result of the study will be taken into consideration by midwives in terms of the effect of the education given on cancer screenings on women's knowledge, attitude and shyness levels.


Eligibility criteria:
inclusion criteria: * being between the ages of 50-65 * being literate * having a smart mobile phone * no cognitive, visual or orthopedic disabilities exclusion criteria: * not answering questions completely. being diagnosed with a psychiatric disease.

Keywords: cancer screenings midwife knowledge attitude shyness woman online education
associations of fecal bile acid profile and intestinal flora with chronic radiation enteritis

Conditions: Radiation Enteritis

Summary: to explore the fecal bile acid profile of patients with radiation enteritis, to clarify the types of bile acids that are closely related to the occurrence of radiation enteritis; to explore the interaction between fecal bile acids and intestinal flora in patients with radiation enteritis, and to lay the foundation for further elucidation of the pathogenesis of radiation enteritis.


Eligibility criteria:
inclusion criteria: 1. . non-surgical cervical cancer patients aged 18 to 75 years who received radiotherapy; 2. . patients who can fully understand the content of informed consent for this trial and voluntarily sign the written informed consent; 3. . able to receive follow-up examinations, follow-up examinations, and specimen retention on time; 4. . the case group met the diagnostic criteria for chronic radiation enteritis in the "expert consensus on the diagnosis and treatment of radiation proctitis in china (2018 edition)"; control group 1: non-surgical cervical cancer patients without chronic radiation enteritis after radiotherapy; control group 2: patients with cervical cancer who did not receive any treatment. exclusion criteria; 1. . presence of diseases affecting bile acid metabolism, such as hepatitis and cirrhosis of the liver from various causes, gallstones, etc; 2. . patients who have previously undergone cholecystectomy or partial resection of the intestine; 3. . taking drugs affecting bile acid metabolism due to other diseases, such as cholestyramine, anti-inflammatory and xiaoyan lidan tablets, danshu capsules, ursodeoxycholic acid, obeticholic acid, and proprietary chinese medicines such as schisandrin b, tanshinone iia, and yinjiazhuang; 4. . recent use of drugs that affect gastrointestinal motility; 5. . patients with moderate or severe renal impairment (blood creatinine \> 2 mg/dl or 177 mmol/l), or abnormal liver function (alt \> 2 times the upper limit of normal value); moderate or severe chronic obstructive pulmonary disease; patients with severe hypertension, patients with cerebrovascular accidents; patients with congestive heart failure, unstable angina pectoris; 6. . patients with mental or legal disabilities; 7. . suspected or confirmed history of alcohol/substance abuse or other pathology that, in the judgment of the investigator, reduces the likelihood of enrollment or complicates enrollment; 8. . refuse to sign informed consent;

Keywords: radiation enteritis bile acid gut microbiota
efficacy and safety of esd for the treatment of superficial gastric neoplasms

Conditions: Gastric Cancer

Summary: endoscopic submucosal dissection (esd) is the technique that has replaced surgery in the treatment of early neoplastic lesions of the stomach (lnps). esd of lnps allows: a) less invasiveness compared to surgery; b) greater chances of "en bloc" resection and r0 resection compared to mucosectomy for lesions larger than 15 mm. recent 2015 esge guidelines provide precise recommendations for the use of esd in the treatment of lnps, but italy lacks prospective data on the efficacy and safety of esd in a large sample of patients. a multicenter prospective observational study to create a database on the use of esd in lnps is essential to provide information regarding the efficacy and safety of esd in italy. this database would also provide information regarding the criteria applied in the use of esd in the treatment of early gastric neoplasia


Eligibility criteria:
inclusion criteria: * age \> 18 years old * endoscopic and histologic diagnosis of gastric superficial neoplasm that can be treated by esd according to esge guidelines. * gastric neoplasm outside of latest esd guidelines criteria in patients unfit for surgery exclusion criteria: * final diagnosis of non neoplastic lesion. * gastric neoplasm outside of latest esd guidelines criteria in patients fit for surgery * evidence of muscolar layer invasion or limph nodes or other organs metastasis at eus or tc when performed.

Keywords: endoscopic submucosal dissection endoscopic resection
comparison of two doses of enoxaparin for thromboprophylaxis in hospitalized covid-19 patients

Conditions: Covid19

Summary: the purpose of this study is to determine whether a higher dose of low molecular weight heparin (enoxaparin 40 mg b.i.d.) is superior than the standard prophylaxis dose (enoxaparin 40 mg o.d.) in reducing thromboembolic events in covid-19 patients.

coronavirus disease-19 (covid-19 ), which is caused by sars-cov-2 infection, are apparently at high risk of venous thromboembolism (vte), as a consequence of activation of the hemostatic system which, in the most severe cases, can also be associated with the formation of microthrombi and clinically relevant disseminated intravascular coagulation. concerns about the efficacy of thromboprophylaxis with standard doses of low-molecular-weight heparin (lmwh) has been raised. therefore, lmwh at higher doses than those recommended for thromboprophylaxis is used in some hospitals, although no evidence exists yet of higher efficacy of high doses compared to standard prophylactic doses. this practice might as well increase the risk of major bleeding. the investigators designed a randomized trial comparing standard prophylactic dose of subcutaneous enoxaparin (40 mg o.d.) with higher dose (40 mg b.i.d) with the aim of testing whether high-dose thromboprophylaxis is more effective than standard dose in preventing vte in covid-19 patients.

Eligibility criteria:
inclusion criteria: * all-comers patients aged \>=18 years and admitted to hospital with laboratory-confirmed sars-cov-2 infection exclusion criteria: * patients admitted directly to an intensive care unit; * estimated creatinine clearance \<15 ml/min/1.73m2; * patients needing anticoagulant for prior indication; * participants involved in other clinical trials; * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Keywords: covid19
vitamin a supplementation in children with moderate to severe covid-19

Conditions: Covid19

Summary: severe acute respiratory syndrome (sars)-like coronavirus 2 (sars-cov-2) pandemia is considered to be the current major global health issue. with no specific treatment or vaccine known to be licensed, empowering the immune system to overcome the inflammatory status associated with the late stages of the disease, particularly by anti-inflammatory nutrients, is of great concern. effective in reducing both the morbidity and mortality of respiratory infections, including measles, vitamin a and its derivatives are reported to enhance the immune system and/or antibody response to virus vaccinations in children, particularly those with vitamin insufficiency. retinoids are, therefore, proposed as an adjunct therapy in the treatment of covid-19. the study is aimed to investigate the effects of vitamin a supplementation on disease improvement in pediatric and adolescent patients with either moderate or severe covid-19 disease.


Eligibility criteria:
inclusion criteria: * 1) aged between 1-month to 18-year old (boy or girl), 2) definitive or clinical diagnosis of severe acute respiratory syndrome (sars)-like coronavirus 2 (sars-cov-2) infection (by either a positive sars-cov-2 polymerase chain reaction (pcr) test or a suggestive computed tomography (ct) scan, 3) no history or evidence of cancer or renal, hepatic, endocrine or viral disorders (including hiv/aids), 4) no history of supplementation either with vitamin a (va) or with a multivitamin containing va within the last 4 months, and 5) not participated in other clinical trials. exclusion criteria: * 1) mildly infected with sars-cov-2 virus, and 2) pregnancy or lactation.

Keywords: vitamin a inflammation pediatrics