Kornimate/medical-research-clean huggingface dataset:
helicobacter pylori and iron deficiency: prevalence of association and effect of therapy

Conditions: Anemia, Iron-Deficiency; Helicobacter Pylori

Summary: iron deficiency anemia (ida) is a major health problem in children, effecting up to 20% of young children. helicobacter pylori (hp) infection is also reported to be prevalent in children. several large epidemiologic studies support an association between hp infection and lower iron stores. other small studies suggest improvement in anemia following hp treatment. we assume that the prevalence of hp infection in israeli children diagnosed with ida is high and that that adding therapy for hp in those children will improve the response to iron deficiency.

this is a prospective randomized control study which will be conducted at six large ambulatory pediatrics clinics from the jerusalem district. all of the children diagnosed with ida would be eligible to join the study after informed consent will be obtained. ethics committee approval is obtained. analysis of stool samples will be carried out by the hp stool antigen eia (hpsa, premier platinum hpsa, meridian diagnostics inc, cincinnati, oh, usa). all children enrolled will be treated with standard fe therapy. children with positive hpsa will be randomized, controlled for age and clinic, to receive or not receive antibiotics treatment. assessment of response to iron therapy will be done at eight weeks later. the prevalence of hp infection in children with diagnosed with ida would be reported. statistical analysis will compare the baseline data between hp-positive and -negative children and the response to fe between the three study groups.

Eligibility criteria:
inclusion criteria: * all of the children diagnosed with ida at six large ambulatory pediatrics clinics from the jerusalem district. * the diagnosis of ida would be defined as a low hemoglobin level in the presence of iron deficiency (low iron levels, high transferrin saturation and/or low ferritin). exclusion criteria: * children with clinical symptoms fo helicobacter pylori, i.e. abdominal pain, peptic ulcer etc. * children with underlying chronic disease needing medical treatment.
does plasma reduce bleeding in patients undergoing invasive procedures

Conditions: Blood Coagulation Disorders; Hemorrhage

Summary: the purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in patients with moderately elevated international normalized ratios (inr) prior to undergoing an invasive procedure.

fresh frozen plasma is used very frequently in the us. many plasma transfusions are given prior to a procedure in order to correct perceived bleeding risk, yet there is little evidence to support that use of plasma reduces bleeding. there has never been an adequately powered trial to establish the efficacy of plasma and document the risks. this pilot study will evaluate the feasibility of conducting a research protocol that will lead to a large scale clinical trial designed to evaluate the treatment effectiveness of prophylactic plasma transfusion in patients with moderately elevated inrs prior to undergoing an invasive procedure outside of the operating room. study subjects will be randomly allocated to either receive either plasma transfusion prior to the procedure, or to no treatment. study outcomes will be compared between the two study arms. recruitment rates, protocol adherence, and rates of study outcomes will be assessed to determine the feasibility of the large scale trial.

Eligibility criteria:
inclusion criteria: 1. inr level between 1.50 and 2.50 inclusive 2. undergoing an invasive procedure at the bedside, endoscopy laboratory, or in radiology exclusion criteria: 1. undergoing a surgical procedure in the operating room; 2. active bleeding; 3. undergoing a procedure involving or proximal to the central nervous system or spinal cord; 4. cardiac catheterization, 5. using 4 factor plasma concentrates 6. using systemic heparin/heparinoid therapy, direct factor x inhibitors and other anticoagulants for which plasma will not correct prolonged inr; 7. platelet count less than 50,000/ul, 8. congenital coagulation disorders; 9. acquired disorders (i.e., lupus anticoagulant) for which plasma will not correct the disorder; 10. women who are pregnant and; 11. unwillingness to consider blood transfusion.

Keywords: fresh frozen plasma bleeding
an evaluation of a liberal hydration regimen before elective caesarean section using beside gastric ultrasound

Conditions: Aspiration; Gastric Contents, Anesthesia

Summary: the aim of this study is to compare the residual gastric volumes in non-labouring parturients prior to elective caesarean delivery when fully fasted as per european society of anaesthesia pre-operative fasting guidelines against the 'sip til send' fasting guideline via a paired cohort study. the primary hypothesis is that 'sip til send' would be non-inferior to standard fasting at minimising the residual gastric volume prior to surgery.


Eligibility criteria:
inclusion criteria: * planned caesarean delivery under regional anaesthesia * adhered to national fasting guidance of 6 hrs for food and 2 hours for clear fluids exclusion criteria: * age less than 18 * inability to understand english
extended follow-up of patients with macular edema due to retinal vein occlusion

Conditions: Retinal Vein Occlusion

Summary: this study evaluates long-term safety in patients with macular edema due to retinal vein occlusion (rvo) originally enrolled in the bravo \& cruise trials and subsequently followed in the horizon extension trial.

there is strong evidence that ranibizumab provides benefit in subjects with macular edema due to rvo; however, some subjects required continued injections for years to maintain those benefits. it is likely that such subjects have continued production of vegf (vascular endothelial growth factor) from areas of nonperfused retina in the periphery. one strategy is to perform scatter photocoagulation to areas of nonperfusion to reduce continued production of vegf, but it is important to know if visual benefits are maintained when this is done, because if it is not, it would be better to continue intermittent injections of ranibizumab.

Eligibility criteria:
inclusion criteria: * signed informed consent and authorization of use and disclosure of protected health information * age greater than or equal to 18 years * completion of 12 months in bravo or cruise trials, with subsequent follow-up in the horizon extension study. exit from horizon should be within 90 days of enrollment exclusion criteria: * pregnancy (positive pregnancy test) or lactation * premenopausal women not using adequate contraception. the following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an iud, or contraceptive hormone implant or patch. * any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated. * inability to comply with study or follow up procedures * participation in another simultaneous medical investigation or trial

Keywords: rvo crvo brvo horizon bravo cruise
healthy heart score intervention in the primary care setting

Conditions: Cardiovascular Diseases

Summary: in this pilot study, the investigators will assess the clinical utility and feasibility of the healthy heart score in the primary clinical care setting for the primordial prevention of cardiovascular disease. the investigators will conduct a randomized clinical trial to test the lifestyle intervention based on the healthy heart score compared to usual care. the aim is to include 100 participants (50 in each group). each participant will complete 2 visits (initial and a follow up visit after 12 weeks).

created by the harvard t.h chan school of public health, the healthy heart score is a previously validated online risk calculator that determines the 20-year cardiovascular disease ) risk based on 9 modifiable lifestyle factors including; smoking habits, body mass index, physical activity, alcohol consumption, fruit and vegetables intake, cereal fiber, nuts, sugar-sweetened beverages, and red meat, and processed meats consumption. in this pilot study, the investigators will assess the clinical utility and feasibility of the healthy heart score in the primary clinical care setting for the primordial prevention of cardiovascular disease. the investigators will conduct a clinical trial to test our intervention compared to usual care. the investigators will conduct a randomized clinical trial to test the lifestyle intervention based on the healthy heart score compared to usual care. the aim is to include 100 participants (50 in each group). each participant will complete 2 visits (initial and a follow up visit after 12 weeks).

Eligibility criteria:
inclusion criteria: * 18 years of age or older, no cardiovascular diagnosis, body mass index \> 25 and/or having at least one of the following clinical risk factors: elevated blood pressure, pre-high cholesterol, pre-diabetes but not currently taking medications for the previous conditions. exclusion criteria: * those not meeting the inclusion criteria and women who are pregnant or planning to get pregnant.
autoimmune encephalitis with anti-nmda receptor antibodies following herpetic encephalitis

Conditions: Autoimmune Encephalitis; Anti NMDA Receptor Encephalitis; Herpetic Encephalitis

Summary: herpes simplex virus encephalitis is the most common infectious encephalitis, with an estimated annual incidence of 1 / 250,000 to 1 / 500,000 in industrialized countries. despite a widely used antiviral treatment, the prognosis remains poor with a mortality of 5 to 20% and a considerable morbidity rate. one of the contributing factors of bad prognosis is the development of encephalitis mediated by autoantibodies, most often directed against nmda receptors, in the weeks following viral encephalitis. the description of this pathology is recent, the pathophysiology of this process remains poorly understood, and the management of these patients is not yet codified.


Eligibility criteria:
inclusion criteria: * clinical autoimmune encephalitis with anti-nmda antibodies and documented by cba in the csf * after a herpetic encephalitis documented by a positive viral pcr for hsv in the csf * without age limit exclusion criteria- no respect of inclusion criteria
phase 2 study to determine if rtb101 reduces the severity of covid-19 in older adults residing in nursing homes

Conditions: COVID19

Summary: the purpose of this study is to determine if prophylaxis with rtb101 decreases the severity of laboratory-confirmed covid-19 among adults ≥ 65 years who reside in a nursing homes in which one or more residents or staff have laboratory-confirmed covid-19

rtb101-210 is placebo-controlled study to determine if prophylaxis with rtb101 as compared to placebo reduces the severity of laboratory-confirmed covid-19 in adults age ≥65 years who reside in a nursing home in which one or more residents or staff have laboratory-confirmed covid-19. this trial is being conducted in follow up to a phase 3 trial, in which trends toward a reduction in the severity of laboratory-confirmed rtis including coronavirus rtis were again seen. therefore, rtb101 is a potential pan antiviral immunotherapy that may prevent or ameliorate viral rtis, including covid-19, in older adults.

Eligibility criteria:
inclusion criteria: * informed consent must be obtained from the subject or health care proxy before any assessment is performed. * adults (male and female) aged 65 years and over. * residing in a nursing home in which one or more residents or staff has developed laboratory-confirmed symptomatic covid-19 infection at the time of randomization exclusion criteria: subjects will not be eligible if they meet any of the following criteria: * any subject who is a current smoker or has a ≥ 10 pack year smoking history. * subjects with a medical history of chronic obstructive pulmonary disease (copd). * subjects who are in hospice or receiving comfort care only. * subjects who have symptomatic laboratory-confirmed covid-19 at the time of screening or randomization. * subjects with current evidence of an unstable medical disorder including an unstable respiratory disorder, gastrointestinal disorder (including child-pugh class b and c hepatic impairment), renal disorder (including subjects with an estimated glomerular filtration rate (egfr) ≤30 ml/min/1.73m2), or hematologic disorder (including active leukemia). * subjects receiving immunosuppressive therapy including chronic use of prednisone \>10 mg daily (however, inhaled corticosteroids and acute use of higher doses of prednisone to treat conditions such as exacerbation of asthma or other acute conditions are allowed). * subjects with an immunodeficiency disease, including a positive human immunodeficiency virus (hiv) test result. * sexually active males with a partner of child-bearing potential

Keywords: mechanistic target of rapamycin (mtor) virus
dna chip based prognosis of lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of the study is to determine whether a dna chip, designed by medical prognosis institute (mpi), can provide an accurate prognosis for survival of nsclc (adeno-, squamous and large cell lung cancer).


Eligibility criteria:
inclusion criteria: 1. a histological diagnosis of primary nsclc stage ia 2. surgical removal of the tumor 3. age between 18 and 75 years 4. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. a primary nsclc stage ia diagnosis that is changed to not primary nsclc or nsclc stage ib-iv after surgery. 2. adjuvant treatment with chemotherapy. 3. prior history of cancer in the past 5 years or breast cancer at any time. 4. life expectancy less than 3 years in the opinion of the investigator due to concurrent illnesses.

Keywords: nsclc
livedoid vasculopathy: strong association with smoking, weak association with thrombophilia

Conditions: Livedoid Vasculitis

Summary: a screening of patient histories at the clinics of dermatology of the universities of zurich, basel and bern is performed in order to identify patients with a history of livedoid vasculopathy. patients with a history of livedoid vasculopathy are asked to participate in the study. after reading the patient information and if the informed consent is signed patients are included in the study. patients are questioned about their smoking history and blood is drawn in order to perform a screening for thrombophilia.

a screening of patient histories at the clinics of dermatology of the universities of zurich, basel and bern is performed in order to identify patients with a history of livedoid vasculopathy. patients with a history of livedoid vasculopathy are asked to participate in the study. the presence of livedoid vasculopathy must be confirmed by a histologic specimen. after reading the patient information and if the informed consent is signed patients are included in the study. patients are questioned about their smoking history and blood is drawn in order to perform a screening for thrombophilia. the presence of a history of smoking and thrombophilia is compared to the general swiss population.

Eligibility criteria:
inclusion criteria: * history of livedoid vasculopathy exclusion criteria: * diagnosis was not proved by biopsy specimen * a different reason than livedoid vasculopathy has been found for the symptoms of the patient * no informed consent by the patient

Keywords: livedoid vasculitis smoking thrombophilia
acute effect of topical menthol on neck pain

Conditions: Musculoskeletal Disorders

Summary: topical menthol gels are classified 'topical analgesics' and are used to relieve aching and tenderness of muscles and joints. however, double-blind randomized controlled trials are lacking. here the investigators examine - in a double-blind randomized controlled cross-over trial - the acute effect of topical menthol (biofreeze) and placebo (gel with a menthol scent) on neck pain.


Eligibility criteria:
inclusion criteria: * more than 30 days with neck pain during the last year * frequent pain or discomfort, defined as at least 3 days per week * pain intensity at least 4 on a scale of 0-10 * working at least 30 hours per week exclusion criteria: * blood pressure above 160/100 mmhg * pregnancy * life-threatening disease

Keywords: neck pain menthol
comparison of adjuvanted hepatitis b vaccine to double dose of engerix™-b in pre- /haemodialysis patients aged ≥15 years

Conditions: Hepatitis B

Summary: comparison of adjuvanted hepatitis b vaccine to double dose of engerix™-b in pre- /haemodialysis patients aged ≥15 years


Eligibility criteria:
inclusion criteria: * a male or female \> = 15 years of age at the time of the first vaccination. * written informed consent obtained from the subject/ from the parents or guardians of the subject. * seronegative for anti-hbs antibodies, anti-hbc antibodies \& hepatitis b surface antigen (hbsag). * if the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination. * pre-haemodialysis patient\* or a patient on haemodialysis. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine. * previous vaccination against hepatitis b. * history of hepatitis b infection. * known exposure to hepatitis b virus within 6 weeks. pregnant or lactating female * clinically abnormal alt/ast values (\> 3 times normal values)
meniscal lesions in return to sport after anterior cruciate ligament reconstruction

Conditions: ACL Injury; Meniscus Lesion; Sport Injury

Summary: most athletes who undergo anterior cruciate ligament reconstruction (aclr) plan to return to some level of sporting (rts) activity. however, rates of return to pre-injury sport are often less than might be expected and many factors influence whether individuals return to sport after this surgery. this study aims to better understand the role of meniscal lesions in rts and to assess the advantage of the integrated evaluation with clinical, biomechanical and psychological tests to decide the correct rts timing in non-professional athletes undergoing aclr.

twenty non-professional athletes with acute acl injury were recruited in the orthopaedic and trauma unit of university hospital of bari. all the patients underwent an all-inside semitendinosus (st) tendon autograft aclr with arthrex tightrope cortical fixation. the clinical outcomes (modified cincinnati rating system questionnaire (mcrsq), tegner activity level score (tals), tegner lysholm knee scoring scale (tlkss)), the self-reported psychological scores (tampa scale of kinesiophobia (tsk) and the acl return to sport after injury (acl-rsi) score) and biomechanical outcomes (stability, jump, coordination and fatigue tests) were assessed postoperatively at 18 months.

Eligibility criteria:
inclusion criteria: * aged 18-35 years old * non professional athletes * aclr between january 2017 and december 2017 * all-inside semitendinosus (st) tendon autograft aclr with arthrex tightrope cortical fixation exclusion criteria: * diabetes * bmi \> 30 kg/m2 * heart disease

Keywords: return to sport acl reconstruction knee athletes
impact of uterotonic agents on isolated human myometrium

Conditions: Postpartum Hemorrhage

Summary: the purpose of this study is to compare the ability of a sample of uterine muscle tissue to contract in the presence of various drugs. the drugs studied are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. amongst the uterotonic drugs (used to contract the uterus), namely oxytocin, ergonovine and carboprost, the most effective one to use is not known. the investigators will be testing uterine muscle samples in the presence of these drugs at various concentrations, to see what their contractility measures over time, as compared with a control sample, in which no drugs will be applied.

postpartum hemorrhage (pph) is a major cause of maternal mortality and morbidity. in 80% cases of pph, the primary cause is failure of the uterus to contract after delivery of the baby, which then requires further treatment of the mother with uterotonic drugs (drugs used to contract uterus and thus prevent bleeding). patients participating in this study will be asked to donate a very small sample of uterine tissue during cesarean section, which will be tested for the ability to contract after treatment with various uterotonic drugs (oxytocin, ergonovine and carboprost) in the laboratory. this information will help us know the effect of these drugs by comparing the contractile capability of the uterine tissue.

Eligibility criteria:
inclusion criteria: * gestational age 37-41 weeks * non-laboring patients, not exposed to exogenous oxytocin * patients requiring primary cesarean section * cesarean section under spinal anesthesia exclusion criteria: * patients who require general anesthesia * patient who had previous uterine surgery or cesarean section * patients with placental anomalies * emergency cesarean section in labor * patients with bleeding disorders

Keywords: uterine contraction dose-response oxytocin pre-treatment
fosrenol post-marketing surveillance for hemodialysis in japan

Conditions: Hyperphosphatemia

Summary: this study is a regulatory post marketing surveillance in japan, and it is a local prospective and observational study of patients in hemodialysis who received fosrenol for hyperphosphatemia. the objective of this study is to assess safety and efficacy of using fosrenol in clinical practice. a total 3,000 patients will be recruited and followed 5 years.


Eligibility criteria:
inclusion criteria: * patients undergoing hemodialysis who received fosrenol for hyperphosphatemia exclusion criteria: * patients who are contraindicated based on the product label

Keywords: fosrenol hyperphosphatemia hemodialysis
trial to assess vitamin d requirements in lactating women

Conditions: Vitamin D Deficiency; Vitamin D Insufficiency

Summary: this is a randomized, placebo-controlled trial of vitamin d supplementation with 20mcg cholecalciferol (to achieve a total intake of 25mcg/day), with or without 500mg calcium to assess vitamin d requirements in lactating women and to ascertain whether vitamin d supplementation at levels sufficient to achieve defined thresholds of maternal serum 25-hydroxyvitamin d will increase the vitamin d content of maternal milk. the study will also report serum 25-hydroxyvitamin d in maternal-cord dyads over a 12-month period and describe the relationship between them. information on maternal ipth levels, anthropometry, diet and sun exposure will also be reported.


Eligibility criteria:
inclusion criteria: * pregnant women intending to breast feed their infant for at least 12-weeks * pregnant women \>20 weeks gestation * pregnant women \>18 years of age * pregnant women in good general health exclusion criteria: * consumption of a vitamin d-containing supplement(\>10µg/day) in the 3 months prior to commencing the trial * consumption of a vitamin d or calcium containing supplement during the 12- week trial * mothers taking a vacation to a sunny climate or using a solarium during the 12-week trial * mothers with pre-existing type 1 or type 2 diabetes * mothers with pre-existing hypertension * mothers with diagnosed hypercalcemia * mothers with diagnosed intestinal malabsorption conditions * mothers with multiple fetuses (e.g. twins) * consumption of medications known to interfere with vitamin d metabolism.

Keywords: vitamin d cholecalciferol nutrient requirements randomised controlled trial lactation pregnancy cord blood human milk serum 25-hydroxyvitamin d deficiency insufficiency nutrition