Kornimate/medical-research-clean huggingface dataset:
effect of iron supplements on the growth of enteric pathogens

Conditions: Iron-deficiency; Iron Deficiency Anaemia Due to Dietary Causes; Iron Deficiency Anemia Treatment; Iron Deficiency Anemia

Summary: iron supplementation is a common approach to address iron deficiency with recommendations for women of childbearing age, particularly those at risk of iron deficiency. because of its considerably higher absorption, ferrous sulphate is the common iron compound used in iron supplements. however, concerns about iron supplements arise from the knowledge that a large portion of the supplement consumed is not absorbed. this unabsorbed iron travels to the colon and, in preclinical studies, has been shown to promote the growth of enteric pathogens at the expense of beneficial commensal bacteria and increase infection risk, including the clinical incidence of diarrhea. the objective of this study is to compare the effects of iron as ferrous sulfate (feso4) or feso4-enriched aspergillus oryzae (ao iron) on the growth and virulence of common enteric pathogens using an in vitro fecal fermentation model. stool samples will be collected from women of reproductive age following ingestion of an iron supplement as either feso4 or ao iron. stool samples will be spiked with common enteric pathogens, and outcome measures will be determined following in vitro fecal fermentation.


Eligibility criteria:
inclusion criteria: * women 18-44 y * are able to swallow the iron pills provided for the study * bmi 18.5 to 29.9 kg/m2 * willing to provide blood samples * willing to collect stool samples exclusion criteria: * currently taking any antibiotics * iron overload condition/hemochromatosis * history of chronic gastrointestinal disorders/diseases * currently smoke cigarettes (including vaping) * have donated blood recently (in the last two weeks) * currently taking a vitamin and mineral supplement containing iron * pregnant and lactating/breastfeeding women * allergic to any of the ingredients (wheat, egg, butter, milk, and baking powder, blue dye) in the muffins
non-inferiority study comparing firehawk stent with abbott xience family stent (target-ac)

Conditions: Coronary Artery Disease

Summary: purpose the target all comers trial is a prospective, multicenter, randomized, two-arm, non-inferiority, open-label study with 1656 patients at 20 centers in europe. the study is a "real world, all comers" study.

primary objective: to compare the microport medical (group) co., ltd firehawk™cobalt chromium coronary stent ( rapamycin target eluting ) system with abluminal grooves containing a biodegradable polymer with the abbott xience family ees (everolimus-eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), target lesion revascularization at 1 year in a "real world" patient population.

Eligibility criteria:
inclusion criteria: * minimal age 18 years * symptomatic coronary artery disease * patient acceptable candidate for treatment with drug eluting stent in accordance with applicable guidelines * presence of one or more coronary artery stenosis \>50% with reference diameter 2.25-4.0mm which can be covered by one or multiple stents * patient indication, lesion length and vessel diameter according to 'instructions for use' of study stents * patient is willing and able to cooperate with study procedures and required follow up visits and patient or legal representative has been informed and agrees by signing ec approved written informed consent exclusion criteria: * women of childbearing potential who do not have a negative pregnancy test within 7 days before procedure and women who are lactating * known intolerance to aspirin, clopidogrel or ticlopidin, heparin, cobalt, nickel, chromium, molybdenum, polymer coatings, sirolimus, everolimus, or contrast material * participating in other trial before reaching primary endpoint * planned surgery within 6 months of pci unless dual antiplatelet therapy is maintained throughout the peri-surgical period.
efficacy/safety of amlodipine plus losartan versus losartan in patients with essential hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and losartan alone in patients with essential hypertension inadequately controlled on losartan monotherapy.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age * essential hypertensive patients whose blood pressure is not controlled before the study (sit dbp≥90 mmhg for drug-treated patient, sit dbp≥95mmhg for drug-naïve patient) * non-responder to 4 weeks treatment of losartan 100 mg monotherapy (sit dbp≥90mmhg) exclusion criteria: * mean sit sbp≥200mmhg or mean sit dbp≥120mmhg at screening * mean sit sbp≥180 mmhg or mean sit dbp≥120mmhg after 4 weeks of losartan 100mg treatment * has a history of hypersensitivity to dihydropyridines or angiotensin ii receptor blockers * secondary hypertensive patient or suspected to be * uncontrolled diabetes mellitus patients * severe heart disease or severe neurovascular disease * known as severe or malignant retinopathy * patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (alt or ast) * history of malignancy tumor * history of autoimmune disease * history of alcohol or drug abuse * positive to pregnancy test, nursing mother, has an intention on pregnancy * considered by investigator as not appropriate to participate in the clinical study with othe reason

Keywords: amlodipine losartan hypertension
blu-5937: first-in-human, single and multiple doses escalation, safety, tolerability, pharmacokinetics and food effect

Conditions: Cough

Summary: this is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of blu-5937 using a double blind, placebo controlled, randomized, adaptive, single center study design. the influence of food on the pharmacokinetics of blu-5037 will also be investigated.

blu-5937 is a selective p2x3 receptor antagonist being developed for the treatment of chronic cough. this phase 1 study will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of blu-5937 administered orally to healthy volunteers.

Eligibility criteria:
inclusion criteria: * healthy adult male and/or female (non-childbearing potential or, for women of childbearing potential, using 2 forms of acceptable birth control or agreed to abide by true abstinence), * age: 18 to 55 years (inclusive). * body mass index (bmi) : ≥18.5 and ≤30 kg/m². * non or ex smoker. exclusion criteria: * any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ecg) outside from normal and deemed by the investigator to be clinically significant. * use of any prescription drugs (with the exception of hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of the investigator would put into question the status of the volunteer as healthy. * volunteers who took an investigational product in the 28 days prior to the first study drug administration. * volunteers who donated 50 ml or more of blood in the 28 days prior to the first study drug administration. * donation of 500 ml or more of blood in the 56 days prior to the first study drug administration.
local gentamicin application to reduce postoperative infection rate

Conditions: Surgical Wound Infection

Summary: the majority of elderly patients with a displaced fracture of the proximal femur are now treated with a hemiarthroplasty. prosthetic joint infection is a devastating complication, and the infection rate is high in this group of elderly patients. local application of gentamicin produces high antibiotic concentrations in the wound. the aim of this study is to determine whether locally administered collagen-gentamicin in the joint perioperatively in addition to routine iv prophylaxis with beta-lactam antibiotics can reduce the early postoperative infection rate (\< 4 weeks postoperative)after hemiarthroplasty in proximal femoral fractures.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of proximal femoral fracture * must be planned operated with a prosthesis of the hip exclusion criteria: * known allergy to gentamicin * ongoing treatment with aminoglycosides * reduced renal function * pregnancy

Keywords: humans prostheses and implants gentamicin administration and dosage surgical sponges treatment outcomes
effect of aerobic exercises on static & dynamic balance

Conditions: Down Syndrome

Summary: to determine the effect of aerobic exercises on static \& dynamic balance of children in down syndrome. when a person has down syndrome, they have an extra chromosome. in the body, chromosomes are discrete collections of genes. they control how a baby's body develops and works both throughout pregnancy and after birth. a newborn typically has 46 chromosomes. down syndrome is a genetic disorder that affects physical and developmental growth and can cause minor to severe issues. mental impairment, unusual facial features, an increased risk of cardiac defects, and digestive issues that can range in severity from mild to severe are all symptoms associated with the syndrome.

this will be a randomized controlled trial. total sample size of 20 will be divided into control and experimental groups. control group will be given with the standard physical therapy intervention as a baseline treatment while experimental group will be given with the aerobic exercise along with baseline treatment. pediatric balance test and the six-minute walk test will be used before and after the intervention. data will be analyzed on spss 26.0 and necessary analysis will be done after checking the normality of data.

Eligibility criteria:
inclusion criteria: * children with medical diagnosis of ds * children with mild (iq 50-70) to moderate (iq 35-40) mental retardation * age 5-12 years * children who were able to stand and walk exclusion criteria: * recent injury to lower extremities * history of or ongoing vestibular neuritis * use of walking aids

Keywords: down syndrome aerobic exercises static & dynamic balance
prevention of travelers' diarrhea in subjects traveling outside the u.s.

Conditions: Diarrhea

Summary: the primary objective of this study is to assess the safety and tolerability of rifaximin 600 mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy subjects to prevent travelers' diarrhea (td) from all causes.

travelers' diarrhea (td) is the most common illness in travelers to the developing world, occurring in 60% or more of international travelers to high-risk areas. it can be quite debilitating for the usual 2 to 4 days of the illness and may lead to disruption of travel plans. findings from recent studies have indicated that the chronic post-travel illness may prove to be of greater clinical and public health significance than the acute illness. specifically, persistent diarrhea has been reported in 2% to 10% of travelers developing diarrhea. moreover, bacterial enterocolitis, including that associated with td, leads to post-infectious irritable bowel syndrome in 4% to 31% of patients.

Eligibility criteria:
inclusion criteria: 1. subject is in good health (as determined by medical history) 2. subject is planning on traveling anywhere outside the us (except canada) for at least 5 and no more than 14 days 3. subject is scheduled to depart on their planned trip no later than 14 days and no earlier than 4 days after having blood drawn for clinical laboratory assessments and urine collected for a pregnancy test (females of childbearing potential only) exclusion criteria: 1. subject has hypersensitivity or allergy to rifaximin or rifampin 2. subject has known or suspected alcohol abuse or illicit drug use within 1 year of enrollment 3. subject participated in an investigational drug or device study within the 30 days prior to enrollment 4. subject received rifaximin in a previous clinical study 5. subject received any systemic or gastrointestinal-specific antibiotic within 7 days of the first dose of study drug 6. subject received antidiarrheal medication (eg, loperamide, lactobacillus, bss, kaopectate®) within 24 hours of the first dose of study drug

Keywords: travelers' diarrhea xifaxan rifaximin escherichia coli e coli eaec enteroaggregative e coli etec enterotoxigenic e coli
efficacy study of low-dose glucocorticoid prophylaxis for acute graft-versus-host disease(gvhd)

Conditions: Leukemia

Summary: hematopoietic stem cell transplantation (hsct) is one of the best, and sometimes the only, option for the treatment of leukemia. however, gvhd rate was still high after haploidentical hsct. it was found in our previous study that cd4/cd8\>=1.16、cd56bright nk\>1.9×106/kg in the graft was associated with higher risk of developing acute graft-versus-host disease (gvhd). the study hypothesis: risk stratification-directed low-dose glucocorticoid prophylaxis for acute gvhd after unmanipulated haploidentical blood and marrow transplantation can reduce the incidence of acute gvhd

patients undergone haploidentical hsct following day 5 post transplant were randomized to treated group(low-dose glucocorticoid) and controlled group(no intervention).

Eligibility criteria:
inclusion criteria: * no severe diarrhea no serious infection exclusion criteria: * serious diarrhea active,uncontrolled infection
combination or sequential therapy of peginterferon alfa-2a and entecavir for patients with chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: currently, seven medications are approved for the treatment of hepatitis b: two formulations of interferon and five nucleons(t)ide analogues. the current treatment strategy of chronic hepatitis b is now standard: initial selection of entecavir, tenofovir, or peginterferon alfa-2a (peg-ifnα-2a). interferon is administered for a finite duration while nucleotide analogues are usually administered for many years. but among hepatitis b e antigen （hbeag） positive patients with high serum hepatitis b virus dna levels, the rates of virological response are poor. and antiviral drug resistance is a major limiting factor to the success of nucleotide analogue treatment. therefore, combination therapy using peginterferon with an oral agent with a high genetic barrier to resistance might be superior to standard current monotherapy. however, the addition of lamivudine to peg-ifnα-2a therapy led to a greater decrease in serum hbv dna levels during treatment but did not increase the rate of hbeag sero¬conversion. entecavir is a nucleoside analogue superior to lamivudine and adefovir in achieving higher virological response, histological improvement and normalisation of alt. moreover, entecavir has a high genetic barrier with a very low incidence of drug resistance. this study is aimed to investigate the efficacy of combination or sequential therapy using peg-ifnα-2a and entecavir in hbeag-positive chronic hepatitis b(chb) patients.


Eligibility criteria:
inclusion criteria: 1. age≥16 years 2. hbsag positive for more than 6 months, and hbeag detection is positive for two times in 6 months before enrollment 3. serum hbvdna \>2×10\^4iu/ml 4. 80u/l \< serum alt \< 400u/l, and tbil \< 34 umol/l 5. serum alt \< 80u/l, but hepatic inflammation scores ≥ g2 or hepatic fibrosis stage ≥ s3 exclusion criteria: 1. co-infected with hcv, hdv or hiv, or autoimmune liver diseases combined 2. hepatic decompensation 3. received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment 4. blood routine examination: wbc \<3×10\^9/l，neutrophile granulocyte \< 1.5×10\^9/l，plt \<80×10\^9/l 5. renal function: creatinine \>1.5 times of upper normal limit 6. alcoholism or a history of addiction and abuse 7. combined with hepatocarcinoma

Keywords: hbv entecavir peginterferon
sleep application diary and sleep hygiene in adolescents

Conditions: Dyssomnias

Summary: the purpose of this study will be to see if adolescents can advance bedtime above what can be accomplished by counseling alone simply by inputting their information into a sleep application diary and reporting this information back to their sleep doctor.

using a smart phone application, participants will record bedtime and wake up times as well as answer questions about their sleep throughout their participation in this study . reaction time will also be measured through a smart phone application.

Eligibility criteria:
inclusion criteria: * males \& females age 12-17 * have access to a smart phone (iphone or android) * present to a sleep disorder clinic with poor sleep hygiene and seen by a pediatric sleep specialist exclusion criteria: * significant developmental delays * english is not the primary language spoken
reporting, evaluating, preventing and treating the cardiotoxicity induced by anticancer drugs during a specific cardio-oncology consult and follow up in routine care

Conditions: Cardiovascular Complication; Cardiovascular Insufficiency; Cardiac Complication; Oncologic Complications; Cardiac Insufficiency; Metabolic Disorder; Vascular Disorder; Cardiac Disorder

Summary: several drugs used in routine care in oncology induce rare but often severe or fatal cardiovascular or metabolic side effects. this study will investigate, evaluate, report and treat the cardiovascular side effects of anticancer drugs, through a specific cardiovascular routine checkup and follow-up taking place in several cardio-oncology programs throughout france. the different including centers will be: assistance publique - hôpitaux de paris (aphp.6: pitié-salpétrière, saint antoine and tenon's hospitals, paris, france).

several anticancer and supportive care drugs used in oncology have an impact on the cardiovascular and metabolic systems, leading to a wide range of cardiovascular and metabolic disorders and side effects. those are poorly described, due to the evolution of the anticancer pharmacopeia, and recent recognition of these adverse events. this study will investigate the potential benefits of a specialized cardio-oncology check-up and follow-up in this context.

Eligibility criteria:
inclusion criteria: * suffering a cancer * evaluated within a cardio-oncology program exclusion criteria: * none

Keywords: anticancer drugs cardiac toxicities cardiovascular prevention vascular toxicities metabolic toxicities adverse drug reactions
a single-arm trial of neurovascular drug-eluting balloon dilatation catheter treating symptomatic intracranial atherosclerotic stenosis

Conditions: Intracranial Atherosclerosis

Summary: this is a trial designed to test the efficacy and safety of the neurovascular drug-eluting balloon dilatation catheter.

this is a prospective multicentre single-arm trial conducted by 11 centers in mainland china. approximately 132 subjects with symptomatic intracranial atherosclerotic stenosis receive endovascular treatment using the neurovascular drug-eluting balloon dilatation catheter designed by zylox.

Eligibility criteria:
inclusion criteria: * age 18 to 80 years, any gender; * subject has symptomatic intracranial atherosclerotic stenosis that the degree of the artery stenosis is between 70% and 99% diagnosed by intracranial angiography; * the target stenotic artery locates in internal carotid artery (intracranial segment), middle cerebral artery (m1, m2), basilar artery, vertebral artery (intracranial segment); * intracranial artery stenosis requiring interventional treatment is a single lesion; * subject has at least two atherosclerosis risk factors including history or present hypertension, diabetes, hyperlipidemia, smoking, age\>45; * modified rankin scale(mrs) score≤2 before enrollment; * subject or guardian is able to understand the purpose of study, agree to provide follow-up data and has provided written informed consent. exclusion criteria: * history of acute ischemic stroke within 2 weeks; * history of intracranial hemorrhage (including intraparenchymal hemorrhage, subarachnoid hemorrhage, subdural hemorrhage and epidural hemorrhage) within 3 months; * hypertension uncontrolled by medicine (systolic pressure≥180 mmhg or diastolic pressure≥110 mmhg continuously); * combined with the intracranial tumor, aneurysm or intracranial arteriovenous malformation; * the length of intracranial artery stenosis \>10mm and extremely angulated \>90°, which indicated by angiography; * history of stent intervention within the target lesion; * allergic to heparin, sirolimus (i.e. rapamycin), contrast agents, aspirin, clopidogrel, anesthetics; * history of gastrointestinal hemorrhage within 6 months before signing the informed consent form, which is unable to receive antiplatelet therapy; * platelet (plt)\<90\*10\^9/l; * creatinine\>250 umol/l; * international normalized ratio (inr)\>1.5; * female subject who is pregnant or breast-feeding, or who has a pregnancy plan within 12 months; * expected life \<12 months; * unable to cooperate with or tolerate the interventional surgery; * subject who has participated in other drug or device clinical trials or hasn't reached the primary end point; * angiography indicates intracranial artery stenosis caused by arterial dissection, arteritis, and thrombosis; * angiography indicates the vascular path is tortuous, the experimental device is difficult to reach the target position or be retracted; * other circumstances judged by researchers that are not suitable for enrollment.
a study to investigate the antimicrobial activity of 2 test toothpastes

Conditions: Dental Plaque

Summary: the aim of this exploratory study is to assess the ability of two test toothpastes containing 0.6% w/w zinc chloride stabilised with sodium citrate in a sodium lauryl sulfate (sls)-containing base to reduce glycolytic metabolism and viability of de novo plaque bacteria using the plaque glycolysis regrowth model (pgrm).


Eligibility criteria:
inclusion criteria: * demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination. * plaque sample acidogenicity in the ph range 5.0 to 5.7 at visit. exclusion criteria: * women who are known to be pregnant or who are intending to become pregnant over the duration of the study. * women who are breast-feeding. * currently taking antibiotics or have taken antibiotics within 2 weeks of plaque assessment (visit 2). a participant with any medical history that may prevent them from participating in the study until study conclusion (such as diabetes). * any sign of grossly carious lesions (active), moderate or severe periodontal conditions, or severe tooth wear. * known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. * current smokers, or smokers who have quit within 6 months of screening, or participants currently using smokeless forms of tobacco, e.g. gutkha, pan containing tobacco, pan masala. * current active caries or periodontitis that may compromise, in the opinion of the investigator, study outcomes or the health of the subject. * restorations in a poor state of repair that may, in the opinion of the investigator, compromise study outcomes or the health of the participant. * partial dentures or orthodontic appliances that may, in the opinion of the investigator, compromise study outcomes or the health of the participant. * recent history (within the last year) of alcohol or other substance abuse.