Kornimate/medical-research-clean huggingface dataset:
efficacy of three toothpastes using an in situ caries model

Conditions: Dental Caries

Summary: this will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period crossover, incomplete block design, in situ caries study in healthy adults who wear a removable bilateral mandibular partial denture. the denture will be modified to accommodate 4 gauze-covered specimens of human dental enamel (4x3mm) that have been previously demineralized in vitro to form either s or low-r lesions (2 specimens of each lesion type will be used with each participant). after 14 days of twice daily product use off-site, the 2 s lesion specimens will be removed at the study site, with the remaining 2 low-r lesion specimens removed at the study site after a further 14 days of product use. to determine the remineralization ability of the treatments, all specimens will be analyzed by transverse microradiography (tmr) and enamel fluoride uptake (efu), with the s lesions additionally analyzed by surface micro hardness (smh) and the low-r lesions additionally analyzed by quantitative light fluorescence (qlf).


Eligibility criteria:
inclusion criteria: 1. demonstrates understanding of the study. 2. aged 18 to 85 years. 3. understands and is willing, able and likely to comply with all study procedures and restrictions. 4. has good general health (in the opinion of the investigator or medically qualified designee). 5. a salivary flow-rate in the range of normal values (unstimulated whole saliva flow- rate ≥ 0.2 g/minute (min); gum base stimulated whole saliva flow-rate ≥ 0.8 g/min). 6. currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens. 7. have no current active caries or periodontal disease and all restorations in a good state of repair. 8. willing and capable of brushing their natural teeth with the lower partial denture in place. exclusion criteria: 1. pregnant or breast feeding women. 2. known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients. 3. currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit. 4. unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated. 5. participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. 6. have received a professional fluoride treatment within 14 days of randomization to the first treatment. 7. recent history (within the last year) of alcohol or other substance abuse.
prospective observational study to evaluate biomarkers of aminoglycoside nephrotoxicity in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the project is designed to test new biomarkers that are more sensitive than the current standard in detecting injury to the proximal kidney tubule and will establish better criteria for when kidney safety concerns may halt further testing of a drug in humans.

the goal of this clinical study is to advance the acceptance of new biomarkers designed to detect drug-induced kidney injury in clinical trials. the kidney safety project is being conducted at four major medical centers: * university of southern california * university of minnesota * md anderson cancer center * dana-farber cancer institute. blood and urine samples will be collected from patients undergoing treatment with either cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the proximal tubule of the kidney. aminoglycosides are a common antibiotic drug taken by patients with cystic fibrosis. cisplatin is a common chemotherapy drug taken by patients with head and neck cancer. the aminoglycoside study of the kidney safety project is being conducted at the university of southern california and the university of minnesota and aims to evaluate aminoglycoside induced acute kidney injury in patients with cystic fibrosis. the companion study, the cisplatin study of the kidney safety project, is being conducted at the md anderson cancer center and the dana-farber cancer institute and aims to evaluate cisplatin induced acute kidney injury in patients with head and neck cancer. the data from the kidney safety project, from both the aminoglycoside study and the cisplatin study, will be combined for determination of the best biomarkers for predicting drug-induced acute kidney injury.

Eligibility criteria:
inclusion criteria: 1. males and females ≥ 18 years of age. 2. documentation of cf diagnosis as evidenced by one or more clinical features consistent with the cf phenotype and one or more of the following criteria: * sweat chloride greater than or equal to 60 meq/l by quantitative pilocarpine iontophoresis test. * two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene; or * abnormal nasal potential difference. 3. hospitalized and initiated on systemic antibiotic therapy for treatment of an acute pulmonary exacerbation. 4. willingness and ability to comply with study procedures and study restrictions. 5. ability to provide written informed consent. exclusion criteria: 1. chronic kidney disease defined by microalbuminuria (\> 30 mcg/mg creatinine) or egfr \< 60 ml/min/1.73m2. 2. receiving medications known to alter the tubular secretion of creatinine (e.g. trimethoprim, cimetidine). 3. hospitalized for treatment of an acute pulmonary exacerbation or received intravenous aminoglycoside antibiotics within 3-months of study entry.

Keywords: kidney safety biomarkers serum creatinine bun cystic fibrosis head and neck cancer renal injury drug induced acute kidney injury aminoglycoside cisplatin nephrotoxicity biomarker qualification
prevalence and treatment of anal incontinence (ai) in primiparous women

Conditions: Fecal Incontinence

Summary: traumatic tears of the sphincter ani muscles after delivery may result in symptomatic urinary and anal incontinence, particularly in primiparas. the efficacy of pelvic floor muscle exercise (pfme) in treating urinary incontinence (ui)is well documented, however, to date there is little evidence to support the efficacy of pfme in treating symptomatic anal incontinence. this project consists of three separate studies. the prevalence survey/ study (1), investigates the prevalence of symptomatic anal incontinence among primiparas at ostfold hospital trust fredrikstad, norway and st olav's hospital, trondheim university hospital, norway, and the results in this study will form the basis of the two identical randomized controlled trials (rct) investigating the treatment efficacy of pfme two groups of postpartum women. women reporting symptomatic anal incontinence at six months postpartum (2) and women who have sustained a traumatic 3rd or 4th degree tear of the sphincter ani muscles during delivery (3), respectively, are randomized to an intervention group receiving pfme treatment for six months, or a control group. all rct participants will undergo examination of pfm strength and activity, as well as anal ultrasound prior to randomization and after the intervention period.

the recruitment in rct ( 2) has been lower than expected (49/72). due to financial reasons and problems with logistics and preparations for the main hospital (ostfold hospital trust) moving into a new hospital, we were unable to extend the recruitment period in study 1. in rct (3) ai was not an inclusion criterion. however, as both rcts had the same outcome measure; anal incontinence, and a joint randomization process, stratified on hospital site and whether the participants had sustained an obsteric anal sphincter injury at delivery or not, the results from these studies will be reported together.

Eligibility criteria:
inclusion criteria: * primiparas aged 18 years or over with adequate knowledge of the norwegian language (prevalence study) * primiparas (prevalence study and rct 2) * women with obstetric anal sphincter injury with primary repair at delivery (rct 3) exclusion criteria all studies: * inadequate knowledge of the norwegian language * diabetes mellitus * irritable bowel syndrome * neurological diseases such as multiple sclerosis * previous abdominal/colon surgery in rct studies: women who have already started pelvic floor muscle training postpartum due to severe anal incontinence or pelvic floor dysfunction

Keywords: anal incontinence urinary incontinence primiparas prevalence pelvic floor exercise treatment quality of life (qol)
act lung health intervention: phase two

Conditions: Smoking Cessation; Smoking Behaviors; Smoking, Tobacco; Smoking, Cigarette; Smoking (Tobacco) Addiction

Summary: this study aims to test a counseling and educational program designed to improve lung health through smoking cessation for chinese and korean american smokers at high risk for lung cancer.

this two-arm stratified randomized clinical trial is to test a counseling and educational program designed to improve lung health through smoking cessation for chinese and korean american smokers at high risk for lung cancer. participants will be randomized into one of two groups: group a: act lung health intervention versus group b: standard care. randomization means a participant is placed into a study group by chance. the research study procedures include screening for eligibility, questionnaires, and saliva tests. it is expected participation in this study will last about 6 months. about 128 participants are expected to take part in this research study. the national cancer institute is providing funding for this trial.

Eligibility criteria:
inclusion criteria: * self-identify as either chinese or korean * speak either korean, mandarin, or english * eligible for ldct screening (50-80 years of age and 20- pack-year smoking history) * currently smoking (i.e., having smoked within the prior 30 days), * currently have active health insurance coverage and a primary healthcare provider and * have access to a video-call device with internet or wireless connection. * eastern cooperative oncology group functional status \<2 * live in the united states for the next 12 months exclusion criteria: * had ldct screening done within the last 2 years. * hospitalization due to a serious mental illness (e.g., psychotic disorders) during the prior 6 months. * previous history of lung cancer. * we will not include any of the following special populations: * adults unable to consent. * adults younger than 50 or older than 80 years * individuals who are not yet adults (infants, children, teenagers) * pregnant women * prisoners

Keywords: smoking cessation lung cancer screening smoking (tobacco) addiction smoking, cigarette smoking, tobacco smoking behaviors
pharmacokinetics and pharmacodynamics trial with linagliptin (bi 1356) 5mg in african american type 2 diabetic patients

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of linagliptin (bi 1356) 5 mg administered orally in patients with type 2 diabetes mellitus of african american origin.


Eligibility criteria:
inclusion criteria: 1. glycosylated haemoglobin \>=7 and \<= 10% 2. age \>=21 and \<= 65 3. body mass index \>=18.5 and \<=38 kg/m2 4. african american origin 5. signed and dated informed consent prior to admission to the study exclusion criteria: 1. any finding of the medical examination considered clinically relevant by the investigator 2. clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency new york heart association (nyha) ii-iv, known cardiovascular disease including hypertension \>160-100 mmhg (under current treatment), stroke and transient ischemic attack (tia). 3. clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes 4. clinically relevant diseases of central nervous system or psychiatric disorders or relevant neurological disorders besides polyneuropathy 5. diagnosis of sickle cell anemia or known chronic anemia 6. history of chronic or relevant infections (for example human immunodeficieny virus (hiv), hepatitis b) 7. history of relevant allergy/hypersensitivity 8. intake of drugs with a long half life (\>24hours) within at least one month or less than 10 half lives of the respective drug prior to administration except allowed co medication 9. alcohol abuse, drug abuse 10. any laboratory value of clinical relevance that is outside an acceptable range 11. change of drug dosing of allowed co medication 12. any (electrocardiogram) ecg value outside the reference range and of clinical relevance. 13. fasted glucose \>270 mg/dl or randomly determined blood glucose \>400 mg/dl on two consecutive days during screening or wash out 14. serum creatinine above upper limit normal at screening
improving sexual function after myocardial infarction

Conditions: Sexual Function Disturbances; Myocardial Infarction

Summary: the study is completely digital. men and women who recently had an mi will be invited through a written brochure that will be present in all norwegian departments of cardiology. post-mi patients can check the investigators web site (www.sefh.no) to determine whether they are eligible for the study. after consent and answering the baseline questionnaire, each participant will be randomized to either the intervention or control group. control group: standard surveillance after mi (no specific focus on sexual activity and functioning) intervention group: online sexual counselling including a short information film. in order to assess the generalizability of the results, we will compare the age, sex and mi treatment of the respondents with data on norwegian mi-patients in general.

the investigators will include 600 women and 600 men within 4 weeks after an acute mi. the investigators will invite the same number of women and men from the general population, invited through mass and social media. all participants will be provided the same questionnaire at 4 weeks. then outcome data will be obtained by a follow-up quest after 6 and 12 months. the intervention is a film with the following main message: * sexual activity after mi does not increase risk of recurrence or death * sexual activity is associated with improved outcome after mi * resuming sexual activity as normal is recommended and completely safe

Eligibility criteria:
inclusion criteria: * men and women ≥18 years old * acute mi during the last 6 weeks * informed consent for participation exclusion criteria: * lack of ability to cooperate * known alcohol- or drug-abuse, or use of narcotics * pregnancy or breast-feeding * serious comorbidity with a life expectancy \<12 months * unstable or refractory angina * uncontrolled hypertension * congestive heart failure (nyha class iii/iv) * high-risk arrhythmias * hypertrophic obstructive and other cardiomyopathies * severe valvular disease
traction assisted polypectomy of the intestine

Conditions: Colonic Polyps; Adenomatous Polyps

Summary: the purpose of the study is to verify if the ablation of lesions (polyps, adenomas) in the large (and small) intestine can be facilitated by using a traction on the lesions.

we want to facilitate the ablation of lesions (polyps, adenomas) in the large (and small) intestine by using a traction assisted technique. the traction will be performed by using a haemoclip connected to surgical suture materials. the haemoclip will be fixed to the intestinal mucosa next to the lesion and a loop will be mounted to perform an endoscopic mucosal resection. the aim of the study is to show the feasibility of this technique.

Eligibility criteria:
inclusion criteria: * benign lesions in the large and small intestine * diameter of lesion smaller than 3cm exclusion criteria: * malign lesions of the large and small intestine * diameter of lesions larger than 3cm
a study on administration choices of vedolizumab and outcomes for adults with inflammatory bowel disease (ibd) (variety - croatia and slovenia)

Conditions: Inflammatory Bowel Diseases; Crohns Disease; Colitis, Ulcerative

Summary: inflammatory bowel disease consists of either ulcerative colitis (uc) or crohn's disease (cd). the main aim of this study is to describe real-world treatment patterns in adults with moderate to severe ulcerative colitis or crohn's disease when treated with vedolizumab. this will include the administration choices which can either be an infusion through a vein (intravenous or iv), or an injection just under the skin (subcutaneous injection, or sc). treatment will be determined by the study doctor according to routine clinical practice.

this is a non-interventional, prospective study of participants with ibd who initiated or who are currently ongoing induction or maintenance with vedolizumab in the real world setting. the study will enroll approximately 120 participants. the data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-crfs). all the participants will be assigned to a single observational cohort: * participants with ibd this multi-center study will be conducted in croatia and slovenia having specialized gastroenterology centers. the overall duration of the study will be at least 26 months. data will be collected at baseline, at 3 months (+/- 1 month) after induction, and every 6 months (+/- 1 month) after that, and at the time of switch, discontinuation and/or at routine follow-up visits up to 12 months.

Eligibility criteria:
inclusion criteria: 1. has moderately to severely active ibd (uc or cd), initiating or ongoing iv induction treatment with vedolizumab in accordance with the current smpc at baseline or ibd participants receiving ongoing/maintenance iv vedolizumab treatment, with the option to switch to sc vedolizumab maintenance treatment. exclusion criteria: 1. prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy) to vedolizumab therapy as defined in the current smpc. 2. current or planned participation in an interventional clinical trial for cd or uc. 3. cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Keywords: drug therapy
prosthetic hip infections: prospective study

Conditions: Hip Prosthesis Infection

Summary: data from large prospective cohort studies of prosthetic joint infections are lacking. aim of this study: analyzing prospectively the incidence of reinfection in patients with prosthetic hip infections who underwent surgery and received antibiotic therapy. hypothesis: to confirm in a large group that the incidence of reinfection after excision -synovectomy in acute prosthesis hip infection is 30% and 15% for chronic infection after exchange arthroplasty (one or two stage exchange).

aim of the study: to analyze the incidence of reinfection in patients with prosthetic hip infection who underwent surgery and received antibiotic therapy methods: prospective cohort study in a french referral center for osteoarticular infections from november 2002 to march 2010. population * all patients who consented to participate in the study with prosthetic hip infections treated by: * debridement-synovectomy for acute infection or with one-stage or two-stage * exchange arthroplasty or resection arthroplasty for chronic infection * antibiotic therapy outcome: * follow-up: minimum of 2 years * events monitored: reinfection including relapse and new infection, joint revision for mechanical reasons, prosthetic hip infection related and non-related deaths

Eligibility criteria:
inclusion criteria: * patients with hip arthroplasty infection * surgical treatment: either debridement-synovectomy and prosthesis retention for acute infection or one or two-stage exchange arthroplasty or resection arthroplasty for chronic infection * antibiotic therapy * signed informed consent exclusion criteria: * prolonged suppressive antibiotic therapy * no surgical treatment

Keywords: hip prosthesis infection reinfection excision-synovectomy one stage/two stage revision antibiotherapy
maternal and infant vitamin status during the first nine months of infant life

Conditions: Rickets; Osteomalacia; Osteoporosis

Summary: in this study the investigators wanted to assess vitamin d status and possible consequences of low plasma 25-hydroxyvitamin d levels in a population of healthy mothers and their infants, in the community of aarhus, denmark.

danish people living at northern latitudes (56°n), often with overcast and foggy weather and few sunshine hours are at increased risk of vitamin d insufficiency. although vitamin d is obtainable from fortified food and oily fish, the major source is the dermal synthesis of the vitamin d through exposure to solar ultraviolet light. in the 19th century rickets was endemic in northern europe, and many children developed rickets, a severe bone-deforming disease. encouragement of sensible sun exposure, supplementation with cod liver oil and fortification of milk with vitamin d, resulted in an almost complete eradication of rickets by the end of the 19th century. at present vitamin d deficiency seems again to be more widespread. the classical outcomes of severe vitamin d deficiency are rickets in growing individuals and osteomalacia in adults. low vitamin d status also relates to low bone density and increased risk of osteoporotic fractures. although the incidence of rickets has declined over the last decades, cases attributable to inadequate vitamin d intake and low exposure to sunlight continue to be reported, and maternal vitamin d status may have permanent effects on newborns' health. pregnant women, newborns, breastfed children, and lactating women are at a high risk of vitamin d deficiency, especially during winter and early spring. since fetal plasma 25-hydroxyvitamin d (25ohd) depends on maternal 25ohd, fetal vitamin d status may show seasonal changes parallel to those observed in the mothers. to prevent rickets and vitamin d deficiency in infants, most western countries, including denmark, recommend a daily maternal intake during pregnancy and lactation of 10 μg and that breastfed children are given a supplement of 10 μg of vitamin d/day. despite these recommendations, approximately one third of danish pregnant and lactating women have vitamin d insufficiency. however, childhood rickets is nowadays rare in denmark, although it still exists especially among immigrants and mothers with prolonged lactation. accordingly, in 2010, the danish national board of health extended the recommendations for vitamin d supplementation to the first two years of life.

Eligibility criteria:
inclusion criteria: * healthy pregnant caucasian women aged 24-41 years, * a normal pregnancy giving birth between 38-42 gestational weeks. exclusion criteria: * chronic diseases, * other ethnic origin than caucasian, and * alcohol or drug abuse.
is there a correlation between sypmtoms of gastroparesis and the duration of video caspule retention in the stomach

Conditions: Gastroparesis

Summary: gastroparesis is a syndrome characterized by delayed gastric emptying in absence of mechanical obstruction of the stomach. the cardinal symptoms include postprandial fullness (early satiety), nausea, vomiting, and bloating.capsule endoscopy (ce) has evolved to become a first-line, noninvasive diagnostic technique for the small bowel. ce is now being utilized to assess patients for obscure gastrointestinal bleeding, possible crohn's disease, celiac disease and small bowel tumors. capsule endoscopy is preformed in a fasting state, and usually past the pylorus of the stomach into the duodenum after up to 30-40 minutes. the aim of the study is to determine the correlation between gasytoparesis symptoms to duration of capsule retention in the stomach


Eligibility criteria:
inclusion criteria: * age \> 18 years * undergoing video capsule endoscopy for any indication exclusion criteria: -endoscopic intraduodenal insertion of the capsule -

Keywords: gastroparesis small bowel video capsule gastric retention