Kornimate/medical-research-clean huggingface dataset:
curcumin in preventing colorectal cancer in patients undergoing colorectal endoscopy or colorectal surgery

Conditions: Colorectal Cancer

Summary: rationale: chemoprevention is the use of certain drugs to keep cancer from forming. the use of curcumin may prevent or treat colorectal cancer. purpose: this phase i trial is studying the side effects of curcumin in preventing colorectal cancer in patients undergoing colorectal endoscopy or colorectal surgery.

objectives: primary * to determine levels of curcumin and its metabolites in normal colorectal tissue in patients undergoing colorectal endoscopy or colorectal cancer surgery following a 14-day course of curcumin. secondary * to assess the practicality, acceptability, and safety of administering 5 capsules of curcumin daily for 14 days. * to check the presence of curcumin and its metabolites in peripheral blood and urine. outline: patients receive oral curcumin once daily for 14-28 days. patients then undergo colorectal endoscopy or resection. normal colorectal tissue samples are collected via biopsy for curcumin assay after the last dose of curcumin. patients also undergo blood and urine sample collection at baseline and after the last dose of curcumin for pharmacokinetic analysis by high performance liquid chromatography. after completion of study treatment, patients are followed up at 14 days.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * has a positive fecal occult blood test found during a pilot colorectal cancer screening program * awaiting diagnostic or surveillance colonoscopy * diagnosis of colorectal cancer patient characteristics: * able to return for follow-up tests * fertile patients must use effective contraception * no discrete gastric or duodenal ulcer \> 5 mm in the past year * patients with a history of helicobacter pylori-related peptic ulcer disease are eligible after successfully completing antibiotic treatment for helicobacter pylori * no significant medical or psychiatric problem, including significant renal, hepatic, or hematological dysfunction, that would make the patient a poor candidate for this study prior concurrent therapy: * more than 3 months since prior investigational agents * no prior pelvic radiotherapy * no other concurrent investigational agents

Keywords: colon cancer rectal cancer
internet-based study of fertility and early pregnancy (peeps)

Conditions: Fertility; Infertility; Pregnancy; Abortion, Spontaneous

Summary: the purpose of this study is to assess the feasibility of conducting an internet-based prospective pregnancy study with preconception enrollment with women completing daily journals for up to 12 months while trying to conceive and weekly through pregnancy if it occurs.

there is a dearth of knowledge regarding the role that preconception health plays in fertility and early pregnancy loss. classical methods of conducting prospective pregnancy studies with preconception enrollment to answer these questions are time-consuming in terms of recruitment efforts and expensive to carry out. the purpose of this project is to assess the feasibility of conducting an internet-based prospective pregnancy study with preconception enrollment in the united states using the gold standard data collection approach of daily diaries during the trying to conceive period. we will accomplish this by enrolling 200 females of reproductive age who attempting to conceive and following them for up to 12 months and through pregnancy for those who become pregnant. feasibility will be assessed by measuring: the number of women who screen eligible, the number of women who enroll, and compliance with journal use over time. we will also estimate the incidence of infertility, pregnancy and pregnancy loss as well as compare the demographics of women who enroll to the demographics of women who participate in community-based prospective pregnancy studies with preconception enrollment. the data from this project will be used to assess the feasibility of launching a larger prospective pregnancy study that is appropriately powered to examine the impact of preconceptional lifestyle factors on the incidence of infertility and early pregnancy loss.

Eligibility criteria:
inclusion criteria: * women * ages 18-44 * in a stable relationship * sexually active with a male partner * reliable daily access to the internet exclusion criteria: * woman or her partner has a known fertility problem * trying to conceive for three or more months.

Keywords: fertility infertility pregnancy conception behavioral lifestyle preconception care women's health abortion, spontaneous cohort studies epidemiology internet
comparative study of error rates between ellipta® dry powder inhaler (dpi) and other dpis

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: for effective drug delivery using inhalation route, it is important to use the inhalers correctly. this open-label study will evaluate the error rates during the use of ellipta dpi, alone or in combination, in comparison with other dpis. the study aims to provide clinical evidence in subjects with copd that the reduced number of steps required to use the ellipta dpi could result in fewer errors made by subjects, and therefore a more consistent treatment. approximately 450 subjects prescribed with either of relvar® ellipta, anoro® ellipta, incruse® ellipta, symbicort® turbuhaler®, seretide® diskus®, spiriva® handihaler®, ultibro® breezhaler® or seebri® breezhaler will be included in the study and will have 2 clinical visits. at visit 1, subjects will take their maintenance dpis and the critical and overall errors made by subjects will be assessed. after the assessment, subjects will be instructed on correct use or informed of their correct use of their dpis. the total duration of the study is approximately 6 weeks. ellipta, seretide and diskus are registered trademarks of the gsk group of companies. symbicort and turbuhaler are registered trademarks of the astrazeneca group of companies. spiriva and handihaler are registered trademarks of boehringer ingelheim pharmaceuticals. ultibro, breezhaler and seebri are registered trademarks of the novartis group of companies.


Eligibility criteria:
inclusion criteria: * subjects with documented physician's diagnosis of copd, and currently receiving maintenance therapy. * aged \>=40 years of age at inclusion. * using one of the maintenance therapies of interest for at least 3 months prior to inclusion on the study. * males or females. * capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. exclusion criteria: * asthma: subjects with a current diagnosis of asthma. subjects with a prior history of asthma are eligible if they have a current diagnosis of copd. * drug/alcohol abuse: subjects with a known or suspected alcohol or drug abuse history at screening (visit 0) that in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirement. * investigational product: subjects who have received an investigational drug and/or medical device within 30 days of entry into this study (screening/visit 1), or within five half-lives of the investigational drug, whichever is longer. * investigational product: subjects who have been trained during participation in any device study in the 6 months prior to entry into this study.

Keywords: overall error error rate critical error copd ellipta dry powder inhaler
proms to improve care- standardized vs patient specific

Conditions: Hand Injuries

Summary: to examine the impact of using 2 validated proms during the care of an orthopaedic condition on shared decision making, patient centered care, and patient outcomes.


Eligibility criteria:
inclusion criteria: * hand surgery patients over age 18, english fluency and literacy, able to take informed consent exclusion criteria: -
prevention and rehabilitation of stroke in uganda

Conditions: Stroke

Summary: stroke is increasing in low-income countries in africa, and knowledge is lacking on risk factors and how to prevent stroke as well as how to best use the resources for rehabilitation after stroke which are very limited. knowledge generation within this area is therefore urgently needed. this collaboration between the research group held (health and everyday life among people with neurological disorders), karolinska institutet (ki) and the research surveillant site africa medical and behavioral sciences organization (ambso) population health surveillance (phs), will create substantial research opportunities to develop and improve prevention and rehabilitation for stroke, which is in line with the sustainable development goals to reduce the prevalence and mortality rates due to ncds. ambso is collecting data from 17 000 households on many potential risk factors for stroke. questions about stroke primary and secondary prevention of stroke and impact of stroke or need of rehabilitation could be added to the existing questionnaires such as the validated ugandan version of the stroke impact scale. this is intended to fulfill the aim of the network which is to increase the knowledge of occurrence and consequences of ncds with a specific focus on stroke, which will be valuable for the development of preventive healthcare policy documents and guidelines for appropriate prevention strategies and rehabilitation interventions. research questions in relation to ncds with focus on stroke prevention and rehabilitation: * how many cases (prevalence) are reported in the targeted study sites and what is the mortality rate (incidence) that can specifically relate to stroke? * how does stroke and other ncds affect and impact the quality of life for persons living in uganda? * which factors impact the recovery process after stroke? * what sort of rehabilitation is needed in the study areas for persons affected by stroke? in addition, risk factors of stroke such as diabetes and hypertension will be mapped.


Eligibility criteria:
inclusion criteria: * stroke * risk factors for stroke: hypertension, diabetes, hiv, malaria, physical inactivity, obesity exclusion criteria: * not having had stroke and/or having no risk factor for stroke
a phase ii study of bi-505 in smoldering multiple myeloma

Conditions: Smoldering Multiple Myeloma

Summary: the purpose of this study is to investigate the effect of bi-505 on tumor burden in patients diagnosed with smoldering multiple myeloma.


Eligibility criteria:
inclusion criteria: * diagnosis of smoldering multiple myeloma based on the international myeloma working group criteria: * serum m-protein greater than or equal to 3 g/dl and/or bone marrow plasma cells greater than or equal to 10 percent. * absence of end-organ damage such as lytic bone lesions, anemia, hypercalcemia or renal failure that can be attributed to a plasma cell proliferative disorder. * male or female, 18 years or older. * eastern cooperative oncology group (ecog) performance status of 0-1. exclusion criteria: * patients with a diagnosis of symptomatic multiple myeloma or a clinical suspicion of an ongoing progression into symptomatic multiple myeloma. * prior or current treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, biological therapies, immunomodulatory drugs, or proteasome inhibitors), as judged by the investigator. * severe other conditions.
the efficacy of scaling and root planing on endothelin-1 level

Conditions: Periodontitis

Summary: periodontitis is a chronic inflammatory disease resulting from bacterial invasion. endothelin (et-1) is a potent vasoconstrictor critical in the pathophysiology of periodontal diseases. aim the present study aimed to measure the et-1 concentrations in gingival crevicular fluid (gcf) at baseline, one and three months subsequently to non-surgical periodontal therapy. material and methods designed as a clinical trial, 24 periodontitis individuals will be voluntarily consented to participate. following non-surgical periodontal treatment, gcf samples will be collected to determine the amount of endothelin-1 at baseline, one, and three months. clinical periodontal parameters will be recorded.

periodontitis is a chronic inflammatory disease resulting from bacterial invasion. endothelin (et-1) is a potent vasoconstrictor critical in the pathophysiology of periodontal diseases. aim the present study aimed to measure the et-1 concentrations in gingival crevicular fluid (gcf) at baseline, one and three months subsequently to non-surgical periodontal therapy. material and methods designed as a clinical trial, 24 periodontitis individuals will be voluntarily consented to participate. following non-surgical periodontal treatment, gcf samples will be collected to determine the amount of endothelin-1 at baseline, one, and three months. clinical periodontal parameters will be recorded.

Eligibility criteria:
inclusion criteria: * systemically healthy * generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm) exclusion criteria: * subjects who wore dental prosthesis * teeth with grade ii mobility, * alcoholic and smoker, had treated caries * underwent periodontal therapy within the last four months

Keywords: periodontitis endotheiln-1 scaling and root surface debritment
bmi-driven tolerability and efficacy of entresto in heart failure patients

Conditions: Heart Failure; Obesity

Summary: this study aims to determine if patients with higher bmi can tolerate higher doses of entresto (sacubitril/valsartan) and experience better symptomatic and functional outcomes compared to patients with lower bmi.

this prospective cohort study will enroll heart failure patients with reduced ejection fraction (hfref) to evaluate the tolerability and efficacy of entresto uptitration across different bmi categories (normal weight, overweight, obese, and very obese). primary outcomes include the maximum tolerable dose and incidence of adverse drug reactions. secondary outcomes include changes in heart failure symptoms, functional capacity measured by the 6-minute walk test, hospitalization rates, and mortality.

Eligibility criteria:
inclusion criteria: * adults aged 18 and older * diagnosed with heart failure with reduced ejection fraction (hfref) (lvef ≤ 35%) * naïve to entresto therapy or willing to switch from previous ace inhibitor/arb therapy * ability to provide informed consent exclusion criteria: * severe renal or hepatic impairment (e.g., egfr \&lt; 30 ml/min/1.73m², severe liver disease) * history of angioedema * pregnant or breastfeeding women * patients with malignancies or other severe comorbid conditions * non-compliance with medication regimen

Keywords: heart failure entresto obese sacubitril/valsartan bmi tolerability efficacy nt-probnp
efficacy assessment of three non pharmacological therapies in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: etna3 is a multicentric randomised clinical trial conducted in france to evaluate the impact of cognitive training, reminiscence therapy and a "made-to-measure" program on the progression rate of dementia.

etna3 is a multicentric randomised clinical trial conducted in france to evaluate the impact of non pharmacological treatments on the progression rate of dementia: three non pharmacological treatments are being studied: cognitive training therapy, reminiscence therapy and a "made-to-measure" program. nearly 40 "memory clinics" are participating. 800 patients suffering alzheimer's disease in the mild to moderate stage of the disease will be included. for each therapy, a standard intervention protocol has been defined. the main objective is to determine whether any or several of these non pharmacological treatments can delay the severe stage of dementia during a 2-year follow-up. the secondary outcomes assess cognitive abilities, functional abilities in activities of daily living, behavioural disturbance, apathy, quality of life, depression, caregiver burden and resource utilization

Eligibility criteria:
inclusion criteria: * patients in the mild to moderate stages of alzheimer's disease : mmse score between 16 and 26 ; and stages 3 to 5 of the global deterioration scale * patients over 50 years of age * patients with social security affiliation exclusion criteria: * patients suffering other type of dementia * institutionalized patients * patients with psychiatric disorder * patients with severe pathology in the terminal stages * patients receiving non pharmacological therapies other than that proposed in the study * enrollment in a pharmacological trial in the first 6 months

Keywords: dementia ; alzheimer's disease ; non pharmacological treatments ; cognitive training ; reminiscence therapy ; efficacy assessment
occult gastrointestinal bleeding in non-pulsatile left ventricular assist device(vad)patients

Conditions: Gastrointestinal Bleeding; Complication of Internal Device

Summary: the purpose of this study is to estimate the proportion of ventricular assist device (vad) patients with abnormal gastrointestinal bleeding as assessed by hemoquant fecal occult blood test. also, in patients with gastrointestinal bleeding present, to summarize the extent of gastrointestinal bleeding; to examine the behavior of hemoquant fecal occult blood test over time by estimating the proportion of vad patients with a positive test prior to implantation; at one week, one month, three months, six months and one year post implantation, and after explantation of the vad and to evaluate whether presence of any abnormal fecal hemoquant test is predictive of a future major bleeding event.


Eligibility criteria:
inclusion criteria: * group 1 - cross sectional study. patients with implanted non-pulsatile ventricular assist devices of any type and at any time after implantation * group 2 - prospective study. patients with usual vad indications will be invited to participate, when, in the opinion of their treating physician a vad will be highly likely within one month. exclusion criteria: * unwillingness to provide stool samples for study * unwillingness to be followed for study endpoints. * unwillingness to follow dietary restrictions necessary for accurate hemaquant measurement

Keywords: ventricular assist device gastrointestinal bleeding vad
record: rosiglitazone evaluated for cardiac outcomes and regulation of glycaemia in diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study is a phase 3b, multicentre, randomised, open label, parallel group study. a 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. patients inadequately controlled on background su will be randomised to receive, in addition to su, either rosiglitazone or metformin in a ratio of 1:1. equal numbers of patients receiving background metformin and su at entry will be entered into the study.

a record follow-up study is being performed to monitor the incidence of cancer and bone fractures in record patients for a period of 4 years after the end of the main record study (2008 - 2012).

Eligibility criteria:
inclusion criteria: * patients with type ii diabetes mellitus as defined by 1999 world health organisation criteria. * glycated haemoglobin (hba1c) \>7.0 % to = 9.0 % at visit 1. * use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening. * body mass index \>25.0 kg/m2. exclusion criteria: * patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea. * patients with systolic blood pressure \>180 mmhg or diastolic blood pressure \>105 mmhg. * patients who have required the use of insulin for glycaemic control at any time in the past. * hospitalisation for any major cardiovascular event in the last 3 months.

Keywords: diabetes cv outcomes rosiglitazone type ii diabetes sulfonylurea record metformin
evaluation of the effect of root canal shaping with trunatomy on postoperative pain and operative torque generated during instrumentation

Conditions: Postoperative Pain

Summary: the aim of the present study is to compare the effect of canal shaping using trunatomy and race rotary systems in bi-rooted maxillary premolars in terms of: * post operative pain: incidence and intensity * real time torque generated during mechanical instrumentation using real time torque motoring endodontic motor * time needed for the instruments to reach to the full working length


Eligibility criteria:
inclusion criteria: * patients who are free from any physical or mental handicapping condition and no contributory systemic disease. * age between 30-60 years old. * males \& females. * patients' acceptance for participating in the trial through an informed consent * maxillary permanent premolar teeth: * diagnosed clinically and radiographically with pulp necrosis * with or without periapical radiolucency * negative response of pulp tissue to thermal and electric pulp tester * possessing two independent roots each having a type i canal * patent canals with no internal calcification or resorptive lesions * fully formed roots * root curvatures less than 30 exclusion criteria: * patient with contributory medical condition * badly destructed teeth * patients with pre-operative pain * patients having significant systemic disorders * patients with two or more adjacent teeth requiring root canal therapy * patients who had received antibiotics in the last month * teeth presenting with: * positive response to thermal or electric pulp tester * history of trauma or previous endodontic treatment * immature or open apices * association with acute periapical abscess and swelling or fistulous tract * fused roots at any level * canals larger than size 15# k-file * periodontonal/ endodontic lesions * mobility higher than grade i * radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification. * severe root curvature (\>30)