Kornimate/medical-research-clean huggingface dataset:
transcatheter mitral valve intervention single center registry in chinese patients with mitral valve disease (torch-m)

Conditions: Mitral Valve Disease

Summary: the purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in chinese population with mitral valve disease.

prospective, single-arm, single-center clinical evaluation of transcatheter mitral valve intervention in subjects with mitral valve disease who are treated per standard of care and who have been determined by the local heart team as appropriate for interventional treatment. eligible subjects will be treated by transcatheter mitral valve repair or transcatheter mitral valve replacement. this single-arm registry will provide valuable new information regarding use of multiple mitral valve interventional devices and evaluate the safety and effectiveness of transcatheter mitral valve intervention in chinese population with mitral valve disease.

Eligibility criteria:
inclusion criteria: 1. patients with mitral valve disease, as determined by the site from a transthoracic echocardiogram (tte), and in the judgment of the investigator intervention is likely to provide clinical benefit for the patient. 2. subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. 3. the subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed. 4. patients are technical and anatomical eligible for interventions. exclusion criteria: 1. in the judgment of the investigator, subjects are not anatomical eligible for interventions. 2. known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically. 3. active endocarditis or active rheumatic heart disease. 4. history of severe bleeding diathesis or coagulopathy or subject will refuse blood transfusions. 5. subject has any kind of conditions that might prevent patients benefiting from therapeutic benefit (i.e., severe mental illness) or life expectancy is less than one year. 6. subject has any kind of disorder per investigator's judgement that compromises his/her ability to give written informed consent and/or to comply with study procedures.
normal saline versus balance salt solution resuscitation on kidney function

Conditions: Acute Kidney Injury; Shock

Summary: the purpose of this study is to determine acute kidney injury incidence between sterofundin and normal saline ; resuscitation shock patients

sample size:compare proportion for independent two groups formula. n=sample size α risk of 0.05, statistical power of 80% p1 =incidence of acute kidney injury (aki) in control (0.6)\* p2 =incidence of acute kidney injury (aki) in balanced salt solution (0.4)\*\* from ratanarat r,hantaweepant c,tangkawattanakul n,et al.the clinical outcome of acute kidney injury in critically ill thai patients stratified with rifle classification.j med assoc thai 2009 mar;92 suppl 2:61-7. α risk of 0.05, statistical power of 80% sample size for interim analysis 1.11 x 97 = 107.67 total 108 (at least 50 cases each arm)

Eligibility criteria:
inclusion criteria: * shock patients (hypotension with signs of poor tissue perfusion) exclusion criteria: * age \< 18 yr * cardiogenic shock patients (history of st elevation and left ventricular ejection fraction (lvef) \< 35%), * prolong shock \>24 hrs, * received chloride rich crystalloid (0.9% saline) or chloride rich colloid \> 1000 ml within 72 hrs before recruitment * do-not-resuscitation patients, * contraindication for iv fluid administration such as pulmonary edema., * stage v chronic kidney disease (ckd), * chronic hemodialysis or peritonealdialyse

Keywords: balanced salt solution
a clinical trial to study the effects of two home made mouthwashes in patients with gum diseases

Conditions: Gingivitis; Periodontitis

Summary: periodontal disease is a ubiquitous in nature affecting about 80% population of india. the periodontal disease is a multifactorial but the dental plaque is considered as main etiological agent.the dental plaque, a adhesive bacterial coating accumulate around and in between teeth, if not removed by effective daily brushing and flossing, plaque can cause gum infection and tooth loss. though, many scientific periodontal procedures are available to get the treatment but because of lack of man power and poor socioeconomic condition it is not possible for every group of population in our india.

the need exist for continued research to find the use of home made mouthwashes in preventing periodontal diseases. although, chlorhexidine mouthwash is regarded as gold standard mouthwash as antiplaque but have some limitations like cost factor and side effects like staining of teeth, loss of taste, oral mucosal ulcerations,paresthesia and may enhanced supragingival calculus formation. use of various indigenous products and home made preparations are easily available and are being used since ancient time in india and still in practice in various parts of india especially rural and remote areas. at the same time the use of potassium permanganate is still in practice in various parts of india and also it was in practice before the availability of chlorhexidine, povidone iodine and other antiseptic solutions, as they are used since about 30 years only. use of hot salt water rinsing is in practice especially to reduce the symptoms of various throat infections such as pharyngitis, tonsillitis and also to improve oral hygiene.it is also being used in oral surgery and their effects are also mention in literature. hence, the aim of this study is to assess and compare the efficacy of home made remedies like hot salt water and potassium permanganate as a mouthwash in reducing plaque accumulation and improving gingival conditions with gold standard chlorhexidine mouthwash if found effective may be used as affordable mouthwash for the benefit of population of india.

Eligibility criteria:
inclusion criteria: * subject of chronic generalized gingivitis and mild generalized periodontitis. * not undergone any major periodontal treatment earlier in last 06 months . * otherwise clinically healthy patient. exclusion criteria: * subjects with significant systemic diseases (e.g. diabetes mellitus, cancer or coronary heart disease etc.). * pregnant or lactating women. * smoker. * patients on anti-inflammatory drugs or antibiotics * patients allergic to any material used for the study
nirs in pda vlbw infants

Conditions: PDA

Summary: aim of study: to conduct an observational study to collect cerebral and renal perfusion data through nirs before and after treatment of pda by medication or by pda ligation. the data post treatment would form the basis for normative baseline data in vlbw preterm newborn babies, particularly in the asian population. study population/inclusion criteria: vlbw newborn babies with hemodynamically significant pda by echocardiography. exclusion criteria: major malformations moribund patients

aim of study: to conduct an observational study to collect cerebral and renal perfusion data through nirs before and after treatment of pda by medication or by pda ligation. the data post treatment would form the basis for normative baseline data in vlbw preterm newborn babies, particularly in the asian population. study population/inclusion criteria: vlbw newborn babies with hemodynamically significant pda by echocardiography. exclusion criteria: major malformations moribund patients protocol: consent will be obtained from parents of eligible newborns before treatment of hemodynamic significant pda. to attach cerebral and renal oximeter by nirs to these vlbw infants with pdas for until 24 hours post closure of pda. doppler ultrasound will be performed on anterior cerebral artery (aca) and/or middle cerebral artery (mca) artery and/or renal artery(ra) before pda treatment and/or 24hours after pda closure.this study aims to use one of the more popular neonatal/paediatrics nirs machine, which is the invos cerebral/somatic oximeter the same patient will hence form its own control after treatment. echocardiographic follow-up or clinical assessment for closure of the pda will be performed 24-48 hours after the course of medication or surgical closure.

Eligibility criteria:
inclusion criteria: * vlbw infants with hemodynamically significant pda by echocardiography exclusion criteria: * major malformation * moribund
predictive factors of analgesic response in patients with pain associated with bone metastasys

Conditions: Cancer Pain

Summary: the study aims to improve the knowledge of pain associated with bone metastases, in particular to analyze the clinical course of patients who are affected by pain due to bone metastases, in order to better understand which factors may be related to a faster response to pain therapy.

this is a non-profit, non-pharmacological, multicenter prospective observational study. enrollment will last for 24 months from the opening of the study. the overall duration of the study will be 36 months. based on the primary endpoint, patients will be stratified into 5 groups, corresponding to different times of achievement of stable pain: 1. patients who achieve stable pain at the first assessment (3 days) 2. patients who achieve stable pain at the second or third assessment (6-9 days) 3. patients who achieve stable pain at the fourth or fifth assessment (12-15 days) 4. patients who achieve stable pain at the sixth or seventh assessment (18-21 days) 5. patients who do not reach stable pain on the twenty-first day based on the secondary endpoints, patients with and without neuropathic pain and with and without reaching ppg will be compared with the results of the hads, eort-qlq-c30 \[11\] and karnofsky scale \[12-13\] tests, in terms of final medd (morphine equivalent daily opioid dose) and type of drugs taken. enrolled patients will undergo validated tests, administered by appropriately trained personnel. all the tests mentioned here are in use in clinical practice.

Eligibility criteria:
inclusion criteria: obtaining informed consent; age greater than or equal to 18 years definite diagnosis of solid tumor (histological and/or radiological, as indicated by the corresponding guidelines), already in charge of an oncology service. bone metastases at any site, regardless of the type of primary tumor; patient with pain related to established, new-onset, or current bone metastases of the recrudescence of painful symptoms enrollment must occur at the time of requesting medical intervention for pain related to bone lesions, within 72 hours of reporting. exclusion criteria: patients with cognitive and/or conscious impairments that could affect the evaluation; patients with a history of substance/alcohol abuse/dependence or conditions that contraindicate administration of opioid analgesics; presence of non-oncological pathologies in the decompensation phase. non-understanding of the italian language, both spoken and written.

Keywords: bone metastasis
difficult intravenous access perception: difficult iv access - assessment of patient understanding

Conditions: Understanding Emergency Room Procedures

Summary: aim: patient perception: this aim broadly intends to use traditional script versus a brief video education vignette to determine understanding and preferences among general emergency department patients of rescue access techniques. a challenge of emergency care is providing patient education surrounding procedures in a standardized and patient-oriented manner. this data would provide insight on a patient's understanding of the risks and benefits of rescue access, assess patient preference, and potentially influence what rescue technique is employed in the future. this information may also give us insight onto why diva patients might refuse randomization.


Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years of age * fluent in english * hemodynamically stable emergency department patient exclusion criteria: * history of or current status of difficult intravenous access
compliance in the physicians' health study

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Infarction

Summary: to evaluate the relationships of compliance in taking aspirin or aspirin placebo with the risk of major cardiovascular endpoints, using data collected in the physicians' health study.

background: the physicians' health study was a randomized, double-blind placebo-controlled primary prevention trial designed to test whether 325 mg aspirin every other day reduced risks of cardiovascular disease and whether 50 mg beta-carotene on alternate days decreased cancer incidence among 22,071 male u.s. physicians, aged 40-84 years in 1982. compliance with study pills, the use of non-study aspirin and platelet active drugs, specific side effects of aspirin, the incidence of conditions indicating aspirin use, and study outcomes were assessed at six month intervals during the first year and annually thereafter. the blinded aspirin component of the trial was terminated early and participants were unblinded on january 25, 1988, due to the emergence of a statistically extreme benefit of aspirin on both fatal and nonfatal myocardial infarction, as well as the extraordinarily low cardiovascular mortality rates among study participants. design narrative: separate dose-response relationships were estimated in the aspirin and in the placebo group to determine whether compliance in the placebo group was associated with lower risk, as had been found in some previous trials. rates of cardiovascular endpoints in the placebo group relative to the aspirin group were adjusted for time-varying compliance with study tablets, and the use of non-study aspirin and platelet active drugs. in addition, baseline characteristics of the population and longitudinal assessment of side-effects and new conditions suggesting aspirin therapy were used as predictors of compliance in taking study pills separately in the aspirin and placebo groups. similar longitudinal analyses determined predictors of the use of non-study aspirin and platelet active drugs. the analyses were intended to supplement the already published intent-to-treat analyses. they provided observational evidence concerning dose of aspirin and the risks of major cardiovascular endpoints. examining modification of the aspirin effect in reducing risk of myocardial infarction according to level of compliance aided in the generalizability of results to less motivated populations. evaluating determinants of good study compliance should be of benefit to future large scale clinical trials. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
comparative study of bay86-5300 with a flexible extended regimen for dysmenorrhea

Conditions: Dysmenorrhea

Summary: the is a multi-center, randomized, open-label, active-controlled, parallel-group comparative study (24-week treatment period). the objective of this study is to prove the superiority of bay 86-5300 with flexible extended regimen for treatment of dysmenorrhea to bay 86-5300 with 28-day cyclic regimen in terms of primary efficacy variable, number of days with dysmenorrheic pain over 140 days of evaluation period. in addition, the long-term safety of the flexible extended regimen of bay86-5300 in patients treated for one year will be investigated.


Eligibility criteria:
inclusion criteria: - dysmenorrhea patients with a total dysmenorrhea score (sum of the two sub-scores: severity of dysmenorrhea and use of analgesics) of at least 3 points in each of the last two menstruations before randomization (baseline observation phase) * patients with dysmenorrheic pain during the 2 baseline cycles before randomization. dysmenorrheic pain means any spasmodic pelvic pain or lower abdominal pain with possible radiation towards back or thighs recorded in the patient diary in correspondence with a withdrawal and/or menstrual bleeding episode. pain could start up to 2 days before the onset of the bleeding episode the bleeding and terminates on the last day of bleeding of before * patients having the regular cyclic menstrual period (25 to 38 days) in the latest two menses before randomization (baseline observation phase) * willingness to use a barrier method (i.e., non-hormonal method) for contraception during the study. acceptable methods of contraception include (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device. exclusion criteria: - patients who have organic diseases of which surgical treatment is prioritized by the investigator * patients aged 40 years or older with ovarian chocolate cysts being more than 10 cm in size of the longest diameters * patients with ovarian chocolate cysts having solid part in the cyst * patients for whom yaz combination tablet is contraindicated (according to japanese labeling)

Keywords: yaz flexible regimen drospirenone ethinylestradiol betadex dysmenorrhea japanese patients
ashtangayoga for ibs show positive preliminary effects on symptoms and well-being

Conditions: IBS - Irritable Bowel Syndrome

Summary: the study aims to test the effect of ashtanga yoga on well-being in patients with irritable bowel syndrome (ibs). the intervention comprises group sessions on the ashtanga school of yoga. participants are recruited from primary care and measurements on well-being and ibs symptoms are conducted at pre-treatment, post-treatment and 6-month follow-up.

the intervention comprises participants with ibs to undergo ashtanga yoga sessions in a group led by an authorized yoga teacher for a total period of 10 weeks. the first 4 weeks consisted of 1 session/week and the following 6 weeks consisted of 1 session/2 weeks. all movements and exercises are performed based on the individual's personal capacity in order to avoid distinct discomfort or pain. patients testing positive for ibs will be recruited for the study from primary care. measurements of ibs symptoms, visceral sensitivity, extraintestinal symptoms and quality of life will be assessed at pre-treatment, post-treatment and 6-month follow-up. specific statistical methods will be performed to assess changes from pre- to post-treatments and changes from post-treatment to 6-month-follow-up. effects sizes for within group changes will also be calculated.

Eligibility criteria:
inclusion criteria: * ibs diagnosis exclusion criteria: * prior yoga practise, unable to speak swedish, other serious illness
ezetimibe plus atorvastatin versus atorvastatin alone in subjects with primary hypercholesterolemia (study p03406)

Conditions: Hypercholesterolemia; Atherosclerosis

Summary: to compare the efficacy of ezetimibe 10 mg added daily to ongoing treatment with atorvastatin 10 mg daily versus ezetimibe placebo added daily to ongoing treatment with atorvastatin 10 mg daily in reducing the concentration of ldl-cholesterol (ldl-c) at endpoint after 6 weeks of treatment.


Eligibility criteria:
inclusion criteria: * \>=18 years and \ = 2.6 mmol/l (100 mg/dl) to \<= 4.1 mmol/l (160 mg/dl) using the friedewald calculation available at the time of randomization visit 3 (baseline visit) and triglyceride concentrations of \< 3.99 mmol/l (350 mg/dl) at baseline visit * documented coronary heart disease * currently taking atorvastatin 10 mg daily and history has taken 80 % of daily doses for the preceding 6 weeks prior to visit 3 * liver transaminases (alt, ast) \< 50 % above the upper limit of normal, with no active liver disease, and ck \< 50 % above the upper limit of normal at baseline visit. * cholesterol lowering diet and exercise program for at least 4 weeks prior to and during the study, and stable weight history. * women receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose and regimen for at least 8 weeks and continue same regimen during the study. * women of non-childbearing potential or using acceptable method of birth control. * subjects must be free of any clinically significant diseases other than hyperlipidemia or coronary heart disease that would interfere with study evaluations. exclusion criteria: * subjects whose body mass index is \>=30 kg/sqm at baseline. * subjects who consume \>14 alcoholic drinks per week. * any condition or situation that, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study. * women who are pregnant or nursing. * subjects who have not observed designated washout periods for prohibited medications (eg, potent inhibitors of cyp3a4, prescription or over-the-counter agents know to lower lipid levels, corticosteroids), or have been on a stable regimen of any cardiovascular agent for \<6 weeks.
study of anti-atherosclerotic activity of inflaminat in asymptomatic participants with subclinical atherosclerosis

Conditions: Carotid Atherosclerosis

Summary: the purpose of this study is to investigate the anti-atherosclerotic effect of long-term anti-inflammatory therapy (inflaminat) in asymptomatic participants with subclinical atherosclerosis of carotid arteries.


Eligibility criteria:
inclusion criteria: * men aged 40 to 70 years * subclinical carotid atherosclerosis detected by b-mode ultrasound (increased intima-media thickness 1000-2000 mcm) * arterial normotension or mild arterial hypertension (systolic blood pressure \<160 mm hg, diastolic blood pressure \<90 mm hg) * absence of chronic diseases demanding permanent drug administration (more than 2 month per year) exclusion criteria: * personal history of stroke or transient ischemic attacks * chronic diseases demanding drug administration more than during 2 month per year * individual intolerance of inflaminat or appearance of side effects

Keywords: atherosclerosis inflammation intima-media thickness
textbook outcome in colon carcinoma

Conditions: Outcome Assessment; Cancer of Colon

Summary: background: textbook outcome (to) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an "ideal" surgical result for a particular pathology. the aim of the present study is to record the rate of to in patients undergoing elective surgery for colon cancer. material and methods: retrospective study of all patients undergoing scheduled colon cancer surgery at a spanish university hospital from september 2012 to august 2016. patients with rectal cancer were excluded. the variables included in the definition of to were: r0 resection, number of isolated nodes ≥12, no clavien-dindo ≥iiia complications, no prolonged stay, no readmissions, and no mortality in the first 30 days. the main objective of this study is to analyse the achievement of to in a series of patients undergoing scheduled colon cancer resection at the doctor balmis general university hospital in alicante, spain. the investigators assess the relationship between to and overall and disease-free survival, and analyse the indicators included in the definition of to in colon cancer surgery in order to establish recommendations for its standardization.


Eligibility criteria:
inclusion criteria: * patients undergoing elective colon cancer resection with confirmed histological diagnosis were eligible for the study exclusion criteria: * age under 18 years * emergency surgery * resections of the rectum or resections for pathologies other than cancer * follow-up of less than two years (with the exception of patients who died)