Kornimate/medical-research-clean huggingface dataset:
clinical trial of cbs-2004 in prevention of travelers' diarrhea

Conditions: Traveler's Diarrhea

Summary: this study is designed as a randomized double-blinded treatment trial among travelers' to geographical areas with moderate-severe rates of traveler's diarrhea. travelers will be randomized to receive cbs 2004 or masked placebo to be taken daily while traveling. the test article or placebo will be taken starting 7 days prior to travel.


Eligibility criteria:
inclusion criteria: 1. healthy subjects, 18 years old or older 2. travel on moderate-high risk itinerary for traveler's diarrhea for minimum of 14 days and maximum of 6 weeks travel 3. able to comply with study and follow-up procedures 4. subjects willing and able to enter data in the diary card 5. an irb approved informed consent form is signed and dated 6. subjects must have adequate general health (as determined by investigators) 7. women: non-nursing and negative urine/serum pregnancy test with understanding through informed consent process to avoid pregnancy during the study while on the study drug. should an individual have a documented surgical sterilization in her medical record, a pregnancy test will not be required. if a volunteer becomes pregnant during the study, the principal investigator (pi) will notify the study research monitor and the institutional review boards (irbs). the pregnancy outcome will be followed per irb and other regulatory requirements. exclusion criteria: 1. allergy to investigational product 2. history of functional bowel disorder (including ibs) 3. chronic intestinal disease (ulcerative colitis, crohn's disease), post vagotomy diabetic autonomic neuropathy, malabsorption, short bowel syndrome, celiac disease, bacterial overgrowth due to blind loops, pancreatitis 4. antibiotic use within 7 days prior to enrollment (except for malaria prophylaxis excluding doxycycline) 5. use of other probiotics or prebiotics (outside of the study product) in the prior 3-weeks or intent to use during the study period. this includes the over-the-counter preparations of probiotics, prebiotics (including inulin, lactulose) or consumption of a bio-yogurt product. 6. lactose intolerant (allergies to dairy products). 7. medications usage as deemed by the pi to interfere with gi function 8. diarrheal illness within 7 days prior to enrollment 9. subject has a concomitant disease or condition that could interfere with or for which treatment could interfere with the conduct of the study, or could in the opinion of the investigator increase the risk of adverse events (aes) during the subject's participation in the study. 10. use of any investigational or non-registered drug other than the study drug within 30 days preceding the study enrollment.
laparoscopic surgical management of endometriosis on fertility

Conditions: Endometriosis

Summary: the aim of the investigators study is to know the results of the endometriosis surgery and particularly to highlight a benefit of this surgery on fertility.


Eligibility criteria:
inclusion criteria: * patients over 18 years * patients operated by laparoscopy for endometriosis in our department between 2006 and 2014. exclusion criteria: * patients under 18 years

Keywords: endometriosis fertility endometriosis surgery
postpartum contraception counseling on the rate of unintended pregnancy

Conditions: Improving Quality of Life

Summary: unwanted pregnancies are not only the major cause of maternal mortality and morbidity but are also a great social and financial burden on societies and countries. according to world-health-organization statistics, there are an estimated 200 million pregnancies around the world each year, and a third of these, 75 million, are unwanted. unintended pregnancy also is a major health problem in the united states of america. in the 2002 national survey of family growth assessment, 1.22 million, or 31%, were reported as unintended. when abortions were included, unintended pregnancies increased to 2.65 million, or 49% of all pregnancies


Eligibility criteria:
inclusion criteria: 1. age: above 18 years 2. primigravida 3. women who will accept to participate in exclusion criteria: 1. women who are not intended to use contraception 2. multiparous 3. women who refuse to participate in the study
healthy and positive pathways for young people with type 1 diabetes (happy t1d)

Conditions: Type 1 Diabetes

Summary: in this 2-year randomized clinical trial, we will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress and improve glycemic outcomes in adolescents and young adults, aged 14-25 years, with t1d in order to optimize their short-term and long-term health.

in this study, we will recruit 180 adolescents and young adults (ages 14-25) with type 1 diabetes for at least 1 year and suboptimal diabetes control (a1c 7-13%) to participate in a 2-year randomized clinical trial aimed at reducing diabetes distress and improving glycemic outcomes. adolescents and young adults with type 1 diabetes represent a population that often has uncontrolled diabetes with elevated a1c levels and experiences diabetes distress, making such patients ideal for this study. participants will be randomly assigned to one of two groups (control or intervention). the intervention group will participate in monthly intervention sessions with a research assistant during the first year of the study. four sessions will focus on improving glycemic outcomes and 8 sessions will focus on reducing diabetes distress. the sessions will be conducted face-to-face or remotely. to ensure adequate recruitment and retention, the control group will participate in the intervention sessions during the second year of the study. participants in both groups will use continuous glucose monitoring (cgm), with cgm data downloaded every 3 months. participants in both groups will complete surveys and have a1c measured every 6 months. we will compare the two groups on percent time in target glucose range (70-180 mg/dl), a1c, and diabetes distress from baseline to 1 year. we hypothesize that the intervention group will have an improvement in percent time in range, a1c, and diabetes distress, compared with the control group.

Eligibility criteria:
inclusion criteria: * age 14-25 years * diagnosis of type 1 diabetes (according to ada criteria) * type 1 diabetes duration ≥12 months * a1c 7-13% * smartphone or regular access to wifi via computer * fluency in english at a 5th grade level or higher (based on investigator assessment of grade level in school or highest grade level achieved and presence in mainstream academic classes) exclusion criteria: * physical or mental health condition that in the determination of the investigators may limit the ability to fully participate in the study (e.g., autism) * participation in another intervention study within the last 3 months * currently pregnant or intending to become pregnant during the study (assessed by self-report)
vitamine d in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: two hundred and forty patients with multiple sclerosis who met the study criteria will be enrolled in this randomized double blind placebo-controlled clinical trial. they will randomly assigned to placebo or vitamin d treatment group. the total time of study is 52 weeks and the vitamin d group will be treated by weekly 50000 international unit(iu) vitamin d, while the other group will receive weekly placebo. the annual relapse rate and edss will be compared at baseline, month 6 and 12.


Eligibility criteria:
inclusion criteria: * bmi:18-30kg/m2 * caucasian race * relapsing remitting multiple sclerosis * treatment with interferon beta exclusion criteria: * recent vitamin d supplement therapy * restricted fat diet * nephrolithiasis in recent 5 years * past history of hyperparathyroidism, sarcoidosis, cancer * past history of hepatic disease * past history of gastrointestinal disease * past history of mycobacterial infection * past history of hypercalcemia and hypercalciuria * serum creatinine\>1.5 * smoking, drug abuse and corticosteroid therapy in recent year * treatment with thiazides or other drugs that inhibit vitamin d absorption * disease attack in recent 2 months * serum ca\>2.6mm0l/l * serum 25(oh)d\>85mmol/l * hypersensitivity to cholecalciferol * past history of heart disease * major depression * uncontrolled hypertension (bp\>180/110) * immunosuppressive therapy

Keywords: multiple sclerosis vitamin d edss arr
beb conditioning regimen for autologous stem-cell transplantation(asct) in non-hodgkin's lymphoma

Conditions: Lymphoma, Non-Hodgkin

Summary: phase ii study for safety and efficacy of beb (bendamustine, etoposide, busulfan) conditioning regimen for asct in non-hodgkin's lymphoma


Eligibility criteria:
inclusion criteria: 1. patients with histologically diagnosed non-hodgkin's lymphoma 2. 16 ≤ age ≤ 65 years 3. adequate cardiac function with cardiac ejection fraction greater than 50% by echocardiogram or multiple gated acquisition scan(muga) 4. adequate kidney function with serum creatinine\< 2.0 mg/dl 5. adequate liver function with /serum bilirubin lower than 2 times the normal upper limit, aspartate aminotransferase(ast)/ alanine aminotransaminase(alt) lower than 3 times the normal upper limit. in case of dlbcl liver invasion; serum bilirubin lower than 5 times the normal upper limit, ast/alt lower than 5 times the normal upper limit. 6. adequate bone marrow function with absolute neutrophil count ≥ 1,500/µl; platelets ≥ 75,000/µl; hemoglobin ≥ 9.0 g/dl 7. patients who voluntarily gave informed consent before performing any test that is not part of routine care of patients 8. candidate for asct exclusion criteria: 1. positive serology for hiv, hepatitis c virus(hcv) if the hepatitis b virus(hbv) patient was administrated prophylactic antiviral agents. it would be eligible following the judgment of the investigator 2. pregnant or breast-feeding. females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial. 3. patients with serious or uncontrolled medical condition; 1) abnormalities in cardiac function or clinically significant heart disease such as congestive heart failure, arrhythmia, unstable angina with treatment within 6 months or acute myocardial infarction; 2) previous history of serious neurological or psychiatric disease; 3) acute, severe active infection requiring immediate treatment(virus, bacteria, fungal infection); 4) chronic obstructive pulmonary disease requiring oral steroid therapy or forced expiratory volume 1 sec(fev1)\<0.8 l less than the test of pulmonary function at rest; 5) if there are other diseases that are deemed inappropriate as a target of the present clinical trial following the investigator's judgment; 6) congenital or acquired bleeding disorders 4. patients receiving any other investigational systemic therapy (hormone, immune, chemotherapy) 5. allergic to the investigational drug 6. patients who have difficulty understanding the informed consent form or patients who did not give consent 7. serum bilirubin upper than 2 times the normal upper limit 8. major surgery procedure within 30 days prior to start of investigational treatment 9. patients vaccinated against yellow fever
thiol-disulfide homeostasis in patients with ovarian cancer

Conditions: Ovarian Cancer

Summary: ovarian cancer is the third most common after endometrial and cervical cancer in societies with a high standard of living; it is the second most common type of gynecological cancer after cervical cancer in societies with a low standard of living, and it is also the deadliest among gynecological cancers. dynamic thiol-disulfide homeostasis is an antioxidant system that minimizes oxidative damage and prevents cell damage. in the presence of oxidative stress, the thiol groups combine to form the disulfide structure, and when the oxidative stress condition is over, they are separated into thiol groups again. this homeostasis is impaired in conditions that cause oxidative processes such as diabetes, cardiovascular diseases, cancers, rheumatoid arthritis, and chronic kidney failure. this can be determined by measuring the total thiol and native thiol levels. likewise, the level of ischemia modified albumin increases in the case of oxidative stress. there are studies on this homeostasis in the literature on many types of cancer; there are studies on endometrial cancer and cervical cancer, which are gynecological cancers in this study, the usability of these tests together with other diagnostic tests in the diagnosis of ovarian cancer will be evaluated.


Eligibility criteria:
inclusion criteria: * histopathological diagnosis of ovarian cancer exclusion criteria: * having an acute or chronic disease that will cause oxidative stress * using alcohol/cigarettes/drugs * using antioxidant agents (such as vitamins a, c, e)
rhinopharyngeal retrograde clearance is effective to adequate upper airways function in adults

Conditions: Nasal Obstruction; Exposure to Pollution

Summary: professionals working in polluted areas may present increased clinical airways symptoms and dysfunction. rhinopharyngeal retrograde clearance (rrc) has been used to improve mucus clearance in infants with bronchitis and bronchiolitis, and instillation the nasal cavity with saline has been used to reduce nasal inflammation in rhinitis and sinusopathies. the aim of this study was to assess the effects of rrc and rcc combined with saline (rrc+s) on nasal mucociliary clearance (mcc), mucus surface property, cellularity and airways symptoms in professional motorcyclists.

male motorcyclists (mean age 36 years) were recruited and randomly assigned to rrc or rrc+s. subjects were assessed at baseline and 15 days after interventions for saccharin test, mucus contact angle, cellularity in nasal lavage and airways symptoms with the use of snot-20 questionnaire. data were analyzed by two-way anova for repeated measures with bonferroni´s correction. a passive monitoring-system of nitrogen dioxide was used to assess the individual air pollution exposure along the study period. the association between nitrogen dioxide and the airways outcomes was analyzed by spearman correlation test.

Eligibility criteria:
inclusion criteria: * professional motorcyclists aged 18 years to 45 years * minimum of one year in that occupation * agreement with the written informed consent exclusion criteria: * smokers * inability to understand and to follow commands * previous nasal surgery * respiratory infection in the previous 30 days

Keywords: motorcyclist nasal mucociliary clearance physical therapy
locally administered clodronate in the prevention of aseptic implant loosening

Conditions: Hip Arthrosis

Summary: periprosthetic bone-loss after total hip arthroplasty (tha), detected as an early migration of the prosthesis, may predict later loosening. the investigators hypothesized that by reducing bone resorption after tha with bisphosphonates, it might be possible to achieve better early fixation of the implant. nineteen patients suffering arthrosis were recruited to a prospective, double-blinded, randomized, placebo-controlled clinical pilot trial. patients were operated with an uncemented bimetric stem with tantalum markers, the acetabular cup and liner were chosen by the surgeon. the femoral proximal intramedullary canal was rinsed with 1mm (millimole) clodronate, that was done by adding the clodronate to the 1000 ml 0.9% nacl (sodium chloride) in nine patients and rinsing solution was the pure 0.9% nacl for 10 patients. these rinsing packages were labeled only with the code from the pharmacy of the hospital. these patients were followed for two years using radiostereometric analysis (rsa), dual energy x-ray absorptiometry (dxa) and the harris hip score (hhs). the purpose of the investigator's study was to examine whether the local intraoperative administration of clodronate could reduce periprosthetic bone loss and further stem migration after primary tha.


Eligibility criteria:
inclusion criteria: * hip arthrosis and * a primary tha was planned exclusion criteria: * renal insufficiency * hypercalcemia * malignant tumors * contemporaneously treatment with another bisphosphonate or aminoglycoside

Keywords: rsa dxa bisphosphonates migration of stem aseptic loosening of prosthesis
reduced-dosed rivaroxaban in the long-term prevention of recurrent symptomatic vte(venous thromboembolism)

Conditions: Pulmonary Embolism; Thromboembolism; Thrombosis; Venous Thrombosis; Venous Thromboembolism

Summary: this is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy. patients with confirmed symptomatic dvt (deep vein thrombosis) or pe (pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial


Eligibility criteria:
inclusion criteria: * patients with confirmed symptomatic pe and/or dvt who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week exclusion criteria: * legal lower age limitations (country specific) indication for therapeutic-dosed anticoagulants indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (nsaid) hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk calculated creatinine clearance \< 30 ml/min

Keywords: deep vein thrombosis pulmonary embolism long-term prevention of recurrent symptomatic vte
quality of life (qol), coping and psychological symptoms in children and adolescents with cyclic vomiting syndrome

Conditions: Vomiting Syndrome

Summary: 1. characterize the quality of life of young children with cvs (i.e., psychological, social, physical, school functioning) and the impact of the child's illness on the parent's and family's quality of life (i.e., emotional, social, cognitive functioning, communication, worry, daily activities and family relationships). 2. assess symptoms of depression, anxiety, adhd and behavioral problems in what our preliminary data suggests is a psychiatrically vulnerable population. 3. evaluate the associations between quality of life and psychiatric symptoms and the frequency and intensity of cvs attacks. 4. use the data generated from this study to develop a psychosocial intervention targeted at young children with cvs and their families who evidence risk for functional disability, with the aim of intervening as early as possible to limit the psychological and social morbidity experienced by children with cvs and their and families.


Eligibility criteria:
inclusion criteria: * diagnosis of cvs exclusion criteria: * children and parents who are not english speaking * youth with significant developmental delay, mental retardation, psychotic symptoms, or other significant mental impairments and those with other major medical disorders such as iddm, congenital heart disease, cystic fibrosis, etc.

Keywords: youth consensus criteria cvs
lithium cannabis withdrawal study

Conditions: Cannabis Dependence; Substance Withdrawal Syndrome

Summary: this trial will examine the efficacy of lithium in providing symptomatic relief from the withdrawal discomfort experienced by some dependent users of cannabis on cessation of regular use. significant withdrawal may be a barrier to achieving abstinence in some clients and can be associated with marked disturbances in mood, sleep, hostility and aggression. relief from such symptoms may be important in helping some clients achieve a period of abstinence and facilitate subsequent entry into a relapse prevention program.

there are currently no accepted pharmacotherapies for the management of cannabis withdrawal. a recent study by cui et al (2001) investigated the effects and mechanism of lithium on cannabinoid withdrawal in rats. the researchers found that lithium administration prevented the development of withdrawal symptoms, and suggested that increased oxytocin secretion resulting from lithium dosing prevented the withdrawal syndrome from occurring. although caution should be exercised in generalising the results of an animal study, preliminary results of a small pilot study in humans are consistent with the potential utility of lithium in the management of human cannabis withdrawal (zhang, personal communication). furthermore, human use of lithium is well established and the addition of a readily available drug such as lithium carbonate would be a useful clinical tool should it prove efficacious in a series of clinical trials.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of cannabis dependence with at least a three-month history. * seeking treatment for primary cannabis problem * withdrawal identified as barrier to abstinence exclusion criteria: * other drug dependency (excluding nicotine) * client is breastfeeding or pregnant. * client has contraindicated medical or psychiatric conditions. * client currently taking other medications that may interact with lithium. * known hypersensitivity / side effects with lithium. * currently receiving lithium from another source. * currently prescribed any antidepressant / mood stabilising / antipsychotic medication. * currently receiving opioid pharmacotherapy.

Keywords: cannabis withdrawal lithium cannabis withdrawal syndrome
choosing wisely: de-implementing fall prevention alarms in hospitals

Conditions: Accidental Fall; Patient Safety; Hospital Acquired Condition; Clinical Alarms; Mentoring

Summary: this is a hybrid ii de-implementation study to reduce use of fall prevention alarms in hospitals. the intervention consists of tailored, site-specific approaches for three core implementation strategies: education, audit/feedback and opinion leaders. hospital units will be randomized to low-intensity or high-intensity coaching for the implementation of the tailored strategies.

inpatient falls result in significant physical and economic burdens to patients (increased injury and mortality rates and decreased quality of life) as well as to medical organizations (increased lengths of stay, medical care costs, and litigation). the centers for medicare \& medicaid services (cms) considers falls with injury a "never event"- an error in medical care that indicates a real problem in the safety and credibility of a health care institution. hospitals are no longer reimbursed for extra costs incurred in the diagnosis and management of inpatient fall-related injuries. thus, because patient falls are common, costly and interpreted as poor care quality, hospitals are highly incentivized to prevent them. alarm systems are designed to reduce falls by alerting staff when patients attempt to leave a bed or chair without assistance. there is now strong evidence that alarms are ineffective as a fall prevention maneuver in hospitals. despite this, more than one-third of hospital patients are undergoing fall prevention alarm monitoring. in nursing homes, cms regulates the use of fall prevention alarms as it does physical restraints. instructions to nursing home surveyors state these devices should be used only when medically necessary and continuously reevaluated. guided by the choosing wisely de-implementation framework, this project will generate a generalizable approach using coaching and tailored de-implementation strategies to reduce use of fall prevention alarms in hospitals. the investigators will conduct a hybrid ii implementation study in 30 medical or medical-surgical units from us non-federal hospitals participating in the national database of nursing quality indicators. findings from this study could also support future trials aimed at de-implementing low-quality alarm use in other care settings with known high fall rates (e.g., stroke care, cancer care). evaluation of high versus low intensity coaching addresses an urgent need to evaluate use of tailored strategies and to establish effective thresholds for coaching within health service settings that have varying resources to support de-implementation efforts

Eligibility criteria:
inclusion criteria: * stakeholders in fall prevention at up to 30 participating ndnqi hospitals exclusion criteria: -