Kornimate/medical-research-clean huggingface dataset:
valacyclovir suppression to improve the stability of vaginal flora among hsv-2 seropositive women

Conditions: Bacterial Vaginosis; Herpes Simplex Virus Type II

Summary: we will be examining the effects of suppressive valacyclovir therapy on the stability of vaginal flora in women who are seropositive for hsv-2. we have preliminary data that suggests the presence of hsv-2 increases the risk for group b streptococcus colonization as well as many other deleterious organisms (e.g. streptococcus pseudoporcinus), in addition to increasing the risk for acquisition of bv-associated vaginal flora. we will be examining the effects of suppressive therapy on the vaginal flora of any hsv-2 seropositive woman.


Eligibility criteria:
screening inclusion criteria: * women 18-40 years of age at the time of screening * willing to be screened for hsv-2 using a rapid, fda approved test * using an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence x 90 days, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy) screening exclusion criteria: * pregnant or nursing mother * use of any antimicrobial agents (vaginal or systemic) for the treatment of any condition within 7 days * presence of any intrauterine device * allergy or hypersensitivity to valcyclovir or nucleoside analogues enrollment inclusion criteria: * women 18-40 years of age at the time of screening * hsv-2 seropositive as determined by rapid hsv-2 testing * using an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence x 90 days, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy) * willing to avoid use of any intravaginal products during study period * capable of providing written informed consent * capable of cooperating to the extent and degree required by this protocol enrollment exclusion criteria: * pregnancy (all women will have a urine pregnancy test prior to randomization and treatment) * nursing mother * menopausal women * use of any antimicrobial agents (vaginal or systemic) for the treatment of any condition within 7 days of study enrollment * known immunocompromised state * significant medical disorder that precludes accurate evaluation of participants condition * presence of any intrauterine device * history of significant hepatic or renal impairment * sensitivity/allergy to valacyclovir or nucleoside analogues * history of acyclovir or valacyclovir resistant hsv infection * participation in a study using an investigational product in the past 30 days

Keywords: bacterial vaginosis herpes simplex virus type ii
decision aids in improving knowledge in patients with newly diagnosed prostate cancer

Conditions: Stage II Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage I Prostate Cancer; PSA Level Five to Ten; PSA Level Less Than Five; PSA Level Ten to Fifty

Summary: this randomized phase iii trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.

primary objectives: i. to test the comparative effectiveness of decision aids (da's) on patient knowledge. secondary objectives: i. to test the impact of in-visit da's alone compared to usual care on quality of life outcomes and treatment utilization. ii. to test the impact of out-of-visit da's alone compared to usual care on quality of life outcomes and treatment utilization. iii. to test the impact of combined in-visit and out-of-visit da's compared to both usual care and individual das on quality of life outcomes and treatment utilization. iv. to test the comparative effectiveness of da's on minority men's knowledge. v. to compare clinic time required to administer the da's across arms. outline: patients are randomized into 1 of 4 arms. arm a: patients receive decision aids "knowing your options" before and "prostate choice" during their consultation visit. arm b: patients receive "knowing your options" decision aid before their consultation visit. arm c: patients receive "prostate choice" decision aid during their consultation visit. arm d: patients undergo usual care. after completion of study, patients are followed up at 12 months.

Eligibility criteria:
inclusion criteria: * patients must have prostate biopsy within 4 months prior to registration showing newly diagnosed prostate cancer, stage t1-3n0m0; in addition, patients must have: gleason score 6-10 * prostate-specific antigen (psa) \< 50 ng/ml * patients who have had a history of non-cutaneous malignancy in the previous 5 years are not eligible; exception: patients with history of non-melanoma skin cancer are eligible * scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not a second-opinion or a consultation following previous discussions of treatment options) * patients may not be concurrently enrolled to another clinical trial for the treatment of cancer; co-enrollment to biospecimen studies is allowed * patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study * patients must be able to read and comprehend english; non-english-speaking patients may participate so long as an interpreter (e.g., family member, clinic staff, etc.) is present for consent, for the decision aid administration, and gathering of baseline and follow-up measures
study for breathing interventions in congestive heart failure

Conditions: Congestive Heart Failure

Summary: slow breathing may reduce stress. adults with congestive heart failure have higher stress than the general population. this study will examine if using slow breathing is feasible among adults with heart failure.


Eligibility criteria:
inclusion criteria: * documented heart failure from medical chart review with signs and symptoms consistent with disease * reduced left ventricular function with ejection fraction of less than or equal to 40% * english speaking exclusion criteria: * new york heart failure association class i or iv * myocardial infarction in the last 3 months * cardiac surgery in the last 3 months * significant valvular heart disease * uncontrolled cardiac arrhythmias * uncontrolled diabetes mellitus (hemoglobin a1c ≥ 8) * uncontrolled hypertension * systolic greater than 140 mmhg * diastolic greater than or 90 mmhg * cognitive impairment (mini-mental state exam less than or equal to 24) * acute major depression in the last 3 months * other psychiatric conditions including schizophrenia or bipolar disorder * attention-deficit-disorder or attention-deficit-hyperactivity disorder * musculoskeletal condition limiting capacity to perform simple movements such as significant chronic lower back pain or neck pain * unstable or severe chronic lung conditions * current participation in a mind-body practice/program * current cancer other than non-melanoma skin cancer * regular swimmer * plays wind or brass musical instruments

Keywords: breathing mind-body
could the intraoperative radiation exposure (fluoroscopy) of percutaneous pedicle screw fixation be reduced using an electronic conductivity device?

Conditions: Fracture Fixation, Internal

Summary: to compare classical pedicle finder versus pedicle finder with impedancemetry on the perioperative radiation exposure of pptlo. these two devices are already used in common practice.


Eligibility criteria:
inclusion criteria: * men and women between 18 and 80 years-old; * patient with an indication of pptlo for one or two segments * patient in a position to understand protocol information; * patient who received information about the protocol and who did not show opposition to participate exclusion criteria: * history of posterior spinal fusion surgery on the spinal level concerned by the study; * morbid obesity (body mass index greater than 35 kg / m²); * major incapable (safeguard of justice, guardianship) and persons deprived of liberty. * simultaneous participation in another research protocol involving the human person
evaluation of the effects of a low free sugar diet in patients with nonalcoholic fatty liver disease

Conditions: Nonalcoholic Fatty Liver Disease

Summary: to study the effects of a low free sugar diet on lipid profile, glycemic indices, liver enzymes, inflammatory factors and hepatic steatosis and fibrosis in patients with nonalcoholic fatty liver disease, 50 patients who referred to gastrointestinal (gi) clinic with steatosis grade 2 and 3 will be randomly allocated to receive low free sugar diet or regular diet for 12 weeks; both groups will be advised to adherence the investigators' nutrition recommendation and exercise program too. at the first and the end of the intervention, lipid profiles, liver enzymes,glycemic indices, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.


Eligibility criteria:
inclusion criteria: 1. age of 18 to 60 years 2. body mass index (bmi) between 25-40 3. sonographic findings compatible with hepatic steatosis (degree 2 or more) exclusion criteria: 1. alcohol consumption 2. pregnancy or lactation 3. other liver disease (viral,cirrhosis,...) 4. use of drugs such as phenytoin,tamoxifen,lithium 5. a history of cancer, autoimmune disease,renal disease \& celiac disease, hypothyroidism or cushing's syndrome 6. lack of desire to continue studying 7. have to use antibiotics with hepatotoxic drugs while studying 8. non-compliance with diet
clonal hematopoiesis of immunological significance

Conditions: Immune System Diseases; Autoimmune Diseases; Inflammation; Autoinflammatory Diseases; Vexas Syndrome; Hematopoiesis Clonal; Clonal Hematopoiesis of Indeterminate Potential; Hematologic Diseases; Myelodysplastic-Myeloproliferative Diseases; Leukemia Myelomonocytic Chronic; Myelodysplastic Syndromes; Myeloproliferative Disorders; Lymphoproliferative Disorders; Lymphoma; Leukemia; Monoclonal Gammopathy of Undetermined Significance

Summary: ambispective, national, multicenter observational cohort study aimed at characterizing the satellite dysimmune manifestations of clonal hematopoiesis, including vexas (vacuoles, e1 enzyme, x-linked, autoinflammatory and somatic) syndrome.

the clinical spectrum of dysimmune manifestations associated with blood diseases is wide. the pathophysiology of these manifestations is not well understood and their management is poorly codified. this observational cohort aims to list the different clinical pictures, the therapeutic management and the prognosis of patients according to the type of dysimmune manifestations and the type of hemopathy. we wish to have an inventory of the demographic, genetic, clinical and evolutionary data of patients with an inflammatory manifestation associated or not with a myeloid or lymphoid hemopathy. this will make it possible to establish quantitative data on the morbidity and mortality of these rare diseases and to propose therapeutic trials for the most serious patients.

Eligibility criteria:
inclusion criteria: * age \>=18 years old * confirmed dysimmune manifestations: clinical or biological abnormality or systemic disease * presence or absence of myeloid or lymphoid blood disease according to world health organization (who) classification exclusion criteria: * persons benefiting from special protection: adults under guardianship and curatorship; people hospitalized without their consent and not protected by law; persons deprived of liberty. * persons not affiliated to the social security system

Keywords: inflammation autoinflammatory diseases vexas syndrome autoimmune diseases clonal hematopoiesis of indeterminate potential myelodysplastic-myeloproliferative diseases lymphoproliferative disorders monoclonal gammopathy of undetermined significance
use of lumbar drain to remove clots in patients admitted to the neuro-icu after subarachnoid hemorrhage.

Conditions: Subarachnoid Hemorrhage.

Summary: recently, a clinical trial showed that the use of lumbar drains compared to ventricular drain in patients suffering from subarachnoid hemorrhage resulted in less delayed ischemic neurological deficits but failed to show a clinical benefit after 6 months. the underlying assumption was, that the cerebrospinal fluid (csf) obtained from lumbar drains has a higher concentration of blood than csf from lumbar drains. the investigators decided to test this assumption. in this study, the investigators will randomize patients to either placement of a ventricular or a lumbar drain and analyze the csf drainage on a daily basis.


Eligibility criteria:
inclusion criteria: * patients admitted to the neuro-icu with aneurysmal subarachnoid hemorrhage * in need for csf drainage based on clinical judgment exclusion criteria: * intraventricular clots * intraparenchymal clots causing midline shift * pregnancy
polypharmacy in clozapine-resistant schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the aim of this randomized, double-blind study is to verify the hypothesis that clozapine monotherapy is as efficient as a combination of clozapine and olanzapine therapy in treatment-resistant schizophrenia. a third of schizophrenia patients are non -responders to medications used nowadays. these patients are usually treated with clozapine, but a large proportion of patients don't recover sufficiently. therefore, these patients are treated with combination of two or more drugs to achieve better treatment results. until now the scientific evidence has been insufficient to assess the utility of polypharmacy. the aim is to study during 2009 with voluntary patients, if there is any benefit of olanzapine augmentation compared with pure clozapine monotherapy. during the study the patients are not exposed to any additional intervention. the intervention in this study is just to reduce the previously used polypharmacy. methods: this study lasts for 24 weeks. participants (30) are randomized in one of two alternative interventions (a or b) before the study. after 12 weeks the intervention arms cross over (from a to b and from b to a). group b: in addition to clozapine, the participants receive their normal dosage of olanzapine (=the same as on the hospital ward) for 12 weeks, next the decreasing dosage of olanzapine for four weeks and subsequently placebo for 8 weeks group a: : in addition to clozapine the participants receive the decreasing dosage of olanzapine for four weeks, next placebo for 8 weeks, after that the increasing dosage of olanzapine for four weeks and subsequently the normal dosage of olanzapine for 8 weeks the response for the medical treatment is assessed by clinical global improvement scale (cgis) and global assessment of functioning (gaf) -scale. the primary outcomes are gaf and modified cgis during the parallel phase of the study (the first 12 weeks). the second phase (the last 12 weeks) of the cross-over study is used in the secondary analysis. the use of additional medication (such as benzodiazepines) is used as a secondary outcome measure.


Eligibility criteria:
inclusion criteria: * age ≥18 years, (adult), legally competent * the patient is able to understand the purpose of the study and is eligible to sign the written informed consent form. * insufficient response to the valid clozapine-olanzapine -polypharmacy * psychotropic medication has been constant (unchangeable) during the past 2 months exclusion criteria: * pregnancy
cognitive behavioral therapy delivered over the internet for women with postpartum depression

Conditions: Postpartum Depression

Summary: this study will develop and test a web-based program to treat women with postpartum depression.

after a woman gives birth, she will often feel anxious, depressed, or upset. for most women, these feelings go away within a week of giving birth, but for some, postpartum depression (ppd) can develop. ppd involves long-term, more severe feelings of anxiety, depression, and despair that impair normal functioning. untreated ppd threatens both the mental health of mothers and the development of their infants, but many cases go untreated. this may be because of the stigma of mental health treatment, limited availability of programs, cost of treatment, or difficulty finding the time to schedule trips out of the home. treatment through a web-based program addresses all these concerns by providing a private, cost-efficient program available anywhere with computer access. this study will develop and test a web-based version of cognitive behavioral therapy (cbt) to treat women with ppd to determine its feasibility and acceptability. participation in this study will last 3 months. all participants will be offered a web-based version of cbt for ppd. the cbt program will include guided behavioral strategies for dealing with depression, online videos of women who have used these strategies, web forums in which participants can ask questions of peers and experts, and periodic phone coaching. the program will last 6 weeks. all participants will complete assessments at baseline, post-treatment, and 3-month follow-up. safety monitoring questionnaires will also be completed at weeks 2 and 4 of treatment. assessments will include clinical interviews and questionnaires related to the following: health; depression; demographics; maternal skills, stress, and self-efficacy; internet use, experience, and self-efficacy; behavioral self-efficacy; and program acceptability.

Eligibility criteria:
inclusion criteria: * within 6 months postpartum * home access to the internet * use of personal e-mail * score from 12 to 20, inclusive, on the edinburgh postnatal depression scale * diagnosed as having postpartum depression exclusion criteria: * current diagnosis of substance abuse, bipolar disorder, or psychotic depression * currently receiving treatment for depressive symptoms, including antidepressant medication or psychotherapy * currently has suicidal intentionality, lethality, access to means, and history of suicide attempts

Keywords: web-based intervention cbt treatment
the implementation of intravascular ultrasound and fractional flow reserve in the percutaneous treatment of very long coronary artery lesions

Conditions: Coronary Artery Disease

Summary: a single center, prospective, observational study to investigate the impact of intravascular ultrasound (ivus) on the functional percutaneous coronary intervention (pci) result (assessed with fractional flow reserve (ffr)) and one-year target vessel failure (tvf) rate after percutaneous treatment of long coronary artery lesions


Eligibility criteria:
inclusion criteria: * chronic coronary syndrome (stable angina; staged pci to other lesions after acute myocardial infarction with st segment elevation); * acute coronary syndrome without st segment elevation (unstable angina or myocardial infarction without st segment elevation); * functionally significant (ffr ≤ 0.8) lesion requiring a stent length of ≥ 30 mm and amenable for percutaneous coronary intervention. exclusion criteria: * patient's age ≤ 18 years; * acute myocardial infarction with st segment elevation; * treatment with dual antiplatelet therapy contraindicated; * survival expectancy ≤ 1 year; * known allergy to sirolimus, everolimus or zotarolimus.
effects of replacing lantus with basalin on the glycemic variation in patients with type 2 diabetes mellitus

Conditions: Type2 Diabetes

Summary: the study will assess the glycemic variationusing continuous glucose monitoring system in type 2 diabetic patients with euglycemia control respectively when patients was treated with basalin and one week after changing the insulin into lantus.

the participants will take continuous glucose monitoring system for 3 days when they change the insulin into lantus after reach euglycemia control with basalin treatment for one week.

Eligibility criteria:
inclusion criteria: 1. patients with t2dm, which was defined bypublished criteria of world health organization in 1999; 2. patients were using basalin with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 3 month would be recruited into this study; 3. patients had relatively constant diet and exercise in 2 month before the study. 4. fasting blood glucose\<6.1mmol/l, and postprandial (or random) blood glucose \<14mmol/l exclusion criteria: 1. patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure; 2. patients with severe infectious diseases; 3. patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis; 4. patients with history of psychiatric disorders and were unsuitable to use cgms; 5. any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.
the pio ii study: in-office post-op placement of a steroid-eluting sinus implant

Conditions: Chronic Sinusitis, Ethmoidal

Summary: randomized, controlled, blinded clinical trial with 40 patients randomized in a 1:1 ratio to either treatment (bilateral in-office placement of a drug-eluting implant in the ethmoid sinuses following ethmoidectomy) or control (post-op standard of care) group and followed for 6 months.

this prospective, randomized, controlled, blinded trial aimed to assess the efficacy of a drug-eluting sinus implant placed following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids, compared to the same standard of care alone (control). patients returned for follow-up examination at 2 weeks and again at 1, 3 and 6 months after placement. follow-up examination consisted of patient-reported outcomes and endoscopic grading by clinical investigators and an independent sinus surgeon based on a centralized, blinded video-endoscopy review.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of chronic rhinosinusitis, defined by the aao-hns 2015 guidelines, including presence of bilateral ethmoid disease. * ess including bilateral ethmoidectomy with middle meatal antrostomy within 7 days prior to scheduled implant placement. concurrent septoplasty and surgical treatment of the other paranasal sinuses also permitted. exclusion criteria: * known history of intolerance to corticosteroids or an oral steroid-dependent condition. * known history of immune deficiency, insulin-dependent diabetes, cataracts, or glaucoma

Keywords: steroid-eluting sinus implant mometasone furoate endoscopic sinus surgery