Kornimate/medical-research-clean huggingface dataset:
efficacy of hydrocortisone in treatment of severe sepsis/septic shock patients with acute lung injury/acute respiratory distress syndrome (ards)

Conditions: Septic Shock; Severe Sepsis; Acute Lung Injury; Acute Respiratory Distress Syndrome

Summary: severe sepsis/septic shock is a serious condition associated with high mortality rate. hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. during the progression of severe sepsis/septic shock, multi-organ dysfunction can develop. acute lung injury (ali) and its more severe form, acute respiratory syndrome (ards) is one of the common organ dysfunction associated with septic shock. information from a meta-analysis suggested that moderate dose of hydrocortisone may improve the ards patients' outcome. whether hydrocortisone can effectively prevent disease progression and death in severe sepsis/septic shock patients who complicated with ali/ards has not been proven.

severe sepsis/septic shock is a serious condition associated with high mortality rate. the pathophysiology of the disease involves the complex interaction between host's immunity and the microorganisms toxin. the release of immune complex and cascade of inflammatory cytokines are responsible for multiorgan dysfunction, especially the cardiovascular system. hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. both anti-inflammation and supplementation of relatively adrenal insufficiency are the main hypothesis of the benefit of hydrocortisone. during the progression of severe sepsis/septic shock, multi-organ dysfunction can develop. acute lung injury (ali) and its more severe form, acute respiratory syndrome (ards) is one of the common organ dysfunction associated with septic shock. although there is controversy about timing and favorable patients'characteristic, the information from a meta-analysis suggested that moderate dose of hydrocortisone may improve the ards patients' outcome. whether hydrocortisone can effectively prevent disease progression and death in severe sepsis/septic shock patients who complicated with ali/ards has not been proven.

Eligibility criteria:
inclusion criteria: * age 18 years and older * diagnosis of severe sepsis or septic shock according to the american college of chest physicians/society of critical care medicine consensus conference 1992 * diagnosis of acute lung injury or acute respiratory distress syndrome according to the american-european consensus conference on ards 1994 * onset of organ dysfunction within 12 hours before enrollment exclusion criteria: * indicated for receive corticosteroid * congestive heart failure * contra-indication for hydrocortisone: for example: allergy to hydrocortisone * pregnancy * not agree to sign the consent form

Keywords: septic shock severe sepsis acute lung injury acute respiratory distress syndrome ards
toxin retrospective study

Conditions: Neurogenic Bladder

Summary: aims of this study were to assess the long-term outcomes of detrusor injection of onabotulinumtoxina (botox® injection) associated with clean intermittent-catheterization (cic) for the treatment of neurogenic detrusor overactivity (ndo) and to identify risk factors for failure.

neurogenic detrusor overactivity (ndo) remains a major concern for patients with neurological diseases. fifty to eighty percent of patients with multiple sclerosis (ms) or traumatic spinal cord injury (sci) and more than 60% of patients with myelomeningocele suffer from urinary incontinence episodes (ui) due to ndo. ndo is characterized by involuntary detrusor contractions during the filling phase, leading to leakage and increase in bladder pressure, which can, precipitate renal failure. detrusor injection of onabotulinumtoxina (botox®), is licensed worldwide and recommended as a second line therapy for the treatment of urinary incontinence due to ndo after failure of anticholinergic drugs (grade a). these recommendations are based on the results of international multicentric, randomized controlled trials. these studies established not only clinical benefits, with a significant decrease of urinary incontinence episodes, but also urodynamic benefits. there are very few data about the real prevalence of failure of botox® in the long term. thus, aims of this study were to assess the long-term outcomes of detrusor injections of botox® associated with clean intermittent-catheterization (cic) for the treatment of ndo and to identify risk factors for failure .

Eligibility criteria:
inclusion criteria: * ndo due to ms, sci or spina-bifida. * follow-up ≥3 years from the first botox® injection. * performing clean intermittent catheterization exclusion criteria: * bladder surgery
isleepms: an internet-delivered intervention for sleep disturbance in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: sleep disturbance, especially insomnia (i.e., difficulty initiating and maintaining sleep), affects over half of people with ms. cognitive behavioral strategies have been shown to improve sleep quantity and quality in several neurologic populations (e.g., traumatic brain injury, parkinson's disease), and cognitive behavioral therapy for insomnia (cbt-i) is considered the first-line insomnia treatment for adults in the general population. although cognitive behavioral interventions have historically been delivered in-person, a growing body of literature supports telephone- and internet-delivered approaches. however, more work is needed to understand the effects of internet-delivered cbt-i on patient-reported and objective outcomes. this study is a pilot randomized controlled trial to test the preliminary effects of isleepms, a cbt-i-based online intervention with telephone support for individuals with ms. after completing a baseline assessment (week 1), 90 participants with ms will be randomized (1:1) to four weeks (weeks 2-5) of isleepms (intervention group) or treatment as usual (tau; control group), and complete post-treatment (week 6) and follow-up (week 12) assessments. isleepms participants will complete daily sleep diary forms and weekly online educational modules. tau participants will continue usual care without access to the isleepms materials. the primary outcomes will be patient-reported and actigraphic measures of sleep quality and quantity. secondary outcomes will be treatment satisfaction, adherence, and integrity (isleepms group only). exploratory outcomes will be fatigue symptoms, depression symptoms, and cognitive function.


Eligibility criteria:
inclusion criteria: * ages 18 and older * ms diagnosis56 of at least 1 year duration * able to speak and read english * sleep disturbance as indicated by an isi score of at least 11 * willingness to commit to a 4-week intervention and 12-week follow-up assessment exclusion criteria: * neurological disorder other than ms * hazardous alcohol use, as indicated by the alcohol use disorders identification test (audit-c) * hazardous substance use, as indicated by the drug abuse screening test (dast-10)
cll empirical antibiotic regimen

Conditions: Chronic Lymphocytic Leukaemia (CLL)

Summary: the purpose of this study is to evaluate whether patients with previously untreated, early stage cll respond to empirical broad spectrum antibiotics and therefore test the hypothesis that occult bacterial infections are involved in the induction and maintenance of cll.


Eligibility criteria:
inclusion criteria: * age \> 18 * ecog performance status of 2 or less. * cll with a diagnostic score of 4 or 5. * clinical stage a disease. * no disease progression over a minimum of 1 month prior to commencement of therapy. * less than 2 adverse prognostic factors. * absence of adverse cytogenetics. * expected survival \> 6 months. * able to give informed consent. * no clinical evidence of active infection at the time of study entry. * no known allergy to any of the study medications. * renal and liver function tests within normal limits. exclusion criteria: * disease progression during screening period. * known positivity for hiv types 1 or 2. * active infection at the time of screening. * pregnancy or lactation. * females of childbearing potential† and males not willing to practice an effective method of contraception whilst receiving the antibiotic regimen and for 4 weeks after the last dose. * concomitant medication likely to produce serious interaction with study drugs including warfarin type oral anticoagulants and anti-epileptics.
exogenous ketone esters for refractory status epileptics

Conditions: Status Epilepticus

Summary: this study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus

generalized convulsive status epilepticus (gcse) is a common neurological emergency in children with significant morbidity and mortality. benzodiazepines (bzs) are the initial anti-seizure medications (asms) for children with gcse, but nearly a third of cases are not controlled by (bzs). moreover, about 40% of cases not responding to bzs are not controlled by second-line asms. ketogenic diet (kd) has been classically used for treating children with drug resistant epilepsy. recently, kd has been used for refractory and super refractory status epilepticus. however, kd takes time to achieve ketosis and may be practically challenging in emergency situations and critically ill patients. exogenous ketone esters (eke) could be a more convenient and rapid way to achieve ketosis in acute settings.

Eligibility criteria:
inclusion criteria: * refractory generalized convulsive status epilepticus. exclusion criteria: * failure to obtain informed consent. * recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications. * hemodynamic or cardio-respiratory instability. * traumatic brain injury. * hypo-/hyperglycemia. * metabolic acidosis. * ketosis (βhb \> 2 mmol/l). * associated severe disease condition, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems. * malnutrition/obesity. * limitations to nasogastric tube feeding. * inborn errors of metabolism. * allergies or any other contraindication to exogenous ketone esters. * current or recent (within the last 24 hours) propofol therapy. * intake of carbonic-anhydrase inhibitors.

Keywords: status epilepticus refractory status epilepticus generalized convulsive status epilepticus exogenous ketone esters children seizures
evaluation of the effects of four different flap designs on tissue healing in lower third molar surgery

Conditions: Soft Tissue Injuries

Summary: the aim of this study is to prospectively evaluate the effectiveness of 4 different flap types used during mandibular impacted wisdom teeth surgery on postoperative quality of life, soft tissue and hard tissue healing at the end of the 3rd month.

patients will be randomly included in 4 groups with 4 different incision types planned among the patients who will apply for impacted third molar tooth extraction, and each group will consist of 25 patients. triangular flap will be applied to the patients in group 1, berwick incision will be applied in group 2, suarez incision will be applied in group 3, and heitz incision will be applied in group 4.the operation time will be recorded on the form. the operation time will be evaluated as the period from anesthesia to the last suture. the patient will be called for control on the 2nd and 7th days after the operation. during control periods, pain value will be recorded using a vas scale numbered between 0 and 10. parameter data such as trismus, edema, halitosis, color of the healing tissue, presence/type of granulation will be recorded on the forms created during the control periods, and the patients' sutures will be removed on the 7th control day, as is done in impacted third molar surgery. patients will be called for a check-up at the end of 3 months to detect hard tissue healing, and a panoramic radiography will be taken to check hard tissue healing. using the patient's 3rd month follow-up x-rays, fractal analysis will be performed in the area to evaluate the quality of the newly formed bone in the extracted tooth area.

Eligibility criteria:
inclusion criteria: 1. patients aged between 18-45 2. do not have a systemic disease that prevents tissue healing 3. patients needed impacted third surgery exclusion criteria 1. pregancy 2. allergic conditions 3. diabetes 4. smokers 5. patients with low oral hygiene

Keywords: third molar surgery flap design fractal analysis soft tissue healing
treatment of crohn's disease with an antibiotic regimen directed against mycobacterium avium paratuberculosis

Conditions: Crohn's Disease

Summary: crohn's disease is a chronic inflammatory disorder of the gastrointestinal tract. the origin of crohn's disease remains unknown and there is no curative therapy, either medical or surgical, for this gut disorder. it is believed that an infectious agent is important in the development of crohn's disease. the similarity of crohn's disease to the animal form of ileitis, termed johne's disease, supports the possibility that both disorders are caused by exposure to mycobacterium avium paratuberculosis or map. multiple investigators have demonstrated good clinical responses of patients with crohn's disease to treatment with triple antibiotic therapy directed against mycobacterial infection. the hypothesis of this protocol is that triple antibiotic therapy is useful as a medical therapy for patients with crohn's disease. the aim of this study is to examine the response of patients with crohn's disease who are not receiving therapy with biological agents to triple antibiotic therapy.

clinical remission will be determined by a decline in the crohns disease activity index to \<151; clinical improvement will be examined using the inflammatory bowel disease (ibd) quality of life questionnaire; and endoscopic improvement will be examined using a crohn's disease endoscopic activity index. all individuals must have had colonoscopy within 3 months of enrollment. an estimated 20 individuals will be enrolled in this protocol. each patient will be treated for 6 months with a combination of rifabutin, clarithromycin, and clofazimine. at the end of 6 months of treatment for each patient, the crohns disease activity index will be recalculated, each patient will again complete the ibd quality of life questionnaire, and each patient will undergo repeat colonoscopy.

Eligibility criteria:
inclusion criteria: * this study will only include patients capable of providing informed consent, ages 18 and older. * patients must have a documented diagnosis of crohn's disease and have had a colonoscopy with photographs within 3 months prior to randomization. * all patients must have a cdai of 220 or greater at enrollment. * all females must be post-menopausal, surgically sterilized, or either abstain from sexual intercourse or use a non-hormonal method of birth control other than or in addition to oral contraceptive during the study and for 6 weeks after the end of the study. exclusion criteria: * any patient with ulcerative colitis * all women of child-bearing age must have a negative urine pregnancy test within 1 week prior to the initial clinic visit. * patients receiving a biological therapy for crohn's disease including remicade * patients with a known allergy to any of the three antibiotics used in this protocol.
skills training for adolescents with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the proposed study will be an initial test of a cognitive-behavioral intervention for adolescents with adhd who are receiving medication treatment. it is based on our successful work with adults with adhd who have been treated with medicines but are still having symptoms. it involves learning skills for organization and planning, attention, and mood.

attention deficit hyperactivity disorder (adhd) is a prevalent, distressing, and interfering condition that affects between 2% and 6% of adolescents. although medications have been widely used as an effective treatment for many years as the sole treatment for adhd, for many, clinically significant and interfering continued symptoms remain. even after medication treatment, adolescents still experience residual adhd symptoms and continue to have problems with inattention, concentration, disorganization, and other symptoms. however, research suggests that adolescents who have received some benefit from medication treatment can then experience further symptom reduction from participation in skills-based cognitive behavioral therapy. this study, adapted from a similar research study for adults with adhd, will examine whether cognitive behavioral therapy (cbt) plus medication is more effective at treating adhd than medication therapy alone in adolescents with adhd. eligible participants will be randomly assigned to receive twelve weekly treatment sessions either immediately upon enrolling in the study or after a four-month waiting period. questionnaires (that participants complete and ones that are done with an interviewer) will be used to assess participants' adhd symptoms at study entry, after receiving the treatment, and at 4 month follow-up. parents will have some involvement in therapy. note: participants must be able to come to boston or another study location in the greater boston area for 4 assessment visits and 12 weekly therapy visits in order for participation to be feasible.

Eligibility criteria:
inclusion criteria: * between the ages of 14 and 18 * in high school * principal diagnosis of adhd * stable prescription of medications for adhd * adhd has childhood onset * clinically significant adhd symptoms exclusion criteria: * organic mental disorders * active substance abuse or dependence * diagnosis of conduct disorder * mental retardation or pervasive developmental disorder * active suicidality * previous history of cbt therapy in adolescence * other condition interfering with consent or participation

Keywords: adolescent adhd
a trial of prednisolone in combination with spi-62 or placebo in subjects with polymyalgia rheumatica (pmr)

Conditions: Polymyalgia Rheumatica

Summary: this will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without spi-62 in participants with pmr.

this will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without spi-62 in participants with pmr. up to 6 cohorts of 12 participants could be recruited (12 to 72 participants). each participant who provides consent and meets all inclusion and exclusion criteria will participate in 3 periods: a screening period up to 28 days (day -28 to day-1), a 4-week treatment period (day 1 to day 28) and a follow up period (day 29 to day 56). during the 4-week treatment period for the first cohort, all participants will receive prednisolone 10mg per day for 4-weeks plus spi-62 for 2-weeks and matching placebo for 2-weeks. for cohorts 2 through 6, the dose of prednisolone co-administered with spi-62 could be adjusted. for cohorts 5 and 6, the dose of spi-62 could be adjusted.

Eligibility criteria:
inclusion criteria: * written informed consent * diagnosis of pmr according to eular/acr classification criteria * absence of pmr relapse based on symptoms and acute phase markers * daily oral prednisolone 10mg dose that will have been stable for at least 1-week at the baseline visit and is expected to remain stable during the treatment period exclusion criteria: * any contraindication for prednisolone administration. * a diagnosis or any clinical features of giant cell arteritis. * any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than pmr. * use of medications for treatment of pmr within specified intervals prior to the baseline visit other than oral prednisolone. * use of other medications likely to interfere with trial assessments. * history or diagnosis of endogenous hypercortisolism. * any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the trial or the evaluation of its results.

Keywords: polymyalgia rheumatica pmr steroids prednisolone glucocorticoid glucocorticoids
vrap-heart - virtual reality assisted patient empowerment for interventions in structural heart disease

Conditions: Severe Aortic Valve Stenosis

Summary: this prospective, randomized-controlled multicenter study investigates whether virtual reality-assisted patient education in patients undergoing transfemoral transcatheter aortic valve implantation (tavi) can improve patient understanding and simulative orientation, thereby reducing postinterventional complications, resulting in significantly shorter length of stay.

this prospective, randomized-controlled multicenter study investigates whether vr-assisted patient education in patients undergoing transfemoral transcatheter aortic valve implantation (tavi) can improve patient understanding and simulative orientation, thereby reducing postinterventional complications, resulting in significantly shorter length of stay. disorientation, anxiety, and pain can lead to the development of delirium and, through complications, to prolonged hospital stays during elective procedures. virtual reality can combine different learning modalities (auditory, visual, written, haptic) and improve patient understanding of the procedure through educational interventions. more detailed knowledge of the environment, the players, the procedure, and safety aspects will reduce anxiety and stress before and during the procedure and reduce complications during post-interventional care. as a result, length of stay should be reduced.

Eligibility criteria:
inclusion criteria: * high-grade aortic valve stenosis * indication for elective transfemoral transcatheter aortic valve implantation under analgesia (tavi) * existing heart center decision * age ≥ 18 years * signed informed consent form exclusion criteria: * surgery planned under general anesthesia * language barrier * severe hearing or vision impairment * advanced dementia syndrome * known seizure disorder (epilepsy) * positive pregnancy test on inclusion and/or pregnancy is present * court ordered placement in an institution * any psychosocial condition that makes compliance with the protocol unlikely
endometrial cancer, risk factors and prevention strategies: perspectives of patients and at-risk women

Conditions: Endometrial Cancer

Summary: to learn more about women's attitudes toward and knowledge about endometrial cancer and options that might decrease the risk of developing

to obtain pilot data regarding women's attitudes and perspectives about endometrial cancer and potential endometrial cancer prevention strategies.

Eligibility criteria:
inclusion criteria: 1. women who present to md anderson cancer center including mda houston area locations with a diagnosis of endometrial cancer 2. women who present to md anderson cancer center including mda houston area locations with a diagnosis of abnormal uterine bleeding or endometrial hyperplasia 3. women without a diagnosis of endometrial cancer or endometrial hyperplasia 4. women must be at least 18 years or age 5. women must be able to read, write, and speak english 6. women must be willing and able to provide written informed consent exclusion criteria: