Kornimate/medical-research-clean huggingface dataset:
comparison of alendronate with atorvastatin in chronic periodontitis

Conditions: Chronic Periodontitis

Summary: the present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of two local drug delivery systems containing 1% aln gel and 1.2% atv gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to srp.

background: alendronate and atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. the aim of the present study is to evaluate and compare the efficacy of 1% aln and 1.2% atv gel as a local drug delivery system in adjunct to scaling and root planning (srp) for the treatment of intrabony defects in patients with chronic periodontitis. methods: a total of 90 intrabony defects were treated with either1%aln, 1.2% atv or placebo gel. clinical parameters (plaque index, modified sulcus bleeding index, probing depth \[pd\], and clinical attachment level \[cal\]) were recorded at baseline, 3, 6 and 9 months. radiographic parameters intrabony defect depth (ibd) and defect depth reduction (ddr%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months.

Eligibility criteria:
inclusion criteria: * systemically healthy patients with pds ≥5mm or cals ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included exclusion criteria: * patients with a known systemic disease; * known or suspected allergy to the aln/bisphosphonate group and atv/statin group; * on systemic aln/bisphosphonate and therapy atv/statin group; * with aggressive periodontitis; * who used tobacco in any form; * alcoholics; * immunocompromised patients; * and pregnant or lactating females were excluded from the study
surgical treatment of marfan syndrome with subluxation lens

Conditions: Marfan Syndrome; Lens Subluxation or Dislocation

Summary: to analyze the postoperative visual effects, and to compare the safety and efficacy of different surgical treatment with of marfan syndrome with subluxation lens.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with mfs according to the revised ghent etiology. 2. refractive errors difficult to correct. 3. pupillary block glaucoma caused by severe dislocation of the lens exclusion criteria: keratoconus, late glaucoma, uveitis, history of traumatic lens dislocation, and preoperative retinal rupture with or without retinal detachment (rd)
oral contraceptives as infertility treatments for premature ovarian failure

Conditions: Primary Ovarian Insufficiency; Menopause, Premature

Summary: premature ovarian insufficiency (poi) is a life-changing condition that affects women in their reproductive age. there is a lack of reports which focus on how to improve the reproductive outcome of these women who wish to conceive spontaneously or use assisted conception with their own oocytes. however, one could surmise that it is important to lower gonadotropin levels into the physiological range before embarking on any treatment, even if natural conception is the only choice for the woman/couple.


Eligibility criteria:
inclusion criteria: * premature ovarian failure * normal anatomy * normal secondary sexual characteristics * essential or idiopathic exclusion criteria: * chromosomal disorder * iatrogenic injury * autoimmune diseases * infection * genetic diseases
natriuretic peptides as a prognostic and risk stratification tool in assessment of valvular heart disease

Conditions: Valvular Heart Disease Stenosis and Regurgitation

Summary: nps can be used to detect subset of asymptomatic with subtle lv dysfunction for further evaluation and earlier referral for intervention and its correlation with echocardiographic finding.

each patient included in the study will undergo: 1. history taking: analysis of patient symptoms and signs (dyspnea , orthopnea , paroxysmal nocturnal dyspnea, lower limb edema , tachypalpitations,...etc ) 2. clinical examination: * detecion of each patient body weight , height , calculation of bmi. * general examination for detection of signs of heart failure (raised jvp , lower limb edema, ..etc) * examination to respiratory system * auscultation of the heart for detection of valvular affection before echocardiography invesigations: laboratory investigations: urea and creatinine . b) ecg : for exclusion of atrial fibrillation and other arrythmias. 2d transthorathic echocardiography (tte) evaluation of valve morphology and thickness , gradients and valve area , regurgitant lesions and its severity. evaluation of internal cardiac dimensions and function. 5- natriuretic peptides: as a useful screening tool to differentiate symptomatic and asymptomatic patients.

Eligibility criteria:
inclusion criteria: * all patients echocardiographically diagnosed with significant valve lesions. rheumatic heart disease with significant but asymptomatic valvular heart disease especially (mitral valve disease )(ms and mr) gender: male \& female exclusion criteria: * cases with increased level of bnp as in : renal impairment advanced age and obesity atrial fibrillation and acute coronary syndromes prior lung diseases and acute illness
safety, tolerability, pharmacokinetics of intravenous rpx7009 in healthy adult subjects

Conditions: Healthy Volunteers; Bacterial Infections

Summary: rpx7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem to treat bacterial infections, including those due to multi-drug resistant bacteria.

the worldwide spread of resistance to antibiotics among gram-negative bacteria, particularly members of the eskape group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. in particular, the recent dissemination of a serine carbapenemase (e.g., kpc) in enterobacteriaceae in us hospitals now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents. rempex is developing a fixed combination antibiotic of a carbapenem plus a new beta-lactamase inhibitor (rpx7009) which has activity against serine beta-lactamases, including kpc. this phase 1 study will assess the safety, tolerability and pharmacokinetics of rpx7009, administered alone, in healthy adult subjects.

Eligibility criteria:
inclusion criteria: * healthy adult males and/or females (of non child-bearing potential), 18 to 55 years of age * body mass index (bmi) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive). * medically healthy with clinically insignificant screening results * non-tobacco/nicotine-containing product users for a minimum of 6 months prior to day 1. * sexually abstinent or use acceptable methods of birth control exclusion criteria: * history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease. * history or presence of alcoholism or drug abuse within the 2 years prior to day 1. * documented hypersensitivity reaction or anaphylaxis to any medication. * use of any over-the-counter (otc) medication, including herbal products and vitamins, within the 7 days prior to day 1. up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the pi. * plasma donation within 7 days prior to day 1. * subjects who have any abnormalities on laboratory values at screening or check-in (day -1).
functional and aesthetic outcomes after mandible reconstruction with fibula osteomyocutaneous free flaps

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to assess the functional and esthetic outcomes in patients who had removal of a part of the lower jaw bone due to mouth cancer and reconstruction of the jaw bone with a bone ( fibula) from the leg at mskcc between the years 1987 to 2014.


Eligibility criteria:
inclusion criteria: * able to read and write in the english language * patients who underwent segmental mandibulectomy and free fibular flap reconstruction at msk between 1987 and 2014 * able to travel to the msk outpatient clinic or have access to email, the msk patient portal and a computer with a camera for the follow up examination by a physician and completion of the questionnaires. exclusion criteria: * patients who underwent marginal mandibulectomy * patients who underwent mandibular reconstruction with a different type of vascularized bone free flap * patients who underwent mandibular reconstruction with soft tissue free flap

Keywords: mandible reconstruction fibula osteomyocutaneous free flaps quality of life 15-244
a study to assess safety and tolerability of oral azd3241 in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: this is a study where azd3241 or placebo is given to patients with parkinson's disease in a blinded and randomized assignment. the main objective is to see if safety and tolerability of the drug is acceptable.

a phase iia, 12 week, multicentre, double-blind, randomized, placebo-controlled, parallel-group study to assess the safety and tolerability of oral azd3241 in patients with parkinson's disease

Eligibility criteria:
inclusion criteria: * each patient must be able and willing to provide signed and dated informed consent prior to the study. * female and male patients aged 30 to 80 years at the day of enrollment (visit 1). * patients must meet the criteria for "diagnosis of idiopathic parkinson's disease" according to the ukpds brain bank criteria (hughes et al 1992). * have a modified hoehn and yahr stage 1-2.5. * having no treatment for parkinson's disease and have no need to add anti-parkinson's disease treatment during the 14 weeks of study or are on stable anti-parkinson's disease medication. exclusion criteria: * diagnosis is unclear or a suspicion of other parkinsonian syndromes exists, such as secondary parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), parkinson-plus syndromes or heredodegenerative diseases. * have undergone surgery for the treatment of parkinson's disease (eg, pallidotomy, deep brain stimulation, fetal tissue transplantation) or have undergone any other brain surgery at any time, even for non-parkinson's disease conditions. * presence of dyskinesias, motor fluctuations, swallowing difficulties or loss of postural reflexes, defined as scoring 2 or more on item 30 of the updrs. * current/history of psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, i.e. bipolar disorder or mdd, or other psychiatric, neurological or behavioral disorders/symptoms that may interfere with conduct of study. * current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, hematological disease, hepatic disease, renal disease, gastrointestinal (gi) disease, or other major disease as judged by the investigator.

Keywords: parkinson's disease safety tolerability
a study to look at the efficacy and safety of keppra® extended release formulation - xr

Conditions: Epilepsy

Summary: this is a safety and efficacy study of keppra® extended release formulation - xr in patients with epilepsy.


Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of refractory epilepsy * patients must be receiving a stable dose of 1 - 3 concomitant anti-epileptic drugs (aed) * female patients without childbearing potential. female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method exclusion criteria: * seizures occurring in clusters * status epilepticus within 3 months of visit 1 * history of non-epileptic seizures * known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients * pregnant or lactating women. any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control

Keywords: epilepsy keppra® xr levetiracetam xr extended release
impact of the scs with different waveforms over the quality of life (scs-quality)

Conditions: Failed Back Surgery Syndrome; Spinal Cord Stimulation

Summary: prospective, randomized, multicentre, parallel, controlled, and double-blind trial. it is a study with 2 groups with evaluation pre and post treatment with spinal cord stimulation (scs) implantation of patients with failed back surgery syndrome (fbss). the study has been designed to assess primarily non-inferiority and secondarily superiority of scs dtm therapy

over 18 years old patients, with leg with or without low back neuropathic pain (dn4 ≥4), previously undergoing low back surgery that, after an evidence-based (eb) medical therapy, can be eligible to scs therapy following the good clinical practice (gcp) guidelines will be implanted of two leads in the epidural thoracic level with at least two poles (medtronic vectris) covering the t9-t10 interspace and, if the trial is positive, a medtronic intellis internal pulse generators (ipg) will be implanted. the patients will be randomized to two groups to compare the improvement of pain control, the functional state and the quality of life of the patients by scs therapy across 12 months.

Eligibility criteria:
inclusion criteria: * leg with/without low back pain with neuropathic characteristics (vas ≥ 5 and dn4≥4) during at least 6 months before the screening consultation. * stable medical therapy with evidence based medicine (ebm) during at least one month before the screening * ready and able to accomplish the procedures of the study and use the activity monitor and the medication diary. * have 18 years old or older when the patient signs the informed consent * pain kept during at least the last 6 months with vas ≥ 6 and functional limitation due to the pain * refractory to treatment (during at least 3 months), and/or * intolerable adverse effects that avoid an optimum medical treatment * previous lumbosacral surgery for treatment of the cause of his pain * pain attributable to a low back pathology exclusion criteria: * pregnant or with planned pregnancy * life expectancy \<1 year. * polyneuropathy. * important heart disease or peripheral vascular disease * degenerative disease that can decrease the functional capacity * alcoholism - drug abuse * active infection * oncological active disease * haematological disorder with increased bleeding risk * patient unable to understand / follow the target of the study and the work flow * when trial period has finished, the negative clinical response will be considered an exclusion criterion. the treatment could be completed, and the data collected but the patient will be excluded of the randomized clinical trial (rct) and the data analysed separately.

Keywords: fbss scs hd quality of life pain activity monitoring
azacitidine compared to conventional chemotherapy as consolidation of elderly patients with aml

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to determine whether azacitidine consolidation is superior to standard da consolidation treatment of acute myeloid leukemia in first complete remission in elderly patients.


Eligibility criteria:
inclusion criteria: 1. subjects \>65 years of age at the time of signing the informed consent form 2. a confirmed diagnosis of aml according to the 2008 who classification * this includes: bone marrow aspirate with a good clot or biopsy for morphology, flow cytometry, cytogenetic analysis, and in case of normal cytogenetics, molecular genetic analyses including flt3-itd, npm-1 and cebp a * bio-banking of leukemic cells at diagnosis performed (according to guidelines of the swedish national aml biobank). 3. a documented cr or crp achieved after one or two induction courses. exclusion criteria: 1. subjects who are not considered to be candidates to complete the consolidation therapy due to medical or psychological reasons. 2. subjects who have taken any investigational drugs or participated in an interventional clinical trial within 30 days prior to screening. 3. patients with acute promyelocytic leukemia 4. patients with t(8;21) or inv(16) 5. cns leukemia 6. patients with a previous diagnosis of mds, i.e. aml preceded by a diagnosed mds 7. subjects who are candidates for allogeneic stem cell transplantation (sct) 8. another cancer diagnosis with a life expectancy of less than two years
effect of tolvaptan on cognitive function in cirrhosis

Conditions: Cirrhosis; Hepatic Encephalopathy; Hyponatremia

Summary: hypothesis: tolvaptan will improve cognitive function, brain edema and health-related quality of life in cirrhotic patients with hyponatremia

baseline assessment will include a 1. battery of eight cognitive tests 2. health related quality of life 3. mri head evaluating mr spectroscopy and diffusion tensor imaging patients will then be given tolvaptan 15-30mg qd for 14 days after which the tests will be repeated. during the first 3 days of tolvaptan administration, patients will be admitted and serum sodium will be drawn every 8 hours. 24 hr urine collection will also be performed. between the initiation and end of tolvaptan, patients will be seen at least every 3-5 days in between. participation will be terminated in case patients get transplanted or develop overt he in between.

Eligibility criteria:
inclusion criteria: * cirrhosis diagnosed by liver biopsy or radiological evidence of nodular cirrhotic liver or varices on endoscopy or laboratory features (platelet count \ 1). * history of he controlled on lactulose and/or rifaximin * last he episode \>2 months prior to enrollment and \<2 episodes within 6 months * mini-mental status exam score ≥25 * serum sodium \<130mg/dl within the last 14 days and the day of enrollment * availability of a caregiver * able to undergo mr of the head exclusion criteria: * uncontrolled he manifested by mmse \<25 * alcohol abuse within 3 months * illicit drug use within 3 months * psychoactive drug use other than regularly scheduled anti-depressants or methadone. * contraindication to mr examination (see attached mri safety form) * placement of a transjugular intra-hepatic portosystemic shunt (tips) * creatinine clearance less than 10 ml/min or undergoing hemodialysis * hiv infection * use of azole medications * pregnancy * current use of tolvaptan, hypertonic saline or other medical therapies for hyponatremia

Keywords: cirrhosis hepatic encephalopathy hyponatremia brain mri health-related quality of life cognitive function
impact of a breath-controlled video game app

Conditions: Anxiety Acute

Summary: the proposed research study will assess the impact of a newly developed, breath-controlled app and custom-designed tablet (equipped with a breathing sensor) on the patient and parent's preoperative anxiety and anesthesia induction experience.

aim 1: determine whether induction distress differs between patients using the breathing-controlled app and those using standard care interventions: the investigators will measure patient compliance with induction using the child induction behavioral assessment (ciba). the investigators predict that patients using the breathing-controlled app will demonstrate significantly better induction compliance. older children (ages 6-8) are typically more cooperative with induction than younger children (ages 3-5 years). both age groups will be studied to determine whether there are age-related differences impacting receptiveness to the app. aim 2: compare patient anxiety between the breath-controlled app and control group. the investigators will measure child preoperative anxiety (modified yale preoperative anxiety scale, the "mypas-sf"). the investigators predict there will be significantly lower anxiety (mypas-sf) during induction for children in the breath-controlled app group. aim 3: compare parent anxiety between the breath-controlled app and control group. the investigators will measure parental anxiety using the visual analog scale for anxiety, the "vas-a". the investigators predict there will be significantly lower anxiety (mypas-sf) during induction for parents in the breath-controlled app group. aim 4: determine overall family satisfaction with the induction experience. a survey will be administered to assess satisfaction levels with induction behavioral interventions and determine whether these scores differ between the intervention and standard care group. the investigators predict that satisfaction scores will be higher in the intervention group than the control group.

Eligibility criteria:
inclusion criteria: * presenting to same day surgery department at cchmc liberty campus * outpatient or 23 hour admission * any surgery or procedure under anesthesia * ages 3 to 8 years * male or female * any ethnicity * american society of anesthesiologists (asa) physical classification status i or ii * patient has never had a prior anesthetic * family and participant communicate primarily in english \& signed english anesthesia consent * normal neurocognitive development * patient is undergoing inhalation induction using an anesthesia mask * parent/guardian is present for induction * patient does not receive a premedication for anxiety exclusion criteria: * neurocognitive delays * developmental delays/behavioral diagnoses, such as (but not limited to) adhd, autism, oppositional defiant disorder, obsessive compulsive disorder, anxiety disorder * patient takes medications routinely for behavioral issues * tracheostomy * inpatient or planned \>23 hour admission

Keywords: anxiety, children
serological response to mrna and inactivated covid-19 vaccine in health care workers in hong kong

Conditions: Covid-19 Vaccine

Summary: since the first local case of covid-19 confirmed on 4 feb 2020, hong kong has already experienced 4 waves of covid-19 surge, with more than 9000 cases reported. a number of vaccines have been shown to be efficacious against symptomatic and severe infection by inducing neutralizing antibody (nab) against spike protein of the sars-cov-2 virus. however, the duration of protection and longevity of antibody response is unknown. health care workers (hcws) who are planning to receive covid-19 vaccine will be recruited. the level of antibody against spike protein by different quantitative assays will also be serially measured .


Eligibility criteria:
inclusion criteria: 1. any staff, visiting doctor, nursing student of hksh who are aged 18 or above 2. no contraindication for covid-19 vaccination and plan to receive the intended dosages at the appropriate interval. 3. a baseline serology taken within 1 week before vaccination shows no evidence of recent infection. 4. no history of documented covid-19 infection exclusion criteria: -