Kornimate/medical-research-clean huggingface dataset:
a randomised controlled trial of coenzyme q10 in patients with schizophrenia and schizoaffective disorder

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the study is a randomised placebo controlled trial of coenzyme q10 (coq10) vitamin supplementation in a sample of patients with schizophrenia or schizoaffective disorder. coq10 is produced in the mitochondria of our cells, and is involved in the production of energy. however, some people do not produce enough coq10, which can result in difficulties with concentration and memory, depressive symptoms, low energy levels and high blood pressure. the study will examine the impact of taking oral coq10 supplementation on patients with schizophrenia and schizoaffective disorder.

coenzyme-q10 (coq10) is an essential cofactor in the mitochondrial electron-transport-chain in addition to being a potent lipophilic antioxidant. deficits in coq10 status have been linked to cardiovascular disease, cognitive decline, fatigue, and depression. coq10 supplementation may have a potential therapeutic value for patients with schizophrenia and schizoaffective disorder. this is a double-blind, placebo-controlled, randomised trial that will compare neurocognitive performance and symptoms of schizophrenia and schizoaffective disorder in participants randomised to active coq10 compared to scores from participants who received placebo. coq10 will be administered at a dose of 300mg/day, delivered in 3 doses of 100mg each. participants will take coq10/placebo for 6 months. at three time points (baseline, 3 months and 6 months) each participant completes a neurocognitive and psychological battery of assessments. blood pressure is monitored, and blood samples to assess mitochondrial function and plasma coq10 status are taken at each assessment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia or schizoaffective disorder exclusion criteria: * current substance abuse * history of epilepsy/seizures * head injury with loss of consciousness (\>3 minutes) * taking warfarin or blood thinning medication * uncontrolled thyroid dysfunction
study of children's activity and nutrition (scan)--extended analyses

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Heart Disease Risk Reduction

Summary: to continue analysis of data from a longitudinal study of 246 urban black preschool children and their families in order to identify the long-term effects of social and environmental influences on nutrition and activity and the consequences of these influences for the children's cardiovascular disease (cvd) risk status.

background: this study contributed to understanding the development of patterns of eating and exercise, focusing on environmental influences that promoted healthful life styles and prevented risk behaviors for cvd. design narrative: the data set included additional measures of activity and nutrition of the preschool child as well as measures of the activity of an older sibling and mother. the data were gathered in the homes and schools of the children and included both self-report and direct measurement of activity and nutrition. additional assessments of activity, lipid fractions and apolipoproteins, and type a behavior patterns and life stress in the preschool child, i.e., target child , an older sibling and the children's mother added considerably to the complexity and value of the data set permitting additional questions regarding the development of activity, the influences of siblings and parents on this development, and the relationship to cvd risk status and type a behavior patterns. hypotheses addressed included 1. activity levels and the activities selected showed increasing stability with age in preschool and older black children. 2. the influence of parental prompts and family environment on activity increased asymptotically with age: the effects increased during early childhood; the effects did not increase significantly in older children. 3. older sibling's influence on the target child's behavior increased with age. the target child's cvd risk status became more like the older sibling's with age. 4. perceptions of recent life stress and ratings of type a behavior patterns for target child, the older sibling, and mother were predisposing variables that were positively related to the target child's activity. 5. long-term patterns of physical activity were associated with hdl and apo a-1 in the target child and the older sibling; the effect was stronger for the older sibling. long-term patterns of the target child's nutrient intake were associated with his/her lipid levels. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
the follow-up of mesh/native tissue complications study(part ii)

Conditions: Pelvic Organ Prolapse

Summary: to study the incidence and distribution of complications after different pelvic reconstruction surgeries (mesh/native tissue) in multi-centers. the investigators aimed to report and summarize the postoperative complications diagnosed in the prior 1 year, 3 years and 5 years respectively, according to the international urogynecological associationinternational continence society(iuga-ics) complication classification coding(category-time-site coding system) .

patients are inferred to 27 tertiary hospitals with the complaint of de novo complications after pelvic reconstructive surgeries using mesh, tape and native tissue between june 2018 and june 2023. the subjects include patients who accept treatment not only at 27 participating hospitals but also from other hospital. and the date of surgeries carried is not restricted in the study period. this is a study of real world. the researchers focus to investigate the incidence of complications in clinical practice.

Eligibility criteria:
inclusion criteria: * 1) patients are inferred to the clinic with the complaint of de novo complications after pelvic reconstructive surgeries with mesh,tape or native tissue. * 2) pelvic reconstructive surgeries include but not limited to open/laparoscopic sacrocolpopexy (y-shape tape/self-cut synthesized mesh), anterior, apical, posterior or total pelvic reconstruction with trans-vaginal mesh(commercial mesh kits or self-cut synthesized mesh), repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation, the lefort operation) and as well as anti-urinary incontinence surgeries(tension-free vaginal tape). * 3) both primary and repeated pelvic surgery are included. exclusion criteria: * if the same patient who developed complications after pelvic floor reconstructive surgeries has been diagnosed and reported in 27 participating hospitals, and again treated for "the same code complication in other 26 hospitals, she will be ruled out.

Keywords: pelvic reconstructive surgery mesh native tissue tape complications category-time-site (cts) coding
andrositol® test as diagnostic assay to predict the fertilization potential in ivf

Conditions: Male Infertility

Summary: andrositol® test allows to obtain additional information besides the who parameters and to evaluate the semen energetic status. the diagnosis is performed by analyzing the semen at two different time points: before the treatment and 30' after the addiction of myo-inositol directly to the semen. the purpose of this study is to evaluate if the responsiveness to the andrositol® test of a sperm sample can be predictive of its fertilization rate in an icsi (intracytoplasmic sperm injection) cycle (primary outcome). secondary outcomes as embryo development, embryo euploidy status and embryo implantation rate will be evaluated.


Eligibility criteria:
inclusion criteria: * male partners of couples undergoing an egg donor cycles exclusion criteria: * sperm volume lower than 1 ml * sperm count lower than 5 x 106 /ml * total sperm motility lower than 10%

Keywords: myo-inositol fertilization rate infertility intracytoplasmic sperm injection sperm
rct comparing espb solutions in breast surgery

Conditions: Breast Cancer

Summary: the object of our research is to investigate the relative efficacy of liposomal bupivacaine administered via an erector spinae plane (esp) block as compared to our standard of care medication solution of (bupivacaine mixed with epinephrine, dexamethasone, and clonidine) for pain management in subjects undergoing bilateral surgical intervention for breast cancer. this will be an investigator-initiated, double-blind, patient-controlled, randomized control trial comparing pain scores at 48 hours after injection.


Eligibility criteria:
inclusion criteria: 1. adults 18 to 75 years of age at screening 2. scheduled to undergo oncoplastic bilateral mastectomy and reconstruction surgery at tufts medical center exclusion criteria: 1. adults unable to consent (inability to read, write, or has some impairment that hampers consent process or documentation, or cognitively impaired adults) 2. pregnant women 3. pregnant minors 4. woman of childbearing potential who are unwilling or unable to complete a pregnancy test 5. minors i.e., individuals who are not yet adults (neonates, children, teenagers) 6. wards of the state 7. non-viable neonates 8. neonates of uncertain viability 9. prisoners 10. adults with known allergy, hypersensitivity, intolerance or contraindication to study medication

Keywords: bilateral breast surgery
effect of gait training with a walking assist robot on gait function and balance in patients with chronic stroke

Conditions: Gait Disorders, Neurologic; Stroke

Summary: the purpose of this study was to investigate the effects of gait training with the new wearable hip assist robot developed by samsung advance institute of technology (samsung electronics co, ltd, korea) in patients with chronic stroke.

seven chronic stroke patients will participate in this study. all subjects will receive training 3 times per week for 8 weeks for 24 training sessions. each session is directed by a licensed physical therapist and lasted 60 min (including rest period of 10 min). brain activity and gait assessment will be performed at visits 0 (baseline), 24 (post-test), and at 3 months (follow-up) after training. primary objective is to demonstrate the effects of hip assist robot on spatio-temporal parameters measured by motion capture system (motion analysis corporation, santa rosa, ca, usa), muscle activation patterns measured by surface electromyography (semg) (noraxon inc., scottsdale, az, usa), metabolic energy cost parameters measured by portable cardiopulmonary metabolic system (cosmed k4b2, rome, italy) and cortical activation measured by functional near-infrared-spectroscopy (fnirs) (nirscout, nirx, germany). secondary objective is to demonstrate the effects of hip assist robot on motor function improvement evaluated by berg balance scale (bbs), dynamic gait index (dgi), timed up and go (tug) test, push and release (p\&r) test, functional reach test (frt), korean version fall efficacy scale (k-fes), manual muscle test (mmt) and range of motion (rom).

Eligibility criteria:
inclusion criteria: 1. age: between 20 and 84 years 2. ≥ 3 months post stroke 3. ability to walk at least 10m regardless of assist devices 4. adequate gait function (fac \> 3) 5. physician approval for patient participation exclusion criteria: 1. serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living) 2. advanced liver, kidney, cardiac, or pulmonary disease 3. history of concussion in last 6 months 4. history of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits 5. preexisting neurological disorders such as parkinson's disease, amyotrophic lateral sclerosis (als), multiple sclerosis (ms), dementia

Keywords: exoskeleton device gait rehabilitation chronic storke
vitamin d levels in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome is the commonest endocrinopathy among women of reproductive age. its worldwide prevalence has been estimated between5-10%. vitamin d, a fat-soluble vitamin, can be produced in two ways: by intestinal absorption and endogenous synthesis from a precursor of 17-hydroxyl cholesterol on the skin with sufficient exposure to ultraviolet sunlight.

the aim of this work is assessment of the level of vitamin d in female have polycystic ovary syndrome \& healthy female.and also make diagnostic criteria for patient who is in need for supplementations with vitamin d.

Eligibility criteria:
inclusion criteria: * hyperandrogenism * polycystic ovary syndrome exclusion criteria: * thyroid disease * parathyroid disease * diabetes mellitus * cushing syndrome * congenital adrenal hyperplasia * hyperprolactinemia * renal, liver or chronic disease
stricture definition and treatment (strident) endoscopic therapy study

Conditions: Crohn Disease; Inflammatory Bowel Diseases; Stricture; Bowel

Summary: two thirds of patients with crohn's disease require intestinal surgery at some time in their life. intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. the strident (stricture definition and treatment) studies aim to develop such strategies.

prospective randomised controlled study. patients with crohn's disease and symptomatic stricture(s) will undergo randomisation to receive standard or intensive endoscopic therapy.

Eligibility criteria:
inclusion criteria: * inflammatory bowel disease patients with intestinal stricture(s) identified on ct, mri or endoscopy. exclusion criteria: * acute bowel obstruction requiring urgent surgical intervention * deemed by treating physician to have high risk of acute bowel obstruction * concurrent active perianal sepsis * internal fistulising disease in association with strictures (entero-enteric stulas) * low rectal or anal strictures * evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies * patients for whom endoscopy is not suitable due to co-morbidities or clinical state * inability to give informed consent * suspected perforation of the gastrointestinal tract * pregnancy * inability to undergo mri small bowel due to a contraindication.

Keywords: crohn disease inflammatory bowel disease intestinal stricture
decompression versus instrumented fusion for lumbar degenerative disease. clinical and biomechanical outcome study

Conditions: Lumbar Spinal Stenosis; Degenerative Lumbar Spinal Stenosis

Summary: identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis.

degenerative lumbar spine is the most common cause of chronic pain and disability with remarkable economic impact. treatment begins with conservative options (physical combined with antalgic therapy) but often requires surgical treatment. two different groups of patients affected by symptomatic lumbar stenosis with no preoperative radiological signs of instability will be recruited in a prospective trial and proposed for surgery: microsurgical decompression (mid) or decompression and instrumented fusion (mid + f). clinical and mechanical outcomes of two different treatments (mid vs. mid+f) will be compared. an in-vitro biomechanical study will evaluate the biomechanical effect of the two surgical techniques. the aim of this project is to obtain robust data for tailoring the surgical approach to patient individual characteristics and needs, to gain the best clinical evidence, and possibly reducing the overall costs of management of this disease.

Eligibility criteria:
inclusion criteria: * degenerative lumbar stenosis caused by bone hypertrophy, osteoarthritis of facet joints, ligamentous hypertrophy, disc protrusion * midsagittal spinal canal diameter of 12 mm or less * no radiological signs of instability, i.e. pathological motion on preoperative dynamic lumbar x-ray * ongoing symptoms for a minimum of 12 weeks with no improvement to conservative treatment * eligibility for decompression alone (mid) or decompression and fusion (mid+f) exclusion criteria: * congenital, traumatic, infectious and neoplastic lumbar stenosis, * spondylolisthesis (on static x-ray), lumbar scoliosis (cobb\>10°), * previous lumbar surgery, other types of operations (endoscopic decompression, anterior interbody fusions, interspinous devices etc.). * patients with spine deformity requiring long fusion (i.e. \>=3 levels)
does a thoracolumbar interfacial plane (tlip) block with liposomal bupivacaine provide tlip block in spinal surgery

Conditions: Pain, Postoperative

Summary: the investigators are looking to recruit patients into a study demonstrating the effectiveness of a superficial nerve block involving the thoracolumbar interfascial plane (tlip) in reducing postoperative pain in those undergoing spinal surgery

patients undergoing spine surgery with or without fusion experience a great deal of pain especially in the first 3 days after surgery. spine surgeons are looking for ways to reduce the pain that you experience. anesthesiologists have introduced a procedure, called a "tlip block" to provide pain relief. the block involves injecting local anesthetic (numbing pain medication) in the lower back around the site of the surgery. this block has been used by other surgeons for other types of surgeries in the past and has been shown to work. to determine how effective the block is, the investigators are conducting this investigational study where pain severity in patients who receive one of 2 kinds of local anesthetic or placebo are compared

Eligibility criteria:
inclusion criteria: * adult patients undergoing multilevel lumbar spine surgery, age 18-75 exclusion criteria: * opioid use disorder, previous spine surgery, non english-speaking patients, patients with anticipated communication disorders, patients with coagulopathy, prisoners, children, pregnant women, single level hemilaminectomy with or without discectomy

Keywords: thoracolumbar spine pain postoperative
non-contact respiratory rate monitoring

Conditions: Hypoxia

Summary: the purpose of this study is to compare thermographic estimates of respiratory rate to manual counting (visual inspection) and thoracic impedance-based methods. thermographic methods rely on detection of temperature changes in the nose and mouth that occur as room temperature air passes through the nose and mouth during ventilation, and may offer a non-invasive means of measuring respiratory rate without requiring any patient contact.


Eligibility criteria:
inclusion criteria: * underwent surgery at the university of virginia * able to provide verbal consent to participate in the study exclusion criteria: * unable to provide verbal consent to participate in the study * youth * prisoners

Keywords: post-surgical
safety and immunogenicity of flulaval™ tr and fluarix® (influenza vaccines) in young and older adults

Conditions: Influenza

Summary: the purpose of this trial is to describe the immunogenicity, the safety, and tolerability of flulaval™ tr and fluarix®, the latter serving as active comparator. the results will be compared to a standard immune response criteria, for both young and elderly populations.

this randomized trial will assess the immune protection offered at day 21 by flulaval™ tr, fluarix® being the comparator. in both groups, immune response will be assessed through a blood test before and 21 days following vaccination. the safety and tolerability of the study vaccine will be contrasted to the comparator vaccine over a period of 42 days following vaccination.

Eligibility criteria:
inclusion criteria: * male or female adults (≥18 yrs) * stable health status * provide informed consent * access to direct phone service (not a pay phone or a common-use phone service) * eligible females must have a negative pregnancy test exclusion criteria: * febrile illness (\>38.0°c oral temperature) * high blood pressure (≥140/90 mmhg) * significant acute or chronic * uncontrolled medical or psychiatric illness within 1 month prior to vaccination * immunosuppressive condition (confirmed or suspected) * renal impairment * hepatic dysfunction * complicated insulin-dependent diabetes mellitus * unstable cardiopulmonary disease * blood dyscrasias * cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed) * history of demyelinating disease * active neurological disorder * significant alcohol or drug abuse * significant coagulation disorder (prophylactic antiplatelet medications allowed) * influenza vaccine administrated within 6 months prior to study vaccination * administration of any other vaccine from 30 days prior to the end of the study * use of non-registered drug within 30 days prior to study vaccination * receipt of immunoglobulins and/or any blood products within 3 months of study vaccination * history or suspected allergy to previous influenza vaccine, or to any constituent of flulaval™ tr and fluarix®, or reaction to eggs consumption * pregnant or nursing female subjects * female subjects not protected by an acceptable contraception method (except if surgically sterile or post-menopausal)

Keywords: thimerosal reduced content immunogenicity, safety, reactogenicity young and elderly adults influenza vaccine
tmj fibrocartilage detection using mri

Conditions: TMJ Disorders; MRI Scans

Summary: objective: the aims of this study will be to detect the fibrocartilage layer (fc) of the human temporomandibular joint (tmj) using 3d spgr (spoiled grass sequence) (t1 wats) sequence and to compare these results with those of conventional magnetic resonance imaging (dp, t2 mri) sequences in patients with temporomandibular disorders (tmd).

this prospective and observational study will focused on analyzing morphological characteristics of the fibrocartilage layer of the tmj based on the mri scans of 59 patients. all 118 tmjs of these patients will be suitable for analysis, (range: 18-60 years old), females and males affected by tmd and did not undergo previous tmj treatment.

Eligibility criteria:
inclusion criteria: \* internal derangement in thetmj exclusion criteria: * cardiac pacemaker * cochlear implant * intracranial vascular clips * metal particles in the orbit * head or face trauma * gout * generalized osteoarthrosis * joint hyperlaxity * congenital malformity * facial cysts * facial tumors * previous tmj surgery