Kornimate/medical-research-clean huggingface dataset:
evaluation of radiculitis following use of bone morphogenetic protein-2 for interbody arthrodesis in spinal surgery

Conditions: Lumbar Degenerative Disease

Summary: clinician directed use of bone morphogenetic proteins (bmps) in ways other than fda approved, has increased recently due to the morbidity associated with harvest of iliac crest bone graft in spinal arthrodesis procedures. fda approved for the use in anterior lumbar fusions with lt cage, other clinical applications of these proteins is becoming widely adopted due to their effectiveness in forming bone and facilitating fusion. clinicians have realized while these proteins are potent stimulators of bone formation there have been anecdotal reports of increased rates of radicular pain in the postoperative period when used in interbody arthrodesis procedures. speculation as to the mechanism of this radiculitis is postulated to be due to the inflammatory effects of these proteins. excess bone overgrowth around the spinal nerves in proximity to the fusion cage has been reported. no prospective studies have been performed assessing the incidence and etiology of this complication. the investigators propose a prospective study evaluating the incidence of this complication as well as postoperative imaging studies to help determine whether bony overgrowth is indeed occurring adjacent to the effected spinal nerves.


Eligibility criteria:
inclusion criteria: * male or female age 18-75 * candidate for tlif * lumbar levels l1-s1 exclusion criteria: * more than 3 tlif levels * had a previous fusion attempt at involved level(s) * had more than 2 previous open, lumbar spine procedures at the involved level(s) * currently implanted with anterior instrumentation at the involved level(s) * bmi \>40 * active localized or systemic infection * presence of a disease entity or condition which significantly affects the possibility of bony fusion * has immunosuppressive disorder actively requiring treatment * pregnant or interested in becoming pregnant during the study * has a known sensitivity to device materials * mentally incompetent or is a prisoner * currently a participant in another study for the same indications

Keywords: lumbar degenerative disease bone morphogenetic protein tlif
study of the effect of sr57667b on 18f-dopa pet imaging in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: * the primary objective is to study the effect of sr57667b at the dose of 4 mg/d on progression of dopaminergic nigro-striatal lesions assessed by 18f-dopa pet imaging. * secondary objectives are to assess the effect of sr57667b on symptomatic decline in patients with early pd, to assess the safety/tolerability of sr57667b in patients with early pd and to document plasma concentrations of sr57667 in patients with early pd.

multinational, multicenter, randomized, parallel-group, double-blind, phase ii study.randomization stratified on the dopaminergic treatment, in two strata: treatment by levodopa or dopamine agonist.

Eligibility criteria:
inclusion criteria: * male or female outpatients. * age \>=35 years at screening. * diagnosis of parkinson's syndrome, on at least two of the three key parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity. * duration of the disease of less than 3 years since diagnosis. * modified hoehn and yahr stage \<= 2.5. * patient optimized on monotherapy by levodopa or a dopamine agonist· * generally healthy and ambulatory. * patient has given his informed written consent and is capable of following study procedures. exclusion criteria: * any indication of forms of parkinsonism other than pd. * severe resting tremor. presence of either dyskinesia, fluctuations, or loss of postural reflexes· * treatment with amantadine, anticholinergics, catechol-o-methyltransferase (comt ) inhibitors, selegiline, dopamine receptor antagonists, catecholamine depleters, indirect dopamine agonists or alphamethyldopa. electroconvulsive therapy (ect).use of cyp3a4 strong, and moderate inducers or inhibitors. participation in another clinical trial with an investigational drug within two months prior to randomization. * dementia, uncontrolled depression, psychotic disorder. history of substance-related disorders including alcohol or other substance use disorders. * females of child bearing potential. * evidence (detected by history, physical examination and/or laboratory/ecg tests) of any clinically significant or unstable medical disorder that could interfere with the patient's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. alterations of laboratory tests or ecg findings of potential clinical significance.

Keywords: parkinson disease 5-fluorodopa
measuring the morphological characteristics of thoracolumbar fascia in low back pain

Conditions: Low Back Pain

Summary: recently, it has been reported that the thoracolumbar fascia may play a role in the pathophysiology of chronic low back pain.there is still no standard method for imaging and analyzing the thoracolumbar fascia.the aim of this study is to advance the understanding of the role of the thoracolumbar fascia in chronic low back pain as well as to advance the analysis methods.


Eligibility criteria:
inclusion criteria: * 18-65 years old * patients with low back pain for more than 6 months * healthy volunteers exclusion criteria: * previous low back or back surgery * uncontrolled diabetes mellitus * mental retardation * metabolic disorders
randomized comparison of morning versus bedtime administration of aspirin: a cardiovascular circadian chronotherapy (c3) trial

Conditions: Atherosclerosis; Cardiovascular Diseases; Drug Effect

Summary: wide variability in the antiplatelet effects of aspirin may lead to recurrent thromboembolic events. several pilot studies have suggested potential benefits of taking aspirin at bedtime rather than in the morning. the primary objective of this study is to examine whether aspirin administration at bedtime versus in the morning provides a superior reduction in the incidence of major adverse cardiovascular events among patients with or without established atherosclerotic cardiovascular disease, who are already taking aspirin.

the study is a pragmatic, registry-based, open-label, randomized controlled trial combining the utilization of the danish nationwide health registries and the official danish electronic letter system (digital post/eboks) into an innovative, decentralized trial requiring no study visits from participants. the nationwide health registries will be used for identification of potential participants and data collection, including baseline information and follow-up data, while the electronic letter system will be used for sending recruitment letters and communicating with participants. study participants will provide electronic informed consent from home before inclusion and randomization. the trial will include patients currently in aspirin treatment regardless of the presence or absence of established cardiovascular disease. participants will be randomized 1:1 to either aspirin administration at bedtime or in the morning. the trial is event-driven.

Eligibility criteria:
inclusion criteria: * age \>=18 years * current chronic treatment with aspirin (as recorded in the danish national prescription registry and confirmed by the participant via questionnaire) * signed informed consent exclusion criteria: * there are no exclusion criteria for this trial

Keywords: aspirin cardiovascular disease prevention circadian rhythm randomized controlled trial pragmatic outcomes
two stepped care models for posttraumatic stress disorder (ptsd) among cambodian refugees with ptsd

Conditions: Posttraumatic Stress Disorder (PTSD)

Summary: this project aims to investigate the efficacy of two models to treat posttraumatic stress disorder (ptsd) for cambodian refugees in primary care. the first step in both models is giving a medication, which is a serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (ssri/ssrn), with paroxetine being the first-line agent. for those patients who still have ptsd, the second step is either another medication or a culturally sensitive cognitive behavioral therapy (cbt). the investigators hypothesize that patients will improve in both models, but more so in the the cbt model.

this project aims to investigate the efficacy of two models to treat ptsd for cambodian refugees in primary care. the first step in both models is giving a medication (an ssri/ssrn, e.g., paroxetine). for those who still have ptsd, the second step is either adding another medication (e.g., prazosin) or providing culturally sensitive cognitive behavioral therapy (cbt). we hypothesize that patients will improve in both models, but more so in the the cbt model. the primary outcome measure is ptsd severity as assessed by the ptsd checklist (pcl). eligibility requirements include having ptsd and having been old enough to remember the khmer rouge period.

Eligibility criteria:
inclusion criteria: * ptsd; * pcl great or equal to 44; * survivor of the cambodian genocide; * at least 7 years old at the time of the cambodian genocide exclusion criteria: * pregnant; * active suicidality; * mental retardation; * organic mental disorder; * bipolar disorder; * alcohol dependence; * marijuana dependence; * unable to give conformed consent

Keywords: ptsd cognitive behavioral therapy (cbt) medication augmentation treatment-resistant ptsd cambodian refugees culturally sensitive treatment
allogeneic umbilical cord blood therapy in children with cp

Conditions: Cerebral Palsy

Summary: this open-label study aims to analyze cytokines related to clinical outcomes of allogeneic umbilical cord blood therapy for children with cerebral palsy.

cerebral palsy (cp) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. it is the most common cause of motor disability in childhood. most therapies are palliative rather than restorative. umbilical cord blood (ucb) may be used as restorative approach for children with cp. many experimental animal studies have revealed that ucb is beneficial to improve and repair neurological injuries. based on animal studies and some clinical trials, ucb is suggested as a potential therapy for children with cp. this study was designed to find cytokines relevant to ucb therapy.

Eligibility criteria:
inclusion criteria: * diagnosed with cerebral palsy * age of ≤15 years * mismatch in hla-a, b, and dr ≤2, and total nucleated cell count ≥3x10\^7/kg. if the cell count is less than given values, more than 1 unit could be used. * decision of participation in the study by and acquisition of informed consent from the subject's representative * willingness and ability to be hospitalized according to the schedule specified in the protocol and continue the study for 12 months after study entry exclusion criteria: * current aspiration pneumonia * known genetic disease * history of hypersensitivity reaction to any study drugs pertinent to the study * patient with severe seizure disease who has clinical convulsion despite combination therapy with 3 or more agents * uncontrolled hypertension defined as systolic blood pressure \>115 mmhg and/or diastolic blood pressure \>70 mmhg * hepatic impairment defined as asparate aminotransferase (ast) \>55 iu/l and/or alanine aminotransferase (alt) \>45 iu/l * renal impairment defined as creatinine (cr) ≥1.2 mg/dl * presence of diagnosed or suspected malignant tumor and/or hematologic malignancy * non-compliance with study visits specified in the protocol or unwillingness of care-giver due to lack of understanding of the patient

Keywords: cerebral palsy umbilical cord blood rehabilitation cytokine outcome
effectiveness of kegel exercise device in strengthening pelvic floor and treating urinary incontinence (ui)

Conditions: Stress Urinary Incontinence; Sexual Dysfunction

Summary: this study will assess the effectiveness of a new pelvic floor exercise device in strengthening pelvic floor muscles and treating urinary incontinence among women who are experiencing symptoms of pelvic floor weakness. the study will be conducted over 12 weeks and results will be collected through self-assessment questionnaires and clinical pelvic examination. effectiveness outcomes will be tracked over the duration of the trial and measured against historical symptoms.

the objective of the study is to test the device with women who are experiencing symptoms of pelvic floor weakness, namely urinary incontinence, vaginal laxity and sexual sensation problems, to assess the changes in pelvic floor muscle strength, before and after the intervention. the study device is a pelvic floor exercise device that provides biofeedback and exercise guidance. women who meet the inclusion criteria will be recruited from the regular patients at the investigation site and given the device to use at home daily for 12 weeks. subjects will submit information regarding their experience with the device and self-assessed improvements in their symptoms. a pelvic examination will be conducted at the start and conclusion of the study to measure a pelvic floor muscle strength reading. the research hypothesis is that strength level, subjective assessment of vaginal tightness and sexual sensations will be greater at the end of the study than at the baseline and the mean value of frequency and volume of bladder leaks will be less than at the baseline.

Eligibility criteria:
inclusion criteria: 1. subject provides written informed consent and hipaa authorization before any study procedures are conducted; 2. experience urinary incontinence and/or vaginal laxity and/or decreased sexual sensation for a period of 6 weeks or more. exclusion criteria: 1. subject has any condition or exhibits behavior that indicates to the principal investigator that the subject is unlikely to be compliant with study procedures and visits 2. has had prior surgery for incontinence, prolapse or vaginal tightening 3. has been diagnosed with pelvic organ prolapse more severe than grade 2 4. suffers from vaginal penetration difficulties 5. has had more than 3 urinary tract infections in the past 12 months 6. has any conditions of the bladder that effect continence 7. suffer from vaginal/vulvar/pelvic pain 8. is currently taking any medication for incontinence 9. is pregnant or trying to become pregnant 10. has given birth less than 6 weeks prior to enrollment 11. has been diagnosed obese - bmi \> 30 12. is a heavy smoker - \> 20 cigarettes per day 13. has a history of neurological conditions - parkinson's, multiple sclerosis and other 14. suffers from chronic constipation
new haven moms partnership

Conditions: Depression; Stress

Summary: phase ii of the moms partnership aims to: 1. conduct a needs assessment of the mental health of mothers residing in new haven, ct; 2. provide on-site group intervention services (randomized by housing community) to improve signs/symptoms of depression/stress/trauma among mothers living onsite.

the purpose of this project is to expand and enhance the new haven mental health outreach for mothers (moms) coalition beyond pregnancy and depression to include a broader definition of mental illness (depressive, anxiety, and substance use disorders), and a larger target population (low-income, racially and ethnically diverse, pregnant and parenting women) in the city of new haven. through this expansion, the coalition will bring together the community of women, their families and advocates, healthcare providers, policy and agency leaders, and academics, to inform the development and conduct of public health approaches around the mental health of low-income, racially and ethnically diverse, pregnant and parenting women. the specific goals of this phase i proposal are: 1. to conduct a community-led needs assessment on the mental health of low-income, ethnically and racially diverse pregnant and parenting women in the city of new haven. 2. to provide randomized intervention services to improve signs/symptoms of depression/stress/trauma among mothers living in public housing in new haven, ct

Eligibility criteria:
inclusion criteria: * ces-d score \>=16 * child under the age of 18 (participant must be a mother) * resident of public housing authority complex in new haven, ct or an affiliated section 8 recipient exclusion criteria: * positive for psychosis * active suicidal ideation * non-english or spanish speakers * unable to provide informed consent * unwilling to accept randomization * moving within the intervention \& follow-up period

Keywords: mothers depression stress trauma public housing
pulmonary fibrosis foundation community registry

Conditions: Pulmonary Fibrosis; Interstitial Lung Disease; Lung Fibrosis; Idiopathic Pulmonary Fibrosis

Summary: pulmonary fibrosis (pf) results from a diverse group of health conditions and affects the lives of patients (including those who are post lung transplant), caregivers and family members. the pulmonary fibrosis foundation community registry will offer an online portal where participants can self-enroll and directly contribute information about their experience with pf to be compiled into a longitudinal data set for use by researchers.

the pff community registry is an observational, longitudinal cohort study. the community registry will enroll three different cohort groups: 1. patients with pf, including those who are post lung transplant 2. caregivers of patients with pf 3. family members of patients with pf this is an online registry open to individuals affected by pf in the us. it is not associated with a physical location or institution. individuals may self-enroll online and contribute data to the community registry by answering a series of surveys at regular intervals. participants may also elect to be contacted about future research projects through the pff community registry portal. however, this is not required to participate in the community registry itself.

Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. provision of signed and dated informed consent form online 2. male or female, aged 18 or older 3. affected by pf as a member of at least one of the following cohorts: 1. an individual diagnosed with pf or ild, including those who are post lung transplant, or 2. an individual who has cared (currently or in the past) for an individual with pf or ild, and / or 3. a family member (defined as parent, full or half-sibling, or child) of an individual with pf or ild. 4. has internet access and a valid email address. exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in this study: 1. primary residence or place of care is outside of the us. 2. inability or unwillingness of a participant to provide informed consent or comply with study protocol. 3. any condition or circumstance not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. 4. patients who were diagnosed with any of the below lung diseases. similarly caregivers and family members associated with these diseases would be excluded. * sarcoid * lymphangioleiomyomatosis (lam) * pulmonary alveolar proteinosis (pap) * cystic fibrosis (cf) * amyloidosis
perioperative supplementation with immunonutrition and its impact on surgical outcome and pain in oral cavity or mandibular tumours

Conditions: Immunonutrition; Surgical Outcome; Pain; Oral Cavity; Mandibular Tumor

Summary: the aim of this study was to investigate the effect of adding omega 3 and dipeptiven to standard feeding in head and neck patients who will undergo oral cavity tumour resection or mandibular tumour resection (immunonutrrition mixture) on wound infection, fistula formation and length of hospital stay ,total dose of intraoperative and postoperative opioids (opioid consumption and pain incidence ,mortality and other postoperative complications as urinary tract infection (uti) and pneumonia.

enhanced recovery after surgery (eras). a series of components that combine to minimize stress and to facilitate the return of function have been described: these include preoperative preparation and medication, fluid balance, anesthesia and postoperative analgesia, pre- and postoperative nutrition, and mobilization. nutrition therapy is the provision of nutrition or nutrients either orally (regular diet, therapeutic diet, e.g. fortified food, oral nutritional supplements) or via enteral nutrition (en) or parenteral nutrition (pn) to prevent or treat malnutrition. head and neck cancer surgery usually means surgery to treat cancer of the mouth, throat or larynx . the surgery is complicated and people often experience problems such as wound infections and wound breakdown, as well as infections such as pneumonia. the use of a nutritional supplement enriched with omega 3 fatty acids is associated with a greater preoperative weight loss, reduced postoperative pain and decreased postoperative levels of c reactive protein in patients undergoing roux-en-y gastric bypass.

Eligibility criteria:
inclusion criteria: * age between 18 and 60 years. * both sexes. * american society of anesthesiologists (asa) physical status i or ii . * patient undergoing mandibular or oral cavity tumour resection. * body mass index (bmi) between 18.5-24.9. * patient with serum albumen above 3 gm. * patient with written valid consent exclusion criteria: * patient refusal and uncooperative patients. * patient asa iii or iv. * age more than 60 or less than 18. * serum albumen less than 3. * pre-existing severe malnourishment. * allergy to test drugs. * patients on tranquilizers, hypnotics, sedatives and other psychotropic patient on steroids and nsaid.