Kornimate/medical-research-clean huggingface dataset:
treating chronic pain in buprenorphine patients in primary care settings

Conditions: Pain; Depression; Substance Use

Summary: individuals will be recruited by posted advertisements in the waiting rooms of the pcp offices and by physician referral. after an initial phone screen, research staff will meet with interested individuals in their pcp offices for informed consent, baseline interview and randomization. participants will be randomized into a health education study arm, and receive 7 individual sessions on general health education, or an intervention study arm, and receive 7 individual sessions of the treating opioid patients' pain and sadness (topps) intervention.


Eligibility criteria:
inclusion criteria: * chronic pain, defined as pain duration for at least six months with a mean score of 5 or higher on the bpi pain interference scale; * pain severity of 40 or higher on a visual analog scale (0-100) indicating "worst pain in the last week"; * previous attempt at initial steps of pcp guideline pain care: must have had at least one trial of recommended medication (i.e. acetaminophen, nsaids, skeletal muscle relaxants) judged through interviews with patients and pcps; * qids score of ≥ 10 (depression severity) * if using an antidepressant, the dose must be stable for the previous 2 months; * age 18 or older * has received buprenorphine/naloxone (suboxone)for at least the last 3 months; * plan to continue buprenorphine/naloxone (suboxone)for at least 3 months. exclusion criteria: * lifetime dsm-iv diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition; * current dsm-iv diagnosis of substance dependence for sedative/hypnotic drugs, alcohol, stimulants, or cocaine; * suicidal ideation or behavior requiring immediate attention; * in psychotherapy or in a multidisciplinary pain management program at baseline; * anticipate having surgery in the next 6 months; * pain thought to be due to cancer, infection, inflammatory arthritis, or associated with severe or progressive neurological deficits; * ssdi or ssi claim pending; * pregnancy.

Keywords: pain depression substance use
perineal massage in women with gynecological cancer

Conditions: Cancer Pain; Neck Cancer

Summary: the high incidence of gynecological cancers, together with dyspareunia and vaginal stenosis, some of its most frequent sequelae, create the need to continue studying and researching oncological physiotherapy techniques that treat and prevent these sequelae, in order to preserve and/or improve the quality of life of cancer patients. therefore, through this study, we sought to verify the effectiveness of oncological perineal massage to treat pain during sexual intercourse and vaginal stenosis. the objective of this study will be to demonstrate the effectiveness of a treatment that will consist of a health education session related to the pelvic floor and the consequences related to cancer along with ten sessions of oncological perineal massage that will be carried out for fifty minutes, once a week.


Eligibility criteria:
inclusion criteria: * women between 18 and 52 years old * oncology patients with a diagnosis of dyspareunia and vaginal stenosis related to treatments. * patients with qt/rt/bt treatment who have a diagnosis of dyspareunia and vaginal stenosis. * patients on hormonal suppressive treatment with a diagnosis of dyspareunia and vaginal stenosis. exclusion criteria: * patients who do not accept intracavitary treatment. * patients with abdominopelvic surgical treatment prior to oncological process. * patients with a diagnosis of dyspareunia prior to cancer. * patients with vaginal narrowing prior to cancer. * patients with menopause at the time of cancer diagnosis
effect of cerefolin®/cerefolinnac® on biomarker measurements

Conditions: Mild Cognitive Impairment; Alzheimer's Disease; Alzheimer's Disease Related Disorders

Summary: in a retrospective analysis of data from 1100 patients, disease-delaying effects of cerefolin®/cerefolinnac® were examined in terms of cognition. the purpose of the current study is to expand the retrospective study dataset by prospectively collecting additional biomarker and imaging data.

cerefolinnac® is an orally administered prescription medical food, and is formulated as a combination of l-methylfolate calcium (as metafolin®), methylcobalamin, and n-acetylcysteine. in a retrospective analysis, disease-delaying effects of cerefolin®/cerefolinnac® (cfln) are examined in terms of cognition (measured by mci screen (mcis)), and functional capacity (measured by functional assessment staging test (fast)). - the treatment effect of cfln on cognitive and functional measures, and on biomarker measures in patients with alzheimer's disease and related disorders (adrd). the current study will expand the nac-002b study dataset by prospectively collecting additional biomarker and imaging data in a more comprehensively assessed, matched sample of patients. this will allow more precise evaluation of cognitive and functional outcome measures, and biomarker measures will be assessed in an attempt to identify specific populations or conditions in which cfln is most effective. the sample will consist of patients with homocysteinemia plus past/current cfln treatment (treatment group) matched to those without homocysteinemia plus no past/current b12, folate or cfln treatment (non-treatment group). also 65 additional subjects will be recruited for the non-treatment group, which will be used to improve the rate of decline estimates for the cognitive and functional outcome measures.

Eligibility criteria:
inclusion criteria: * with a diagnosis of normal aging (nl), cognitive impairment or dementia not otherwise specified (ci/d), or adrd * with at least one previous quantitative mri (qmri) * with at least one previous homocysteine level * without homocysteinemia plus no past or current b12, folate or cerefolin® treatment, or with homocysteinemia plus past or current cerefolin® treatment exclusion criteria: subjects who do not meet the inclusion criteria will be excluded from the study.

Keywords: homocysteinemia dementia depression vitamin b12 folate mild cognitive impairment alzheimer's homocysteine
bbpa pet/ct in patients with malignant tumors

Conditions: Malignant Tumors

Summary: this study is an open-labeled phase ii diagnostic clinical trial to explore the safety and clinical value of bbpa-pet/ct in suspected malignant tumor patients. the investigation regarding the clinical value of bbpa concerning the metabolic characteristics of bbpa in suspected malignant tumors. quantitative features will be extracted to analysis the pet images. for patient who took surgery after multiple examination, histopathology, molecular pathology and lat-1 immunohistochemistry will also be obtained.

in this study, we utilized bbpa, a novel boron amino acid, which replaces the carboxyl group of 4-boronate phenylalanine (bpa) with a boron trifluoride group (-bf3) (-cooh), as a diagnostic molecule for pet imaging of brain tumors, is also a highly efficient boron carrier for bnct. preclinical studies suggested \[18f\]bbpa to be a pan-cancer probe that transmembrane transported through large neutral amino acid transporter type-1 (lat-1). however more studies and evidence are warranted to investigate the clinical value of bbpa pet imaging in human. this study aim to observe the safety of bbpa, and investigate the diagnostic value of bbpa in the patient with suspected malignant tumors. patients who meet the eligibility criteria are included in clinical trials after fully communicating the condition, explaining the benefits and risks of clinical trials, clarifying the patient's willingness to include the clinical trial, and signing informed consent. the cohort number, bbpa administrative dose, imaging protocols are decided based on the investigators' preliminary data. the diagnosis and post- examination treatment are based on the recommended guideline, combined with the subject's own situation for standardized diagnosis and treatment

Eligibility criteria:
inclusion criteria: * have suspected diagnosis of brain tumors, based on clinical performance and imaging results. * meet the indications for pet examination, show a clear indication and no contraindications; * have a performance status of score ≥80 on kps scale or score 0-1 points on ecog scale, a relatively good general situation; * does not appear agonal stage, deep coma, over grade 2 major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection; * be ≥ 18 years of age on day of signing informed consent. * be willing and able to understand the research content and provide written informed consent/assent for the trial. exclusion criteria: * have a history of imaging agent allergies; * does not meet the pet-ct scan sedation requirements, or there are contraindications for pet-ct examination; * be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial; * unable to adhere strictly to protocol requirements.

Keywords: malignant tumors bbpa-pet/ct
bay94-9027 pk study comparing to another long acting product

Conditions: Hemophilia A

Summary: the purpose of this study is to compare the pharmacokinetics of bay94-9027 and elocta after intravenous administration.


Eligibility criteria:
inclusion criteria: * males, age 18 to 65 years. * subjects with severe hemophilia a with a documented plasma fviii level of \< 1% * ≥ 150 exposure days with fviii concentrate(s) as supported by medical records exclusion criteria: * evidence of current or past inhibitor antibody: * history of any congenital or acquired coagulation disorders other than hemophilia a. * platelet count \<75,000/mm\*3. * abnormal renal function (serum creatinine \>2 x the upper limit of the normal range). * active liver disease verified by medical history or persistently elevated alanine aminotransferase or aspartate aminotransferase \>5 x the upper limit of the normal range or severe liver disease as evidenced by, but not limited to any of the following: international normalized ratio \>1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
safety and efficacy of lumiracoxib versus naproxen in acute musculoskeletal pain

Conditions: Musculoskeletal Pain

Summary: this study is designed to develop our understanding of the risk-benefit of using lumiracoxib in patients with acute musculoskeletal pain due to uncomplicated soft tissue injury.


Eligibility criteria:
inclusion criteria * patients with acute musculoskeletal pain following an uncomplicated soft tissue injury (within the last 72 hours) which is expected to be self-limiting, requiring short-term treatment with a nsaid. * patients' acute musculoskeletal pain at baseline must be ≥ 50 mm on a 0 - 100 mm on a visual analogue scale. * patients may have taken analgesic therapy following injury. however, the baseline pain intensity assessment should be taken: (i) 4 hours after the last dose of ≤ 400 mg ibuprofen, ≤ 1000 mg paracetamol, ≤ 600 mg aspirin or ≤ 2 tablets of other over-the-counter analgesic aspirin-based or paracetamol-based combination medications (ii) or 8 hours after the last dose of \> 400 mg ibuprofen or ≤ 50 mg diclofenac exclusion criteria * patients whose pain is due to an acute exacerbation of a chronic condition e.g. osteoarthritis, rheumatoid arthritis, systemic lupus erythematosus. * patients who have taken non-steroidal anti-inflammatory drugs in the previous 24 hours (other than aspirin, ibuprofen, diclofenac, as described above). other protocol-defined inclusion/ exclusion criteria may apply.

Keywords: musculoskeletal pain cyclooxygenase-2 inhibitors lumiracoxib naproxen
effects of lactobacillus plantarum ps128 on symptoms of early-onset parkinson's disease: a pilot study

Conditions: Early Onset Parkinson Disease

Summary: this study is designed to examine l. plantarum ps128 can improve symptoms in early onset pd patients. l. plantarum ps128 is a psychobiotic that regulates the level of dopamine in specific brain regions. patients with early onset pd will receive ps128 treatment for 12 weeks. symptoms of pd will be clinically evaluated before and after the treatment, and the results will be compared.


Eligibility criteria:
inclusion criteria: * early onset parkinson's disease, eopd * at least 9 years education * age between 20 and 80 years old exclusion criteria: * patients on antibiotics within the preceding one month * patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks * have undergone surgery of liver, bladder, or gastrointestinal tract * have current or history of inflammatory bowel disease * have history of cancer * known allergy to probiotics * patients with comorbid dementia (mini-mental state examination score ≤ 26) or major depression (the beck depression inventory-ii score ≥ 29) * have received deep brain stimulation * patients receiving artificial enteral or intravenous nutrition * diagnosed before 40 years old * poor control of other chronic diseases * not eligible judged by pi
real word study on myopia control with repeated red light therapy for ages of 3~6 years old

Conditions: Myopia; Amblyopia

Summary: repeated red light therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. however, ultra low lever of red light therapy with irradiance of 0.37mw and 0.60mw effectiveness and safety for 3\~ 6 year-old myopia treatment or slow myopia progression are seldom reported.

repeated red light therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. however, ultra low lever of red light therapy with irradiance of 0.37mw and 0.60mw effectiveness and safety for 3\~ 6 year-old myopia treatment or slow myopia progression are seldom reported. here we design this control and random prospective study to find the two types light with different irridance to two ages (3\~4 years old and 5\~6 years old) respectively. wether the dose and effectiveness exit or not for 3\~6- year- old myopia control.

Eligibility criteria:
inclusion criteria: * 3\~6 years old; * myopia spherical equivalence refraction \<=-0.50d; * written informed consent; exclusion criteria: * cannot approval with written informed consent; * photophobia or allergy to red light; * with other severe conditions the principle investigators refused to enroll this study

Keywords: myopia children lllt pbm
autologous stem cell therapy in stroke

Conditions: Stroke

Summary: the purpose of this study was to study the safety and effect of stem cell therapy on the functional recovery in patients with sub acute/chronic stroke.


Eligibility criteria:
inclusion criteria: * age18 years-80 years * diagnosed as stroke by clinical and mri findings exclusion criteria: * presence of respiratory distress * presence of acute infections such as human immunodeficient virus/hepatitis b virus/ hepatitis c virus * malignancies * acute medical conditions such as respiratory infection, fever * hemoglobin less than 8 * bleeding tendency * bone marrow disorder * left ventricular ejection fraction \< 30% * pregnancy or breastfeeding

Keywords: chronic stroke subacute stroke autologous bone marrow mononuclear cell therapy stem cell
reducing hypertension disparities in rheumatoid arthritis

Conditions: Hypertension; Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is a autoimmune disease associated with an increased risk of developing coronary artery disease (cad) and premature death, particularly in black patients. traditional cad risk factors like hypertension (htn) are both very common and poorly controlled among black ra patients. disparities in ra disease activity further increase the risk of cad in this population. black patients face significant barriers when seeking ra care, and the investigators suspect similar challenges affect htn care in this population. the goals of this project are to identify and address barriers to htn care in patients with ra to reduce disparities in htn and cad outcomes for black ra patients. interviews with black ra patients, rheumatology providers, and primary care providers in the duke university health system will be conducted to describe barriers to htn care in black ra patients. interviews will focus on access to care, patient-provider communication, coordination of care, and the challenges of managing htn in patients with ra. these interviews will help us to develop an intervention that will focus on improving uncontrolled htn in black ra patients. the investigators plan to do this by empowering black ra patients to actively participate in their htn care, improving patient-provider communication, and improving coordination between primary care and rheumatology providers. if successful, our intervention has the potential to reduce rates of cad and associated death for black ra patients.


Eligibility criteria:
inclusion criteria: * 18 years old or older * race self-identified as "black" or "african american" * uncontrolled hypertension * history of rheumatoid arthritis * receive both primary care and rheumatology care from duke health system exclusion criteria: * age less than 18 years old * other self-identified race * healthy volunteers without rheumatoid arthritis and hypertension * do not receive both primary care and rheumatology care from duke health system * cognitive impairment with lack the capacity to consent to study participation * pregnant women * prisoners
brimonidine for intraoperative hemostasis

Conditions: Dermatochalasis of Eyelid; Ptosis, Eyelid; Ectropion; Entropion

Summary: the purpose of this study is to observe and report the effects of topical ophthalmic brimonidine in oculofacial plastic surgery.

brimonidine ophthalmic solution (alphagan) is mainstay in glaucoma therapy to reduce intraocular pressure. the medication is an alpha2 adrenergic agonist, which increases uveoscleral outflow of aqueous humor. alpha2 agonists also have vasoconstrictive properties, which has been utilized in over-the-counter medications like lumify for redness relief. an unexploited utility of its vasoconstrictive property is reduction in intraoperative bleeding during ophthalmic surgery. the purpose of this study is to observe and report the effects of brimonidine in oculofacial plastic surgery. there are reports in ophthalmic literature that observe the hemostatic effect of topical brimonidine across different subspecialties. it has been shown to reduce intraoperative bleeding and post-operative subconjunctival hemorrhages in pterygium removal, strabismus surgery, lasik, and cataract surgery. one study claimed that it had a comparable hemostatic effect to phenylephrine. many of the procedures in oculoplastic surgery involve manipulation and incision of eyelid skin and conjunctival tissue. some examples include blepharoplasty, ptosis repair, medial spindles, lateral tarsal strips, canthotomy and cantholysis with subsequent repair, retraction repair, and orbital fracture repair. rapid and adequate control of intraoperative bleeding is crucial to the success of oculoplastic surgery. although surgeons take proper precautions to prevent inadequate hemostasis (discontinuing blood thinners, use of electrocautery, and administration of intradermal epinephrine), excessive bleeding can still occur. this can impair surgeon performance by obscuring visualization, and negatively affect the patient due to prolonged operative times, and delayed healing due to hematoma formation. the most feared complication of oculoplastic surgery is intraorbital hemorrhage, which can cause orbital compartment syndrome causing vision loss. therefore, any intervention to minimize bleeding is very advantageous to the patient. use of brimonidine drops intraoperatively will improve hemostasis, resulting in improved visualization, reduced operative time under anesthesia, and reduced risk of significant intraorbital hemorrhage. due to both brimonidine's vasoconstrictive properties and relatively favorable safety profile, it raises the question: can brimonidine be used to achieve better hemostasis in oculoplastic procedures?

Eligibility criteria:
inclusion criteria: * above the age of 18 * ophthalmic conditions requiring oculoplastic surgery exclusion criteria: * known allergy or adverse effects to brimonidine * hypotony * acute ophthalmic infection * history of hypotension * orthostatic hypotension * pregnancy * history of central nervous system (cns) depression from medication use * thrombotic disorders * asymmetrical oculoplastic conditions that may interfere with tear drainage (e.g. unilateral nldo) * current use of brimonidine
pain outcomes following intralesional corticosteroid injections

Conditions: Keloid; Alopecia Areata; Acne; Hypertrophic Scar; Epidermal Inclusion Cyst; Frontal Fibrosing Alopecia; Lichen Plano-Pilaris; Keratoacanthoma; Plaque Psoriasis; Lichen Simplex Chronicus; Prurigo Nodularis; Nummular Eczema; Granuloma Annulare; Morphea; Lichen Planus

Summary: corticosteroid therapy, including intralesional and topical applications, has many indications within the fields of dermatology, plastic surgery, and orthopedics. however, these injections can be quite painful, which leads many patients to discontinue treatment. often, the injection involves a mixture of local anesthetic and corticosteroids despite a lack of evidence that the use of lidocaine improves pain. due to the acidic ph, the lidocaine component of the injection can actually cause a significant burning sensation during the procedure. lidocaine does not have anti-inflammatory properties and does not treat the underlying pathology. by including another medication, lidocaine also adds cost and risk to the procedure. the purpose of this study is to see if removing lidocaine from intralesional injections decreases the pain of injection.


Eligibility criteria:
inclusion criteria: * \>12 years old presenting with an indication for intralesional steroid injection exclusion criteria: * unconsentable * not a candidate for corticosteroid injection * contraindication to lidocaine

Keywords: corticosteroid local anesthetic