Kornimate/medical-research-clean huggingface dataset:
treatment of the symptomatic sacral perineurial cysts

Conditions: Pain

Summary: there are very few data and analysis in the literature regarding the symptomatic sacral perineurial cysts. most studies are case reports or small retrospective sample, which rarely more than 20 cases. there is no an consensus on the choice of treatment (medicine conservative treatment and surgical treatment) for symptomatic sacral perineurial cysts.our aim, therefore, is to compare the efficacy of medicine conservative treatment and surgical treatment for symptomatic sacral perineurial cysts by a randomized controlled trial. meanwhile, resting-state functional magnetic resonance imaging is used to detect the changes at pain related brain areas, which will be develop an objective method to evaluate the clinical curative effect of the two treatment options.


Eligibility criteria:
inclusion criteria: * 1. diagnosed with symptomatic sacral perineurial cysts(e.g., lumbosacral or perineal pain, fecal or urinary functions change, sexual function change, lower limb radiation pain, muscle abate, paresthesia, etc) * 2. visual analog scale more than or equal to 4 * 3. signed the informed consent * 4. years, range 18-60 * 5. self-rating anxiety scale (sas) and self-rating depression scale (sds) scores \< 50 * 6. no congenital,mental and other nervous system diseases * 7. no serious cardiac,pulmonary,hepatic and nephritic disease * 8. no history of drug allergy * 9. no pain(including dysmenorrhea) or drug use (e.g., antipyretics,sleeping pills) within the last month * 10. mri finding of sacral perineurial cysts, but without any clinical symptoms, included in the negative control group * 11. mri finding healthy volunteers don't have sacral perineurial cysts, included in the negative control groupblank control group exclusion criteria: * 1. patients with lumbar common diseases(e.g., lumbar disc, lumbar spinal stenosis, lumbar slippage, etc) * 2. researchers think that patients with disease may be interference results(e.g., spinal deformity, spine fracture, ankylosing spondylitis, spinal tuberculosis and spinal infection, spinal tumor, pelvic inflammatory disease and other disease of department of gynaecology, etc) * 3. patients with other nervous system diseases(e.g., cerebral tumor, neurinoma, trigeminal neuralgia,etc) * 4. patients with magnetic resonance imaging contraindication ,including claustrophobic syndrome patients * 5. patients with recent (less than 3 years) use chemical drugs or have obvious psychological problems * 6. in the past 2 months involved in other drugs or devices clinical trials

Keywords: sacral perineurial cysts(tarlov cysts) resting state functional magnetic resonance imaging (rfmri) vas medicine conservative treatment surgical treatment
a study of real-world treatment patterns and outcomes in chinese advanced nsclc patients who previously received at least 2 line treatments

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: this study will retrospectively collect data of patients with advanced non-small cell lung cancer who have received at least 2 line treatment to investigate treatment patterns, relevant outcomes, and biomarkers detection patterns in chinese patients with actionable genomic alterations (aga) or non-aga.


Eligibility criteria:
inclusion criteria: 1. participants aged ≥18 years when diagnosed with advanced nsclc. 2. histologically or cytologically confirmed stage iv nsclc. 3. for non-aga participants , second- or third-line systemic treatment occurred between september 1, 2019 and december 31, 2022, and participants received corresponding immunotherapy in the first or second line. 4. for aga participants , second- or third-line systemic treatment occurred between september 1, 2019 and december 31, 2022. among them, participants with documented positive result for egfr, alk, or ros1 testing received corresponding targeted therapy in the first or second line. exclusion criteria: this study excludes participants who met any of the following criteria. 1. having records of participation or past participation in clinical trial for lung cancer within the data collection period of the study. 2. participants with a concomitant cancer at the time of diagnosis of nsclc (except for non-metastatic non-melanoma skin cancers, in situ or benign neoplasms). occurrence of cancer within 5 years after nsclc diagnosis will be considered as secondary cancer. 3. histology of the tumor is small cell lung cancer, neuroendocrine in origin, or a mixed histologic type with small cell and non-small cell lung cancers. 4. participants with significantly missing medical record data or patients deemed inappropriate for inclusion by investigators.

Keywords: nsclc lung cancer
an observational study assessing effects in patients with combination therapy with raloxifene/cholecalciferol

Conditions: Osteoporosis

Summary: this study examines quality of life and patient satisfaction in postmenopausal women receiving raloxifene to prevent/treat osteoporosis, and vitamin d to reduce risk of fracture using clinical practice data. the purpose of this study is to observe quality of life(qol), medication compliance and patient satisfaction who got combination therapy with raloxifene/cholecalciferol (raloxifene 60mg + cholecalciferol 800 iu, rabone d®, hanmi pharma, south korea) for 6 months.

preventing bone loss is an important concern for women during post-menopausal period. menopause significantly speeds bone loss and increases the risk for osteoporosis. this study was to investigate the effectiveness on quality of life (qol), patient satisfaction in postmenopausal women receiving raloxifene/cholecalciferol combination therapy. in addition, we analyzed adverse events to assess the safety profile of this drug. this study is a multicenter, prospective, non-critical observational study of women receiving raloxifene/cholecalciferol (raloxifene 60mg + cholecalciferol 800 iu, rabone d®, hanmi pharma, south korea) combination therapy to treat or prevent postmenopausal osteoporosis. data will be collected from patients receiving routine treatment at about 105 primary, secondary, or tertiary medical institutions in south korea. each subject visits the institution according to the protocol that designed the follow-up visits for six months to examine changes in, and factors influencing quality of life (eq-5d-5l method), patient satisfaction with efficacy and convenience (questionnaire), and safety. this study will approved by the institutions' irbs and is in compliance with clinical research ethics regulations.

Eligibility criteria:
inclusion criteria: * postmenopausal women who need to prevent/treat osteoporosis * subject who got raloxifene/cholecalciferol combination therapy prescription with confirmation by the investigator's medical decision * subjects who can consent voluntarily exclusion criteria: * patients for whom use of raloxifene/cholecalciferol combination therapy is prohibited * pregnant women, nursing women or child-bearing aged females deemed capable of pregnancy

Keywords: raloxifene cholecalciferol osteoporosis quality of life
functional assessment in liver transplantation

Conditions: End Stage Liver Disease

Summary: this will be a prospective cohort study of patients with liver disease. subjects will undergo geriatric assessments of frailty, functional status, and disability using functional status measures at baseline and at every clinic visit in the pre-transplant setting. subjects will also answer questions regarding quality of life, personality, and/or cognitive function. subjects will again undergo assessments at every clinic visit through 12 months after transplant. then, they will be followed annually.

patients will be asked to perform the following study procedures: 1. assessment of cognitive function, quality of life, and/or personality using cognitive tests and questionnaires. 2. measures of frailty and disability selected to capture the multi-dimensional aspects of frailty including functional status and physiologic reserve: fried frailty score: weakness (test of grip strength), exhaustion (patient interview), slowness (gait speed), low activity (patient interview) short physical performance battery: repeated chair stands, balance testing with feet together, 13-foot walk 3. laboratory tests will all be obtained from the medical record: creatinine, total bilirubin, inr, sodium, albumin. all of these tests are necessary for listing for liver transplantation. 4. blood draw, urine and stool samples will be collected for a sub-group of 1000 patients. 5. adipose, muscle, liver tissue, and blood will be collected during the liver transplant surgery for a sub-group of 1000 patients.

Eligibility criteria:
inclusion criteria: * adult (≥18 years old) * are seen for the treatment of liver disease

Keywords: cirrhosis liver liver transplant frailty end stage
a multicenter, double blind, placebo-controlled, safety and tolerability study of bms-708163 in patients with prodromal alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to determine the safety and tolerability of bms-708163 in patients with prodromal alzheimer's disease over a treatment period of a minimum of 104-weeks. in addition patients will be seen for safety visits at 4 and 12 weeks post treatment.


Eligibility criteria:
inclusion criteria: * patient meets clinical criteria for prodromal alzheimer's disease (mmse 24-30) * memory complaint by subject or study partner * csf aβ42 levels \< 200pg/ml or total tau/aβ42 ratio of ≥ 0.39 * score of ≤4 on the modified hachinski ischemia scale * ct results consistent with alzheimer's disease * medically stable * 6 years education * reliable study partner * must be able to swallow capsules exclusion criteria: * premenopausal women * dsm-iv diagnosis of dementia history of stroke * immunocompromised * active peptic ulcer, gi bleed, chronic inflammatory bowel disease, chronic diarrhea or past gi surgery that would impact drug absorption * unstable vitamin b-12 deficiency * hematologic or solid malignancy within 5 years * geriatric depression scale ≥ 6 * unstable medical condition * alcohol or drug abuse history with 12-months of study entry * significant drug allergy * prisoners, compulsory psychiatric patients, or residents of nursing home or skilled nursing facility at entry * any other experimental therapy with 30-days of study entry
anastrozole 1 mg tablets under fed conditions

Conditions: Healthy

Summary: the objective of this study is to evaluate the comparative bioavailability between anastrozole 1 mg tablets (teva pharmaceuticals, usa) and arimidex® 1 mg tablets (astrazeneca pharmaceuticals lp, usa), after a single-dose in healthy subjects under fed conditions.

criteria for evaluation: fda bioequivalence criteria statistical methods: fda bioequivalence statistical methods

Eligibility criteria:
inclusion criteria: * healthy, non-smoking, post-menopausal or surgically sterile female subjects 18 years of age or older. * body mass index between 18 and 30, inclusive. * indicate non-child bearing status by one of the following criteria: * indication of successful hysterectomy. * no spontaneous menses for at least 1 year, must have luteinizing hormone (lh) and follicle stimulation hormone (fsh) levels within the postmenopausal range. * indication of successful bilateral oophorectomy. * negative for: * hiv. * hepatitis b surface antigen and hepatitis c antibody. * urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines, and methadone). * urine cotinine test. * serum pregnancy test. * no significant diseases or clinically significant findings in a physical examination. * no clinically significant abnormal laboratory values. * no clinically significant findings in the 12-lead electrocardiogram (ecg). * no clinically significant findings from the vital signs measurement. * be informed of the nature of the study and given written consent prior to receiving any study procedure. * participants in this study will be unable to have children (i.e. post-menopausal, hysterectomy). exclusion criteria: * known history or presence of any clinically significant medical condition. * known or suspected carcinoma. * known history or presence of: * hypersensitivity or idiosyncratic reaction to anastrozole and/or any other drug substances with similar activity. * alcoholism within the past 12 months. * drug dependence and/or substance abuse. * use of tobacco or nicotine containing products within the last 6 months. * taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing. * taken any hormone replacement therapy (hrt) for 4 weeks prior to dosing. * on a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet). * participated in another clinical trial or received an investigational product within 30 days prior to drug administration. * donated up to 250 ml of blood within the previous 30 days or donated from 251 to 500 ml of blood in the previous 45 days or donated more than 500 ml of blood in the previous 56 days. * requirement of any non-topical medication (prescription and/or over-the-counter) on a routine basis. * difficulty fasting or consuming the standard meals. * do not tolerate venipuncture. * unable to read or sign the informed consent form.

Keywords: bioequivalence healthy subjects
phase 1/2a study on allogeneic osteoblastic cells implantation in delayed-union fractures

Conditions: Long Bone Delayed-Union Fracture

Summary: fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone. there is for now no universally accepted approach to evaluate the progression of fracture healing. typically, a fracture is considered as a delayed-union when the bone has not united within a period of time that would be considered adequate for bone healing. delayed-union suggests that union is slow but will eventually occur without additional surgical or non-surgical intervention, whereas non-union is defined as the cessation of all reparative process of healing. the incidence of impaired healing is estimated to range from 5 to 10% of all long bone fractures, depending on the fracture site, the type and degree of injury, among other factors. currently the treatment of choice remains bone allograft or autograft. this procedure shows in general good results but requires an invasive surgery of several hours under general anesthesia, followed by a few days of hospitalization. because of this, major complications have been reported in up to 20-30% of patients. the present phase 1/2a study aims at demonstrating the safety and efficacy of allob®, a proprietary population of allogeneic osteoblastic cells, in the treatment of delayed-union fractures of long bones. in this study, delayed-union is defined at the time of screening as an absence of healing of minimum 3 months and maximum 7 months (+/- 2 weeks) after the onset of the fracture.


Eligibility criteria:
inclusion criteria: * patient (or patient's legally acceptable representative) capable to provide a written, dated, and signed informed consent prior to any study related procedure * non-infected delayed-union fracture of a long bone of minimum 3 months and maximum 7 months (+/- 2 weeks) exclusion criteria: * fracture interline larger than 2.5 cm * insufficient fracture stability * multifocal fracture * positive serology for hepatitis b, hepatitis c, human immunodeficiency virus (hiv) * current or past medical disease that could interfere with the evaluation of the safety and efficacy, as judged by the investigator * severe renal or hepatic impairment

Keywords: delayed-union fractures impaired healing fractures orthopedics bone musculoskeletal disorders
a multi-centre study to assess the long-term performance of the summit™ hip in primary total hip replacement

Conditions: Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis

Summary: the purpose of this study is to monitor the performance of the summit™ hip in the treatment of patients with hip joint disease requiring a total hip replacement. patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility criteria:
inclusion criteria: i) male or female subjects, aged between 18 and 70 years (inclusive). ii) subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. iii) subjects who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. iv) subjects who require primary total hip replacement and are considered suitable for a cementless femoral stem. exclusion criteria: i) subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study. ii) subjects who have previously undergone a hemi-arthroplasty or total hip arthroplasty. iii) women who are pregnant. iv) subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes. v) subjects who have participated in a clinical study with an investigational product in the last 12 months. vi) subjects who are currently involved in any injury litigation claims.

Keywords: hip cementless
lifestyle remodeling in subjective memory complaint (smc): brain imaging and blood biochemistry study

Conditions: Subjective Memory Complaint

Summary: the specific study aims: 1. to investigate whether the brain function is affected by the past life experiences, such as lifestyle and physiology-related factors in smc. 2. to examine whether the lifestyle remodeling could improve smc's cognitive function and modulate the reactivity of inflammatory factors, leading to significantly slow down the disease progression to mci or dementia. 3. to investigate the lasting duration of the intervention.

although there is much evidence showing age-related reduction of cognitive function, many researchers point out a more optimistic viewpoint that aging is not a progressive loss. by remodeling the lifestyle, or/and monitoring the physical factors, the risk to develop dementia could be reduced. the above statements are mostly based on the epidemiological research, while it remains unclear how the aging modulates the brain changes. in previous study, the investigators have found that individuals with subjective memory complaint (smc) showed altered brain changes in terms of resting-state connectivity when compared to those without smc. the present study further aims to examine whether the brain function is affected by the past life experiences, such as lifestyle and physiology-related factors in smc. more importantly, this study aims to clarify whether the lifestyle remodeling could improve smc's cognitive function and modulate the reactivity of inflammatory factors, leading to significantly slow down the disease progression to mci or dementia. in summary, the present study aims to understand how the lifestyle remodeling affects smc's brain function and biochemical indicators. before and after the intervention, this study will use neuropsychological tests to assess all the aspects of cognitive functions, use electroencephalogram to investigate the brain activation patterns, and use biochemical analyses to quantify the reactivity of inflammation, toxic as well as neurotrophic factors. through the follow-up design, this study also plan to investigate the lasting duration of the intervention and the how the neural reorganization occurs as function of time.

Eligibility criteria:
inclusion criteria: 1. age over 50 years old. 2. diagnosed with subjective memory complaint (smc) and with lower cognitive activities and physical activities. 3. voluntary to sign the informed consent form. exclusion criteria: 1. participants or first-degree relatives diagnosed with mental diseases. 2. participants have history of severe neurological diseases or brain injury led to loss of consciousness. 3. participants have diagnosis of cardiovascular disease. 4. participants have history of alcohol, nicotine, or substance dependence. 5. participants suffer from visual, hearing degradation (including hearing aid user).

Keywords: subjective memory complaint alzheimer's disease mild cognitive impairment neuroinflammation lifestyle
buprenorphine for cancer pain

Conditions: Cancer-Related Pain

Summary: this study will evaluate patients on both buprenorphine and full agonist opioids (fao) to assess for withdrawal symptoms. patients will be evaluated by clinicians and using validated tools to assess for pain and withdrawal. at the same time, patients will use a cpm rx application on their phone to track medication use.

this prospective study will recruit patients with pain related to cancer or its treatment who are on buprenorphine in combination with a full agonist opioid where dose of the full agonist opioids (fao) is \> 30 mg ome per day. they will be provided a mobile application (cpm rx) for reporting of pain level daily and at each as needed dose. withdrawal will be assessed using a modified clinical opioid withdrawal scale (cows) score and patients will be instructed to be aware of changes in these symptoms. they will also be followed in person at the initial visit, and at days 14, 28, 56 , and 84 with brief pain inventory (bpi) and cows scale to assess for pain or withdrawal and other reported side effects. pill counts will be done on days 28, 56, and 84 to further assess medication usage. nurses will check-in to complete bpi and ask about withdrawal symptoms at days 42 and 70. the study seeks to assess if patients on buprenorphine and fao have withdrawal symptoms, what are the highest doses of buprenorphine and fao tolerated, and assess usage of the cpm rx app. each patient will be followed on the study for 3 months, unless the choose or it is deemed appropriate to end sooner.

Eligibility criteria:
1. age greater than or equal to 18 years 2. english speaking and able to understand and sign informed consent and hipaa consent document. 3. the patient will have pain from any cause with a pain level greater than or equal to 4 on a visual analog scale. 4. the patient will be able to complete study assessments including use of the cpm app (requires smart phone) 5. patients who may become pregnant are using adequate contraceptives. 6. patient is on the combination of buprenorphine and full agonist opioid \> 30 mg oral morphine equivalent or being started on both buprenorphine and full agonist opioid \>30 mg oral morphine equivalent at the time of enrollment

Keywords: cancer pain buprenorphine
safety & efficacy study of quetiapine fumarate (seroquel®) vs. placebo and active control in major depressive disorder

Conditions: Major Depressive Disorder

Summary: this study is to evaluate that (seroquel®) quetiapine sustained-release is efficacious and safe in the treatment of patients with mdd.


Eligibility criteria:
inclusion criteria: * patient has a documented clinical diagnosis of major depressive disorder. * be able to understand and comply with the requirements of the study. * able to understand and provide written informed consent exclusion criteria: * patients (female) must not be pregnant or lactating * current or past diagnosis of stroke or transient ischemic attack (tia).

Keywords: mdd quetiapine fumarate, sustained release depression