Kornimate/medical-research-clean huggingface dataset:
comparison of the epifaith® syringe with the plastic syringe

Conditions: Epidural; Anesthesia, Headache; Analgesia

Summary: the goal of this clinical trial is to compare the efficiency of identifying epidural space with either the epifaith® syringe or the plastic syringe in parturients. the main questions it aims to answer are: * whether it consume less time identifying epidural space with the epifaith® syringe * whether the usage of the epifaith® syringe decrease the complication rate and failure of labor analgesia participants will receive labor analgesia either with the epifaith® syringe or the plastic syringe conducted by experienced resident doctors.


Eligibility criteria:
inclusion criteria: * asa ii to iii * require labor analgesia * has submitted inform consent exclusion criteria: * asa iv or above * coagulopathy * spinal deformity * neurological, psychological, cardiopulmonary disorder * active liver or kidney injury
a study of epinastine nasal spray in subjects with seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: the purpose of this trial is to determine the safety, efficacy and tolerability of two doses of the study drug compared to placebo for the treatment of subjects with seasonal allergic rhinitis.


Eligibility criteria:
inclusion criteria: * a documented history of seasonal allergic rhinitis to mountain cedar pollen exclusion criteria: * significant medical condition * cardiovascular abnormality * have a significant physical obstruction in the nose * started or had a change in immunotherapy within the 30 days prior to screening * have nasal ulceration(s) or any active nasal bleeding * require use of allergy medications during the study * require use of asthma medications other than as needed albuterol
effectiveness of aidsvax b/e vaccine in intravenous drug users in bangkok, thailand

Conditions: HIV Infections; HIV Seronegativity

Summary: the purpose of this study is to determine if the vaccine, aidsvax b/e, will protect intravenous drug users from becoming infected with hiv.

volunteers are immunized and followed for a minimum of 2 years. any volunteer that becomes infected with hiv-1 is followed every 4 months post infection for up to 36 months. behavior effects associated with study participation are assessed.

Eligibility criteria:
inclusion criteria volunteers may be eligible for this study if they: * are 20 to 60 years old. * are hiv-negative. * have used intravenous drugs in the previous 12 months. * are available and commit to 3 years of follow-up. * have a thai national id or its equivalent such as government official id or state enterprise id. * are able to understand the study and pass a test showing they understand it, and give written informed consent. exclusion criteria volunteers will not be eligible for this study if they: * have a serious disease or condition, or history of a serious disease or condition such as lymphoma, that would interfere with the study. * are hiv-positive. * have ever received an experimental hiv-1 vaccine. * have had or expect to have any treatments or medications that interfere with the immune system (e.g., long-term use of systemic steroids, chemotherapy, or radiation). * have received a vaccine or immunoglobulin within 2 weeks of receiving the first study injection, or other vaccines within 4 weeks of the first study injection. * have received immunoglobulins for a long time. * have received non-licensed, research agents within 4 weeks of the first study injection. * expect to miss study visits or plan to move within 36 months. * are pregnant or breast-feeding or plan to become pregnant during the 36-month study period. * are women who have sex with men and do not plan to use effective birth control.

Keywords: recombinant proteins hiv-1 aids serodiagnosis substance abuse, intravenous enzyme-linked immunosorbent assay blotting, western hiv envelope protein gp120 aidsvax
study to optimize the quality of samples for cell-mediated immunity (cmi) in art-naïve hiv-1-infected subjects

Conditions: AIDS; AIDS Vaccines

Summary: the purpose of this study is to investigate a combined set of parameters deemed to impact the quality of cmi analyses in terms of the proportion of viable lymphocytes in antiretroviral therapy-naïve hiv-1 infected subjects.

this study will address the respective and combined impact of (i) timing between blood collection and peripheral blood mononuclear cells (pbmc) processing \["time-to-process"\] and (ii) timing of pbmc resting before stimulation \["resting -time"\].

Eligibility criteria:
inclusion criteria: all subjects must satisfy all the following criteria at study entry: * subjects who the investigator believes can and will comply with the requirements of the protocol. * written informed consent obtained from the subject prior to any study procedure. * a male or female between and including 18 and 55 years of age at the time of enrollment. * confirmed hiv-1 infection. * art-naïve and not eligible for art treatment as per established guidelines. subjects must never have received art after hiv diagnosis, including lamivudine used for chronic hepatitis b infection. the exception to this is short-term art for prevention of mother-to-child transmission (pmtct) which must have been completed at least 360 days prior to enrollment. * viral load level between and including 2,000 and 100,000 copies/ml at screening. * cd4+ t cell count \>500 cells/mm3 at screening. * if the subject is female, she must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal. female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test at screening, and * has agreed to continue adequate contraception during the entire study period. exclusion criteria: the following criteria should be checked at the time of study entry. if any exclusion criterion applies, the subject must not be included in the study: * infection with hiv-2. this includes subjects with dual infection with hiv-1/hiv-2. * planned use of any hematotoxic product during the study period. * planned use of any investigational or non-registered product during the study period. * acute or chronic, clinically relevant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination, serology and/or medical history at screening. * grade 3 or grade 4 laboratory abnormalities, as defined by division of aids (daids) grading table, at screening. * any condition which, in the opinion of the investigator, could compromise the subject's adherence to the study protocol. * planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the sample collection visit (visit 2). vaccine can be administered as after sampling in visit 2. * pregnant or lactating female.

Keywords: cmi antiretroviral therapy-naïve hiv
edaravone dexborneol for treatment of acute ischemic stroke with endovascular therapy in extended time windows

Conditions: Stroke, Ischemic

Summary: to explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows.


Eligibility criteria:
inclusion criteria: 1. 18 to 80 years of age; 2. acute ischemic stroke with national institute of health stroke scale (nihss) ≥ 10 and volume of infarction on dwi \<31ml or with a nihss ≥20 and 31ml\<volume of infarction\<51ml(dwi); 3. patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation; 4. endovascular therapy in 6-24 hours of stroke onset; 5. the availability of informed consent. exclusion criteria: 1. first ever stroke or mrs≤1 after previous disease; 2. hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage; 3. coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia 4. severe hepatic or renal dysfunction, increase in alt or ast (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis; 5. severe cardiac or pulmonary disease; 6. patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months; 7. pregnancy, plan to get pregnant or during lactation; 8. patients with contraindication or allergic to any ingredient of drugs in our study; 9. unsuitable for this clinical studies assessed by researcher

Keywords: endovascular therapy extended time windows
a study of palbociclib (pd-0332991) + letrozole vs. letrozole for 1st line treatment of postmenopausal women with er+/her2- advanced breast cancer (paloma-2)

Conditions: Breast Neoplasms

Summary: the study is designed to compare the clinical benefit following treatment with letrozole in combination with pd-0332991 versus letrozole in combination with placebo in postmenopausal women with er(+)/her2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.


Eligibility criteria:
inclusion criteria: * adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy. * confirmed diagnosis of er positive breast cancer * no prior systemic anti-cancer therapy for advanced er+ disease. * postmenopausal women * measurable disease as per response evaluation criterion in solid tumors \[recist\] or bone-only disease * eastern cooperative oncology group \[ecog\] 0-2 * adequate organ and marrow function * patient must agree to provide tumor tissue exclusion criteria: * confirmed diagnosis of her2 positive disease * patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term * known uncontrolled or symptomatic cns metastases * prior (neo)adjuvant treatment with letrozole or anastrozole with dfi ≤ 12-months from completion of treatment. * prior treatment with any cdk 4/6 inhibitor.

Keywords: breast cancer postmenopausal women estrogen-receptor positive her2 negative locoregionally recurrent metastatic palbociclib (pd-0332991) paloma-2
china headache disorders registry

Conditions: Headache Disorders, Primary; Migraine; New Daily Persistent Headache; Medication Overuse Headache; Tension-Type Headache; Trigeminal Autonomic Cephalalgia

Summary: it is planned to include 10000 patients. in the china headache disorders registry chairs）, patients aged over 12 years with primary headache and medication-overuse headache(moh) were collected. the biomarkers, imaging features, cognition, genetic characteristics, ocial and demographic data, medical data, therapeutics used, and outcome of headache-related diseases were studied, and long-term follow-up was planned.


Eligibility criteria:
inclusion criteria: 1. age ≥ 12 years old,any gender; 2. the first onset age of primary headache was less than 50 years old(age \<65 years at first diagnosis of chronic migraine); 3. patients with primary headache (migraine, tension headache and other types of primary headache) or primary headache complicated with moh according to ichd-3; 4. sign the informed consent form. exclusion criteria: 1. according to the ichd-3 diagnostic criteria, there are still headaches directly related to secondary factors (except drug overuse) at the time of enrollment; 2. those who cannot be diagnosed as primary headache or primary headache combined with medication overuse headache according to ichd-3; 3. according to dsm-v diagnostic criteria, patients with severe mental diseases (such as schizophrenia, mental disorders associated with mental retardation, etc.); 4. patients with severe organic diseases, such as malignant tumors, and the expected survival time is less than 1 year; 5. pregnant,planning pregnancy or lactating women; 6. subjects participating in other clinical trials; 7. unable to cooperate to complete the follow-up due to geographical or other reasons
co2 laser revision for burn related donor site scars

Conditions: Burn Scar; Scar; Skin Graft Scar

Summary: scarring from burn wounds remains a chronic and often severe sequela of burn injury. burn wounds may be left to heal by secondary intention or treated with surgical skin grafting; in both circumstances, significant scars likely result. when surgical skin grafting is employed, skin graft harvest sites ("donor sites") likewise result in clinically significant scars. this study will have interventional and observational components. patients will receive the standard fractional ablative co2 treatments to their scars resulting from burn wounds allowed to heal by secondary intention and/or those treated with skin grafts. these will be prospectively observed for the duration of the study as well as adjacent normal skin. in addition, a donor site that meets inclusion criteria that would not have otherwise received lsr will be identified as a treatment site. patients with have one half of their donor sites randomized to standard of care (soc) treatment, which consists of wound dressings, compression therapy, physical and occupational therapies and the other half randomized to soc + ablative fractional co2 laser therapy (lsr).


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * at least 1 second or third degree burn wound that required treatment with split-thickness skin grafts * donor site with at least a 4 x 4 inch surface area * able to return to clinical site for treatments and assessments of burn injuries exclusion criteria: * pregnancy or nursing * oral retinoid medication use within the past 6 months * medical history of ehlers-danlos syndrome, aids * nutritional deficiencies in the opinion of the investigator that would affect wound healing * wounds complicated by clinically significant infection within past 30 days

Keywords: laser
opioid laws and pediatric use

Conditions: Burns; Knee Injuries; Opioid Use; Pain

Summary: the legitimate need for opioid medications for acute pain management in pediatric trauma patients is recognized, however, the high dose and duration of opioid drugs prescribed by medical providers has been associated with an increased risk of opioid abuse and chronic use by patients. the overarching goal of application is to assess opioid use and outcomes of pediatric patients treated for either burn injuries or knee arthroscopy procedures at a large academic pediatric medical center before and after ohio opioid prescription rules for acute pain were implemented on august 21, 2017. also, to evaluate patient use of opioids at 90-days post-treatment.

this study has a prospective and retrospective component. phase 1 involves a retrospective chart review will be performed among pediatric patients undergoing burn care or knee arthroscopy at our institution to determine a whether there was a reduction in prescribed opioid medications following the 2017 ohio opioid prescription law. a 24-month pre-law period (august 1st, 2015, to august 31st, 2017) and 24-month post-law period (september 1st, 2017, to august 31st 2019) will be compared. this phase will include 300 patients (n=150 burn, n=150 knee arthroscopy) evenly divided between the pre-law and post-law periods. phase 2 involves a prospective patient telephone survey 90 days after burn care or knee arthroscopy procedure to assess the association of opioid prescribing, consumption and amount of left-over medications, and pain control status after 90 days. this phase will include 100 patients (n=50 burn, n=50 knee arthroscopy) recruited via convenience sampling.

Eligibility criteria:
inclusion criteria: * pediatric patients age 0-18 years (inclusive) * treated at our institution for either a burn injury or knee arthroscopy procedure * received at least one opioid prescription exclusion criteria: * patients age 19 years and above * patients who did not receive any opioid medications * patients undergoing knee arthroscopy with simultaneous anterior cruciate ligament (acl) reconstruction * families unable to to communicate in english

Keywords: burns knee arthroscopy opioid pain chronic
gamification in knee replacement rehabilitation

Conditions: Knee Osteoarthritis

Summary: after total knee arthroplasty (tka), knee is usually swollen, painful, and stiff. the main goal of post-operative physical rehabilitation is to achieve full extension and flexion of the knee to avoid contractures and stiffness. also strengthening of quadriceps muscle and balance to help activities of daily living and overall mobility are important. the post-operative knee replacement rehabilitation includes the standard protocol in hospital phase and the standard home exercise instructions. computer based exercising games (exergames) may be new method to increase training adherence and volume after tka and thus improve results and effectiveness of the rehabilitation. however, evidence of effectiveness of rehabilitative exergaming on physical functioning is sparse and more research is needed to conduct evidence-based rehabilitation practices. therefore the present study examines the effectiveness of a 16-week gamified physiotherapy on physical functioning, life satisfaction and pain for patients after tka compared to treatment as usual home exercise. the second objective is to validate the psychometric properties of whodas 2.0 (who disability assessment schedule) and brief icf (international classification of functioning, disability and health) core set of osteoarthritis questionnaire. other objectives are to find out, what kind of understanding and experiences the participants have about the rehabilitation with exergames and to evaluate the usability and user experience of exergames.


Eligibility criteria:
inclusion criteria: * first primary (m17.0, m17.1) unilateral tka * mechanical axis of the limb in varus * model of the tka is posterior stabilizing (ps) or cruciate retaining (cr) prosthesis * normal vision with or without eyeglasses exclusion criteria: * fractures, rheumatoid arthritis, or other biomechanical disruptions in affected lower limb within one year before operation * diagnosed memory disorder or cognitive impairment * neurological condition as parkinson's disease, multiple sclerosis or stroke

Keywords: total knee replacement exergame total knee arthroplasty exercise physiotherapy physical functioning
a study to evaluate the pharmacokinetics and the safety after administration of "br1019" and co-administration of "br1019-1" and "br1019-2"

Conditions: Type 2 Diabetes Mellitus; Essential Hypertension

Summary: the objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "br1019" and co-administration of "br1019-1" and "br1019-2" in healthy volunteers


Eligibility criteria:
inclusion criteria: * those who have body mass index (bmi) within the range of 18.0 to 30.0kg/m² at screening visit * in case of a male subject, those who weigh 50 kg or more * in case of a female subject, those who weigh 45 kg or more * those who decide to voluntarily participate after listening to and understanding the detailed explanation of this clinical trial and who sign a written consent to comply with the subject's precautions during this clinical trial. exclusion criteria: * those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken etc, otc, oriental medicine, health functional food concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as interaction of investigational products, half-life of concomitant drugs, etc.) * those who have participated in bioequivalence tests or other clinical trials administered their investigational products within 6 months prior to the first administration date. (however, the termination for participation in other clinical trials are based on the last administration date of their investigational products) * those who have a medical history of gastrectomy(except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs. * those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or its products, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration. * in the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
tha with and without computer navigation

Conditions: Hip Osteoarthritis; Avascular Necrosis of Hip

Summary: the goal of this observational study is to compare postoperative results between patients who had total hip arthroplasty (tha) with and without the use of a computer navigation program. the main questions this study aims to answer are: * can using computer navigation produce better tha implant placement? * can using computer navigation make surgery more efficient? participant data collected include their postoperative x-rays and total operative time.

the goal of this retrospective study is to compare implant placement and operative time of patients who underwent direct anterior total hip arthroplasty with and without the use of a computer navigation program. x-rays are used to measure acetabular cup orientation, leg length discrepancy, and total operative time.

Eligibility criteria:
inclusion criteria: * patients who underwent direct anterior (da) tha with the principal investigator between august 2018 and february 2020 and received actis stem and pinnacle cup with or without computer navigation exclusion criteria: * patients who underwent subsequent revision tha, conversion arthroplasty, hybrid procedures, experienced native or postoperative dislocations, and missing or inadequate radiographs at time of data collection.

Keywords: total hip arthroplasty, computer navigation
effect of duration of symptoms on the clinical and functional outcomes of lumbar microdiscectomy

Conditions: Lumbar Disc Herniation

Summary: 97 patients in 3 randomized groups were treated by microdiscectomy for lumbar disc herniation; group a was operated at 6 weeks of symptoms, group b at 3 months and group c at 6 months. these patients were followed for 3 years for the clinical and functional outcomes.

150 patients were enrolled in this study and only 97 patients were finally analyzed for primary outcomes measures of oswestry disability index and roland-morris questionnaire and secondary outcome measures of visual analogue scale for back pain and leg pain as well as length of hospital stay and time to return for daily activities. assessments done at different periods of 2 weeks, 3 months, 6 months, 1year, 2 years and 3 years.

Eligibility criteria:
inclusion criteria: * age more than 18 years * disc herniation of l3-4, l4-5 or l5-s1 * mri showed disc protrusion or extrusion with nerve root compression corresponding to clinical features. exclusion criteria: * spondylolysis or spondylolisthesis. * spinal deformity like scoliosis. * previous spinal surgery or infection. * cauda equina syndrome. * lumbar segmental instability on dynamic radiograph: translation more than 3 mm or change in angulation more than 10 degrees * smoking * diabetes mellitus * disc herniation other than levels l3-l4, l4-l5 and l5-s1 * more than single level disc hernaition. * body mass index 30 or more than 30 * contained disc herniation by mri

Keywords: duration of symptoms outcomes lumbar microdiscectomy oswestry disability index roland-morris questionnaire