Kornimate/medical-research-clean huggingface dataset:
study of pregabalin in the prevention of central neuropathic pain in acute spinal cord injury

Conditions: Spinal Cord Trauma; Pain

Summary: this research study will test to see if people who receive pregabalin after their spinal cord injury will develop less nerve damage pain than people who do not receive it.

pregabalin is one of the few agents that have demonstrated effectiveness in the treatment of central nep in sci. research is now proving that it is possible to prevent the development of pain in certain conditions. pregabalin has been proven effective in this area with post surgical pain. therefore, after traumatic sci there may be a small window of time where we could prevent the development of nep by administering an agent like pregabalin. objective: to test the hypothesis that pregabalin is an effective treatment in preventing post-spinal cord injury neuropathic pain. design: double-blind, placebo controlled, randomized, trial setting: spinal cord injury program, neurosurgery and tertiary care rehabilitation center subjects: 30 patients with acute traumatic spinal cord injury method: pregabalin will be offered to patients with acute traumatic spinal cord injury pain in a double blind crossover, placebo control design. main outcome measures: the primary outcome measures will be the development of neuropathic pain and intensity of pain secondary outcome measures will be ashworth's scale for spasticity and asia motor and sensory scores. results: to be determined. conclusion: to be determined.

Eligibility criteria:
inclusion criteria: * eligible participants will be 18 years of age or older * have suffered a traumatic spinal cord injury (complete or incomplete) * be free of neuropathic pain * be in stable medical condition exclusion criteria: * pregnant or lactating women: because we do not know the risks of pregabalin in pregnancy, females of child bearing years must have a negative pregnancy test (performed on screening and subsequent follow up visits) and be using a reliable method of birth control including oral or injectible birth control hormones, barriers, intrauterine devices or tubal ligation, or abstinence throughout the duration of the study. * should a female become pregnant while participating in the study she will be un-blinded and, if on pregabalin, she will be weaned from the medication as quickly as is safe and withdrawn from the study. appropriate follow-up for any pregnancy complications will be conducted. * persons with known hypersensitivity to pregabalin or its constituents * persons with neuropathic pain at the time of enrollment * persons with a chronic pain diagnoses that may interfere with the evaluation of the presence of neuropathic pain

Keywords: the outcome is to prevent central neuropathic pain participants will have suffered spinal cord trauma
comparative effectiveness of two tobacco cessation interventions for employees of partners healthcare, inc.

Conditions: Smoking Cessation; Tobacco Use Disorder

Summary: specific aim: to conduct a randomized controlled trial among permanent employees of partners healthcare, inc., and their adult dependents, who are current tobacco smokers. the trial will compare two interventions designed to help smokers stop using tobacco: (1) external coaching program (standard care) and (2) internal coaching program, a chronic disease management strategy for treating tobacco use and dependence.


Eligibility criteria:
inclusion criteria: * current permanent employee of partners healthcare, inc. or their adult dependent * current tobacco smoker (smoked a cigarette, even a puff, in the past 30 days) exclusion criteria: * temporary, per diem or former employee of partners healthcare, inc. * plan to leave partners employment in the next 12 months * inability to give informed consent or participate in counseling due to serious psychiatric disorder or cognitive disorder
safety, tolerability, and immunogenicity of gc3106 (quadrivalent cell-culture based influenza vaccine)

Conditions: Influenza

Summary: the purpose of this study is to evaluate the safety, tolerability, and immunogenicity of gc3106 after single intramuscular administration in korean healthy adults.

this study is the first in human trial of gc3106 and is designed as an adaptive phase i/iia to ensure participants protection. part a is an open-label and single arm study in 9 healthy volunteers. data and safety monitoring board (dsmb) will review the solicited/unsolicited adverse events conditionally if any toxicity of grade 3 or 4 has been reported during 7 days after vaccination from the first 9 healthy volunteers. part b is a randomized (2:1), double-blind, active controlled study and a total of 75 volunteers will participate in this part. adverse events assessment will be done according to the 'toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials'.

Eligibility criteria:
inclusion criteria: * given written informed consent * healthy korean adults (age: between over 19 and under 65) * korean adults who agree with 21 days follow up after vaccination and good compliance to study procedures * those who are able to comply with the requirements for the study exclusion criteria: * inability in written/verbal communication * subjects who have participated in other interventional study within 30 days * alcohol or drug abuse within 6 months * heavy drinkers or subjects who do not agree to stop drinking for 3 days before vaccination and other 3 days after vaccination * who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment * hypersensitivity with drug or active ingredient * disorders in immune function * history of guillain-barré syndrome * disease/medications which are likely to cause any severe bleeding * active infection or experience of fever (\>38.0 ℃) within 72 hours following vaccination * oral temperature \>38.0 ℃ at the vaccination day * erythema, tattoo, injury at shoulder (vaccination site) * influenza vaccination within 6months * any vaccination within 30 days * concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products, or anti-cancer chemotherapy or radiation therapy within3 months * pregnant or breast-feeding women * clinically significant underlying diseases or medical history at investigator's discretion

Keywords: influenza vaccine vaccination cell-culture based influenza vaccine cell culture derived influenza vaccine cciv
risk factors for piperacillin/tazobactam resistance in extended-spectrum beta-lactamase (esbl) producing organisms

Conditions: Enterobacteriaceae Infections

Summary: this research will be conducted to determine whether risk factors exist for piperacillin/tazobactam resistance in esbl organisms.

this is chart review at upmc. no human subject interaction will occur.

Eligibility criteria:
inclusion criteria: * clinical information is collected by chart review of "case" and "control" patients. * a "case a" patient is defined as follows: one or more clinical cultures are positive for an esbl producing bacteria and the organism is piperacillin/tazobactam resistant. * a "case b" patient is defined as follows: one or more clinical cultures are positive for an esbl producing bacteria and the organism is piperacillin/tazobactam susceptible. * additionally, 1 control patient in the hospital at the same time as the case patients will be randomly selected for each case and are not in either case group. exclusion criteria: * patients \< 18 years of age

Keywords: esbl positive cultures
investigation of kinetic oscillation stimulation by the chordate system s101 in the treatment of non allergic rhinitis

Conditions: Nasal Congestion; Non-allergic Rhinitis

Summary: this is an interventional, multicenter, double-blind, placebo-controlled trial in which patients diagnosed with non-allergic rhinitis will be randomized to either intranasal stimulation, or placebo treatment with the chordate system at two occasions.

this is a double-blind, placebo-controlled, multi-center study in which patients diagnosed with non-allergic rhinitis will receive intranasal stimulation with the chordate system at two occasions. objectives are to evaluate the efficacy of the procedure in reducing disease specific symptoms such as nasal congestion, rhinorrhea, nasal itching and sneezing, but also to investigate the influence on quality of life, safety and tolerability.

Eligibility criteria:
inclusion criteria: 1. patients with persistent (\>12w) symptoms of non-allergic rhinitis dominated by nasal congestion (± secretion) for an average of at least 1 h per day for at least 5 days during a period of 14 days. 2. having nasal congestion as major symptom, and a median nasal congestion score of at least 2 (scale 0-3) 3. male or female 18 - 65 years 4. judged by the investigator as suitable for participation in the study without safety concerns based on medical history and physical examination. 5. willing and able to provide written informed consent prior to participation in the clinical investigation 6. willing and able to comply with all study related procedures exclusion criteria: 1. patients with allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or rast during the last year. 2. ongoing respiratory tract infection including nasal cavity at inclusion 3. systemic steroid treatment less than 4 weeks before the inclusion in the study 4. patients with a history of nasal surgery like: septoplasty, cosmetic surgery, conchal surgery or any other nasal surgery except closed reposition for nasal fracture during last year 5. history of frequent nose bleeds or a condition that increases the risk of excessive bleeding 6. pronounced anterior septal deviation or other significant nasal pathology at endoscopic examination 7. current malignancy of any kind 8. known allergy to polyvinylchloride or medicinal liquid paraffin 9. any disease, condition (medical or surgical) or drug or alcohol abuse which, in the opinion of the investigator, might compromise the study results, or would place the patient at increased risk. 10. any implant with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulation, spinal stimulator, bone growth stimulator, or cochlear implant or any other implant in the head-, and neck region. 11. previous treated with radiation on the face, head or neck regions 12. female patients who are pregnant or become pregnant at any time from inclusion of the study until end of the 8 week follow-up visit 13. received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer
prospective study of detection of sarcopenia in clinical practice for patient with ovarian or endometrial cancer

Conditions: Ovarian Neoplasms; Sarcopenia

Summary: prospective monocentric study, non-randomized of the detection of sarcopenia in clinical practice in patients with ovarian or endometrial cancer requiring systemic oncological treatment. main question : identify the criteria correlated with the presence of sarcopenia (defined by the measurement of the ims by the ct-x method in l3) among the impedancemetry and the has malnutrition criteria. data collection will be done at 6 months, 12 months after the date of inclusion.

primary objective:identify the criteria correlated to the presence of sarcopenia (defined by the measurement of the ims by the ct-x method in l3) among the impedancemetry and the has malnutrition criteria main judgment criteria : comparison between the groups of patients with sarcopenia (morphometric measurement of the musculoskeletal surface index \<39cm²/m² in l3 cross section) and without sarcopenia of the different evaluation criteria: * impedancemetry values:: muscle mass index in kg/m2 (ims), fat-free mass in kg/m2 and metabolic activity index (phase angle) * percentage of weight loss * bmi \< 18.5 kg/m2 * quantified reduction in muscle mass and/or function for patients \< 70 years old * quantified reduction in muscle mass and function for patients \> 70 years old * physical tests: walking speed and "hand grip" dynamometer secondary objectives:- proposal of a composite score for the detection of sarcopenia usable in clinical routine * evaluation of nutritional intake * evaluation of the severity of undernutrition * verification of a correlation between the sarcopenia indices of ovarian and endometrial cancer * evaluate tolerance profiles to systemic treatments with regard to sarcopenia figures * assess the relationship between pfs, os and sarcopenia index in cancer diagnosis secondary judgment criteria : * statistical analysis of sarcopenia and undernutrition data * quantification of ingestates (sefi scale) +/- intake of oral nutritional supplement * serological tests: nfs, crp and albuminemia * comparison of sarcopenia index figures between ovarian and endometrial cancer * collection of the grades of toxicities and adverse events to systemic treatments in parallel with the measurement of sarcopenia. * correlation between progression-free survival, death and sarcopenia index at cancer diagnosis

Eligibility criteria:
inclusion criteria: * patients at least 18 years old * patient presenting with a diagnosis of cancer of ovarian origin with an indication for chemotherapy * patient with a diagnosis of endometrial cancer with an indication for chemotherapy * patient with no diagnosis of other types of cancer in the previous five years * collection of consent * patient affiliated to a social security scheme exclusion criteria: * patient with cancer of ovarian origin not requiring chemotherapy treatment * patient with endometrial cancer not requiring chemotherapy treatment * discovery of an intercurrent cancer other than skin or cervix cancers. * patient wearing a pace maker
a post-marketing observational study to evaluate the effectiveness of adalimumab in patients with moderately to severely active rheumatoid arthritis in china

Conditions: Arthritis; Rheumatoid

Summary: a post-marketing uncontrolled observational study to explore and describe the effectiveness of adalimumab, as prescribed according to the local product label, in patients with moderately to severely active rheumatoid arthritis (ra) in china.

this post-marketing, multi-center, uncontrolled observational study will be conducted in an open-label, non-interventional setting, for ra patients using commercially available adalimumab administered subcutaneously (sc). adalimumab effectiveness will be assessed based on data from clinic visits beginning at baseline and continuing per standard of care for ra. the primary objective is to evaluate the effectiveness of adalimumab in improving patients' disease activity measured by disease activity score (das28) at week 12. the maximum observation period for each patient is approximately 52 weeks, as long as the patient continues to receive adalimumab injections. the study was terminated due to low enrollment.

Eligibility criteria:
inclusion criteria: 1. male or female patient greater than or equal to 18 years of age with diagnosis of ra (rheumatoid arthritis) and no history of chronic arthritis before age 16. 2. patient meets the requirements for treatment with adalimumab per the local product label. 3. patient is naïve to adalimumab, and has not used any other immunomodulatory biologic\* dmard (disease modifying antirheumatic drugs) in the past 8 weeks before the baseline visit (\*rituximab may not have been used in the past 104 weeks before the baseline visit). 4. patient must be able and willing to provide written authorization (or informed consent where applicable) to disclose and use personal health information and comply with the requirements of this study protocol as well as agree to data being collected by abbott. exclusion criteria: 1. patient is currently being treated with or has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half lives (whichever is longer) of the drug prior to the baseline visit. 2. prior clinically active tb (tuberculosis): if patient has had prior clinically active tb, there should be documentation that a full course of appropriate anti-tb therapy was completed or an ongoing full course of appropriate anti-tb therapy has been started before initiation of adalimumab in accordance with the local product label; otherwise, the patient will not be eligible to participate in this study. 3. patient who intends to take less than 6 consecutive (every other week) injections of adalimumab. 4. patients should not be enrolled if they cannot be treated with adalimumab in accordance with the local product label or if the investigator determines that they should not be enrolled based on his/her clinical judgment.

Keywords: study prospective rheumatoid observational study arthritis adalimumab
clinical trial nusmile crowns

Conditions: Primary Dental Caries, Multisurface Origin (Diagnosis)

Summary: a clinical trial comparing two types of nusmile anterior crowns to composite strip crowns on anterior dental restorations.

stainless steel crowns have been the most common treatment for large cavities in baby teeth until recently. these crowns are silver in color, and aesthetically are not a good option for restoring front teeth. several tooth colored options have been developed to meet the growing demand for more aesthetics on front teeth. with the variety of new options for restoring anterior primary teeth, the investigators would like to evaluate the long-term success of three tooth-colored restoration options: nusmile signature crowns, nusmile zr crowns, and composite crowns. the investigators are interested in looking at the outcomes of these three restoration types, in terms of durability, aesthetics and cost effectiveness for the treatment of front baby teeth. the purpose of this pilot study is to evaluate the clinical performance of two types of nusmile crowns compared to composite crowns in treating large multi-surfaced cavities on front baby teeth.

Eligibility criteria:
inclusion criteria: * patients of record at the university of washington's center for pediatric dentistry * patients in general good health (asa i) * patients aged 5 years old or younger * patients in need of at least one preformed crowns, on anterior primary teeth * patients undergoing general anesthesia for dental treatment * parent or guardian of patient able and willing to provide informed consent exclusion criteria: * medically compromising condition * teeth with proximal space closures of sufficient magnitude to preclude placement of crown * teeth with complete absence of facial or lingual walls following tooth preparation * teeth that are expected to be exfoliated/extracted within one year will not participate in the study * anterior crowding * occlusion class iii

Keywords: anterior primary teeth restorations
evaluation of 3d translabial ultrasound imaging for pessary size estimation

Conditions: Prolapse

Summary: symptoms of female pelvic floor dysfunction, such as incontinence and pelvic organ prolapse, can be alleviated by using pessaries, which are passive medical devices that are inserted in the vagina to support the pelvic organs. currently, pessaries are fit through trial and error after manual examination, the accuracy of which depends on the physician's expertise level. the objective of this study is to evaluate the feasibility of using 3d translabial ultrasound imaging of the vagina at various distension volumes to predict the pessary size for successful fit. ultrasound images will be obtained using commercially available 3d ultrasound probes (philips, netherlands), as well as a commercially available 2d ultrasound probe (philips, netherlands), which is linearly scanned to capture a 3d volume. the linear scanning will be performed by attaching the 2d probe to a motorized hand-held scanner, which is used to tilt and move the probe to acquire images. please note that the hand-held scanner does not come in contact with the patient. to distend the vagina, a sterile bag is inserted in the vagina and gradually filled with water using a commercially available urodynamic system (laborie, canada) until the vaginal capacity is reached, without causing any discomfort to the patient. this image acquisition technique, previously reported in the literature, is referred to as 3d ultrasound vaginal manometry in this study. to achieve the objective of this project, 35 pelvic organ prolapse patients, who (i) are current pessary users, (ii) can perform self-care of the pessary, and (iii) can provide informed consent, will be invited to participate in the study. patients will be asked to remove their pessary prior to ultrasound imaging. then, 3d ultrasound vaginal manometry will be performed, using the technique described above. ultrasound images will be analyzed once data acquisition is completed. the size of the pessary estimated from ultrasound images will be compared with the actual pessary size used by the patient.


Eligibility criteria:
inclusion criteria: * current pessary users (\> 6 months) who have no pessary related complication, including discomfort, repeated vaginal bleeding, and pessary extrusion * are able to provide informed consent * can perform self-care, i.e. removing and inserting the pessary themselves * are willing to remove their pessary 2 days before the ultrasound examination date. exclusion criteria: * inability to give informed consent * inability to communicate with the person performing the consent and the sonographer performing ultrasound scanning * history of pelvic radiation or surgery, (including hysterectomy) * using pessaries other than ring, incontinence dish, donut, shaatz, marland, or gellhorn. * inability to perform the valsalva maneuver or pelvic floor contraction * restricted mobility that prevents them from ambulating to assess the comfort level of the pessary during the initial pessary fitting visit. * lack of sensation at the pelvic floor. * being pregnant at the time of the examination.
a study to test if tvb-009p is effective in relieving postmenopausal osteoporosis

Conditions: Osteoporosis, Postmenopausal

Summary: the purpose of this study is to demonstrate similar efficacy and safety between tvb-009 and prolia® (denosumab)

this is a multinational, multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of tvb-009 compared to prolia® administered subcutaneously at doses of 60 mg every 26 weeks. approximately 326 postmenopausal women with osteoporosis will be randomized to receive either tvb-009 or prolia®. at week 52, patients in the prolia® arm will be re-randomized 1:1 to either continue with a third dose of prolia® or transition to tvb-009 and receive a single dose of tvb-009 in the transition period to assess immunogenicity and safety after a transition from prolia® to tvb-009. the total treatment duration for each patient is 78 weeks.

Eligibility criteria:
inclusion criteria: * postmenopausal womeen (≥60 and ≤90 years) with a diagnosis of osteoporosis * body weight ≥50 kg and ≤90 kg * bone mineral density (bmd) measurement t score of less than -2.5 but not less than -4.0 by dual-energy x-ray absorptiometry (dxa) at the lumbar spine at screening * at least 3 vertebrae in the l1 l4 region that are evaluable by dual-energy x-ray absorptiometry (dxa) exclusion criteria: * one severe or more than two moderate vertebral fractures * history and/or presence of hip fracture or atypical femur fracture * any prior treatment with denosumab * ongoing use of any bone active drugs which can affect bone mineral density (bmd) * vitamin d deficiency or hyper- or hypocalcemiacium at screening * hyperthyroidism, hypothyroidism, hypoparathyroidism or hyperparathyroidism * any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study other inclusion/exclusion criteria may apply