Kornimate/medical-research-clean huggingface dataset:
auricular acupuncture to facilitate outpatient opioid weaning

Conditions: Narcotic Addiction

Summary: this study is to compare two groups undergoing opioid weaning as ordered by their referring physicians. one group will undergo the standard opioid weaning process and the other group will have the addition of the nada protocol to the weaning process.

the nada (national acupuncture detoxification association) protocol is a standardized acupuncture technique in which five designated points in the ear are needled (+/-beads/seeds at points for home acupressure therapy in between treatments). the nada protocol is indicated for treatment of the following conditions: detoxification, withdrawal, emotional trauma, craving, stress syndromes, relapse prevention, rehabilitation \& recovery maintenance. it is also commonly used for ptsd and addiction; however it has not been studied as an adjunct to outpatient opioid weaning protocols for pain. it is cited in the literature as yielding improvements in engagement, retention, decreased cravings, anxiety, and physical symptoms. given these documented results, it seems feasible the outpatient opioid weaning patient would likely benefit from this procedure.

Eligibility criteria:
inclusion criteria: * adults aged 18 and older * referral to the vumc interventional pain clinic for opioid weaning and discontinuation. exclusion criteria: * none

Keywords: opioid addiction opioid weaning
assessment of patients treated with jetrea® for vitreomacular traction

Conditions: Vitreomacular Traction; Vitreomacular Adhesion

Summary: the purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (jetrea®) over a 6-month follow-up period.

after receiving a single intravitreal injection as per country's product label (day 0), subjects were followed for a 6-month period (day 180).

Eligibility criteria:
inclusion criteria: * diagnosis of vitreomacular traction/symptomatic vitreomacular adhesion (vmt/svma), with evidence of focal vma visible on spectral domain optical coherence tomography (sd-oct). * read, sign, and date an institutional review board/ethics committee-approved informed consent form. * other protocol-defined inclusion criteria may apply. exclusion criteria: * women of childbearing potential if pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. * hypersensitivity to ocriplasmin or any of the jetrea® excipients. * active or suspected intraocular or periocular infection. * presence of epiretinal membrane (erm) over the macula at baseline. * broad vmt/vma \>1500 microns at baseline. * history of vitrectomy in the study eye. * history of laser photocoagulation to the macula in the study eye. * any relevant concomitant ocular condition that, in the opinion of the investigator, could be expected to worsen or require surgical intervention during the study period. * macular hole of \>400µm diameter in the study eye. * high myopia in the study eye. * pseudo-exfoliation, marfan's syndrome, phacodonesis or any other finding in the investigator's opinion suggesting lens/zonular instability. * aphakia. * history of retinal detachment. * diabetic retinopathy, ischaemic retinopathies, retinal vein occlusions. * recent ocular surgery or ocular injection. * vitreous hemorrhage. * exudative age-related macular degeneration (amd). * therapy with another investigational agent within 30 days prior to visit 1. * active, simultaneous enrollment in another ophthalmology clinical study. * other protocol-defined exclusion criteria may apply.

Keywords: vitreomacular traction symptomatic vitreomacular adhesion ocriplasmin jetrea
optimization management study of community urinary tract infections spectrum

Conditions: Urinary Tract Infections; Resistant Infection; Community-Acquired Infections; Beta Lactam Resistant Bacterial Infection

Summary: urinary tract infections are the second most common community-acquired infections. even if extended spectrum β-lactamase-producing enterobacteriaceae (esble) cause fewer urinary tract infections, their proportion is increasing. new recommendations were published by ansm in 2015, with specific recommendations for infections due to esbl-producing enterobacteriaceae. in this study, we wanted to evaluate the effectiveness of a recall of the 2015 recommendations in the form of a table attached to the ecbu report, associated with hygiene recommendations. methodology: this prospective, multi-center, non-interventional study was conducted in collaboration with the labazur laboratory over two 2-month periods, one without modification of the laboratory's practices, the other with the addition of documents on the cbeu report. the primary endpoint was the adequacy of prescriptions to ansm 2015 recommendations.


Eligibility criteria:
inclusion criteria: * adult patient who were prescribed by a gp a cbeu during the 2 inclusion periods (from 1/10/2016 to 28/02/2017 with a first period from 01/10/2016 to 30/11/2016 and a second period from 02/01/2016 to 28/02/2017) * cbeu analyzed by labazur laboratory * cbeu positive for a spectrum β-lactamase-producing enterobacteriaceae (esble) exclusion criteria: * children * refusal of consent * cbeu prescribed by a specialist * patient hospitalised for management of the infection
green tea consumption and coronary heart disease

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases

Summary: to examine the prospective association of green tea consumption to the incidence and mortality of coronary heart disease (chd) using multivariate analysis while controlling for the potential confounding effects of cholesterol, triglycerides, glucose and dietary nutrients.

background: both in vivo and in vitro experiments have show that flavonoids, antioxidants which are rich in green tea, are potentially as beneficial as vitamin e, beta-carotene and vitamin c in reducing the risk of cardiovascular disease. thus, the possible preventive effects of green tea on chd have begun to raise research interests in green tea sufficiently to inquire about its beneficial effects formally in humans. however, few epidemiologic studies have been carried out to directly examine the effects of green tea on chd. the honolulu heart program (hhp) is a 30 year longitudinal study of chd and stroke among 8,006 japanese american men living on oahu hawaii. until the end of 1992, 1,888 men from this cohort were defined as having incident chd; this includes 396 deaths due to chd. the baseline examination for the hhp was conducted during 1965-68. a comprehensive physical examination and 24 hour dietary recall interview were administered. within the original cohort more than 75 percent men reported to have drunk green tea daily. the amount consumed per day varied considerably from low to high doses. the high prevalence of green tea consumption coupled with dose information (i.e low, moderate and high consumption) provides good opportunities to examine the relationships of green tea consumption and chd. design narrative: the study uses the honolulu heart program data to examine the prospective association of green tea consumption to the incidence and mortality of chd using multivariate analysis while controlling for the potential confounding effects of cholesterol, triglycerides, glucose and dietary nutrients. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
trial of cannabidiol (cbd; gwp42003-p) for infantile spasms (gwpcare7)

Conditions: Infantile Spasms

Summary: this trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. the pilot phase only will be described in this record. 2 cohorts of 5 participants will be enrolled sequentially. all participants will receive gwp42003-p.


Eligibility criteria:
key inclusion criteria: * participant is aged 6- 24 months (inclusive) in the first cohort or aged 1-24 months (inclusive) in the second cohort, at the time of consent. * participant is diagnosed with is and has failed to respond adequately following treatment with 1 or more approved is therapies. * to be considered hypsarrhythmia, as defined for use in the study, the electroencephalography (eeg) background must be slowed and have multifocal spikes. in addition, it must be either high voltage (above 300 µv) or have electrodecrement/discontinuity. key exclusion criteria: * participant is currently taking or has taken clobazam or any mammalian target of rapamycin (mtor) inhibitor within the 2 weeks prior to the screening visit. * participant has a qt interval, corrected for heart rate with bazett's formula (qtcb), of 460 msec or greater on ecg. * participant's caregiver is currently giving or has given recreational or medicinal cannabis, or synthetic cannabinoid-based medications, within the 1 month prior to the screening visit. * participant's caregiver is unwilling to abstain from giving the participant (including the participant's mother abstaining themselves, if breastfeeding)recreational or medicinal cannabis, or synthetic cannabinoid-based medications (other than the study drug) during the trial. * participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study drug, such as sesame oil. * participant has significantly impaired hepatic function at the screening visit. * participant has received an investigational medicinal product as part of a clinical trial within a minimum of 5 half-lives prior to the screening visit.

Keywords: gwp42003-p cannabidiol
multicenter worksite nutrition study

Conditions: Diabetes; Overweight

Summary: the purpose of this study is to study the potential benefits of low fat vegan diet in a randomized, controlled and multi-centered workplace setting, the investigators will enroll participants from 10 worksites of government employee insurance company (geico). after randomization, 5 will be the vegan sites and 5 will be the control sites for 10 month study. the vegan sites will receive low fat vegan diet instructions and weekly group sessions starting from year 1. no intervention is done to the control sites until the week 18 when the identical program will be given. at various time points, health measurements will be give to all participants.

the purpose of this study is to study the weight loss and other potential benefits of low fat vegan diet as compared to the standard american diet in a randomized, controlled and multi-centered workplace setting. the 10 months study involves 5 vegan sites and 5 control sites generated through a random process after recruitment. the vegan sites will receive low fat vegan diet instructions and weekly group sessions starting from the january, 2011. the control sites will also receive identical instructions starting from the 5th month and lasting for 18 weeks. for each participant at baseline and week 18 a blood test will be conducted, along with blood pressure, weight, hip and waist measurements. a questionnaire will also be administered during these time points to assess dietary intake, work productivity, quality of life, and healthcare utilization. at the end of one year, information about health insurance utilization will be obtained from health maintenance organization(hmo) or preferred provider organization(ppo) for each participant.

Eligibility criteria:
inclusion criteria: * paid employee at a participating geico worksite for at least 6 months * currently a full-time employee at geico working for geico (at least 38.75 hours/week) * age of at least 18 years * ability and willingness to participate in all components of the study * a willingness to be assigned to the vegan diet group or the control group * body mass index ≥ 25 kg/m2 and/or a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥ 126 mg/dl on two occasions or a prior physician's diagnosis of type 2 diabetes exclusion criteria: * a history of alcohol abuse or dependency followed by any current use * current or unresolved past drug abuse * pregnancy or plans to become pregnant in the next 12 months * intention to leave geico in the next 12 months * history of severe mental illness * unstable medical status * already following a low-fat, vegetarian diet * an inordinate fear of blood draws * previously participated in geico two site study

Keywords: vegan diet diabetes overweight workplace nutrition diabetes and/or overweight
kinematics in posterior cruciate retaining and bi-cruciate retaining total knee replacements

Conditions: Arthroplasty, Replacement, Knee; Osteoarthritis, Knee

Summary: the purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who were implanted with the smith \& nephew journey ii posterior cruciate retaining (pcr) total knee arthroplasty (tka) or journey ii bi-cruciate retaining (bcr) tka. cmr has previously collected data for the smith \& nephew bcs tka and compared these kinematics data to those of normal knees.

the objective for this study is to analyze the in vivo kinematics for subjects implanted with either a journey ii pcr or bcr tka and compare those patterns to subjects having a normal knee from our previous study and to those patterns from subjects having a smith \& nephew journey ii bcs tka.

Eligibility criteria:
inclusion criteria: * must have must either a smith \& nephew journey ii pcr or bcr tka * must be at least three months post-operative * must have a knee society score of \>90 with no ligamentous laxity or pain * weigh 250 pounds or less * should have good-to-excellent post-operative flexion * must be able to perform activities (without aid of any kind) and without pain, walking up and down a ramp, performing a deep knee bend and rising from that kneeling position after the deep knee bend * must not have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities * must have body mass index (bmi) of less than 38 * must be between 40-85 years of age * must be willing to sign the informed consent (ic) / hipaa and phi release forms to participate in the study exclusion criteria: * pregnant, potentially pregnant or lactating females. to satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. a pregnant person will not be allowed to participate in the study * subjects without the required types of knee implants * subjects who are unable to walk up and down a ramp, perform a deep knee bend or rising from that kneeling position without aid or support and without pain * subjects who have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities

Keywords: total knee arthroplasty
combination of cisplatin, docetaxel and bevacizumab in patients with non-small cell lung carcinoma (nsclc)

Conditions: NSCLC

Summary: despite recent advances in the treatment of nsclc overall survival within these patients remains dismal and there is yet an unmet medical need for additional treatment options. in this phase ii study a combination of chemotherapy with an antibody (cisplatin, docetaxel and bevacizumab) is tested to determine the objective response rate in patients with unresectable and advanced non-small cell lung cancer. this response rate will be compared with historical data.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented inoperable, locally advanced, metastatic or recurrent nsclc other than squamous cell * at least 1 measurable lesion according to recist criteria * ecog performance score 0 or 1 * age between 18 and 70 years exclusion criteria: * mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component. * history of haemoptysis * evidence of tumour invading major blood vessels on imaging. * previous neoadjuvant/adjuvant chemotherapy. * previous radiotherapy. * serious uncontrolled coagulation disorder or thrombo-embolic complications within 6 months prior to study start or history of serious bleeding complications. * major surgical procedures within 4 weeks prior to study entry. * minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion. * non-healing wound, active peptic ulcer or bone fracture. * history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment.

Keywords: agmt nsclc non-small cell lung cancer bevacizumab avastin cisplatin docetaxel taxotere inoperable stages iiib and iv
the application of ultrasound in the evaluation of patients with colon cancer-related obstruction receiving colonic stent placement

Conditions: Resolution of Bowel Obstruction

Summary: bowel ultrasound may serve as a diagnostic tool to detect the resolution of bowel obstruction. in this study, we aim to validate the use of bowel ultrasound to evaluate patients with colon obstruction receiving colonic stents at national taiwan university hospital from january 2010 to june 2023. we will investigate the association between decompression of the ascending colon and the following surgical procedure, complication, and occurrence of bacteremia.


Eligibility criteria:
inclusion criteria: acute colorectal obstruction without perforation due to malignancy or extra-colonic tumor. exclusion criteria: acute colorectal obstruction with perforation
effect of fasting versus feeding on the bone metabolic response to running

Conditions: Feeding Patterns; Bone Resorption

Summary: this study examined changes in bone metabolism (markers of bone turnover, calcium metabolism) with a bout of acute treadmill running preceded by either a single, mixed meal or an overnight fast.

ten physically active males aged 28 ± 4 y (mean ± 1sd) completed two, counterbalanced, 8 d trials. after 3 d on a standardised diet, participants performed 60 min of treadmill running at 65% vo2max on day 4 following an overnight fast (fast) or a standardised breakfast (fed). blood samples were collected at baseline, before exercise, during exercise, for 3h after exercise and on four consecutive follow-up days (fu1-fu4). plasma/serum were analysed for β ctx, p1np, oc, bone alp, pth, aca, po4, opg, cortisol, leptin and ghrelin.

Eligibility criteria:
inclusion criteria: * history of weight bearing exercise * fasting vitamin d concentration of \>30 nmol•l-1 and/or a fasting parathyroid hormone (pth) concentration of \<6.9 pmol•l-1. exclusion criteria: * smokers * suffered a bone fracture in the previous 12 months * musculoskeletal injury * condition/medication known to affect bone metabolism

Keywords: feeding patterns aerobic exercise osteoclasts
virtuoso improving anatomic bladder lesion excision trial

Conditions: Bladder Neoplasm

Summary: a robotic assisted surgery for bladder lesion excision.

this is a single-center, non-randomized study to evaluate the use of the virtuoso endoscopy system (ves) to perform safe and effective bladder lesion excisions.

Eligibility criteria:
inclusion criteria: 1. the subject is 22 years or older. 2. the subject is eligible and fit for transurethral bladder lesion removal and/or biopsy and has an appropriate indication to go through this surgery. 3. the subject is willing and able to provide written informed consent and comply with the study protocol. 4. the subject can undergo general anesthesia per anesthesiologist assessment. 5. the subject's aggregate bladder lesion(s) size is smaller than 3 cm. exclusion criteria: 1. the subject has acute untreated urinary tract infection or urosepsis. 2. the subject has a documented nickel allergy or nickel sensitivity. 3. the subject is confirmed to be or suspected to be pregnant. 4. the subject is receiving anticoagulants and is unable or not willing to cease the medication for the investigational procedure. 5. the subject belongs to a vulnerable group (prisoner, etc.) 6. the subject has bladder dome or diverticular lesions that are at an increased risk for perforation of the bladder. 7. the subject's lesion(s) involve a ureteral orifice(s) necessitating additional endoscopic management and stenting. 8. the subject has a urethral abnormality, implant, or previous surgery which would conflict with the procedure. 9. the subject has undergone a transurethral bladder resection procedure in the past 6 months. 10. the subject has a history of radiation treatment within the pelvis. 11. bladder tumor base maximal dimension is greater than 3 cm. 12. bladder tumor detected during intravesical therapy. 13. previous histological diagnosis different than non-muscle invasive bladder cancer. 14. presence or prior history of upper urinary tract malignancy. 15. eastern cooperative oncology group performance status greater than or equal to 3. 16. american society of anesthesiologists physical status classification of iii or above. 17. history of bleeding disorder, coagulation abnormality, or use of anticoagulants. 18. the presence of other active malignancy. 19. life expectancy \<1 yr.

Keywords: bladder lesion resection excision bladder tumor
evaluation of esthetic outcomes of m-shaped flap implant uncovering technique versus i-shaped incision around single implants in the anterior maxilla using pink esthetic score

Conditions: Dental Implant Failed

Summary: the aim of this study is to evaluate the soft-tissue profile around a single-tooth implant in the anterior maxilla utilizing the pes after implant uncovering using "m" flap versus i-shaped incision.the primary objective is evaluation of esthetic outcomes around implant using pes. hypothesis: the use of i-shaped incision exposure technique will result in better esthetic outcomes.


Eligibility criteria:
inclusion criteria: * patients with osseointegrated dental implant in the anterior maxilla. * patients of 20 - 50 years * periodontally healthy patients. * no intraoral soft and hard tissue pathology. * no systemic condition that contraindicate surgical intervention. exclusion criteria: * intraoral soft and hard tissue pathology. * heavy smokers more than 20 cigarettes per day. * patients with systemic disease that may affect normal healing. * psychiatric problems. * immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.