Kornimate/medical-research-clean huggingface dataset:
prevention of gestational diabetes

Conditions: Gestational Diabetes

Summary: gestational diabetes mellitus (gdm)is a major health problem * growing prevalence of obesity * the older age of pregnant women a randomized controlled trial in 54 pregnant voluntary women at high risk for gdm. * feasibility of an early intervention * glucose tolerance at weeks 26-28

1. a 75-g oral glucose tolerance test (ogtt) was performed at weeks 8-12 1. voluntary women in early pregnancy (n=96) 2. 54 high risk mothers were randomized * lifestyle intervention group (n=27) * close follow-up (n=27) 2. an ogtt was performed again at weeks 26-28 * the lifestyle intervention group (n=27) * the close follow-up group (n=27) * other high-risk women of the early care group (n=42)who were not randomized 3. an ogtt was also performed at weeks 26-28 in two neighboring municipalities * a standard care high-risk group(n=171)who did not undergo early intervention 4. primary outcomes * number of at risk participants developing gdm during pregnancy in the two arms 5. secondary outcomes * the effect of intervention on fetal growth

Eligibility criteria:
inclusion criteria: * high risk for gestational diabetes * fasting glucose 4.8-5.5 mmol/l and 2-hour glucose of ogtt \<7.8 mmol/l exclusion criteria: * normal glucose tolerance at weeks 8-12 * gestational diabetes at weeks 8-12

Keywords: gestational diabetes mellitus lifestyle intervention oral glucose tolerance test insulin treatment pregnancy outcomes
irrigation endoscopic decompressive laminotomy

Conditions: Lumbosacral Spinal Stenosis

Summary: the classic laminectomy for surgical treatment of spinal stenosis has considerable morbidity .this is further magnified by the disease being more common in elderly with associated medical comorbidities and being usually global involving multiple levels.the purpose of this study is to present and to evaluate a new endoscopic technique named irrigation endoscopic decompressive laminotomy (iedl) for lumbar spinal canal decompression.

in the iedl group,2 portals 0.5cm were used one for the endoscope and the other for instruments. for every additional level one portal is added. the endoscope and instruments are directly placed over the surface of lamina without any dissection and saline under pump pressure is used to open a potential working space. unilateral laminotomy and bilateral decompression under endoscopic vision is performed. in the microsurgical group, bilateral fenestration is performed in the usual manner

Eligibility criteria:
inclusion criteria: * neurogenic claudication,that correlated with moderate to severe spinal canal stenosis as shown on mri and resistant to 3 months of conservative management . exclusion criteria: * predominant back pain or instability

Keywords: irrigation endoscopic decompression minimally invasive surgery spinal stenosis
hypotension prediction index based perioperative protocolized hemodynamic management in geriatric orthopedic surgery

Conditions: Orthopedic Disorder; Hemodynamic Instability

Summary: blood pressure optimization has been considered as a crucial factor to avoid perioperative vital organ hypoperfusion, and perioperative hypotension has been addressed as a risk factor for complications and adverse clinical outcomes. hypotension prediction index (hpi) is an novel machine-learning derived parameters, and was developed to predict the risk of future hypotension.series of clinical studies have verified its clinical efficacy in avoiding perioperative hypotension. major orthopedic surgeries, such as spine surgery, joint surgery, long bone fracture surgery, are quite common in elder people, who are vulnerable to perioperative adverse outcomes.thus the investigator design this study to testify the clinical efficacy of implementing hpi in perioperative goal-directed hemodynamic therapy in elder patients receiving major orthopedic surgery.


Eligibility criteria:
inclusion criteria: * adults elder or equal to 60 years old receiving scheduled orthopedic surgery exclusion criteria: * patients with a history of arrhythmia, congestive heart failure, preoperative neurocognitive disorder, cerebrovascular event, chronic obstructive pulmonary disease, chronic kidney disease, ongoing infectious disease, will be excluded.
transcranial direct current stimulation in conjunction with individualized physical therapy for individuals with chronic knee pain

Conditions: Knee Pain Chronic

Summary: background: there is a high prevalence of chronic pain in the us, with nearly half of adults experiencing chronic pain. chronic pain is associated with impaired mobility, specifically ambulation. treatment for chronic knee pain is complex given that pain is not only due to peripheral sources, but also due to alterations of the central nervous system (cns). majority of physical therapy (pt) interventions involve a bottom-up approach targeting the peripheral pain sources and many patients (\~66%) do not respond to this treatment approach. noninvasive brain stimulation techniques such as transcranial direct current stimulation (tdcs) is a novel and promising option for a top-down intervention that can have neuromodulatory effects on the cns and may better target central factors associated with chronic pain. purpose: to determine if tdcs delivered to the primary motor cortex in conjunction with individualized pt will result in greater improvements in pain and function compared to sham tdcs with individualized pt in individuals with chronic knee pain. methods: this study will be performed at outpatient pt clinics at the university of illinois hospital. eligible participants will include patients with chronic knee pain (duration \> 3 months) who have not undergone surgery to this area and are scheduled to receive formal pt intervention. subjects will be randomized to the active tdcs + pt group or sham tdcs + pt group and will receive the intervention for 8 sessions. outcomes include pain ratings, pressure pain thresholds, patient specific functional scale, lower extremity functional scale, quadriceps strength, knee range of motion, 2-minute walk test, 5 time sit to stand, patient health questionnaire-2, and central sensitization inventory. impact: the use of adjuvant therapies such as tdcs have the potential to optimize rehabilitation treatment for individuals with chronic pain by offering a more comprehensive treatment that targets peripheral and central sources of pain.


Eligibility criteria:
inclusion criteria: * age \>/= 18 years old * knee pain * knee pain duration \>/= 3 months exclusion criteria: general exclusion criteria * history of surgery on affected knee * pregnant tdcs exclusion criteria * skin hypersensitivity * history of contact dermatitis * any other skin or scalp condition that could be aggravated by tdcs * previous adverse reactions to tdcs
comparison of pk after administration of hcp1201 and co-administration of metformin sr 750mg and rosuvastatin 20mg

Conditions: Diabetes Mellitus

Summary: to compare the pharmacokinetic characteristics between hcp1201 tablet 750/20 mg and co-administration of metformin 750 mg plus rosuvastatin 20 mg under fasted and fed state, respectively.

an open-label, randomized, single-dose crossover study to compare the pharmacokinetics after the administration of hcp1201 tablet 750/20 mg and coadministration of metformin sr 750 mg and rosuvastatin 20 mg in healthy volunteers

Eligibility criteria:
inclusion criteria: 1. healthy male volunteer, age 20\~55 years 2. the result of body mass index(bmi) is not less than 19 kg/m2 , no more than 27 kg/m2 3. subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial 4. subject who has the ability and willingness to participate the whole period of trial exclusion criteria: 1. presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system. 2. glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value. 3. liver enzyme (ast, alt) level exceeds the maximum normal range more than one and a half times. 4. sbp: lower than 90mmhg or higher than 150mmhg, dbp: lower than 60mmhg or higher than 100mmhg 5. history of relevant drug allergies or clinically significant hypersensitivity reaction. 6. history of drug abuse or positive drug screening. 7. participation in other drug studies within 60days prior to the drug administration. 8. whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days. 9. subjects who took prescription drugs within 14 days from the patient screening or non-prescription medicine within 7 days which can affect the result of this clinical trial (acceptable according to the investigator's judgement) 10. subjects who took medicines(e.g. proton pump inhibitor, rifampicin, oriental medicines, etc.) within 30days that can affect absorption, distribution, metabolism, elimination of metformin/rosuvastatin. 11. intake of more than 140g of alcohol per week or who can't abstain from alcohol during the trial. 12. subjects who smoke more than 10 cigarettes per day or who can't quit smoking during the trial. 13. positive screening on hepatitis b surface antigen(hbsag), anti-hepatitis c virus(hcv) or anti-human immunodeficiency virus(hiv). 14. genetic myopathic disorder or related family history, medical history of myopathic disorder caused by medication. 15. clinically inappropriate laboratory test result. 16. clinically inappropriate electrocardiogram result. 17. subjects who judged ineligible by the investigator.
evaluation of software generated customized foot orthoses

Conditions: Arthropathy of Ankle or Foot

Summary: the purpose of this study is to determine whether custom-made foot orthoses generate a significant decrease in the perception of pain among individuals with foot pain and/or ankle pain.

the investigators aim to enroll up to 60 participants over the course of 1-3 months. each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted. subsequently, consecutive surveys will be carried out at 0, 7, 30, 120, and 360 days from the first day of foot orthoses use to measure the change in pain and comfort with use of the foot orthoses. an interim analysis will be conducted after all subjects have completed the 30-day time point. this interim analysis will allow the sponsor to determine whether subjects are using the foot orthoses that the subjects have been provided. complete primary analysis is estimated to be completed within 3 months after the termination of the study.

Eligibility criteria:
inclusion criteria: 1. foot/ankle pain or pathology or diagnosed pes planus, pes cavus, pronator foot, supinator foot, metatarsalgia, morton's neuroma, sesamoiditis, hallux valgus, intermetatarsal bursitis 2. between 18 and 65 years of age 3. bmi is greater than 18.5 or less than 30 exclusion criteria: 1. individuals who have had surgery in the lower limbs during this past year. 2. individuals who already have custom-made orthopedic orthoses. 3. patients with active diabetic ulcers or chronic foot pressure ulcers.
barriers to efficient pacu discharge at a major academic orthopaedic ambulatory surgery center

Conditions: Achilles Tendon Rupture; Database

Summary: this is a retrospective chart review to determine the etiologies contributing to prolonged pacu discharge at a major orthopedic ambulatory center

increasing number of surgeries are now performed at ambulatory surgical centers including orthopaedic procedures. while healthier patients usually undergo non-major orthopaedic procedures using regional anesthesia to facilitate faster discharges, prolonged pacu discharges are frequently encountered necessitating characterization and identification of modifiable variables. this is a retrospective chart review to determine the etiologies contributing to prolonged pacu discharge at a major orthopedic ambulatory center.

Eligibility criteria:
inclusion criteria: * adult patients (18 years and older) undergoing ambulatory foot and ankle surgery exclusion criteria: * n/a
modified story memory technique (msmt) in persons with tbi

Conditions: Traumatic Brain Injury

Summary: the current rct is designed to: 1. test the efficacy of the group based msmt in persons with tbi on npe, the current gold-standard for measuring memory functioning 2. assess the effectiveness of the group msmt on more global measures of everyday life, including an objective measure shown through our previous work to be sensitive to memory changes following the msmt, as well as additional questionnaires to be completed by both the participant and a significant other 3. evaluate the changes in brain functioning following treatment with the msmt via fmri and 4. evaluate the long-term effects of the treatment protocol. to accomplish these goals investigators will conduct a double-blind, placebo-controlled, rct, applying the group msmt to a sample of 60 participants with moderate to severe tbi (30 treatment; 30 control).

outcome measures will assess objective memory abilities, everyday memory abilities and patterns of cerebral activation during learning. a long-term follow-up assessment will be conducted, designed to measure the impact of the msmt 3 months following treatment completion. alternate forms will be utilized wherever available.

Eligibility criteria:
inclusion criteria: * i am between the ages of 18-65. * i have had a traumatic brain injury at least one year ago. * i can read and speak english fluently. * i have difficulties with learning and memory skills. exclusion criteria: * i am currently taking steroids and /or benzodiazepines as determined by study staff review of my medications. * i have had a prior stroke or neurological injury/disease other than a traumatic brain injury. * i have a history of significant psychiatric illness (for example, bipolar disorder or psychosis) or a current diagnosis of major depressive disorder, schizophrenia, bipolar disorder i or ii. * i have unstable or uncontrolled seizures. * i have a significant alcohol or drug abuse history.

Keywords: memory learning cognition traumatic brain injury treatment and therapy
cefepime/aai101 phase 2 study in hospitalized adults with cuti

Conditions: Urinary Tract Infections

Summary: phase 2, randomised, double-blind, 2-cohort study in hospitalised adults with complicated urinary tract infection (cuti), including acute pyelonephritis. all study cohorts were randomised in a 2:1 ratio. treatment duration for each cohort was 7 to 10 days. patients were not permitted to switch to oral therapy. cohort 1: 15 patients treated with cefepime 1 g/aai101 500 mg intravenous (i.v.) infusion over 2 hours once every 8 hours (q8h), and 7 patients treated with cefepime 1 g i.v. infusion over 2 hours q8h. cohort 2: 15 patients treated with cefepime 2 g/aai101 750 mg i.v. infusion over 2 hours q8h, and 8 patients treated with cefepime 2 g i.v. infusion over 2 hours q8h.


Eligibility criteria:
inclusion criteria: • male or female patients with clinical signs and/or symptoms of cuti or acute pyelonephritis that were expected to require hospitalization and initial treatment with at least 7 days of i.v. antibiotics. exclusion criteria: * patients with concurrent infection that would interfere with evaluation of response to the study antibiotics; * patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups; * patients receiving effective antibacterial drug therapy for any indication for a continuous duration of \>24 hours during the previous 72 hours before the study-qualifying baseline urine was obtained or receiving any amount of potentially therapeutic antibacterial therapy after collection of the pre-treatment baseline urine culture and before administration of the first dose of study drug; * patients likely to require the use of an antibiotic for cuti or acute pyelonephritis prophylaxis during participation in the study; * patients with confirmed fungal urinary tract infection at the screening visit (with ≥103 fungal colony forming units \[cfu\]/ml); or * patients with intractable urinary infection at baseline that the investigator anticipated would require \>10 days of study drug therapy were excluded from participation
a study comparing nivolumab, nivolumab in combination with ipilimumab and placebo in participants with localized kidney cancer who underwent surgery to remove part of a kidney

Conditions: Carcinoma, Renal Cell

Summary: the purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

the study has two primary endpoints. the first primary completion date is anticipated to be reached july 2022 (dfs in part a). the second primary completion date is anticipated to be reached july 2024 (dfs in part b).

Eligibility criteria:
inclusion criteria: * kidney tumor has been completely resected with negative surgical margins obtained. the randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy * pathologic tumor, node, and metastasis (tnm) staging meeting one of the following: pt2a, g3 or g4, n0 m0; pt2b, g any, n0 m0; pt3, (a, b, c), g any, n0 m0; pt4, g any, n0 m0; pt any, g any, n1 m0 * post-nephrectomy tumor shows renal cell cancer (rcc) with a predominantly clear cell histology, including participants with sarcomatoid features * participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy * eastern cooperative oncology group (ecog) performance status (ps) 0-1 * women must agree to follow methods of contraception, if applicable exclusion criteria: * participants with an active known or suspected autoimmune disease * known history of positive test for human immunodeficiency virus (hiv) or known acquired immunodeficiency syndrome (aids) * prior treatment with an anti-pd-1, anti-pd-l1, anti-pd-l2, or anti-ctla-4 antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways * any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation * history of allergy or hypersensitivity to study drug components * participants with a condition requiring systemic treatment with corticosteroids * participants who have received a live/attenuated vaccine within 30 days of first treatment other protocol-defined inclusion/exclusion criteria apply

Keywords: localized resected adjuvant renal cell carcinoma kidney cancer nephrectomy clear cell high risk of relapse/recurrence
preemptive analgesia with celecoxib for acute dental pain management

Conditions: Pain, Postoperative

Summary: the purpose of this study is to compare the effect on postoperative pain of a single agent nonsteroidal anti-inflammatory drug (nsaid) \[celecoxib plus placebo\] to an nsaid combination \[celecoxib plus acetaminophen\] administered preemptively to patients prior to impacted third molar surgery. .

this randomized, double-blind, placebo-controlled, prospective clinical trial is designed to compare the postoperative pain reduction of a single agent nonsteroidal anti-inflammatory drug (nsaid) and nsaid combination regimen administered preemptively. subjects will be given a single oral dose of a cyclooxygenase-2 (cox-2) selective inhibitor (celecoxib 200mg), or celecoxib 200 mg in combination with acetaminophen (apap 1000 mg) 30 to 60 minutes prior to the procedure. oral surgery involving at least one impacted mandibular third molar will be performed using a combination of intravenous sedation and local anesthesia following uthealth school of dentistry (utsd) surgical protocol. all subjects will be released with identical postoperative instructions and prescriptions for pain management. nonopioid pain management will be prescribed as follows: 600mg ibuprofen with 500 mg apap every 6 hours for the first 3 days, then as needed for pain. subjects will be asked to document medication consumption, postoperative pain and complications for the following 3 days using a qualtrics survey. an oral and maxillofacial surgery resident or faculty on call can offer emergency intervention with prescription of an opioid analgesic.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status classification 1 or 2 * at least 1 impacted mandibular third molar planned for extraction exclusion criteria: * asa 3 or higher for physical status classification * severe pericoronitis associated with third molar to be extracted * any known allergies to nsaids, aspirin, acetaminophen, sulfa drugs * history of cardiovascular or cerebrovascular disease * hepatic disease or impairment * pregnancy
accuracy of guided ridge splitting with simultaneous implant placement

Conditions: Dental Implant

Summary: assessing whether is there a difference between computer-guided ridge splitting and conventional technique with simultaneous implant placement in patients with maxillary width deficiency.

two groups one treated with ridge splitting using guided surgery and the other one treated with freehand surgery and both groups had simultaneous dental implants the first one had guided placement and the other one was freehand.

Eligibility criteria:
inclusion criteria: * patient with missing maxillary anteriors or premolars teeth. * tooth extraction at the implant sites was performed at least 4 months before the surgery. * the bone width of the crestal one -third (3-5 mm) with sufficient bone height allowing for simultaneous implant placement. * free from any systemic disease or local pathological lesions that may affect bone healing or contraindicate implant placement. * with no history of any previous grafting surgeries at the area of interest. exclusion criteria: * sever concavity of the alveolar ridge. * bad oral hygiene ( silness-löe index (score 2-3). * heavy smoker (smoke greater than or equal 25 cigarettes per day). * presence of acute infections or periapical lesions in adjacent teeth. * parafunctional habits. * pregnant females.

Keywords: guided ridge splitting, atrophic maxilla, osseodensification drills.