Kornimate/medical-research-clean huggingface dataset:
low level laser therapy in the treatment of temporomandibular joint disorders (tmjds) related pain

Conditions: Temporomandibular Joint Disorders

Summary: the low level laser therapy (lllt) has been recently introduced with success in the management of the pain associated to this condition. this double blind placebo controlled clinical trial analyzes a new home lllt protocol to verify whether it was possible to avoid to the repeated presence at dental chair required by traditional lllt protocols.

90 patients with pain deriving from mono- or bi-lateral tmjds were enrolled in the study. randomly subdivided in 3 groups. the study group (sg n=30) receive a lllt by the b-cure dental pro 808nm diode low level laser (biocare enterprise ltd, good energies, haifa, il). the therapeutic protocol previews 2 applications a day for 7 consecutive days performed at 5 joules/min, 250 milliwatts and 15 kilohertz for 8', (40 joules total each) in contact mode over the painful area. the first application is performed at the department of oral sciences of sapienza university of rome, by a laser expert blinded examiner and serves as instruction. the remnants applications must be performed at home by the patients themselves. the placebo group (pg n=30) follows the same protocol by a sham device, seemingly identical to the effective ones, including the pointer light, but devoid of the main diode source. the drug control group (dg n=30) follows the conventional drug treatment for tmjds related pain, 2 non-consecutive cycles of 5 days of nimesulide (100mg a day), interspersed with one 5 days cycle of cyclobenzaprine hydrochloride (10 mg a day) two pain evaluation are registered, before and after treatment.

Eligibility criteria:
inclusion criteria: * tmjd diagnosed clinically and by ct and mri; presence of pain in the tmj area or radiating to the face, jaw, or neck; reduced mouth opening or jaw locks, painful clicking, popping or grating when opening or closing mouth, occlusal alterations exclusion criteria: * muscle tenderness; nsaids assumption within 3 weeks before the treatment; pregnancy; neurocognitive diseases; autoimmune diseases; connective diseases

Keywords: biomodulation lllt temporomandibular joint disorders pain management
efficacy and safety of exenatide in japanese patients with type 2 diabetes who are treated with oral antidiabetic(s)

Conditions: Type 2 Diabetes

Summary: this long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in japanese patients with type 2 diabetes who are treated with oral antidiabetic(s) but not well controlled.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes. * has been treated by sulfonylurea (su) alone, su and biguanide, or su and thiazolidinedione for at least 90 days prior to study start. in a patient receiving su alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. the patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start. * have hba1c 7.0% to 10% at study start. * have a body weight \>=50 kg. exclusion criteria: * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * have participated in this study previously or any other study using exenatide or glucagon-like peptide-1 (glp-1) analogs within the last 90 days. * have been treated with any exogenous insulin within 90 days before study start. * have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start. * the combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.

Keywords: diabetes exenatide ly2148568 byetta lilly amylin
a long-term evaluation of a novel intravaginal device

Conditions: Pelvic Floor Disorders; Sexual Dysfunction; Stress Incontinence

Summary: an open-label long-term evaluation of a novel intravaginal device in female patients experiencing sexual and bladder function issues.

to determine the long-term clinical efficacy of the vsculpt therapy on treating the pelvic floor area and vaginal tissue for females who experience bladder and sexual dysfunction.

Eligibility criteria:
inclusion criteria: * all study participants are required to be biological females (genotype xx) to participate * female participants will be of adult age, over 18 * female participants with self-reported concerns with bladder and sexual function * female participants who have reliable and consistent computer and internet access on a daily basis exclusion criteria: * female participants shall not have an active sexually transmitted disease and/or infection * female participants who are actively undergoing chemotherapy or radiation * female participants who are currently taking any cancer-related or photosensitivity drugs * female participants who are pregnant, who may think they are pregnant, and/or actively trying to get pregnant during the clinical study
pilot study of irreversible electroporation (ire) to treat metastatic liver cancer & cholangiocarcinoma

Conditions: Metastatic Liver Cancer; Cholangiocarcinoma; Neoplasm Metastasis

Summary: single-arm pilot clinical trial. patients will be subjected to irreversible electroporation (ire) as the sole treatment of nodules not considered treatable by resection or thermal ablation.

single-arm pilot clinical trial. patients will be subjected to irreversible electroporation (ire) as the sole treatment of nodules not considered treatable by resection or thermal ablation. this pilot study was designed to study the feasibility and safety of treatment as an alternative therapeutic ire in the treatment of neoplastic nodules in the liver, with particular reference to metastatic liver cancer and cholangiocarcinoma, where the current therapeutic arsenal is inadequate or counter-indicated. to perform the ire procedure the ire nanoknife™ system (angiodynamics) will be used.

Eligibility criteria:
inclusion criteria: * older than 18 years, * male or female, * diagnosis of secondary liver cancer or cholangiocarcinoma based on positive biopsy or noninvasive criteria, * presence of at least one lesion untreatable by surgical resection or ablation for microwave or radio frequency, * the target nodule must have a diameter of ≤ 5 cm * ecog score(eastern cooperative oncology group) 0, * asa score (american society of anesthesiologists) ≤ 3, * prothrombin time ratio \>50% * platelet count \>50x10\^9/l, * patient's ability to discontinue anticoagulant and antiplatelet therapy for seven days before and seven days after surgery with nanoknife™, * ability to understand and willingness to sign the written informed consent form (icf), * life expectancy of at least 3 months. exclusion criteria: * presence of more than 5 liver lesions, * previous treatment of the target nodule, * patient received systemic chemotherapy within 30 days of treatment with the ire nanoknife™, * heart failure, coronary artery disease or arrhythmia in progress, active implantable devices (eg pacemaker), * pregnant women or women of childbearing potential not using an acceptable method of contraception, * patient undergoing treatment with an investigational drug within 30 days of treatment with the ire nanoknife™, * in the opinion of the researcher, anyone who can not follow the calendar of visits and assessments of the protocol.

Keywords: laparotomic surgery laparoscopic surgery percutaneos tumour ablation irreversible electroporation (ire)
comparison of outcomes between parenteral and enteral nutrition

Conditions: Deglutition Disorders

Summary: short-term outcomes of parenteral and enteral nutrition for patients unable to eat normally were compared and analyzed.

data were acquired from patients selected from a national inpatient database covering 1,057 hospitals in japan. participants had received artificial nutrition between april 2012 and march 2013, were 20 years or older, and did not have cancer. participants were grouped into two groups: those receiving parenteral nutrition and those receiving enteral nutrition. the investigators performed one-to-one propensity-score matching between the groups. the primary outcome measurements were mortality rates at 30 and 90 days after the start of the procedure. the secondary outcomes were post-procedural complications, pneumonia, and sepsis. the investigators analyzed survival length of stay after the procedure using a cox proportional hazards model.

Eligibility criteria:
inclusion criteria: * investigators selected participants aged 20 years or older who had undergone either parenteral nutrition by central venous port insertion or enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between april 1, 2012, and march 31, 2013. patients who received both gastrostomy and central venous port insertion were assigned to the gastrostomy group. exclusion criteria: * investigators excluded participants who had been diagnosed with cancer.

Keywords: parenteral nutrition enteral nutrition
emergency medicine pharmacist prescriptive authority for resolution of outpatient prescription issues

Conditions: Outpatient Prescription Issues

Summary: the study aims to document the utility of methodist charlton medical center (mcmc's)emergency medicine pharmacist (emp) collaborative practice agreement (cpa )utilization for the resolution of outpatient prescription issues. evaluation of utility will involve describing all emp-written prescriptions pursuant to resolution of prescription issues realized after discharge.

use of an emp cpa, which allows for broad prescriptive authority, will assist emergency department (ed )workflow by preventing a significant volume of new prescriptions needing to be sent by physician and mid-level providers. will improve rates of ed re-visits. in addition, this collaborative practice agreement (cpa) will not be associated with a large volume of new prescription errors.

Eligibility criteria:
inclusion criteria: * patients at mcmc who had a prescription sent by an emp between november 1, 2021 and june 30, 2023 and a progress note and documenting the reason for the call and action taken by the emp. exclusion criteria: * cpa actions were misclassified as discharge prescription issue resolutions. * patients with prescriptions pursuant to late culture review, formulation changes not requiring a new prescription, prescription transfers to another pharmacy, or simple retransmission of prescriptions. * patients documented to have left the ed against medical advice.
prevention of nephrotoxicity following bone marrow transplantation using urodilatin and mannitol

Conditions: Renal Dysfunction; Acute Renal Failure; Mortality

Summary: the purpose of the study is to combine urodilatin (anp analogue), which will increase glomerular filtration rate (gfr), and mannitol, which will increase the rate of urinary flow and solute excretion. we intend to treat twenty consecutive allogeneic bone marrow transplant patients in a phase ii study comparing results with historical controls. we hypothesize that the incidence of renal dysfunction, arf and thus mortality in allogeneic bone marrow transplantation can be significantly reduced by the use of protective agents urodilatin and mannitol. we feel that this combination is best administered prior to and during the first two weeks of treatment when patients encounter immunosuppressive agents and the onset of early transplantation complications.


Eligibility criteria:
inclusion criteria: * age 18-65 years * presence of malignancy or hematological disease whose treatment will be allogeneic stem cell transplant and high-dose conditioning therapy. * adequate baseline evaluation: adequate renal function (creatinine clearance \> 60 ml/min); adequate hepatic function (sgot, sgpt, bilirubin and alkaline phosphatase \ 45%); adequate pulmonary function (dclo \> 60%). exclusion criteria: * known hypersensitivity to anp or mannitol * congestive heart failure * previous bone marrow transplant * bp less than 90 mm systolic or less than 60 mm hg diastolic

Keywords: urodilatin mannitol acute kidney failure
a comparison: high intense periodic vs. every week therapy in children with cerebral palsy (achieve)

Conditions: Cerebral Palsy

Summary: the achieve study is a comparison of the effectiveness of 2 intensities of physical therapy treatment for children with cerebral palsy in an outpatient physical therapy setting. high intensity periodic is 2 hours of focused and high intense treatment per weekday for 4 weeks. in comparison, usual weekly is considered standard of care; although both dosing models are used clinically for children with cp. participants are assign to the treatment group at random. participant who are unable to consent to randomization are allowed to chose a treatment group.

the overall goal of this project is to compare the effectiveness of high intense periodic and usual weekly therapy in treating cerebral palsy (cp) in children 2-8 years of age for motor rehabilitation. in this prospective randomized controlled trial (rct), 108 children ages 2 to 8 years of age with cp will be enrolled and assigned to one of 2 service delivery models: 1 hour per day, 1 x per week for 40 weeks (usual weekly); and 2 hours every weekday for two 10-consecutive-weekdays (total 4 weeks), for a repeated "periodic" bout (high intense periodic). participants unable to consent to randomization are allowed to chose a treatment group. all patients enrolled in achieve will also have 1 hour per month of physical therapy consultation (ptc) during the treatment period of 40 weeks (9 months). ptcs provide monthly motor skill monitoring, consultation, and home therapy program progression. outcome evaluations will be performed by blinded evaluators at baseline (month 0, before treatment), month 9 for all patients to assess short term effects, and at months 12 and 18 for patients to assess long term effects. parent surveys will be collected at 0, 4.5, and 9 months only (pc-2). short-term and long-term effects will be analyzed to determine individual differences in children's response to intensity. a subset will be analyzed at 12 and 18 month.

Eligibility criteria:
inclusion criteria: * 2 to 8 years of age at initiation of treatment * a diagnosis of motor delay or cp in gmfcs levels 1-v * ability to tolerate a 2 hour therapy session based on parent report and evaluating therapists. exclusion criteria: * uncontrollable seizures or any co-morbid condition that prevents full participation during treatment sessions * participation in another daily treatment program in the last 6 months * auditory or visual conditions that prevent full participation during treatment sessions * progressive neurological disorder with no potential for improvement. * recent surgery where physical therapy is contraindicated.

Keywords: cerebral palsy motor impairments
tamoxifen to reduce unscheduled bleeding in new users of the levonorgestrel-releasing intrauterine system (lng-ius)

Conditions: Menorrhagia; Metrorrhagia; Medicated Intrauterine Devices

Summary: this study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in new users of the 52mg levonorgestrel-releasing intrauterine device (iud). half of participants will receive a course of tamoxifen three weeks after insertion of the iud, while the other half of participants will receive a course of placebo.

new users of the lng iud will be eligible. subjects will be randomized to receive tamoxifen 10 mg twice daily for 7 days or placebo. study drug will be started 3 weeks after placement of the iud. subjects will maintain a record of daily bleeding and spotting using an electronic text messaging diary.

Eligibility criteria:
inclusion criteria: * initiating use of 52mg levonorgestrel-releasing iud for contraceptive purposes * access to reliable cell phone * willing to receive and respond to daily text or email message to assess bleeding exclusion criteria: * using iud for indication other than contraception * postpartum within 6 months, pregnant, or breastfeeding * removal and replacement of iud * undiagnosed abnormal uterine bleeding prior to placement of iud * bleeding dyscrasia * anti-coagulation use * active cervicitis * allergy to tamoxifen * history of venous thromboembolism * personal history of breast or uterine malignancy * use of medication contraindicated with use of tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)

Keywords: levonorgestrel breakthrough bleeding
cardiovascular outcomes and hba1c among patients with type 2 diabetes newly initiating glp1ras vs basal insulin

Conditions: Diabetes Mellitus, Type 2

Summary: this study will compare hemoglobin a1c (hba1c) and cardiovascular (cv) outcomes among patients with type 2 diabetes newly initiating a glp1-receptor agonist or basal insulin.

the 2019 ada-easd clinical treatment guidelines recommend a glp-1ra over basal insulin for patients with type 2 diabetes with suboptimal glycemic control despite metformin and a second-line glucose lowering agent. the basis of this recommendation is due to the side effect profiles of these two medications (i.e. reduced risk of hypoglycemia, some weight loss with glp-1ra), convenience (once weekly injection) and the fact that the price of insulin has skyrocketed in recent years. prior head-to-head randomized trials (eagle, lead 5) comparing select glp-1ra and basal insulin have found mixed results. in eagle, adding either insulin glargine or liraglutide to patients with poorly controlled type 2 diabetes found no differences in the primary outcome (percentage of people reaching hba1c \< 7%). in lead 5, liraglutide was associated with a slightly greater hba1c reduction than glargine, however the dose of insulin was approximately 50% less than the dose used in eagle. the objective of this observational study is to describe the comparative effectiveness and safety of newly initiating a glp1ra versus basal insulin in patients with type 2 diabetes using metformin and another oral glucose lowering medicine.

Eligibility criteria:
inclusion criteria: * age\>=18 years * at least 180 days of continuous enrollment prior to index date * at least 1 type 2 diabetes diagnosis code prior to index date * (for cohort #1) at least 2 metformin dispensings prior to index date and days supply overlap on cohort entry date (with 14 days of grace period before) exclusion criteria: * any type 1 diabetes diagnosis code prior to index date * medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (both black box warnings) prior to index date * h/o pancreatitis * h/o recurrent hypoglycemia (i.e. more than 1 hospitalization / emergency department encounter in primary diagnosis position for hypoglycemia) * index injectable is a combination of glp1-ra plus insulin * index glp1-ra is saxenda (indicated for weight loss) or liraglutide at 3.0mg dose * index insulin regimen includes both basal and prandial insulin, or premixed insulin * any prior glp1-ra use (applied washout for 180 days) * any prior insulin use; sometimes insulin is transiently used at diagnosis (applied washout for 180 days) * secondary diabetes * gestational diabetes * nursing home admission (because we don't have pharmacy claims) * age \<18 years * chronic kidney disease stage 4-6 * advanced cancer * end stage renal disease for a1c cohort only: -hba1c \>12%
identification of critical outcomes in sarcopenia

Conditions: Sarcopenia

Summary: patients will be recruited on each site according to inclusion criteria. participants willing to participate will received an information sheet and a consent form. after given their consent to participate, they will receive a questionnaire composed of 13 choice questions. in this dce, patients will be asked to choose which one of two hypothetical patients (patient a and patient b) suffering from sarcopenia with different levels of outcomes deserves the most the treatment. after completion of the choice tasks, respondents will be asked how difficult they found the choice tasks on a seven-point scale and to questions on their socio-economic and disease characteristics.

the participants will first receive an information letter and consent form. participants will be free to ask any questions to the doctor/researcher. once the consent form signed, participants will receive the questionnaire and will be asked to complete it. explanation of the task and an example choice task should be provided by a doctor or a researcher but the questionnaire is intended to be self-administered. nevertheless, some level of support can be brought if necessary. the questionnaire is composed by a general explanation of the purpose of the study followed by a definition of sarcopenia and a clear description of the dce task. the attributes and levels are carefully explained in the introduction part of the questionnaire and an example of a completed choice set is provided. each patient will then receive 13 choice sets. after completion of the choice tasks, respondents will be asked how difficult they found the choice tasks on a seven-point scale. participants who graded the level of difficulty as "extremely difficult" will be removed from the analyses. the dce task is presented in appendix 1. the questionnaire also asks questions on patients' characteristics. the questionnaire has been created with experts during the phase of "identification and prioritization of important outcomes of sarcopenia". five attributes and different levels of consequences have been identified by the panel.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of sarcopenia : * muscle mass * muscle strength and physical performance should be measured exclusion criteria: * problem of cognitive function * diagnosis of dementia * unability to understand the study and the the questionnaire * unability to fill in the questionnaire * major depression
comparison of insulin glargine and nph human insulin in progression of diabetic retinopathy in type 2 diabetic patients

Conditions: Diabetes Mellitus, Type 2

Summary: to compare the progression of diabetic retinopathy in type 2 diabetic patients with mild-to-moderate diabetic retinopathy treated with insulin glargine vs nph human insulin.

randomized, open-label assignment of type 2 patients who are on a stable antidiabetic regimen to treatment with either insulin glargine or bid nph human insulin, with baseline diabetic retinopathy of severity 53/\<53 on the etdrs scale, for 5 years of followup. outcomes measured by seven-field fundus photography at baseline, 1.5, 3,6,and 9 months, and annually.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus for at least 1 year * treated with oral antidiabetic agents or insulin at stable doses for at least 3 months * hba1c between 6 and 12% inclusive * baseline retinopathy severity not to exceed 53/\<53 on the etdrs scale * unlikely to require laser surgery or vitrectomy within upcoming year exclusion criteria: * prior treatment with insulin glargine * treatment with insulin analogs (eg insulin lispro or aspart) in the year prior to enrollment

Keywords: diabetes diabetic retinopathy