Kornimate/medical-research-clean huggingface dataset:
effectiveness of magnetic therapy on pain intensity

Conditions: Postoperative Pain

Summary: static magnetic therapy is increasingly used to alleviate pain; however, its efficacy has not been determined yet. the aims of this proposal are to evaluate the effect of magnetic therapy on pain intensity levels, opioid requirements, and opioid side effects.

static magnetic therapy is increasingly used to alleviate pain; however, its efficacy has not been determined yet. the aims of this proposal are to evaluate the effect of magnetic therapy on pain intensity levels, opioid requirements, and opioid side effects. a randomized, double blind, controlled trial is proposed. patients from 8 years old and older subjected to a variety of surgical procedures with pain of intensity at least 5/10 will be randomized into two groups: magnetic therapy or placebo. the devices will be placed around the surgical wound for 2 hours. every ten minutes, patients will rate their pain intensity on a 0-10 numerical rating scale, and morphine will be administered until pain intensity is ≤ 4/10. pain intensity will be the primary outcome. opioid requirements and opioid side effects will be secondary outcomes. to detect a difference of 1 unit (from 0 to 10) between the groups with 80% power, assuming that the baseline pain intensity is 7.9 ± 2.0, we estimated the need for 70 patients per group. we will use an intention-to-treat analysis. to analyze the effect of the treatment on pain intensity, an analysis of repeated measures using generalized estimating equations will be used. the proportion of subjects in each group who exhibit 50% or more pain relief one hour after application of the magnetic devices and the number needed to treat will also be calculated. to analyze the effect of the treatment on opioid requirements, a difference in morphine requirements between groups two hours after placement of the magnets will be estimated. to analyze the effect of the treatment on opioid side effects, a variable that summarizes the presence of any side effect two hours after the placement of the magnets will be created, and the absolute risk difference for developing any side effect will be estimated. ninety five percent confidence intervals will be reported. this proposal would contribute substantially to the complementary medicine field, not only because of its scientific rigor, but also because the pain model that it evaluates strengthens the validity of the results.

Eligibility criteria:
inclusion criteria: * hospitalized or ambulatory patients 8 years old or older subjected to surgical procedures under general anesthesia, who reported at least moderate pain. exclusion criteria: * subjects with surgeries longer than 3 hours * multiple surgical wounds * back or craniofacial surgeries, or surgeries which required cast placement, bulky dressing or the implantation of metallic devices. * subjects who did not understand the pain scales employed

Keywords: static magnetic therapy pain analgesia opioids
six month clinical trial assessing efficacy and safety of inhaled insulin in type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: to determine in subjects with type 1 diabetes mellitus: 1. whether glycemic control can be achieved at least as effectively with a) an intensive insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous nph insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular insulin plus twice daily nph, given as 4 injections per day. the treatment regimens differ only by the route of delivery of the short acting insulin. 2. the toleration and safety of inhaled insulin therapy and its effects after 6months, if any, on measures of pulmonary function.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for more than 1 year * stable insulin regimen of at least 2 injections per day exclusion criteria: * any smoking within the last 6 months. smoking is not permitted at any time during this study. * subjects on insulin pump during 2 months prior to screening. * subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.
biologically modified saphenous vein transplants for improved cabg outcomes

Conditions: Atherosclerosis

Summary: the purpose of this study is to study the effects of polyarginine treated vein grafts on graft patency for patients undergoing coronary artery bypass surgery.

double blind study with lactated ringers solution and lactated ringers solution with arginine soaked for 10 minutes prior to grafting on the coronary arteries.

Eligibility criteria:
inclusion criteria: 1. subjects must be 25-95 years of age and able to give informed consent 2. use of an approved statin and anti-platelet medication for at least 24 months. 3. agreeable to cardiovascular imaging at 12 months post-coronary artery bypass graft (cabg). 4. first time coronary artery bypass surgery,redo coronary artery bypass surgery and combined valve repair/replacement surgery and coronary artery bypass graft surgery are eligible to participate in study. exclusion criteria: 1. acute traumatic injury, vasculitis or planned concurrent ventricular surgical restoration, automatic implantable cardioverter defibrillators (aicd) placement or valvular surgery. 2. hypercoaguable state. 3. comorbid illness making 2 year survival unlikely. 4. participation in another interventional investigative study of a cardiovascular drug or device within 30 days prior to cabg. may participate concurrently in other studies where the intervention/observation will not hinder execution of this study. 5. patients with any medical condition that, in the investigator's judgment, makes the patient ineligible or places the patient at undue risk (e.g. conditions that preclude standard invasive follow up procedures such as angiography, i.e. renal failure, bleeding diathesis or peripheral vascular disease preventing catheterization via the groin). 6. subject has clinical evidence of infection that the investigator deems significant to the completion of the procedure or that could compromise the subject's safety. 7. any patient was has undergone more than 20 computerized tomography (cat) scans. 8. any patient who is pregnant.

Keywords: atherosclerosis of autologous vein bypass graft
phase 2 study of mgcd265 in patients with non-small cell lung cancer with activating genetic alterations in met

Conditions: Non-Small Cell Lung Cancer

Summary: mgcd265 is an orally administered receptor tyrosine kinase inhibitor that targets met and other receptors. this study is a phase 2 trial of mgcd265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (nsclc) that has activating genetic changes of the met gene (mutation or amplification \[increase number of gene copies\]). testing for tumor gene changes can be performed in tumor tissue or blood samples. patients must have previously received treatment with chemotherapy. the number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. mgcd265 will be administered orally, twice daily. the study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments.

if testing has not already been performed, the study will provide for the testing.

Eligibility criteria:
inclusion criteria: * diagnosis of non-small cell lung cancer * metastatic or locally advanced disease * prior platinum chemotherapy or immunotherapy * test result showing genetic change in met tumor gene * at least one tumor that can be measured on a radiographic scan exclusion criteria: * prior treatment with inhibitor of met or hgf * prior positive test for egfr mutation or alk gene rearrangement * uncontrolled tumor in the brain

Keywords: mirati mgcd265 met nsclc
a phase 1 study in japanese subjects with type 2 diabetes mellitus as monotherapy

Conditions: Type 2 Diabetes Mellitus

Summary: study b1621018 will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of two dose levels of pf-04937319 in japanese subjects with type 2 diabetes mellitus as monotherapy


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes, on diet/exercise therapy only or background therapy with 1 oral anti-diabetic agent (excluding actos) exclusion criteria: * patients with cardiovascular event * patients with diabetic complications * female subjects who are pregnant or planning to become pregnant * subjects with unstable medical conditions (eg, hypertension)

Keywords: phase 1 type 2 diabetes monotherapy pf-04937319
an open study of the effect of itraconazole oral solution for the treatment of fluconazole refractory oropharyngeal candidiasis in hiv-positive subjects.

Conditions: Candidiasis, Oral; HIV Infections

Summary: to assess the efficacy and safety of itraconazole oral solution in hiv-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.

patients receive itraconazole oral solution twice daily. per 08/15/94 amendment, patients with complete resolution of oropharyngeal candidiasis lesions upon completion of treatment are eligible for maintenance treatment on protocol fda 236c. patients who decline maintenance are followed for 6 weeks. patients who relapse during follow-up are re-treated for 14-28 days; if lesions clear, patients may enter the maintenance protocol.

Eligibility criteria:
inclusion criteria patients must have: * hiv antibody seropositivity or diagnosis of aids. * confirmed oropharyngeal candidiasis. * failed fluconazole treatment within the past 14 days. * life expectancy of at least 3 months. * no symptoms of esophageal candidiasis (e.g., dysphagia) unless endoscopic exam of esophagus was performed and fungal esophagitis was not present. * no prior disseminated candidiasis. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * underlying clinical condition that precludes study completion or places the patient at significant risk. * considered unreliable about following physician's directives. concurrent medication: excluded: * investigational drugs (approved expanded access drugs are permitted). * rifampin. * rifabutin. * phenobarbital. * phenytoin. * carbamazepine. * terfenadine. * astemizole. patients with the following prior conditions are excluded: * history of hypersensitivity to imidazole or azole compounds. * clinical evidence of significant hepatic disease within the past 2 months. prior medication: excluded: * investigational drugs within 1 month prior to study entry (approved expanded access drugs are permitted).

Keywords: itraconazole acquired immunodeficiency syndrome aids-related complex candidiasis, oral
symptom management program based on story theory for postmenopausal women (semstop)

Conditions: Menopause

Summary: purpose: to investigate the effect of the symptom management program based on story theory on vasomotor symptoms and sleep quality in postmenopausal women. design: the type of this research is mixed method (qualitative and quantitative research design together). it enables to strengthen the weaknesses of mixed method research, to increase the generalizability of the results, and to produce more reliable outputs regarding theory and practice. the quantitative research dimension is a randomized single-blind pretest-posttest experimental model with a control group. the qualitative research dimension is the descriptive phenomenological design. method: the research will be carried out at ömürevleri, atakum, mimar sinan, çobanlı and yenimahalle family health centers located in different regions of the atakum district of samsun. after informing the women who come to the family health centers about the face-to-face research, the research will be conducted completely online (due to the covid-19 pandemic) after the verbal consent of the women who volunteered to participate in the research and their contact numbers are obtained. the postmenopausal women who apply to the institutions where the research will be conducted and meet the inclusion criteria constitute the population of the research. when the sample size calculated with the g.power program was taken as pittsburgh sleep quality index score mean and standard deviation value as 6.57±1.23, with 5% significance level, 80% test power, 0.700 effect size, there were at least 68 groups, 34 for the experimental group and 34 for the control group. identified as a person. considering the sample loss in the experimental and control groups, with 10% more sampling, a total of 76 women will be included in the sample, with 38 women in each group. n the study, the data will be collected with the personal information form, the menopause symptoms assessment scale, the pittsburgh sleep quality index and the story theory based semi-structured interview form (for qualitative research) developed by the researchers in line with the literature. as a result of the study, the data will be evaluated separately as qualitative and quantitative.


Eligibility criteria:
inclusion criteria: * be a volunteer, * to be literate to have a smart mobile phone/computer * to be in the first 2 years after menopause * experiencing vasomotor symptoms exclusion criteria: * having a communication barrier * having problems with internet access * being in the premenopausal period * undergoing surgical menopause * getting a diagnosis of respiratory system * getting a diagnosis of hypertension and cardiovascular disease * getting treatment for menopause, getting training on breathing exercises * treatment for sleep disorders receive

Keywords: sleep quality postmenopause
drug-coated balloons in big de novo coronary disease

Conditions: Coronary Heart Disease

Summary: a prospective, multicenter, randomized controlled, open-label, non-inferiority trial. plan to recruit 240 patients whose lesions are de novo coronary artery disease (reference vessel diameter ≥ 3.0 mm), diameter stenosis ≥ 75% with ischemic symptoms or objective evidence of ischemia (ecg, cardionuclide, or ffr), and are suitable for implantation des or dcb. after successful preconditioning, patients were randomly assigned to two pci treatment groups(drug-coated balloon or drug-eluted stent) in a 1:1 ratio. the safety and efficacy of drug-coated balloons in pci treatment of de novo coronary artery lesions (reference diameter 3.0 mm and above) were evaluated by comparing the late lumen loss of two groups of subjects in 12 months.


Eligibility criteria:
inclusion criteria: * over 18 years old; * asymptomatic myocardial ischemia, stable or unstable angina; * the subject (or legal guardian) understands the trial requirements and treatment process, and signs a written informed consent before performing any prescribed inspection or operation; * willing to undergo all follow-up evaluations requested by the trial, including admission angiographic evaluation at 12 months; * the target lesion must be the de novo lesion, and the diameter of the reference vessel is ≥3.0mm. exclusion criteria: * patients with acute st-segment elevation myocardial infarction/non-st-segment elevation myocardial infarction within 3 months; * hypersensitivity to the investigational balloon/stent system or concomitant medications required by the protocol; * intolerant of dual antiplatelet therapy, or clinical conditions requiring long-term use of oral anticoagulants; * life expectancy is less than 12 months; * egfr≤30ml/min/1.73m2 or blood purification treatment; * lvef≤40% or nyha cardiac function class≥iii; * clinical conditions of severe hepatic insufficiency and coagulation disorder * pregnant or breastfeeding women; * participating in another clinical trial and have not completed the primary endpoint observation of the trial; * reference lumen diameter \> 4.0mm; * branch vessels ≥ 2.0 mm in diameter that may require intervention in the target lesion; * the vessel where the target lesion is located has an independent lesion with a diameter stenosis of ≥50% and requires interventional therapy; * chronic total occlusive disease; * left main stem disease; * severe calcification, tortuous blood vessels, existing dissection or severe thrombus burden, the investigator judges that dcb is not suitable for treatment of lesions; * lesions with failed preprocessing, or lesions whose length exceeds the length of a single des/dcb need to be covered after preprocessing

Keywords: drug-coated balloon de novo coronary disease
augmented reality for mri-guided interventions

Conditions: Infections; Pain; Diagnosis; Image Guided Needle Biopsy

Summary: the purpose of this study is to determine feasibility and safety of using an augmented reality system in patients undergoing mri-guided needle procedures.

this pilot clinical study is designed to evaluate the feasibility of using a needle guidance system during mri-guided procedures in up to 12 patients. the mri-compatible needle guidance system was developed under an nih funded sbir phase ii grant. this system has been evaluated by our interventional radiology team in phantom, volunteer, and cadaver studies which showed potential benefit of use in patients. inclusion of the needle guidance system will not change the standard of care or substantively affect procedural technique as currently performed. this system provides the operator with an augmented reality (ar) display to better visualize the needle entry point and trajectory as it is inserted toward the target. this additional information could improve needle placement accuracy and shorten procedural time.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * male or female, ages 3 to 21 * patient referred to interventional radiology for image-guided needle injection, aspiration, or biopsy. exclusion criteria: * patients who are unable to give informed consent themselves or through their parents. * patients under 3 years of age * patients over 300 pounds. * patients who are claustrophobic and unable to tolerate mri-guided procedure. * contraindications to mri such as mr-unsafe implants.
scooping mobilization with and without scapulothoracic mobilization in patients of lateral epicondylalgia

Conditions: Lateral Epicondylitis

Summary: lateral epicondylalgia is well known musculoskeletal disorder now a day. lateral epicondylalgia is a disorder in which pain and tenderness at lateral part of elbow. this study is targeting the scapulothoracic mobilization and scooping mobilization at lateral epicondylalgia. this study is single-blinded randomized clinical trial will be conducted in fatima memorial hospital and bajwa hospital lahore. non-probability convenience sampling will be used with 38 participants involved in this study is with age of 18 to 45 with presence of pain and tenderness around lateral epicondyle, positive cozens test and maudsley test, scapular dyskinesia, pain on resisted elbow extension, wrist extension and gripping activities. in this study, one group is treated with scooping mobilization with scapulothoracic mobilization. second group is treated with scooping mobilization alone. the participants will be randomized into two groups by computer generated randomization software. outcomes measures which are used in this study is numeric pain rating scale for pain, goniometer for range of motion and patient related tennis elbow evaluation for activities of daily livings for patients of lateral epicondylalgia.


Eligibility criteria:
inclusion criteria: * age 20-40 years * pain and tenderness around lateral epicondyle * pain on resisted elbow extension ,wrist extension and gripping activities * gender both male and female. * scapular dyskinesia. * positive cozen test and maudsley test for lateral epicondylalgia. * with moderate pain intensity on numeric pain rating scale (nprs) with a score of 3 or higher exclusion criteria: * any injury or disease around the shoulder, elbow and wrist on affected side * cervical radiculopathy. * local steroid injection * history of fracture of humerus, radius, ulna which is affected upper extremity

Keywords: scooping mobilization scapulothoracic mobilization activities of daily livings lateral epicondylalgia
high flow nasal cannula and diaphragmatic function

Conditions: Diaphragm Injury; Postoperative Complications

Summary: prospective randomized study investigating the effect of postoperative oxygen delivery on diaphragmatic function. two different modalities of oxygen delivery will be compared: high flow nasal cannula versus standard oxygen therapy with facial mask


Eligibility criteria:
inclusion criteria: * patients scheduled for elective thoracic surgery exclusion criteria: * asa score \>3 * body mass index \> 35 kg/m2 * history of neuromuscular disease * history of thoracic surgery * phrenic nerve paisy
the potential effects and mechanisms of flax lignans on type 2 diabetes mellitus

Conditions: Type 2 Diabetes; Hypercholesterolemia

Summary: the purpose of the study is to improving the lipid profile and glucose control in type 2 diabetic patients with supplementation of flax lignans. we hypothesize that flax lignans supplement will improve the cholesterol profile and glucose control in type 2 diabetic patients.

the prevalence of type 2 diabetes is increasing dramatically in the last decade in china. hyperlipidemia is a comorbid condition in type 2 diabetes and increase the adverse health outcomes. flax lignans, a phytoestrogen found in flaxseed is thought to be the compound responsible for cholesterol-lowering effect of flaxseed. our purpose is to improving the lipid profile in type 2 diabetic patients with supplementation of flax lignans.

Eligibility criteria:
inclusion criteria: * diagnosed type 2 diabetes * age: 50-79 years old * ldl-cholesterol more than 2.9 mmol/l exclusion criteria: * current or previous (within 6 months) use of estrogen therapy * cancer * chronic gastrointestinal diseases * current use of antibiotics * any severe liver or renal diseases * systolic blood pressure more than 180 mmhg or phase 3 hypertension * any severe mental diseases * severe cardio- or cerebro-vascular diseases

Keywords: type 2 diabetes lignans flaxseed cholesterol