Kornimate/medical-research-clean huggingface dataset:
gallant 6 tesaglitazar vs. pioglitazone

Conditions: Diabetes Mellitus, Type 2

Summary: this is a 24-week randomized, double-blind, multi-center, active-controlled (pioglitazone) study of tesaglitazar (0.5 mg and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. the study comprises a 3-week enrollment period, 6 week placebo single blind run in period followed by a 24-week double blind treatment period and a 3-week follow-up period.


Eligibility criteria:
inclusion criteria: * provision of a written informed consent * men or women who are ³18 years of age * female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control * diagnosed with type 2 diabetes * treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents exclusion criteria: * type 1 diabetes * new york heart association heart failure class iii or iv * treatment with chronic insulin * history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin) * history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells) * creatinine levels above twice the normal range * creatine kinase above 3 times the upper limit of normal * received any investigational product in other clinical studies within 12 weeks * any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study

Keywords: type 2 diabetes
effects of tranexamic acid in tumescent solution for liposuction procedures

Conditions: Liposuction; Bruising; Inflammation; Skin Condition; Edema Arm; Ecchymosis; Hematoma

Summary: the goal of this trial is to evaluate the effect of adding tranexamic acid (txa) to the tumescent solution used in arm liposuction on postoperative outcomes. study population includes healthy volunteer adults undergoing liposculpture procedures. the main question it aims to answer is: 1. does tranexamic acid exert benefit on postoperative outcomes after liposuction? researchers will compare txa versus traditional tumescent solution to see if there are benefits on adding it to the tumescent solution. participants will undergo high definition liposculpture involving arms, legs and their torso. one arm will be infiltrated with traditional klein's tumescent solution and the other one with the same one but adding tranexamic acid.

study design: allocation: randomized (one arm with txa, one without) intervention model: crossover assignment (each subject serves as their own control with one arm receiving txa and the other not) masking: double-blind (participant and outcomes assessor) interventions: experimental arm (txa): infiltration with klein's tumescent solution (1000 ml of ringer's lactate + epinephrine 1 mg + lidocaine 1 mg) plus 250 mg of tranexamic acid. control arm: infiltration with klein's tumescent solution (1000 ml of ringer's lactate + epinephrine 1 mg + lidocaine 1 mg) without tranexamic acid. recruitment information: adults aged 18-60 undergoing elective high definition liposuction. no known allergies to txa or lidocaine. bmi of 30 kg/m\^2. study start date: january 2022. primary completion date: january 2024. study completion date: june 2024. study locations: clinica dhara, bogota dc, colombia. data collection: photomicrographic analysis with imagej (fiji): photos taken on days 1, 3, and 7 will be processed to calculate the surface area of ecchymosis. manual arm circumference measurements: measurements will be taken with a tape measure to monitor local swelling/inflammation. ethical considerations: informed consent: participants will be provided with detailed information about the study and will be required to provide informed consent prior to participation. irb approval: the trial will be conducted in compliance with ethical standards and will be reviewed and approved by an institutional review board (irb).

Eligibility criteria:
inclusion criteria: * adults aged 18-60 undergoing elective arm liposuction. * no known allergies to txa or lidocaine. * bmi \&lt; 30. exclusion criteria: * previous surgery or trauma to the arms. * known coagulation disorders. * history of thromboembolic events. * asa \&gt; ii.

Keywords: tranexamic acid body contouring liposuction liposculpture patient outcomes high definition liposculpture
study of crs-207, nivolumab, and ipilimumab with or without gvax pancreas vaccine (with cy) in patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to study the safety and clinical activity of nivolumab and ipilimumab in combination with either sequential administration of cy/gvax pancreas vaccine followed by crs-207 (arm a) or with administration of crs-207 alone (arm b) in patients with pancreatic cancer.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years. 2. have histologically or cytologically proven adenocarcinoma of the pancreas. 3. have metastatic disease. 4. have disease progression. 5. patients with the presence of at least one measurable lesion. 6. patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator). 7. ecog performance status 0 or 1 8. life expectancy of greater than 3 months. 9. patients must have adequate organ and marrow function defined by study-specified laboratory tests. 10. must use acceptable form of birth control while on study. 11. ability to understand and willingness to sign a written informed consent document. exclusion criteria: 1. known history or evidence of brain metastases. 2. had surgery within the last 28 days 3. had chemotherapy, radiation, or biological cancer therapy within the last 14 days 4. have received a prophylactic vaccine within 14 days or received a live vaccine within 30 days of planned start of study therapy. 5. prior treatment with anti-pd-1, anti-pd-l1, anti-pd-l2,or anti-ctla4 6. systemic steroids within the last 14 days 7. use more than 2 g/day of acetaminophen. 8. patients on immunosuppressive agents. 9. patients receiving growth factors within the last 14 days 10. known allergy to both penicillin and sulfa. 11. severe hypersensitivity reaction to any monoclonal antibody. 12. have artificial joints or implants that cannot be easily removed 13. have any evidence of clinical or radiographic ascites. 14. have significant and/or malignant pleural effusion 15. have had a new pulmonary embolism, extremity deep venous thromboembolism, or portal vein thrombosis within 2 months of study treatment 16. infection with hiv or hepatitis b or c at screening 17. significant heart disease 18. conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures 19. are pregnant or breastfeeding. 20. have rapidly progressing disease

Keywords: cy cyclophosphamide pancreatic vaccine gvax nivolumab vaccine ipilimumab crs-207 immunotherapy pd-1 adenocarcinoma carcinoma neoplasms
assessment of esophageal motility with transnasal endoscopy

Conditions: Esophageal Motility Disorder

Summary: the purpose of this study is to assese esophageal motor function by simplified transnasal endoscopy compared with esophageal manometry.

esophageal manometry is a gold standard for diagnosis of esophageal motility disorder. however, esophageal manometry can not detect non-occulsive contraction. endoscopic evaulation of esophageal motility is difficult becausea swallowing is nearly impossible during endoscopy. simplified trans nasal endoscopy (e.g. scantm, intromedic co.,ltd.)composed with dysplay system,controller,and disposable probe with compact size. the esophageal motor function will be assessed with both esophageal manometry and simplifed trnasnasal endoscopy in patients with esophageal motility disorder (such as achalasia) and healthy volunteer. the results of simplifed trnasnasal endoscopy is compared with the results of esophageal manometry.

Eligibility criteria:
inclusion criteria: * 1) healthy volunteer without organic esophageal or gastric disorder 2) patients knwon esophageal motility disorder (such as achalasia) exclusion criteria: * severe organic esophageal disorder including severe reflux esophagitis, stricture, and bleeding. * previous opertion of esophagus or stomach * gi bleeding, mechanical obstruction * medication which can infulence gi motility
a study to evaluate the efficacy and safety of narlumosbart (jmt103) in patients with giant cell tumor of bone

Conditions: Giant Cell Tumor of Bone

Summary: this is a phase ⅲ, multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of narlumosbart (jmt103) in patients with unresectable or surgically difficult giant cell tumor of bone (gctb). this clinical trial study hypothesizes narlumosbart administration groups are not inferior to active control administration groups.


Eligibility criteria:
inclusion criteria: 1. fully informed and signed informed consent; 2. male or female adults aged ≥ 18 years or skeletally mature adolescents must weigh at least 45 kg and ≥ 12 years of age; 3. pathologically confirmed giant cell tumor of bone that is surgically unresectable or for which the planned surgery is associated with functional compromise or morbidity; 4. eastern cooperative oncology group (ecog) performance status of 0, 1 or 2. exclusion criteria: 1. previous or ongoing osteomyelitis or osteonecrosis of the jaw, non-healed dental/oral surgery, active dental or jaw condition requiring oral surgery, planned invasive dental procedure during the study; 2. known or suspected diagnosis of other giant cell-rich tumors, brown cell tumor of bone, or paget's disease; 3. known diagnosis of malignancy within the past 5 years, except for definitively treated superficial basal cell carcinoma or cervical carcinoma in situ; 4. bone metabolic disease including hypo-/hyperparathyroidism, hypo-/hyperthyroidism (except for no need treatment subclinical hypothyroidism), hypopituitarism, hyperprolactinemia, cushing's syndrome, acromegaly, etc.; 5. active infections requiring systematic treatment within 7 days prior to randomization; 6. known human immunodeficiency virus (hiv), syphilis infections or viral hepatitis; 7. current receiving other anti-tumor therapy (such as radiation, chemotherapy, or embolization, etc.); 8. concurrent bisphosphonate treatment; 9. use of anti-receptor activator of nuclear factor-κb ligand (rankl) antibody within six months prior to screening, or no response to previous rankl antibody treatment; 10. known allergic/hypersensitive reaction to jmt103, positive control drug, calcium and vitamin d; 11. pregnant or lactating females; for those of child bearing potential, refusal to use effective contraception methods from signing informed consent to 6 months after last administration.

Keywords: giant cell tumor of bone
study of safety of elotuzumab administered over approximately 60 minutes in combination with lenalidomide and dexamethasone for newly diagnosed or relapsed/refractory multiple myeloma patients

Conditions: Multiple Myeloma

Summary: to explore whether elotuzumab dose administration over approximately 60 minutes is feasible and safe.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * eastern cooperative oncology group (ecog) performance status ≤2 * documented evidence of active multiple myeloma: * newly diagnosed, not candidate for transplant * relapsed/refractory who have received up to 3 prior lines of therapy * prior lenalidomide exposure is permitted only if the following criteria are fulfilled: * not refractory to prior lenalidomide which is defined as no progression while receiving lenalidomide or within 60 days of last dose of lenalidomide * subject did not discontinue lenalidomide due to a grade ≥3 related adverse event (ae) exclusion criteria: * target disease exceptions * plasma cell leukemia * monoclonal gammopathy of undetermined significance (mgus) * smoldering myeloma * primary amyloidosis * polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (poems) syndrome
a microneurography study of nav1.8 inhibition in healthy adults

Conditions: Pain

Summary: the purpose of this study is to determine the effects of nav1.8 inhibition on activity-dependent slowing (ads) of c-nociceptor nerve fibers, evoked action potential (ap) conduction velocity of c-nociceptor nerve fibers using vx-150, vx-993 and vx-548.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 30.0 kilogram per meter square (kg/m\^2) * a total body weight of more than (\>) 50 kg key exclusion criteria: * history of febrile illness or other acute illness that has not fully resolved within 14 days before study drug dosing * any condition possibly affecting drug absorption * any dermatological (generalized) or autoimmune disease that may affect c-nociceptor excitability * participants with type 1 or type 2 diabetes mellitus * participants who have any 1 of the following criteria in the foot in which microneurography (mng) will be performed: * injection of local anesthetics or steroids within 35 days prior to randomization. * unsuitable anatomy of the superficial peroneal nerve (i.e., nerve cannot be seen or palpated at the dorsum of the foot) * infection, disease (dermatologic or vascular), ongoing pain, or recent trauma or surgery that may affect study assessments note: participants must have 1 foot that does not meet any of the above criteria to be eligible. other protocol defined inclusion/exclusion criteria may apply.
effectiveness between nutritional counseling monthly phone call versus self help informative booklet

Conditions: Obesity; Overweight

Summary: the purpose of this study is to evaluate the most effectiveness between a personalized nutritional program with a counseling monthly phone call versus personalized nutritional program with self help informative booklet in a group of obesity or overweight patients without counseling phone call.

evaluate the best effectiveness between two methods applied in the dietary service of institute orthopedic rizzoli for the achievement of the weight loss. personalized nutritional program with counseling phone call versus personalized nutritional program with self help informative booklet in a controlled group.there will be compared two groups of patients: first group: patients subject to balanced personalized nutritional program associated to counseling monthly phone call ; compliance and loss of weight will be done monthly for one year. second group: patients subject to balanced personalized nutritional program associated to self help informative booklet; compliance and loss of weight will be done after six months and after one year from the first meeting.

Eligibility criteria:
inclusion criteria: * female and male * bmi \>25 and \<35 * ages eligible for study: 18 years old to 75 years old * patients of the institute orthopedic rizzoli subject to personalized nutritional program admitted to the wards and patients attending the clinic of anaesthesiology, analgesic therapy, rheumatology * participants gave informed consent exclusion criteria: * patients with psychiatric disorders (depression, bulimia, anorexia * concomitant use of medicines or food supplements that can alter the weight loss. * patients with inclusion criteria that have not signed the informative report and the declaration of consent.

Keywords: obesity counselling weight loss
patient observational pain and activity survey (popas) study using rs-4i sequential stimulator with intersperse technology in axial spine and peripheral joint pain

Conditions: Osteoarthritis

Summary: spine pain and joint pain are among the most common worldwide ailments and directly contributes to disability as well as increased duration of care. spine and joint pain affect work sick leave, production and increased financial costs to healthcare. non-invasive treatments for spine and joint pain can vary widely from lifestyle changes, physical therapy, oral medication, and select medical devices, that can improve pain level and help improve the quality of life of individuals. thus, the general population suffers from an ailment that has multiple conservative treatment options with variable outcomes. transcutaneous electrical neuromuscular stimulation (tens) has been show to decrease pain and restore function. interferential therapy (inf) is a specific signal type that is effective for reducing musculoskeletal pain. neuromuscular electrical stimulation (nmes) uses a specific signal type to cause muscles to contract and therefore provide functional improvement. the rs-4i plus is an fda-regulated prescription tens medical device that outputs an inf signal and a nmes signal, and a unique intersperse signal, which combines nmes and inf into a single treatment. therefore, the goal of this study is to determine if use of the prescribed rs-4i plus in patients presenting with pain, axial or peripheral joint, can be efficacious in decreasing the patient's pain and improving their activity measured at one month, three months, and six months of use.


Eligibility criteria:
inclusion criteria: 1. chronic and persistent msk lumbar back pain for greater than 12 weeks as documented in patient records 2. age 18 to 89 3. willingness to comply with study protocol 4. signed patient consent on file 5. verified patient usage collected from rs-4i plus via patient data adapter exclusion criteria: 1. pregnancy 2. any contraindications, as indicated in the rs-4i plus prescribing information 3. substantial allergy to adhesives 4. skin infection or irritation of skin where electrodes are to be placed 5. pacemaker/icd 6. abnormal skin sensation 7. serious psychological disorder 8. end-stage cardiac, peripheral arterial or pulmonary disease 9. h/o recent vertebral fracture 10. severe degenerative or traumatic neuromuscular disease 11. non-english speaking 12. uncontrolled diabetes meelitus (hb a1c\> 8.5%) 13. esrd or eshd 14. active cancer
reduction of falls in the elderly - parkinson's disease

Conditions: Parkinson's Disease

Summary: the refine-pd study is a controlled trial embedded within a larger cluster controlled study (the impact study). the study aims to investigate the efficacy of a multifactorial falls prevention program for patients with parkinson's disease (pd). this program contains pd-specific elements (e.g., optimizing dopaminergic therapy), plus a generic falls prevention program. the intervention will be tailored to each individual's specific risk profile for falls, as identified during detailed baseline examination.

falls and postural instability are common complications of advanced parkinson's disease (pd). falls in pd often have devastating consequences, leading to a poor overall prognosis. in addition, falls in pd are associated with substantial medical expenses due to treatment of injuries and nursing home admission. the risk of falls in older pd patients is aggravated by "generic" age-related factors, such as sedative medication or poor vision. observations on elderly persons without pd suggest that a multifactorial prevention program might be more effective. we propose to investigate the effectiveness of a multifactorial prevention program aimed at the prevention of falls in pd, which is based on disease-specific treatment strategies with demonstrated efficacy in pd, as well as prevention strategies with proven effectiveness for the general elderly population. in this study an individualised multifactorial program aimed at the prevention of falls in pd containing pd-specific elements and a generic falls prevention program will be compared to usual care.

Eligibility criteria:
inclusion criteria: * patients with idiopathic parkinson's disease, diagnosed according to the brain bank criteria of the uk parkinson's society * regular control by the neurologist * living independently in the community * able to complete the trial questionnaires * an increased risk for falling, defined as: * at least one fall in the preceding 12 months or * recurrent (monthly) near falls in the preceding 12 months or * fear of falling or (iv) avoidance of activities due to fear of falling or a combination of these findings exclusion criteria: * atypical parkinsonian syndromes * hoehn and yahr stage 5 * severe cognitive impairment (mmse \< 24) * severe co-morbidity (e.g., cancer) * planned surgical procedure for pd within the intervention period * patients who have already visited the multidisciplinary assessment center

Keywords: accidental falls prevention treatment effectiveness