Kornimate/medical-research-clean huggingface dataset:
evaluation of the novatech ® luciola tm eb fiducial marker during radiotherapy sessions in lung cancer patients

Conditions: Lung Cancer

Summary: following ce certification, this post market clinical follow-up investigates the performance and safety of using the new fiducial marker, novatech® luciola™ eb, in the lung airways to monitor in real-time tumor location during radiotherapy. at the time of insertion near the tumor, the luciola's 3 fiducial marker arms are deployed simultaneously. optimal detection of the fiducial marker is considered during the radiotherapy treatment.

novatech® luciola™ eb fiducial marker will be implanted near the lung tumor by bronchial endoscopy by a pulmonologist. following a dosimetry visit, participants will be proposed a maximum of 5 radiation therapy sessions. a follow-up visit at 3 months will take place after the last radiotherapy session. the participation period for each participant will be between 4.5 and 6 months. this study will evaluate the luciola implant's performance and safety (visibility, migration, complications, tumoral response).

Eligibility criteria:
inclusion criteria: * participants ≥ 18 years of age * participants with primary, secondary or metastatic lung cancer with an indication for radiotherapy and placement of a fiducial marker * participants who will be able to tolerate the flexible bronchoscopic implantation procedure and radiotherapy treatment. * participants who give their written informed consent exclusion criteria: * participants with uncontrolled infection / participants with active infections. * participants with a bronchoscopy contra-indication * pregnant or breast-feeding women * participants with known allergy to one of the components (tantalum and nickel titanium alloy for the marker and polymer materials which are contained in the delivery device)

Keywords: fiducial marker bronchoscopy sbrt radiotherapy novatech luciola eb
lidocaine-prilocaine cream on iud insertion pain

Conditions: IUD Pain

Summary: the purpose of the investigators' study was to evaluate whether cervical lidocaine-prilocaine cream will improve pain scores compared to placebo. the investigators hypothesized that lidocaine-prilocaine cream will reduce the insertion pain.

iud can cause pain and discomfort in several ways: use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the iud insertion tube, and removing the tube; and placement of the device in the uterus. to minimize the discomfort and the hazards of an iud insertion, several measures have been proposed including nsaids, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. according to the review published in the cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an iud insertion pain. many trials have been done about effectiveness of lidocaine gel in reducing pain during iud insertion and only one of those trials showed positive effect of 2% lidocaine gel, while others failed. lidocaine 2.5% and prilocaine 2.5% cream, is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine cream in a ratio of 1:1 by weight. this eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as liquid oil rather than as crystals. its absorption of from the genital mucosa is more rapid and onset time is shorter (5 to 10 minutes) than after application to intact skin. after a 5 to 10 minute application of lidocaine-prilocaine cream to female genital mucosa, the average duration of effective analgesia was 15 to 20 minutes.

Eligibility criteria:
inclusion criteria: * women not taken analgesics or anxiolytics in the 24 hours prior insertion * women not taken misoprostol prior to iud insertion * no contraindication to or history of allergic reaction to lidocaine * women who will accept to participate in the study exclusion criteria: * lidocaine allergy * any contraindication to iud placement
a trial comparing the efficacy and safety of insulin degludec/liraglutide and insulin degludec in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia, europe and the united states of america (usa). the aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (ideglira) and insulin degludec (ideg) in subjects with type 2 diabetes. subjects continue their pre-trial treatment with metformin throughout the entire trial.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes * hba1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive) * subjects on stable daily doses for at least 90 days prior to trial start of: basal insulin (total daily basal insulin dose within the range of 20-40u in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and su (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label) * bmi (body mass index) more than or equal to 27 kg/m\^2 exclusion criteria: * treatment with glucagon like peptide-1 (glp-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (dpp-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start * impaired liver function * impaired renal function * screening calcitonin equal to or above 50 ng/l * subjects with personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men 2) * cardiac disorder defined as: congestive heart failure (nyha class iii-iv), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures * severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm hg or diastolic blood pressure equal to or above 100 mm hg) * acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion * history of chronic pancreatitis or idiopathic acute pancreatitis
postoperative rehabilitation in operation for lung cancer (proluca)

Conditions: Lung Cancer

Summary: purpose the purpose of the proluca study is to investigate the efficacy of early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer, with focus on exercise training. design/methods one hundred and twenty-eight (n=128) participants (64 patients/study arm) with non-small cell lung cancer (nsclc), stage i-iiia, referred for surgery, will be randomized to one of the following two groups: 1. early postoperative rehabilitation initiated as early as two weeks after surgery 2. postoperative rehabilitation initiated 14 weeks after surgery intervention the intervention consists of a supervised group exercise program comprising resistance and cardiorespiratory exercise two hours weekly for 12 weeks combined with individual counseling. the primary study endpoint is maximal oxygen uptake measured by a vo2peak test (direct measurement) secondary endpoints include: six minutes walk distance (6mwd), one-repetition-maximum (1rm) patient-reported outcomes (pros) on health related quality of life, fatigue, depression, lifestyle, postoperative complications, hospitalization time, sick leave, work status and survival. results the results of proluca will identify the optimal timing of postoperative rehabilitation in nsclc patients with focus on increasing physical capacity and health related quality of life and reducing the side effects from the treatment of the cancer disease.


Eligibility criteria:
inclusion criteria: * all subjects are assigned for curative lung cancer surgery at department of cardiothoracic surgery rt at copenhagen university hospital (rigshospitalet) * performance status 0-2 (who) * living in the city of copenhagen or surrounding municipalities * ability to read and understand danish * approval by primary surgeon exclusion criteria: * presence of metastatic disease or surgical inoperability. diagnosis of lung cancer not verified by histological diagnosis. * decompensated heart failure, severe aortic stenosis, uncontrolled arrhythmia, acute coronary syndrome * contraindications to maximal exercise testing as recommended by the american thoracic society and exercise testing guidelines for cancer patients
hormonal status and quality of life in female postmenopausal patients with burning mouth syndrome

Conditions: Burning Mouth Syndrome; Progesterone; Dehydroepiandrosterone; Quality of Life; Hormone Disturbance; 17β-Estradiol

Summary: the aim of this study was to determine the level of salivary estradiol, progesterone and dehydroepiandrosterone in female postmenopausal women with and without burning mouth syndrome. in all participants the quantity of unstimulated and stimulated saliva would be determined and they would fulfill self-perceived quality of life questionnaire oral health impact profile-14 (ohip-14). intensity of burning symptoms would be determined on visual-analogue scale grading 0-10. all data would be compared between study and control group.


Eligibility criteria:
inclusion criteria: * postmenopausal women with burning mouth syndrome exclusion criteria: * women with burning mouth syndrome who are not in menopause

Keywords: burning mouth syndrome hormonal status quality of life
a multicenter prospective study of application of platelet mapping in acute-on-chronic-liver failure in china

Conditions: Thrombelastography; Acute on Chronic Liver Failure; Platelet; Multicenter Prospective Study

Summary: ineffective hemostasis or a paradoxical prothrombotic state of acute-on-chronic liver disease (aclf) has been well established. thrombelastography measures the dynamics of thrombin production and provides a global assessment of coagulation incorporating the cumulative effect of the interactions at various levels between plasma components and cellular component of coagulation. and through the platelet mapping, it can help provide a picture of patients' function of platelet. based on the primary result of our derivation cohort(nct03281278), aclf patients with high adp inhibition rate had high 28-day mortality.this multicenter validation cohort aims to validate the predictive role of platelet mapping in aclf prognosis, organ failure developments and short term mortality.


Eligibility criteria:
inclusion criteria: * inr≥1.5 and total bilirubin≥85μmol/l exclusion criteria: * inr≤1.5 or total bilirubin≤85μmol/l; * those who had hepatocellular carcinoma or other types of malignancies; * obstructive biliary diseases or other disease lead to bilirubin evaluation; * those who had acute hemorrhage one week before admission * those who received platelet, cryo transfusion or plasmapheresis one week before admission * pregnancy and breastfeeding * those who received liver transplantation or kidney transplantation; * combine with other disease lead to organ failure including heart failure (nyha iv),respiratory failure（pao2\<60mmhg),renal insufficiency(ckd 5) and conscious disturbance (gcs\<8) * readmission; * death within 24 hours.

Keywords: thrombelastography acute on chronic liver failure platelet multicenter prospective study
outcomes of low-impact exercise program for people with ankle, knee, and/or hip pain

Conditions: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis Ankle

Summary: the primary objective of this study is to study how low-impact group exercise classes affect pain scores in patients with knee, hip, and ankle pain when paired with concurrent standard of care dietitian and behavioral health consults.

osteoarthritis is estimated to affect at least 10% of men and 13% of women over 60 years old in the united states. it's estimated roughly 1 million total joint replacements are being performed each year. studies have suggested that for patients with knee pain that have high bmis, low strength, and/or have not participated in conservative measures, a low-impact exercise plan when paired with diet counseling and behavioral health classes can improve patient reported outcomes scores in both pain and function. this study seeks to build upon this research and will provide low-impact exercise plans that will be paired with standard of care dietician and behavioral health interventions in order to offer patients a full-scope approach to battling osteoarthritis pain, especially for those with high bmis, low strength, and/or for patients that have not attempted conservative therapy in the past. we will include patients with knee, hip, and ankle pain.

Eligibility criteria:
inclusion criteria: * 18 and over * ability to attend classes 3x weekly for 6 months with at least a 66% attendance rate * ability to concurrently attend standard of care dietitian and behavioral health classes for 6 months * joint pain (knee, ankle, hip) exclusion criteria: * pregnant * prisoners

Keywords: joint pain osteoarthritis hip pain knee pain ankle pain
study of the effect of botulinum toxin injection in rectus femoris and triceps on the length and the strength during locomotion in chronic hemiparetic patients

Conditions: COMPARISON BETWEEN GROUP TREATED WITH BOTULINUM TOXIN AND PLACEBO

Summary: the aim of this randomized controlled study is to quantify the modification during locomotion of chronic hemiparetic patients of the strength and the length of rectus femoris and triceps surae induced by botulinum toxin injection type a. the main hypotheses of this study based on previous studies are that botulinum toxin injection increases on one hand the length of the muscle injected during gait and on the other hand decreased the strength of the muscles injected. the investigators also hypothesized that botulinum toxin injection improved the strength of the antagonist muscles and normalized the pattern of strength of the muscles injected during gait.

the aim of this study is to compare versus placebo the effects of btx-a injection on : * the maximal length of the muscles injected during gait * the maximal lengthening velocity of the muscles injected during gait * the maximal strength of muscles injected during gait * the inter-limb coordination assessed by continuous relative phase * the kinematic parameters such as peak knee flexion during swing phase of the gait cycle and peak ankle dorsiflexion during stance phase. to that end each patient included in the study will be assessed before injection, one month after the btx-a injection and 3 months after btx-a injections. all patients will underwent a clinical examination, a 3d gait analysis and a isokinetic dynamometer analysis. the comparison of the results in the group treated by btx-a will permit to show that one month after btx-a injection peak length during gait of muscles injected, maximal lengthening velocity peak knee flexion during swing phase and peak ankle dorsiflexion increase significantly. it will also permit to show that the maximal strength of muscles injected decreases whereas the strength of antagonist increases it will also permit to demonstrate that multisite btx-a injection improve coordination of paretic and non paretic lower limb the inter-group comparison will permit to demonstrate that these modification are mainly due to multisite btx-a injections.

Eligibility criteria:
inclusion criteria: * men or women aged \> 18 ans * unilateral stroke more than 6 months * ability to walk 10 meters without assistive device * decrease of peak knee flexion in swing phase of the gait cycle due to a spasticity of rectus femoris muscle * plantarflexion in swing phase of the gait cycle due to a spasticity of the triceps surae * informed consent approved * oral contraception exclusion criteria: * aphasia * anteriority of lower limb surgery less than 6 months * underlying disease * pre-existing neuro-muscular disorders * pregnancy * absence of oral contraception * last botulinum toxin injection \< 3months * hypersensitivity reactions * co-administration of aminoglycosides

Keywords: botulinum toxin injection,3d motion analysis, muscular lengthening,muscle strength
open label continuation treatment study with levodopa-carbidopa intestinal gel in advanced parkinson's disease

Conditions: Advanced Parkinson's Disease

Summary: the primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (lcig), to participants who have already participated in an open-label efficacy and safety study with the same treatment (study s187.3.003 \[nct00360568\] or study s187.3.004 \[nct00335153\]).


Eligibility criteria:
inclusion criteria: * the participant should have completed participation in study s187.3.003 or s187.3.004; and, in the opinion of the principal investigator, would benefit from long-term treatment with lcig. * for canada, participants will be allowed to participate in the s187.3.005 study with a minimum of 6 months of exposure to lcig in the s187.3.004 study. * the participant must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study related procedures. if the participant does not have the capacity to provide informed consent, full informed consent must be obtained from the participant's legally authorized representative. consenting will be performed according to local regulations. exclusion criteria: * medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be clinically significant and which could interfere with the participant's participation in the study.

Keywords: levodopa/carbidopa intestinal gel severe motor fluctuations levodopa carbidopa parkinson's disease dyskinesia
effect of testosterone replacement on exercise capacity in hypogonadal men after a recent myocardial infarction

Conditions: Hypogonadism; Acute Myocardial Infarction: Rehabilitation Phase

Summary: the purpose of this study is to determine the effects of testosterone replacement in hypogonadal men on exercise tolerance and cardiac rehabilitation after an acute myocardial infarction.

testosterone deficiency can decrease muscle strength. the researchers will replace testosterone in hypogonadal men undergoing rehabilitation exercises after heart attack.

Eligibility criteria:
inclusion criteria: 1. all men status-post myocardial infarction or non-st elevation-acute coronary syndrome within the last 3-8 weeks enrolling in the cardiac rehabilitation program at mission fitness-medical center hospital. 2. baseline free testosterone levels less than age-specific normal values. 3. males 18 years and older exclusion criteria: 1. prostate specific antigen greater than age based, ethnic-specific cut points (see appendix), history of metastatic prostate cancer or symptoms suggestive of severe benign prostatic enlargement. 2. current use of testosterone, clomiphene or over the counter testosterone boosters 3. patients initiating cardiac rehabilitation 8+ weeks after mi or non-st elevation-acute coronary syndrome 4. congestive heart failure, new york heart association class iv 5. life expectancy less than 1 year, 6. baseline hematocrit of \>50% 7. allergic reactions to testosterone or testosterone vehicle (i.e. cotton seed oil, etc.) 8. physical inability to participate in rehabilitation program (examples: severe claudication, massive obesity, etc.) 9. participation in any other concurrent clinical trial, use of an investigational agent or therapeutic regimen within 30 days of study 10. patients formerly diagnosed with obstructive sleep apnea. 11. patients using opiate analgesics 12. patients with aspartate aminotransferase/alanine aminotransferase values more than 3 times normal 13. history of deep venous thrombosis
new combination regimen of l-asparaginase, dexamethasone, ifosfamide, cisplatin and etoposide in nk/t-cell lymphoma

Conditions: Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of l-asparaginase plus dice regimen in the patients with early stage nk/t-cell lymphoma.

dice regimen was found to be highly effective as induction chemotherapy in patients with early stage nk/t-cell lymphoma in the ongoing study. l-asparaginase, an agent with unique anti-cancer mechanism, was also found to be effective in salvage setting. in terms of non-overlapped efficacy and toxicity, the investigators designed this phase ii study to verify the efficacy and tolerability of this new combination.

Eligibility criteria:
inclusion criteria: * age range 14-75 years old * histological confirmed, previously untreated stage i/ii nk/t cell lymphoma in the upper-aerodigestive tract * ecog performance status less than 2 * life expectancy of more than 3 months * normal laboratory values: hemoglobin \> 80 g/dl, neutrophil \> 2×109/l, platelet \> 100×109/l, serum creatine \< 1.5×upper limitation of normal (uln), serum bilirubin \< 1.5×uln, alt and ast \< 2.5×uln exclusion criteria: * pregnant or lactating women * serious uncontrolled diseases and intercurrent infection * the evidence of cns metastasis * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Keywords: nk/t cell lymphoma dice l-asparaginase
kidney-sparing surgery compared with kidney removal in treating patients with kidney cancer

Conditions: Kidney Cancer

Summary: rationale: kidney-sparing surgery is a less invasive type of surgery for kidney cancer, and may have fewer side effects and improve recovery. it is unknown whether kidney-sparing surgery is more effective than kidney removal in treating kidney cancer. purpose: randomized phase iii trial to compare the effectiveness of surgery to completely remove the kidney with kidney-sparing surgery in treating patients with resectable kidney cancer.

objectives: * compare time to recurrence and survival of patients with single, low stage, nonmetastatic, well localized, and well delineated renal cell cancer treated with partial vs radical resection. * establish the side effects of kidney-sparing tumor resection in terms of morbidity and mortality in these patients. * study the relationship between tumor size, histologic grade, histologic type, and the extent of local control following partial resection. * determine which prognostic factors are important in selecting candidates for conservative surgery. outline: this is a randomized, multicenter study. patients are randomized to undergo radical nephrectomy and limited lymphadenectomy (arm i) or conservative surgery (arm ii). patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually thereafter. projected accrual: a total of 1300 patients will be accrued for this study over 8 years.

Eligibility criteria:
disease characteristics: * single renal t1-2 tumor suspicious for adenocarcinoma that meets the following requirements: * solitary tumor on ct scan * maximum diameter 5 cm * located such that negative resection margins are assured * n0, m0, i.e., no nodal involvement or distant metastases * no invasion of renal pelvis, calices, or perirenal fat as determined by ct scan or intravenous urography * normal contralateral kidney present * no von hippel-lindau disease patient characteristics: age: * any age performance status: * who 0-2 hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no second malignancy except adequately treated nonmelanomatous skin cancer prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: stage i renal cell cancer stage ii renal cell cancer