Kornimate/medical-research-clean huggingface dataset:
a study of km602 in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this study is a phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and activity of km602 as monotherapy in patients with advanced solid tumors.

this phase 1 study is comprised of dose escalation and expansions for km602 monotherapy. monotherapy dose escalation is designed with initial accelerated titration followed by a standard 3+3 dose escalation; patients will remain on study treatment until progression of disease, unacceptable toxicity, or other specified reason for discontinuation.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed, disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments (predominantly melanoma and non-small cell lung cancer) 2. all patients must have at least one measurable lesion at baseline according to recist v1.1 3. ecog performance status of 0 or 1 4. life expectancy of ≥ 12 weeks 5. adequate baseline hematologic, renal, and hepatic function exclusion criteria: 1. patients with meningeal metastasis or symptomatic central nervous system metastasis 2. any second malignancy active within the previous 5 years 3. any active, known, or suspected autoimmune disease 4. active or prior pneumonitis or interstitial lung disease 5. prior organ allograft or allogeneic hematopoietic stem cell transplantation 6. treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 4 weeks prior to the first dose of km602 7. prior treatment with a ctla-4 antagonist, including ipilimumab and tremelimumab 8. history of ≥ grade 3 immune-related adverse event leading to treatment discontinuation 9. systemic treatment with corticosteroids (\> 10 mg/day prednisone) or other immunosuppressive medication within 14 days prior to the first dose of km602 or during the study 10. known seropositivity for or active infection by human immunodeficiency virus, hepatitis b or c 11. known allergies, hypersensitivity, or intolerance to km602 or excipients in the drug product formulation 12. active infection requiring therapy at the time of the first dose of km602 13. pregnancy or breastfeeding 14. any serious or uncontrolled health condition, which, in the opinion of the investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.
long-duration ultrasound for knee osteoarthritis

Conditions: Osteo Arthritis Knee

Summary: this study will measure the 24-week pain relief from long-duration ultrasound on the symptoms of knee arthritis pain.


Eligibility criteria:
inclusion criteria: * are you between 18 and 80 years of age (inclusive)? * can you speak, read, and write in english? * do you have knee pain that has lasted at least 3 months? * are you willing and able to self-administer the ultrasound device daily within your place of residence or during normal daily activity? * are you willing to keep all pain medications stable and discuss with the investigator any needs to change medications during the study period? this may include drugs administered topically, orally, transdermally, or by injection. * are you willing to document usage of any medications during the study period? * do you agree to discontinue all other interventional treatment modalities on the lower back during the study? (e.g., transcutaneous electric nerve stimulation \[tens\], electronic muscle stimulation, traditional ultrasound, massage therapy, chiropractic services) * on a numeric rating scale (nrs) of 0 (no pain) to 10 (pain as bad as you can imagine), how would you rate your average pain over the past week? pain must be ≥4 for the subject to be enrolled in this study. this criterion will be assessed by self-report at visit 1. exclusion criteria: * have you participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening? * are you pregnant? * are you a prisoner? * are you non-ambulatory (unable to walk)? * do you have a pacemaker? * do you have a malignancy in the treatment area? * do you have an active infection, open sores, or wounds in the treatment area? * do you have impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia? * do you have a known neuropathy (disease of the brain or spinal nerves)? * do you have a hereditary disposition (tendency) for excessive bleeding (hemorrhage)? * do you have peripheral artery disease? * does the subject display any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions?
ppargamma activation by losartan in hypertensive patients: the importance of losartan-metabolites

Conditions: Hypertension

Summary: the purpose of this study is to determine whether losartan metabolites are effective in inducing pparγ target genes in monocytes in losartan-treated patients.

the losartan metabolite exp3179 potently induces the activity of the peroxisome proliferator-activated receptor γ (ppar-γ) as a partial agonist in vitro. ppar-γ is a nuclear hormone receptor and functions as a regulator of lipid- and glucose metabolism. ppar-γ ligands improve insulin sensitivity and glucose tolerance, and reduce cardiovascular morbidity and mortality in diabetic patients. angiotensin ii receptor 1-blocking and ppar-γ-activating properties of losartan metabolites in patients would markedly improve the pharmacological profile of losartan by combining anti-hypertensive and highly beneficial metabolic actions. we developed the following hypothesis: 1. hypertensive patients chronically treated with losartan exhibit sufficient plasma levels of exp3179 to activate pparγ. 2. pparγ target genes are induced in monocytes from losartan-treated patients.

Eligibility criteria:
inclusion criteria: * age: 19-80 * sex: male or female * prior diagnosis of treated hypertension * treatment with losartan 100mg/daily during at least the past 2 months (n=20/ case); * or: no prior angiotensin receptor 1-blocker treatment during the last 2 months (n=10/ control). exclusion criteria: * non-steroidal anti-inflammatory drugs (exception: acetyl salicylic acid) for the past 21 days (due to structural homologies to glitazones, and activating effects on pparγ) * therapy with glitazones for the past 21 days.

Keywords: hypertension angiotensin receptor blockers peroxisome proliferator activated receptor gamma
rheumatoid arthritis coping enhancement

Conditions: Rheumatoid Arthritis; Obesity; Pain

Summary: this study will test an enhanced lifestyle behavioral weight management program that integrates pain coping strategies with a lifestyle intervention that we expect to enhance obese ra patient's ability to cope with pain-related weight challenges. in the proposed study, up to 120 obese (ra-bmi \> 28) rheumatoid arthritis patients will be consented in order to randomly assign 80 patients to one of two conditions: 1) an enhanced lifestyle weight management protocol or 2) standard care control. patients randomized to the enhanced lifestyle weight management condition will participate in a 12-week protocol in which training in coping skills to increase self-efficacy and decrease the impact of ra pain on behavioral (e.g., activity, eating) and psychosocial (e.g., mood, relationships) weight loss factors will be integrated into a lifestyle behavioral weight loss intervention.


Eligibility criteria:
inclusion criteria: * had ra for at least one year * were 18 to 85 years of age * were obese according to established ra obesity criteria (ra-bmi \> 28) * had experienced ra pain in the last two weeks. exclusion criteria: * subjects were excluded if they 1) have a significant rheumatic disorder other than ra or another organic disease that would significantly affect functioning (e.g., copd, cancer) * had a significant medical condition that would expose them to increased risk of a significantly adverse experience during the course of the study (e.g., a recent myocardial infarction) * they were already involved in a regular exercise program and/or pain coping skills training program * they had an abnormal cardiac response to exercise such as exercise-induced vt, abnormal blood pressure response, etc., * are pregnant at enrollment or at the initiation of intervention * are younger than 18 years of age or older than 85 years of age * are known or judged by the physician to be cognitively impaired (dementia, retardation, psychosis)

Keywords: rheumatoid arthritis pain obesity
telehealth virtual reality gaming on cardiometabolic health among youth with cerebral palsy

Conditions: Cerebral Palsy

Summary: the primary purpose of this study is to examine the preliminary efficacy of 12-weeks of home-based exercise using consumer available virtual reality gaming technology, compared with a 12 week wait-list control group. the secondary purpose is to understand behavioral mechanisms that explain participation in exergaming through semi-structured interviews with participants from both groups at post-intervention or dropout.

youth with cerebral palsy (ywcp) do not have adequate exercise options that empower them to independently maintain their cardiometabolic health and, thus, live inactive, sedentary lifestyles that place them at substantially higher risk for cardiovascular disease, related conditions (e.g., hypercholesterolemia, diabetes, and hypertension), and mortality than the general population. no randomized controlled trial (rct) has demonstrated clinically meaningful improvements in cardiometabolic health in people with cerebral palsy. vr gaming delivered via telehealth may be an optimal method of promoting sustainable exercise behavior among large groups of youth. home-based telehealth programs that incorporate 'virtual' behavioral coaching (tele-coaching) are a desirable approach for promoting non-supervised, exercise behavior among people with disabilities who do not have convenient access to community programs. the addition of behavioral coaching strategies such as goal-setting, confidence building, setting reasonable expectations, and understanding benefits, underpinned by theory such as the social cognitive theory (bandura, 2004), have been found to enhance the likelihood that people engage in and sustain a behavior. therefore, this study hypothesizes that 3-months of tele-monitored vr exergaming with behavioral coaching will result in strong adherence to moderate-intensity exercise and greater changes in key indicators of cardiometabolic health in ywcp, compared with a wait-list control group that maintains habitual activity (before receiving the intervention).

Eligibility criteria:
inclusion criteria: 1. medical diagnosis of cerebral palsy 2. between the ages of 13-24 years to accommodate the world health organization definition of youth and the minimum age of 13 years specified by the quest 3. physician clearance to participate 4. access to a wi-fi internet connection in the home via mobile phone or tablet computer 5. a caregiver to support the child exclusion criteria: 1. physically active (defined as \>150 minutes per week of moderate-to-vigorous intensity exercise in a typical week) 2. cannot use their arms for exercise or a classification of gmfcs level v, which we have found to preclude the ability to use the oculus quest hand-held controllers 3. complete blindness or deafness. 4. contraindications to exercise based on the american college of sports medicine (acsm) guidelines

Keywords: physical activity exercise telehealth
drug-coated chocolate pta balloon in patients with peripheral arterial disease - the endure trial

Conditions: Peripheral Vascular Disease

Summary: this first-in-man study is to evaluate the drug-coated chocolate (dcc) balloon for percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease. the study focuses on acute device performance and peri-procedural safety and also seeks to further characterize the performance of the device.

this is a prospective, multi-center, single-arm study. symptomatic lower extremity peripheral arterial disease (pad) patients presenting for endovascular revascularization will be enrolled in the study if they meet all entry criteria. the study will include patients from new zealand and the european union. the endpoints were designed to establish safety of the dcc and to identify long-term clinical benefits of this technology. the patients treated in this study will be designated into the above the knee (atk) follow-up schedule if they are treated with the dcc in the sfa or popliteal vessels. this schedule calls for clinical visits with duplex ultrasounds at 1,6 and 12 months. patients will be designated into the below the knee (btk) follow-up schedule if they are treated with the dcc in the peroneal, anterior tibial, posterior tibial or pedal vessels. these patients will have clinical visits at 1, 3 and 6 months with duplex ultrasound at the 1 and 6 months visits only.

Eligibility criteria:
key inclusion criteria: * intermittent claudication or critical limb ischemia * atherosclerotic target lesion \>70% stenosis * reference vessel diameter (rvd) between 2.0 and 6.0mm * angiographic evidence of distal run-off * target lesion length \<150mm that consists of no more than two adjacent lesions( \< 25mm apart) and is able to be completely covered with inflation of no more than two dcc devices key exclusion criteria: * acute limb ischemia or thrombolytic therapy * known and relevant allergies/hypersensitivities * known impaired renal function * known bleeding disorder * severe calcification at the target lesion * previous bypass or stent at, or proximal to, target vessel * aneurysm in target limb * prior major limb amputation * use of a any of the following: re-entry device, atherectomy, laser or other ablation procedure, or cutting/scoring balloon at the target lesion; use of drug eluting stent, or non-study drug coated balloon in the target limb.
effects of hyaluronic acid vs. hyaluronic acid on knee osteoarthritis

Conditions: Physical Activity

Summary: using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis.

a total of 76 patients will be collected. the participants will be randomized into two groups, including hyaluronic acid injection group and hyaluronic acid combined corticosteroid injection group. physical activity will be evaluated. the hyaluronic acid group will receive three times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined corticosteroid group will receive hyaluronic acid combined corticosteroid injection in the first week, followed by hyaluronic acid injection at the second and third week. re-evaluation will be arranged at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection.

Eligibility criteria:
inclusion criteria: * osteoarthritis of knee with kellgren/lawrence grade ii or iii exclusion criteria: * who have implant in knee * history of neurological deficit, such as stroke

Keywords: knee osteoarthritis hyaluronic acid corticosteroid intra-articular injection therapeutic effect
indwelling pleural catheter for trapped lung

Conditions: Pleura; Effusion

Summary: malignant pleural effusion (mpe) is a complication of almost any site of primary cancer as well as primary tumors of the pleura. half of mpe patients have non-expendable trapped lungs not suitable for talc pleurodesis. indwelling pleural catheters (ipcs), however, can be used in this cohort of patients, bringing about an improvement in dyspnea and quality of life (qol). the aim of this study is to obtain pilot data - comparing patients receiving two different types of indwelling pleural catethers normally used in clinical practice (10 patients receiving pleurocath® and 10 patients receiving pleurx®) - for power calculation of a randomized controlled trial comparing two different drainages for mpe trapped lung.


Eligibility criteria:
inclusion criteria: * adult patients, with a clinical confident diagnosis of symptomatic malignant pleural effusion, enrolled for vats exploration but not amenable of vats talc poudrage because of trapped lung (patients with only partial expansion however receiving talc poudrage, but needing permanent pleural cathetes, are also eligible) exclusion criteria: * - age younger than 18 years * expected survival of less than 3 months * chylothorax * total white blood cell count less than 1000/microl * pregnancy or lactating mothers * irreversible bleeding diathesis * irreversible visual impairment * contraindications to general anesthesia * poor general clinical conditions ( ecog ps \>=2) * patients unable to provide informed consent
optimized cardioprotection therapy in obese subjects with cad

Conditions: Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)); Obesity; Adiposis; Heart

Summary: the purpose of this study is to investigate the efficacy and mechanism of adipokines cardiac protection in obese patients with coronary artery disease (cad).

adipokines (or adipocytokines) can be defined as a group of more than 600 bioactive molecules made from adipose tissue that acts as paracrine and endocrine hormones. adipokines are involved in maintaining varieties of processes such as, appetite and satiety, energy expenditure activity, endothelial function, blood pressure, hemostasis, adipogenesis, insulin sensitivity, energy metabolism in insulin-sensitive tissues, fat distribution and insulin secretion in pancreatic β-cells. adipokines may contribute to reduce scar formation and improve cardiac function in coronary artery disease (cad). reperfusion therapy such as percutaneous coronary intervention (pci) should be administered to all eligible patients with cad symptom. however, our previous work showed that obese patients may benefit more from pci. thus, the aim of the present study was to investigate the efficacy and mechanism of adipokines cardiac protection for obese and non-obese patients with coronary artery disease (cad).

Eligibility criteria:
inclusion criteria: coronary artery disease according to the who definition with or without percutaneous coronary intervention exclusion criteria: previous coronary artery bypass grafting (cabg) cardiomyopathy atrial fibrillation or flutter previous heart surgery severe valvular heart disease disease of the hematopoietic system nyha functional class iv heart failure at baseline severe renal, lung and liver disease cancer

Keywords: coronary artery disease adipokines obesity diabetes mellitus
usability of vibro-tactile stimulation to treat spasmodic dysphonia

Conditions: Spasmodic Dysphonia; Laryngeal Dystonia

Summary: the general aim of the study is to provide evidence for usability and feasibility of applying vibro-tactile stimulation (vts) at home as a non-invasive form of neuromodulation to improve speech in people with spasmodic dysphonia (sd). this work addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with very limited treatment options. successful completion of the proposed work will be an important step in advancing laryngeal vts as a therapeutic intervention for improving voice symptoms in sd.


Eligibility criteria:
inclusion criteria: * diagnosis of spasmodic dysphonia (laryngeal dystonia) for a minimum of 6 months with documented symptom relief after botox injection. * diagnosis is made by a voice disorder specialist. exclusion criteria: * regular intake of benzodiazepines * cognitive impairment: score \< 27 on mini-mental state examination * identifies with a neurological or musculoskeletal impairment affecting speech motor function. these impairments may include a form of: dyskinesia, dystonia, essential tremor, huntington's disease, multiple system atrophy, muscle tension dysphonia, parkinsonism, progressive supranuclear palsy, spasticity, intracranial neoplasm (brain tumor), spinal neoplasm, cerebrovascular accident (stroke), mild traumatic brain injury, intracranial hemorrhage, multiple sclerosis
cik cell transfusion plus chemotherapy as adjuvant therapy for stage ib-iiia non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer

Summary: non - small cell lung cancer ( nsclc ) accounts for more than 80% of lung cancer. the main treatment for early stage patients is surgical resection, but about 30% -70% patients will relapse. postoperative chemotherapy is the major systemic treatment for surgical resection nsclc patients. however, data show only 5-10% improvement in overall survival with systemic adjuvant chemotherapy. it is necessary to further improve the survival time of patients with lung cancer. biological treatment is becoming a new treatment modality for cancer following with surgery, radiotherapy and chemotherapy, and has been confirmed as an effective adjuvant treatment in comprehensive cancer treatment. cytokine induced killer cells ( cik) characterized as fast amplification, strong anti-cancer activity and broad anti-tumor spectrum is most widely used and thought to be the first choice for the new generation of anti-tumor adoptive immunotherapy. this phase ii study is investigating the efficacy of autologous cytokine-induced killer cell transfusion plus chemotherapy as adjuvant therapy for stage ib-iiia nsclc.


Eligibility criteria:
inclusion criteria: 1. stage ib-iiia post-surgery nsclc patients with histologically confirmed. 2. with an eastern cooperativeoncology group performance status of 0 or 1, 3. at least 18 years of age 4. adequate bone marrow reserve and organ function including calculated creatinine clearance 45 ml/min based on the standard cockcroft and gault formula 5. patients had fully recovered from its acute effects. exclusion criteria: 1. hiv positive 2. autoimmune disease 3. immune deficiency disorder 4. organ transplantation 5. received high dose glucocorticoid or other immune depressant within 4 weeks 6. active clinically serious infections (\> grade 2 nci-ctc version 3.0) 7. life threatening medical condition

Keywords: cytokine-induced killer cell nsclc adjuvant therapy