Kornimate/medical-research-clean huggingface dataset:
vorinostat and bortezomib as third-line treatment in advanced non-small cell lung cancer

Conditions: Carcinoma, Non Small Cell Lung

Summary: the purpose of this study is to evaluate the efficacy of vorinostat and bortezomib in the third line treatment of advanced nsclc, as well as to assess toxicity (including neuropathy) and tolerability of this regimen.

current treatment for non-small cell lung cancer (nsclc) remains inadequate. vorinostat is a novel agent that inhibits the enzymatic activity of histone deacetylases (hdacs). bortezomib is a small molecule proteasome inhibitor. preclinical and clinical studies have shown the advantages of combining these two agents in the treatment of nsclc

Eligibility criteria:
inclusion criteria: * pathologically/histologically confirmed nsclc * advance nsclc (stage iiib w/ effusion, stage iv, or recurrent disease) * measurable disease * two prior systemic anti-cancer (cytotoxic or biologic) regimens for advanced/metastatic disease, including one (1) platinum-based chemotherapy * prior treatment allowed if side effects have resolved and 3 weeks has passed since last dose of treatment (1 week for palliative radiation therapy) * ecog performance status 0, 1, or 2 * patients with brain metastases are allowed, if clinically stable after treatment * normal liver, kidney, and marrow function * 18 years of age or older * negative pregnancy test for women of child-bearing potential. * life expectancy 3 months or more * no concurrent use of other antitumor agents exclusion criteria: * prior therapy with vorinostat, hdac inhibitors, or bortezomib * pre-existing neuropathy grade \>/= 2 * myocardial infarction within 6 months prior to enrollment or have ny heart association class iii or class iv heart failure * have taken valproic acid \</= 4 weeks prior to enrollment * previous or current malignancies of other histologies within the past 5 years, except cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin * hypersensitivity to bortezomib, boron, or mannitol * serious medical or psychiatric illness likely to interfere with participation in the clinical study * pregnant women * hiv positive patients * hepatitis infection (hcv or hbv) patients

Keywords: non small cell lung cancer hdac proteasome inhibitor
the effect of sodium-glucose cotransporter 2 inhibitors on advanced glycation end products

Conditions: SGLT-2 Inhibitors; Advanced Glycation End Products; Diabetes

Summary: single-center open-label multiple dose randomized two period cross-over study to examine advanced glycation end product (age) levels in human subjects pre and post empagliflozin administration.

single-center open-label multiple dose randomized two period cross-over study. the north-shore long island jewish institutional review board will be used to approve our study protocol. all patients will give written informed consent and comply with the helsinki agreement and good clinical practices guidelines. treatment plan: eligible patients will be randomized to receive linagliptin 5mg daily or empagliflozin 25mg daily for 30 days followed by a 30 day washout period and crossover. all pre-existing diabetic medications will continue unchanged. fasting blood carboxymethyl lysine (cml), methylglyoxal (mg), vascular cell adhesion molecule (vcam), tumor necrosis factor (tnf) alpha, 8-isoprostane, and routine chemistries and urinary cml, mg, and creatinine will be measured at baseline, after 30 days, 60 days and 90 days. age levels will be measured by elisa.

Eligibility criteria:
inclusion criteria: * t2dm * age ≥ 18 * glomerular filtration rate ≥ 30 ml/min/1.73 m2 body-surface area * a1c ≥ 7% any higher limit * slgt-2 inhibitor naïve * on stable doses of current medications for at least 3 months. exclusion criteria: * indication of liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 2 x upper limit of normal during screening or run-in phase * blood dyscrasias or any disorders causing hemolysis or unstable red blood cells * contraindications to background therapy according to the local label * any uncontrolled endocrine disorder except type 2 diabetes * pre-menopausal women (last menstruation ≤1 year prior to informed consent) who were nursing, pregnant, or of child-bearing potential and were not practicing an acceptable method of birth control, or did not plan to continue using this method throughout the study, or did not agree to submit to periodic pregnancy testing during the trial o acceptable methods of birth control include tubal ligation, transdermal patch, intrauterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method, vasectomy of partner * alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake * intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial involving an investigational drug and/or follow-up
tolerance to electrostimulation in copd patients

Conditions: COPD

Summary: the study was designed to test the following hypothesis patients with high cardio-respiratory response to electrostimulation (es), high perception of pain during es and high es-induced muscle fatigue, have low tolerance to es (more difficulties to increase intensity during training).

background: muscle electrostimulation (es) appears as a promising alternative to general physical reconditioning in advanced copd and its feasibility has been confirmed in this population. however, patients are not equal in tolerance to es. certain patients are not able to increase es intensity during training, limiting its benefits. furthermore, little is known about the effect of one es training session on cardio-respiratory response, muscle fatigue and systemic inflammation in copd patients. objective: to evaluate the tolerance to es in copd patients and to identify the physiological parameters involved in es tolerance. method: we propose to conduct a prospective study including 21 copd patients of different pulmonary severity (7 in each group of gold ii, iii and iv). patients will be evaluated 3 times: at day 1, day 2 and day 9. in the first session, patients will be initiated to es and evaluated in walking distance. in the second session, patients will become autonomous with es and they will be evaluated in muscle strength and body composition. in the third session, cardio-respiratory measurements will be performed during es and patients will be evaluated in muscle strength and systemic inflammation (blood sampling) before and after es. between the 2d and the 3d sessions, patients will have to perform 5 es sessions at home (from day 3 to day 8). tolerance (symptoms assessed with visual analogical scale (vas)) and intensity of es will be measured during each es session. planning analysis: the main outcome will be the change in es intensity between session 2 and 3 (delta intensity). the other end-points will be minute ventilation, heart rate, vo2 and sao2 during es, but also change in es tolerance (vas) during es at equal es intensity, leg muscle fatigue after es, body composition and changes in plasmatic proteins after es. simple and multiple regressions analysis will be done between delta intensity and 1/cardio-respiratory response during es, 2/muscle fatigue after es, 3/body composition, 4/perception of pain at session 2 (vas), 5/changes in plasmatic proteins after es.

Eligibility criteria:
inclusion criteria: * subject is diagnosed with copd. * 40 years-old and older * currently or previously smoking with a smoking history of at least 10 pack-years * subject understands and is able to read and write french or english exclusion criteria: * absence of neuromuscular pathology * absence of vascular pathology * absence of dermatosis on legs

Keywords: electrostimulation copd tolerance muscle fatigue cardio-respiratory response
treatment of knee osteoarthritis (koa) by injection of autologous adipose-derived vascular matrix components (svf) into joint cavity

Conditions: Knee Osteoarthritis

Summary: the purpose of this study was to analyze and study the efficacy and safety of autologous adipose-derived vascular matrix components (svf) in patients with knee osteoarthritis before and after treatment through clinical evaluation, radiation index, and metabolic index comparison between plasma and irrigation solution before and after svf injection.


Eligibility criteria:
inclusion criteria: * the age range is 20-70 years old * patients with unilateral or bilateral knee degenerative inflammation (koa) with kellgren-lawrence rating of level 3 or lower * the physical health status is mainly in the asa grade ⅰ, ⅱ and ⅲ * subjects had no active tumors, no active inflammation, no treponema pallidum, hiv, hepatitis b virus, or hepatitis c virus * the subject shall provide the physical examination report of knee x-ray examination, mri examination and other items exclusion criteria: * patients with nonunion or displaced fractures around defective cartilage * pregnant or lactating women * autoimmune disease * subjects with diabetes (exceptions are patients whose blood sugar levels remain within the normal range and diabetes has not caused other complications) * the patients had severe neurological diseases affecting the evaluation of postoperative results

Keywords: stromal vascular fraction
safety and efficacy of ho/02/02 20µg vs. soc (aloe vera) to reduce radiation dermatitis

Conditions: Breast Cancer

Summary: this is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of ho/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (soc), aloe vera treatment

this is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of ho/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (soc), aloe vera treatment in addition to sterile water for irrigation applied daily for 15 minutes (with gauze) on treatment fields to create the same cooling effect as in treatment arm 1. both treatment arms 1\&2 treatments will be applied topically once daily for up to 8 weeks to reduce radiation dermatitis in up to 90 breast cancer patients undergoing adjuvant radiation therapy.

Eligibility criteria:
inclusion criteria: * female patients 18 years old and above. * histology confirmed unilateral breast cancer following lumpectomy * planned to receive 50 gy, whole breast xrt and regional lymph nodes radiation. * ecog performance status 0-2 * completed chemotherapy 3 weeks prior to xrt (if applicable) * patient should be available for the entire study period, and be able and willing to adhere to protocol requirements; * patient must sign an informed consent form prior to undergoing any study-related procedures exclusion criteria: * known uncontrolled diabetes * prior radiation to breast * known connective tissue disorder * known skin disease over the treated breast * prior burn over treated area * evidence of infection or inflammation of breast to be treated. * receiving biological therapy or hormone therapy (other than herceptin) during radiation treatment/study duration and 4 weeks prior to study entry. * pre-existing skin breakdown within the planned radiotherapy field at the time of study entry. * pregnancy, planned pregnancy, lactation or inadequate contraception as judged by the investigator. * participation in another investigational drug or vaccine trial concurrently or within 30 days. * use of any other topical or systemic treatments aimed at radiation dermatitis. * use of a prescription or over-the-counter medication that contains hydrocortisone or any other cortisone or corticosteroid containing preparation

Keywords: breast cancer radiation therapy radiation dermatitis
evaluation of text neck syndrome and hand grip force in smart phone addiction among students of jazan university

Conditions: Pain, Back; Neck Pain; Postural; Strain; Myofascial Pain Syndrome

Summary: this study will be conducted in the department of physical therapy, college of applied medical sciences,jazan university, to investigate text neck syndrome and hand grip force in smart phone addiction among students of jazan university

four hundreds students with age 19 to 26 years old, and right dominant hand, will be recruited from the college of applied medical sciences, jazan university. subjects will be randomly assigned to into a heavy user group (n=300; female and male students) and a control or regular use group (n=300; female and male students) according to their smartphone addiction proneness scale. baseline hydraulic hand dynamometer: (fabrication enterprises incorporated, white plains,new york, usa) is used to measure the hand grip strength and pinch strength. algometer commander (jtech medical company) is used on the location of the trigger point to assess the amount of pressure the patient could sustain before the patient registered the pressure as being painful for upper fiber of trapezius muscle and sternocleidomastoid muscle

Eligibility criteria:
inclusion criteria: 1. the participant will be right-handed. 2. no abnormal findings confirmed through physical and neurological examination. 3. no congenital abnormalities in either the cervical or the lumbar spine. 4. no history of severe surgical procedures ( park et al., 2015) . exclusion criteria: 1. history of a neurological disease. 2. history of musculoskeletal injury of neck and lumbar region. 3. unstable medical condition.
tbw vs plating in olecranon fractures

Conditions: Olecranon Fracture

Summary: background: while the tension band wiring (tbw) technique is commonly used for simple, displaced olecranon fractures, it is associated with complications such as hardware prominence. to date, studies comparing between the efficacy and safety of tbw and plate fixation for these fractures have not provided a conclusive answer. purposes: to investigate which of the two techniques provide better functional and radiological outcomes for simple displaced mayo type 2a olecranon fractures, which technique provides better patient-reported outcomes, what are the complication rates associated with each technique

background: while the tension band wiring (tbw) technique is commonly used for simple, displaced olecranon fractures, it is associated with complications such as hardware prominence. to date, studies comparing between the efficacy and safety of tbw and plate fixation for these fractures have not provided a conclusive answer. purposes: to investigate which of the two techniques provide better functional and radiological outcomes for simple displaced mayo type 2a olecranon fractures, which technique provides better patient-reported outcomes, what are the complication rates associated with each technique methods: a long-term, prospective, randomized study on 50 adult patients who underwent surgery to treat acute, simple, displaced olecranon fractures in a hand and upper extremity surgery unit at a tertiary care center between november 2012 and october 2017. patients were randomized on a 1:1 basis to either tension band or plate fixation and were evaluated at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery. evaluation of long-term complications continued after 1 year as clinically indicated. the primary outcome measure was the 1-year postoperative disabilities of the arm, shoulder and hand (dash) score. additional outcome measures included patient-reported oxford elbow score, functional (i.e., range of motion) and radiographic assessments and complication rates.

Eligibility criteria:
inclusion criteria: 1. traumatic non-pathological simple olecranon fracture 2. age 18 years or older 3. presentation within 2 weeks of injury. exclusion criteria: 1. inability to sign an informed consent 2. inability to comply with follow-up 3. associated elbow fractures 4. open fractures 5. pregnancy.
pet imaging of subjects using 124i-pu-ad

Conditions: Lymphoma; Solid Malignancy; Alzheimer Disease; Myeloma

Summary: this is a first in-human, open-label pilot (microdose) study of the positron-emitting agent 124i-pu-ad in subjects with specific cancer types (solid malignancy, lymphoma, and/or myeloma) and/or alzheimer's disease.

this first in-human trial of the positron-emitting agent 124i-pu-ad is an open-label pilot (microdose) study. up to 10 evaluable subjects who have active disease will be enrolled to evaluate the pk, metabolism, biodistribution, and radiation dosimetry of 124i-pu-ad. following a 28-day screening period, eligible subjects will return to the clinic on day 1. a single dose of 124i-pu-ad will be administered by intravenous (iv) injection to subjects. after 124i-pu-ad tracer injection, pet scans will be performed at 4 time points. at each time-point, an axial body image is acquired on a state-of-the-art pet-ct scanner. a low-dose ct will be obtained immediately-prior to pet imaging, at each time-point. serial blood samples will also be obtained at multiple time points. subjects will be evaluated to ensure that there are no clinically significant ongoing aes prior to discharge.

Eligibility criteria:
inclusion criteria: 1. subjects with a diagnosis of cancer and/or alzheimer's disease, meeting trial eligibility criteria as specified below for either disease: cancer: 1. subjects with eligible histologic types of cancer. eligible histologic types of cancer include solid malignancy, myeloma, and lymphoma. 2. cancer histology confirmed by pathology. 3. cancerous disease is radiologically-measurable or evaluable as defined by published tumor response criteria (including but not limited to recist 1.1). alzheimer's: 1. established diagnosis of mild-moderate alzheimer's disease based upon neurological and neuropsychological evaluation following the national institute on aging - alzheimer's disease association criteria that recently revisited the nincds-adrda criteria. 2. documentation of diagnosis of mild-moderate alzheimer's disease, as above, by board-certified neurologist. 2. subjects who have both cancer and alzheimer's disease, subjects are considered eligible if they meet all eligibility requirements for either alzheimer's disease or cancer patients, as specified above. exclusion criteria: 1. subject has unacceptable pre-study organ function during screening defined as: 1. bilirubin \> 1.5 x institutional upper limit of normal (uln) 2. ast/alt \>2.5 x uln 3. albumin \< 2 g/dl 4. ggt \> 2.5 x uln (if alkaline phosphatase \> 2.5 x uln) 5. creatinine \>1.5 x uln or creatinine clearance \< 60 ml/min. 2. subject has history of acute major illness (i.e., unstable cardiovascular condition.) 3. subject has concurrent participation in any interventional studies within 30 days of first dose of study drug.
a multi-center, randomized, double-blind, parallel group study to compare the efficacy and tolerability of valdecoxib and diclofenac in patients with a sprained ankle

Conditions: Pain; Sprains and Strains; Sprain

Summary: to determine whether valdecoxib 40 mg twice a day the first day and then 40mg once a day until day 7, was at least as effective as diclofenac 75 mg twice a day for 7 days, in treating acute first or second degree ankle sprain. the study also compared valdecoxib and diclofenac with respect to time to onset of pain relief (measured after the first dose), tolerability (adverse events) and time to return to normal function/activity, among other measures.


Eligibility criteria:
inclusion criteria: * patients had sprained their ankle within 48 hours * the sprain was a first or second degree ankle sprain of the lateral aspect, specifically: anterior talofibular ligament and/or calcaneofibular ligament * at presentation patients were to have had moderate-severe ankle pain, (i.e., patient's assessment of ankle pain, on full weight bearing, using a 100 mm visual analog scale (vas) was ≥ 45 mm), have a minimum rating of 2 on the patient's global assessment of ankle injury and patient's assessment of normal function/activity * investigator must have thought that the patient required and was eligible for therapy with an anti-inflammatory agent and/or analgesic to control symptoms exclusion criteria: * women who were not post-menopausal or surgically sterilized, or who had have a positive urine pregnancy test prior to randomization and/or were not using adequate contraception according to the judgment of the investigator * patients with a similar injury of the same joint within the last 6 months * clinical evidence of complete rupture of ankle ligaments (third degree sprain), required bed rest, hospitalization, surgical intervention for the ankle injury or non-removable full cast, bilateral occurrence of ankle injury or ankle and knee injury on the same side * patients with esophageal, gastric or duodenal ulcer within 30 days prior to randomization or had active gi or other disease that in the opinion of the investigator would preclude safe participation by the subject in the study.

Keywords: acute ankle sprain, acute pain, south america
outcomes of laparoscopic sleeve gastrectomy in patients with hypothyroidism and depression

Conditions: Obesity and Obesity-related Medical Conditions

Summary: sleeve gastrectomy (sg) continues to be one of the most popular bariatric procedures all over the world. it has been established that obesity is a predisposing factor for several comorbidities, including life-threatening conditions. many studies have discussed the impact of sleeve gastrectomy on tsh level. but, since most obese patients have some sort of depression, we will try to study the impact of sleeve gastrectomy, depression and hypothyroidism on each other.


Eligibility criteria:
inclusion criteria: * obese patients with depression and hypothyroidism controlled by medical treatment candidate for sleeve gastrectomy exclusion criteria: * patients less than 18 or above 60 * other psychiatric or medical disorders. * patients not fit for surgery * un controlled patients

Keywords: obesity hypothyroidism depression
assessment of suspected intracranial malignancy using 3'-deoxy-3'18 f-flourothymidine pet

Conditions: Brain Tumor

Summary: the primary objective of this study is to detect and quantify tumor cells of high grade malignant gliomas and metastatic brain lesions both before and after initial surgical resection in a cohort of newly diagnosed patients.

in this study, 35 patients will be selected to undergoing sequential imaging with flt-pet. prior to surgical resection, patients will undergo a preliminary flt-pet. additional flt scans for a maximum of four scans.

Eligibility criteria:
inclusion criteria: * 18 years or older * women must not be pregnant or breast feeding * histologic or strong radiologic suspicion of high grade malignant glioma or ogliometastatic tumor(s) exclusion criteria: * may not have received previous therapy for their malignancy

Keywords: brain scan