Kornimate/medical-research-clean huggingface dataset:
ocular tolerability of voclosporin ophthalmic solution versus restasis® in subjects with dry eye disease

Conditions: Dry Eye

Summary: evaluate the tolerability, efficacy and safety of vos versus restasis® in subjects with mild to moderate dry eye disease (ded).

this is a phase 2, multi-center, investigator-masked, randomized, parallel-group study to evaluate the tolerability, efficacy and safety of vos versus restasis® over a 28-day treatment period in subjects with mild to moderate ded. approximately 90 subjects will be randomized to either vos or restasis® at approximately 7 centers located in the us

Eligibility criteria:
inclusion criteria: 1. have a best corrected visual acuity (bcva) in both eyes of +0.7 logarithm of the minimum angle of resolution (logmar) or better as assessed by early treatment of diabetic retinopathy study (etdrs) chart. 2. have a documented history of ded in both eyes supported by a previous clinical diagnosis. 3. have ongoing ded, as defined by at least one eye (if one eye, the same eye) meeting all the following criteria: * a symptom severity score of ≥30 for eye dryness on a visual analog scale (vas) (0-100) * an unanesthetized schirmer tear test (stt) score of ≥1 mm and ≤10 mm per 5 minutes (note: stt score obtained at visit 1) * evidence of ocular surface staining (total fluorescein staining score of at least 3 \[0-15 scale\]). 4. have normal lid anatomy. exclusion criteria: 1. have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes. 2. be unable to demonstrate correct instillation of over-the-counter (otc) ocular lubricant. 3. report discomfort in both eyes from instillation of otc ocular lubricant during visit 2 (based on score of ≥30 on the drop discomfort vas). 4. have used restasis® (cyclosporine ophthalmic emulsion) within 30 days prior to visit 1. 5. have used restasis® for more than 1 month (if prior use is reported). 6. have used xiidra® (lifitegrast ophthalmic solution) within 14 days prior to visit 1. 7. have had corneal graft surgery in either eye within 1 year. 8. have recent or current evidence of ocular infection or inflammation in either eye. 9. have current evidence of clinically significant blepharitis (defined as requiring lid hygiene therapy), conjunctivitis, or a history of herpes simplex or zoster keratitis in either eye.

Keywords: dry eye calcineurin inhibitors
cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in peritoneal carcinomatosis from gastric cancer

Conditions: Gastric Cancer; Peritoneal Carcinomatosis

Summary: gastric cancer associated peritoneal carcinomatosis has a poor prognosis with a median survival of less than one year. systemic chemotherapy including targeted agents has not been found to significantly increase the survival in gastric cancer associated peritoneal carcinomatosis. since recurrent gastric cancer remains confined to the abdominal cavity in many patients, regional therapies like aggressive cytoreductive surgery and hyperthermic intraperitoneal chemotherapy have been investigated for gastric cancer associated peritoneal carcinomatosis. hyperthermic intraperitoneal chemotherapy has been used for three indications in gastric cancer- as an adjuvant therapy after a curative surgery, hyperthermic intraperitoneal chemotherapy has been shown to improve survival and reduce peritoneal recurrences in many randomised trials in asian countries; as a definitive treatment in established pc, hyperthermic intraperitoneal chemotherapy along with cytoreductive surgery is the only therapeutic modality that has resulted in long-term survival in select groups of patients. while the results of randomised trials of adjuvant hyperthermic intraperitoneal chemotherapy from western centres are awaited, the role of hyperthermic intraperitoneal chemotherapy in the treatment of gastric cancer associated peritoneal carcinomatosis is still evolving and needs larger studies before it is accepted as a standard of care.


Eligibility criteria:
inclusion criteria: * confirmed peritoneal carcinomatosis from gastric cancer * metachronous/synchronous peritoneal carcinomatosis exclusion criteria: - gastric origin of peritoneal carcinomatosis unconfirmed
a case study of nivolumab for relapsed/refractory primary central nervous system lymphoma

Conditions: Refractory Central Nervous System Lymphoma; Relapsed Primary Central Nervous System Lymphoma; Primary Central Nervous System Lymphoma

Summary: the purpose of this study is to determine whether nivolumab given intrathecally is effective in the treatment of relapsed/refractory primary central nervous system lymphoma (pcnsl)

this is a case study aiming to recruit 1 patient. this study is indicated for relapsed/refractory primary central nervous system lymphoma. primary objective is to explore the safety.

Eligibility criteria:
inclusion criteria: * subjects with ecog 0,1,2,3 * subjects with pathologically confirmed pcnsl with lesion in brain who progressed after or did not respond to at least 1 line of systemic therapy. pcnsl prior therapy may include hd-mtx, hd-mtx-based regimen, high-dose cytarabine, radiation therapy alone as treatment or as part of consolidation therapy, high-dose therapy with autologous stem cell transplant as part of consolidation therapy, and/or intraocular mtx alone or as part of consolidation therapy * subject with sufficient function of liver, kidney, heart, lung and hematopoiesis * subjects with relapsed pcnsl and are able to receive biopsy exclusion criteria: * subjects that are not dlbcl type pathologically * intraocular pcnsl without evidence of brain disease * subjects who cannot undergo mri assessments * relapsed pcnsl patients who cannot undergo biopsy * biopsy suggests no significant tumor-infiltration t cell or poor pd-1 expression * subjects with other malignancy * subjects with history of any inflammatory cns diseases * subjects with an active, known, or suspected autoimmune disease * subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment * prior treatment with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-ctla-4 antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways other protocol defined inclusion/exclusion criteria could apply
study examing the effect of omeprazole on safety, tolerability and how the body processes an experimental drug

Conditions: Obesity

Summary: experiment in the test tube indicated that cp-945,598 becomes less soluble with increase of ph (less acidity). changes in stomach acid levels may affect the solubility of cp-945,598, therefore, alters its availability in the blood. omeprazole decreases acid levels in stomach. this study will compare the time course of drug concentrations in the body, safety, and tolerability of cp-945,598 given with and without omeprazole.


Eligibility criteria:
inclusion criteria: * healthy * body mass index (bmi) of 26.6 to 40.5 kg/m2. exclusion criteria: * non-prescribed use of drugs or abuse of recreational drugs; recent treatment with experimental drugs or herbal experiments; ekg and blood pressure measurements falling outside of protocol-specified limits; history of regular alcohol or tobacco use exceeding protocol-specified limits; medically important health conditions; recent use of prescription or non-prescription medications.
assessment of glypican 3 as apredictive marker in colorectal cancer patients

Conditions: Colorectal Cancer

Summary: * evaluation of glypican 3 in serum of colorectal cancer patients . * correlation between glypican 3 and clinicopathological characteristics of colorectal cancer .

colorectal cancer (crc) is the third most common malignancy and the fourth most prominent cause of cancer-related deaths worldwide. also it is the 7th commonest cancer in egypt, representing 3.47% of male cancers and 3% of female cancers.the glypicans , a family of proteins classified as hspgs (heparan sulfate proteoglycan) , have been shown to interact with a number of growth factors and modulate growth factor activity and are linked to the xtracellular side of cell membrane by a glycosylphosphatidylinositol (gpi) anchor . members of this large family of transmembrane proteins have been identified in both mammals and drosophila: 6 glypicans (gpc-1 through gpc-6) in mammals, and two others in the fly .glypican-3 (gpc3) as one of this family is a protein of about 70 kd . it has multiple sugar chains and heparan sulfate modification sites . these proteins (glypicans) participate in organ development by modulating extracellular growth signals and morphogen gradient formation, and are involved in human overgrowth and skeletal dysplasia problems .in some cancers, they are highly expressed, associated with tumorigenesis, and regulating angiogenesis for cancer progression and invasion . abnormal expression of glypicans has been noted in multiple types of cancer. for examples, gpc-1 expression was found to be increased in breast cancer tissues and ovarian malignant tumors .gpc-2 is associated with neuroblastoma .expression of gpc-3 was found in high-grade urothelial carcinoma and also reported in some non-cns tumors of the brain.there have been several reports about the clinical usefulness of the n-terminal form of gpc3. enzyme-linked immunosorbent assay methods capable of detecting the n-terminal form of gpc3 . a study of colorectal cancer tissue speciment shows a correlation between expression of gpc3 with the clinicopathologic variables such as the level of differentiation, gpc3 was found to be expressed in ( 42.8% ) of the well-differentiated tumors, and (50%) of the moderately differentiated tumors, (75%) of the moderately and poorly differentiated tumors .therefore, it was found that the expression of gpc3 was correlated with the pathological grade of the tumors .

Eligibility criteria:
inclusion criteria: * patients with colorectal cancer and admitted to south egypt cancer institute . exclusion criteria: * other malignant diseases . * patients received chemotherapy for colorectal cancer .

Keywords: glypican 3
impact of coronary artery bypass graft (cabg) surgery on skeletal muscle mass and insulin sensitivity, followed by exercise intervention

Conditions: Coronary Artery Disease

Summary: in this study, the investigators want to examine the impact of coronary artery bypass graft (cabg) surgery on skeletal muscle mass, muscle metabolism, and insulin sensitivity in 90 subjects. in extent, the impact of a subsequent exercise intervention will be examined, with a follow-up up to 12 months after surgery.

90 subjects undergoing elective cabg surgery will be included. these subjects are free from orthopedic limitations, will have no severe complications during surgery, and are willing to participate in a 12-week exercise training intervention. at baseline (before surgery), following parameters will be assessed: blood parameters (glycemic control, lipid profile, anabolic/catabolic hormones, inflammatory markers), body composition (by dual x-ray absorptiometry), handgrip strength, and general subject features (medication, gender, age, etc.). the first three days after surgery, blood samples will be collected for the analysis of glycemic control, lipid profile, anabolic/catabolic hormones, inflammatory markers. next, at the start of exercise intervention, after 6 and 12 weeks of exercise training, and after a 12-month follow-up, following parameters will be assessed: blood parameters (glycemic control, lipid profile, anabolic/catabolic hormones, inflammatory markers), body composition (by dual x-ray absorptiometry), handgrip strength, maximal exercise capacity (by ergospirometry testing), physical activity (by questionnaire), and quality of life ( by questionnaire). at 12 months of follow-up, cardiovascular mortality and morbidity (re-occurrence of angina, acute myocardial infarction, need for surgery, death) will be assessed. when initiating exercise intervention, subjects will randomly (n=30 in each group) be assigned to 12 weeks of standard exercise intervention (endurance exercise training), modified exercise intervention (endurance exercise training + strength training), or modified exercise intervention (endurance exercise training + strength training + oral protein supplements). this will be a cluster randomized clinical trial. investigators executing the measurements will be blinded for treatment allocation.

Eligibility criteria:
inclusion criteria: * elective cabg surgery * willing to participate in 12-week exercise intervention exclusion criteria: * complicated surgery * severe complications during first days after cabg surgery * orthopedic limitations that interfere with proper exercise intervention participation

Keywords: cabg surgery exercise intervention insulin sensitivity muscle mass
dna methylation biomarkers and metastasis of gastric carcinoma

Conditions: Gastric Carcinoma

Summary: gastric carcinoma (gc) is the second leading cause of cancer death throughout the world. in previous multi-center study, we have found that the prevalence of gdnf family receptor alpha 1(gfra1), serum response factor (srf), and znf382 methylation alterations were inversely and coordinately associated with gc metastasis and the patients' overall survival throughout discovery and testing cohorts in china, japan and korea. the present cohort study is to investigate whether methylation of those genes can predict the metastasis and prognosis of gc.

background: metastasis is the leading cause of death for gastric carcinoma (gc). currently, gc prognosis is primarily determined based on the clinical data and pathological stages of patients at the time of diagnosis and treatment. however, successful management of gc patients is still hampered by lack of highly sensitive and specific biomarkers capable of predicting prognosis and likelihood of metastasis. gfra1 hypomethylation along with srf and znf382 hypermethylation were found to be potential synergistic biomarkers for the prediction of gc metastasis in our previous multi-center study. in addition, p16 and e-cadherin were also correlated with gc metastasis in chinese cohort. to investigate the predictive value of those genes' methylation on metastasis potential in gc, we carried out the prospective cohort study. methods: 198 early stage gc patients without lymph node or distal metastasis were included in the present study. baseline information of e-cadherin, gfra1, p16, srf and znf382 methylation status of the gc from 191 cases was obtained by methylight. the follow-up examination was carried out in a double-blind study with a 6-month interval. the association between gene methylation and metastasis of gc was analyzed with spss16.0 software. all p-values were two-sided.

Eligibility criteria:
inclusion criteria: * histological diagnosis of gastric adenocarcinoma; * early stage gc without lymph node and distal metastasis; * availability of frozen, fresh gc and corresponding surgical margin samples; * available of methylation status of gene cpg island in the extracted dna sample. exclusion criteria: * gc with lymph node or distal metastasis; * quality of the prepared dna is not good enough for detection of gene methylation; * gc cases were subjected to the neoadjuvant chemotherapy.

Keywords: dna methylation
reliability and validity of the taiwan-version of multidimensional fatigue inventory and fatigue severity scale

Conditions: Fatigue; Taiwan-version Questionnaire

Summary: the multidimensional fatigue inventory (mfi) is a 20-item self-report instrument designed to measure fatigue. it covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. fatigue severity scale (fss) contains nine statements that rate the severity of fatigue symptoms. the purposes of this study are to translate fatigue questionnaires of -mfi- and -fss- to taiwan-version, and to examine the reliability and validity of the scales. a hundred adult people without diagnosed physical nor mental disabilities will be recruited. subjects will fill out the taiwan-version of mfi, fss, sf-36 and pittsburg sleep quality index (psqi) to establish the validity. subjects will re-fill the mfi and fss one week later to evaluate the test-retest reliability. another twenty people who are familiar with both english and chinese will be recruited to evaluate the translation reliability. subjects will fill out the english version of mfi and fss and, then, fill out the taiwan-version of the mfi and fss with at least ten minutes apart. the translation reliability will be evaluated by paired t test and the intraclass correlation coefficient.


Eligibility criteria:
inclusion criteria: * no cognition or mental disorders
prevention of type 2 diabetes amongst south asians with central obesity and prediabetes

Conditions: Type 2 Diabetes

Summary: the investigators' general goal is to identify approaches to risk stratification and health promotion through lifestyle modification that are acceptable, effective and efficient for prevention of t2d in south asian communities from diverse settings.

the specific aims of the proposed ihealth-t2d study are: 1. determine whether intensive lifestyle modification vs usual care reduces risk of t2d (primary endpoint) amongst south asians with i. central obesity; ii. prediabetes and iii. overall (with central obesity and / or obesity). 2. investigate secondary endpoints, including health gains in family members. identify social, demographic and environmental factors influencing primary and secondary endpoints. 3. carry out a health economic analysis of lifestyle modifications vs usual care for prevention of t2d on the indian subcontinent and europe. quantify the cost-effectiveness of screening by waist circumference vs hba1c.

Eligibility criteria:
inclusion criteria: * waist circumference≥100cm or hba1c≥6.0% * south asian, male or female, and age 40-70 years exclusion criteria: * known type 1 or 2 diabetes * fasting glucose≥7.0 mmol/l or hba1c ≥6.5% * normal or underweight (body mass index\<22kg/m2) * pregnant or planning pregnancy * unstable residence or planning to leave the area * serious illness * lack of capacity to consent
smyls multi-site trial

Conditions: Sickle Cell Disease

Summary: the purpose of this study is to find out whether a web-based intervention using a mobile app is helpful for teens and young adults with sickle cell disease (scd) in learning how to care for and manage their symptoms.

the purpose of this study is to test the effectiveness of and identify barriers and facilitators to the implementation of smyls, an mhealth intervention designed to facilitate self-management behaviors in adolescents and young adults (aya) with sickle cell disease (scd). specifically, the investigators propose to determine the effect of the intervention on the primary outcome of self-management behaviors and the secondary outcomes of quality of life, transition readiness, healthcare utilization, and pain interference. in addition, the investigators will explore how patient activation moderates development of self-management behaviors and systemic, structural, and social variables that moderate relationships between patient activation, the primary outcome, and secondary outcomes.

Eligibility criteria:
inclusion criteria: * documentation in the electronic health record of any type of scd * owns mobile device compatible with the intervention * access to the internet exclusion criteria: * plans to relocate outside of study site area in the next 12 months * plans to transition to adult care in 12 months or less * parent/caregiver or provider report of neurocognitive impairment that precludes ability to use intervention and participate in study * non-english speaking
cryospray ablation(tm)thoracic patient registry

Conditions: Lung Cancer; Emphysema; Chronic Bronchitis; COPD; Asthma; Sarcoidosis; Mesothelioma

Summary: the purpose of this study is to create a patient registry to collect and analyze information on subjects treated with the cryospray ablation™ system post-510k approval.

the proposed registry is a prospective, multi-center study of patients that are currently undergoing cryospray ablation™. a maximum of 50 investigational sites will participate in this study. the study population consists of patients who are being treated with the cryospray ablation™ system for thoracic diseases. enrolled subjects must have a signed consent form for data collection.

Eligibility criteria:
inclusion criteria: patients who are being treated with the cryospray ablation™ system for lung and for thoracic diseases. exclusion criteria: * subjects with thoracic or airway obstructions and diseases who were not treated with the cryospray ablation™ system. * subjects under the age of 18 years. * subjects unable to provide consent.

Keywords: malignant airway disease benign airway disease lung cancer emphysema chronic bronchitis copd asthma sarcoidosis mesothelioma cryospray ablation cryotherapy cryospray cryo
iris hook assisted phacoemulsification in vitrectomized eyes

Conditions: Cataract; Vitrectomy

Summary: although phacoemulsification in previously vitrectomized eyes is a relatively safe procedure comparing with extracapsular cataract surgery, it is still more challenging than in eyes without previous vitrectomy because of the anatomical differences after ppv. intraoperative difficulties such as abnormal anterior chamber deepening, unstable posterior capsules, and weakened zonules have been reported. the investigators aim to evaluate the efficacy and safety of a new simple iris hook assisted maneuver in phacoemulsification, then compare the incidence of intraoperative and postoperative complications of this technique with traditional phacoemulsification and phacoemulsification with 25-gauge vitreous irrigation. the latter two surgery methods are currently popular for cataract in vitrectomized eyes.

with the continuous evolution in vitrectomy techniques and instrumentation, an increasing number of vitreorential disorders are being successfully managed with pars plana vitrectomy (ppv). cataract is one of the most common complications seen in phakic patients following ppv, and the incidence of it ranges from 4 to 80%, even up to 100% in various studies. although phacoemulsification in previously vitrectomized eyes is a relatively safe procedure comparing with extracapsular cataract surgery, it is still more challenging than in eyes without previous vitrectomy because of the anatomical differences after ppv. intraoperative difficulties such as abnormal anterior chamber deepening, unstable posterior capsules, and weakened zonules have been reported. the investigators aim to evaluate the efficacy and safety of a new simple iris hook assisted maneuver in phacoemulsification, then compare the incidence of intraoperative and postoperative complications of this technique with traditional phacoemulsification and phacoemulsification with 25-gauge vitreous irrigation. the latter two surgery methods are currently popular for cataract in vitrectomized eyes.

Eligibility criteria:
inclusion criteria: 1. patients with visually significant cataract following ppv 2. after ppv vitreous substitutes were air / gas (perfluoropropane:c3f8) or bss, 3. after ppv if vitreous substitute was silicone oil, that should be removed at least 3 months. 4. the duration between ppv / silicone oil remove and phacoemulsification should more than 3 months 5. willing and able to comply with clinic visits and study-related procedures 6. provide signed informed consent exclusion criteria: 1. eyes with a history of acute angle-closure glaucoma, trauma, 2. eyes with a clinically dislocated or subluxated lens. 3. active ocular or periocular infection in the study eye 4. uncontrolled blood pressure 5. pregnant or breast-feeding women 6. participation in another simultaneous medical investigator or trial