Kornimate/medical-research-clean huggingface dataset:
topical dexamethasone - cyclodextrin microparticle eye drops for diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: the research group has developed new ocular drug delivery technology based on cyclodextrin nanoparticles (np). the investigators plan to develop and test this technology to help treat diabetic macular edema (dme). an important step in research was the invention of cyclodextrin nanoparticles, which has just received a us patent. the investigators pre-clinical and clinical work has demonstrated the investigators eye drop suspension with cyclodextrin nano-particles to be superior to conventional eye drops. they increase drug absorbance into the eye and decrease systematic distribution of the drug, hence reducing side effects. cyclodextrin nanoparticle eye drops deliver drugs to the posterior part of the eye, thus solving one of the biggest obstacles in ocular pharmacology.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * pseudophakic in study eye, i.e. with iol (intra ocular lens) after cataract surgery * diabetic macular edema with central macular thickness over 300 µm on oct in study eye. if both eyes have dme, then the treatment will be applied to the eye with thicker central macula on oct. * age 18 years or older exclusion criteria: * glaucoma or use of any glaucoma medication * known steroid iop response * any infectious eye disease * treatment for dme within 6 months, such as laser treatment, intravitreal or subtenon injections of steroids, intravitreal injections of anti vascular endothelelial growth factor medication. * any eye surgery within 3 months or other eye conditions e.g. corneal disorders, ocular hypotony and retinal detachments. * crystalline lens present in study eye * known allergy to cyclodextrins, dexamethasone, ranibizumab or any of the components of the study medications

Keywords: diabetic macular edema intravitreal injection dexamethasone cyclodextrin eye drops bevacizumab macular laser
a study of nt-112 in hla-c*08:02-positive adult subjects with unresectable, advanced, and/ or metastatic solid tumors positive for the kras g12d mutation

Conditions: Non-small Cell Lung Cancer; Colorectal Carcinoma; Pancreatic Ductal Adenocarcinoma; Endometrial Cancer; Solid Tumor, Adult; KRAS G12D

Summary: phase i study of nt-112, an autologous t-cell therapy product genetically engineered to express an hla-c\*08:02-restricted t cell receptor (tcr), targeting kras g12d mutant solid tumors.

this is a phase 1, open-label, multicenter study to evaluate the safety and preliminary antitumor activity of nt-112 in hla-c\*08:02 subjects with unresectable, advanced, and/or metastatic nsclc, colorectal adenocarcinoma, pancreatic adenocarcinoma, endometrial cancer, or any other solid tumor histology that is positive for the kras g21d mutation.

Eligibility criteria:
key inclusion criteria: * age ≥18 years * diagnosed with nsclc, colorectal adenocarcinoma, pancreatic adenocarcinoma, endometrial cancer or any other solid tumor * tumors must harbor a kras g12d variant mutation and subject must be hla-c\*08:02 positive * subject has advanced solid cancer, defined as unresectable, advanced, and/or metastatic disease (stage iii or iv) after at least 1 line of approved systemic standard of care (soc) treatment regimen and for which there are no available curative treatment options. * presence of at least 1 measurable lesion per recist v1.1 * eastern cooperative oncology group (ecog) performance status of 0 to 1 at the time of enrollment key exclusion criteria: * any other primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer * known, active primary central nervous system (cns) malignancy * history of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation. * history of stroke or transient ischemic attack within the 12 months prior to enrollment. * history of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment. * systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment. * any form of primary immunodeficiency. * active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy) * female of childbearing potential who is lactating or breast feeding at the time of enrollment

Keywords: tcr-t cell therapy kras kras g12d autologous pdac nsclc colorectal cancer solid tumors pancreatic ductal adenocarcinoma
low vs. standard dose ct for appendicitis trial

Conditions: Appendicitis

Summary: to determine whether low-dose (ld) ct is noninferior to standard-dose (sd) computed tomography (ct) as the first-line imaging test in adolescents and young adults in regard to negative appendectomy rate (nar).

* acute appendicitis is a very common disease. many patients are adolescents or young adults. * ct is the current standard imaging test for the diagnosis of appendicitis. * in recent years, the awareness of carcinogenic risk associated with ct radiation has increased. * according to a recent single-institutional randomized controlled trial, ld ct (employing a quarter of standard radiation dose) was found to be noninferior to sd ct with respect to nars in adolescents and young adults with suspected appendicitis. * however, ld ct is not yet widely accepted. * to establish ld ct as the first-line imaging test, a multi-institutional study is needed to confirm the generalizability of the prior single-institutional study.

Eligibility criteria:
inclusion criteria: * emergency department visit with suspected symptoms and signs of acute appendicitis * intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis * willing to provide telephone or cell phone numbers for follow-up * signed informed consent provided prior to study entry exclusion criteria: * prior cross-sectional imaging tests to evaluate the presenting symptoms and signs * prior history of surgical removal of the appendix

Keywords: appendectomy appendicitis false positive reactions humans radiation dosage tomography, x-ray computed young adult
efficacy and safety of fibrin sealant (fs) vh s/d-apr for hemostasis and wound healing in endoscopic browlift

Conditions: Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant

Summary: the primary objective is to evaluate the safety and efficacy of artiss (fibrin sealant) in reducing the incidence of early postoperative bruising and swelling.


Eligibility criteria:
inclusion criteria: * subjects planned for endoscopic browlift, subjects who read, understand and sign the written informed consent, healthy female or male subjects, 18-75 years old, and subjects who are able and willing to comply with the protocal requirements exclusion criteria: * subjects who had previous browlift, subjects indicated for concurrent facial surgeries, subjects considered to be active smokers, subjects with ecchymosis/edema on day 0, significant laboratory abnormalities, subjects with known bleeding or coagulation disorders, subjects treated with anti-coagulants.
efficacy of gamified cognitive control training using de:)press on depression severity add-on to treatment as usual

Conditions: Depression; Cognitive Impairment; Cognitive Dysfunction; Depressive Disorder

Summary: depression is one of the most frequent and devastating psychiatric diseases with a substantial bur-den for patients and society. it is specifically associated with dysfunctional activity in brain networks subserving cognitive control of emotional information processing. normalization of this activity is a hallmark of various treatment approaches. computerized training of cognitive control has shown antidepressant effects in experimental lab settings and small clinical pilot trials. however, motiva-tion, treatment adherence, and access for patients are major challenges that limit its broader use. to address these challenges, we developed a software application (de:)press®) that integrates gamification elements in a standard cognitive control task to support motivation, usage time, usabil-ity, and therefore symptom reduction. in a previous pilot trial, we were able to document that de:)press® is superior to a non-gamified standard cognitive control training in reducing depression symptomatology. based on these data, we now designed a full-size confirmatory trial for the pur-pose of testing the hypothesis that de:)press® provides a positive healthcare effect by means of reduction in depression severity compared to treatment as usual (tau). in this randomized, con-trolled, clinical trial 112 patients will be randomized to the intervention group (ig) with de:)press® additional to tau, or the control group (cg) receiving only tau. for a period of 6 weeks, the ig is provided with de:)press®. to prove a stable efficacy of de:)press®, the primary endpoint is the dif-ference in the montgomery-åsberg depression scale (madrs) change 4 weeks after the end of training between ig and cg.


Eligibility criteria:
inclusion criteria: * male, female, diverse, * age \>= 18, * informed consent, * sufficient understanding of german (native speaker or cefr level b skills or higher), * unipolar depression diagnosed according to icd-10 (f32.0, f32.1, f32.2 or f33. 0, f32.1, f32.2). * consultation with a physician due to depressive symptomatology within the last 6 months exclusion criteria: * inability to give consent, * inability to use de:)press® on a tablet or smartphone, * acute suicidality, * schizophrenia (f20), * brief psychotic disorder (f23), * schizoaffective disorder (f25), * mental disorders due to known physiological conditions (f00 - f09), * major depressive disorder, single episode, severe with psychotic features (f32.3), * major depressive disorder, recurrent, severe with psychotic features (f33.3), * intellectual disability (f70 - f79).
evaluation of immunohistochemical expression of heparanase in helicobacter pylori-associated chronic gastritis

Conditions: Chronic Gastritis

Summary: treatment of h.pylori may not be achieved in many patients with chronic gastritis. termination of the inflammatory respose produced by h.pylori may be useful in management of difficult cases. heparanase is a pro-inflammatory mediator. blocking of heparanase may relief the symptoms of chronic gastritis.

chronic gastritis (cg) is a very common disease. the incidence of cg is not accurately known. however, it is clear that the incidence of cg is increasing by advancing age. cg is divided into two main types; type a or immune and type b or non-immune gastritis. both types of cg share the same histological features. however, type a is less common, usually affects the gastric fundus in a diffuse manner and separates the antrum. on the contrary; type b or non-immune cg, which is by far more common, inevitably develops in the antrum and progresses proximally. h. pylori-induced cg usually requires antibiotic therapy to eradicate the causative organism and subsequently terminate the inflammatory response and the symptoms of gastritis. however, eradication of h. pylori is difficult to be achieved in many patients. previous studies established that there is a vicious circle between h. pylori-infected gastric epithelial cells and the gastric mucosal inflammatory cells. heparanase (hpse) is a mammalian ᵦ-endoglucoronidase. hpse plays a critical role in multiple inflammatory processes by degrading and remodeling heparan sulfate polysaccharide chains in the extracellular matrix (ecm). this leads to release of multiple cytokines and chemokines which are located in the ecm. hpse is a drug target, three inhibitors of this enzyme have been tested in early stage clinical trials. many studies reported that the expression of hpse is up-regulated in a variety of inflammatory conditions as ulcerative colitis, acute pancreatitis, acute vasculitis and sepsis. the aim of this work is to evaluate the role of heparanase (hpse) in chronic gastritis (cg) by correlating the expression of hpse to different histological features of cg as presence of h. pylori, chronic inflammatory infiltrate, gastric atrophy, intestinal metaplasia and neutrophil infiltrate (activity), to detect new treatment modalities in cg.

Eligibility criteria:
inclusion criteria: * patients with symptomatic chronic gastritis who underwent upper endoscopy. exclusion criteria: * patients with gastric carcinoma.

Keywords: heparanase chronic gastritis helicobacter pylori
high risk screening breast mr using a rapid imaging exam

Conditions: Breast Cancer

Summary: this study is being done to find out if breast cancer detection will be improved using a short mri (magnetic resonance imaging) scan, in addition to mammography, in patients who are at an increased risk of developing breast cancer.


Eligibility criteria:
inclusion criteria: 1. high risk for the development of breast cancer. for the purposes of this study high risk women will be defined as those having one of the following: 1. one or more first degree blood relative(s), maternal or paternal, with known primary breast cancer, plus a gail model calculated 5 year risk of greater than or equal to 1.67% 2. first, and/or second degree blood relative(s) with a family history suggestive of a brca mutation (those families having a member(s) with primary breast cancer diagnosed at or before the age of 40, primary breast cancer and ovarian cancer within the same family or family member, male relative with primary breast cancer, a relative with bilateral breast cancer, or multiple generations of family members with primary breast and/or ovarian cancer) 3. a known brca mutation 4. a family member carrying a known brca mutation 5. a personal history of a high risk breast lesion, including lobular carcinoma in situ and atypical hyperplasia 6. a personal history of primary breast cancer (invasive or in-situ) treated with unilateral mastectomy 2. patients must have a mammogram performed within the last 6 months, and the mammography images must be available for review at the time of the mr interpretation. 3. age 25-75 4. female exclusion criteria: 1. they are unable to return in one year for follow-up exam 2. medical history includes: 1. previous breast cancer treated with breast conservation 2. history of benign excisional biopsy in the previous 24 months 3. history of a benign core needle biopsy or fna in the previous 12 months 4. history of metastatic cancer 3. 45 minute prone scan cannot be tolerated 4. pregnant, as a mammogram for correlation with mr is required 5. history of breast mr in the last 6 months
effects of carnitine on oxidative stress to ivir administration to ckd patients:impact of haptoglobin genotype

Conditions: Anemia

Summary: anemia is a common disorder in ckd patients. it is largely attributed to decreased erythropoietin (epo) production and iron deficiency. therefore, besides epo, therapy includes iron replenishment. however, the latter induces oxidative stress. haptoglobin (hp) protein is the main line of defense against the oxidative effects of hemoglobin/iron. there are 3 genotypes: 1-1, 2-1 and 2-2. hp 2-2 protein is inferior to hp 1-1 as antioxidant. so far, there is no evidence whether haptoglobin genotype affects iron-induced oxidative stress in ckd patients. in this proposed study we wished to examine whether hp genotype influences intravenous iron administration (ivir)-induced oxidative stress in ckd patients, and its impact on the response of these patients to l-carnitine therapy.

this study will include at least 25 anemic ckd patients (stages 3-4) that will be given a weekly ivir (sodium ferric gluconate, \[125 mg/100 ml\] for 8 weeks, and during weeks 5-8 also received carnitine (20mg/kg, iv) prior to ivir. weekly blood samples will drawn before and after each ivir for hp genotype, c-reactive protein (crp), advanced oxidative protein products (aopp), neutrophil gelatinase-associated lipocalin (ngal), besides complete blood count and biochemical analyses.

Eligibility criteria:
inclusion criteria: 1. patients that have been diagnosed as suffering from chronic kidney diseases at stages 3-4 and confirmed by mdrd. 2. ckd patients with hb of less than 10 g%. 3. at age ≥18 y. exclusion criteria: 1. pregnant women. 2. patient with ckd stage 5 on dialysis. 3. patients with severe liver diseases. 4. patients with severe chf. 5. inter-current illness such as fever. 6. allergic rhinitis.
digital mammography for the detection and preoperative staging of breast cancer

Conditions: Breast Cancer

Summary: breast tumors are normally seen with mammography or ultrasound without the use of a dye but the size and extent of the tumor may be hard to see. currently, after initial mammography, many patients undergo bilateral breast mr to further stage the local tumor. it is able to not only detect anatomic abnormalities but can also evaluate changes such as the development of new blood vessels, which occurs with the development of cancers. mri is extremely sensitive and detects unsuspected disease in up to 25% of patients, which affects their treatment. it also detects unsuspected cancer in the other breast in some patients. however, mri is expensive, not always available, and some patients are unable to undergo mri due to the presence of pacemakers, clips, or claustrophobia. dual energy contrast enhanced digital mammography (de cedm) is an investigational procedure that uses a non-standard contrast in a regular digital mammography exam that has been changed to give the needed dual energy and image. de cedm is not fda approved. it is our hope that de cedm will also be able to detect unknown tumors because it will also detect new blood vessels. it is less expensive than mri, could be more available to patients, and can be done on patients with pacemakers and clips. claustrophobia will not be a problem. we plan to see if (de cedm) will help us better see the breast tumor and size of the breast tumor. we will also want to see if de cedm can detect additional unsuspected disease in the breast with the known tumor and in the other breast without a known tumor.


Eligibility criteria:
inclusion criteria: * women with newly diagnosed unilateral breast cancer proven through core biopsy or fna who are planned to have (preoperative) mri within 30 days of de cedm to assess extent of disease/multifocality. (all women will have bilateral digital mammography as per standard of care.) the preoperative mri will be based on the surgeon's recommendation. * both breasts are present. * women consenting to a bilateral de cedm examination. exclusion criteria: * women under 21. * women who have already had a lumpectomy. (index lesion has been removed and therefore, not evaluable for the purpose of this study.) * women undergoing neoadjuvant chemotherapy, hormone treatment, or radiation therapy. * known pregnancy. * women who have a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent. * women with breast implants. * women with pacemakers. * women with aneurysm clips that don't allow for mri. * women too claustrophobic to undergo mri.

Keywords: breast mammography mri digital mammography 10-024
tachosil versus standard surgical treatment for air leakage in pulmonary lobectomy (tc-021-im)

Conditions: Pulmonary Diseases; Intraoperative Complications

Summary: the purpose of this study is to compare the sealing efficacy and safety of tachosil® (hereafter referred to as tachosil) versus standard surgical treatment as the secondary management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung malignancies with or without metastases.


Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of lung malignancy with or without metastases may be included in the trial if the entry criteria apply.

Keywords: standard surgical treatment for air leakage in pulmonary lobectomy
a study to evaluate the effects of tedizolid phosphate on the pharmacokinetics and safety of midazolam and rosuvastatin (mk-1986-004)

Conditions: Skin Diseases, Bacterial

Summary: the purpose of this study is to assess the effect of steady-state tedizolid phosphate on the single-dose pharmacokinetics of midazolam and rosuvastatin in healthy, adult participants.


Eligibility criteria:
inclusion criteria: * healthy, adult males or females (women of non-childbearing potential) * continuous non-smokers who have not used nicotine-containing products for the previous 3 months exclusion criteria: * mentally or legally incapacitated or has significant emotional problems * history or presence of clinically significant medical or psychiatric condition or disease * history or presence of alcoholism or drug abuse within the past 2 years * female participants who are pregnant, lactating, or of childbearing potential * donated blood or had significant blood loss within 56 days prior to first dose of study drug * plasma donation within 7 days prior to first dose of study drug
a non-interventional study of the occurrence rate of non-small cell lung cancer, colon cancer, breast cancer, gastric cancer and malignant melanoma in turkey, and diagnosis and treatment characteristics

Conditions: Cancer

Summary: this non-interventional study will assess the occurrence rate of non-small cell lung cancer, colon cancer, breast cancer, gastric cancer and malignant melanoma in turkey, and the diagnostic methods and treatments used. data will be collected over 36 months.


Eligibility criteria:
inclusion criteria: * participants diagnosed with non-small cell lung, colon, breast, gastric cancer and melanoma * participants who give consent to the collection of their information after the first record and pathological confirmation of their cancer exclusion criteria: * participants not living in the city or representative region of the study center