Kornimate/medical-research-clean huggingface dataset:
combination treatment of intravitreal ranibizumab, focal/grid laser and panretinal photocoagulation in patients with diabetic macula edema

Conditions: Diabetic Macula Edema

Summary: the purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (ivr) injections under the combination treatment of ivr, focal/grid laser and panretinal photocoagulation. our hypothesis is that suitable photocoagulation decreases the number of ivr injections.


Eligibility criteria:
inclusion criteria: * stable medication for the management of diabetes within 3 months * visual impairment due to focal or diffuse diabetic macula edema * decreased vision due to diabetic macula edema and not other causes exclusion criteria: * concomitant conditions in the study eye that could prevent the improvement in va on the study * active intraocular inflammation or infection in either eye * uncontrolled glaucoma in either eye * treatment with antiangiogenic drugs in the study eye within 3 months * history of stroke and uncontrolled hypertension
a phase ib study of neoadjuvant of cetuximab plus motolimod and cetuximab plus motolimod plus nivolumab

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: protocol vrxp-a106 will enroll patients with stage ii-iva head and neck cancer patients who will be treated with surgical resection. cetuximab and motolimod (cohort 1); and cetuximab, motolimod, and nivolumab (cohort 2) will be administered for a 3-4 week period before surgery. the primary objective of the study is to determine the extent to which the administration of neoadjuvant motolimod plus cetuximab and motolimod plus cetuximab and nivolumab modulates immune biomarkers (nk, mdc and t cell activation as well as tumor infiltration and serum cytokines) in peripheral blood and head and neck cancer tumors. an exploratory objective of the study is to assess whether modulation of biomarkers as described above can predict anti-tumor response.


Eligibility criteria:
inclusion criteria: * previously untreated stage ii, iii, or iva histologically or cytologically confirmed squamous cell carcinoma of the head and neck * primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx * macroscopic complete resection of the primary tumor must be planned * age ≥ 18 years * ecog performance status 0-1 * adequate hematologic, renal and hepatic function * have signed written informed consent exclusion criteria: * subjects who fail to meet inclusion criteria * primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors * prior severe infusion reaction to a monoclonal antibody * pregnancy or breastfeeding * evidence of distant metastasis * any other malignancy active within 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix, dcis or lcis of the breast * prior history of head and neck cancer * prior therapy with motolimod, nivolumab, or other agents targeting pd-1/pd-l1 * prior therapy targeting the egfr pathway * acute hepatitis, known hiv, or active uncontrolled infection * patients with active autoimmune disease * history of uncontrolled cardiac disease within prior 6 months * uncontrolled peptic or gastric ulcer disease, or gastrointestinal bleeding within prior 6 months * active alcohol abuse or other illness or circumstance that carries a likelihood of inability to comply with study treatment and follow-up or otherwise compromise the study's objectives * treatment with a non-approved or investigational drug within 30 days prior to day 1 of study treatment * live vaccine within 30 days of planned start of study therapy * history of pneumonitis or interstitial lung disease * history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab
a long-term moderate intervention with n-3 lc-pufa-supplemented dairy products in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the effects of n-3 lc-pufa-supplemented dairy products on inflammation and immunological parameters, biomarkers of oxidative stress, serum lipids, and disease activity were determined in patients with rheumatoid arthritis (ra).

recent studies suggest that n-3 lc-pufa may improve cardiovascular and inflammatory diseases. as a precondition for participating in this study, the subjects were provided information in writing and verbally about the details of the study. informed consent was obtained from all volunteers. before the beginning of the study, all participants were subject to a medical examination in the clinic for rheumatology (internal medicine iii, friedrich schiller university, jena). the ra was diagnosed according to the 1987 revised criteria of the american rheumatism association (ara). severity of disease activity was evaluated by using the disease activity score das 28. forty five subjects (43 f, 2 m) were randomly divided into two groups to carry out a double-blind, placebo-controlled cross-over study. the study consisted of two investigation periods of 12 weeks, with an eight-week washout period in between. patients received about 40 g fat daily (200 g yoghurt with 3.8% fat, 30 g cheese with about 50% fat in the dry matter, and 20-30 g butter). the milk fat was partially exchanged by special oils with high amounts of eicosapentaenoic acid (epa), docosahexaenoic acid (dha), and alpha linoleic acid (ala). the daily dose of n-3 fa amounted to 2.4 g, consisting of 1.1 g ala, 0.7 g epa, 0.1 g dpa, and 0.4 g dha. the placebo products were commercial dairy products with comparable fat contents. venous blood and 24h urine were collected at the beginning and at the end of each period. the das 28 score was assessed at the beginning and the end of each period, respectively.

Eligibility criteria:
inclusion criteria: * clear diagnosis of rheumatoid arthritis * patients receiving nonsteroidal anti-inflammatory drugs (nsaid) or corticosteroids (max. 15 mg/d) or both were eligible if dosage had been stable for at least 4 weeks before day 1 of the study and remained below this limit throughout the study * patients on disease-modifying antirheumatic drugs (dmard) had to be on a constant dosage for at least 8 weeks before and throughout the study exclusion criteria: * subjects with gastrointestinal or metabolic diseases, alcohol abuse, taking dietary supplements (e. g. fish oil capsules), known allergies or foodstuff indigestibility * patient's request, serious infections, inadequate control of arthritis symptoms (over 50% increase of the number of swollen or tender joints), reinstitution of therapy with dmard, or if patient compliance with the study protocol was doubtful.

Keywords: n-3 lc-pufa rheumatoid arthritis disease activity inflammation oxidative stress immune system
use of 81 vs 325mg of asa in treatment of bcvi

Conditions: Carotid Artery Injuries; Traumatic Injury; Vertebral Artery Injury

Summary: blunt cerebrovascular injury (bcvi), or injury to the carotid and vertebral arteries, occurs in 1-3% of blunt traumas, often as a result of injury to the head, neck, or chest. if unrecognized or untreated, bcvi can lead to stroke, which occurs in approximately 20% of untreated patients, potentially causing significant and sometimes permanent disability. early diagnosis and treatment significantly reduce the risk of stroke. currently, there is wide variation across centers and trauma care providers in treatment strategies for bcvi and the most recent guidelines are unable to make specific recommendations about the optimal agent and/or dose of treatment to reduce the risk of stroke after bcvi while minimizing bleeding complications in patients with multiple traumatic injuries. recent systematic reviews and meta-analyses evaluating the most common treatment strategies for bcvi have shown similar stroke rates with the use of anticoagulants (usually heparin) vs. antiplatelets (usually aspirin/asa), however, treatment with antiplatelets was associated with a lower risk of bleeding complications. the optimal dose of asa for stroke prevention while minimizing bleeding complications is unknown, and more research is required to inform future care. this project will investigate two doses of antiplatelet therapy (81 mg daily vs. 325 mg daily aspirin) for bcvi treatment, and will look at the risk of stroke and bleeding complications with each strategy. the goal of the research is to determine whether a large-scale study looking at this question is feasible, which will ultimately help determine the best medical therapy for patients with bcvi.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * diagnosed with bcvi via ct angiography (cta) within 72 hours of injury at a level i trauma center exclusion criteria: 1. ≤18 years old 2. known pregnancy 3. diagnosis of bcvi made based on imaging from another hospital (non-lth) 4. known pre-existing carotid/vertebral artery disease 5. stroke on presentation/before bcvi diagnosis 6. determined to require immediate surgical or interventional management of bcvi 7. known allergy to asa 8. unable to consent or absence of a substitute decision maker (sdm)
to examine whether or not the primary causes of oa or ra might be bone alterations

Conditions: Progression of Rheumatoid Arthritis; Osteoarthritis of Multiple Joints

Summary: generally, osteoarthris (oa) is considered as primarily cartilage disease. however, as we and others have previously reported, a portion of oa might be caused primarily by bone alterations. in this study, we prospectively and retrospectively show that the bone altertations may affect oa primarily in all of the joints. in addition, rheumatoid arthritis (ra) is a joint disease when immune system attacks synovium. joint destruction occurrs continuously if suitable treatment is not performed. the etiology of ra is still largely unknown. as with oa, ra can be primarily damaged in bone, instead of cartilage. here we prospectively and retrospectively show that the bone altertations may affect ra primarily in all of the joints.


Eligibility criteria:
inclusion criteria: * ra and/or oa exclusion criteria: * n/a
the prevalence of hiv drug resistance and transmission risk in opioid agonist treatment

Conditions: HIV Positive; Opioid Dependence; Opioid Agonist Treatment; HIV Infections

Summary: hiv drug resistance presents a significant public heath problem. this proposal is designed to explore the association between ongoing illicit drug use and the prevalence of hiv drug resistance among hiv+ opioid dependent patients receiving opioid agonist treatment with the following hypotheses: 1. hypothesis 1: the prevalence of hiv drug resistance will range between 10% and 30%. 2. hypothesis 2: patients with evidence of ongoing illicit drug use will be more likely to have hiv drug resistance.


Eligibility criteria:
inclusion criteria: * hiv+ * opioid dependent * receiving methadone or buprenorphine for at least one month exclusion criteria: * age \< 18 years * current dementia; * inability to read or understand english * inability to provide written informed consent

Keywords: hiv resistance opioid dependence
a single and multiple ascending dose study of subcutaneously administered jnj-75220795

Conditions: Fatty Liver Disease

Summary: the purpose of the study is to assess the safety and tolerability of single and multiple subcutaneous (sc) doses of jnj-75220795.


Eligibility criteria:
inclusion criteria: * participants with certain genetic predisposition to non-alcoholic fatty liver disease (nafld) determined at screening * presence of liver steatosis at screening * participants on anti-hypertensive and/or lipid lowering medications and/or glucose lowering medications must be on stable dose(s) for at least 4 weeks prior to screening * weight stable defined as no more than 5% body weight loss or gain within 3 months prior to screening and no more than 5% body weight loss or gain from screening to randomization exclusion criteria: * known allergies, hypersensitivity, or intolerance to jnj-75220795 or its excipients * history of hepatitis b surface antigen (hbsag) or hepatitis c antibody (anti-hcv) positive, or other clinically active liver disease, or tests positive for hbsag or anti-hcv at screening * history of human immunodeficiency virus (hiv) antibody positive, or tests positive for hiv at screening
effects of music on post-cesarean pain, anxiety, breastfeeding and mother infant attachment impact

Conditions: Cesarian Section; Bonding; Pain; Anxiety

Summary: the physiological effects of music therapy include creating a behavioral change and changing the mood by reducing psychophysiological stress, pain, anxiety and isolation. music has the ability to create deep relaxation. it is known to have relieving effects on insomnia. in addition, it has been reported that music therapy application before and during birth reduces labor pain and reduces postpartum anxiety and depression levels. the postpartum period, which begins with the birth of the newborn, covers the 6-8 week period that it takes for the changes that occur in the woman's body during pregnancy to return to its pre-pregnancy state. this period is an important transition period in which physical, social and emotional changes occur in mothers. in addition to rapid anatomical and physiological changes, mothers experience a difficult process in which the transition to motherhood is experienced, new roles and responsibilities are assumed, and relationships with their spouses and other family members are reorganized. although a woman begins to feel the changes that having a baby creates in her daily life during pregnancy, she usually experiences the biggest change after the baby is born. the period when the first emotional bond between the newborn and her family is formed and a sense of trust develops is defined as mother-baby bonding. many factors affect mother-baby bonding in the postpartum period, which is the most important time when the bond established between the expectant mother and the baby during pregnancy, referred to as prenatal bonding, is strengthened after birth. it is particularly affected by the mother's upbringing, as well as her experiences during pregnancy, birth, puerperium, and the baby's first months. healthy and early interaction between mother and baby initiates a healthy bonding process.


Eligibility criteria:
inclusion criteria: * being 18 years of age or older * being in the third trimester (up to 2 weeks before the planned cesarean delivery date) * being primigravida * having a single fetus * not having a hearing problem * voluntarily participating in the study exclusion criteria: * having any chronic disease * having a risky pregnancy condition (gestational diabetes, gestational hypertension, preeclampsia, etc.) * having a psychiatric medical diagnosis and using medication.
role of macrophage in inflammation resolution in periodontal patients

Conditions: Periodontitis

Summary: there is a growing body of evidence to suggest that the resolution of an inflammatory reaction is an active process. this process requiring signals that turn off early inflammatory stages, as neutrophil infiltration and promote resolution phase, as clearance of apoptotic cells. in this array,the relationship between neutrophils, monocytes, and macrophages is crucial for the concert process. macrophages possess a plasticity of phenotype that explains their protective as well as potentially detrimental role in chronic inflammation and tissue injury. such heterogeneity arises as macrophages differentiate from monocytes and are exposed to specific tissue- and hematopoietic cell-derived stimuli. it is important to be able to identify the different types of macrophages in this setting. today's literature can distinguish between 3 main phenotypic groups of macrophages. the classically activated m1 macrophages, the alternatively activated-m2 macrophages and the "resolution phase" - rms macrophages. the third phenotypic macrophage might play a crucial rule in the resolution phase, and is called the "resolving macrophage". all of those pro-resolving lipid mediators promote the return to tissue homeostasis . the investigators hypothesis is that in periodontal patients the inflammatory process continues because the process does not reach the resolution phase, and in that milieu, the macrophage might be a key component. within the overall concept of periodontal disease as a model for an inflammatory disease with an stoppable inflammatory reaction, the primary aim of the study is to check the macrophage characteristics in periodontal patients and to compare it to healthy people.


Eligibility criteria:
inclusion criteria: * 18 years old and more, male \& female * generally healthy * does not take medicine on a regular basis * has a periodontal disease. control - without a periodontal disease * no periodontal treatment for at list 6 months prior to his acceptance to the trail * willing to donate 50 ml of blood twice during the trail * understands the trail and gave a consent to participate exclusion criteria: * pregnancy or nursing * chronic use of alcohol * systemic conditions - diseases, neoplastic lesions in the oral cavity
hyperbaric oxygen for ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the investigators aim to prospectively study the feasibility and clinical impact of hyperbaric oxygen therapy in acute hospitalized moderate to severe ulcerative colitis flares as an adjunct to standard medical treatment. specifically, we will investigate the impact of hyperbaric oxygen therapy on clinical response/remission and serum and mucosal inflammatory markers. the investigators expect that hyperbaric oxygen therapy will improve patient responsiveness to steroids and avoid progression to second line therapy during hospitalization.


Eligibility criteria:
inclusion criteria: * known or newly diagnosed moderate to severe ulcerative colitis with a mayo score of greater than 6 * mayo endoscopic sub-score of greater than or equal to 2 * risk score of greater than or equal to 4 points exclusion criteria: * complication requiring urgent surgical intervention (in the opinion of the investigators) clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic impairment in the opinion of the investigator, including but not limited to: * pulmonary i. copd with co2 retention; previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs (opinion of investigators) ii. current pneumothorax or previous spontaneous pneumothorax iii. bronchogenic cyst(s) * cardiac i. uncontrolled htn (systolic \>160 or diastolic \>100) ii. unstable angina or myocardial infarction within the previous 3 months iii. ejection fraction \< 35% iv. current or previous amiodarone use v. icd in place vi. pacemaker in place not approved for chamber use * hematological/oncological i. current chemotherapeutic drug use, and past history of bleomycin use. ii. hereditary spherocytosis iii. sickle cell anemia * gastrointestinal and infectious disease i. known or suspected crohn's disease ii. previous infection with mycobacterium, fungus, hiv, hepatitis b or c iii. gastrointestinal or systemic infection including, but not limited to, --clostridium difficile iv. current capsule endoscopy or previously non-retrieved capsule endocrinology i. uncontrolled hyperthyroidism neurological and psychological i. vagal or other nerve stimulators ii. uncontrolled seizure disorder iii. medications or medical conditions that lower seizure threshold (in the opinion of the investigator) iv. drug or alcohol abuse/dependence v. current treatment for alcohol cessation with disulfiram vi. current or recent (within past week) use of baclofen head and neck i. previous middle ear damage, surgery or infection(s) which may increase the risk for needing ear tubes (in the opinion of the investigator) ii. current or previous retinal detachment or optic neuritis iii. retinal or vitreous surgery within the past 3 months miscellaneous i. implanted devices not on the approved list for use with hbot women who are pregnant or nursing. women with childbearing potential were required to use effective birth control if not surgically sterile or postmenopausal for \>2 years.

Keywords: hyperbaric oxygen
5ht3 antagonism and auditory gating in schizophrenia

Conditions: Schizophrenia

Summary: the target groups in this study are brain waves and neurotransmitters (chemical messengers) in the brain. subjects with diagnosed with schizophrenia will be studied. the study will help understand more about normal brain functioning and how that functioning differs in people with schizophrenia. another purpose of this study is to determine how the altered brain functioning in schizophrenia contributes the symptoms found in the illness.


Eligibility criteria:
subjects with diagnosed with schizophrenia will be studied.

Keywords: schizophrenia ondansetron nicotine haloperidol
use of digital tomosynthesis for detection and case management of scaphoid and distal radius fractures: a volumerad data collection study

Conditions: Distal Radius Fracture; Scaphoid Fracture

Summary: the study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the volumerad advanced application.

the study described herein is being conducted to collect clinical data associated with diagnosis and treatment information to support additional, on-label claims for gehc's volumerad advanced application. the results of this study are intended for use in the submission of fda 510(k) claims in the united states.

Eligibility criteria:
inclusion criteria for control-arm subjects: subjects who meet all of the following inclusion criteria may be enrolled in this study: 1. are adults aged 18 years or older; 2. are able and willing to comply with study procedures; and 3. are able and willing to provide written informed consent to participate in this study. exclusion criteria for control-arm subjects: subjects who meet any of the following exclusion criteria will be excluded from this study: 1. are documented as pregnant based on pi's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy; 2. have had known prior trauma in either wrist. inclusion criteria for test-arm subjects: subjects who meet all of the following inclusion criteria may be enrolled in this study: 1. are adults aged 18 years or older; 2. have a confirmed or suspected distal radius or scaphoid wrist fracture; 3. have completed an x-ray imaging exam per standard of care; 4. have a standard of care (soc) ct or mri exam ordered; 5. are able and willing to complete dts imaging exam (if not already completed); 6. are able and willing to comply with study procedures; and 7. are able and willing to provide written informed consent to participate in this study. exclusion criteria for test-arm subjects: subjects who meet any of the following exclusion criteria will be excluded from this study: 1. are documented as pregnant based on pi's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy; 2. have additional trauma within the image field of view that either impacts the visualization or changes the treatment of the scaphoid or distal radius fracture; 3. have had prior reconstructive surgery or fixation in the wrist.