Kornimate/medical-research-clean huggingface dataset:
identification of predictive parameters for colitis in melanoma patients treated with immunotherapy.

Conditions: Melanoma; Colitis

Summary: the aim of this trial is to identify biomarkers and genetic predisposition for the development of immune checkpoint related colitis.

immunotherapy with immune checkpoint-inhibitors is standard treatment for patients with melanoma. however, in about 15% of patients treated with ipilimumab a grade 3-4 colitis will occur. in programmed cell death protein 1 (pd1) inhibitors colitis is also seen as adverse event, although less prominent. we want to find a good predictive biomarker to select patients that are prone to colitis.so far no test is available that might be predictive whether a patient will develop a grade 3-4 colitis. the study will consists of four parts: 1.) to identify a genetic profile associated with ipilimumab-induced colitis, 2.) to identify predictive (serum or fecal) biomarkers for ipilimumab-induced colitis, 3.) to study the tissue of ipilimumab-induced colitis and 4) to study the role of the gut microbiome in the development of colitis. patients are able to participate in one, or more parts of the study.

Eligibility criteria:
inclusion criteria: 1. patients with melanoma who will be treated with immune checkpoint inhibitors (ipilimumab, nivolumab, pembrolizumab) 2. signed written informed consent. 3. able to comply with the protocol. exclusion criteria: 1. patients with a pre-existing colitis (e.g. crohn's disease, ulcerative colitis).

Keywords: melanoma colitis ipilimumab nivolumab pembrolizumab
blood screening for adult colorectal cancer

Conditions: Cancer Colorectal

Summary: multicenter, inter-regional, case-control study with the primary objective of evaluating the discriminative power of the blood biomarker tfpi-1 to separate patients with histologically proven crc from an asymptomatic control population between 50 and 75 years of age with normal colonoscopy.


Eligibility criteria:
inclusion criteria: * patients with suspected colorectal cancer for which colonoscopy is indicated. * patients between 50 and 75 years old, asymptomatic from the digestive point of view (for example referred for colonoscopy as part of a pre-operative check-up of an inguinal hernia or 3 months after an episode of complicated sigmoiditis), for whom a follow-up colonoscopy is indicated. note. * if the post-inclusion colonoscopy is normal, no biopsy will be performed and patients will be assigned to the control group. * if the colonoscopy performed after inclusion is abnormal (presence of at least one mucosal lesion), patients will be assigned to the "colorectal cancer" group or to the "polyps" group depending on the results of the anatomopathological analysis of the lesion(s) exclusion criteria: * all clinical situations outside of crc that could increase tfpi-1 or 2 blood levels: acute coronary syndrome (unstable angina, acute myocardial infarction), severe sepsis, decompensated cirrhosis, pregnancy, chronic inflammatory bowel disease (crohn's or ulcerative colitis), colitis or radiation rectitis. * endoscopic polypectomy without prior histological confirmation. * emergency (occlusion or peritonitis) * minor patients. * persons of full age under legal protection or unable to express their consent * persons not affiliated to a social security system or beneficiaries of such a system. * pregnant women, women in labor or nursing mothers.

Keywords: oncology biology
etanercept (enbrel) in ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the study has the aim to investigate the efficacy and safety of etanercept in patients with active ankylosing spondylitis (as) over 520 weeks.


Eligibility criteria:
inclusion criteria: 1. patients 18 to 65 years of age. 2. proven ankylosing spondylitis according to the modified new york criteria 3. acute phase of disease with high disease activity the bath ankylosing spondylitis disease activity index (basdai) score ≥ 4 or a pain score ≥ 4 on a numeric rating scale (nrs) at two occasions in 2 weeks 4. understand, sign. and date the written informed consent at the screening visit. 5. sexually active women participatittg in the study must use a medically acceptable form of contraception until 6 month after the last injection of study medication. medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. additionally, the use of condoms is suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy. 6. sexually active men must agree to use a medically accepted form of contraception during the study until 6 month after the last injection of study medication. 7. negative serum or urine pregnancy test taken at screen in all women except those surgically sterile or at least 1 year postmenopausal. 8. able to self-administer injectable drug supplies or have a caregiver who will do so. 9. able to store injectable test article at 2° to 8° c. exclusion criteria: 1. pregnancy/lactation 2. previously exposure to murine or chimeric monoclonal antibodies 3. receipt of any live (attenuated) vaccines within 4 weeks before screening visit 4. history of chronic or a recent serious infection 5. history of tuberculosis within the last 3 years 6. history of malignancy 7. significant concurrent medical diseases including uncompensated congestive heart failure, myocardial infarction within 12 months, stable or unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of human immunodeficiency virus (hiv) infection, central nervous system demyelinating events suggestive of multiple sclerosis 8. presence or history of confirmed blood dyscrasias 9. history of any viral hepatitis within 1 year prior screening or history of any drug-induced liver injury at any time prior to screening 10. laboratory exclusions are: hemoglobin level \ 175 mcmol/l, liver enzymes \> 1.5 times the upper limit of normal or alkaline phosphatase \> 2 times the upper limit of normal. 11. participation in trials of other investigational medications within 30 days of entering the study 12. clinical examination showing significant abnormalities of clinical relevance 13. concomitant medication with disease-modifying anti-rheumatic drugs (dmards) or corticosteroids 14. history or current evidence of abuse of "hard" drugs (eg., cocaine/heroine) or alcoholism

Keywords: ankylosing spondylitis atanercept therapy magnetic resonance imaging
high-definition 3d visualization system for ophthalmic surgery

Conditions: Cataract

Summary: to validate a high-definition (hd) three-dimensional (3d) visualization system in cataract surgery


Eligibility criteria:
inclusion criteria: * the patients are scheduled to cataract surgery on both eyes. exclusion criteria: * the patients who have other complicating ophthalmic diseases or previous history of ophthalmic surgeries were excluded

Keywords: cataract hd 3d microscope
study of pain control in diagnostic hysteroscopy

Conditions: Pain, Postoperative

Summary: the goal of this clinical trial study is to learn about how to decrease the pain during the diagnostic hysteroscopy. the main question it aims to answer is "do the paracetamol and ibuprofen taken before the procedure can lower the pain during the diagnostic hysteroscopy".

after the participants those are indicated for diagnostic hysteroscopy and eligible for the study undergo informed consent, then they were divided to two groups for control group those get no medication and study group those get paracetamol 500mg and ibuprofen40mg per oral before the hysteroscopy, and both group needs to evaluate the pain score in vas before, during hysteroscopy and after hysteroscopy for 30 minutes to compare the pain level in two groups.

Eligibility criteria:
inclusion criteria: * women with indication and informed to undergo diagnostic hysteroscopy over or equal the age of 20 years old exclusion criteria: * women with contraindication for undergoing diagnostic hysteroscopy includes women with pregnancy, uterine infection, diagnosed with cervical cancer or endometrium cancer and women who is undergoing with active vaginal bleeding * women with history of allergy to paracetamol or ibuprofen medicine * women with currently or pre-existing medical conditions that contraindicate the use of ibuprofen includes kidney disease, heart disease, cirrhosis, gastritis or individuals with a history of peptic ulcer or gastrointestinal bleeding * women with currently taking anticoagulant or antiplatelet medications * women with history of psychiatric disorders
abthera advance™ use without wittman patch

Conditions: Necrotizing Pancreatitis

Summary: the objective of this study is to evaluate the use of the abthera advance for patients requiring open abdomen due to necrotizing pancreatitis. the institutions traditional approach is to use the abthera open abdomen dressing with wittmann patch. however, the abthera advance has shown in vitro to have improved tension on the abdominal wall that may obviate the need for costly wittmann patch placement.

the objective of this study is to evaluate the use of the abthera advance for patients requiring open abdomen due to necrotizing pancreatitis. the instiutions traditional approach is to use the abthera open abdomen dressing with wittmann patch. however, the abthera advance has shown in vivotro to have improved fascia movement that may obviate the need for costly wittmann patch placement. primary objective: determine the variable cost savings associated with use of abthera advance™ without the use of wittmann patch hypothesis: the hypothesis is that with use of the abthera advance will lead to reduced variable costs compared to abthera open abdomen dressing with wittmann patch secondary objective(s): determine the rate of abdominal closure, component separation, and mesh placement with the abthera advance™ without the use of wittmann patch hypothesis: the hypothesis is that rate of abdominal closure, component separation, and mesh placement will appear similar with use of abthera advance compared to abthera open abdomen dressing with wittmann patch

Eligibility criteria:
inclusion criteria: * male or female patients aged ≥ 22 * severe necrotizing pancreatitis with abdominal compartment syndrome or severe sepsis requiring decompressive laparotomy and/or pancreatic debridement * patients that require open abdomen at the conclusion of their index operation exclusion criteria: * female patients who are pregnant or lactating * if in the opinion of the treating physician a patient should not participate in this study.

Keywords: abdominal compartment syndrome necrotizing pancreatitis severe sepsis necrotizing pancreatitis with abdominal compartment syndrome necrotizing pancreatitis with severe sepsis
verticalization robotic exoskeleton doc

Conditions: Brain Injuries; Disorder of Consciousness

Summary: mobilization, specifically verticalization, has been shown to play a role in enhancing consciousness. vestibular stimulation has the potential to influence the neural substrate of consciousness, but this modality has not been thoroughly explored. the primary aim of this study is to compare the influence of verticalization with and without vestibular input on level of consciousness in patients experiencing disorders of consciousness (doc).


Eligibility criteria:
inclusion criteria: 1. unresponsive wakefulness syndrome/vegetative state (uws/vs) or minimally conscious state (mcs) following traumatic brain injury (tbi), intracerebral bleeding, ischemic infarction, or hypoxic brain injury 2. medical clearance by a physician 3. 18-75 years old 4. mobilization into standing for at least 10 minutes without signs of orthostasis exclusion criteria: 1. time since injury less than 4 weeks or more than 6 months 2. mobilization into standing lasts more than 30 minutes 3. severe osteoporosis 4. muscle tone that prevents joint motion (modified ashworth scale (mas) 4) 5. unstable fractures 6. decubiti on areas contacted by robotic mobility device (i.e. heels, tibia, greater trochanter, ischial tuberosity, sacrum) 7. inability to fit device requirements\* * height 4'8"-6'4", weight 88-222 lbs., hip flexion 0-90˚, knee flexion 0-90˚, plantigrade
periodontal therapy in thalassemia major patients

Conditions: Thalassemia Major; Chronic Periodontitis

Summary: the study aims to evaluate the effect of local non surgical periodontal therapy on the systemic pro-inflammatory markers in the β-thalassemia (tm-β) patients with chronic periodontitis and systemically healthy demographically matched controls with chronic periodontitis. both groups will receive non surgical periodontal therapy.

treatment modalities in patients with thalassemia include long-term transfusion therapy, iron chelation, splenectomy, allogeneic hematopoietic transplantation and supportive measures. attempts to downgrade the systemic proinflammation and thereby reducing the morbidity of the disease warrants investigation in patients with β-thalassemia (tm-β). in blood disorders, as with most other diseases, achieving and maintaining inflammatory homeostasis is essential and necessary for survival. both tm and gingival diseases cause increased levels of pro-inflammatory cytokines in the body fluids. moreover, higher prevalence of gingival diseases is reported in children with tm. with oral hygiene maintenance and care, down-regulation of the systemic burden of the disease might be attained which will subsequently aid in achieving reduced morbidity in children with tm. both the groups will receive non surgical periodontal therapy (scaling and root planing) with the chlorhexidine containing adjunct in the form of a mouthrinse. additionally, they will be taught standard tooth brushing technique (fones technique). participants will receive both verbal instructions and practical demonstrations.

Eligibility criteria:
inclusion criteria: 1. written and verbal consent 2. (tm-β) patients with gingivitis 3. age: ≥10 years 4. patients who have received or are receiving iron chelation therapy with deferasirox, calcium, vitamin d, and regular erythrocyte transfusion. exclusion criteria: 1. presence of hepatitis b or c or hiv-aids (human immunodeficiency virus- acquired immunodeficiency syndrome). 2. presence of any other known systemic disease. 3. use of antibiotics or anti-inflammatory drugs within the past 6 months. 4. dental prophylaxes in the last 6 months

Keywords: cytokines scaling root planing oral hygiene systemic inflammation
surgical stress measured by microdialysis

Conditions: Trauma

Summary: paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery. minimal invasive surgery is postulated to result in less muscle damage and better outcome. the aim of this study is to monitor metabolic changes of the paraspinal muscle and to evaluate paraspinal muscle damage during surgery using microdialysis (md).

posterior approach is a common and important surgical procedure for various lumbar diseases. owing to the anatomy, the damage of paraspinal muscle is inevitable during conventional posterior lumbar fusion surgery. degeneration and malfunction of the paraspinal muscle might associate with pain and inferior postoperative clinical outcome.

Eligibility criteria:
inclusion criteria: * patients who undergo conventional instrumented posterolateral lumbar fusion. exclusion criteria: * previous fusion * chronic metabolic disease * tumor or metastasis * postoperative surgical complications and complications during surgery

Keywords: glucose lactate pyruvate ratio glycerol paraspinal muscle microdialysis
a study of the safety, tolerability, and immunogenicity of a 9-valent human papillomavirus vaccine ([9vhpv]; v503) administered to 9- to 15-year-old japanese girls (v503-008).

Conditions: Papillomavirus Infections

Summary: this study will evaluate the safety, tolerability, and immunogenicity of v503 in japanese girls between the ages of 9 and 15 and will determine whether v503 induces an acceptable immune response to all human papillomavirus (hpv) strains contained in the vaccine. the success criterion for the primary analysis requires that point estimates for seroconversion rate be greater than 90% for all 9 hpv types.


Eligibility criteria:
inclusion criteria: * participant is in good physical health- * participant's parent/legal guardian is able to read, understand, and complete the vaccine report card * participant's parent/legal guardian agrees to provide a phone number for follow-up purposes * participant is not sexually active and does not plan to become sexually active during the time from day 1 to month 7 of the study exclusion criteria: * participant has a history of severe allergic reaction that required medical intervention * participant has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection * participant is pregnant * participant intends to donate blood during the time from day 1 to month 7 of the study * participant is immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (hiv) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition. * participant has had a splenectomy * participant has received any of the following immunosuppressive therapies in the year prior to enrollment: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (arava), tumor necrosis factor alpha (tnf-α) antagonists, monoclonal antibody therapies, antilymphocyte sera, or other therapy known to interfere with the immune response. * participant has received any immune globulin product or blood-derived product in the three months prior to the day 1 vaccination, or plans to receive any such product through month 7 of the study * participant has received any inactivated vaccines within 14 days of the day 1 vaccination or any live vaccines within 28 days of the day 1 vaccination * participant has received a marketed hpv vaccine or has participated in an hpv vaccine clinical trial * participant has had a fever (oral temperature ≥37.8°c) within 24 hours of the day 1 vaccination * participant has a history of a positive test for hpv or history of genital warts

Keywords: papillomavirus vaccines uterine cervical cancer human papilloma virus infections
study on whether tart cherry juice can reduce oxidative stress and inflammation

Conditions: Oxidative Stress; Antioxidant Capacity; Inflammation

Summary: oxidative stress has been linked to many diseases associated with aging, including coronary heart disease and alzheimer's disease. antioxidants and special proteins in the body work together to help prevent damage by free radicals. some studies have indicated that as people age, they are less able to fight off oxidative stress and have increased levels of inflammation. tart cherries are known to be rich in antioxidants and plant-nutrients. the product we are using in this study is an all-natural tart cherry juice, mixed with apple juice concentrate and containing no additives and no preservatives. we hope to learn whether antioxidant supplementation, such as tart cherry juice, can measurably decrease oxidative damage and inflammation associated with aging.

objectives the primary objective of this pilot study is to investigate whether tart cherry juice consumption can reduce oxidative stress in older adults as measured by attenuation of f2-isoprostane responses to a forearm ischemia-reperfusion, and a decrease in urinary excretion products of oxidative damage. the secondary objective is to examine whether age-sensitive markers of inflammation are reduced in response to the cherry juice consumption.

Eligibility criteria:
inclusion criteria: * men and women, ages 55-80y, in good health, with \>8 years of education * non-smoker * able to give informed consent exclusion criteria: * use of anti-oxidant supplements, in excess of a standard multi-vitamins * current hormone replacement therapy * any history of significant chronic disease * uncontrolled hypertension * body mass index (bmi) \> 30 kg/m2 * high physical activity level, as determined by questions on the screening questionnaire * use of anti-inflammatory medication

Keywords: oxidative stress aging ischemia-reperfusion
duchenne muscular dystrophy tissue bank for exon skipping

Conditions: Duchenne Muscular Dystrophy

Summary: we will utilize the cooperative international neuromuscular research group (cinrg) network to collect and store tissue and blood from patients with duchenne muscular dystrophy (dmd) with specific genetic mutations within the dystrophin gene that could be treated by antisense oligonucleotide (ao) drugs.

the purpose of this tissue bank is to collect blood and skin samples from participants who are diagnosed with duchenne muscular dystrophy (dmd) and carry one of nine specific changes in the dystrophin gene. the specific dystrophin changes that we are interested in studying are those that would work with exon-skipping therapies in patients with dmd, specifically deletions of the follow exons: 10-52, 13-50, 29-50, 43-52, 44, 43-50, 45-50, 45-52, 46, 46-47, 46-48, 46-49, 46-51, 46-53, 46-55, 46-60, 47-50, 47-52, 48-50, 49-50, 50, 52, 52-63, 48-52, 49-52, 50-52. these blood and skin samples will be held in a tissue bank at carolinas medical center for future dmd research.

Eligibility criteria:
inclusion criteria: * age 4 and above * diagnosis of dmd with a confirmed out-of-frame dystrophin gene deletions that could be corrected by skipping exon 45, 51, or 53 based on past genetic testing. exclusion criteria: * investigator assessment of inability to comply with blood and skin sample collection

Keywords: muscular dystrophy tissue bank
driving pressure during general anesthesia for open abdominal surgery

Conditions: Postoperative Respiratory Complication

Summary: the purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high peep strategy, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications.


Eligibility criteria:
inclusion criteria: * scheduled for open abdominal surgery * high or intermediate risk for postoperative pulmonary complications according to ariscat score \[j.canet et al, anesthesiology 2010;113\] * general anesthesia exclusion criteria: * laparoscopic surgery * surgery in prone or lateral position * combined procedure with open abdominal and intrathoracic surgery * body mass index \> 40 kg/m2; * reported pregnancy; * mechanical ventilation \> than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days; * any major previous lung surgery; * history of previous severe chronic obstructive pulmonary disease (copd) gold iii or iv, or with (noninvasive) ventilation and/or oxygen therapy at home; * (previous) acute respiratory distress syndrome (ards); * expected to require postoperative mechanical ventilation; * persistent hemodynamic instability or intractable shock; * severe cardiac disease (new york heart association class iii or iv, or acute coronary syndrome, or persistent ventricular tachyarrhythmia's); * consented for another interventional study during anesthesia or refusal to participate in the study

Keywords: mechanical ventilation positive end-expiratory pressure driving pressure post-operative postoperative complications open abdominal surgery recruitment maneuver peep