Kornimate/medical-research-clean huggingface dataset:
evaluation of low-level laser therapy efficacy in pain management of grade 2 oral mucositis induced by radiotherapy or chemoradiotherapy: a study in patients with upper aerodigestive tract cancer

Conditions: Upper Aerodigestive Tract Neoplasms

Summary: prospective, monocentric, randomized phase ii study evaluating low-level laser therapy (lllt) as a treatment for the pain due to grade 2 oral mucositis in patients with upper aero-digestive tract cancer treated by radiotherapy or chemoradiotherapy. patients with upper aero-digestive tract cancer receiving their first cervicofacial radiotherapy or chemoradiotherapy will be included in this study if they suffer from oral mucositis due to their treatment. the study procedure will consist in 5 applications of the lllt that will be performed at three days intervals for a maximum duration of 15 days. each patient will be followed until 3 days after the end of the study treatment, for a total duration of the study of 18 days.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. patients with upper aero-digestive tract cancer receiving a first cervicofacial radiotherapy or chemoradiotherapy 3. patients with a grade 2 mucositis (according to the nci ctcae version 5.0) appearing during treatment. 4. patients available to perform the lllt treatment: 5 visits at 3 days intervals 5. patients must provide written informed consent prior to any study specific procedures. 6. patients affiliated to a social health insurance in france. exclusion criteria: 1. patients who have already received a cervicofacial radiotherapy 2. patients who have already received an induction chemotherapy for their upper aero-digestive tract cancer 3. patients under targeted therapy for their upper aero-digestive tract cancer 4. patients under systemic corticotherapy 5. patients with a non-grade 2 mucositis (according to the nci ctcae version 5.0) 6. patients with ulceration or any other oral mucosa pathology than mucositis 7. pregnant or breastfeeding women 8. any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure 9. patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)

Keywords: upper aerodigestive tract neoplasms low-level laser therapy (lllt) mucositis
a study of the safety and tolerability of bms-986183 in patients with liver cancer

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the safety and tolerability of bms-986183 in patients with liver cancer.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * must have advanced liver cancer that cannot be treated with surgery or other local methods * liver cancer is confirmed by a microscopic examination of tissue * liver disease is classified as 'a' by a standard method called child-pugh score * daily living abilities are classified as '0 or 1' by a standard method from the eastern cooperative oncology group (ecog) * women must use contraception exclusion criteria: * prior liver transplant * increase in blood pressure in some of the veins entering the liver * cancer that has spread to the brain or the layers of tissue that cover the brain or spinal cord * infection with both hepatitis b and c, both hepatitis d and b, infection with hiv, or other infections * disease of the heart or blood vessels around the heart * active cancers within the last 2 years * no more than 2 prior systemic treatments or other investigational agents except pd-1/pd-l1 or ipilimumab (part 2) * currently on anti-platelet or anti-coagulation therapy * radiotherapy within 4 weeks of treatment * any major allergies other protocol defined inclusion/exclusion criteria could apply
pain reduce following refractive surgery

Conditions: Pain

Summary: applying a material over the exposed stromal bed following refractive surgery to prevent local abrasion and significantly reduce pain

assessed for pain at 1, 2 and 4 hours and 1, 3 and 5 days. comparison to non study eye will be performed.

Eligibility criteria:
inclusion criteria: 1. patients who underwent bilateral prk for myopic correction. 2. age 18-60. 3. patient complains of significant pain. 4. patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits exclusion criteria: 1. any other anterior segment abnormality other than that associated with prk. 2. any abnormalities associated with the eye lids. 3. prior laser treatment of the retina. 4. any ophthalmic surgery performed within three (3) months prior to study excluding prk. 5. diagnosis of glaucoma. 6. active diabetic retinopathy. 7. clinically significant inflammation or infection within six (6) months prior to study. 8. uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the investigator. 9. participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational device. 10. specifically known intolerance or hypersensitivity to contact lenses. 11. a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up. 12. any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.

Keywords: refractive surgery
study to evaluate effect of lapatinib on pharmacokinetics of jtz-951 in subjects with end-stage renal disease

Conditions: Anemia of Chronic Kidney Disease

Summary: study to evaluate the effect of lapatinib, a breast cancer resistance protein (bcrp) inhibitor, on the pharmacokinetics (pk) of jtz-951 and to evaluate the safety and tolerability of jtz-951 when administered alone and one hour after the administration of lapatinib.


Eligibility criteria:
inclusion criteria: * subjects with end stage renal disease on hemodialysis * post-dialysis body weight \>45.0 kg * bmi between 18.0 and 40.0 kg/m2 (inclusive) exclusion criteria: * subjects with positive test results for hbsag (hepatitis b surface antigen), hcv antibody or hiv antibody * subjects with known history of liver failure or liver surgery * subjects with a history or current clinically significant chronic or acute blood loss

Keywords: jtz-951 lapatinib pharmacokinetics
the role of budesonide intrapolyp injection in crswnp

Conditions: CRS; Polyp, Nasal

Summary: chronic rhinosinusitis with nasal polyps is a common nasal comorbidity with a wide range of symptoms that might cause severe distress and disabilities for patients. many patients undergo repeated courses of systemic steroids and are exposed to various adverse effects. many cases finally revert to surgery. budesonide was safely used as a nasal wash in cases of nasal polyps, our aim to determine if intrapolyp injection is a better method for delivering budesonide.

chronic rhinosinusitis with nasal polyps can be a severely debilitating disease, it's classically treated with steroids, and different methods of steroid delivery have been used for years. patients usually receive repeated courses of systemic steroids and experience many side effects. there have been trials of intrapolyp injection of steroids, especially triamcinolone acetate. these trials concluded that it's a safe intervention. budesonide has been used as a nasal wash frequently in cases of nasal polyps, it also has been used safely as an intratympanic injection for cases of sudden hearing loss.. it's used as a systemic steroid in cases of inflammatory bowel diseases. the aim of our study is to test whether polyp injection is a more effective method of budesonide delivery and less dependent on subjective compliance rather than irrigation, and if it has comparable results with oral systemic steroids on polyps

Eligibility criteria:
inclusion criteria: * all patients with type 2 crswnp -indicated by elevated serum ige \& high absolute eosinophilia- with nasal polyps whose * ages between 18 and 60 years old * who don't have any contraindications of systemic steroids such as glaucoma, peptic ulcer, acute psychosis, chronic infections, severe osteoporosis, severe hypertension, uncontrolled diabetes mellitus, history of thromboembolic events exclusion criteria: * cystic fibrosis * ciliary dyskinesia, * antrochoanal polyp * fungal sinusitis, * unilateral nasal polyps, a * patients who took systemic steroids in the last 6 months before our study were excluded.

Keywords: budesonide crswnp chronic rhinosinusitis nasal polyps intrapolyp injection
efficacy and safety of dkf-306 in patients with periodontal diseases

Conditions: Periodontal Diseases

Summary: this is a multi-center, randomized, double-blinded, placebo-controlled study to evaluated the efficacy and safety of dkf-306 in patients with periodontal diseases.


Eligibility criteria:
inclusion criteria: * aged 19 years and older * periodontal diseases * having not less than 16 permanent teeth including at least 4 molars (third molars excluded) * having teeth with not less than 2 sites of both probing pocket depth (ppd) ≥ 4 mm and gingival index (gi) ≥ 2 in at least 2 quadrants * agrees not to use over-the-counters (oral, ointment, toothpaste, film, etc.) or quasi-drugs (gargle and mouthwash) to alleviate or treat the symptoms of gingivitis or periodontitis during the study * voluntarily signed the informed consent form * willing to participate in the study exclusion criteria: * hypersensitivity to ingredients of investigational products * hypersensitivity to azo dyes, acetylsalicylic acid or other prostaglandin synthase inhibitors * following diseases or state in the mouth: 1. rampant caries or decayed tooth/teeth remained untreated for a long time 2. multiple restorations which may be related to periodontal inflammation 3. poor oral hygiene with heavy plaque or calculus deposition 4. soft or hard tissue tumor 5. systemic chronic diseases with oral manifestations 6. fibrotic gingival enlargement * use of orthodontic appliances or removable partial denture(s) * having teeth or state in need of immediate treatment such as periodontal abscess, a tooth indicated for extraction, etc. * history of aggressive periodontitis or acute necrotizing ulcerative gingivitis * received dental treatments such as endodontic treatments or periodontal therapy (including both nonsurgical and surgical therapy) within 3 months from randomization * received the following drugs for more than 2 weeks within 3 months from randomization: 1. systemic/local antibiotics in the mouth or non-steroidal anti-inflammatory drugs 2. cyclosporine or corticosteroids 3. phenytoin, calcium antagonists, anticoagulants or antiplatelets * initiated drugs in treatment of chronic diseases within 3 months from randomization * received the same drug with investigational products within 3 months from randomization * medical conditions or diseases affecting the efficacy and safety of investigational products at the investigator's discretion * heavy smoker (20 cigarettes or more a day) * pregnant or breast-feeding * plans to have a child or unwilling to comply with using medically accepted contraception methods during the study * alcohol or drug abuse * other investigational products or procedures within 3 months from screening * not eligible due to other reasons at the investigator's discretion
fibrinogen replenishment in surgery

Conditions: Deficiency; Fibrinogen, Acquired

Summary: this is a pragmatic, prospective, multi-center, randomized, active-control, single-blinded, non-inferiority phase 3 trial in adult cardiac surgical patients. up to 12 canadian hospitals will participate, and the trial will require up to 2 years for patient recruitment. twelve-hundred bleeding adult cardiac surgical patients who require fibrinogen supplementation due to acquired hypofibrinogenemia after cpb will be included. patients will be randomized to receive equivalent doses of either fibrinogen concentrate (octafibrin) or cryoprecipitate when the blood bank receives the first order for fibrinogen supplementation and deems it to be in accordance with accepted clinical standards. thereafter, patients will be treated according to their assigned group each time fibrinogen supplementation is ordered during the treatment period (24 hours after termination of cpb). no other aspects of care will be modified. the primary efficacy outcome will be the number of allogeneic blood products (abp) (red blood cells \[rbcs\], pooled or apheresis platelets, and plasma) administered during the first 24 hours after termination of cpb. safety outcomes will be measured for the first 28 days after surgery, which is the duration of participation of each patient in the trial. comparisons will be by intention-to-treat (itt) (primary) and per-protocol (pp) analysis. one interim analysis will be conducted after 600 patients have been treated to determine whether the study should be terminated for safety reasons, demonstrated non-inferiority or futility reasons.


Eligibility criteria:
inclusion criteria: 1. patients undergoing index cardiac surgery with cpb in whom fibrinogen supplementation is ordered in accordance with accepted clinical standards (significant hemorrhage and known or presumed hypofibrinogenemia). exclusion criteria: 1. receipt of fibrinogen rich products (fibrinogen concentrate or cryoprecipitate) within 24 hours before surgery 2. history of severe allergic reaction to cryoprecipitate or fibrinogen concentrate 3. refusal of abps, fibrinogen concentrate or cryoprecipitate due to religious or other reasons 4. fibrinogen level known to be \>3.0 g/l within 30 minutes of imp order (to eliminate the risk of raising patients' fibrinogen levels to \>4.0 g/l with supplementation 5. known pregnancy

Keywords: cyroprecipitate fibrinogen cardiac surgery
comparison of quadratus lumborum block and erector spina plane block in nephrectomy

Conditions: Pain, Postoperative; Postoperative Complications

Summary: postoperative pain is important due to the limitation of physical functions, delay in recovery of quality of life, long-term opiate use, length of hospital stay, increased care costs and early postoperative pain trigger chronic pain. it is associated with postoperative morbidity. multimodal analgesia techniques with fascial plan blocks are frequently used.the investigators aimed to evaluate the effect of qlb2 and esp on postoperative pain scores in nephrectomy surgery, total opiate consumption, initial analgesia requirement, additional analgesia consumption, patient and surgeon satisfaction.

at the end of the operation, patients will be randomly divided into 2 groups as group e (esp block) and group q (qlb). the blocks will be administered under general anesthesia in lateral position by same anesthesiologist. group e (esp block) will be applied 20 ml of %0.25 bupivacaine between the erector spina muscle and transverse process at the 8th thoracic level. group q (qlb2 block) will be applied 20 ml of %0.25 bupivacaine at lumbar interfacial triangle (lift). at the end of the operation, the patients with a modified aldreate score ≥9 will be sent from the postoperative anesthesia unit. all patients will be equipped with an iv morphine patient-controlled analgesia (pca) device. the solution will be prepared such that morphine is 0.5 mg / ml. pca 1mg bolus dose will be delivered with 10 min lock-out time. in the postoperative period, the patient was evaluated by another researcher who blind to the groups at the 1st and 6th, 12th and 24th hours. visual pain scores (vas) in rest and movement, hemodynamic values, morphine consumption, initial analgesic requirement, nausea-vomiting score, ramsey sedation scale, length of hospital stay, patient and surgeon satisfaction, and postoperative complications will be recorded.

Eligibility criteria:
inclusion criteria: * partial or radical nephrectomy * american society of anesthesiologist physical status i-iii exclusion criteria: * infection in the incision area * coagulation disorder * known allergy history against to the study drugs * lack of adequate cognitive activity in the use of patient-controlled analgesia and vas

Keywords: erector spina plan block quadratus lumborum block nephrectomy postoperative pain
safety and activity of 90y-labeled idec-159 in subjects with metastatic colorectal adenocarcinoma

Conditions: Colorectal Cancer; Metastases

Summary: this is a phase i/ii open-label, dose-escalating study in patients with metastatic colorectal cancer. the objectives of the study are to obtain information on the safety of radiolabeled idec-159, as well as its activity in colorectal cancer. another objective is to determine the maximum tolerated dose (mtd). the study duration is 2 years with visits occuring daily and/or weekly for the first 3 months, and every 6 weeks until the end of the 2 year period.


Eligibility criteria:
inclusion criteria: * sign an institutional review board (irb)-approved informed consent. * metastatic colorectal adenocarcinoma that has been pathologically confirmed following failed response or relapse while on or following fluoropyrimidine, irinotecan, and oxaliplatin chemotherapy. (prior therapy with cetuximab is recommended if the tumors are epidermal growth factor receptor \[egfr\] positive.) * age 18 or above. * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2. * recovered to baseline toxicity from any significant toxicity associated with prior surgery, chemotherapy, biological therapy, or investigational drug. * adequate bone marrow reserve (absolute neutrophil count \> 1500 cells/mm3, platelet count \> 125,000 cells/mm3, hemoglobin concentration ≥ 10 g/dl). * radiographically measurable disease (recist criteria). * life expectancy of at least 3 months. * male and female subjects of reproductive potential must agree to follow accepted birth control methods, as determined by the investigator, during treatment and for 12 months after completion of treatment. exclusion criteria: * prior radioimmunotherapy. * known presence of central nervous system (cns) metastasis. * any lesion \> 7.5 cm. * total bilirubin \> 2.0 mg/dl. * total creatinine \> 2.0 mg/dl. * ast and alt \> 2.5 times upper limit of normal (uln), if metastases to the liver \> 5 times uln. * presence of a second primary malignancy requiring active treatment (except for hormonal therapy). * serious non-malignant disease or infection that, in the opinion of either the investigator or sponsor, would compromise protocol objectives. * history of external beam radiation therapy to \> 25% of active bone marrow. * history of bone marrow or stem cell transplant. * history of granulocyte colony-stimulating factor (g-csf) or granulocyte macrophage colony stimulating factor (gm-csf) therapy within 2 weeks before study day 1. * history of pegylated g-csf therapy within 4 weeks before study day 1. * history of major surgery, other than diagnostic surgery, within 4 weeks of study day 1. * history of receiving investigational product within 4 weeks before study day 1 or long term toxicity from a previous investigational therapy. * known history of hiv or aids. * concurrent systemic corticosteroid therapy or other immunosuppressive agents, unless for the treatment of computed tomography (ct) dye allergy reactions. * pregnant or lactating female.

Keywords: metastatic colorectal adenocarcinoma anti tag-72 monoclonal antibody
a study following males with haemophilia b on prophylaxis with refixia/rebinyn

Conditions: Haemophilia B

Summary: this study will collect information on side effects and how well refixia/rebinyn works during long-term treatment (prophylaxis) in males with haemophilia b. while taking part in this study, participants will receive the same treatment as given to them by their study doctor. all visits at the clinic are done in the same way as the participants are used to. during visits at the clinic, participants might be asked for some relevant tests if considered useful by their study doctor. during the visits, the participants study doctor might ask if the participants had any side effects since their last study visit. the participants will be asked to note down the number of bleeds and the treatment of their bleeds as well as their regular prophylaxis. during the visits to the clinic, the participants will be asked to answer some questionnaires about their quality of life and their ability to be physically active. the participant's participation in the study will last for 4-9 years, depending on when they join the study. participants are free to leave the study at any time and for any reason. this will not affect their current and future medical care.


Eligibility criteria:
inclusion criteria: * signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * male patients at any age with haemophilia b assigned to n9-gp prophylaxis treatment * decision to initiate treatment with commercially available n9-gp has been made by the patient(s)/legally authorised representative(s) (lar(s)) and the treating physician before and independently from the decision to include the patient in this study exclusion criteria: * previous participation in this study. participation is defined as signed informed consent * known or suspected hypersensitivity to n9-gp or related products * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * clinical suspicion or presence of fix inhibitor at time of inclusion.
study of ischemic colitis compared to other diagnoses in patients with lower gastrointestinal bleeding

Conditions: Colitis, Ischemic

Summary: the purpose of this study is to study the demographic,laboratory,endoscopic, and outcomes of ischemic colitis patient presented with severe lower gastrointestinal bleeding compared to other diagnoses.

secondary purpose of this study is to assess the risk factors for predicting diverticulosis versus ischemic colitis.

Eligibility criteria:
inclusion criteria: * bright red blood clots or burgundy colored stool documented by a health care worker * clinical or laboratory evidence of significant blood loss, manifested by any one of the following: (a) more than three bloody bowel movements in eight hours (b) a decrease of two grams of hemoglobin (hgb) from baseline, or (c) transfusion of more than three units of red blood cell (urbc). exclusion criteria: * age less than 18 year * history of inflammatory bowel disease * hypotension or shock refractory to resuscitation * severe coagulopathy refractory to resuscitation (platelet count \< 30,000; prothrombin time \[pt\]- more than 2 times normal; partial thromboplastin time \[ptt\]- more than 2 times normal) * acquired immune deficiency syndrome or neutropenia * the inability to provide informed consent * documentation of anal disorders as a cause of bleeding such as internal hemorrhoids, anal fissures, polyps or cancer of the anal canal, and fistulae