Kornimate/medical-research-clean huggingface dataset:
study of the efficacy and safety of kalinox® 170 bar for the performance of care procedures in children with burns

Conditions: Burns

Summary: the purpose of this study is to assess the efficacy and the safety of kalinox® 170 bar, over a period of three consecutive care procedures in burned children. it's a international (spain, france, tunisia and belgium) study with 8 investigator centers.

pain due to burns is one of the most intense and persistent types of pain. this pain consists of a permanent background pain, overlaid by episodes of temporary exacerbations triggered by treatment procedures or burn-care procedures. care procedures, such as changing the dressings or cleaning the wounds, make it necessary to handle the painful areas, and this causes transient intense pain. analgesia with a 50/50 mix of nitrous oxide and oxygen is a simple and effective technique, which induces a state of light sedation during which verbal contact is not lost, which is rapidly reversible and is devoid of any major side effects. this gas is used in paediatrics for carrying out painful procedures of a short duration, such as lumbar puncture and minor surgery. the nitrous oxide/oxygen mix has also been used to treat the pain induced by care procedures in children with burns for more than 30 years. the objective of our study is to obtain qualitative and quantitative data about the efficacy of kalinox® 170 bar in care procedures in children with burns.

Eligibility criteria:
inclusion criteria: * child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care * potentially mildly to moderately painful * lasting for at least 15 minutes and for less than 30 minutes * eligible to receive short-term prophylactic analgesic treatment * for whom the consent form has been signed (parent and child) exclusion criteria: * child treated under general anaesthesia * child physically or mentally incapable of responding to an assessment of his/her pain on a visual scale. * child suffering from moderate to severe pain when beginning the care procedure (fpsr \> 4) * exclusion criteria linked to the product

Keywords: children with burns child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care
efficacy and safety study of bms-986142 in patients with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine whether the study drug, bms-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (tnf) inhibitors. patients who qualify will be randomized to either one of 3 doses of bms-986142 or placebo in 1:1:1 randomization for 12 weeks. disease activity and safety will be assessed over the course of the study.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * male and female age 18 and above * diagnosed with active rheumatoid arthritis (ra) by standard criteria at least 16 weeks before screening, have functional acr class i-iii * have an inadequate response to methotrexate * in addition to an inadequate response to methotrexate have an inadequate response or intolerance to 1 but not more than 2 tnf inhibitors * have a minimum of 6 swollen and 6 tender joints (from 66/68 joint count) * have hscrp of ≥ 0.8 mg/dl (8mg/l) \[by central laboratory values\] or an esr ≥ 28 mm/hr * willing to use effective birth control for the entire length of the study exclusion criteria: * diagnosed with juvenile rheumatoid arthritis * have been treated with other biologic treatment than a tnf inhibitor * active systemic bacterial, viral or fungal infection or evidence of prior or current hepatitis b or c infection or hiv infection, latent bacterial, viral or fungal infections * have been treated with intramuscular or intra-articular glucocorticosteroids within 4 weeks of randomization * taking oral steroids at dose above 10 mg/day of prednisone (or prednisone equivalents) * have other autoimmune disease other than ra like lupus, multiple sclerosis * have significant concurrent medical condition at the time of screening or baseline visit
the clinical efficacy of immunomodulators in ra patients

Conditions: Arthritis, Rheumatoid

Summary: this study includes naive patients and csdmards-ir ra patients, treated with different regimens such as iguratimod combination of different csdmards, or csdmard with tnf inhibitors for 24 weeks. the disease activity and drug response will be observed. the immune disorder and synovial function will be evaluated at the same time.

in this study cohorts, naïve or csdmards-ir patients are treated with different csdmards combination or tnf inhibitors for 24 weeks to get remission in clinical. the biomarkers in their plasma and synovial fluid and tissue specimens from ra patients are screened to predict the efficacy of specific treatment.

Eligibility criteria:
inclusion criteria: - 1.patients with ra who meet acr 1987 rheumatoid arthritis classification criteria or acr/eular 2010 rheumatoid arthritis classification criteria and have knee dysfunction. 1. acr 1987 rheumatoid arthritis classification criteria 1. morning stiffness lasting at least 1 hour (≥6w) 2. there are 3 or more joint areas swollen (≥6w) 3. swelling of the wrist, metacarpophalangeal, and proximal phalangeal joint areas (≥6w) 4. symmetrical arthrogryposis (≥6w) 5. hand x-ray changes (at least osteoporosis and joint space narrowing) 6. positive rheumatoid factor (titer \> 1:32) ra can be diagnosed by meeting 4 of the above 7 items 2. acr/eular 2010 rheumatoid arthritis classification criteria 1. involved joints - 1 large joint (0 points) * 2-10 large joints (1 point) * 1-3 small joints (with or without large joints) (2 points) * 4-10 small joints (with or without large joints) (3 points) * more than 10 small joints (at least one small joint) (5 points) 2. serological indicators * rf and acpa negative (0 points) * rf and acpa, at least one of which is low titer positive. (2 points) * rf and acpa with at least one high titer positive (3 points) 3. acute chronotropic reactants * both crp and esr normal (0 points) * abnormal crp or esr (1 point) 4. duration of synovitis * \<6 weeks (0 points) * ≥6 weeks (1 point) 2.patients with oa who meet the 1995 classification criteria for oa and have knee dysfunction 1995 classification criteria for osteoarthritis of the knee clinical criteria a. knee pain most of the time in the last 1 month b. bone rubbing sound c, morning stiffness ≤ 30 minutes d, age ≥ 38 years e, with bony enlargement knee oa can be diagnosed if a+b+c+d or a+b+e is met 3.age-sex matched healthy volunteers who checked in our hospital. 4.age \> 18 years old; 5.voluntarily participate in this study and sign an informed consent form exclusion criteria: 1. patients with combined active hepatitis 2. patients with active tuberculosis 3. patients withinfection and malignancy

Keywords: csdmards tnfi
clinical efficacy and safety of dendritic cytotoxic lymphocyte(dc-ctl) cell infusion in nsclc patients

Conditions: NSCLC

Summary: patients in group a will receive dc-ctl treatment and chemotherapy. patients in group b will receive only chemotherapy.

60 patients with stage iii-iv nsclc will be randomly divided into group a (receive dc-ctl treatment with chemotherapy) or group b (just receive chemotherapy), and the randomize ratio will be 1:1, patients in group a will receive 3 cycles of dc-ctl treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks). patients in group b will receive only 4 cycles chemotherapy(every 2 weeks).

Eligibility criteria:
inclusion criteria: * the patient who have signed the informed consent; * histologically confirmed with nsclc at stage iii-iv * expected survival time is more than 2 month; * eastern cooperative oncology group(ecog) performance status was 0-2 exclusion criteria: * hemoglobin \<8.0 g/dl, white blood cell \<3 x 10\^9/l; platelet count \<75 x 10\^9/l; alanine aminotransferase(alt), aspartate aminotransferase(ast), blood urea nitrogen(bun) and creatinine(cr) more than normal limits on 3.0 times; * known or suspected allergy to the investigational agent or any agent given in association with this trial; * pregnant or lactating patients; * known history of human immunodeficiency virus (hiv), hepatitis c virus (hcv) or treponemapallidun (tp) infection; * patients who are suffering from serious autoimmune disease; * patients who had used long time or are using immunosuppressant; * patients who had active infection; * patients who are suffering from serious organ dysfunction; * patients who are suffering from other cancer; * other situations that the researchers considered unsuitable for this study.

Keywords: dc-ctl, nsclc
impact of the covid-19 pandemic on diet quality and food insecurity: a nutriquébec sub-study

Conditions: Eating Habits

Summary: the unprecedented confinement and social distancing rules imposed by the fight against covid-19 has forced the majority of the population worldwide to stay home for periods of time ranging from weeks to months. eating habits are undoubtedly perturbed during this period, with consequential impact on food security. therefore, the primary aim of this nutriquébec sub-study is to document the impacts of the covid-19 pandemic on diet quality and food insecurity of adults in the province of québec in canada. nutriquébec is a web-based prospective cohort study launched in june 2019 whose primary aim is to provide data for the evaluation of the government health prevention policy on the québec population's eating habits over the years (nct04140071). participants of nutriquébec are invited to complete on a web-based platform nine core questionnaires on a yearly basis. questionnaires assess several dimensions related to lifestyle, including eating habits and physical activity habits, as well as a large number of personal characteristics and global health status. for the purpose of this sub-study, nutriquebec will invite the 2465 active participants who completed the first-year questionnaires prior to the covid-19 pandemic to fill out again those questionnaires during the peak period of the confinement period in april and may, 2020. this nutriquébec sub-study will provide invaluable data on how the covid-19 pandemic impacts diet quality and food insecurity of adults in the province of québec.

the 2465 active participants of nutriquébec who completed the first-year questionnaires prior to the covid-19 pandemic will be invited to provide informed consent to participate in this sub-study. once having consented, participants will be invited to complete the core questionnaires by logging into their personal and secured account. participants will have a three-week period to complete the questionnaires, from april 16 to may 7, 2020. core questionnaires in nutriquébec assess lifestyle habits including eating habits, physical activity habits, sleep quality, tobacco, alcohol and drug habits as well as pandemic behaviors, personal characteristics, food insecurity, health status and health-related quality of life. most of these questionnaires are based on a one-month recall timeframe, with the exception of the eating habits questionnaires, which is in the form of repeated 24-h recall. for the purpose of this nutriquébec substudy, questionnaires were adapted to focus on habits during the last 7 days of questionnaire completion, to reflect more specifically the confinement period.

Eligibility criteria:
inclusion criteria: * adults aged 18 and over with a residential address in québec (canada) * be able to read and understand french or english * have access to internet (with a computer, electronic tablet or cell phone) * have an active email address exclusion criteria: * none

Keywords: eating habits web-based prospective cohort study lifestyle habits diet quality covid-19 food insecurity health
efficacy and safety of sqv in patients who have chronic idv nephrotoxicity

Conditions: IDV Associated Nephrotoxicity

Summary: efficacy and safety of a saquinavir (sqv) based regimen in hiv-1 infected thai patients who have chronic indinavir (idv) associated nephrotoxicity.

primary objective: to determine whether a switch to a sqv can cause improvements in renal function in patients with chronic idv associated nephrotoxicity without improvement after idv dose reduction. secondary objective: 1. to describe the pathophysiology of chronic idv associated renal impairment through renal biopsies at baseline and week 48 2. to describe the pathophysiology of chronic idv associated renal impairment through renal tubular function at baseline and week 48 3. to determine whether a switch to an sqv can cause improvements in renal pathophysiology in patients with chronic idv associated nephrotoxicity through renal biopsies performed at baseline and at weeks 48 4. to determine whether a switch to an sqv results in improvements in hypertension, lipid profiles and cutaneous side effects

Eligibility criteria:
inclusion criteria: * idv containing regimen for more than 1 year and have creatinine more than 1.4 at least 6 months/abnormal renal imaging/abnormal urinary examinations * viral load less than 50 copies exclusion criteria: * saquinavir intolerance

Keywords: idv nephrotoxicity
feasibility of intraperitoneal chemotherapy in the surgical treatment of colon cancer ct4

Conditions: Colon Cancer

Summary: this is a randomised controlled study aims to determine the oncological effectiveness of adjuvant hipec, using intraperitoneal mytomicin c following a curative resection of a ct4 colon cancer in preventing the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment.

in the experimental group (50 patients) after laparotomy and revision of the abdominal cavity organs, peritoneal lavage will be performed followed by immunological examination. after performing the surgical intervention, the patient will undergo intraoperative intra-abdominal chemotherapy with mitomycin c. further, lavage of the abdominal cavity will be repeated, followed by immunological examination. in the control group (40 patients), after laparotomy and revision, peritoneal lavage will also be performed, followed by immunological examination. patients of this group will not receive intraoperative intra-abdominal chemotherapy. after performing the surgical intervention, the patient will perform irrigation of the abdominal cavity with physiological saline. further, lavage of the abdominal cavity will be repeated, followed by immunological examination.

Eligibility criteria:
inclusion criteria: 1. colon cancer which represent ct4n0-2 m0 on the basis of preoperative examination data (ct of the chest, abdominal and pelvic organs) in line with the american joint committee on cancer: the 7th edition of the ajcc cancer staging manual: 2. histologically verified adenocarcinoma of the colon. 3. signed informed consent. exclusion criteria: 1. pregnancy or lactation. 2. the presence of synchronous or metachronous malignant tumors. 3. distant metastases to the liver, lungs, peritoneal carcinomatosis and other organs. 4. neoadjuvant chemotherapy. 5. suspected lynch syndrome.

Keywords: intraperitoneal chemotherapy peritoneal carcinomatosis colonic diseases
palliative management of inoperable malignant bowel obstruction

Conditions: Malignant Bowel Obstruction

Summary: to identify the role of palliative medical management of inoperable malignant bowel obstruction (mbo) with octreotide, dexamethasone and metoclopramide given together as triple therapy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age. * diagnosis of partial bowel obstruction secondary to active or prior malignancy (primary or metastatic gi, gyn, and carcinomatosis) caused either by tumor itself or adhesions inthe setting of active malignancy. * cross-sectional imaging performed within 24 hours of clinical symptoms of bowel obstruction (nausea, vomiting, and constipation ± abdominal pain) during hospital admission. * patient must have an inoperable mbo * participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved writteninformed consent form prior to receiving any study related procedure. exclusion criteria: * evidence of complete bowel obstruction by imaging. * bacteremia/septicemia with a documented positive blood culture: if a blood culture comes back positive after study enrollment, patient will be excluded. * patients already taking a steroid equivalent to 8 mg of dexamethasone per day prior to study enrollment. * patients undergoing bowel surgery or stent placement for bowel obstruction. * those patients with mbo in setting of incarcerated hernia. * known history of qt prolongation syndrome or if qtc is \> 450 msec in males or \> 470 msec in females on baseline ekg within 2 weeks of enrollment. * lack of decision making capacity/delirium. * pregnant or nursing female participants. * actively suicidal patients. * acute cholecystitis

Keywords: bowel obstruction
study of sugemalimab (or placebo) plus pgemox regimen in participants with extranodal nk/t-cell lymphoma

Conditions: Extranodal NK/T-cell Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and safety of sugemalimab (cs1001) in combination with pgemox regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with extranodal nk/t-cell lymphoma (enktl) who have relapsed or become refractory to asparaginase-based regimens.


Eligibility criteria:
inclusion criteria: * has enktl histologically confirmed by the study center. nasal and non-nasal enktl are both allowed. * has relapsed or refractory enktl after prior asparaginase-based chemotherapy or chemoradiotherapy. * has eastern cooperative oncology group (ecog) performance status score of 0-2. * has at least one measurable lesion per lugano 2014 classification. * is willing to provide stained tumor tissue sections and corresponding pathological reports or unstained tumor tissue sections (or tissue block) for central pathology review. * has adequate organ function. * has life expectancy of greater than 3 months. exclusion criteria: * has aggressive natural killer-cell leukemia, current central nervous system (cns) involvement or is concomitant with hemophagocytic lymphohistiocytosis. * has known additional malignancy within 5 years prior to randomization. * has an active autoimmune disease or has had an autoimmune disease that may relapse. * has had a major surgical procedure within 28 days or radiotherapy within 90 days before the first dose of study treatment. * has active tuberculosis infection. * has a known history of human immunodeficiency virus (hiv) infection and/or acquired immune deficiency syndrome (aids). * has a known active hepatitis b or c virus infection. * has received systemic anti-cancer therapy within 28 days before the first dose of study treatment, including chemotherapy, immunotherapy, biological therapy (e.g. cancer vaccine, cytokine therapy or growth factors to treat cancer). * has used traditional chinese medicines or herbal preparations with anti-tumor indications within 7 days before the first dose of study treatment. * has received systemic corticosteroid or any other immunosuppressive therapy within 14 days before the first dose of study treatment. * has received any treatment of antibody or drug that targets at t-cell coregulatory pathways or immune checkpoint pathways. * has toxicity from prior anti-cancer treatment, except for alopecia and fatigue, that has not recovered to baseline or ≤ grade 1 according to common terminology criteria for adverse events (ctcae) v5.0 before the first dose of study treatment. * has had allogenic hematopoietic stem cell transplantation (hsct) within 5 years or autologous hsct within 90 days before the first dose of study treatment. * has a known severe hypersensitivity to sugemalimab, its active substance and/or any of its excipients, or to other monoclonal antibodies. * female participants who are pregnant or breastfeeding. * is currently participating in or has participated in a trial of an investigational agent within 28 days before to the first dose of study treatment.
evaluate the effect of hyaluronic acid in the treatment of furcation involvement

Conditions: Furcation Defects

Summary: the effect hyaluronic acid in the treatment of furcation involvement

the materials to be used in the study are the following: * hyaluronic acid * cone-beam computed tomography(cbct) x-ray the patients with grade ii furcation will be divided into two groups. both groups will have the same number of patients and the same procedure, such as the scaling root planning. however, the control group will use hyaluronic acid and membrane. the placebo group, on the other hand, will use hyaluronic acid without membrane and will use cbct x-ray. the x-rays will be done at the beginning of the treatment. then, two monitoring processes will be done. the first monitor will be done after three months. the data will be recorded. then, after another three months, the patients will undergo an x-ray check again, and the data will be recorded. the goal is only to have the patients exposed to x-ray twice so they would not be compromised to the high dose of radiation. the evaluation to be done for the 3-month interval will only be clinical assessments.

Eligibility criteria:
inclusion criteria: 1. selected teeth: permanent first and second molars in the mandible. 2. furcation dimension: radiographic and clinical evidence of exhibiting defects due to grade ii furcation with at least 2 millimeters probing depth horizontally and at least 5 millimeters probing depth circumferential. 3. gender: both males and females. 4. age range: between 18 and 55 years. 5. health status: healthy patients non-systemic diseased except controlled diabetic. 6. compliance: patients will be willing and able to comply with adequate oral hygiene protocols. exclusion criteria: 1. patients that received periodontal regenerative therapy within the past 12 months. 2. patients that are lactating. 3. pregnant patients. 4. smokers. 5. patients with pulp infection. 6. patients with trauma resulting from occlusion. 7. patients with receding gum. 8. patients with tooth mobility greater than grade ii. 9. patients that will not comply with the hygiene protocols in phase i therapy. 10. patients with potential illnesses that can influence the periodontal therapy outcomes. 11. patients that are taking medications that can interfere with the healing outcomes of the periodontal wound. 12. patients allergic to any drugs.

Keywords: hyaluronic acid furcation involvement
sk-1403 long-term treatment study; long-term study in patients with secondary hyperparathyroidism receiving hemodialysis

Conditions: Secondary Hyperparathyroidism

Summary: to evaluate the safety and efficacy of treatment with sk-1403 for 52 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.


Eligibility criteria:
inclusion criteria: * serum pth\>240 pg/ml at the screening * serum corrected ca≥8.4 mg/dl at the screening * stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration exclusion criteria: * primary hyperparathyroidism * severe liver disease * severe cardiac disease * history or family history of long qt syndrome * malignant tumor * uncontrolled diabetes mellitus * uncontrolled hypertension * a history of severe drug allergy