Kornimate/medical-research-clean huggingface dataset:
a first-in-human single and repeated dose escalation study of sar442501 in healthy adults subjects

Conditions: Osteochondrodysplasia

Summary: the purpose of the first-in-human (fih) study is to obtain safety, tolerability, and pharmacokinetic information on sar442501 in a healthy adult volunteer population using an integrated single ascending dose (sad)-multiple ascending dose (mad) parallel cohort study design.


Eligibility criteria:
inclusion criteria: * male and female participants, between 18 and 45 years of age, inclusive. * body weight between 50.0 and 85.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m2, inclusive. * certified as healthy by a comprehensive clinical assessment. * having given written informed consent prior to undertaking any study-related procedure. exclusion criteria: * any history or presence of clinically relevant medical status as per the protocol. * any participant who, in the judgment of the investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. the above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
human egfr mutations quantitative detection kit (real-time fluorescent pcr method)

Conditions: Non Small Cell Lung Cancer; EGFR-TKI Resistant Mutation; EGFR-TKI Sensitizing Mutation

Summary: in this clinical trial, investigators select ffpe and plasma samples of non-small cell lung cancer which are used for quantitative detection of four kinds of egfr(epidermal growth factor receptor) mutations. by the following two aspects, investigators evaluate the clinical performance of the egfr quantitative kits. 1. methodology validation: to certify the equivalence between the egfr quantitative kit and the common used detection methods. 2. analysis of the relationship between the type and proportion of egfr sensitive mutation and egfr-tki benefit.

according to the types of samples and the purpose of the study, the research consists of two groups: plasma and tissue matching group and predicting clinical efficacy group. the samples of the plasma and tissue matching group are the same period plasma and matched ffpe(formalin-fixed paraffin-embedded tissue)samples which will be collected before the first time patients accept any anti-tumor treatment. the samples of predicting clinical efficacy group are ffpe samples which will be collected before the patients receive egfr-tki treatment. in addition, the subjects have the complete prognostic follow-up data.

Eligibility criteria:
plasma and tissue matching group: inclusion criteria: * 18\~80 years old * diagnosis of nsclc (stage iii or iv) which is confirmed by histology or cytology methods. * did not receive any anti-tumor treatment. * sufficient samples for analysis exclusion criteria: * female patients of childbearing potential who are nursing or are pregnant. * samples are collected after patients receiving anti-tumor treatment. * the plasma sample hemolysis. * tumor cells are not found in ffpe samples. * incomplete information of subjects predicting clinical efficacy group: inclusion criteria: * 18\~80 years old * diagnosis of nsclc (stage iii or iv) which is confirmed by histology or cytology methods. * at least one measurable focus * with egfr-tki treatment * complete follow-up information after egfr-tki treatment * sufficient samples for analysis exclusion criteria: * ffpe samples are collected after egfr-tki treatment. * female patients of childbearing potential who are nursing or are pregnant. * tumor cells are not found in ffpe samples. * incomplete information of subjects

Keywords: nsclc egfr egfr-tki pcr
atazavanir/ritonavir-based haart in children

Conditions: HIV

Summary: there are no data on efficacy, safety and pharmacokinetics of atv/r-based haart in hiv-infected asian children. therefore, the investigators aim to evaluate the pharmacokinetics, efficacy and safety of atv/r-based haart in thai hiv-infected children.

non-nucleoside reverse transcriptase inhibitor (nnrti)-based haart have been commonly prescribed as the first-line haart for hiv-infected children in resource-limited settings. protease inhibitor (pi)-based haart are the recommended second-line regimen after failing nnrti-based haart. the most commonly used pi in thailand is lopinavir/ritonavir (lpv/r). however, the metabolic complications of lopinavir/ritonaive (lpv/r) such as hyperlipidemia and lipodyrtrophy are common and a concern for hiv-infected children as it may contribute to the development of cardiovascular disease in the longer term. there are data on efficacy, safety and pharmacokinetics of atv/r-based haart in hiv-infected adults but none in children. furthermore, many studies in both adults and children have shown that different ethnicities can result in different pharmacokinetic response to antiretroviral drugs. as a result of this, this study investigated the efficacy, safety and pharmacokinetics of atv/r-based haart in hiv-infected asian children.

Eligibility criteria:
inclusion criteria: 1. hiv-infected children 2. age from 6- 18 years old 3. body weight ≥ 25 kg at screening visit 4. arv history, the children can be categorized in one of these 2 groups 5. alt \<200 iu/l at screening visit 6. total bilirubin \< 3 mg/dl at the screening visit 7. can swallow capsule 8. written informed consent from caregivers and assent (from children aged 7-17 years who know their hiv status) exclusion criteria: 1. active opportunistic infection 2. relevant history or current condition, illness that might interfere with atazanavir/ritonavir absorption, distribution, metabolism or excretion. 3. use of concomitant medication that may interfere with the pharmacokinetics of atv/r (i.e. efavirenz, indinavir, proton pump inhibitor, antacids, cisapride, clarithromycin, rifampin etc.) 4. pregnancy or lactating at screening visit 5. liver diseases e.g. hepatitis b carrier, chronic hepatitis, cirrhosis 6. inability to understand the nature and extent of the study and the procedures required.

Keywords: pharmacokinetics atazanavir/ritonavir hiv-infected children
guo&amp;'s distal entry tear repair with weflow-endopatch system (gallant study)

Conditions: Aortic Dissection; Distal Entry Tear

Summary: a multicenter, randomized controlled study about the safety and efficacy of weflow-endopatch aortic endovascular patch system manufactured by endonom medtech (hangzhou) co., ltd. for chronic aortic dissection . (gallant study)

this study is a multicenter, prospective, superiority, randomized controlled trial about the safety and efficacy of weflow-endopatch aortic endovascular patch system. it is expected to complete the implantation of 204 patients in 15 centers within 24 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24th month, 36th month, 48th month and 60th month postoperatively.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 80 years old, no gender limitation; * the patient was diagnosed with chronic aortic dissection after the repair of the main artery dissection, with distal tears required seal; * the maximum diameter of the descending thoracic aorta is 3.5-5cm； * the number of thoracic descending aorta tears is ≤2, and the maximum diameter of the tears is 2-30 mm； * with appropriate artery approaches, endovascular treatment can be performed； * those who can understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form by themselves or their legal representative, and are willing to complete the follow-up according to the protocol requirements. exclusion criteria: * rupture or threatened rupture of aortic dissection; * proximal type i internal leakage after aortic repair; * new distal sine; * abdominal aortic dissection aneurysm diameter ≥5 cm; * the edge of the tear from the opening of celiac trunk is\<4 mm; * the same operation requires intervention in other vascular diseases (such as coronary artery, renal artery, superior mesenteric artery, etc.); * acute systemic infection; * history of myocardial infarction, tia or cerebral infarction within the past 3 months; * cardiac function grade iv (nyha rating) or lvef \&lt; 30%; * hematological abnormalities: leukopenia (wbc \&lt; 3×10\^9/l), anemia (hb \&lt; 90 g/l); coagulation dysfunction, thrombocytopenia (plt count \&lt; 50×10\^9/l); * renal insufficiency: serum creatinine \&gt; 150 umol/l (or 3.0 mg/dl) and/or advanced kidney disease requiring renal dialysis, as determined by the investigator after thorough analysis; * severe liver insufficiency: alanine aminotransferase (alt) or aspartate aminotransferase (ast) exceeds the normal upper limit by 5 times; serum total bilirubin (stb) exceeded the normal upper limit by 2 times; * allergic to contrast agents, anesthetics, patchs, and delivery materials; * pregnant or breastfeeding; * participated in clinical trials of other drugs or devices during the same period; * life expectancy is less than 12 months (such as advanced malignant tumors); investigator judged that not suitable for interventional treatment.

Keywords: aortic dissection distal tear descending aorta
involvement of plasmatic factors in the peripheral muscle dysfunction of copd patients - in vitro study

Conditions: Chronic Obstructive Pulmonary

Summary: chronic obstructive pulmonary patients is a defined by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. it is associated with an atrophy of the skeletal muscle that impairs the patient's prognosis. the biological mechanisms of this muscle atrophy have not been elucidated, and the "spill-over theory" has recently emerged. indeed, in copd patients, the pulmonary inflammation is associated with a systemic low-grade inflammation, and the increased pro-inflamatory molelcules in the blood - which constitute the cellular micro-environement of the muscle fibre - could activate the mechanisms of the cell atrophy.


Eligibility criteria:
inclusion criteria: 35 to 85 years old * copd patients: association of symtoms (breathlessness, cough, sputum) and chronic exposure to inhalated risk factors (like tobacco smoke) and a fev1/vc ratio \<70% assessed by a spirometry * healthy subjects: a sedentariness assessed by a voorrips score \<9.4 and/or a report of \<150 min/week of moderate-to-vigorous physical activity exclusion criteria: * a recent copd exacerbation (\< 4weeks) * the decompensation of a comorbidity * an antioxidant supplementation or medication * a long-term systemic corticosteroid medication

Keywords: copd (chronic obstructive pulmonary patients) atrophy cell cultur systemic inflammation catabolism
analysis of human to human transmission of middle east respiratory syndrom coronavirus (mer-cov)

Conditions: Viral Infection

Summary: this study aimed to analysis the characteristics of mers transmission and the effect of our institutional personal protective equipment on the controlling the mers at a tertiary korean hospital.

between may 2015 and nov 2015, total 186 cases of mers-cov infections were reported in south korea. in june 2015, a female patient visited our emergency department (ed) for care of femur fracture. she was suspected of having mers-cov and isolated after 10 hours from the visit of our hospital because her clinical feature was not concordance with typical mers-cov infection and she denied the any contact of mers-cov patient. before the transport to the isolation room, she stayed at ed during 8 hours, and admitted the general ward during 2 hours. approximately 150 including the healthcare providers, patients and laypersons were exposed to the case-patient directly or indirectly. the investigators monitored all possible contacts in the hospital during that time, and analysed the cctv data of hospital and interviewed all risk-persons. after the hospital outbreak ended, the investigators analysed the data of all behavior and contact history of mers patient, epidermic and clinical data of infected patients and data of personal protective equipments (ppe) of all exposed persons. descriptive analysis were conducted for basic epidemiology, transmission rout of mers in hospital, and the effect of hospital infection control system and ppe of each contacts.

Eligibility criteria:
inclusion criteria: * all aged persons who have risk of mers transmission from a case-patients exclusion criteria: * no risk of transmission

Keywords: mers-cov infection control case-control studies
metabolism des lam

Conditions: Iron; Acute Myeloid Leukemia; Diagnosis; Oxydative Stress

Summary: in this study, the investigators study the prognostic role of oxidative stress metabolism and iron in acute myeloid leukemia.

primary goal of this study is to evaluate the characteristics of regulatory networks of iron and redox balance in leukemic cells, to study the correlations between the prognosis of aml patients (in terms of response to induction chemotherapy and survival i) and metabolism of these markers. secondary ones areto assess the impact of induction therapy on markers of oxidative stress and to correlate biological iron and redox metabolism with the molecular status of patients (eg flt3/idh/cebpa/npm...). eligibility criteria are patients at diagnostic of de novo acute myeloid leukemia (promyelocytic excluded) aged from 18 to 100 years.

Eligibility criteria:
inclusion criteria: de novo acute myeloid leukemic patient from 18 years to 99 years at diagnosis exclusion criteria: age under 18 years promelocytic leukemia secondary leukemia
real-time mv/kv image guided radiation therapy

Conditions: Prostate Cancer

Summary: in current radiation therapy, imaging (typically, cone beam ct imaging or two orthogonal x-ray projection imaging) is done for patient setup before radiation dose delivery. dose delivery typically takes 2 to 5 minutes depending on the delivery technique used for treatment. a tumor target may change its position during the dose delivery process. the goal of this project is develop a real-time imaging strategy to monitor the tumor position during dose delivery and evaluate its potential clinical impact.


Eligibility criteria:
inclusion criteria: * the study population will be drawn from available patient population that will be treated using imrt/vmat. the stanford population of imrt/vmat will be taken as roughly representative of prospective imrt patients and will not be subdivided by any additional characteristics. exclusion criteria: * the study population will be drawn from available patient population that will be treated using imrt/vmat. the stanford population of imrt/vmat will be taken as roughly representative of prospective imrt patients and will not be subdivided by any additional characteristics.
disease risk reduction and omega-3 rich rainbow trout (fish for health)

Conditions: Obesity

Summary: the purpose of this study is to determine how eating fish raised to have different levels of omega-3 fatty acids will reduce cardiovascular risk markers in people with elevated cardiovascular risk.

consumption of fish high in long chain omega-3 fatty acids (lcn3) is associated with reduction of cardiovascular disease (cvd) risk. cvd is a major cause of death in the united states. the current obesity epidemic contributes significantly to elevated cvd risk by increasing inflammation and platelet dysfunction. prevention of cvd is a public health goal and comprises several avenues of action, of which inclusion of lcn3-rich fish in the diet may be one of the most effective. obese participants will participate in a double blind, randomized, cross-over designed trial in which they will consume twice-weekly a prepared meal containing diploid (2n) farmed rainbow trout, triploid (3n) farmed rainbow trout containing higher levels of lcn3, or tilapia, a low lcn3 fish.

Eligibility criteria:
inclusion criteria: * bmi of 30 - 39.9 kg/m2 exclusion criteria: * are allergic to fish * use tobacco products or nicotine in any form including snuff, pills, and patches, or e-cigarettes in the past 6 months * have established cardiovascular, pulmonary, and/or a metabolic disease such as diabetes * have uncontrolled high blood pressure * have alcohol, anabolic steroids, or other substance abuse issues * consume more than 3 alcoholic drinks/week * have cancer * are pregnant or nursing * take non-steroidal anti-inflammatory drugs such as aspirin, ibuprofen or aleve, lipid modifying drugs such as statins, take medications for blood glucose such as insulin or metformin

Keywords: obese omega-3 fatty acids fish
laparotomy closure techniques: do surgeons follow the latest guidelines? results of a questionnaire.

Conditions: Incisional Hernia; Laparotomy Closure Technique

Summary: incisional hernias after laparotomy are associated with significant morbidity and increased costs. research is focused on development of new techniques to prevent incisional hernia. little is known about application of this evidence in daily practice. therefore, a survey was performed among dutch surgeons.

incisional hernias after laparotomy are associated with significant morbidity and increased costs. research is focused on development of new techniques to prevent incisional hernia. little is known about application of this evidence in daily practice. therefore, a survey was performed among dutch surgeons. all members of the dutch surgical society were invited to participate in a 24-question online survey on techniques and materials used for abdominal wall closure after midline laparotomy. subgroup analysis based on surgical subspecialty, hospital and experience was performed.

Eligibility criteria:
inclusion criteria: * surgeon in the netherlands exclusion criteria: * not practicing surgery * not practicing in the netherlands

Keywords: incisional hernia prevention laparotomy closure quality improvement survey guideline
study evaluating refacto in hemophilia a

Conditions: Hemophilia A

Summary: to identify the causative mutations in previously untreated patients with hemophilia a enrolled in the refacto® clinical safety and efficacy study ctn 93-r833-0xx/c9741-28, using two established hemophilia mutation testing laboratories (one in europe and one in north america).


Eligibility criteria:
inclusion criteria: * patients who were or are enrolled in study ctn 93-r833-0xx/c9741-28, and have been treated with refacto® during this study are eligible for participation. * the patient (or legal guardian) must be willing to give written informed consent before any study-related procedures are performed. * a blood sample will be collected from each patient for the purpose of this study and will be analyzed at one or both of the designated central laboratories. exclusion criteria: * any condition which, in the investigator's opinion, places the patient at undue risk.
anxiolytic effects of lavender and orange oil

Conditions: Anxiety State; Pediatric ALL; Dental Anxiety; Oil; Inhalation; Anesthesia

Summary: the aim of this study is to determine the possible anxiety reducing effects of lavender oil and orange oil on parents with children receiving dental care under sedation during perioperative wait.

anxiety is a common problem for parents with children under sedation. it has long been known that operations, unconsciousness, the risks of the anesthesia and airway problems can cause a considerable amount of anxiety. anxiety is associated with an uncertain psychological distress , and may vary to minor disturbances to extreme stress. the study aims to help parents improve their satisfaction by reducing their anxiety levels and ensure they have a better experience. in addition, anxiety can also prevent active participation of the parents during postoperative recovery. the physical and psychological effects of essential oils and traditional medicine practices as aromatherapy has been used for a long time and has potency to reduce using sedatives. lavender oil is a fragrance that many of us have experienced in growing up at home and is also popular today. the lavender plant belongs to the labitae family and has been used for centuries in dried or essential oil form. lavender is obtained from flower heads and leaves with vapor distillation. this oil has also been specifically investigated and is an essential oil scientifically shown to reduce patient anxiety before various interventions. orange oil is an essential oil produced by cells within the rind of an orange fruit (citrus sinensis fruit). in contrast to most essential oils, it is extracted as a by-product of orange juice production by centrifugation, producing a cold-pressed oil. it is composed of mostly d-limonene. this oil has been investigated and shown to reduce anxiety and improve mood before various interventions.the anxiolytic effects of these essential oils has not been investigated for parents with children undergoing pediatric dental procedures under sedation. the aim of this study is to investigate the effects of lavender oil and orange oil diffused in the perioperative waiting room of parents with children under sedation.

Eligibility criteria:
inclusion criteria: to be the parent of a child undergoing pediatric procedures under deep sedation. to be over 18 years old. volunteering to fill pre-operative anxiety tests. exclusion criteria: hypersensitivity to lavender/orange and its products. being on any medication. being a psychiatric or psychological problem and being under treatment. current upper airway infection or asthma story. not want to be involved in the study.

Keywords: perioperative anxiety lavender oil orange oil pediatric dentistry deep sedation
comparison of ipack and adductor canal block combination versus epidural analgesia for total knee arthroplasty

Conditions: Knee Injuries

Summary: to compare the efficacy and complications of ipack and adductor canal block combination and epidural block in patients who will be operated for knee arthroscopy under spinal anesthesia.

between 15.08.2022 and 15.04.2023, the patients who will be operated on for knee surgery under spinal anesthesia, older than 18 years of age were included in the study. demographic characteristics of the patients, comorbidities, asa scores, mobilization time, amount of postoperative analgesic use, and postoperative pain scores of the 1. 8. 24. hours will be observed. the vas score at the 3rd month was learned over the phone.

Eligibility criteria:
inclusion criteria: * those who consented to participate in the study * patients over the age of 18 who will be operated on due to knee pathology * patients to be operated under spinal anesthesia * disease that will limit cooperation exclusion criteria: * patients under the age of 18 * patients to be operated under general anesthesia * disease that will cause limited cooperation