Kornimate/medical-research-clean huggingface dataset:
study project comparing the sequelae of covid-19 infection in patients who have and have not received ventilatory support in critical care

Conditions: Covid19

Summary: to assess the proportion of post-intensive care syndrome (pics) of patients who received high flow humidified oxygen with fio2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for covid-19 pneumonia


Eligibility criteria:
inclusion criteria: - group 1: patients hospitalized in intensive care units for ards with sars-cov-2 * major * admitted between march 1 and may 10, 2020 in one of the sectors of the bicêtre hospital approved for critical care * proven sars-cov-2 infection * treated by invasive mechanical ventilation or high flow humidified oxygen with fio2 ≥50% for more than 48 hours. group 2: patients hospitalized outside intensive care units * major * admitted between march 1 and may 10, 2020 in an area of bicêtre hospital having cared for patients infected with sars-cov-2 excluding critical care: pulmonology, internal medicine / orthopedics, infectious diseases, nephrology , acute geriatrics, neurology. exclusion criteria: * patients having refused the post consultation at 3 month * without social security coverage
curative study of chinese traditional medicine to treat lung cancer

Conditions: Cancer

Summary: the purpose of this study is to observe the efficacy of chemotherapy combined with chinese patent drugs for patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.

lung cancer is the most common malignant tumor in the world with about 80%-85% non small cell lung cancer. the investigators perform a multi-center, randomized, controlled, prospective study in patients with advanced nsclc. patients are randomized over observational group(chinese patent drugs plus chemotherapy), and control group (chemotherapy). the investigators will observe 2 cycles and after that regular follow-up will be arranged. the primary end point is: objective response rate; the secondary end points are: 1. progression-free survival(pfs); 2. overall survival(os); 3. time to progression (ttp); 4. quality of life questionnaire（qol); 5. other end points are: toxicity, side effects and security of the treatments will be assessed at the same time. the investigators expect that integrated tcm combined with chemotherapy has a better efficacy on enhancing objective response rate，prolonging pfs, os, improving qol, reducing the adverse reaction of patients than that of chemotherapy.therefore our study can provide evidences for optimizing and promoting integrated tcm combined with western medicine treatment.

Eligibility criteria:
inclusion criteria: 1. pathologically or cytologically confirmed of stage ⅲb-ⅳ nsclc 2. ages eligible for study: 18-65 years old; 3. physical status score (ecog ps) ≤ 2 scores； 4. estimated life expectancy of at least 6 months； 5. participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥10g/dl, absolute neutrophil count (anc) ≥1.5\*109/l, platelets ≥80\*109/l, liver and kidney function is normal; 6. informed consent from the patient. exclusion criteria: 1. patient with other malignant tumor except nsclc 5 years previous to study entry. 2. patients who have received targeted drug treatment； 3. serious problem of heart, liver or kidney with severe dysfunction; 4. pregnant or child breast feeding women; 5. mental or cognitive disorders; 6. participating in other drug trials; 7. who are allergic to the study drug. 8. diabetic patients.

Keywords: chinese traditional medicine
efficacy and safety of vildagliptin compared to gliclazide in drug naive patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study is not being conducted in the united states. the purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.


Eligibility criteria:
inclusion criteria: * not currently on drug therapy for type 2 diabetes * body mass index (bmi) in the range 22-45 * blood glucose criteria must be met exclusion criteria: * pregnancy or lactation * type 1 diabetes * evidence of significant diabetic complications * evidence of serious cardiovascular conditions * laboratory value abnormalities as defined by the protocol * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
individualized blood pressure management during endovascular stroke treatment

Conditions: Acute Ischemic Stroke

Summary: optimal blood pressure management during endovascular treatment of acute ischemic stroke is not well established. several retrospective data indicate, that there is a u-shaped relationship of admission blood pressure and functional outcome, where either very high or very low blood pressure are disadvantageous for the patient. low blood pressure might lead to hypoperfusion in ischemic areas (i.e. penumbra) and to larger infarction sizes, while on the other hand, maladaptive high blood pressure might lead to edema and hemorrhage. retrospective data investigating intraprocedural blood pressure and its influence on outcome is limited. some studies indicate that hypotensive blood pressure drops from the level of the admission blood pressure lead to a worse outcome. intraprocedural hypotensive drops are common during endovascular thrombectomy due to application of necessary sedative drugs for agitated stroke patients. we aim to investigate whether individualized blood pressure management with patient-specific blood pressure targets situated at the level during presentation might be associated with better functional outcome compared with general blood pressure targets for patients during thrombectomy. for this purpose, we plan to perform this single center, parallel-group, open-label randomized controlled trial with blinded endpoint evaluation (probe).


Eligibility criteria:
inclusion criteria: 1. decision for thrombectomy according to local protocol for acute recanalizing stroke treatment 2. age 18 years or older, either sex 3. national institutes of health stroke scale (nihss) ≥ 8 4. acute ischemic stroke in the anterior circulation with isolated or combined occlusion of: internal carotid artery (ica) and/or middle cerebral artery (mca) 5. informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment exclusion criteria: 1. intracerebral hemorrhage 2. coma on admission (glasgow coma scale ≤ 8) 3. severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary 4. intubated state before randomization 5. severe hemodynamic instability (e.g. due to decompensated heart insufficiency)
a study to evaluate the effect of rifampicin on the pharmacokinetics of oral hrs-5041 in healthy subjects

Conditions: Prostate Cancer

Summary: the study was designed to evaluate the pharmacokinetic effects of rifampicin on hrs-5041 after oral administration of hrs-5041 tablets in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. males aged 18-55 years (inclusive). 2. male participants whose partner was a woman of childbearing potential were required to use contraception from the time they provided written informed consent until 3 months after the last dose of the investigational product. 3. weight ≥ 50 kg and body mass index (bmi) : 19-28 kg/m2 (inclusive). 4. participants were able to communicate well with the investigators, understand and comply with the requirements of the study, and sign the informed consent form. exclusion criteria: 1. patients who have had or are currently suffering from any clinically serious diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry or metabolic system or any other diseases that may interfere with the test results. 2. patients who had undergone surgery within 6 months before screening or who were scheduled to undergo surgery during the study or who had undergone any previous surgery affecting gastrointestinal absorption (including gastrectomy, bowel resection, or gastric contraction). 3. patients who had donated blood or had massive blood loss (≥400 ml), received blood transfusion, or used blood products within 3 months before screening. 4. allergic constitution, including severe drug allergy or history of drug allergy; he had a history of allergy to hrs-5041 tablets, rifampicin, or their excipients. 5. history of drug abuse within 1 year before screening; those with positive urine drug abuse screening. 6. who participated in any clinical trial and took a study drug within 3 months before the first dose. 7. drinking more than 14 units of alcohol per week in the 6 months prior to screening (1 unit = 285 ml for beer, 25 ml for spirits, or 100 ml for wine); or have taken alcohol-containing products 48 hours before administration; or positive alcohol breath test at baseline. 8. patients with abnormal vital signs and judged by the investigator to be clinically significant. 9. hcv (hepatitis c virus) antibody positive, hiv antibody positive, hbsag positive, syphilis antibody positive. 10. those who have special requirements for diet and cannot abide by the uniform diet. 11. patients with a history of needle fainting and blood fainting, difficulty in blood collection or inability to tolerate venous puncture blood collection.
study of association between peripheral immune cells and recurrence in stage ii/iii colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine association between peripheral immune cells(pic) and recurrence in stage ii/iii colorectal cancer

the investigators hypothesize differentiation of peripheral immune cells(pic) would result in resistance of chemotherapy and tumor local of metastatic recurrence. the primary endpoint of this study is disease free survival and the secondary endpoint is 5-year overall survival. 5ml peripheral blood will be sorted and counted through flow cytometry at the point of before primary treatment(surgery for colon cancers, neoadjuvant therapy for rectal cancers) , before the first chemotherapy postoperatively and 1 month after last chemotherapy. patients will be followed up with 3 monthly assessments in the first two years and 6 monthly assessments in the rest three years. stratification factors include age , bmi , gender , tumor location , rectal or colon cancer stage,the chemotherapy (folfox, xelox, degramont or capecitabine ),laparoscopic or laprotomy, anastomosis, concomitant medications and complications.

Eligibility criteria:
inclusion criteria: * clinically /pahohistologically diagnosed as stageii/iii crc * ecog 0-2 * age 18-90 * gender both exclusion criteria: * distant metastases noticed before or during surgery * history of malignant tumor disease * history of autoimmune diseases or immunodeficiencies * history of hematological disease * history of hepatic cirrhosis or splenomegaly * history of chronic kidney disease * history of organ transplant * history of chronic inflammatory disease * use of hematological drugs within 1 year prior to surgery * use of immunodulatory drugs within 1 year prior to surgery * use of chemotherapeutic drugs within 1 year prior to surgery * long term use of non-steroid anti-inflammatory drugs(\>6 months) * unable or unwilling to undergo all the standard treatment

Keywords: peripheral immune cells colorectal cancers stage ii/ stage iii recurrence metastasis
phase 2a study to assess civi 007 in patients on a background of statin therapy

Conditions: Hypercholesterolemia

Summary: evaluation of the clinical profile (lipid efficacy, safety and pk) across a number of doses of civi 007, a pcsk9 inhibitor. patients to be evaluated will be on a stable background of statin therapy with or without ezetimibe.


Eligibility criteria:
key inclusion criteria: 1. body mass index (bmi) between 18.0 and 40.0 2. stable (\>4 weeks prior to the screening visit) dose of statin therapy with or without ezetimibe 3. fasting low-density lipoprotein cholesterol (ldl-c): ≥100 mg/dl for those without cardiovascular disease, or ≥70 mg/dl for those with cardiovascular disease. 4. fasting triglycerides (tgs) \<400 mg/dl key exclusion criteria: 1. women who are pregnant, nursing or breast feeding 2. currently prescribed a lipid lowering agent other than a statin or ezetimibe. 3. clinically significant disorder or laboratory abnormality that could contraindicate the administration of study drug, affect compliance, interfere with study evaluations, or confound the interpretation of study results
inflammation, platelets and sickle cell disease

Conditions: Platelet Activation; Thromboinflammation; Sickle Cell Disease

Summary: sickle cell disease (scd) is an autosomal recessive genetic disorder linked to a single mutation on beta-globin chains. this leads to red blood cell deformation and chronic hemolysis which can result in vaso-occlusive events, anemia and vasculopathy. pathophysiology is incompletely understood, and beyond red blood cell's abnormalities this involves hemostasis and innate immunity. the aim of our study is to describe the mechanisms of thrombo-inflammation during the vaso-occlusive crisis (voc) in adults with sickle cell disease.

pathophysiology of sickle cell disease is incompletely understood. the typical change of red blood cells into sickle cells lead to post-capillary stream abnormalities. this phenomenon is responsible of ischemia-reperfusion injuries. chronic hemolysis is the second part of the pathophysiology. the consequences are vasoconstriction, endothelial lesions, chronic inflammation, hemostasis and platelets activation. thrombo-inflammation concept was proposed by tanguay to describe the interactions between hemostasis, platelets and innate immune cells (neutrophils polynuclear) during thrombotic process. since this time, this concept was largely described in many clinical situations such as septicemia, covid-19, coronaropathy, auto-immune diseases and sickle cell disease. in this project, we will study platelets activation and thrombo-inflammation markers in the beginning of a vaso-occlusive crisis, during the crisis and two months after the crisis. blood samples will be collected during a routine care sample. biological markers studied will be: * soluble and surface markers of platelet activation; platelet-leukocytes aggregates * plasmatic eicosanoids produced by platelets (txb2) and immune cells * in vitro platelets reactivity; dynamic thrombus formation in normal and pathologic arterial blood stream * platelet's inflammasome

Eligibility criteria:
inclusion criteria: * patient with sickle cell disease diagnosis, hospitalized in emergency department and/or internal medicine department * patient older than 18 years * written consent to participate to the study * patient with health insurance * patient able to receive information about the study exclusion criteria: * age \< 18 years * non consent to participate to the study * women in pregnancy or breastfeeding * treatment with aspirin or non steroidal anti inflammatory drug * protected patient * patient already involved in a study requiring collection of additional biological samples

Keywords: sickle cell disease vaso-occlusive crisis platelets thrombo-inflammation
prediction of intrahospital cardiac arrest outcomes

Conditions: Cardiac Arrest

Summary: intrahospital cardiovascular arrest is one of the most common causes of death in hospitalized patients. in contrast to extramural cases of cardiovascular arrest, hospitalized patients often have severe medical conditions that can affect the outcome of resuscitation. nevertheless, survival rates from resuscitation are better in hospitals than outside, because there is often a rapid start of resuscitation measures and predefined resuscitation standards. regular cpr training and the availability of defibrillators in all bedside units can also positively influence outcome. despite these many efforts, survival rates, especially of patients with good neurological outcome, remained stable at low levels even within hospitals in recent years and did not improve. most outcome parameters are nowadays well known. (e.g., initial rhythm, age, early defibrillation, etc.) nevertheless, we still do not know today how relevant the corresponding factors actually are, especially in relation to each other. one approach to this might be machine learning methods such as "random forest", which might be able to create a predictive model. however, this has not been attempted to date. the hypothesis of this work is to find out if it is possible to accurately predict the probability of surviving an in-hospital resuscitation using the machine learning method "random forest" and if particularly relevant outcome parameters can be identified. design: retrospective data analysis of all data sets recorded in the resuscitation register of kepler university hospital. measures and procedure: review of the registry for missing data as well as false alarms of the cpr team and, if necessary, exclusion of these data sets; evaluation of the data sets using the machine learning method random forest.


Eligibility criteria:
inclusion criteria: * all adults patients suffering cardiac arrest and having been resuscitated by the medical emergency team of the kepler university hospital, linz, austria in the period of 2006-01-01 to 2018-10-31. exclusion criteria: * none.
starting pediatric obesity prevention in pregnancy

Conditions: Obesity; Pregnancy

Summary: the purpose of this study is to examine whether we can use social networks to spread health information and health behaviors during pregnancy to prevent excessive gestational weight gain.

the long-term goal of this research is to prevent obesity-related adverse health outcomes for future generations by applying information emerging from social network studies to the development of new population-based behavioral interventions. there are a number of critical periods during fetal development that appear to influence the later development of obesity. interventions that prevent insult to these critical windows from occurring could improve children's life course trajectories. this project sets the groundwork for examining whether social networks could explicitly be utilized to support women in gaining weight during pregnancy within their clinically recommended weight gain target.

Eligibility criteria:
inclusion criteria: * any race/ethnicity * speak spanish or english * ≥16 years * \>10 and \<28 weeks pregnant * in prenatal care * anticipating remaining in middle tennessee for their full gestation * willing to sign a medical information release form so that we can abstract weight measures from their obstetric and pediatric records exclusion criteria: * speak neither spanish or english * \<16 years * \ 28 weeks pregnant * not in prenatal care * anticipating leaving middle tennessee before full gestation * unwilling to sign medical information release form * current or past (within last 12 months) enrollment in another research program that targets weight, physical activity, nutrition

Keywords: gestational weight gain
pilot evaluation of atomoxetine on attention deficit hyperactivity disorder (adhd) symptoms in adolescents with cannabis abuse

Conditions: Attention Deficit Hyperactivity Disorder; Cannabis Abuse

Summary: the purpose of this study is to determine whether atomoxetine is effective in reducing adhd (attention deficit/hyperactivity disorder) symptoms in adolescents with adhd and comorbid cannabis abuse.

in the past adolescents with cannabis abuse have been excluded from studies in which atomoxetine for adhd symptoms was studied. in this study the efficacy of atomoxetine on symptoms of adhd in adolescents with adhd and comorbid cannabis abuse will be studied.

Eligibility criteria:
inclusion criteria: * diagnosis adhd based on the diagnostic and statistical manual of mental disorders (dsm-iv-tr) * at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the adhd rating scale-iv-parent version * cannabis abuse or dependence based on the dsm-iv-tr, and using a minimum of 5 joints per week exclusion criteria: * weight under 20 kilograms (kg) * patients at serious suicidal risk * patients with alcohol or drug abuse (other than cannabis) * patients who in the investigator's judgement are likely to need psychotropic medication + psychotherapy apart from atomoxetine

Keywords: attention deficit hyperactivity disorder with cannabis abuse marihuana abuse comorbid cannabis abuse
conjugate pneumococcal vaccine in ataxia telangiectasia (at)

Conditions: Ataxia Telangiectasia (AT)

Summary: ataxia telangiectasia (at) is an autosomal recessive inherited condition caused by mutations in the atm gene1. patients suffer from neuro-degenerative problems, usually commencing in the second year of life, and affecting predominantly the cerebellum. they also develop the characteristic superficial telangiectases. between 60 and 80% of affected children are immunodeficient. this is associated with deficiency of immunoglobulin a (iga ) 2, of igg23 and of antibody responses to pneumococcal polysaccharides4. patients suffer recurrent sino-pulmonary infections but a recent study suggests poor correlation between immune status and immunological parameters5. if uncontrolled, recurrent pulmonary infections can contribute to the development of chronic lung disease and bronchiectasis. preventative management includes continuous prophylactic antibiotic treatment in some with the need for replacement immunoglobulin therapy in only a small proportion of cases. antibiotics have been reasonably effective in this situation but the emergence of resistance amongst community acquired pneumococcal isolates is a cause for concern. appropriate immunisation strategies may also have a role. this study is designed to look at antibody responses in a one versus two dose regimen in a cohort of at patients recruited through the at society a national charitable organisation involved in providing support to families with this condition and in fostering education and research in the field.


Eligibility criteria:
inclusion criteria: * genetically confirmed diagnosis of at

Keywords: ataxia telangiectasia, conjugated pneumococcal, prevenar, immunogenicity , vaccine