Kornimate/medical-research-clean huggingface dataset:
a study of bevacizumab (avastin) in women with her2 negative metastatic breast cancer

Conditions: Breast Cancer

Summary: this study will evaluate the efficacy and safety of 2 doses of avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic her2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. the anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.

five participants randomized to the docetaxel 100 mg/m\^2 plus placebo group actually received docetaxel 100 mg/m\^2 plus bevacizumab 7.5 mg/kg and are included in the docetaxel 100 mg/m\^2 plus bevacizumab 7.5 mg/kg group for the adverse event results. sixteen participants randomized to the docetaxel 100 mg/m\^2 plus placebo group actually received docetaxel 100 mg/m\^2 plus bevacizumab 15.0 mg/kg and are included in the docetaxel 100 mg/m\^2 plus bevacizumab 15.0 mg/kg group for the adverse event results.

Eligibility criteria:
inclusion criteria: * female patients ≥ 18 years of age. * human epidermal growth factor receptor 2 (her2)-negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy. * no adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization. * eastern cooperative oncology group (ecog) performance status of 0-1. exclusion criteria: * previous chemotherapy for metastatic or locally recurrent breast cancer. * radiotherapy for treatment of metastatic disease. * other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix. * spinal cord compression or brain metastases. * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization. * inadequate bone marrow, liver, or renal function. * uncontrolled hypertension.
personality profile of children and adolescents with adhd and with or without emotional dysregulation

Conditions: Attention Deficit Disorder; Emotional Dysfunction

Summary: attention deficit hyperactivity disorder (adhd) is frequently associated with emotional dysregulation (ed). ed is characterized by excessive and inappropriate emotional reactions compared to social norms, uncontrolled and rapide shifts in emotion and attention focused on emotional stimuli. according to research, there are strong correlations between personality traits and psychiatric disorder as adhd. in a longitudinal study, the persistence of adhd symptoms during adolescence is associated with high neuroticism, low agreeableness and low conscience. studies show that these personality traits are factors of vulnerabilities for comordities associated with adhd and are predictive of overall functioning difficulties. studies show correlations between adhd in childhood and personality disorders at adulthood . adhd is frequently associated with emotional dysregulation (ed) that is characterized by an inability to modulate emotional responses in a given context . ed is observed in 24% to 50% children with adhd . children with adhd and ed are more likely to present a severe and complex symptomatology and are at risk for antisocial and bordeline personality disorders than children without ed. to date, there would be no studies which would have been interested in personality traits in children with adhd and ed. the main objective is to determine if children with adhd and ed present from childhood traits of personality as low agreeableness, low conscience and high neuroticism that are predictive of personality disorders at adulthood. it would involve earl identification of children at increased risk of pejorative developmental trajectories. the second objectives are: * improve understanding of the heterogeneity of adhd symptom expression; * have a better understanding of the child's personalit and temperament traits to identify riks and protective factors; * identify children with adhd with profiles at risk of personality disorders in order to adapt the care according to the child's needs.


Eligibility criteria:
inclusion criteria: * children and adolescents aged 7-12 years followed at montpellier university hospital ; * children and adolescents with a diagnostic of adhd (diagnostics criteria from dsm-v); * children and adolescents benefiting from a multidisciplinary evaluation or therapeutic group at the child psychiatry unit of montpellier university hospital exclusion criteria: - family non-french speaking

Keywords: personality traits children attention deficit hyperactivity disorder emotion dysregulation
safety, tolerability, pharmacokinetics and pharmacodynamics study of rlyb116 in healthy participants

Conditions: Hematologic Diseases; Autoimmune Diseases

Summary: this study will investigate the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of rlyb116 (with an improved impurity profile) following repeated administration of rlyb116 in healthy participants.


Eligibility criteria:
inclusion criteria: 1. male and female participants, 18 to 55 years of age. 2. able to provide written informed consent. 3. body mass index (bmi) of 18.0 to 32.0 kg/m2. 4. must have been vaccinated against n. meningitidis and s. pneumoniae with approved vaccine according to product label. all participants considered eligible for enrollment will be vaccinated or willing to receive vaccination according to the following: 1. vaccination with meningococcal group a, c, w135, and y conjugate vaccine (menveo® or an acceptable alternative) + pneumococcal polysaccharide vaccine (pneumovax® 23 or an acceptable alternative) at least 28 days prior to receiving the first dose of rlyb116. 2. vaccination with meningococcal group b (bexsero®) at least 14 days prior to receiving the first dose of rlyb116. exclusion criteria: 1. participants that smoke more than 10 cigarettes per week 2. positive serology for hiv or active infection with hepatitis b virus or hepatitis c virus. 3. pregnant or nursing 4. donation or loss of greater than 400 ml of blood within 56 days of study enrollment 5. history of severe hypersensitivity to any drug, including penicillin or ciprofloxacin, or to n. meningitidis or s. pneumoniae vaccines.

Keywords: complement-mediated diseases
bay43-9006 phase ii study for renal cell carcinoma

Conditions: Carcinoma, Renal Cell

Summary: to evaluate efficacy, safety, and pharmacokinetics of bay 43-9006 in patients with unresectable and/or metastatic renal cell cancer (rcc) who have failed at least one cytokine containing regimen.


Eligibility criteria:
inclusion criteria: * patients who suffer from unresectable and/or metastatic, measurable rcc histologically or cytologically documented. * patients with rare subtypes of rcc, such as pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors, are excluded from study participation. exclusion criteria: * more than three regimens of previous treatment for rcc

Keywords: bay 43-9006 phase ii renal cell carcinoma response rate
aceis and arbs treatment in diabetic patients -drug interactions and adverse drug effects

Conditions: Diabetes Mellitus Type 2

Summary: proteinuria is an expression of diabetic nephropaty in type 1 and type 2 patients. hypertenshion treatment and decreasing urine protein excretion, slow down renal deterioration. treating diabetic ,hypertensive patients with angiotensin converting enzyme inhibitors (acei), angiotensin receptor blockers (arbs)is common practice. the aim of our work is to examine 1.the prevalence of ace and arb treatment in diabetic patients with or without hypertension.2. adverse drug reactions of acei and arbs alone or in combination.

the study group- men and women with diabetes mellitus type 2,who were hospitalized in the department of internal medicine in assaf- harofeh medical center. during hospitalization, data regarding the clinical history,chronic diseases and drugs were collected from the medical files. blood tests results were recorded during hospitalization .the patients were asked about adverse drug effects.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients admitted to department of internal medicine in assaf harofeh medical center exclusion criteria: * type 1 diabetes mellitus

Keywords: diabetes mellitus type 2 ace inhibitors arbs adverse drug effect
immunotherapy with cd19 cart-cells for b cell acute lymphoblastic leukemia

Conditions: Leukemia, B-Cell

Summary: this study aims to evaluate the safety and clinical activity of cd19 chimeric antigen receptor (car) redirected autologous t-cells in treating patients with recurrent or refractory cd19 positive b cell ccute lymphoblastic leukemia,and dynamically observe the changes of car-t in patients and the residual tumor.

in this single-center, open-label, single-arm, prospective clinical trial, a total of 20 recurrent or refractory cd19+ b cell acute lymphoblastic leukemia patients will be enrolled.after recruiting eligible patients,autologous peripheral blood mononuclear cells(pbmcs) will be purified from whole blood.the cd3+ t cells were subsequently selected and re-stimulated by anti-cd3 and anti-cd28 monoclonal antibodies.t cells will be transduced with lentiviral vector for the generation of the cd19 cart cell and administered by i.v. injection.the purpose of current study is to determine the safety and clinical efficacy of cd19 car t cells therapy in patients with recurrent or refractory cd19+ all.

Eligibility criteria:
inclusion criteria: * recurrent or refractory b cell derived acute lymphoblastic leukemia (all) * patients who have failed at least one line of a standard treatment without effective treatment measures at present * cd19 expression on the surface of b-all cells must be detected * kps\>80 * life expectancy \>3 months * patients must have adequate cardiac function (no electrocardiogram with obvious abnormality, lvef≥50%),adequate pulmonary function as indicated by room air oxygen saturation of \> 90%, and adequate renal function (cr≤2.5 times of the normal range) * the alanine aminotransferase (alt) and the aspartate aminotransferase (ast)≤ 3 times of the normal range, and the total bilirubin (tbil)≤2.0mg/dl(34.2umol/l) * hemoglobin(hgb)≥80g/l * without contraindication of apheresis and cell isolation * patients and their families volunteer to participate in the research with signed written informed consent exclusion criteria: .other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease; another severe and/or life-threatening medical disease. * evidence of uncontrolled current serious active infection * hiv/hbv/hcv infection * pregnancy and nursing females * systemic glucocorticoid therapy within one week

Keywords: chimeric antigen receptor-modified t cells cart recurrent b cell acute lymphoblastic leukemia refractory b cell acute lymphoblastic leukemia all
pathophysiological subtyping of abnormalities in cocaine dependence - 9

Conditions: Cocaine-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to define pathophysiological subtypes of abnormalities in subjects with cocaine dependence.

the objective of this study is to define subgroups of patients with differential treatment outcome on the basis of differential baseline electrophysiological clusters.

Eligibility criteria:
inclusion criteria: cocaine dependence. seeking residential treatment.
serum pepsinogen after h. pylori eradication

Conditions: Helicobacter Pylori Eradication

Summary: helicobacter pylori has been recognized as a major pathogen in gastric carcinogenesis. current guidelines recommend the h. pylori "test-and-treat" strategy for the purpose of primary and secondary gastric cancer prevention. considering the "point of no return" theory, however, h. pylori eradication cannot reduce the risk of gastric cancer in subjects with gastric atrophy and intestinal metaplasia. the intragastric hypoacidic environment is associated with the risk of intestinal-type gastric cancer development. recently, the secretory ability of the stomach can be measured using the serum pepsinogen (pg) assay.

this study aimed to evaluate the change of serum pgs after h. pylori eradication success and identify the optimal timing of eradication.

Eligibility criteria:
inclusion criteria: * gastroscopy can be performed * serologic markers including serum pepsinogen can be measured exclusion criteria: * age \ 70 years * anemia (serum hemoglobin level \< 10 g/dl) * severe systemic disease * advanced chronic liver disease * use of certain medications, including proton pump inhibitors, h2- receptor antagonists, or antibiotics * history of h. pylori eradication * history of gastric surgery * recent history of upper gastrointestinal bleeding
sedation versus no sedation for detection rates of precancerous lesions and cancer

Conditions: Early Detection of Cancer

Summary: the influence of sedation on the endoscopic detection rate of the precancerous lesions and cancer of upper digestive system has not been assessed. in the daily medical routine of china, patients have the right to choose the sedation style according to his or her own situation, whose detailed endoscopic data of patients are recorded in the endoscopy quality control system. the aim of this research is to detect whether the use of sedation can help improve detection rate of precancerous lesions and cancer of upper digestive system.

the influence of sedation on the endoscopic detection rate of the precancerous lesions and cancer of upper digestive system has not been assessed. in the daily medical routine of china, patients have the right to choose the sedation style according to his or her own situation, whose detailed endoscopic data of patients are recorded in the endoscopy quality control system. the aim of this research is to detect whether the use of sedation can help improve detection rate of precancerous lesions and cancer of upper digestive system.

Eligibility criteria:
inclusion criteria: * patients aged more than 18 years with or without gi symptoms attending for endoscopy from 2012 to 2019. exclusion criteria: * patients unable to cooperated the endoscopy or unable to complete it. people with endoscopy contraindications are naturally excluded.

Keywords: early detection of cancer gastrointestinal neoplasms endoscopy, gastrointestinal
prehospital analgesia intervention trial (pain)

Conditions: Traumatic Injury

Summary: the prehospital analgesia intervention trial (pain) is a proposed 4 year (3-year enrollment) multicenter, prehospital, randomized, double-blind, clinical trial that will enroll approximately 994 patients at select lites network sites. the objective is to perform a prospective, interventional, randomized trial among prehospital trauma patients with compensated shock (si≥0.9) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.


Eligibility criteria:
inclusion criteria: * transport after injury to a participating pain trauma center * patient with compensated shock as defined by shock index (si) ≥0.9 * intravenous pain medication indicated (cpot≥2, nrs≥5) prior to arrival at the trauma center exclusion criteria: * no iv access * age \<18 years * females \<50 years of age * sbp\>180 mmhg at time of enrollment * advanced airway management prior to first dose administration * known allergy to fentanyl citrate or ketamine hydrochloride * known prisoner * objection to study voiced by subject or family member at scene * pain treatment contraindicated by local protocol * wearing a "no pain study" bracelet

Keywords: trauma ketamine hydrochloride fentanyl citrate shock pain
a clinical trial to evaluate the safety and pharmacokinetics of aju-c52l in healthy volunteers

Conditions: Hypertension

Summary: to evaluate the safety and pharmacokinetic characteristics of aju-c52l in healthy adults

this study is to assess the safety and pharmacokinetic characteristics between co-administration of c52r1h with c52r2 and administration of aju-c52l. this is an open-label, randomized, single-dose, 2x2 crossover study in healthy subjects to assess the bioequivalence after taking the study drugs.

Eligibility criteria:
inclusion criteria: 1. healthy adult volunteers aged ≥ 19-year-old 2. weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(bmi) of 18 to 30 kg/m2 3. those who are eligible for adequate blood pressure criteria during screening tests systolic blood pressure: 90 to 139 mmhg diastolic blood pressure: 60 to 89 mmhg 4. those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings 5. those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ecg results during screening tests 6. those who agree to contraception during the participation of clinical trial 7. those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial exclusion criteria: 1. those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug 2. those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug 3. those who donated whole blood and apheresis within 8 weeks or received transfusion within 4 weeks 4. those who has a history of gastrointestinal surgery 5. those who exceeding an alcohol and smoke consumption criteria alcohol: men - 21 glass/week, women - 14 glass/week (1 glass: soju 50 ml, beer 250ml, wine 30 ml) smoke: 20 cigarettes/day 6. those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema 7. genetic problems such as galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption 8. those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests 9. women who are pregnant or who may be pregnant and breastfeed
incidence of chronic pain after thoracotomy

Conditions: Postoperative Pain; Postoperative Pain, Acute; Postoperative Pain, Chronic; Thoracotomy

Summary: thoracotomy is frequently performed in thoracic surgery. it is widely accepted that thoracotomy causes severe acute pain. many factors such as postoperative analgesia treatment plan, operation time, number of chest tubes, and duration of chest tube stay can affect acute pain. this acute pain prolongs the discharge time of the patients and increases the frequency of postoperative pulmonary complications and postoperative morbidity. postoperative acute pain may cause chronic thoracotomy pain in the later period, and may adversely affect the quality of life of the patients. this study aims to analyze the symptoms of chronic pain in the 3rd and 6th months postoperatively in patients who had undergone thoracotomy.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * american society of anesthesiologists physical status i-ii-iii * body mass index (bmi) between 18-35 kg/m2 * patients undergoing elective thoracotomy exclusion criteria: * advanced cancer * history of chronic analgesic therapy * patients with previous thoracic surgery * patients who were operated under emergency conditions

Keywords: postoperative pain postoperative pain, acute postoperative pain, chronic thoracotomy
hemodynamic and inflammatory responses in thoracic surgery

Conditions: Video-Assisted Thoracic Surgery

Summary: video-assisted thoracoscopic surgery (vats) for thoracic surgery is practical, has been shown to reduce postoperative discomfort, and has improved cosmetic results when compare to open thoracotomy. the specific aims of this project are: to clarify the physiologic and immunologic effects of different approaches for minimally invasive thoracic surgery: (1) multiple-port vats; (2) single-port vats

video-assisted thoracoscopic surgery (vats) was first reported in the early 1990s. since then, the safety and efficacy of thoracoscopy for diagnosing and treating pleural, pulmonary, and mediastinal disease has been demonstrated with similar oncological results, which were confirmed by multiple clinical studies. although vats for thoracic surgery is practical, has been shown to reduce postoperative discomfort, and has improved cosmetic results when compare to open thoracotomy, unfortunately chronic thoracic wound discomfort and postoperative neuralgia were found in a significant portion of patients . recently, a minimally invasive approach that is different from the conventional multiport thoracoscopic technique is gradually becoming of great interest in the diagnosis and treatment of thoracic surgical disease. single-port vats is one of the most promising emerging surgical techniques which allows the surgeon to perform a majority of thoracic surgeries and with similar perioperative outcomes that are comparable with the conventional multiport technique. however, a very limited number of clinical studies have demonstrated the advantages of single port vats in postoperative pain reduction, when comparing to the traditional multiport thoracoscopic approach. to clarify the physiologic and immunologic effects of different approaches for minimally invasive thoracic surgery, investigators aim to compare the perioperative physiological changes, immunological responses, and postoperative pain between standard (multi-port) transthoracic thoracoscopic and single-port transthoracic thoracoscopic surgery for thoracic disease.

Eligibility criteria:
inclusion criteria: * patient with thoracic surgical diseases(lung cancer. mediastinal tumor. solitary pulmonary lesion. pneumothorax) who will be underwent video-assisted thoracic surgery exclusion criteria: * unresectable mediastinal tumor * previous history of ipsilateral pulmonary resection * patients with complex cardiopulmonary dysfunction * unresectable pulmonary hilar tumor

Keywords: thoracoscopic surgery
interaction study of clopidogrel 300/75 mg given alone or concomitantly with omeprazole 80 mg in healthy subjects

Conditions: Healthy

Summary: primary objective: * assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on adenosine diphosphate (adp)-induced platelet aggregation when given concomitantly with omeprazole 80 mg/day compared to given alone in healthy male and female subjects secondary objective: * compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone or concomitantly with omeprazole

the total study duration per subjects is 8 - 9 weeks broken down as follows: * screening: 2 to 21 days before the first dosing * period clopidogrel/placebo: 7 days including 5 days treatment * period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment * washout between periods: at least 14 days after last dosing with respect to clopidogrel treatment * end of study: 7 to 10 days after the last dosing

Eligibility criteria:
healthy subject: * as determined by medical history, physical examination including vital signs and clinical laboratory tests: * with a body weight between 50 kg and 95 kg if male, between 40 kg and 85 kg if female, and with a body mass index (bmi) between 18 and 30 kg/m² exclusion criteria: * evidence of inherited disorder of coagulation/hemostasis functions * smoking more than 5 cigarettes or equivalent per day * abnormal hemostasis screen * unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration * any contraindication to clopidogrel and/or omeprazole the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.