Kornimate/medical-research-clean huggingface dataset:
a study of the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin naive type 2 diabetic patients inadequately controlled with metformin plus sulphonylurea.

Conditions: Diabetes Mellitus Type 2

Summary: this 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 iu/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. the anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at least 12 weeks; * c-peptide (fasting) \>=1.0ng/ml; * hba1c \>=7.0% and \<=10.0% at screening; * bmi \>=25 (\>23 for asians) and \<=45kg/m2 at screening; * stable weight +-5% for at least 12 weeks prior to screening. exclusion criteria: * history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months; * evidence of clinically significant diabetic complications; * symptomatic poorly controlled diabetes; * clinically symptomatic gastrointestinal disease; * myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months; * known hemoglobinopathy or chronic anemia.
pilot trial of kb001 in mechanically-ventilated patients colonized with pseudomonas aeruginosa

Conditions: Pseudomonas Aeruginosa; Ventilator Associated Pneumonia

Summary: pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. experts estimate that there are greater than 100,000 patients in the united states, europe and japan where pseudomonas pneumonia occurs. patients with pseudomonas pneumonia currently represent only about 20% of the patients in the hospital who get pseudomonas infections.

this trial will evaluate kb001 in patients in the intensive care setting who are receiving ventilator therapy and who have pseudomonas infections. they will receive either placebo, or one of two dose levels of kb001, a humaneered™, high-affinity antibody fragment that kalobios is developing for the treatment of pseudomonas aeruginosa (pa) infections. this trial will evaluate the ability of kb001 to protect host epithelium and immune cells, and evaluate reduction of pulmonary pa burden.

Eligibility criteria:
inclusion criteria: * provision of written informed consent obtained from patient or patient's surrogate if unconscious or altered sensorium * age \>18 years * on mechanical ventilation and expected to remain mechanically ventilated for at least 3 days * documented pulmonary pa colonization exclusion criteria: * patients with known chronic pulmonary infection with pa (i.e., patients with cystic fibrosis) * patient currently diagnosed with pa vap * change in systemic antibiotic therapy active against gram negative bacteria within 72 hours * use of an investigational medication within 4 weeks prior to randomization

Keywords: mechanical ventilation mechanically ventilated pseudomonas aeruginosa ventilator associated pneumonia
a comparison of mcgrath mac videolaryngoscopy and macintosh laryngoscopy for orotracheal intubation in children with torticollis

Conditions: Anesthesia, Endotracheal

Summary: the primary purpose of this study is to investigate the effects of mcgrath mac videolaryngoscopy on the intubation time for orotracheal intubation in children with torticollis. the secondary purpose of this study is to investigate the effects of mcgrath mac videolaryngoscopy on cormack and lehane grade for orotracheal intubation in children with torticollis.


Eligibility criteria:
inclusion criteria: * orotracheal intubation under general anesthesia * torticollis exclusion criteria: * •oral lesions, congenital anomaly, cervical spine instability, rapid sequence intubation
a safety and efficacy study evaluating ctx001 in subjects with severe sickle cell disease

Conditions: Sickle Cell Disease; Hematological Diseases; Hemoglobinopathies

Summary: this is a single-arm, open-label, multi-site, single-dose phase 1/2/3 study in subjects with severe sickle cell disease (scd). the study will evaluate the safety and efficacy of autologous crispr-cas9 modified cd34+ human hematopoietic stem and progenitor cells (hhspcs) using ctx001.


Eligibility criteria:
key inclusion criteria: * diagnosis of severe sickle cell disease as defined by: * documented severe sickle cell disease genotype * history of at least two severe vaso-occlusive crisis events per year for the previous two years prior to enrollment * eligible for autologous stem cell transplant as per investigators judgment key exclusion criteria: * an available 10/10 human leukocyte antigen (hla)-matched related donor * prior hematopoietic stem cell transplant (hsct) * clinically significant and active bacterial, viral, fungal, or parasitic infection other protocol defined inclusion/exclusion criteria may apply
endothelial dysfunction, biomarkers, and lung function -ancillary to mesa

Conditions: Chronic Obstructive Pulmonary Disease (COPD); Emphysema; Endothelial Dysfunction

Summary: the purpose of mesa-lung is to assess the role of endothelial dysfunction and genetic susceptibility in subclinical copd.

chronic obstructive pulmonary disease (copd) is currently the fourth leading cause of death in the united states, and morbidity and mortality from copd continue to rise. despite the magnitude of the problem, therapeutic options are limited - particularly in comparison to cardiovascular disease. smoking cessation is essential to the treatment and prevention of copd. however, although smoking is the principal cause of copd, only a minority of smokers develops symptomatic copd and many former smokers develop copd years to decades after they have stopped smoking. the only other medical intervention proven to reduce mortality from copd is supplemental oxygen therapy. there is therefore an urgent need for newer understandings of the pathophysiology of copd that might lead to the development of better therapies for copd. mesa-lung is ancillary of the ongoing multi-ethnic study of atherosclerosis (mesa). mesa-lung will utilize the various existing measures of endothelial function that have been already been collected in mesa (flow-mediated dilatation \[fmd\] and related biomarkers and gene polymorphisms) to test the hypotheses that the endothelial dysfunction occurs in the clinical copd.

Eligibility criteria:
inclusion criteria: * a random sample of mesa participants active at exam 3 and/or 4. exclusion criteria: * mesa participants without mesa exam 3 or 4 measurements. * mesa participants without fmd measurements in exam 1. * mesa participants who have not consented to genetic testing.

Keywords: copd mesa lung biomarkers
raltitrexed-based chemotherapy plus bevacizumab in retreated patients with advanced colorectal cancer

Conditions: Advanced Colorectal Cancer

Summary: the objective is to investigate the efficacy and safety of raltitrexed-based chemotherapy plus bevacizumab in the treatment of advanced colorectal cancer


Eligibility criteria:
inclusion criteria: * 18-70 years; * histological and/or cytological confirmation of acc; * disease progression while on first-line palliative fluoropyrimidine-based chemotherapy or relapse within 6 months after adjuvant chemotherapy; * at least one measurable objective tumor lesion by spiral ct examination, the maximum diameter ≥ 1cm（according to recist 1.1） * ecog performance status 0-1 * life expectancy of at least 3 months * satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (hgb) ≥90g/l, neutrophil count（anc） ≥1.5×109/l, platelet count（plt） ≥80×109/l, serum creatinine（cr）≤1.5 upper normal limitation (unl)，total bilirubin (tbil) ≤1.5 upper normal limitation (unl), alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤2.5 unl (for patients with liver metastasis, the ast/alt must be ≤5.0 unl), alkaline phosphatase（alp）≤3 unl(for patients with liver metastasis, the alp must be ≤5.0 unl); * written informed consent exclusion criteria: * prior exposure to raltitrexed; * clinically significant cardiovascular disease, for example symptomatic coronary artery disease, myocardial infarction (\ = grade 3）,stroke or transient ischemic attack * accept kidney dialysis treatment now * chronic enteropathy on unresolved bowel obstruction; * previous malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma of the skin; * the ugt1a1 \*28（7/7）\*6（a/a） gene type; * pregnant or lactated women; * unsuitable for the study or other chemotherapy determined by investigator.
effect of metabolic syndrome on complex decongestive physiotherapy outcomes in lymphedema patients

Conditions: Lymphedema

Summary: as a result of our research, investigators could not find any study investigating the effectiveness of complex decongestive physiotherapy (kbf) in lymphedema patients with metabolic syndrome. therefore, our aim is to compare the effectiveness of kbf in patients with and without metabolic syndrome.

this study was planned to investigate the effects of metabolic syndrome seen in patients with lymphedema on the results of complex decongestive physiotherapy. lymphedema is a chronic disease characterized by the accumulation of protein-rich fluid in the interstitial space. among all the treatment approaches known in the field, complex decongestive physiotherapy (cdt) is accepted as the gold standard in the treatment of lymphedema. cdt is a treatment approach consisting of manual lymph drainage, skin care, compression bandage and exercises. in clinical studies conducted to date, the effectiveness of cdft in the treatment of lower and upper extremity lymphedema has been clearly demonstrated. metabolic syndrome is a medical term that describes the combination of various cardiovascular risk factors such as insulin resistance, impaired glucose tolerance or diabetes mellitus, obesity, abdominal fat accumulation, dyslipidemia, hypertension, and coronary artery disease. obesity, the cardinal component of the metabolic syndrome, is a well-known risk factor for lymphedema, and increased body mass index (bmi) is associated with the frequency and severity of lymphedema. obesity often accompanies lymphedema due to the effect of lymphedema and the characteristics of patients with lymphedema. our aim in this study, which was planned in the light of these data, is to examine whether the presence of metabolic syndrome in patients with lymphedema changes the effectiveness of cdt.

Eligibility criteria:
inclusion criteria: * those between the ages of 18-65, * to be diagnosed with lymphedema in the lower or upper extremities * volunteering to participate in the study * getting \>24 points from the standardized mini mental test exclusion criteria: * having a score of \<24 on the standardized mini mental test * finding any problem preventing communication

Keywords: lymphedema metabolic syndrome
self-injection of adalimumab in adult japanese subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the long-term safety of subcutaneous (sc) self-injections (by the subject or subject's family member) of adalimumab in adult japanese subjects with rheumatoid arthritis in an open-label study.


Eligibility criteria:
inclusion criteria: * completed week 36 of study m03-651 \[nct 00235872\] * wish to participate in self-injection study * give written informed consent * comply with protocol requirements exclusion criteria: * subject develops serious adverse events at time of eligibility confirmation * subject develops severe infections requiring hospitalization or iv injection of antibiotics within 28 days before eligibility confirmation * subject develops infections requiring oral administration of antibiotics within 14 days before eligibility confirmation * the investigator considers the subject inappropriate for participation

Keywords: rheumatoid arthritis
phase iii study of tas-118 plus oxaliplatin versus s-1 plus cisplatin in patients with advanced gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this trial is to evaluate the efficacy of tas-118 plus oxaliplatin compared with s-1 plus cisplatin in overall survival in patients with advanced gastric cancer.


Eligibility criteria:
key inclusion criteria: * patients who are diagnosed as gastric cancer. * no prior treatment for gastric cancer. * negative or unknown for her2 testing. * ecog performance status of 0 or 1. key exclusion criteria: * unmanageable diarrhea. * current peripheral sensory neuropathy or paresthesia. * pregnant or lactating female.

Keywords: gastric cancer gastrointestinal diseases gastrointestinal neoplasms first line treatment antineoplastic agents
acute supplementation with beta-alanine improves performance in aerobic-anaerobic transition zones in endurance athletes

Conditions: Beta-alanine

Summary: the use of beta-alanine (ba) to increase physical performance is widely documented. however, the acute effect of this amino acid on maximal tests in the aerobic-anaerobic transition zone is still uncertain. the objective of this study was to determine the acute effect of low and high-dose ba trials on maximal aerobic speed (mas) in endurance athletes. we hypothesized that high doses of ba have a greater effect than low doses, both compared to baseline. twelve male endurance athletes volunteered for the study. the experimental design applied was randomized cross-over, double-blind. treatment included three 6-minute run tests (6-mrt), the first as a baseline, then randomized 6-mrt with low (30 mg·kg-1) and high (45 mg·kg-1) dose ba trials. the 6-mrts were separated by 72 hours. the main variable of the study was the distance (m) performed in the 6-mrt. differences between tests were established through anova and tukey's multiple comparison tests (p \< 0.05).

in this original research, we determined the acute effect of low (30 mg·kg-1) and high-dose (45 mg·kg-1) ba trials on maximal aerobic speed (mas) in endurance athletes. at the same time, we compared the effect size with of ba.

Eligibility criteria:
inclusion criteria: * the inclusion criterion was years of training for endurance events (participants had a minimum of two years running middle-distance and long-distance events). exclusion criteria: * the exclusion criterion was the inability to perform the 6-minute run test

Keywords: beta-alanine ergogenic aid physical performance aerobic-anaerobic transition zones maximal aerobic speed
antibiotic safety (scamp)

Conditions: Complicated Intra Abdominal Infections

Summary: the main purpose of this study is evaluate whether it is safe or not to use various combination of antibiotics (ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, gentamicin) in treating infants with complicated intra-abdominal infections

the most commonly used antibiotics in infants with complicated intra-abdominal infections are not labeled for use in this population because safety and efficacy data are lacking. this study will provide the safety information required for labeling. in addition, the pharmacokinetics(pk) and effectiveness data will also be collected during this study.

Eligibility criteria:
inclusion criteria: 1. informed consent obtained from parent(s) or legal guardian(s) (groups 1-5) 2. ≤33 weeks gestation at birth (groups 1-3, 5) 3. ≥34 weeks gestation at birth (groups 4 and 5) 4. pna \<121 days (groups 1-5) 5. sufficient venous access to permit administration of study drug (intravenous \[iv\]) (groups 1-5) 6. presenting physical, radiological, and/or bacteriological findings of a complicated intra-abdominal infection within 48 hours prior to randomization/first study drug dose (groups 1-4)\*\*. complicated intra-abdominal infections include secondary peritonitis, nec grade ii or higher by bell's criteria, hirschsprung's disease with perforation, spontaneous intestinal perforation, meconium ileus with perforation, bowel obstruction with perforation, gastroschisis with necrosis and/or perforation, omphalocele with necrosis and/or perforation, neonatal appendicitis, intestinal pneumatosis or portal venous gas, free peritoneal air on abdominal radiographic examination, or abdominal abscess. 7. suspected or confirmed infection for which the study drug may provide therapeutic benefit and planned csf collection per standard of care (group 5). exclusion criteria\* 1. history of anaphylaxis in response to study drugs (groups 1-5) 2. serum creatinine \>2 mg/dl within 48 hours on measurement prior to and closest to randomization /first study drug dose (groups 1- 5)\*\* 3. known alt \>250 u/l or ast \>500 u/l on measurement closest to the time of randomization or first study drug dose (groups 1-5)\*\* 4. any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety (groups 1-5) * do not apply for group 5 participants receiving drug per standard of care * criteria must be satisfied by randomization (randomized groups 1-3) or first study drug dose (non-randomized groups 1-3, group 4 and group 5), whichever comes first.

Keywords: antibiotics ampicillin metronidazole clindamycin piperacillin-tazobactam safety infants intra abdominal infections
pulsed electromagnetic fields for analgesia post mastectomy

Conditions: Female Breast Cancer; Post Operative Pain

Summary: study aim is to test algocare, a device that uses the technology pemf (pulsed electromagnetic fields) for the treatment of postoperative pain in oncological breast surgery, in order to demonstrate that the use of algocare in the postoperative period allows for a reduction in pain intensity in terms of numerical rating scale (nrs) score and use of analgesic drugs.

the treatment of postoperative pain is a priority issue for both the doctor and the patient. obtaining adequate analgesia in the first postoperative days, in fact, is essential for the patient's comfort, but also to promote and accelerate functional recovery and prevent chronic pain, which in the case of breast surgery has a high incidence (20-60 %). the use of pulsed electromagnetic fields (pemf) for the treatment of pain and inflammation has been widely studied and validated. study aim is to test algocare, a device that uses the technology pemf (pulsed electromagnetic fields), for the treatment of postoperative pain in oncological breast surgery. this is a field of application in which this technique analgesic has never been tested, but in which it could prove valid within a multimodal analgesia protocol, as the pain caused by this type of intervention is predominantly parietal and resulting from tissue trauma caused by the surgical wound. algocare is a non-invasive and non-pharmacological device, developed specifically for treatment of post-operative inflammation and pain, ce certified and registered with the ministry of health. it emits a pulsed radio frequency electromagnetic field at 27.1 mhz, a frequency already studied and approved for medical use.

Eligibility criteria:
inclusion criteria: * breast cancer patients undergoing unilateral mastectomy with reconstruction and without axillary dissection exclusion criteria: * patients with pacemakers (pms), implantable cardioverter defibrillators (icds), neurostimulators or other active medical devices or metal implants near the application area * pregnancy * amyloidosis, sarcoidosis, scleroderma, infectious arthritis, paget's disease or joint tumors

Keywords: unilateral mastectomy with reconstruction post operative pain
the effect of age and inspiratory resistance on the inspiratory gas levels while wearing air purifying respirator "

Conditions: Aging

Summary: 20 healthy young subjects and 20 healthy older subjects will go through a medical examination. subjects will be asked for their medical history especially on respiratory and cardiac diseases. all subjects will go through a spirometry test to evaluate their respiratory function. after their medical clearance each subjects will be asked to wear a cbrn respirator for 45 minutes. 15 minutes without filter, 15 minute with 0.8 cmh2o resistance, and 15 minutes with 1.2 cmh2o resistance. throughout the test, pco2 and po2 will be measured. the investigator will evaluate the effect of resistance (filter resistance) and the age of the subject on co2 accumulation in the mask.

after signing the consent form, 20 healthy young subjects and 20 healthy older subjects will go through a medical examination. subjects will be asked for their medical history especially on respiratory and cardiac diseases. all subjects will go through a spirometry test to evaluate their respiratory function. after their medical clearance each subjects will be asked to wear a cbrn respirator for 45 minutes. 15 minutes without filter, 15 minute with 0.8 cmh2o resistance, and 15 minutes with 1.2 cmh2o resistance. throughout the test, pco2 and po2 will be measured with mass spectrometer. oxygen saturation, pulse rate, and minute ventilation will also be monitored. the investigator will evaluate the effect of resistance (filter resistance) and the age of the subject on co2 accumulation in the mask.

Eligibility criteria:
inclusion criteria: healthy females and males, with no respiratory, cardio vascular diseases, high blood pressure, psychiatric problem, degenerative nervous system problem, and chronic head ache, muscular disease, or severe acute disease within the two weeks before the study. age 18 and 25, and 55 and 70 years old. who volunteer to the study - exclusion criteria: did not pass the inclusion criteria, pregnant women, o2 saturation lower then 95%, pathological sound from the heart or lungs. claustrophobia, smoking history more then 2.5 packs years.
sickle cell improvement: enhancing care in the emergency department

Conditions: Sickle Cell Crisis

Summary: sickle cell disease (scd) is an inherited blood disorder affecting approximately 36,000 children in the united states, approximately 90% of whom are black. the disease is characterized by recurrent, severe pain crises which result in high rates of emergency department visits and hospitalizations, and decreased quality of life. the national heart, lung and blood institute, as well as the american society of hematology, have endorsed pain management guidelines regarding the timeliness of care for children presenting with these acute pain crises. these evidence-based guidelines are infrequently followed, resulting in increased pain and hospitalizations. in additional to other barriers to following the guideline, structural racism has been proposed as a significant contributor and the new england journal of medicine recently called for the institution of scd-specific pain management protocols to combat structural racism and reduce time to opioid administration. the investigators' long-term goal is to improve the care and health outcomes of children with acute painful vaso-occlusive crisis treated in the emergency department. the overall aim of the investigators is to test a care pathway using multifaceted implementation strategies to increase guideline adherent care for children in the emergency department with acute painful vaso-occlusive crisis.


Eligibility criteria:
inclusion criteria: * ed visit for uncomplicated pain crisis * sickle cell disease * receipt of at least one opioid exclusion criteria: * acute chest syndrome * fever \> 38.5 in the ed * priapism * sickle cell trait