Kornimate/medical-research-clean huggingface dataset:
expanded access multicenter study of lucanix® (belagenpumatucel-l)

Conditions: Non-small Cell Lung Cancer

Summary: this is an expanded access protocol designed to make lucanix® available to subjects with advanced non-small cell lung cancer (nsclc) who are not eligible for the phase iii protocol, nr001-03. a total of 45 patients will be enrolled into the study.

the primary objective of this study is to increase the overall survival of the study subjects by providing expanded access to lucanix. overall survival and progression-free survivals will be compared with historical controls. the secondary objectives of this study are: * evaluate the best overall tumor response. * evaluate progression-free survival (pfs). * evaluate treatment toxicity.

Eligibility criteria:
inclusion criteria: * signed informed consent * ≥ 18 years * histological confirmed non-curable stage iii or iv nsclc. * must have completed at least one (1) regimen of anti-cancer therapy. * following frontline therapy, subjects must observe the following wash- out periods: * subjects with stable disease or better must have received the last anti-cancer therapy not less than five months prior to enrollment. * subjects with progressive disease must have received the last anti-cancer therapy at least one (1) month prior to enrollment. * all subjects who have received two (2) or more regimens of therapy must have received the last anti-cancer therapy at least one (1) month prior to enrollment. * performance status (ecog) ≤ 2 * absolute granulocyte count ≥ 1,500/mm3 * platelet count ≥ 100,000/mm3 * total bilirubin ≤ 2× upper limit of normal * ast and alt ≤ 2× upper limit of normal * creatinine ≤ 2× upper limit of normal * negative pregnancy test for women of childbearing potential. exclusion criteria: * concurrent systemic steroids \> 2 mg prednisone/day * prior splenectomy * any chemotherapy, steroid therapy, or investigational anti-cancer agent within 4 weeks of study entry. * subjects who received prior monotherapy with lucanix. * symptomatic brain metastases unless treated and stable for ≥ 2 months * known hiv positivity * serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives. * prior malignancy (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years * history of psychiatric disorder that would impede adherence to protocol * pregnant or nursing women or refusal to practice contraception if of reproductive potential

Keywords: lung cancer nsclc stage iii or iv nsclc
severe acute respiratory syndrome coronavirus 2 (sars-cov-2) neutralizing antibody bgb-dxp593 in participants with mild-to-moderate coronavirus disease 2019 (covid-19)

Conditions: Covid19

Summary: the primary objective of this study is to evaluate the efficacy of bgb-dxp593 administered intravenously as a single dose in participants with mild to moderate covid-19


Eligibility criteria:
key inclusion criteria: 1. laboratory-confirmed severe acute respiratory syndrome (sars)-cov-2 infection (positive reverse transcription-polymerase chain reaction \[rt-pcr\] test or other authorized antigen testing methods) in any samples following local practice ≤ 72 hours prior to screening. 2. have experienced covid-19 symptoms for ≤ 7 days prior to treatment assignment, such as fever, cough, shortness of breath, sore throat, diarrhea, vomiting, and dysgeusia 3. agree to the collection of nasopharyngeal swabs, saliva, and venous blood key exclusion criteria: 1. severe covid-19 having oxygen saturation (spo2) ≤ 93 % on room air at sea level or ratio of arterial oxygen partial pressure (pao2 in millimeters of mercury) to fractional inspired oxygen (fio2) \< 300, respiratory rate ≥ 30/min, heart rate ≥ 125/min 2. requires mechanical ventilation or anticipated impending need for mechanical ventilation 3. known allergies to any of the components used in the formulation of the interventions 4. have received an investigational intervention for sars-cov-2 prophylaxis within 30 days before dosing 5. have received treatment with a sars-cov-2 specific monoclonal antibody note: other protocol defined inclusion/exclusion criteria may apply.
effect of capnography feedback during cardiopulmonary resuscitation (cpr ) on patient's outcome

Conditions: Cardiopulmonary Arrest

Summary: compare the quality performance of rescuers and resuscitation outcomes of cardiac arrest patients in both groups with and without capnography feedback

this study has done at mashhad ghaem educational center. two nurses and an anesthesia resident selected and trained according to the latest guidelines of cpr . in the control sample, with the declare of code 99 and attend the team on the patient's bedside, cpr begins and then every two minutes, return of the patient checks in the usual way. quality performance of rescuers ,recovery or death of the patient and the result is recording. in the second phase , group members were educated how to use capnography (comdek's md-660p oxi-capnography) in cpr and guiding restoration efforts by it. with the code 99 and attend the team on the patient's bedside capnography uses and its waveforms will appear on the monitor device which is visible to all rescuers and the quality of performance is renewed based on the its guidance. the two groups patients for age, sex, initial rhythm of arrest, time of arrest until the first action, the time of arrest until the first shocks are comparing to control these factors influence on the outcome. quality performance of rescuers , resuscitation outcomes and cpr duration and relative factors in each of the groups were recorded and compared.

Eligibility criteria:
inclusion criteria: * cardiac arrest patient age more than 18 exclusion criteria: * age more than 80 cardiac arrest due to pulmonary embolism

Keywords: cpr feedback capnography outcome quality resuscitation
trial of mongolian medicine zhenbao pills for upper-limb dysfunction after stroke

Conditions: Ischemic Stroke

Summary: the trial was designed to test the hypothesis that treatment with mongolian medicine zhenbao pills has a positive effect on upper-limb motor recovery after acute ischemic stroke.

the study is a randomized, double-blinded, placebo-controlled, multi-center trial.

Eligibility criteria:
inclusion criteria: 1. adult subjects (male or female ≥18 years). 2. the diagnosis of ischemic stroke should be met and the onset should be within 30 days. 3. patients with prestroke modified rankin scale score 0-1. 4. fam-ue score of 20-57 at randomization. 5. the patients and legal guardians signed informed consent. exclusion criteria: 1. cranial ct or mri findings of hemorrhage or other pathologic brain disorders, such as vascular malformations, tumors, abscesses, encephalitis, or other common non-ischemic brain diseases (e.g., multiple sclerosis). 2. chronic liver disease or elevated alt, ast (greater than two times the upper limit of normal), renal insufficiency or elevated blood creatinine (greater than 1.5 times the upper limit of normal). 3. coagulation disorders or history of systemic hemorrhage. 4. life expectancy is less than 3 months. 5. unable to complete the study due to mental illness, cognitive or emotional impairment. 6. suspected or known allergy to the components of the trial medication. 7. pregnancy, breastfeeding or potential pregnancy. 8. treatment within the last 3 months that may affect limb function, such as botulinum toxin injections or medications to improve limb motor function, etc. 9. within three months or currently participating in another investigational study. 10. other patients who, in the opinion of the investigator, are not suitable for participation of the study.

Keywords: ischemic stroke mongolian medicine zhenbao pills efficacy safety randomized controlled trial
estrogen treatment (oral vs. patches) in turner syndrome

Conditions: Turner Syndrome; Hypogonadism; Premature Ovarian Failure

Summary: the study attempts to evaluate if the way of administering estrogen, the principal female hormone, via patches or orally, affects the way estrogen works in girls with turner syndrome. these are girls who are very short and whose ovaries do not work. we will examine changes bone, protein and fat metabolism under the influence of estrogen delivered by a patch trough the skin vs estrogen taken orally. these studies are conducted while the girls are taking gh therapy.

girls with turner syndrome, between the ages of 10-16 years, were chosen as the study population. the study requires 3 overnight admissions to an in-patient clinical research center(crc). a baseline study is performed using stable isotope tracers of leucine, glycerol and glucose and serial blood sampling to measure protein and fat metabolism. indirect calorimetry is used to measure substrate oxidation rates and total energy expenditure. dexa scan is used to measure bone mineral density and body composition. once the baseline study is complete subjects are randomly assigned to receive either estrogen orally or through a patch placed onto the skin in increasing doses changed every 2 weeks. after 6 weeks of estrogen treatment a second metabolic study, identical to the first, is performed, followed by a wash out period of 4 weeks. subsequently, the subjects are switched to the alternate form of estrogen. at the end of 6 weeks a third and final metabolic study is repeated. all subjects continue to be on growth hormone throughout the study procedures.

Eligibility criteria:
inclusion criteria:girls with turner syndrome 10-16 years old who are receiving growth hormone treatment. - exclusion criteria:systemic disease or concomitant treatment wtih oxandrolone. significant obesity or chronic steroid use. -

Keywords: turner syndrome hypogonadism gh estrogen estrogen patches igf-i body composition protein metabolism lipolysis
identification of molecular biomarkers to stratify patients with refractory asthma

Conditions: Asthma

Summary: the purpose of this study is to learn more about asthma in people who are not well-controlled with current asthma medication (refractory asthma). the investigators will compare data from refractory asthmatic patients here at national jewish health to mild asthmatics subjects and to people without asthma. study experiments involve looking at samples from all 3 groups and comparing them at a molecular level. these laboratory experiments may help identify subtypes of refractory asthmatics that require different treatments.


Eligibility criteria:
inclusion criteria: * able to receive informed consent * at least 18 years of age * ics \< 880 mcg (fp equivalents) * pc20\<=16 mg/ml * no more than 1 oral steroid bursts in previous 12 months * less that 3 urgent care visit in previous 12 months * no deterioration with \<=25% decrease in steroids * no near fatal asthma event exclusion criteria: * pregnancy * current smoker, smoking within the past year or pack/year history \>10 years * respiratory infection within past 6 weeks * antibiotics within the past 6 weeks * active lung disease other than asthma * cancer within past 5 years (excluding basal cell skin cancer) * active or chronic infection * hematological or autoimmune disease * unable to safely undergo bronchoscopy as determined by doctor or study doctor

Keywords: asthma
a study to evaluate ertapenem versus it's comparator in the treatment of complicated intra-abdominal infections in adults (0826-050)(completed)

Conditions: Complicated Intra-abdominal Infection

Summary: this was a prospective, randomized, controlled, open, and multi-center trial conducted to compare the clinical efficacy and safety of ertapenem with it's comparator before or following adequate surgical management of complicated intra-abdominal infection.


Eligibility criteria:
inclusion criteria: * males or females between the ages of 18 and 75 who have complicated intra-abdominal infection.
i am protecting my child from the sun program

Conditions: Skin Neoplasms; Parents; Behavior and Behavior Mechanisms; Child Behavior; Health Behavior

Summary: this study aimed to examine the effect of the "i am protecting my child from the sun" program, based on social cognitive theory, on parents' sun-protection product use and sun avoidance behaviors. the "i am protecting my child from the sun" program, based on social cognitive theory, and the sending of short reminder messages had positive effects on the parents' behaviors related to protecting themselves and their children from the sun.

this study aimed to examine the effect of the "i am protecting my child from the sun" program, based on social cognitive theory, on parents' sun-protection product use and sun avoidance behaviors. organized as a randomized controlled experimental study conducted on three groups with a pre- and post-test follow-up design, the study was carried out in manavgat between april 2018 and october 2018 and included the participation of 185 parents, of which 63 were in the education group, 62 were in the education+sms group, and 60 were in the control group. the parents in the intervention group were administered the "i am protecting my child from the sun" program for a period of six weeks, while the education+sms group, in addition to the program, also received a total of 25 short text messages twice a week. data were collected using the parent information form, skin cancer risk perception form, skin cancer and sun knowledge scale, parental self-efficacy scale, parental sun protection scales, and parent behaviors regarding protecting themselves and their children from the sun question form.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the research * being least literate * no communication problems in terms of hearing, seeing and understanding * being a mobile phone user to receive text messages sent by the researcher * living in the same home with the child * joining both parents or one of the parents * no possibility of leaving the region during the research exclusion criteria: * skin cancer diagnosis / history * having a family history of skin cancer

Keywords: skin cancer sun protection parent behavior social cognitive theory public health nursing
evaluation of body mass index and eating behaviour changes in female patients with fibromyalgia under medical treatment

Conditions: Eating Behavior; Body Weight; Fibromyalgia

Summary: the purpose of this study is to evaluate of body mass index and eating behaviour changes in female patients with fibromyalgia under medical treatment.

the female patients with fibromyalgia under medical treatment say that body mass index and eating behaviour changes,for this reason, this relationship will be investigated in this study. demographic data (sex, age, education level, occupation) of patients with fibromyalgia diagnosis will be questioned and height lengths will be measured. the group of medications (serotonin and norepinephrine reuptake inhibitor or gabaergic drugs) that begins with the diagnosis of the disease fibromyalgia will be recorded. all patients will be assessed when diagnosed, followed by 2nd week and then 4nd week. in each follow-up, the patients' weights will be measured again (the body mass index will be calculated from the measured value). in each follow-up, the effect of fibromyalgia on the daily life of the patients will be questioned with fibromyalgia impact questionnaire (fiq). the fiq was developed from information gathered from patient reports, functional status instruments, and clinical observations. this instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week. in each follow-up, patients' eating behaviour will be questioned with three factor eating questionnaire. the 18-item three-factor eating questionnaire is a scale that measures three domains of eating behavior: cognitive restraint , uncontrolled eating and emotional eating. in each follow-up, the right calf circumference of the patients will be measured in centimeters with a tape measure .

Eligibility criteria:
inclusion criteria: * female subjects between the ages of 18-40 * subjects, who met the 2013 american college of rheumatology (acr) criteria for fibromyalgia exclusion criteria: * history of eating disorders such as anorexia nervosa, bulimia nevroza * history of hypothyroidism or hyperthyroidism * pregnant or breast feeding * history of central or peripheral nervous system disorders * history of infectious, chronic inflammatory disease, malignant tumors * subjects with active psychiatric illness or who use psychiatric medication * uncooperative subject * history of cardiac pathology such as heart failure, coronary artery disease * history of diabetes, chronic renal insufficiency, chronic liver failure

Keywords: chronic pain body mass index eating habits
perioperative anticoagulant use for surgery evaluation study

Conditions: Atrial Fibrillation

Summary: the aim of the perioperative anticoagulant use for surgery evaluation (pause) study, is to establish a safe, standardized protocol for the perioperative management of patients with atrial fibrillation (af) who are receiving a novel oral anticoagulant (doac) drug, either dabigatran, rivaroxaban or apixaban, and require an elective surgery/procedure.

the primary aim is to demonstrate that a standardized but patient-focused protocol for the perioperative management of each doac is safe, with acceptably low rates of perioperative major bleeding (mb) and arterial thromboembolism (ate). the perioperative protocol is adjusted based on patient renal function and surgery/procedure-related bleed risk, to optimize patient safety, and does not involve heparin bridging anticoagulation. the secondary aim of the pause study is to determine the effect of the pre-operative doac interruption protocol on the level of residual anticoagulation, when measured by 'everyday' coagulation tests that are not doac-specific (e.g., activated partial thromboplastin time \[aptt\]) and 'specialized' coagulation tests that are doac-specific (dilute thrombin time \[tt\] - hemoclottm, and anti-factor xa assays). approximately 3,300 patients from 15 to 25 centres over a 3.5 year period will be recruited across canada for the pause study. patients with atrial fibrillation and are currently taking dabigatran, rivaroxaban and apixaban (doacs) and require elective surgery/procedure will follow a standardized management perioperative protocol for discontinuation of their doac prior to surgery. patients will be discontinuing the doac they are currently receiving from 1 to 4 days prior to surgery or procedure, depending on bleed risk, type of doac, and creatinine clearance rate. a blood sample will be taken on the day of the surgery or procedure for measurement of laboratory outcomes (residual level of anticoagulant on day of surgery). patients will be followed up weekly up to a month for primary outcome assessments.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. receiving a doac (dabigatran or rivaroxaban or apixaban) for atrial fibrillation 3. ability to assess patient at lease one day prior to doac discontinuation exclusion criteria: 1. crcl less than 30 ml per min for dabigatran- and rivaroxaban-treated patients ( less than 25 ml per min for apixaban-treated patients) as estimated by cockroft-gault formula 2. cognitive impairment or psychiatric illness that precludes collection of followup data 3. inability or unwillingness to provide informed consent

Keywords: anticoagulant atrial fibrillation surgery oral anticoagulant discontinue doac noac blood thinner interruption
an efficacy and safety study of ivacaftor in patients with cystic fibrosis and two splicing mutations

Conditions: Cystic Fibrosis

Summary: this postmarketing n of 2 study is designed to evaluate the efficacy and safety of open-label ivacaftor treatment in two sisters with cystic fibrosis and pancreatic sufficiency.

the two sisters have a splicing mutation that is predicted to respond favorably to ivacaftor therapy. in addition to measurement of usual clinical outcomes (i.e. lung function, nutritional status), there is great interest on the impact on nontuberculous mycobacteria (ntm) airways infection. subjects will undergo sputum cultures at baseline and monthly during treatment, initially in the absence of anti-ntm therapy but with the intent to treat with antibiotics if there is persistence of the infection in cultures. other clinical outcomes will include changes in sweat chloride, lung function and weight. safety measures will include periodic assessment of liver enzymes. all serious and non-serious adverse events will be collected

Eligibility criteria:
inclusion criteria: * subjects are \>18 years of age and able to provide informed consent. * subjects reside in the us and are willing to be treated with ivacaftor. * subjects have the splicing mutation of interest. * subjects are willing and able to perform requirements of the study. exclusion criteria: * there are no relevant exclusion criteria for this n-of-2 study.
older emergency department users and short-term adverse events at the index visit

Conditions: Health Impairment; Adverse Event; Hospitalization

Summary: this study evaluates the difference between prisma-7 and er2 tool. there are some differences between prisma-7 and er2 tool. the differences consist in evaluation criteria that are used to perform the both surveys. we suppose that evaluation criteria of prisma-7 is not accurately enough to calculate the length of hospital stay and to predict the short-term outcomes.

the "program of research on integration of services for the maintenance of autonomy" (prisma-7) is the ministry of health and social services' reference tool for the assessment of older ed users in quebec (canada). prisma-7 has been initially designed to screen disability in community-dwelling older adults and has never been validated for risk for short-term adverse events in older ed users. "emergency room evaluation and recommendations" (er2) is another clinical tool which is currently evaluated in quebec. compared to prisma-7, er2 has been especially designed for assessing risk for short-term ed adverse events. no study has compared prisma-7 and er2 risk for short-term adverse events. we hypothesised that er2 could be a better prognostic tool compared to prisma-7 for long length of stay in ed and hospital stay, and hospital admission because it was designed and validated for this specific goal. the study aims to 1) examine and compared prisma-7 and er2 risk for long length of ed and hospital stay and hospital admission, and 2) to establish their performance criteria (i.e., sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios) for these three short-term adverse events in older ed users.

Eligibility criteria:
inclusion criteria: * being 75 years old and over * brought at emergency on medical stretcher exclusion criteria: * being less than 75 years old * never come at emergency