Kornimate/medical-research-clean huggingface dataset:
safety and tolerability of single ascending doses of pul-042 inhalation solution in healthy subjects

Conditions: Healthy

Summary: the purpose is to determine if single doses of pul-042 inhalation solution are safe in healthy subjects.

the study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of pul-042 inhalation solutions in healthy subjects. subjects will be enter a screening period of up to 14 days to determine eligibility. subjects will be admitted to the phase 1 unit the day prior to dosing and remain in the unit until 24 hours post-dose. subjects will be seen in the clinic at 3 and 7 days post-dose a modified 3+3 design will be used to determine the maximum tolerated dose (mtd) based on the occurrence of dose-limiting toxicities (dlts) defined by common terminology criteria for adverse events (ctcae) v4. additional specific dlts will be defined as: 1) hypoxia, defined as a non-artifactual drop in pulse oximetry to \< 90% on room air, 2) a decrease in forced expiratory volume in one second (fev1) of 12% or greater compared to the last observation prior to dosing, 3) any evidence of bronchospasm or wheezing requiring medical intervention. doses will be doubled until the maximum tolerated dose (mtd- defined as the largest dose with 0/6 or 1/6 dlts) is reached.

Eligibility criteria:
inclusion criteria: * males or females of non-childbearing potential * body mass index between 18 and 30 kg/m2 * normal spirometry * normal diffusing capacity of lung for carbon monoxide * normal pulse oximetry * males willing to practice contraception or have a female partner using contraception exclusion criteria: * febrile * abnormal chest x-ray * history of tobacco products within the last year and total exposure of \> 5 pack/years * clinically significant laboratory findings * history of chronic pulmonary disease * history of atopic reactions * mediastinal lymphadenopathy * oral corticosteroid therapy within 4 weeks prior to randomization * alcohol, caffeine or strenuous exercise within 72 hours prior to dosing * grapefruit within 7 days prior to dosing * administration of concomitant medications within 14 days prior to dosing * exposure to any investigational agent with 30 days * significant concurrent illness * know positive for hiv, hepatitis b or hepatitis c * inability to tolerate a nebulization test with sterile water for injection * positive test for drugs of abuse

Keywords: single ascending dose safety and tolerability in healthy subjects
a study of nivolumab in advanced non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to determine whether nivolumab monotherapy or in combination with standard of care (soc) therapies will provide clinical benefit (i.e., pfs, os, and dor) without unacceptable toxicity in advanced non-small cell lung cancer patients.

epidermal growth factor receptor (egfr), anaplastic lymphoma kinase (alk) \*\*please note that the study is no longer enrolling patients for groups a, b, c, and e.

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * histologically confirmed locally advanced or stage iv nsclc * eastern cooperative oncology group (ecog) performance status (ps) 0-2 * tumor tissue sections must be available for biomarker evaluation exclusion criteria: * untreated or active/progressing central nervous system (cns) metastases * active, known or suspected autoimmune disease * known history of testing positive for hiv or aids * active or chronic infection of hepatitis b virus or hepatitis c
conventional versus hypofractionated radiotherapy with temozolomide in elderly glioblastoma

Conditions: Glioblastoma

Summary: in newly diagnosed glioblastoma patients aged 70 years or older who are suitable for concurrent temozolomide, the optimal dose of radiation therapy is controversial . the purpose of this study is to compare conventional radiotherapy of 60 gy (6 weeks) versus hypofractionated radiotherapy of 40 gy (3 weeks) in terms of overall survival as the primary endpoint along with progression-free survival, toxicity, quality of life, and prognostic biomarkers.


Eligibility criteria:
inclusion criteria: * newly diagnosed glioblastoma according to the 2021 world health organization classification * interval of ≤4 weeks between pathological diagnosis and randomization * aged 70 years or older * gadolinium-enhanced mri within 72 hours of surgery * known o6-methylguanine-dna-methyltransferase promoter methylation status * karnofsky performance score ≥60 * stable or decreasing dose of steroid (if necessary) * no history of brain radiotherapy * no history of any systemic chemotherapy * adequate hematological, renal and hepatic functions for temozolomide * able to start radiotherapy within 3 weeks from randomization exclusion criteria: * patients with spinal leptomeningeal carcinomatosis * history of cancer other than the followings: * carcinoma in situ of the cervix * completely excised non-melanoma skin cancer * cancers without any evidence of residual disease for 5 years or longer * patients with serious active infection or other serious underlying medical conditions * patients with psychological issues that cannot comply to the protocol * patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide * patients who are currently participating in other clinical trials
frailty, hip fractures and inflammatory biomarkers

Conditions: Frailty; Hip Fracture; Inflammatory Biomarkers

Summary: we ought to investigate if hip fracture patients suffering from frailty have higher inflammatory burden according to simple inflammatory biomarkers.

frailty (f) is a prevalent syndrome among elderly patient with hip fractures (hf) and has been linked to poor prognosis. inflammatory biomarkers have been used as prognostic indexes in patients with hf. we ought to investigate if hip fracture patients suffering from frailty have higher inflammatory burden according to simple inflammatory biomarkers.

Eligibility criteria:
inclusion criteria: * age \&gt;65 years, asa ps i-iii, non- institutionalized, able to communicate patients exclusion criteria: * patients with severe cognitive dysfunction, those treated conservatively, those with pathological fractures and patients who refused to participate
dose dense abraxane in adjuvant chemotherapy for breast cancer

Conditions: Breast Cancer

Summary: the purpose of this trial is to see if abraxane, which is a new form of paclitaxel, is safe as a replacement form of paclitaxel in dose-dense chemotherapy. this trial will also determine if using abraxane will allow patients to receive treatment every two weeks without requiring injects of g-csf, a white blood cell stimulating growth factor.

* patients will receive regular chemotherapy every 2 weeks for up to 8 cycles (approximately 16 weeks total)of treatment. during the first four cycles patients will be treated with adriamycin and cytoxan, and for the second four cycles they will be treated with abraxane. * patients will be taught to give themselves injections with either short or long acting g-csf as prescribed by their doctor for the first four cycles of chemotherapy. during the last four cycles (while the patient is taking abraxane) they will not receive g-csf unless they have low blood counts. * if the patient has her-2 positive breast cancer, they will also receive 52 weeks of herceptin as part of standard cancer care and will begin to receive herceptin at the same time they begin abraxane (after 4 cycles of adriamycin and cytoxan treatment). * this study involves a series of quality of life questionnaires that will be completed prior to beginning study treatment, then again at 2 months, 4 months, 6 months, and 1 year after starting study treatment. * the following tests and procedures will be performed at the time periods specified. cycle 1-4 day 1: physical exam, vital signs, and blood tests. cycle 5 day 1: physical exam, vital signs, blood tests, rvg (measurement of heart function) and questionnaire. cycle 6 \& 7 day 1: physical exam, vital signs, and blood tests. cycle 8 day 1: physical exam, vital signs, blood tests, questionnaire. follow-up (6 months and 1 year after cycle 1 day 1): questionnaire.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed breast cancer, with clinical stage i, ii, or iii disease * must register at the beginning of adjuvant or neoadjuvant chemotherapy * 18 years of age or older * ecog performance status of 0 or 1 * normal organ and marrow function exclusion criteria: * previous cytotoxic chemotherapy or therapeutic radiation therapy for any reason * pregnant or nursing * receiving any other investigational agents * patients with stage iv breast cancer * current grade ii or greater peripheral neuropathy or prior history of grade ii or greater neuropathy * uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements * immune deficiency when treated with marrow-suppressive therapy or hiv-positive patients receiving anti-retroviral therapy * patients with sickle cell disease * known history of hyperviscosity syndrome * patients on lithium

Keywords: abraxane dose-dense chemotherapy taxol
alcohol effects on driving-related skills of young drivers

Conditions: Psychomotor Impairment

Summary: given the known driving behavior of driving under the influence of alcohol and some of its parallel to driving under the influence of cannabis, this supplemental study aims to validate the sensitivity of the primary and secondary outcome measures employed in a cannabis and driving study currently in progress.

this study will examine the effects of an intoxicating dose of alcohol on driving-related skills among young drivers using driving simulator technology. this study is a double-blind, placebo-controlled mixed design study, including randomized between-subjects comparison of the effects of alcohol intoxication and both between- and within-subjects examination of acute and residual effects at approximately 24 and 48 hours following one-time alcohol administration. initial contact with potential participants will be made by telephone, where study personnel will conduct a telephone screen for eligibility. those telephone screened as eligible will attend camh for an eligibility assessment. enrolled participants will complete four sessions on consecutive days: a practice day, an alcohol administration day, and a 24-hour and 48-hour post-alcohol session.

Eligibility criteria:
inclusion criteria: * males and females aged 19 to 25. * reported consumption of at least 1 heavy drinking episode (according to niaaa criteria of 5 drinks for males and 4 for females within an occasion) in the 6 months prior to eligibility assessment. * held a valid class g or g2 ontario driver's license (or equivalent from another jurisdiction) for at least 12 months. * willing to abstain from alcohol use for the duration of the study, and for 48 hours prior to session 2. * provides written and informed consent. exclusion criteria: * taking medications or have any medical condition for which alcohol is contraindicated * is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants). * diagnosis of severe medical or psychiatric conditions. * meets criteria for current or lifetime substance use disorders (dsm-iv) with the exception of nicotine. * meets criteria for alcohol dependence (dsm-iv) * is pregnant, is trying to become pregnant, or is currently breastfeeding. * severe allergic reaction to citrus.

Keywords: alcohol impaired driving driving simulation residual effects of alcohol acute psychomotor effects of alcohol young drivers
glucome usability study

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: the glucome device, in its original packaging, along with the user manual and quickstart guide will be provided to the patient in a simulated home use environment. the patient labeling will be in the format intended for distribution. ten (10) subjects identified as potential end users of the glucome device will receive the user manual. an additional ten (10) subjects also identified as potential end users of the glucome device will not receive the user manual. all subjects will be provided with a pre-test and post-test questionnaire and a list of tasks to complete, including applying and operating the device. the observer and user post-test questionnaire will collect information regarding device use. the device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. additionally, measurable usability criteria for specific, critical steps will be evaluated.

twenty (20) subjects identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. subjects will be asked to sign informed consent. the glucome device, in its original packaging, along with the user manual and quickstart guide will be provided to the patient in a simulated home-use environment. the patient labeling will be in the format intended for distribution. ten (10) subjects identified as potential end users of the glucome device will receive the user manual and quickstart guide. an additional ten (10) subjects also identified as potential end users of the glucome device will not receive the user manual, but will receive the quickstart guide. all subjects will be provided with a pre-test and post-test questionnaire and a list of tasks to complete, including applying and operating the device. the observer examination and user post-test questionnaire will collect information regarding device use. the device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. additionally, measurable usability criteria for specific, critical steps will be evaluated.

Eligibility criteria:
inclusion criteria: 1. subject is male or female equal to or greater than 18 years of age. 2. subject is a potential candidate for purchasing the glucome device (e.g., subjects diagnosed with diabetes type 1 or 2). 3. subject has facility with both hands. 4. subject monitors himself. 5. subject knows how to download and install apps. 6. subject is capable of understanding and is willing to sign informed consent. exclusion criteria: 1. subject has dementia. 2. subject has mental disorders. 3. subject was diagnosed with diabetes other than type 1 or 2 (e.g. gestational diabetes, congenital diabetes, drug induced diabetes, etc.). 4. subject does not monitor himself. 5. subject is visually impaired. 6. subject cannot draw blood samples from fingertip.

Keywords: glucose blood measurements, glucometers ,audio communication
research of the correlation between metabolic syndrome, retinal thickness and visual acuity

Conditions: Visual Acuity

Summary: purpose: to investigate the relationship between retinal thickness (rt) and metabolic risks (mrs) in patients without retinal lesion. methods: fifty-two patients over 60 y/o were divided into four groups according to their mrs of hypertension, hyperlipidemia or hyperglyceremia. after complete ophthalmic examination, optical coherence tomography was performed to measure rt.


Eligibility criteria:
inclusion criteria: * we enrolled the patients included age more than 60 years old, no positive finding during dilated fundus examination. exclusion criteria: * the exclusion criteria were as followed: * systemic disease that will affect visual acuity evaluation (for example: cva), \*opaque cornea and vitreous * glaucoma * uvietis and other clinically established ocular disease. * according to the locs iii11, those who had nuclear opalescence, nuclear color more than grade 3 or any grade of cortical cataract and posterior subcapsular cataract were also eliminated.

Keywords: to investigate the relationship between retinal thickness (rt) and metabolic risks (mrs) in patients without retinal lesion
autologous bone marrow mononuclear cells transplantation in treating diabetes patients

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: the study evaluates the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating patients with type 1 or 2 diabetes mellitus. we hypothesize that autologous bone marrow stem cell transplantation will promote β-cells regeneration by directly differentiated from the transplanted bmmcs or stimulated local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.

patients with type 1 or 2 diabetes mellitus will be recruited according to eligibility criteria. bone marrow mononuclear cells (bmmcs) will be separated from the bone marrow aspirate of each patient and be directly delivered to pancreas via splenic artery with the distal lumen occlusion through an arterial catheter. all patients will be explained in details about the procedures involved in bmmc transplantation and sign the informed consent for the study; the ethics committee of qilu hospital, shandong university approved the treatment protocol. all patients undergo scheduled follow-up evaluations for 5 years after transplantation. clinical, hematological, metabolical evaluations are performed to analyses the effect of the transplant, patients fitting the inclusion criteria but not agreeing to perform the transplantation are the control group and will received the regular oha and/or insulin therapy .they are followed in parallel with transplanted patients and will be subjected to the same follow-up management including extensive endocrinological monitoring, diet and exercise program as transplantation patients during the follow-up.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes * between 16 to 65 years of age * requiring daily exogenous insulin injection for the glycaemic control * with poor β-cell function * body mass index (bmi) \< 28 exclusion criteria: * acute or chronic infections * chronic uncompensated organic insufficiency including heart, liver, renal and lung * any malignancies, congenital or acquired immunodeficiency * hematological diseases or coagulopathy * acute or chronic pancreatitis * history of thoracic or abdominal aorta diseases * allergy to iodine * pregnancy

Keywords: diabetes mellitus bone marros mononuclear cells transplantation
investigating the impact of proactive palliative care

Conditions: Metastatic Solid Tumor Cancers; Locally Advanced Solid Tumor Cancers

Summary: this study will test whether adding personalized supportive care to medical treatment on a clinical trial affects the study participants' ability and desire to discuss their symptoms, their concerns about the future, and their approach to coping with cancer. the effects of supportive care on participants' responses to questions about these topics will be compared with those of other study participants who are being treated for cancer in a clinical trial, but are not receiving personalized supportive care.


Eligibility criteria:
inclusion criteria: * patients with disease progression on at least one standard chemotherapy regimen, and now eligible and consented to begin phase i, phase i/ib, phase i/ii and non-randomized phase ii (including basket studies) investigational targeted and immune-based therapeutics in msk medical oncology, edd, or itc clinics * able to speak, read, and understand english well enough to complete study assessments in the judgment of the consenting professional * 18 years of age and older * has a progressive or metastatic solid tumor cancer with msk pathology confirmation at the primary or metastatic anatomic site exclusion criteria: * patients who already are receiving specialty supportive care (already referred for a supportive care consultation) prior to enrollment in a phase i protocol. * patients will be excluded if the phase i, phase i/ib, phase i/ii or phase ii trial involves known active drugs in combination with experimental drugs, in which the patient has not previously received the known active drug or active drugs of the same class. for example, a patient with metastatic pancreatic cancer who has not received gemcitabine/nab-paclitaxel, but enrolls on a study that tests an experimental drug in addition to gemcitabine/nab-paclitaxel, will be excluded. * significant psychiatric or cognitive disturbance in the primary clinician"s or investigator"s judgment, to preclude providing informed consent or participating in the interventions (i.e. acute psychiatric symptoms which require individual treatment)

Keywords: quality of life supportive care 18-363
a study of sterile saline infusion in healthy volunteers

Conditions: Healthy Volunteers

Summary: the purpose of the study is to evaluate the influence of needle size, injected fluid volume, and rate of fluid on the degree of pain experienced by adult healthy volunteers after subcutaneous infusion of sterile saline.


Eligibility criteria:
inclusion criteria: * body mass index greater than (\>)18 and less than (\<) 36 * able to understand the english language * has a negative coronavirus-2019 (covid-19) test result at the time of admission, prior to administration of study intervention exclusion criteria: * age \ 60 years * bmi \ 36 * unable to understand the english language * currently pregnant or lactating * history of skin sensitivity or allergy to steel needle or adhesive tape * history of abnormal blood coagulation or bleeding * history of abnormal immune function or frequent skin infections * active cardiovascular, pulmonary, dermatologic, endocrine, rheumatologic, hematologic, ophthalmologic, psychiatric, metabolic, hepatic, renal, immune, gastrointestinal, neurological, or musculoskeletal disease * has tattoo(s) or scarring at the site of injection or any other condition which may interfere with the injection site examination, in the opinion of the investigator