Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the effects of pre-meal whey protein microgels administration on post-prandial glycemic response.

Conditions: Dietary Supplement

Summary: this is a mechanistic, randomized, investigator-blinded, placebo-controlled, single-center, crossover study designed to evaluate the effects of premeal administration of whey protein microgels compared to placebo on postprandial glycemia in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * willing and able to sign written informed consent prior to study entry. * male or female, \>18 years of age. * established diagnosis of type 2 diabetes (documented by either hba1c 6.5 - 10.0% or a history of type 2 diabetes diagnosis). * treatment naïve or on active therapy with metformin at a daily dose of 1000-3000mg at screening. dose of metformin must have been stable for at least 3 months prior to screening. * patients must have a hematocrit value greater than or equal to 34.0% for females and 40% for males. * patients must have a hemoglobin value greater than or equal to 11.0 g/dl for females and 13.5 g/dl for males. exclusion criteria: * fasting plasma glucose \>220mg/dl at screening. * impaired kidney function, epidermal growth factor receptor of \<60ml/min/1.73m2 at screening. * bmi \>40kg/m2. * elevated liver transaminase \> 3 upper limit of normal at screening. * ongoing or recent (i.e. \< 3month) treatment with any oral or injectable glucose-lowering drug other than metformin. * ongoing or recent (i.e. \< 3month) injectable insulin therapy. * ongoing or recent (i.e. \ 5% within previous 6 months. * ongoing or recent (i.e. \< 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption. * major medical/surgical event requiring hospitalization in the last 3 months. * known allergy and intolerance to product components or acetaminophen. * alcohol intake higher than 2 servings per day. a serving is 0.4dl of strong alcohols, 1dl of red or white wine, or 3dl of beer. * are unable to comply with protocol procedures in the opinion of the investigator. * have a hierarchical link with the research team members. * positive pregnancy test at screening. * patients who have been dosed in another clinical trial with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening, or patients currently participating in any investigational trial. * donation of blood or significant amount of blood loss within 8 weeks prior to screening. patients must also agree to not donate blood within 8 weeks after their last visit.
hiv/sti risk reduction for incarcerated women with interpersonal violence

Conditions: Unsafe Sex; Physical Violence; Sexual Assault; Sexual Abuse

Summary: the pilot study aims to conduct a randomized pilot trial in a sample of 40 incarcerated women with lifetime interpersonal violence who are 6-10 weeks away from release to demonstrate the feasibility and acceptability of the proposed recruitment methods and research design, of the intervention training methods, of delivering the enhanced women's coop and nutrition control interventions. per recent guidance from nimh, the investigators will also examine 95% confidence intervals around differences between the proposed intervention and a dose-matched control condition (nutrition program), for the following outcomes through 8 months post prison release: reduced unprotected vaginal or anal sex occasions and fewer cases of vaginal trichomoniasis (primary); reduced interpersonal violence episodes, symptoms of ptsd and depression, and drug using/heavy drinking days (secondary); and increased affect management and social support (including effectiveness in obtaining substance use, mental health treatment and other resources) (tertiary).


Eligibility criteria:
inclusion criteria: * females in prison * experienced lifetime interpersonal violence (includes physical or sexual assault or abuse) * at least one unprotected sexual occasion with a male partner within the 90 days prior to incarceration * approximately 6-10 weeks before release * expect to be released to locations within ri or ma exclusion criteria: * cannot complete intake interview due to problems with reality testing, brain impairment, or language barrier

Keywords: hiv sexually transmitted infections sexual abuse physical abuse women prison
a study of nivolumab in participants with locally advanced or metastatic (stage iiib-iv) non-small cell lung cancer (nsclc) with squamous and non-squamous histology after prior chemotherapy treated in real world settings in greece and cyprus

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this observational study is to estimate the overall survival (os) rates in the overall study population treated with nivolumab in the second and third line setting in real world clinical practice in greece and cyprus. the study is descriptive in nature and is not planned to reject or affirm any formal statistical hypothesis.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * male or female adult greek-speaking patients, of any race (residing in greece or cyprus), aged at least 18 years at time of initiation of nivolumab treatment. * histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic (stage iiib-iv) non-small cell lung cancer (nsclc) with squamous cell carcinoma (scc) or non-squamous cell carcinoma (nscc) histological subtype * initiated on second or third line treatment with nivolumab as monotherapy after prior chemotherapy as per the product's summary of product characteristics (smpc) prior to informed consent obtainment, and for whom therapy is ongoing and no more than one infusion has been administered from treatment initiation to obtaining the signed informed consent * decision to prescribe nivolumab treatment has been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study * provided signed informed consent for participating in the study and for collecting and analyzing medical data pertinent to the objectives of this study exclusion criteria: * current primary diagnosis of a cancer other than nsclc that requires systemic or other treatment * previously treated with nivolumab or other non-chemotherapy agents, with the exception of immune checkpoint inhibitors (anti-pd-1(programmed cell death-1)/anti-pd-l1 (programmed death-ligand 1) agent, other than nivolumab) administered in combination with chemotherapy * currently receiving or are planned to receive treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to nivolumab therapy initiation

Keywords: bms-936558 greece cyprus locally advanced metastatic nsclc nivolumab opdivo® prospective study stage iiib/iv 2nd line treatment 3rd line treatment observational study lucence study
phase ii study of sorafenib + carboplatin and docetaxel in first line treatment of stage iiib/iv nsclc

Conditions: Non-Small Cell Lung Cancer

Summary: this is an open-label, single institution, phase ii study of sorafenib in combination with docetaxel and carboplatin in patients with advanced non-small cell lung cancer. docetaxel and carboplatin will be given on day 1 of every three week cycle. patients will take sorafenib twice a day on the 1st day of treatment and continue to take the medication every day until progression of disease, prohibitive toxicity, or patient withdrawal from the study. chemotherapy courses will repeat every 21 days in the absence of disease progression or unacceptable toxicity for a total of four cycles.

patients will be monitored after every two cycles (6 weeks) for tumor response, stability, or progression by radiographic imaging studies. the primary goal of this study is to determine the clinical response rate of this regimen in patients with advanced lung cancer. secondary endpoints include time to progression, overall survival, and toxicity. blood levels of erk-phosphorylation, activated caspase 3, cyclin d1, anti -ciap2, p-akt, and mcl1 activity will be measured at the beginning, middle and end of therapy to help identify predictors of drug response and toxicity during the first cycle of treatment.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed nsclc with clinical or radiological evidence of advanced disease (stage iiib/iv) * uni-dimensionally measurable disease * age =\> 18 years * ecog performance status of 0-1 * life expectancy \> 3 months exclusion criteria: * small-cell or mixed histologies including a small cell component * prior chemotherapy, biotherapy, radiotherapy to an area of measurable disease * patients with peripheral neuropathy grade =\> 2

Keywords: stage iiib/iv
in vivo multispectral optoacoustic imaging of thyroid nodules

Conditions: Thyroid Nodule

Summary: thyroid nodules are common in clinical practice. head and neck ultrasound is recommended as a routine examination for all patients with thyroid lesions. the thyroid imaging reporting and documentation system (tirads) criteria helps to estimate the risk of malignancy based on ultrasound patterns and nodule sizes guiding the performance of fine-needle-aspiration (fna). approximately 20% of fna results cannot be specified whether being benign or malig-nant tissue. a definitive diagnosis can only be made from histopathology after diagnostic (hemi)thyroidectomy. however, (hemi)thyroidectomy has disadvantages as it leads to over-treatment and has a risk of postoperative morbidity (e.g. hypothyroidism and laryngeal nerve injury). furthermore, (hemi)thyroidectomy is known to be associated with poor quality of life. clearly, there is an unmet need for additional diagnostic tools in order to identify malignant thyroid nodules and thereby support the decision making for treatment of the thyroid. multispectral optoacoustic tomography (msot) is an innovative, non-invasive imaging method currently available in the umcg that enables visualization of endogenous chromophores and exogenous contrast agents using the generation of ultrasound waves due to light absorption by using high frequency pulsed laser light. recently, this system has been used by other groups for non-invasive determination of thyroid nodules. results show that multispectral optoacoustic imaging of thyroid nodules may distinguish benign from malignant nodules. however, most certainly, a larger cohort is necessary to confirm this finding.


Eligibility criteria:
inclusion criteria: 1. patients with thyroid nodules who underwent or will undergo an ultrasonography (with tirads score) with fna if indicated and will be scheduled for a (hemi)thyroidectomy if indicated; 2. age ≥ 18 years; 3. written informed consent. exclusion criteria: 1. medical or psychiatric conditions that compromise the patients' ability to give informed consent; 2. previous surgery in head and neck area 3. previous radiotherapy in head and neck area 4. pregnancy
a pilot study to improve preventive asthma care for urban adolescents

Conditions: Asthma

Summary: the goal of this pilot study is to implement directly observed therapy with preventive asthma medications through a partnership with the school nurse (with input and direction from the primary care provider) to assure that the teen receives guideline based preventive medications, and provide a motivational interviewing intervention to help the teen transition to independence with their medical treatment plan. we hypothesize that this community-based pilot intervention will; 1) be feasible and acceptable among this population and among school personnel, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). we anticipate that enhancing preventive healthcare for urban teens with asthma through partnerships with schools will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs. this new method of preventive care delivery could be sustained within the school nursing system, and could be implemented in schools nationwide. further, it could be applied to other chronic illnesses affecting disadvantaged populations.


Eligibility criteria:
inclusion criteria: * physician-diagnosed asthma * persistent asthma (criteria based on nhlbi guidelines). * age \>12 and \<15 years. * attending school in the rochester city school district. * signed physician permission to enroll the child. * current prescription of a daily preventive asthma medication * parent or caregiver and the adolescent must consent to the intervention. exclusion criteria: * inability to speak and understand english. * no access to a working phone for follow-up surveys * the family planning to leave the school district within fewer than 6 months. * the teen having other significant medical conditions * the teen having a diagnosed developmental condition per parent report. * adolescents in foster care or other situations in which consent cannot be obtained from a guardian. * adolescents that were previously enrolled in our school-based asthma study

Keywords: asthma
symptomatic treatment of common cold symptoms

Conditions: Common Cold

Summary: a two-arm, multicenter, randomized, double-blind, single dose placebo-controlled parallel groups study evaluating efficacy and tolerability of 800 mg acetylsalicylic acid (aspirina c) in adult patients with a common cold during a two hour in patient phase; and a follow-up period of five days of home treatment as required.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * onset of cold symptoms within 48 hours before screening * objective symptoms of common cold * subjective symptoms of common cold exclusion criteria: * pregnancy or lactation period * active peptic ulcer * hemorrhagic diathesis * history of chronic or recurrent ulcer disease or history of gastro-intestinal bleeding * hypersensitivity to acetylsalicylic acid, to paracetamol, to any other component of the study medication, to anti-inflammatory or antirheumatic drugs, to other allergens

Keywords: symptomatic treatment of common cold symptoms
the effectiveness of two nursing programs on the surgery-related pressure injury

Conditions: Pressure Injury; Surgery

Summary: introduction: this study was to compare the differences in the incidence, grade, and time of surgery-related pressure injuries between the two interventions; and describe the locations of surgery-related pressure injuries between the two interventions. methods: this study adopted a true experimental research design with a convenience sampling method from the operating rooms of a teaching hospital in a northern region. the experimental group was randomly assigned by block to receive intervention a (full bed silicone mattress plus other measures), and the control group received intervention b (full bed silicone mattress plus usual care). measurements include basic personal attributes, risk factors, grade, time, and location of occurrence related to surgery-related pressure injuries.


Eligibility criteria:
inclusion criteria: * 20 and more years old * over 4 hours lying flat on the operating table (eg., orthognathic surgery, microtia reconstruction surgery, etc.) * those who are conscious clearly and can communicate in mandarin and taiwanese * those with agree to participate in this study exclusion criteria: * those whose skin is red, swollen, hot, painful, redness, rash, purple spots, bruising, scaly skin, damaged, etc. * refuse to participate in the study

Keywords: surgery-related pressure injury incidence grade sites time
lllt and fractional co2 laser in the treatment of stria alba

Conditions: Striae; Albicantes

Summary: stria alba (aka white or atrophic stretch marks) is a very common dermatologic condition that causes major psychological distress to those afflicted. we study the effect of low level light therapy using infra red diode 808/915 nm laser in comparison to fractional co2 alone and combined both therapies.

all patients will be subjected to the following: * written informed consent. * detailed history and clinical evaluation. the treated areas will be photographed (in standardized settings of light and position) and measured in order to allow comparison and assessment of striae improvement following treatment. patients will be allocated according to randomization into one of 3 arms: arm a will be treated by fractional co2 laser. arm b will be treated by low level light therapy (lllt). arm c will be treated with a combination of fractional co2 laser and lllt. digital photographs will be taken for each patient, at the baseline and 1 and 3 months after last session and the width of the widest striae in each patient will be measured at the same time. patients will be assessed before and after treatment by one unblinded and 2 blinded investigators to measure the clinical improvement on a 4-point scale by comparing the photographs. the criteria for evaluation using a quartile grading scale will be as follows; 0=no improvement, 1=mild improvement (\ 76%). in addition, a patient satisfaction score will be rated using the following scale; 0=not satisfied, 1=slightly satisfied, 2= satisfied, 3=very satisfied, 4=extremely satisfied as well as patients' satisfaction questionnaire (yang and lee; 2011).

Eligibility criteria:
inclusion criteria: * subjects, above the age of 18 years old, with stria alba. * both genders. exclusion criteria: * pregnant or lactating females. * subjects who were treated with any interventional procedure (lasers, radiofrequency, dermabrasion, microdermabrasion, or chemical peeling) within 6 months prior to the study. * subjects who applied topical corticosteroids, retinoid, vitamin c, or vitamin e within 3 months prior to the study. * subjects who orally took retinoids or corticosteroids within 3 months. * subjects who had a history of hypertrophic scar, keloid or immunosuppression or cancer.

Keywords: stria alba fractional co2 fractional carbon dioxide laser 00 low level light therapy striae atrophicae infra red diode laser 808 nm 915 nm 10600 nm
long term oxygen therapy in patients with interstitial lung disease

Conditions: Long Term Oxygen Therapy; Interstitial Lung Disease

Summary: study the effect of using long term oxygen therapy in patients with interstitial lung disease and chronic hypoxia

long term oxygen can be used in patients with interstitial lung disease with hypoxia and the aim of this study is to k ow whether this will improve life style , exercise tolerance in those patients

Eligibility criteria:
inclusion criteria : * patients with ild and hypoxia with so2\<88 at room air and po2 \< or equal 7.3k.pa or \< or equal 8 k.pa in presence of lower limb edema , pulmonary hypertension or polycythemia * age group 18 : 70 exclusion criteria : * causes of chronic respiratory failure other than ild.
examining the validity and reliability of the dresden falls questionnaire in patients with parkinson's diagnosis living in turkey

Conditions: Parkinson Disease; Falls; Scale Reliability Validity

Summary: the aim of this study is to adapt the dresden falls questionnaire scale (drefaq) to turkish society and to make its validity and reliability in turkish. the drefaq) scale developed by frank, anika, et al assesses falls in patients with parkinson. it has 5 questions. this study will be conducted with parkinson patients. the patients will be sought to answer questionnaires during regular rehabilitation sessions. 50 participants will be included in the study. in order to evaluate the validity of the drefaq, the modified falls efficacy scale (mfes), which can evaluate the efficacy of falls and has been validated in turkish, and the parkinson's disease quality of life (pdqol) questionnaire, which can evaluate the quality of life and has been validated in turkish, will be used. scales will be repeated after 15 days to assess test-retest reliability.

the reliability and validity of the scale will begin with language equivalence and cultural adaptation. the scale will be translated from english to turkish by two people who are fluent in turkish and english. a single turkish translation will be obtained from these two turkish translations with a common opinion. the scale, which has been translated into turkish, will be translated into english by two other people who are fluent in turkish and english. the scale translated into english will be compared with the original. if the developer of the scale, frank, anika, et al approves the translation of the scale, participants will be recruited for the study. in the pre-trial phase, a reassessment will be conducted with 15 participants to test the intelligibility of the scale. based on the results of the pre-test phase, the final version of drefaq will be able to be modified. the data of drefaq are collecting through face-to-face when the patients came to the rehabilitation center. 50 participants will be included in the study. in order to evaluate the validity of the drefaq, the modified falls efficacy scale (mfes), which can evaluate the efficacy of falls and has been validated in turkish, and the parkinson's disease quality of life (pdqol) questionnaire, which can evaluate the quality of life and has been validated in turkish, will be used. scales will be repeated after 15 days to assess test-retest reliability.

Eligibility criteria:
inclusion criteria: * individuals with a hoehn \& yahr score between 1-4, * individuals who can ambulate with or without assistive equipment, * individuals with a mini mental state examination score of \>24, * individuals with a history of falling at least once in the last year, exclusion criteria: * communication or cognitive problems, * aphasia and speech disorders * unstable medical conditions

Keywords: parkinson disease falls scale reliability validity
acalabrutinib (acp-196), a btk inhibitor, for treatment of de novo activated b-cell (abc) subtype of diffuse large b-cell lymphoma

Conditions: Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL)

Summary: to characterize the safety profile of acalabrutinib in subjects with relapsed or refractory de novo activated b-cell (abc) subtype of diffuse large b-cell lymphoma (dlbcl).


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age. * pathologically confirmed de novo abc dlbcl * relapsed or refractory disease * subjects must have ≥ 1 measurable disease sites exclusion criteria: * a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk * significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the new york heart association functional classification, or lvef \< 50% * malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. * breast feeding or pregnant

Keywords: de novo activated b-cell (abc) subtype of diffuse large b-cell lymphoma diffuse large b-cell lymphoma de novo activated b-cell (abc) de novo activated b-cell abc dlbcl dlbcl lymphoma b-cell immunoproliferative disorders immune system diseases bruton's tyrosine kinase