Kornimate/medical-research-clean huggingface dataset:
a study to learn about how itraconazole affects the blood level of study medicine (pf-07817883) in healthy adults.

Conditions: Healthy

Summary: the purpose of this study is to learn how itraconazole affects the blood level of pf-07817883 in healthy adults. this study is seeking participants who are: * male and female aged 18 to 65 years old, * overtly healthy. this can be determined my medical evaluation, medical history, lab tests etc. this study will consist of 2 parts, period 1 and period 2. period 1: participants will take pf-07817883 one time by mouth at the study clinic. period 2: participants will take pf-07817883 one time by mouth at the study clinic. they will also take daily itraconazole by mouth for 7 days. participants will stay at the study clinic for 2 weeks in total. the study doctors will collect blood and urine samples from everyone. the study doctors will check participants' reactions to the study medicine for safety measures. there is a follow-up call at 28 to 35 days from the last dose of pf-07817883. itraconazole is an approved medicine. it is also a metabolism inhibitor. when taken with some medicines, it affects the actual level of these medicines in the body. this study will compare blood levels of pf-07817883 given with and without itraconazole. this will help decide safety and right amount for pf-07817883 when given with metabolism inhibitors.

this is a phase 1, open-label, 2-period, fixed sequence study to estimate the effect of itraconazole, a strong cyp3a4 inhibitor, on the plasma pk of pf-07817883 in healthy adults. the study will consist of 2 treatments: a single oral dose of pf-07817883 alone and a single oral dose of pf-07817883 in combination with multiple oral doses of itraconazole. the pk and safety will be assessed and compared for single dose of pf-07817883 in period 1 and period 2.

Eligibility criteria:
inclusion criteria: * male and female participants aged 18 to 65 years of age, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ecg. * bmi of 17.5 to 32 kg/m2; and a total body weight \>50 kg (110 lb). * capable of giving signed informed consent. exclusion criteria: * any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cv, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. * any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). * positive test result for sars-cov-2 infection at admission.

Keywords: covid-19
impact of nimodipine on sublingual microcirculation in patients with hemorrhage - a prospective monocentric observational study

Conditions: Subarachnoid Hemorrhage

Summary: nimodipine can increase functional capillary density (fcd) as a parameter of the sublingual microcirculation in patients with subarachnoid hemorrhage (sah) compared to patients without nimodipine.

sah group - in patients with sah and documented vasospasms by digital subtraction angiography (dsa) of trans-cranial doppler imaging (tcd) of arteria cerebri media nimodipine is indicated because it is proven to improve the clinical outcome. the disfunction of cerebral microcirculation in rats with sah has been documented \[1-6\]. changes in sublingual microcirculation in patients with sah with documented vasospasms with nimodipine has not been described.

Eligibility criteria:
inclusion criteria: * adulthood * icu admission * diagnosis of non-traumatic subarachnoid hemorrhage exclusion criteria: * inherited coagulation disorder * rheumatic disease * microangiopathy * patient of representative refusal

Keywords: nimodipine sublingual microcirculation side-stream dark field imaging
fatigability of lower limb muscle in older adults: protective effects of strength training exercise in old men and women

Conditions: Aging

Summary: the proposed studies will assess 1) the mechanisms for the age-related increase in fatigability during dynamic exercise (aims 1 and 2) and 2) the effectiveness of high-velocity resistance training coupled with blood flow restriction (bfr) in improving muscle power output and fatigability in older adults (aim 3). the first two aims are cross-sectional studies comparing young (18-35 years old) and older adults (≥60 yrs old) to test our central hypothesis that the greater accumulation of metabolites and increase in fatigability in older adults is due to either age-related impairments in skeletal muscle bioenergetics (aim 1) and/or vascular dysfunction (aim 2). these two aims will integrate techniques to assess whole-muscle bioenergetics (31p-mrs) and in vivo vascular function (near infrared spectroscopy; nirs and doppler ultrasonography) with in vitro assessment of single fiber bioenergetics (epifluorescence microscopy) and vasoreactivity of isolated skeletal muscle arterioles (video microscopy). we will then determine whether bioenergetics, vascular function and fatigability are altered in older men and women in response to 8 weeks of resistance exercise training of the lower limb both with and without blood flow restriction (aim 3).


Eligibility criteria:
inclusion criteria: * men and women aged 18-40 years and \>60 years exclusion criteria: * body mass index ≥40 kg/m2; * type 1 or type 2 diabetes; * uncontrolled hypertension; * active cancer, cancer in remission, or having received treatment for any form of cancer in the previous five years; * coronary artery disease; * cardiovascular disease (e.g., pad, pvd); * abnormal and untreated thyroid function; * chronic and/or regular nonsteroidal anti-inflammatory drugs (nsaid) consumption, * tobacco use (includes smoking); * any condition that presents a limitation to exercise (e.g., severe arthritis, copd, neuromuscular disorder, moderate or severe cognitive impairment, alzheimer's disease, severe untreated sleep apnea). * women who are pregnant or likely to be pregnant. * subjects will be excluded if they have joint pain in the exercising leg or arm. medication use. medications currently taken or in the previous year and known to influence muscle mass (e.g., glucocorticoids, testosterone) and cortical and neuromuscular excitability will be exclusionary, while medications that may be prevalent among older adults (e.g., statins) will be accounted for with a covariate statistical model.

Keywords: aging fatigue resistance training skeletal muscle knee extensor muscles limb power
comparison of efficacy of combination of tam formula vs kligman formula for melasma.

Conditions: Melasma

Summary: this study would offer the participants about the knowledge of these formula in the treatment of melasma and help the investigators in incorporating and updating the management protocols in medical practice.


Eligibility criteria:
inclusion criteria: * patients between 25-65 years of age, either gender having melasma for over one month will be included in the study * exclusion criteria: * pregnancy, breastfeeding, taking birth control pills or plans to become pregnant during the study * history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis * history of skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy * history of uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy) * history of sensitivity to hydroquinone or retin-a * history of evidence of a compromised immune system or hepatitis
cell therapy with anti-cd19 car-nk cells in patients with relapsed or resistant b-all

Conditions: Acute Lymphocytic Leukemia in Relapse

Summary: immunotherapy has shown promise in treating hematological malignancies, including resistant b-all. one approach is car-nk cell therapy, which involves genetically modifying natural killer (nk) cells to target specific cancer antigens. while car-nk therapy offers advantages over car-t therapy, such as reduced immune system reactions and lower production time and cost, challenges remain regarding antitumor efficacy and the tumor microenvironment. preclinical and early clinical studies have targeted various antigens, including cd19, with car-nk cells in resistant b-all. to further investigate the potential of anti-cd19 car-nk cell therapy, this study aims to evaluate its safety and determine the maximum tolerated dose (mtd) in patients who have not responded to standard treatment.


Eligibility criteria:
inclusion criteria: eligible diseases: acute lymphocytic leukemia (all cd19+). patients 3 years of age or older, and must have a life expectancy \> 12 weeks. eastern cooperative oncology group (ecog) performance status of 0-2 or karnofsky performance status (kps) score is higher than 60. females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of car nk cells. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: white blood cell count (wbc) ≥ 2500c/ml, platelets ≥ 50×10\^9/l, hb ≥ 9.0g/dl, lymphocyte (ly) ≥ 0.7×10\^9/l, ly% ≥ 15%, alb ≥ 2.8g/dl, serum lipase and amylase \< 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dl, aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dl. these tests must be conducted within 7 days prior to registration. ability to give informed consent. exclusion criteria: pregnant or nursing women may not participate. active hiv, hepatitis b virus (hbv) or hepatitis c virus (hcv) infection at the time of screening. serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders. history of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin. concurrent use of systemic steroids. recent or current use of inhaled steroids is not exclusionary. the existence of unstable or active ulcers or gastrointestinal bleeding. patients need anticoagulant therapy (such as warfarin or heparin). patients need long-term antiplatelet therapy (aspirin at a dose \> 300mg/d; clopidogrel at a dose \> 75mg/d). patients using fludarabine or cladribine chemotherapy within 3 months prior to leukapheresis.

Keywords: car-nk therapy anti-cd19
role of bronchoscope in diagnosis of lung cancer

Conditions: Lung Cancer

Summary: the study aims to compare the diagnostic yields of bronchial brushing performed before and after forceps biopsy and bronchial wash performed before and after biopsy during flexible bronchoscopy.

lung cancer is the most common cause of cancer-related mortality in both sexes in the world. to treat the disease successfully, it should be diagnosed at the earliest possible stage. several studies have demonstrated that early detection, localization, and aggressive treatment of lung cancer result in the 5-year survival rate of 70-80%. nowadays, bronchoscopy is an invaluable tool for diagnosis of lung cancer and various diagnostic tools have been developed using flexible fiber-optic bronchoscopy (fob). bronchoscopy, while essential for diagnosing and staging lung cancer, can give variable diagnostic yields ranging from37-77%. one reason for this variability is limitations in tissue sampling techniques, which can make it impossible to obtain the most representative area of neoplastic tissue. numerous basic diagnostic procedures using fb, including bronchoalveolar lavage or washing, brushing, endobronchial or transbronchial biopsy(tbb), and transbronchial needle aspiration, have been evaluated in various combinations to improve the diagnostic yield of fb in patients with suspected lung cancer. however, the optimum sequence of brushing, washing and biopsy samples for diagnosing peripheral lung cancer is not clear and requires further study.

Eligibility criteria:
inclusion criteria: patients in whom clinical findings, radiological examination suggested lung malignancy. patients with chronic cough, hemoptysis and lymph node enlargement. exclusion criteria: patients with no evidence of malignancy.
views of nurses on alarm fatigue in icus

Conditions: Nurse's Role

Summary: this study focused on determining the views of nurses on alarm fatigue and its reduction in adult intensive care units.

backround: physiological monitoring of critically ill patients in icu is a complex nursing task, and nurses are key professionals managing multiple monitoring devices. aim: the aim of this study is to determine the views of nurses on alarm fatigue and its prevention in adult intensive care units. study design: in the study, the minimum sample size was calculated as 67 for a population size of 106 and a 95% confidence interval, taking into account the alarm fatigue standard deviation (σ=6.82) found in the turkish validity study of the "nurses' alarm fatigue scale" (t=1.96; d=1) . considering that there may be losses, 74 nurses will be included in the study by taking 10% more. in the qualitative phase of the research, intensive care nurses who agreed to be interviewed during the collection of quantitative data will be included. method: in this study, parallel data type will be used in convergent parallel mixed design. the quantitative phase of the study is a descriptive study to determine alarm fatigue levels in nurses working in adult intensive care units. in the qualitative phase of the research; a case study will be conducted at the same time in order to examine the findings revealed with quantitative data in more depth and to determine the views of nurses on reducing alarm fatigue. individual in-depth interviews will be held in a suitable room using the "semi-structured interview form" created by the researchers with those who agree to participate in the qualitative study.

Eligibility criteria:
inclusion criteria: * 18 years and older * who volunteered to participate in the research * working in adult intensive care units exclusion criteria: * under the age of 18 * not working in adult intensive care unit

Keywords: alarm fatigue intensive care nursing mixed method
a study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis

Conditions: Axial Spondyloarthritis; Ankylosing Spondylitis; r-axSpa; Nr-axSpa

Summary: the purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axspa, also known as radiographic axspa (r-axspa)) including ankylosing spondylitis (as) and nonradiographic axial spondyloarthritis (nr-axspa).


Eligibility criteria:
inclusion criteria: * study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the investigator * in the opinion of the investigator, the study participant is expected to benefit from participation in this extension study * study participant completed as0010 (nct03928704) or as0011 (nct03928743) exclusion criteria: * female study participants who plan to become pregnant during the study or within 20 weeks following final dose of investigational medicinal product (imp). male study participants who are planning a partner pregnancy during the study or within 20 weeks following the final dose * study participants who meet any withdrawal criteria in as0010 or as0011. for any study participant with an ongoing serious adverse event (sae), or a history of serious infections (including hospitalizations) in the feeder study, the medical monitor must be consulted prior to the study participant's entry into as0014 * study participant has a positive or indeterminate interferon gamma release assay (igra) in as0010 or as0011, unless appropriately evaluated and treated

Keywords: axspa radiographic non-radiographic as bimekizumab axial spondyloarthritis ankylosing spondylitis
peerscope b system™ clinical protocol

Conditions: Colon Cancer; Colon Diseases; Colon Polyps; Colon Adenomas

Summary: the peerscope b system™ by peermedical ltd. is intended to provide visualization (via a video monitor) and therapeutic access to the lower intestinal tract. the lower intestinal tract includes, but is not restricted to the organs, tissues and subsystems: large bowel and cecum. the device is introduced rectally, as with any standard colonoscope when indications consistent with the need for the procedure are observed in the adult patient population. the purpose of this prospective clinical study is to establish the usability of the peerscope b system™ when used during standard colonoscopy procedure. the study population is comprised of patients indicated for colonoscopy. the primary endpoint is reaching the cecum of the colon with peerscope b system™.secondary endpoints: 1. the first secondary endpoint is the incidence of complications using the peermedical colonoscope. 2. the second secondary endpoint is successful therapeutic interventions as biopsies, polypectomies, apc etc. 3. the third secondary endpoint is the procedure time. 4. the fourth secondary endpoint is the subjective evaluation of the additional view angle by the physician. 5. the fifth secondary endpoint is patient satisfactory.

founded in 2009, peermedical develops colonoscopes capable of wide view angle at the press of the button. the peerscope b system™ is an endoscopic platform that enables the physician to get a wide angle view while maintaining all of the features commonly used during gastrointestinal (gi) procedures with very limited learning curve and in service process. the current standard devices have viewing limitations. by adding this viewing functionality, peermedical will potentially empower physicians to improve polyps detection and cancers within the colon.

Eligibility criteria:
inclusion criteria: * subject between the ages of 18 and 70 * the patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup; * written informed consent must be available before enrollment in the trial * for women with childbearing potential, adequate contraception exclusion criteria: * patients with a history of colonic resection; * patients with inflammatory bowel disease; * patients with a personal history of polyposis syndrome; * patients with suspected chronic stricture potentially precluding complete colonoscopy; * patients with diverticulitis or toxic megacolon; * patients with a history of radiation therapy to abdomen or pelvis; * patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Keywords: wide angle view colonoscopy peerscope b system™
a comparison of indirect and direct mr arthrography of the shoulder using arthroscopic correlation

Conditions: Shoulder Pain

Summary: this study will prospectively compare the findings of two diagnostic tests, direct magnetic resonance arthrography(mra) and indirect mra, to the findings during shoulder arthroscopy in patients with shoulder pain. the sensitivity and specificity of both direct and indirect mra's in diagnosing specific pathologies of the shoulder will be determined using shoulder arthroscopy as the gold standard.

direct mr arthrography (mra) requires the injection of a contrast agent into the shoulder under fluoroscopic or ultrasound guidance, followed by magnetic resonance imaging (mri). this is invasive, risks infection, and requires time and resources. it has recently been shown that the intravenous administration of gadopentetate dimeglumine enhances the joint cavity during an mri and thus indirectly produces an arthrographic effect(indirect mra). the study will enroll patients who have already had a direct mra as part of their standard of care diagnostic test for shoulder pain, if it is determined by their surgeon that arthroscopic surgery is indicated they will be asked if they would be willing to have an indirect mra prior to their arthroscopic surgery. the patient will need to have a blood test(bun and creatinine)done to ensure kidney function is normal, and a serum and urine pregnancy test, if female, to ensure there is no pregnancy, prior to the completion of the indirect mra. after the patient's scheduled shoulder arthroscopic surgery, the results of the two mr arthrography techniques will be compared for sensitivity and specificity in detecting partial and full thickness rotator cuff tears, labral tears, long head biceps dislocation/tearing, and grade iv cartilage lesions by comparing the results to the actual arthroscopic findings. the direct mr arthrography and arthroscopic surgery are standard of care and would occur regardless of this study, the indirect mr arthrography is the diagnostic intervention that is study-related.

Eligibility criteria:
inclusion criteria: * patients between 18 - 70 years old * continued shoulder pain for 2 months duration that limits his/her activity despite conservative treatment * had a standard of care direct mr arthrogram performed from which the surgeon determined that arthroscopic surgery was indicated. exclusion criteria: clinical evidence of * tumor * infection * previous shoulder surgery * contraindication for mri * allergy to contrast * coagulopathy * known allergy to gadolinium dtpa * renal failure with creatinine clearance of less than 30ml/min * pregnancy

Keywords: indirect magnetic resonance arthrogram direct magnetic resonance arthrogram diagnostic tests for shoulder pain
the effects of hesperidin on biochemical factors and hepatic fibrosis in nonalcoholic fatty liver disease

Conditions: Non Alcoholic Steatohepatitis

Summary: to study the effects of hesperidin supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with nonalcoholic steatohepatitis (nash), 50 patients who referred to gastrointestinal (gi) clinic with steatosis grade 2 and 3 will be randomly allocated to receive placebos or 2 capsules hesperidin for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. at the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.


Eligibility criteria:
inclusion criteria: * age of 18 to 70 years * body mass index (bmi) between 25-40 * sonographic findings compatible with hepatic steatosis (degree 2 or more) exclusion criteria: * diabetes * taking any kind of antibiotics two weeks before recruitment * history of alcohol consumption * pregnancy or lactation * professional athletes * other liver disease (viral/etc) * use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin e * a history of hypertension, cardiovascular disease, pulmonary disease, renal disease \& celiac disease; cirrhosis * history of upper gi surgery / prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty * following program to lose weight in recent 3 mo * a history of hypothyroidism or cushing's syndrome