Kornimate/medical-research-clean huggingface dataset:
a study to determine the correct dose of amikacin which is delivered directly to the lungs of ventilated patients as an aerosol via an investigational device called the pulmonary delivery device system (pdds)

Conditions: Pneumonia

Summary: this study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with iv antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. the primary purpose of this study is to determine the correct dose of amikacin which is delivered directly to the lungs as an aerosol via an investigational device called the pulmonary delivery device system (pdds).


Eligibility criteria:
inclusion criteria: * male and female patients 18 years of age or older with a clinical diagnosis of vap, hap or hcap who are expected to be on mechanical ventilation for at least 3 days exclusion criteria: * patients with compromised of suppressed immune systems, severe hypoxemia, peep\>15cm h2o, creatinine\>2 mg/dl, or who are pregnant

Keywords: pneumonia adjunctive treatment gram-negative bacteria
a study to evaluate safety and efficacy of novoseven® in patients with glanzmann's thrombasthenia in japan

Conditions: Congenital Bleeding Disorder; Glanzmann's Disease

Summary: this study is conducted in asia. the aim of the study is to evaluate the safety and efficacy of novoseven® (activated recombinant factor vii, eptacog alfa (activated)) during bleeding episodes and for the prevention of bleeding during surgery/delivery in patients with glanzmann's thrombasthenia (gt)/glanzmann's disease.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities (study related activity are any procedure related to recording of data according to the protocol). * all-treated patients in the registration period exclusion criteria: * known or suspected allergy to study product(s) or related products * septicaemia (especially, septicaemia followed severely infected patients caused by gram-negative bacteria \[the risk of dic (disseminated intravascular coagulation) caused by endotoxemia could not denied\] * patients with a history of hypersensitivity to any of the product components
the gut microbiome in adult multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study aims to assess the following research questions: 1. map and benchmark the gut microbiome of patients with rrms, and ppms versus matched healthy controls 2. determine whether rrms or ppms have a unique bias for a gut microbiome classification recently characterized. 3. search for relationship with inflammation, amino acid plasma levels, heart rate variability (vagus nerve tone) and hair cortisol as a biological marker of chronic stress 4. determine whether the gut microbiome is different in ms patients during a relapse. 5. determine whether the gut microbiome remains stable after 3 months

this study is a prospective multi-center cohort study (university hospital brussels, national multiple sclerosis center melsbroek). this is an exploratory study and there is no specific outcome on which a power calculation can be made. we will include different subgroups of patients with ms: stable non-benign rrms, ppms, benign ms \[benign ms is defined as rrms with an edss ≤ 3, 15 years after disease onset\], rrms during a relapse (before the administration of corticosteroids) \[relapses are defined as the development of new or recurrent neurologic symptoms not associated with fever or infection or change in medication, lasting at least 24 hours, and accompanied by new, objective neurologic findings\]. age and sex matched healthy controls will be included as well. all participants will provide a faecal, hair, and blood sample twice (baseline and after 3 months). patients will be assessed clinically at baseline, 3 months after baseline, and approximately 1, 2, 4.5 years after baseline. the results of this study have the potential to identify novel simple strategies to strengthen or alter the microbiome ecosystem and strengthen the overall treatment process. in case of a positive result, this would form the basis for a follow-up study on medical modulation of the microbiome with the aim of finding new treatment options for ms.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent. 2. rrms or ppms, as defined by the mcdonald criteria. 3. ages 18-65 years. 4. edss \< 7 5. treatment with ifn-beta exclusion criteria: 1. spms without relapses during the past year at screening. 2. use of high dose systemic steroids within the last 2 months. 3. gastrointestinal disease, such as inflammatory bowel disease 4. use of antibiotics within the last 4 weeks.

Keywords: gut microbiome
evaluation of osteoporosis support after a severe osteoporotic fracture in women over 50 years in university hospital

Conditions: Osteoporosis

Summary: evaluate the support of osteoporosis in women over 50 years with severe osteoporotic fractures (hip, vertebral, rib, humeral, pelvic fractures) in the nîmes university hospital taking prediction of treatment of osteoporosis as criterion.


Eligibility criteria:
inclusion criteria: * patients over 50 years (\> 50 years) with severe osteoporotic fractures (hip, vertebral, rib, humeral, pelvic fractures) hospitalized in the nîmes university hospital exclusion criteria: * patient under 50 years * non osteoporotic fractures
a study of granix to disrupt the bone marrow microenvironment in patients with multiple myeloma undergoing autologous transplantation

Conditions: Multiple Myeloma

Summary: this randomized phase ii trial compares how well adding xmo2 filgrastim (granix) to melphalan before a stem cell transplant works in treating patients with multiple myeloma. chemotherapy drugs, such as melphalan, are given to prepare the bone marrow for the stem cell transplant. giving colony-stimulating factors, such as xmo2 filgrastim (granix), may help multiple myeloma cells move from the patient's bone marrow to the blood where they may be more sensitive to treatment with melphalan. it is not yet known whether adding xmo2 filgrastim (granix) to melphalan before a stem cell transplant will work better than melphalan alone in treating multiple myeloma


Eligibility criteria:
inclusion criteria: * symptomatic multiple myeloma requiring treatment * received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-12 months of the first dose of initial therapy * at least 18 years of age * adequate autologous stem cell collection, defined as an unmanipulated, cryopreserved, peripheral blood stem cell collection containing at least 2 × 10\^6 cd34+ cells/kg based on patient body weight. * adequate organ function as measured by: * cardiac function: left ventricular ejection fraction at rest ≥40% * hepatic function: bilirubin ≤2 × uln and aspartate amino transferase/alanine amino transferase (ast/alt) ≤3 × uln * renal function: creatinine clearance ≥40 ml/minute (measured or calculated/estimated) * pulmonary function: carbon monoxide diffusing capacity (dlco; corrected for hemoglobin \[hgb\]), forced expiratory volume in 1 second (fev1), forced expiratory vital capacity (fvc) ≥50% of predicted value * oxygen saturation ≥92% on room air * eastern cooperative oncology group (ecog) performance status 0, 1, or 2. * able to understand and willing to sign an irb-approved written informed consent document exclusion criteria: * evidence of multiple myeloma disease progression (as defined by imwg) any time prior to asct * prior stem cell transplant (autologous or allogeneic) * smoldering mm not requiring therapy * plasma cell leukemia * systemic amyloid light chain amyloidosis * active bacterial, viral, or fungal infection * seropositive for human immunodeficiency virus (hiv) * known, active hepatitis a, b, or c infection * pregnant or breastfeeding. * receiving other concurrent anticancer therapy (including chemotherapy, radiation, hormonal treatment, or immunotherapy, but excluding corticosteroids) within 7 days prior to the asct or planning to receive any of these treatments prior to the last study visit on day +100. * hypersensitive or intolerant to any component of the study drug(s) formulation * receiving growth factors (filgrastim, xm02-filgrastim, peg-filgrastim, plerixafor, etc) or undergoing apheresis \< 14 days prior to the start of treatment on protocol (day -7).
efficacy of ciclesonide on small airways in patients with stable asthma (18 to 60 y) (by9010/m1-131)

Conditions: Asthma

Summary: the aim of this study is to evaluate the involvement of small airways in asthma, as determined by bronchial challenges, ct-scanning, and cellular markers of inflammation. ciclesonide will be inhaled at one dose level once daily. the study duration consists of a baseline period (2 to 3 weeks) and a treatment period (5 to 6 weeks). the study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria:
main inclusion criteria: * written informed consent * history of bronchial asthma * fev1 more than or equal to 60% of predicted * stable asthma * patients who are in good health with the exception of asthma main exclusion criteria: * concomitant severe diseases, diseases expected to interfere with the outcome of the study, or diseases which are contraindications for the use of ics * copd (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function * use of ics 4 weeks before entry into the baseline period * pregnancy * intention to become pregnant during the course of the study * breast feeding * lack of safe contraception * use of other drugs not allowed * current smokers and ex-smokers with more than or equal to 10 pack-years

Keywords: asthma ciclesonide small airways
azd0305 as monotherapy or in combination with anticancer agents in participants with relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a phase i/ii, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, tolerability, pk, immunogenicity, pharmacodynamics, and preliminary efficacy of azd0305 in participants with rrmm.

this is a phase i/ii, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, tolerability, pk, immunogenicity, pharmacodynamics, and preliminary efficacy of azd0305 in participants with rrmm. this study will follow a modular protocol design evaluating azd0305 as monotherapy and in combination with other anticancer agents. the study includes dose escalation and dose expansion phases. this study will enroll subjects with rrmm who received at least 3 prior lines of treatment including at least one proteasome inhibitor (pi), one immunomodulator (imid), and an anti-cd38 antibody.

Eligibility criteria:
principal inclusion criteria: * participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place. * eastern cooperative oncology group (ecog) performance status of ≤ 2. * documentation of multiple myeloma (mm) as defined by international myeloma working group (imwg) diagnostic criteria for multiple myeloma. site should ensure that multiple myeloma diagnosis is confirmed in accordance with the imwg diagnostic criteria. * participants must have one or more of the following measurable disease criteria: 1. serum m-protein level ≥ 0.5 g/dl. 2. urine m-protein level ≥ 200 mg/24h. 3. serum immunoglobulin free light chain ≥ 10 mg/dl and abnormal serum immunoglobulin kappa lambda free light chain ratio. * adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the csp. * participants must have received at least 3 prior lines of treatment which include a proteasome inhibitor (e.g., bortezomib), an immunomodulator (e.g., lenalidomide), and an anti-cd38 antibody (e.g., daratumumab). principal exclusion criteria: * participants exhibiting clinical signs of central nervous system involvement of mm. * participants with known copd, or previous history of ild. * participants with known moderate or severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification. * participants who have severe cardiovascular disease which is not adequately controlled. * participants who have a history of immunodeficiency disease. * participants with peripheral neuropathy ≥ grade 2. * primary refractory mm. * participants who have previously received anti-gprc5d or mmae-containing treatment. * participants who have previously received allogenic stem cell transplant, or participant has received autologous stem cell transplant within 3 months before the first dose of study intervention.

Keywords: gprc5d adc azd0305 relapsed refractory multiple myeloma rrmm mmae
intra-articular injection in arthroscopic management of temporomandibular diseases

Conditions: Temporomandibular Joint Disorders

Summary: the aim of this study is to evaluate the efficacy of intra-articular injection of platelet rich plasma versus hyaluronic acid following diagnostic arthroscopy in the management of patients suffering from degenerative temporomandibular joint (tmj). this is a prospective randomized study of 20 patients with tmj degenerative joint diseases wilkes iv, v. patients will be divided into two groups; group a: will be treated with operative arthroscopy plus intra-articular platelet rich plasma. group b: will be treated with operative arthroscopy plus intra-articular hyaluronic acid.


Eligibility criteria:
inclusion criteria: * - all patients with reduced mouth opening and/or painful maximum mouth opening. * joint pain. * patients with radiological evidence of degenerative joint disease. * patients with unsuccessful medical conservative treatment for at least two months. * unilateral or bilateral temporomandibular joint involvement. * wilkes stages iv and v exclusion criteria: * - patients with bony ankylosis . * patients with advanced resorption of the glenoid fossa. * patients with infection or tumors around joint area * patients unfit for intervention medically. * patients who refused to share in the study
vitamin d level and risk of infections in cirrhotic patients

Conditions: Vitamin D Deficiency; Infection; Liver Cirrhosis

Summary: it is widely known that vitamin d has an important role in calcium metabolism and bone mineralization. its deficiency is related to rickets and osteomalacia in children and adults respectively. vitamin d had a role in innate and acquired immunity. it increases innate defense and modulates lymphocytes activation, leading to a change toward a t2 helper response ). the role of vitamin d deficiency on the risk of bacterial infection among patients in intensive care units has been reported. an observational studies in children reported an association between low 25-oh vitamin d level and infectious viral diseases . the deranged metabolism of vitamin d in liver cirrhosis was first reported in the late '70s and was attributed mainly to impaired 25(oh)-vitamin d hydroxylation of the precursor vitamin d caused by impaired liver function. low level of vitamin d was found independently to be associated with increased risk of bacterial infections in patients with liver cirrhosis. the observed relationship between the lack of vitamin d and the increase risk of mortality in cirrhotic patients could be attributed to bacterial infections. thus, the association of low vitamin d levels with liver insufficiency and infections supports the use of vitamin d as a prognostic marker in the population of cirrhosis. studies on the role of vitamin d as a risk factor for infections in patients with liver cirrhosis are not well studied in our locality(upper egypt).


Eligibility criteria:
inclusion criteria: * admitted patients with liver cirrhosis irrespective of the underlying etiology during 6 months in al rajhi liver hospital, assiut, egypt who accept to participate in the study exclusion criteria: * patients with cholestatic liver disease, patients receiving antibiotics to treat their infection prior hospital admission and patients refusing to participate in the study.
insulin glargine in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this project is to confirm the efficacy and safety profile of insulin glargine in daily practice and to improve the physicians' knowledge and experience concerning insulin glargine


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patients, * diabetic patients receiving insulin or patients who are insulin-naive and whose glycemic control cannot be sufficiently maintained with single or combined oral antidiabetic agents, * patients with hba1c\>8 * patients able to self-measure its blood glucose levels. exclusion criteria: * according to package insert information (summary of product characteristics)
phase ii study of perioperative s-1 plus docetaxel in patients with localized advanced gastric cancer

Conditions: Stomach Neoplasms

Summary: this study is an open-label, single center, and a single arm phase ii study to evaluate the clinical response and safety of perioperative s-1 plus docetaxel. perioperative chemotherapy is composed of 3 cycles of preoperative s-1/docetaxel and 3 cycles of postoperative s-1/docetaxel.chemotherapy regimen: * s-1 80 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning) * docetaxel 35 mg/m2 mixed in d5w 250 ml iv over 60-min on days 1 and 8


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed localized gastric adenocarcinoma as defined by ct stage iii and iv (m0) (but not n3, which is metastatic node in who tnm classification), according to japanese tnm classification system 2. no distant metastatic disease in laparoscopy 3. age: 18-70 years 4. eastern cooperative oncology group (ecog) performance status 0-1 5. disease status must be that of measurable disease as defined by recist: measurable lesions: lesions that can be accurately measured in at least one dimension by abdominal ct, if the longest diameter to be recorded is at least 10 mm with spiral ct 6. adequate major organ function including the following: hematopoietic function: wbc ³ 4,000/mm3, anc ³ 1,500/mm3, platelet ³ 100,000/mm3hepatic function: serum bilirubin £ 1.5 mg/dl, ast/alt levels £ 2.5 x unlrenal function: serum creatinine £ 1.5 mg/dl 7. patients should sign a written informed consent before study entry exclusion criteria: 1. ct stage i, ii, m1 or n3, which is metastatic node in who tnm classification, according to japanese tnm classification system 2. prior chemotherapy or radiotherapy 3. inadequate cardiovascular function:new york heart association class iii or iv heart diseaseunstable angina or myocardial infarction within the past 6 monthshistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality 4. serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy 5. other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix 6. psychiatric disorder that would preclude compliance 7. pregnant, nursing women or patients with reproductive potential without contraception 8. patients receiving a concomitant treatment with drugs interacting with s-1 such as flucytosine, phenytoin, or warfarin et al.

Keywords: stomach neoplasms secondary combination chemotherapy s-1 docetaxel oxaliplatin
nsaids and pge2 levels in vitrectomy patients

Conditions: Vitreous Inflammation

Summary: the purpose of this study is to assess vitreous concentrations of nonsteroidal antiinflammatory drugs (nsaids) and prostaglandin e2 in patients treated with nsaids before vitrectomy. a total of 0.5 to 1 ml undiluted vitreous was removed from the midvitreous cavity at the beginning of the surgery before infusion with balanced salt solution. samples were immediately frozen and stored at -40°c until analysis. samples were evaluated in a masked fashion. vitreous concentrations of the study drugs were quantified using a reverse-phase liquid chromatography mass spectroscopy system. the minimum quantification limit for ketorolac, bromfenac, nepafenac, and amfenac was 0.8 ng/ml. prostaglandin e2 concentrations were determined using a commercially available competitive enzyme immunoassay kit (r \& d systems, minneapolis, mn).


Eligibility criteria:
inclusion criteria: * patients with pucker scheduled for vitrectomy exclusion criteria: * diabetes * active inflammation

Keywords: nonsteroidal antiinflammatory drugs prostaglandin e2 vitrectomy
a pilot study for the brain health support program

Conditions: Dementia; Mild Cognitive Impairment; Subjective Cognitive Impairment; Pre-dementia; Dementia Prevention

Summary: prior studies have shown that programs that focus on promoting brain health and managing lifestyle risks (such as poor diet, obesity, physical inactivity, sleep issues, loneliness) may help in preventing or lowering the risk of dementia. to address this, investigators have developed the can-thumbs up program to conduct studies that target lifestyle risk and focus on dementia prevention. an online brain health support program (bhsp) has been developed. the bhsp is an educational program designed to teach about dementia. before the full bhsp is offered to a large group, we are conducting an initial pilot study to help assess the usability of the program.


Eligibility criteria:
inclusion criteria: * meets criteria for no dementia and one of the following (according to ccna criteria): cognitively intact (ci) cognitively intact plus subjective cognitive impairment (ci + sci) mild cognitive impairment (mci) • and classified as being at increased risk of dementia based on at least one of the following: first-degree family history of dementia self-reported or documented current and/or history at midlife (45-60) on any of the following risk factors: * hypertension (documented systolic blood pressure \> 140 mm hg; or physician diagnosis of hypertension; or treatment for hypertension; or other approaches to treatment (e.g. diet, exercise)) * hypercholesterolemia (documented total cholesterol \> 6.5 mmol/l; or physician diagnosis of hypercholesterolemia; or treatment for hypercholesterolemia; or other approaches to treatment (e.g. diet, exercise)) * body mass index \> 30 kg/m2 (derived from nih metric bmi calculator) * physical inactivity (active is defined as engaging in a minimum of 20- 30 min of physical activity causing sweating and breathlessness, at least 2 times a week)
mapping multidimensional illness trajectories of patients with end-stage kidney disease

Conditions: End Stage Kidney Disease

Summary: patients with end-stage kidney disease (eskd) must manage not only the demands of dialysis and comorbid conditions but also associated symptoms and acute life-threatening events that contribute to functional limitations and increased risk of mortality. yet little is known about the trajectories of quality of life dimensions in patients with eskd when they experience acute life-threatening episodes, to guide palliative care for this population. in this prospective, descriptive study, we will identify trajectories of symptoms, physical functioning, psychosocial needs, and emotional and spiritual well-being in 200 patients with eskd who are at a high risk of experiencing acute life-threatening events and mortality within 12 months.


Eligibility criteria:
inclusion criteria: * aged 18 years or older; * receiving either hemodialysis or peritoneal dialysis * on dialysis either \< 3 months or ≥ 6 months with a charlson comorbidity index (cci) score ≥ 5 exclusion criteria: * patients who are enrolled in hospice or too sick to participate in questionnaire completion will not be eligible. * kidney transplant candidates will be excluded because their illness trajectories after transplant are likely to differ.