Kornimate/medical-research-clean huggingface dataset:
a double-blind, randomized, placebo-controlled, multicenter, phase iii study of tariquidar + paclitaxel/carboplatin as first-line therapy in non-small cell lung cancer (nsclc)

Conditions: Stage IIIb Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Summary: to determine whether tariquidar + combined first-line chemotherapy of paclitaxel/carboplatin in patients with stage iiib/iv nsclc will, with an acceptable safety profile, significantly improve overall survival compared with placebo + paclitaxel/carboplatin. to compare the effects of tariquidar/paclitaxel/carboplatin with placebo/paclitaxel/carboplatin on tumor response, time to disease progression, performance status, symptom progression, and quality of life in patients with stage iiib/iv nsclc.


Eligibility criteria:
inclusion criteria: 1. patients who have histologically or cytologically proven nsclc, stage iiib or stage iv, requiring first-line chemotherapy. 2. patients who have a who performance status of 1 or 0 and life expectancy of greater than 3 months. 3. patients who are 18 years of age or older and age of consent. 4. patients who are women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test (serum or urine) at screening, and must be practicing an adequate method of birth control. 5. patients who have neutrophils greater or equal to 1.5 x 103/µl; platelets greater or equal to 100 x 103/µl; bilirubin less or equal to 1.5 times the upper limit of normal or less or equal to 26 µmol/l (1.5 mg/dl); transaminases less or equal to 2.5 times the upper limit of normal or, for patients with known liver metastases, less or equal to 5 times the upper limit of normal; and creatinine less or equal to 141 µmol/l (1.6 mg/dl) or calculated creatinine clearance greater or equal to 60 ml/min prior to study treatment. 6. patients who are able to give written informed consent and comply with the protocol. exclusion criteria: 1. patients who are eligible for radiotherapy or surgery for curative intent. 2. patients who have had previous chemotherapy for nsclc. 3. patients who have a who performance status greater than 1. 4. patients with bronchoalveolar carcinoma (an adenocarcinoma in which cylindrical tumor cells grow upon the walls of pre-existing alveoli, from who histological typing of lung tumors \[1\]). 5. patients who have previous or current primary malignancies at other sites within the last 5 years, with the exception of adequately treated cone-biopsied carcinoma of the cervix and basal or squamous cell skin carcinoma. 6. patients who are a poor medical risk because of other nonmalignant systemic diseases or active uncontrolled infections. 7. patients who have symptomatic brain metastases. 8. patients who have peripheral neuropathy of ctc grade 2, 3, or 4. 9. patients who have other medical or surgical conditions that would contraindicate chemotherapy. 10. patients who have received experimental therapies within the last 4 weeks. 11. patients who have known hypervitaminosis or known sensitivity to ascorbic acid, vitamin a, vitamin d, thiamine, riboflavin, pyridoxine, niacinamide, d-panthenol, or vitamin e.
association of ultrasonographic temporal artery lesions and relapse in patients with giant cell arteritis

Conditions: Giant Cell Arteritis

Summary: ultrasound evaluation of the temporal and axillary arteries is currently well recognized in the field of giant cell arteritis (gca), a disease primarily affecting medium- and large-caliber vessels. structural ultrasound abnormalities are now well described in this pathology, but their association with relapse and clinical concordance is unknown. there is currently a follow-up score (the ogus score) for medium- and large-caliber arteries that could also predict the clinical course of the disease.

prospective bicentric longitudinal study evaluating the association between ultrasound lesions and clinico-biological relapse in patients with giant cell arteritis. this is a non-interventional study with patients routinely followed for their pathology and classically benefiting from temporal artery ultrasound as part of their disease. recruitment will be facilitated by the fact that these will be "general population" patients with suspected giant cell arteritis. the center will enroll 100 patients. the study will take place over 3 visits, including a clinical, biological and ultrasound examination. ultrasound will not be blinded to the clinic, so we will only need one examiner in the center. this is a study in routine care, with no additional costs and no expected constraints. the ultrasound examination will be performed as part of their routine follow-up.

Eligibility criteria:
inclusion criteria: * major patient * patients meeting acr 2022 criteria for giant cell arteritis. * no opposition expressed exclusion criteria: * patients unable to understand the protocol, under guardianship or curatorship. * patients not affiliated to the french social security system.

Keywords: giant cell arteritis ultrasound follow up monitoring ogus score
longitudinal analysis of respiratory and intestinal microbiome in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: respiratory und intestinal microbiome will bei analyzed during a period of 6 months. in a retrospective analysis it will be looked for correlations between microbiome and cf therapy (e.g. inhaled and systemic antibiotics, cftr modifiers, proton pump inhibitors, enzymes, nutritional habits), clinical status and self reported outcome.

dna will be isolated from sputum, throat swabs and stool samples and used for the generation of microbial profiles. both bacterial and fungal profiles will be analyzed by next generation sequencing. clinical outcome parameters (lung function test, weight, calprotectin, elastase, blood parameters, self reported outcome) will be recorded and analyzed along with medication.

Eligibility criteria:
inclusion criteria: * subject has confirmed diagnosis of cystic fibrosis (sweat chloride \>60mmol/l and/or 2 mutations in the cftr gene known to cause cystic fibrosis) * subject is able to perform informed consent exclusion criteria: * inability to give informed consent * antibiotic therapy in the last 4 weeks prior to study start (exception: long term azithromycin therapy, long term antistaphylococcal therapy, long term inhaled antibiotics)

Keywords: respiratory and intestinal microbiome antibiotic therapy cftr modifier diversity
surgery and photodynamic therapy in treating patients with malignant mesothelioma

Conditions: Malignant Mesothelioma

Summary: rationale: photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. combining photodynamic therapy with surgery may be an effective treatment for malignant mesothelioma. purpose: phase ii trial to study the effectiveness of combining photodynamic therapy with surgery in treating patients who have malignant mesothelioma.

objectives: * determine the feasibility of adjuvant photodynamic therapy with large diffuser fibers in patients with malignant mesothelioma undergoing surgery. * compare results of this regimen in these patients to historical controls. * determine the toxic effects of this regimen in these patients. outline: this is a pilot study. patients receive porfimer sodium iv over 5-10 minutes on day 1. patients undergo pleurectomy or pleuropneumonectomy followed by intracavitary photodynamic therapy on day 3. patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 3 years. projected accrual: a total of 20 patients will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed malignant mesothelioma, including the following cell types: * mixed mesothelial * sarcomatous * stage i or ii disease using the butchart system as determined by ct scan or mri * disease confined to 1 hemithorax * no tumor involvement of esophagus or heart as evidenced by ct scan * pericardial or diaphragmatic involvement allowed if disease is limited to the ipsilateral chest * n2 disease allowed if no contralateral pleural involvement * no adenocarcinoma or nonmesothelioma sarcoma of the chest wall patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * not specified hematopoietic * wbc greater than 4,000/mm\^3 * platelet count greater than 100,000/mm\^3 * hemoglobin greater than 8.5 g/dl (transfusion allowed) hepatic * bilirubin less than 3.0 mg/dl * alkaline phosphatase less than 2 times upper limit of normal (uln) * sgot less than 2 times uln renal * creatinine less than 3.0 mg/dl cardiovascular * no myocardial infarction within the past 6 months pulmonary * arterial partial pressure of carbon dioxide (pco_2) less than 50 torr at rest * predicted postoperative fev_1 at least 800 ml with maximum oxygen consumption/kg at least 15 ml/min * predicted postoperative total lung capacity at least 40% of hemoglobin and alveolar ventilation other * not pregnant * no other concurrent malignancy except nonmelanoma skin cancer * no contraindication to general anesthetic * no history of porphyria * no indicated sensitivity to porfimer sodium prior concurrent therapy: biologic therapy * not specified chemotherapy * more than 30 days since prior chemotherapy endocrine therapy * not specified radiotherapy * no prior radiotherapy to the chest * no prior radiotherapy for mesothelioma surgery * not specified

Keywords: localized malignant mesothelioma recurrent malignant mesothelioma epithelial mesothelioma sarcomatous mesothelioma
empagliflozin after aortic valve replacement

Conditions: Aortic Valve Stenosis

Summary: the study is a randomized, placebo-controlled, and double-blinded trial in patients with aortic stenosis (as) undergoing aortic valve replacement (avr). after avr, patients will be randomized 1:1 to empagliflozin (sglt2i) or placebo to investigate whether empagliflozin is superior to placebo in reducing left ventricular mass and improve symptoms to 6 months.

in this randomized, placebo-controlled, and double-blinded trial we investigate whether empagliflozin (sglt2i) is superior to placebo in reducing left ventricular mass and improve symptoms. all patients with as who are referred to rigshospitalet for avr (both surgical and transcatheter approaches) will be screened for in- and exclusion criteria in the medical record based on the danish health act §46 by the pi, co-pi, or a delegated study nurse. if the patient fulfills the inclusion criteria and none of the exclusions criteria, the patient is invited to participate in the study. included patients will be randomized 1:1 in blocks of 2, 4, and 6 patients to either empagliflozin 10 mg daily or placebo. point of randomization will be in the hospital when the patients has undergone avr. the total treatment period is 6 months with either 10 mg empagliflozin or placebo. the trial participants will receive conventional treatment, which will be carried out irrespective of the inclusion in the trial in accordance with national guidelines. routine clinical check-ups irrespective of the trial setup will be performed at 3 months after discharge, and study-outcomes will be assessed at discharge, 3 months, and 6 months (eg. echocardiography). blood samples (including n-terminal-probnp, renal function and electrolytes, hemoglobin and hba1c) will be part of such routine visits as well as a standardized symptom-scoring tool (kccq and nyha classification). compliance will be evaluated at 1-, 3- and 6-months. the assessment for 1-month will be per telephone and the assessment at 3- and 6-months will be at the routine clinical check-ups in the outpatient clinic. the ct scan performed in the planning of the procedure will be used for the baseline assessment (before avr). an identical exam (ct scan) will be performed at 6 months to assess change in lv mass.

Eligibility criteria:
inclusion criteria: severe symptomatic aortic stenosis and surgical or transcatheter aortic valve replacement within 14 days exclusion criteria: * prior treatment with a sglt2i * left ventricular ejection fraction \< 45% * estimated glomerular filtration rate (egfr) \< 30 ml/min * hypersensitivity to empagliflozin or placebo tablet * type i diabetes * patients who do not understand danish or english * women who are pregnant or are nursing or plan to become pregnant during trial

Keywords: aortic valve stenosis aortic valve replacement transcatheter aortic valve implantation aortic valve sodium-glucose cotransporter-2 inhibitor sglt2i empagliflozin
predicting violent outburst in inpatient pediatric psychiatry ward using a wearable device.

Conditions: Child Behavior Disorders

Summary: the investigator will investigate the use of non-invasive wearable device physiological measures. this in order to predict aggression, and violence outburst in children under 12 years old, which are admitted at an inpatient psychiatric ward. also, the investigator will try to do a characterization of those physiological measures in the prediction of aggression and violence outbursts.


Eligibility criteria:
inclusion criteria: * the investigator will include patients under the age of 13 with various mental disorders admitted to our inpatient psychiatry ward at 'edmond and lily safra' children's hospital, sheba medical centre, tel hashomer, ramat gan, israel during 2024. exclusion criteria: * the investigator will exclude patients that were hospitalized but did not want to participate, or couldn't participate due to increased sensorial sensitive to the device. the investigator will exclude patients with no violence outburst or aggressive attitude that were hospitalized at our inpatient psychiatric ward during 2024. additional, patients who suffers dermatological illnesses and might show allergic reactions to the device material on their wrist will be excluded.
acetaminophen and aki after aortic surgery

Conditions: Aortic Surgery

Summary: acute kidney injury is commonly accompanied major complication after aortic surgery. cardipulmonary bypass lyses erythrocyte and induces lipid peroxidation. this increases plasma free hemoglobin, f2-isoprostane, and isofuran concentration. cell free hemoglobin have been reported to be associated with poor prognosis such as acute kidney injury, myocardial infarction, and death. acetaminophen is reported to attenuate hemeprotein mediated lipid peroxidation. thus, investigators hypothesized that acetaminophen might have protective effect on the incidence of acute kidney injury in patients undergoing aortic surgery with moderate hypothermic circulatory arrest.


Eligibility criteria:
inclusion criteria: 1) patients undergoing aortic surgery with moderate hypothermic circulatory arrest. exclusion criteria: 1. patients with chronic kidney disease or with dialysis, egfr \< 15ml/min/1.73m2 2. allergy to acetaminophen or propacetamol hcl 3. history of liver cirrhosis or total bilirubin \> 2.0mg/dl 3) patients taking acetaminophen or diclofenac 4) patients who cannot understand informed consent
a canadian study to evaluate early use of adalimumab after methotrexate failure in early rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: a canadian study to evaluate early use of adalimumab after methotrexate failure in early rheumatoid arthritis. the study hypothesis will verify if adalimumab effectively reduces joint damage in more participants when introduced earlier than in current practice.


Eligibility criteria:
inclusion criteria: 1. subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised american college of rheumatology-classification criteria and has disease duration of less than 2 years from diagnosis. 2. subject must have been on a dose of methotrexate therapy either subcutaneously or orally administered (15-25 mg/week) for at least 3 months prior to baseline visit and has had an inadequate response to treatment defined as having a disease activity score das28 \> 3.2 (at screening visit). 3. subject must also meet the following three criteria (at screening visit): at least 4 swollen joints out of 66 assessed; at least 4 tender joints out of 68 assessed; subject must have an elevated erythrocyte sedimentation rate \>/= 20 mm/1h or c-reactive protein \> upper limit of normal. 4. subject must fulfill at least one of the following three criteria: history of rheumatoid factor positive; history of at least one erosion on x-ray or magnetic resonance imaging; history of anti-cyclic-citrullinated protein antibody positive. exclusion criteria: 1. subject has previous exposure to any biologic therapy including adalimumab. 2. prior disease-modifying antirheumatic drugs triple therapy with methotrexate. 3. subject has been treated with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks prior to baseline visit. inhaled corticosteroids for stable medical conditions are allowed. 4. subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study) of baseline. 5. subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator, would put the subject at risk by participating in the study.

Keywords: rheumatoid arthritis anti-inflammatory biological therapy adalimumab disease-modifying antirheumatic drugs antirheumatic agents agents
investigation of the relationship between the use of social media and functional level in children with cp

Conditions: Social Media Addiction; Cerebral Palsy

Summary: the aim of this study is to examine the relationship between screen usage time and problematic social media use in children with cerebral palsy (cp) with motor function, hand function, speech and vision function.

problematic media use measure, strengths and difficulties questionnaire were administered to 158 parents of children with cp. in order to determine the screen usage time, parents were asked about the screen usage time of their children on weekdays and weekends, and the average usage time in a week was calculated. gross motor function classification system (gmfcs), manual abilities classification system (macs), eating and drinking ability classification system (edacs), communication function classification system (cfcs),and visual function classification system (vfcs) were used to determine functional levels.the structural equation model was used for statistical analysis.

Eligibility criteria:
inclusion criteria: * parents of children with cp aged 4-18 years * parents of children with cp without severe cognitive problems, being a primary caregiver. exclusion criteria: * not being a primary caregiver

Keywords: problematic media use cerebral palsy physical therapy motor function
efficacy of virtual reality based exercise regimes on kinesiophobia, pain and functional disability in patients with knee osteoarthritis

Conditions: Knee Osteoarthristis

Summary: knee osteoarthritis is one of the most prevalent degenerative conditions in pakistan. although a variety of physical therapy treatments have been proven to be beneficial in patients with early stages of knee osteoarthritis. however, a few secondary impairments like kinesiophobia which is the fear of movement have been unaddressed. usually after conventional physical therapy, patients find immediate or short-term relief and that leads to cessation of follow up sessions. in situations like these, kinesiophobia is the greatest threat to mobility and can eventually effect quality of life by decreasing functional disability.


Eligibility criteria:
inclusion criteria: * patients with unilateral knee oa involving mediolateral compartment * knee oa grade 2 * aged 40-65 years * both male and female * nprs value greater than exclusion criteria: * patients with history of * history of systemic disorder (e.g., rheumatoid arthritis, ankylosing spondylitis). * history of malignancy. * history of trauma. * previous knee surgery. * congenital musculoskeletal deformity (e.g., scoliosis, kyphosis). * patients with history of fracture * patients with history of chondropatella malacia

Keywords: range of motion, proprioception
clinical study on endometrial receptivity

Conditions: Endometrial Receptivity;RNA; Progesterone

Summary: to explore the differential expression of mirna in the implantation window of patients with endometriosis and the time of progesterone and route of administration on planting window


Eligibility criteria:
inclusion criteria: 1. the endometriosis group treatment group: previous laparoscopy or laparotomy confirmed endometriosis;regular menstruation, no rule vaginal bleeding;ovarian reserve function is normal. control group: laparoscopic bilateral salpingectomy was performed due to ectopic pregnancy, benign ovarian changes and other reasons, with the exception of endometriosis during the operation.regular menstruation, no rule vaginal bleeding;ovarian reserve function is normal 2. progesterone group women with hypothalamic amenorrhea or premature ovarian failure;ages 18-40 exclusion criteria: patients with medical complications

Keywords: endometrial receptivity rna progesterone
burden of disease and living situation in desmoid patients

Conditions: Desmoid Tumor; Quality of Life

Summary: the main aim of the study is to assess the situation and quality of life of desmoid patients. impaired areas of quality of life and the associated factors are to be identified. the survey is planned as a cross-sectional study (patient survey). prevalent and incident desmoid patients will be identified at the university hospital mannheim and checked for eligibility. quality of life and patient-reported data are collected by means of written questionnaires. medical data is collected from patient files in the clinics. the aim is to include 100 patients. descriptive analyses of the variables collected and regression models are planned as statistical analysis.


Eligibility criteria:
inclusion criteria: * desmoid diagnosis (primary neoplasia, all stages) * age ≥18 years at diagnosis exclusion criteria: * inability to complete a structured questionnaire (insufficient language skills; dementia)

Keywords: health-related quality of life unmet needs return to normal life
amniomics: a prenatal rapid genome validation study

Conditions: Multiple Anomalies of Fetus; Genetic Predisposition Suspected; Amniocentesis Affecting Fetus or Newborn; Family Members

Summary: the purpose of this study is to validate whole genome sequencing (wgs) on amniotic fluid to reduce the time to diagnosis and enhance the care for the fetus/neonate.


Eligibility criteria:
inclusion criteria * fetus with multiple anomalies/suspected genetic disease. * pregnant patient already planning on having an amniocentesis for another reason separate from this study. exclusion criteria * parents under the age of 18. * parents lacking the capacity to consent. * institutionalized (i.e., federal medical prison).