Kornimate/medical-research-clean huggingface dataset:
gender disparity and hormones in cystic fibrosis

Conditions: Cystic Fibrosis (CF)

Summary: the objective of this study is to investigate the impact of hormones on lung disease in cystic fibrosis (cf) patients. due to improved therapies, cf patients are living longer and healthier lives than they did 20 years ago. however, females have been shown to have a survival disadvantage. the median life expectancy is 33 in women and 37 in men with cf. the hypothesis is that estrogen and/or progesterone negatively impact lung health in cf. therefore, understanding the impact of sex hormones (including the use of birth control pills) on the disease process is increasingly important. the purpose of this study is to determine if lung function, respiratory symptoms, or various markers of lung health change during different phases of the natural ovulatory cycle in order to understand if estrogen or progesterone hormones are impacting the disease relative to fluctuations in men with stable testosterone levels. the research objectives of this project are to: * determine if lung function, respiratory symptoms, or various markers of lung health change during different hormonal phases of the ovulatory cycle in women. * determine if men change lung function, respiratory symptoms, or various markers of lung health over time. * determine if oral contraceptive pills in women stabilize fluctuations in symptoms and improve lung health.


Eligibility criteria:
inclusion criteria: * male and female cystic fibrosis patients * must be greater than or equal to 18 years of age. * all subjects must understand and sign the informed consent. * subjects must have the ability to read and write in english. * female subjects starting this study must be willing to use a double barrier method of birth control (such as condom or diaphragm) used with a spermicide (a substance that kills sperm), while participating in the study. exclusion criteria for main study: * women who are pregnant, breast feeding, or who have had an oophorectomy. * women who have received a hormone contraceptive injection (such as depo provera) within the last 3 months. exclusion criteria for substudy: * men * women who have a history of breast cancer, abnormal vaginal bleeding, liver disease, coronary artery disease, cerebrovascular disease, uncontrolled hypertension, diabetes mellitus with vascular disease, or have had a stroke, heart attack, or blood clot within the past year, due to a possible reaction to loestrin. * women who currently smoke cigarettes, due to the increased risk of serious cardiovascular events with loestrin use.

Keywords: cystic fibrosis loestrin hormone
cannabidiol for anxiety

Conditions: Anxiety

Summary: this pilot trial seeks to investigate the effect of 25 mg full-spectrum cbd soft gel capsules (up to a total dosage of 100mg per day) on individuals with diagnosed anxiety. all participants will take cbd soft gel capsules for 12 weeks, and will be assessed at 6 weeks and 12 weeks post-enrollment using measures of anxiety, sleep and perception of change.


Eligibility criteria:
1. male or female patients 18 years of age or older with a gad-7 score of 10 or greater 2. presenting to a participating clinic for initial evaluation for a medical cannabis card 3. willingness to abstain from the use of all other cannabis products for the trial period (3 months) 4. not pregnant or planning to become pregnant during the trial period (3 months) 5. not breastfeeding or planning to breastfeed during the trial period (3 months) 6. no history of cannabis use within 4 weeks of enrollment 7. no history of lifetime cannabis use disorder or other substance use disorders (except: tobacco use disorder) 8. no history of lifetime daily cannabis use 9. no family history of psychosis (e.g., bipolar disorder or schizophrenia) 10. no history of adverse reactions to cannabis 11. no recent changes to prescribed anxiety medications (within the last 1 month) 12. provision of informed consent
a four-week multicenter study evaluating the safety and efficacy of gefapixant (af-219/mk-7264) in subjects with osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this study is to assess the efficacy of a single dose level of gefapixant (af-219/mk-7264) in subjects with moderate to severe pain associated with osteoarthritis (oa) of the knee compared with placebo after 4 weeks of treatment. the study will also assess the safety and tolerability, changes in physical function, stiffness, treatment response and health outcomes.

subjects who satisfy entry criteria at screening will enter the washout phase, discontinuing their current nonsteroidal anti-inflammatory drug (nsaid) therapy. up to 220 subjects who fulfill flare (and other entry) criteria will be randomized to gefapixant or placebo. subjects will complete treatment visits 1, 2, 3, and 4 weeks after starting study drug. at each treatment visit, subjects will undergo efficacy assessments and safety procedures. during the washout and treatment phases subjects will complete the 'average pain' numeric pain rating scale (nprs) and count of rescue medication used for the preceding 24 hours. subjects will return 2 weeks after their last treatment visit (for a follow-up visit).

Eligibility criteria:
inclusion criteria: * men or women * women of child bearing potential must not be pregnant during the study and must use two forms of birth control * men and their female partners must use two forms of birth control * clinical and radiographic evidence of chronic knee osteoarthritis * an average nprs score of \>=5 and \<=9 over a 4-7 day washout period of their previous osteoarthritis medications * ambulatory * have provided written informed consent
regulatory post marketing surveillance (rpms) study of xultophy® (insulin degludec/liraglutide) to evaluate safety and effectiveness in patients with type 2 diabetes mellitus in routine clinical practice in korea

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this study is to assess the safety and effectiveness of xultophy® initiated according to label in adults with type 2 diabetes mellitus (t2dm) under routine clinical practice conditions. participants will get xultophy® as prescribed to them by the study doctor. the study will last for about 26 weeks.


Eligibility criteria:
inclusion criteria: * the decision to initiate treatment with commercially available xultophy® has been made by the participant/legally acceptable representative (lar) and the study doctor before and independently from the decision to include the participant in this study. * informed consent obtained before any study related activities. study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * male or female, age 19 years or older at the time of signing informed consent form. * participants diagnosed (clinically) with t2dm and who is scheduled to start treatment with xultophy® based on the clinical judgment of their treating physician as specified in the approved korean-prescribing information (local label). exclusion criteria: * participants who are or have previously been on xultophy® therapy. * known or suspected hypersensitivity to xultophy® (the active substance or any of the excipients). * previous participation in this study. participation is defined as having given informed consent in this study. * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
emergency department management of patients with renal infarction

Conditions: Renal Infarct; Renal Infarction - Venous; Renal Infarction - Arterial

Summary: the aim of this study is to investigate laboratory parameters from medical records of patients diagnosed with renal infarction in our emergency clinic to establish early diagnostic indicators. additionally, we will evaluate imaging methods such as ct or ct angiography and identify mortality-morbidity markers to contribute to the literature.

it is planned to include 80 patients who presented to the hospital emergency department and were diagnosed with renal infarction between january 1, 2014, and june 1, 2023, in the study. he data of patients diagnosed with renal infarction will be retrospectively collected from the hospital database and recorded in a data collection form. this includes information such as cbc (complete blood count), neutrophils, lymphocytes, platelets, lactate, anion gap, ph, bicarbonate, creatinine, urea, ast, alt, fibrinogen, d-dimer, ldh, crp, ct scan, and ct angiography results. patients' demographic characteristics, physical examination findings, imaging, and laboratory results will be evaluated using patient records and the hospital registry system. our aim is to identify early morbidity and mortality indicators in cases of renal infarction where diagnosis is often delayed or missed, contributing to the survival of patients. we believe that the findings from our statistical analysis can guide routine practice, especially in the management of patients presenting to the emergency department with complaints of abdominal and/or flank pain

Eligibility criteria:
inclusion criteria: adult patients aged 18 years and older cases diagnosed with renal infarction presenting to the emergency department of dışkapı yıldırım beyazıt training and research hospital exclusion criteria: patients without imaging methods patients with incomplete laboratory and file follow-ups patients previously diagnosed with renal infarction and currently under treatment patients diagnosed with other clinical conditions such as pyelonephritis, lower urinary tract infections, nephrolithiasis

Keywords: renal infarction emergency department
life improving factors after a hip fracture

Conditions: Hip Fractures; Older Adults

Summary: the primary objective of the proposed research is to investigate the association between protein intake and nutritional status with bone health and physical functioning in older hip fracture patients. in addition, it will be investigated which patient characteristics and modifiable factors can predict mobility, clinical frailty, living situation and mortality. this study will be a 3-month prospective cohort study in adults aged 70 years and older with an acute hip fracture. this study will lead to knowledge about how protein intake and nutritional status in combination with patient characteristics can predict the degree of recovery (bone health and physical functioning) 3 months after the hip fracture. knowledge on factors related to recovery can contribute to an improved and shorter rehabilitation in the future, which results in a reduction of health care costs.

only half of the patients with an acute hip fracture regain their pre-fracture functional level and 24% dies within the following year. identifying and targeting modifiable risk factors for optimal recovery after a hip fracture is therefore essential. these factors include protein intake and nutritional status, which may affect markers of bone health and physical functioning and thereby influence recovery. measurements will be performed at baseline (within 5 days after the hip surgery) and after 3 months during an outpatient clinic visit for the evaluation of the hip fracture surgery. a total of 95 older adults (aged 70 years or older) recovering from an acute hip fracture will be recruited from rijnstate hospital.

Eligibility criteria:
inclusion criteria: * age ≥ 70 years * community-dwelling * proximal femur fracture: femoral neck fracture/ pertrochanteric fracture, subtrochanteric fracture * able to give informed consent * pre-fracture clinical frailty scale 3-6 exclusion criteria: * pathological fracture or periprosthetic fracture * current participation in scientific research that interferes with the proposed study * history of dementia * no permission to request information from the general practitioner/ treating specialist(s) about medical history, medication use, liver and kidney values, and details about the broken hip
tbi project amsterdam

Conditions: Traumatic Brain Injury

Summary: traumatic brain injury (tbi) is the world leading cause of acquired brain injury. literature suggests a pivotal role for attentional functioning in neurocognitive and behavioural consequences of paediatric tbi. limitations of traditional neuropsychological measures of attentional functioning have interfered with identification of the effect of paediatric tbi on attentional networks so far. moreover, the associations between attentional networks, learning abilities, academic performance and behavioural and emotional problems following paediatric tbi are yet to be explored.

background: traumatic brain injury (tbi) is the world leading cause of disability in children (winslade, 1998), causing deficits in motor function, neurocognition and adaptive behaviour (anderson, 2001). literature shows that age at injury is inversely related to the magnitude of deficits following tbi, highlighting the vulnerability of children for the effects of tbi. the neurocognitive consequences of paediatric tbi have primarily been characterized by impairments in speed of information processing, attentional functioning and learning (babikian \& asarnow, 2009; catroppa \& anderson, 2009), interfering with typical neurocognitive development. we aim at elucidating the effects of tbi on neurocognitive function and investigate the relations between neurocognitive deficits, academic achievement and emotional and behavioural function, in order to improve our understanding of the post-injury functioning of children that have suffered tbi. methods: patients with tbi will be compared to a control group consisting of orthopedically injured patients. orthopaedic control (oc) groups offer a better comparison to tbi patients than typically developing children by controlling for tbi risk factors related to neurocognition (e.g. attention deficit hyperactivity disorder, socioeconomic status), hospitalisation and the type of injuries other than brain injuries. measures: child's orientation and amnesia test, attention network test, probabilistic learning test, child behaviour checklist, strengths \& difficulties questionnaire, experimental neurocognitive test developed at the vu university and pupil monitoring system.

Eligibility criteria:
inclusion criteria: tbi patients will be included if they * have parental written informed consent * provide written informed consent if aged over 11 years * are dutch speaking * have a clinical diagnosis of tbi (closed head injury) * have a time post-injury that is longer than 1 month * are aged between 6-12 years. trauma control patients will be included if they: * have parental written informed consent * provide written consent if aged over 11 years * are dutch speaking * have suffered an orthopaedic injury * have no history of tbi * and are aged between 6-12 years.

Keywords: tbi traumatic brain injury children prognosis neurocognition
correlation between aqueous protein level and clinical grading of flare and flaremetry.

Conditions: Uveitis

Summary: the purpose of this study is to compare flaremetry readings with the protein content of the aqueous humor and the clinical grading of flare.

a total of 20 patients will be included. 10 patients with uveitis and 10 control patients scheduled for phacoemulsification. each patient will undego complete ophthalmic examination and clinical biomicroscopic grading of the anterior chamber flare applying the sun working group grading system. aqueous specimens will be obtained by anterior chamber paracentesis for protein analysis. each patient will undego paracentesis and 0.2 ml of aqueous will be obtained. the aqueous sample will be stored at -70°c until the time of analysis for protein content. objective assessment of flare will be done.

Eligibility criteria:
inclusion criteria: * 10 patients with uveitis with cataract * 10 patients without uveitis with cataract * inactive inflammation for at least 3 months exclusion criteria: * infectious uveitis * endophthalmitis * cases with corneal scar

Keywords: flaremetry aqueous proteins clinical grading compare flaremetry readings with the protein content of the aqueous compare flaremetry readings with clinical grading of flare
taxol carboplatin and erythropoetin

Conditions: Ovarian Cancer

Summary: time to progression (physical examination and radiologic imaging


Eligibility criteria:
inclusion criteria: * patients with primary ovarian cancer * ecog- 0-2 * age \>= 18 * no chemotherapy, radiation or immunotherapy in medical history for ovarian cancer * adequate bone marrow, liver and kidney reserve: leukocytes ≥ 2.0 x 109/l, platelets ≥ 100 x 109/l, bilirubin \<= 2,0 mg%, creatinine \<= 1,5 mg% or creatinine clearance ≥ 60 ml/ min, hemoglobin ≥ 9 g/ dl sgot, sgpt an ap within 3 fold of the reference laboratory's normal range * written informed consent exclusion criteria: * before-existing heart illness, cardiac infarct within last 6 months * radiotherapy within 4 weeks for study entry * patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intrauterine devices, surgical methods of sterilization, or, in hormone insensitive tumors only, oral, subcutaneous or transvaginal hormonal, non-estrogen containing contraceptives)
efficacy study of atorvastatin in pelvic pain relief in women with endometriosis

Conditions: Endometriosis; Pain

Summary: the purpose of this study is to determine whether atorvastatin (alone or in combination with oral contraceptive) is effective in treatment of pelvic pain and inflammatory response in women with endometriosis.


Eligibility criteria:
inclusion criteria: * informed written consent * premenopausal women aged 18-45 * clinical signs and symptoms of endometriosis for minimum 3 months with endometriosis confirmed at laparoscopy or laparotomy within last 4 months - 5 years (preferably with histological confirmation) * pain symptoms of moderate intensity (dysmenorrhoea + dyspareunia + nonmenstrual pelvic pain \> 6 points on biberoglu \& behrman scale \[1981\]) * no clinical signs of sexually transmitted disease exclusion criteria: * cancer of the ovary, adrenals, endometrium, uterine cervix, breasts * pregnancy or lactation * unexplained uterine/cervical bleeding * hormonal therapy within last 3 months (for gnrh analogs 6 months) * irregular menses (\> 35 days) or secondary amenorrhoea (\>3 months) * other chronic disease affecting pelvic or abdominal cavity (including pid, ulcerating colitis , crohn's disease, recurrent interstitial cystitis) * sexually transmitted disease (gonorrhoea, chlamydia) * uncontrolled diabetes mellitus type i or ii, vte or other contraindications to medicine used in the study * chronic therapy with cyp3a4 inhibitors (including ketoconazole, erythromycin and others)

Keywords: endometriosis atorvastatin oral contraception pain relief pelvic pain in women with endometriosis
biomarkers of angiogenesis for response to therapeutic combination in advanced or metastatic kidney cancer

Conditions: Renal Cell Carcinoma; Renal Cancer; Renal Cancer Metastatic

Summary: this is a multicenter, exploratory, prospective study to identify angiogenesis and immune-related biomarkers predictive of progression free survival in patients with metastatic or advanced renal cell carcinoma treated by a combination of immunotherapy and antiangiogenic.

recently, the management of renal cell carcinoma has undergone major changes with the emergence of combined therapies associating tyrosine kinase inhibitors (tki) and immune checkpoint inhibitors (ici) as first line treatments. however, there are no criteria to guide the choice between the different combinations validated and or between ici combinations. angiogenesis and immunity are intimately linked and some markers related have could be interesting to predict the efficacy of these combinations. angiogenesis and immunity are highly related. this link may lead to new biomarkers to be explored to predict the response to tki + ici therapy combinations. on this basis, the investigators propose to conduct an open-label exploratory, multicenter prospective trial to study the association between angiogenesis and immune markers and the effect of combined tki+ici treatments.

Eligibility criteria:
inclusion criteria: * histologically proven advanced or metastatic renal carcinoma * treated in first line with an ici-ici or itk-ici combination (following current recommendations at inclusion) exclusion criteria: * previous systemic treatment for renal cell carcinoma * other cancer developed in the last 5 years except local forms apparently healed as basal cell cancer. * contraindication for ici-ici or tki-ici combinations recommended on 1st line * refusal to participate in the study * no affiliation to a social security regime (beneficiary or entitled) * vulnerable patients as defined by french law (public heath code sections l1121 -5 to l1121-8) : * major patient subjected to legal protection (guardianship, curatorship, protection of justice) * pregnant or breastfeeding woman

Keywords: renal cell carcinoma blood biomarkers predictive factor tyrosine kinase inhibitor immune checkpoint inhibitor
automated central retinal artery occlusion diagnosis on fundus photographs

Conditions: CRAO - Central Retinal Artery Occlusion

Summary: acute central retinal artery occlusion is associated with a poor prognosis and optimal treatment is not defined as randomized control trials struggle to enroll patients in part due to delayed diagnostic. patient lack of knowledge and difficult access to ophthalmologists in emergency situations delay the diagnostic. a simple, rapid and widely accessible method that can recognize acute central retinal artery occlusion in color fundus photographs could benefit patients and doctors.the prurpose of this study is to develop, train and test a deep learning system.


Eligibility criteria:
inclusion criteria: * color fundus photographs taken within 30 days from the date of onset * diagnosis confirmed by the provider's expertise in identifying clinical symptoms and signs. exclusion criteria: * photographs with unconfirmed diagnosis * duplicates * photographs with combined retinal conditions * photographs taken after thrombolysis.