Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and pk of crn04894 for the treatment of cushing's syndrome

Conditions: Cushing Syndrome; Cushing Disease; Ectopic ACTH Syndrome

Summary: a phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (pk), and pharmacodynamic biomarker responses associated with crn04894 (an adrenocorticotropic hormone \[acth\] receptor antagonist) in participants with acth-dependent cushing's syndrome (cushing's disease or ectopic acth syndrome \[eas\])

this is a phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (pk), and pharmacodynamic biomarker responses associated with atumelnant (also known as crn04894) (an adrenocorticotropic hormone \[acth\] receptor antagonist) over a 10-day or 14-day treatment period in participants with acth-dependent cushing's syndrome (cushing's disease or ectopic acth syndrome \[eas\]). participants will receive oral atumelnant once daily for 10 days followed by monitoring during 4 'wash-out' days, or for 14 days.

Eligibility criteria:
inclusion criteria: 1. adult male or female, aged 18 years or more 2. evidence of chronic 'active' acth-dependent cushing's syndrome 3. evidence of acutely 'active' acth-dependent cushing's syndrome within 10 days of day 1 4. participants with documented acth-dependent cushing's syndrome taking short-acting steroidogenesis inhibitors (ketoconazole, levoketoconazole, osilodrostat, or metyrapone) may participate after a washout period of at least 5 days, if they meet other study inclusion criteria, relative to investigator's judgment. participants with documented acth-dependent cushing's syndrome taking cabergoline may participate after a washout period of at least 14 days, if they meet other study inclusion criteria exclusion criteria: 1. women who are pregnant or lactating 2. history of bilateral adrenalectomy 3. previous pituitary mri findings of a putative acth-secreting lesion within 3 mm of the optic chiasm 4. presence of any known malignancy 5. use of mitotane 6. previous unsuccessful surgery for cushing's syndrome within 6 weeks

Keywords: cushing syndrome cushing disease ectopic acth syndrome crn04894 atumelnant
morphine-sparing effect and safety of parecoxib administered intravenously for the treatment of postoperative pain

Conditions: Pain, Postoperative

Summary: to validate the morphine-sparing effect and safety of parecoxib administered intravenously for the treatment of chinese subjects with postoperative pain following gynecological or orthopedic surgery.


Eligibility criteria:
inclusion criteria: * undergo gynecological or orthopedic surgery under epidural anesthesia exclusion criteria: * a previous history of intolerance or hypersensitivity to any nsaid, cyclooxygenase-2 selective inhibitors, sulphonamides, or any of the excipients of parecoxib.
developing novel microbiota-targeted therapies for irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: this longitudinal study is being done to understand mechanisms underlying development of irritable bowel syndrome (ibs) and the role of the gut bacteria in development of symptoms. this information will be used to determine whether temporal changes in gut microbial taxonomy and metabolism are associated with changes in symptom severity in ibs, and if targeted dietary interventions, including prebiotics, can reverse or moderate these changes.


Eligibility criteria:
ibs-c and ibs-d subjects: inclusion criteria: * clinical diagnosis of ibs-c or ibs-d * age 18 to 65 exclusion criteria: * prior history of abdominal surgeries (except appendectomy and cholecystectomy) * known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory condition * antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout period and subsequent use during the 6-month study duration does not exclude them) * bleeding risk or medications which may increase risk of bleeding for patients who agree to undergo flexible sigmoidoscopy * bowel preparation for colonoscopy within the past week * pregnancy or plans to become pregnant within the study time frame * vulnerable adults * age greater than or equal to 66 * any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, would increase risks of flexible sigmoidoscopy (for those opting for this), or in the judgment of the investigator would potentially interfere compliance to this study or would adversely affect study outcomes healthy subjects: inclusion criteria: * age 18 to 65 * no clinical diagnosis of ibs-c or ibs-d exclusion criteria: * prior history of abdominal surgeries (except appendectomy and cholecystectomy) * known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory condition * antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout period and subsequent use during the 6-month study duration does not exclude them) * bleeding risk or medications which may increase risk of bleeding for patients who agree to undergo flexible sigmoidoscopy * bowel preparation for colonoscopy within the past week * pregnancy or plans to become pregnant within the study time frame * vulnerable adults * age greater than or equal to 66 * any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, would increase risks of flexible sigmoidoscopy (for those opting for this), or in the judgment of the investigator would potentially interfere compliance to this study or would adversely affect study outcomes * clinical diagnosis of ibs-c or ibs-d

Keywords: ibs
systemic immune inflammatory index in systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus; Lupus Nephritis

Summary: this study aims to investigate the association between the systemic immune-inflammation index and disease activity, as well as lupus nephritis in patients with systemic lupus erythematosus


Eligibility criteria:
inclusion criteria: * o older than 16 years * in a patient with sle, patients who fulfill the criteria of the american college of rheumatology (acr) and european league against rheumatism (eular). * in patients with ln, patients whose diagnosis is confirmed by kidney biopsy and pathohistological verification (who classification, and the international society of nephrology/renal pathology society (isn/rps) classification. exclusion criteria: * patients with other autoimmune rheumatological diseases, lymphoproliferative disorders, malignancies, liver diseases, end-stage kidney disease, diabetic nephropathy, active infections, recent history of blood transfusion and patients with deficiencies in vitamin b12, folate, and iron are excluded from the study.
prevention of groin injuries in rink hockey

Conditions: Groin Injury; Groin Strain; Adductor Strain

Summary: rink hockey teams from senior category (adults) will be recruited to implement a groin injury prevention program consisting on the copenhagen adduction exercise (cae) throughout the regular season, 0 times, once or twice per week (september 2023-march 2024) weekly team exposure to training sessions and games will be collected as well as cases of groin problems in the entire population when the season ends, the number of groin problems will be compared between teams that used the prevention program once a week against twice a week or no sessions a week.

rink hockey teams will be offered a prevention program consisting on the cae to be performed during the season. teams will decide to implement the protocol once, twice or 0 times per week, depending on their schedule. no formal control group will be set, comparison of injuries will be performed between teams that used +80% of the total possible sessions and -80% (28 weeks equals a potential 42 cae sessions throughout the season). on a weekly basis, coaches will be contacted to report number of training sessions, games, and training sessions where they implemented cae. bi-weekly, players will report any episode of groin problems (both leading to time-loss and those only affecting performance while not limiting participation).

Eligibility criteria:
inclusion criteria: * #1 be part of a rink hockey team competing in senior league (either local (third division/lower) or national (first and second division)) * 2 accept participating in the study (signing the informed consent) exclusion criteria: * #1 not playing rink hockey in the previous season * 2 serious illness, injury or surgery in the previous 6 months that prevented rink hockey participation

Keywords: rink hockey groin pain injury prevention
health-related quality of life in patients with systemic lupus erythematosus:focusing on fibromyalgia

Conditions: Quality of Life

Summary: systemic lupus erythematosus (sle) patients show a high prevalence of fibromyalgia though rates vary considerably from one study to another (from 8.2% to 45%). although fibromyalgia can bring out the disability in daily life, the majority of previous reports only ascertained no significant association between the presence of fibromyalgia and the severity of sle. it is necessary to make unremitting effort to reduce the mortality and life-threatening disease flare-up due to sle disease itself. additionally, we think that physicians need to pay more attention to improve health-related quality of life (hrqol) in the patients with sle. hrqol could be influenced by various factors such as depression, fibromyalgia, disease duration, disease activity and etc. to improve the hrqol in sle patients, it might be the clinically important and constructive theme to investigate that which is the most important factor among the fibromyalgia, depression, sleep quality, sle activity and sle duration. the objective of this study is to evaluate the degree of contribution of fibromyalgia for reduced hrqol and to identify the status of managing fibromyalgia in korean patients with sle.


Eligibility criteria:
inclusion criteria: 1. woman between 30 and 60 years of age, inclusive 2. have a diagnosis of systemic lupus erythematosus according to the 1997 updated american college of rheumatology criteria for classification of systemic lupus erythematosus exclusion criteria: 1. patients were excluded if they had had a history of head injury that led to unconsciousness 2. have unstable disease necessitating an increase in prednisone dose or the addition of another immunosuppressive medication 3. have a current malignancy 4. have a history of or current evidence of substance abuse (drug or alcohol) problem within the previous 2 years

Keywords: systemic lupus erythematosus, disease activity, sleep, quality of life
a study to examine the implantation characteristics of two drug-eluting stents

Conditions: Coronary Artery Disease

Summary: despite recent advances in stent technology and clot reducing drug therapy, acute stent occlusion or thrombosis (st), still occurs and can be life threatening. it has been shown that certain features of how the stent relates to the artery wall may predict st. one such feature, so-called stent strut malapposition (ssm), can be assessed after implantation but current imaging techniques are relatively unreliable. optical coherence tomography (oct) is a newer technology that can be performed safely and easily after angioplasty and may allow the stent struts to be assessed more accurately and reliably. this study will use oct to examine how two different types of commonly used drug-eluting stents relate to the artery wall. the xience v (abbott vascular, usa) stent has thinner struts and a more open frame than the cypher (cordis, usa) stent. we hypothesise therefore that the potentially more pliable structure of the xience v stent will be associated with greater contact with the vessel wall. this may have a bearing on the relative rate of ssm, although large studies have shown the rate to be low in both the cypher and the xience v stent. we believe that oct imaging of ssm and symmetry of the stent immediately after angioplasty will compliment conventional visual assessment and may identify those patients in whom further improvement of stent with a balloon is necessary. this study will involve the random allocation of forty patients requiring coronary angioplasty to one of the cypher or xience v stent. the procedure will be performed in the usual manner as indicated clinically and will include imaging of the stented artery segment with oct once the operator is satisfied with the visual result by angiography.


Eligibility criteria:
inclusion criteria: * presence of a coronary artery stenosis undergoing percutaneous coronary intervention and stenting (pci). * eligibility for drug eluting stent (des) deployment. * stable or unstable coronary syndrome presentation, including st elevation myocardial infarction (stemi). * aged 18-90 exclusion criteria: * contraindication to the use of a des. * target lesion located within previous stent (in stent restenosis). * sustained haemodynamic instability following stent deployment (systolic bp 90≤ mmhg or sustained ventricular arrhythmia).

Keywords: percutaneous coronary intervention coronary artery stenosis acute myocardial infarction coronary artery stent optical coherence tomography
validation of hand held indirect calorimeter in overweight and obese patients

Conditions: Obesity

Summary: the purpose of this study is to determine, in a group of overweight or obese volunteers, if a handheld indirect calorimeter can accurately measures oxygen consumption to determine resting metabolic rate compared to a portable indirect calorimeter.

1. background and rationale: with the growing number of overweight and obese americans, health professionals need accurate and convenient tools to help personalize weight loss programs. portable indirect calorimetry measurements are more expensive than handheld devices and often limited to research setting only, making them impractical for clinical use. additionally equations used to estimate resting metabolic rate may be significantly inaccurate in overweight patients. several studies have been conducted to determine the accuracy of handheld devices, however none have been done in the overweight and obese populations. if handheld calorimeters can accurately measure resting metabolic rate in overweight and obese patients, these tests may be used to improve and personalize weight management programs. 2. key objectives: to determine in a group of overweight or obese volunteers if a handheld indirect calorimeter can accurately measures oxygen consumption to determine resting metabolic rate.

Eligibility criteria:
inclusion criteria: * age at least 18 years (no upper limit). * able to fast overnight. * have a bmi no less than 25 kg/m2. exclusion criteria: * all others

Keywords: obesity
immunogenicity and safety study of rotarix tm in taiwanese infants who received hepatitis b immunoglobulin after birth.

Conditions: Infections, Rotavirus

Summary: the purpose of this study is to assess immunogenicity and safety of rotarix tm when administered in healthy taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received hepatitis b immunoglobulin after birth.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol. * a male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * written informed consent obtained from the parent(s)/legally acceptable representative(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * infants who have received a previous dose of hepatitis b immunoglobulin after birth. exclusion criteria: * child in care. * use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs with the exception of hepatitis b immunoglobulin since birth. child is unlikely to remain in the study area for the duration of the study. * planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * previous vaccination against rotavirus. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * family history of congenital or hereditary immunodeficiency. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness. * acute disease and/or fever at the time of enrolment. * administration of immunoglobulins (with the exception of hbig) and/or any blood products since birth or planned administration during the study period. * gastroenteritis within 7 days preceding the study vaccine administration. * previous confirmed occurrence of rotavirus gastroenteritis.

Keywords: human rotavirus vaccine
validation and evaluation of a portable body scanner for determination of obesity

Conditions: Obesity

Summary: the objective of this study is to validate a portable 3d human body measurement system which will improve approaches in obesity assessment.

obesity has become an epidemic in the united states. a new technique of three-dimensional (3 d) photonic scanning will be used to create and validate a portable instrument that rapidly assesses obesity in clinical and field settings. this new portable body scanner will be a safe and easy method to help determine the incidence and type of obesity.

Eligibility criteria:
inclusion criteria: * 18-60 years old * bmi between 18.50 to 39.99 kg/m3 * free of known diseases * hispanic and not hispanic or latino whites exclusion criteria: * women who are pregnant, could be pregnant, or lactating

Keywords: body scanning body fat body volume obesity no conditions
clinical validation of molecular triage in hr-hpv positive women

Conditions: Cervical Carcinoma

Summary: women accessing the hpv-based screening programme for primary screening, will undergo cervical sampling and clinical data recording. samples from high-risk hpv positive women (around 2000 expected) will be aliquoted for testing with new hpv molecular test, that will allow full genotyping and viral load quantification.


Eligibility criteria:
inclusion criteria: * women participating in a cervical cancer screening program using an hpv assay as primary screening test * positivity to hrhpv; * written informed consent given. exclusion criteria: * total hysterectomy; * diagnosis of cin2+ in the last two years; * hrhpv negative or inadequate.

Keywords: molecular hpv test pap-test triage
quality of life in caregivers of hospitalized older patients with cancer

Conditions: Hematopoietic/Lymphoid Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Summary: this clinical trial studies quality of life in caregivers of hospitalized older patients with cancer.

primary objectives: i. identify patient and caregiver factors associated with increased caregiver burden and decreased quality of life in caregivers of older adults with cancer. secondary objectives: i. determine characteristics of informal caregivers of older adults with cancer admitted to hospital. ii. determine type and amount of care informal caregivers provide for older adults with cancer admitted to hospital. iii. determine quality of life in informal caregivers of older adults with cancer admitted to hospital. iv. identify caregiver needs, both informational and resource related. v. explore the association between re-admission to the hospital within 30 days and caregiver burden. vi. explore whether feedback of information attained from the assessment of the caregiver influences services implemented by the health care team. vii. determine reasons for non-participation. outline: caregivers complete a questionnaire about their sociodemographics, physical health, social supports, social activity, mental health and caregiver burden. they will also provide an assessment of the person they care for.

Eligibility criteria:
inclusion criteria: * patient: age \>= 65 years old * patient: diagnosis of cancer (solid or hematologic malignancy) * patient: be able to provide informed consent * patient: unplanned admission to hospital * caregiver: primary caregiver (person who provides all of the majority of the unpaid care for the care recipient) * caregiver: be able to provide informed consent exclusion criteria: * patient: planned admission to hospital for treatment (chemotherapy, transplant) * caregiver: not fluent in english (because not all questionnaires have been validated in other languages) * caregiver: paid and trained to care for the patient
topical r-hirudin ( thrombexx ) efficacy in treatment of haematomas

Conditions: r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas

Summary: single centre ,phase iv , interventional, the study includes : 200 patients, 100 patients will have topical r-hirudin (thrombexx) and 100 patients will have placebo . the patients will be randomized to the active product (arm 1) or to placebo (arm 2). the study consists of 4 visits as the following : * visit 1 : on day 1 to check patient eligibility and also for randomization . * visit 2 : on day 4 to assess target parameters * visit 3 : on day 8 to assess target parameters * visit 4 : on day 16 to assess target parameters

single centre ,phase iv , interventional, the study includes : \* 200 patients, 100 patients will have topical r-hirudin (thrombexx) and 100 patients will have placebo . the patients will be randomized to the active product (arm 1) or to placebo (arm 2). the study consists of 4 visits as the following : * visit 1 : on day 1 to check patient eligibility and also for randomization . * visit 2 : on day 4 to assess target parameters * visit 3 : on day 8 to assess target parameters * visit 4 : on day 16 to assess target parameters * study objective :assessment the efficacy of topical r-hirudin in treatment of haematomas ,also in resolving of the associated oedema * study duration : 6 months * selection of trial subjects: inclusion criteria : 1. age of patients between 20 and 60 years old. 2. patients with all types of haematomas. exclusion criteria: 1. presence of infected wound requiring hospitalization or surgical intervention. 2. history of allergy or hypersensitivity to any of the ingredients. 3. patients with coagulation disorders like haemophilia. 4. patients who are on anticoagulants like warfarin and acetylsalicylic acid . 5. patients who are taking digestive enzymes like alfa chemotrypsin. * target parameters : 1.size of haematoma.( measured by ruler) , the ruler will measure the longest 2 intersecting line. 2.size of oedema : by measurement of oedema circumference 3.pain (by vas score). 4.change in colour ( by colour grade scale ) .

Eligibility criteria:
inclusion criteria: * age of patients between 20 and 60 years old. * patients with all types of haematoma. exclusion criteria: * presence of infected wound requiring hospitalization or surgical intervention. * history of allergy or hypersensitivity to any of the ingredients. * patients with coagulation disorders like haemophilia. * patients who are on anticoagulants like warfarin and acetylsalicylic acid . * patients who are taking digestive enzymes like alfa chemotrypsin.

Keywords: thrombexx topical r-hirudin efficacy haematoma