Kornimate/medical-research-clean huggingface dataset:
topical statin eye drop in the management of the dry eye

Conditions: Dry Eye Disease

Summary: in the first stage, to evaluate the safety of the topical medication produced by sina pharmaceuticals, this medication is experimentally tested on 10 volunteer patients. if no side effects occur, eligible patients are enrolled in the study after examination by a specialist. the second stage is a randomized, double-blind clinical trial, during which selected patients are randomly assigned to the control and intervention groups. for patients in the intervention group, in addition to standard treatment, including eyelid hygiene and the use of artificial tears, a topical drop of atorvastatin (50 microm) will be administered, one drop eight times a day in both eyes. in the control group, a placebo will be used in the same manner. the patients will be unaware of their assigned group. clinical examinations, including schirmer's test, tear breakup time, fluorescein staining, and completion of the dry eye syndrome questionnaire and dry eye questionnaire, will be conducted before and after the intervention to assess the level of eye dryness.


Eligibility criteria:
inclusion criteria: * age\>20 years old * dry eye induced by meibomian gland dysfunction * tear break up time less than 10 seconds exclusion criteria: * hematologic disorders * coagulopathies * use of anticoagulant medication * use of peptic ulcer disease * history of ocular surgeries in the last 3 months * history of any ocular malignancies * history of ocular trauma * history of statin use
evaluation of evolocumab (amg 145) efficacy in diabetic adults with hypercholesterolemia/mixed dyslipidemia

Conditions: Hypercholesterolemia; Mixed Dyslipidemia; Type 2 Diabetes

Summary: the purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (ldl-c) in adults with type 2 diabetes mellitus and high blood cholesterol on a maximally tolerated oral dose of statin of at least moderate-intensity.

this study will enroll adults with type 2 diabetes mellitus and elevated ldl-c or non-high-density lipoprotein cholesterol (non-hdl-c) levels on a stable, maximally tolerated statin dose of at least moderate-intensity at signing of the informed consent; statin therapy must remain unchanged during screening and the remainder of the study.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years * type 2 diabetes mellitus * hemoglobin a1c \< 10% * stable diabetes therapy * must be on maximally tolerated dose of statin of at least moderate intensity * fasting triglycerides ≤ 600 mg/dl * not at ldl-c or non-hdl-c goal. exclusion criteria: * moderate to severe renal dysfunction * uncontrolled hypertension * persistent active liver disease or hepatic dysfunction * has taken a cholesterylester transfer protein inhibitor in the last 12 months, * myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months prior to randomization

Keywords: diabetes type 2 diabetes high blood cholesterol hypercholesterolemia mixed dyslipidemia high cholesterol statin intolerant
expanded access program (eap) for participants with advanced cancers and fibroblast growth factor receptor (fgfr) genetic alterations who have exhausted all treatment options

Conditions: Advanced Cancers and FGFR Genetic Alterations

Summary: the purpose of this program is to provide participants an early access to erdafitinib prior to market authorization (that is, food and drug administration \[fda\] approval in the united states). the program is limited to participants with advanced cancers and fibroblast growth factor receptor (fgfr) genetic alterations who have exhausted at least 2 lines of standard of care therapy and who are not eligible for an erdafitinib clinical trial.


Eligibility criteria:
inclusion criteria: * participant has a documented fibroblast growth factor receptor (fgfr) alteration * participant does not have co-morbidities that would alter risk-benefit of providing erdafitinib (determined by treating physician's assessment) * life expectancy is greater than (\>) 3 months (determined by treating physician's assessment) * participant has exhausted treatment options for their disease (review of prior treatments) * participant is not eligible for other erdafitinib clinical trials including but not limited to blc3001/nct03390504 and blc2002/nct03473743
improving beta-2 adrenergic signaling in alzheimer's disease

Conditions: Alzheimer's Disease; Cognitive Dysfunction

Summary: the purpose of this study is to test the effects of long-term therapeutic doses of formoterol, on a) cerebrospinal fluid (csf) tau levels, and amyloid beta protein 40/42 levels in the csf, and b) cognitive function in people with mild to moderate alzheimer' disease (ad).

the purpose of this study is to test the effects of long-term therapeutic doses of formoterol, on a) cerebrospinal fluid csf tau levels, and a-beta amyloid protein 40/42 levels, and b) cognitive function: ne-ergic neurons undergo significant degeneration in ad. this system plays a significant role in cognition. recent studies have indicated that increasing ne levels in the brain would significantly improve microglia migration and clearance of a-beta amyloid protein 40/42 levels in mouse models of ad. the investigators plan to test whether long- term daily treatment with inhaled formoterol solution would improve the structure and function of hippocampal neurons in ad. study design: randomization and initiation of experimental treatment: all participants will be given formoterol daily for 52 weeks. the active regimen will be initiated as (20 micro gram, bid). the dose will be decreased if there is evidence of side effects, including cardiac or respiratory alteration changes, gastro-intestinal disturbances or neurological issues.

Eligibility criteria:
inclusion criteria: * males and females between the ages of 50-85, * mild-to-moderate ad (nincds/adrda criteria for probable ad will be used to establish ad diagnosis). * mmse 16-26. exclusion criteria: * non-ad dementia or significant neurological disease such as parkinson's disease, stroke, brain tumor,multiple sclerosis, seizure disorder, focal brain lesion, or head injury with loss of consciousness. * hypothyroidism, congestive heart failure (new york heart association class iii or iv), significant extrapyramidal symptoms on neurological examination, serum creatinine\>1.3 mg/dl, significant arrhythmias or conduction defect abnormalities on ecg, * use of another beta2 adrenergic drug within the last 2 months. * residence in a long-term care facility. * evidence of any significant clinical disorder or laboratory finding that renders the person unsuitable for receiving an investigational new drug. * known hypersensitivity or prior exposure to formoterol. * active asthma or family history of asthma.
the evaluation of mozart music on pain and respiratory rate after thyroidectomy

Conditions: Postoperative Pain

Summary: to investigate the effect of mozart music on postoperative pain and physiological parameters in patients after total thyroidectomy.

postoperative pain is a major concern in postsurgical patients. meanwhile, there is a general consensus on minimizing the use of analgesic drugs in patients undergoing total thyroidectomy. therefore, alternative methods need to be investigated in order to reduce postoperative pain. although the clinical importance of music has been recognised in other pathological situations, further research is needed to investigate the effect of music on postoperative pain.

Eligibility criteria:
inclusion criteria: * adults scheduled for total thyroidectomy under general anesthesia exclusion criteria: * visual impairments * hearing impairments * severe anxiety or other psychiatric disorders * history of chronic pain * past complications during anesthesia or surgery * american society of anesthesiologists (asa) physical status beyond ii
impact of cto pci (chronic total occlusion percutaneous intervention) on regular physical activity

Conditions: Chronic Total Occlusion; Occlusion

Summary: heart disease is a leading cause of death in the us. . heart blood vessel chronic total occlusions are 100% blockages of the heart vessels. these patients often suffer from chest pain, shortness of breath, and depression. heart doctors thread special cables from the groin and wrist to the heart and open up these 100% blocked vessels. . this treatment improves symptoms and quality of life. exercise is very beneficial for health. previous studies suggest that even a 1000 steps/day increase in daily steps can improve health. but, patients with occluded heart vessels are often inactive because they have chest pain, feeling tired, or are short of breath. it is unknown whether opening these 100% blocked heart vessels will help patients have a more active lifestyle, which is good for health. the goal is to measure the impact of opening these occluded heart vessels on daily exercise in this project. specifically, the investigators will give a smart watch to patients referred for this treatment. the smart watch will track the patients' daily steps before and after the procedure.

the investigators will compare the daily steps before and after the procedure to understand if the patients are more active. in addition to tracking daily steps, the investigators will track calorie expenditure with the watch. the investigators will also use surveys to evaluate chest pain and depression. in sum, the investigators will study the impact of opening occluded heart vessels on daily exercise. if the investigators find that this routinely used treatment leads to increased daily steps, the investigators will know better which patients this treatment can help live longer and healthier

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. willing and able to provide informed consent 3. patients referred for clinically indicated cto-pci 4. access to smart phone (apple or android platform) 5. willing and able to wear a smart watch 6. clinically stable and able to walk/ exercise independently exclusion criteria: 1. inability to exercise due to non-cardiac problems (e.g., orthopedic restrictions, amputation, musculoskeletal/neurological disease affecting mobility etc.-as determined by investigator discretion) 2. plan for major surgical procedure (other than cto pci) which would limit exercise capability 3. any other criteria that in the opinion of the investigator would preclude patient participation in the study and/or impact exercise capability.

Keywords: physical activity cto pci quality of life percutaneous coronary intervention
bortezomib in combination with ibrutinib in ibrutinib relapsed mantle cell lymphoma

Conditions: Mantle Cell Lymphoma

Summary: this is a phase ii study to evaluate the efficacy of ibrutinib in combination with bortezomib in in mcl (mantle cell lymphoma) patients who relapsed on single agent ibrutinib.


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age * diagnosis of mantle cell lymphoma established by histologic assessment by a hemato-pathologist with additional assessment of the histologic diagnosis by immunohistochemistry or flow cytometry. * patients with history of mcl that has relapsed (documented disease progression after previously responding) to therapy (cr/pr) on single agent ibrutinib (treated for at least 6 months) as the last treatment prior to enrollment. * adequate liver, renal and bone marrow function * adequate coagulation (unless abnormalities are unrelated to coagulopathy or bleeding disorder) * female subjects of childbearing potential must have a negative urine/serum pregnancy test upon study entry. women as well are not advised to breastfeed during treatment with bortezomib and for 2 months after treatment. * male and female subjects of reproductive potential must agree to use both a highly effective method of birth control and barrier method during the period of therapy and for 30 days after the last dose of study drug for females and 90 days for males. * eastern cooperative oncology group (ecog) performance status of \<2 (eastern cooperative oncology group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death.) exclusion criteria: * concurrent diagnosis of another malignancy unless treated with curative intent more than 2 years from study start (basal/squamous cell carcinoma of the skin is not an exclusion). * previous treatment with bortezomib. * patients who are eligible for autologous stem cell transplant are excluded unless they refuse this procedure. * history of allogeneic stem cell transplant. * other exclusions (certain concurrent conditions) per protocol

Keywords: relapsed
resceu: defining the burden of rsv disease

Conditions: Respiratory Syncytial Virus Infections; RSV Infection

Summary: this observational study will determine the burden of rsv disease in at least 2000 healthy infants over 6 years until november 2026. the study will determine the incidence of acute respiratory tract infection (arti) associated with rsv, of medically attended arti and rsv related hospitalisation. mortality (rsv associated and all-cause) through all rsv seasons and the health care costs, resource use and health related quality of life will also be determined. the study also aims to determine important risk factors for rsv infection (by severity and healthcare utilisation.

infants will be recruited into one of two cohorts: passive (around 1800 participants) - demographic data will be collected at inclusion and a parental questionnaire at one year of age. infants admitted to a hospital with an acute respiratory tract illness will be followed up to the age of 3 years or 6 years with additional consent. active (around 200 participants) - demographic data, parental questionnaire and the following samples will be collected at inclusion; blood, nasopharyngeal swabs, urine and stool. during the infants first rsv season (oct - may) weekly phone contact will monitor respiratory symptoms. infants with respiratory symptoms associated with rsv (confirmed by point of care testing) will have further samples of blood, nasopharyngeal swabs, urine and stool collected at the time of infection and 7 weeks later. infants in the active cohort will be followed up for up to 3 years or 6 years with additional consent.

Eligibility criteria:
inclusion criteria: * healthy children, gestation age at least 37+0 weeks, born at participating centres. * written informed consent obtained from the mother. * parents able and willing to adhere to protocol-specified procedures (active cohort). exclusion criteria: * major congenital defects or serious chronic illness (i.e. severe congenital heart and/or lung disease, genetic, immunologic and/or metabolic disorder). * gestational age of less than 37+0 weeks. * acute severe medical condition at moment of sampling (e.g. sepsis, severe asphyxia, for which the child is admitted to the hospital). * child in care. * parents not able to understand and communicate in the local language. * living outside catchment area of study sites. * mother vaccinated against rsv during pregnancy (by parental report).
study evaluating the efficacy and safety of subcutaneous methylnaltrexone (moa-728) for the treatment of opioid-induced-constipation

Conditions: Constipation

Summary: the primary purpose of this study is to evaluate the safety, efficacy, and tolerability of subcutaneous (injection beneath the skin) moa-728 versus placebo in adult asian subjects with opioid-induced constipation associated with advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease) or chronic nonmalignant pain.

subjects received subcutaneous methylnaltrexone (also referred to as moa-728 or mntx) or placebo every other day beginning on day 1 up to a maximum of 7 doses during the 2-week double-blind period. inclusion criteria for this study included subjects with advanced illness or subjects with chronic nonmalignant pain. the actual study population included only subjects with cancer-related advanced illness. all subjects who completed the double-blind treatment phase of this study could elect to receive methylnaltrexone during a 12-week open-label extension study, provided eligibility criteria were met. subjects who did not continue in the open-label extension study had a follow-up visit 2 weeks after their last dose of test article.

Eligibility criteria:
inclusion criteria: * men and women who are at least 18 years of age, and who have a diagnosis of advanced illness with anticipated life expectancy \>= 1 month; * is receiving a regular dose of opioids for the control of pain; * has a diagnosis of opioid induced constipation; * is on a stable laxative regimen. exclusion criteria: * has a known or suspected mechanical gastrointestinal obstruction, or any potential non-opioid cause of bowel dysfunction contributed to constipation; * has evidence of current fecal impaction; * has evidence of active diverticulitis, or peritonitis, or a history of bowel surgery within 30 days before test article administration; * has a body weight less than 27 kg * has any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study, or could preclude the evaluation of the subject's response.

Keywords: opioid induced constipation
bpa levels relationship with ivf/icsi outcomes in patients with male factor

Conditions: Infertility, Male; IVF

Summary: association between blood and semen bpa levels and icsi outcomes in patients with male factor


Eligibility criteria:
inclusion criteria: * female patients aged 23-40 years who underwent ivf due to male factor * men with semen sample obtained from ejaculate * male patients provided blood, and ejaculate samples on the oocyte retrieval day * patients who did not smoke or use alcohol * patients did not work in the plastic industry exclusion criteria: * men with a diagnosis of azoospermia * patients who underwent ivf due to low ovarian reserve or unexplained infertility indications * patients diagnosed with endometriosis * patients with freeze-all cycles * women with metabolic disease (such as hypertension or diabetes mellitus) * patients (male or females) with a known genetic problem (male or female)
quantitative magnetic resonance imaging (mri) sub-study of ms paths

Conditions: Multiple Sclerosis

Summary: the primary objective is to assess the performance of a new magnetic resonance imaging (mri) metrics software prototype when used in radiological practice in multiple sclerosis (ms).


Eligibility criteria:
key inclusion criteria: * board-certified neuroradiologists or experienced neuroradiology fellows. * employed at a participating ms paths institution. * at least 3 years of experience in interpreting brain mri scans of ms participants. key exclusion criteria: * inability to comply with sub-study procedures. * other unspecified reasons that, in the opinion of biogen or the ms paths radiology lead at the institution, make the radiologist unsuitable for participation.
comparison of insulin detemir plus insulin aspart against insulin glargine plus insulin aspart in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe and the united states of america (usa). the purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 12 months * treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs * bmi of maximum 40 kg/m2 * hba1c greater than or equal to 7.0% and less than or equal to 11.0% exclusion criteria: * proliferative retinopathy or maculopathy * recurrent major hypoglycaemia * impaired hepatic or renal function * cardiac problems or uncontrolled hypertension
kinetic of cytokines decrease and hodgkin lymphoma prognostic

Conditions: Hodgkin's Disease

Summary: more than 90% of patients with hodgkin lymphoma (hl) can recover thanks to conventional polychemotherapy regimens - abvd or beacopp - with or without radiotherapy. nevertheless, some patients relapse and others are resistant to any treatment. these patients represent 2-5% of stage i / ii and 5-10% of disseminated stages. the usual prognostic index based on clinical and biological data (supradiaphragmatic hl: eortc and advanced hl international prognostic score) cannot always detect patients at risk. new prognostic factors are required to screen out these high risk patients. among available biological factors, we will retain the cytokines secreted by tumor cells and cells from the environment. indeed, the prognostic value of plasma cytokines levels and their soluble receptors has recently been described by at least two teams. olivier casasnovas set up a prognostic index based on quantities of il-1 ra, il-6, scd30 and tnfr1 at diagnosis,and the v. diehl team published the prognostic value of the decrease of tarc (cc thymus and activation-related chemokine). in daily practice, the early assessment of response by pet ct-scan is now an undeniable prognostic factor. early identification of no-response or relapse is, in fact, based on clinical and imaging (pet-ct scan). we propose to evaluate the decrease of cytokines concentration with a prognostic value (tarc, il-6, il1-ra, scd30, tnfr1) as markers of response during treatment and during early follow-up. the dosage of these cytokines will be paired with radiological assessments. a correlation between the decrease of cytokines plasma levels overtime and event-free survival will be searched afterwards.

to evaluate the decrease of cytokines concentration with a prognostic value as markers of response, the dosage of tarc, il-6, il1-ra, scd30 and tnfr1 will be performed during treatment at :diagnosis, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, day 1 of consolidation (cycle 5 day 1 or before radiotherapy) and evaluation of end of treatment. an early follow-up with a dosage of cytokines will be performed 3 months after the end of treatment. an evaluation for event free survival will be done at 3 years from diagnosis.

Eligibility criteria:
inclusion criteria: * hodgkin lymphoma diagnosis * i-ii or iii-iv stages * untreated patient (including corticosteroids) * patient treated and followed exclusively in center henri becquerel * informed consent signed exclusion criteria: * psychological, social or family conditions not allowing a suitable follow-up for study * mental deficiency not allowing the good understanding of study procedures * positive hiv serology * positive b or c hepatitis serology * pregnant or lactating * patient registered with a social security scheme or in an equivalent situation * patient in a period of exclusion on another biomedical study.

Keywords: hodgkin lymphoma, adult cytokines tarc il-6 il1-ra scd30 tnfr1