Kornimate/medical-research-clean huggingface dataset:
a study to investigate the effect of rosuvastatin (crestor®) on high density lipoprotein kinetics in patients with the metabolic syndrome

Conditions: Metabolic Syndrome; Dyslipidemia

Summary: the purpose of this study is to investigate the dose-related effect of treatment with rosuvastatin on production and fractional catabolism of apolipoprotein a-i (apoa-i) and apolipoprotein a-ii (apoa-ii), and on the plasma apoa-i, apoa-ii and high-density lipoprotein cholesterol (hdl-c) concentration.


Eligibility criteria:
inclusion criteria: * signed informed consent * male aged 30 to 70 years of age * ldl-c \<6 mmol/l * hdl-c ≤1.2 mmol/l * at least 2 of the following: * insulin resistance (fasting glucose \>6 mmol/l or insulin \>10 mu/l or homa score \>2.5) * central obesity (waist circumference \>=94 cm). * plasma triglycerides \>=1.7 and \<4.5 mmol/l. * blood pressure \>=130/ \>=85 mm hg or on drug treatment for hypertension exclusion criteria: * ldl cholesterol \>=6 mmol/l * pre-existing or history of cardiovascular disease, diabetes, renal dysfunction, anaemia, history of significant dyspepsia or gastrointestinal disease * apolipoprotein genotype e2/e2

Keywords: metabolic syndrome dyslipidaemia
study in adult and adolescent subjects with par (perennial allergic rhinitis)

Conditions: Rhinitis, Allergic, Perennial

Summary: the purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.


Eligibility criteria:
inclusion criteria: * informed consent * documented history of perennial allergic rhinitis * a demonstrated sensitivity to at least one allergen known to induce par through a standard skin prick test. * minimum subject-reported reflective total nasal symptom score (rtnss) of at least 6 (out of a possible 12) * other criteria apply exclusion criteria: * history of physical findings of nasal pathology (within 60 days prior to screening visit) * participation in any investigational drug study 30 days preceding screening visit * history of respiratory infection/disorder with 14 days preceding screening visit or during the run-in period * use of any prohibited concomitant medications
nervous system symptoms associated with covid 19

Conditions: Covid19

Summary: this study aim to prospectively evaluate the neuropsychiatric symptoms of patients infected with the sars-cov-2 virus by a standardized neuropsychiatric examination : the global case scale (clinical assessment scale in autoimmune encephalitis), and the prevalence of disturbances of consciousness, focal neurological deficit, cognitive impairment, headache, anosmia, sleep disturbances, impaired autonomic nervous system and peritraumatic stress.


Eligibility criteria:
inclusion criteria: * being hospitalized at the toulouse university hospital for a covid-19 infection proven by a probable pcr or covid-type examination on the chest scan * have given oral consent for the collection of clinical neurological data * be in a clinical state compatible with a 30-minute neurological examination * be french-speaking * be affiliated to a social security scheme exclusion criteria: * refusal of the neurological examination * history of neurological pathology at a severe stage * pregnant or breastfeeding woman * persons with tutors or curators

Keywords: nervous system coronavirus sars-cov-2 nervous system symptoms
pentoxifylline treatment of acute pancreatitis

Conditions: Acute Pancreatitis

Summary: the purpose of this study is to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis, to see if it can improve blood tests associated with inflammation (tissue damage). pentoxifylline is approved by the us food and drug administration (fda) for treatment of circulation problems, but its use in this study is investigational, which means that the fda has not approved it for the treatment of pancreatitis. however, the fda has allowed the use of pentoxifylline in this research study.

subjects will be put in one of two groups by chance (as in the flip of a coin). this is done so that neither you nor the investigator will know which group you are in. you will be put into either the treatment group or the control group. * the treatment group will receive a drug called pentoxifylline * the control group will receive a placebo (matching pill that has no medication in it) you will take the pills by mouth starting from the time of admission. you will receive a total of 9 doses over the first three days of your hospitalization (72 hours). when subject have standard patient care blood draws, additional blood will be taken to do the research tests. the additional blood tests will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. the additional tests will require about 2 teaspoons (10 ml) of blood per day; the maximum amount of extra blood taken would be less than 3 tablespoons (40.0 ml). information from your medical record will be gathered while you are hospitalized and after your discharge. the study will continue to gather clinical follow up information up to four months.

Eligibility criteria:
inclusion criteria: 1. predicted severe acute pancreatitis 2. enrollment within 72 hours of diagnosis 3. ability to give informed consent 4. age \>17 years exclusion criteria: 1. moderate or severe congestive heart failure 2. history of seizure disorder or demyelinating disease 3. nursing mothers 4. pregnancy 5. history of prior tuberculosis or risk factors for tuberculosis 6. evidence of immunosuppression (malignancy, chronic renal failure, chemotherapy within 60 days, ongoing steroid treatment\*, and hiv)- (\*the exception of prednisone use will be allowed to participate). 7. evidence of chronic pancreatitis from history and examination (however, "acute on chronic pancreatitis" diagnosis is allowed) 8. evidence of active or pending hemorrhage. 9. paralytic ileus with vomiting

Keywords: pancreatitis pancreatic necrosis severe acute pancreatitis (sap) alcoholic pancreatitis gallstone pancreatitis
oral contraceptive (oc) estrogen dose and breast proliferation

Conditions: Oral Contraceptive

Summary: the purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). some research indicates that women who use birth control pills with lower amounts of estrogen (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of estrogen; this research will examine that in detail. this research will also test whether the results found in hs-07-00269 can be confirmed.


Eligibility criteria:
inclusion criteria: 1. age 18-35 2. bmi \<30 kg/m2 3. premenopausal with regular cycles or currently taking an oc 4. not currently or recently pregnant or nursing (within previous 6 months) 5. non-smoker 6. no use of antibiotics within the prior 4 weeks 7. competent to provide written informed consent (as judged by study team) 8. willing to adhere to the oc regimen 9. willingness to refrain from the use of aspirin or nsaids 10 days pior to the biopsy appointment and one week following the biopsy procedure 10. willing and able to refrain from use of fish oils 10 days prior to the biopsy appointment and one week following the biopsy procedure exclusion criteria: 1. diabetes 2. abnormal breast examination 3. abnormal pt/inr and/or cbc with platelets test results (as determined by one of the study physicians) 4. history or current therapeutic or prophylactic use of anticoagulants 5. known bleeding disorder or history of unexplained bleeding or bruising 6. history of breast cancer or previous diagnostic breast biopsy 7. known allergy to local anesthetic
multi-parametric ultrasound versus multi-parametric mri for prostate cancer detection

Conditions: PROSTATE CANCER; Prostate Biopsy

Summary: the goal of this cohort study is to investigate multiparametric ultrasound versus multiparametric mri for clinically significant prostate cancer detection in patients scheduled for initial biopsy. the main questions it aims to answer are: * whether the clinically significant prostate cancer detection rate of multiparametric ultrasound is comparable to multiparametric mri * the any cancer detection of multiparametric ultrasound versus multiparametric mri participants will undergo multiparametric ultrasound and multiparametric mri before prostate biopsy. in case of suspicious findings on ultrasound or mri, they will undergo combined systematic biopsy and targeted biopsy. in case of nonsuspicious imaging finding, they will undergo systematic biopsy alone.

in recent years, the multi-parametric mri targeted biopsy showed inspiring results for improving clinically significant prostate cancer (pca) detection rate \[1\]. two techniques have been developed for mri targeted prostate biopsy: in-bore mri guided biopsy and mri/ultrasound fusion biopsy. however, these biopsy techniques require specific equipment and software. moreover, mri has contradictions and cannot be performed in all patients. therefore, an imaging targeted biopsy adjunct to mri targeted biopsy is needed. besides mri, multi-parametric ultrasound can also visualize pca lesions by providing information about the blood supply, perfusion and stiffness of the prostate gland for pca detection. our hypothesis is as follows, (1) clinically significant pca detection rate by multi-parametric ultrasound targeted biopsy is comparable with multi-parametric mri targeted biopsy; (2) clinically significant pca detection rate by either multi-parametric ultrasound targeted biopsy or multi-parametric ultrasound targeted biopsy is higher than standard systematic biopsy. our secondary outcome also includes the any cancer detection rate and clinically insignificant prostate cancer detection rate.

Eligibility criteria:
inclusion criteria: 1. scheduled for prostate biopsy; 2. signed the informed consent. exclusion criteria: 1. contraindications to mri, such as metal implants, claustrophobia, etc; 2. contraindications to ultrasound, such as acute myocardial infarction, acute cerebral infarction and rectal tumor after miles operation; 3. contraindications of prostate biopsy, such as abnormal routine urine test, coagulation function and electrocardiogram 4. any medical condition or other event that may significantly reduce the chances of obtaining reliable data, achieving the purpose of the study or completing the study and follow-up; 5. the study doctor thinks it is not suitable to participate in this study.

Keywords: prostate cancer multiparametric ultrasound multiparametric mri
pharmacokinetics (pk)/safety study of atorvastatin in children with kawasaki disease and coronary artery abnormalities

Conditions: Kawasaki Disease

Summary: kawasaki disease (kd) is the leading cause of acquired heart disease in children in the developed world. despite available treatment, 25% of children in san diego county appropriately treated for kd develop coronary artery abnormalities that could lead to complications later in life, including heart attack. although investigators can identify children with kd that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. inflammation and damage to the arterial wall is central to these coronary artery abnormalities. statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. therefore, the investigators propose to study the safety of the drug atorvastatin in children with coronary artery abnormalities from kd.


Eligibility criteria:
inclusion criteria: 1. age ≥ 2 years to 17 years old 2. meets clinical criteria for kd according to american heart association guidelines (table 2): fever (t≥38oc or 100.4oc) ≥ 3 days and ≥ 2 clinical criteria with left anterior descending coronary artery/right coronary artery z-score ≥ 2.5 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary arteries 3. patient presents within the first 20 days after fever onset 4. parent or legal guardian able and willing to provide informed consent and subject willing and able to provide assent when appropriate. 5. post-menarchal females: negative pregnancy test at screening and willing to use two forms of contraception during the study 6. males engaging in sexual activity that could lead to pregnancy must use a condom. exclusion criteria: 1. use of a statin, fibrate, or niacin within the 3 months prior to enrollment 2. have any chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder 3. screening creatine phosphokinase (ck) ≥ 3x upper limit of normal for age 4. patient taking a cyp3a4 inhibitor (ie. cyclosporine or clarithromycin) in the last 7 days 5. patient has a history of allergy to atorvastatin or its derivatives

Keywords: kawasaki disease
pm8002 in combination with chemotherapy as first line therapy in hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this is a multicenter, single-arm, open-label phase ii study to evaluate the efficacy and safety of pm8002 in combination with chemotherapy in the first-line treatment of subjects with inoperable hcc.

pm8002 is a bispecific antibody targeting pd-l1 and vegf.

Eligibility criteria:
inclusion criteria: 1. voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures; 2. male or female aged \>= 18 years; 3. hcc diagnosed by pathology or clinical; 4. bclc stage c or b (unresectable or/and not suitable for local therapy); 5. child-pugh score \<= 7; 6. ecog performance status of 0 or 1. exclusion criteria: 1. histological diagnosis of fibrolamellar hcc, sarcomatoid hcc, or mixed cholangiocarcinoma and hcc; 2. symptomatic cns metastases, not suitable for the study assessed by investigator; 3. evidence of major coagulopathy or other obvious risk of bleeding; 4. unable to accept enhanced imaging examination (ct or mri) for any reason; 5. history of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study; 6. human immunodeficiency virus infection or known acquired immunodeficiency syndrome; 7. known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8. known history of alcohol abuse, psychotropic drug abuse or drug abuse; 9. patients with psychiatric disorders or poor compliance; 10. women who are pregnant or breastfeeding; 11. the condition of the subject, as determined by the investigator, may increase the risk of after study treatment, or may cause confusion about the interpretation of the toxic reaction and ae; 12. other conditions lead to inappropriate to participate in this study as judged by the investigator.

Keywords: pd-l1/vegf folfox-4
prevalence, etiology and therapy of micturition disorders of children with a mental and/or motoric disability

Conditions: Micturition Disorder

Summary: investigation of the prevalence etiology and therapy of micturition disorders of children with a mental and/or motoric disability

overview of the problem by a questionnaire, diary of micturition and drinking behaviour, filled out by the parents or by the staff of the institution. investigation of the etiology by clinical and functional examination (uroflowmetry, bladder scan, video-urodynamic examination). frequency: * uroflowmetry: two periods of two weeks, with 6 weeks break between both periods. during the follow-up period every 3 months during 12 months * bladder scan: once during the periods of the uroflowmetry * video-urodynamic examination: once in selected participants, after consent of the parents * adaptation of the drinking behaviour: start after two weeks of observation, after uroflowmetry and bladder scan. continuous proces. * therapeutic measures (medication, miction clock): start after 10 weeks of observation or after video-urodynamic examination. development of a therapeutic plan: adaptation of the micturition and drinking behaviour, anticholinergic therapy.

Eligibility criteria:
inclusion criteria: * children with a motoric and/or mental disability * 4-14 years exclusion criteria: * known neurogenic bladder disorder
improving depression care for elders: coordinating center

Conditions: Major Depression; Dysthymic Disorder; Both Major Depression and Dysthymic Disorder

Summary: purpose: to determine the effectiveness of the improving mood-promoting access to collaborative treatment(impact) collaborative care management program for late-life depression.

this study tested an organized method of delivering care for late life depression in primary care. specifically, the investigators evaluated the effectiveness of this intervention as compared to 'care as usual'. the investigators studied the effect of the intervention on clinical outcomes such as depressive symptoms, functional status, health related quality of life. they also determined the cost-effectiveness of the intervention compared to care as usual.

Eligibility criteria:
inclusion criteria: * major depression or dysthymia as diagnosed by a structured diagnostic interview. * patient plans to receive primary care at the study clinic for the next year. exclusion criteria: * age under 60. * current symptoms or history of psychosis or mania as determined by structured diagnostic interview. * cognitive impairment as defined by a score less than 23 on a mini mental status examination. * terminal illness - defined as having a life expectancy of less than 6 months. * active alcohol abuse as determined by a screening interview. * high suicide risk as determined by current plan for suicide or a history of more than 3 prior suicide attempts in the past 10 years.
urdu translation, validity and reliability of quick disabilities of arm, shoulder & hand (quickdash)

Conditions: Shoulder Pain

Summary: the purpose of this study is to translate quick disabilities of arm, shoulder \& hand (quickdash) into urdu and determine the validity and reliability of the urdu version of quickdash.


Eligibility criteria:
inclusion criteria: individuals with for shoulder, arm/wrist, or hand musculoskeletal injury/pain/symptoms. capable of understanding and completing the self-reported questionnaires. the exclusion criteria were the - exclusion criteria: presence of any systemic disease or any neurological disorder. the upper limb involvement is due to any recent surgery in less than 6 weeks. -
a study of alectinib (ch5424802/ro5424802) in participants with anaplastic lymphoma kinase (alk)-rearranged non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: this non-randomized, open-label, multicenter study will evaluate the safety and efficacy of alectinib in participants with alk-rearranged non-small cell lung cancer who failed crizotinib treatment. in phase i, cohorts of participants will receive escalating doses of alectinib orally twice daily. in phase ii, patients who failed crizotinib treatment will receive the recommended phase ii dose.


Eligibility criteria:
inclusion criteria: * histologically confirmed, locally advanced, not amenable to curative therapy, or metastatic nsclc * alk-rearrangement confirmed by the food and drug administration (fda) approved test * nsclc that has failed crizotinib treatment * measurable disease as defined by recist v1.1 * eastern cooperative oncology group (ecog) performance status less than or equal to (\<=) 2 * adequate hematologic, hepatic and renal function exclusion criteria: * prior therapy with alk inhibitor other than crizotinib * brain or leptomeningeal metastases that are symptomatic and/or requiring treatment * history of serious cardiac dysfunction * history of or current active infection with hepatitis b, hepatitis c or human immunodeficiency virus (hiv) * clinically significant gastrointestinal abnormality that would affect absorption of the drug * pregnant or lactating women
knowledge level of pelvic floor in different age groups

Conditions: Pelvic Floor Disorders

Summary: having knowledge and awareness about pelvic floor muscles and pelvic floor dysfunctions makes it easier for individuals to understand their own body and the treatment provided to them by healthcare professionals (fante, 2019). in the literature, there are studies investigating the knowledge and awareness levels of different participant groups about pelvic floor and pelvic floor dysfunctions (parden, 2016; hill, 2017; falvey, 2020). it has been shown that most women lack knowledge of pelvic floor muscle dysfunction, do not understand treatment options for the pelvic floor, and are unable to identify risk factors (fante, 2019). a pelvic floor health knowledge quiz was created by al-deges in order to evaluate the level of knowledge about pelvic floor and pelvic floor dysfunction in women and men in our country (al-deges, 2019). in line with this information, the aim of our study is to determine the level of knowledge about pelvic floor and pelvic floor dysfunctions in women and men of different age groups. the target audience of our research is male and female individuals over the age of 18, and our research will be conducted online. as a result of the information we obtained from our research, the level of knowledge of individuals living in our country about pelvic floor and pelvic floor dysfunctions will be determined and the literature will be contributed. in addition, by determining the missing information of the society about the pelvic floor, contribution will be made to the development of appropriate intervention methods in order to eliminate the deficiencies in this area and to increase the level of awareness.


Eligibility criteria:
inclusion criteria: * female and male participants over the age of 18 * volunteering to participate in research exclusion criteria: * not answering all questions in the questionnaire

Keywords: pelvic floor, knowledge, turkey
tumor recurrence after abdominal-perineal amputation in squamous cell carcinoma of the anus

Conditions: Squamous Cell Carcinoma of the Anal Canal

Summary: squamous cell carcinoma of the anal canal is a rare cancer with an increasing incidence. it represents 2.5% of digestive cancers and occurs more frequently in immunocompromised persons, in particular hiv positive. it is a cancer that develops essentially locally, with only 5% of metastases at diagnosis. the reference treatment for forms deemed localized after clinico-bio-radiological pre-therapeutic evaluation is radiochemotherapy allowing a 5-year survival rate of about 80%. however, up to 30% of patients fail radiochemotherapy. failure is defined as persistent disease (non response or progression in 10 to 15% of patients) or relapse (local or metastatic in 10 to 15% of patients). salvage surgery by abdominoperineal amputation is indicated in this case after elimination of the metastatic character with an overall survival rate at 5 years varying from 23 to 69%. this complex and cumbersome surgery is burdened with significant postoperative morbidity with alteration of the quality of life. investigators would like to perform a retrospective and prospective study in the paris saint-joseph hospital group to evaluate the interest of abdominoperineal amputation in case of failure of radiochemotherapy in patients with squamous cell carcinoma of the anal canal.


Eligibility criteria:
inclusion criteria: * patient with abdominoperineal amputation for squamous cell carcinoma of the anus * patient whose age ≥ 18 years * french speaking patient exclusion criteria: * patient under guardianship or curatorship * patient deprived of liberty * patient under court protection * patient objecting to the use of his data for this research