Kornimate/medical-research-clean huggingface dataset:
effectiveness of metformin in recurrent miscarriage in a woman with hyperinsulinaemia

Conditions: Abortion, Habitual

Summary: the prevalence of insulin resistance is increased in women with recurrent miscarriage compared with matched fertile controls,insulin resistance (ir) in this syndrome is not only implicated toward early pregnancy loss (epl) but also pathognomic for various obstetrical complications during pregnancy.an elevated free androgen index appears to be a prognostic factor for a subsequent miscarriage in women with recurrent miscarriage. there is insufficient evidence to evaluate the effect of metformin supplementation in pregnancy to prevent a miscarriage in women with recurrent miscarriage.

the patients with pco and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy, the other group will stop the drug once pregnancy test become positive. pregnancy follow up including the early and second trimester pregnancy loss, secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine growth restriction were also analyzed at the end of the study.

Eligibility criteria:
inclusion criteria: * women who are diagnosed to have pcos and/or haven hyper insulinaemia and have a previous history of recurrent miscarriages. exclusion criteria: * any patients with pcos or hyper insulinaemia previously treated by any forms of insulin sensitizers. age above forty years old . * antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies \[igg or igm\]); other recognised thrombophilic conditions (testing according to usual clinic practice). * intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy). * fibroids distorting uterine cavity . * abnormal parental karyotype . * other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (sle).

Keywords: pcos hyper insulinaemia metformin recurrent abortion
gallium-68 psma-11 positron emission tomography (pet) imaging in patients with biochemical recurrence

Conditions: Prostate Cancer

Summary: the investigators are imaging patients with prostate cancer using a new pet imaging agent (ga-68-psma-11) in order to evaluate its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.


Eligibility criteria:
inclusion criteria * histopathologically proven prostate adenocarcinoma. * rising prostate-specific antigen (psa) (at least two consecutive rising psas) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy). * post radical prostatectomy (rp) - american urological association (aua) recommendation for biochemical recurrence after radical prostatectomy * psa greater than or equal to 0.2 ng/ml measured more than 6 weeks after rp. * post-radiation therapy -astro-phoenix consensus definition of biochemical recurrence after radiation therapy * nadir + greater than or equal to 2 ng/ml rise in psa * karnofsky performance status of \> 50 (or eastern cooperative oncology group (ecog)/world health organization (who) equivalent). * age \>= 18. * ability to understand a written informed consent document, and the willingness to sign it. exclusion criteria * unable to lie flat, still or tolerate a pet scan. * concomitant investigational therapy. * patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer. * contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (note: this exclusion criteria can be removed if furosemide is omitted as part of the pet imaging protocol if a second-generation scatter correction is available for the used pet device).
whole body dynamic 68ga-dotatoc pet/ct in neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: neuroendocrine tumors (net) are a network of rare tumors with common embryological origin. functional imaging plays a major role in the extension assessment and tumor characterization of nets. spect/ct with 111in-pentetreotide is the recommended test when tumors are well differentiated (grade g1 or g2). it has a real interest in diagnosis, in therapeutic decision-making (in particular by cold somatostatin analogues or in prrt) and in the systematic follow-up of patients. nevertheless, spect/ct procedure makes for a relatively long review. in addition, scintigraphy has a lower spatial resolution than pet technology and remains of limited interest for signal quantification. however, the ability to locate and quantitatively measure the absorption of radiopharmaceuticals in the target tissues is a major challenge in oncology for the characterization of the disease. recent developments in radiopharmacy have made it possible to target nets in pet imaging through the use of somatostatin analogues coupled with positron emitters, called 68ga-dota peptides. the diagnostic performance of 68ga-dotapeptide pet/ct appears to be superior to spect/ct with 111in-pentetreotide. a marketing authorization has thus recently been issued in france for the use of 68ga-dotatoc. historically, the recommended quantification method in pet was based on the instantaneous measurement in static acquisition (3d) of the maximum of the standardized uptake value (suvmax). this approach has the disadvantage to measure the signal at a time "t" for a single voxel of the image. dynamic acquisition methods (4d) have been proposed to extract a radiotracer absorption coefficient (ki) for a lesion. several studies have demonstrated the superiority of ki versus suvmax in 18fdg pet/ct for the diagnostic management, therapeutic evaluation and prognosis of various solid cancers. however, no work has validated this approach in pet / ct at 68ga-dotatoc as part of the prognostic evaluation of nets. the objective of the study is to evaluate the prognostic value of the tumor absorption coefficient ki resulting from a 4d whole-body dynamic acquisition in pet / ct at 68ga-dotatoc in patients with well-differentiated nets grade i or ii according to the who classification


Eligibility criteria:
inclusion criteria: * patient majeur ≥ 18 year old * présenting a well differentiated neuroendocrine tumor (g1 ou g2) * indication performing a68ga-dotatoc pet/ct * non-opposition exclusion criteria: * patient \<18 years old * breastfeeding/ pregnancy * other type of tumor * refusal of participation

Keywords: positron emission tomography computed tomography whole body dynamic acquisition gallium 68
effect of lixisenatide on postprandial lipid profile in obese type 2 diabetic patients

Conditions: Type II Diabetes Mellitus

Summary: primary objective: to evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in particular, the effects on plasma changes in triglycerides. secondary objectives: the effect of lixisenatide on the following postprandial lipids: apolipoprotein (apo) b48; free fatty acid, lipoprotein distribution, cholesterol, and low-density lipoprotein (ldl) oxidation. the effect of lixisenatide on chronic low-grade inflammation present in non-insulin dependent diabetes mellitus (niddm) and obesity. the effect of lixisenatide on microvascular dysfunction. to evaluate the effect of lixisenatide on postprandial plasma glucose, insulin and c-peptide and glucagon.

maximum study duration of approximately 2.5 months (study treatment) ± 2 days day 0 (baseline) plus a 10-week open-label, active-controlled treatment period (final/end-of-treatment visit).

Eligibility criteria:
inclusion criteria: male and female patients, 18-70 years of age. diagnosis of type 2 diabetes treated with metformin and obesity (body mass index \[bmi\] \>30 kg/m\^2) and the following other abnormalities: * abdominal obesity (waist circumference \>102 cm in men and \>88 cm in women). according to national cholesterol education program-adult treatment panel (ncep-atp) iii (2001). * glycated hemoglobin a1c (hba1c) ≥7 and ≤8.5% (after sponsor approval providers might reasonably suggest more stringent a1c goals \[such as 6.5%\] for selected individual patients, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. appropriate patients might include those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease). * hypertriglyceridemia (fasting triglyceride levels between 150 mg/dl and 600 mg/dl, cholesterol \<300 mg/dl. in order to exclude patients who might be suffering from a primitive dyslipidemia). * low high-density lipoprotein (hdl) cholesterol (serum hdl-cholesterol \<40 mg/dl in men and \<50 mg/dl in women). written informed consent. exclusion criteria: smoking. thyroid disease even if under appropriate hormonal replacement therapy or thyroid suppressant (thyroid stimulating hormone \[tsh\] \>5 mu/l with clinical symptoms of hypothyroidism). hepatic disease (aspartate aminotransferase \[asat\] or alanine aminotransferase \[alat\] \>2 times the upper limit of normal). renal disease (serum creatinine \>1.7 times the upper limit of normal). a history of coronary heart disease, cerebrovascular disease, or peripheral arterial disease in the 6 months before enrollment. history of malignancies. use of lipid lowering therapy. systolic blood pressure ≥180 mmhg and/or diastolic blood pressure ≥110 mmhg. triglycerides \>600 mg/dl. history of chronic pancreatitis or of idiopathic acute pancreatitis. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effect of physical activity in fingolimod treated patients (pace) with relapsing-remitting multiple sclerosis

Conditions: Fatigue in Multiple Sclerosis

Summary: this study evaluated the effect of an individualized web-based physical training in fingolimod -treated patients.

in this study, it was planned to randomize 226 participants. however, only 178 participants were randomized during a timeframe of 2 years and 8 months. therefore, the study was terminated due to slow enrollment and low participant compliance to the physical training schedule.

Eligibility criteria:
inclusion criteria: * subjects with relapsing remitting ms defined by 2010 revised mcdonald criteria * patients with expanded disability status scale (edss) score of 0-3.5 (including) * immunomodulatory treatment with prescribed fingolimod for at least one month prior to baseline * fatigue score assessed by mfis of equal or greater than 14 at screening * neurologically stable with no evidence of relapse within 30 days prior to inclusion date exclusion criteria: * patients who have been treated with: * systemic corticosteroids or immunoglobulins within 1 month prior to randomization; * immunosuppressive medications such as azathioprine, cyclophosphamide, or methotrexate within 3 months prior to randomization; * monoclonal antibodies (including natalizumab) within 3 months prior to randomization; * mitoxantrone within 6 months prior to randomization * cladribine at any time. * patients with any medically unstable condition, as assessed by the primary treating physician at each site. * patients with any of the following cardiovascular conditions : * history of cardiac arrest; * history of myocardial infarction or with current unstable ischemic heart disease; * history of angina pectoris due to coronary spasm or history of raynaud syndrome * heart failure (nyha iii-iv) or any severe cardiac disease as determined by the investigator; * history or presence of a second-degree av block, type ii or a third-degree av * block * patients receiving class ia (ajmaline, disopyramide, procainamide, quinidine) or * iii antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, * dofelitide); * proven history of sick sinus syndrome or sino-atrial heart block; * uncontrolled hypertension * clinically relevant internal disease (e.g. uncorrected anemia) or orthopedic diseases (e.g. scoliosis) that might interfere with physical training * any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator's discretion other protocol-defined inclusion/exclusion criteria may apply.

Keywords: fatigue ms multiple sclerosis exercise physical activity physical training fingolimod
effects of roxithromycin on quality of life and physiological outcomes in bronchiectasis

Conditions: Quality of Life; Respiratory Function Tests

Summary: roxithormycin 300 mg per day for 12 weeks could improve quality of life and physiological outcomes in bronchiectasis

a randomized, double blinded, placebo controlled study was conducted to evaluate the effects of a 12-week administration of roxithromycin 300 mg once daily and a 12-week follow-up period in symptomatic stable bronchiectasis

Eligibility criteria:
minimum 15 year maximum 75 years criteria inclusion criteria: symptomatic bronchiectasis stable clinical bronchiectasis exclusion criteria: adverse drug reaction to macrolide recent exacerbation within 2 weeks history of macrolide therapy within 2 weeks active malignancy and end stage diseases 5. not perform lung function tests females who were lactating

Keywords: bronchiectasis quality of life pulmonary function tests
geriatric population covid-19 observational study (gerocovidobs)

Conditions: COVID-19

Summary: the gerocovid e-registry is a european de-identified clinical data electronic registry of geriatric patients at risk or suffering from covid-19 (suspected and confirmed cases) observed since 1st march 2020 in the participating investigational sites.

older adults (≥ 65 years) and pre-geriatric population (≥60 years and \<65 years) are the ones most at risk from complications of covid-19, including increased mortality, possibly in relationship with their comorbidity and frailty status. the gerocovid e-registry is intended to track covid-19 pandemic impact on the general geriatric population and on age/care-setting related sub-populations. the analysis of results is expected to facilitate the adoption of optimal standard of geriatric care during the pandemic.

Eligibility criteria:
inclusion criteria: 1. applying only to the " acute ward patients " cohort: 1. hospitalised patients 2. suspected or known sars-cov-2 infection 2. applying only to the "nursing homes (rsa)" cohort: 1. nursing home resident older adults 2. suspected or known sars-cov-2 infection 3. applying only to the" home and outpatients' care " cohort: a. outpatients at risk of sars-cov-2 infection 4. applying only to the" dementia outpatients " cohort: 1. outpatients suffering from dementia according to nia-aa criteria 2. at risk of sars-cov-2 infection 3. ongoing treatment with anti-cholinesterase- dugs and/or anti-psychotics 5. applying only to the" at home " cohort: a. outpatients at risk of sars-cov-2 infection 6. applying only to the " outcomes " cohort: 1. age≥65 years 2. hospitalised patients diagnosed with sars-cov-2 infection exclusion criteria: 1. lack of a signed informed consent if the patient received and understood the information about the study. 2. lack of a signed declaration by the responsible physician stating that no explicit opt-out advanced directives by the subject were known to be in place at the moment of inclusion if it had been impossible to inform the patient due to her/his state of consciousness and/or awareness of disease condition.

Keywords: coronavirus electronic registry geriatrics best practices
early versus late crrt in aclf patients with septic shock and aki

Conditions: Septic Shock and Acute Kidney Injury

Summary: consecutive patients with aclf (acute on chronic liver failure) and septic shock with aki (acute kidney injury) who give written informed consent will be included in this prospective trial at ilbs. at baseline s, endotoxin levels, nt-pro bnp, , urine n-gal will be done for all patients. a 10 ml serum sample will be stored for doing a cytokine profile. septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (map) of ≥ 65 mm hg. a record of cvp, ivc diameter and b-lines on ultrasound lung would also be done. patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, copd) pregnancy, chronic kidney disease, patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group, patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.


Eligibility criteria:
inclusion criteria: - patients with aclf defined based on apasl criteria with septic shock associated aki exclusion criteria: * patients with age less than 18 years * severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, copd) * pregnancy * chronic kidney disease on hemodialysis * patients with hepatorenal syndrome, post renal obstructive aki, aki due to glomerulonephritis, interstitial nephritis or vasculitis * patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group (serum potassium\>6 meq/lt, metabolic acidosis ph\<7.12, acute pulmonary edema, severe volume overload with hypoxemia non-responsive to diuretic treatment) * patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit * extremely moribund patients with an expected life expectancy of less than 24 hours * failure to give informed consent from family members. * hemodynamic instability requiring very high dose of vasopressors
femoral remodeling following total hip arthroplasty with omni apex modular™ and omni apex arc™ stem compared to competitive designs

Conditions: Osteoarthritis, Hip

Summary: this study compares the change in bone density which occurs after hip replacement with different femoral stem devices.


Eligibility criteria:
inclusion criteria: * minimum age 20 years, maximum age 80 years * osteoarthritis of the hip * elective tha * signed informed consent exclusion criteria: * osteoporosis * revisions * clinically obese (\>40 body mass index \[bmi\]) * femoral dysplasia * trochanteric osteotomy * inflammatory arthritis * breast-feeding, pregnancy, or women of childbearing potential without documentation of a negative pregnancy test and not utilizing contraception * patients with a history of having taken or currently taking bisphosphonates, pth, fluoride therapy or strontium ranelate or patients taking other chronic medications that in the investigator's opinion are known to affect bone mineral density in a substantial way * patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study * use of other investigational agent in the last 30 days * unable to sign informed consent

Keywords: total hip arthroplasty bone loss femoral remodeling bone mineral density tha dxa dexa dual energy x-ray absorptiometry
assessment of non-medical use of misoprostol in case of miscarriage or threatened miscarriage.

Conditions: Threatened Miscarriage

Summary: non-medical used of misoprostol for abortion is a growing concern in guadeloupe. such situation is reasonable for countries in which abortion is not easy to obtain or prohibited. however regarding the risk of complications, it is less understandable in region like guadeloupe where legal abortion with medical assistance is accessible for all and free. the aim of the study is to investigate on the amount of misoprostol taken by women in guadeloupe, by doing an analytical measurement. the aim is to evaluate batter this practice in guadeloupe, when the main objective of the study is to detect the presence or the absence of misoprostol in the urine sample of the woman coming at hospital for threatened miscarriage or miscarriage complications. moreover, these abortions can be more important than spontaneous miscarriage.

previous assessments in many countries as well in guadeloupe were based on self-declaration. such assessment is suspected to lead to underestimation. in addition, to our knowledge, no comparison has been done between those induced abortions and the natural miscarriages. illegal aspects of non-medical use of misoprostol and consequently bad self-declaration are hindrance to good assessment of the burden of such practice among patients asking for medical care at emergency unit for miscarriage or threatened miscarriage. they may also impair quality of evaluation of the relative risk associated to miscarriage threatened miscarriage induced by misoprostol compared to the same obstetrical complication without absorption of misoprostol. after a dose, misoprostol is quickly active and metabolised. it is mainly eliminated in urine. this elimination seems to be a way to increase the length of detection of the use of misoprostol. the aim of our study is to perform a detection of misoprostol in urine sample of patients hospitalised for a miscarriage or threatened miscarriage. this sample will be done during emergency cares. the study will not change the procedure of medical care of the patients during or after hospitalisation. all data will be obtained from information and result of tests normally done in such situation.

Eligibility criteria:
inclusion criteria: * inclusion criteria: * all patients who come at the maternity emergency unit for miscarriage or threatened miscarriage by 24 weeks of amenorrhea or patient receiving misoprostol for voluntary abortion. * age ≥ 12 years old * patient insured under the french social security system exclusion criteria: * refusal to participate in the study * age \< 12 years old

Keywords: non-medical abortion misoprostol miscarriage complications guadeloupe
amistem primary hip system prospective post-marketing multi-centre surveillance study

Conditions: Osteoarthritis; Arthritis; Avascular Necrosis; Fracture of the Femoral Neck or Head; Congenital Hip Dysplasia

Summary: this is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of amiistem primary hip system.


Eligibility criteria:
inclusion criteria: * patient is a good candidate for a primary hip arthroplasty using amistem hip system * patient is willing and able to give informed consent to participate in the follow-up program * patient is suitable for surgery and able to participate in the follow-up program. * those presenting with disease that meets the indication for use for medacta implants defined in the study (on-label use) exclusion criteria: * acute systemic or chronic infection * skeletal immaturity * severe muscular, neurological, vascular deficiency or other pathologies of the affected limb that may compromise the stability of the implant. * bone condition that may compromise the stability of the implant. * patient who are unwilling or unable to give consent, or to comply with the protocol and the follow-up program.