Kornimate/medical-research-clean huggingface dataset:
l-carnitine and clomiphene citrate for induction of ovulation in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of the study to assess the efficacy of adding l-carnitine to clomiphene citrate for increasing the ovulation and the pregnancy rate in women with pcos.

a total of 106 women with the diagnosis of pcos based on the european society of human reproduction and embryology/ american society for reproductive medicine (eshre/asrm) guidelines criteria (rotterdam criteria, 2003) will be randomly assigned using a computer-generated randomization sheet and they will be distributed into two groups: 1. group l (53 patients): this group will receive oral clomiphene citrate (clomid, global napi pharmaceuticals (gnp), egypt) (50 mg tablet, two times per day) from the third day of the cycle until the seventh day of the cycle plus oral carnitine supplementation (carnivita forte, eva pharma, egypt) (1g tablet, three times per day) from the third day of the cycle until the day of the pregnancy test. 2. group c (53 patients): this group will receive oral clomiphene citrate only (clomid, global napi pharmaceuticals (gnp), egypt) (50 mg tablet, two times per day) from the third day of the cycle until the seventh day of the cycle. serum fsh, lh \& free testosterone concentrations will be measured on day 3 (basal) of the cycle. trans-vaginal folliculometry will be performed on all women on days 7 and 9 of the cycle and then individualized according to the response. when one leading follicle attains a diameter of 17mm or more, the endometrial thickness will be measured and 10,000 iu of human chorionic gonadotropin (hcg) will be given (im injection; pregnyl, organon, holland). timed intercourse will be advised after 36-48 hours from the night of hcg administration for 2 successive days. ovulation success will be confirmed by transvaginal ultrasound which will show that the leading follicle has collapsed, and some fluid appeared in the douglas pouch. serum progesterone will be measured on day 8 post hcg injection, ovulation will be confirmed if the serum progesterone level is ≥ 5 ng/ml (leiva et al., 2015). luteal-phase support will not be provided in both groups. pregnancy test will be done in the form of testing the level of beta hcg in the blood after 14 days once the success of the ovulation process has been confirmed.

Eligibility criteria:
inclusion criteria: 1. age ranging from 18-35 years. 2. normal hysterosalpingo-graphy (hsg). 3. normal semen analysis of the husband. 4. diagnosed with pcos based on the (eshre/asrm) guidelines criteria (rotterdam criteria 2003). exclusion criteria: 1. patient's refusal. 2. male factors of infertility and/or abnormal hsg. 3. hyperprolactinemia (prolactin ≥ 22 ng/dl). 4. fsh on day 3 \> 15 miu/ml. 5. gross ovarian pathology diagnosed by ultrasound.
luteinizing hormone-releasing hormone agonist therapy and iodine i 125 implant in treating patients with previously untreated prostate cancer

Conditions: Prostate Cancer

Summary: rationale: androgens can cause the growth of prostate cancer cells. luteinizing hormone-releasing hormone agonists may lessen the amount of androgens made by the body. internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. giving luteinizing hormone-releasing hormone agonist together with an iodine i 125 implant may be an effective treatment for patients with prostate cancer. purpose: this randomized phase iii trial is studying how well giving luteinizing hormone-releasing hormone agonist therapy together with an iodine i 125 implant works with or without additional luteinizing hormone-releasing hormone agonist therapy in treating patients with previously untreated prostate cancer.

objectives: * to evaluate the biochemical progression-free survival (pfs), overall survival, clinical pfs, and disease-free survival of patients with previously untreated intermediate-risk prostate cancer treated with neoadjuvant luteinizing hormone-releasing hormone (lhrh) agonist therapy and permanent iodine i 125 implantation with vs without adjuvant lhrh agonist therapy. * to determine the non-adaptive interval to salvage therapy in patients treated with these regimens. * to determine the safety of these regimens in these patients. outline: this is a multicenter study. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive neoadjuvant luteinizing hormone-releasing hormone (lhrh) agonist therapy for up to 3 months and undergo permanent iodine i 125 implantation. patients then receive adjuvant lhrh agonist therapy for up to 9 months. * arm ii: patients receive neoadjuvant lhrh agonist therapy and undergo permanent iodine i 125 implantation as in arm i.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed prostate cancer * previously untreated disease * intermediate-risk disease, as defined by the following: * clinical stage \< t2c * prostate-specific antigen (psa) ≤ 20 ng/ml * gleason score \< 8 patient characteristics: * ecog performance status 0-1 * life expectancy ≥ 3 months * leukocyte count ≥ 3,000/ul * hemoglobin ≥ 10.0 g/dl * platelet count ≥ 100,000/ul * serum creatinine ≤ 2.0 mg/dl * alt and ast ≤ 100 iu/l * no other cancer requiring treatment * no poorly controlled hypertension (i.e., diastolic blood pressure ≥ 120 mm hg) * no severe psychiatric disorders, including schizophrenia or dementia * no poorly controlled diabetes * considered appropriate for study participation, as determined by the principal investigator or clinical investigator prior concurrent therapy: * no prior drugs for benign prostatic hyperplasia (other than antiandrogen therapy) * no prior surgery for prostate cancer * no concurrent steroid drugs (except for ointment) * no other concurrent antiandrogen therapy

Keywords: stage iib prostate cancer stage iia prostate cancer stage i prostate cancer
sanitary napkins for urinary assessment of micronutrients

Conditions: Focus: Nutritional Deficiency

Summary: this study aims to find an easy urinary collection method for the assessment of urinary markers of micronutrient status.

urinary collection in newborns and infants can be difficult. our study aims to find an easy and cheap alternative to urinary collection bags and specialized pads that can be used to measure biomarkers of iodine and vitamin b12 status in urine and can be employed in large scale trials. using correlation analyses, the association of urinary iodine and methylmalonic acid from healthy volunteers will be assessed between untreated sample and a sample expressed from a sanitary napkin. participants will be recruited based on their dietary pattern (omnivorous, vegetarian and vegans) to have a broad spectrum of analyte concentration. participants weight, height, age, nutritional supplement use and diet will be assessed.

Eligibility criteria:
inclusion criteria: healthy volunteers written informed consent exclusion criteria: bmi \ 24,9 use of medication (except contraceptives) smoking
blood-brain barrier permeability in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the main aim of the present study is to improve our understanding of the role of blood-brain barrier function in dementia of the alzheimer's type. the investigators hypothesize that microvascular dysfunction - more specifically "cerebral perfusion and blood-brain barrier leakage" - is a determinant of cognitive decline and cortical atrophy in alzheimer's disease.


Eligibility criteria:
inclusion criteria: patients with ad: * informed consent before participation in the study * received standard diagnostic procedure according to the parelsnoer initiative procedure * diagnosed with dementia of the alzheimer's type * clinical dementia rating (cdr) of 1, which means a mild to moderate stage of dementia * mmse ≥ 20 and patients are mentally competent (in general, individuals with an mmse ≥ 18 are considered mentally competent) patients with prodromal ad: * informed consent before participation in the study * received standard diagnostic procedure according to the parelsnoer initiative procedure * diagnosis of prodromal dementia according to the dubois criteria (16) * cdr of 0.5, which suggests a very mild stage of dementia * memory impairment defined as delayed recall on verbal learning test (15 wlt) \< 1.5 sd * mmse ≥ 20 and patients are mentally competent. * medial temporal lobe atrophy scale mta ≥ 1 (17) or abnormal levels of aß42, t-tau or p-tau healthy participants: * informed consent before participation in the study * no diagnosis of dementia, prodromal dementia, or mild cognitive impairment. * mmse ≥ 26 * no substantial memory complaints (according to participant) * age, gender and education is matched to the patient groups. exclusion criteria: * contraindications for scanning (e.g. brain surgery, cardiac pacemaker, metal implants, claustrophobia, large body tattoos) * contraindications for contrast agent gadovist (renal failure) as determined by the estimated glomular filtration rate egfr \< 30 ml/min. * major vascular disorders (e.g. stroke, heart disease) * psychiatric or neurological disorders: major depression (\< 12 months); history of schizophrenia; bipolar disorder; psychotic disorder nos or treatment for a psychotic disorder (\< 12 mnd); cognitive impairment due to alcohol abuse; epilepsy; parkinson's disease; ms; brain surgery; brain trauma; electroshock therapy; kidney dialysis; meniere's disease; and brain infections. * structural abnormalities of the brain * cognitive impairment due to alcohol/drug abuse * absence of reliable informant (for patient groups)
early identification and severity prediction of acute respiratory infectious disease

Conditions: Acute Respiratory Infection; Severe Pneumonia; Next Generation Sequencing; Multiplex PCR

Summary: early identification and severity prediction of acute respiratory infectious disease has become a top priority for clinicians at department of infectious and respiratory diseases after covid-19 broke out. this is a multicenter, prospective, and randomized study, which aims to figure out the best way of early identification and severity prediction of acute respiratory infectious diseases. patients with suspected acute respiratory infectious diseases will be enrolled into this study and received two different diagnostic pathways.


Eligibility criteria:
inclusion criteria: 1. patients aged between 18 and 80 years old 2. no limits in gender 3. patients who are newly present with cough, sputum, or exacerbated with pyogenic sputum, with or without chest pain within 2 weeks; 4. patients who meet at least one of the following 4 requirements: 1. fever; 2. sign of pulmonary consolidation or wet wales 3. wbc\>10×10\^9/l or \<4×10\^9/l; 4. patchy, infiltrating shadows or interstitial changes, with or without pleural effusion on chest radiological examination. exclusion criteria: 1. highly suspected or diagnosed pulmonary non-infectious disease (tumor, immune disease, etc.) without evidence for infection; 2. pathogen has been identified without evidence for co-infection; 3. insufficiency of respiratory and blood samples; 4. patients who are unable to collaborate due to physical or mental disorders; 5. patients who have been engaged to other clinical trials; 6. any conditions make it unsafe for the subject to participate;

Keywords: mngs multiplex pcr acute respiratory infectious disease severe pneumonia
atrial ganglionated plexi ablation guided by the sumo technology with and without conventional pulmonary vein isolation in patients with persistent af

Conditions: Atrial Fibrillation

Summary: although circumferential pulmonary vein isolation (pvi) has been considered as the cornerstone for atrial fibrillation ablation, there has been a substantial recurrence rate. the investigators designed a prospectively randomized study to evaluate whether additional atrial ganglionated plexi ablation guided by the sumo technology improves the clinical outcome in patients with persistent af.


Eligibility criteria:
inclusion criteria: 1. male or female patients, age ≥ 18 and ≤ 80 years. 2. persistent af (ecg documentation). 3. indication for af ablation. 4. lvef ≥ 50% 5. able to provide written informed consent 6. able to comply with the requirements of the study exclusion criteria: 1. reversible cause of atrial fibrillation 2. previous af ablation therapy 3. clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality 4. recent (3 months) myocardial infarction (mi), stroke or transient ischemic attack (except if the patient had a des implanted stent post-mi it would be one year) 5. contra-indication to iodine-123 meta-iodobenzylguanidine (123i-mibg), iodine, isoproterenol 6. use of medication for non-cardiac medical conditions that is known to interfere with 123i-mibg uptake and cannot be safely withheld for at least 24 hours prior to the d-spect study procedures 7. inability to undergo d-spect and ct imaging
a study of shr6390 in combination with fulvestrant in patients with hr positive and her2 negative advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: this is a phase iii clinical trial to evaluate the efficacy and safety of shr6390 in combination with fulvestrant versus placebo combined with fulvesrant in patients who have hr positive and her2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.


Eligibility criteria:
inclusion criteria: 1. has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, her2 negative breast cancer. 2. age: 18 - 75 years old, postmenopausal women or prepostmenopausal women 3. received prior endocrine therapy 4. one previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy. 5. eastern cooperative oncology group \[ecog\] 0-1 exclusion criteria: 1. patients who received prior treatment with any cdk4/6 inhibitor, everolimus or fulvestant. 2. clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, congestive heart failure (new york heart association (nyha) class \> 2), or ventricular arrhythmia which need medical intervention.
lapatinib plus caelyx in patients with advanced metastatic breast cancer following failure of trastuzumab therapy

Conditions: Metastatic Breast Cancer

Summary: the aim of this study is to evaluate the potential of a lapatinib plus caelyx combination therapy as an effective and safe therapeutic regimen with a favourable cardiotoxicity profile, in the treatment of metastatic breast cancer following failure of prior trastuzumab.


Eligibility criteria:
inclusion criteria: * female patients, age ≥ 18 years * advanced or metastatic breast cancer, histologically confirmed * documented her2 overexpression (ihc 3+ and/or fish positive) * at least one measurable lesion according to recist criteria. patients with bone-only lesions are not eligible for study entry * documented disease progression * patients may have no more than 1 line of palliative treatment, however prior therapies must include trastuzumab in adjuvant or metastatic setting * life expectancy of at least 12 weeks * performance status 0-1 * cardiac ejection fraction \>= 50% as measured by echocardiogram or muga scan * adequate hematology, liver and renal function exclusion criteria: * pregnant or lactating women * serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent * severe cardiac disease (uncontrolled angina, arrhythmia, chronic heart failure (chf) or cardiac disease requiring a device) * ejection fraction below the institutional normal limit * maximum cumulative dose of 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin * active bacterial, viral or fungal infection * patients with clinically apparent brain metastases * positivity for hiv, hepatitis b or c * history of other malignancy; patients who have been disease-free for 5 years * concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy) or concurrent treatment with an investigational drug or participation in another clinical trial * known hypersensitivity to the study drugs lapatinib and caelyx or their excipients

Keywords: metastatic breast cancer her2 lapatinib caelyx cardiotoxic
safety study of 2.0mg lucentis to treat polypoidal choroidal vasculopathy

Conditions: Polypoidal Choroidal Vasculopathy

Summary: this phase i/ii study will investigate the safety and tolerability of intravitreally administered 0.5mg and 1.0 or 2.0mg ranibizumab in three monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month of drug safety follow up in subjects with exudative polypoidal choroidal vasculopathy (pcv) for a total of 24 months.

twenty eyes will be randomized will receive 3 consecutive monthly intravitreal 1.0 or 2.0 mg/0.5mg (3:1 ratio) ranibizumab injection with the first injection occuring at day 0 and second and third injection occuring at month 1 and month 2 respectively. retreatment with intravitreal ranibizumab or other therapies will be at the investigators discretion but guidelines for recommended retreatment.

Eligibility criteria:
inclusion criteria: * males and females \>18 years of age. females of child bearing potential will undergo urine pregnancy testing and be required to use appropriate methods of birth control. * icg and fluorescein angiographic characteristics consistent with active, leaking pcv with subfoveal lesions and/or subfoveal hemorrhage, lipid exudates, ped or fluid diagnosed within the past 6 months or diagnosed as newly active within the past 6 months. subjects who completed the 24 month follow up in the original fvf3671s protocol may enter the study without necessarily demonstrating active exudative pcv at enrollment. * best-corrected etdrs visual acuity at 4 meters between 20/20 - 20/800. * lesion size - no limitations. * lesions characteristics - leaking lesions consistent with pcv. no limitations on hemorrhage, fibrosis or atrophy. * no therapy (includes non foveal laser, pdt, intravitreal steroids, ttt, radiotherapy, or anti-vegf therapy) or intraocular surgery within the past 30 days for any condition. * clear ocular media to allow for photography/angiography. * ability to provide written informed consent and comply with study assessments for the full duration of the study. exclusion criteria: * patients with features of age related macular degeneration such as abundant drusen and demographic features consistent with this diagnosis. * allergy to fluorescein, icg, iodine, shellfish. * pregnancy (positive pregnancy test) * any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. * participation in another simultaneous medical investigation or trial. * exclude other anti-vegf agents as therapy options. * history of previous subfoveal laser. * advanced glaucoma (iop \> 25 or cup/disc ration \> 0.8) * any condition in the opinion of the investigator that would interfere with disease status/progression or jeopardize patients' participation in the study.

Keywords: polypoidal choroidal vasculopathy choroidal neovascularization ranibizumab lucentis
safety, performance and usability of balt medical devices: the evidence post marketing clinical follow-up platform

Conditions: Intracranial Aneurysm; Brain Arterial Disease; Acute Ischemic Stroke; Peripheral Vascular Diseases; AVM - Cerebral Arteriovenous Malformation; AVM

Summary: balt has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices. this platform is purely exploratory, without hierarchical order of the objectives and associated outcomes.


Eligibility criteria:
inclusion criteria: * provision of a signed, written and dated informed consent or non-opposition (where applicable) exclusion criteria * device(s) used in multiple procedures (two, or more, pathologies treated during the same procedure) * contra-indications of each device as described in the instructions for use.
changes in arterial stiffness and endothelial glycocalyx in patients with poorly controlled diabetes mellitus type 1 or type 2 after optimization of antidiabetic medication.

Conditions: Diabetes Mellitus

Summary: arterial stiffness is associated with increased risk for cardiovascular disease. moreover, the integrity of endothelial glycocalyx plays a vital role in vascular permeability, inflammation and elasticity. the purpose of this study is to investigate changes in arterial stiffness and endothelial glycocalyx thickness in patients with poorly controlled diabetes mellitus type 1 or type 2 after glycemic control by optimal medication.

the investigators will study two groups matched for age and sex: 30 patients with uncontrolled type 1 diabetes and 30 patients with uncontrolled type 2 diabetes. individuals should not be treated with statins, beta-blockers, ace inhibitors, sartans, hormonal preparations, drugs that interfere with the function of platelets and hemostasis. furthermore, they should not have heart failure, nephropathy and retinopathy. 10 people will remain uncontrolled after the expiration of 3 months after the modification of antidiabetic medication used as a control group . at 0, 3, 6 and 12 months the investigators will measure: 1. carotid-femoral pulse wave velocity (pwv, m/sec) and augmentation index (ai%) by the method of arteriography (arteriograph, tensiomed) and complior (sp alam). 2. perfused boundary region (pbr, micrometers) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using sideview darkfield imaging (microscan, glycocheck). increased pbr is considered an accurate non invasive index of reduced endothelial glucocalyx thickness. 3. flow mediated dilatation (fmd) of the brachial artery. 4. determination of following parameters in blood: glucose, insulin, free fatty acids, triglycerides, glycerol, c-reactive protein (crp), transforming growth factor-b (tgf-b), lipoprotein-associated phospholipase a2 (lp-lpa2), tumor necrosis factor-a (tnf-a), il6 and il10 (interleukins), propeptide of type i procollagen (pip), propeptide of procollagen type iii (piiinp), matrix metallopeptidases 9 and 2 (mmp), macrophage-colony stimulating factor (mcsf), growth differentiation factor-15 (gdf-15), n-terminal pro b-type natriuretic peptide (nt-probnp) and galectin-3.

Eligibility criteria:
inclusion criteria: * patients with uncontrolled diabetes mellitus exclusion criteria: * valvular heart disease * congestive heart failure * peripheral vascular disease * liver or kidney failure * history of alcohol or drug abuse * treatment with statins, beta- blockers, ace inhibitors or sartans

Keywords: arterial stiffness endothelial glycocalyx coronary flow reserve