Kornimate/medical-research-clean huggingface dataset:
exploration of treatment effect of novel hormone therapy combined with local treatment based on psma pet/ct evaluation in mhscp patients

Conditions: Prostate Cancer Metastatic Disease

Summary: at present, there is still controversy over the treatment of metastatic hormone sensitive prostate cancer (mhspc). major guidelines and consensus suggest that novel hormone therapy (nht) should be used as the basic treatment for mhspc, and metastasis directed therapy can be combined depending on the clinical situation. however, it is still unclear how to develop more specific and individualized treatment plans for mhspc patients. on the other hand, prostate-specific membrane antigen (psma) which is highly specifically expressed in prostate epithelial cells has been widely used as a pet/ct target for the diagnosis and staging of prostate cancer. however, there is still a lack of clinical evidence on how to use it to guide the treatment of prostate cancer. therefore, this study intends to include patients diagnosed with mhspc by psma pet/ct. after 6 months of nht, psma pet/ct will be re-evaluated and patients with remaining active lesions on psma pet/ct will be included for randomization. the aim of this study is to explore the effect of nht combined with local treatment on delaying disease progression and prolonging survival in patients with active lesions on psma pet/ct after nht, providing new insights into the treatment of mhscp patients.


Eligibility criteria:
inclusion criteria: 1. male patients over the age of 18; 2. the physical condition (ps) score of the eastern cooperative oncology group (ecog) is 0, 1, or 2 points; 3. expected lifespan \>2 years; 4. all newly diagnosed patients with metastatic prostate cancer (mhspc, metastatic hormone sensitive prostate cancer) diagnosed by psma pet/ct, and still present active lesions on psma pet/ct after receiving new endocrine therapy; 5. has not received any other treatment for prostate cancer before; 6. no significant organ dysfunction upon evaluation; 7. agreed to sign the written consent form for this study, indicating a comprehensive understanding of the purpose and process of this study, and willingness to participate in this study. exclusion criteria: 1. a medical history of any other active malignant tumor within 2 years (excluding fully treated basal cell or squamous cell skin cancer, superficial bladder cancer or any other cancer in situ that is currently in complete remission); 2. prostate biopsy shows sarcomatoid cells, ductal carcinoma, or neuroendocrine cell components; 3. severe complications, immune suppression, severe mental illness, severe activity restriction, or inability to comply with this study; 4. currently participating in other clinical trials for prostate cancer; 5. according to the researcher's judgment, there are conditions that are not in line with the best interests of the subjects participating in the study, or may hinder, limit, or interfere with the study protocol.
use of essure® micro-inserts in women with hydrosalpinx prior to in vitro fertilization: a prospective, multicenter, international feasibility study

Conditions: Women Who Suffer From Hydrosalpinx That is Causing Infertility and Whom Want a Safer Way of Treamtent

Summary: the purpose of this study is to gather safety data related to the use of essure® micro-inserts in women with hydrosalpinx prior to in vitro fertilization and during pregnancy and to collect data with regard to implantation rates, clinical pregnancy rates, and pregnancy outcomes.


Eligibility criteria:
inclusion criteria: women age 21-38 (unless women in ovum donor cycle then age will be included up to 43) who: are willing to participate in this clinical study are able to comprehend and give informed consent for participation in this study have read, understood and signed an informed consent form have been unable to achieve pregnancy after trying for 1 year or greater and who have unilateral or bilateral hydrosalpinges as evidenced by laparoscopy or ultrasound or hsg have a day #3 serum fsh\<10, and day #3 estradiol\<80 recipient women undergoing a ovum donor cycle the donor must have a day 3 serum fsh \< 10 and day 3 estradiol \< 80 have an antral follicle count 10 or greater for both ovaries combined, if women using ovum donor (follicle count) will be based on eligible donor have a desire to receive treatment for their hs are willing to undergo a hysterosalpingogram (hsg) 3 months after essure placement to confirm proximal tubal occlusion exclusion criteria: active or recent upper or lower pelvic infection known hypersensitivity to nickel as confirmed by skin test known allergy to contrast media pregnancy or suspected pregnancy delivery or termination of pregnancy less than six weeks prior to essure micro-insert placements bmi \> 35 abnormal pap smear (cin2 or greater abnormality) within the past year pelvic malignancy severely retroverted uterus evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum abnormal clomid challenge test or abnormal lab values on day #3 serum fsh and estradiol antral follicle count less than 10 (both ovaries combined) poor general or gynecologic health inability or refusal to provide informed consent -

Keywords: hydrosalpinx or infertility
methods of confirmation of brain death

Conditions: Brain Death; Organ Donation

Summary: the purpose of this study is to describe the use of methods confirming brain death in the real clinical practice of the transplant program in the czech republic.

organ donation is possible in the czech republic only after meeting the legislative requirements. these require confirmation of brain death by one of the statutory methods before organ harvesting. the use of these methods in clinical practice has not yet been described.the aim of this retrospective observational study is to describe the use of these methods in the real clinical practice of the transplant program in the czech republic, taking into account the legislation of other european countries.

Eligibility criteria:
inclusion criteria: * age ≥18 years * organ donor exclusion criteria: * age under 18 years
innovative imaging of the conjunctiva, cornea, and ocular adnexa

Conditions: Corneal Disease; Blepharitis; Lacrimal Apparatus Diseases

Summary: in vivo confocal microscopy (ivcm) used in tertiary care ophthalmology centers is performed with two reflectance microscopes attached on a mounting with limited movement along the xyz axes. consequently, ocular diseases in the central area have been described (mostly cornea and adjacent conjunctiva). two dermatology ivcm (an handheld small ivcm and a multifluorescent one) present significant innovations that the investigators want to assess in ophthalmology for the diagnosis of conjunctiva, cornea, eyelid and lachrymal tract diseases. the handheld ivcm have unlimited degrees of freedom and a small diameter objective. it could dramatically increase the area accessible to ivcm (whole conjunctiva, eyelids, proximal lachrymal tract) (part 1 of the present study). the fluorescent ivcm allows the use of a wide range of fluorescent markers liable to increase the specificity of the diagnosis by revealing staining patterns corresponding to a specific disease and not to others (part 2 of the study)


Eligibility criteria:
inclusion criteria: * presenting with an ocular or ocular adnexa disease (infectious keratitis, stromal dystrophy, corneal surgery, ocular surface toxicity of eyedrops, cornea-conjunctival tumors, chronic blepharitis, eyelid tumors, diseases of the proximal lachrymal tract). * for the microangiography: diabetic patients exclusion criteria: * allergy to one of the 3 dyes (fluorescein, indocyanine green, rose bengal) * pregnancy and breast feeding * predicable impossible follow up * for patient volunteer for intravenous injections: beta blockers

Keywords: in vivo confocal microscopy corneal disease blepharitis lacrimal apparatus diseases microscopy, confocal
efficacy and safety of pulsatile gonadotropin releasing hormone pump treatment in patients with idiopathic hypogonadotropic hypogonadism

Conditions: Idiopathic Hypogonadotropic Hypogonadism

Summary: idiopathic hypogonadotropic hypogonadism (ihh) is the most common disorders of sex development (dsd).therapy for ihh includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (gnrh).in the present study, we compared the different efficacy and safety of pulsatile gnrh pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with ihh.

idiopathic hypogonadotropic hypogonadism (ihh) is the most common disorders of sex development (dsd).therapy for ihh includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (gnrh).in the present study, we compared the different efficacy and safety of pulsatile gnrh pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with ihh. the primary endpoint was the achievement of pregnancy in female partner. secondary endpoints were time to actual attainment of various sperm thresholds: sperm concentration\>0\*10\^6/ml , \>1.0 \*10\^6/ml and \>15 \*10\^6/ml, respectively. the clinical and laboratory characteristics including testicular and prostatic volume, tanner stage for pubic hair and genital, serum hormone levels \[especially serum testosterone,luteinizing hormone (lh) , and follicle-stimulating hormone (fsh) levels\], sperm concentration per ejaculate, and adverse events at baseline and at the end of treatment were also evaluated.

Eligibility criteria:
inclusion criteria: 1. age greater than 16 yr 2. diagnosed as idiopathic hypogonadotropic hypogonadism with clinical signs or symptoms of hypogonadism 3. hypogonadal serum testosterone levels (\<166ng/dl) in the presence of low or normal gonadotropins 4. normal levels of other anterior pituitary hormones 5. normal mri scans of the hypothalamo-pituitary region 6. had discontinued any prior treatment (testosterone or gonadotropin therapy) for at least three months before enrollment exclusion criteria: 1. with any significant medical condition (including malignant disease), laboratory abnormality, or psychiatric disorders that will prevent the subject from participating in the study 2. congenital hypopituitarism 3. any medical or surgical conditions possibly affecting the experiment result 4. any clinically significant allergic diseases or allergic to the study drugs 5. recently drug or alcohol abuse(\>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)
integrative molecular characterization of mit family translocation renal cell carcinomas (imcor)

Conditions: Renal Carcinoma

Summary: microphthalmia transcription factor (mit) family translocation renal cell carcinomas (trcc) are rare subtypes of kidney cancers, which often arise in children and young adults. trcc are characterized by translocations affecting transcription factors: transcription factor binding to immunoglobulin heavy constant mu enhancer 3 (tfe3) and transcription factor eb (tfeb). little is known about trcc molecular heterogeneity, in particular their transcriptomic and epigenetic subtype classification. clinical behavior of trcc is varying with age and tumor, node, metastasis (tnm) stage. however, the biological basis of this aggressiveness is poorly understood. purpose: the primary goal of this study is to decipher specific alterations in aggressive trcc, defined as cases with metastatic dissemination at diagnosis. to tackle this problem, a retrospective cohort of trcc cases in children and young adults will be created. we will then perform integrative comprehensive multi-omics analysis of these tumors to identify genetic, epigenetic and immune biomarkers associated with metastatic behavior in a training and validation datasets. comparison of the multi-omics data will be compared to other type of rare kidney tumors as well as clear-cell renal cell carcinomas

this retrospective cohort study aims to allow tumor collection of trcc from three different networks: the french research network in renal cancer (uroccr), the international society of paediatric oncology (siop) database and the network for rare renal carcinomas (carare). those samples will be divided in training and validation datasets. we will also collect samples from patients with other rare kidney cancers and clear-cell renal cell carcinomas allowing comparisons of similarity and differences between these tumors.

Eligibility criteria:
inclusion criteria: * patients treated for kidney cancer in a clinical center located in france for molecular biology study : * patients with tumor sample available for genetic and epigenetic analysis. tumor sample stored in biological resource facilities and consent given from patient or from parents for the use of biological sample for biomedical research purposes. exclusion criteria: * objection from patient or parents

Keywords: mit family translocation renal cell carcinomas multiomics genetic epigenetic
ventriculo-arterial coupling and myocardial work in sepsis and septic shock

Conditions: Sepsis; Septic Shock

Summary: sepsis is a term which describes an excessive response of the body to an infection and, if not promptly treated, can turn into septic shock a condition in which the organs don't receive enough oxygen to satisfy their needs. the aim of the study is to assess how the treatment of sepsis and septic shock will modify myocardial work and ventriculo-arterial coupling, that can be considered as indicators of ventricular and arterial performance efficacy respectively. each patient will be treated according to updated guidelines for sepsis and septic shock management, they will voluntarily be enrolled and they can decide to withdraw in each moment without any consequence on their treatment. the investigators, after receiving the consent, will collect patients' data, take blood samples and perform ultrasound measurements and then will start the treatment which can be based on fluids infusion, vasopressors or both. the investigators think that a modern cardiovascular assessment approach can be used to individually set the optimal blood pressure target in sepsis and septic shock with the combined evaluation of myocardial work and ventriculo-arterial coupling.


Eligibility criteria:
inclusion criteria: * 18 or more years old * sepsis * septic shock exclusion criteria: * lack of consent * less than 18 years old * pregnancy * more than moderate aortic stenosis ( aortic valve area (ava) \< 1.4 cm2, aortic valve area indexed (avai) \< 0.85, doppler velocity index (dvi) \< 0.5) * more than mild mitral regurgitation (vena contracta (vc) width \<= 3 mm, mitral regurgitation (mr) effective regurgitant orifice area (eroa) \< 20, mr regurgitant volume (regv) \< 30 ml) * cardiac arrythmias (e.g. atrial fibrillation/flutter, frequent ventricular and supraventricular or nodal activity) * renal replacement therapy * other than continous modes of mechanical ventilation

Keywords: sepsis septic shock myocardial work ventriculo-arterial coupling icu intensive care
lgi1-antibody patients follow-up

Conditions: Anti-LGI1 Encephalitis

Summary: autoimmune encephalitis involve autoantibodies targeting central nervous system, and particularly the synapse or its structure like for lgi1 protein. anti-lgi1 encephalitis is revealed by an inflammation of the limbic system, with mainly temporal lobe, faciobrachial dystonic or generalized seizures, and cognitive disorders. this disease is rare and its clinical, eeg and radiological characterisation is not sufficiently established. the investigators will evaluate these three aspects for the anti-lgi1 cohort of patients of the national reference center of autoimmune encephalitis.


Eligibility criteria:
inclusion criteria: * age \> 18 years * diagnosis of anti-lgi1 encephalitis based on sera or csf samples in the national reference center of autoimmune encephalitis from 2011/06 to 2019 july 1st. * clinical follow-up in france exclusion criteria: * anti-lgi1 antibody associated with another encephalitis antibody * foreign follow-up
hes and nicor data linkage for cardiac failure population analysis

Conditions: Heart Failure; Registries; Patient Readmission

Summary: this study is a population-based, patient-level analysis of heart failure in england over a 5-year period using a dataset created by linking hes and nicor databases. our analyses will look into the re-occurrence of hospitalisation after the initial diagnosis of heart failure, the influence of population factors on risk of re-hospitalisation, and the resultant cost implications in an nhs environment.

data from the national heart failure audit (nicor) and hospital episodes statistics (nhs digital) will be linked, by nhs digital, using fields that are recorded in both databases (for example, nhs number). we will receive de-anonymised data that has been pseudo-anonymised, allowing for patient-level analyses but without identifying individual patients.

Eligibility criteria:
inclusion criteria: * patients \>17 years old * individual patient data appears on both hes and nicor databases * 4-character primary diagnosis codes i50.0-i50.9 exclusion criteria: * patient requests withdrawal from analyses

Keywords: hospital episode statistics hes national institute for cardiovascular outcomes research nicor national heart failure audit
predictive role of circulating angiogenic factors for second-line paclitaxel and ramucirumab.

Conditions: Gastric Cancer Stage IV

Summary: the project is primarily aimed at identifying and subsequently validating the predictive role of plasma concentrations of vegf-a (vascular endothelial growth factor a), vegf-d (vascular endothelial growth factor d) and s-vegfr2 (soluble vascular endothelial growth factor receptor 2) measured prior to initiation and during second-line treatment with paclitaxel and ramucirumab in patients with unresectable gastric cancer pretreated with first-line chemotherapy. for the primary endpoint, the efficacy parameter chosen is pfs, calculated from day 1 of treatment to date of progression or death.


Eligibility criteria:
inclusion criteria: * histologically confirmed carcinoma of the stomach, cardia or gastroesophageal junction; * eastern cooperative oncology group performance status (ecog ps) 0 or 1; * life expectancy \>3 months; * age \>18 years; * metastatic disease measurable or evaluable according to recist (response evaluation criteria in solid tumors) 1.1; * progression after previous first-line treatment with fluoropyrimidines and platinum derivative; previous neoadjuvant/adjuvant treatment terminated ≤6 months after instrumental evidence of relapse will be considered first-line treatment; * prior treatment with trastuzumab in case of her-2 (human epidermal growth factor receptor 2) positive disease, defined as a 3+ immunohistochemistry (ihc) or 2+ ihc score and subsequent gene amplification demonstrated by fluorescent in situ hybridization (fish); exclusion criteria: * previous treatment with ≥2 lines of systemic therapy for metastatic disease; * symptomatic peripheral neuropathy ≥2 grades according to common terminology criteria for adverse events (ctcae) version 4.03; * uncontrolled infections in active phase, disseminated intravascular coagulation in activity; * clinically significant cardiovascular disease, such as cardiovascular accidents (less than 6 months after initiation of treatment), myocardial infarction (less than 6 months after initiation of treatment), unstable angina, chronic heart failure ≥2 new york heart association (nyha) grade, uncontrolled arrhythmias; * past (within 2 years of treatment initiation, except for curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix) or current history of malignancy other than gastric cancer.

Keywords: ramucirumab gastric cancer paclitaxel predictive factors vegf
assessing innovative wireless and wearable sensors for continuous blood pressure measurement in obese pregnant women

Conditions: Blood Pressure

Summary: this study is a prospective study targeting at least 20 obese and super-obese patients admitted to labor \& delivery (l\&d) for delivery at unc medical center. patients with clinical indicated radial a-lines either planned or already in-situ will be offered participation. the study will evaluate the accuracy of noninvasive blood pressure measurements with the anne one system to blood pressure readings with the radial a-line.


Eligibility criteria:
inclusion criteria: * age \>= 18 years old * ability and willingness to provide written informed consent * admitted for delivery at unc medical center * bmi of \>= 40 kg/m2 * clinically indicated radial a-lines either planned or already in-situ prior to delivery exclusion criteria: * skin sensitivity or allergy that precludes placement of anne one * any condition (social or medical) which, in the opinion of the study staff would make any study participation unsafe or complicate data interpretation * expected delivery within \<= 1 hour of arrival to l\&d
efficacy and safety of fiasp compared to insulin aspart both in combination with insulin detemir in adults with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe and the united states of america (usa). the aim of the trial is to investigate efficacy and safety of fiasp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes. this trial consists of two periods: a 26 week treatment period followed by a 26 week additional treatment period.


Eligibility criteria:
inclusion criteria: - type 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (visit 1) - currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (visit 1) - currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (visit 1) - hba1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - body mass index (bmi) below or equal to 35.0 kg/m\^2 exclusion criteria: - use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (visit 1) - recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (visit 1) - cardiovascular disease, within the last 6 months prior to screening (visit 1), defined as stroke, decompensated heart failure new york heart association (nyha) class iii or iv, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty