Kornimate/medical-research-clean huggingface dataset:
an upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult fontan patients.

Conditions: Congenital Heart Disease With Fontan Circulation

Summary: the aim of this open-label (ol) trial is to study the long-term use of macitentan for up to 2 years in fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent rubato double-blind (db) study (ac-055h301, nct03153137). this ol trial studies the long-term effect of macitentan in fontan-palliated patients as it is not known if the effect of macitentan is sustained beyond 52 weeks (end of the parent rubato db study). in addition, the trial also studies the long-term safety of macitentan as this is also unknown. furthermore, the opportunity will be given to patients who were on placebo in the parent rubato db study to receive macitentan 10 mg and benefit from a potentially active treatment.


Eligibility criteria:
inclusion criteria: * written informed consent/assent from the subject and/or a legal representative prior to initiation of any study-mandated procedures. * subjects who have completed week 52 of the parent ac-055h301/rubato db study (nct03153137) * women of childbearing potential must: 1. have a negative serum pregnancy test prior to first intake of ol study drug, and, 2. agree to perform monthly pregnancy tests up to the end of the safety follow up (s-fu) period, and, 3. use reliable methods of contraception from enrollment up to at least 30 days after study treatment discontinuation. exclusion criteria: * clinical worsening leading to medical interventions including reoperation of fontan circulation (fontan take-down) during the enrollment period * systolic blood pressure \< 90 mmhg (\< 85 mmhg for subjects \< 18 years old and \< 150 cm of height) at rest * criteria related to macitentan use * any known factor or disease that may interfere with treatment compliance or full participation in the study

Keywords: congenital heart failure macitentan univentricular heart cavopulmonary anastomosis fontan circulation
benigh prosatic hyperplasia/lower urinary tract symptoms

Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Summary: benign prostatic hyperplasia (bph) is a common condition in aging men that is frequently associated with troublesome lower urinary tract symptoms (luts) which can be divided into storage phase symptoms (urinary frequency, urinary urgency, increased nocturia, urinary incontinence, etc.), voiding phase symptoms (interruption of urination, thinning of the urine line, straining to urinate, etc.), and post-void symptoms (incomplete sensation of urination, dribbling after urination, etc.).bph is prevalent in as many as 40% of men in their fifties and 90% of men in their eighties.yet, few effective therapiesare available for treating bph/luts. acupuncture may be an effective treatment option for bph/luts.however, effects of acupuncture on bph/luts remain uncertain because of the small sample sizes or other methodological limitations. the objective of this randomized,conventional electroacupuncture-controlled trial is to assess the effectiveness of electroacupuncture at'four sacral points'for relieving symptoms of bph/luts. the results will provide a robust conclusion with a highlevel of evidence.


Eligibility criteria:
inclusion criteria: * diagnosis of bph in accordance with the criteria of the chinese urological diagnosis and treatment guidelines 2014 edition. * male patients aged 40-80 years. * not on any 5a-reductase inhibitor, a1 receptor blocker or traditional chinese medicine in the past two weeks. * international prostate symptom score (ipss) scores range from 1 to 19. * family members or patients give informed consent and sign informed consent. exclusion criteria: * patients with recurrent urinary tract infections. * patients with neurogenic bladder and urethral stricture, bladder tumor and prostate cancer. * patients with benign prostatic obstruction who have failed invasive treatment. * patients with serious cardiovascular and cerebrovascular diseases, hematopoietic system and other primary diseases and mental disorders. * patients who are participating in other clinical trials or who are participating in other clinical trials within one month.

Keywords: benign prostatic hyperplasia lower urinary tract symptoms electroacupuncture four sacral points
sofosbuvir/velpatasvir fixed-dose combination in adults with chronic hcv infection

Conditions: Hepatitis C Virus Infection

Summary: the primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (sof/vel) in participants with chronic genotype 1, 2, 4, 6 or indeterminate hcv infection who received placebo in the gilead-sponsored study gs-us-342-1138.


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent * chronic hcv infection (≥ 6 months) documented by prior medical history or liver biopsy * was administered placebo to match sof/vel in gilead study gs-us-342-1138 * hcv rna ≥ 10\^4 iu/ml at screening * classification as treatment naive or treatment experienced * males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception key exclusion criteria: * current or prior history of clinically-significant illness (other than hcv) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than hcv) are also excluded. * screening electrocardiogram (ecg) with clinically significant abnormalities * laboratory results outside of acceptable ranges at screening * prior exposure to sof or other nucleotide analogue hcv ns5b inhibitor or any hcv ns5a inhibitor * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: sofosbuvir sof/gs-5816 gs-5816 hepatitis c hcv cirrhosis velpatasvir
exosome as the prognostic and predictive biomarker in ebc patients

Conditions: Triple Negative Breast Cancer; HER2-positive Breast Cancer

Summary: this study is the experimental study for serial ctdna and exosome evaluation in ebc patients


Eligibility criteria:
inclusion criteria: * early breast cancer * planned neoadjuvant chemotherapy * triple negative breast cancer or her2-positive breast cancer exclusion criteria: * stage iv breast cancer * hormone receptor positive breast cancer
cystoscopic imaging collection and enhancement project

Conditions: Urinary Bladder Neoplasms

Summary: this study will collect video recordings of routine flexible cystoscopy examinations, medical history and diagnosis information, from up to 100 participants who have a history of bladder cancer, or symptoms suggestive of bladder cancer, in order to develop a new computer system for recording and reviewing images of the bladder, and to assess the utility of this system.

flexible cystoscopy is commonly used in the diagnosis and post-treatment care of bladder cancer, the 7th most common cancer in the united kingdom. while the equipment to record bladder examinations exists, it is not simple or quick to use so examinations are rarely recorded. methods of enhancing the images obtained during these examinations also exist but these are generally hardware based, requiring specific equipment, or use a fluorescent dye and special endoscope, which is expensive for the clinical service provider, inconvenient for the patient and may cause allergic reactions. the new proof-of-concept device will record high-definition video in a lossless format to a computer hard-drive from any existing cystoscopy equipment to which it can be connected. additionally, the device incorporates a foot pedal which allows the operator to "bookmark" points of interest during the examination. these points are marked in the recorded video data file and aid later navigation and review of examination session videos. the recordings will be used to develop novel image enhancement software, which is intended to make abnormalities in the bladder easier to identify. once the software has been developed, the enhanced and un-enhanced videos will be reviewed by experts (clinical urology specialists) and non-experts (other healthcare staff and laypeople), who will be asked to report areas of interest in the videos, without knowledge of the diagnosis for each examination. a statistical analysis of reporting of areas of interest by expert and non-expert reviewers will be produced, to assess the usefulness of the software image enhancement in identifying abnormalities in the bladder.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo cystoscopy examination as they are considered to possibly have undiagnosed bladder cancer, or; * patients scheduled to undergo a post-treatment follow-up or routine surveillance cystoscopy examination, having previously been treated for bladder cancer; and * have provided written informed consent agreeing to participation in the study prior to any study-specific procedures being carried out. exclusion criteria: * patients who are incapable of providing written informed consent agreeing to participation in the study.

Keywords: cystoscopy bladder cancer bladder imaging
efficacy of nicotine acid on dyslipidaemia in patients with metabolic syndrome

Conditions: Metabolic Syndrome; Dyslipidaemia

Summary: placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome. nicotine acid decreases postprandial hyperlipidaemia in patients with metabolic syndrome which reduces the low-grade inflammation and the risk of atherosclerosis.


Eligibility criteria:
inclusion criteria: * dyslipidemia (triglycerides \>= 150 mg/dl and/or decreased levels of hdl-cholesterol \<40 mg/dl in men or \< 50 mg/dl in women) * further components of the metabolic syndrome: hypertension: blood pressure \>= 130/85 mmhg or/and hyperglycemia: fasting plasma glucose \>= 100 mg/dl or/and 2 hour plasma glucose after 75g glucose load (ogtt) \>= 140 mg/dl or/and obesity: waist circumferences \> 102 cm in men or \>88 cm in women exclusion criteria: * contraindication and incompatibility of nicotine acid * patients with ulcus ventriculi or ulcus duodeni * intake of lipid lowering drugs \< 6 weeks before randomization * therapy of type 2 diabetes with insulin, glitazones, acarbose or more than one antidiabetic drug (only mono-therapy with metformin or sulfonyl urea is permit) - no acceptable therapy of diabetes with levels of hba1c\>=8.0% * cardiovascular events in the last 6 months * chronic inflammatory diseases (lupus erythematodes, arthritis, morbus crohn or colitis ulcerosa) * alat elevation 2.5 times more than the normal limit * pregnancy
clinical and live birth rates after following long antagonist protocol versus classical antagonist protocol

Conditions: Pregnancy, Ovarian

Summary: a randomized prospective study of the evaluation of the clinical ivf results after following long antagonist protocol for controlled ovarian stimulation versus following classical antagonist protocol

a randomized prospective study of administration of degarelix in late luteal phase of women undergoing ovarian stimulation for ivf: single dose of degarelix (24mg, 16mg or 12 mg), on day 24th of previous luteal face cycle, was administered. the clinical pregnancy and live birth rates were estimated for this group of patients, comparing to the rates of the group which followed classical antagonist protocol. the number of the formed blastocysts in each group is measured, as well.

Eligibility criteria:
inclusion criteria: * primary infertility * age 18-39 years; body mass index (bmi) 18-29kg/m2; * regular menstrual cycle of 26-35days, * presumed to be ovulatory; * early follicular- phase serum concentration of fsh within normal limits (1-12 iu/l). exclusion criteria: * women with diabetes and other metabolic disease * women with heart disease, qt prolongation,heart failure * elevated liver enzymes, liver failure, hepatitis * women with inflammatory or autoimmune disease * abnormal karyotype; * polycystic ovarian syndrome, * endometriosis stage iii/iv; * history of being a 'poor responder', * defined as \>20 days of gonadotrophin in a previous stimulation cycle, or any previous cancellation of a stimulation cycle due to limited follicular response, or development of less than 4 follicles 15 mm in a previous stimulation cycle; history of recurrent miscarriage; severe ohss in a previous stimula- tion cycle or any contraindication for the use of gonadotrophins.

Keywords: long antagonist classical antagonist live birth rate clinical pregnancy rate ovarian stimulation ivf
artificial intelligent accelerates the learning curve for mastering contrast-enhanced ultrasound of thyroid nodules

Conditions: Thyroid Nodule

Summary: the goal of this observational study is to learn about the learning curve for mastering the thyroid imaging reporting and data system of contrast-enhanced ultrasound with the assistance of artificial intelligence in patients with thyroid nodules. the main questions it aims to answer are: 1. can we develop a artificial intelligent software to assist doctors in the diagnosis of thyroid nodules using contrast-enhanced ultrasound? 2. can artificial intelligent reduce the number of cases and time for doctors to master the contrast-enhanced ultrasound diagnosis of thyroid nodules? participants will be asked to undergo contrast-enhanced ultrasound examination and ultrasound-guided fine-needle aspiration of thyroid nodules. researchers will compare the number of cases and time for doctors with and without artificial intelligent assistance to master the contrast-enhanced ultrasound diagnosis of thyroid nodules to see if artificial intelligent reduce the number of cases and time.


Eligibility criteria:
inclusion criteria: * patients with thyroid nodules with a solid component ≥5 mm confirmed by conventional ultrasound; * patients who underwent conventional ultrasound, contrast-enhanced ultrasound, and fine-needle aspiration biopsy; * patients with a final benign or malignant pathological results. exclusion criteria: * patients with cytopathology of bethesda i, iii, or iv and without final benign or malignant pathology； * patients with a history of thyroid ablation or surgery; * patients with low-quality ultrasound images.

Keywords: ultrasonography contrast media deep learning thyroid nodule learning curve
a blended intervention for adjustment disorder.

Conditions: Adjustment Disorders

Summary: the aim of this study is to evaluate the feasibility (including usability and satisfaction) and preliminary effectiveness of a blended intervention for adjustment disorder. this intervention combines a self-applied internet-based program (tao) with face-to-face sessions with a therapist via videoconference.

adjustment disorder (ajd) is one of the most commonly diagnosed disorders in clinical practice. however, although there is still no evidence-based treatment for this problem, cognitive behavioral therapy (cbt) is the most studied. internet-based treatments emerge as an alternative to reach more people in need while reducing intervention costs. however, high drop-out rates in this format highlight the need to develop new ways of delivering treatments. the present study aims to test a blended treatment for ajd that combines a self-applied cbt programme online (tao: adjustment disorder online) with face-to-face sessions with a therapist via videoconference every 10-12 days. only one treatment group has been included and patients will be evaluated at pre-treatment, post-treatment and follow-up (3 and 12 months). the study will be conducted following the extension of the consolidated standards of reporting trials (consort) statement for pilot and feasibility studies (eldridge et al., 2016), the consolidated standards of reporting trials of electronic and mobile health applications and online telehealth guidelines (eysenbach, 2011), and the standard protocol items: recommendations for interventional trials (spirit) guidelines (chan et al., 2013a; 2013b). specific objectives of the study include: (1) to analyse the feasibility of different recruitment and data collection methods (e.g., how broad or restrictive are the eligibility criteria, how willing are patients to participate, time needed to collect data), (2) to explore reasons for non-participation and drop-outs from treatment, (3) to assess patient satisfaction and acceptance of treatment (both quantitatively and qualitatively), (4) in addition, as a secondary objective to explore the potential effectiveness of the treatment at post-treatment and follow-up.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * meeting diagnostic criteria for adjustment disorder based on the international classification of diseases 11 edition (icd-11). * exceed the cut-off point of 47.5 on the adjustment disorder new module-20 scale (adnm-20; lorenz et al., 2016). * sign an informed consent. * ability to understand and read spanish. * ability to use a computer and having access to the internet. * having an e-mail address. exclusion criteria: * presence of risk of suicide or self-destructive behaviors. * presence of another severe mental disorder (substance abuse or dependence, psychotic disorder, dementia, bipolar disorder or personality disorder). * receiving other psychological treatment during the study for ajd. * an increase and/or change in the medication during the study period.

Keywords: adjustment disorders internet-based treatment blended intervention feasibility videoconferencing
aminopterin in treating patients with recurrent or refractory endometrial cancer

Conditions: Endometrial Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of aminopterin in treating patients who have refractory or recurrent endometrial cancer.

objectives: i. estimate the antitumor activity of aminopterin in patients with persistent, recurrent, or refractory endometrial carcinoma who have failed prior first line cytotoxic chemotherapy. ii. determine the quantitative and qualitative toxic effects of aminopterin in this patient population. iii. determine the overall patient survival and time to progression of these patients. iv. assess the pharmacokinetic profile of these patients. outline: patients receive oral aminopterin every 12 hours twice weekly. treatment continues for up to 15 months in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months until death. projected accrual: a total of 15-25 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed persistent, recurrent, or refractory endometrial carcinoma who have failed prior first line chemotherapy bidimensionally measurable disease by physical exam or medical imaging techniques (sonography acceptable if lesion(s) are clearly defined and measurable in two dimensions) ascites and pleural effusions are not measurable patient characteristics: age: not specified performance status: gog 0-2 life expectancy: at least 2 months hematopoietic: wbc at least 3,000/mm3 platelet count at least 100,000/mm3 granulocyte count at least 1,500/mm3 hemoglobin at least 8 g/dl hepatic: bilirubin no greater than 1.5 times upper limit of normal (uln) sgot no greater than 3 times uln alkaline phosphatase no greater than 3 times uln renal: creatinine no greater than 2.0 mg/dl other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception no significant infection prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics at least 4 weeks since prior chemotherapy and recovered endocrine therapy: not specified radiotherapy: at least 4 weeks since prior radiotherapy and recovered surgery: at least 4 weeks since prior surgery and recovered other: at least 4 weeks since any prior therapy directed at malignant endometrial tumor(s) at least 4 weeks since prior folate-containing vitamins no concurrent folate-containing vitamins no other concurrent anticancer therapy

Keywords: recurrent endometrial carcinoma
open-label, randomized, active-controlled study of lev used as monotherapy in patients with partial-onset seizures

Conditions: Epilepsy; Partial Seizures

Summary: to demonstrate the non-inferiority of levetiracetam (1000 mg/day) versus carbamazepine immediate-release (400 mg/day) used as monotherapy for at least 6 months in a chinese population with newly or recently diagnosed epilepsy who are experiencing partial-onset seizures (pos).


Eligibility criteria:
inclusion criteria: * subject is of chinese origin and ≥ 16 years of age * subject is newly or recently diagnosed with epilepsy, having experienced unprovoked partial-onset seizures (pos) * subject has experienced at least 2 unprovoked seizures in the year preceding randomization, of which at least 1 unprovoked seizure occurred in the 3 months preceding randomization * subject has had an electroencephalogram (eeg) and a brain computed tomography (ct) scan or brain magnetic resonance imaging (mri) scan consistent with a diagnosis of epilepsy with pos exclusion criteria: * subject tests positive for human leukocyte antigen major histocompatibility complex, class i,b (hla-b)\* 1502 allele * subject has a history or presence of seizures of other types than partial-onset seizures (pos) * subject has only experienced type ia nonmotor seizures * subject has a history or presence of seizures occurring only in clustered patterns * subject has a history of clinical or electroencephalogram (eeg) findings suggestive of idiopathic generalized epilepsy prior to randomization * subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures * subject has a history of status epilepticus

Keywords: levetiracetam keppra monotherapy china epilepsy partial-onset seizures
using navigation to improve accuracy of maxillary balloon sinusotomy

Conditions: Chronic Maxillary Rhinosinusitis

Summary: the purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis.

the purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis. adult patients (18 and over) with a confirmed diagnosis of chronic maxillary rhinosinusitis without nasal polyposis (crswnp) will undergo maxillary balloon sinusotomy. block randomization will be performed to determine which side will receive balloon sinusotomy with navigation and which will have balloon sinusotomy using traditional anatomic landmarks. participants will be followed for approximately 1 month post-procedure for a total study participation time of approximately 3 months.

Eligibility criteria:
inclusion criteria: * adults 18 years of age or older * candidate for primary endoscopic sinus surgery (ess) for chronic maxillary rhinosinusitis without nasal polyposis (crswnp) * failed medical (non-surgical) therapy exclusion criteria: * history of previous sinus surgery * presence of nasal polyps * extensive sinonasal osteogeneis * cystic fibrosis * presence of sinonasal tumors * any records flagged "break the glass" or "research opt out." * any additional finding which in the opinion of the investigator precludes patient from participating in the study