Kornimate/medical-research-clean huggingface dataset:
ticon-day 3, time lapse versus conventional method in day 3 embryo culture and assessment

Conditions: Infertility

Summary: the main purpose of the study was to evaluate the overall clinical value of geri+ as an integrated embryo culture and assessment system, providing an undisturbed culture environment, continuous monitoring of embryo development and automated scoring using a predictive algorithm.


Eligibility criteria:
inclusion criteria: * couples with less than or equal to (\<= ) two failed fresh in vitro fertilization/intracytoplasmic sperm injection (ivf/icsi) embryo transfer cycles * age greater than or equal to (\>=) 18 and \<= 40 years * body mass index (bmi): 18-30 kilogram per meter square (kg/m2) * normal uterine cavity under ultrasound * participant and her husband/partner must have read and signed the informed consent form (icf) * at least four normally fertilized oocytes (2pronuclear stage (pn)) in the current cycle exclusion criteria: * male with non-ejaculated sperm * participants with abnormal, undiagnosed gynecological bleeding or with genitourinary malformations * participants with any contraindication to controlled ovarian stimulation (cos) for assisted reproductive technologies (art) or to gonadotropins * planned "freeze all" cycle (oocytes or embryos) * planned preimplantation genetic screening (pgs) or pre-implantation genetic diagnosis (pgd) cycle * concurrent participation in another clinical study

Keywords: geri+ ticon eeva embryo culture in vitro fertilization intracytoplasmic sperm injection
prospective study on rehabilitation patients with pulmonary hypertension and other pulmonary diseases

Conditions: Pulmonary Diseases; Rehabilitation

Summary: this monocentric registry should provide information on the extent how patients with pulmonary diseases such as pulmonary hypertension will benefit from rehabilitation treatment. the data may provide a basis for further prospective studies showing the treatment of patients with pulmonary diseases especially by physical activation.


Eligibility criteria:
inclusion criteria: * pulmonary disease exclusion criteria: * inability or refusal to give written informed consent
vitaa registry pre- and post-operative monitoring for endovascular aortic aneurysm repair and serial monitoring for aaa

Conditions: Abdominal Aortic Aneurysms

Summary: this is a prospective registry study to collect imaging and clinical data both on patients with aortic aneurysm disease undergoing serial monitoring and on patients pre and post-endovascular repair, using vitaa (the sponsor) aortic mapping technology.

this a prospective, multi-center, registry of patients that are being assessed with the vitaa software. patients will be enrolled at selected north american centers in the us and canada. the registry will enroll patients from the following two populations: * patients who are scheduled and ultimately receive endovascular infrarenal aortic aneurysm repair (evar); * patients who do not yet qualify for infrarenal aortic aneurysm repair based on anatomic size criteria who are enrolled in a serial monitoring program.

Eligibility criteria:
inclusion criteria: 1. patient is aged 18 years or over 2. infrarenal aortic aneurysm ≥ 45 mm in diameter. 3. patient meets on-ifu criteria for endovascular reconstruction exclusion criteria: 1. patient has a known or clinically suspected major connective tissue disorder, autoimmune disorder, vasculitis, or aortic dissection. 2. patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.0mg/dl or 175umol/l 3. patients with previous aortic reconstruction in the involved segment. 4. patients receiving oral or parenteral corticosteroid therapy for other unrelated disease. (excludes inhaled corticosteroids). 5. patient has a sensitivity to contrast imaging agents. 6. patient has aortic dissection. 7. patient has atrial fibrillation. 8. patient has arrhythmia.
evaluation of the safety, feasibility and usability of the epd d700 system in atrial flutter ablation procedures

Conditions: Atrial Flutter

Summary: demonstrate the safety, feasibility and usability of the epd d700 system, for the first time in humans, in subjects undergoing ablation for the treatment of atrial flutter. prospective, single-center, non-randomized, open label, single arm study. ten consented subjects who are scheduled to undergo ablation due to atrial flutter. all subjects will undergo baseline assessment; intervention (standard fluoroscopy guided rf ablation procedure) and post procedure follow up. all subjects will have a follow up visit within 24 hours post procedure.

all procedures will be performed under standard fluoroscopic guidance for the treatment of atrial flutter ablation procedure, and the d700 system will be used additionally to demonstrate system safety, feasibility and usability. the entire procedure will be conducted as customary, using standard and approved off- the-shelf equipment (body surface electrodes, diagnostic and irrigated ablation catheters, rf generator and recording system), in a completely clinically independent manner from the d700 system that will merely be a 'silent witness'. the operator will neither use nor rely on any of the d700 system output for clinical decision making.

Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years of age. 2. subject or authorized representative, signed a written informed consent form to participate in the study, prior to any study related procedures. 3. subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations. 4. subject is generally in good health. 5. a female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days. 6. subject is deemed amenable to therapeutic ablation for atrial flutter. exclusion criteria: 1. any planned surgical or endovascular intervention within 30 days before or after the index procedure. 2. subject is enrolled in another drug or device study protocol that has not reached its primary endpoint. 3. patient had experienced previous stroke (tia or cva). 4. patient has a pacemaker. 5. thrombi detected in the heart. 6. known marked valvar insufficiency. 7. life expectancy less than 12 months. 8. known severe renal insufficiency.
observational study of cll/sll treatment and ibrutinib treatment of cll/sll in routine clinical practice

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: this is a non-interventional, phase 4 study designed to improve understanding of current clinical practice in the treatment of cll/sll and to describe treatment pattern and evaluate outcomes of ibrutinib-treated cll patients in china. this study will include both retrospective and prospective data collection.


Eligibility criteria:
inclusion criteria: * in the retrospective part: 1. male or female patients above 18 years old 2. patients underwent cll treatment after jan 1st, 2013 3. patient understand and voluntarily sign an icf, if applicable. * in the prospective part: 1. male or female patients above 18 years old 2. patients diagnosed with cll，including treatment- naïve patients or patients who have received ≤3 prior therapies 3. patients treated with ibrutinib as monotherapy or a part of combination therapy 4. patient understand and voluntarily sign an icf. exclusion criteria: * in the retrospective part: 1. patients with documented diagnosis of other cancers prior to the diagnosis of cll 2. patients enrolled in interventional clinical trials of any drug for cll treatment * in the prospective part: 1. patients with documented diagnosis of other cancers prior to the diagnosis of cll 2. patients with contraindication listed in the package insert of ibrutinib 3. patients enrolled in interventional clinical trials of ibrutinib or any other drug for cll treatment 4. patient received ibrutinib treatment as maintenance therapy.
mri-ultrasound fusion or cognitive registration in mr-targeted prostate biopsy

Conditions: Prostate Cancer

Summary: this randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of mri-ultrasound fusion targeted biopsy compared to cognitive registration targeted biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.

prostate biopsy with multiple samples using a standardized template (standard biopsy, sb) under transrectal ultrasound (trus) guidance is the current standard diagnostic approach in suspicion of prostate cancer (pca). however, many biopsies are unnecessary or cannot detect clinically significant pca (cspca). with the introduction of multiparametric magnetic resonance imaging (mpmri) of the prostate and the improvement for pca detection and localization, an alternative procedure, known as mri-targeted biopsy (mri-tb), has been shown comparable or even higher detection rates of cspca compared to trus-system biopsy (sb). mri-ultrasound fusion tb (fus-tb) and cognitive registration tb (cog-tb) are two techniques of mri-tb commonly used. however, the optimal methodology for targeting mri-suspicious regions remains unknown. the accuracy of cog-tb compared with fus-tb remains unclear. this randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of cog-tb compared to fus-tb (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.

Eligibility criteria:
inclusion criteria: 1. men more than 18 years old with clinical suspicion of prostate cancer; 2. serum psa ≤ 20 ng/ml within the previous 3 months; 3. suspected stage ≤ t2 on rectal examination (organ-confined prostate cancer) within the previous 3 months; 4. no evidence of psa increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis; 5. mpmri pi-rads v2.1 score ≥3； 6. able to provide written informed consent. exclusion criteria: 1. prior prostate biopsy or prostate surgery; 2. prior treatment for prostate cancer; 3. contraindication to mri (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min); 4. contraindication to prostate biopsy; 5. men in whom artifact would reduce the quality of the mri.
psychosomatic, physical activity or both for post-covid19 syndrom

Conditions: Post-COVID-19 Syndrome

Summary: post-covid(poc)-patients with fatigue symptoms respond very differently to physical rehabilitation programs. while poc-patients with psychological symptoms benefit little from physical interventions, fatigue and exercise capacity improves significantly without the presence of psychological symptoms. rct studies on effects of psychotherapy or the combination of phsical activity with psychotherapy in poc are not yet available. therefore, the aim is to investigate the unimodal effects of psychotherapy and exercise therapy or the combination of both on fatigue in poc patients with fatigue in a randomized clinical trial. patients will be assigned to the three intervention groups (psychotherapy, physical rehabilitation, combination of both) stratified for sex, gender and bmi status. the intervention duration is 3 months with therapeutic online sessions for 50 min every 2 weeks. after another 3 months without intervention, the sustainability will evaluated. secondarily, the investigators analyzes which patient benefits most from which therapeutic approach and seek for specific predictors of patient´s individual response.


Eligibility criteria:
inclusion criteria: * patients aged over 18 and * diagnosed post-covid-19 syndrome: (positive pcr or antibody test) and fatigue assessment scale (fas) ≥ 22 points exclusion criteria: * current participation in another intervention study * illnesses or functional disorders that potentially explain the fatigue symptoms otherwise * any illness or impairment that the examining physician judges to preclude participation in a physical training intervention * suicidality or severe mental illness (e.g. mania, acute phase of schizophrenia) that requires acute treatment.

Keywords: physical actvity psychotherapy cobined exercise and psychotherapy covid-19 post-covid-19-syndrom
the effects of different modalities of exercise in patients with schizophrenia

Conditions: Schizophrenia

Summary: introduction: numerous studies support the practice of different physical exercise modalities as an effective treatment to address the different problems associated with schizophrenia, reporting that they result in significant improvements in patient symptoms and quality of life. given the lack of studies comparing different types of training in controlled environments, the aim of this proposed study will be to compare the effects of three physical exercise programs (strength, aerobic, and mixed) on the symptoms, body composition, level of physical activity, and health-related quality of life of patients with schizophrenia. ethics and dissemination: this study was approved by the ethics committees for biomedical research at the ceu cardenal herrera university of valencia in spain (reference number: cei18/215). participants will be fully informed of the purpose and procedures of the study, and written informed consent will be obtained from every participant. the results from this study will be published in peer-reviewed journals and presented in scientific conferences.

the aim of this proposed study will be to compare the effects of three physical exercise programs (strength, aerobic, and mixed) on the symptoms, body composition, level of physical activity, and health-related quality of life of patients with schizophrenia. a multicentre, single-blinded (evaluator), randomised, wait-list controlled (ratio 2:2:2:1) trial will be conducted with 105 patients recruited from different psychosocial care centres. the participants will be randomised into three 16-week training groups comprising 48 sessions lasting one hour each, or to the wait-list control group. the training groups will complete aerobic, strength, or mixed (aerobic + strength) training. the participants will be assessed before, immediately after, and 6 months after the end of the intervention. all the patients in the wait-list control group (n = 15) will receive one of the three trainings immediately after the intervention. the study variables will include positive symptomatology, negative symptomatology, and general symptomology (using the positive and negative syndrome scale) as the primary outcome; as secondary outcome: body composition (by assessing body mass index, body fat mass and waist circumference), physical activity levels (international physical activity questionnaire-short form), and quality of life (abbreviated world health organization quality of life questionnaire).

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia * age between 18-65 years exclusion criteria: * patients with other mental diseases * patients with mental disabilities * patients who present motor or behavioral pathologies that prevent the realization of the exercise training.
re-energize fontan

Conditions: Single-ventricle

Summary: survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged fontan palliation. yet, long-term morbidity remains high. by the age of 40, 50% of fontan patients will have died or undergone heart transplantation. with \>1,000 fontan palliations performed in the us annually, there is a burgeoning population of fontan patients at risk for progressive heart failure and death. factors that contribute to onset and progression of heart failure in fontan patients remain incompletely understood. however, it is established that fontan patients have poor exercise capacity, associated with a greater risk of morbidity and mortality, in addition to decreased muscle mass, abnormal muscle function, and endothelial dysfunction contributing to disease progression. in adult patients with two ventricles and heart failure, reduced exercise capacity, muscle mass, and muscle strength are powerful predictors of poor outcomes, and exercise interventions can not only improve exercise capacity and muscle mass, but also reverse endothelial dysfunction. limited exercise interventions in children with congenital heart disease have demonstrated that exercise is safe and effective; however, these studies have been conducted in small, heterogeneous groups, and most had few fontan patients. furthermore, none of these interventions have studied the impact of exercise on muscle mass or mitochondrial function, or endothelial function. the investigators propose a milestone-driven, randomized controlled trial in pediatric fontan patients to test the hypothesis that a live-video-supervised exercise (aerobic + resistance) intervention will improve cardiac and physical capacity; muscle mass, strength and function; and endothelial function. the investigators' ultimate goal is the translation of this model to clinical application as an "exercise prescription" to intervene early in pediatric fontan patients and decrease long-term morbidity and mortality.


Eligibility criteria:
inclusion criteria: * 8-19 years of age * fontan palliation * ability to fast overnight * cardiac clearance to exercise by primary cardiologist * presence of an adult at home during exercise sessions for patients \<14 years old * english-speaking patient. exclusion criteria: * nyha class iv (severe heart failure) * acute illness within the past three months * active protein losing enteropathy (albumin \<2.5 mg/dl) * implanted pacemaker * cognitive delay deemed severe enough to inhibit the ability to follow the exercise

Keywords: fontan palliation
injection of autologous adipose-derived stromal vascular fraction in the finger of systemic sclerosis patients

Conditions: Systemic Sclerosis

Summary: this study outlines the safety of the autologous svf cells injection in the hands of patients with ssc. preliminary assessments at 6 months will suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population

in patients with systemic sclerosis(scleroderma, ssc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relived by currently available therapies. adipose tissue-derived stromal vascular fraction (svf) is increasingly recognized as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. the investigators aimed to measure for the first time the safety, tolerability, and potential efficacy of autologous svf cells local injections in patients with ssc with hand disability.

Eligibility criteria:
inclusion criteria: * age over 18 year old * cochin hand function scale (chfs) \> 20/90 exclusion criteria: * new vasodilators or immunosuppressive therapy for ssc in the 3 months prior to enrolment * new vasodilators or immunosuppressive therapy for ssc during the 6-month follow-up * clinical or radiological signs of digital infection * positive status for hiv * positive status for hepatitis b or c * positive status for human t-cell leukemia virus 1-2 * positive status for syphilis * pregnancy * bmi less than 17kg/m2

Keywords: stromal vascular fraction hand disability mesenchymal stem cells phase i trial
"hepatic substrate flux rates in type 2 diabetes"

Conditions: Type 2 Diabetes

Summary: investigation of the effects of redox shuttle inhibition by metformin on gluconeogenic flux rates of lactate and glycerol in humans with type 2 diabetes

type 2 diabetes (t2d) is characterized by insulin resistance and relative insulin deficiency leading to hyperglycemia. enhanced endogenous glucose production during fasting is a key feature of hepatic insulin resistance and a major contributor to deterioration of glycemia. metformin reduces fasting gluconeogenesis (gng); the underlying mechanisms are still not fully understood, but involve the inhibition of complexes of the electron transport chain and thus the redox shuttle. the investigators have previously provided evidence for abnormal hepatic atp synthesis and mitochondrial efficiency in t2d, but it remains unknown, how and which substrate fluxes account for excessive gng in t2d. for this reason, this proposal aims at investigating hepatic glucose and energy fluxes in t2d with focus on gluconeogenic contribution of lactate and glycerol to hepatic mitochondrial substrate flux, mitochondrial atp synthase flux and the activity of the redox shuttle, also after metformin intake, by using a novel combination of positional isotopomer nuclear magnetic resonance (nmr) analysis (pinta) with multinuclei magnetic resonance spectroscopy (mrs).

Eligibility criteria:
inclusion criteria: * type 2 diabetes (duration \<7 years), * age (18-75 years) * bmi \<40 kg/m2 * hba1c 6-15% exclusion criteria: * uncontrolled hyperglycaemia (\>340 mg/dl) * diabetes types other than type 2 diabetes (ada criteria) * thiazolidinedione use during the preceding 6 months * clinically relevant angiopathy, restrictive or obstructive lung diseases * other acute or chronic diseases including wounds and the use of pharmacological agents known to affect insulin sensitivity, lipid metabolism or immunological function.

Keywords: type 2 diabetes, redox shuttle, gluconeogenesis
a clinical trial of tqb3006 tablets in patients with advanced malignant cancer

Conditions: Advanced Malignant Neoplasm

Summary: this study includes two stage: dose escalation and dose extension, with a single dose and a multiple dose study. this is a single-center, open, non-randomized, single arm, study to evaluate the safety, tolerability and pharmacokinetics of tqb3006 tables in patients with advanced malignant cancer.


Eligibility criteria:
inclusion criteria: * evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study; * age: 18 to 75 years old; an eastern cooperative oncology group (ecog) performance status of 0 or 1; * has at least one assessable lesion according to response evaluation criteria in solid tumors (recist) v1.1; * female patient had no plans to become pregnant and voluntarily took effective contraceptive measures during the study period to at least 6 months after the last dose of study drug. exclusion criteria: * there were other malignant tumors within 3 years; * has multiple factors affecting oral medication; * unalleviated toxicity ≥ grade 1 of ctcae v5.0 due to any previous therapy , excluding hair loss; * major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study，or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period; * arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; * have a history of psychotropic drug abuse and can not quit or have mental disorders; * subjects with any severe and / or uncontrolled disease including active hepatitis, a history of immunodeficiency, etc.; * tumor-related symptoms and treatment: 1. has known symptomatic central nervous system metastases and/or cancerous meningitis; 2. thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within 1 month after receiving the investigational drug for the first time; 3. has participated in other clinical trials within 4 weeks before first dose. * according to the judgement of the investigators, there are other factors that may lead to the termination of the study.