cyrilzakka/clinical-trials huggingface dataset:
Gender-related Characteristics of Bladder Cancer Treatment

The most frequent cancer of the urinary tract is the bladder cancer (BC), in Italy its incidence reaches the 7% of all the new diagnosis of cancer, accounting for the fifth cause of death in the western countries, overall 140.000 new cases per year in Europe. In the year 2017, the Italian association for medical oncology (AIOM) recorded in our country about 21.700 new diagnosis of BC men and 5.300 in women. This data show not only a relevant gender disparity on the disease incidence (in 5th to 7th decade male incidence: 11-12% of all new diagnosis of cancer versus 1% in women) but also on the outcomes of treatment. Overall, the 30% of all the new diagnosis have a muscle-invasive (MIBC) onset, the female gender suffer a correlation with a more advanced disease at the time of first diagnosis. As a consequence, men have lower BC-related mortality when compared to women (p\<0,001). This discrepancy in the mortality rate has been investigated by many authors, resulting in the evidence that female gender suffers higher risks, especially during the first two-years after the radical cystectomy. A comprehensive explanation has not been formulated yet, but a multiplicity of cofactors, including variations in the hormone receptors and tumor biology as well as the different anatomy between male and female, have been identified as potentially relevant. Another important issue in the pre-operatory management of female patients with BC is the misleading interpretation of hematuria. It seems to directly correlate with the evidence that women suffer a more advanced stage at diagnosis, and this element has been withheld in the list of relevant risk factors for prognosis. Nevertheless, a thorough analysis of their effect will only be possible in the future, as well-designed prospective and randomized clinical trials are currently not available.

A part from the preoperatory disparity, it has also been described that men are more frequently candidates to an orthotopic urinary diversion, leading female patients to an irreversibly altered perception of personal integrity and body image, namely to a lower quality of life after radical cystectomy. The female anatomy has been considered as a limitation to continence recovery, resulting in preoperative counselling more frequently against in favor of ileal conduit or not-continent urinary diversions.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing radical cystectomy since September 2016 December 2020
* Development of bladder cancer confirmed histologically
* Written informed consent

Exclusion Criteria:

• Lack of clinical and prognostic data on selected patients
the Effect of Hyaluronic Acid Intrauterine Wash on Endometrial Receptivity and Pregnancy Outcome

Hyaluronic acid intrauterine wash is done for infertile females undergoing intracytoplasmic sperm injection on the day of oocyte retrieval. endometrial receptivity parameters, including the subendometrial vasculature indices were measured before and after the intervention for purpose of studying the effect of hyaluronic acid on improvement of the endometrial receptivity and subsequently the pregnancy outcome


Eligibility Criteria:
Inclusion Criteria:

* Infertile females aged 18-40 years.
* Infertile females scheduled for GnRH antagonist protocol of fresh ICSI cycle.
* Females use dual stimulation (GnRH agonist plus Ovetrelle) for ovulation triggering.

Exclusion Criteria:

* Infertile females diagnosed as a poor responder.
* Infertile females diagnosed with uterine pathology.
* Infertile females who are scheduled for a frozen ICSI cycle.
* Infertile females diagnosed with endocrine diseases like thyroid disease, diabetes mellitus, and hyperprolactinemia.
* Infertile females diagnosed with thrombocytopenia.
The Influence of Light Exposure on Exercise Performance Dependent on Chronotype.

The purpose of this study is to determine if an exposure to light in the evening has a positive influence on physical performance regarding endurance, strength and reaction time.


Eligibility Criteria:
Inclusion criteria:

* BMI 18 to 30 kg/m2
* endurance performance \>= 55 ml/min/kg peak oxygen uptake

Exclusion criteria:

* cardiovascular disease
* renal dysfunction
* shiftworking
* travels over time zones in the last 4 weeks
* high blood pressure (systolic blood pressure \>170mmHg, diastolic blood pressure \>100mmHg)
* depression
6-year Follow-up Data After the Berberine Intervention Trial

Colorectal cancer (CRC) is a common malignancy of the digestive tract, which constitutes a major public health burden. Almost 90% of CRC cases progress from precursor adenomatous polyps through adenoma-carcinoma sequence. Endoscopic detection and removal of colorectal adenoma (CRA) could reduce the incidence and mortality risk of CRC, but the recurrence rate is still high. Therefore, chemoprevention is quite important, not only solve the urgent public health problem, but also be cost-effective.

In 2020, the investigators published a multicenter, randomized, double-blind, placebo-controlled clinical study (NCT02226185) in the Lancet Gastroenterology \& Hepatology. The result concluded that oral BBR for 2 years significantly reduced recurrence after endoscopic removal of CRA (RR 0.77, 95%CI 0.66-0.91; p=0.001). BBR also has a significant preventive effect on all polypoid lesions, including adenomas and serrated lesions (adjusted RR 0.78, 95%CI 0.66-0.91; p=0.002) . Does BBR still have a long-term protective effect on the recurrence of CRA after discontinuation? That's what the investigators concerned.

The present study is performed to observe and compare retrospectively the recurrence rate of CRAs in patients of the original BBR RCT study (NCT02226185) within 6 years after discontinuation of medication, including the overall recurrence rate of traditional adenomas within the first year, 1-3 years, 3-6 years, and the entire follow-up period of 6 years. The aim is to evaluate the long-term efficacy of BBR in preventing recurrence and carcinogenesis after endoscopic resection of CRAs.


Eligibility Criteria:
Inclusion Criteria: participants who completed the previous berberine intervention study (NCT02226185) Exclusion Criteria: no
Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation

Uses the video stylet with different angulation to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea.

In oro-maxillo-facial surgery, it is a common practice for patients receiving general anesthesia with nasotracheal intubation to widen the surgical field and to ease undergoing surgery. However, a nasotracheal tube blindly passing through the nasal cavity may easily result in nasal cavity and oropharynx damages.

The aim of the study is to investigate use which angulation including 45 degree, 70 degree and 90 degree is appropriate to assist the nasotracheal tube passing the nasal cavity, oropharynx, and advanced into the tracheal. Patients are randomized into three groups by 45 degree, 70 degree and 90 degree to facilitate nasotracheal tube sliding through into trachea and compared with each other group.

Hemodynamic changes in each time interval, each time taken of tube going through the nasal cavity, tube advanced from oropharynx into trachea will be recorded. The incidence of using the video stylet with different angulation to accurately place tube tip into trachea, intubation related side effects and complications are recorded at postoperative time stages.

Eligibility Criteria:
Inclusion Criteria:

* undergoing oro-maxillofacial surgery with general anesthesia(GA)
* ASA(American Society of Anesthesiologists):Ι to III
* 20-65 y/o
* mouth Open \> 3cm
* the systemic disease exclusion
* conscious clear and without major Neurocognitive Disorder
* Mandarin or Taiwanese speaker
* agree the purpose of the study and sign the ICF

Exclusion Criteria:

* difficult airway assessment \[limited mouth opening\<3cm, limited neck motion(thyromental distance \< 6cm\]
* previous head neck surgery history
* upper abnormal airway diagnosed, easily epistaxis, and both sides nasal cavities obstruction.
* reject to participate
Goal Directed Numeric Coaching as a Means of Preoxygenation

Pre-oxygenation is an anesthetic technique that allows for extended apneic (suspension of breathing) time prior to attempted endotracheal intubation. A common method to achieve adequate pre-oxygenation is having a patient take four vital capacity breaths of 100% oxygen in thirty seconds. This study seeks to determine if goal directed numeric coaching can lead to more accurate vital capacities during this technique.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Physical Status 1 and 2
* nonsmokers
* primary English speaking
* undergoing elective surgery with planned endotracheal intubation

Exclusion Criteria:

-
Shingrix in Renal Transplant Recipients

This study evaluates the safety and immune response of the Shingrix vaccine in kidney transplant recipients. Participants on the waiting list for kidney transplant will be given the standard 2 doses of Shingrix. Those participants who have been transplanted by 16 months, may be given a 3rd dose of Shingrix.

Herpes Zoster (HZ) is a common complication of kidney transplant because of the immune suppressive drugs necessary to prepare the recipient for the transplanted organ and to protect it from rejection. The use of the live vaccine, Zostavax, in transplant recipients is contraindicated due to their impaired immune status. This study is being done to determine vaccine responses to the FDA approved shingles vaccine, Shingrix, in patients with chronic renal failure eligible for kidney transplant. Persistence of immune responses after kidney transplantation, and immunologic advantage of a third dose of Shingrix to renal transplant recipients will be assessed. Additionally, safety, tolerability, and occurrence of HZ will be evaluated. 60 participants will be enrolled from the renal transplant services at University of Colorado Anschutz Medical Campus.

Eligibility Criteria:
Inclusion Criteria:

* On the waiting list at the participating institutions for renal transplantation with anticipated transplantation to occur at \> 3 months to 16 months after listing.
* Female subjects of non-childbearing potential (tubal ligation, hysterectomy,ovariectomy or post-menopausal
* Female subjects of childbearing potential who have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on day of vaccination, and have agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccine series

Exclusion Criteria:

* Therapy in the pre-transplant period that in the opinion of the investigator is immune suppressive
* Herpes Zoster in prior 3 years
* Herpes zoster vaccine or varicella vaccine within 3 years of study entry
* Any positive cPRA score prior to enrollment
* Acute illness at the time of vaccination which in the opinion of the investigator will alter immune response
* Any other active immunosuppressive or immunodeficient condition resulting from disease (e.g. malignancy, HIV, or a medical therapy).
* Allergy to any of the components of Shingrix
* No investigational drugs from 30 days before enrollment or planned during the study.
* No non-live vaccines within the 2 weeks prior to any dose of Shingrix or until 30 days after any dose of Shingrix. No live virus vaccines within 4 weeks prior to any dose of Shingrix or until 30 days after any dose
* Pregnant or lactating female
* Multi-organ transplantation
* Travel time from study site that is more than 2 hours for visit or transport of fresh blood samples
Efficacy of Pythagorean Self-Awareness for Aging Biomarkers Improvement, in T2D Patients and Healthy Individuals.

The present study explored the effects of the implementation of the Pythagorean Self Awareness Intervention (PSAI) on the dynamics of stress-related aging factors of immune cells in healthy volunteers and a cohort patients with type 2 diabetes mellitus . The primary aim was to evaluate the effectiveness of PSAI on two key biomarkers of biological age, telomere length and proteasome levels, indicative of the crosstalk between cellular oxidative status and replicative potential, with respect to metabolic, hormonal and mental status changes. Secondary aims of this study included reduction of depression, perceived stress, anxiety and the establishment of lifestyle changes to enhance the quality of everyday life, including better quality of sleep, eating behaviours and an overall healthier status.

Study design This non randomized non blinded parallel trial was conducted at the Laiko Hospital of Athens, Diabetes Centre, First Department of Propaedeutic Internal Medicine of Attica, Greece, from 4.10.2018 to 26.11.2019. The study protocol was approved by the Ethics Committee of the Laiko Hospital (protocol number 5134/5-4-19) and was in accordance with the declaration of Helsinki. All participants were enlisted in the study only after being fully informed by the researcher about the aims and procedures of the research and submitting written consent.

Procedures Patients eligible for the above mentioned criteria were randomized in two groups: the group of healthy adult volunteers, and adults with type 2 diabetes who attended the outpatient diabetes clinic. This study was non-blinded, as patients and researchers were aware of the group assignment.

Eligibility Criteria:
Inclusion Criteria:

* adequate knowledge of the Greek language
* For participants with T2DM, a minimum of 3-month stable antidiabetic, hypolipidemic and antihypertensive treatment
* habitants of Athens, Greece

Exclusion Criteria:

* participation in other stress management program
* corticosteroid intake
* diagnosis of psychiatric co-morbidity or autoimmune disease
* change in antidiabetic, hypolipidemic, and antihypertensive treatment within the previous 3 months
* patients with type 2 diabetes treated with insulin
Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea

Atrial fibrillation (AF) is the most common rhythm disorder and involves an increased risk of cardiovascular disease and death, impaired quality of life and a high proportion of healthcare consumption. An important risk factor is obstructive sleep apnea (OSA). However, it is not fully understood why OSA induces AF. It may be due to a proinflammatory state, sympathetic activation and acute changes in blood pressure during apnéas, but few studies are performed. Hypertension with its coherent arterial stiffness is related to all these factors, is common in OSA, and is the most common cause of AF. The cause of AF in hypertensive subjects is believed due to a pressure overloaded left heart, with dilation and fibrosis of the left atrium, promoting the development of AF. Hypertension and arterial stiffness can thus be important triggering factors for AF in OSA.

In this project, teh investigators investigate the occurrence of OSA in AF patients. Furthermore, underlying mechanisms for the development and recurrence of AF after intervention in OSA patients are investigated.

300 patients scheduled for AF ablation or cardioversion are invited and examined with sleep registration, 24h blood pressure, aortic stiffness measurement, test of autonomic function, echocardiography, ECG and labs. The patients are followed at months 3, 6 and 12 with 7 days ECG for recurrence. The aim is to give insights into the need for screening for OSA in patients with AF. The study also aim at enabling preventive treatment through better understanding of underlying treatable mechanisms. The results are believed to lead to fewer new AFs, as well as fewer AF recurrences in patients with OSA.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years scheduled for AF ablation or cardioversion

Exclusion Criteria:

diagnosis of AF for more than 7 years

* previous cardiac surgery including AF ablation
* severe valvular heart disease
* diagnosed structural heart disease
* systolic function in sinus rhythm \<50%.
* severe hypertensive heart disease or known hypertrophic heart disease (amyloidosis, hereditary hypertrophic heart disease)
* invalidating chronic diseases imaging material on echocardiography not of sufficient quality.
Modes of Delivery Impact Maternal Oxidative Stress Biomarkers and Dynamic Thiol Disulphide Homeostasis

Modes of delivery impact maternal oxidative stress biomarkers and dynamic thiol disulphide homeostasis


Eligibility Criteria:
Inclusion Criteria:

For VD group:

* Women with spontaneous uncomplicated vaginal delivery
* Women who were in the 38th week and vertex presentation and whose contractions had started naturally.

For CS group:

• Women in their 38th week of pregnancy who delivered by elective CS without uterine contractions

Exclusion Criteria:

* Participants who were smokers
* Participants who had a non-optimal pre-pregnancy body mass index
* Systemic diseases such as diabetes mellitus and gestational hypertension.
Nexfin®-Monitoring System

In many surgical procedures, anaesthesiological care is provided according to the best scientific and clinical information available. However, since hemodynamic monitoring until recently did not allow for beat-to-beat information of the haemodynamical changes, many fast-changing events may have been unnoticed or have not been investigated as precisely as is possible today. Moreover, in several surgical procedures - like eye surgery - the invasiveness of the classical haemodynamical monitoring devices was of such a degree that until now, in these circumstances these vital parameters were not investigated yet.

Therefore, the availability of this new device, which allows for noninvasive beat-to-beat assessment of these haemodynamical parameters gives a unique opportunity to investigate our anaesthesiological management and to elucidate whether improvements are desirable and possible.

The Nexfin monitor consists of a cuff-micromanometer that is located around the third finger. It simultaneously uses continuous pressure readings and light-absorption spectrometry to determine valuable haemodynamical information. Data is recorded and available for subsequent offline analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients that are accepted for surgery

Exclusion Criteria:

* Patients unable or unwilling to provide consent.
A Repeatability Study of Fatty Acid Uptake Using PET/MR Imaging in Patients With T2DM and Non-diabetic Control Subjects

The main purpose of this study is to evaluate the overall variation in the assessment of fatty acid uptake and blood flow in adipose tissue and skeletal muscle in the fasted and postprandial states by evaluating the repeatability of whole-body three-dimensional kinetic (4D) combined positron emission tomography and magnetic resonance imaging (PET/MRI) readouts in participants with type 2 diabetes mellitus (T2DM), and non-diabetic control participants. Each volunteer participates 4 scanning sessions.

A total of approximately 13 T2DM and 6 control subjects (a total of 19 subjects) are planned to be enrolled to achieve 11 T2DM and 5 control subjects to complete the study, assuming a 15% drop-out rate. The test-retest repeatability of the ratio of FTHA uptake rates in subcutaneous adipose tissue (SAT) to skeletal muscle is measured using the intra-class correlation coefficient (ICC). Assuming an ICC of 0.85, with a 5% two-sided type I error rate, a sample size of 16 completers will yield approximately 90% power to detect an ICC statistically significantly greater than 0.4 (usually considered as a criterion for moderate agreement).

The total radiaooin burden for tshi sitdu yis 27.4 mSv. The study is approved by the local Ethical committtee and Fimea.

Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) between 25 to 40 kilograms per meter squared (kg/m²),
* For participants with a confirmed type 2 diabetes diagnosis: The condition must be managed either by diet and exercise alone or on a stable dose of metformin
* For nondiabetic subjects: participants must agree to keep their diet and physical activity habits stable throughout the study
* Female participants must be post-menopausal and male participants

Exclusion Criteria:

* Poorly controlled diabetes
* Unstable body weight within 30 days prior to screening.
* For non-diabetic control subjects: evidence of diabetes or prediabetes at screening.
* Having worked as a metal worker or welder
* History of alcohol or drug abuse within 5 years of the screening
* Currently participating, or previous participation in another clinical trial within 30 days prior to the screening visit, or previous participation in another PET imaging study within 12 months.
Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth

This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) \& hepatitis B surface antigen (HBsAg). The purpose of this study is to demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with respect to immunogenicity of the hepatitis B antigen.

Randomized study with two groups to receive one of the following vaccination regimens:

* GSK Biologicals' Tritanrix™-HepB/Hib-MenAC
* GSK Biologicals' Tritanrix™-HepB/Hiberix™

Eligibility Criteria:
Inclusion criteria:

* Healthy infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for HIV \& HBsAg, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.

Exclusion criteria:

* Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease since birth.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects or serious illness.
* Any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* A birth dose of hepatitis B vaccine given outside the frame of this study.