cyrilzakka/clinical-trials huggingface dataset:
The Diagnostic Efficacy of Computer-Aided Detection (CAD) in Full-Field Digital Mammography (FFDM)- A Prospective Study

The purpose of this study is to evalute whether CAD (computer-aided detection) in FFDM (full-field digital mammography) can facilitate the detection rate of breast cancer on mammography compared with FFDM without CAD.

Mammography is currently the only documented effective imaging tool for breast cancer screening. However, the sensitivity of mammography may be reduced in dense breasts, and sometimes it is difficult to even perceive a very subtle cancer which presents as a small stellate lesion, or very faint microcalcifications, missed diagnosed thus occurs. Herein, some researchers in Western countries developed computer-aided detection (CAD) system to help radiologists detect subtle, easily overlooked findings to facilitate early breast cancer detection, and most of the research regarding CAD was used in screen-film mammography (SFM) system. Ikeda, et al, worked on the retrospective CAD usage of those negative mammograms which later developed breast cancers. CAD could correctly mark 40% of the areas on these mammograms reported negative previously that later developed evident cancers. However, 80% of these are only nonspecific findings, and do not warrant recall for additional workup even at retrospective unblinded review by well-trained mammographers. The other research concluded that CAD could improve early cancer detection rate of mammography, with the sensitivity of 92% in detection of breast cancer size smaller than 5mm, 94% for cancer size 11-15mm. CAD can detect more microcalcifications than masses (sensitivity for microcalcifications 98%, masses 84%, mass with microcalcifications 92%). CAD could mark an average of 1.3 false positive marks per mammographic exam.

Full-field digital mammography (FFDM) is a new approved technology for breast cancer detection after SFM era since 2000. The diagnostic accuracy of FFDM versus SFM is still under clinical trials, and it is believed the sensitivity and accuracy of FFDM for screening population is relatively equivalent to SFM. However, there are very few reports regarding the CAD application in FFDM, since FFDM can offer the post-acquisition processing on high-resolution review workstation for interpretation. Nevertheless, the spatial resolution of soft-copy reading on monitors for FFDM is slightly inferior to but the contrast resolution is slightly superior to that of conventional SFM. Herein, the diagnostic efficacy and role of CAD in FFDM are still unclear. Therefore, the goal of our study is to explore the sensitivity, false-negative (FN) and false-positive (FP) rates of combination usage of CAD in FFDM system, in comparison with the sensitivity, FN and FP rates of interpretation based on FFDM without CAD combination. We are also about to evaluate the efficacy, additional time spent in adjunct application CAD in FFDM interpretation, in order to assess the feasibility of CAD in FFDM.

Eligibility Criteria:
Inclusion Criteria:

* women for mammographic screening
* women with breast disease

Exclusion Criteria:

* pregnant women
MK0524B Bioequivalence Study (0524B-070)

This study will evaluate:

1. the bioequivalence of simvastatin and simvastatin acid following dose of simvastatin (ZOCOR™) given together with one tablet of MK0524A or as a component of the triple combination tablet MK0524B.
2. the bioequivalence of laropiprant and ER niacin when administered as the triple combination tablet MK0524B or as the double combination tablet MK0524A given together with simvastatin.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health
* Subject is a nonsmoker
* Subject is willing to follow the study guidelines

Exclusion Criteria:

* Subject has or has a history of any illness that might confound the results of the study or make participation in the study unsafe for the subject
A Trial to Evaluate the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery

High-dose statin therapy around the time of surgery, decreases inflammation in patients undergoing cardiac valve surgery, and thereby improves clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Single or multiple valve repairs or replacements without coronary artery bypass grafting
* Bentall procedure, but no other aortic procedures
* With or without accompanying MAZE procedure (surgical treatment for atrial fibrillation)

Exclusion Criteria:

* Age under 18 years old
* Urgent or emergency surgery
* Unable to provide consent
* Presently on statin therapy or exposure to statins within a month of surgery
* Chronic anti-inflammatory use, including steroids and NSAID's (nonsteroidal anti-inflammatory drugs) (not to be used during the treatment period)
* Known hypersensitivity to rosuvastatin
* Active liver disease Indicated by AST/ALT higher than 3 times the upper limit of normal
* Pregnant or nursing women
* On drugs with interactions (Cyclosporine, gemfibrozil, lopinavir/ritonavir or atazanavir/ritonavir, niacin) Severe renal impairment not on dialysis
* Creatinine clearance \< 30 ml/min/1.73 m2
* Known myopathy and inflammatory diasthesis (such as systemic lupus erythromatosus, rheumatoid arthritis, and inflammatory bowel disease)
* Human Immunodeficiency Virus
Teach Back Method in Individuals With Heart Failure

This study will be conducted to determine the effect of the training given to indivuduals with heart failure by teach back method on their symptom control, adherence to treatment and self care behaviours.

İntroduction: At least 40 million individuals worldwide live with heart failure. Although it is progressive, heart failure symptoms can be controlled through pharmacological treatment and self-care practices. The aim of heart failure treatment is to improve the quality of life of patients, prolong their lifespan, and prevent the progression of symptoms of the disease and re-admission to the hospital. Heart failure guidelines state that patient education and post-discharge follow-up are necessary for successful management of symptoms.

Purpose:This study will be conducted to determine the effect of the training given to indivuduals with heart failure by teach back method on their symptom control, adherence to treatment and self care behaviours.

Method:This study will be conducted using a randomized controlled research design. The research sample will consist of 58 with heart failure in the cardiology department of a training and research hospital. Research data will be collected using introductory information form, the Morsky Treatment Compliance Scale, European Heart Failure Self-Care Behavior Scale-12, Heart Failure Symptom Status Scale. Training and consultancy services based on the teach-back method will be provided to individuals in the training group using the "Heart Failure Training Guide" in the form of 3 follow-ups in the cardiology clinic and telephone counseling. Telephone interviews were conducted by the researcher in the first week after discharge, it will be held in the first month and 3rd month. In addition, patients will receive counseling by calling the researcher if necessary. After the patients are discharged, they will be called 1 week later, at the end of the 1st month and at the end of the 3rd month, and training will be repeated and counseling will be provided in line with the issues needed. Research posttest data will be collected 3 months after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with heart failure at least 6 months ago
* Individuals who speak and understand Turkish
* Able to communicate by phone
* İndividuals who can read and write
* Those who gave consent to participate in the research

Exclusion Criteria:

* under 18 years old
* Patients with cognitive dysfunction
* Those with neuro-psychiatric disease
* Those who did not consent to participate in the research
EASYER (EpiAccess SYstem Registry) A Post Market Observational Registry

The objective of the Registry is to provide post market clinical outcome and potential health economics data and confirm the continued safety of the EpiAccess system.

The Registry will be a prospective non-randomized single-arm trial of up to 150 patients enrolled in up to ten (10) centers in the United States. The overall duration of the registry is estimated to be 18 months per site. For the patients the registry duration will be from the time of procedure until discharge from the hospital, estimated to be approximately four (4) days.

Prior to enrollment, patients will be evaluated on the basis of the latest available data to establish eligibility. Eligible patients will be considered enrolled in the registry after written informed consent is obtained.

As EpiAccess is only used for the access portion of the procedure, the safety performance and effectiveness endpoints are acute from the time of needle insertion until pericardial sac access is achieved. Follow up clinical examinations will be performed according to institutional standard of care. No special tests are required for this device.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older
* Pericardial access is clinically indicated
* Patient is willing and able to provide written informed consent

Exclusion Criteria:

* Patients who have any condition which contraindicates pericardial access or who have any condition specified in the Contraindications section of the Instructions for Use. This includes:
* Previous cardiac surgery or myocardial infarctions resulting in pericardial fibrosis
* Congenital absence of a pericardium
* Absence of a free epicardial space
* Patients with active infection
* History of chronic pericarditis
* Patient requiring anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
* Patient not in normal sinus rhythm
* Presence of thrombus in the left atrium
* Coagulopathy
* Known allergy to contrast media
An Observational Study Investigating the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes

This study investigated the effectiveness of pravastatin on renal function in Korean dyslipidemic patients with Type 2 diabetes.

This survey study investigated the effect of routine initiation single dose of pravastatin (10 mg, 20 mg, or 40 mg) on renal function in Korean dyslipidemic patients with Type 2 diabetes. The study also examined the effect of pravastatin on lipid profiles, glucose metabolism, and safety.

Eligibility Criteria:
Inclusion Criteria:

* Participants with Type 2 diabetes (currently using an antidiabetic drug or satisfying diagnostic criteria of diabetes as defined by American Diabetes Association)
* Participants with dyslipidemia (currently using an antidyslipidemic drug or satisfying the Health Insurance Review \& Assessment Service insurance coverage treatment criteria\*) for whom drug treatment with pravastatin is confirmed
* Participants determined to be eligible as subjects at the discretion of the investigator
* Participants who voluntarily provided written consent using the Informed Consent Form on Use of Information

Exclusion Criteria:

* Participants who had administered pravastatin prior to study participation
* Participants with hypersensitivity to the investigational product or its history
* Participants with an active liver disease or persistent elevation of transaminase with an unknown cause
* Pregnant woman or women with childbearing potential, breastfeeding mothers
* Children
* Participants with severe hepatic or renal insufficiency
* Participants with myopathy
* Participants with cholestasis
* Participants with hypercholesterolemia due to hyperalphalipoproteinemia accompanied by HDL cholesterol elevation
* Participants with a genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Using the S100B Protein for Emergency Headache Management Care (S100)

The purpose of this study is to determine the negative predictive value of protein S100B that could exclude subarachnoid and intracranial haemorrhage for patient that present severe headache within the last 3 hours.

This study will be proposed to every patient that correspond to eligibility criteria, such as presenting a severe headache (Visual Analog Scale ≥ 6/10) within 3 hours before arriving to the emergency.

After signing the informed consent, a blood sample will be taken in order to dosage S100B protein of each patient, and then they will have a brain scan.

The trial ends after the brain scan for each patient. Results of brain scans will be compared with results of S100B dosage.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years-old
* Patient presenting at the Emergency Service a non-traumatic severe headache lasting for less than 3 hours. The severity is defined as a VAS ≥ 6/10
* Blood sample can be taken within 1 hour following the emergency admission
* VAS \> 6 or Glasgow \< 8
* Signed and dated informed consent by patient, or trusted person, or family

Exclusion Criteria:

* Patient presenting headache after head trauma
* Pregnant or breastfeeding women
* Patient with a pathology causing the elevation of PS100B's rate such as Alzheimer's disease, Creuzfeld-Jacob's disease, Multiple Sclerosis, cerebral tumour, trisomy 21, melanoma (diabetes excluded)
* Patient covered by social security regimen or equivalent
* Patient under guardianship (legal protection)
* Patient deprived of liberty by court or administrative order
* Any condition that could influence PS100B's dosage results according to the physician.
Reproductive Health Survivorship Care Plan Pilot

Most young breast cancer patients undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation (e.g., hot flashes and vaginal dryness), which are distressing in young breast cancer survivors (YBCS). The goal of this pilot study is to test the feasibility of a 4-week text message based intervention on hot flashes and vaginal dryness in YBCS. YBCS will be randomized in a 1:1 ratio to the intervention (text messages on hot flash and vaginal dryness management) and control arms. All participants will be prompted to provide daily hot flash frequency and severity via text messaging. The primary hypothesis is YBCS will have high rates of daily hot flash reporting via text messaging. Secondarily, we will compare changes in hot flash frequency, hot flash severity and vagina dryness between the intervention and control arms.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer
* Female
* Completed primary breast cancer treatment
* Age \<=45
GnRH Agonist Triggering Supplemented With Hcg in Women With Poor Ovarian Response

During the last decades, owing to the growing tendency of women to delay childbearing plans because of career and personal priorities, fertility specialists today are seeing more and more women with poor ovarian reserve and with poor ovarian response Controlled ovarian hyperstimulation (COH) is considered a important factor in the success of in vitro fertilization-embryo transfer (IVF-ET), enabling the recruitment of multiple oocytes and, thereby, resulting in more than one embryo. However, owing to the extreme variability in ovarian response to COH, in a subgroup of patients with poor ovarian response, this method may yield a very small number of follicles After succeeding in maximal recruitment of the follicles, the triggering of ovulation is extremely important in order to achieve, as many as, mature oocytes.

Several studies have reported retrieval of more mature oocytes after GnRH agonist triggering compared to the number of oocytes retrieved after hCG. Among the possible advantages of GnRH agonist for final oocyte maturation is the simultaneous induction of an FSH surge. The role of the natural mid-cycle FSH surge is not fully clear. FSH was reported to induce LH receptor formation in luteinizing granulosa cells, and to promote oocyte nuclear maturation and cumulus expansion .

Another method described to trigger ovulation is the "Dual triggering"- GnRH agonist 40 h prior to ovum pickup and hCG added 6 h after the first trigger. The dual triggering was described as the treatment in cases with recurrent empty follicles.

The aim of the present study is to evaluate three different methods of ovulation triggering in women with poor ovarian response

Inclusion criteria:

* Women with low ovarian response according to the Bologna criteria, undergoing IVF treatments for this cause.

Exclusion criteria:

* Women with good ovarian response.
* Women with low ovarian response who are carriers of fragile X

Eligibility Criteria:
Inclusion Criteria:

* Women with low ovarian response according to the Bologna criteria, undergoing IVF treatments for this cause.

Exclusion Criteria:

* Women with good ovarian response.
* Women with low ovarian response who are carriers of fragile X
LASER and Radiofrequency and Genitourinary Syndrome of Menopause

This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic strogen to treat symptoms of vulvovaginal atrophy of post menopause.

Post menopause women with moderate or severe signs or symptoms of vulvovaginal atrophy will be eligible for the study.

The patients will be randomized to receive one of the three intravaginal therapies: LASER, Micro Ablative radiofrequency or Estriol. The applications will occur in the interval of 30 days for 3 times, for LASER and Radiofrequency groups. For the estriol group, the application will be done by the patient, daily for 2 weeks and them twice a week for 3 months, and each 30 days, the patients will have an appointment when will be checked the weight of the estriol tube, to verify the correct use.

The follow-up visits will occur 30, 90, 180 and 360 days after the conclusion of the third month of treatment.

Will be evaluated: vulvar and vaginal histology before and after the use of LASER, radiofrequency or estriol; microbiota and vaginal pH before and after the use of LASER, radiofrequency or estriol; extracellular matrix and metalloproteinases in the remodeling of vulvovaginal collagen induced by estrogen, LASER and radiofrequency; quality of life, sexual dysfunctions and complaints before and after the use of LASER, radiofrequency or hormones; metabolomics and vaginal microbiome.

Eligibility Criteria:
Inclusion Criteria:

1. Women between 2 and 5 years after menopause, without hormone therapy for at least 2 years
2. To present, at least moderate, or severe intensity (score 4 or more of visual analog scale ( 0-10)) of one of the signs or symptoms of of vulvovaginal atrophy:

   * Burning
   * Discomfort
   * Dryness
   * Cracks
   * Pruritus
   * Lack of vaginal lubrication
   * Penetration dyspareunia that began at the menopausal or postmenopausal transition
   * Decreased vaginal epithelium turgor and trophism
   * Deletion of mucous and skin folds.

The Exclusion criteria will be:

1. Active genital infection, active infection of HPV (human papillomavirus) or Herpes, users of medications with estrogenic effect (digoxin, tamoxifen and other chemicals)
2. Postmenopausal genital bleeding, uncontrolled diabetes, use of multivitamins with zinc, use of copper or hormonal IUDs (intrauterine device) at the time of inclusion, presence of genitourinary or rectovaginal fistulas.
Image Guided RFA/MWA/CRYO of RCC Biomarker Profile Study

Often kidney cancer is diagnosed when the tumour is small and hasn't spread. Rather than major surgery to remove the whole kidney, image-guided ablation involving heat (microwave or radiofrequency) or freezing (cryotherapy) is often used to destroy the tumour using minimal invasive technique with much less risk and discomfort. Limited evidence suggests that ablation also activates the immune system which may help in fighting the cancer. We will investigate the immune and other changes by analysing blood samples from patients before and after ablation. Understanding this will help in designing more effective new treatments combining ablation with biological therapies.

Image-guided ablation therapies are increasingly being used in renal and other cancers as an alternative to major surgery, particularly in the context of small localised masses or when patients have significant co-morbidities. Published analyses now also support the effectiveness of such treatments in terms of outcomes. Tumour ablation has been reported to generate immune and inflammatory responses following tumour destruction, essentially through release of tumour antigens in effect acting as a tumour "vaccine", resulting in systemic anti-tumour responses. Such studies are still limited but indicate possibilities in terms of combination therapies with immunotherapies and synergistic effects.

In order to take this forward in renal cancer it is now critical that studies are undertaken to explore further the immunobiological and inflammatory changes associated with ablation therapies. We propose to do this using a relatively new multiplex and highly sensitive proteomic biomarker array technology which allows the profiling of circulating proteins using arrays targeted at specific disease areas or processes. We have used this platform to generate some pilot data on RCC patients undergoing ablation to show feasibility and now propose to extend this further. The main benefits to patients will be in terms of understanding how the immune and inflammatory responses are affected by ablation which ultimately may lead to the design of new more effective therapeutic strategies combining ablation with immunotherapies. Ultimately more effective combination therapies would have health economic benefits and improved quality of life with potentially lower toxicity if the doses of the biological therapies could be reduced. Some of the protein changes may also act as surrogate markers of response and guide optimal treatment administration.

Eligibility Criteria:
Inclusion Criteria:

1. Patients underwent image guided ablation for renal cell carcinoma (RCC) with heat-based energy (RFA/MWA) or ice-based energy (CRYO)
2. No other prior treatment to RCC in either kidneys

Exclusion Criteria:

1. Patients with RCC that is not suitable for image guided ablation
Dexmedetomidine for Non-invasive Ventilation After Chest Trauma

Crossover randomized controlled double blinded trial :

* The primary endpoint is the duration of Non Invasive Ventilation (NIV) session (minutes) with dexmedetomidine (DEX) or placebo.
* Secondary endpoints will be the sedation level as assessed by the Richmond Agitation Sedation Scale (RASS), the number of interventions to allow the completion of NIV session, the pain intensity level as assessed by visual analogue scale, the morphine and ketamine consumption during NIV sessions, the comparison of blood gas measurements before and after NIV sessions, the reproducibility of NIV cycles. The side effects of DEX will be notified.


Eligibility Criteria:
Inclusion Criteria:

* Blunt chest trauma with thoracic trauma score\> 6, ICU admission and spontaneous breathing

Exclusion Criteria:

* Contra indication for NIV or Dexmedetomidine as specified by the French marketing authorization