cyrilzakka/clinical-trials huggingface dataset:
Outcome of CHAllenging lesioNs and Patients Treated With Polymer Free Drug-CoatEd Stent

Length of DAT (Dual Antiplatelet therapy) represents one of the most challenging choices for interventional cardiologist.

Prolonged DAT reduces risk of subsequent MI (Myocardial Infarction) with an increase in major bleedings, consequently with a neutral effect on survival \[1\].

Recently a Polymer-free Drug-Coated coronary stent has been tested in a randomized controlled trial with only one month of DAT due to its peculiar features, with an increased efficacy compared to BMS (Bare Metal Stent) and with a not negligible risk of ST at one year (about 2%)\[2,3\].

The RCT despite its promising design (inclusion of high risk patients like those with previous bleeding or with severe renal disease) showed a major limitation, that is:

1. patients who are often offered a Biofreedom in real life, that is those with active cancer or needing major surgery or on OAT (Oral Anticoagulation)
2. and patients with bifurcation and multivessel disease, that is those with an increased risk of ST \[4\]
3. STEMI patients \[5\] were underrepresented (less than 30%). Consequently we performed this multicenter study to evaluate safety and efficacy of Biofreedom in real life patients.

POCE (a composite end point of death, myocardial infarction, target lesion revascularization) and DOCE (cardiac death, MI-TLR and TLR) will be the primary end points, while its single components will be the secondary ones along stent thrombosis and with bleedings (Barc classification).

At least 12 months The Leaders FREE (2) reported an incidence of MACE of 9.4% at one year in overall patients. If there is a true difference in favour of the experimental treatment of 1.2%, then 870 patients are required to be 80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference when compared to non selected patients of more than 2% \[5\]

All patients implanting Biofreedom with these prespecified analysis:

1. Clinical

   * Diabetic patients (both insulin and not insulin depenent)
   * Requiring oral anticoagulation
   * On active cancer (that is requiring chemio or radio-therapy and or surgery)
   * Requiring surgery
   * STEMI
2. Interventional

   * Bifurcation (both provisional both 2 stents)
   * Multivessel
   * Ostial

Our interest is to test the performance of these stents in real life patients

Eligibility Criteria:
Inclusion Criteria:

1. Clinical

   * Diabetic patients (both insulin and not insulin depenent)
   * Requiring oral anticoagulation
   * On active cancer (that is requiring chemio or radio-therapy and or surgery)
   * Requiring surgery
   * STEMI
2. Interventional

   * Bifurcation (both provisional both 2 stents)
   * Multivessel
   * Ostial

Exclusion

1. clinical less than 18 years old or more than 80
2. interventional last remaing vessel
Serious Game On Stoma Care Education For Nursing Students

Today, rapidly developing technology needs to be integrated into teaching environments and reconstructed teaching environments. When virtual reality applications, which are among the popular and innovative technologies, are examined, it is seen that participants are used in many areas of education. In this randomized controlled study, it was aimed to evaluate the impact of stoma care education by designing a serious game based web application that enables nursing students to gain skills and practice in psychomotor applications. The universe of the study will be students enrolled in the Surgical Diseases Nursing course in the spring semester of the 2020-2021 academic year at the Faculty of Health Sciences, Gümüşhane University. Students will be divided into two groups as control and experiment by randomization method. The data will be collected through introductory features form, 'Stoma Care Information Form', 'Stoma Care Skill Checklist' and Computer System Usability Survey. In the first stage of the study, the students will be given a 'Stoma Care Information Form' (first knowledge). 'Stoma Care Information Form' (second information) and 'Stoma Care Skill Checklist' will be applied after completing the theoretical lesson of stoma care and group work in the laboratory of students in the experimental and control groups. Unlike the control group, of students in the experimental group; A serious game-based web application on stoma care prepared as a support for formal education will be installed. After four weeks of the students attending formal education, 'Stoma Care Information Form' (third knowledge) and 'Stoma Care Skill Checklist' (second skill) will be applied. In the experiment and control group, two weeks later, the "Stoma Care Information Form" (fourth information) and "Stoma Care Skill Checklist" (third skill) will be applied again to test the permanence of the methods. Skill measurements of students will be made with an objective structured clinical exam. The results obtained after the application will be analyzed and the impact of serious game based web application on stoma care education will be determined


Eligibility Criteria:
Inclusion Criteria:

* Enrolling in the HEMSEC-217 Emergency Nursing course for the first time,
* Having successfully completed the Internal Medicine Nursing course,
* He voluntarily agreed to participate in the study.
* Having internet access

Exclusion Criteria:

* To have received training (in-service training, course, seminar, etc.) on stoma care,
* Having graduated from a health vocational high school and having experience in stoma care,
* Taking the HEMSEC-217 Emergency Nursing course for the second time
Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults

This study is a prospective, multicentric, observational test negative design study on adults hospitalized for Severe Acute Respiratory Infection (SARI), regardless of their vaccination status.

Participation to the study will be systematically proposed to all patients hospitalized fitting inclusion criteria. Patient's screening will be done in emergency department or hospital department with direct admission. Medical investigators explain the objectives of the studies, procedure and propose the patient to participate in the study. Socio-demographic data, clinical and virological data will be collected in an electronic clinical research form.

A follow-up at 1 and 3 months after hospitalization discharge will be scheduled to evaluate health status.

The remainder of respiratory samples that have been performed for care will be used for further testing depending on epidemiological situation and will be stored at -80°C.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Admitted in a hospital for at least 24 h
* Presents SARI criteria within onset within the last 14 days before sampling and less than 48 h after hospitalisations:

At least one of the following signs (without treatment): fever or feverishness, malaise, headache, myalgia or sign of fatigue (loss of weight or anorexia or confusion or dizziness) Associated with at least one respiratory symptom or sign (cough, sore throat or shortness of breath; or tachypnoea or signs of low oxygen saturation)

* completed non-opposition form
* Respiratory samples within 14 days after symptoms onset, in the context of care

Exclusion Criteria:

* Contraindication of vaccination
Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.

Our research has shown that pressure sensation from the soles of the feet (plantar mechanoreceptors) plays an important role in controlling several key aspects of balancing reactions, particularly during compensatory stepping . As a result, age-related loss of plantar pressure sensation, which is very common, can lead to impaired control of these reactions. However, we have shown that it is possible to compensate for balance impairments resulting from this loss of sensation by using special footwear insoles to facilitate sensation from the perimeter of the sole. To date, we have demonstrated the feasibility of this approach in laboratory studies, and we have obtained a U.S. patent for the design concept. However, it remains to be determined whether the benefits of the footwear persist over the long term, or whether there is a habituation of the effect. Also, we need to determine whether there are any practical problems associated with wearing such footwear, e.g. due to discomfort or irritation of the skin.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 to 75 years

Exclusion Criteria:

* Any neurological or musculoskeletal ailments that affect their balance
* Any drugs that affect balance
Factors Affecting The Recurrence Of Acute Cholecystitis After Treatment With Percutaneous Cholecystostomy

Percutaneous cholecystostomy is used to reduce the complications and mortality associated with surgery in patients with high surgical risk in acute cholecystitis. Although this method generally acts as a bridge treatment for interval cholecystectomy in patients, interval cholecystectomy is not performed in every patient after percutaneous cholecystostomy. The aim of this study was to determine the recurrence rate of patients who did not have interval cholecystectomy after treatment with percutaneous cholecystostomy and to investigate the factors that may affect the recurrence.

Acute cholecystitis is an inflammatory disease of the gallbladder and is often associated with cholelithiasis. According to Tokyo Guide 2018 (TG18), acute cholecystitis is grouped with various risk factors and predictive factors. Early laparoscopic cholecystectomy or late cholecystectomy after medical therapy is recommended for patients with grades 1 and 2. On the other hand, non-operative treatments such as percutaneous cholecystostomy catheter and antibiotic therapy are recommended for selected patients with high surgical risk and serious comorbidities in order to prevent morbidity and mortality. They suggested that percutaneous cholecystostomy catheter could be used as the definitive treatment of acute cholecystitis in these high-risk patients who are not suitable for surgery. Debate continues as to whether cholecystectomy is necessary for these patients. Because studies have shown that the recurrence rate of acute cholecystitis after percutaneous cholecystostomy catheter treatment varies between 4% and 22%. For these reasons, assessing the risk of recurrence of acute cholecystitis in patients initially treated with percutaneous cholecystostomy is essential to aid decision making.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with acute cholecystitis on admission to the emergency department
* Patients treated with percutaneous cholecystostomy catheter according to TK18 acute cholecystitis diagnosis and treatment guideline
* Patients older than 18 years
* Patients who can give their own consent

Exclusion Criteria:

* Patients with missing data or not followed up regularly
* Patients whose cholecystostomy catheter was removed during the operation or operated within the first year following the catheter extraction
* Patients with choledocholithiasis, abscess secondary to acute cholecystitis, or hepatopancreatobiliary system malignancy
* Patients who are pregnant
Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.

During intrauterine life, some babies are smaller or grow less than expected. This fetal growth abnormality, called fetal growth restriction (FGR), can be diagnosed by ultrasound. Since there are currently no curative treatments for this condition, nor methods to optimize the growth of babies in the womb, the only effective strategy is intensive monitoring of fetal conditions, accompanied by early planning of delivery.

The diagnosis of early FGR (i.e. diagnosed before 32 weeks of gestation) confers a greater risk of short- and long-term respiratory problems.

The study aims to examine the association between parameters that can be assessed during pregnancy by ultrasound, such as the estimate of lung volumes, the thickness and contractility of the diaphragm, and cardiac kinetics, and any perinatal complications and respiratory function in the first years of life of premature infants, both with and without evidence of fetal growth pathology. Therefore, the study is divided into two phases: a prenatal and a postnatal phase.

The study includes two groups of patients:

1. Study group: Fetuses and preterm infants with a prenatal history of FGR;
2. Control group: Preterm infants without a prenatal history of FGR followed during neonatal follow-up.

Pregnant women with fetuses with FGR are followed at the Ultrasound clinics dedicated to Growth Pathology.

These pregnancies usually receive weekly ultrasound monitoring, which includes a Doppler study of the maternal and fetal circulation and an estimate of fetal weight every two weeks. Cardiotocographic monitoring is also planned once or twice a week, depending on fetal well-being.

The child will be assessed from a respiratory point of view during hospitalization and subsequently in the outpatient clinic, as required by clinical practice.

He/she will undergo respiratory function tests. Visits are scheduled at 3, 6, 12 and 24 months of corrected age, during which at least two respiratory function tests will be performed.

In addition, routine clinical data (personal data, medical history, blood tests, biological and instrumental tests) present in the medical record of the child will be collected.

Data from preterm infants without fetal growth restriction will be collected after informed consent. These infants are routinely followed at our Institution and undergo clinical assessment and lung function tests in the first two years of life as previously indicated.


Eligibility Criteria:
Inclusion Criteria:

* Fetuses and Infants born before 32 weeks of gestation, with and without fetal growth restriction

Exclusion Criteria:

* Lack of informed consent
* Need for palliative care
* Major malformations
URO-BCG-4 : Bladder Tumors Immunotherapy

Evaluation of maintenance BCG immunotherapy (dose 27 mg) in superficial bladder tumors. Two randomized arms (every 3 or 6 months) will be studied for a population of 300 patients.

BCG maintenance immunotherapy 1/3 dose : 27 mg two randomized arms : 3 or 6 months for 36 months clinical side effects according to OMS score efficacy regarding recurrence : cytology and cystoscopy PSA, leucocyturia and N-ramp gene evaluation

Eligibility Criteria:
Inclusion Criteria:

* Ta and T1 bladder tumors

Exclusion Criteria:

* BCG contra-indications
Anxiety in Older Veterans

Anxiety leads to poor quality of life, avoidance of activities, decreased social engagement, functional decline, and disability in older patients. This study will compare two self-directed treatments delivered via Digital Versatile Disc (DVD) videos that can be viewed in one's own home. The two treatments being compared are: psychoeducation, which refers to information and education about anxiety, and a behavioral treatment program, called BREATHE (Breathing, Relaxation and Education for Anxiety Treatment in the Home Environment). BREATHE teaches diaphragmatic breathing and progressive muscle relaxation. Participants will be randomly assigned to either treatment. The study is 12 weeks long. There are 4 weeks of treatment via DVD and 8 weeks of follow-up. Participants will be asked questions about anxiety symptoms, mood, health and functioning.

Anxiety is pervasive, costly, and leads to behavioral avoidance, disability, and poor quality of life. The proposed Career Development Award level-2 (CDA-2) study will examine the efficacy of a brief psychosocial intervention for anxiety in older Veterans with anxiety disorders. The psychosocial intervention is called BREATHE (Breathing, Relaxation and Education for Anxiety Treatment in the Home Environment) and teaches diaphragmatic breathing and progressive muscle relaxation via DVD videos that can be viewed in Veterans' own homes. The BREATHE treatment includes age-appropriate vignettes of anxiety-evoking situations. This project is aligned with older adults' preference of psychotherapy to pharmacotherapy for treating anxiety. BREATHE is expected to benefit older Veterans ( 60 years) by reducing anxiety and avoidance and thereby increasing their engagement in activities and improving overall functioning. This aim will be tested in a randomized control trial of DVD-based BREATHE compared with DVD-based psychoeducation in 60 older Veterans with anxiety disorders (Generalized Anxiety Disorder, Panic Disorder, Agoraphobia, Social Anxiety Disorder, and unspecified/other specified anxiety disorder). The study is 12 weeks long with both treatments lasting 4 weeks followed by an 8 week follow-up period. It is hypothesized that BREATHE will result in a statistically and clinically significant reduction of anxiety symptoms as measured with the Geriatric Anxiety Scale compared with psychoeducation. Improvements in functioning (Activity Card Sort) are expected for participants randomized to the BREATHE condition compared with those randomized to psychoeducation. Hypotheses in will be addressed with mixed effects models.

Eligibility Criteria:
Inclusion Criteria:

* Veterans aged 60 years or older.
* Meets criteria for an anxiety disorder (Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Anxiety Disorder Unspecified, Anxiety Disorder Other Specified).
* English-speaking.

Exclusion Criteria:

* Diagnosis of dementia or significant cognitive impairment as determined by a brief cognitive screen.
* Diagnosis of serious mental illness (bipolar disorder, psychosis, schizophrenia),
* taking benzodiazepines more than once a week per self report.
Adjunctive Bright Light Therapy for Patients With Depression

The study would enroll depressed adolescents and adults with bipolar I or II disorder or major depressive disorder who are receiving stable psychiatric medication (excluding patients with hypomania or mania, mixed symptoms, or rapid cycling). Participants would be randomly assigned to treatment with either 1,0000-lux bright white light therapy in the morning or 1,0000-lux bright white light therapy in the afternoon, or \<100-lux dim red placebo light therapy in the afternoon (N=59 for each group). Participants would be treated for 6 weeks. Symptoms would be assessed every two weeks with the 24-items Hamilton Depression Scale, the Young Mania Rating Scale, and the Pittsburgh Sleep Quality Index; salivary melatonin and cortisol concentrations will be also measured.

The investigators would divide the participants enrolled into three groups: adjunctive morning bright light therapy (BLT) group (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period of intervention: 7:00\~9:00 a.m.), adjunctive afternoon BLT group (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period of intervention: 12:00\~14:00 p.m.), adjunctive placebo therapy group (light intensity: \<100lux, color: dark red, duration of each intervention session: 30min, time period of intervention: 12:00\~14:00 p.m.).

Eligibility Criteria:
Inclusion Criteria:

* 12-75 years old
* Diagnosed using DSM-5 criteria based on the Structured Clinical Interview for Patient Edition (SCID-P) for adults or Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (Kiddie-SADS-PL) for adolescents for the diagnosis of bipolar I or II disorder or major depressive disorder
* 24-items Hamilton Depression Rating Scale score ≥ 20, Young Mania Rating Scale score \< 6
* Participants with bipolar disorder taking at least one mood stabilizer, and the types of drugs have not changed in one week;
* Antidepressants can be taken, and the types of antidepressants have not changed in one week
* Low-dose benzodiazepines can be used, with a maximum of 2 mg of lorazepam equivalent per day
* Right-handed
* Primary school education or above
* Sign informed consents after a full explanation of this study.

Exclusion Criteria:

* A history of brain organic disease or severe traumatic brain injury and severe physical disease;
* Drug, alcohol or other psychoactive substance abusers
* Severe suicide risk;
* Received modified electric convulsion therapy (MECT) in the past three months
* Comorbid with ophthalmic diseases (cataract, macular degeneration, glaucoma, retinitis pigmentosa, etc.) and diseases affecting the retina (retinopathy, diabetes, herpes, etc.)
* Taking photosensitive drugs (phenothiazines, antimalarials, propranolol, melatonin, hypericum, stimulants or NSAIDs)
Evaluation of the Relationship Between Oxidative Stress and Human Reproduction

The aim of the study is to investigate the role of oxidative stress in female infertility and the relationship between the stress as it is illustrated by questionnaires, serum markers, follicular fluid markers, and ovarian response in assisted reproduction.

The investigators included patients that underwent an in vitro fertilization procedure in CALLA IVF Clinic.

All the patients had at least one ovarian stimulation cycle. In day two of the menstrual cycle the patients had a blood test for serum FSH(follicular stimulant hormone) E2 (estradiol) LH(Luteinizing hormone) and P(progesterone) as well as an ultrasound to asses the antral follicular count(AFC). The same day(day 2) the stimulation protocol begins. These four parameters are tested few times during the stimulation. The average stimulation protocol is 11 days. When the serum levels of hormones and ultrasound measurements of follicles reach the needed values (E2\>1000pg/mL and follicles over 17mm) the hCG trigger is received. Transvaginal ultrasound guided oocyte retrieval was performed at 34-36 hours later. ICSI (intracitoplasmatic sperm injection) was performed and the fertilization by the presence of two pronuclei was confirmed 16-20 hours after the injection.

Follicular fluid and serum were obtained within 1 hour of oocyte recovery. Considerable care was taken to pool follicular fluid uncontaminated with blood. The samples were processed by centrifuge and 1-mL aliquots stored ar -80ºC until assay. Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins were measured from follicular fluid and plasma according to manufacturer's protocol. This assay has been described as highly sensitive. Data were expressed as millimoles per liter from the reference curve.

The parameters that are being observed are: number of oocytes, fertilisation rate and number of embryos.

Eligibility Criteria:
Inclusion Criteria:

* all patients with the Infertility diagnosis (trying to conceive for over 12 months having regular unprotected sexual intercourse) and having an ovarian puncture during an IVF procedure

Exclusion Criteria:

* patients that need sperm and egg donors
* patients that refuse being enrolled in the study