cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Polymer-free Amphilimus-eluting Stent According to the Diabetes

Drug-eluting stents (DES) have been found to reduce the rate of stent restenosis compared to bare metal stents (BMS), but the first generation DES caused an increase in stent thrombosis. The second generation DES, including the Cre8Evo stent, has been designed to address these issues. The Cre8Evo stent is made of cobalt chromium and releases the drug amphilimus into the vessel wall, which is quickly absorbed and then lost, creating a BMS-like form. The Cre8Evo stent does not contain polymers and does not induce an inflammatory response. It inhibits cdk2 and RhoA, reducing the proliferation and migration of vascular smooth muscle cells. In diabetic patients, the Cre8Evo stent showed superior results in suppressing late proliferation compared to conventional DES. The Cre8Evo stent has been found to be safe and effective in clinical studies, and it has a superior effect in the clinical course of diabetic patients compared to other stents. The purpose of the study is to evaluate the effectiveness and safety of the Cre8Evo stent in actual clinical practice, specifically comparing outcomes in patients with and without diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 or older

  * Patients who agreed to the research protocol and clinical follow-up plan, voluntarily decided to participate in this study, and gave written consent to the consent form ③ Patients who underwent coronary angioplasty by inserting Cre8™ or Cre8™ EVO stent for coronary artery disease for a lesion confirmed within the last 1 month

Exclusion Criteria:

* Patients with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, amphilimus, cobalt chrome, stainless steel nickel, 316L metal, and contrast media If it can be controlled by pheniramine and pheniramine, registration is possible, but if there is known anaphylaxis, it is excluded.)

  * Pregnant women, lactating women, or women of childbearing age who are planning to become pregnant during the study period ③ Patients who are planning surgery to stop antiplatelet drugs within 12 months from registration

    * Patients whose remaining life expectancy is expected to be less than 1 year

      * Patients who visited the hospital due to cardiogenic shock and are predicted to have a low survival rate based on medical judgment ⑥ Subjects participating in medical device randomization research ⑦ Patients who underwent surgery using a stent other than Cre8™/Cre8™ EVO at the time of registration
Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression

The overarching goal of the present study is to evaluate the effect of a subanesthetic dose of ketamine 24-hour post-injection on resting state functional connectivity, cognitive control, and reward learning.

Major Depressive Disorder (MDD) participants with treatment-resistant depression (TRD) will be recruited from McLean's Ketamine clinic. Suitability for Ketamine treatment will be determined as typically done by the service - through evaluation by the clinicians on the staff of the Ketamine Service who perform psychiatric consultations and assessments for Ketamine suitability. Potential subjects will be informed about the study only after they have received a positive consultation at the clinic and have already agreed to receive the treatment.

This study consists of a set of questionnaires, urine drug screen, and electroencephalogram (EEG) recordings.

Eligibility Criteria:
Inclusion Criteria (MDD Subjects):

* All genders, races, and ethnic origins, aged between 18 and 70;
* DSM-5 diagnostic criteria for MDD (diagnosed with the use of the Structured Clinical Interview for DSM-5 (SCID-5));
* A score of ≥32 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30).
* Capable of providing written informed consent, and fluent in English;
* Right-handed;
* Treatment Resistant (as assessed using the MGH Antidepressant Response Questionnaire)
* Have already decided to receive ketamine treatment as part of their standard clinical care

Inclusion Criteria (Control Subjects):

* All genders, races, and ethnic origins, aged between 18 and 70;
* Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (SCID-I/NP);
* A baseline Quick Inventory of Depressive Symptomatology (QIDS) score ≤ 5;
* A baseline Hamilton Depression Rating Scale (HDRS) score ≤ 7;
* Capable of providing written informed consent, and fluent in English;
* Right-handed;
* No first-degree relative with mood or psychotic disorder.

Exclusion Criteria (All Subjects):

* Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
* History of seizure disorder;
* History or current diagnosis of any of the following DSM-5 psychiatric illnesses: schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, substance abuse disorder;
* Clinical or laboratory evidence of hypothyroidism, hyperthyroidism, or other thyroid disorder that is not controlled by medication;
* Substance use assessed by physician as dangerous for ketamine treatment;
* Untreated glaucoma;
* Complex post-traumatic stress disorder (PTSD) with dissociation;
* Patients with a lifetime history of electroconvulsive therapy (ECT).
* Participants with a lifetime history of ketamine use.
Effect of Vitamin D3 and Omega-3FA on Leptin and HbA1C With Vitamin D Deficiency

The Combined effect of Vitamin D3 and Omega-3 supplements on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.

Nothing is published in the literature about effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on serum leptin and glycated hemoglobin ( HbA1C)

This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.

This randomized, controlled clinical trial will be designed to test effects of 50,000 IU VD3 weekly and 1000 mg omega-3FA daily for eight weeks, separately and with each other, on on serum leptin and Glycated hemoglobin (Hb A1C) levels .

Eligibility Criteria:
Inclusion Criteria:

* jordanian people aged 25-55
* medical diagnosis of vitamin D deficiency ( VD \<25 ng/ ml)

Exclusion Criteria:

* Blood disorders including
* thalassemia
* sickle cell disease
Optimal Flow Rate During Cardiopulmonary Bypass

Regardless of the development of cardiac surgery techniques and technologies, the question of an optimal extracorporeal circulation is still unanswered. There are globally accepted standards of perfusion, however, keep many of these procedures was not evidence-based review.

Generally accepted are flow rates during cardiopulmonary bypasses of 2.5 L/min/m2. This target was derived from the physiological conditions, but they are not the result of an adapted adjustment to the fundamentally non-physiological processes during extracorporeal circulation. Among other things, an increased metabolic demand during re-perfusion is not taken into account.

An increasing and optimizing of the standard flow rate of 0.5 L/min/m2 should be the aim of this investigation. Under optimal perfusion, the investigators are maintaining the microcirculation and organ protection in receipt of endothelial function and oxygen transport.


Eligibility Criteria:
Inclusion Criteria:

* Extracorporeal circulation
* Age \> 18
* Written consent

Exclusion Criteria:

* Emergency cases
Cerebral Perfusion During Neonatal Cardiac Surgery

Neonates with a congenital heart defect are often in need of early cardiac surgery. In complex congenital heart defects, cardiopulmonary bypass is usually employed, with or without deep hypothermic circulatory arrest (DHCA). The brain is especially vulnerable to ischemic injury, which puts neonates undergoing complex operations at high risk of neurodevelopmental disorders. Selective antegrade cerebral perfusion (ACP) instead of DHCA during these complex operations may contribute to less cerebral damage, but literature is not conclusive on this issue.

Therefore, the investigators will perform a randomised controlled trial comparing DHCA and ACP in neonatal aortic arch reconstructions, focusing on cerebral damage and neurological outcome.


Eligibility Criteria:
Inclusion Criteria:

* Aortic arch reconstruction (diagnosis of hypoplastic left heart syndrome, hypoplastic aortic arch, severe coarctation and/ or interrupted aortic arch)
* Infants \<4 months old

Exclusion Criteria:

* Anticipated arch reconstruction time longer than 60 minutes
* Sedation and intubation especially for the pre-operative MRI-scan of this research project
* Participation in another clinical trial
* Failure of data collection
Complicated Infections in Otorhinolaryngology

This observational study aims to learn more about complicated infections treated by otorhinolaryngologists. The main questions to answer are:

* What is the management of complicated sinonasal infections in Ljubljana, Slovenia,
* What is the management of complicated ear and temporal bone infections in Ljubljana, Slovenia,
* What is the management of complicated neck soft tissue infections in Ljubljana, Slovenia,
* What is the management of complicated laryngeal infections in Ljubljana, Slovenia

Participants will receive standard treatment according to the established evidence-based clinical practice.

The main purpose of the research is to obtain own data on the treatment of patients with infections in ENT areas that require targeted treatment by an otolaryngologist at the hospital level. Based on these results, treatment outcome would be improved and hospitalization time would be shortened. We would establish clinical pathways for the treatment of these diseases in Slovenia. There is still no data on the treatment of these diseases in ENT departments in Slovenia, so one of the main purposes of the research is to obtain objective indicators of the success of treatment in comparison with other countries and a rough epidemiological assessment of the disease in Slovenia.

The research would establish a database of patients with complicated infections in ENT areas at the University Clinical Center Ljubljana, which would be used for prospective analysis even after the research was completed. The register would also enable transparency in the treatment of these patients in the future.

The main questions to answer are:

* What is the management of complicated sinonasal infections in Ljubljana, Slovenia,
* What is the management of complicated ear and temporal bone infections in Ljubljana, Slovenia,
* What is the management of complicated neck soft tissue infections in Ljubljana, Slovenia,
* What is the management of complicated laryngeal infections in Ljubljana, Slovenia

Participants will receive standard treatment according to the established evidence-based clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Diagnoses: rhinitis AND/OR sinusitis AND/OR facial cellulitis AND/OR facial abscess AND/OR nasal furuncle AND/OR infection of the outer AND/OR middle AND/OR inner ear AND/OR temporal bone AND/OR infection of the soft tissues of the neck with/without bone and cartilage involvement AND/OR laryngitis AND/OR epiglottitis (or supraglottitis) AND/OR
* complication of inflammation of the nose and paranasal cavities AND/OR ear AND/OR temporal bone AND/OR:
* treated at the Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Center Ljubljana.

Exclusion Criteria:

* disagreement of the patient and/or parents (or legal guardians) with inclusion in the research,
* failure to meet the inclusion criteria.
Identifying Predictors of Bipolar Disorder Relapse During Pregnancy and the Postpartum Period

This study will evaluate pregnant women who have bipolar disorder to gain a better understanding of risk factors for bipolar disorder relapse during pregnancy and the postpartum period.

Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes significant changes in a person's mood and energy. The onset of bipolar disorder usually occurs during young adulthood and persists for the rest of a person's life, making women who are of childbearing age at risk for this disorder. Although overall relapse rates for pre-existing mood disorders are typically higher in women who are pregnant or recently gave birth than in other women, very little is known about the impact of pregnancy and the postpartum period on someone with bipolar disorder. The course and treatment of maternal mental illness during pregnancy and the postpartum period remains the center of much debate, particularly with respect to the use of psychotropic medications during pregnancy and breastfeeding. Identifying predictors of bipolar disorder recurrence during pregnancy and the postpartum period may help to determine which women are at highest risk and to develop new treatment guidelines. However, more information is needed to both identify predictors and develop guidelines that will improve outcomes for pregnant women with bipolar disorder and their babies. This study will evaluate pregnant women who have bipolar disorder to gain a better understanding of risk factors for bipolar disorder relapse during pregnancy and the postpartum period.

Participation in this study will last up to 6 months postpartum. Study visits will be scheduled every 4 weeks during pregnancy and every 6 weeks after delivery for up to 6 months postpartum. During study visits, data will be collected on factors that may predict bipolar disorder recurrence and overall burden of bipolar disorder illness. Specific potential factors that will be evaluated include severity of illness in the past, type and severity of both recent and past life stressors, and any treatment received during pregnancy and the postpartum period. The study will also evaluate how antidepressant medications, if taken, affect the mother and baby during pregnancy and the postpartum period. Additionally, plasma, serum, and urine samples will also be processed and stored at each study visit.

Eligibility Criteria:
Inclusion Criteria:

* Medically healthy
* Meets DSM-IV criteria for bipolar disorder of any subtype
* No more than 32 weeks gestation, dated by last menstrual period

Exclusion Criteria:

* Active suicidality or homicidality
* Acute psychotic symptoms
Treatment of Myelodysplastic Syndromes Comparing Hydralazine/Ac. Valproic and Supportive Care in Patients Not Candidates, Refractory and/or Intolerant to Intensive Chemotherapy

Transfusional dependence has been associated closely and independently with low survival in patients with myelodysplastic syndrome (MDS), especially in patients at low risk according to IPSS. Treatment of patients with hydralazine + valproic acid as an alternative to treatment with 5-azacytidine has lower cost and possibly as effective with fewer side effects. The objective of this phase II study is to determine the effectiveness of combination therapy with hydralazine + Ac. Valproic compared with best supportive care. The investigators will select 42 patients per group, and after 14 weeks of treatment the investigators will study in both groups the hematological response (transfusion-dependent, hemoglobin, cytogenetics and morphology) and treatment safety (adverse reactions and vital signs) to 1 year after starting treatment. The concentration of hemoglobin, the number of transfusions, platelets, neutrophils and other continuous variables in both groups will be compared by Student t or Mann-Whitney, as appropriate. For comparison of cytogenetic and morphological response and other categorical variables between groups Chi square will be used. And within each group the investigators will compare each of these variables before and after treatment by t-test for paired data or Wilcoxon test.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and voluntarily sign the consent form.
2. Age ≥ 18 years at the time of signing the informed consent form.
3. Ability and willingness to meet the schedule of study visits and other protocol requirements.
4. Documented diagnosis of SMDs according to the criteria of disease risk IPSS intermediate-2, high risk or any risk with transfusion requirements.
5. Transfusion-dependent anemia erythrocytes defined as the absence of a period of 56 consecutive days without transfusion of red blood cells for at least 112 days prior (16 weeks).
6. Engage both women and men to use highly effective contraception.
7. Patients are not candidates for treatment with azacitidine or chemotherapy

Exclusion Criteria:

* Patients who have any of these exclusion criteria may not be included in the trial:

  1. Pregnant or breastfeeding.
  2. After hematopoietic stem cell transplantation.
  3. Patients with vitamin B12 deficiency, Folic Acid and Iron
  4. Any severe psychiatric illness or condition that prevents the patient sign the consent form for the patient or involves an unacceptable risk in case of participating in the study.
  5. Hypersensitivity to hydralazine and / or AC. Valproic
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy

This study is a multi-site, cluster randomized, two group implementation trial comparing a low- versus high-intensity implementation strategy for supporting hospital-based opioid use disorder treatment (HBOT) in community hospital settings where medication for opioid use disorder (MOUD) treatment has not been implemented.

The study will randomize approximately 24 community hospitals meeting defined eligibility requirements, including a desire to address OUD among inpatients through the use of MOUD. Community hospitals will be randomized 1:1 to implement a low- or high-intensity strategy. Hospitals will be randomized with intervention implementation and oversight assigned to one of 3-4 geographically diverse hub academic medical centers with existing clinical and research expertise in HBOT. The randomization will be stratified by site/hub. Participants will be assessed for "engagement with MOUD", measured as the proportion of community hospital OUD discharges engaged with MOUD within 34 days following hospital discharge during months 13-24 of the intervention. Further outcomes will be assessed during the entire 4-year study period.

Eligibility Criteria:
Inclusion Criteria:

1. Be a community hospital deemed by the lead investigators to be in the region of a site/hub. Region will usually be defined as state unless a compelling case can be made as to geographic feasibility of implementing the intervention and access to relevant Medicaid data.
2. Be willing to identify a site champion to promote and adopt change that can address OUD in hospitalized patients.
3. Have hospital personnel who state that their institution is interested in and would be willing to work to implement MOUD prior to hospital discharge.
4. Commit to having buprenorphine-waivered prescribers willing and able to write prescriptions to bridge discharged patients to post-discharge OUD treatment, or available direct entry into outpatient MOUD with methadone or buprenorphine.
5. Have hospital staff who express willingness to engage with a site/hub team for training and for data collection.
6. Be willing to be randomized to low-intensity or high-intensity implementation support.
7. Provide inpatient general medical care.
8. Have sufficient numbers of Medicaid OUD discharges (any listed diagnosis; sufficient is defined as at least enough such that when added to the other hospitals in the region there are on average 100 discharges per year). Medicaid data must capture at least 3 discharge diagnoses, outpatient MOUD, and be available within no more than 12 months of discharge.

Exclusion Criteria:

1. Have an ACS routinely prescribing MOUD at discharge.
2. Have an existing, functioning HBOT program or be imminently starting an HBOT initiative, as confirmed by the investigator team.
3. Be a Veterans Affairs hospital.
A Thin Catheter For Hystrosalpingography

The investigators will use a thin catheter for HSG and apply pressure on the cervix with the vaginal speculum to prevent leakage of the dye during injection to study the uterine cavity and fallopian tubes and reduce the pain as compared to a standard metal cannula.

Hysterosalpingography (HSG) remains one of the most reliable methods to study tubal patency and the uterine cavity (1-3). The relative indications and importance of HSG and laparoscopy in the diagnosis of tubal factor infertility have been extensively discussed. Recently a multicenter randomized controlled trial (4) has demonstrated that the routine use of HSG at an early stage of infertility work up, prior to laparoscopy and dye, does not influence the cumulative pregnancy rate compared with the routine use of laparoscopy and dye alone. However, HSG is an efficient method which is less invasive and less costly than laparoscopy (5), and than transvaginal hydrolaparoscopy (6). The main disadvantages of HSG are being unable to confirm adhesions, endometriosis and being a painful procedure (7,8). Different cannulas and catheters have been tried to reduce pain such as the Rubin cannula (9), Jorcho cannula (10), and Whitehead cannula or Foley catheter (11). Minimal difference in the degree of pain was found when the balloon catheter was compared with the cervical cup (12). General and local medications have been tried to alleviate pain during the procedure. (3,13).

HSG is widely practiced in our country, however, for cost effective reasons, the standard metal cannula is the only method used at our hospital. It is painful procedure because it requires grasping the cervix with a tenaculum and inducing some cervical dilatation during introduction of the cannula. The aim of this pilot study was to develop a simple and painless technique for HSG using a thinner than normal catheter, and without grasping the cervix with a tenaculum. Leakage of the dye through the cervix was prevented by pressing on the portiovaginalis of the cervix using the vaginal speculum. This technique for performing HSG is a novel one and has not been described previously in the medical literature.

Eligibility Criteria:
Inclusion Criteria:

* infertile women during their fertility workup and requesting to do hysterosalpingography

Exclusion Criteria:

* women with pelvic inflammatory disease
Follow-up of a Cohort of Patients With Aortic Valve Bicuspidia

The aortic valve bicuspidia (BVA) is a congenital condition corresponding to the presence of 2 sigmoids instead of 3. This is the most common cardiac congenital anomaly affecting 0.5 to 2% of the population The general rule. BVA may be associated with structural damage to the ascending aorta, which exposes BVA patients to a risk of developing ascending aortic aneurysm and acute aortic accidents. Recent data from the literature have revealed that the natural history of BVA is marked by a possible development towards significant valvulopathy and / or an ascending aortic aneurysm often requiring surgical treatment. However, the natural history of bicuspid disease remains poorly understood and the prognostic factors for progression to severe valvulopathy and / or aneurysmal dilatation of the ascending aorta remain to be determined.


Eligibility Criteria:
Inclusion Criteria:

* All patients examined in the echocardiography laboratory whose objective examination was a bicuspid valve of the aortic valve
* Bicuspidia may be formerly known

Exclusion Criteria:

* Refusal to participate
* Patients who had already undergone bicuspid surgery or ascending aorta before being examined at the echocardiography laboratory