cyrilzakka/clinical-trials huggingface dataset:
Cytidine and Omega-3 Fatty Acids in Bipolar Disorder

The goal of the proposed clinical trial is to assess the effect of oral cytidine and omega-3 fatty acids (O3FA) on bipolar disorder symptoms. This study is a 4-month, randomized, parallel-group, double-blind, placebo-controlled pilot study of a combination of cytidine and omega-3 fatty acids in 90 recently ill subjects with bipolar disorder. During the 16 week period of the study, subjects are assigned to one of three groups: 1) omega-3 fatty acids + cytidine supplementation, 2) omega-3 fatty acids supplementation alone, and 3) placebo supplementation.

Previous studies examining the effect of omega-3 fatty acids on bipolar depression have had mixed results. Some studies have found that omega-3 fatty acids have a positive effect on bipolar depression symptoms, while other studies have found no difference between placebo and omega-3 fatty acid treatment.

The variable effects noted with omega-3 fatty acids may be due in part to a real effect with limited potency. Larger effects might be achieved by combining agents with synergistic effects.

Cytidine is necessary to form key intermediates in the biosynthesis of the phospholipids phosphatidylcholine and phosphatidylethanolamine, which are major components of eukaryotic cell membranes. Recent human studies by our group have shown that CDP-choline (a compound composed of cytidine and choline) can modify brain phospholipid synthesis in healthy adults and may have antidepressant effects (Babb et al., 1996; Babb et al., 2002; Carlezon et al., 2002; Renshaw et al., 1999). The combination of omega-fatty acids and the related pyrimidine, uridine, was associated with enhanced antidepressant-like activity in rats (Carlezon et al., 2005). Thus, the combination of omega-3 fatty acid and cytidine, which is interconverted with uridine in the body, may provide a safe and powerful way to treat bipolar disorder, especially bipolar depression.

This study is a 4-month, randomized, parallel-group, double-blind, placebo-controlled pilot study of a combination of cytidine and omega-3 fatty acids in 90 recently ill subjects with bipolar disorder. During the 16 week period of the study, subjects are assigned to one of three groups: 1) omega-3 fatty acids + cytidine supplementation, 2) omega-3 fatty acids supplementation alone, and 3) placebo supplementation.

Eligibility Criteria:
Inclusion Criteria:

* bipolar disorder
* mood episode within past year
* stable medication regimen

Exclusion Criteria:

* primary psychiatric disorder other than bipolar disorder
* significant suicide or homicide risk
* unstable medical conditions
* current or planned pregnancy
* lactose intolerance
* medications affecting lipid absorption or metabolism
* clozapine treatment
High-Fidelity Simulation Training: A Mixed Method Study

The goal of this clinical trial is to compare in describe first-year nursing students' skills. The main questions it aims to answer are:

* Are nursing students who perform the simulation practice with the scenario-based high-fidelity simulation manikin higher than those who perform the practice with the standard demonstration method?
* Are the satisfaction levels of nursing students who perform the simulation practice with the scenario-based high-fidelity simulation manikin higher than those who perform the practice with the standard demonstration method? Researchers will compare two groups of nursing students training with high-fidelity simulation manikin and training with standard demonstration method.


Eligibility Criteria:
Inclusion Criteria:

* First-year nursing students
* Not have been trained in simulation before
* Taking a nursing fundamentals course for the first time
* Open to communication and volunteering to be involved in the study

Exclusion Criteria:

* Not meeting the inclusion criteria
* Not volunteering to participate in the study
LLETZ Under Direct Colposcopic Vision

To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven cervical dysplasia
* colposcopy Prior to conization
* informed consent

Exclusion Criteria:

* significant language barrier
* a personal history of conization
* pregnancy
* the use of blood thinner
* unwillingness to participate
Transperineal Ultrasound and the Place of Sonopartograph in Travay Follow-up in Term Pregnancy

Investigators aimed to determine the progression of the descent angle and head symphysis distance measured by intrapartum transperineal ultrasound as an alternative to vaginal examination and bishop score, according to time and cervical dilatation and to draw a sonopartograph as a new indicator also aimed to evaluate the success of the use of transperineal ultrasound in the active phase of labor in predicting prolonged labor, duration and mode of of delivery.

Descent angle and head symphysis distances by transperineal ultrasound of pregnant women who are in the active phase of labor was measured hourly in the first phase of the active phase (the period from 4 cm to full dilation of the cervical opening); every 15 minutes in the second phase of the active phase (time from full dilation to delivery of the baby) Cervical dilatation and head levels were noted by simultaneous digital vaginal examination. The physician who performed the imaging and the physician who made the vajinal examination worked independently of each other and did not see each other's results.

Eligibility Criteria:
Inclusion Criteria:

* multiparous pregnancy
* active phase in labor
* vertex position

Exclusion Criteria:

* multiple pregnancy
* BMI over 35
* preterm labor
* congenital anomalies
Evaluation of VLER-Indiana Health Information Exchange Demonstration Project

Three out of four Veterans receive a portion of their care from non-VA providers. On April 9, 2009, President Barack Obama directed the Department of Veterans Affairs and the Department of Defense to create the Virtual Lifetime Electronic Record (VLER). On August 2010, Secretary of Veterans Affairs Eric K. Shinseki visited Indianapolis, and after visiting with leaders from the VA Health Services Research \& Development (HSR\&D) Center of Excellence and the Regenstrief Institute, he made the following public comments regarding the latest partnership between the two institutions: "This new technology allows safer, more secure, and private access to electronic health information which, in turn, enhances our ability to continue providing Veterans with the quality care that they have earned."

This new technology refers to the VLER HEALTH program that the Indianapolis VA is now implementing in partnership with the Regenstrief Institute and Indiana Health Information Exchange (IHIE). This VA-IHIE demonstration project is intended to create the capacity for VA institutions to exchange health information with community partners.

Investigators from the VA HSR\&D Center on Implementing Evidence-Based Practice are active collaborators in building and implementing this program. The VA-IHIE program provides the bi-directional exchange of health information between VA and non-VA providers. Based on our pilot study of linked VA-IHIE data, investigators are conducting an evaluation of the impact of the VA-IHIE demonstration project upon health care quality and cost of Veterans by taking advantage of the initiation of the implementation as a natural experiment.

This study will perform a pre-post evaluation of the VA-IHIE implementation, with a concurrent control group, among Veterans seen at the Indianapolis VA. Data on care received by Veterans will be obtained for one year before, and one year after, VA-IHIE enrollment. Patients will be recruited into the VA-IHIE program in a rolling manner over the course of a year, and thus will have different calendar intervals of follow-up. For purposes of evaluation, investigators will approach the VA-IHIE implementation as a patient-directed intervention given that additional information available from the exchange is available only on a patient-by-patient basis, i.e., a provider cannot use exchange information available for one patient in the care of another. Although the VA-IHIE program will be implemented at the site level, patients will be enrolled individually.

Eligibility Criteria:
Inclusion Criteria:

* Veteran's receiving care at the Indianapolis VAMC at least one year prior and one year post VA-IHIE enrollment
* Veteran's receiving care from a facility other than the Indianapolis VAMC one year prior and one year post VA-IHIE enrollment

Exclusion Criteria:

None
Outcome of Failed and Neglected Terrible Triad Injury of the Elbow

The aim of the study is to evaluate the results of reconstruction of neglected and failed cases of terrible triad of the elbow

A terrible triad injury consists of posterior dislocation of the elbow associated with a radial head fracture and a coronoid fracture. This injury occurs during a fall onto an outstretched arm, and it presents a disruption of the bony and capsuloligamentous structures from the lateral side, which progresses anteriorly and medially.The primary goal of surgical treatment for terrible triad injury is to restore elbow function with. good stability. The current standard treatment involves internal fixation and reconstruction of the bony and ligamentous structures to allow early mobilization. Fixation or replacement of radial head fractures and lateral ligament reconstruction represent the main operative procedures. A biomechanical and clinical study showed that restoration of the coronoid process and anterior capsule is an important step for a stable elbow. old "terrible triad" of elbow with no operative history is difficult to treat. The elbow's functions and stabilization can be recovered by thorough elbow release, repair of coronoid process and anterior capsule, radial head fixation or replacment reconstruction or repaire of, lateral collateral ligament and reinsertion of the common extensor tendon, combined with hinged external fixator Although improved knowledge of this injury has yielded favourable clinical outcomes, complications continue to occur, including stiffness, recurrent subluxation or dislocation, heterotopic ossification, ulnar nerve neuropathy, and arthritis.The common causes of revision after terrible triad injury reconstruction are stiffness and recurrent instability, Stiffness and instability, among all these complications, are indeed the most recurring. A stiff or unstable elbow is very poorly tolerated because of the lack of compensatory motion in adjacent joints, So it's very important to detect causes and risk factors that leading to fail terrible triad reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* • Age from 15 to 70 years' old

  * Neglected cases more than 4 weeks
  * Early failed cases whom had any intervention whether conservative treatment as cast or hinged elbow brace etc or operative and still complaining of instability of the elbow. In less than 6 weeks
  * Late Failed cases whom had any intervention whether conservative treatment as cast or hinged elbow brace etc or operative and still complaining of instability of the elbow after more than 6 weeks .

Exclusion Criteria:

* • Older than 70 years old and younger than 15 years old

  * Nerve injury
  * Associated soft tissue loss
  * Patients needs Total Elbow Replacement or Arthrodesis
Coronary Microvascular Disease (CMD) Registry

The purpose of this project is to provide appropriate administrative and technical supports for the warehousing and use of a database of patients with coronary microvascular disease (CMD). This protocol will outline the process for identification and capture of data, storage, as well as data use and sharing internally and externally for research purposes.


Eligibility Criteria:
Inclusion Criteria:

* Those with Coronary Microvascular Disease
Low Level Laser Therapy for Autoimmune Thyroiditis

INTRODUCTION: Chronic autoimmune thyroiditis (TCA) is the main cause of acquired hypothyroidism, which requires continuous treatment with levothyroxine (LT4). A randomized, placebo-controlled trial including 43 patients with hypothyroidism caused by TCA without nodules on ultrasonography study (US) was conducted from March 2006 to March 2009 (NCT01129492). Among them, 23 were submitted to low-level laser therapy (LLLT) and 20 to placebo. The LLLT was effective in improving the echogenicity, the volume and of the thyroid vascularization pattern by US. There was also improvement in the thyroid function and reduction of serum thyroid peroxidase antibodies (TPOAb). Although the results have shown promising and LLLT has shown to be safe in many study models, the long-term LLLT actions on the thyroid parenchyma are unknown. Thus, the objective of this study is to perform biochemical tests and thyroid US six years after the clinical trial interventions to evaluate levothyroxine dose, serum levels of autoantibodies and, especially, the frequency and nature of nodules in the gland and then compare these variables between LLLT and placebo groups. METHODS: This study will include the trial participants performed six years before. The levothyroxine dose and serum levels of thyrotropin (TSH), T3, T4, free T4, TPOAb and anti-thyroglobulin antibodies (TgAb) will be evaluated in these patients. The thyroid US will assess the texture (with particular attention to identifying nodules), echogenicity, volume, as well as vascularization of the gland. The US nodules features, such as dimensions, shape, margins, extracapsular invasion, echogenicity, texture, hypoechoic halo, calcification, internal content, vascularization pattern and resistivity index will be searched. Regional lymph nodes and other characteristics will be also investigated. The USs will be carried out by only one examiner who will be blinded for the previously performed intervention (LILT or placebo). The same investigator will execute a fine needle aspiration (FNA) of patients with thyroid nodules. The cytological analysis of the material collected from the nodules will be undertaken by a pathologist who will be also blinded for the treatment assignments. RESULTS: The following variables will be compared between the two groups: levothyroxine doses, antithyroid antibodies, US parameters, thyroid nodules (if detected) and in this case, the result of their respective FNA.


Eligibility Criteria:
Inclusion Criteria:

All patients who have hypothyroidism caused by autoimmune thyroiditis included in the randomized, placebo controlled clinical trial (NCT01129492)

-

Exclusion Criteria:

All patients who have hypothyroidism caused by autoimmune thyroiditis included in the aforementioned trial (NCT01129492) who underwent surgery and/or therapeutic administration of radioiodine for thyroid diseases during the period between the initial assessment of patients up to the present study.
SARS Cov-2 in Conjunctival Secretion in COVID-19 Patients

Observational study to evaluate the presence of SARS COV-2 in tears collected in COVID-19 patients in Lombardia region, northern Italy, and to correlate virus presence to concomitant systemic clinical conditions.

Since February 2020, Coronavirurus Disease 2019 associated to a severe acute respiratory syndrome started in China and rapidly spread all over the world and in particular in northern Italy. There are many reasons to justify this rapid diffusion in Italian Lombardia region as the high population density with more possibilities of interpersonal contact, high prevalence of respiratory pathologies, in particular in elderly people, due to pollution, high number of contacts with Chinese population for travelling and business reasons, and at last the non-windy temperate climate conditions, that increases the persistence of virus in the environment.

At now, more than eighty thousand citizens from Lombardia Region have been officially affected by the disease with a high death toll, also considering that actual numbers are certainly much underestimated.

The aim of the present study was to evaluate the prevalence of SARS COV-2 virus in tears collected from COVID-19 patients by rtPCR analysis directed to target sites of viral RNA, and to correlate virus presence to concomitant systemic clinical conditions

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized COVID 19 patients

Exclusion Criteria:

* Patients with respiratory support that interferes with tears sampling
Prevalence of Human Papillomavirus in Men Living in the Northern Plains

HPV infection is associated with cervical and other anogenital cancers. HPV may also be associated with the development of prostate cancer. The purpose of the study is to determine the prevalence of HPV infection in men living in South Dakota.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Ages 18-65
* Living in South Dakota (AKA Northern Plains)

Exclusion Criteria:

-
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes

The goal of this study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely (a condition abbreviated as PPROM). Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age, when the risks of prematurity to the baby are lessened. Research shows that antibiotics help the pregnancy last longer, but there have been limited studies about which combination works best. Currently, both azithromycin and erythromycin are accepted antibiotic treatments, in addition to ampicillin and amoxicillin. Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin, in addition to the care they would normally receive. Studying these two drugs will help decide the best care for future patients with PPROM.

Preterm pre-labor rupture of membranes (PPROM) complicates 3% of pregnancies and accounts for one-fourth to one-third of preterm births. PPROM is associated with significant maternal and neonatal morbidities, including chorioamnionitis, endometritis, neonatal sepsis, prematurity-related pathologies. In the absence of labor or indication for immediate delivery, patients who present at less than 34 weeks gestational age are treated with antibiotics to prolong pregnancy until 34 weeks when the risks of prematurity are decreased. Based on randomized trials, both the American College of Obstetrics and Gynecology (ACOG) and the Society of Maternal Fetal Medicine (SMFM) recommend IV ampicillin and IV erythromycin for 2 days, followed by an oral regimen of amoxicillin and erythromycin for 5 days. Due to the recent limited availability of erythromycin, azithromycin has been used a substitute. There have been observational studies showing no difference in duration of pregnancy between azithromycin and erythromycin, however no randomized controlled trial has been carried out to our knowledge. This study performs a cluster randomized controlled trial to examine the efficacy of azithromycin versus erythromycin as a component of the "latency antibiotics" used to prolong pregnancy in PPROM patients.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy at 22 weeks 0 days to 32 weeks 6 days of gestation.
* Rupture of membranes confirmed by biochemical testing.
* Membrane rupture within the past 36 hours.
* Cervical dilation 3 cm or less and 4 or fewer contractions within 60-minutes at the time of admission.
* Age ≥18 and \<50 years.

Exclusion Criteria:

* Non-reassuring fetal heart tracing, vaginal bleeding, chorioamnionitis or any indication for delivery at admission.
* Allergy to penicillin, erythromycin, or azithromycin.
* Multiple gestations.
Evidence-based Laboratory Test Order Sets in Primary Care

Cluster randomised controlled trial to evaluate what the effect is of evidence-based order sets aimed at five indications on the appropriateness of laboratory test ordering in primary care.

Cluster randomised controlled trial in Belgian primary care practices. Participants will be primary care physicians working in primary care practices affiliated to one of three collaborating laboratories in the Leuven, Ghent or Antwerp regions.

Primary care practices will be allocated and randomized to either the intervention or control group. Physicians in PCPs randomized to the intervention will be offered order sets based on indication when using the CPOE for ordering laboratory tests. The effect of order sets will be analyzed for 17 common indications for ordering laboratory tests in Belgian primary care: diabetes mellitus, hypertension, cardiovascular disease, general check-up, unexplained fatigue, anemia, liver pathology, medication monitoring, gout, chronic kidney disease, lung embolism, acute coronary syndrome, diarrhea, thyroid disease, sexually transmitted disease, rheumatoid arthritis and obesity.

Eligibility Criteria:
Inclusion Criteria:

* Primary care practices will be considered eligible if all the physicians active in the practice agree to be involved in the study
* All family physicians will be considered eligible if they:

  * Collaborate with either MCH, Anacura or AML for their laboratory test orders
  * Agree to use the online CPOE for their laboratory test orders
  * Use a computerized EHR for patient care
  * Agree to the terms in the informed consent

Exclusion Criteria:

* Primary care practices where one or more physicians refuse to be enrolled will be excluded
Improving Outcomes and Quality of Life After CABG

The principal objective to this randomized trial is to compare the efficacy of two strategies of intra-operative hemodynamic management during cardiopulmonary bypass among patients undergoing primary elective coronary artery bypass graft (CABG) surgery in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality and post-operative deterioration in the patient's quality of life as measured by the seven domains of SF-36 Health Survey (bodily pain, health perceptions, energy, and mental, physical, social and role function).

In one group, mean arterial pressure (MAP) was 65 mmHg. In the other, the MAP target was determined by the patients usual preoperative MAP. Thus, the trial will evaluate whether tailoring the MAP target for the period of cardiopulmonary bypass to within 10 mmHg of the patients usual MAP, but \< 90 mmHg (and thus achieving pressures during bypass within the patients usual autoregulatory range) reduces major neurologic and cardiac morbidity and mortality, as well as cognitive complications, thereby improving post-operative quality of life.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing primary elective/urgent coronary artery bypass graft (CABG) surgery.

Exclusion Criteria:

* Patients who elect not to participate in the study
* Patients undergoing valve replacement or other cardiovascular surgical procedures
* Patients who are not fluent in English
* Patient who cannot provide informed written consent
Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma

The purpose of this study is to evaluate the safety and CTL reaction of novel peptide vaccination for advanced renal cell carcinoma


Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS advanced renal cell carcinoma which already showed resistance to standard treatments

PATIENTS CHARACTERISTICS

1. Patients who showed resistance to hormonal therapy and chemotherapy
2. Histological diagnosis is adenocarcinoma
3. HLA-A\*0201/0206
4. ECOG performance status of 0 to 2
5. Age ≥ 20 years, ≤80 years
6. WBC≥ 2,000/mm³, ≤12000/mm³ hemoglobin≥ 8.0g/dl Platelet count ≥ 70000/mm³ AST, ALT ≤100 IU/l Total bilirubin ≤ 1.5 mg/dl Creatinine ≤ 1.0 mg/dl PaO2≥ 70mmHg
7. life expectancy ≥ 3months
8. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
2. Breastfeeding
3. Patients willing to childbearing ( Refusal or inability to use effective means of contraception)
4. Serious infections requiring antibiotics
5. Concomitant treatment with steroids or immunosuppressing agent
6. Other malignancy difficult to control.
7. Decision of unsuitableness by principal investigator or physician-in-charge