cyrilzakka/clinical-trials huggingface dataset:
Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound

The purpose of this study is to verify whether additional administration of Alirocumab exerts a stronger stabilizing effect on the vulnerable plaque in CAD, compared with statin alone administration in patients receiving PCI. Therefore, the change in maxLCBI (4 mm) of the coronary artery 9 months after administration by addition administration of Alirocumab is evaluated as the main evaluation item as compared with statin administration alone for patients who have CAD and received PCI. Also, change of plaque properties is compared with baseline and evaluated. This study is a single-center, randomized, open-label study, using alirocumab, rosuvastatin as test drugs. Based on the findings obtained in this study, it is possible to clarify the mechanism of stabilization of the plaque in a patient with coronary artery disease, which in turn suppresses the progress of plaque in coronary artery disease, resulting in primary or secondary There is a possibility that it can contribute to prevention.

The investigators investigate the change in the maxLCBI (4 mm) value calculated by NIRS-IVUS at the time of PCI and at the treatment evaluation after 9 months compared with the group of Alirocumab(Alirocumab75mg/2week+losuvastatin10mg/daily) and standard treatment (losuvastatin10mg/daily alone). And also the investigators evaluate LCBI(lesion), Angle of a lipid core, EEM CSA, Lumen CSA, Minimum lumen diameter, Plaque burden, Lesion length by NIRS-IVUS.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent PCI for ACS or stable coronary heart disease
* Patients with LDL-C ≥70 mg/dL under daily 10mg rosuvastatin
* Patients who remained 25-75% stenosis with coronary angiography
* Patients who obtained analyzable images and calculated maxLCBI (4 mm) with NIRS-IVUS
* Patients aged ≥20 years old at PCI
* Patients who agree to be enrolled in the trial give signed written informed consent

Exclusion Criteria:

* Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody
* Patients had uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) between the time of PCI and randomization visit
* Known hypersensitivity to alirocumab or rosuvastatin
* All contraindications to alirocumab and/or rosuvastatin as displayed in the respective national product labeling for these treatments
* Known history of hemorrhagic stroke
* Currently under treatment for cancer
* Patients on lipoprotein apheresis
* Patients with severe liver or renal dysfunction
* Pregnant or breastfeeding women
* Patients recognized as inadequate by attending physician
A Novel Patent Platform of Detection of Circulating Tumor Cells to Early Detect Colorectal Cancer Recurrence

The best strategy to prevent colorectal cancer (CRC) death lies in early detection and early treatment at the local disease status of tumor. After curative resection of tumor, there are about 5\~10% of stage I, 20\~30% of stage II and 40\~50% of stage III patients suffering metastasis during subsequent follow-up periods. Although carcinoembryonic antigen (CEA) is the most widely used biomarker for postoperative monitoring of recurrence on asymptomatic patients, it is difficult to use CEA as biological marker to identify the population with high recurrent risk in patients with early-stage cancer because lower than half of patients with early-stage cancer do not have CEA elevation. For improving the survival of patients with early-stage CRC, we need effort to search more useful biological markers to predict the risk of tumor recurrence and to select out patients with high recurrent risk to receive preventive adjuvant therapy.

Circulating tumor cells (CTCs) in the blood play an essential role in cancer metastasis. Hence, the detection of CTCs and subsequent analysis can potentially revolutionize the cancer care ranging from screening, diagnosis, monitoring, to drug selection and so on. In the past decade, many methods using magnetic beads (CellSearch), filtration (RareCelletc), or flow cytometry have been developed but all of them have the shortcomings from low sensitivity, low purity, to unable to retrieve cells for downstream molecular analysis and cell culture. Recently, a biomimetic affinity based microfluidic platform has overcome abovementioned technical challenges. Importantly, by using only 2 ml of peripheral blood, Sinica's team has shown that the enumeration of CTCs increases with the CRC disease progression, where the mean CTC counts are 3, 15, 29 and 60 per ml for the stages I, II, III and IV, respectively. The results imply that monitoring CTC enumeration serially may serve as a prediction marker to identify the CRC patients with high probability of recurrence. The aims of this study are toestablishing CTC platform standard operation protocol (SOP) that leads to certification of ISO 13485 and to establish CTC criteria and evaluate its prediction power of early detection of colorectal cancer recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of colorectal cancer

Exclusion Criteria:

* age younger than 20
* Pregnancy
* Inmates
Homeless Veterans and Peer Whole Health Coaching

Use of acute care services (e.g., hospitalizations, Emergency Department visits) contributes substantially to the cost of healthcare for Veterans. Homelessness is a robust social determinant of super utilization of acute care. The goal of this project is to test if Peer Specialists trained in Whole Health Coaching can reduce homeless Veterans' frequent use of acute care.

Ten percent of patients account for up to 70% of acute care costs. Among these "super-utilizer" patients, homelessness is a robust social determinant of acute care utilization. Through a field-based dashboard and clinical aids, the Hot Spotter Analytic program assists Patient Aligned Care Teams (PACT) with targeting and tailoring care for the highest-need homeless Veterans. However, many Veterans identified by the Analytics do not engage in supportive services that reduce risk for acute care utilization. Peer Specialists (PS) are a high-value workforce that can facilitate Veterans' engagement in care. Yet, there is a need to enhance the PS role with a structured approach that can capitalize on known facilitators of care engagement among homeless Veterans. Whole Health Coaching (WHC) is one such approach. By focusing on patients' values and goals rather than treatment of specific conditions, WHC reduces patients' stigma regarding their care needs and increases patient activation and well-being, which can increase engagement in supportive services.

The goal of this project is to integrate use of Hot Spotter Analytics with Peer Specialists trained in Whole Health Coaching (PS-WHC) and evaluate whether this approach reduces homeless Veterans' frequent use of acute care. Using a Hybrid Type 1 design at the Palo Alto, Bedford, and North Little Rock VAs, the investigators will test whether receipt of PS-WHC (vs. Enhanced Usual Care; EUC) predicts (1a) lower acute care utilization, (1b) better health-related outcomes, and whether (1c) the effects of PS-WHC on 1a and 1b are mediated by increased (i) patient activation and well-being, and (ii) access to supportive services. Aim 2: Conduct a process evaluation to inform VA's potential widespread implementation of Hot Spotter Analytics + PS-WHC on PACTs. Aim 3: Conduct a Budget Impact Analysis to determine the impact on total costs of VA care due to implementing PS-WHC.

Eligibility Criteria:
Inclusion Criteria:

Veterans who:

* are on VA's Homeless Registry, which comprises those who utilized any VA homeless programs and services in the past 2 years
* are enrolled on a Patient Aligned Care Team (or "PACT") at a study site
* had a hot spotter qualifying event in two or more quarters in the past year will be eligible for participation

Exclusion Criteria:

* Veterans who have a suicidal and/or behavioral flag in their medical record and those who are too cognitively impaired to understand the informed consent process and other study procedures will be excluded
Comparison of Techniques for Breast Cancer-Related Lymphedema.

This crossover study compares two different treatment techniques for Breast Cancer-Related Lymphedema: 1. Complex Physical Therapy plus Pressotherapy.

2. Kinesio Taping.

Breast Cancer-Related Lymphedema (BCRL) tends to progress in stage and grade if it is not treated.

Complex Physical Therapy (CPT), that includes Manual Lymph Drainage + Multilayer Bandage + Self-care, is the most used technique in order to join the benefits of each technique by the lack of great results with only one technique. The most volume reduction found in a study was achieved combining CPT and Pressotherapy(P). On the other hand, the use of Kinesio Taping (KT) for BCRL has been spreading lately although its clinical efficacy has not been determined by high quality studies.

GOALS:

Main objective: To analyze the effectiveness in the reduction of BCRL volume with KT versus CPT+P in patients attended at the rehabilitation service at HU12Octubre.

Secondary objectives:

To analyze possible changes after each therapy in:

* DASH (Disability Arm, Shoulder and Hand) outcome measure score.
* TTDL (textile therapeutic device for lymphedema) questionnaire score (a quality of life questionnaire for patients with breast cancer-related upper lymb lymphedema using textile therapeutic device that has been validated previously).
* Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using visual analogue scale (VAS).
* Goniometry of Upper Limb.

METHODOLOGY OF THE STUDY:

Design: crossover trial, with a 3-month washout period between both treatment phases. Open design: it is impossible during the treatment to blind physiotherapists and patients, due to the observable differences between both therapies neither during their application nor in the hours after their removal, by the marks left in the skin. The statistical analysis will be supervised by staff of the Clinical Research Unit-Clinical Trials (i+12) of HU12Octubre with the variables coded to blind the analyst.

Interventions: The two therapies compared are:

* CPT+ P.
* KT. Sample size: a sample of 50 patients (25 in each group) was calculated. Subjects of study and randomization: An initial computerized randomized sample was generated among the patients who had attended the Breast Pathology Rehabilitation visit at HU12Octubre during the previous year and who met the eligibility criteria and they were randomly assigned to the groups.

Eligibility Criteria:
Inclusion Criteria:

1. Submit BCRL
2. Be a patient of the Breast Pathology Rehabilitation at Hospital Universitario 12 de Octubre.
3. Signing the informed consent.

Exclusion Criteria:

1) Breast Cancer metastasis or other active tumor. 2) Intravenous chemotherapy or radiotherapy actually. 3) Heart or kidney failure. 4) Use diuretics. 5) active infection (erysipelas) or any cutaneous disease in UL or back. 5) Bilateral lymphadenectomy. 6) present deterioration or cognitive delay that would prevent understanding instructions and purpose of the study.

7) Have performed treatment for BCRL during the 3 months prior to the start of the study (previous washing phase).
Study to Reduce Intravenous Exposures (STRIVE)

The purpose of this study is to determine whether a six-session, small group behavioral intervention based on "peer-volunteer activism" is effective in (1) decreasing distributive sharing of syringes and other injection paraphernalia and (2) increasing utilization of HCV-related healthcare services among HCV-infected injection drug users

The purpose of this study is to determine the efficacy of a peer-volunteer intervention to reduce high-risk transmission behaviors among hepatitis C virus (HCV)-infected young adult injection drug users (IDUs), and to identify the proportion of these individuals who would be eligible and willing to undergo treatment to eradicate HCV infection. HCV is one of the most frequently occurring human viral infections, having an estimated worldwide prevalence of 3%. In many regions of the United States, between 65% and 95% of IDUs are HCV-seropositive and capable of transmitting the infection. To date, research studies targeting infected individuals to prevent secondary transmission of chronic blood-borne viral infection have generally been limited to post-test counseling and case management. In addition, recent data suggest that medical treatment of HCV infection may be most effective when offered soon after HCV seroconversion. However, the proportion of HCV-infected IDUs who meet strict national guidelines for HCV treatment is likely to be small because treatment is usually postponed while drug use continues. Determining the proportion of infected individuals who may be both eligible and willing to undergo HCV therapy is highly important for guiding national standards and objectives to achieve greater numbers of IDUs in HCV therapy. We have previously reported that fewer than 1% of HCV-infected IDUs in Baltimore are currently receiving such therapy. Early initiation of HCV treatment among young IDUs in conjunction with a reduction in HCV transmission risk behaviors may ultimately lead to a reduction in incident HCV infection at the individual and the community levels.

This study is a randomized controlled trial to determine the efficacy of a "peer-volunteer activism" intervention to reduce distributive syringe and injection paraphernalia sharing behaviors among HCV positive IDUs and promote the uptake of HCV care and treatment. If proven effective, this intervention would substantially decrease the risk of HCV infection in the community. To address these aims, we plan to recruit, screen, and randomly assign 750 IDUs age 18-35 years who are HCV-seropositive but HIV-seronegative in Baltimore, New York and Seattle to a behavioral intervention (250 per site), and prospectively monitor participants behavior at 3- and 6-month follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* HCV antibody positive
* age between 18 and 35 years old;
* reported injection drug use in the past 6 months
* willing to provide a blood sample for liver function testing

Exclusion Criteria:

* HIV antibody positive
* planned on moving from city within the next 12 months;
* unable to comprehend English well enough to complete English-only assessments and group sessions
Intra Incisional Infiltration of Bupivacaine Versus Meloxicam on Post Cesarean Section Pain Relief

Investigation: compare the effect of local infiltration of incision site with bupivacaine and local infiltration with meloxicam in women undergoing cesarean sections on postoperative pain relief and analgesic requirement.

Condition: post cesarean sections analgesia intervention: infiltration of incision bupivacaine versus meloxicam Phase: Not applicable

study type: randomized clinical trial actual enrollment: 119 allocation: Random intervention model: three groups assignment masking: open lebal primary purpose: pain relief after Cesarean section actual study start: March 3, 2019 Primary Completion: March 5, 2020 actual study completion date: May 9, 2020

Eligibility Criteria:
Inclusion Criteria:

* Age between 21-40 years
* Elective C.S at term
* Patient having no medical disorders
* Patient with no obstetrical complications

Exclusion Criteria:

* extreme of reproductive age
* allergy to local anesthetic infiltration agent
* any medical disorders or obstetrical complications as ante partum hemorrhag, pre-eclampsia
* refusal to participate in the trial.
Preterm Infants Fed a Human Milk Fortifier

This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).


Eligibility Criteria:
Inclusion Criteria:

* Birth weight between 700 g-1500 g.
* ≤ 32 weeks and 0 days GA at birth.
* Participant has been classified as appropriate for GA (AGA).
* Enteral feeding of human milk must be initiated by 21 days of life (birth date is day of life 0)
* Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if fortified with study fortifier and use of mother's own milk (when available) is prioritized.
* Parent(s) agrees to allow infant to receive both human milk and study HMF.
* Singleton or twin births only.
* Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

* Enteral feeding of preterm infant formula or HMF for \> 7 days.
* Expected to be transferred to another facility within 30 days of randomization.
* Serious congenital abnormalities or underlying disease that may affect growth and development.
* 5-minute APGAR ≤ 4.
* Receiving systemic steroids at time of randomization.
* Receiving probiotics at time of randomization.
* Grade Ill or IV PVH/IVH.
* Dependent on invasive ventilation at time of randomization.
* Maternal incapacity.
* Mother or infant is currently receiving treatment consistent with HIV therapy.
* Documentation of maternal use of alcohol or marijuana during pregnancy that in the opinion of the physician is considered abuse.
* Positive toxicology report for cocaine, opiates, or methamphetamine in mother or infant.
* Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).
* Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score \<3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas \< 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life.
* Confirmed NEC (Bell's Stage II or III).
* Confirmed current sepsis.
* Infant has any other condition that, in the opinion of the investigator, precludes participation in the study.
* Participation in another study that has not been approved as a concomitant study by AN.
* Participant has an allergy or intolerance to any ingredient in study fortifier.
Predictive Value of Scoring System in Neonates with Disseminated Intravascular Coagulation

The aims of this study were to investigate underlying diseases associated with neonatal DIC diagnosed on the first 28 days of life, and whether DIC score could predict mortality in neonates.

Disseminated intravascular coagulation (DIC) is a syndrome caused by the activation of blood coagulation, in which systemic intravascular micro thromboses result in multiple organ failure and severe bleeding due to consumption of platelets and coagulation factors \[1\]. Compared with adults, neonates have an immature coagulation-fibrinolysis system and are prone to complications that cause DIC, such as hypoxia, acidosis, and infection \[2\]. Additionally, preterm infants have a lower hemostatic profile than term infants, which increases their risk of DIC \[3\]. However, gold standard interventions and treatments for DIC are lacking in neonatal medicine, Veldman et al. suggested that DIC in neonates is caused by prenatal risk factors such as placental abruption (PA), pregnancy induced hypertension (PIH), and neonatal factors such as sepsis, asphyxia, and interventricular hemorrhage (IVH), along with postnatal factors, such as necrotizing enterocolitis, gastrointestinal perforation, and infection \[4\]. The Japan Society of Obstetrical, Gynecological \&amp; Neonatal Hematology (JSOGNH) revised its diagnostic guidelines for neonatal DIC in 2016 and proposed a DIC scoring system \[5\]. Anticoagulant therapy, such as antithrombin administration and fresh frozen plasma (FFP), has been used to treat neonatal DIC \[6\]. Since 2008, recombinant human soluble thrombomodulin (rTM) has emerged as a novel anticoagulant for DIC in Japan \[7\]. Reversal of the underlying condition is paramount in achieving treatment success in the newborn with DIC. Strategies such as early antibiotic therapy and identification and control of the source of disease in cases of necrotizing enterocolitis, sepsis, and septic shock should always precede interventions directed at normalizing the coagulation system \[8\]. reports are lacking about diseases associated with neonatal DIC and whether anything predicts mortality in this context. We discuss the clinical andlaboratory criteria using (JSOGNH) scoring system to see if DIC score could predict mortality in neonates.

Eligibility Criteria:
Inclusion Criteria:

1. age at enrollment from the first day of life to 28 days of life.
2. Neonates diagnosed as DIC.

Exclusion Criteria:

1. Neonates born to mothers with ITP.
2. Autoimmune thrombocytopenic patients.
Metabolomics and Breast Cancer Risk in a Nested Case-control Study of the Cancer Prevention Study-II Nutrition Cohort

This study aims to investigate diet, lifestyles, serum metabolomics in relation to breast cancer risk in a nested case-control study including 1,547 postmenopausal women from the Cancer Prevention Study II (CPS-II) Nutrition Cohort. The CPS-II Nutrition Cohort is a prospective cohort study of cancer incidence and mortality among 184,185 men and women, established by the American Cancer Society in 1992. Participants completed a self-administered baseline questionnaire in 1992/1993 including demographic, medical, and lifestyle information. Follow-up questionnaires were sent to living participants in 1997 and every other year to update exposure information and ascertain newly diagnosed cancers. From June 1998 through May 2001, blood specimens were collected from 21,963 women. All participants completed a short questionnaire and provided informed consent at the time of blood draw. Non-fasting whole blood collected from each participant was shipped chilled overnight to a central repository, processed, and frozen in liquid nitrogen at approximately -130 °C for long-term storage.

Of the 21,963 women who provided a blood sample, investigators identified 782 postmenopausal women diagnosed with invasive breast cancer between blood draw date and June 2011 who had not been diagnosed with cancer (other than nonmelanoma skin cancer) before blood draw or prior to their breast cancer diagnosis. Controls were 1:1 matched to cases on date of birth, date of blood draw, and race and were cancer free at the date of case diagnosis. Seventeen women who were selected as controls were later diagnosed with breast cancer, at which time they became a case. A total of 1,547 postmenopausal women were included in the breast cancer nested case-control study.


Eligibility Criteria:
Inclusion Criteria:

* blood sample
* cancer free at blood draw

Exclusion Criteria:

* unverified breast cancer
* non-invasive breast cancer