cyrilzakka/clinical-trials huggingface dataset:
Effects of Yoga on Heart Rate Variability and Mood in Women

Background: Women are more likely to suffer from depression and anxiety, which have been linked to reduced heart rate variability (HRV) and increased cardiovascular morbidity and mortality. The purpose of this study was to examine the effects of an 8-week yoga program on HRV and mood in generally healthy women. The investigators hypothesized that there would be improvements in HRV and reductions in perceived stress and symptoms of depression and anxiety after the yoga intervention.

Methods: Fifty-two healthy women were randomized to either a yoga group or a control group. Participants in the yoga group completed an 8-week yoga program, which comprised a 60-minute session, twice a week. Each session consisted of breathing exercises, yoga pose practice, and supine meditation/relaxation. Participants' HRV, perceived stress, depressive symptoms, and state and trait anxiety were assessed at baseline and week 9.


Eligibility Criteria:
Inclusion Criteria:

* women
* aged 18-50 years old
* body mass index \< 30 kg/m2

Exclusion Criteria:

* currently engaged in regular yoga practice
* pregnant
* nursing
* had physical contraindications to exercise
Quality of Care in Centers Providing Extracorporeal Membrane Oxygenation

Cardiac arrest centers are specialized in treating critically ill patients with severe cardiovascular diseases, such as cardiac arrest, cardiogenic shock or acute myocardial infarction. Diagnostic and therapeutic measures, such as the use of devices for extracorporeal life support, require highly specialized training and skills. Apart from extensive medical expertise, physicians and nurses may be exposed to exceptional levels of occupational stressors. Therefore, excellent medical, psychological and inter-personal training of the medical staff is essential to improve patient outcomes. Assessment of quality of care is important to provide continuous improvement in patient care and team performance. To the best of our knowledge, there is no study which examined the quality of care in cardiac arrest centers across key dimensions of quality of care. Therefore, we aim to assess a bundle of key dimensions, that is psychological strain (P), resource utilization (R), interaction (I) between doctoral and nursing staff, costs of care (C) and education (E) programs for staff (PRICE scheme). A cross-sectional study will be conducted with doctors and nurses, using a digital quesitonnaire that will cover the five dimensions of the PRICE scheme.


Eligibility Criteria:
Inclusion Criteria:

* Adult medical doctors or nurses
* Permament staff in the cardiac arrest center
* Cardiac arrest center that provides therapy with extracorporeal membrane oxygenation (ECMO)

Exclusion Criteria:

* No permanent employment in a cardiac arrest center
* Non-adult staff
* Not a medical doctor or nurse
* Cardiac arrest center that does not provide therapy with ECMO
FloSeal in CRS and HIPEC

Introduction

Modern treatment of peritoneal carcinomatosis (PC) combines an aggressive cytoreductive surgery (CRS) of all macroscopic disease and hyperthermic intraperitoneal chemotherapy (HIPEC) performed at the time of surgery. It is considered a high risk procedure and post-operative intra-abdominal bleeding is a major issue as it can delay recovery and promote intra-abdominal infections. In most severe cases (10 to 20% of patients), a second surgery to control the bleeding will be necessary. Major causes of bleeding are : radical resection, extensive peritonectomy, length of surgery, massive transfusion and use of HIPEC.

To reduce the risk of intra-abdominal hemorrhage, many strategies have been tried and one of these is the liberal use of FloSeal, but there is no data in this particular field of interest. Over the last 18 months, the investigators have started to use FloSeal in all their cases with large PC and they have observed a dramatic reduction in the rate of reoperation for bleeding and probably secondarily, in the use of blood products, but this has not been measured.

Hypothesis

FloSeal can reduce the risk of bleeding after CRS and HIPEC procedure.

Primary objective

To evaluate if the use of FloSeal can reduce the risk of reoperation after CRS and HIPEC procedure in the treatment of PC.

Secondary objectives

* To evaluate if the use of FloSeal can reduce operative blood loss.
* To evaluate if the use of FloSeal can reduce the need of blood products after CRS and HIPEC procedure.
* To evaluate if the use of FloSeal can have an impact on other common surgical complications (which can be indirectly bleeding related).
* To evaluate if the use of FloSeal can have an impact on length of hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients older than 18 year old
* All cases of PC regardless of primary tumour (colorectal carcinoma, peritoneal mesothelioma, appendiceal carcinoma etc.)

Exclusion Criteria:

* Prophylactic HIPEC
* Peritoneal Carcinomatosis Index (PCI) \< 5
Effect of Concord Grape Juice on Endothelial Function

The study will compare Concord grape juice to a beverage that contains no grape flavonoids, but has a similar appearance and taste (placebo juice). A total of 60 overweight and obese participants over age 50 will be enrolled. Each participant will drink each beverage for 4 weeks with a 2-week rest period between two beverage consumption periods. The order of beverages (grape juice first or placebo juice first) will be randomized. The investigators will use ultrasound to measure brachial artery flow-mediated dilation, a measure of endothelial vasodilator function. The investigators will also collect blood samples to further assess the cardiovascular effects of grape juice.

The aim of the study is to determine whether Concord grape juice improves endothelial function in patients at risk who do not have cardiovascular disease and may provide information that would guide dietary recommendations. The results may also be used by the sponsor to substantiate claims and labeling of their product.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index ≥ 25 and \< 40 kg/m2
* Age ≥ 50 years
* Otherwise healthy

Exclusion Criteria:

* Clinical diagnosis of atherosclerotic vascular disease.
* Clinical history of diabetes mellitus or fasting glucose ≥126 mg/dl
* Uncontrolled hypertension
* Treatment with an investigational new drug within the last 30 days
* Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, or other conditions that in the opinion of the principal investigator make the study inappropriate
* Psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study
* Use of Vitamin E, Vitamin C, beta carotene, lipoic acid, or other food or herbal supplements within 1 month of enrollment. Subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the recommended daily allowance will not be excluded
* Extreme dietary habits (i.e. Atkins, very high protein/low carbohydrate, or vegan diet
Physiologic Assessment of Thrombus Aspiration in Acute ST-segment Elevation Myocardial Infarction Patients

The Physiologic Assessment of Thrombus Aspiration in ST-segment Elevation Myocardial Infarction (PATA-STEMI) trial is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first ST-segment elevation myocardial infarction (STEMI). Patients are, before coronary angiography, randomly assigned to thrombus aspiration using 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary percutaneous coronary intervention (PCI). The primary endpoint is index of microcirculatory resistance (IMR), measured in infarct-related artery, in thrombus aspiration compared to conventional PCI group.

Background and Objective Routine thrombus aspiration is superior to conventional primary PCI in terms of improved myocardial perfusion in STEMI patients. However, myocardial perfusion after thrombus aspiration has not been evaluated by a quantitative, invasive method. Investigators intend to determine whether thrombus aspiration of the infarct-related artery increases myocardial perfusion, as measured by IMR, compared to conventional primary PCI.

Study design PATA-STEMI is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first STEMI. Patients are randomly assigned, before coronary angiography, to thrombus aspiration using the 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary PCI. The IMR will be determined in infarct-related artery and non-infarct-related arteries without critical stenosis to measure microcirculatory resistance. The primary endpoint is defined as IMR in infarct-related artery in thrombus aspiration compared to conventional PCI group. Secondary end points are myocardial perfusion grade and resolution of ST-segment elevation, infarct size and left ventricle remodeling, as assessed by echocardiographic indices. Transthoracic echocardiography will be conducted within 24 hours and at 4 months after the primary PCI.

Implications: If manual thrombus aspiration reduces microcirculatory resistance, indicating improved myocardial perfusion, as compared to conventional PCI, it might become the preferred strategy in patients with STEMI.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with STEMI
* chest pain onset ≤12h, or \>12 h with persistent ST-segment elevation
* hemodynamically stable patients

Exclusion Criteria:

* patients without diagnosis of STEMI (pericarditis, for example)
* no written informed consent obtained
* prior Q or non-Q MI
* prior resuscitation
* prior thrombolysis
* prior surgical myocardial revascularisation
* life expectancy \<6 months
* periprocedural death
Patient Blood Management Program in Total Hip or Total Knee Arthroplasty

Total hip and knee arthroplasty are among the most common surgical procedures for which blood transfusion is prescribed. Patient blood management program has been proposed to decrease the need for transfusion. This program involve three pillars: preoperative improvement of erythropoiesis, intraoperative reduction of bleeding and postoperative management of anemia.

Among the different steps of this program, reduction of bleeding and optimization of anemia are gaining popularity, but preoperative improvement of erythropoiesis is underused. The preoperative step of the blood management program is not systematically used because it requires a complex organization, is considered expensive, and finally because the others available techniques to reduce blood transfusion are easier to implement.

The aim of this study was to assess, within a patient blood management program, the effectiveness of erythropoietin on reducing allogenic blood transfusion and anemia in patients requiring elective total hip or knee arthroplasty. "

This is a post-hoc analysis using part of the patients involved in the Cross Iron Study (Anesthesiology. 2018 Oct;129(4):710-720 ) Included patients were all the patients scheduled for elective primary total hip or knee arthroplasty and assessed by an anesthesiologist involved in the Cross Iron Study. Exclusion criteria were pregnancy, age under 18 years old, systemic infection, bilateral arthroplasty, revision arthroplasty, and participation in a preoperative autologous donation program.

This was a observational study. The patient blood management program included: erythropoietin with iron supplementation if preoperative hemoglobin was lower than 13 g/dl; tranexamic acid during surgery; intravenous iron postoperatively and use of prespecified thresholds for homologous blood transfusion. Blood transfusion and anemia were assessed until day 5 or discharge, whichever came first. Major thromboembolic or cardiovascular events were assessed during admission and one month after discharge.

Eligibility Criteria:
Inclusion Criteria:

* patient from the flow chart of the Cross Iron Study (Anesthesiology. 2018 Oct;129(4):710-720 )
* patient scheduled for elective primary total hip or knee arthroplasty

Exclusion criteria:

* pregnancy patient,
* patient under 18 years old
* systemic infection
* bilateral arthroplasty
* revision arthroplasty,
* participation in a preoperative autologous donation program.
Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on the Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 15 mg in Japanese Healthy Male Adult Subjects

Researchers in this study wanted to compare the effect of the formulation (orally disintegrating tablet and film-coated tablet) on the bioequivalence of drug Rivaroxaban (brand name: Xarelto) at dose of 15 mg in Japanese healthy male subjects aged 20 to 40 years. Rivaroxaban is an approved drug to be used for the prevention of events/diseases caused by blood clots. Currently, there are two formulations of Rivaroxaban available on the market in Japan and they are film-coated tablets and fine granules. To further improve patients' convenience, a new formulation, orally disintegrating tablet (ODT, a drug dosage form designed to be dissolved on the tongue rather than swallowed whole) is under development. The goal of this study was to compare the effect of this new formulation with film-coated tablets when taken with or without water.

Participants in this study received one oral dose of rivaroxaban 15 mg ODT either with or without water and one oral dose of rivaroxaban 15 mg film-tablet. There were at least 5 days between the two doses. Observation for each participant lasted about 6 weeks in total. Blood samples were collected from the participants to measure the blood level of the study drug.


Eligibility Criteria:
Inclusion Criteria:

* Japanese healthy male subjects, aged 20 to 40 years (inclusive), with body mass index 17.6 to 26.4 kg/m²

Exclusion Criteria:

* Subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study drugs will not be normal
* Subject with known hypersensitivity to the study drugs (active substances or excipients of the preparations)
* Subject with known coagulation disorders (e.g. von Willebrand disease, hemophilia)
* Subject with febrile illness within 1 week before the first study drug administration
* Subject with suspicion of drug or alcohol abuse
* Subject with intake of foods or beverages containing grapefruit, pomelo, Seville orange, and tangelo within 1 week before the first study drug administration
* Subject with therapies (e.g. physiotherapy, acupuncture, etc.) within 1 month before starting study treatment
* Subject with clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 msec or of the corrected QT (QTc) interval over 450 msec
* Subject with systolic blood pressure below 90 or above 130 mmHg
* Subject with diastolic blood pressure below 45 or above 85 mmHg
* Subject with clinically relevant deviations of the screened laboratory parameters from reference ranges
Improving Outcomes for Individuals With Serious Mental Illness and Diabetes

This project tests a model for improving illness self-management among persons who have both serious mental illness and diabetes and will be performed within a primary care setting at a safety net hospital system. The information gained from the randomized trial will be supplemented with reports from participants about their experiences of trying to improve illness self-management. Improvements in self-management should result in a reduction of psychiatric symptoms and improvements in functioning and physical health.

This project will test a novel intervention, Targeted Training in Illness Management (TTIM), intended to improve both serious mental illness (SMI) and diabetes mellitus (DM) self-management in 100 individuals with SMI-DM vs. 100 individuals with SMI-DM receiving treatment as usual (TAU). The intervention will be conducted in a safety-net health system primary care setting and will be conducted as a randomized controlled trial (RCT). The primary effects of TTIM will be assessed with respect to SMI symptoms, Functional Status/Role Impairment, General Health Status, and DM outcomes. Secondary outcomes include adherence to psychotropic and DM medication, and engagement in healthy behaviors.

This assessment will include quantitative assessment of facilitators/barriers targeted by the proposed intervention as well as a supplemental qualitative assessment. The qualitative assessments will include input from patients and interventionists. Specific aims for the qualitative analysis are to validate findings from the RCT, expand understanding of "key active ingredients" of TTIM, and provide information to inform future studies on individuals with SMI and related medical conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Have Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression
2. Have DM based upon either previous diagnosis or laboratory values
3. Be ≥ 18 years of age
4. Be able to communicate in English
5. Be able to provide written, informed consent to participation.

Exclusion Criteria:

1. Actively suicidal/homicidal
2. Unable to be rated on study rating scales
3. Demented
4. Pregnant
5. Unable to provide informed consent.
An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)

The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18 to \<40 years with ALL or LBL who have developed a hypersensitivity to native E. coli asparaginase or pegaspargase.


Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of ALL or LBL
2. Be 18 to \<40 years of age at the time of enrollment
3. Have a documented ≥ Grade 2 clinical hypersensitivity reaction to native E. coli asparaginase (e.g., Elspar or Kidrolase) or pegaspargase (Oncaspar)
4. Have the following asparaginase doses remaining in their treatment plan:

   * At least two (2) consecutive weeks of native E. coli asparaginase treatment OR
   * At least one (1) dose of pegaspargase (Oncaspar)
5. Have a direct bilirubin ≤ Grade 2 (\<3.0 mg/dL \[52 µmol/L\])
6. Have amylase and lipase within normal limits (per institutional standards)
7. Have a serum asparaginase activity below the detectable limit during screening prior to the first dose of study drug (Erwinaze)
8. Consent to use a medically acceptable method of contraception throughout the entire study period and for 4 weeks after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or the partner include abstinence, birth control pills or patches, diaphragm and spermicide, condom and vaginal spermicide, surgical sterilization, postmenopausal, vasectomy (\>6 months prior to baseline), and progestin implant or injection.
9. Have signed informed consent

Exclusion Criteria:

1. Prior history of ≥ Grade 3 pancreatitis
2. Prior history of a major thrombotic event as assessed by the investigator, or any subject with a history of asparaginase-associated serious hemorrhagic or thrombotic event requiring prolonged anticoagulation therapy with agents such as heparin
3. Prior treatment with Erwinaze
4. Pregnant or lactating female subjects or female subjects of childbearing potential not willing to use an adequate method of birth control (listed above) for the duration of the study
5. Subjects with a history of human immunodeficiency virus (HIV) or hepatitis.
6. Any other condition that would cause a risk (in the investigator's judgment) to subjects if they participate in the trial
Comparing Tai Chi Chih and Relaxation Therapy in the Treatment of Rheumatoid Arthritis

The purpose of this study is to compare the effectiveness of relaxation therapy and tai chi in treating the symptoms of rheumatoid arthritis (RA).

RA is a debilitating disease characterized by inflammation of the joints, leading to chronic pain, loss of function, and disability. Complementary and alternative medicine (CAM) treatments are being used with increased frequency by patients with chronic pain and rheumatic diseases to relieve their symptoms. While patients find these treatments helpful, there is limited scientific evidence of the effectiveness of these interventions. This study will compare relaxation therapy (a commonly used treatment for RA) to tai chi chih (a combination of slow, deliberate movements and meditation) in treating the symptoms of RA.

Participants will be randomly assigned to receive 12 weeks of either relaxation therapy or tai chi chih. At study entry and Weeks 6 and 12, participants will complete questionnaires about their RA symptoms, health functioning, overall quality of life, and complete a brief medical exam.

Eligibility Criteria:
Inclusion Criteria:

* Active adult onset rheumatoid arthritis
* Stable on disease-modifying antirheumatic drugs (DMARDs) or biologic medications
* Able to walk without use of an assistive device
* Resides in greater Los Angeles area
* Willing and able to comply with study requirements

Exclusion Criteria:

* Uncontrolled or untreated medical conditions
* Frequent or uncontrolled disease flares
* Use of certain medications any medical condition deemed by the investigators to interfere with either the patient's safe participation or interpretation of the study data
A Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.

This is a three arm study, comparing the Novadress, Mepilex Ag, and Xeroform Occlusive dressings for healing, drainage, and pain management. NovaDress is constructed of pure cellulose derived from tree pulp. Mepilex Ag is a antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment. Xeroform Occlusive Dressing is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.


Eligibility Criteria:
Inclusion Criteria:

* Is ≥18 years of age.
* Has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta or The Advanced Wound Clinic, needing a split-thickness skin graft and will undergo a subsequent donor site harvest.
* Subject is able to provide informed consent.
* Has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) if available or if stated by patient.

Exclusion Criteria:

* Has a Baux Score of ≥130.
* Subject is intubated, unable to state pain levels.
* Has active diagnosis of any autoimmune process, cancer, or organ failure that in the opinion of the investigator would prevent the subject from successfully participating in the study,
* Has coagulopathy that in the opinion of the investigator, would place subject at an increased risk for bleeding.
* Vulnerable subjects who, in the opinion of the Investigator, present with poor skin integrity (i.e. Elderly), is a prisoner, non-English speaking, or is without means of follow-up or return to clinic (i.e. homeless).
* Is pregnant, plans to become pregnant, or is actively breastfeeding.
* Active illicit drug use.
* Is moribund, or in the opinion of the investigator is not expected to survive.