cyrilzakka/clinical-trials huggingface dataset:
Transfusion Ratio of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) During Burn Excision and Grafting

The purpose of this study is to determine if burn injured patients who receive blood transfusions in the operating room have better outcomes when given transfusions at a set ratio (1:1)of PRBC to FFP.

Traditionally, patients that need blood transfusions during surgery are given mostly packed red blood cells (PRBC) and some fresh frozen plasma (FFP). This is usually about 1:4 ratio of FFP to PRBC.

In this study, we will compare this traditional approach (1:4) to a 1:1 ratio of FFP to PRBC during the operative period.

The hypothesis of the study is that the use of FFP/PRBC ratio of 1:1, compared to a ratio of 1:4 will result in a(n)

1. decrease in the amount of blood transfused in the operating room
2. decrease in the amount of blood transfused during hospitalization
3. improvement in coagulation parameters (PT/PTT, INR, antithrombin III, Protein C and Fibrinogen in the operative period (from operation start to 12 hours post operatively) and at 24 hours postoperatively
4. decrease the hospital length of stay, lung dysfunction, infections, and mortality

The hypothesis of the study is that the use of a fresh frozen plasma/packed red blood cells (FFP/PRBC) ratio of 1:1, compared to a ratio of 1:4 during operative excision of \>20% TBSA will: result in a decrease in the amount of blood transfused in the operating room, a decrease in the amount of blood transfused during hospitalization, an improvement in coagulation parameters (PT/PTT, INR) in the operative period (from operation start to 12 hours postoperatively) and at 24 hours postoperatively, and a decrease in hospital length of stay, lung dysfunction, number of infections, and mortality.

The primary objective of the study is to determine if aggressive correction of intraoperative coagulopathy during burn excision and grafting results in improved outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 1 month to \</= 18 yrs of age
* Admitted to Shriners Hospitals for Children Northern California
* Patient has a third degree burn \>/= 20 % total body surface area (TBSA)

Exclusion Criteria:

* Infants \< 5 kg
* Pregnancy

  * 18 years of age
* Inability or unwillingness to receive blood products
* Pre-existing need for hemodialysis
* Brain death or imminent brain death
* Non-survivable burn as determined by the attending burn surgeon
* Pre-existing hematologic disease
* Closed head injury with Glasgow Coma Score \<9
Immune Response in Patients Who Have Undergone Vaccine Therapy for Stage III or Stage IV Breast Cancer That Overexpresses HER2

RATIONALE: Studying the immune response to a vaccine made from HER2/neu protein may help doctors plan better treatment for patients with breast cancer that overexpresses HER2.

PURPOSE: This clinical trial is studying the immune response in patients who have undergone vaccine therapy for stage III or stage IV breast cancer that overexpresses HER2.

OBJECTIVES:

Primary

* Determine whether immunologic memory to the HER-2/neu (HER2) intracellular domain (ICD) protein has been generated by active immunization with a HER2 ICD plasmid-based vaccine by assessing the delayed-type hypersensitivity response to HER2 ICD peptides 6 months after vaccination in patients with HER2-overexpressing stage III or IV breast cancer.

Secondary

* Characterize the memory T-cell population and quantitate memory precursor frequency at 3, 6, and 12 months after active immunization using intracellular cytokine staining.

OUTLINE: This is an open-label study.

Patients receive HER2 intracellular domain (ICD) protein mixture intradermally and sterile water injected intradermally (as a negative control) at 6 months post-vaccination with pNGVL3-hICD vaccine. Vital signs and injection site will be monitored prior to skin test and at 60 minutes post-test. Patients return 48-72 hours after skin test for delayed-type hypersensitivity (DTH) measurements. The injection site is biopsied and examined by immunohistochemistry for infiltrating T-cell and antigen-presenting cell populations.

Blood is drawn at 3, 6, and 12 months post-vaccination for assessment of immune memory response. Blood draws are coordinated with parent study. Blood samples are examined by flow cytometry for the presence of memory markers including L-selectin, CD45 isoforms, cytokines, and CCR7.

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of stage III/IV breast cancer

  * Completed chemotherapy
  * Receiving trastuzumab (Herceptin®) monotherapy
* Successful completion of HER-2/neu (HER2) intracellular domain (ICD) plasmid-based vaccine trial (Protocol 01-9773-D06: "A Phase I Safety and Efficacy Trial of a DNA Plasmid Based Vaccine Encoding the HER-2/neu Intracellular Domain In Subjects With HER-2/neu-Overexpressing Tumors") within the past 3 months
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Male or female (male patients are not excluded)
* Menopausal status not specified
* Zubrod performance status 0
* Unable to bear children (female patients)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No cytoreductive chemotherapy within the past 30 days
* No cytotoxic treatment and/or systemic corticosteroids within the past month
* Concurrent local radiotherapy or hormonal therapy allowed
Obesity and Oral Contraceptive Failure

Contraceptive failure is the primary cause of unintended pregnancy in the United States. With obesity rates at epidemic proportions, any association between obesity and strategies that prevent undesired pregnancies constitutes a significant public health and economic concern. Evidence from recent epidemiological studies and our preliminary data (sub-therapeutic levels of steroid hormones due to drug clearance and half-life) suggest that obesity reduces oral contraceptive efficacy. Furthermore, preliminary analysis suggested that a sub-group of obese women, defined by their own birth weight, are at higher risk of contraceptive failure. Further studies are necessary to investigate whether birth weight, a surrogate marker of in utero growth restriction, is a useful diagnostic marker for the identification of women prone to contraceptive failure. Such an understanding is critical to finding a contraceptive strategy with better efficacy for these women.

The overall goal of this project is to test pharmacokinetics of oral contraceptive agents in obese women with low birth weight and compare to obese women with normal birth weight. The main hypothesis for this proposal is that an adverse in utero environment programs the expression and function of enzymes and transporters that underlie pharmacokinetics of oral contraceptives, and leads to contraceptive failure.

Reproductive-aged, ovulatory women of obese BMI \>30 kg/m2 with normal birth weight (5.5-8 lbs; n=10) and low birth weight (\<5.5 lbs; n=10), will be placed on oral contraceptives for 1 month. At several key time points, synthetic steroid pharmacokinetics, gonadotropins (luteinizing hormone, follicle-stimulating hormone) and ovarian hormone levels (estradiol, progesterone) will be monitored.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 35.
* single progesterone level of 3 ng/mL or greater during the luteal phase (days 18 to 25) in the menstrual cycle prior to dosing with oral contraceptives.

Exclusion Criteria:

* absolute/relative contraindications to ethinyl estradiol and levonorgestrel.
* impaired liver function.
* history of deep venous thrombosis.
* hypertension (\> 140/90).
* diabetes with vascular changes.
* migraines with aura or neurological changes.
* history of myocardial infarction, pulmonary embolus, stroke or breast cancer.
* anemia (hematocrit \< 36%).
* actively seeking or involved in a weight loss program (must be weight stable)
* pregnancy, breastfeeding, or seeking pregnancy.
* diagnosis of Polycystic Ovarian Syndrome.
* recent (4 week) use of hormonal contraceptives (patch or ring included), intrauterine, or implantable hormonal contraception.
* DepoProvera use within six months.
* current use of drugs that interfere with metabolism of sex steroids.
* smokers.
* uncontrolled thyroid dysfunction.
High Intensity Resistance Training Combined With Blood Flow Restricted Exercise in Elite Handball Players

Purpose of the study is: to investigate the effects of 8 weeks intervention of high intensity resistance training(HIRT) combined with Blood Flow Restricted Exercise (BFRE) compared to high intensity resistance training alone.

Detailed Description: 30 elite handball players will be randomized into 2 groups of 15 participants each. Participants will be evaluated in the week before and the week after an 8-weeks training intervention with 2 weekly sessions. Based on their baseline muscle strength the participants will be randomized into two groups: HIRT-BFRE or HIRT-HIRT. Participants in both groups will perform a full-body training programme of HIRT. After the Full-body programme, Back squat exercise with low intensity and Blood flow restriction will be performed to the HIRT-BFRE group and back squat exercise with high intensity without blood flow restriction will be performed by HIRT-HIRT. Evaluation protocol includes: muscle strength measurement with 1 repetition maximum of Back squat and knee extension, muscle mass with Dual-Energy X-ray absorptiometry, muscle thickness of the thigh with ultra sound measurement, vertical jump height with linear Encoder, sprint performance with 30m sprint time.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Ds
* Minimum of 2 years of resistance training experience
* \>\< Two resistance training sessions each week
* \>\< three handball sessions each week
* No injuries that prevent participants to perform test of maximal muscle strength
* No injuries, that affects the muscle strength or the ability to train

Exclusion Criteria:

* Elevated blood pressure (\>140/90)
* Anabolic steroids or prescription-only medical products with know or potential effect on muscle hypertrophy
Preoperative Survey to Evaluate Patient Allergy

The study will only involve identification of the listed allergies from the electronic medical record and investigation into the symptoms that prompted this allergy listing. The purpose is to evaluate demographics and prevalence of allergies in patients presenting for surgery, evaluate the medical decision making process behind allergy identification, and determine its potential impact on perioperative care. The participants will be asked to complete a survey in REDCap using an iPad during the visit.


Eligibility Criteria:
Inclusion Criteria:

* Patients 0-21 years of age presenting for surgery or procedure requiring anesthesia

Exclusion Criteria:

* Patients who are not able cognitively to complete the computerized survey due to physical or intellectual impairment or communication issues related to non-English speaking patients
Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis

The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed thinking because of the hay fever will improve when treated with an effective anti-hay fever medication, an intranasal steroid, that is will have less daytime sleepiness and demonstrate better thinking.

In this study of patients with seasonal allergic rhinitis we will monitor daytime sleepiness as measured by validated daytime sleep score (Eppworth Daytime Sleepiness Scale) and cognitive performance weekly as measured by a validated test of cognitive performance (TOVA). The treatment group with intervention of fluticasone furoate nasal spray 110 mcg two sprays in each nostril once daily will be compared to a placebo treated group of similar subjects with seasonal allergic rhinitis.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic seasonal allergic rhinitis symptoms for at least 2 years at the time of study in the season of the study.
* Allergy skin tests positive for the airborne allergens present at the study time within the past 12 months.
* A score of 2 or more on the NRQLQ of the Rhinitis Quality of LIfe Questionnaire.
* Active allergic rhinitis on 4 of 7 days during run-in week, and evidence on sleep scales of drowsiness on 3 of 7 days.
* Ability to read, understand and give informed consent.
* Ability to understand and carry out responsibilities of the study

Exclusion Criteria:

* Any chronic disease or other acute disease, which could influence central nervous system.
* The use of any medication, which could affect central nervous system function.
* Unwillingness to participate in the study.
* Inability to understand testing procedures or use of medication.
* Hypersensitivity to fluticasone or vehicle of nasal sprays.
* Any sleep disorders including obstructive sleep apnea.
Clinical Effect of Chlorhexidine Mouthwash After Periodontal Surgery

Chlorhexidine is the gold standard of dental plaque prevention. Recent research have demonstrated that 0.2% Chlorhexidine solutions are more effective than 0.12% and 0.06% Chlorhexidine solutions. Several 0.2% solutions are available on the market. This study aimed to compare effectiveness of two commercially available 0.2% chlorhexidine mouthwashes. Patients, that after initial periodontal therapy, had a need for two periodontal surgeries, will be invited to join. After one surgical session, the patient will receive one 0.2% chlorhexidine solution, and after the next surgical session the patient will receive the other 0.2% chlorhexidine solution. Plaque and gingivitis will be recorded, as well as side effects.


Eligibility Criteria:
Inclusion Criteria:

Periodontitis, stage III and IV

Exclusion Criteria:

Uncontrolled diabetes Systemic conditions associated with excessive bleeding Uncontrolled hypertension
Music Therapy to Promote Emotion and Cognition for Dementia

The purpose of this study is to determine if the effects of music therapy alter emotion and cognition performances of individuals with mild to moderate dementia. The music therapy intervention protocol is structured by drum improvisation, rhythm imitation, music cognition and song discussion. Attentive listening and active participation of the music training activities allow participants to utilize their focus of attention and comprehension of informational texts. Music therapy intervention is proposed to provide positive stimulations on emotion and cognitive functions of individuals with dementia. The results of the present study will clarify relationship between the effect of music therapy and the neural substrate of music therapy in anatomical and functional brain data obtained from MRI (fMRI).

Individuals with dementia often exhibit deterioration in cognitive functions and experience changes in emotions and personalities. Due to the changes in the frontal and temporal lobes of the brain, individuals with dementia often experience an impaired ability to judge situations. Empirical studies have indicated that cognitive stimulation is essential to facilitate individuals with dementia in thinking, concentration, and memory. Structured music activities provide cognitive stimulation to individuals with dementia through attentive listening and active participation. Additionally, drum improvisation not only reflects the current status of an individual, but also serves as an audio feedback through free play.

Eligibility Criteria:
Inclusion Criteria:

* a mild dementia diagnosis with Clinical Dementia Rating (CDR) score: 1 and The Mini Mental State Examination (MMSE) score: 18-24

Exclusion Criteria:

* significant visual and hearing impairment that hinders music listening and score reading
* for fMRI safty: with shrapnel or other metal or electronic implants in their bodies
Biomarkers of Injectable Extended Release Naltrexone Treatment

This study evaluates the biological markers of treatment of opioid dependent individuals with an extended release formulation of the opioid antagonist naltrexone. The biological measures include functional MRI, blood levels of naltrexone and its metabolites, urine toxicology and behavioral tests probing various aspects of personality, memory, reward processing and attention.

This study is using blood oxygenation level dependent (BOLD) functional magnetic resonance imaging (fMRI) to examine the brain predictors of adherence and outcomes of opioid antagonist therapy. Opioid-dependent intravenous heroin users are offered up to 3 monthly injections of the extended-release naltrexone (XRNTX) contingent upon successful outpatient non-opioid detoxification, with an additional 4 weeks of follow up. Brain responses to heroin-related pictures are recorded using fMRI prior to the 1st XRNTX injection and approximately 2 weeks thereafter the 1st XRNTX injection. Primary clinical variables include the number of injections (maximum of 3) accepted by participants, change in self-reported craving for opioids after exposure to drug-related visual cues during the brain fMRI sessions, urine levels of ten commonly abused substances and self-report of cigarette use.

Eligibility Criteria:
Inclusion Criteria:

1. DSM-IV-TR diagnosis of opioid dependence, active opioid use, confirmed by urine toxicology screen and self-reported monthly intravenous heroin use for more than 2 weeks in the past 3 months
2. urine toxicology screen negative for opioids after detoxification
3. good physical health as indicated by history and physical examination, screening blood work-up and urinalysis.

Exclusion Criteria:

1. chronic medical illnesses;
2. current use of medications potentially confounding brain activity, such as anti-dopaminergic agents, anti-depressants and beta-blockers;
3. current DSM-IV-TR Axis I psychiatric disorders other than opioid and nicotine dependence;
4. life time history of concurrent IV cocaine and heroin (speedball) administration;
5. pregnancy or breastfeeding;
6. history of clinically significant head trauma;
7. contraindications for naltrexone treatment including medical conditions requiring opioid analgesics, e.g. chronic pain or planned surgery, obesity, elevated liver enzymes (\> 3 times upper limit of normal), failure to complete opioid detoxification
8. contraindications for MRI, i.e. indwelling magnetically active foreign bodies and phobia to enclosed spaces
Effects of SEvoflurane on Gas Exchange and Inflammation in Patients With ARDS (SEGA Study)

Numerous trials support the efficacy and safety of volatile anesthetic agents, namely inhalation of sevoflurane through dedicated devices, for the sedation of ICU patients. Several preclinical studies have shown that sevoflurane inhalation improves gas exchange and decreases pulmonary and systemic inflammation in experimental models of acute respiratory distress syndrome (ARDS).

The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of an early 48-hour sevoflurane inhalation on gas exchange and inflammation in patients with ARDS.

BACKGROUND:

Acute respiratory distress syndrome (ARDS) is characterized by hypoxemic respiratory failure that can be lethal in 30 to 60% of patients. Its pathophysiological landmark, diffuse alveolar damage, is associated with alveolar inflammation, epithelial injury and alveolar fluid clairance impairment.

Several preclinical studies have shown that early sevoflurane inhalation improves gas exchange, reduces alveolar edema and attenuates pulmonary and systemic inflammation in experimental models of ARDS.

To date, no clinical trial has assessed the effects of early sevoflurane inhalation in ARDS patients.

DESIGN NARRATIVE:

The purpose of this prospective, randomized, controlled study is to evaluate the effects of a 48-hour sevoflurane inhalation strategy on gas exchange and both systemic and pulmonary inflammation in the early phase of ARDS.

After inclusion, ICU patients with moderate to severe ARDS (according to the Berlin definition of ARDS criteria; JAMA 2010) will be randomized into two groups :

* a "conventional group", in which intravenous sedation with midazolam will be administered
* a "sevoflurane group", in which patients will inhale sevoflurane during a 48 hour-period, through dedicated devices Arterial blood gases will be analyze before randomization and at 24, 48, 72, 96, and 120 hours.

Bronchoalveolar lavages (BAL) and blood samples will be assessed before randomization and at 48 hours, in order to measure tumor necrosis factor-alpha (TNFα), interleukin (IL)-1β, IL-6, IL-8 and sRAGE levels. Duplicate assays will be performed with Multiplex (TNFα/interleukins) or ELISA (sRAGE).

During the 48-hour treatment period, bispectral index (BIS®) values ranging from 40 to 50 will be targeted and neuromuscular blocking agents (cisatracurium) will be administered in both groups. Protective ventilation strategies will be applied, as well as other guidelines or recommendations on the management of ICU patients with ARDS.

Eligibility Criteria:
Inclusion Criteria:

* Patients with criteria for moderate to severe ARDS since less than 24 hours (
* Informed consent

Exclusion Criteria:

* Suspected or proven intracranial hypertension
* Midazolam, sevoflurane or cisatracurium allergy
* Medical history of malignant hyperthermia
* Severe liver failure
* Chemotherapy treatment in the last month
* Severe neutropenia (\< 0.5 G/l)
Evaluation of Myocardial Improvement in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy

Cardiac function may improve in patients with end-stage heart failure who receive long-term support with ventricular assist devices (VAD). Reverse left ventricular remodeling may be sufficient in some cases to allow explantation of the VAD. However, some questions continue to await definitive answers. This study is designed to assess the myocardial recovery under VAD support with optimal pharmacological therapy (high doses \[group I\] of statins, beta-blockers, angiotensin-converting enzyme inhibitors versus standard doses \[group II\]).

The study is a randomized, single-blind trial performed at the Department of Cardiac Surgery, University of Strasbourg, France. Twenty patients with end-stage heart failure who will be supported by VAD (Thoratec paracorporeal device) as a bridge to heart transplantation will be included. Reverse left ventricular remodeling and myocardial function will be studied by: echocardiography, respiratory mitochondrial function, exercise testing, cardiac hormonal function, and inflammatory response. Myocardial biopsies will be obtained at the time of VAD implantation and heart transplantation. The follow-up will be performed every 4 weeks during the VAD support period. The hypothesis of this trial is that reverse left ventricular remodeling and myocardial function will improve under optimal medical therapy especially by a high dose statin.

Evaluation of Myocardial Improvement (Reverse Left Ventricular Remodeling, Mitochondrial Respiratory Function) in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy

Eligibility Criteria:
Inclusion Criteria:

* Patients with end-stage heart failure refractory to medical therapy and who fulfill criteria for VAD implantation as a bridge to heart transplantation
* Age \> 18

Exclusion Criteria:

* Myocarditis