cyrilzakka/clinical-trials huggingface dataset:
Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care

Emergency intubation of patients in intensive care is a high-risk endeavour. For many decades, succinylcholine has been the neuromuscular blocking agent of choice. However, succinylcholine may have life-threatening side effects and is contraindicated in a variety of diseases relevant in intensive care. The nondepolarizing agent rocuronium has been propagated as alternative for succinylcholine. Though a recent meta-analysis found no difference in intubating conditions between succinylcholine and rocuronium in elective cases, there are no data in emergent cases in intensive care. The aim of the present study is to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.

Objective: to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.

Design: prospective, randomized, single-blind study. Setting: Intensive care units of an University Hospital. Patients: adult patients in intensive care requiring emergency intubation. Randomization: 1:1 randomization to either succinylcholine (1mg/kg) or rocuronium (0.6 mg/kg).

Data: 1) assessment of the quality of intubating conditions by means of a score, 2) length of the intubating sequence defined as time between injection of neuromuscular blocking agent and first end-tidal CO2 on the monitor, 3) number of failed intubating attempts, 4) hemodynamic sequelae of intubation, defined as events requiring injection of vasoactive drugs, and 5) desaturations, defined as saturation below 90% and/or any decrease in saturation of 5% or more.

Eligibility Criteria:
Inclusion Criteria:

* indication for emergency intubation in intensive care
* availability of qualified study physician

Exclusion Criteria:

* contraindication against succinylcholine or rocuronium
* indication for awake fibreoptic intubation
Clinical Utility of Caduet in Achieving Blood Pressure and Lipid Endpoints in a Specific Patient Population

The purpose is to demonstrate the utility of Caduet (amlodipine/atorvastatin) in the African American population


Eligibility Criteria:
Inclusion Criteria:

* African American men and women with concurrent hypertension and dyslipidemia that is either treated or untreated
* Subjects must satisfy the blood pressure and LDL-C inclusion criteria for their respective Cardiovascular Risk group determined at screening

Exclusion Criteria:

* Subjects currently being treated with concomitant amlodipine and atorvastatin therapy, including Caduet
* Subjects with blood pressure at goal
A Study To Investigate The Effect Of Food On The Pharmacokinetics Of PH-797804

The purpose of this study is to investigate the effect of food on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 21 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week for males.
Iron Therapy for Autosomal Dominant Hypophosphatemic Rickets: A Pilot Project.

The purpose of the study is to gain a better understanding of the effect of iron on fibroblast growth factor 23 (FGF23) in the inherited disorder, autosomal dominant hypophosphatemic rickets (ADHR). ADHR is an inherited disorder in which the body makes too much FGF 23 and causes low blood phosphorus levels and bone problems such as rickets (bowed legs in children) or bone pain and weakness in adults. This study is to test whether or not giving iron helps correct the high FGF23 and there by correcting the phosphate problem.

Iron will be provided in an open label treatment to all enrolled subjects. Iron levels will be monitored in blood and doses adjusted with the target of getting the iron levels to or a little above 100 mcg/dl.

The study will look to see if there is a decrease of FGF23 level. It will also look at how long does it take to decrease the level of FGF 23 and how long it takes for the serum and urine phosphate to normalize.

Eligibility Criteria:
Inclusion Criteria:

* FGF Mutation in either Arginine 176 or arginine 179
* able and willing to provide consent or have a parent that is able/willing to consent, if a minor
* either serum iron \<50mcg/dl (regardless of phosphate or intact FGF23 concentration); or iron between 500 and 100mcg/dl with serum phosphorus value below 3.0mg/dl for adults or less than or equal to 0.5 mg/dl the lower limit of normal for age in children and intact FGF23 about 30pg/ml
* age \>2 years
* May be receiving treatment with phosphate and calcitriol, but must be willing to undergo dose adjustments by the investigators if iron resolves the phosphate wasting defect.

Exclusion Criteria:

* malignancy within the last 5 years, except treated squamous or basal cell skin carcinoma
* terminal illness/hospice.
* severe end-organ disease, e.g. cardiovascular, pulmonary, etc, which may limit ability to complete study.

estimated GFR \<45ml/min/1.73m2, calculated using MDRD formula for adults or modified Schwartz equation for children

* pregnancy or plan on becoming pregnant
Effect of Intermittent Versus Continuous Energy Restriction on Compensatory Mechanisms Activated During Weight Reduction

Obesity has become a global epidemic with huge public health implications. Although clinical significant weight loss can be achieved by a combination of diet and behavioral modification, strong metabolic adaptations, with increased appetite and suppressed energy expenditure, are activated, which compromise weight loss maintenance and increase the risk of relapse. The aim of this project is to compare the effects of intermittent versus continuous energy restriction on the compensatory responses previously described using two low calory diets, with a similar macronutrient distribution. More specifically, this study will analyze, in the short-term, if an intermittent energy restricted diet is associated with less appetite and low reduction in energy expenditure when compared with a continuous energy restricted diet. This project can bring large practical benefits concerning the design of weight loss programs to minimize weight relapse.


Eligibility Criteria:
Inclusion Criteria:

* adult (18-50 years old)
* obese healthy volunteers (30\<BMI\<40 kg/m2)
* weight stable on the last three months (\<2kg), not currently dieting to lose weight and with an inactive lifestyle

Exclusion Criteria:

* history of endocrine/cardiovascular/pulmonary/kidney disease
* anaemia
* milk intolerance
* depression or other psychological disorders
* eating disorders
* drug or alcohol abuse within the last two years
* current medication known to affect appetite or induce weight loss
* a planned surgery during the study period
* participating in another research study
Volatile Anesthetics to Reduce Mortality in Cardiac Surgery

There is initial evidence that the choice of anesthesia can influence survival in the specific setting of coronary artery bypass grafting surgery (CABG).

A recent international consensus conference included volatile agents among the few drugs/techniques/strategies that might reduce perioperative mortality in cardiac surgery and that should be further studied. Volatile anesthetics (desflurane, isoflurane and sevoflurane) have non-anesthetic pharmacological characteristics that confer cardiac protection when compared to Total IntraVenous Anesthesia (TIVA). Several randomized controlled studies were summarized in a meta-analysis that documented a reduction in perioperative cardiac troponin release and mortality in patients receiving volatile anesthetics when compared to patients receiving a TIVA. There are four published studies (Bignami et al. 2009) (De Hert et al. 2009) (Jackobsen et al. 2007) (Landoni et al. 2007) suggesting that these benefits can translate into a reduced mortality rate in patients receiving volatile agents. The level of evidence for these four studies is not high (one meta-regression, one underpowered randomized controlled study, one retrospective study and one meta-analysis of small randomized studies) and there is need for a large multicentre randomized controlled study to confirm these findings, as suggested by the international consensus conference on this topic published in 2011 (Landoni et al 2011).

The purpose is to provide a large multicentre controlled randomized trial to demonstrate that volatile anesthetics can reduce 1 year mortality from 3% to 2% in patients undergoing CABG (either with or without cardiopulmonary bypass).

The results of this study can support the use of volatile agents in all CABG procedures worldwide (more than 500.000 per year) with 2.500 lives saved per year (in the hypothesis that nowadays half the procedures are performed with a TIVA and that 1 year mortality can be reduced from 3% to 2% using volatile agents).


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* written informed consent
* scheduled procedures
* planned isolated CABG (multiple bypass are allowed; planned combined intervention such as CABG plus valve surgery are not allowed

Exclusion Criteria:

* pregnancy
* planned valve surgery or surgery on the aorta
* planned locoregional anesthesia without general anesthesia
* unstable or ongoing angina
* recent (\< 1 month) or ongoing acute myocardial infarction
* use of sulfonylurea, theophylline or allopurinol
* previous unusual response to an anesthetic agent
* inclusion in other randomised controlled studies in the previous 30 days
* any general anesthesia performed in the previous 30 days
* emergency operation (not scheduled)
* Kidney or liver transplant in medical history
* Liver cirrhosis (Child B or C)
Trial to Investigate Viral Shedding in Healthy Children Vaccinated With Vaccine Virus Liquid (CAIV-T)

The primary objective of this study was to determine the proportion of subjects, seronegative to all three strains of influenza, as defined by a serum hemagglutination inhibition antibodies (HAI) antibody titer of \<1:10, who shed each vaccine virus strain following a single dose of CAIV-T.


Eligibility Criteria:
Inclusion Criteria:

* children at least 6 months of age and less than or equal to 18 months of age at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment;
* whose parent/legal guardian has provided written informed consent after the nature of the study has been explained;
* who, along with their parent or legal guardian, will be available for the two month duration of the trial (from enrollment to study completion).

Exclusion Criteria:

* whose parents or legal guardians are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
* with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
* with Down's syndrome or other known cytogenetic disorders;
* with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; intranasal steroids or cytotoxic agents;
* have an immunosuppressed or an immunocompromised individual living in the same household;
* with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
* who, at anytime prior to study enrollment, receives any influenza vaccine (commercial or investigational);
* with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results.

Note: A pregnant household member is not considered a contraindication to enrollment.
Prazosin Use in Adults With Anxiety Disorders

Prazosin has shown effectiveness in treating Post-Traumatic Stress Disorder through improving sleep quality and global functioning. Given the significant evidence for its utility in treating PTSD, in combination with the fact that many anxiety symptoms overlap with PTSD (e.g.insomnia, hyperarousal, and irritability), it is essential to evaluate its potential effectiveness in treating symptoms of other anxiety disorder and patient tolerability.


Eligibility Criteria:
Inclusion Criteria:

1. Existing Diagnosis of any anxiety disorder according to DSM-5 criteria (i.e. GAD, Panic Disorder, Agoraphobia, Social Phobia or Specific phobias)
2. Newly diagnosed patients or patients who are either resistant or not adherent to their current treatment are eligible to be enrolled in the study.
3. If patient is on anti-hypertensive therapy, the dose of anti-hypertensive(s) must be stable for at least 4 weeks prior to the study and blood pressure must be well controlled.

Exclusion Criteria:

1. Patients with comorbid condition of psychosis, a diagnosis of PTSD, an active severe substance use disorder, or actively suicidal.
2. Patients actively enrolled in psychotherapy sessions at the time of the study.
3. Patients experiencing baseline systolic blood pressure ≤100 mmHg supine, orthostatic hypotension (a decrease in systolic blood pressure from a sitting position of 20 mmHg or more after 2 minutes standing accompanied with light-headedness), or a baseline diastolic blood pressure less than 60 mmHg.
4. Pregnant or lactating women.
5. Patients with acute medical or psychiatric conditions that require immediate hospital admission.
6. Patients with a history of allergic reaction to prazosin or any of its components.
7. Patients unable to communicate in English.
8. Patients who are scheduled to undergo cataract surgery are excluded from the study until after the surgery has been completed.
Improving Self-Efficacy Through a Telenovela: Feasibility Study

In the NOVELA intervention, hospice care will be enhanced with the telenovela videos for hospice family caregivers (HFCG) education during weekly hospice visits to prepare caregivers for proper use of hospice support and healthcare services

Telenovela is a television drama or soap opera that can be used to lead viewers to contemplate and discuss critical issues through video storytelling. Prior work showed informational telenovelas had a positive effect on Latino family caregivers' attitudes toward end-of-life (EOL) care services. The role of videos in hospice and palliative care shows significant promise, underscoring the videos as a mode of education for family caregivers that could potentially enhance caregiver's self-efficacy, decrease caregiver's anxiety, and reduce burnout. Despite the value of video education, many programs have failed to provide engaging material.

Based on input from HFCG, the investigators have produced a bilingual (Spanish and English version) four chapter telenovela video series (To Care/ El privilegio de cuidar) as part of NCI funded diversity supplement study. Founded upon extensive preliminary work, To Care portrays the journey of one hospice family as the family struggle with the hospice decision, pain management, decision-making, and finally the dying process. Averaging only 4:65 minutes, each chapter addresses one of these problems, validating family experiences and identifying potential solutions. Based on this work and interviews with hospice staff the investigators have built an intervention, NOVELA, to disseminate telenovelas to family caregivers in hospice agencies. The investigators will test the feasibility of NOVELA delivery in the hospice setting and evaluate efficacy of the intervention. The overall expectation is that NOVELA will improve self-efficacy thus lowering anxiety in hospice family caregivers. This proposal has the following aims:

* Specific Aim 1: To pilot test the feasibility and acceptability of integrating NOVELA with hospice care for family caregivers of hospice patients
* Specific Aim 2: To investigate the preliminary efficacy of integrating NOVELA with hospice care for family caregivers of hospice patients

Eligibility Criteria:
Inclusion Criteria:

* Identified family caregiver of patients enrolled in hospice
* Caregivers must be over the age of 18
* Without cognitive impairment
* With access to wireless device and internet.

Exclusion Criteria:

* HFCG of patients that are actively dying
* Caregivers younger than 18 years
* With cognitive impairment
* Without internet access.
Intensive Versus Traditional Voice Therapy

The purpose of this study is to determine if there are differences in treatment outcomes between traditional voice therapy, performed weekly for a maximum of 6 weeks versus intensive voice therapy, consisting of 4-6 therapy sessions performed within one day.

The goal of voice therapy is optimal long-term vocal quality and communication function with minimal recurrence. Traditional voice therapy for dysphonia typically consists of one to two therapy sessions each week with a single clinician for about 8 weeks. Another approach of voice therapy is intensive short-term therapy also known as "boot camp." This approach, borrows from the disciplines of neurobiology, exercise physiology, motor learning, and psychotherapy which describe desirable learning and behavior changes influenced by practice that involves high-intensity overload, variability, and specificity of training. A few studies have showed that "Boot Camp" model of intensive therapy resulted in comparable gains in voice quality and vibratory mechanics and may promote better patient satisfaction and attendance.

While such findings support the notion that intensive voice therapy may enhance voice therapy outcomes, no study to date has examined patient response to the "Boot Camp" approach to voice therapy. The investigators will compare the outcomes of traditional, weekly voice therapy and intensive voice therapy with multiple sessions in one day.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a Voice disorder
* Diagnosed with benign vocal fold lesions and/or hyper-function
* First/primary propose treatment modality is voice therapy
* Patients who are appropriate for either standard of care treatment modality (traditional or intensive voice therapy)
* Willingness to participate in either standard of care treatment modality
* All races
* Males and females
* English speaking

Exclusion Criteria:

* Younger than 18
* Inability or unwillingness to participate in one of the standard of care treatment modalities
* Laryngeal Surgery or procedures during course of study
* Prisoners
EVALUATION OF RESPIRATORY MECHANICS AND FUNCTIONALITY IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

To associate a lean mass, peripheral muscle strength, kinematic thoracic-abdominal, respiratory metabolic response, mobility and diaphragmatic thickness, verifying its relation with the obstruction level of COPD

Individuals with COPD present restriction in their daily lives due to changes and bodily disorders promoted by the disease, such as changes in types of muscle fibers and chronic inflammatory process, causing a low level of physical activity and quality of life, besides being closely Related to the need for hospitalizations and increased mortality. A cross-sectional study with a convenience sample was performed at the Laboratory of Cardiopulmonary Physiotherapy of the Federal University of Pernambuco during the period from December 2016 to February 2018. As measurements of body composition were performed with a bio-balance scale, Evaluation of the peripheral muscle strength will be used the dynamometer, a load cell and electromyography, a kinematic thoracic-abdominal will be measured by optoelectronic plethysmography, a respiratory metabolic response will be verified during the 6-minute walk test using the gas analyzer, and for evaluation of mobility and diaphragmatic thickness are used on ultrasound associated with pneumotachograph.

Eligibility Criteria:
Inclusion Criteria:

* Young adults, adults and elderly subjects

Exclusion Criteria:

* Others respiratory diseases;
* Heart diseases;
* Those who are in some previous training program or rehabilitation;
Effects of Chronic Leucine Supplemetion on Glucose Homeostasis, Body Compositin, Muscle Mass and Strength of Healthy and Young Subjects

This study aims to evaluate the effects of chronic leucine supplemetion on glucose homeostasis, body compositin, muscle mass and strength of healthy and young subjects


Eligibility Criteria:
Inclusion Criteria:

* Non-smokers;
* Healthy;
* Non-users of dietary supplements and drugs
* Not engaged in any regular physical activity program

Exclusion Criteria:

* Vegetarians
A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA

Primary objective:

* To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10 µg .

Secondary objectives:

* Additional immunogenicity assessments
* Standard safety assessment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy child of 4 to 7 years of age of either gender,
* Child vaccinated with 2 doses of HEXAVAC® during the first 6 months of life and with a 3rd dose of HEXAVAC® before the end of the second year of life or Child vaccinated with 2 doses of INFANRIX®-HEXA during the first 6 months of life and with a 3rd dose of INFANRIX®-HEXA before the end of the second year of life,
* Informed consent form signed by the parent(s) or by the legal representative.
* Parent(s) or legal representative able to understand and comply with the study procedures.

Exclusion Criteria:

* Any recent (\<=3 days) history of febrile illness prior to vaccination,
* Receipt of more than 3 doses of any Hepatitis B containing vaccine, either alone or in any combination,
* History of clinical or serological-confirmed diagnosis of infection due to hepatitis B,
* History or current close contact with known carriers of hepatitis B virus,
* Prior known sensitivity/allergy to any component of the study vaccines,
* Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,
* Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
* Any immune impairment or humoral/cellular deficiency or depressed immunity,
* Any recent (\<=30 days) long-term (\>=14 days) administration of systemic corticosteroids given daily or on alternate days at \>=20 mg/day prednisone equivalent or scheduled administration through Visit 2,
* Any receipt (\<=3 months) of immunoglobulins or blood-derived products, or scheduled administration through Visit 2,
* Any recent (\<=14 days) receipt of an inactivated vaccine or scheduled administration through Visit 2,
* Any recent (\<=28 days) receipt of a live vaccine or scheduled administration through Visit 2