cyrilzakka/clinical-trials huggingface dataset:
The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU

While most studies in the medical literature that indicate "music" as an intervention may recognize its impact and capacity to decrease pain perception, anxiety, and/or its role in the regulation of cardiac and respiratory function in ICU patients, no identifiable studies have implemented entrained live music therapy protocols into clinical trials. Music therapy treatment is a non-pharmacological intervention that is individually tailored to the patient's needs and focuses on the assessment and intervention of a specific music application that is provided by a certified music therapist. Entrained music therapy focuses on a dynamic interaction between the patient and music therapist in which the music therapist attempts to promote relaxation and comfort through the patient's identified Song of Kin (SOK). This study measures the effects of live music therapy entrained to the vital signs of adult patients on duration of mechanical ventilation.

The study will include 178 adult patients on mechanical ventilation. These patients will be randomly assigned to the music therapy group or control group and matched for diagnosis, co-morbidities, age, and gender. The music therapy group will utilize a certified music therapist to provide live music based on the patient's cultural preferences and entrainment. The primary outcome is a reduction in mechanical ventilation hours of 35% compared to the control group. Secondary outcomes include: Amount of sedation, Richmond Agitation-Sedation Scale (RASS), delirium and pain score, ICU and hospital length of stay. The researchers hypothesize that live entrained music therapy compared to control will result in a reduction in the time of extubation, amount of sedation administered, ICU and hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with acute hypoxemic respiratory failure, acute hypercapnic respiratory failure, and ARDS admitted to the ICU requiring mechanical ventilation
* Patients that are anticipated to remain on invasive mechanical ventilation for 48 hours or more will be screened for participation in the study

Exclusion Criteria:

* Under 18 years of age
* Identified hearing disorder
* Prior history of chronic respiratory failure requiring mechanical ventilation
* RASS score of -4, or -5
* Active seizures, or status epilepticus
* Cardiac arrest
* Coma
* End of life
* More than 2 vasopressors
Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix

The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length (\<=25mm) and without prior spontaneous preterm birth

Singleton pregnancies between 18 0/7 to 23 6/7 weeks without a prior spontaneous preterm birth found to have a short transvaginal ultrasound cervical length (\<=25mm) and meeting all other eligibility criteria will be randomized to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for daily vaginal progesterone 200mg suppository or 90mg gel from randomization until 36 6/7 weeks. The primary outcome will be the incidence of spontaneous preterm birth \<35 weeks

Eligibility Criteria:
Inclusion Criteria:

* 18 year old or older
* Singleton pregnancy
* No prior SPTB or second trimester losses between 160 and 366 weeks
* TVU CL ≤25mm between 180 and 236 weeks

Exclusion Criteria:

* Multiple pregnancy
* Prior SPTB or second trimester losses between 160 and 366 weeks
* Cerclage in situ
* Painful regular uterine contraction and/or preterm labor
* Rupture membranes
* Major fetal anomaly or aneuploidy
* Active vaginal bleeding
* Placenta previa and/or accreta
* Cervical dilation \>1.0 cm and/or visible membranes by pelvic exam
* Suspicion of chorioamnionitis
The Influence of Passive Leg Elevation on the Cross-sectional Area of the Internal Jugular Vein in Infants or Young Children Undergoing Open Heart Surgery

The trendelenburg position is usually applied to increase the cross-sectional area of the IJV. However, trendelenburg position requires a tilt table to place the head in the down position. Trendelenburg position could also increase intracranial pressure. Passive leg elevation redistributes more blood from the lower extremity into the central veins and is proved to increase the cross-sectional area of IJV in adults. However, the effect of leg elevation on the cross-sectional area of IJV in small infants and children has not been evaluated.

The investigators evaluated the effect of passive leg elevation on the cross-sectional area of IJV in subjects undergoing open heart surgery for congenital anomaly.

Internal jugular vein (IJV) cannulation is essential for open heart surgery of small infants and children for transfusion or inotropics infusion. The trendelenburg position is usually applied to increase the cross-sectional area of the IJV.

However, trendelenburg position requires a tilt table to place the head in the down position. Trendelenburg position could also increase intracranial pressure. Passive leg elevation redistributes more blood from the lower extremity into the central veins and is proved to increase the cross-sectional area of IJV in adults. However, the effect of leg elevation on the cross-sectional area of IJV in small infants and children has not been evaluated. Furthermore, the children undergoing open heart surgery due to cardiac anomaly have an altered hemodynamics and often congested right heart. Therefore, the response of passive leg elevation may be different from that of normal heart physiology. Therefore, we evaluated the effect of passive leg elevation on the cross-sectional area of IJV in subjects undergoing open heart surgery for congenital anomaly.

Eligibility Criteria:
Inclusion Criteria:

* infants or children under 5 yrs undergoing elective open heart surgery for congenital anomaly for study period

Exclusion Criteria:

* previous history of internal jugular vein cannulation
* concurrent pulmonary disease that can influence the hemodynamics of right heart
* increased intracranial pressure
* hemodynamic unstability
Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea

The purpose of this study is to look at the metabolic (use of energy) and hormonal features of sleep problems in women with polycystic ovary syndrome (PCOS).

The prevalence of obesity and chronic sleep loss are at record levels among Americans and evidence continues to emerge to support a causal link between the two conditions. Metabolic abnormalities related to sleep disruption are particularly evident in individuals with obstructive sleep apnea (OSA), a disorder traditionally associated with male gender. While more prevalent in men, OSA is underrecognized in women in part because its clinical and polysomnographic features differ from those of men. Women with polycystic ovary syndrome (PCOS) are particularly susceptible to OSA with at least a 5-fold higher risk for its development compared to obese women without PCOS. This study will enroll obese women with PCOS, with and without OSA. Those with OSA will be randomized to receive CPAP or to receive depot leuprolide to suppress ovarian steroid output over 12 weeks, reassessed at 6 weeks, and then randomized (double-blind, placebo controlled) to 6 weeks of either micronized estrogen + placebo or micronized progestin + placebo. The independent effects of androgen, estrogen, and progesterone on OSA and metabolic function will be assessed. In addition, primary human adipocytes will be prepared from fat biopsies obtained from subjects. Insulin sensitivity will be determined by phospho-specific immunoblotting in conjunction with glucose uptake and anti-lipolysis assays. In parallel, adipocytes from these subjects will be cultured for 1-5 days prior to metabolic assays to ascertain if removal of from circulating factors will improve insulin signaling, or if insulin resistance persists in vitro. Finally, there will be an interface with the Metabolomics Laboratory at Duke University (C. Newgard, Lab Director), and metabolomics assessment will be done on blood and urine samples.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PCOS
* Obese (BMI of at least 30 kg/m2)

Exclusion Criteria:

* Diagnosis of nonclassic 21-hydroxylase deficiency, Cushing syndrome, hypothyroidism, or significant elevations in prolactin
* Taking steroid preparations (including oral contraceptives), medications known to alter insulin secretion and/or action, or medications known to influence sleep during the 2 months prior to starting the study
* Positive pregnancy test
* Diagnosis of diabetes mellitus
* Hypertension (systolic \> 140 mmHg and/or diastolic \> 90 mmhg) not well-controlled on stable medication with either ACE inhibitors or diuretics
* Habitual alcohol use
* Excessive caffeine intake of more than 300 mg/day
* Known peanut allergies, or allergies to medications used in the study
* Hemoglobin \< 11g/dL and/or hematocrit \< 33%
* Systemic illnesses, including heart, renal, liver, or malignant disease
Safety of a Second Dose of Biken's Varicella Vaccine

The objective of the present study is to assess and document the safety of a second dose of Varicella Biken vaccine administered at 4 to 6 years of age in healthy children having previously received a first dose of Varicella Biken vaccine.

All subjects will receive a second dose of Varicella vaccine (Varicella Biken) at 4 to 6 years of age.

The expected total duration of follow-up (first visit to last visit) for each subject will be one month.


Eligibility Criteria:
Inclusion Criteria :

* Aged 4 to 6 years on the day of inclusion.
* Informed consent form signed by the parent(s) or legal guardian and by an independent witness.
* Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
* Written documentation of receipt of a first dose of Varicella Biken vaccine more than 3 months before inclusion.

Exclusion Criteria:

* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
* Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination;
* Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
* Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C seropositivity.
* History of varicella infection (confirmed either clinically, serologically or microbiologically).
* Previous vaccination against varicella disease with a vaccine different from Varicella Biken vaccine.
* Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.
Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that did not receive palivizumab

This is an observational, non-interventional, retrospective cohort study of infants with hemodynamically significant congenital heart disease (HSCHD) who were less than 24 months of age when the first dose of palivizumab was administered (CASES), and infants who were diagnosed with hemodynamically significant congenital heart disease but did not receive palivizumab in a historical respiratory syncytial virus (RSV) season during the first 24 months of life (CONTROLS). CASES are matched to CONTROLS based on RSV season, age, type of cardiac lesion, and type of prior corrective cardiac surgery. Subject medical records are reviewed for occurrences of the clinical end points of infection, arrhythmia, and/or death that meet criteria for serious adverse events. The groups will be compared for number and percent of subjects who experience these primary serious adverse events (both individually and collectively) during a defined 8-month chart review period.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must have documented hemodynamically significant congenital heart disease (Note: Children with uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus are not eligible).
2. Subject must have unoperated or partially corrected congenital heart disease.
3. Subject must have received at least one dose of palivizumab for prophylaxis during the Respiratory Syncytial Virus season - September 1 through April 30 (CASES), or would have been considered eligible for palivizumab prophylaxis (CONTROLS).
4. Subject must be \< 24 months of age at the time of the first dose of palivizumab prophylaxis (CASES) or \< 32 months of age at the end of the assigned Respiratory Syncytial Virus season in which they would have been eligible to receive palivizumab if the drug had been approved in the European Union (CONTROLS).
5. Subject's parent, guardian, or legal representative has voluntarily signed and dated a Release of Information Form to allow the review of medical records and collection of pertinent study data.

Exclusion Criteria:

1. Subject was contraindicated for treatment with palivizumab according to the current European product label.
2. Subject had full correction of Congenital Heart Disease.
3. Subject received palivizumab before approval for use in Congenital Heart Disease (CASES), or subject received palivizumab at any time (CONTROLS).
4. Subject has already been included in this study in a prior Respiratory Syncytial Virus season.
Effects of Vibrations on the Biceps Brachii Muscle and Grip Strength

It has been suggested that applying acute vibration exercises enhances muscle force, like several weeks of resistance training. The present study investigated the effects of local vibration with two different frequencies on biceps brachii isometric muscle strength and grip strength in healthy young men. Isometric strength of the biceps brachii muscle and grip strength were assessed at baseline and after vibration training (immediate, 10 minutes, and 20 minutes post vibration training).


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males

Exclusion Criteria:

* history of recent upper extremity injury
* sensory deficits in the upper extremity
* history of recent upper extremity surgery
* participation in any resistance training
Default Mode Network in Multiple Sclerosis

The study will evaluate connectivity regardless whether patients present a clinical type that requires medical treatment. In this point, investigators will include patients with progressive evolution as well as initial forms of the disease (CIS) and properly established forms of multiple sclerosis (MS) in remittent-recidivant (RR) forms. The researches will not focus on medical treatment as some of these clinical forms have no indication for disease modifying drugs.

To date, no clear consensus has been reached related to default mode network (DMN) activity and different clinical types of MS. Due to this controversy on the literature regarding increment and decrement of DMN activity along the natural history of MS evolution, this study aim to add experimental information and more data that might help to disentangle this paradox, also correlating this DMN activity with anatomic and cognitive indexes. The investigators will also introduce a novel experimental design, including a prospective measure of the investigators connectivity and cognitive measures.

In this study, investigators aim to evaluate connectivity regardless whether patients present a clinical type that requires medical treatment. In this point, patients with progressive evolution as well as initial forms of the disease (CIS) will be included and properly established forms of MS in RR forms. Researchers will not focus on medical treatment as some of these clinical forms have no indication for disease modifying drugs. Nevertheless, investigators consider that the study of connectivity is worth regardless their pharmacological treatment.

The investigators also aim to offer data on the natural history of MS evolution for distinct MS type patients and healthy controls, as this study is planned to collect data longitudinally.

Eligibility Criteria:
Inclusion Criteria:

* MS diagnostic following McDonald 2010 diagnosis criteria.
* 18 to 60 years old.
* Consent form signature.

Exclusion Criteria:

* Dementia diagnosis, following Spanish Neurological Society criteria.
* Mayor psychiatric illness.
* Physical or intellectual limitations to successfully perform - neuropsychological evaluation.
* Any other circumstance that may interfere with functional magnetic resonance session.
* Abnormal renal function previous to magnetic resonance image (MRI) session.
The Use of Electrical Stimulation by Capacitive Field in the Repair of Skin Burns and Quality of Life

The high incidence of burn injuries and mortality and morbidity as well as the high economic impact associated with this type of injury justifying the need to develop new technologies for the treatment of burn patients. Electrical stimulation for wound healing is a resource that has been increasingly used in routine physical therapists, but has the disadvantage of needing means of wet contact between the electrode and injury. The other resource used for therapeutic healing is conventional electrical stimulation of low intensity for capacitive field, a technique of physical therapy intervention not commercially available in Brazil. This new technology seems to have significant physiological effects in tissue repair and has been used for the treatment of chronic wounds which healed with difficulty. The objective is to analyze the effects of electrical stimulation of low intensity for capacitive field in healing skin burns. Patients from both genders aged over 18 years who have burns, will be evaluated and treated at the Emergency Unit of the Hospital of the Faculty of Medicine of Ribeirão Preto, University of São Paulo. The stimulation will be initiated within 24 hours after surgery to perform the graft and will be held daily for 60 minutes during the patient's stay or until complete healing of the skin. The electromagnetic field will be placed on the care of the burned area and / or the donor skin graft, not interfering with departmental procedures. Will be performed photographic record standardized wound by a digital camera, and then quantified by a computer program. Expected to reduce the period of hospitalization and thus lowering the cost of treatment, and the possibility of improving the quality of life of patients.


Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to the Burns Unit of Clinical Hospital, Faculty of Medicine of Ribeirão Preto / USP, in the period between September 2014 and June/2013.
* greater than 18 years.
* deep acute burn requiring excision and grafting

Exclusion Criteria:

* patients who use medicines that may interfere with the process of tissue repair.
* body mass index less than 16 kg / m²
* older than 65 years
Efficacy and Safety of Tabetri on Osteoarthritis

This study is a 12-week, multicenter, randomized, double-blind, placebo-controlled clinical trial in order to evaluate the efficacy and safety of tabetri on osteoarthritis.

This study is prospectively conducted to investigate the efficacy and safety of tabetri in patients diagnosed with osteoarthritis at 4 locations of Jaseng Hospital of Korean Medicine (Gangnam, Haeundae, Daejeon, and Bucheon).

Eligibility Criteria:
Inclusion Criteria:

* Male or female 40 \~ 75 years of age
* VAS (Visual Analogue Scale) over 30mm
* Kellgren \& Lawrence Grade I\~II by X-ray
* Subject who agrees to participate in this clinical trial by themselves and signs the Informed Consent Form (ICF)

Exclusion Criteria:

* Subjects who diagnosed inflammatory arthritis (rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, septic arthritis, gout)
* Joint space under 2 mm by X-ray
* Kellgren \& Lawrence Grade over III with osteophyte, irregularly-shaped auricular surfaces, or subchondral bone cyst by X-ray
* Subjects who diagnosed cardiovascular disease, immune disease, infectious diseases, tumor diseases
* Subjects having gastrointestinal diseases
* Uncontrolled hypertension patients (Blood pressure ≥ 160/100mmHg)
* Uncontrolled diabetes mellitus patients (fasting glucose level ≥ 180mg/dl)
* Patients with TSH \<= 0.1 uIU/mL or \>= 10 uIU/mL
* Subjects have attended abnormal values at AST or ALT (3 times excess at upper limit of the normal values)
* Subjects have attended abnormal values at creatinine (2 times excess at upper limit of the normal values)
* Pregnancy, breast-feeding, or subjects who have a plan to pregnancy within 3 months
* Use of osteoarthritis treatment drugs or dietary supplements within 2 weeks prior to screening
* Psychiatric disorder patient (schizophrenia, depressive disorder, drug abuse)
* History of osteoarthritis treatment therapy within 2 weeks prior to screening
* Have participated in another clinical trial within the 3 months prior to screening
* Subjects who have hypersensitivity history about investigational product
* Have difficulty to be participated in this clinical trial by investigator's decision