cyrilzakka/clinical-trials huggingface dataset:
Automate Music Therapy for the Management of Behavioral Disorders in Nursing Homes

Alzheimer disease is the most common neurodegenerative brain disease that causes cognitive impairment in the elderly but also behavioral and psychological symptoms. Among these symptoms, agitation is one of the most dangerous because it put the patient and their caregivers in danger. Sleep disorders can be the cause of many psychiatric symptoms leading directly or indirectly to agitation. Music therapy is the non-drug therapy which has been shown to be the most effective in managing agitation and sleep disorders. With the MAGE protocol, the investigators propose to take care of behavioral disorders in severe Alzheimer patients living in nursing home through sequences of music therapy (stimulation, relaxation) automatically initiated by an actigraph that will detect sleep disorders. These subjects will be exposed for 2 weeks over a month. Behavioral and sleep disorders will be evaluated objectively by actigraphy but also by standardized scales, as the others neuropsychiatric symptoms found classically in this disease. Thanks to this project, the investigators hope to improve the quality of life of these patients by preventing them from putting themselves in danger, by reducing their neuropsychiatric symptoms and their use of medication, which has often deleterious side effect and also by reducing the workload of caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years old
* Male or Female
* Patients with a diagnosis of Alzheimer disease according to the criteria of NINCDS-ADRDA or typical or atypical Alzheimer disease
* MMSE \< 20
* Patient residing in nursing home
* Voluntary, written and informed consent of the patient himself or its legal representative (guardian/curator)
* Affiliation to a social security system

Exclusion Criteria:

* Prescription of a new psychotropic treatment (hypnotic, anxiolytic, antidepressant, antipsychotic) in week prior to the evaluation
* Hearing loss preventing the patient from responding perfectly to the therapeutic solutions provided
Requirement of Propofol for Induction of Unconsciousness in Patients With Parkinson's Disease

Parkinson's disease (PD) is the second most prevalent neurodegenerative disease. The investigators clinical experience showed a trend of delayed emergence among patients undergoing deep brain stimulator (DBS) implantation and pulse generator placement under general anesthesia. Abnormal pharmacodynamics might be present among these patients, which had never been investigated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's disease undergoing deep brain stimulator implantation and pulse generator placement under general anesthesia
* non-Parkinsonian patients without Parkinson's disease undergoing intracranial surgery under general anesthesia

Exclusion Criteria:

* ASA score higher than Class III
* predicted difficult airway
* hearing impairment
* inability to corporate with instruction
* alcohol or drug abuser
* patients refusing to provide informed consent
Trends of the Pre-hospital Emergency Care Spectrum in Beijing From 2005 to 2014: A Retrospective Analysis

This was a retrospective analysis of a cohort of all emergency care patients in Beijing from January 2005 to December 2014. This aim of this study was to analyze the trends in pre-hospital emergency care need and the emergency response times, with the intention of aiding the government to optimize medical resources and improve pre-hospital emergency care.

Pre-hospital emergency care is a very important part of Emergency Medical Service (EMS) System, crucial to patients' life support, disability and mortality rate reduction. The level of pre-hospital emergency care reflects the comprehensive ability of the organizational, management and public welfare of a country. Beijing Emergency Center and Beijing Red Cross Emergency Center are in the charge of all the pre-hospital emergency care in Beijing, which respectively subordinate to Beijing government and Chinese Red Cross Society. This study collected the data of 3,909,746 cases from these two pre-hospital care centers from January, 2005 to December, 2014 and retrospective analyzed the pre-hospital emergency call demand and first aid related time. The results of this study can help the government optimize medical resources; strengthen the prevention of related emergency diseases. The changes and trends of pre-hospital care disease spectrum also present the same problems and situation of developing megacities like Beijing. Based on the meticulous work in these 2 centers, this study has collected the most complete pre-hospital emergency care data in China.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated by pre-hospital care from the Beijing Emergency Medical Center and Beijing Red Cross Emergency Center from January 2005 to December 2014

Exclusion Criteria:

* missing data
* duplicate records
* no identifiable chief cause cases
* not emergency cases
Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response

The purpose of this study is to find out how the brain of people with autism is affected by Propranolol. Propranolol is not FDA approved for the treatment of autism. Propranolol is FDA approved for the treatment of heart conditions such as blood pressure

This research is being done because there are currently no drug treatment options for language impairments and social difficulties often experienced by people with autism.

The specific aim of this study is to examine the effects of serial doses of propranolol on social interaction, and secondarily on language tasks, anxiety, adaptive behaviors, and global function in high functioning adults and adolescents with autism in a double-blinded, placebo-controlled trial. The investigators will also examine whether response to treatment can be predicted based upon markers of autonomic functioning, such as skin conductance, heart rate variability (HRV), and the pupillary light reflex (PLR), and whether anxiety can predict treatment response. The hypothesis is that social functioning and language abilities will benefit from serial doses of propranolol, and that those with the greatest degree of autonomic dysregulation, or the lowest functional connectivity, will demonstrate the greatest benefit from the drug.

Eligibility Criteria:
Inclusion Criteria:

* Autism Spectrum Disorder diagnosis
* intelligence quotient (IQ) \>= 85 (if aged 15-24), \>= 75 (if aged 7-14)
* Native English speaker
* Parent or caregiver must older than 18 years and be a native English speaker

Exclusion Criteria:

* Taking Alpha 2 agonists
* Non-autism learning disorder
* Other major psychiatric disorders
* Other neurological disorders
* Major head trauma
* Reaction to adhesives
* Diabetes
* Reactive airway disease
* Thyroid disease
* Bradyarrhythmias
* Unexplained syncope
* Pregnancy
* Possible interacting drugs
* Underweight (\<20kg if aged 7-14 years)
* Factors affecting ability to have an MRI (if aged 15-24 years)
Light to Maximize Vision, Minimize Insomnia

The purpose of this study is to determine whether specific wavelengths of light at night can be used to improve mobile balance while simultaneously not increasing alertness.


Eligibility Criteria:
Inclusion Criteria:

* Aged 55-85
* At least 20/200 corrected visual acuity
* Greater than 20° visual field with no lower visual field loss
* Stable health
* Male or female
* Normal color vision
* Normal hearing

Exclusion Criteria:

* Extreme chronotype
* Sleep disorders
* Dementia
* Smoker
* Depression
* Alcohol abuse
* Use of illegal drugs
* Use of sleep/wake altering drugs on an acute or as needed basis (including nutraceuticals, antihistamines)
* Use of light sensitizing drugs
* Self-reported history of nocturia (\>3 times per night)
Effects of Chronic Insomnia on the Neuroendocrine Regulation of Glucose and Lipid Metabolism

We aim to assess the influence of chronic insomnia on the neuroendocrine regulation of the glucose and lipid metabolism to more clearly define the metabolic derangements associated with chronic insomnia and to prove that chronic insomnia is associated with increased levels of stress hormones, cytokines and impaired insulin sensitivity.

Sleep fragmentation has previously been shown to result in activation of the stress axis as indicated by enhanced cortisol and catecholamine release and a proinflammatory state mirrored by increased concentrations of proinflammatory cytokines such as IL-6 and TNFa. Therefore sleep deprivation is associated with a similar pattern of endocrine and proinflammatory alterations that may promote the insulin resistant state. Thus, it is of paramount interest to clearly define the metabolic alterations in patients with primary insomnia.

Patients with with suspected primary insomnia will be recruited from the sleep clinic at the University Hospital Basel and by newspaper ads. Primary insomnia will be diagnosed by a polysomnographic study and the exclusion of secondary causes such as depression, sleep apnea and restless legs syndrome. Eligible patients will be admitted to the CRC for metabolic studies, including baseline blood samples for the measurement of hormones, cytokines and adipokines, a euglycemic-hyperinsulinemic clamp study for the assessment of glucose turnover and insulin sensitivity and in vivo NMR studies to determine intrahepatic and intramyocellular lipid content.

The data obtained in insomnic patients will be compared to those of a control group matched for age, sex, BMI, menopausal status and physical activity selected from the general population.

Eligibility Criteria:
Inclusion Criteria:

• Patients with primary chronic insomnia based on clinical history and a polysomnographic study.

Exclusion Criteria:

* Diabetes mellitus
* Known other sleep disorders, such as depression, obstructive sleep apnea and restless legs syndrome
* Alcohol consumption \> 40 g / d in males, \> 20 g / d in females, respectively,
* Patients treated with medications potentially interfering with glucose metabolism, such as systemic steroids, immunosuppressive drugs (cyclosporine, tacrolimus, sirolimus), highly active antiretroviral therapy, hydrochlorothiazide \> 25 mg/d
* Patients treated with lipid lowering drugs such as statins, fibrates, nicotinic acid derivatives, resins and ezetimibe in whom the lipid lowering therapy cannot be safely withheld for the duration of the study.
* Patients with LDL-cholesterol concentrations \> 4.9 mmol/l and fasting triglyceride concentrations \> 12 mmol/l.
* Any significant or unstable hepatic, cardiac, pulmonary, renal, neurological, musculoskeletal, hematological or endocrine disease.
* Pregnant or Breast Feeding women
* Woman of childbearing potential not using a reliable method of birth control such as oral contraceptives or IUD.
* History of claustrophobia
* Ferromagnetic implants including pacemakers.
* Subjects refusing or unable to give written informed consent
Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department

In emergency medicine, acute pain is a common reason for consultation. It is recommended that patients in moderate to severe pain should receive a combination of intravenous acetaminophen and morphine. However, the data are sparse to support this strategy. Thus, the purpose of our research is to test non-inferiority of IV morphine alone versus IV acetaminophen and morphine in a multicenter, randomized, controlled double blind trial in ED patients with moderate to severe acute pain.

This study is designed to assess whether IV morphine alone is non inferior to combination IV acetaminophen and morphine for the management of moderate to severe pain in the ED. Numeric rating scale pain score will be compared between those who receive morphine alone and who will receive acetaminophen and morphine at 15, 30, 45 and 60 min post first injection.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older
* Moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to 5.
* Conscious patient
* Clinical stability at the physician's discretion
* Patient able to talk and give a verbal assessment of his/her pain with the numerical verbal scale
* Out of guardianship and/or tutorship
* Affiliated to the social security plan.

Exclusion Criteria:

* Pregnancy and Breast-feeding
* Patient Unable to give numeric rating scale scores
* Patient with a weight strictly less than 50kg.
* acute pulmonary edema, acute respiratory failure
* Acute coronary syndrome or unbalanced ischemic heart disease in progress.
* Acute alcoholic intoxication.
* Patient who received morphine, or acetaminophen, or analgesic, or anti-inflammatory, for the current acute pain episode, within 8 hours prior to arrival at the emergencies
* No possibility of having venous access
* History of chronic pain during treatment.
* Allergy, intolerance or know contraindication to paracetamol or morphine or to an excipient.
* Renal or hepatic insufficiency.
* Association with buprenorphine, nalbuphine and pentazocine.
* Patient unable or unable to give written consent.
GRAFted Patients' anxieTY Report

Autograft is a technique requiring several weeks of hospitalization in a protected environment and can be a source of anxiety of different natures for patients. In this study, level of anxiety will be reported weekly throughout hospitalizations for autologous transplant, to detect the most stressful period.

Autograft is one of hematological malignancies treatment, such as lymphoma and myeloma. This technique requires several weeks of hospitalization in a protected environment and can be a source of anxiety of different natures for patients. According to the medical and scientific report of the Biomedicine Agency in 2016, 3 043 patients were involved in an autologous transplant, which represents a significant number of patients potentially exposed to these types of anxiety.

That is why it will be interesting in this study to report weekly the level of anxiety throughout their hospitalization for the autologous transplant, to detect the most stressful period.

A validated questionnaire will be used: the HAD (Hospital Anxiety and Depression) scale of anxiety and depression.

Eligibility Criteria:
Inclusion Criteria:

* Autograft indication according to the Multidisciplinary Concertation Meeting

Exclusion Criteria:

* Incapacity to complete surveys
Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for BPH

This prospective, multicenter, two-arm, 1:1 randomized controlled trial (RCT) will enroll approximately 250 males at approximately 25 sites located within the United States. All enrolled subjects will be 45 years of age or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). They will be randomized to one of two readily available, marketed BPH therapies; Prostatic Urethral Lift procedure with the UroLift System (PUL Arm) or 0.4mg tamsulosin HCl (MED Arm).

This prospective, multicenter, two-arm, 1:1 randomized controlled trial (RCT) will enroll approximately 250 males at approximately 25 sites located within the United States. All enrolled subjects will be 45 years of age or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). They will be randomized to one of two readily available, marketed BPH therapies; Prostatic Urethral Lift procedure with the UroLift System (PUL Arm) or 0.4mg tamsulosin HCl (MED Arm).Men 45 or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). BPH symptoms may range from mild (8) to severe (35) on the IPSS scale. All enrolled men must meet selection criteria and be candidates for therapy with both UroLift System and 0.4 mg tamsulosin HCl.

Eligibility Criteria:
Inclusion Criteria:

1. Male 45 years of age or older
2. Diagnosis of BPH
3. Experiencing symptoms of BPH as indicated by an IPSS ≥8 and ≤30
4. Willing to wash out of current BPH medication(s), as applicable
5. An appropriate candidate for both BPH therapies evaluated in this study.
6. Ability to understand and consent to participate in this study
7. Willing and able to participate in follow-up evaluations

Exclusion Criteria:

1. Use of alpha blocker for BPH unless washed-out for 30 days
2. Use of daily phosphodiesterase type 5 inhibitor (PDE5i) for BPH unless washed-out for 30 days
3. 5-alpha-reductase inhibitors for BPH used within 6 months of therapy initiation
4. Current urinary tract infection or prostatitis
5. Current gross hematuria
6. Urinary incontinence presumed due to incompetent sphincter
7. Catheter-dependent urinary retention within 1 month prior to enrollment
8. Prostate volume greater than 100 cc as measured by TRUS
9. Prostate specific antigen level of greater than 10 ng/ml within one year of enrollment unless prostate cancer has been ruled out
10. History of neurogenic or atonic bladder
11. History prostate cancer treatment
12. Known to be hypersensitive to tamsulosin HCl or any component of tamsulosin HCl capsules
13. Known allergy to nickel, titanium, or stainless steel
14. Prior minimally invasive or surgical intervention for BPH
15. Urethral conditions that may prevent insertion of delivery system into bladder.
16. Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint
17. History of medical, surgical or other conditions that, in the opinion of the investigator, would interfere with the treatment or evaluation of the subject
Association Between Oxidative Parameters in Fertilization Medium of Cumulus Oocyte Complex and Outcome in IVF

Medium of cumulus-oocyte complex will be assessed for oxidative status.


Eligibility Criteria:
Inclusion Criteria:

•Patients undergoing in vitro fertilization treatment

Exclusion Criteria:

•Patients undergoing intracytoplasmic sperm injection
Assessing Fluid Responsiveness With PWTT

Pulse wave Transit time (PWTT) is a parameter calculated from ECG and pulseoximeter. It is supposed to help assessing the preload Status and guide intraoperative fluid therapy. This Project aims to validate the benefit of PWTT assessment in an observational clinical fluid study. In case of hypovolemia, patients will receive a fluid Bolus and hemodynamic data from clinical Standard Monitoring, esophageal doppler and PWTT will be recorded before and after the fluid Bolus. Receiver operating characteristic (ROC) curve will be used to determine the validity of PWTT as indicator for fluid responsiveness and its cut off value.

PWTT is determined by measuring the beginning and the end of pulse wave duration and can be calculated as the time interval from the ECG R-wave peak to the rise point of the pulse oximeter wave.

it consists of two components: pre ejection period (PEP) and arterial pulse wave transit time (a-PWTT). PEP is defined as the time from the ECG R wave to the rise point of the aortic root pressure wave. a-PWTT is defined as the time from the rise point of the aortic pressure wave to the rise point of the pulse oximeter wave. a-PWTT is the component which is directly related to the velocity of the pulse wave. However noninvasively, we can measure only PWTT, which also includes PEP. In general, PEP change over short periods of time is negligible in most cases, so we can assume that PWTT corresponds to

a-PWTT. In studies using several studies using animals and healthy volunteers, PWTT showed good correlation with stroke volume or systolic blood pressure. Also in experimental and clinical setting, it is shown that PEP changes indicate change in preloads.

It is not known at this moment, which of the following factors to be considered in processing raw data to acquire accurate PWTT value on predicting fluid responsiveness.

1. The beginning of pulse wave can be assessed by the appearance of either Q wave, which represents the initial phase of depolarisation going through the interventricular septum or R wave, which represents the ventricular depolarisation in ECG.
2. The end of pulse wave duration can be assessed by peripheral plethysmography mostly from a finger tip but also from an ear lobe.
3. The pulse wave time can be simply measured as it is, but can also be adjusted by heart rate using Bazett-Formula.
4. Not only the simple PWTT but also ventilatory induced fluctuation of PWTT (ΔPWTT) may be used for predicting fluid responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 - 80 years old
* elective open abdominal surgery
* clinical indication for direct arterial blood pressure Monitoring
* supine Position intraoperatively

Exclusion Criteria:

* under 18 years, over 80 years old
* pregnant
* no informed consent
* systemic inflammatory response syndrome (SIRS) or Sepsis
* Severe cardiac, coronary or vascular disease
* Arrythmia
* Cardiac valves anomaly
* BMI \> 35
* American Society of Anesthesiologists (ASA) physical status classification system: 4
* Lung disease that excludes Ventilation with a tidal volume \>8ml/kg
* esophageal pathology
* planned prone position surgery
The Efficacy and Safety of Electronic Stimulation in Patients Who Underwent Reconstruction of the Anterior Cruciate Ligament

This study is designed to evaluate the efficacy and safety of Myospare, a non-invasive device, which is connected to the body via electrodes placed in the injured leg. The electrodes which are placed in the middle or upper thigh will stimulate the quadriceps muscle.

Myospare will be installed 1 day after the anterior cruciate ligament (ACL) reconstruction surgery and will be removed after 6 weeks of treatment. The patients will be assigned to two groups:

1. Physiotherapy plus Myospare
2. Only physiotherapy

The hypothesis of the study is that electrical stimulation combined with voluntary exercise is more effective than voluntary exercise alone.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between 18-40 years old.
2. Subjects who are planning to undergo ACL surgery.
3. The surgery is performed within 3 weeks - 5 years since the injury.
4. Ability to follow instructions during the study period.
5. Signed Informed Consent.

Exclusion Criteria:

1. Bi-lateral surgery of the knee
2. Recurrent ACL surgery (patients who already underwent ACL surgery)
3. Complex injuries (a combination of posterior and anterior cruciate and lateral ligament injury)
4. Patients who underwent or are planned to undergo cartilage implantation.
5. Patients who underwent or are planned to undergo meniscus stitching.
6. Additional fracture/s in the lower limbs as a result of the same injury.
7. Signs of infection in the surgical wounds while installing the Myospare device.
8. Known skin hypersensitivity.
9. Known heart disease
10. Patients with a cardiac pacemaker.
11. History of peripheral blood vessel disease
12. Administration of drugs which might disrupt bone metabolism:

    * Total accumulating dosage of 150 gr' prednisone or any other glucocorticoid for seven days or more, within 6 months prior to the trial.
    * Calcitonin for 7 days or more, within 6 months prior to the trial.
    * Bisphosphonates for 30 days or more within 12 months prior to the study.
    * Fluoride for bone strengthening for 30 days or more within 12 months prior to the study.
    * Vitamin D or vitamin D metabolite for bone strengthening for 30 days or more within 12 months prior to the study.
    * Current treatment with chemotherapeutic drugs.
13. Past or current malignant disease within 10 years of study entry.
14. Participating in another clinical study during the past four weeks.
15. Patients who are planned to undergo femoral nerve block.
16. Patients claiming social security/work accident benefits.
17. Professional athletes whose livelihood depends on sports.
18. Pregnant and or lactating women.
19. Additional symptoms, which in the doctor's opinion would prevent inclusion of the patient in the study.