cyrilzakka/clinical-trials huggingface dataset:
Pre-ROSC Intra-Nasal Cooling Effectiveness

The purpose of the study was to demonstrate the safety and feasibility of early intranasal cooling prior to return of spontaneous circulation (ROSC) in the emergency medical services (EMS) environment. It was hypothesized that cooling during the resuscitation attempt would increase ROSC and subsequent survival. The study was not powered to demonstrate statistically-significant differences in any outcome parameter, but was intended as an exploratory study only.

Out of hospital cardiac arrest remains a significant cause of death. Mild hypothermia induced after resuscitation from cardiac arrest has been shown to improve neurologically intact survival. Studies in dogs and rodents have demonstrated improved outcomes when cooling is initiated intra-arrest.

The RhinoChill is a non-invasive cooling device through which rapid cooling is achieved via the intranasal delivery of an evaporative coolant into the nasopharynx. Due to its non-invasive and portable nature, the RhinoChill can be used to begin cooling earlier than other cooling devices.

Studies performed using the RhinoChill in a porcine model of cardiac arrest suggest that cooling with the RhinoChill prior to the first defibrillation attempt facilitates resuscitation and improves resuscitation rate and neurologically intact survival.

This study is being performed to assess the feasibility of using the RhinoChill device in the pre-hospital setting to improve resuscitation from cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* Collapse was witnessed
* No pulse
* Unresponsive to external stimuli

Exclusion Criteria:

* Have an etiology of cardiac arrest due to trauma, severe bleeding, drug overdose (OD), cerebrovascular accident (CVA), drowning, smoke inhalation, electrocution, hanging
* Already hypothermic
* Head trauma
* Cannot place intra nasal catheters
* Do Not Attempt to Resuscitate (DNAR) orders
* Known or clinically apparent pregnancy
* Have a known coagulopathy (except therapeutically induced)
* Are known to have a need for supplemental oxygen
* Achieve return of spontaneous circulation (ROSC) prior to initiating cooling
* Are reached by emergency medical services (EMS) personnel more than 20 minutes after collapse
A Study of the NeoVista Ophthalmic System for the Treatment of Subfoveal CNV Associated With Wet AMD in Patients That Require Persistent Anti-VEGF Therapy

The objective of the MERITAGE Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD) in patients that require persistent injections of Anti-VEGF therapy to maintain an adequate response to treatment.

Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Brachytherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. Treatment with radiotherapy and anti-VEGF compounds is a promising approach to treating AMD. The current treatment for neovascualar AMD involves multiple injections over an indefinite period of time. This trial will evaluate whether treatment with brachytherapy can reduce or eliminate the need for continued injections.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the Investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of \< 12 total disc areas (21.24 mm2) and a GLD ≤5.4 mm.
* Subjects must have completed anti-VEGF induction treatment, defined as the first 3 months of treatment. Following the induction period, subjects must have required at least 5 additional injections of Avastin or Lucentis in the 12 months preceding enrollment, or 3 additional injections of Avastin or Lucentis in the 6 months preceding enrollment, given on an as needed basis. Subjects may have previously received Macugen, although must meet the criteria above for Lucentis or Avastin.
* Subjects must be age 50 or older

Exclusion Criteria:

* Subjects with prior or concurrent subfoveal CNV therapy with agents, surgery or devices (excluding Macugen, Avastin, or Lucentis) including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, intravitreal or subretinal steroids, and transpupillary thermotherapy (TTT)
* Subjects who underwent previous radiation therapy to the eye, head or neck
* Subjects who have been previously diagnosed with Type I or Type II Diabetes Mellitus. Subjects that DO NOT have a documented diagnosis, but have retinal findings consistent with Type I or Type II Diabetes Mellitus.
The Effect of Intelligent Exercise on Vascular Function, Grip Strength and Adherence in Patients With AVF After Surgery

Isometric exercise can effectively promote the vascular function of arteriovenous fistula and increase hand grip strength, but patients needs to perform isometric exercises patiently. The purpose of this study want investigate the effect of using individual intelligent devices for forearm isometric exercise training on the increase of arteriovenous fistula vascular function and hand grip strength, and the improvement of patients' adherence with forearm isometric exercise.

An arteriovenous fistula(AVF) is the most preferred and safe vascular access for long-term hemodialysis patients. Isometric exercise can effectively promote the vascular function of AVF and increase hand grip strength, but patients needs to perform isometric exercises patiently. However, the patient's disease factors, muscle soreness caused by the exercise process, etc., may easily prevent the patient from effectively performing isometric exercise every day.This study will be the first isometric exercise training intervention program for eight weeks after AVF surgery with an intelligent device in Taiwan. Investigators expect to promote the vascular function of AVF and increase hand grip strength, as well as improve participant' adherence performance after the re-intervention protocol. To construct an intelligent forearm isometric exercise, as a reference for clinical care guidance.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years old
* Regular follow-up in the nephrology clinic
* Diagnosed with chronic kidney disease at stage 5 (or 5D)
* Expect to do the first autologous arteriovenous fistula surgery

Exclusion Criteria:

* Not the first autologous arteriovenous fistula surgery
* Have undergone percutaneous transluminal angioplasty in the arm receiving autologous arteriovenous fistula
* Have undergone orthopedic disease-related surgery in the arm receiving autologous arteriovenous fistula
* Have been cardiovascular events within the past 3 months
* Have been heart function Left ventricular ejection fraction within the past 3 months \<30%.
Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.

Diagnosis of fibromyalgia is complex and treatment options are limited. Pharmacological management of fibromyalgia is mainly centered on the central nervous system. In particular there is robust evidence for the use of tricyclic antidepressants (e.g., amitriptyline), anti-convulsants such as gabapentin or pregabalin and agents from the serotonin norepinephrine reuptake inhibitor (SNRI) family such as milnacipran. Aim of the work: To compare the efficacy of pregabalin agent (averopreg) alone versus combined pregabalin and serotonin norepinephrine reuptake inhibitor (milnacipran) in the management of fibromyalgia.

Subjects: The study will include 50 patients diagnosed as having fibromyalgia according to the ACR 2010 Fibromyalgia diagnostic criteria.

Methods: Patients will be classified into two groups:

1) Group 1: Patients will receive pregabalin as a monotherapy and the doses will be administered according to the treatment recommendations for fibromyalgia in the package insert, starting by 50mg twice daily increasing to 100 mg twice daily within 1 week based on efficacy and tolerability.

7) Group 2: Patients will receive combined pregabalin and milnacipran and the doses will be administered according to the treatment recommendations for fibromyalgia in the package insert, starting by 50mg twice daily increasing to 100 mg twice daily within 1 week for the pregabalin and starting by 12.5 mg increasing gradually to reach 100 mg daily of milnacipran based on efficacy and tolerability.

Eligibility Criteria:
Inclusion Criteria:

* female patients
* diagnosed as fibromyalgia according to the 2016 revision to the 2010/2011 fibromyalgia diagnostic criteria

Exclusion Criteria:

* Patients with major medical disorders or uncontrolled medical conditions
* Patients with recent myocardial infarction or stroke,
* Patients with active liver disease,
* Patients with renal impairment (creatinine clearance \< 60 ml/min),
* Patients with documented autoimmune disease,
* Patients with severe chronic obstructive pulmonary disease,
* Patients with unstable diabetes,
* pregnancy or breastfeeding patients
* Patients with exposed to any investigational drug within the past 6 months
AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment

We hypothesize that AndroGel may offer some relief to subjects with low or borderline testosterone levels who suffer from depression and have failed to respond to a trial of a standard antidepressant.

During this nine week, outpatient, double-blind study, male subjects between the ages of 30 and 65 years with treatment-refractory depression and low or borderline low testosterone levels will be treated with either AndroGel or placebo. Following this nine week, double-blind phase, eligible subjects will have the option to continue into a six month, open-label phase during which time all subjects will receive the AndroGel patch.

We will recruit 100 men between the ages of 30 and 65 years who have treatment-refractory depression and low or borderline low testosterone levels for participation in this study. For a period of nine weeks subjects will receive double-blind treatment with either AndroGel (testosterone gel) or placebo. During this double-blind treatment phase subjects will come to McLean Hospital for a total of seven visits. Both clinical assessments (including ratings of your levels of depression and anxiety, quality of life, and visuospatial memory)and laboratory tests will be performed at these visits. Following the nine week, double-blind phase, eligible subjects may enter into a six month, open-label treatment phase in which all subject receive AndroGel. If you participate in the open-label phase, you will be asked to return to the site for 8 visits during the six month period.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 30-65 years old
* Taking at least one serotonergic antidepressant at adequate dose for at least six weeks but still meeting DSM-IV criteria for major depressive disorder within the past year
* HAM-D score \>12

Exclusion Criteria:

* Current suicidal ideation
* Substance abuse or dependence within the past year
* Current or past psychotic symptoms
* A history of bipolar disorder
* A prostate-specific antigen (PSA) level greater than 4.0 ng/ml
* Other clinically significant medical condition
* A history of failing to show any clinically significant response to two or more adequate trials of different antidepressants.
Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea

Primary objectives:

To investigate the incidence of adverse events occurred following administration of Hexaxim in infants from 2 months of age under routine clinical practice, as per approved indications

The duration of each enrolled participant's participation in the study will be up to 36 or 43 days.

Eligibility Criteria:
Inclusion Criteria:

* An infant aged 2 months or more on the day of enrollment
* Infant whose parent or legal representative has signed and dated the ICF
* Receipt of 1 dose of Hexaxim on the day of enrollment according to the approved local product label (regardless of vaccinated dose)

Exclusion Criteria:

* Deviational use (off-label vaccination) from the approval local product label of Hexaxim
* Previous history of enrollment in this study
* Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device or medical procedure
Prevention of Renal Failure by Nitric Oxide in Prolonged Cardiopulmonary Bypass.

Prolonged periods of cardiopulmonary bypass (CPB) cause high levels of plasma free haemoglobin(Hb) and are associated with increased morbidity. We hypothesized that repletion of nitric oxide (NO) during and after the surgical procedure on CPB may protect against endothelium dysfunction and organ failure caused by plasma-Hb induced NO scavenging.

Prolonged periods of cardiopulmonary bypass (CPB) cause high levels of plasma free haemoglobin(Hb) and are associated with increased morbidity. We hypothesized that repletion of nitric oxide (NO) during and after the surgical procedure on CPB may protect against endothelium dysfunction and organ failure caused by plasma-Hb induced NO scavenging. There are three possible beneficial mechanisms of delivering NO:

1. Nitric oxide reduces ischemia-reperfusion injury (such as in acute myocardial infarction, stroke, and acute tubular necrosis).
2. Nitric oxide has anti-inflammatory properties. As antioxidants, exogenous NO may reduce injury by counteracting the cytotoxic effects of reactive oxygen species, modulating leukocyte recruitment, edema formation and tissue disruption.
3. Exogenous nitric oxide prevents noxious effects of hemolysis-associated NO dysregulation. During hemolysis, nitric oxide gas oxidized of plasma oxyhemoglobin to methemoglobin, thereby inhibiting endogenous endothelium NO scavenging by cell-free Hb.

NO depletion during hemolysis and its sequelae. The release of plasma free Hb (with Fe2+ iron) by hemolysis avidly scavenges nitric oxide (NO) by the dioxygenation reaction. Elevated plasma ferrous Hb levels can induce a "NO deficiency" state. Reduced vascular nitric oxide levels can contribute to vasoconstriction, inflammation, and thrombosis, potentially contributing to systemic endothelial dysfunction after cardiac surgery with CPB.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* Are \> 18 years of age
* Elective cardiac or aortic surgery with CPB, when the surgeon plans double valve replacement.
* Stable pre-operative renal function, without dialysis.

Exclusion Criteria:

* Emergent cardiac surgery
* Life expectancy \< 1 year
* Hemodynamic instability as defined by a systolic blood pressure \<90 mmHg
* Administration of ≥1 Packed Red Blood Cell transfusion in the week before surgery
* X-ray contrast infusion less than 1 week before surgery
* Anticipate administration of nephrotoxic agents, such as hydroxyethyl starch
* Evidence of intravascular or extravascular hemolysis
Acoustic Analysis of the First Babies Crying in Delivery Room and Adaptation to Extra Uterine Life

Interpreting the cry of new-borns is a real challenge not only for perinatal professionals but also for parents, who are confronted daily with those sounds.

The description and the acoustic analysis of baby's cry can allow healthcare professionals to better adapt their care during the first months of life.

Thanks to an objective analysis method as acoustic analysis, the particularities of the first cry should provide us information on the quality of adaptation to ambient air life.

Interpreting the cry of new-borns is a real challenge not only for perinatal professionals but also for parents, who are confronted daily with those sounds.

The description and the acoustic analysis of baby's cry can allow healthcare professionals to better adapt their care during the first months of life. Aiming for this objective, many studies have already been carried out on infants crying in the first months of life, in order to better understand their significance (pain, discomfort, hunger) and the mechanisms of recognition and discrimination by parents or listeners. Various techniques are promising to characterize the acoustic space of cry (maximum frequency, intensity, harmonics, duration...).

However, few studies have investigated the acoustic characteristics of the first cry of life in the delivery room. Its intensity and characteristics are closely related to the laryngeal anatomy and respiratory capacity. Thus, a vigorous cry with its own acoustic characteristics could be the witness of a good adaptation to extra uterine life, while a weak or plaintive cry should warn the caregiver on difficulties in this adaptation.

Thanks to an objective analysis method as acoustic analysis, the particularities of the first cry should provide us information on the quality of adaptation to ambient air life.

The investigators hypothesize that the acoustic characteristics of the first cries of newborns recorded at birth are correlated with the criteria of extra uterine life adaptation (Apgar score, pH and lactates collected from the umbilical cord), with the respiratory score (Silverman) and with the early neonatal outcome (transfer to the intensive care unit).

Eligibility Criteria:
Inclusion Criteria:

* Infant born between 37 and 42 SA
* Live infant at birth
* Parent who received informed written information about the study

Exclusion Criteria:

- Emergency after childbirth (haemorrhage)
Does Dairy Benefit Bone & Body Composition in Overweight Girls Undergoing a Weight Management Program?

The purpose of this study is to examine whether increased dairy intake, at the level recommended by Canada's Food Guide, combined with healthy eating and exercise, will improve body composition and bone turnover over 12 weeks in overweight and obese girls.

Three groups will participate in this study. Participants must be low dairy consumers (0-1 svgs/d) and do little to no structured physical activity at study entry. Each participant will be assigned to a group; one of two experimental groups or a control group. The two intervention groups will differ only in the amount of dairy consumed (4 svgs vs. 0-1 svg/d). Both will undergo the same exercise program (3x/wk) and will be counseled on healthy eating by a trained nutritionist-dietitian every month. The control group will be tested at the beginning and end of the study to help account for any growth-related changes during the study but will not receive any formal intervention. In each group, the investigators will assess body composition (muscle mass, fat mass, % body fat and regional fat mass) and bone (bone turnover markers). The investigators will also measure various metabolic and inflammatory markers, hormones as well as dietary intake, strength and fitness.

This study will determine whether increased intake of dairy products improve bone and body composition during a 12-week weight management intervention. The investigators expect the two groups participating in the intervention to show significant changes in body weight and body composition and greater gains in fitness compared to the control group. The investigators expect those consuming dairy to show greater improvements in body composition and bone health compared to those not consuming added dairy. The investigators also anticipate better vitamin D status and less whole-body inflammation in those consuming dairy. Both intervention groups should show improvements in fasting insulin, glucose and cholesterol.

Eligibility Criteria:
Inclusion Criteria:

* at or above the age appropriate cut-offs for overweight (OW) or obese (OB) on WHO growth charts: ≥85-97% for OW and \>97% for OB for BMI
* between 10 and 18 years old
* menarcheal
* low dairy consumers (0-2 svgs/d and \<700 mg Ca/d measured by baseline FFQ)
* otherwise healthy (i.e. no diagnosed disease or illness)
* lower levels of physical activity (0-2 times/week)
* no allergy to dairy foods or diagnosed lactose intolerance
* not on medications related to a chronic condition or that affect bone health

Participants will be excluded from participation in the study if they do not meet one or more of the above inclusion criteria.
Study of the Interest of ECG Teletransmission in Retirement Home (EHPAD) In the Ile-de-France Region.

The aim of the study is to evaluate the interest and the workability of ECG teletranmission in EHPAD in Île-de-France. ECG for the elderly is beneficial to detect or monitor cardiovascular disease.

Main objectives :

* Evaluate the workability of ECG uploaded by a caregiver who was trained before
* Evaluate the prevalence of ECG anomalies highlighted thanks to the realisation of an uploaded ECG (supraventricular and ventricular rhythm disorder and coronary pathology)

Secondaries objectives :

* Evaluate the prevalence of unknown ECG anomalies and thus determine the number of new diagnostics highlighted thanks to uploaded ECG
* Evaluate the prevalence of ECG iatrogenic anomalies

The study is observational, multicentre and prospective. It is going to include 3211 elderly living in EHPAD in Île-de-France. 150 EHPAD or involved in the study, they are split in two groups : 100 EHPAD will receive ECG and 50 EHPAD will not. This last group will enable to lead a comparative analysis, only global data about death will be collected.

The study will last 36 months with 12 months of participation for each resident.

Eligibility Criteria:
Inclusion Criteria:

Elderly living in nursing homes (EHPAD) who requires electrocadiogram (ECG) due to :

* Cardiac pathology : coronary artery disease, heart failure, high blood pressure, diabetes, valvular disease, atrial fibrillation
* A medication which could causes electrocadiogram (ECG) anomalies Patients living in nursing homes (EHPAD) who give their agreement.

Exclusion criteria :

Protected adult under a protection of the court
Efficacy of Dietary Sodium Restriction of Improving Vascular Endothelial Function in Middle Aged and Older Adults

The investigators hypothesize that reducing salt in the diet will improve the function of blood vessels in middle aged and older adults with moderately elevated systolic blood pressure, by increasing the amount of BH4 and nitric oxide in your blood vessels and reducing the amount of oxidative stress.

The improvement in blood vessel function will be determined over a 10 week period. Subjects will be randomly assigned to either a 'low salt' condition (placebo pills + 1200 mg dietary sodium) or a 'normal salt' condition (2300 mg sodium chloride pills + 1200 mg dietary sodium) and monitored for 5 weeks. After the initial set of 5 weeks, the subjects are switched into the opposite condition, completing the cross-over study design. During weeks 1-4 and 6-9, subjects are monitored weekly with 24 hour urine collections and diet logs. The assessment of the primary outcome (blood vessel function) is completed during weeks 5 and 10. BH4 and ascorbic acid are also administered during weeks 5 and 10 to measure the effects of sodium intake on endogenous BH4 levels and vascular oxidative stress.

Eligibility Criteria:
Inclusion Criteria:

* 50-79 years of age
* SBP 130-159 mmHg

Exclusion Criteria:

* Have been sick with an infection in the past two weeks
* Are currently sick or have ongoing health problems such as kidney or CVD
* Have lost more than 11 lbs. in the last 3 months
* Are taking any type of antioxidants
* Smoke or have alcohol problems
* Have blood glucose levels higher than 126 mg/dL
* Have resting SBP below or less than 100 mmHg or greater than 159 mmHg
* Have a resting diastolic blood pressure greater than 99 mmHg
* Have a BMI greater than 40 kg/m\^2
* Are presently consuming less than 9 or greater than 18 grams of salt / day
* Have a baseline FMD of greater than 6%
* Are taking any of the following types of drugs: blood thinners, anti-seizure medications, ant-inflammatory drugs
* Participate in any high endurance athletic training
* Taking Hormone Replacement Therapy
* Have not been post-menopausal for at least 1 year