cyrilzakka/clinical-trials huggingface dataset:
Intubation of Patients With an Unstable Cervical Spine Using the CMAC Device

The purpose of this study is to evaluate whether tracheal intubation with the CMAC device decreases the time required for intubation as compared to intubation with the fiberoptic bronchoscope in patients with an unstable cervical spine. Both the CMAC device and the fiberoptic bronchoscope are currently commonly used in standard of care practices in the intubation of patients with cervical spine injury.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an unstable Cervical-spine as a result of C-spine injury.
* Patients scheduled to undergo inpatient surgical procedures under general anesthesia.
* Willingness and ability to sign an informed consent document.
* 18-80 years of age.
* ASA Class I - III adults of either sex

Exclusion Criteria:

* Patients deemed to be at significant airway risk to necessitate awake fiber optic intubation.
* Patients with a history of oral-pharyngeal cancer or reconstructive surgery.
* Emergency surgeries.
* Any other conditions which may interfere with the conduct of the study.
The Influence of Obesity to Esophageal Reflux Severity Measured by pH-Metri Impedans on Gastroesophageal Reflux Disease Patients

To see a more convincing relationship between increased body mass index and the severity of esophageal reflux in GERD patients, GERD diagnosis should be performed with greater precision or precision. From the available data, it appears that no studies in Indonesia have correlated the body mass index with the severity of esophageal reflux events measured by multical intraluminal intraluminal pH-metric in patients with GERD due to the invasive nature of the test. Therefore, research needs to be done to assess the effect of increased body mass index on the severity of esophageal reflux as measured by multical intraluminal impedance pH-metric in GERD patients.

Gastroesophageal reflux disease (GERD) prevalence is increasing worldwide. It is known that GERD correlates with obesity. In order to see further association between obesity and severity degree of esophageal reflux, GERD must be diagnosed with greater precision and accuracy. Therefore, study to see the impact of obesity in esophageal reflux severity measured by multicanal intraluminal impedance pH-meter (MII-pH) in GERD patient is compulsory.

The objective of this study is to explain the impact of obesity on severity of esophageal reflux in GERD patient measured by DeMeester score, hiatal hernia incidence, and the prolongation of acid exposure time in GERD patient.

This cross-sectional study recruited patients from Gastroenterology Clinic, Internal Medicine Department Cipto Mangunkusumo Hospital during May-August 2017. Patient with normal and obese body mass index (BMI) suspected having GERD were surveyed using GERDQ to diagnose GERD in these patients. Upper gastrointestinal endoscopy were performed to see hiatal hernia. All patients recruited underwent MII-pH examination to measure DeMeester score and acid exposure time. Results were analyzed using bivariat analysis.

Eligibility Criteria:
Inclusion Criteria:

1. GERD patients diagnosed by GerdQ
2. Adult patient age 18-60 years
3. Patients with nutritional status based on normal BMI (18.5-24.9) and obesity (≥30)
4. Willing to participate in research and sign informed consent

Exclusion Criteria:

1. At the endoscopic examination found Barrett's esophagus, peptic ulcer, severe gastritis, severe NSAID gastropathy, hemorrhage (melenae), gastric cancer, esophageal cancer
2. MII-pH check failed to install
3. Patients are not cooperative
4. Patients with acute psychiatric disorders
5. Patients with severe heart trouble, persistent asthma patients, decompensated liver cirrhosis and chronic renal disease
Group vs. Traditional Diabetes Prenatal Care

This study aims to use an innovative and integrated educational curriculum to deliver prenatal care and diabetes care for pre-gestational diabetic women from approximately the first trimester of pregnancy through delivery and the early postpartum period in a group care model. The group care model will be compared to a control group, a traditional, individual care model.


Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed viable pregnancy at the time of enrollment.
* Able to provide consent for participation.
* Diabetes diagnosed prior to 12 weeks gestation.
* Initiation of care by 20 weeks gestation.
* Age 18 years or older.

Exclusion Criteria:

* Not planning to deliver at UnityPoint Health- Meriter Hospital.
The Efficacy of CILostazol ON Ischemic Complications After DES Implantation

Objectives :

* To evaluate the influence of concomitant use of cilostazol with aspirin and clopidogrel on the composite cardiovascular adverse outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) after drug-eluting stent implantation

Study Design : Prospective, open label, two arm, randomized multicenter trial to test the superiority of cilostazol group compared with the control group. Patients will be randomized according to the use of cilostazol

Patient Enrollment: 960 patients enrolled at 5 centers in Korea

Patient Follow-up : Clinical follow-up will occur at 1, 3 and 6 months. Angiographic follow-up will be recommended to all patient at 6 months after index procedure.

Primary Endpoint

* Composite of adverse cardiovascular/cerebrovascular outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) within 6 months

Secondary Endpoint

* All cause of death, stent thrombosis, and each component of primary endpoint at six months
* PRU level measured at discharge after the index procedure and after six months

Safety Endpoint

* Bleeding complications according to TIMI criteria
* The incidence of drug discontinuation
* Heart rate

Stratified randomization by statin type (rosuvastatin or atorvastatin) and the center was performed

Eligibility Criteria:
Inclusion Criteria:

* Subject must be at leat 18 years of age
* Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of cilostazol and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
* Subject must have significant coronary artery stenosis (\>50% by visual estimate)
* Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia. In subjects with coronary artery stenosis\>75%, evidence of myocardial ischemia does not have to be documented.
* Coronary lesions must be amenable for percutaneous coronary revascularization with drug eluting stents.

Exclusion Criteria:

* Subject who undergoes primary percutaneous coronary intervention due to acute ST elevation myocardial infarction
* Subject who has contraindication or allergy to anti-platelet agents (aspirin, clopidogrel or cilostazol)
* Subject who has thrombocytopenia (\<120,000/uL)
* Subject who has liver cirrhosis (Child class B or C)
* Subject who is on the anticoagulation therapy
* Subject who has severe congestive heart failure (left ventricular ejection fraction \<30%)
Warfarin Versus Aspirin Recurrent Stroke Study

The goal of this study is to compare aspirin to warfarin for the prevention of recurrent stroke.

This study compared aspirin to warfarin to determine optimal therapy for the prevention of recurrent stroke. Both drugs slow clotting of the blood. Blood clots are involved in the final stages of the most common type of stroke due to blockage of the vessels that supply oxygen-rich blood to the brain. Aspirin affects the blood platelets, while warfarin inhibits circulating clotting proteins in the blood. Numerous previous studies have proven that use of aspirin reduces recurrent stroke by about 25 percent. Part of the controversy about aspirin versus warfarin for stroke prevention has been the thinking among clinicians that warfarin may be a better blood thinner than aspirin to prevent almost all forms of stroke, but that it has greater side effects, increased risk of hemorrhage, and higher costs due to the need for blood tests to monitor the treatment effect for patients.

To make the aspirin and warfarin arms of the study as unbiased as possible, the investigators matched both groups of patients for primary stroke severity, age, gender, education, and race/ethnicity. The two groups were also matched for stroke risk factors, including hypertension, diabetes, cardiac disease, smoking, alcohol consumption, and physical activity. The investigators used an aspirin dose of 325 mg/day and a warfarin dose specifically tailored to each individual patient.

This study found that aspirin works as well as warfarin in helping to prevent recurrent strokes in most patients.

Eligibility Criteria:
Inclusion:

* Acceptable candidates for warfarin therapy
* Had an ischemic stroke within the previous 30 days
* Had scores of 3 or more on the Glasgow Outcome Scale

Exclusion:

* Base-line INR above the normal range (more than 1.4)
* History of stroke due to a procedure or that was attributed to high-grade carotid stenosis for which surgery was planned
* History of stroke associated with an inferred cardioembolic source
A Study of the Experience of Music Therapy in Cancer Patients With Delirium

The purpose of this study is to improve our understanding of the experience of music therapy by cancer patients with delirium, and the experience of music therapists working with these patients. The researchers are focusing on patients with delirium because of the challenging symptoms of this condition.

At MSK, music therapy is routinely used in patients with cancer. Music therapy sessions are done at the patient's bedside, where the music therapist plays live music on a guitar, keyboard, harp, or percussion instrument, sometimes as accompaniment to singing.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (ages 18-75) with delirium
* referred for and receive music therapy.
* were identified as having delirium by the Confusion Assessment Method (CAM), Confusion Assessment Method for ICU patients (CAM-ICU) or a documented diagnosis by a clinician from the Department of Psychiatry and Behavioral Sciences in the patient's electronic medical record (EMR).
* Patients that have had music therapy in the past will be eligible for the study
* Only patients that recover from delirium (per CAM, CAM-ICU, or progress note by a clinician from the Department of Psychiatry and Behavioral Sciences) after receiving music therapy will be approached for interview by the researcher.

This study will also include their caregivers, music therapists, primary nurse, and bedside companions who have participated in or observed the participants' response to music therapy.

The music therapist participants are:

* Board-certified senior music therapists with 10 or more years experience in the research site who sign a blanket consent form to participate in study.
* Assigned to eligible patients by Integrative Medicine Service Client Service Representative (CSR).

The caregivers are:

* Family or unrelated adult (\>18) caregivers who observed bedside music therapy session(s) with patients meeting inclusion criteria

The staff caregivers are:

* Primary nurse caring for eligible patients who receive their first music therapy session while experiencing delirium.
* Patient care technicians (PCT) assigned as bedside companions for eligible patients who receive music therapy

Exclusion Criteria:

* have a known hearing impairment
* do not speak English.
* are heavily sedated, comatose, or expected to be discharged or expire within 48 hours
* have known comorbidities of delirium tremens, steroid psychosis, or dementia

Caregivers will be excluded from the study if they do not speak English. Music therapists, nurses, or bedside companions will be excluded if they are not assigned to eligible patients.
This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy Subjects

The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after single IV doses.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures.
* Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
* Healthy male and female volunteers. Females must be of non childbearing potential.

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
* History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
Family-centered Support Program for Caregivers of Stroke Survivors

The goal of this study is to evaluate the effect of a family-centered support program on the care burden, depressive symptoms, perceived social support, and quality of life of stroke survivor' caregivers and on care recipients' rehabilitation adherence and depressive symptoms.

The family-centered support program included stroke and rehabilitation education, problem-solving skills training, long-term care information support, and instant messaging applications-based 24-h peers-support group for caregivers.

Investigators hypothesized that (1) Compared with those in the control group, caregivers who undergo a family-centered support program have lower care burdens, do not have a high risk of depression, and perceive better social support and quality of life; (2) Compared with those in the control group, care recipients in the family-centered support group have ideal rehabilitation adherence and are not at a high risk of depression.

Eligibility Criteria:
Inclusion Criteria:

1. Caregivers:

   * Aged 20 years or older
   * Primarily responsible for caring for the stroke survivor in the hospital and after discharge.
2. Stroke survivors:

   * Diagnosed with moderate stroke (National Institute of Health Stroke Scale ≥5 or Modified Rank in Scale ≥3), including ischemic and hemorrhagic stroke, via computed tomography or magnetic resonance imaging within one month. admitted to the stroke unit at a medical center
   * Had a primary family caregiver.

Exclusion Criteria:

1. Caregivers:

   * Refusal to participate in the study
   * Unable to communicate, for example, non-Chinese speakers
   * Reported having been diagnosed with psychiatric illness (such as major depression) and undergoing treatment.
2. Stroke survivors:

   * Unstable vital signs
   * Terminal illness
   * Transfer to long-term care facilities after hospital discharge
   * Self-reported having been diagnosed with psychiatric illness (such as major depression) and undergoing treatment.
Assessment of Drug-eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation

The purpose of this study is to determine the clinical effects of a triclosan stent on adherent bacteria, stent biofilms, and patient urine cultures in patients with an indwelling triclosan ureteral stent. The patient populations that will be tested include: patients following ureteroscopy and patients scheduled to undergo shockwave lithotripsy who require a ureteral stent. It is hypothesized that triclosan eluting ureteral stents will reduce the number of bacteria both on (within biofilm) and around (in the urine) a ureteral stent.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo ureteroscopy for any reason and require a ureteral stent post-operatively as determined by the surgeon (e.g. renal obstruction, ureteral edema, ureteral perforation, large stone fragments to pass, following ureteral dilation, ureteral trauma, solitary kidney, or any other reason left to the discretion of the surgeon).
* Patients undergoing extracorporeal shockwave lithotripsy (ESWL) who will require a stent as determined by the treating urologist (e.g. solitary kidney, ureteral stone \> 1 cm, renal stone \> 1.5 cm, significant renal obstruction, history of pyelonephritis, or any other reason left to the discretion of the surgeon).
* Patients who have or are going to have chronic ureteral stents, for any reason.
* Patients willing to return to St. Joseph's Hospital's Urology Clinic for follow-up.

Exclusion Criteria:

* Age ≤ 17 years
* Patients unable to consent.
* Any patient requiring endocarditis or prosthetic device prophylaxis (e.g. fresh arthroplasty etc.).
* Pregnant females
* Immunocompromised patients
* Significant urinary symptoms (urgency, dysuria, strangury, hematuria) or other bladder pathology that may cause these symptoms (e.g. interstitial cystitis)
* Anyone in the investigator's opinion that would be unsuitable.
Development and Validation of a Mindfulness Intervention for Problem Gambling: An Exploratory Study

In recent years, mindfulness meditation has been shown to be a promising approach for alleviating emotional distress associated with chronic medical and psychiatric conditions and in reducing relapse following treatment for depression. The applicability of mindfulness meditation to problem gambling has not yet been explored. Mindfulness meditation may be particularly suitable for this clinical disorder as it stresses a process-oriented, metacognitive, approach to cognitive pathology in contrast to a content-focused approach, characteristic of traditional approaches to treating cognitive psychopathology. Gambling-related cognitive psychopathology is a well-known characteristic of problem gambling and frequently the target of therapy. Although there is growing evidence that cognitive-behavioral treatments are effective for gambling, outcomes may be improved by teaching gamblers additional ways to cope with cognitive distortions that emphasize metacognitive processes.

Hypothesis The mindfulness-enhanced CBT (MCBT) will report significant reductions in the frequency of gambling, gambling urges, gambling cognitions and gambling-related expenditures compared to the relaxation-enhanced CBT (RCBT) at end-of-treatment and at the 3-month follow-up.

Significance

1. feasibility of mindfulness interventions for problem gamblers
2. tentative data for the effectiveness of the intervention
3. an additional clinical tool to treat problem gamblers
4. basis of a larger, grant-funded study obtain more definitive data

Eligibility Criteria:
Inclusion Criteria:

* current diagnosis of pathological gambling
* willingness to practice mindfulness or relaxation

Exclusion Criteria:

* substance abuse/dependence (except nicotine)
* concurrent attendance at any treatment in which their gambling is addressed (including Gamblers Anonymous)
NATURE 3.2_New Approach for the Reduction of REnal Uremic Toxins

The objective of the pilot study is to validate a combined approach based on the use of an innovative symbiotic and an innovative dialysis cartridge in patients on hemodialysis (HD).

The symbiotic consists of a mixture of probiotics (Lactobacilli and Bifidobacteria), prebiotics (fructoligosaccharides and inulin) and natural antioxidants (a mix of quercetin, resveratrol and proanthocyanidins).

The cartridge is composed of a divinylbenzene (DVB) adsorbing resine, expected to have high affinity to protein-bound uremic toxins pCS and IS, on the basis of its chemical structure.

This combined approach will be aimed at achieving two main objectives:

1. reduction of blood levels of microbial-derived uremic toxins, involved in cardiovascular complications
2. reduction of inflammation markers and oxidative stress and reduction of intestinal permeability


Eligibility Criteria:
Inclusion Criteria:

* CKD patients on bicarbonate hemodialysis
* Aged between 30 to 65
* BMI between 18.5 and 29.9
* Omnivore diet
* Informed consent signed

Exclusion Criteria:

* Use of antibiotics or probiotics up to 30 days prior to recruitment
* Chronic gastrointestinal disorders
* Systemic inflammatory diseases
* Suspicion or clinical diagnosis of malignancy
* Chronic liver disease
* Treatment with corticosteroids or immunosuppressive drugs
* Psychiatric conditions reducing the compliance to treatment protocols
A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106

Several subjects included in a Pilot study (CTN 31GB0106) during 2002-2003 still had Macrolane deposits in the breast when the last study visit was performed. An additional follow up visit is planned to follow duration and safety of the former formulation of Macrolane that was used in the Pilot study (CTN 31GB0106).

All subjects included in a Pilot study between 2002-2003 (CTN 31GB0106) are offered to take part in a seven year safety follow up after the initial injection of the former formulation of Macrolane into the breasts. The study will not involve any additional treatments.

The follow up will include relevant medical history, weight, breast examination, ultrasound and mammography to determine if there are/have been any safety issues since the final study visit in the Pilot study (CTN 31GB0106), as well as a comprehensive MRI investigation to assess the breast structure and determine if there are still deposits of Macrolane in the breast.

Eligibility Criteria:
Inclusion Criteria:

* Participant in 31GB0601

Exclusion Criteria:

* There are no exclusion citeria in this study
Study Evaluating the Safety of Enbrel (Etanercept)

The purpose of this study is to collect post-marketing information on the safety of Enbrel in Filipino patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients from the study center who received or will receive at least one dose of Enbrel according to the approved product indication.

Exclusion Criteria:

* Previously discontinued Enbrel therapy due to significant safety concern.
One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish

In Italy, few data about anaphylaxis due to peanuts in pediatric age are available, conversely data about walnuts/hazelnuts, shellfish/mollusks anaphylaxis have not yet been collected.

Children with physician-confirmed food allergy to peanuts, walnuts/hazelnuts and shellfish/mollusks will be recruited from 9 allergy clinics located in the Italian Territory (Bologna, Lecce, Napoli, Palermo, Parma, Pavia, Roma, Torino, Trento).

Parent of food allergic children will compile a food allergy questionnaire (questions about general information on the family, on life and food habits, on indoor environment, on health status, on clinical aspects of the allergy, on the access to diagnostic and treatment resources).

Parent of healthy children will compile a control questionnaire (questions about general information on the family, on life and food habits and on indoor environment) The 1-year survey will determine the frequency of anaphylaxis in allergic outpatient children.


Eligibility Criteria:
Inclusion criteria

* Cases: 0-14 years old patients with food allergy to peanuts, walnuts/hazelnuts, shellfish/mollusks.
* Controls: 0-14 years old subjects without allergy to peanuts, walnuts/hazelnuts, shellfish/mollusks.

Exclusion criteria

* Patients/subjects in acute phase of disease or with not controlled chronic pathologies;
* missing written informed consent by parents