cyrilzakka/clinical-trials huggingface dataset:
Validation of a Proteomic Signature and Assessment of Viremia in Children With Fever Without Source

The study is an observational blinded Validation study in pediatric patients below 3 years old with a diagnosis of Fever Without Source (FWS). In this study the investigators aim to validate the performance of a proteomic signature aiding the physicians to discriminate between viral and bacterial infections in febrile children. The study will also assess the prevalence of Human Enteroviruses (HEV), Human Parechoviruses (HPeV), Adenovirus (AdV) and Human Herpesvirus type 6 (HHV-6) viremia, as well as Kingella Kingae bacteremia in the study cohort.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of FWS (fever of less than 7 days with no cause determined by the history or the physical exam)
* Age \< 3 years old
* Informed consent (IC) given by parent or legal guardian

Exclusion Criteria:

* Unavailable blood
* Comorbidities predisposing to infections such as cancer, primary or secondary immunodeficiency, and iatrogenic immunosuppression

Inclusion Criteria for healthy controls:

* Age \< 3 years old
* Informed consent (IC) given by parent or legal guardian
* No suspicion of infectious or inflammatory disease at presentation and during the two weeks before.
Remote Ischemic Conditioning and Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG)

Recent studies indicate that remote ischemic conditioning can protect the heart and other organs during cardiac surgery. The investigators aim to investigate whether such a stimulus can reduce the incidence of atrial fibrillation or other complications following coronary artery bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elective on-pump CABG surgery
* Informed consent

Exclusion Criteria:

* Prior cardiac surgery (Re-operations)
* Prior atrial fibrillation
* Use of class 1 or 3 anti arrhythmic medication or digoxin Use of intermittent aortic cross clamping during surgery
* Age \<18 years
* Left ventricular ejection fraction ≤30%
* Serious pulmonary disease (resting pO2 \<90% at room air)
* Renal failure (clearance \<30 ml/min as calculated using the Modification of Diet in Renal Disease formula)
* Liver failure
* Use of the sulfonylurea derivative glibenclamide (this drug is known to block any preconditioning stimulus
Impact of Radial Arterial Location on Arterial Catheter Lifetime in Surgical Intensive Care

Dysfunctions radial arterial catheter are frequent. This was a prospective, randomized observational study monocentric in ICU in France. Patients are randomized in 2 groups : One to less than 4 four centimeters to the wrist joint (Group A) and the other, to more than four centimeters to the wrist joint. (Group B). The primary outcome was the incidence of catheter dysfunction (defined by the impossibility of taking blood from the catheter and / or the impossibility having a reliable blood pressure curve). Investigators compared also the incidence of infection, satisfaction of doctors and nurses, the numbers of days with catheter and the cause of withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* all patients admitted in ICU, older than 18 years and who required an arterial catheter are include
Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients.

Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin.

The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients.

The investigators hypothesize that neonatal and pediatric ECMO patients receiving bivalirudin will spend more time at goal anticoagulation and will experience less hemorrhagic and thrombotic complications when compared to patients receiving unfractionated heparin. Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin. The investigators secondary aim will be to define the incidence of hemorrhagic and thrombotic complications in patients receiving bivalirudin during ECMO.

Eligibility Criteria:
Inclusion Criteria:

* Age 1 day to less than 18 years
* Cared for in the pediatric intensive care unit or pediatric cardiac intensive care unit
* receiving venovenous or venoarterial ECMO

Exclusion Criteria:

* Patients with known or suspected heparin induced thrombocytopenia prior to consent
* Patients with hepatic failure defined as coagulopathy with elevated transaminases more than three times normal values
* Patients with plan to decannulate from ECMO within 48 hours
* Known or suspected pregnant women
* Previous enrollment in this study
* Primary language spoken that is not English or Spanish
Long-term Behavior Change - 1

The purpose of this study is to determine if different reinforcement procedures (i.e., schedules) produce different patterns of long-term abstinence from methamphetamine. We anticipate that the three contingency management conditions will promote longer periods of abstinence in the year following treatment relative to the standard control group. Furthermore, we predict that the intermittent reinforcement procedures will produce longer periods of continued abstinence (i.e., long-term behavior change) in the year following treatment than the continuous reinforcement procedure. Finally, we predict that the intermittent unpredictable schedule will produce longer lasting behavior change than the intermittent predictable schedule. Methamphetamine use will be measured using urine toxicology and self-report of methamphetamine use.

Briefly the four study conditions are: (1) standard treatment which consists of 16 weeks of psychosocial treatment, (2) continuous contingency management which consists of 16 weeks of psychosocial treatment with a contingency management procedure in effect during the first twelve weeks in which vouchers are made available after each provision of a methamphetamine-negative urine test, (3) intermittent predictable contingency management which consists of 16 weeks of psychosocial treatment with a contingency management procedure in effect during the first twelve weeks in which vouchers are available after the provision of every three consecutive methamphetamine-negative urine samples, and (4) intermittent unpredictable contingency management which consists of 16 weeks of psychosocial treatment with a contingency management procedure in effect during the first twelve weeks in which vouchers are available on one day each week (randomly selected after the first week) for the provision of methamphetamine-negative urine samples provided all urine samples since delivery of the last reinforcer were also methamphetamine negative.

Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for methamphetamine dependence
* Willing and able to comply with study procedures
* Willing and able to provide written informed consent

Exclusion Criteria:

* Have a medical condition that, in the study Principal Investigator (PI's) judgment, might interfere with safe study participation
* Have a recent (past 30 days) history of suicide attempts and/or current serious suicidal intention or plan as assessed by the Beck Depression Inventory (BDI)
* Have a history of violent criminal behavior or be on parole
* Any other circumstances that, in the opinion of the PI, would interfere with safe study participation
ROMA (Reminiscence, Reality Orientation, Music and Art ) Therapy, Cognition, Depression and Behavioral Problems in the Population With Dementia

This study aimed to conduct a randomized controlled trial to examine the effectiveness of ROMA therapy( Reminiscence, Reality Orientation, Music, and Art) on improving cognitive function, behavioral and psychological symptoms in population with dementia. The hypotheis of this study is that these patients with dementia receiving ROMA therapy featuring reminiscence, reality orientation, music, and art would improve their cognition, depressive symptoms, and behavioral symptoms.

This study aimed to conduct a randomized controlled trial to examine the effectiveness of ROMA therapy( Reminiscence, Reality Orientation, Music, and Art) on improving cognitive function, behavioral and psychological symptoms in demented population. A total of 60 patients with mild to moderate dementia will be recruited and randomly assigned to two groups: experimental group and control group. The experimental group will undergo ROMA therapy with a 60 minute per week for eight weeks. The control group will receive three times ROMA therapy after completing outcome measurements. Two groups will receive questionnaire interview at pre-test, post-test, and at 4 weeks after intervention. The measurements comprises: Short Portable Mental Status Questionnaire(SPMSQ), Cornell Scale for Depression in Dementia(CSDD),and Neuropsychiatric Inventory-Questionnaire(NPI-Q). By identifying the effectiveness of ROMA therapy, suitable intervention can be suggested for those demented population to improve cognitive function, behavioral and psychological symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Been diagnosed as mild to moderate dementia and CDR score between 0.5\~2
2. can communicate in Chinese or Taiwanese
3. without visual or auditory impairment after equipping assist devices

Exclusion Criteria:

1. severe dementia and Clinical Dementia Rating (CDR) score more than 2 points
2. functional dependence
3. incapable of expressing their feelings
Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Procedure

Surgerys used in thymectomy for myasthenia gravis and anterior mediastinal tumours have become much less invasive in recent years. In our study, the surgical technique which resected the thymus below the xiphoid process and the technique which was regarded as conventional video- assisted thoracoscopic surgery (VATS) thymectomy was compared.


Eligibility Criteria:
Inclusion Criteria:

1. Thymoma with or without myasthenia gravis；
2. Generalized myasthenia gravis not sensitive to conservative medicine treatment;
3. Good cardiopulmonary function.

Exclusion Criteria:

1. Cardiopulmonary function can't bear surgery;
2. Generalized myasthenia gravis with MuSK(+).
Effects of Virtual Reality Meditation in Older Adults

Virtual reality (VR) allows users to interact within a simulated environment using electronic devices such as a VR headset or goggles. Multiple studies with younger adults have demonstrated that VR meditation can be an important tool in reducing stress, however, this has not been studied in older adults. In this study, the investigators aim to assess the effects of a 4-week program of 15-minutes sessions, twice per week of meditation delivered through VR with the aim of evaluating its impact on stress in older adults.


Eligibility Criteria:
Inclusion Criteria:

* Living in the Greater Montreal area and able to speak English or French
* Perceived Stress Score (PSS)equal or greater than 10
* Over \>=60 years of age

Exclusion Criteria:

* Diagnosis of epilepsy, schizophrenia, brain tumor
* History of recurrent migraines or seizures or TBI in the past year
* Substance use disorders in the last year
* Psychiatric hospitalizations in the last year.
* Acute psychotic symptoms
* Acute suicidal ideation or intent
* Glaucoma
* PTSD
* Changes to psychoactive medications in the past 4 weeks
* Alcohol, caffeine or cannabis consumption within 24 hr before the session, or nicotine consumption within 15 min of the session
* Important hearing impairment
* Recovery phase of any eye surgery
The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice) Study

To examine the current disease progression of PDP, the clinical, economic, and humanistic impact of anti-psychotic therapy in the management of the condition in real-world settings, and the burden of the condition on patients and their caregivers


Eligibility Criteria:
Inclusion Criteria:

1. Adult males and females ≥ 18 with PDP
2. Ability to understand and read English
3. Patient is willing and able to sign an Informed Consent Form (ICF), or have a Legally Authorized Representative willing and able to consent on the patient's behalf
4. Possess the symptoms commonly associated with PDP, e.g., hallucinations and delusions that cannot be reasonably attributed to other causes

Exclusion Criteria:

1. Patient is unwilling to participate in the non-interventional study
2. Patient is currently participating in or is planning to participate in an investigational clinical trial
Follow-up of Abnormal and Inadequate Smear-test Results

Denmark has a higher incidence of cervical cancer than other Nordic countries, although all Danish women (aged 23-65) are screened regularly to identify possible cervical dysplasia or asymptomatic invasive cancer.

Annually 40 000 women receives an abnormal or inadequate test result and a follow-up recommendation.

However problems with delayed follow-up may threaten the effectiveness of the Danish Cervical Cancer Screening Program, as 20% of women are delayed and dysplasia potentially can progress into cancer.

Delayed follow-up is found in situations where women either consciously or unconsciously postpone follow-up, or because of organizational aspects of the screening program, where communication regarding test results can fail either in content or with delay.This study will evaluate two interventions designed to increase follow-up:

1. A letter with the test result and potential recommendation for follow up will be sent to the women (RCT). The intention is to ensure that all women will be notified about the test result, quickly, homogenously and in layman's written language, still with the opportunity to contact or be contacted by the general practitioner, if there is special needs. Furthermore, it is assumed that general practitioner consultations regarding delivery of normal test results will decrease, so that cost savings is a potential side benefit
2. Electronic reminder to the general practitioner if women have not had the recommended follow up, giving the general practioner´s an opportunity to remind the women (retro perspective cohort study).

The results will be of great importance to the future organisation of cervical and colorectal cancer screening programmes in Denmark, but will also have international interest because of their similar challenges.


Eligibility Criteria:
Inclusion Criteria:

* woman with a pap-smear test

Exclusion Criteria:

* less than 23 years
Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility Criteria:
Inclusion Criteria:

* clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
* taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.

Exclusion Criteria:

* requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
* scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.

Other protocol-specific exclusion/inclusion criteria may apply.
Warming Blanket Comparison Study

The purpose of the study is to compare the effectiveness of resistive blanket warming to forced air warming in maintaining body temperature in participants undergoing renal transplantation.

The study will involve two arms: a resistive blanket warming system arm and a forced air warming system arm. Both devices will be set to warm the participant at a standard 41 degrees Celsius when the participant is to be rewarmed.

During the study, the forced air warming system (FAWS) will be placed on the (resistive blanket warming system (RBWS), with the participant laying on top of the forced air warming system. The arm components will be wrapped around the participant's arms to assist with patient positioning for surgery. Both the forced air and resistive blanket warming systems will be attached to their respective heating units before the participant is brought to the OR and transferred to the operating room table. After the needed standard monitors for surgery have been placed, general anesthesia will be induced and maintained with participant's hemodynamics and other vitals maintained per standard care (no additional measurements beyond standard of care which is recorded in EPIC). The certified registered nurse anesthetists (CRNA) will be involved in the placement of the blankets. Operating Room Nurse managers and CRNA's will be informed by research team regarding participant's involvement in the study.

Participant's core temperature will be measured with a nasopharyngeal temperature probe. Vital signs, including continuous blood pressure, heart rate, oxygen saturation, and end-tidal carbon dioxide, will be monitored and recorded in Epic as is routine with all anesthetics performed.

Standard anesthetic care of the participant will occur for the duration of the surgery. The participant will be randomized to either the FAWS or RBWS before arrival to the operating room. The participant's temperature will be monitored and recorded for the duration of surgery with the selected warming system. The primary outcome variable is the nasopharyngeal temperature as recorded at the end of the surgery.

Temperature measurement in the PACU will be standardized with skin temperature probes that will be placed on the forehead prior to leaving the operating room.

Eligibility Criteria:
Inclusion Criteria:

- Undergoing elective renal transplantation

Exclusion Criteria:

* Previous surgery involving organ transplantation or nephrectomy. These patients are at higher risk of blood loss, making temperature regulation subject to more variables outside our control.
* End stage renal disease with decreased or no urine output from normal. Bladder temperature will not be valid in these patients.
* Previous upper extremity amputations
* Ongoing sepsis or other infection
* Thyroid dysfunction
* Emergency surgery
* Refusal of consent to participate in study
* Pregnancy
DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer

To evaluate whether Transoral Laser Microsurgery (TLM) is non-inferior compared to Accelerated Radiotherapy (accRT) in the treatment of T1aN0M0 glottic SCC

Since 2003 the Danish national standard treatment for T1aN0M0 glottic SCC has been accelerated RT (66Gy. 2 GY/fraction, 6 fractions/week). In 2012 cordectomy type I-III using TLM was introduced as an experimental treatment.

The DAHANCA 27 trial is a comparative non-inferiority phase II study comparing two timely separated national patient cohorts. Patients treated with radical TLM from September 2012 to April 2016 were included in the TLM cohort, and patients treated with accelerated RT from January 2003 to august 2012 were included in the RT cohort

Eligibility Criteria:
Inclusion Criteria:

* Danish patients aged ≥18 years diagnosed with a T1aN0M0 glottic squamous cell carcinoma (SCC)

Exclusion Criteria:

* Unable to complete curative intended protocol treatment and/or planned follow up
* informed concent
Child-Physician Recommendation on Parental Adherence to Colorectal Cancer Screening

Physician recommendation has been shown to be one of the most significant predictors for colorectal cancer (CRC) screening. This study aims to identify the amount of parents of internal medicine residents at NYU who are eligible for CRC screening but have not received it. Investigators will perform an intervention and quantify the amount of parents eligible for CRC screening after the intervention. This study will entail sending 2 brief surveys (one before the intervention and one after) which determine if the parents of the residents are eligible for CRC screening. The intervention will be asking the residents with eligible parents to have a discussion with their parents about CRC screening options and to address their concerns. Investigators will provide a one page document the residents can give their parents as a reference as part of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Internal medicine residents at NYU - PGY1, PGY2, and PGY3 during 2017-2018 academic year
Effectiveness of Lemon Essential Oil of Aromatherapy in Reducing Test Anxiety in Nursing Students

This study examines the effectiveness of lemon essential oil in reducing test anxiety in first-year nursing students.

While studies on the role of aromatherapy in reducing test anxiety exist, those evaluating the effects of lemon essential oil on test anxiety are extremely limited. In this study, the effect of a different aromatherapy application on reducing test anxiety was tried to be determined by using lemon essential oil. It is envisaged to provide an alternative aromatherapy application to students and educators to reduce test anxiety through the results obtained in the study.

Eligibility Criteria:
Inclusion Criteria:

* No respiratory system diseases (Asthma, Flu etc.)
* no allergy to any smell, no pregnancy status,
* absence of epilepsy discomfort,
* not having a condition that prevents smell, not using any medication that will affect heart rate and blood pressure,

exclusion criteria

* Any respiratory system disease (Asthma, Flu, etc.).
* have a known allergic response to essential oil to be used,
* Lack of smell, use of any medication affecting heart rate and blood pressure,
* to use other complementary medicine practices
Heart Rate Variability in Depression

The purpose of this study is to understand if there is a relationship between the way that emotions are regulated by the brain and the way that heart rate is regulated by the brain. The study also seeks to understand whether having depression changes the way that emotions and heart rate are regulated.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65 years
* Able to understand and provide informed consent
* Male and female

Depressed Subjects:

* Current diagnosis of major depressive disorder (MDD) and currently in an major depressive episode (MDE)
* Quick Inventory of Depressive Symptomology (QIDS-SR16) score of 11 or greater
* Anticipated treatment with ketamine infusion for depression

Exclusion Criteria:

* Current daily use of tricyclic antidepressants
* Current diagnosis of cardiac arrhythmia or heart failure
* Pregnancy
* Current use of cardiac medications of the class beta-blockers
* Current treatment with deep brain stimulation for any reason

Healthy Controls:

* Current psychiatric treatment, including use of antidepressants or daily use of anxiolytic medication

Depressed Subjects:

* Previous history of ketamine infusion for depression
* Psychotic symptoms
* Active co-morbid psychiatric diagnosis including anxiety disorder or personality disorder that significantly affects the current clinical condition, as determined by medical records