louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06464016: Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.
Official title: Relapse of VAD Infections After Discontinuation of Anti-infective Therapies in Children.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart-Assist Devices
Infections
Heart Transplant Infection
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2024-06-18
Enrollment: 47
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with terminal heart failure receiving BH assistance as bridge to transplant or bridge to recovery.

Brief summary: Heart failure is a major cause of mortality and morbidity in children. Heart transplantation can significantly improve the prognosis of patients with severe heart failure, but access is limited by a shortage of transplants.

Long-term mechanical circulatory support is a major advance in the management of heart failure and can provide haemodynamic support while awaiting myocardial recovery or heart transplantation. The Berlin Heart (BH) EXCOR is the only long-term support system available for children.

Despite technical and medical advances in circulatory support, infection is a common complication and a major cause of morbidity and mortality in patients on BH.

There are few studies on the management of infection with mechanical support. Current ISHLT (International Society for Heart and Lung Transplantation) recommendations are based on expert opinion and observational studies. Some experts recommend anti-infective therapy until transplantation for specific support infections or for support-associated infections with persistent bacteraemia.


Eligibility criteria: Inclusion Criteria:

* patients under 18yo of age with Berlin Heart assisting device in Hospices Civils de Lyon, in France.

Exclusion Criteria:

* patients over 18 yo at the time of BH assistance
* unavailable documentation

Primary outcomes:
measure: Relapse of VAD-infection after discontinuation of anti-infective therapy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Luc Panetta, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05938816: Feasibility and Acceptability of Stress Induction, Physiological Data Collection, and Mindfulness-Based Stress Reduction Among Combat Veterans With PTSD
Official title: Feasibility and Acceptability of Stress Induction, Physiological Data Collection, and Mindfulness-Based Stress Reduction Among Combat Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ptsd
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Oregon Clinical and Translational Research Institute
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-07-10
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators will recruit up to 20 veterans with PTSD. Participants will be randomized into two conditions: MBSR and Health and Wellness Education (HWE; control group). Participants will be randomized at a 1:1 ratio. Purpose of the study is to learn how mindfulness meditation may be helpful in treating PTSD. Participants will undergo 2 screening sessions, 8 weekly sessions of intervention (MBSR or HWE), 3 laboratory visits that will include completing survey questionnaires, stress test and recording of heart rate, blood pressure and breathing rate.


Eligibility criteria: Inclusion Criteria:

* Adult (18-85yo)
* Military veteran
* Experiencing PTSD symptoms
* Reading and speaking in English
* Be able to travel to OHSU for three two-hour lab visits, 8 weekly intervention sessions and one long extended session, and a two- hour focus group

Exclusion Criteria:

* Pregnancy
* Severe untreated depression, cognitive impairment, or active suicidality\*
* Life-threatening or severely disabling medical conditions
* Excessive use of alcohol, nicotine, or cannabis

Primary outcomes:
measure: Qualitative Interview Targeting Feasibility of MBSR
timeFrame: 2 weeks post conclusion of intervention
measure: Qualitative Interview Targeting Acceptability of MBSR
timeFrame: 2 weeks post conclusion of intervention. Data were not collected due to prematurely study closure due to PI change of career.
Secondary outcomes:
measure: Psychological Resilience 1
timeFrame: Pre (week 0), mid (week 4), and post intervention (week 10). Data were not collected due to prematurely study closure due to PI change of career.
measure: Blood Pressure Reactivity
timeFrame: Pre (week 0), mid (week 4), and post intervention (week 10).
measure: PTSD Symptoms 1
timeFrame: Pre (week 0), mid (week 4), and post intervention (week 10).
measure: Psychological Resilience 2
timeFrame: Pre (week 0), mid (week 4), and post intervention (week 10).
measure: PTSD Symptoms
timeFrame: Pre (week 0), mid (week 4), and post intervention (week 10).
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Josh Kaplan, PhD, MCR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02326116: TTE and Dysphagia in Anterior Cervical Surgery
Official title: Investigating the Role of Tracheal Traction Exercises (TTE) in Reducing Dysphagia Following Anterior Cervical Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate if Tracheal Traction Exercises (TTE) performed prior to anterior cervical spine surgery can result in a decreased rate of dysphagia.


Eligibility criteria: Inclusion Criteria:

* Elective Anterior cervical spine surgery (C2-C7) for degenerative disc disease or myelopathy

Exclusion Criteria:

* More than four levels of fusion
* Trauma or urgent cases of anterior cervical spine surgery
* Prior anterior cervical spine surgery (a known risk factor for dysphagia),
* Prior neck surgery (eg. Thyroidectomy)
* Tumors
* Infections
* Neurological disorders that can predispose to dysphagia such as Parkinson's, Cerebrovascular Accidents (CVA), Alzheimer's and Amyotrophic Lateral Sclerosis.

Primary outcomes:
measure: SWAL-QOL
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References:
Clinical trial NCT00564616: Simulation-Based Study of Adding Video Communication to Dispatch Instruction
Official title: A Randomized Controlled Study Focused on Impact of Adding Video Communication to Dispatch Instruction on the Quality of CPR, Including Chest Compressions and Rescue Breaths, in Simulated Cardiac Arrests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: cardiac arrest
video cell phone
dispatcher-assisted CPR
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2007-11-28
Enrollment: 96
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether adding interactive video communication to dispatch instruction improves the quality of bystander cardiopulmonary resuscitation in simulated cardiac arrests.

Detailed description: Sudden cardiac death (SCD) is a leading cause of adult death and bystander cardiopulmonary resuscitation (CPR) significantly improves survival. Dispatch assistance increases the chance of bystander CPR but the quality of dispatcher-assisted CPR (DA-CPR) remains unsatisfactory. This study is conducted to assess the effect of adding interactive video communication to dispatch instruction on the quality of bystander CPR, including chest compressions and rescue breathing, in simulated cardiac arrests.

Eligibility criteria: Inclusion Criteria:

* Volunteers above 16 years of age who have not received any CPR training within the last 5 years were recruited.

Exclusion Criteria:

* Healthcare providers, non-Mandarin speaking individuals, and those with illness/physical conditions that prevent them from receiving telephone instructions or performing CPR were excluded.

Primary outcomes:
measure: quality of chest compressions and rescue breaths
timeFrame: every 30 seconds
Secondary outcomes:
measure: spent time to first effective chest compression and rescue breath
timeFrame: expressed as seconds
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Matthew Huei-Ming Ma, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Cheung S, Deakin CD, Hsu R, Petley GW, Clewlow F. A prospective manikin-based observational study of telephone-directed cardiopulmonary resuscitation. Resuscitation. 2007 Mar;72(3):425-35. doi: 10.1016/j.resuscitation.2006.07.025. Epub 2007 Jan 16.
citation: Yang CW, Wang HC, Chiang WC, Chang WT, Yen ZS, Chen SY, Ko PC, Ma MH, Chen SC, Chang SC, Lin FY. Impact of adding video communication to dispatch instructions on the quality of rescue breathing in simulated cardiac arrests--a randomized controlled study. Resuscitation. 2008 Sep;78(3):327-32. doi: 10.1016/j.resuscitation.2008.03.232. Epub 2008 Jun 25.
Clinical trial NCT01074216: Vitamin D Levels in Stage IV Colorectal Cancer Patients
Official title: Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Vitamin D
Vitamin D3
colon cancer
rectum cancer
Cholecalciferol
09-143
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-02-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out what effects, good and/or bad, vitamin D blood levels has on stage IV colorectal cancer. Tbe doctors want to see if it is possible to increase low vitamin D levels into normal range using vitamin D supplements taken by mouth. Low vitamin D levels have been associated with worse outcomes in persons who have cancer. Low vitamin D may also cause people to have symptoms such as pain and fatigue. We want to see if increasing low vitamin D levels will help improve cancer outcomes. Vitamin D is routinely repleted in all subjects known to be vitamin D deficient. Therefore, the treatment given would be considered standard of care.


Eligibility criteria: Inclusion Criteria:

* Patients with Stage IV (metastatic) colorectal cancer
* Baseline 25-hydroxy vitamin D level \< 30 ng/ml
* Age ≥18 years of age

Exclusion Criteria:

* Current or previous malignancy except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \> 3 years
* Albumin \< 3.2
* Patients on concurrent chronic steroids, other than those allowed for routine antiemetics, or inhaled steroids
* Patients receiving phenobarbital, phenytoin, orlistat and cholestyramine
* Hypercalcemia (Calcium \>10.5 mg/dl)
* Calcium x Phosphorus \> 70 mg2/dL2

Primary outcomes:
measure: To Achieve Target Vitamin D Level
timeFrame: Within 6 weeks of beginning vitamin D
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering Cancer Center
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center @ Suffolk
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan-Kettering at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kathleen Wesa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06679816: Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors
Official title: Study on the Efficacy of Hydrocortisone in Perioperative Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors:a Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pituitary Adenoma
Pituitary Neuroendocrine Tumor
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 882
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to assess the need for hydrocortisone replacement therapy during the perioperative period for large pituitary neuroendocrine tumors. The main questions it aims to answer are:

• Does hydrocortisone replacement therapy reduce the incidence of adrenal insufficiency in participants? Researchers will compare hydrocortisone to a placebo (a look-alike substance that contains no drug) to see if hydrocortisone works to reduce the incidence of adrenal insufficiency.

Participants will:

* Take or intravenous infusion drug hydrocortisone or a placebo every day for 2 weeks
* Visit the clinic three months after surgery for checkups and tests
* Keep a diary of their symptoms


Eligibility criteria: Inclusion Criteria:

* (1) Age range: 18-70 years old;
* (2) Accept PitNETs patients who can be treated with endoscopic transsphenoidal surgery;
* (3) The maximum diameter of the tumor is ≥ 2 centimeters;
* (4) Preoperative hypothalamic pituitary adrenal axis integrity;
* (5) The subject or their legal representative signs the informed consent form

Exclusion Criteria:

* (1) Patients with a history of Cushing's disease or adrenal insufficiency;
* (2) Emergency and combined hormone therapy patients;
* (3) Pituitary stroke patients;
* (4) Patients lacking head magnetic resonance imaging;

Primary outcomes:
measure: The incidence of adrenal insufficiency on the first or second day after surgery
timeFrame: the first or second day after surgery
Secondary outcomes:
measure: The incidence of adrenal insufficiency within 90 days after surgery
timeFrame: Within 90 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing, Beijing Tiantan Hospital,Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT03178396: Effects and Mechanisms of Melatonin on Blood Pressure, Insulin Resistance, and Platelets
Official title: Effects and Mechanisms of Melatonin on Blood Pressure, Insulin Resistance, and Platelets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehypertension
Healthy
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-06-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will be studying the effect of melatonin on blood pressure, insulin resistance, and platelets, along with possible reasons for how melatonin cases these effects.

Detailed description: The investigators will be studying the effect of melatonin on blood pressure and insulin resistance, and possible reasons for how melatonin works on blood pressure and IR. Along with blood testing to measure adipokines, insulin resistance (IR), and platelet function (how well your blood clots), 24-hour ambulatory blood pressure monitoring (ABPM) will be used to measure blood pressure, since ABPM is the gold standard (best method) for accurate assessment of blood pressure status and associated cardiovascular risk. Vascular (blood vessel) function, IR, adipokine levels and sleep quality will also be measured. All study endpoints will be measured at baseline and following 6 weeks of daily melatonin 9 mg dosing.

Eligibility criteria: Inclusion Criteria:

* Normotensive (SBP \<120) or prehypertensive (SBP = 120-139 mm Hg)
* Age: Young/middle-aged (ages 18-45) and (2) 10 elderly subjects ages 65 and older

Exclusion Criteria:

* Patients with a diagnosis of

  * clinical hypertension and/or diabetes mellitus
  * pregnancy
  * coronary or cerebrovascular disease
  * collagen vascular disease,
  * organ failure (heart, kidney, liver).
* Patients taking anti-inflammatory medications: NSAIDs, corticosteroids, thiazolidinediones, and statins,
* Patients who have taken melatonin previously in the past year.

Primary outcomes:
measure: Office Systolic Blood pressure change
timeFrame: Baseline to 6 weeks
measure: Office Diastolic Blood pressure change
timeFrame: Baseline to 6 weeks
measure: Ambulatory Systolic Blood pressure change
timeFrame: Baseline to 6 weeks
measure: Ambulatory Diastolic Blood pressure change
timeFrame: Baseline to 6 weeks
measure: HOMA: Homeostasis Model Assessment change
timeFrame: Baseline to 6 weeks
measure: QUICKI: Quantitative insulin sensitivity check index change
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Arachidonic acid stimulated aggregation change
timeFrame: Baseline to 6 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Cynthia Cheng, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01834196: Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging
Official title: Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Retinal Vascular Disease
Keywords: retinal vascular disease
Swept-Source Ocular Coherence Tomography
SSOCT
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a clinical pilot study to assess the feasibility of using a swept-source optical coherence tomography (SSOCT) system to perform noninvasive imaging of the retinal vasculature in patients with existing microvascular disease.

Detailed description: This project is being conducted under an abbreviated IDE. Subjects with existing retinal microvascular disease will be recruited from among the patients of the Duke Eye Center and/or its associated satellite clinics. Following informed consent, subjects undergo imaging, per established standard operating procedure, at the Duke University Medical Center/Duke Center or at one of the Duke Eye Center satellite clinics. Pharmacologic dilation of eyes will not be necessary for completion of imaging and will not be used for the purposes of this study. The resulting images will not be used in the clinical care of any of the subjects recruited for this project.

Subjects will be identified from patients presenting for ophthalmologic consultation at the Duke Eye Center and/or its satellite clinic locations.

Eligibility criteria: Inclusion Criteria:

1. Capable and willing to provide consent
2. history of clinically-diagnosed retinal microvascular diseases, including but not limited to diabetic retinopathy, retinal vein occlusion, idiopathic macular telangiectasias, hypertensive retinopathy, and age-related macular degeneration
3. At least 18 years of age

Exclusion Criteria:

1. Unable or unwilling to give consent
2. Under 18 years of age

Primary outcomes:
measure: OCT images and metrics derived from the OCT images
timeFrame: Day of imaging, approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Prithu Mettu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00622596: Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance
Official title: Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opiate Dependence
Keywords: opiate dependence
buprenorphine
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-02-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to expand access to buprenorphine using a mobile health care system among marginalized populations with or at high risk for HIV and observe longitudinal effects of treatment.


Eligibility criteria: Inclusion Criteria:

* HIV +
* At high risk for HIV (IV drug use, commercial sex worker, partner of HIV+)
* Mental Health (unmanaged or diagnosed mental illness)

Exclusion Criteria:

* Benzodiazepine use
* Opiate use due to pain management issues only (present or past)
* Non-IDU

Primary outcomes:
measure: Attendance
timeFrame: 10/1/03-9/30/08
measure: Opioid free urine toxicology
timeFrame: 10/1/03-9/30/08
Secondary outcomes:
measure: Access to other health care, incarceration, hospitalization acceptability of the site of care from both patient and provider perspectives, and attendance and adherence to counseling.
timeFrame: 10/1/03-9/30/08
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University School of Medicine/AIDS Program
name: Frederick L Altice, MD
role: PRINCIPAL_INVESTIGATOR
References: